Enzo Biochem, Inc. (NYSE:ENZ), a vertically integrated biotechnology
company engaged in the research, development, manufacture, licensing and
marketing of innovative health care products, platforms and services
based on molecular and cellular technologies, today reported for the
fiscal first quarter ended October 31, 2009, record operating revenues
and sharply improved operating results.
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Total operating revenues increased 19% year-over-year, to a record
$25.2 million.
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Gross profit advanced 63%, to a record $13.3 million.
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Royalty and licensing fee income increased 14% over the year ago
quarter.
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Organic Core Product Sales Growth at Enzo Life Sciences topped 26%.
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Enzo Clinical Labs posted a 36% gain in revenues, and improved gross
profit margins
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Net loss was reduced by more than 70%.
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Enzo Life Sciences formed a strategic collaboration with a key
equipment manufacturer to provide innovative systems for the study of
live cells
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Agreements have been signed at Enzo Clinical Labs for new molecular
diagnostic tests, including a proprietary blood test for colorectal
cancer and cervical cancer.
"Fiscal 2010 is off to a good start, as a result of the significant
changes that have taken place and implemented across our business units,
said Barry Weiner, Enzo President. "Expanded management, enhancements to
infrastructure, focused performance driven goals and objectives, and
adoption of strategies that are aligned with the company’s core
competencies and assets, have resulted in sharply improved operating
results. They also are contributing to a new promising chapter for the
Company based on our long established gene-related activities and
intellectual properties. Integration of recent acquisitions at Enzo Life
Sciences is progressing well resulting in a shift to higher margin
products which have benefited results. Additionally, at Enzo Clinical
Labs we have seen increases in our test volume resulting from the
expansion of our marketing efforts, our updated billing capabilities and
from adding new esoteric testing. At Enzo Therapeutics, plans for the
clinical trial of Optiquel™ in conjunction with the National Eye
Institute are moving forward, as is our program to develop partnerships
and joint ventures related to several other proprietary modalities that
we believe have advanced medical and commercial applications. We are
very encouraged regarding the Company’s outlook.”
Operating Results
The gain in revenues was across-the-board, with double-digit growth
being recorded by Clinical Labs and royalty and license fee income at
Life Sciences. A solid 8% product revenue increase at Life Sciences
reflected a favorable shift in product revenues from lower margin to
higher margin core products. Total revenues for the quarter were $25.2
million. Gross profit was up 63%, to $13.3 million, from $8.2 million a
year ago, and gross profit margins advanced to 53%, from 39%. The net
loss for the quarter was $1.8 million, or ($0.05) per share, basic and
diluted. The net loss for the quarter was 72% below the year ago’s net
loss of $6.4 million, or ($0.17) per share, basic and diluted. EBITDA
(earnings before interest, taxes, depreciation and amortization), a
non-GAAP measure, for the quarter was a loss of $960,000, an improvement
of nearly $5 million compared to an EBITDA loss of $5.9 million in the
2009 first fiscal quarter. On a sequential basis, EBITDA improved by
$3.4 million from the fiscal 2009 fourth quarter.
On October 31, 2009, working capital amounted to $59.2 million, and cash
and cash equivalents and short-term investments approximated $46.4
million. Cash and cash equivalents decline was just ($0.9) million for
the 2010 period. Stockholders’ equity totaled $131.7 million. There was
no debt.
Segment Analysis
At Enzo Life Sciences, product revenues for the segment increased
overall by 8% or $0.8 million in 2009 as compared to the 2008 period.
Core product revenues demonstrated strong organic growth of 26% or
$1.0 million and revenues from the May 2009 acquisition of Assay
Designs, Inc. contributed $2.7 million. This overall growth
was partially offset by declines in lower margin third-party
distribution business of $2.9 million. The shift to higher margin
products was reflected in a 26% reduction in cost of products, to $5.1
million, from last year’s $6.8 million. Gross profit, including both
product and royalty income, amounted to $9.0 million, a 48% gain. Gross
margin was 64%, up from 47% a year ago. Segment operating income
advanced 77%, to $2.0 million.
