Ilex Oncology Announces Fourth Quarter and Year-end Results, Record Revenue Achieved For 1997.SAN ANTONIO--(BUSINESS WIRE)--Feb. 9, 1998--ILEX(TM) Oncology, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ILXO) a developer of drugs to treat and prevent cancer and a provider of contract drug development services to pharmaceutical and biotech companies, today reported its financial results for the fourth quarter and year ended December 31, 1997. For the year, revenue totaled a record $12.9 million, up 58% over the $8.1 million recorded in 1996. Net loss for the year was ($8.7) million compared to ($0.6) million in 1996. Excluding amortization of non-cash expenses associated with ILEX's strategic alliance with Physician Reliance Network (PRN (PRiNter) The DOS name for the first connected parallel port. See DOS device names. ), the loss for 1997 was ($8.1) million or ($0.67) per share. Cash, cash equivalents and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has were approximately $43 million at the end of the year, an increase of approximately $20 million compared to the prior year. Revenue for the fourth quarter totaled $3.5 million, compared to the $4.4 million recorded in the same period last year; however, excluding one-time licensing fees of $3.0 million recorded in fourth quarter 1996, revenue from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the actually increased 153%. The fourth quarter net loss was ($3.2) million, or ($0.26) per share (excluding amortization of non-cash expenses related to the PRN strategic alliance), compared to a net profit of $1.1 million, or $0.12 per share, in fourth quarter 1996. Excluding one-time licensing fee revenues from prior year results, continuing operations incurred a loss of ($0.21) per share in fourth quarter 1996. The fourth quarter loss in 1997 was the result of planned expenditures to further develop ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. products, including late-stage joint venture products. During the fourth quarter, ILEX initiated a Phase I trial of intoplicine for treatment of solid tumors. Intoplicine inhibits the enzymes topoisomerase topoisomerase an enzyme involved in DNA replication that introduces a single-strand nick in the DNA enabling it to swivel and thereby relieve the accumulated winding strain generated during unwinding of the double helix. I and II, which are involved in cancerous cell proliferation proliferation /pro·lif·er·a·tion/ (pro-lif?er-a´shun) the reproduction or multiplication of similar forms, especially of cells.prolif´erativeprolif´erous pro·lif·er·a·tion n. . The compound has demonstrated substantial activity against a wide variety of tumor tumor: see neoplasm. types in laboratory studies. Also during the quarter, ILEX and its joint venture partner LeukoSite, Inc. held an "end-of Phase II meeting" and several follow-up meetings with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for pursuing marketing approval of CAMPATH-1H(R). In several published studies, CAMPATH-1H, a humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , has demonstrated substantial antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. activity in patients with chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. (CLL CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ), an often fatal disease which afflicts an estimated 60,000 adults in the U.S. and a similar number in Europe. ILEX and LeukoSite plan to conduct a pivotal Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II to pursue accelerated marketing approval based on the results of this study and previously conducted clinical studies. ILEX and LeukoSite expect to file a Biologics License Application (BLA BLA abbr. Bachelor of Liberal Arts ) in 1999. ILEX's contract services business demonstrated significant growth during the fourth quarter. Gross revenues from this business segment were a record $2.6 million, an increase of 276% over the same period last year. Full year revenues were $7.5 million, a 390% increase over full year 1996. Growth was recorded in both preclinical (toxicology toxicology, study of poisons, or toxins, from the standpoint of detection, isolation, identification, and determination of their effects on the human body. Toxicology may be considered the branch of pharmacology devoted to the study of the poisonous effects of drugs. and chemical synthesis In chemistry, chemical synthesis is purposeful execution of chemical reactions in order to get a product, or several products. This happens by physical and chemical manipulations usually involving one or more reactions. ) and clinical services. "Our first year as a public company was a year of real progress for us," said Richard Love, President and Chief Executive Officer. "At year-end, ILEX had seven new compounds under clinical development, with six compounds in Phase II or III development and one compound in Phase I. We enhanced our product portfolio with the addition of a 50% interest in CAMPATH-1H and established a plan with the FDA for accelerated approval. In addition, we made significant progress on the development of the rest of our portfolio, initiating 13 clinical trials and moving closer to the filing of an IND (Investigational New Drug application) for our Vitamin D vitamin D Any of a group of fat-soluble alcohols important in calcium metabolism in animals to form strong bones and teeth and prevent rickets and osteoporosis. It is formed by ultraviolet radiation (sunlight) of sterols (see steroid) present in the skin. 3 analog, one of our chemoprevention che·mo·pre·ven·tion n. The use of chemical agents, drugs, or food supplements to prevent disease. chemoprevention compounds. "We also made significant strides in our contract research services business. During 1997, we entered into a strategic alliance with PRN, the largest physician practice management company for oncologists in the U.S., which gives ILEX a strategic advantage with respect to enrollment of cancer patients to clinical trials. We also entered into an alliance with P.F.K., a mid-sized European CRO, (renamed P.F.K.