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EXHIBIT 99.1
[ILEX ONCOLOGY LOGO]
NEWS
RELEASE
FOR IMMEDIATE RELEASE
ILEX ONCOLOGY ANNOUNCES THIRD QUARTER RESULTS
-- COMPANY CONTINUES TO EXPAND AND ADVANCE ITS PRODUCT PIPELINE --
SAN ANTONIO, Texas (November 1, 2000) - ILEX(TM) Oncology, Inc. (Nasdaq: ILXO)
today reported that total revenues for the third quarter of 2000 reached $7.4
million, up 48% over the third quarter of 1999, driven by a strong increase in
contract research (CRO) services revenue. The third quarter 2000 loss decreased
to $8.6 million, or a loss of $0.34 per share, compared to the third quarter
1999 loss of $16.2 million, or a loss of $1.00 per share.
"We continue to deliver on our business plan by deploying capital to expand our
product pipeline and accelerate our development program," said President and CEO
Richard Love. "We are taking our first angiogenesis inhibitor, NM-3, into the
clinic and advancing our apoptosis inducer, APOMINE(TM), into Phase II
development. Additionally, we are acting quickly to move ILX-651, our newly
in-licensed dolastatin compound, into the clinic early next year."
Commenting on the status of CAMPATH(R) (alemtuzumab), the company's leading drug
candidate, Love said, "ILEX and our development partner, Millennium
Pharmaceuticals, Inc., are continuing to work constructively with the reviewers
at both the U.S. Food and Drug Administration and the European Agency for the
Evaluation of Medicinal Products toward obtaining approvals in both markets. We
are actively preparing to present our Biologics License Application for CAMPATH
at
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the upcoming December meeting of the FDA's Oncologic Drugs Advisory Committee,
and I remain optimistic that CAMPATH will be approved in the U.S. by the end of
this year."
RECENT OPERATING HIGHLIGHTS
In addition to releasing its third quarter financial results, the company
reviewed the following recent highlights of operations:
o Notification from the FDA that CAMPATH will be reviewed by the Oncologic
Drugs Advisory Committee (ODAC) at the panel's December 14 meeting.
o Initiation of a Phase II clinical trial in France of APOMINE, an orally
active bisphosphonate tetra-ester derivative being co-developed by ILEX and
Symphar S.A. of Geneva, Switzerland, in prostate cancer.
o Initiation of a Phase I clinical trial in France of NM-3, the company's
lead angiogenesis inhibitor.
o In-license of ILX-651, a novel, orally active anti-cancer compound, from
BASF Pharma of Ludwigshafen, Germany. A synthetic pentapeptide analog of
dolastatin, ILX-651 has a mechanism of action similar to taxanes (e.g.,
TAXOL(R) and Taxotere(R)), yet appears to be active against
taxane-resistant tumor models. ILEX plans to file an Investigational New
Drug application with the FDA by year-end 2000 and launch clinical trials
in early 2001. ILEX and BASF are finalizing an agreement giving ILEX an
option on a second compound, Elinafide, and discussing additional oncology
product opportunities in the BASF R&D pipeline.
THIRD QUARTER 2000 FINANCIAL RESULTS
Total revenue for the quarter increased 48% to $7.4 million, compared with $5.0
million in the third quarter of 1999. This includes $6.6 million in revenue from
the company's CRO business, up 69% from $3.9 million in the same period a year
ago.
Research and development (R&D) spending totaled $10.8 million, up 177% from $3.9
million in the same period a year ago, due primarily to in-licensing costs of
$4.0 million for ILX-651, as well as
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increased development spending on the company's product pipeline, particularly
for NM-3 and OXYPRIM(TM).
The company's share of the loss from the CAMPATH joint venture, Millennium &
ILEX Partners, L.P., totaled $2.1 million for the third quarter of 2000, up 5%
from $2.0 million in the same period a year ago. Losses in the current period
are primarily attributable to sales and marketing expenses in anticipation of
CAMPATH commercialization.
Net interest income for the third quarter of 2000 increased to $3.5 million,
compared to $0.4 million in the same quarter last year.
