CellPro reports results for fiscal 1997.SEATTLE--(BUSINESS WIRE)--May 14, 1997--CellPro, Incorporated (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 : CPRO CPRO Columbia Pike Revitalization Organization CPRO Connecticut Peer Review Organization, Inc. ) today reported a net loss of $24.1 million, or $1.67 per share, for its fourth fiscal quarter ended March 31, 1997, and a net loss of $40.9 million, or $2.84 per share, for the 1997 fiscal year. The net loss for the fourth fiscal quarter and for the fiscal year includes a $17 million charge related to on-going patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . Excluding this charge, net loss would have been $7.1 million, or $0.49 per share, for the fourth fiscal quarter and $23.9 million, or $1.66 per share, for the fiscal year ended March 31, 1997. This compares with a net loss of $5.3 million, or $0.37 per share, and $15.7 million, or $1.13 per share, for the fourth fiscal quarter and fiscal year ended March 31, 1996, respectively. At March 31, 1997, the Company's 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 totaled $54 million. Shares issued and outstanding at the fiscal year-end Fiscal Year-End The completion of a one-year, or 12-month, accounting period. Notes: The reason that a company's fiscal year often differs from the calendar year and does not close on Dec 31, is due to the nature of company's needs. totaled 14.5 million. CellPro reported $3.1 million in product sales for the fourth fiscal quarter and $9.5 million in product sales for the fiscal year ended March 31, 1997. This compares with $2.3 million and $6.8 million for the fourth fiscal quarter and the fiscal year ended March 31, 1996, respectively. Increased sales of the CEPRATE(R) SC Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. Concentration System accounted for the improvement. The CEPRATE(R) SC System is used to provide stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young to repopulate the bone marrow of patients being treated for diseases such as breast and ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast , lymphoma, multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility and acute hematological malignancies. The CEPRATE(R) SC System is approved for use in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , the 18-nation European Economic Area European Economic Area: see European Free Trade Association; European Union. and Canada, and is commercially available in other European countries and in several countries in the Asia Pacific region and Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. . Research and development expense totaled $4.2 million and $16.2 million for the fourth fiscal quarter and the fiscal year ended March 31, 1997, respectively. Research and development expense was $4.3 million and $16.5 million for the prior year's fiscal quarter and year ended March 31, 1996, respectively. The Company has completed patient enrollment in a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial designed to demonstrate the CEPRATE(R) SC System's ability to deplete de·plete v. 1. To use up something, such as a nutrient. 2. To empty something out, as the body of electrolytes. tumor cells from peripheral blood peripheral blood Cardiology Blood circulating in the system/body stem cell transplants in patients being treated for multiple myeloma. This clinical trial is in the post-treatment patient follow-up phase. Additionally, in October 1996, the Company began a multicenter Phase I/II clinical trial utilizing the CEPRATE(R) SC System together with a new second generation product, the CEPRATE(R) TCD TCD Trinity College Dublin TCD Chad (ISO Country code) TCD Transcranial Doppler TCD Thermal Conductivity Detector TCD Traffic Control Device TCD Tropical Conservation and Development T-Cell Depletion System, for mismatched allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically transplantation in children with leukemia. Trial subjects are children who need stem cell transplants, but for whom no matched-donor can be found. These children typically do not have any other viable treatment option. The CEPRATE(R) SC System is also being used to deplete T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. from stem cell products used to repopulate the marrow of patients receiving marrow-killing chemotherapy to treat certain autoimmune disorders Autoimmune Disorders Definition Autoimmune disorders are conditions in which a person's immune system attacks the body's own cells, causing tissue destruction. including multiple sclerosis, rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and lupus lupus (l  `pəs), noninfectious chronic disease in which antibodies in an individual's immune system attack the body's own substances. . The CEPRATE(R) SC System is being used in numerous
additional clinical trials, including applications in dose-intensified,
multicycle chemotherapy to treat solid-tissue tumors and allogeneic
matched- and mismatched-donor trials to treat leukemias. Further, the
Company is participating in various gene therapy trials in which the
CEPRATE(R) SC System is used to concentrate stem cells to enhance the
efficiency of gene insertion to treat genetic disorders and diseases
