UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2006
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
Commission File # 0-24875
BIOENVISION, INC.
(Exact name of issuer as specified in its charter)
Delaware 13-4025857
---------------- ----------------
State or other jurisdiction IRS Employer ID No.
of incorporation or organization
345 Park Avenue, 41st Floor, New York, NY 10154
-----------------------------------------------
(Address of principal executive offices)
(212) 750-6700
(Issuer's Telephone Number)
Indicate by checkmark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Exchange Act during the preceding
twelve months (or such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for the past
90 days. Yes _X_ No ___
Indicate by checkmark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of "accelerated
filer and large accelerated filer" in Rule 12b-2 of the Exchange Act. (Check
one):
Large accelerated filer __ Accelerated filer ___ Non accelerated filer __X_
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 April 25, 2006, there were 41,121,282 shares of the issuer's common stock,
par value $.001 per share (the "Common Stock") outstanding.
C O N T E N T S
PART I FINANCIAL INFORMATION Page
----
Item 1. Consolidated Financial Statements
Condensed Consolidated Balance Sheets -
As of March 31, 2006 (Unaudited) and June 30, 2005 2
Condensed Consolidated Statements of Operations (Unaudited) -
For the three and nine months ended March 31, 2006 and 2005 3
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) -
For the nine months ended March 31, 2006 4
Condensed Consolidated Statements of Cash Flows (Unaudited) -
For the nine months ended March 31, 2006 and 2005 5
Notes to Condensed Consolidated Financial Statements (Unaudited) 6
Item 2. Management's Discussion and Analysis of Financial Condition 17
and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk 22
Item 4. Controls and Procedures 22
PART II OTHER INFORMATION
Item 1. Legal Proceedings 24
Item 1A. Risk Factors 24
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 24
Item 3. Defaults Upon Senior Securities 24
Item 4. Submission of Matters to a Vote of Security Holders 24
Item 5. Other Information 24
Item 6. Exhibits 25
SIGNATURES
BIOENVISION, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
March 31, June 30,
2006 2005
-------------- ----------
ASSETS (Note B)
Current assets
Cash and cash equivalents $ 8,594,245 $ 31,407,533
Restricted cash - 290,000
Short-term securities 41,217,264 32,746,948
Accounts receivable, less allowances of $897,472 and $869,220 at
March 31, 2006 and June 30, 2005, respectively 2,454,289 1,785,779
Inventories 352,315 277,908
Other current assets 603,725 342,628
------------- -------------
Total current assets 53,221,838 66,850,796
Property and equipment, net 284,748 279,778
Intangible assets, net 7,768,929 8,252,936
Goodwill 1,540,162 1,540,162
Security deposits 207,818 209,665
Deferred costs 3,483,421 3,656,798
------------- -------------
Total assets $ 66,506,916 $ 80,790,135
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 1,095,592 $ 1,602,267
Accrued expenses 5,194,524 4,581,444
Accrued dividends payable 55,479 56,404
Deferred revenue 498,607 498,607
------------- -------------
Total current liabilities 6,844,202 6,738,722
Deferred revenue 7,063,639 7,437,598
------------- -------------
Total liabilities 13,907,841 14,176,320
Commitments and contingencies - -
Stockholders' equity
Convertible preferred stock - $0.001 par value; 20,000,000 shares
authorized; 2,250 2,250
2,250,000 shares issued and outstanding at March 31, 2006 and
June 30, 2005 (liquidation preference $6,750,000)
Common stock - par value $0.001; 70,000,000 shares authorized; 41,004 40,559
41,003,847 and 40,558,948 shares issued and outstanding at
March 31, 2006 and June 30, 2005, respectively
Additional paid-in capital 132,235,677 128,946,717
Deferred compensation - (145,646)
Accumulated deficit (79,321,115) (62,331,005)
Shareholder receivable (340,606) -
Accumulated other comprehensive (loss) income (18,135) 100,940
------------- -------------
Total stockholders' equity 52,599,075 66,613,815
------------- -------------
Total liabilities and stockholders' equity $ 66,506,916 $ 80,790,135
============= =============
The accompanying notes are an integral part of these financial statements.
-2-
BIOENVISION, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended Nine months ended
March 31, March 31,
--------- ---------
2006 2005 2006 2005
------------- ----------- ------------ ------------
Revenue
Licensing and royalty revenue $ 502,584 $ 430,411 $ 1,446,633 $ 1,012,068
Product sales 124,029 149,364 493,005 364,495
Research and development contract revenue 1,114,482 819,194 1,562,982 2,283,657
------------- ----------- ------------ ------------
Total revenue 1,741,095 1,398,969 3,502,620 3,660,220
Costs and expenses
Cost of products sold, including royalty expense of $316,000 386,818 279,596 1,153,127 434,394
and $181,000 for the three months ended March 31, 2006 and
2005, respectively and $847,000 and $205,000 for the nine
months ended March 31, 2006 and 2005, respectively.
Research and development 2,785,004 2,136,849 7,227,185 5,986,496
Selling, general and administrative 6,913,698 1,893,895 12,383,350 6,680,405
Depreciation and amortization 247,365 346,504 728,520 1,028,197
------------- ----------- ------------ ------------
Total costs and expenses 10,332,885 4,656,844 21,492,182 14,129,492
------------- ----------- ------------ ------------
Loss from operations (8,591,790) (3,257,875) (17,989,562) (10,469,272)
Interest and finance charges
- - (66,761) -
Interest income 453,488 185,465 1,319,568 297,479
------------- ----------- ------------ ------------
Net loss (8,138,302) (3,072,410) (16,736,755) (10,171,793)
Preferred stock dividend (83,219) (83,219) (253,355) (319,935)
------------- ----------- ------------ ------------
Net loss applicable to common stockholders $ (8,221,521) $(3,155,629) $(16,990,110) $(10,491,728)
============ ============ ============ ============
Basic and diluted net loss per share of common stock $ (0.20) $ (0.08) $ (0.42) $ (0.33)
============ ============ ============ ============
Weighted average shares used in computing 40,870,688 37,602,163 40,734,286 31,907,864
basic and diluted net loss per share ============ ============ ============ ============
The accompanying notes are an integral part of these financial statements.
-3-
BIOENVISION, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
FOR THE NINE MONTHS ENDED MARCH 31, 2006
(unaudited)
Convertible Additional
Preferred Stock Common Stock Paid-In Deferred
Shares $ Shares $ Capital Compensation
------ - ------ - ------- ------------
Balance at July 1, 2005 2,250,000 $2,250 40,558,948 $ 40,559 $128,946,717 $ (145,646)
Net loss for the period
Preferred stock dividend
Currency translation
adjustment
Due from shareholder
Employee stock-based
compensation 2,998,506
Deferred compensation (136,457) 145,646
Options exercised to common
stock 381,196 381 310,244
Warrants and options issued
in connection with services 65,897
Warrants exercised to common
stock 63,703 64 50,770
--------- ------ ---------- -------- ------------ ----------
Balance at March 31, 2006 2,250,000 $2,250 41,003,847 $ 41,004 $132,235,677 $ -
========= ====== ========== ======== ============ ==========
Accumulated
Other
Comprehensive Total
Accumulated Shareholder Income Stockholder's
Deficit Receivable (Loss) Equity
------- ---------- ------ ------
Balance at July 1, 2005 $(62,331,005) $ - $ 100,940 66,613,815
Net loss for the period (16,736,755) (16,736,755)
Preferred stock dividend (253,355) (253,355)
Currency translation
adjustment (119,075) (119,075)
Due from shareholder (340,606) (340,606)
Employee stock-based
compensation 2,998,506
Deferred compensation 9,189
Options exercised to common
stock 310,625
Warrants and options issued
in connection with services 65,897
Warrants exercised to common
stock 50,834
-------------- ---------- ----------- -----------
Balance at March 31, 2006 $ (79,321,115) $(340,606) $ (18,135) $52,599,075
============== ========== =========== ===========
The accompanying notes are an integral part of these financial statements.
-4-
BIOENVISION, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Nine months ended
March 31,
2006 2005
-------------- --------------
Cash flows from operating activities:
Net loss $(16,736,755) $(10,171,793)
Adjustments to reconcile net loss to net
cash used in operating activities
Depreciation and amortization 728,520 1,028,197
Loss on disposal of assets 1,621 -
Provision for bad debts 28,615 -
Stock-based compensation 3,073,592 687,290
Deferred revenue (373,959) (400,568)
Deferred costs 173,377 178,705
Changes in operating assets and liabilities:
Accounts payable (510,745) 1,496,396
Inventories (42,211) (433,335)
Other current assets (264,829) (329,104)
Security deposits - (132,686)
Accrued interest on investments (806,386) -
Accounts receivable (740,981) 423,111
Accrued expenses 642,486 390,003
------------ ------------
Net cash used in operating activities (14,827,655) (7,263,784)
Cash flows from investing activities:
Release of restricted cash 290,000 -
Additions to intangible assets (166,926) (241,998)
Capital expenditures (90,016) (236,793)
Redemption of short-term securities 17,558,214 -
Purchase of short-term securities (25,350,012) -
------------ ------------
Net cash used in investing activities (7,758,740) (478,791)
Cash flows from financing activities:
Proceeds from issuance of common stock, net of related expenses - 55,650,000
Proceeds from exercise of options and warrants 361,459 3,906,436
Due from shareholder (340,606) -
Dividends paid (254,281) (354,597)
------------ ------------
Net cash (used in) provided by financing activities (233,428) 59,201,839
Effect of exchange rates on cash and cash equivalents 6,535 -
------------ ------------
Net (decrease) increase in cash and cash equivalents (22,813,288) 51,459,264
Cash and cash equivalents, beginning of period 31,407,533 18,875,675
------------ ------------
Cash and cash equivalents, end of period $ 8,594,245 $70,334,939
============= ===========
The accompanying notes are an integral part of these financial statements.
-5-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2006
(Unaudited)
NOTE A - Description of Business and Significant Accounting Policies
Description of Business
Bioenvision, Inc. (the "Company") is a product-focused biopharmaceutical company
with two approved cancer therapeutics. On December 29, 2004, the FDA approved
our lead cancer product, Evoltra(R) (clofarabine), for the treatment of
pediatric acute lymphoblastic leukemia, or ALL, in patients who have received
two or more prior regimens. Clofarabine has received Orphan Drug designation in
the U.S. and the European Union. Genzyme Corporation, the Company's
co-development partner, currently holds marketing rights in the U.S. and Canada
for clofarabine for certain cancer indications and controls U.S. development of
clofarabine in these indications. Genzyme is selling clofarabine under the brand
name Clolar(R) in the U.S. On February 23, 2006, the Company announced that the
European Medicines Evaluation Agency, or "EMeA", had adopted a positive opinion
on the marketing authorization application for Evoltra(R), for the treatment of
pediatric ALL, in patients who have relapsed or are refractory to at least two
or more prior regimens. The positive opinion is now actively being converted
into a Marketing Authorization by the European Commission, a process that is
expected to take up to 3 months, at which time the Company will launch
Evoltra(R) throughout Europe.
The Company is currently selling its anti-cancer drug, Modrenal(R), in the
United Kingdom. Modrenal(R) is approved in the U.K. for the treatment of
post-menopausal advanced breast cancer following relapse to initial hormone
therapy.
Significant Accounting Policies
Revenue recognition
In accordance with SEC Staff Accounting Bulletin No. 104 "Revenue Recognition",
or "SAB 104", upfront nonrefundable fees associated with research and
development collaboration agreements in which the Company has continuing
involvement in the agreement, are recorded as deferred revenue and recognized
over the estimated research and development period using the straight-line
method. If the estimated period is subsequently modified, the period over which
the up-front fee is recognized is modified accordingly on a prospective basis
using the straight-line method. Continuation of certain contracts and grants are
dependent upon the Company and/or its co-development partners' achieving
specific contractual milestones; however, none of the payments received to date
are refundable regardless of the outcome of the project. Upfront nonrefundable
fees associated with licensing arrangements are recorded as deferred revenue and
recognized over the period of the licensing arrangement using the straight-line
method, which approximates the life of the last to expire of the underlying
patents.