Net loss for the third quarter of 2000 totaled $8.6 million, or a loss of $0.34
per share, on 24.9 million weighted average shares outstanding. That compares to
a net loss of $16.2 million, or a loss of $1.00 a share, on 16.2 million
weighted average shares outstanding in the third quarter of 1999.
As of September 30, 2000, ILEX had $206.4 million in cash, cash equivalents,
restricted investments and investments in marketable securities.
FIRST NINE MONTHS OF 2000 FINANCIAL HIGHLIGHTS
Total revenue for the first nine months of 2000 increased 71% to $21.6 million,
compared with $12.6 million in the first nine months of 1999. This includes
$19.0 million in revenue from the Company's CRO business, up 100% from $9.5
million a year ago.
R&D spending totaled $23.0 million in the first nine months of 2000, up 102%
from $11.4 million in the first nine months of 1999. The increase was
attributable to the in-licensing costs for ILX-651 and to an April 2000 license
payment of $1 million for APOMINE, as well as to higher levels of development
spending on the company's product pipeline, including NM-3 and the other
emerging angiogenesis inhibitors and OXYPRIM, which is in a pivotal study.
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The company's share of the loss from the CAMPATH joint venture totaled $3.5
million for the first nine months of 2000, a decrease of 10% from $3.9 million
in the same period of 1999. Losses in the current period are primarily
attributable to sales and marketing expenses in anticipation of CAMPATH
commercialization, as well as a license fee incurred by the joint venture in
June 2000. CAMPATH development costs have been offset in 2000 by milestone
payments received from Schering AG, the marketing and distribution partner for
CAMPATH.
Total net loss for the first nine months was $16.5 million, or a loss of $0.69
per share, compared to a net loss of $18.3 million, or a loss of $1.31 per
share, a year ago, excluding $25.0 million related to in-process R&D expense and
special charges.
BUSINESS OUTLOOK
The following projections, based on current expectations, are forward-looking
statements. Actual results may differ materially. These statements do not
include the potential impact of any product in-licensing or other business
transactions outside the normal course of business that may be completed after
September 30, 2000.
o The company expects R&D spending for the year 2000 to range between $31.0
to $33.0 million. In addition, a milestone payment of 500,000 shares of
ILEX common stock is expected to be made in the fourth quarter of 2000
related to the 1999 acquisition of Convergence Pharmaceuticals, Inc. The
in-process R&D expense for the payment will be recorded at the fair market
value of the stock on the date of issuance.
o Equity in the loss of the CAMPATH joint venture is expected to be between
$5.0 and $7.0 million for the full year 2000.
o Revenues from the company's Services business are expected to total between
$24.0 and $26.0 million for the year 2000, with a projected 2000 operating
margin in the range of 14% to 16%.
o General and administrative expense is expected to be between $5.0 and $7.0
million for the year 2000.
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THIRD QUARTER CONFERENCE CALL
ILEX management will host a conference call to review the company's third
quarter 2000 results and business outlook for the year 2000 at 11:00 a.m.
Eastern Time on November 1, 2000. The call can be accessed live from the
Investors section of the ILEX website at http://www.ilexoncology.com. A replay
of the call will also be available at the same address starting approximately
two hours following the call and continuing for three days following the live
webcast.
ABOUT ILEX ONCOLOGY
ILEX Oncology, Inc. is a drug development company focused predominantly on the
accelerated development of drugs for the treatment and prevention of cancer. The
company does this in two ways: by advancing a diversified portfolio of
anti-cancer drugs through its ILEX Products subsidiary, and, by offering drug
development services on a contract basis to pharmaceutical and biotech companies
through its ILEX Oncology Services subsidiary. These complementary businesses
draw from the company's core relationships with international oncology experts,
strategic alliances providing unparalleled access to patient recruitment for
clinical trials, and simultaneous European and US drug development and approval
capabilities. Further information about ILEX can be found on the company's
website at www.ilexoncology.com.
