UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
Mark one
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended April 30, 2007
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________ to ______________
Commission File Number 001-09974
ENZO BIOCHEM, INC.
------------------------------------------------------
(Exact name of registrant as specified in its charter)
New York 13-2866202
- --------------------------- -------------
(State or Other Jurisdiction (IRS. Employer
of Incorporation or Organization) Identification No.)
527 Madison Ave, New York, New York 10022
- ------------------------------------ --------
(Address of Principal Executive office) (Zip Code)
212-583-0100
- -------------------------
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Common Stock, $0.01 par value New York Stock Exchange
- ----------------------------- -----------------------
(Title of Class) (Name of Each Exchange on which Registered)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant has
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes [X] No [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer (as defined in Rule 12b-2 of the
Exchange Act).
Large accelerated filer [ ] Accelerated filer [X] Non-accelerated filer [ ]
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act.)
Yes [ ] No [X]
As of June 1, 2007, the Registrant had approximately 36,704,000 shares of
Common Stock outstanding.
ENZO BIOCHEM, INC.
FORM 10-Q
April 30, 2007
INDEX
PART I - FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
Consolidated Balance Sheets
April 30, 2007 (unaudited) and July 31, 2006 3
Consolidated Statements of Operations
For the three and nine months ended April 30, 2007 and 2006 (unaudited) 4
Consolidated Statements of Cash Flows
For the nine months ended April 30, 2007 and 2006 (unaudited) 5
Notes to Consolidated Financial Statements 6
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations 17
Item 3. Quantitative and Qualitative Disclosures About Market Risk 30
Item 4. Controls and Procedures 30
PART II - OTHER INFORMATION
Item 1. Legal Proceedings 31
Item 1A. Risk Factors 31
Item 6. Exhibits 31
Signatures 31
2
PART 1 - FINANCIAL INFORMATION
ITEM 1 - CONSOLIDATED FINANCIAL STATEMENTS
ENZO BIOCHEM, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE DATA)
ASSETS April 30, July 31,
2007 2006
(unaudited) (Note 1)
----------- --------
Current assets:
Cash and cash equivalents $120,024 $69,854
Accounts receivable, net of allowances 11,779 10,447
Other receivables 1,500 -
Inventories 2,121 2,401
Prepaid expenses 739 1,465
Recoverable and prepaid income taxes 1,765 1,931
-------- --------
Total current assets 137,928 86,098
Property, plant, and equipment, net of accumulated
depreciation and amortization 6,181 5,848
Goodwill 7,452 7,452
Patent costs, net of accumulated amortization 1,198 1,257
Other 1,699 869
-------- --------
Total assets $154,458 $101,524
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable - trade $1,595 $1,304
Accrued liabilities 6,233 4,403
Other current liabilities 1,024 230
-------- --------
Total current liabilities 8,852 5,937
Deferred revenue 1,050 -
Commitments and contingencies
Stockholders' equity:
Preferred Stock, $.01 par value; authorized 25,000,000 shares; no
shares issued or outstanding - -
Common Stock, $.01 par value; authorized 75,000,000 shares; shares
issued: 37,298,500 at April 30, 2007 and 32,844,200 at July 31, 2006 373 328
Additional paid-in capital 295,272 236,002
Less treasury stock at cost: 596,500 shares at April 30, 2007
and 569,700 shares at July 31, 2006 (8,915) (8,499)
Accumulated deficit (142,174) (132,244)
-------- --------
Total stockholders' equity 144,556 95,587
-------- --------
Total liabilities and stockholders' equity $154,458 $101,524
======== ========
3
The accompanying notes are an integral part of
these consolidated financial statements
ENZO BIOCHEM, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Three Months Ended Nine Months Ended
April 30, April 30,
2007 2006 2007 2006
---- ---- ---- ----
Revenues:
Product revenues $883 $1,179 $2,699 $3,900
Royalty income 1,547 717 3,756 2,251
Clinical laboratory services 11,530 7,734 28,543 23,759
------ ----- ------ ------
13,960 9,630 34,998 29,910
Costs and expenses and other (income):
Cost of product revenues 773 588 1,698 1,515
Cost of clinical laboratory services 5,253 3,384 12,815 10,296
Research and development expense 2,614 1,901 6,935 5,361
Selling, general, and administrative expense 6,235 6,153 19,015 18,935
Provision for uncollectible accounts receivable 1,338 517 3,433 2,870
Legal expense 3,049 1,719 7,159 5,213
Interest income (1,548) (839) (3,627) (2,226)
Other income - - (2,699) -
------ ------ ------ ------
17,714 13,423 44,729 41,964
------ ------ ------ ------
Loss before income taxes (3,754) (3,793) (9,731) (12,054)
(Provision) benefit for income taxes (79) 357 (199) 896
------ ------ ------ ------
Net loss ($3,833) ($3,436) ($9,930) ($11,158)
======== ======= ======== =========
Net loss per common share:
Basic ($0.10) ($0.11) ($0.29) ($0.35)
======= ======= ======= =======
Diluted ($0.10) ($0.11) ($0.29) ($0.35)
======= ======= ======= =======
Weighted average common shares outstanding:
Basic 36,630 32,245 34,465 32,201
====== ====== ====== ======
Diluted 36,630 32,245 34,465 32,201
====== ====== ====== ======
4
The accompanying notes are an integral part of
these consolidated financial statements
ENZO BIOCHEM, INC
CONSOLIDATED STATEMENTS OF CASH FLOWS
UNAUDITED
(IN THOUSANDS)
Nine Months Ended
April 30,
2007 2006
------------------------
OPERATING ACTIVITIES
Net loss ($9,930) ($11,158)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization of property, plant and equipment 736 791
Amortization of patent costs 59 56
Provision for uncollectible accounts receivable 3,433 2,870
Write-off and/or reserve for obsolete inventory 365 280
Deferred taxes - 640
Share based compensation charges 1,182 1,353
Issuance of stock for 401(k) employer match 419 400
Loss on marketable securities - 153
Other 8 25
Changes in operating assets and liabilities:
Accounts receivable (4,765) (627)
Other receivables (1,500) -
Inventories (85) (184)
Prepaid expenses 726 1,077
Recoverable and prepaid income taxes 166 (1,566)
Accounts payable - trade 291 (633)
Accrued liabilities 1,098 176
Other current liabilities 794 (509)
Long term deferred revenue 1,050 -
------ -
Adjustments 3,977 4,302
-------- -------
Net cash used in operating activities (5,953) (6,856)
-------- -------
INVESTING ACTIVITIES
Capital expenditures (1,069) (1,249)
Sales of marketable securities - 6,764
Purchases of marketable securities - (69)
Increase in cash surrender values (88) (14)
Increase in security deposits (10) (8)
---- ---
Net cash (used in) provided by investing activities (1,167) 5,424
-------- -------
FINANCING ACTIVITIES
Net proceeds from issuance of common stock 56,997 -
Proceeds from the exercise of stock options 293 363
--- ---
Net cash provided by financing activities 57,290 363
-------- -------
Net increase (decrease) in cash and cash equivalents 50,170 (1,069)
Cash and cash equivalents at the beginning of period 69,854 76,981
-------- -------
Cash and cash equivalents at the end of period $120,024 $75,912
======== =======
5
The accompanying notes are an integral part of
these consolidated financial statements
ENZO BIOCHEM, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
As of April 30, 2007
and for the three and nine month periods ended
April 30, 2007 and 2006
(Unaudited)
NOTE 1 - BASIS OF PRESENTATION
The accompanying unaudited consolidated financial statements include the
accounts of Enzo Biochem, Inc. and its wholly owned subsidiaries, Enzo Clinical
Labs, Enzo Life Sciences, Enzo Therapeutics and Enzo Realty LLC (the "Company"
or "Companies"). The consolidated balance sheet as of April 30, 2007 and the
consolidated statements of operations and statements of cash flows for the three
and nine month periods ended April 30, 2007 and 2006 are unaudited and reflect
all adjustments (consisting only of normal recurring adjustments) which are, in
the opinion of management, necessary for a fair presentation of the financial
position and operating results for the interim periods. The consolidated
financial statements should be read in conjunction with the consolidated
financial statements for the year ended July 31, 2006 and notes thereto
contained in the Company's Annual Report on Form 10-K filed with the Securities
and Exchange Commission. The consolidated balance sheet at July 31, 2006 has
been derived from the audited financial statements at that date. The results of
operations for the three and nine months ended April 30, 2007 are not
necessarily indicative of the results to be expected for the entire fiscal year
ending July 31, 2007.
Recent Accounting Pronouncements
In May 2005, the FASB issued SFAS No. 154, "Accounting Changes and Error
Corrections ("SFAS 154"), a replacement of APB Opinion No. 20, Accounting
Changes, and FASB Statement No. 3, Reporting Accounting Changes in Interim
Financial Statements". SFAS 154 changes the requirements for the accounting for
and reporting of a change in accounting principle. Previously, most voluntary
changes in accounting principles required recognition via a cumulative effect
adjustment within net income for the period of the change. SFAS 154 requires
retrospective application to prior periods' financial statements, unless it is
impracticable to determine either the period-specific effects or the cumulative
effect of the change. SFAS 154 is effective for accounting changes made in
fiscal years beginning after December 15, 2005; however, SFAS 154 does not
change the transition provisions of any existing accounting pronouncements. The
adoption of SFAS 154 did not have a material impact on the Company's financial
condition or results of operations.