Royalty revenue from product licenses is recorded as earned.
The Company currently sells its products to wholesale distributors and directly
to hospitals, clinics, and retail pharmacies. Revenue from product sales is
recognized when the risk of loss is passed to the customer, the sales price is
fixed and determinable, and collectibility is reasonably assured.
Research and development contract revenue includes sales in our pre-commercial
stage Named Patient Program for clofarabine as well as certain payments due from
our co-development partner relating to the reimbursement of 50% for certain of
our ongoing research costs in the development of clofarabine outside the United
States. Currently, the Company has billed but not recorded approximately
$2,513,000 of revenue relating to the reimbursement from our co-development
partner for certain of our ongoing research costs in the development of
clofarabine outside the United States. If and when the Company has determined
that collectibility is reasonably assured, the Company will record the revenue.
At March 31, 2006, the Company continues to hold a reserve for bad debts of
$869,000 relating to the outstanding receivables due from the co-development
partner.
The Company follows the guidance of Emerging Issues Task Force 99-19, or EITF,
"Reporting Revenue Gross as a Principal versus Net as an Agent" in the
presentation of revenue and direct costs of revenue. This guidance requires the
Company to assess whether it acts as a principal in the transaction or as an
agent acting on behalf of others. The Company records revenue transactions gross
in its statements of operations if it is deemed the principal in the
transaction, which includes being the primary obligor and having the risks and
rewards of ownership.
-6-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE A - Description of Business and Summary of Significant Accounting Policies
- continued
Research and development
Research and development costs are charged to expense as incurred. Research and
development costs include the cost of clofarabine sold prior to product approval
through our Named Patient Program.
Accounting for stock-based compensation
On July 1, 2005, the Company adopted the fair value recognition provisions of
SFAS No. 123 (revised 2004), "Share-Based Payment" ("SFAS 123 (R)"), requiring
the Company to recognize expense related to the fair value of stock-based
compensation. The modified prospective transition method was used as allowed
under SFAS 123 (R). Under this method, the stock-based compensation expense
includes: (a) compensation expense for all stock-based compensation awards
granted prior to, but not yet vested as of July 1, 2005, based on the grant date
fair value estimated in accordance with the original provisions of SFAS 123,
"Accounting for Stock-Based Compensation"; and (b) compensation expense for all
stock-based compensation awards granted subsequent to July 1, 2005, based on the
grant date fair value estimated in accordance with the provisions of SFAS 123
(R). Prior to the adoption of SFAS 123 (R), the Company had accounted for
stock-based compensation arrangements in accordance with provisions of
Accounting Principles Board ("APB") Opinion No. 25 "Accounting for Stock Issued
to Employees", as permitted by SFAS 123. Under APB Opinion No. 25, no
stock-based employee compensation cost was reflected in reported net loss, when
options granted to employees have an exercise price equal to the market value of
the underlying common stock at the date of grant.
Upon adoption of SFAS 123 (R), beginning July 1, 2005, the Company reversed the
unrecognized deferred compensation costs associated with options granted to
certain employees of approximately $136,000 with a corresponding reduction to
the Company's additional paid-in capital (see Note E). The Company also no
longer re-measures the intrinsic value of the 380,000 re-priced options granted
to an officer of the Company (see Note E). The Company recognized compensation
expense of approximately $12,000 and $36,000 for these options during the three
and nine months ended March 31, 2006, respectively, based on the fair value, as
determined in accordance with SFAS 123 (R), of the modified award that remains
unvested.
Beginning July 1, 2005, the Company is recognizing compensation expense for
stock option awards to employees based on their grant-date fair value. The
weighted average fair value per share for stock options granted to employees
during the three and nine months ended March 31, 2006 was $3.66 and $3.67,
respectively, and the weighted average fair value per share for stock options
granted to employees during the three and nine months ended March 31, 2005 was
$4.77 and $4.77, respectively. The fair value of each stock option grant is
estimated on the date of grant using the Black-Scholes option-pricing model
which incorporates the following weighted average assumptions:
Three Months Ended March 31, Nine Months Ended March 31,
2006 2005 2006 2005
---- ---- ---- ----
Risk-free interest rate 4.31% 3.40% 4.31% 3.36%
Expected term (in years) 3.82 3.95 3.82 3.88
Expected volatility 66% 80% 66% 80%
Expected dividend yield 0% 0% 0% 0%
As required by SFAS 123 (R), management made an estimate of expected forfeitures
for all unvested awards and is recognizing compensation costs only for those
equity awards expected to vest. The impact on previously reported pro forma
disclosures under SFAS 123 where forfeitures were recognized as incurred is not
material. As of March 31, 2006, the total compensation cost related to unvested
equity awards granted to employees but not yet recognized is approximately
$4,276,000. This cost will be amortized on a straight-line basis over the
remaining weighted average vesting period of 2.1 years.
-7-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE A - Description of Business and Summary of Significant Accounting Policies
- continued
A summary of the Company's stock option activity for options issued to employees
and related information follows:
Weighted
Average
Remaining Aggregate
Number Weighted Average Contractual Intrinsic
of Shares Exercise Price Life Value
--------- -------------- ---- -----
Balance - June 30, 2005 4,156,000 $3.18
Granted 1,202,000 6.51
Exercised (415,000) 1.43 $368,000
Cancelled (252,000) 4.05
Forfeited (18,000) 8.28
---------
Balance - March 31, 2006 4,673,000 $4.12 4.66 $11,531,000
=========
Exercisable - March 31, 2006 3,308,000 $2.93 6.58 $6,258,000
A summary of the Company's nonvested employee options at March 31, 2006 and
changes during the nine months ended March 31, 2006 is presented below:
Weighted
Non-vested Average Fair
Number Value at
of Shares Grant Date
--------- ----------
Balance - June 30, 2005 1,434,000 $ 3.13
Granted 1,123,000 3.52
Vested (1,001,000) 2.98
Cancelled (173,000) 2.70
Forfeited (18,000) 4.72
---------
Balance - March 31, 2006 1,365,000 $ 3.86
=========
-8-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE A - Description of Business and Summary of Significant Accounting Policies
- continued
The Company recorded, as a component of net loss, employee stock-based
compensation expense of $2,058,000 and $2,999,000 for the three and nine months
ended March 31, 2006, respectively. For the three and nine months ended March
31, 2005, the Company accounted for stock-based compensation in accordance with
APB No. 25. The following table summarizes the pro forma effect of stock-based
compensation as if the fair value method of accounting for stock options had
been applied in measuring compensation cost for the three and nine months ended
March 31, 2005:
Three months ended Nine months ended
March 31, March 31,
2005 2005
---- ----
Net loss applicable to common stockholders,
as reported $ (3,155,629) $ (10,491,728)
Add: Stock-based employee compensation expense
as reported (628,508) (365,016)
Deduct: Total stock-based employee compensation
expense determined under fair value-based method
for all awards (1,268,146) (1,859,343)
----------- ---------------
Pro forma net loss applicable to common stockholders $(5,052,283) $(12,716,087)
============ =============
Loss per share
Basic and diluted - as reported $ (0.08) $ (0.33)
Basic and diluted - pro forma $ (0.13) $ (0.40)
The Company accounts for equity instruments issued to non-employees in
accordance with the provisions of SFAS 123 and EITF No. 96-18, "Accounting for
Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling Goods or Services." Under EITF No. 96-18, where the
fair value of the equity instrument is more reliably measurable than the fair
value of services received, such services will be valued based on the fair value
of the equity instrument.
Income taxes
The Company accounts for income taxes under SFAS No. 109, "Accounting for Income
Taxes", or SFAS 109. Under SFAS 109, deferred tax assets and liabilities are
determined based on the differences between the financial reporting and tax
basis of assets and liabilities and are measured using the enacted tax rates
that will be in effect when the differences are expected to reverse.
We have not generated any taxable income, subject to federal taxes, to date and,
therefore, have not paid any federal income taxes since inception. We record a
valuation allowance to reduce deferred income tax assets to an amount that is
more likely than not to be realized. Assessment of the realization of deferred
income tax assets requires that estimates and assumptions be made as to the
taxable income of future periods. Our deferred tax assets are reduced to zero,
as management believes that it is more likely than not that the deferred tax
assets will not be realized. Projection of future period earnings is inherently
difficult as it involves consideration of numerous factors such as our overall
strategies and estimates of new product development and acceptance, product
lifecycles, selling prices and volumes, responses by competitors, manufacturing
costs and assumptions as to operating expenses and other industry specific and
macro and micro economic factors.
Net loss per share
Basic net loss per share is computed using the weighted average number of common
shares outstanding during the periods. Diluted net loss per share is computed
using the weighted average number of common shares and potentially dilutive
common shares outstanding during the periods. As the Company has incurred a net
loss for both the three and nine months ended March 31, 2006 and 2005, the basic
earnings per share equals the diluted earnings per share. Options and warrants
to purchase 11,940,314 and 11,572,415 shares of common stock have not been
included in the calculation of net loss per share for the three and nine months
ended March 31, 2006 and 2005, respectively, as their effect would have been
anti-dilutive.
-9-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE A - Description of Business and Summary of Significant Accounting Policies
- continued
Comprehensive loss
Total comprehensive loss for the three months ended March 31, 2006 and 2005 was
approximately $8,242,000 and $3,186,000, respectively and approximately
$17,109,000 and $10,514,000 for the nine months ended March 31, 2006 and 2005,
respectively. The amount included in comprehensive loss includes unrealized
translation losses of approximately $20,000 and $31,000 for the three months
ended March 31, 2006 and 2005 and approximately $119,000 and $22,000 for the
nine months ended March 31, 2006 and 2005 resulting from the translation of our
wholly-owned subsidiary to US dollars.
Foreign currency translation
The reporting currency of the Company is the US dollar. The functional currency
of Bioenvision Limited, the Company's wholly-owned subsidiary, organized under
the laws of the United Kingdom with offices in Edinburgh, Scotland, is the Pound
Sterling. We translate assets and liabilities to their US dollar equivalents at
rates in effect at the balance sheet date and record translation adjustments in
accumulated other comprehensive income (loss). We translate statement of
operations accounts at average rates for the period. For the three months ended
March 31, 2006 and 2005, the net foreign currency transaction gains (losses)
included in selling, general and administrative expense were approximately
$(13,000) and $23,000, respectively. For the nine months ended March 31, 2006
and 2005, the net foreign currency transaction gains included in selling,
general and administrative expense were approximately $16,000 and $23,000,
respectively.
Cash and cash equivalents and Short-term securities
The Company considers all highly liquid financial instruments with a maturity of
three months or less when purchased to be cash equivalents. All funds invested
in a Certificate of Deposit with maturities greater than three months and less
than one year are classified as short-term securities and determined by
management to be available-for-sale securities.
Deferred costs
Deferred costs represent payments to Southern Research Institute, or SRI, and to
Stegram Pharmaceuticals Limited, which directly relate to milestone payments
received in connection with the Genzyme Co-Development Agreement and the Dechra
Sub-License Agreement, respectively. These costs are being amortized
straight-line over the life of the contract and the amortization of these costs
has been presented in research and development expense on the statement of
operations.