such as cancer, AIDS and severe combined immunodeficiency Severe Combined Immunodeficiency DefinitionSevere combined immunodeficiency (SCID) is the most serious human immunodeficiency disorder(s). It is a group of congenital disorders in which both the humoral part of the patient's immune system and the cells (SCID SCID severe combined immunodeficiency (disease); see under immunodeficiency. SCID abbr. severe combined immunodeficiency SCID severe combined immunodeficiency disease. ). Additional research and development is underway to develop a number of new products for use in cellular therapeutics and cancer diagnostics. Selling, general and administrative expenses increased to $5.0 million and $15.4 million for the fourth fiscal quarter and the fiscal year ended March 31, 1997, respectively. This compares with $3.1 million and $12.5 million for the fiscal quarter and the fiscal year ended March 31, 1996. The increase in fiscal year 1997 expenses resulted primarily from higher legal fees and sales and marketing expenses. Legal fees were incurred to defend the Company in patent litigation brought jointly by Baxter Healthcare Corporation, Becton Dickinson & Co. and Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. against the Company, discussed further below. Increased sales and marketing expenses resulted from activities in support of commercialization of the CEPRATE(R) SC System in the United States and Europe. The US product launch began in December 1996 following 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. approval of the CEPRATE(R) SC System for purification of stem cells for bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. . The CEPRATE(R) SC System is the only cell processing system which has been approved by the FDA for this indication. At March 31, 1997, the Company established an accrual of $17 million to cover potential losses from, and future expenses for, on-going patent litigation. CellPro is optimistic that it will ultimately prevail in this dispute, however, the reserve has been made in recognition of the fact that a judgment against the Company is currently pending at the federal district court level. The amount of damages have not yet been decided by the court. The Company believes that a number of reversible errors have been made by the court, and that the judgment against the Company is contrary to the evidence and facts of the case. As a result, the Company intends to appeal this judgment vigorously. The ultimate amount of damages, if any, and the ultimate amount of future expenses incurred in pursuing this litigation may vary significantly from the amount reserved. The Company also reported interest income totaling $779,000 for the fourth fiscal quarter and $3.6 million for the fourth fiscal quarter and the fiscal year ended March 31, 1997, respectively. In the prior period, the Company earned $1.1 million and $4.2 million for the fiscal quarter and the fiscal year ended March 31, 1996, respectively. The decrease was due to lower average cash balances available for investment in the current year. This news release contains forward-looking statements. However, the Company's business involves risks and uncertainties that could cause actual results or events to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, those mentioned in CellPro's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended March 31, 1996, and CellPro's quarterly reports on Form 10Q for the fiscal quarters ended December 31, 1996, September 30, 1996 and June 30, 1996 under the heading "Investment Considerations" and in CellPro's other public filings. Particular attention should be given to the Investment Considerations labeled "Uncertainty of Product Acceptance" and "Legal Proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. " in CellPro's Annual Report on Form 10-K for the fiscal year ended March 31, 1996. CellPro, Incorporated is a biotechnology company in Bothell, Washington specializing in the development, manufacturing and marketing of proprietary continuous-flow, cell-selection systems for use in a variety of therapeutic, diagnostic and research applications. -0-
CELLPRO, INCORPORATED
(a Company in the development stage)
SELECTED FINANCIAL DATA
STATEMENT OF OPERATIONS DATA:
(UNAUDITED)
Three Months Ended
March 31,
1997 1996
REVENUES:
Product sales $ 3,128,228 $ 2,309,185
Related party revenue
Contract and other revenue 80,559
------------ ------------
Total revenue 3,208,787 2,309,185
------------ ------------
COSTS AND EXPENSES:
Cost of product sales 1,596,895 1,275,172
Research and development 4,188,031 4,307,083
Selling, general and
administrative 4,995,660 3,097,890
Litigation provision 17,000,000
------------ ------------
Total costs and expenses 27,780,586 8,680,145
------------ ------------
Loss from Operations -24,571,799 -6,370,960
------------ ------------
OTHER INCOME (EXPENSE):
Interest income 778,726 1,082,849
Interest expense -7,413 -15,099
Other, net -308,348 -15,915
------------ ------------
Total other income 462,965 1,051,835
------------ ------------
Net loss ($24,108,834) ($ 5,319,125)
============ ============
Net loss per share ($ 1.67) ($ 0.37)
============ ============
Weighted average number of
shares outstanding 14,478,735 14,282,214
============ ============
Year Ended
March 31,
1997 1996
REVENUES:
Product sales $ 9,515,984 $ 6,801,985
Related party revenue 6,000,000/a
Contract and other revenue 146,390 41,600
------------ ------------
Total revenue 9,662,374 12,843,585
------------ ------------
COSTS AND EXPENSES:
Cost of product sales 5,161,389 3,723,421
Research and development 16,243,501 16,474,133
Selling, general and
administrative 15,379,650 12,515,870
Litigation provision 17,000,000
------------ ------------
Total costs and expenses 53,784,540 32,713,424
------------ ------------
Loss from Operations -44,122,166 -19,869,839
------------ ------------
OTHER INCOME (EXPENSE):
Interest income 3,590,157 4,164,218
Interest expense -46,053 -86,718
Other, net -337,323 139,679
------------ ------------
Total other income 3,206,781 4,217,179
------------ ------------
Net loss ($40,915,385) ($15,652,660)
============ ============
Net loss per share ($ 2.84) ($ 1.13)
============ ============
Weighted average number of
shares outstanding 14,421,908 13,847,929
============ ============
BALANCE SHEET DATA:
March 31, March 31,
1997 1996
Cash, cash equivalents and
marketable securities $54,043,175 $74,143,851
Total assets 76,123,697 97,941,349
Long-term debt, net of current
portion 152,943 208,001
Total stockholders' equity 52,780,648 92,213,233
/a This is non-recurring revenue received for prior research and development services rendered by CellPro as part of the termination of business arrangements between CellPro and Corange International Ltd. CONTACT: CellPro, Incorporated Joann Reiter, 206/485-7644 e-mail: invest@cellpro.com http://www.cellpro.com |
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