UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 2002, or
[_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT
OF 1934
For the transition period from ___________to____________
Commission File No. 0-18728
INDEVUS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 04-3047911
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
One Ledgemont Center 02421-7966
99 Hayden Avenue (Zip Code)
Lexington, Massachusetts
(Address of principal executive offices)
Registrant's telephone number, including area code: (781)861-8444
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes [X] No [_]
Indicate the number of shares outstanding of each of the issuer's class of
common stock, as of the latest practicable date.
Class: Outstanding at February 13, 2003:
Common Stock $.001 par value 46,875,885 shares
INDEVUS PHARMACEUTICALS, INC.
INDEX TO FORM 10-Q
PART I. FINANCIAL INFORMATION PAGE
Item 1. Financial Statements
Consolidated Balance Sheets as of December 31, 2002 and September
30, 2002 ............................................................ 3
Consolidated Statements of Operations for the Three Months ended
December 31, 2002 and 2001 .......................................... 4
Consolidated Statements of Cash Flows for the Three Months ended
December 31, 2002 and 2001 .......................................... 5
Notes to Unaudited Consolidated Financial Statements ................. 6
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations .......................................... 8
Item 3. Quantitative and Qualitative Disclosures about Market Risk ... 15
Item 4. Controls and Procedures ...................................... 15
PART II. OTHER INFORMATION
Item 1. Legal Proceedings ............................................ 16
Item 6. Exhibits and Reports on Form 8-K ............................. 18
SIGNATURES ........................................................... 19
2
Item 1. Financial Statements
INDEVUS PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Amounts in thousands except share data)
ASSETS
December 31, September 30,
2002 2002
------------ -------------
Current assets:
Cash and cash equivalents $ 16,224 $ 19,977
Marketable securities 19,877 20,516
Accounts receivable 63 550
Prepaids and other current assets 991 533
--------- ---------
Total current assets 37,155 41,576
Marketable securities - 1,050
Equity securities 22 31
Insurance claim receivable 1,258 1,258
Property and equipment, net 22 16
--------- ---------
Total assets $ 38,457 $ 43,931
========= =========
LIABILITIES
Current liabilities:
Accounts payable $ 813 $ 350
Accrued expenses 5,859 6,326
Deferred revenue - 24
--------- ---------
Total current liabilities 6,672 6,700
Minority interest 13 13
STOCKHOLDERS' EQUITY
Preferred stock, $.001 par value, 5,000,000 shares authorized;
Series B, 239,425 shares issued and outstanding (liquidation
preference at December 31, 2002 $3,034); 3,000 3,000
Series C, 5,000 shares issued and outstanding (liquidation
preference at December 31, 2002 $503) 500 500
Common stock, $.001 par value, 80,000,000 shares authorized;
46,875,885 shares issued and outstanding at December 31 and
September 30, 2002 47 47
Additional paid-in capital 302,669 302,678
Accumulated deficit (274,310) (268,879)
Accumulated other comprehensive loss (134) (128)
--------- ---------
Total stockholders' equity 31,772 37,218
--------- ---------
Total liabilities and stockholders' equity $ 38,457 $ 43,931
========= =========
The accompanying notes are an integral part of these unaudited consolidated
financial statements.
3
INDEVUS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months ended December 31, 2002 and 2001
(Unaudited)
(Amounts in thousands except per share data)
Three months ended December 31,
-------------------------------
2002 2001
---------- ------------
Revenues:
Royalties $ - $ 3,199
Contract and license fees 822 342
---------- ------------
Total revenues 822 3,541
Costs and expenses:
Cost of revenues 210 838
Research and development 3,777 3,245
General and administrative 2,457 1,578
---------- ------------
Total costs and expenses 6,444 5,661
---------- ------------
Loss from operations (5,622) (2,120)
Investment income, net 191 228
Minority interest - (54)
---------- ------------
Net loss $ (5,431) $ (1,946)
========== ============
Net loss per common share:
Basic and diluted $ (0.12) $ (0.04)
========== ============
Weighted average common shares outstanding:
Basic and diluted 46,876 43,659
========== ============
The accompanying notes are an integral part of these unaudited consolidated
financial statements.