Credit risk
Our accounts receivable are primarily due from wholesale distributors and our
co-development partners. One customer comprises approximately 26% and 37% of
revenues earned for the three and nine months ended March 31, 2006,
respectively, and 68% and 69% for the three and nine months ended March 31,
2005, respectively. At March 31, 2006, the Company continues to hold a provision
for bad debts of $869,000 relating to the outstanding receivables due from the
customer. Revenues from two additional customers comprise approximately 33% and
7% for the three months ended March 31, 2006, respectively, and 16% and 14% for
the nine months ended March 31, 2006, respectively. The same two customers
comprised approximately 0% and 10% of revenue earned for the three months ended
March 31, 2005, respectively, and 0% and 11% of revenue earned for the nine
months ended March 31, 2005, respectively.
Inventories
Inventories are stated at the lower of cost or market, with cost being
determined under the first-in, first-out method. We only capitalize inventory
that is produced for commercial sale. The Company periodically reviews inventory
on hand. Items considered outdated or obsolete are reduced to their estimated
net realizable value.
March 31, June 30,
Asset Description 2006 2005
----------------- ---- ----
Work in Process $235,000 $171,000
Finished Goods 117,000 107,000
-------- --------
Total Inventories $352,000 $278,000
======== ========
-10-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE A - Description of Business and Summary of Significant Accounting Policies
- continued
Fair value of financial instruments
The Company has estimated the fair value of financial instruments using
available market information and other valuation methodologies in accordance
with SFAS 107, "Disclosures about Fair Value of Financial Instruments."
Management of the Company believes that the fair value of financial instruments,
consisting of cash, cash equivalents, short-term securities, accounts
receivable, accounts payable and accrued expenses, approximates their carrying
value due to the immediate or short-term maturity associated with these
instruments.
Goodwill and Other intangible assets
Goodwill represents the excess of costs over the fair value of identifiable net
assets of Pathagon, Inc. Intangible assets include patents and licensing rights
acquired in connection with the acquisition of Pathagon. The Company accounts
for these assets in accordance with SFAS 142, "Goodwill and Other Intangible
Assets." Goodwill is not amortized, but instead tested for impairment at least
annually in accordance with the provisions of SFAS 142. SFAS 142 also requires
that intangible assets with definite useful lives be amortized over their
respective estimated useful lives to their estimated residual values, and
reviewed for impairment in accordance with SFAS 144, "Accounting for Impairment
or Disposal of Long-Lived Assets."
For goodwill, each year and whenever impairment indicators are present, we will
calculate the implied fair value of goodwill and record an impairment loss for
the excess of book value over the implied fair value, if any.
Impairment of long-lived assets
In accordance with SFAS 144, long-lived assets, such as property and equipment
and intangible assets subject to amortization are reviewed for impairment
whenever events or changes in circumstances indicate that the carrying amount of
an asset may not be recoverable. Recoverability of assets to be held and used is
measured by a comparison of the carrying amount of an asset to estimated
undiscounted future cash flows expected to be generated by the asset. If the
carrying amount of an asset exceeds its estimated future cash flows, an
impairment charge is recognized by the amount by which the carrying amount of
the asset exceeds the fair value of the asset.
Recent Accounting Pronouncements
In May 2005, the FASB issued SFAS 154 "Accounting Changes and Error
Corrections," a replacement of APB Opinion 20 and SFAS 3. SFAS 154 changes the
accounting for, and reporting of, a change in accounting principle. SFAS 154
requires retrospective application to prior period's financial statements of
voluntary changes in accounting principle, and changes required by new
accounting standards when the standard does not include specific transition
provisions, unless it is impracticable to do so. SFAS 154 is effective for
accounting changes and corrections made in fiscal years beginning after December
15, 2005.
In March 2005, the FASB issued FIN 47, "Accounting for Conditional Asset
Retirement Obligations," an interpretation of SFAS 143. FIN 47 clarifies that
the term conditional asset retirement obligation as used in SFAS 143 refers to a
legal obligation to perform an asset retirement activity in which the timing or
method of settlement are conditional on a future event that may or may not be
within the control of the entity. FIN 47 also clarifies when an entity would
have sufficient information to reasonably estimate the fair value of an asset
retirement obligation. FIN 47 is effective for fiscal years ending after
December 15, 2005.
In December 2004, the FASB issued SFAS 153 "Exchange of Nonmonetary Assets."
SFAS 153 was a result of a joint effort by the FASB and the IASB to improve
financial reporting by eliminating certain narrow differences between their
existing accounting standards. One such difference was the exception from fair
value measurement in APB Opinion No. 29, "Accounting for Nonmonetary
Transactions", for non-monetary exchanges of similar productive assets. SFAS 153
replaces this exception with a general exception from fair value measurement for
exchanges of non-monetary assets that do not have commercial substance. A
nonmonetary exchange has commercial substance if the future cash flows of the
entity are expected to change significantly as a result of the exchange. SFAS
153 is effective for non-monetary assets exchanges occurring in fiscal periods
beginning after June 15, 2005. The adoption of SFAS 153 did not have a material
impact on the results of operations or financial position of the Company.
-11-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE A - Description of Business and Summary of Significant Accounting Policies
- continued
In November 2004, the FASB issued SFAS 151, "Inventory Costs." SFAS 151 amends
Accounting Research Bulletin No. 43, Chapter 4. SFAS 151 clarifies the
accounting for abnormal amounts of idle facility expense, freight, handling
costs, and wasted material (spoilage). SFAS 151 is the result of a broader
effort by the FASB and the IASB to improve financial reporting by eliminating
certain narrow differences between their existing accounting standards. SFAS 151
was effective for inventory costs incurred during fiscal years beginning after
June 15, 2005. The adoption of SFAS 151 did not have a material impact on the
results of operations or financial position of the Company.
NOTE B - Interim Financial Statements
In the opinion of management, the accompanying unaudited condensed consolidated
financial statements contain all adjustments, consisting of normal recurring
adjustments, necessary to present fairly the condensed consolidated financial
position of the Company as of March 31, 2006, the condensed consolidated results
of operations for the three and nine months ended March 31, 2006 and 2005, the
condensed consolidated statement of stockholders' equity for the nine months
ended March 31, 2006, and the condensed consolidated statements of cash flows
for the nine months ended March 31, 2006 and 2005. Certain reclassifications of
balances previously reported have been made to conform to the current
presentation.
The condensed consolidated balance sheet at June 30, 2005 has been derived from
the audited consolidated financial statements at that date, but does not include
all the information and footnotes required by accounting principles generally
accepted in the United States for complete financial statements. For further
information, refer to the audited consolidated financial statements and
footnotes thereto included in the Form 10-KSB filed by the Company for the year
ended June 30, 2005.
The condensed consolidated results of operations for the three and nine months
ended March 31, 2006 and 2005 are not necessarily indicative of the results to
be expected for any other interim period or for the full year.
NOTE C - License and Co-Development Agreements
Clofarabine (Evoltra(R))
The Company has a license from SRI to develop, manufacture, market, distribute
and sell a class of purine nucleoside analogs which, based on third-party
studies conducted to date, may be effective in the treatment of leukemia,
lymphoma and certain solid tumor cancers. The lead compound of these
purine-based nucleosides is known as clofarabine (Evoltra(R)). Under the terms
of the agreement with SRI, the Company was granted the exclusive worldwide
license, excluding Japan and Southeast Asia, to make, use and sell products
derived from the technology for a term expiring on the date of expiration of the
last patent covered by the license (subject to earlier termination under certain
circumstances), and to utilize technical information related to the technology
to obtain patent and other proprietary rights to products developed by the
Company and by SRI from the technology. Initially, the Company is developing
Evoltra(R) for the treatment of leukemia and lymphoma and studying its potential
role in treatment of solid tumors.
In August 2003, SRI granted the Company an irrevocable, exclusive option to
make, use and sell products derived from the technology (including Evoltra(R))
in Japan and Southeast Asia. The Company intends to convert the option to a
license and is actively working on this initiative.
To facilitate the development of Evoltra(R) in March 2001, the Company entered
into a co-development agreement with ILEX Oncology, Inc. ("ILEX"), our
sub-licensor until it was acquired by Genzyme Corporation ("Genzyme") on
December 21, 2004, for the development of Evoltra(R) in cancer indications.
Under the terms of the co-development agreement, Genzyme is required to pay all
development costs in the United States and Canada, and 50% of approved
development costs worldwide outside the U.S. and Canada (excluding Japan and
Southeast Asia), in each case, for the development of Evoltra(R) in cancer
indications. Currently, the Company has billed but not recorded approximately
$2,513,000 of revenue relating to the reimbursement from our co-development
partner for certain of our ongoing research costs in the development of
Evoltra(R) outside the United States. If and when the Company has determined
that collectibility is reasonably assured, the Company will record the revenue.
Genzyme is responsible for conducting all clinical trials and the filing and
prosecution of applications with applicable regulatory authorities in the United
States and Canada for certain cancer indications. The Company retains the right
to handle those matters in all territories outside the United States and Canada
(excluding Japan and Southeast Asia) and retains the right to handle these
matters in the U.S. and Canada in all non-cancer indications. The Company
retained the exclusive manufacturing and distribution rights in Europe and
elsewhere worldwide, except for the United States, Canada, Japan and Southeast
Asia. Under the co-development agreement, Genzyme will have certain rights if it
performs its development obligations in accordance with that agreement. The
Company is required to pay Genzyme a royalty on direct
-12-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE C - License and Co-Development Agreements -continued
sales outside the U.S., Canada, Japan and Southeast Asia. In turn, Genzyme,
which has U.S. and Canadian distribution rights in cancer indications, is paying
the Company a royalty on sales in the U.S. and Canada. Under the terms of the
co-development agreement, Genzyme also pays royalties to SRI based on certain
milestones. The Company also is obligated to pay certain royalties to SRI with
respect to Evoltra(R).
The Company received a nonrefundable upfront payment of $1,350,000 when it
entered into the co-development agreement with Genzyme and received an
additional $3,500,000 in December 2003 when it converted Genzyme's option to
market clofarabine in the U.S. into a sublicense. Upon Genzyme's filing the New
Drug Application (NDA) for clofarabine with the FDA, the Company received an
additional (i) $2,000,000 in April 2004 and (ii) $2,000,000 in September 2004.
The Company deferred the upfront payment and recognized revenues ratably, on a
straight-line basis over the related service period. The Company has deferred
the milestone payments received to date and recognizes revenues ratably, on a
straight-line basis over the related service period, through March 2021. For the
three and nine months ended March 31, 2006 and 2005, the Company recognized
revenue of approximately $110,000 and $330,000, respectively, in connection with
the milestone payments received.
Deferred costs include royalty payments that became due and payable to SRI upon
the Company's execution of the co-development agreement with Genzyme. The
Company defers all royalty payments made to SRI and recognizes these costs
ratably, on a straight-line basis over the related service period, concurrent
with revenue that is recognized in connection with research and development
costs through 2021. For the three and nine months ended March 31, 2006 and 2005,
the Company recognized costs of approximately $55,000 and $165,000,
respectively, in connection with the above milestone payments.
Modrenal(R)
The Company holds an exclusive license, until the expiration of existing and new
patents related to Modrenal(R), to market Modrenal(R) in major international
territories, and an agreement with a United Kingdom company to co-develop
Modrenal(R) for other therapeutic indications. Management believes that
Modrenal(R) currently is manufactured by third-party contractors in accordance
with good manufacturing practices ("GMP").
The Company has no plans to establish its own manufacturing facility for
Modrenal(R), but will continue to use third-party contractors.
The Company received a nonrefundable upfront payment of $1,250,000 when it
entered into the License and Sublicense Agreement with Dechra Pharmaceuticals in
May 2003. The Company deferred the upfront payment and recognizes revenues
ratably, on a straight-line basis over the related service period, currently
through September 2022. The Company recognized revenues of approximately $15,000
in connection with the upfront payment from Dechra for each of the three months
ended March 31, 2006 and 2005, and $45,000 and $72,000 for the nine months ended
March 31, 2006 and 2005, respectively.
