ILEX Oncology Announces Third Quarter 1997 Results.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. , Texas--(BUSINESS WIRE)--Nov. 3, 1997--ILEX(TM) Oncology, Inc. (Nasdaq: ILXO), a drug development company focused on treating and preventing cancer, today reported financial results for the third quarter ended September 30, 1997. Revenue for the quarter totaled $3.2 million, a 101% increase over the $1.6 million in the same period last year. The 1997 third quarter net loss was $3.9 million, or $0.31 per share, compared to a net loss of $0.7 million, or $0.08 per share, during the same period a year ago. The increased loss is due primarily to a $3.3 million expenditure increase for the development of ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. products, including joint ventured products, and $0.7 million amortization of non-cash expenses associated with ILEX's strategic alliance with Physician Reliance Network. For the first nine months of this year, revenue totaled $8.8 million, up 136% over the $3.7 million in the same period in 1996. Net loss for the first nine months of 1997 was $5.7 million, or $0.47 per share, compared to a net loss of $1.7 million, or $0.20 per share, during the same period a year ago. During the quarter, ILEX restructured its business into two subsidiaries one that is developing ILEX's portfolio of anticancer drugs Anticancer Drugs Definition Anticancer, or antineoplastic, drugs are used to treat malignancies, or cancerous growths. Drug therapy may be used alone, or in combination with other treatments such as surgery or radiation therapy. and one that provides contract research services to other 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. . Each subsidiary is run by a separate, dedicated management team. The reorganization represents a significant step in the company's strategy, balancing the risks inherent in drug development while paving the way for ILEX'S continued growth. Revenue from the development of ILEX's product portfolio was $1.3 million for the quarter, up 12% from $1.2 million in the same period last year. The company continued to initiate clinical trials of its proprietary chemotherapeutic products on schedule during the quarter, including Phase II trials of Piritrexim in the U.S. and Europe for bladder cancer bladder cancer Malignant tumour of the bladder. The most significant risk factor associated with bladder cancer is smoking. Exposure to chemicals called arylamines, which are used in the leather, rubber, printing, and textiles industries, is another risk factor. and a Phase II trial of DFMO DFMO Difluoromethylornithine DFMO Doppler Filter Mixer-Oscillator DFMO Division Financial Management Office (difluoromethylornithine) for breast cancer. Researchers at the University of Texas Southwestern Medical Center at Dallas The University of Texas Southwestern Medical Center at Dallas (also known as “UT Southwestern”) is a medical research center in Texas, USA. It is one of the leading academic medical centers in the world. received a three-year grant to begin Phase II clinical trials 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 of the ILEX compound, Aminopterin aminopterin: see metabolite. . The FDA-funded trial focuses on young leukemia leukemia (l  kē`mēə), cancerous disorder of the blood-forming tissues (bone marrow, lymphatics, liver, spleen) characterized by excessive production of immature or mature patients;
doctors at UT Southwestern are also conducting a separate trial on women
with persistent or recurrent endometrial cancer Endometrial Cancer DefinitionEndometrial cancer develops when the cells that make up the inner lining of the uterus (the endometrium) become abnormal and grow uncontrollably. . Also during the quarter, ILEX received the rights to DHAC DHAC Division of Health Assessment and Consultation DHAC Don't Have A Clue DHAC Don't Have A Cow (dihydro-5-azacytidine) back from MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) Pharma, which decided to discontinue development of the drug for myelodysplastic syndrome Myelodysplastic Syndrome Definition Myelodysplastic syndrome (MDS) is a disease that is associated with decreased production of blood cells. Blood cells are produced in the bone marrow, and the blood cells of people with MDS do not mature normally. and hormone refractory prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . MGI Pharma had licensed the drug from ILEX in 1996. ILEX is now evaluating whether to invest in developing DHAC or seek a new partner. ILEX's net expenditure for the development of proprietary products, including joint-ventured products, increased to $3.5 million during the quarter, compared to $0.2 million for the same period of 1996. This increase was due in part to the company's decision to accelerate the development of Campath-1H, a 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 being developed to treat 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 ). CLL, the most prevalent form of adult leukemia in Western countries, afflicts