SAN DIEGO, Nov. 4 /PRNewswire-FirstCall/ -- Applied Molecular Evolution, Inc. (AME) today reported financial results for the third quarter of 2003.
For the quarter ended September 30, 2003, the Company reported a net loss of $5.7 million or ($0.27) per share, compared to a net loss of $5.1 million or ($0.24) per share for the quarter ended September 30, 2002. For the nine months ended September 30, 2003, the Company reported a net loss of $14.0 million or ($0.68) per share, compared to a net loss of $13.5 million or ($0.62) per share for the same nine-month period in 2002.
Revenues for the third quarter of 2003 were $1.5 million, reflecting revenue recognized under the Company's strategic alliances, licensing agreements and National Institutes of Health grants, which were also $1.5 million for the third quarter of 2002. Total operating expenses were $7.5 million for the third quarter of 2003, as compared to $7.0 million for the third quarter of 2002.
For the nine months ended September 30, 2003, the Company reported revenues of $6.1 million and operating expenses of $22.1 million, compared to revenues of $5.7 million and operating expenses of $21.2 million for the nine months ended September 30, 2002.
On September 30, 2003, unrestricted cash, cash equivalents and short-term investments were $43.7 million, compared to unrestricted cash, cash equivalents and short-term investments of $51.1 million on December 31, 2002. As of September 30, 2003, the Company had no restricted cash, reflecting full repayment of the Merrill Lynch Business Financial Services credit facility, which had a $10.5 million restricted cash balance on December 31, 2002.
"During the third quarter of 2003, AME demonstrated product candidate development progress on both aspects of our biotherapeutic business model," said Lawrence E. Bloch, M.D., J.D., Chief Financial Officer of AME. "On the corporate collaboration side of our business model, MedImmune announced the initiation of two large-scale Phase II trials for Vitaxin(R) in rheumatoid arthritis and melanoma and announced the filing of an IND for Numax(TM). In addition, MedImmune recently announced that they expect to initiate clinical trials in the remainder of 2003 for all three of their product candidates that AME has optimized:
* a large-scale Phase II clinical trial for Vitaxin in prostate cancer
* a large-scale Phase II clinical trial for Vitaxin in psoriasis
* a Phase I clinical trial for Numax, the next-generation of their
flagship product, Synagis(R), in respiratory syncytial virus (RSV)
* a Phase I trial for Anti-IL9 in asthma.
On the internal product development side of our business model, we announced the successful production of clinical-grade AME-527, next-generation Remicade(R), in our Phase I/II GMP bioprocessing facility, a major milestone on the path to filing our first IND this year on a next-generation biotherapeutic to which AME has retained full commercial rights.
We also strengthened our balance sheet with collateralized equipment financing facilities of $6.0 million from Silicon Valley Bank and $4.0 million from GE Capital to contribute to the continued execution of our business model. We have drawn $6.6 million from these financing facilities, and have $3.4 million available for future equipment purchases. Finally, our subsidiary, Novasite Pharmaceuticals, Inc., announced multiple grants from the NIH to implement its technology platform for discovering and optimizing next-generation small-molecule drugs."
Remicade(R) is a registered trademark of Centocor; Synagis(R) and Vitaxin(R) are registered trademarks of MedImmune; and Numax(TM) is a trademark of MedImmune.
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, hormones and enzymes. 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 http://www.ame.biz/ .
This press release contains forward-looking statements 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 for the year ended December 31, 2002, and other SEC Filings. These forward-looking statements speak only as of the date hereof. The Company disclaims any intent or obligation to update these forward-looking statements.
For further information, please contact Christopher Erdman of Applied Molecular Evolution, Inc., +1-858-638-8635.
- Financial Charts Follow -
Applied Molecular Evolution, Inc.
Selected Financial Data
(In thousands, except per share data)
For the Three Months For the Nine Months
Ended September 30, Ended September 30,
2003 2002 2003 2002
(unaudited) (unaudited) (unaudited) (unaudited)
Revenues $1,464 $1,457 $6,121 $5,652
development 5,919 3,315 15,446 10,406
administrative 1,361 2,972 5,582 8,173
based compensation 237 711 1,023 2,615
expenses 7,517 6,998 22,051 21,194
operations (6,053) (5,541) (15,930) (15,542)
Minority interest 106 402 709 402
Net interest income 240 638 1,190 2,281
charges -- (604) -- (604)
Net loss $(5,707) $(5,105) $(14,031) $(13,463)
Basic and diluted
net loss per
common share $(0.27) $(0.24) $(0.68) $(0.62)
shares used in
and diluted loss
per common share 20,921 21,227 20,760 21,672
Balance Sheet Data September 30, December 31,
Cash, cash equivalents and short-term
investments $43,658 $51,119
Other current assets 3,090 1,370
Total current assets 46,748 52,489
Restricted cash, cash equivalents and
short-term investments -- 10,500
Other noncurrent assets 19,117 16,982
Total Assets $65,865 $79,971
Current liabilities $6,045 $3,785
Noncurrent liabilities 6,357 10,244
Stockholders' equity 53,463 65,942
Total Liabilities and
Stockholders' Equity $65,865 $79,971
Applied Molecular Evolution, Inc.