Deferred costs include royalty payments that became due and payable to Stegram
Pharmaceuticals Ltd. upon the Company's execution of the License and Sub-License
Agreement with Dechra in May 2003. The Company defers all royalty payments made
to Stegram and recognizes these costs ratably, on a straight-line basis
concurrent with revenue that is recognized in connection with the Dechra
agreement. Research and development costs related to this agreement include
approximately $3,000 and $6,000 for the three months ended March 31, 2006 and
2005, respectively and $9,000 and $17,000 for the nine months ended March 31,
2006 and 2005, respectively.
NOTE D - Intangible Assets
March 31, June 30,
2006 2005
---- ----
Patents $9,383,000 $9,338,000
Trademarks 199,000 176,000
Other 99,000 -
---------- ---------
9,681,000 9,514,000
Accumulated Amortization (1,912,000) (1,261,000)
----------- -----------
Intangibles, net $7,769,000 $ 8,253,000
========== ===========
-13-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE D - Intangible Assets - continued
Amortization of intangibles amounted to $220,000 and $336,000 for the three
months ended March 31, 2006 and 2005, respectively, and $651,000 and $1,006,000
for the nine months ended March 31, 2006 and 2005, respectively. Intangible
assets are recorded at cost and amortized over periods generally ranging from
1-20 years. Amortization for each of the next five fiscal years is expected to
amount to approximately $860,000 annually.
NOTE E - Stockholder Equity Transactions
Stock Options
The Board of Directors adopted, and the stockholders approved, the 2003 Stock
Incentive Plan at the Annual Meeting held in January 2004. The plan was adopted
to recognize the contributions made by the Company's employees, officers,
consultants, and directors, to provide those individuals with additional
incentive to devote themselves to our future success and to improve the
Company's ability to attract, retain and motivate individuals upon whom the
Company's growth and financial success depends. Under the plan, stock options
may be granted as approved by the Board of Directors or the Compensation
Committee. There are 4,500,000 shares reserved for grants of options under the
plan and, at March 31, 2006, options to purchase 3,918,167 shares of common
stock had been issued. The Company's policy is to issue new shares for option
exercises. Stock options vest pursuant to individual stock option agreements. No
options granted under the plan are exercisable after the expiration of ten years
(or less in the discretion of the Board of Directors or the Compensation
Committee) from the date of the grant. The plan will continue in effect until
terminated or amended by the Board of Directors or until expiration of the plan
on November 17, 2013.
In June 2002, the Company granted options to an officer of the Company to
purchase 380,000 shares of common stock at an exercise price of $1.95 per share,
which equaled the fair value on the date of grant. Of this amount 50,000 options
vested on June 28, 2002 and the remaining 330,000 options vest ratably over a
three-year period on each anniversary date. On March 31, 2003, the Company
entered into an Employment Agreement with such officer of the Company, pursuant
to which, among other things, the exercise price for all of the 380,000 options
were changed to $0.735 per share, which equaled the stock price on that date. In
addition, the Company issued an additional 120,000 options at an exercise price
of $0.735 per share which vested immediately. As a result of the repricing of
all of the 380,000 options, the Company remeasured the intrinsic value of these
options at the end of each reporting period based on changes in the stock price
through June 30, 2005. As a result of the adoption of SFAS 123 (R) on July 1,
2005, the Company no longer re-measures the intrinsic value of the 380,000
re-priced options. The Company determined the fair value of the modified award
in accordance with SFAS 123, the guidance then in effect and has recognized
expense relating to the portion of the options that were unvested on July 1,
2005. For the three months ended March 31, 2006 and 2005, the Company recognized
stock based employee compensation expense (income) of approximately $12,000 and
$(650,000), respectively, related to these options. For the nine months ended
March 31, 2006 and 2005, the Company recognized stock-based employee
compensation expense (income) of approximately $36,000 and $(431,000),
respectively, related to these options.
On March 30, 2006, the Company extended the exercise period of 1,500,000 vested
options originally granted to an officer of the Company from five to ten years.
The extension of the exercise period was treated as a modification of an award
under SFAS 123 (R) and resulted in the immediate recognition of incremental
compensation expense of approximately $591,000.
For the three and nine months ended March 31, 2005, the Company recorded
compensation expense of approximately $22,000 and $66,000, respectively, as a
result of 505,000 options granted to certain employees at an exercise price
below the grant date trading price. Upon adoption of SFAS 123 (R), beginning
July 1, 2005, the Company reversed the unrecognized deferred compensation costs
of approximately $136,000, associated with these options, with a corresponding
reduction to the Company's additional paid-in capital and is recognizing the
fair value estimated in accordance with the original provisions of SFAS 123 for
the unvested options. In December 2005, the Company cancelled a total of 251,667
options relating to the unexercised options issued to three of the employees
that were originally issued below fair market value with a strike price of
$4.05. The Company reissued these options at the fair market value on January
20, 2004 (original grant date) with a strike price of $4.55 and provided cash
bonuses to the employees in return for the increase in the strike price. The
original vesting terms and remaining exercise period of the original grant on
date of modification was utilized in the amended grant. The Company has recorded
additional compensation expense equal to the amount of the cash bonuses paid of
$125,000. The Company will continue to record compensation expense for the fair
value of the stock options over the remaining vesting term.
On January 20, 2004, the Company granted 25,000 options to a board member for
serving as a member of the Board of Directors, at an exercise price of $4.55 per
share which vest ratably on the first and second anniversaries of the grant
date. The Company recognized consulting expense of approximately $3,000 and
$12,000 for the three months ended March 31, 2006 and 2005, respectively, and
$27,000 and $36,000 for the nine months ended March 31, 2006 and 2005,
respectively, relating to said options.
-14-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE E - Stockholder Equity Transactions - continued
On January 6, 2005, the Company granted 7,500 options to a board member for
serving as a member of the Board of Directors, at an exercise price of $8.17 per
share, 1,875 of which options vested immediately on the grant date and the
remaining 5,625 vest ratably on the first, second and third anniversaries of the
grant date. The Company recognized approximately $2,000 and $6,000 as consulting
expense for the three and nine months ended March 31, 2006, respectively. The
Company recognized approximately $11,000 for each of the three and nine months
ended March 31, 2005.
On January 6, 2006, the Company granted 15,000 options to each of two board
members for serving as a member of the Board of Directors, at an exercise price
of $7.01 per share, 3,750 of which options vested immediately and the remaining
11,250 vest ratably on the first, second and third anniversaries of the grant
date. The Company recognized approximately $33,000 as consulting expense for
each of the three and nine months ended March 31, 2006.
During the nine months ended March 31, 2006, certain option holders of the
Company exercised their options to acquire 190,000 shares of the Company's
common stock, in which the Company received proceeds of approximately $311,000.
During the nine months ended March 31, 2006, certain non-employee option holders
exercised their options pursuant to the cashless feature available to such
option holders and the Company issued 191,196 shares of its common stock in
connection therewith.
During the nine months ended March 31, 2005, certain option holders of the
Company exercised their options to acquire 788,542 shares of the Company's
common stock, in which the Company received proceeds of approximately $627,000,
from the exercise of such options.
Warrants
On June 22, 2004, the Company entered into a consulting agreement pursuant to
which the consultant will provide certain investor relations services on behalf
of the Company. In connection therewith, the Company issued a warrant to said
consultant pursuant to which he has the right to purchase 50,000 shares of the
Company's common stock at a price of $8.25 per share upon the completion of
certain milestones, as set forth in such agreement. The Company recognized
consulting expense of approximately $0 and $243,000 for the three and nine
months ended March 31, 2005, respectively. All milestones were met as of
December 31, 2004.
On August 4, 2004, the Company issued a warrant to a consultant pursuant to
which said consultant has the right to purchase 40,000 shares of the Company's
common stock at a price of $7.22 per share, of which 20,000 warrants vested
immediately and 20,000 vest upon satisfaction of certain milestones included in
the warrant. The Company recognized consulting (income) expense of approximately
$(44,000) and $125,000 for the three and nine months ended March 31, 2005,
respectively, related to said warrants. No additional milestones were met during
the nine months ended March 31, 2006.
On August 9, 2004, the Company issued two warrants to a consultant pursuant to
which said consultant has the right to purchase an aggregate of 45,000 shares of
the Company's common stock at a price of $6.10 per share. The Company recognized
consulting expense (income) of approximately $0 and $(57,000) for the three
months ended March 31, 2006 and 2005, respectively. For the nine months ended
March 31, 2006 and 2005, the Company recognized consulting expense of $9,000 and
$142,000, respectively. All milestones were met as of September 30, 2005 related
to said warrants.
During the nine months ended March 31, 2006, certain warrant holders of the
Company exercised their warrants to acquire 63,703 shares of the Company's
common stock, in which the Company received proceeds of approximately $51,000
from the exercise of such warrants.
During the nine months ended March 31, 2005, certain warrant holders of the
Company exercised their warrants to acquire 1,598,411 shares of the Company's
common stock, in which the Company received proceeds of approximately $3,279,000
from the exercise of such warrants.
Common Stock
On December 3, 2004, the Company issued 62,500 shares of common stock to a
consultant for services rendered. In connection with such issuance we recognized
approximately $497,000 as compensation expense.
On February 8, 2005, the Company completed a secondary public offering in which
we sold 7,500,000 common shares at $8.00 per share, with net proceeds to the
Company of approximately $55,747,000, after deducting underwriting discounts and
commissions and offering expenses.
-15-
BIOENVISION, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE E - Stockholder Equity Transactions - continued
Shareholder Receivable
Subsequent to the exercise of an option by a former member of management on
September 27, 2005, the Company became aware of the statutorily required
withholding taxes due to the UK tax regulatory authority. In order to maintain
compliance with the UK tax regulatory authority, the Company remitted the taxes
due on behalf of the former employee in January 2006 and, in return, received a
promissory note from the former member of management dated November 28, 2005 for
$341,000. The Company has classified such note as a shareholder receivable in
the equity section of the condensed consolidated balance sheet.
NOTE F - Quarterly Tax Accounting Policy
Income taxes have been provided for using the asset and liability method in
accordance with SFAS 109. The provision for income taxes reflects management's
estimate of the effective tax rate expected to be applicable for the full fiscal
year. This estimate is re-evaluated by management each quarter based on the
Company's estimated tax expense for the year.
NOTE G - Geographic Information
We define geographical regions as countries in which we operate. Our corporate
headquarters in the United States collects licensing, royalties and research and
development contract revenue from our arrangements with external customers and
our co-development partners. Our wholly owned subsidiary, Bioenvision Limited,
located in the United Kingdom currently manages our product sales (including the
Named Patient Program) for our two lead products.
The following table reconciles our revenue by geographic region to the
consolidated total:
Three Months Ended Nine Months Ended
March 31, March 31,
2006 2005 2006 2005
---- ---- ---- ----
Region
United States $ 503,000 430,000 $ 1,447,000 $ 2,922,000
United Kingdom 1,238,000 969,000 2,056,000 738,000
----------- ---------- ----------- -----------
Total Revenue $ 1,741,000 $1,399,000 $ 3,503,000 $ 3,660,000
=========== ========== =========== ===========
NOTE H - Litigation
On December 19, 2003, the Company filed a complaint against Dr. Deidre Tessman
and Tessman Technology Ltd. (the "Tessman Defendants") in the Supreme Court of
the State of New York, County of New York (Index No. 03-603984). An amended
complaint alleges, among other things, breach of contract and negligence by
Tessman and Tessman Technology and demands judgment against Tessman and Tessman
Technology in an amount to be determined by the Court. The Tessman Defendants
removed the case to federal court, then remanded it to state court and served an
answer with several purported counterclaims. Each of the parties had moved for
summary judgment dismissing all but one of the claims of the other parties.
