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ENZO Biochem Reports Continuing Growth in Second Quarter Operating Results

FARMINGDALE, NY, March 14, 2003 – Enzo Biochem, Inc. (NYSE:ENZ), a leading biotechnology company specializing in gene identification and genetic and immune regulation technologies for diagnostic and therapeutic applications, today announced continued growth in operating results for the fiscal second quarter and six months ended January 31, 2003.

 

“Results in the January quarter benefited from increased shipments of life science products to our customers and the strong improvement we are witnessing at our clinical lab,” said Barry W. Weiner, President. “We are highly encouraged about the outlook and prospects for our Company.”

 

For the three months ended January 31, 2003, total revenues amounted to $13.1 million, compared with $11.8 million in the corresponding year ago period, a gain of 11%. Operating income totaled approximately $2.0 million, double operating income of $1.0 million a year ago. Net income advanced 75.9%, to $1.4 million, or $0.05 per share on a diluted basis, compared with $0.8 million, or $0.03 per share, on a diluted basis, in the corresponding year-ago period.

 

Cash flow from operating activities for the six months was strongly positive, totaling $9.3 million, with cash and cash equivalents on January 31, 2003 at $75.9 million, compared with $61.9 million a year earlier. Working capital on January 31, 2003 stood at $98.4 million. Stockholders’ equity amounted to $110 million. There was no debt.

 

For the first six months of fiscal 2003, total revenues amounted to $30.5 million, compared with $25.2 million a year ago, an increase of 21.0%. Operating income for the first six months this year totaled $7.8 million, compared with $3.6 million a year ago, a gain of 114%. First half net income amounted to $5.1 million, or $0.18 per share fully diluted, compared with $2.6 million, or $0.09 per share fully diluted, in the corresponding period a year ago.

 

Research and development expenses for the second quarter of fiscal 2003 were essentially unchanged year-to-year at $1.6 million. General and administrative expenses, as a percentage of total revenues, increased to 28%, from 21% a year ago, reflecting higher legal expenses in the patent infringement actions commenced by the Company.

 

At Enzo Life Sciences, sales of research products, particularly our BioArray™ line of labeling and detection products for the genomics market, rose 10% for the second quarter, to $6.0 million, with operating income for the quarter increasing to $3.4 million and the operating profit margin rising to 56.4%, from 44.7% a year ago. Research product revenues continued to be strong, although lower sequentially from the prior quarter which benefited from unusually high volume.

 

Enzo Clinical Labs continued to enjoy a solid turnaround from a year ago. Revenues increased 11.6%, to $7.1 million, largely due to increased volume of the Lab’s higher valued tests.

And with increased operating profit margins, the Labs’ operating income for the quarter showed a $1.5 million improvement, increasing to approximately $0.8 million, from a year-ago loss of roughly $0.8 million.

 

“Our Company continues to make solid progress and to sustain its earnings growth momentum,” said Mr. Weiner. “Enzo Clinical Labs has returned to its core business servicing its physician base in the metropolitan New York market. Both Enzo Life Sciences and Enzo Therapeutics are moving aggressively forward. We are in the process of initiating manufacture of EHT899, the Company’s medicine for hepatitis B-associated chronic hepatitis. This would permit start-up of the double blind multi-country Phase 2 trial of EHT899. The Phase 1 trial of ECH18, the Company’s medicine for treating C-associated chronic active hepatitis, according to preliminary data and as noted previously, indicates the design endpoints related to toxicity and safety have been met. Plans are being developed for the next phase of the trial.

 

“In May, we expect to report on final analysis of the Phase 1 clinical trial of Enzo’s immune regulation product for managing Crohn’s disease, a debilitating intestinal ailment for which no satisfactory long-term treatment currently exists. However, based on highly encouraging preliminary results from the study in Israel, we are preparing for a Phase 2 trial, designed to comply with U.S. Food & Drug Administration requirements.

 

“As for Enzo’s StealthVector™ HGTV43™ gene medicine for HIV-1 infection, the approval process for start-up of the Phase 1/2 trial was halted in January by the FDA’s temporary “clinical hold” placed on all active gene therapy trials using retroviral vector to insert genes into blood stem cells. The FDA has indicated it plans to remove the clinical hold on such studies on a case-by-case basis, and we are currently in the process of responding. The HGTV43™ vector differs materially from the one used in the French gene study and has significant safety features. No treatment-related serious adverse events have been identified in any of the subjects treated with the HGTV43™ vector in the up to three years they have been followed. We are optimistic that our study will be able to proceed.”

 

About Enzo

Enzo Biochem is engaged in the research, development and manufacture of innovative health care products based on molecular biology and genetic engineering techniques, and in providing diagnostic services to the medical community. The Company's proprietary labeling and detection products for gene sequencing and genetic analysis, with approximately 200 patents worldwide, are sold to the life sciences market throughout the world. The Company's therapeutic division is conducting clinical trials of its proprietary gene medicine for HIV-1 infection and clinical trials of its proprietary immune regulation medicines for hepatitis B and hepatitis C infection and for Crohn’s Disease. The Company also holds a patent covering a method and materials for correcting point mutations or small insertions or deletions of genetic material that would allow for editing and correcting certain abnormalities in genes. For more information visit our website www.enzo.com.

Except for historical information, the matters discussed in this news release may be considered ”forward?looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management. Investors are cautioned that any such forward?looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this press release.

A conference call conducted by Enzo Biochem, Inc. management will take place on Friday, March 14, 2003 at 8:30 A.M. (ET). It can be accessed by dialing 1- 877-691-0877. International callers can dial 1-973-582-2741. You may also listen over the Internet at www.vcall.com. To listen to the live call on the Internet, please go to the web site at least fifteen minutes early to register, download and install any necessary audio software. For those who cannot listen to the live broadcast, a replay will be available through midnight March 30, 2003, shortly following the live call. For replay, dial 1-877-519-4471 (1-973-341-3080 internationally). You will be prompted for PIN number 3803136.