4
INDEVUS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the three months ended December 31, 2002 and 2001
(Unaudited)
(Amounts in thousands)
Three months ended December 31,
-------------------------------
2002 2001
---------- ----------
Cash flows from operating activities:
Net loss $ (5,431) $ (1,946)
Adjustments to reconcile net loss to net cash used in operating activities:
Deprecation and amortization 4 26
Minority interest in net loss of consolidated subsidiary - 54
Noncash compensation - 604
Change in assets and liabilities:
Accounts receivable 487 (3,196)
Prepaid and other assets (458) (62)
Accounts payable 463 (53)
Accrued expenses and other liabilities (501) (153)
---------- ----------
Net cash used in operating activities (5,436) (4,726)
---------- ----------
Cash flows from investing activities:
Capital expenditures (10) -
Purchase of marketable securities (2,689) (4,108)
Proceeds from maturities and sales of marketable securities 4,382 2,704
---------- ----------
Net cash provided by (used in) investing activities 1,683 (1,404)
---------- ----------
Cash flows from financing activities:
Net proceeds from issuance of common stock - 23,443
Distribution to minority interest stockholder
- (54)
---------- ----------
Net cash provided by financing activities - 23,389
---------- ----------
Net change in cash and cash equivalents (3,753) 17,259
Cash and cash equivalents at beginning of period 19,977 24,923
---------- ----------
Cash and cash equivalents at end of period $ 16,224 $ 42,182
========== ==========
The accompanying notes are an integral part of these unaudited consolidated
financial statements.
5
INDEVUS PHARMACEUTICALS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
A. Basis of Presentation
The consolidated financial statements included herein have been prepared by
Indevus Pharmaceuticals, Inc. ("Indevus" or the "Company") without audit,
pursuant to the rules and regulations of the U.S. Securities and Exchange
Commission ("SEC"). Certain information and footnote disclosures normally
included in financial statements prepared in accordance with generally accepted
accounting principles have been condensed or omitted pursuant to such rules and
regulations. In the opinion of management, the accompanying unaudited
consolidated financial statements include all adjustments (consisting only of
normal recurring adjustments) necessary to present fairly the consolidated
financial position, results of operations and cash flows of the Company. The
unaudited consolidated financial statements included herein should be read in
conjunction with the audited consolidated financial statements and the notes
thereto included in the Company's Form 10-K for the fiscal year ended September
30, 2002.
Indevus is a biopharmaceutical company engaged in the development and
commercialization of a diversified portfolio of product candidates, including
multiple compounds in late-stage clinical development.
B. Basic and Diluted Loss per Common Share
During the three month period ended December 31, 2002, securities not
included in the computation of diluted earnings per share, because their
exercise price exceeded the average market price during the period, were as
follows: (i) options to purchase 9,571,786 shares of Common Stock at exercise
prices ranging from $2.00 to $20.13 with expiration dates ranging up to May 13,
2012; and (ii) warrants to purchase 105,000 shares of Common Stock with exercise
prices ranging from $5.00 to $7.13 and with expiration dates ranging up to July
17, 2006. Additionally, during the three month period ended December 31, 2002,
securities not included in the computation of diluted earnings per share,
because they would have an antidilutive effect due to the net loss for the
period, were as follows: (i) options to purchase 585,739 shares of Common Stock
at exercise prices ranging from $1.22 to $1.88 and expiration dates ranging up
to October 8, 2012; and (ii) Series B and C preferred stock convertible into
622,222 shares of Common Stock.
During the three month period ended December 31, 2001, securities not
included in the computation of diluted earnings per share, because their
exercise price exceeded the average market price during the period, were as
follows: (i) options to purchase 139,565 shares of Common Stock at exercise
prices ranging from $8.37 to $20.13 with expiration dates ranging up to December
5, 2011; and (ii) warrants to purchase 550,000 shares of Common Stock with
exercise prices ranging from $7.88 to $10.00 and with expiration dates ranging
up to June 1, 2002. Additionally, during the three month period ended December
31, 2001, securities not included in the computation of diluted earnings per
share, because they would have an antidilutive effect due to the net loss for
the period, were as follows: (i) options to purchase 9,394,165 shares of Common
Stock at exercise prices ranging from $1.47 to $7.25 and expiration dates
ranging up to November 26, 2011; (ii) Series B and C preferred stock convertible
into 622,222 shares of Common Stock; (iii) warrants to purchase 130,000 shares
of Common Stock at exercise prices ranging from $5.00 to $7.13 and expiration
dates ranging up to July 17, 2006; and (iv) unvested Restricted Stock Awards of
225,000 shares of Common Stock granted pursuant to the Company's 1997 Equity
Incentive Plan.