In June 2006, the FASB issued FASB Interpretation No. 48 ("FIN 48"), "Accounting
for Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109,
Accounting for Income Taxes" ("SFAS 109")", to clarify the accounting for
uncertainty in income taxes recognized in an enterprise's financial statements
in accordance with SFAS 109. This Interpretation prescribes a recognition
threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. FIN
48 also provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure, and transition. The
provisions of FIN 48 are effective for fiscal years beginning after December 15,
2006. The Company has not evaluated the impact of FIN 48 on its financial
statements at this time.
6
In September 2006, the SEC released Staff Accounting Bulletin No. 108
"Considering the Effects of Prior Year Misstatements When Quantifying
Misstatements in Current Year Financial Statements" ("SAB 108"). SAB 108
provides interpretative guidance on how public companies quantify financial
statement misstatements. There have been two common approaches used to quantify
such errors. Under an income statement approach, the "roll-over" method, the
error is quantified as the amount by which the current year income statement is
misstated. Alternatively, under a balance sheet approach, the "iron curtain"
method, the error is quantified as the cumulative amount by which the current
year balance sheet is misstated. In SAB 108, the SEC established an approach
that requires quantification of financial statement misstatements based on the
effects of the misstatements on each of the company's financial statements and
the related financial statement disclosures. This model is commonly referred to
as a "dual approach" because it requires quantification of errors under both the
roll-over and iron curtain methods. SAB 108 is effective for the Company as of
August 1, 2007. The adoption of SAB 108 is not expected to have a material
impact on the Company's consolidated financial statements.
In September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements". This
Statement defines fair value, establishes a framework for measuring fair value
and expands disclosure about fair value measurements, and is effective for
financial statements issued for fiscal years beginning after November 15, 2007,
and interim periods within those fiscal years. The Company has not evaluated the
effect that the adoption of this Statement will have on its financial statements
at this time.
In February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for
Financial Assets and Financial Liabilities - Including an amendment of FASB
Statement No. 115" ("SFAS 159"). This statement permits entities to choose to
measure many financial instruments and certain other items at fair value. The
objective is to improve financial reporting by providing entities with the
opportunity to mitigate volatility in reported earnings caused by measuring
related assets and liabilities differently without having to apply complex hedge
accounting provisions. SFAS 159 is effective as of the beginning of fiscal years
that begin after November 15, 2007. The Company has not evaluated the effect
that the adoption of this Statement will have on its financial statements at
this time.
Reclassifications
Certain balances in the prior period have been reclassified to conform to the
presentation in the current period.
NOTE 2 - NET LOSS PER SHARE
Basic net loss per common share is computed using the weighted average number of
common shares outstanding during the three and nine months ended April 30, 2007
and 2006. Diluted net loss per common shares is computed using the weighted
average number of shares outstanding during the three and nine months ended
April 30, 2007 and 2006, and excludes the effect of dilutive potential common
shares (consisting of employee stock options and unvested restricted stock
awards) as their inclusion would be antidilutive. Accordingly, basic and diluted
net loss per share is the same during these periods.
7
The following table summarizes the potential number of shares issued from
exercise of "in the money" stock options, net of shares repurchased with the
option exercise proceeds, and potential shares from restricted stock awards,
which are excluded from the computation of diluted net loss per share.
Three months ended Nine months ended
April 30, April 30,
(In thousands)
2007 2006 2007 2006
---- ---- ---- ----
Potential net shares, issued from exercise of 733 408 621 451
"in the money" employee and director stock === === === ===
options and restricted stock awards, excluded
from diluted net loss per share calculation
The following table summarizes the number of "out of the money" options excluded
from the computation of diluted net loss per share because the effect of their
potential exercise is anti-dilutive.
Three months ended Nine months ended
(In thousands) April 30, April 30,
2007 2006 2007 2006
---- ---- ---- ----
"Out of the money" stock options 905 1,109 905 1,109
=== ===== === =====
NOTE 3 - SHARE-BASED COMPENSATION
The Company adopted SFAS No. 123(R), "Share-Based Payment" ("SFAS 123(R)") and
related interpretations effective August 1, 2005. Compensation costs recognized
in the three and nine month periods ended April 30, 2007 and 2006 include
compensation costs for all share-based payments granted prior to, but not yet
vested as of July 31, 2005, based on the grant date fair value estimated in
accordance with the original provisions of SFAS No. 123, and compensation costs
for all share-based payments granted subsequent to August 1, 2005, based on the
grant fair value estimated in accordance with the provisions of SFAS 123(R).
The following table sets forth the amount of share-based compensation expense
upon vesting and per share data related to share-based payment arrangements
included in the accompanying statements of operations:
Three months ended Nine months ended
In thousands, except per share data April 30, April 30,
- ----------------------------------- 2007 2006 2007 2006
------ ----- ------ ------
Stock options $91 $427 $767 $1,267
Restricted stock awards 221 57 415 86
------ ----- ------ ------
Total $312 $484 $1,182 $1,353
====== ===== ====== ======
Impact on basic and diluted net loss per
common share $0.01 $0.01 $0.03 $0.04
====== ===== ====== ======
As included in the statements of operations
- -------------------------------------------
Cost of product revenues $4 $ -- $10 $18
Research and development 50 38 148 200
Selling, general and administrative 258 446 1,024 1,135
------ ------ ------ ------
$312 $484 $1,182 $1,353
====== ====== ====== ======
No excess tax benefits were recognized during the three and nine month periods
ended April 30, 2007 and 2006.
8
STOCK OPTION PLANS
A summary of the activity relating to the Company's stock option plans for the
nine month period ended April 30, 2007 is as follows:
Weighted Average Aggregate
Options Exercise Price Intrinsic Value
------- -------------- ---------------
Outstanding at August 1, 2006 2,877,727 $13.20 $3,700,000
==========
Granted - -
Exercised (71,696) $9.88
Cancelled (75,447) $13.12
--------
Outstanding at end of period 2,730,584 $13.29 $11,590,000
========= ===========
Exercisable at end of period 2,552,637 $13.34 $10,850,000
========= ===========
Available for grant at April 30, 2007 607,300
=======
The Company did not grant stock options during the nine months ended April 30,
2007. As of April 30, 2007, there was approximately $495,000 of total
unrecognized compensation cost related to nonvested stock option-based
compensation, which will be recognized over a weighted average life of
approximately one year.
During the nine months ended April 30, 2007 and 2006, the Company received cash
proceeds of approximately $293,000 and $363,000, respectively, from the exercise
of 28,584 and 34,191 stock options, respectively. The aggregate intrinsic value
of stock options exercised during the nine months ended April 30, 2007 and 2006,
including the non-cash transactions (Note 4) was approximately $0.4 million and
$0.6 million, respectively.
During the year ended July 31, 2006, the Company granted 100,000 options to a
consultant with an exercise price of $24.84, which vested over nine months and
have a two year term. The fair value of these options on September 6, 2006 (the
vesting date) was $89,000. The fair value of the options, which was accounted
for as a variable instrument, was fair valued and recognized as expense over the
nine month vesting term. The assumptions used to fair value this option grant
were as follows: risk free interest rate of 4.97%, expected term of 2 years,
expected volatility of 49%, and no dividend yield. In connection with the
options issued to this consultant, the Company recognized an expense of
approximately $8,000 in selling, general and administrative expense in the
accompanying statement of operations for the nine months ended April 30, 2007.
RESTRICTED STOCK AWARDS
During the nine months ended April 30, 2007, the compensation committee of the
Company's board of directors approved grants of restricted stock-based
compensation awards (the "Awards") of 72,400 shares to certain independent
directors, executive officers and employees. During the nine months ended April
30, 2006, the compensation committee of the Company's board of directors
approved Awards of 67,950 shares, inclusive of cancellations of 7,500 shares.
A summary of the activity pursuant to the Company's Awards for the nine months
ended April 30, 2007 is as follows:
Weighted Average
Awards Award Price
------ -----------
Nonvested at August 1, 2006 77,450 $12.21
Granted 72,400 $14.85
Vested (18,663) $13.39
Cancelled (6,800) $13.41
-------
Nonvested at end of period 124,387 $13.30
=======
9
The fair value of nonvested shares is determined based on the closing stock
price on the grant date. As of April 30, 2007, there was approximately $1.3
million of total unrecognized compensation cost related to nonvested restricted
stock-based compensation to be recognized over a weighted average period of two
years.
NOTE 4 - SUPPLEMENTAL DISCLOSURE FOR STATEMENT OF CASH FLOWS
Supplemental information with respect to the Company's consolidated statements
of cash flows is as follows:
Nine months ended April 30,
(In thousands) 2007 2006
---- ----
Taxes paid - net $26 $2
=== ====
During the nine months ended April 30, 2007, certain officers of the Company
exercised 43,112 stock options in a non-cash transaction. The officers
surrendered 26,697 shares of previously acquired common stock to exercise the
stock options. The Company recorded approximately $0.4 million, the market value
of the surrendered shares, as treasury stock.
During the nine months ended April 30, 2006, certain officers of the Company
exercised 221,116 stock options in a non-cash transaction. The officers
surrendered 180,411 shares of previously acquired common stock to exercise the
stock options. The Company recorded approximately $2.4 million, the market value
of the surrendered shares, as treasury stock.