Those motions were all denied by the Court, and a trial date had been set for
early 2006. On April 10, 2006 an out of court settlement was reached and each
party executed a release, releasing all claims against the other. A Stipulation
of Discontinuance was filed with the court.
-16-
BIOENVISION, INC. AND SUBSIDIARIES
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
Except for historical information contained herein, this quarterly report on
Form 10-Q contains forward-looking statements within the meaning of the Section
21E of the Securities and Exchange Act of 1934, as amended, which involve
certain risks and uncertainties. Forward-looking statements are included with
respect to, among other things, the Company's current business plan and
"Management's Discussion and Analysis of Results of Operations." These
forward-looking statements are identified by their use of such terms and phrases
as "intends," "intend," "intended," "goal," "estimate," "estimates," "expects,"
"expect," "expected," "project," "projected," "projections," "plans,"
"anticipates," "anticipated," "should," "designed to," "foreseeable future,"
"believe," "believes" and "scheduled" and similar expressions. The Company's
actual results or outcomes may differ materially from those anticipated. Readers
are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date the statement was made. The Company undertakes
no obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
The following discussion and analysis of significant factors affecting the
Company's operating results, liquidity and capital resources should be read in
conjunction with the accompanying financial statements and related notes.
Overview and Company Status
Bioenvision, Inc. (the "Company") is a product-focused biopharmaceutical company
with two approved cancer therapeutics. On December 29, 2004, the FDA approved
our lead cancer product, Evoltra(R) (clofarabine), for the treatment of
pediatric acute lymphoblastic leukemia, or ALL, in patients who have received
two or more prior regimens. Evoltra(R) has received Orphan Drug designation in
the U.S. and the European Union. Genzyme Corporation, the Company's
co-development partner, currently holds marketing rights in the U.S. and Canada
for Evoltra(R) for certain cancer indications and controls U.S. development of
Evoltra(R) in these indications. Genzyme is selling Evoltra(R) under the brand
name Clolar(R) in the U.S. On February 23, 2006, the Company announced that the
EMeA had adopted a positive opinion on the marketing authorization application
for Evoltra(R), for the treatment of pediatric ALL, in patients who have
relapsed or are refractory to at least two or more prior regimens. The positive
opinion is now actively being converted into a Marketing Authorization by the
European Commission, a process that is expected to take up to 3 months, at which
time the Company will launch Evoltra(R) throughout Europe.
The Company is currently selling its anti-cancer drug, Modrenal(R), in the
United Kingdom. Modrenal(R) is approved in the U.K. for the treatment of
post-menopausal advanced breast cancer following relapse to initial hormone
therapy.
Over the next 12 months, we intend to continue our internal growth strategy to
provide the necessary regulatory, sales and marketing capabilities which will be
required to pursue the expanded development programs for Evoltra(R) and
Modrenal(R) described above. Currently, we are considering all options available
to us for the marketing and distribution of Evoltra(R) in our primary markets,
including, without limitation, doing so directly and internally with our own
sales force, doing so through one or more distributors or wholesalers or
disposing of the marketing and distribution rights to a third party.
We have incurred losses during this early stage of our operations. Our
management believes that we have the opportunity to become a leading
oncology-focused pharmaceutical company in the next four years if we
successfully bring Evoltra(R) to market in Europe and successfully develop
certain of our other product candidates.
We anticipate that revenue derived from our two lead drugs, Evoltra(R) and
Modrenal(R) will permit us to further develop the other products currently in
our product pipeline. In addition to Evoltra(R) and Modrenal(R), we are
performing initial development work on Suvus for the treatment of chronic
Hepatitis C. The work to date on this compound has been limited because of the
need to concentrate on Evoltra(R) and Modrenal(R) but management believe these
compounds have potential value. With Suvus, the Company has commenced a phase II
clinical trial in patients with hepatitis C viral infection. We have had
discussions with potential product co-development partners from time to time,
and plan to continue to explore the possibilities for co-development and
sub-licensing in order to implement our development plans. In addition, we
believe that some of our products may have applications in treating non-cancer
conditions in humans and in animals. Whereas those conditions have been outside
our core business focus until the present time, we are now beginning to expand
development in these areas although and we do not intend to devote a substantial
portion of our resources to addressing those conditions.
In May 2003, we entered into a License and Sub-License Agreement with Dechra
Pharmaceuticals, plc, or Dechra, pursuant to which we sub-licensed the marketing
and development rights to Vetoryl(R) (trilostane), solely with respect to animal
health applications, in the U.S. and Canada, to Dechra. We received $1,250,000
in cash, together with future milestone and royalty payments which are
contingent upon the occurrence of certain events. We intend to continue to try
and capitalize on these types of opportunities as they arise. The Company also
owns rights to OLIGON(R) technology and we have had discussions with potential
product licensing
-17-
partners from time to time, and plan to continue to explore the possibilities
for co-development and sub-licensing in order to implement our development
plans.
You should consider the likelihood of our future success to be highly
speculative in light of our limited operating history, as well as the limited
resources, problems, expenses, risks and complications frequently encountered by
similarly situated companies. To address these risks, we must, among other
things:
o satisfy our future capital requirements for the implementation of our
business plan;
o commercialize our existing products;
o complete development of products presently in our pipeline and obtain
necessary regulatory approvals for use;
o implement and successfully execute our business and marketing strategy
to commercialize products;
o continue to develop new products and upgrade our existing products;
o continue to establish and maintain relationships with manufacturers for
our products;
o respond to industry and competitive developments; and
o attract, retain, and motivate qualified personnel.
We may not be successful in addressing these or any risks associated with our
business and/or products. If we were unable to do so, our business prospects,
financial condition and results of operations would be materially adversely
affected. The likelihood of our success must be considered in light of the
development cycles of new pharmaceutical products and technologies and the
competitive and regulatory environment in which we operate.
Results of Operations
The Company recorded revenue for the three months ended March 31, 2006 and 2005
of approximately $1,741,000 and $1,399,000, respectively, representing an
increase of approximately $342,000. This increase was primarily due to an
increase in Named Patient Program sales and certain research and development
reimbursements in the amount of $863,000, partially offset by a decrease of
$567,000 in research and development contract revenue which the Company did not
record as revenue in the three-month period ended March 31, 2006. The Company
recorded revenue for the nine months ended March 31, 2006 and 2005 of
approximately $3,503,000 and $3,660,000, respectively, representing a decrease
of approximately $157,000. This decrease was primarily due to a decrease in
research and development contract revenue as the Company did not record revenue
for the three and nine months ended March 31, 2006, relating to the
reimbursement from our co-development partner for certain of our ongoing
research costs in the development of Evoltra(R) outside the United States
because it determined that the criteria for recognizing such contract revenue
had not been met. If and when the Company has determined that collectibility is
reasonably assured, the Company will record the revenue. This decrease is
substantially offset by an increase in named patient sales of clofarabine and
royalties from US sales of clofarabine.
The cost of products sold for the three months ended March 31, 2006 and 2005
were approximately $387,000 and $280,000, respectively, representing an increase
of approximately $107,000. The cost of products sold reflects the direct costs
associated with our sales of Modrenal(R) and royalty expense of $315,000 and
$181,000 for the three months ended March 31, 2006 and 2005 respectively. The
cost of products sold for the nine months ended March 31, 2006 and 2005 were
approximately $1,153,000 and $434,000, respectively, representing an increase of
approximately $719,000. The cost of products sold reflects the direct costs
associated with our sales of Modrenal(R) and royalty expense of $847,000 and
$205,000 for the nine months ended March 31, 2006 and 2005, respectively.
Research and development costs for the three months ended March 31, 2006 and
2005 were approximately $2,785,000 and $2,137,000, respectively, representing an
increase of approximately $648,000. Research and development costs for the nine
months ended March 31, 2006 and 2005 were approximately $7,227,000 and
$5,986,000, respectively, representing an increase of approximately $1,241,000.
Our research and development costs include costs associated with the six
projects shown in the table below, three of which the Company currently devotes
time and resources:
-18-
Three Months Ended Nine Months Ended
March 31, March 31,
Product 2006 2005 2006 2005
Evoltra(R) $ 2,314,000 $ 1,668,000 $ 5,744,000 $ 4,661,000
Modrenal(R) 426,000 447,000 1,341,000 1,267,000
Suvus 45,000 7,000 142,000 13,000
Velostan - 15,000 - 32,000
OLIGON - - - 13,000
Gene Therapy - - - -
----------- ----------- ----------- -----------
Total $ 2,785,000 $ 2,137,000 $ 7,227,000 $ 5,986,000
=========== =========== =========== ===========
Evoltra(R) research and development costs for the three months ended March 31,
2006 and 2005 were approximately $2,314,000 and $1,668,000, respectively,
representing an increase of approximately $646,000. Evoltra(R) research and
development costs for the nine months ended March 31, 2006 and 2005 were
approximately $5,744,000 and $4,661,000, respectively, representing an increase
of approximately $1,083,000. The increase primarily reflects costs which are
associated with our increased development activities and clinical trials of
Evoltra(R) being conducted in Europe (which includes the filing process for EU
approval) coupled with recording stock-based compensation expense, relating to
stock options granted to employees that devote their time to clofarabine
research and development, recorded for the three and nine months ended March 31,
2006.
Modrenal(R) research and development costs for the three months ended March 31,
2006 and 2005 were approximately $426,000 and $447,000, respectively,
representing a decrease of $21,000. Modrenal(R) research and development costs
for the nine months ended March 31, 2006 and 2005 were approximately $1,341,000
and $1,267,000, respectively, representing an increase of $74,000. This increase
is due primarily to the costs associated with our Phase II clinical trial in
pre-menopausal cancer and Phase IV clinical trial in patients with
post-menopausal cancer, which are each being conducted in the U.K.
Suvus research and development costs for the three months ended March 31, 2006
and 2005 were approximately $45,000 and $7,000 respectively, representing an
increase of $38,000. Suvus research and development costs for the nine months
ended March 31, 2006 and 2005 were approximately $142,000 and $13,000,
respectively, representing an increase of $129,000. The increase primarily
reflects the costs associated with the investigator sponsored Phase II clinical
trial conducted in Egypt during the nine months ended March 31, 2006 and costs
associated with the preparation of an IND application to be filed with the FDA.
Velostan research and development costs for the three months ended March 31,
2006 and 2005 were approximately $0 and $15,000, respectively, representing a
decrease of $15,000. Velostan research and development costs for the nine months
ended March 31, 2006 and 2005 were approximately $0 and $32,000, respectively,
representing a decrease of $32,000. There were no research and development costs
associated with Velostan for the three and nine months ended March 31, 2006
because the Company is actively working on the manufacturing process to develop
a raceamic form of the compound for use in the Company's clinical development
program. No assurance can be given the Company will be able to create the L-form
Velostan required for the clinical development program or, if it can, the timing
of such development.
There was no research and development costs for OLIGON for the three months
ended March 31, 2006 and 2005 due to the Company's focus on Evoltra(R) and
Modrenal(R) during this period. OLIGON research and development costs for the
nine months ended March 31, 2006 and 2005 were approximately $0 and $13,000,
respectively, representing a decrease of $13,000.
There were no research and development costs associated with Gene Therapy for
the three and nine months ended March 31, 2006 and 2005 due to the Company's
focus on Evoltra(R) and Modrenal(R) during this period. We anticipate that
revenue derived from our two lead drugs, clofarabine and Modrenal(R) will permit
us to further develop these products.
