Maxim Pharmaceuticals Announces 2002 Third Quarter Financial Results
SAN DIEGO--(BW HealthWire)--Aug. 1, 2002--Maxim Pharmaceuticals Inc. (Nasdaq:MAXM - News; SSE:MAXM) today announced results for the quarter ended June 30, 2002, the third quarter of its 2002 fiscal year.
The net loss for the third quarter totaled $8,156,000, or $0.35 per share, compared to a net loss of $6,429,000, or $0.28 per share, for the same period of the prior year. The current year increase in net loss related to accelerated clinical development of the company's lead drug candidate Ceplene(TM), including the ramping up of a confirming Phase 3 clinical trial for the treatment of advanced metastatic melanoma, and a Phase 2 clinical trial in nonresponder hepatitis C patients.
The net loss for the nine months ended June 30, 2002 totaled $53,223,000, or $2.29 per share, compared to a net loss of $29,154,000, or $1.26 per share, for the same period of the prior year. The increase in net loss for the nine months ended June 30, 2002 is largely the result of a non-cash $28,179,000 charge recorded during the quarter ended Dec. 31, 2001 reflecting the write down of the carrying value of goodwill as a result of the adoption, effective Oct. 1, 2001, of Statement of Financial Accounting Standard ("SFAS") No. 142, "Accounting for Goodwill and Other Intangible Assets."
The company had cash, cash equivalents and investments totaling $119.9 million at June 30, 2002. Maxim used net cash of $8.5 million in its operations during the quarter ended June 30, 2002, compared to $6.4 million used in operations for the same period of the prior year.
"Our cash investment required in the third quarter was below our expectations and we remain well positioned to continue the development of our product pipeline, including our three Phase 3 clinical trials currently underway," said Larry G. Stambaugh, Maxim's chairman and chief executive officer. "A major effort during the quarter was the ramping up of the second Phase 3 clinical trial of Ceplene in advanced metastatic melanoma with liver metastases, designed to support U.S. approval of this drug candidate in this deadly form of skin cancer. We also completed the initial phase of our Phase 2 clinical trial of Ceplene triple-drug therapy in hepatitis C nonresponder patients, a large market with a critical need for more effective therapies."
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim's research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
Maxim's lead drug Ceplene(TM), based on the naturally occurring molecule histamine, is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,400 patients have participated in the company's completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. The company's third technology platform, MaxDerm(TM), is an investigational drug candidate designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator technology and MaxDerm, and regarding the company's clinical trials. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the company will not obtain approval to market its products, the risk that clinical trials may not commence when planned, the risks associated with the dependence upon collaborative partners, and the fact that the company will likely need to raise additional funds in the future, and if the company is unable to obtain the funds necessary to continue its operations, it may be required to delay, scale back or eliminate one or more of its product commercialization programs. These factors and others are more fully discussed in the company's periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor's Note: This release is also available on the Internet at maxim.com.
Maxim Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations (unaudited)
Three Months Ended Nine Months Ended
June 30, June 30,
------------------------ ------------------------
2002 2001 2002 2001
----------- ----------- ----------- -----------
Collaboration
and research
revenue $ 776,296 $ 826,715 $ 1,817,831 $ 2,527,643
Operating expenses:
Research and
development 7,631,218 6,129,592 23,501,071 25,430,092
Marketing and
business
development 885,792 1,357,574 2,268,222 7,198,125
General and
administrative 1,501,805 1,383,058 4,980,825 5,204,177
Amortization of
goodwill and
other
acquisition-
related
intangible
assets -- 550,929 -- 1,667,419
----------- ----------- ----------- -----------
Total operating
expenses 10,018,815 9,421,153 30,750,118 39,499,813
----------- ----------- ----------- -----------
Loss from
operations (9,242,519) (8,594,438) (28,932,287) (36,972,170)
Other income
(expense):
Investment income 1,131,731 2,195,013 4,014,672 7,914,143
Interest expense (44,898) (27,631) (135,832) (95,469)
Other income
(expense) (521) (2,182) 9,685 (897)
----------- ----------- ----------- -----------
Total other
income 1,086,312 2,165,200 3,888,525 7,817,777
----------- ----------- ----------- -----------
Loss before
cumulative effect
of accounting
change (8,156,207) (6,429,238) (25,043,762) (29,154,393)
Cumulative effect
of accounting
change -- -- (28,179,466) --
----------- ----------- ----------- -----------
Net loss applicable
to common stock $(8,156,207) $(6,429,238)$(53,223,228)$(29,154,393)
=========== =========== =========== ===========
Basic and diluted
net loss per share
of common stock:
Before cumulative
effect of
accounting
change $ (0.35) $ (0.28) $ (1.08) $ (1.26)
Cumulative effect
of accounting
change -- -- (1.21) --
----------- ----------- ----------- -----------
Basic and diluted
net loss per share
of common stock $ (0.35) $ (0.28) $ (2.29) $ (1.26)
=========== =========== =========== ===========
Weighted average
shares outstanding 23,280,137 23,235,198 23,266,487 23,211,857
=========== =========== =========== ===========
Selected Balance Sheet Information
June 30, Sept. 30,
2002 2001
------------ ------------
(unaudited)
Assets
Cash, cash equivalents and investments $119,866,770 $146,560,006
Total assets 134,352,114 190,756,338
Long-term liabilities 1,468,520 1,759,667
Stockholders' equity 127,130,408 180,646,601
--------------------------------------------------------------------------------
Contact:
Maxim Pharmaceuticals Inc.
Larry G. Stambaugh, Chairman, President and CEO
858/453-4040
or
Burns McClellan
John Nugent (Investors)
212/213-0006
or
Coffin Communications Group
Sean Collins / Valerie Bent (Media)
818/789-0100 |