NOTE 5 - INVENTORIES
Inventories, net of reserves for excess and obsolete inventory of $360,000 and
$238,000, respectively, consist of the following, as of:
(In thousands) April 30, 2007 July 31, 2006
-------------- -------------- -------------
Raw materials $15 $38
Work in process 1,102 1,518
Finished products 1,004 845
------ ------
$2,121 $2,401
====== ======
NOTE 6 - ACCRUED LIABILITIES AND OTHER CURRENT LIABILITIES
Accrued liabilities consist of:
In 000'S April 30, 2007 July 31, 2006
- -------- -------------- -------------
Legal $2,905 $1,974
Payroll, benefits, and commissions 1,227 868
Research and development 469 408
Professional fees 907 369
Outside reference lab testing 50 122
Other 675 662
------ ------
$6,233 $4,403
====== ======
10
Other current liabilities consist of:
In 000'S April 30, 2007 JULY 31, 2006
- -------- -------------- -------------
Installment payable $ - $150
Deferred revenue 770 80
Other 254 -
------ ----
$1,024 $230
====== ====
NOTE 7 - INCOME TAXES
At the end of each interim reporting period, the Company estimates its effective
income tax rate expected to be applicable for the full year. This estimate is
used to determine the income tax provision or benefit on a year-to-date basis
and may change in subsequent interim periods.
The tax provisions for the three and nine months ended April 30, 2007 were based
on state and local taxes, and differed from the expected net operating loss
carryforward benefit at the U.S. federal statutory rate of 34% primarily due to
the inability to recognize such benefit. The carryforward benefit cannot be
recognized because of uncertainties relating to future taxable income, in terms
of both its timing and its sufficiency.
The tax benefit for the three months ended April 30, 2006 differed from the
expected net operating loss carryforward benefit at the U.S. federal statutory
rate of 34% primarily due to limitations on the timing of the recognition of the
Company's then available federal tax carryback benefit for taxes paid in prior
years. The tax benefit also differs from the expected net operating loss
carryforward benefit due to the inability to recognize such benefit. The
carryforward benefit could not be recognized because of uncertainties relating
to future taxable income, in terms of both its timing and its sufficiency.
The tax benefit for the nine months ended April 30, 2006 differed from the
expected net operating loss carryforward benefit at the U.S. federal statutory
rate of 34% primarily due to limitations on the timing of the recognition of the
Company's then available federal tax carryback benefit for taxes paid in prior
years. The tax benefit also differs from the expected net operating loss
carryforward benefit due to the inability to recognize such benefit. The
carryforward benefit could not be recognized because of uncertainties relating
to future taxable income, in terms of both its timing and its sufficiency.
Also due to these uncertainties, the Company recorded during the first quarter
of the 2006 period a valuation allowance equal to its net deferred tax assets,
including the federal net operating loss carryforward benefit generated during
the first quarter of the 2006 period. The Company recorded the valuation
allowance as it concluded that it was not more likely than not that its net
deferred tax assets would be realized in the foreseeable future based on
positive and negative evidence available at the time.
11
In November 2005, the FASB issued FSP FAS 123(R)-3, "Transition Election Related
to Accounting for the Tax Effects of Share-Based Payment Awards", to provide an
alternate transition method for the implementation of SFAS 123(R). Because some
entities do not have, and may not be able to re-create, information about the
net excess tax benefits that would have qualified as such had those entities
adopted SFAS 123(R) for recognition purposes, this FSP provides an elective
alternative transition method. The method comprises (a) a computational
component that establishes a beginning balance of the additional paid in capital
pool ("APIC pool") related to employee compensation and (b) a simplified method
to determine the subsequent impact on the APIC pool of employee awards that are
fully vested and outstanding upon the adoption of SFAS 123(R). The Company
adopted the principles set forth in this FSP to determine its APIC pool.
NOTE 8 - ROYALTY INCOME
In fiscal 2005, the Company as plaintiff finalized and executed a settlement and
license agreement with Digene Corporation to settle a patent litigation lawsuit
(the "Agreement"). Subsequent to the settlement, the Agreement provides for the
Company to receive quarterly running royalties on the net sales of Digene
products subject to the license until the expiration of the patent in April
2018. Royalty income arising from the Agreement is included in the Life Sciences
segment (see Note 12).
NOTE 9 - OTHER INCOME
GAIN ON PATENT LITIGATION SETTLEMENT
The Company as plaintiff and Sigma Aldrich ("Sigma") entered into a Settlement
Agreement and Release effective September 15, 2006 (the "Settlement Agreement").
Pursuant to the Settlement Agreement, the Company's litigation with Sigma was
dismissed and the Company recognized a $2 million gain on patent litigation
settlement included in "Other income" in the accompanying consolidated statement
of operations for the nine months ended April 30, 2007.
PAYMENT FROM FORMER DISTRIBUTOR
During the quarter ended January 31, 2007, the Company received a payment of
approximately $699,000 from Perkin Elmer Inc. ("Perkin Elmer") for amounts due
under a Distribution Agreement (the "Distribution Agreement") which terminated
December 31, 2004. The Distribution Agreement is presently subject to a lawsuit
for breach of contract, patent infringement, unfair competition under state law,
unfair competition under federal law, tortuous interference with business
relations, and fraud in the inducement of contract. Perkin Elmer advised in a
letter to the Company that the payment was owed under the Distribution Agreement
and was delayed because of changes to their accounting system and personnel
changes and that it was always their intent to comply with the Distribution
Agreement. The Company advised Perkin Elmer that the payment did not represent
all amounts owed under the Distribution Agreement. Accordingly, the payment has
been included in "Other income" in the accompanying consolidated statements of
operations for the nine months ended April 30, 2007.
12
NOTE 10 - LICENSING AND SUPPLY AGREEMENT:
On April 26, 2007 (the "Effective Date") Enzo Life Sciences, Inc. ("Life
Sciences") and Abbott Molecular Inc. ("Abbott") entered into an agreement
covering the supply of certain of Life Science's products to Abbott for use in
their product line. The supply arrangement has a term of 5 years. The parties
have also entered into a limited non-exclusive royalty bearing cross-licensing
agreement ("Licensing Agreement") for various patents. The Licensing Agreement
requires each party to pay royalties, as defined through the lives of the
related covered patents. In connection with a component of the License
Agreement, Abbott will pay a one-time fee of $1.5 million, relating to a fully
paid-up license and sublicense, as defined. The one-time fee will be deferred
and recognized as revenue over the expected patents' lives. At April 30, 2007,
the Company's consolidated balance sheet includes a receivable for the
aforementioned $1.5 million and corresponding deferred revenue. No recognition
of the aforementioned deferred revenue occurred through April 30, 2007. During
the quarter ended April 30, 2007, Life Sciences recorded $575,000 in royalties
under the component of the Licensing Agreement that provided for royalty
payments effective from September 1, 2006.
The Company recognizes revenue in accordance with Staff Accounting Bulletin No.
104, "Revenue Recognition" (SAB 104), when (i) persuasive evidence of an
arrangement exists, (ii) delivery has occurred or services have been rendered,
(iii) the price is fixed and determinable, and (iv) collectibility is reasonably
assured. The Company evaluates revenue from agreements that have multiple
elements to determine whether the components of the arrangement represent
separate units of accounting as defined in EITF Issue No. 00-21, "Revenue
Arrangements with Multiple Deliverables" (EITF 00-21). To recognize revenue for
a delivered item in a multiple element arrangement, EITF 00-21 requires that the
delivered items have value to the customer on a stand-alone basis, there is
objective and reliable evidence of fair value of the undelivered items, and
delivery of any undelivered items is probable and within our control.
NOTE 11 - STOCKHOLDERS' EQUITY
On December 8, 2006, the Securities and Exchange Commission ("SEC") declared
effective the shelf Registration Statement the Company filed on Form S-3 on
November 13, 2006. The shelf Registration Statement allows the Company to offer
and sell up to an aggregate of $100 million of common stock from time to time in
one or more offerings. The terms of any such offering would be established at
the time of such offering.
On December 14, 2006, the Company entered into a Placement Agent Agreement with
Lazard Capital Markets LLC, as exclusive placement agent, relating to a
"registered direct" offering ("Offering") of shares of the Company's common
stock. On December 15, 2006, the Company entered into a definitive Subscription
Agreement with various institutional investors relating to the sale of an
aggregate of 3,285,715 shares of common stock for a purchase price of $14.00 per
share. Net proceeds from the Offering aggregating $42.9 million, net of
placement fees and financing costs of $3.1 million, were credited to common
stock and additional paid-in capital. On December 15, 2006, the Company filed a
prospectus supplement with the SEC relating to the Offering under the
Registration Statement and supplement thereto.
13
On February 2, 2007, the Company entered into a Placement Agent Agreement with
Lazard Capital Markets LLC, as exclusive placement agent, relating to a
"registered direct" offering ("Subsequent Offering") of shares of the Company's
common stock. On February 2, 2007, the Company entered into a definitive
Subscription Agreement with an investor relating to the sale of an aggregate of
1,000,000 shares of common stock for a purchase price of $15.00 per share. Net
proceeds from the Subsequent Offering aggregated $14.1 million, net of placement
fees and financing costs of $0.9 million were credited to common stock and
additional paid in capital. On February 5, 2007, the Company filed a prospectus
supplement with the SEC relating to the Subsequent Offering under the
Registration Statement and supplement thereto.