The clinical trials and development strategy for Evoltra(R) and Modrenal(R), in
each case, is anticipated to cost several million dollars and will continue for
several years based on the number of clinical indications within which we plan
to develop these drugs. Currently, management cannot estimate the timing or
costs associated with these projects because many of the variables, such as
interaction with regulatory authorities and response rates in various clinical
trials, are not predictable. Total costs to date for each of our projects is as
follows: (i) clofarabine research and development costs have been approximately
$20,059,000; (ii) Modrenal(R) research and development costs have been
approximately $7,711,000; (iii) Velostan research and development costs have
been approximately $380,000; (iv) Suvus research and development costs have been
approximately $331,000; (v) OLIGON research and
-19-
development costs have been approximately $25,000; and (vi) Gene Therapy
research and development costs have been approximately $451,000.
Selling, general and administrative expenses for the three months ended March
31, 2006 and 2005 were approximately $6,914,000 and $1,894,000, respectively,
representing an increase of $5,020,000. The increase is primarily due to the
Company adopting SFAS 123(R) effective July 1, 2005 and an increase in costs
associated with the expanded sales and marketing and administrative
infrastructure and costs associated with the internal build out of the Company.
For the three months ended March 31, 2006, the Company recorded employee
stock-based compensation expense of approximately $1,949,000 as a selling,
general and administrative expense, whereas for the same period in the prior
year, the Company recorded employee stock-based compensation income of
approximately $650,000, relating to the re-measuring of the intrinsic value of
stock options. Selling, general and administrative expenses for the nine months
ended March 31, 2006 and 2005 were approximately $12,383,000 and $6,680,000,
respectively, representing an increase of $5,703,000. The increase is primarily
due to the Company adopting SFAS 123(R) effective July 1, 2005 and an increase
in costs associated with the expanded sales and marketing and administrative
infrastructure and costs associated with the internal build out of the Company.
For the nine months ended March 31, 2006, the Company has recorded $2,851,000 in
employee stock-based compensation expense, whereas the Company recorded employee
stock-based compensation income of approximately $431,000, relating to the
re-measuring of the intrinsic value of stock options for the same period in the
prior year.
Depreciation and amortization expense for the three months ended March 31, 2006
and 2005 were approximately $247,000 and $347,000, respectively, representing a
decrease of $100,000. The decrease is due to the Company recording an impairment
charge of $5,276,000 at June 30, 2005, which decreased the cost basis of our
methylene blue intangibles. Depreciation and amortization expense for the nine
months ended March 31, 2006 and 2005 were approximately $729,000 and $1,028,000,
respectively, representing a decrease of $299,000. The decrease is due to the
Company recording an impairment charge of $5,276,000 at June 30, 2005, which
decreased the cost basis of our methylene blue intangibles.
Liquidity and Capital Resources
We anticipate that we may continue to incur significant operating losses for the
foreseeable future. There can be no assurance as to whether or when we will
generate material revenue or achieve profitable operations.
At March 31, 2006, we had cash and cash equivalents and short-term securities of
approximately $49,812,000 and working capital of $46,378,000. Management
believes the Company has sufficient cash and cash equivalents and working
capital to continue currently planned operations through March 31, 2007.
Although we do not currently plan to acquire or obtain licenses for new
technologies, if any such opportunity arises and we deem it to be in our
interests to pursue such an opportunity, it is possible that additional
financing would be required for such a purpose.
For the nine months ended March 31, 2006 and 2005, net cash used in operating
activities was approximately $14,828,000 and $7,264,000, respectively,
representing an increase of approximately $7,564,000. This increase is primarily
due to increased costs associated with (i) our expanded research and development
activity, (ii) selling general and administrative expenses, including an
increase in costs associated with the expanded sales and marketing and
administrative infrastructure and costs associated with the internal build out
of the Company and (iii) cash paid for insurance premiums. For the nine months
ended March 31, 2006 and 2005, net cash used in investing activities was
approximately $7,759,000 and $479,000, respectively, representing an increase of
approximately $7,280,000. This increase is primarily due to the Company
investing the proceeds from our February 2005 secondary offering in short-term
securities in order to obtain a higher investment yield. For the nine months
ended March 31, 2006 and 2005, net cash (used in) provided by financing
activities was approximately $(233,000) and $59,202,000 representing a decrease
of $59,435,000. This decrease is primarily due to the completion of the
secondary public offering in February 2005 which yielded proceeds of
$55,747,000, net of related expenses.
On February 8, 2005, we completed a secondary public offering in which we sold
7,500,000 common shares at $8.00 per share, with net proceeds to the Company of
approximately $55,747,000, after deducting underwriting discounts and
commissions and offering expenses. We intend to use the net proceeds for further
development of our lead products, for sales and marketing expenses related to
the commercial launch of our lead products, for working capital and other
general corporate purposes.
-20-
The Company has the following commitments as of March 31, 2006:
Payments Due Fiscal in
2006 2007 2008 2009 2010 Total
Operating Leases $184,000 $729,000 $597,000 $330,000 $158,000 $1,998,000
Contractual obligations - 206,000 - - - 206,000
-------------------------------------------------------------------------
Total $184,000 $935,000 $597,000 $330,000 $158,000 $2,204,000
=========================================================================
Off-balance sheet arrangements
We have no off-balance sheet arrangements.
Other Events
As described in the Company's current report on Form 8-K, filed on April 6,
2006, On March 24, 2006, the Company entered into a Marketing and Distribution
Agreement (the "Agreement") with Mayne Pharma Limited ("Mayne Pharma") pursuant
to which the Company has granted Mayne Pharma the exclusive right, subject to
certain conditions, to import, register, sell, market and distribute clofarabine
(the "Product") for certain hematological indications in Australia and New
Zealand (the "Territory"). Mayne Pharma will maintain the exclusive rights to
import, register, sell, market and distribute the Product within the Territory
provided it obtains a marketing authorization within the Territory for any
indication within 3 years from the date Mayne Pharma files its first application
for a marketing authorization. In consideration for these rights, Bioenvision
will receive certain milestone payments and a royalty based on a percentage of
net sales in the Territory. Under the Agreement, Mayne Pharma agrees to fund and
pay all costs of registering the Product for marketing and government
reimbursement within the Territory during the term of the Agreement.
As described in the Company's current report on Form 8-K, filed on April 19,
2006, effective April 18, 2006, the Company appointed J.H. Cohn LLP ("J.H.
Cohn") for the fiscal year ending June 30, 2006 as the Company's new independent
registered public accounting firm. The decision to engage J.H. Cohn was made by
the Audit Committee of the Company's Board of Directors.
Recent Accounting Pronouncements
In May 2005, the FASB issued SFAS 154 "Accounting Changes and Error
Corrections," a replacement of APB Opinion 20 and SFAS 3. SFAS 154 changes the
accounting for, and reporting of, a change in accounting principle. SFAS 154
requires retrospective application to prior period's financial statements of
voluntary changes in accounting principle, and changes required by new
accounting standards when the standard does not include specific transition
provisions, unless it is impracticable to do so. SFAS 154 is effective for
accounting changes and corrections made in fiscal years beginning after December
15, 2005.
In March 2005, the FASB issued FIN 47, "Accounting for Conditional Asset
Retirement Obligations," an interpretation of SFAS 143. FIN 47 clarifies that
the term conditional asset retirement obligation as used in SFAS 143 refers to a
legal obligation to perform an asset retirement activity in which the timing or
method of settlement are conditional on a future event that may or may not be
within the control of the entity. FIN 47 also clarifies when an entity would
have sufficient information to reasonably estimate the fair value of an asset
retirement obligation. FIN 47 is effective for fiscal years ending after
December 15, 2005.
On July 1, 2005, the Company adopted the fair value recognition provisions of
SFAS 123 (revised 2004), "Share-Based Payment" ("SFAS 123 (R)"), requiring the
Company to recognize expense related to the fair value of stock-based
compensation. The modified prospective transition method was used as allowed
under SFAS 123 (R). Under this method, the stock-based compensation expense
includes: (a) compensation expense for all stock-based compensation awards
granted prior to, but not yet vested as of July 1, 2005, based on the grant date
fair value estimated in accordance with the original provisions of SFAS 123,
"Accounting for Stock-Based Compensation"; and (b) compensation expense for all
stock-based compensation awards granted subsequent to July 1, 2005, based on the
grant date fair value estimated in accordance with the provisions of SFAS 123
(R). Prior to the adoption of SFAS 123 (R), the Company had accounted for
stock-based compensation arrangements in accordance with provisions of
Accounting Principles Board ("APB") Opinion No. 25 "Accounting for Stock Issued
to Employees", as permitted by SFAS 123. Under APB Opinion No. 25, no
stock-based employee compensation cost is reflected in reported net loss, when
options granted to employees have an exercise price equal to the market value of
the underlying common stock at the date of grant. For the three and nine months
ended March 31, 2006 the Company recorded employee stock-based compensation
expense of $2,058,000 and $2,999,000 respectively.
In December 2004, the FASB issued SFAS 153 "Exchange of Nonmonetary Assets".
SFAS 153 was a result of a joint effort by the FASB and the International
Accounting Standards Board, or IASB, to improve financial reporting by
eliminating certain narrow
-21-
differences between their existing accounting standards. One such difference was
the exception from fair value measurement in APB Opinion No. 29, "Accounting for
Nonmonetary Transactions", for non-monetary exchanges of similar productive
assets. SFAS 153 replaces this exception with a general exception from fair
value measurement for exchanges of non-monetary assets that do not have
commercial substance. A nonmonetary exchange has commercial substance if the
future cash flows of the entity are expected to change significantly as a result
of the exchange. SFAS 153 was effective for non-monetary assets exchanges
occurring in fiscal periods beginning after June 15, 2005. The adoption of SFAS
153 did not have a material impact on the results of operations or financial
position of the Company.
In November 2004, the FASB issued SFAS No. 151, "Inventory Costs". SFAS 151
amends Accounting Research Bulletin No. 43, Chapter 4. SFAS 151 clarifies the
accounting for abnormal amounts of idle facility expense, freight, handling
costs, and wasted material (spoilage). SFAS 151 is the result of a broader
effort by the FASB and the IASB to improve financial reporting by eliminating
certain narrow differences between their existing accounting standards. SFAS 151
is effective for inventory costs incurred during fiscal years beginning after
June 15, 2005. The adoption of SFAS 151 did not have a material impact on the
results of operations or financial position of the Company.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our excess cash is invested in certificates of deposit with various short-term
maturities. We hold no derivative financial instruments and we do not currently
engage in hedging activities. We do not have any outstanding debt. Accordingly,
due to the maturity and credit quality of our investments, we are not subjected
to any substantial risk arising from changes in interest rates, currency
exchange rates and commodity and equity prices. However, the Company does have
some exposure to foreign currency rate fluctuations arising from maintaining an
office for the Company's U.K. based, wholly-owned subsidiary which transacts
business in the local functional currency. Management periodically reviews such
foreign currency risk and to date has not undertaken any foreign currency hedges
through the use of forward exchange contracts or options and does not foresee
doing so in the near future.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our principal executive officer and principal financial officer have evaluated
the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, as amended) as of the end of the period covered by this
quarterly report on Form 10-Q. Based on this evaluation our principal executive
officer and principal financial officer concluded that these disclosure controls
and procedures are effective and designed to ensure that the information
required to be disclosed in our reports filed or submitted under the Securities
Exchange Act of 1934, as amended, is recorded, processed, summarized and
reported within the requisite time periods.
Changes in Internal Controls
During the quarterly period ended March 31, 2006, there have been no changes in
our internal controls over financial reporting that materially affected or are
reasonably likely to materially affect our internal control over financial
reporting.
