Maxim Pharmaceuticals Announces 2002 Second Quarter Financial Results
SAN DIEGO--(BW HealthWire)--May 2, 2002--Maxim Pharmaceuticals Inc. (Nasdaq:MAXM - news; SSE:MAXM) today announced results for the quarter ended March 31, 2002, the second quarter of its 2002 fiscal year.
The net loss for the second quarter totaled $9,063,000, or $0.39 per share, compared to a net loss of $9,758,000, or $0.42 per share, for the same period of the prior year.
The net loss for the six months ended March 31, 2002 totaled $45,067,000, or $1.94 per share, compared to a net loss of $22,725,000, or $0.98 per share, for the same period of the prior year. The increase in net loss for the six months ended March 31, 2002 is the result of a non-cash $28,179,000 charge recorded during the quarter ended December 31, 2001 reflecting the write down of the carrying value of goodwill as a result of the adoption, effective October 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 $128.6 million at March 31, 2002. Maxim used net cash of $7.4 million in its operations during the quarter ended March 31, 2002, compared to $11.1 million used in operations for the same period of the prior year.
"During the second quarter we achieved a number of key milestones and advanced our product development candidates while maintaining a reasonable level of investment," said Dale A. Sander, Maxim's senior vice president, finance and chief financial officer. "In January we commenced the second Phase 3 clinical trial of Ceplene in advanced metastatic melanoma with liver metastases to support U.S. approval of this drug candidate. Also that month, results from the first Phase 3 trial were published in the Journal of Clinical Oncology. During the quarter we also undertook substantial research in the areas of non-viral chronic liver diseases such as alcoholic liver disease (ALD) and nonalcoholic steatohepatitis (NASH), and we expect that this work will lead to additional scientific presentations and human clinical trials in these critical diseases. We also completed preparation for three clinical studies of topical histamine in radiation dermatitis, oral mucositis and aphthous stomatitis. Lastly, our apoptosis modulator platform continues to advance as highlighted by our recently expanded collaboration with Celera Genomics."
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 1,300 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 or 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 March 31, Six Months Ended March 31,
---------------------------- --------------------------
2002 2001 2002 2001
------------- ------------- ----------- -------------
Collaboration and
research
revenue $ 594,359 $ 871,499 $ 1,041,535 $ 1,700,928
Operating expenses:
Research and
development 8,412,611 8,417,102 15,869,853 19,300,500
Marketing and
business
development 662,029 2,244,763 1,382,430 5,840,551
General and
administrative 1,815,623 2,082,894 3,479,020 3,821,119
Amortization of
goodwill and
other acquistion-
related intangible
assets -- 553,496 -- 1,116,490
------------ ------------ ------------ ------------
Total operating
expenses 10,890,263 13,298,255 20,731,303 30,078,660
------------ ------------ ------------ ------------
Loss from
operations (10,295,904) (12,426,756) (19,689,768) (28,377,732)
Other income (expense):
Investment
income 1,278,217 2,668,629 2,882,941 5,719,130
Interest
expense (39,349) (6,739) (90,934) (67,838)
Other income
(expense) (5,600) 6,804 10,206 1,285
------------ ------------ ------------ ------------
Total other
income 1,233,268 2,668,694 2,802,213 5,652,577
------------ ------------ ------------ ------------
Loss before
cumulative effect
of accounting
change (9,062,636) (9,758,062) (16,887,555) (22,725,155)
Cumulative effect
of accounting
change -- -- (28,179,466) --
------------ ------------ ------------ ------------
Net loss $(9,062,636) $(9,758,062) $(45,067,021) $(22,725,155)
============ ============ ============ ============
Basic and diluted net loss per share of common stock:
Before cumulative
effect of
accounting
change $ (0.39) $ (0.42) $ (0.73) $ (0.98)
Cumulative
effect of
accounting
change -- -- (1.21) --
------------ ------------ ------------ ------------
Basic and diluted
net loss per
share of common
stock $ (0.39) $ (0.42) $ (1.94) $ (0.98)
------------ ------------ ------------ ------------
Weighted average
shares
outstanding 23,266,001 23,219,833 23,259,663 23,200,189
============ ============ ============ ============
Selected Balance Sheet Information
March 31, 2002 Sept. 30, 2001
-------------- --------------
(unaudited)
Assets
Cash, cash equivalents and investments $128,628,648 $146,560,006
Total assets 143,112,794 190,756,338
Long-term liabilities 1,703,290 1,759,667
Stockholders' equity 134,466,049 180,646,601
--------------------------------------------------------------------------------
Contact:
Maxim Pharmaceuticals Inc.
Larry G. Stambaugh, Chairman, President and CEO /
Dale A. Sander, Chief Financial Officer
858/453-4040
or
Burns McClellan
Stephanie Diaz, 415/352-6262 (Investors) /
Kathy Jones, Ph.D., 212/213-0006 (Media) |