NOTE 12 - SEGMENT REPORTING
The Company has three reportable segments: Life Sciences, Therapeutics, and
Clinical Labs. The Company's Life Sciences segment develops, manufactures, and
markets products to research and pharmaceutical customers. The Company's
Therapeutic segment conducts research and development activities for therapeutic
drug candidates. The Clinical Labs segment provides diagnostic services to the
medical community. Prior to the fourth quarter ended July 31, 2006, the Life
Sciences and Therapeutics segments were reported together as the Research and
Development segment. The April 30, 2006 segment information has been restated to
reflect this change. The Company evaluates segment performance based on segment
income (loss) before taxes. Costs excluded from segment income (loss) before
taxes and reported as other consist of corporate general and administrative
costs which are not allocable to the three reportable segments. Certain expenses
were reclassified among segments in the fiscal 2006 periods for comparative
purposes.
Management of the Company assesses assets on a consolidated basis only and
therefore, assets by reportable segment have not been included in the reportable
segments below. The accounting policies of the reportable segments are the same
as those described in the summary of critical accounting policies.
14
The following financial information (in thousands) represents the operating
results of the reportable segments of the Company:
THREE MONTHS ENDED APRIL 30, 2007
REVENUES: Life Sciences Therapeutics Clinical Labs Other Consolidated
------------- ------------ ------------- ----- ------------
Product revenues $883 -- -- -- $883
Royalty income 1,547 -- -- -- 1,547
Clinical laboratory services -- -- $11,530 -- 11,530
-- -- ------- -- ------
2,430 -- 11,530 -- 13,960
COST AND EXPENSES AND OTHER (INCOME):
Cost of products 773 -- -- -- 773
Cost of clinical laboratory services -- -- 5,253 -- 5,253
Research and development 749 $1,865 -- -- 2,614
Provision for uncollectible accounts -- -- 1,338 -- 1,338
Selling, general and administrative and legal 471 -- 3,575 $5,238 9,284
Interest income -- -- -- (1,548) (1,548)
Other income -- -- -- -- --
-- -- -- -- --
Income (loss) before income taxes $437 ($1,865) $1,364 ($3,690) ($3,754)
====== ======== ====== ======== ========
Depreciation and amortization included above $43 $4 $212 $8 $267
=== == ==== == ====
SHARE-BASED COMPENSATION INCLUDED IN ABOVE:
Cost of products $4 -- -- -- $4
Research and development 17 $33 -- -- 50
Selling, general and administrative and legal 8 -- $65 $185 258
- -- --- ---- ---
Total $29 $33 $65 $185 $312
=== === === ==== ====
Capital expenditures $365 $9 $385 $ - $759
==== == ==== ==== ====
THREE MONTHS ENDED APRIL 30, 2006
REVENUES: Life Sciences Therapeutics Clinical Labs Other Consolidated
------------- ------------ ------------- ----- ------------
Product revenues $1,179 -- -- -- $1,179
Royalty income 717 -- -- -- 717
Clinical laboratory services -- -- $7,734 -- 7,734
-- -- ------ -- -----
1,896 -- 7,734 -- 9,630
COST AND EXPENSES AND OTHER (INCOME):
Cost of products 588 -- -- -- 588
Cost of clinical laboratory services -- -- 3,384 -- 3,384
Research and development 880 $1,021 -- -- 1,901
Provision for uncollectible accounts -- -- 517 -- 517
Selling, general and administrative and legal 631 -- 3,646 $3,595 7,872
Interest income -- -- -- (839) (839)
-- -- -- ----- -----
Income (loss) before income taxes ($203) ($1,021) $187 ($2,756) ($3,793)
====== ======== ==== ======== ========
Depreciation and amortization included above $44 $2 $231 $8 $285
=== == ==== == ====
SHARE-BASED COMPENSATION INCLUDED IN ABOVE:
Cost of products -- -- -- -- --
Research and development $2 $36 -- -- $38
Selling, general and administrative and legal 33 -- $182 $231 446
-- -- ---- ---- ---
Total $35 $36 $182 $231 $484
=== === ==== ==== ====
Capital expenditures $20 $ - $204 $77 $301
=== === ==== === ====
15
NINE MONTHS ENDED APRIL 30, 2007
REVENUES: Life Sciences Therapeutics Clinical Labs Other Consolidated
------------- ------------ ------------- ----- ------------
Product revenues $2,699 -- -- -- $2,699
Royalty income 3,756 -- -- -- 3,756
Clinical laboratory services -- -- $28,543 -- 28,543
-- -- ------- -- ------
6,455 -- 28,543 -- 34,998
COST AND EXPENSES AND OTHER (INCOME):
Cost of products 1,698 -- -- -- 1,698
Cost of clinical laboratory services -- -- 12,815 -- 12,815
Research and development 2,481 $4,454 -- -- 6,935
Provision for uncollectible accounts -- -- 3,433 -- 3,433
Selling, general and administrative and legal 1,479 -- 10,658 $14,037 26,174
Interest income -- -- -- (3,627) (3,627)
Other income (2,699) -- -- -- (2,699)
------- -- -- -- -------
Income (loss) before income taxes $3,496 ($4,454) $1,637 ($10,410) ($9,731)
====== ======== ====== ========= ========
Depreciation and amortization included above $135 $11 $623 $26 $795
==== === ==== === ====
SHARE-BASED COMPENSATION INCLUDED IN ABOVE:
Cost of products $10 -- -- -- $10
Research and development 53 $95 -- -- 148
Selling, general and administrative and legal 23 -- $303 $698 1,024
-- -- ---- ---- -----
Total $86 $95 $303 $698 $1,182
=== === ==== ==== ======
Capital expenditures $426 $16 $627 $ - $1,069
==== === ==== === ======
NINE MONTHS ENDED APRIL 30, 2006
REVENUES: Life Sciences Therapeutics Clinical Labs Other Consolidated
------------- ------------ ------------- ----- ------------
Product revenues $3,900 -- -- -- $3,900
Royalty income 2,251 -- -- -- 2,251
Clinical laboratory services -- -- $23,759 -- 23,759
-- -- ------- -- ------
6,151 -- 23,759 -- 29,910
COST AND EXPENSES AND OTHER (INCOME):
Cost of products 1,515 -- -- -- 1,515
Cost of clinical laboratory services -- -- 10,296 -- 10,296
Research and development 2,659 $2,702 -- -- 5,361
Provision for uncollectible accounts -- -- 2,870 -- 2,870
Selling, general and administrative and legal 1,724 -- 10,648 $11,776 24,148
Interest income -- -- -- (2,226) (2,226)
-- -- -- ------- -------
Income (loss) before income taxes $253 ($2,702) ($55) ($9,550) ($12,054)
==== ======== ===== ======== =========
Depreciation and amortization included above $135 $8 $678 $26 $847
==== == ==== === ====
SHARE-BASED COMPENSATION INCLUDED IN ABOVE:
Cost of products $18 -- -- -- $18
Research and development 92 $108 -- -- 200
Selling, general and administrative and legal 73 -- $474 $588 1,135
-- -- ---- ---- -----
Total $183 $108 $474 $588 $1,353
==== ==== ==== ==== ======
Capital expenditures $32 $ - $819 $398 $1,249
=== === ==== ==== ======
16
NOTE 13- SUBSEQUENT EVENT
Effective May 31, 2007 (the "Effective Date"), the Company's wholly owned
subsidiary, Enzo Life Sciences, Inc., completed the acquisition of the stock of
Axxora Life Sciences, Inc., ("Axxora") a privately owned global manufacturer and
marketer of life sciences research products, for approximately $16.3 million in
cash. On the Effective Date, Axxora became a wholly owned subsidiary of Enzo
Life Sciences. Axxora had revenues of approximately $16 million in 2006. Axxora
has wholly-owned subsidiaries in the U.S., Switzerland, Germany and the United
Kingdom, as well as distributors located in other major markets. At April 30,
2007, the Company has recorded approximately $732,000 in acquisition costs which
are included in "Other assets" in the accompanying balance sheet.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations
should be read in conjunction with our financial statements and related notes.
This discussion contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those anticipated
in these forward-looking statements. See "Forward-Looking and Cautionary
Statements" in our Form 10-K for the year ended July 31, 2006. Because of those
factors, you should not rely on past financial results as an indication of
future performance. We believe that period-to-period comparisons of our
financial results to date are not necessarily meaningful and expect that our
results of operations might fluctuate from period to period in the future.
The Company is a life sciences and biotechnology company focused on harnessing
genetic processes to develop research tools and therapeutics and the provision
of diagnostic services to the medical community. Since its founding in 1976, the
Company's strategic focus has been on the development, for commercial purposes,
of enabling technologies in the life sciences field. The Company's pioneering
work in genomic analysis coupled with its extensive patent estate and enabling
platforms have strategically positioned the Company to play a crucially
important role in the rapidly growing life sciences and molecular medicine
marketplaces.
The Company is comprised of three interconnected operating companies that have
evolved out of the Company's core competence: the use of nucleic acids as
informational molecules and the use of compounds for immune response modulation.
These wholly owned operating Companies conduct their operations through three
segments (see Note 12 in the notes to consolidated financial statements).
The Company's sources of revenue from the Life Sciences segment is from the
direct sales of products consisting of labeling and detection reagents for the
genomics and sequencing markets, as well as through non-exclusive distribution
agreements with other companies and royalty income. The Company's other source
of revenue is from the clinical laboratory service market. Payments for clinical
laboratory testing services are made by the Medicare program, healthcare
insurers and patients. Fees billed to patients, Medicare, and third party
providers are billed on the laboratory's standard gross fee schedule, subject to
any limitations on fees negotiated with the third party providers or with the
ordering physicians on behalf of their patients.
The Company incurs additional costs as a result of our participation in the
Medicare programs, as billing and reimbursement for clinical laboratory testing
is subject to considerable and complex federal regulations. Compliance with
applicable laws and regulations, as well as internal compliance policies and
procedures, adds further complexity and costs to our operations.
