Applied Molecular Evolution, Inc. Reports Financial Results for Fourth Quarter and Year End 2002.Business Editors/Health/Medical Writers BIOWIRE2K SAN DIEGO--(BUSINESS WIRE)--March 4, 2003 Applied Molecular Evolution, Inc. (AME See AIT. ) (Nasdaq: AMEV AMEV Armored Medical Evacuation Vehicle ) today reported financial results for the fourth quarter and year ended December December: see month. 31, 2002. For the year ended December 31, 2002, the Company reported a net loss of $17.4 million or ($0.82) per share, compared to a net loss of $13.2 million or ($0.62) per share for the year ended December 31, 2001. For the quarter ended December 31, 2002, the Company reported a net loss of $4.0 million or ($0.20) per share, compared to a net loss of $3.4 million or ($0.16) per share for the fourth quarter of 2001. Revenues for the year ended December 31, 2002, were $7.9 million, reflecting revenue recognized under the Company's corporate collaborations, licensing agreements and NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. grants, compared to revenues of $3.6 million for the year ended December 31, 2001. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the year ended December 31, 2002, were $24.8 million excluding non-cash, stock-based compensation of $3.2 million, as compared to operating expenses of $15.3 million, excluding non-cash stock-based compensation of $6.8 million for the year ended December 31, 2001. For the fourth quarter of 2002 the Company reported revenues of $2.3 million and operating expenses of $6.3 million, excluding non-cash, stock-based compensation of $571,000, as compared to revenues of $1.1 million and operating expenses of $4.3 million, excluding non-cash, stock-based compensation of $1.2 million, for the fourth quarter of 2001. On December 31, 2002, unrestricted cash, cash equivalents and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments were $51.1 million, compared to unrestricted cash, cash equivalents and short-term investments of $80.2 million on December 31, 2001. In addition, as of December 31, 2002, restricted cash was $10.5 million, compared to no restricted cash on December 31, 2001. "AME accomplished all of its key operational and financial objectives in 2002," stated William D. Huse, President, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and Chairman of AME. "Importantly, we announced our robust preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. data on AME-527 and AME-133, humanized and optimized versions of the FDA-approved, currently marketed monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). Remicade Remicade® Avakine™, cA2™, CenTNF™, infliximab Immunology An agent used to manage severe or mutilating rheumatoid arthritis, or severe or active–eg, fistulizing–Crohn's disease. See Rheumatoid arthritis. (R) and Rituxan Ri·tux·an A trademark for the drug rituximab. rituximab Warning - Hazardous drug! MabThera (UK), Rituxan Pharmacologic class: (R), respectively. Our disease-model validation See validate. validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. of these biotherapeutic candidates demonstrates AME's ability to execute on the internal development component of its business plan. We look forward to continued progress with these product candidates during the coming year. Additionally in 2002, we achieved success in our corporate collaborations and the expansion of our biotherapeutic development capabilities." AME 2002 Achievements -- Announced promising disease-model data on three internal development candidates: AME-527 and AME-133, humanized and optimized versions of the FDA-approved, currently marketed monoclonal antibodies Remicade and Rituxan, respectively and AME-359. AME-527 is in development for the treatment of rheumatoid arthritis and AME-133 is in development for the treatment of non-Hodgkin's Lymphoma. AME-359 is an optimized version of the human enzyme butyrylcholinesterase for the treatment of cocaine toxicity. -- Initiated a second antibody optimization project with Lilly -- Initiated an antibody optimization collaboration with Centocor -- Achieved milestones in collaborations with Lilly for and antibody optimization project and Chiron for a non-antibody optimization project -- Augmented internal product development capabilities including the integration of process sciences and clinical affairs capabilities -- Began expansion of GMP production facilities to be capable of producing clinical grade material through Phase II Remicade(R) is a registered trademark of Centocor. Rituxan(R) is a registered trademark of IDEC IDEC Instituto Brasileiro de Defesa do Consumidor (Portugese: Brazilian Consumer Protection Agency) IDEC Information Design & End-User Computing IDEC Interior Design Educators Council, Inc. Pharmaceuticals, Inc. Applied Molecular Evolution, Inc., (AME) is a leader in applying directed molecular evolution to improve healthcare by optimizing and developing human biotherapeutics. Directed molecular evolution is a process for optimizing genes and proteins for specific commercial purposes. Since its inception, AME's principal focus has been on applying its proprietary AMEsystem(TM) technology platform to human biotherapeutics, the largest market for directed molecular evolution. Biotherapeutics, or biopharmaceuticals, are protein pharmaceuticals such as antibodies, cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. , hormones Hormones Chemicals produced by glands in the body that circulate in the blood and control the actions of cells and organs. Estrogens are hormones that affect breast cancer growth. Mentioned in: Breast Cancer, Hypoparathyroidism and enzymes Enzymes Organic substances (proteins) composed of amino acids that trigger and regulate chemical reactions in the body. There are over 700 identified human enzymes. Mentioned in: Interactions, Nutritional Supplements . AME uses its proprietary technology to develop improved versions of currently marketed, FDA-approved biopharmaceuticals as well as novel human biotherapeutics. For more information, please visit www.AME.biz biz n. Informal Business. biz Noun Informal business Noun 1. . This press release contains 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. that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements, including uncertainties related to product development, uncertainties related to the need for regulatory or other government approvals, dependence on proprietary technology, uncertainty of market acceptance of the Company's products, uncertainties related to business opportunities, the receipt of future payments, including royalties, the continuation of customer relationships and other risks cited in the Company'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 year ended December 31, 2001, and other SEC Filings. These forward-looking statements speak only as of the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" . The Company disclaims any intent or obligation to update these forward-looking statements.
Applied Molecular Evolution, Inc.
Selected Financial Data
(In thousands, except per share data)
For the Three Months For the Year Ended
Ended December 31, December 31,
----------------------- -------------------
Statements of Operations
Data 2002 2001 2002 2001
----------- ----------- --------- ---------
(unaudited) (unaudited)
Revenues $2,275 $1,125 $7,927 $3,613
Expenses
Research and
development 4,727 3,268 15,133 10,933
General and
administrative 1,542 995 9,714 4,361
Non-cash, stock based
compensation 571 1,222 3,187 6,807
----------- ----------- --------- ---------
Total operating expenses 6,840 5,485 28,034 22,101
----------- ----------- --------- ---------
Loss from operations (4,565) (4,360) (20,107) (18,488)
Minority interest 103 58 505 372
Net interest income 482 868 2,763 4,886
Other financing
charges - - (604) -
----------- ----------- --------- ---------
Net loss $(3,980) $(3,434) $(17,443) $(13,230)
=========== =========== ========= =========
Basic and diluted net
loss per common share $(0.20) $(0.16) $(0.82) $(0.62)
Weighted average shares
used in computing basic
and diluted loss per
common share 20,322 21,652 21,332 21,394
Balance Sheet Data December December
31, 31,
2002 2001
----------- ---------
Cash, cash equivalents and short-term
investments $51,119 $80,196
Other current assets 1,370 3,814
Restricted cash 10,500 -
Other noncurrent assets 16,982 6,672
----------- ---------
Total Assets $79,971 $90,682
=========== =========
Current liabilities $3,785 $4,268
Noncurrent liabilities 10,244 478
Stockholders' equity 65,942 85,936
----------- ---------
Total Liabilities and
Stockholders' Equity $79,971 $90,682
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