some 60,000 adults in the U.S. and a similar number in Europe. ILEX is developing Campath in a joint venture with LeukoSite, Inc. "We are enthusiastic about developing Campath in CLL and other indications," said Richard L. Love, ILEX president and chief executive officer. "Our first pre-registration meeting with the 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. on Campath in September was encouraging. We have two more meetings scheduled with the agency prior to year-end to finalize our plans and timetable for filing a Biologics License Application seeking marketing approval." Revenues from ILEX's contract research business reached $1.5 million in the third quarter, a 298% increase over a year ago. During the quarter, ILEX entered into a comprehensive strategic alliance with PRN (PRiNter) The DOS name for the first connected parallel port. See DOS device names. Research, Inc., a subsidiary of Physician Reliance Network, the largest oncology practice management company in the U.S. The alliance enables ILEX to offer its clients the patient access essential to accelerated drug development. Dr. Joseph S. Bailes, PRN executive vice president and national medical director, joined the ILEX board of directors in September. Also during the quarter, ILEX purchased a 30% equity stake in PFK-ILEX, a German-based contract research organization. Together, the two firms are pursuing a leadership position in the European market for clinical research in oncology, offering clients simultaneous development of their oncology compounds in both the U.S. and Europe. Based near Munich, Germany, PFK-ILEX has a subsidiary in Edinburgh, Scotland, with plans to expand to Strasbourg, France; Helsinki, Finland; and London, England. "I am quite pleased with the developments on both sides of our business," Love said. "We believe the steps we have taken in our contract research business afford us strategic advantages over our competitors. This business segment continues to show solid growth. With regard to our products, we are particularly pleased with the progress being made on Campath, Piritrexim, DFMO and Aminopterin, all of which are in advanced clinical trials." ILEX(TM) 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 with compounds for their pipeline as well as drug development and manufacturing services on a contract basis. 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 in this press release, including statements regarding the anticipated development and expansion of the Company's business, the intent, belief or current expectations of the Company, its directors or its officers, primarily with respect to the future operating performance of the Company and other statements contained herein regarding matters that are not historical facts, 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, those risks and uncertainties discussed in filings made by the Company with the Securities and Exchange Commission. -0-
Abbreviated Statement of Operations
Three months ended Nine months ended
September 30, September 30,
1996 1997 1996 1997
REVENUE: (unaudited)(unaudited) (unaudited)
Product development $ 1,181 $ 1,322 $ 2,899 $ 4,156
Contract research
services 385 1,531 842 4,358
Licensing fees - 300 - 300
Total revenue 1,566 3,153 3,741 8,814
OPERATING EXPENSES:
Research and
development costs 906 1,831 2,503 5,030
General and
administrative 849 1,876 1,914 4,258
Costs of contract
research services 553 663 1,040 1,653
Subcontractor costs 213 432 468 1,820
Total operating
exp. without PRN 2,521 4,802 5,925 12,761
PRN amortization
& accrual - 717 - 717
Total operating
expenses 2,521 5,519 5,925 13,478
OPERATING LOSS: (955) (2,366) (2,184) (4,664)
Interest income
(expense) 216 657 455 1,708
Income from
European affiliate - (83) - (83)
Loss on joint ventures - (2,067) - (2,613)
Net loss $ (739) $ (3,859) $(1,729) $ (5,652)
Net loss per share $(0.08) $ (0.31) $ (0.20) $ (0.47)
Weighted average
number of common stock
and common stock
equivalents
outstanding 9,240 12,503 8,560 11,971
Memo: Net ILEX R&D
expenditures on
portfolio products $ 166 $ 3,500 $ 735 $ 5,915
-0-
Abbreviated Balance Sheets
December 31, 1996 September 30, 1997
ASSETS (unaudited)
Cash, cash equivalents
and investments $ 22,984 $ 44,846
Accounts receivable 2,152 2,989
Prepaid expenses and other 1,047 1,226
Investment in joint ventures
and European affil. 250 1,006
Intangible assets - 5,116
Property and equipment (net) 941 2,489
Total assets $ 27,374 $ 57,672
LIABILITIES AND STOCKHOLDER'S
EQUITY
Current liabilities 2,322 3,053
Other long-term liabilities 226 395
Stockholder's equity 24,826 54,224
Total liabilities and
stockholder's equity $ 27,374 $ 57,672
This release and other information about ILEX(TM) Oncology, Inc. can be found on the World Wide Web at: http://www.businesswire.com/cnn/ilxo.htm CONTACT: James Koch, CFO See Chief Financial Officer. Ann Stevens, IR John Lovallo ILEX Oncology ILEX Oncology Makovsky & Co. 210/949-8200 210/949-8230 212/508-9600 |
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