17
Government providers such as Medicare, as well as healthcare insurers have taken
steps and may continue to take steps to control the costs, utilizations and
delivery of healthcare services, including clinical laboratory services. Despite
the added cost and complexity of participating in the Medicare program, we
continue to participate because we believe that our other lab services business
from ordering physicians may depend, in part, on continued participation in
Medicare since certain ordering physicians may want a single laboratory capable
of performing all of their clinical laboratory testing services, regardless of
who pays for such services.
Information systems are used extensively in virtually all aspects of the
clinical laboratory operations, including testing, billing, customer service,
logistics, and management of medical data. Our success depends, in part, on the
continued and uninterrupted performance of our information technology systems.
Through maintenance, staffing, and investments in our information technology
system, we expect to limit the risk associated with our heavy reliance on these
systems.
The clinical laboratory is subject to seasonal fluctuations in operating results
and cash flows. Typically, testing volume declines during the summer months,
year end holiday periods and other major holidays, reducing net revenues and
operating cash flows. Testing volume is also subject to declines in winter
months due to inclement weather, which varies in severity from year to year.
For the three months ended April 30, 2007 and 2006, approximately 6% and 12% of
the Company's operating revenues were derived from product sales and
approximately 11% and 8% were derived from royalty income, respectively, and
approximately 83% and 80% were derived from clinical laboratory services,
respectively. For the nine months ended April 30, 2007 and 2006, approximately
8% and 13% of the Company's operating revenues were derived from product sales
and approximately 11% and 8% were derived from royalty income, respectively, and
approximately 81% and 79% were derived from clinical laboratory services,
respectively.
COMPARATIVE OPERATING DATA
(in 000's) Three months ended
April 30, Increase %
REVENUES: 2007 2006 (Decrease) Change
---- ---- ---------- ------
Product revenues $883 $1,179 $(296) (25)
Royalty income 1,547 717 830 116
Clinical laboratory services 11,530 7,734 3,796 49
------ ----- -----
Total revenues 13,960 9,630 4,330 45
COSTS AND EXPENSES AND OTHER (INCOME):
Cost of products 773 588 185 31
Cost of laboratory services 5,253 3,384 1,869 55
Research & development 2,614 1,901 713 38
Selling, general and administrative 6,235 6,153 82 1
Provision for uncollectible A/R 1,338 517 821 159
Legal expenses 3,049 1,719 1,330 77
Interest income (1,548) (839) (709) 85
Other income - - - -
--- --- -----
Total costs and expenses - net 17,714 13,423 4,291 32
------ ------ -----
Loss before income taxes ($3,754) ($3,793) $39 (1)
======== ======== ===
18
RESULTS OF OPERATIONS
THREE MONTHS ENDED APRIL 30, 2007 AS COMPARED TO APRIL 30, 2006
CONSOLIDATED RESULTS
Product revenues during the three months ended April 30, 2007 were $0.9 million
compared to $1.2 million in the year ago quarter, a decrease of $0.3 million or
25% due to a decline in unit shipments and the continuing competitiveness in the
industry.
Royalty income during the three months ended April 30, 2007 was $1.5 million
compared to $0.7 million in the year ago quarter, an increase of $0.8 million or
116%. Royalties are earned from net sales of Digene products subject to a
license and royalties earned from Abbott under a License Agreement entered into
in the Fiscal 2007 quarter. There are no expenses relating to royalty income.
Clinical laboratory revenues during the three month period ended April 30, 2007
was $11.5 million compared to $7.7 million in the year ago quarter, an increase
of $3.8 million or 49%. The Company experienced an increase in service revenues
during the 2007 period due to an expansion of an insurance provider agreement,
partially offset by an increase in the contractual adjustment expense which
reduced gross billings by 79.8% as compared to 75.4% in the year ago period. The
increase in the contractual adjustment expense is due to continued competitive
pricing throughout the industry.
The cost of products during the three month period ended April 30, 2007 was $0.8
million compared to $0.6 million in the year ago quarter, an increase of $0.2
million or 31%. Gross profit was negatively affected during the 2007 period as
compared to the 2006 period by the incremental increase of $0.3 million in the
write-off or reserve for excess or obsolete inventory, and the decline in
product revenues.
The cost of clinical laboratory services during the three month period ended
April 30, 2007 was $5.3 million as compared to $3.4 million in the year ago
period, an increase of $1.9 million or 55%. Due to the increased volume of
patients serviced and tests performed, the Company incurred increased reagent
costs of $0.9 million, payroll related costs of $0.4 million, and outside
testing costs of $0.5 million.
Research and development expenses were approximately $2.6 million during the
three months ended April 30, 2007, compared to $1.9 million in the year ago
quarter, an increase of $0.7 million or 38%. The increase was primarily due to
an increase at the Therapeutic segment in clinical trial activities of $0.6
million and an increase in other related costs approximating $0.1 million.
Selling, general and administrative expenses were comparable in total, at
approximately $6.2 million during both the three months ended April 30, 2007 and
2006. Increases in compensation costs of $0.5 million were offset by a
comparable decline in professional fees and corporate governance costs.
The provision for uncollectible accounts receivable relating to the Clinical
Labs segment for the three months ended April 30, 2007 was $1.3 million as
compared to $0.5 million in the year ago quarter, an increase of $0.8 million or
159%, and is due to the increase in clinical laboratory revenue and the
composition of patients being serviced.
Legal expense was $3.0 million during the three months ended April 30, 2007
compared to $1.7 million in the year ago period, an increase of $1.3 million or
77%, due to an increase in ongoing patent litigation.
19
Interest income increased by $0.7 million or 85% to $1.5 million during the
three months ended April 30, 2007 compared to $0.8 million during the 2006
period, due to an increase in invested cash from the sales of common stock in
registered direct offerings in December 2006 and February 2007. The net cash
proceeds from the offerings were $57.0 million. See Liquidity and Capital
Resources. The Company earns interest by investing primarily in short term (30
to 90 days) commercial paper and money market funds with high credit ratings.
The tax provision for the three months ended April 30, 2007 was based on state
and local taxes, and differed from the expected net operating loss carryforward
benefit at the U.S. federal statutory rate of 34% primarily due to the inability
to recognize such benefit. The carryforward benefit cannot be recognized because
of uncertainties relating to future taxable income, in terms of both its timing
and its sufficiency.
The tax benefit for the three months ended April 30, 2006 differed from the
expected net operating loss carryforward benefit at the U.S. federal statutory
rate of 34% primarily due to limitations on the timing of the recognition of the
Company's then available federal tax carryback benefit for taxes paid in prior
years. The tax benefit also differs from the expected net operating loss
carryforward benefit due to the inability to recognize such benefit. The
carryforward benefit could not be recognized because of uncertainties relating
to future taxable income, in terms of both its timing and its sufficiency.
SEGMENT RESULTS
The Life Sciences segment's income before taxes was approximately $0.4 million
for the three months ended April 30, 2007 as compared to a loss of $0.2 million
in the year ago quarter. Segment revenues increased $0.5 million to $2.4
million, with an increase in royalty income of approximately $0.8 offsetting a
decrease in product revenues of $0.3 million, which resulted from the decline in
unit shipments and the continuing competitiveness in the industry. The segment's
operations were positively impacted by royalties earned from the License
Agreement entered into with Abbott during the fiscal 2007 quarter. Cost of
products increased approximately $0.2 million, due to the write-off or reserve
for obsolete inventory, offset by lower shipments. Research and development and
selling, general, and administrative declined by approximately $0.3 million
compared to the year ago period.
The Therapeutics segment's loss before taxes was approximately $1.9 million for
the three months ended April 30, 2007 as compared to a loss of $1.0 million in
the year ago quarter. The 2007 period increase in the segment loss was primarily
due to an increase in clinical trial activities of $0.6 million and other
related costs of $0.1 million.
The Clinical Labs segment income before taxes was $1.4 million for the period
ended April 30, 2007 as compared to segment income of $0.2 million in the year
ago quarter. The 2007 period was positively impacted by an increase in service
revenues of $3.8 million, primarily due to the expansion of an insurance
provider agreement, which increased gross profit by approximately $1.9 million.
Selling, general and administrative expenses were comparable. The provision for
doubtful accounts for the three months ended April 30, 2007 increased by
approximately $0.8 million over the year ago period due to the increase in
revenues and the composition of patients being serviced.
The Other segment's loss before income taxes for the three months ended April
30, 2007 was approximately $3.7 million compared to $2.8 million in the year ago
quarter. The increased segment loss reflects an increase in general,
administrative and legal expenses of $1.4 million due to an increase in ongoing
patent litigation and payroll costs, offset by decreases in corporate governance
costs and professional fees. The increased expenses were partially offset by an
increase in interest income of $0.7 million.