At Enzo Clinical Labs, service revenues totaled $11.1 million, up 36%,
reflecting both the increased service volume and the fact that year-ago
revenues reflected downward contractual adjustments of $2.2 million.
However, reflecting greater billing efficiency, the provision for
uncollectible accounts receivable declined to $0.9 million, from $1.9
million a year ago and $1.2 million in the preceding fourth quarter of
fiscal 2009. Gross profit increased to $4.3 million with an improved
gross profit margin of 39 % on a sequential basis, 300 basis points
higher than in the preceding fourth quarter of fiscal 2009. As a result,
the operating loss declined sharply, to $0.8 million, from $3.4 million
in the year ago first quarter and from $1.2 million in the preceding
fourth quarter of fiscal 2009.
Other Events
In line with the Company’s accelerating program to make available to
physician clients in its marketing territories more molecular diagnostic
and other esoteric testing, Enzo Life Sciences recently announced an
agreement with publicly-owned GeneNews Limited, of Toronto, Canada, for
exclusive rights to market its ColonSentry™, a proprietary blood test
for colorectal cancer. The test offers a novel, non-invasive option for
determining an individual’s current risk for colorectal cancer and is
designed to facilitate a decision to undergo colonoscopy as well as help
prioritize patients at greater risk for the disease. Enzo will undertake
to validate and seek approval of the ColonSentry test pursuant to New
York, New Jersey and CLIA requirements, in addition to marketing, and
securing third party reimbursement for the test. Subject to regulatory
and reimbursement approval, among others, its plans are to make the test
available in the second half of calendar 2010.
In addition, the division this week announced an initial exclusive
marketing partnership with privately-owned Ikonisys, Inc., of New Haven,
CT, relating to Ikonisys’ proprietary oncoFish® cervical test, a
molecular diagnostic tool for cancer detection. Enzo Clinical Labs will
make the test available to medical practitioners requesting advanced
analysis of specimens from routine tests that are not definitive as to
the existence of cervical cancer, with Ikonisys conducting the
definitive evaluation of the specimen. The novel test is a
cost-effective supplement for those pap smears in which the results are
not entirely certain, and importantly do not involve patients having to
provide additional specimens.
Conference Call
The Company will conduct a conference call on December 11, 2009 at
8:30 AM EDT. The call can be accessed by dialing 1-888-459-5609.
International callers can dial 1-973-321-1024. Please reference PIN
number 45170643. Interested parties may also listen over the Internet at http://www.wsw.com/webcast/cc/enz4.
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 approximately two hours after the
end of the live call, through midnight (ET) on December 25, 2009. The
replay of the conference call can be accessed by dialing 1-800-642-1687,
and when prompted, use PIN number 45170643. International callers can
dial 1-706-645-9291, using the same PIN number.
NON-GAAP Financial Measures
To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley
Act, Enzo Biochem attached to this news release and will post to the
Company's investor relations web site (www.enzo.com)
any reconciliation of differences between non-GAAP financial information
that may be required in connection with issuing the Company's quarterly
financial results.
The Company, as is common in its industry, uses EBITDA as a measure of
performance to demonstrate earnings exclusive of interest, taxes,
depreciation and amortization. The Company manages its business based on
its cash flows. The Company, in its daily management of its business
affairs and analysis of its monthly, quarterly and annual performance,
makes its decisions based on cash flows, not on the amortization of
assets obtained through historical activities. The Company, in managing
its current and future affairs, cannot affect the amortization of the
intangible assets to any material degree, and therefore uses EBITDA as
its primary management guide. Since an outside investor may base its
evaluation of the Company's performance based on the Company's net loss
not its cash flows, there is a limitation to the EBITDA measurement.