Description of Material Weaknesses in Internal Controls Over Financial Reporting
from June 30, 2005
In connection with the filing of our annual report on Form 10-KSB, for the
fiscal year ended June 30, 2005, under the direction of our principal executive
officer and principal financial officer, we evaluated our disclosure controls
and procedures and concluded that as of June 30, 2005, the following material
weakness in internal control over financial reporting existed:
o we did not maintain effective controls relating to the timely
identification, evaluation and accurate resolution of non-routine or
complex accounting matters, specifically, (i) we did not timely
identify and evaluate a change of circumstances that resulted in an
impairment of our intangible assets relating to certain patents, (ii)
we did not timely identify and accurately resolve an accounting issue
related to contractual revenue recognition and (iii) we did not timely
evaluate our accounts receivable for the need of a valuation allowance,
each of which resulted in a material adjustment to our consolidated
financial statements for the fiscal year ended June 30, 2005.
Management discussed this material weakness with the audit committee. As of
December 31, 2005, we had taken the following measures to remediate the above
material weakness in our internal controls over financial reporting that existed
as of June 30, 2005. The remedial actions include:
o improving training and education for all relevant personnel involved in
the preparation and review of the Company's financial statements;
-22-
o the formation of a Disclosure Committee;
o hiring an additional accountant; and
o Use of prepared checklists for the preparation of periodic SEC reports
to ensure the completeness and accuracy of those reports. The Company
has adopted the practice of using prepared checklists for upcoming SEC
periodic reports that set forth new and changing requirements to ensure
that those requirements are satisfied in the periodic reports.
Notwithstanding the above mentioned weaknesses, we believe that the condensed
consolidated financial statements included in this report fairly present our
consolidated financial position as of, and the consolidated results of
operations for the period ended, March 31, 2006.
-23-
BIOENVISION, INC. AND SUBSIDIARIES
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
On December 19, 2003, the Company filed a complaint against Dr. Deidre Tessman
and Tessman Technology Ltd. (the "Tessman Defendants") in the Supreme Court of
the State of New York, County of New York (Index No. 03-603984). An amended
complaint alleges, among other things, breach of contract and negligence by
Tessman and Tessman Technology and demands judgment against Tessman and Tessman
Technology in an amount to be determined by the Court. The Tessman Defendants
removed the case to federal court, then remanded it to state court and served an
answer with several purported counterclaims. Each of the parties had moved for
summary judgment dismissing all but one of the claims of the other parties.
Those motions were all denied by the Court, and a trial date had been set for
early 2006. On April 10, 2006, an out of court settlement was reached and each
party executed a release, releasing all claims against the other. A Stipulation
of Discontinuance was filed with the court.
Item 1A. RISK FACTORS
None.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
None.
-24-
ITEM 6. EXHIBITS
Exhibit
Number Description
------- -----------
2.1 Acquisition Agreement between Registrant and
Bioenvision, Inc. dated December 21, 1998 for
the acquisition of 7,013,897 shares of
Registrant's Common Stock by the stockholders
of Bioenvision, Inc. (1)
2.2 Amended and Restated Agreement and Plan of
Merger, dated as of February 1, 2002, by and
among Bioenvision, Inc., Bioenvision
Acquisition Corp. and Pathagon, Inc. (5)
3.1 Certificate of Incorporation of Registrant.
(2)
3.1(a) Amendment to Certificate of Incorporation
filed January 29, 1999. (3)
3.1(b) Certificate of Correction to the Certificate
of Incorporation, filed March 15, 2002 (6)
3.1(c) Certificate of Amendment to the Certificate
of Incorporation, filed April 30, 2002 (6)
3.1(d) Certificate of Designations, Preferences and
Rights of series A Preferred Stock (6)
3.1(e) Certificate of Amendment to the Certificate
of Incorporation, filed January 14, 2004 (15)
3.2 Amended and Restated By-Laws of the
Registrant. (13)
4.1 Registration Rights Agreement, dated as of
February 1, 2002, by and among Bioenvision,
Inc., the former shareholders of Pathagon,
Inc. party thereto, Christopher Wood,
Bioaccelerate Limited, Jano Holdings Limited
and Lifescience Ventures Limited. (8)
4.2 Stockholders Lock-Up Agreement, dated as of
February 1, 2002, by and among Bioenvision,
Inc., the former shareholders of Pathagon,
Inc. party thereto, Christopher Wood,
Bioaccelerate Limited, Jano Holdings Limited
and Lifescience Ventures Limited. (8)
4.3 Form of Securities Purchase Agreement by and
among Bioenvision, Inc. and certain
purchasers, dated as of May 7, 2002. (6)
4.4 Form of Registration Rights Agreement by and
among Bioenvision, Inc. and certain
purchasers, dated as of May 7, 2002. (6)
4.5 Form of Warrant (6)
4.6 Registration Rights Agreement, dated April 2,
2003, by and between Bioenvision, Inc. and
RRD International, LLC (14)
4.7 Warrant, dated April 2, 2003, made by
Bioenvision, Inc. in favor of RRD
International, LLC (14)
4.8 Common Stock and Warrant Purchase Agreement,
dated as of March 22, 2004, by and among
Bioenvision, Inc. and the Investors set forth
on Schedule I thereto (16)
4.9 Registration Rights Agreement, dated March
22, 2004, by and between Bioenvision, Inc.
and the Investors set forth on Schedule I
thereto (16)
4.10 Form of Warrant (16)
4.11 Bioenvision, Inc. 2003 Stock Incentive Plan
(17)
10.1 Pharmaceutical Development Agreement, dated
as of June 10, 2003, by and between
Bioenvision, Inc. and Ferro Pfanstiehl
Laboratories, Inc.
10.2 Co-Development Agreement between Bioheal,
Ltd. and Christopher Wood dated May 19, 1998.
(3)
10.3 Master Services Agreement, dated May 14,
2003, by and between PennDevelopment
Pharmaceutical Services Limited and
Bioenvision, Inc.
10.4 Co-Development Agreement between Stegram
Pharmaceuticals, Ltd. and Bioenvision, Inc.
dated July 15, 1998. (3)
10.5 Co-Development Agreement between Southern
Research Institute and Eurobiotech Group,
Inc. dated August 31, 1998. (3)
10.5(a) Agreement to Grant License from Southern
Research Institute to Eurobiotech Group, Inc.
dated September 1, 1998. (3)
10.6 License and Sub-License Agreement, dated as
of May 13, 2003, by and between Bioenvision,
Inc. and Dechra Pharmaceuticals, plc
10.7 Employment Agreement between Bioenvision,
Inc. and Christopher B. Wood, M.D., dated
December 31, 2002 (3)
10.8 Employment Agreement between Bioenvision,
Inc. and David P. Luci, dated March 31, 2003
(14)
10.9 Securities Purchase Agreement with
Bioaccelerate Inc dated March 24, 2000. (4)
10.10 Engagement Letter Agreement, dated as of
November 16, 2001, by and between
Bioenvision, Inc. and SCO Securities LLC. (7)
10.11 Security Agreement, dated as of November 16,
2001, by Bioenvision, Inc. in favor of SCO
Capital Partners LLC. (7)
10.12 Commitment Letter, dated November 16, 2001,
by and between SCO Capital Partners LLC and
Bioenvision, Inc. (7)
10.13 Senior Secured Grid Note, dated November 16,
2001, by Bioenvision, Inc. in favor of SCO
Capital Partners LLC. (7)
10.14 Exclusive License Agreement by and between
Baxter Healthcare Corporation, acting through
its Edwards Critical-Care division, and
Implemed, dated as of May 6, 1997. (12)
10.15 License Agreement by and between Oklahoma
Medical Research Foundation and bridge
Therapeutic Products, Inc., dated as of
January 1, 1998. (12)
10.16 Amendment No. 1 to License Agreement by and
among Oklahoma Medical Research Foundation,
Bioenvision, Inc. and Pathagon, Inc., dated
May 7, 2002. (12)
10.17 Inter-Institutional Agreement between
Sloan-Kettering Institute for Cancer Research
and Southern Research Institute, dated as of
August 31, 1998. (12)
10.18 License Agreement between University College
London and Bioenvision, Inc., dated March 1,
1999. (12)
10.19 Research Agreement between Stegram
Pharmaceuticals Ltd., Queen Mary and
Westfield College and Bioenvision, Inc.,
dated June 8, 1999 (12)
10.20 Research and License Agreement between
Bioenvision, Inc., Velindre NHS Trust and
University College Cardiff Consultants, dated
as of January 9, 2001. (12)
10.21 Co-Development Agreement, between
Bioenvision, Inc. and ILEX Oncology, Inc.,
dated March 9, 2001. (12)
10.22 Amended and Restated Agreement and Plan of
Merger, dated as of February 1, 2002, among
Bioenvision, Inc., Bioenvision Acquisition
Corp. and Pathagon Inc. (5)
10.23 Master Services Agreement, dated as of April
2, 2003, by and between Bioenvision, Inc. and
RRD International, LLC(14)
10.24 Employment Agreement between Bioenvision
Limited and Hugh Griffith, effective as of
October 23, 2002 (18)
10.25 Employment Agreement between Bioenvision
Limited and Ian Abercrombie, effective as of
January 6, 2003 (18)
10.26 Amendment # 2 to the Co-Development Agreement
between Bioenvision and ILEX Oncology, Inc.
dated December 30, 2003.(21)
10.27 Amendment to the Co-Development Agreement
between Bioenvision, Inc. and SRI, dated as
of March 12, 2001.(21)
10.28 Letter Agreement For Co-Development Of An
Oral Clofarabine Formulation and First
Amendment to Co-Development Agreement dated
March 12, 2001 between Bioenvision, Inc. and
ILEX .(21)
10.29 Joinder made by Bioenvision, Inc., dated
February 26, 2004 (22)
10.30 Supply Agreement-Trilostane, by and among,
Stegram Pharmaceuticals, Bioenvision, Inc.,
Dechra Ltd. and Sterling SNIFF, dated as of
August 12, 2005 (22)
10.31 Supply Agreement-Trilostane, by and among,
Stegram Pharmaceuticals, Bioenvision, Inc.,
Dechra Ltd. and Steroid SpA, dated as of
August 12, 2005 (22)
10.32 Amendment to Employment Agreement, by and
between Bioenvision and David P. Luci, dated
February 6, 2006 (23)
10.33* Clofarabine Marketing and Development
Agreement, by and between Bioenvision Inc.
and Mayne Pharma Limited, dated March 24,
2006
14.1 Bioenvision Inc.'s Code of Business Conduct
and Ethics (19)
16.1 Letter from Graf Repetti & Co., LLP to the
Securities and Exchange Commission, dated
September 30, 1999. (9)
--------
* Portions of this exhibit have been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request
under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended. *
16.2 Letter from Ernst & Young LLP to the
Securities and Exchange Commission, dated
July 6, 2001. (10)
16.3 Letter from Ernst & Young LLP to the
Securities and Exchange Commission, dated
August 16, 2001. (11)
16.4 Letter from Grant Thornton LLP to the
Securities and Exchange Commission , dated
April 7, 2005 (20)
21.1 Subsidiaries of the registrant (4)
31.1 Certification of Christopher B. Wood, Chief
Executive Officer, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of
2002.
31.2 Certification of David P. Luci, Chief
Accounting Officer, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of
2002.
32.1 Certification of Chief Executive Officer
pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
32.2 Certification of Chief Accounting Officer
pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
-----------------------
(1) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K filed with the SEC on January 12, 1999.
(2) Incorporated by reference and filed as an Exhibit to Registrant's
Registration Statement on Form 10-12g filed with the SEC on September 3,
1998.
(3) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB/A filed with the SEC on October 18, 1999.
(4) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB filed with the SEC on November 13, 2000.
(5) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K filed with the SEC on April 16, 2002.
(6) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on May 28, 2002.
(7) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on January 8, 2002.