20
RESULTS OF OPERATIONS
NINE MONTHS ENDED APRIL 30, 2007 AS COMPARED TO APRIL 30, 2006
COMPARATIVE OPERATING DATA
(in 000's) Nine months ended
April 30, Increase %
REVENUES: 2007 2006 (Decrease) Change
---- ---- ---------- ------
Product revenues $2,699 $3,900 $(1,201) (31)
Royalty income 3,756 2,251 1,505 67
Clinical laboratory services 28,543 23,759 4,784 20
------ ------ -----
Total revenues 34,998 29,910 5,088 17
COSTS AND EXPENSES AND OTHER (INCOME):
Cost of products 1,698 1,515 183 12
Cost of laboratory services 12,815 10,296 2,519 24
Research & development 6,935 5,361 1,574 29
Selling, general and administrative 19,015 18,935 80 -
Provision for uncollectible A/R 3,433 2,870 563 20
Legal expenses 7,159 5,213 1,946 37
Interest income (3,627) (2,226) (1,401) 63
Other income (2,699) - (2,699) -
------- ------ -----
Total costs and expenses - net 44,729 41,964 2,765 7
------ ------ -----
Loss before income taxes ($9,731) ($12,054) $2,323 (19)
======== ========= ======
CONSOLIDATED RESULTS
Product revenues during the nine months ended April 30, 2007 was $2.7 million
compared to $3.9 million in the year ago quarter, a decrease of $1.2 million or
31%, due to a decline in unit shipments and the continuing competitiveness in
the industry.
Royalty income during the nine months ended April 30, 2007 was $3.8 million
compared to $2.3 million in the year ago quarter, an increase of $1.5 million or
67%. Royalties are earned from net sales of Digene products subject to a license
and from a License Agreement with Abbott which was entered into in the fiscal
2007 third quarter. There are no expenses relating to royalty income.
Clinical laboratory revenues during the nine month period ended April 30, 2007
were $28.6 million compared to $23.8 million in the 2006 period, an increase of
$4.8 million or 20%. The Company experienced an increase in service revenues
during the 2007 period due to an expansion of an insurance provider agreement,
partially offset by an increase in the contractual adjustment expense which
reduced gross billings by 78.4% as compared to 75.0% in the prior period. The
increase in the contractual adjustment expense is due to continued competitive
pricing throughout the industry.
The cost of products during the nine month periods ended April 30, 2007 was $1.7
million compared to $1.5 million in the 2006 period. Gross profit was negatively
affected during the 2007 period as compared to the 2006 period by the
incremental increase of $0.1 million in the write-off or reserve for excess or
obsolete inventory and the decline in product revenues.
21
The cost of clinical laboratory services during the nine month period ended
April 30, 2007 was $12.8 million as compared to $10.3 million in the prior
period, an increase of $2.5 million or 24%. Due to the increased volume of
patients serviced and tests performed, the Company incurred increased reagent
costs of $1.3 million, payroll related costs of $0.6 million, and outside
testing costs of $0.5 million.
Research and development expenses were approximately $6.9 million during the
nine months ended April 30, 2007, compared to $5.3 million in the 2006 period,
an increase of $1.6 million or 29%. The increase was primarily due to increases
at the Therapeutic segment in clinical trial activities of $1.1 million and an
increase in other related costs approximating $0.2 million.
Selling, general and administrative expenses were approximately comparable, at
$19.0 million during the nine months ended April 30, 2007 as compared to $18.9
million in the 2006 period. Increases in payroll and payroll related personnel
costs of $0.6 million and information technology costs of $0.1 million were
offset primarily by declines in corporate governance and professional fees of
$0.8 million, advertising and promotion expenses of $0.1 million and insurance
of $0.1 million.
The provision for uncollectible accounts receivable relating to the Clinical
Labs segment for the nine months ended April 30, 2007 was $3.4 million, compared
to $2.9 million during the year ago period, a increase of $0.5 million or 20%
and is due to the increase in clinical laboratory revenue of 20% and the
composition of patients being serviced.
Legal expense was $7.1 million during the nine months ended April 30, 2007
compared to $5.2 million in the year ago period, an increase of $1.9 million or
37%, due to an increase in ongoing patent litigation.
Other income was $2.7 million during the nine months ended April 30, 2007 versus
$0 in the year ago period. During the 2007 period, the Company as plaintiff and
Sigma Aldrich ("Sigma") entered into a Settlement Agreement and Release
effective September 15, 2006 (the "Settlement Agreement"). Pursuant to the
Settlement Agreement, the Company's litigation with Sigma was dismissed and the
Company recognized a $2 million gain on patent litigation settlement during the
nine months ended April 30, 2007. In addition, during the 2007 period, the
Company received a payment of $0.7 million from Perkin Elmer for amounts due
under a Distribution Agreement which terminated December 31, 2004. The
Distribution Agreement is presently subject to a lawsuit for breach of contract,
patent infringement, unfair competition under state law, unfair competition
under federal law, tortuous interference with business relations, and fraud in
the inducement of contract. Perkin Elmer advised in a letter to the Company that
the payment under the Distribution Agreement was delayed because of changes to
their accounting system and personnel changes and that it was always their
intent to comply with the Distribution Agreement. The Company advised Perkin
Elmer that the payment did not represent all amounts owed under the Distribution
Agreement.
Interest income increased by $1.4 million or 63% to $3.6 million during the nine
months ended April 30, 2007 compared to $2.2 million during the 2006 period, due
to an increase in invested cash from the sales of common stock in registered
direct offerings in December 2006 and February 2007. The net cash proceeds from
the offerings were $57.0 million. See Liquidity and Capital Resources. The
Company earns interest by investing primarily in short term (30 to 90 days)
commercial paper and money market funds with high credit ratings.
The tax provision for the nine months ended April 30, 2007 was based on state
and local taxes, and differed from the expected net operating loss carryforward
benefit at the U.S. federal statutory rate of 34% primarily due to the inability
to recognize such benefit. The carryforward benefit cannot be recognized because
of uncertainties relating to future taxable income, in terms of both its timing
and its sufficiency.
22
The tax benefit for the nine months ended April 30, 2006 differed from the
expected net operating loss carryforward benefit at the U.S. federal statutory
rate of 34% primarily due to limitations on the timing of the recognition of the
Company's then available federal tax carryback benefit for taxes paid in prior
years. The tax benefit also differed from the expected net operating loss
carryforward benefit due to the inability to recognize such benefit. The
carryforward benefit could not be recognized because of uncertainties relating
to future taxable income, in terms of both its timing and its sufficiency. Also
due to the uncertainties, the Company recorded during the first quarter of the
2006 period a valuation allowance equal to its net deferred tax assets,
including the federal net operating loss carryforward benefit generated during
the first quarter of the 2006 period. The Company recorded the valuation
allowance as it concluded that it was not more likely than not that its net
deferred tax assets would be realized in the foreseeable future based on
positive and negative evidence available at the time.
SEGMENT RESULTS
The Life Sciences segment's income before taxes was approximately $3.5 million
for the nine months ended April 30, 2007 as compared to $0.3 million in the 2006
period. The increase is primarily the result of the Company's $2.0 million
patent litigation settlement with Sigma Aldrich, and a payment of $0.7 million
from Perkin Elmer for amounts due under a Distribution Agreement which
terminated December 31, 2004. An increase in royalty income of $1.5 million from
the Digene agreement and the Abbott license agreement entered into in the fiscal
2007 third quarter offset a decrease in revenues from product shipments of $1.2
million due to a decline in unit shipments and the continuing competitiveness in
the industry. Segment operating expenses, such as research and development and
selling, general and administrative, decreased by approximately $0.4 million
during the 2007 period due to lower payroll and marketing expenses.
The Therapeutics segment's loss before income taxes was approximately $4.5
million for the nine months ended April 30, 2007 as compared to a loss of $2.7
million for the 2006 period. The increase in the loss of $1.8 million was
primarily due to increases in clinical trial activities of $1.1 million and
other related costs of $0.4 million.
The Clinical Labs segment's income before taxes was $1.6 million for the nine
months ended April 30, 2007 as compared to a loss of $0.1 million in the 2006
period. The 2007 period was positively impacted by an increase in service
revenues of $4.8 million or 20% due to the expansion of an insurance provider
agreement, which increased gross profit by approximately $2.3 million. The
increase in gross margin was offset by an increase in the provision for
uncollectible accounts for the nine months ended April 30, 2007 of approximately
$0.6 million over the year ago period.
The Other segment's loss before taxes for the nine months ended April 30, 2007
was approximately $10.4 million as compared to a loss of $9.6 million in the
2006 period. The increased segment loss reflects an increase in general,
administrative and legal expenses of $2.3 million due to an increase in payroll
and personnel related costs of $1.0 million partially offset by decreases in
professional fees and corporate governance expenses of $0.8 million and
insurance of $0.1 million and an increase in legal costs of $1.9 million due to
ongoing patent litigation. The increase in general, administrative and legal
expenses was partially offset by an increase in interest income of $1.4 million.
23
LIQUIDITY AND CAPITAL RESOURCES
On December 14, 2006, the Company entered into a Placement Agent Agreement with
Lazard Capital Markets LLC, as exclusive placement agent, relating to a
"registered direct" offering ("Offering") of shares of the Company's common
stock. On December 15, 2006, the Company entered into a definitive Subscription
Agreement with various institutional investors relating to the sale of an
aggregate of 3,285,715 shares of common stock for a purchase price of $14.00 per
share. Net proceeds from the Offering aggregating $42.9 million, net of
placement fees and financing costs of $3.1 million, were credited to common
stock and additional paid-in capital. On December 15, 2006, the Company filed a
prospectus supplement with the SEC relating to the Offering under a shelf
Registration Statement on Form S-3 which was effective December 8, 2006 and
supplement thereto.
On February 2, 2007, the Company entered into a Placement Agent Agreement with
Lazard Capital Markets LLC, as exclusive placement agent, relating to a
"registered direct" offering ("Subsequent Offering") of shares of the Company's
common stock. On February 2, 2007, the Company entered into a definitive
Subscription Agreement with an investor relating to the sale of an aggregate of
1,000,000 shares of common stock for a purchase price of $15.00 per share. Net
proceeds from the Subsequent Offering aggregated $14.1 million, net of placement
fees and financing costs of $0.9 million, were credited to common stock and
additional paid in capital. On February 5, 2007, the Company filed a prospectus
supplement with the SEC relating to the Subsequent Offering under the
Registration Statement and supplement thereto.