Certain statements made above are "forward-looking" statements (as such term is
defined in the Private Securities Litigation Reform Act of 1995). Because these
statements include risks and uncertainties, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Specifically, risks that could affect the development of ILEX's compounds under
development include risks associated with preclinical and clinical developments
in the biopharmaceutical industry in general and in ILEX's compounds under
development in particular including, without limitation, (i) the potential
failure of the Company's compounds under development to prove safe and effective
for treatment of disease; (ii) data from the clinical and preclinical trials of
the Company's compounds under development may not be indicative of results that
may be obtained in subsequent trials; (iii) uncertainties inherent in the early
stage of the Company's compounds under development; (iv) failure to successfully
implement or complete clinical trials; (v) failure to receive market clearance
from regulatory agencies; (vi) the development of competing products; and (vii)
uncertainties related to our dependence on third parties and partners. Other
factors that could cause actual results to differ materially from those
expressed or implied by such forward-looking statements include, but are not
limited to: (i) the FDA may cancel or postpone its December 2000 ODAC meeting;
(ii) the FDA or ODAC may remove the review of CAMPATH from the agenda for such
meeting; (iii) CAMPATH may fail to receive market clearance from regulatory
agencies; (iv) the failure to respond adequately to requests for information
from the FDA or EMEA; (v) ability of ILEX to execute its business plan; (vi)
unanticipated or increased research and development, CAMPATH
pre-commercialization marketing and selling and general and administrative
expenditures; (vii) competitive factors; (viii) demand for the
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Company's CRO services; (ix) uncertainties in outsourcing trends in the
pharmaceutical industry; (x) uncertainties inherent in depending on third
parties and (xi) those risks described in the Company's Form S-3 filed March 8,
2000 (Commission file #333-32000) and the Company's Annual Report on Form 10-K
for the year ended December 31, 1999, and in other filings made by the Company
with the SEC. The Company disclaims any obligation to update these
forward-looking statements.
##
Contact:
Ann Stevens, Investor Relations (210) 949-8230
ILEX ONCOLOGY, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(IN THOUSANDS)
<TABLE>
<CAPTION>
SEPTEMBER 30, DECEMBER 31,
2000 1999
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(Unaudited)
<S> <C> <C>
ASSETS
Cash, cash equivalents, restricted investments and marketable securities $ 206,383 $ 89,126
Receivables, net 12,463 8,481
Prepaid expenses and other current assets 1,246 576
Investment in and advances to research and development partnerships (5,996) (2,534)
Property and equipment, net of accumulated depreciation 6,203 4,705
Other assets 192 --
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TOTAL ASSETS $ 220,491 $ 100,354
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 17,037 $ 10,324
Long-term liabilities 373 369
Minority interest 5,007 5,082
Stockholders' equity 198,074 84,579
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 220,491 $ 100,354
============ ============
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ILEX ONCOLOGY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) (UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
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2000 1999 2000 1999
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<S> <C> <C> <C> <C>
REVENUE:
Product development $ 851 $ 1,078 $ 2,510 $ 3,147
Contract research services 6,565 3,914 19,049 9,482
-------- -------- -------- --------
TOTAL REVENUE 7,416 4,992 21,559 12,629
-------- -------- -------- --------
OPERATING EXPENSES:
Research and development costs 10,820 3,890 22,974 11,387
CRO costs 4,638 3,824 15,379 10,324
General and administrative 1,821 754 4,125 2,944
In-process research and development -- 11,124 -- 11,124
Special charges -- -- -- 13,882
-------- -------- -------- --------
TOTAL OPERATING EXPENSES 17,279 19,592 42,478 49,661
-------- -------- -------- --------
OPERATING LOSS (9,863) (14,600) (20,919) (37,032)
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OTHER INCOME (EXPENSE):
Equity in income (losses) of:
Research and development partnerships (2,088) (1,964) (3,499) (3,851)
Contract research affiliate -- -- -- (3,310)
Interest income, net 3,464 375 8,296 915
Minority interest in loss of consolidated
subsidiary (75) (7) (225) (7)
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LOSS BEFORE INCOME TAXES (8,562) (16,196) (16,347) (43,285)
Provision for foreign income taxes (6) -- 137 --
-------- -------- -------- --------
NET LOSS $ (8,556) $(16,196) $(16,484) $(43,285)
======== ======== ======== ========
BASIC & DILUTED NET LOSS PER SHARE $ (0.34) $ (1.00) $ (0.69) $ (3.11)
======== ======== ======== ========
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK
OUTSTANDING 24,914 16,168 23,929 13,928
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