(8) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on February 21, 2002.
(9) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on October 1, 1999.
(10) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K/A, filed with the SEC on July 26, 2001.
(11) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on December 6, 2001.
(12) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on June 24, 2002.
(13) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended
December 31, 2002.
(14) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended March
31, 2003.
(15) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended
December 31, 2004.
(16) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on March 24, 2004.
(17) Registrant's definitive proxy statement on Schedule 14-A, filed in
connection with the annual meeting held on January 14, 2004.
(18) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three- month period ended
September 30, 2003.
(19) Incorporated by reference and filed as an Exhibit to Registrant's Annual
Report on Form 10-KSB for the year ended June 30, 2004.
(20) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on April 7, 2005.
(21) Incorporated by reference and filed as an Exhibit to Registrant's Annual
Report on Form 10-KSB, filed with the SEC on October 13, 2005.
(22) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three- month period ended
September 30, 2005.
(23) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on February 10, 2006.
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
Date: May 15, 2006 By: /s/ Christopher B. Wood M.D.
-----------------------------
Christopher B. Wood M.D.
Chairman and Chief Executive Officer
(Principal Executive Officer)
Date: May 15, 2006 By: /s/ David P. Luci
-----------------
David P. Luci
Chief Financial Officer and General Counsel
(Principal Financial and Accounting Officer)
Exhibit Index
Exhibit
Number Description
------- -----------
2.1 Acquisition Agreement between Registrant and
Bioenvision, Inc. dated December 21, 1998 for
the acquisition of 7,013,897 shares of
Registrant's Common Stock by the stockholders
of Bioenvision, Inc. (1)
2.2 Amended and Restated Agreement and Plan of
Merger, dated as of February 1, 2002, by and
among Bioenvision, Inc., Bioenvision
Acquisition Corp. and Pathagon, Inc. (5)
3.1 Certificate of Incorporation of Registrant.
(2)
3.1(a) Amendment to Certificate of Incorporation
filed January 29, 1999. (3)
3.1(b) Certificate of Correction to the Certificate
of Incorporation, filed March 15, 2002 (6)
3.1(c) Certificate of Amendment to the Certificate
of Incorporation, filed April 30, 2002 (6)
3.1(d) Certificate of Designations, Preferences and
Rights of series A Preferred Stock (6)
3.1(e) Certificate of Amendment to the Certificate
of Incorporation, filed January 14, 2004 (15)
3.2 Amended and Restated By-Laws of the
Registrant. (13)
4.1 Registration Rights Agreement, dated as of
February 1, 2002, by and among Bioenvision,
Inc., the former shareholders of Pathagon,
Inc. party thereto, Christopher Wood,
Bioaccelerate Limited, Jano Holdings Limited
and Lifescience Ventures Limited. (8)
4.2 Stockholders Lock-Up Agreement, dated as of
February 1, 2002, by and among Bioenvision,
Inc., the former shareholders of Pathagon,
Inc. party thereto, Christopher Wood,
Bioaccelerate Limited, Jano Holdings Limited
and Lifescience Ventures Limited. (8)
4.3 Form of Securities Purchase Agreement by and
among Bioenvision, Inc. and certain
purchasers, dated as of May 7, 2002. (6)
4.4 Form of Registration Rights Agreement by and
among Bioenvision, Inc. and certain
purchasers, dated as of May 7, 2002. (6)
4.5 Form of Warrant (6)
4.6 Registration Rights Agreement, dated April 2,
2003, by and between Bioenvision, Inc. and
RRD International, LLC (14)
4.7 Warrant, dated April 2, 2003, made by
Bioenvision, Inc. in favor of RRD
International, LLC (14)
4.8 Common Stock and Warrant Purchase Agreement,
dated as of March 22, 2004, by and among
Bioenvision, Inc. and the Investors set forth
on Schedule I thereto (16)
4.9 Registration Rights Agreement, dated March
22, 2004, by and between
Bioenvision, Inc. and the Investors set forth
on Schedule I thereto (16)
4.10 Form of Warrant (16)
4.11 Bioenvision, Inc. 2003 Stock Incentive Plan
(17)
10.1 Pharmaceutical Development Agreement, dated
as of June 10, 2003, by and between
Bioenvision, Inc. and Ferro Pfanstiehl
Laboratories, Inc.
10.2 Co-Development Agreement between Bioheal,
Ltd. and Christopher Wood dated May 19, 1998.
(3)
10.3 Master Services Agreement, dated May 14,
2003, by and between PennDevelopment
Pharmaceutical Services Limited and
Bioenvision, Inc.
10.4 Co-Development Agreement between Stegram
Pharmaceuticals, Ltd. and Bioenvision, Inc.
dated July 15, 1998. (3)
10.5 Co-Development Agreement between Southern
Research Institute and Eurobiotech Group,
Inc. dated August 31, 1998. (3)
10.5(a) Agreement to Grant License from Southern
Research Institute to Eurobiotech Group, Inc.
dated September 1, 1998. (3)
10.6 License and Sub-License Agreement, dated as
of May 13, 2003, by and between Bioenvision,
Inc. and Dechra Pharmaceuticals, plc
10.7 Employment Agreement between Bioenvision,
Inc. and Christopher B. Wood, M.D., dated
December 31, 2002 (3)
10.8 Employment Agreement between Bioenvision,
Inc. and David P. Luci, dated March 31, 2003
(14)
10.9 Securities Purchase Agreement with
Bioaccelerate Inc dated March 24, 2000. (4)
10.10 Engagement Letter Agreement, dated as of
November 16, 2001, by and between
Bioenvision, Inc. and SCO Securities LLC. (7)
10.11 Security Agreement, dated as of November 16,
2001, by Bioenvision, Inc. in favor of SCO
Capital Partners LLC. (7)
10.12 Commitment Letter, dated November 16, 2001,
by and between SCO Capital Partners LLC and
Bioenvision, Inc. (7)
10.13 Senior Secured Grid Note, dated November 16,
2001, by Bioenvision, Inc. in favor of SCO
Capital Partners LLC. (7)
10.14 Exclusive License Agreement by and between
Baxter Healthcare Corporation, acting through
its Edwards Critical-Care division, and
Implemed, dated as of May 6, 1997. (12)
10.15 License Agreement by and between Oklahoma
Medical Research Foundation and bridge
Therapeutic Products, Inc., dated as of
January 1, 1998. (12)
10.16 Amendment No. 1 to License Agreement by and
among Oklahoma Medical Research Foundation,
Bioenvision, Inc. and Pathagon, Inc., dated
May 7, 2002. (12)
10.17 Inter-Institutional Agreement between
Sloan-Kettering Institute
for Cancer Research and Southern Research
Institute, dated as of August 31, 1998. (12)
10.18 License Agreement between University College
London and Bioenvision, Inc., dated March 1,
1999. (12)
10.19 Research Agreement between Stegram
Pharmaceuticals Ltd., Queen Mary and
Westfield College and Bioenvision, Inc.,
dated June 8, 1999 (12)
10.20 Research and License Agreement between
Bioenvision, Inc., Velindre NHS Trust and
University College Cardiff Consultants, dated
as of January 9, 2001. (12)
10.21 Co-Development Agreement, between
Bioenvision, Inc. and ILEX Oncology, Inc.,
dated March 9, 2001. (12)
10.22 Amended and Restated Agreement and Plan of
Merger, dated as of February 1, 2002, among
Bioenvision, Inc., Bioenvision Acquisition
Corp. and Pathagon Inc. (5)
10.23 Master Services Agreement, dated as of April
2, 2003, by and between Bioenvision, Inc. and
RRD International, LLC(14)
10.24 Employment Agreement between Bioenvision
Limited and Hugh Griffith, effective as of
October 23, 2002 (18)
10.25 Employment Agreement between Bioenvision
Limited and Ian Abercrombie, effective as of
January 6, 2003 (18)
10.26 Amendment # 2 to the Co-Development Agreement
between Bioenvision and ILEX Oncology, Inc.
dated December 30, 2003.(21)
10.27 Amendment to the Co-Development Agreement
between Bioenvision, Inc. and SRI, dated as
of March 12, 2001.(21)
10.28 Letter Agreement For Co-Development Of An
Oral Clofarabine Formulation and First
Amendment to Co-Development Agreement dated
March 12, 2001 between Bioenvision, Inc. and
ILEX .(21)
10.29 Joinder made by Bioenvision, Inc., dated
February 26, 2004 (22)
10.30 Supply Agreement-Trilostane, by and among,
Stegram Pharmaceuticals, Bioenvision, Inc.,
Dechra Ltd. and Sterling SNIFF, dated as of
August 12, 2005 (22)
10.31 Supply Agreement-Trilostane, by and among,
Stegram Pharmaceuticals, Bioenvision, Inc.,
Dechra Ltd. and Steroid SpA, dated as of
August 12, 2005 (22)
10.32 Amendment to Employment Agreement, by and
between Bioenvision and David P. Luci, dated
February 6, 2006 (23)
10.33* Clofarabine Marketing and Development
Agreement, by and between Bioenvision Inc.
and Mayne Pharma Limited, dated March 24,
2006
14.1 Bioenvision Inc.'s Code of Business Conduct
and Ethics (19)
16.1 Letter from Graf Repetti & Co., LLP to the
Securities and Exchange Commission, dated
September 30, 1999. (9)
16.2 Letter from Ernst & Young LLP to the
Securities and Exchange
--------
* Portions of this exhibit have been omitted and filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request
under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.
Commission, dated July 6, 2001. (10)
16.3 Letter from Ernst & Young LLP to the
Securities and Exchange Commission, dated
August 16, 2001. (11)
16.4 Letter from Grant Thornton LLP to the
Securities and Exchange Commission , dated
April 7, 2005 (20)
21.1 Subsidiaries of the registrant (4)
31.1 Certification of Christopher B. Wood, Chief
Executive Officer, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of
2002.
31.2 Certification of David P. Luci, Chief
Accounting Officer, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of
2002.
32.1 Certification of Chief Executive Officer
pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
32.2 Certification of Chief Accounting Officer
pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
-----------------------
(1) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K filed with the SEC on January 12, 1999.
(2) Incorporated by reference and filed as an Exhibit to Registrant's
Registration Statement on Form 10-12g filed with the SEC on September 3,
1998.
(3) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB/A filed with the SEC on October 18, 1999.
(4) Incorporated by reference and filed as an Exhibit to Registrant's Form
10-KSB filed with the SEC on November 13, 2000.
(5) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K filed with the SEC on April 16, 2002.
(6) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on May 28, 2002.
(7) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on January 8, 2002.
(8) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on February 21, 2002.
(9) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on October 1, 1999.
(10) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K/A, filed with the SEC on July 26, 2001.
(11) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on December 6, 2001.
(12) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on June 24, 2002.
(13) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-
month period ended December 31, 2002.
(14) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended March
31, 2003.
(15) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three-month period ended
December 31, 2004.
(16) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on March 24, 2004.
(17) Registrant's definitive proxy statement on Schedule 14-A, filed in
connection with the annual meeting held on January 14, 2004.
(18) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three- month period ended
September 30, 2003.
(19) Incorporated by reference and filed as an Exhibit to Registrant's Annual
Report on Form 10-KSB for the year ended June 30, 2004.
(20) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on April 7, 2005.
(21) Incorporated by reference and filed as an Exhibit to Registrant's Annual
Report on Form 10-KSB, filed with the SEC on October 13, 2005.
(22) Incorporated by reference and filed as an Exhibit to Registrant's
Quarterly Report on Form 10-QSB for the three- month period ended
September 30, 2005.
(23) Incorporated by reference and filed as an Exhibit to Registrant's
Current Report on Form 8-K, filed with the SEC on February 10, 2006.