At April 30, 2007, our cash and cash equivalents were $120.0 million, an
increase of $50.2 million from cash and cash equivalents at July 31, 2006. The
increase in cash during the nine months ended April 30, 2007 was primarily due
to the Offerings' proceeds, a $2.0 million settlement gain on patent litigation
and cash flow impacts discussed below. The Company had working capital of $129.1
million at April 30, 2007 compared to $80.2 million at July 31, 2006. The
increase in working capital was primarily the result of the Offerings.
Net cash used in operating activities for the nine months ended April 30, 2007
was approximately $6.0 million as compared to net cash used in operating
activities of $6.9 million in the 2006 period. The decline in net cash used in
operating activities of $0.9 million in the 2007 period as compared to the 2006
period was due to a decrease in net loss of $1.2 million offset by a decrease in
non-cash charges.
Net cash used in investing activities for the nine months ended April 30, 2007
was approximately $1.2 million as compared to net cash provided by investing
activities of $5.4 million in the year ago period, primarily due to a decline in
the sales of marketable securities of approximately $6.7 million. During the
nine months ended April 30, 2006, all investments in marketable securities were
sold and the proceeds reinvested in cash equivalents.
Net cash provided by financing activities for the nine months ended April 30,
2007 was $57.3 million as compared to $0.4 million in the year ago period. The
increase was primarily due to the proceeds from the Offerings of $57.0 million
previously discussed.
24
Effective May 31, 2007 (the "Effective Date'), the Company's wholly owned
subsidiary, Enzo Life Sciences, Inc., completed the acquisition of the stock of
Axxora Life Sciences, Inc., ("Axxora") a privately owned global manufacturer and
marketer of life sciences research products, for approximately $16.3 million in
cash. On the Effective Date, Axxora became a wholly owned subsidiary of Enzo
Life Sciences. Axxora had revenues of approximately $16 million in 2006. Axxora
has wholly-owned subsidiaries in the U.S., Switzerland, Germany and the United
Kingdom, as well as distributors located in other major markets. At April 30,
2007, the Company has recorded approximately $732,000 in acquisition costs which
are included in "Other assets" in the accompanying balance sheet.
The Company believes that its current cash position is sufficient for its
foreseeable liquidity and capital resource needs over the next 12 months,
although there can be no assurance that future events will not alter such view.
CONTRACTUAL OBLIGATIONS
There were no significant changes to the Contractual Obligations disclosed in
the Annual Report on Form 10-K for the 2006 fiscal year.
Management is not aware of any material claims, disputes or settled matters
concerning third party reimbursement that would have a material effect on our
financial statements.
CRITICAL ACCOUNTING POLICIES
GENERAL
The Company's discussion and analysis of its financial condition and results of
operations are based upon Enzo Biochem, Inc.'s consolidated financial
statements, which have been prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation of these
financial statements requires the Company to make estimates and judgments that
affect the reported amounts of assets, liabilities, revenues and expenses; these
estimates and judgments also affect related disclosure of contingent assets and
liabilities. On an on-going basis, we evaluate our estimates, including those
related to contractual adjustments, allowance for uncollectible accounts,
inventory, intangible assets and income taxes. The Company bases its estimates
on experience and on various other assumptions that are believed to be
reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
REVENUE RECOGNITION
The Company recognizes revenue in accordance with Staff Accounting Bulletin No.
104, "Revenue Recognition" (SAB 104), when (i) persuasive evidence of an
arrangement exists, (ii) delivery has occurred or services have been rendered,
(iii) the price is fixed and determinable, and (iv) collectibility is reasonably
assured. The Company evaluates revenue from agreements that have multiple
elements to determine whether the components of the arrangement represent
separate units of accounting as defined in EITF Issue No. 00-21, "Revenue
Arrangements with Multiple Deliverables" (EITF 00-21). To recognize revenue for
a delivered item in a multiple element arrangement, EITF 00-21 requires that the
delivered items have value to the customer on a stand-alone basis, there is
objective and reliable evidence of fair value of the undelivered items, and
delivery of any undelivered items is probable and within our control.
25
PRODUCT REVENUES
Revenues from product sales are recognized when the products are shipped, the
sales price is fixed or determinable and collectibility is reasonably assured.
ROYALTIES AND LICENSING REVENUE
Royalty revenues are recorded in the period earned and no related costs exist.
Royalties and license fees received in advance of being earned are recorded as
deferred revenues.
REVENUES - CLINICAL LABORATORY SERVICES
Revenues from the clinical laboratory are recognized upon completion of the
testing process for a specific patient and reported to the ordering physician.
These revenues and the associated accounts receivable are based on gross amounts
billed or billable for services rendered, net of a contractual adjustment, which
is the difference between amounts billed to providers and the expected approved
reimbursable settlements from such providers. The following are tables of the
clinical laboratory segment's net revenues and percentages by revenue category
for the three and nine months ended April 30, 2007 and 2006:
Net revenues Three months ended Three months ended
April 30, 2007 April 30, 2006
-------------- --------------
REVENUE CATEGORY (In 000'S) (In %) (In 000'S) (In %)
---------- ------ ---------- ------
Medicare $2,163 19 $1,727 22
Third party provider 6,632 57 4,761 62
Patient self-pay 1,643 14 682 9
HMO's 1,092 10 564 7
------- ---- ------ ----
Total $11,530 100% $7,734 100%
======= ==== ====== ====
Net revenues Nine months ended Nine months ended
April 30, 2007 April 30, 2006
-------------- --------------
REVENUE CATEGORY (In 000'S) (In %) (In 000'S) (In %)
---------- ------ ---------- ------
Medicare $6,125 21 $5,530 23
Third party provider 17,228 60 13,326 56
Patient self-pay 3,031 11 3,411 15
HMO's 2,159 8 1,492 6
------- ---- ------ ----
Total $28,543 100% $23,759 100%
======= ==== ======= ====
The Company provides services to certain patients covered by various third-party
providers, including the Federal Medicare program. Revenue, net of contractual
adjustments, from gross billings under the Federal Medicare program during the
three and nine months ended April 30, 2007 and 2006 were approximately 19% and
22%, and 21% and 23%, respectively, of the clinical lab segment's revenue. Laws
and regulations governing Medicare are complex and subject to interpretation for
which action for noncompliance includes fines, penalties and exclusion from the
Medicare programs. The Company believes that it is in compliance with all
applicable laws and regulations and is not aware of any pending or threatened
investigations involving allegations of potential wrongdoing.
26
Other than the Medicare program, one provider whose programs are included in the
"third party provider" and "HMO's" categories represents 22% and 15% of the
Clinical Labs segment's revenue for the three and nine months ended April 30,
2007. Other than the Medicare program, no other provider exceeded 10% of the
Clinical Labs segment's revenue for the three and nine months ended April 30,
2006.
CONTRACTUAL ADJUSTMENTS
The Company's estimate of contractual adjustments is based on significant
assumptions and judgments, such as its interpretation of the applicable
providers' reimbursement policies, and bears the risk of change. The estimation
process is based on the experience of amounts approved as reimbursable and
ultimately settled by providers, versus the corresponding gross amount billed to
the respective provider. The contractual adjustment is an estimate that reduces
gross revenue, based on gross billing rates, to amounts expected to be approved
and reimbursed. The Company adjusts the contractual adjustment estimate
periodically, based on its evaluation of historical settlement experience with
providers, industry reimbursement trends, and other relevant factors.
During the three and nine months ended April 30, 2007 and 2006, the contractual
adjustment percentages, determined using average historical reimbursement
statistics, were 79.8% and 75.4% and 78.4% and 75.0%, respectively, of gross
billings. The Company estimates (by using a sensitivity analysis) that each 1%
point change in the contractual adjustment percentage could have resulted in a
change in clinical laboratory services revenues of approximately $1,321,000 for
the nine months ended April 30, 2007, and could have resulted in a change in the
net accounts receivable of approximately $392,000 as of April 30, 2007.
ACCOUNTS RECEIVABLE AND ALLOWANCE FOR DOUBTFUL ACCOUNTS
Accounts receivable are reported at realizable value, net of allowances for
doubtful accounts, which is estimated and recorded in the period of the related
revenue.
For the clinical laboratory segment, the allowance for doubtful accounts
represents amounts that the Company does not expect to collect after the Company
has exhausted its collection procedures. The Company estimates its allowance for
doubtful accounts in the period the related services are billed and adjusts the
estimate in future accounting periods as necessary. It bases the estimate for
the allowance on the evaluation of historical collection experience, the aging
profile of accounts receivable, the historical doubtful account write-off
percentages, payer mix, and other relevant factors.
The allowance for doubtful accounts includes the balances, after receipt of the
approved settlements from third party providers for the insufficient diagnosis
information received from the ordering physician, which result in denials of
payment, and the uncollectible portion of receivables from patients including
deductibles and copayments which are subject to credit risk and patients'
ability to pay. During the three and nine months ended April 30, 2007 and 2006,
the Company determined an allowance for doubtful accounts less than 210 days and
wrote off 100% of accounts receivable (for all payers) over 210 days, as it
assumed those accounts are uncollectible. The Company adjusts the historical
collection analysis for recoveries, if any, on an ongoing basis.