-ILEX), allowing us to develop anti-cancer compounds in the U.S. and Europe simultaneously. In addition, we continued to strengthen our infrastructure with technology advancements and the addition of seasoned industry experts to our team. Finally, we begin our second year as a public company with a strong cash position." ILEX Oncology, Inc. is a drug development company focused exclusively on the development and marketing approval of drugs for the treatment and prevention of cancer. ILEX provides pharmaceutical and biotechnology companies Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. with compounds for their pipeline through its Products subsidiary, as well as drug development and manufacturing services on a contract basis via its Services subsidiary. ILEX's close association with cancer research and treatment institutions allows access to both the opinion leaders and patients necessary for the development of oncology drugs. -0- Certain statements contained herein are "forward-looking" statements, (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. include, but are not limited to, failure to achieve positive results in clinical trials, failure to receive market clearance from regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , and those risks and uncertainties discussed in filings made by ILEX Oncology, Inc. with the Securities and Exchange Commission. -0-
Abbreviated Statement of Operations
(In thousands, except per share amounts)
Three months ended
December 31,
-----------------------------------
1996 1997 1997
(unaudited) (unaudited)
excludes includes
REVENUE: PRN PRN
charge charge
Product development $ 682 $ 871 $ 871
Contract research services 695 2,611 2,611
Licensing fees 3,025 - -
Total revenue 4,402 3,482 3,482
OPERATING EXPENSES:
Research and development
costs 1,134 1,710 1,710
General and administrative 972 2,432 2,432
Costs of contract
research services 406 854 854
Subcontractor costs 255 788 788
PRN amortization & accrual - - (178)
Total operating
expenses 2,767 5,784 5,606
OPERATING LOSS: 1,635 (2,302) (2,124)
Interest Income (Expense): 229 875 875
Income from European Affiliate - (99) (99)
Loss on Joint Ventures (750) (1,682) (1,682)
NET LOSS $ 1,114 $(3,208) $(3,030)
===================================
NET LOSS PER SHARE $ 0.12 $ (0.26) $ (0.24)
Weighted average number of
common stock 9,240 12,558 12,558
and common stock
equivalents outstanding
Abbreviated Statement of Operations (cont.)
(In thousands, except per share amounts)
Twelve months ended
December 31,
-----------------------------------
1996 1997 1997
(unaudited) (unaudited)
excludes includes
REVENUE: PRN PRN
charge charge
Product development $ 3,581 $ 5,027 $ 5,027
Contract research services 1,537 7,534 7,534
Licensing fees 3,025 300 300
Total revenue 8,143 12,861 12,861
OPERATING EXPENSES:
Research and development
costs 3,637 6,740 6,740
General and administrative 2,886 6,690 6,690
Costs of contract
research services 1,446 2,506 2,506
Subcontractor costs 723 3,173 3,173
PRN amortization & accrual - - 539
Total operating
expenses 8,692 19,109 19,648
OPERATING LOSS: (549) (6,248) (6,787)
Interest Income (Expense): 684 2,583 2,583
Income from European Affiliate - (182) (182)
Loss on Joint Ventures (750) (4,295) (4,295)
NET LOSS $ (615) $(8,142) $(8,681)
===================================
NET LOSS PER SHARE $ (0.07) $ (0.67) $ (0.72)
Weighted average number of
common stock 8,744 12,118 12,118
and common stock
equivalents outstanding
-0- Certain reclassifications were made which increased third quarter CRO revenues and related expenses, each by $565. These reclassifications had no impact to operating income Operating Income The profit realized from a business' own operations. Notes: This would not include income from things such as investments in other firms. Also referred to as operating profit or recurring profit. or net income for any period. -0-
Abbreviated Balance Sheets
(In thousands)
December 31, 1996 December 31, 1997
ASSETS (unaudited)
Cash and cash equivalents $ 22,984 $ 42,646
Accounts receivable 2,152 4,652
Prepaid expenses and other 1,047 720
Investment in joint venture 250 (113)
Intangible assets - 4,847
Property & equipment (net) 941 2,559
Total Assets $ 27,374 $ 55,311
========= ==========
LIABILITIES AND STOCKHOLDER'S
EQUITY
CURRENT LIABILITIES 2,322 3,802
OTHER LONG-TERM LIABILITIES 226 433
STOCKHOLDER'S EQUITY 24,826 51,076
--------- ----------
Total liabilities and
stockholder's equity $ 27,374 $ 55,311
========= ==========
-0- This release and other information about ILEX(TM) Oncology can be found on the World Wide Web at http://www.businesswire.com/cnn/ilxo.htm CONTACT: ILEX Oncology Inc., San Antonio San Antonio (săn ăntō`nēō, əntōn`), city (1990 pop. 935,933), seat of Bexar co., S central Tex., at the source of the San Antonio River; inc. 1837. James Koch, 210/949-8200 or Ann Stevens, 210/949-8230 or Makovsky & Co., New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of John Lovallo, 212/508-9600 |
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