EBITDA is not, and should not be considered, an alternative to net loss,
loss from operations, or any other measure for determining operating
performance of liquidity, as determined under accounting principles
generally accepted in the United States (GAAP). The most directly
comparable GAAP reference in the Company's case is the removal of
interest, taxes, depreciation and amortization.
About Enzo Biochem
Enzo Biochem, Inc., is a growth-oriented integrated life sciences and
biotechnology company focused on harnessing biological process to
develop research tools, diagnostics and therapeutics, and serves as a
provider of test services, including exotic tests, to the medical
community. Since our founding in 1976, our strategic focus has been on
the development of enabling technologies in the life sciences field.
Enzo Life Sciences develops, produces and markets proprietary labeling
and detection products for gene sequencing, genetic analysis and
immunological research, among others. Its catalog of over 40,000
products serve the molecular biology, drug discovery and pathology
research markets worldwide. Enzo Clinical Labs division provides
laboratory services for a growing roster of physicians in the New York
Metropolitan area, as well as parts of New Jersey and Pennsylvania. Its
tests include, in addition to routine tests, capabilities for detecting
molecular infection disease, molecular oncology, autoimmune disorders
and genetics. Enzo Clinical Labs also provides clinical diagnostic
services that allow Enzo to capitalize on its extensive advanced
molecular and cytogenetic capabilities and the broader trends in
predictive and personalized diagnostics. Enzo Therapeutics is a
biopharmaceutical venture that has developed multiple novel approaches
in the areas of gastrointestinal, infectious, ophthalmic and metabolic
diseases. It has focused its efforts on developing treatment regimens
for diseases and conditions for which current treatment options are
ineffective, costly, and/or cause unwanted side effects. In the course
of the company’s research and development activities, Enzo has developed
a substantial portfolio of intellectual property assets, with 249 issued
patents worldwide and over 200 pending patent applications.
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.
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ENZO BIOCHEM, INC.
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(in thousands, except per share data)
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Selected operations data:
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Three months ended
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October 31
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(unaudited)
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2009
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Notes
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2008
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Product revenues
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$10,744
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A
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$9,976
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Royalty and license fee income
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3,311
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2,916
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Clinical laboratory services
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11,110
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8,172
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Total revenues
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$25,165
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$21,064
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Gross profit
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$13,329
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B
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$8,168
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Loss before income tax benefit (provision)
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($1,893)
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($6,232)
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Benefit (provision) for income taxes
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79
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C
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(138)
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Net loss
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($1,814)
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($6,370)
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Basic and diluted loss per share
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($0.05)
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($0.17)
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Weighted average shares - basic and diluted
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37,855
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37,337
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Reconciliation of GAAP Net
Loss to Non-GAAP measure EBITDA:
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Net loss
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($1,814)
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($6,370)
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Depreciation and amortization
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943
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754
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Interest income
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(9)
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(410)
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Benefit (provision) for income taxes
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(79)
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138
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EBITDA
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($959)
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D
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($5,888)
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Basic and diluted loss per share - EBITDA
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($0.03)
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($0.16)
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Weighted average shares - basic and diluted
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37,855
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37,337
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A- 2009 includes among other items; $1.0 million in organic growth
from core products, $2.7 million in products revenues from
an acquisition on March 12, 2009, partially offset by a reduction
in low margin distribution product revenue of $2.9 million.
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B- 2009 and 2008 include $0.1 million and $0.5 million, respectively
for inventory fair value adjustments relating to acquisitions.
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C- All periods reflect effective tax rates below the statutory rate
due to limitation on recording future tax benefits.
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D- EBITDA is a non-GAAP measure, see press release comments.
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Selected balance sheet data:
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October 31, 2009
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July 31, 2009
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(unaudited)
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(audited)
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Cash and cash equivalents and short term investments
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$46,382
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$50,235
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Working capital
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$59,176
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$60,518
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Stockholders' equity
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$116,180
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$116,781
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Total assets
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$131,760
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$133,128
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