The Company's ability to collect outstanding receivables from third party
providers is critical to its operating performance and cash flows. The primary
collection risk lies with uninsured patients or patients for whom primary
insurance has paid but a patient portion remains outstanding. The Company also
assesses the current state of its billing functions in order to identify any
known collection or reimbursement issues in order to assess the impact, if any,
on the allowance estimates, which involves judgment.
27
The Company believes that the collectibility of its receivables is directly
linked to the quality of its billing processes, most notably, those related to
obtaining the correct information in order to bill effectively for the services
provided. Should circumstances change (e.g. shift in payer mix, decline in
economic conditions or deterioration in aging of receivables), our estimates of
net realizable value of receivables could be reduced by a material amount.
The following is a table of the Company's net accounts receivable by segment.
The Clinical Labs segment's net receivables are detailed by billing category and
as a percent to its total net receivables. At April 30, 2007 and July 31, 2006,
approximately 84% and 88%, respectively, of the Company's net accounts
receivable relates to its clinical laboratory business, which operates in the
New York and New Jersey Metropolitan area.
Net accounts receivable As of As of
April 30, 2007 July 31, 2006
-------------- -------------
Billing category (In 000'S) (In %) (In 000'S) (In %)
- ---------------- ---------- ------ ---------- -----
Clinical Labs
Medicare $1,668 17 $1,367 15
Third party providers 5,626 57 4,025 44
Patient self-pay 1,993 20 3,294 36
HMO's 616 6 475 5
------ ---- ------- ----
Total Clinical Labs 9,903 100% 9,161 100%
==== ====
Total Life Sciences 1,876 1,286
------- -------
Total accounts receivable $11,779 $10,447
======= =======
INCOME TAXES
The Company accounts for income taxes under the liability method of accounting
for income taxes. Under the liability method, deferred tax assets and
liabilities are recognized for the future tax consequences attributable to
differences between the financial statement carrying amounts of existing assets
and liabilities and their respective tax bases. The liability method requires
that any tax benefits recognized for net operating loss carry forwards and other
items be reduced by a valuation allowance where it is not more likely than not
the benefits will be realized in the foreseeable future. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable
income in the years in which those temporary differences are expected to be
recovered or settled. Under the liability method, the effect of a change in tax
rates on deferred tax assets and liabilities is recognized in income in the
period that includes the enactment date.
INVENTORY
The Company values inventory at the lower of cost (first-in, first-out) or
market. Work-in-process and finished goods inventories consist of material,
labor, and manufacturing overhead. On a quarterly basis, we review inventory
quantities on hand and analyze the provision for excess and obsolete inventory
based on our estimate of sales forecasts based on sales history and anticipated
future demand. Our estimate of future product demand may not be accurate and we
may understate or overstate the provision for excess and obsolete inventory.
Accordingly, unanticipated changes in demand could have a significant impact on
the value of our inventory and results of operations. At April 30, 2007 and July
31, 2006 respectively, the reserve for excess and obsolete inventory was
$360,000 and $238,000.
28
Recent Accounting Pronouncements
In May 2005, the FASB issued SFAS No. 154, "Accounting Changes and Error
Corrections ("SFAS 154"), a replacement of APB Opinion No. 20, Accounting
Changes, and FASB Statement No. 3, Reporting Accounting Changes in Interim
Financial Statements". SFAS 154 changes the requirements for the accounting for
and reporting of a change in accounting principle. Previously, most voluntary
changes in accounting principles required recognition via a cumulative effect
adjustment within net income for the period of the change. SFAS 154 requires
retrospective application to prior periods' financial statements, unless it is
impracticable to determine either the period-specific effects or the cumulative
effect of the change.
SFAS 154 is effective for accounting changes made in fiscal years beginning
after December 15, 2005; however, SFAS 154 does not change the transition
provisions of any existing accounting pronouncements. The adoption of SFAS 154
did not have a material impact on the Company's financial condition or results
of operations.
In June 2006, the FASB issued FASB Interpretation No. 48 ("FIN 48"), "Accounting
for Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109,
Accounting for Income Taxes" ("SFAS 109")", to clarify the accounting for
uncertainty in income taxes recognized in an enterprise's financial statements
in accordance with SFAS 109. This Interpretation prescribes a recognition
threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. FIN
48 also provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure, and transition. The
provisions of FIN 48 are effective for fiscal years beginning after December 15,
2006. The Company has not evaluated the impact of FIN 48 on its financial
statements at this time.
In September 2006, the SEC released Staff Accounting Bulletin No. 108
"Considering the Effects of Prior Year Misstatements When Quantifying
Misstatements in Current Year Financial Statements" ("SAB 108"). SAB 108
provides interpretative guidance on how public companies quantify financial
statement misstatements. There have been two common approaches used to quantify
such errors. Under an income statement approach, the "roll-over" method, the
error is quantified as the amount by which the current year income statement is
misstated. Alternatively, under a balance sheet approach, the "iron curtain"
method, the error is quantified as the cumulative amount by which the current
year balance sheet is misstated. In SAB 108, the SEC established an approach
that requires quantification of financial statement misstatements based on the
effects of the misstatements on each of the company's financial statements and
the related financial statement disclosures. This model is commonly referred to
as a "dual approach" because it requires quantification of errors under both the
roll-over and iron curtain methods. SAB 108 is effective for the Company as of
August 1, 2007. The adoption of SAB 108 is not expected to have a material
impact on the Company's consolidated financial statements.
In September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements". This
Statement defines fair value, establishes a framework for measuring fair value
and expands disclosure about fair value measurements, and is effective for
financial statements issued for fiscal years beginning after November 15, 2007,
and interim periods within those fiscal years. The Company is currently
evaluating the effect that the adoption of this Statement will have on its
financial statements at this time.
29
In February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for
Financial Assets and Financial Liabilities - Including an amendment of FASB
Statement No. 115" ("SFAS 159"). This statement permits entities to choose to
measure many financial instruments and certain other items as fair value. The
objective is to improve financial reporting by providing entities with the
opportunity to mitigate volatility in reported earnings caused by measuring
related assets and liabilities differently without having to apply complex hedge
accounting provisions. SFAS 159 is effective as of the beginning of fiscal years
that begin after November 15, 2007. The Company has not evaluated the effect
that the adoption of this Statement will have on its financial statements at
this time.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The Company does not have an exposure to market risk from changes in foreign
currency exchange rates, commodity price risk or other market risk. We do not
engage in any hedging or market risk management tools. The Company does not have
interest risk with respect to interest rates on cash and cash equivalents that
could impact our results of operations and financial position since the
investments are in highly liquid corporate debt instruments with maturities of
three months or less. There have been no material changes with respect to market
risk previously disclosed in our Annual Report on Form 10-K for our 2006 fiscal
year.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this report, the Company's management
conducted an evaluation (as required under Rules 13a-15(b) and 15d-15(b) under
the Securities Exchange Act of 1934, as amended (the "Exchange Act")) of the
Company's "disclosure controls and procedures" (as such term is defined under
the Exchange Act), under the supervision and with the participation of the
principal executive officer and the principal financial officer. Based on this
evaluation, the principal executive officer and the principal financial officer
concluded that the Company's disclosure controls and procedures are effective as
of the end of the period covered by this report. Notwithstanding the foregoing,
a control system, no matter how well designed and operated can provide only
reasonable, not absolute, assurance that it will detect or uncover failures
within the Company to disclose material information otherwise required to be set
forth in the Company's periodic reports.
(b) Changes in Internal Controls over Financial Reporting
There was no change in the Company's internal controls over financial reporting
during the Company's most recently completed interim fiscal period that has
materially affected, or is reasonably likely to materially affect, the Company's
internal control over financial reporting.
30
PART II - OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
There have been no material developments with respect to previously reported
legal proceedings except as noted in Note 9. See the annual report on Form 10-K
for the fiscal year ended July 31, 2006 filed with the Securities and Exchange
Commission for a discussion of the Company's ongoing legal proceedings.
Item 1A. RISK FACTORS
Risk and uncertainties that, if they were to occur, could materially adversely
affect our business or that could cause our actual results to differ materially
from the results contemplated by the forward-looking statements contained in
this Report and other public statements we make were set forth in the "Item 1A.
- - Risk Factors" section of our Annual Report on Form 10-K for the year ended
July 31, 2006. There have been no material changes from the risk factors
disclosed in that Form 10-K other than the additional risk factors stated below.
CHANGES IN PROVIDER MIX, INCLUDING AN INCREASE IN CAPITATED MANAGED-COST HEALTH
CARE, OR LOSS OF A SIGNIFICANT THIRD PARTY CONTRACT COULD HAVE AN ADVERSE IMPACT
ON THE COMPANY'S NET REVENUES AND PROFITABILITY.
Certain provider companies have adopted national and regional programs which
include multiple managed-care reimbursement models. If the Company is unable to
participate in these programs or if the Company would lose a significant
contract, it could have an adverse impact on the Company's net revenues and
profitability.
Item 6. EXHIBITS
Exhibit No. Exhibit
----------- -------
31(a) Certification of Elazar Rabbani, Ph.D. pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
31(b) Certification of Barry Weiner pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002.
32(a) Certification of Elazar Rabbani, Ph.D. pursuant to 18
U.S.C. ss. 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002.
32(b) Certification of Barry Weiner pursuant to 18 U.S.C.
ss.1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
ENZO BIOCHEM, INC.
------------------
(Registrant)
Date: June 11, 2007 by: /S/BARRY WEINER
---------------
Chief Financial Officer
31