6
C. Comprehensive Loss
Comprehensive loss for the three month periods ended December 31, 2002 and
2001, respectively, is as follows:
Three Months Ended December 31,
--------------------------------
2002 2001
----------- -----------
Net loss $(5,431,000) $(1,946,000)
Change in unrealized net
gain or loss on investments (6,000) (124,000)
----------- -----------
Comprehensive loss $(5,437,000) $(2,070,000)
=========== ===========
D. Agreement
In December 2002, the Company entered into an amended agreement with Eli
Lilly and Company ("Lilly") providing for Lilly to pay the Company (i) an
initial payment of approximately $777,000, (ii) royalties on net sales of
Sarafem commencing October 1, 2002 through the expiration of the Company's
patent related to Sarafem, and (iii) milestones based on Lilly's achievement of
certain levels of Sarafem sales in each quarter commencing January 1, 2003,
subject to an aggregate cap and immediate acceleration upon Lilly's sublicense
of its rights related to Sarafem. The Company recognized the $777,000 initial
payment as revenue upon signing the renegotiated agreement because the Company
has no continuing performance obligations under the contract. Massachusetts
Institute of Technology ("MIT"), our licensor, is entitled to a portion of
payments made to Indevus by Lilly.
E. Recent Accounting Pronouncements
In June 2001, the Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS") SFAS No. 141, "Business
Combinations" ("SFAS No. 141") and SFAS No. 142, "Goodwill and Other Intangible
Assets" ("SFAS No. 142"). SFAS No. 141 requires that all business combinations
be accounted for under the purchase method only and that certain acquired
intangible assets in a business combination be recognized as assets apart from
goodwill. SFAS No. 142 requires that ratable amortization of goodwill be
replaced with periodic tests of the goodwill's impairment and that intangible
assets other than goodwill be amortized over their useful lives. SFAS No. 141 is
effective for all business combinations initiated after June 30, 2001 and for
all business combinations accounted for by the purchase method for which the
date of acquisition is after June 30, 2001. The provisions of SFAS No. 142 are
effective for fiscal years beginning after December 15, 2001. The Company's
adoption of SFAS Nos. 141 and 142 in fiscal year 2003 did not have a material
effect on the Company's financial condition or results of operations.
In October 2001, the FASB issued SFAS No. 144, "Accounting for the
Impairment or Disposal of Long-Lived Assets" ("SFAS No. 144"). SFAS No. 144
supercedes FASB Statement No. 121, "Accounting for the Impairment of Long-Lived
Assets and for Long-Lived Assets to be Disposed of", and provides a single
accounting model for long-lived assets to be disposed of by sale, whether
previously held and used or newly acquired. The provisions of SFAS No. 144 are
effective for fiscal years beginning after December 15, 2001, and, generally,
its provisions are to be applied prospectively. The Company's adoption of SFAS
No. 144 in fiscal year 2003 did not have a material effect on its financial
position or results of operations.
In September 2002, the FASB issued SFAS No. 146, "Accounting for Costs
Associated with Exit or Disposal Activities," ("SFAS No. 146") which supersedes
Emerging Issues Task Force ("EITF') Issue No. 94-3, "Liability Recognition for
Certain Employee Termination Benefits and Other Costs to Exit an Activity
(including Certain Costs incurred in a Restructuring)." The standard affects the
accounting for restructuring charges and related
7
activities. The provisions of this statement are required to be adopted for exit
or disposal activities that are initiated after December 31, 2002. The Company
does not expect the adoption of SFAS No. 146 to have an impact on its financial
position and results of operations.
In July 2000, the EITF released EITF 00-21, "Accounting for Revenue
Arrangements with Multiple Deliverables" ("EITF 00-21") for comment. EITF 00-21
addresses revenue recognition for arrangements with multiple deliverables. The
draft of EITF 00-21 was approved in November 2002 and is effective for revenue
arrangements entered into in fiscal years beginning after June 15, 2003, with
early adoption permitted. The impact of EITF 00-21 on the Company's financial
statements has not yet been determined.
In December 2002, the FASB issued SFAS No. 148, "Accounting for Stock-Based
Compensation -- Transition and Disclosure -- an amendment of SFAS 123" ("SFAS
No. 148"). SFAS No. 148 provides additional transition guidance for companies
that elect to voluntarily adopt the accounting provisions of SFAS No. 123,
"Accounting for Stock-Based Compensation" ("SFAS No. 123") and is intended to
encourage the adoption of the accounting provisions of SFAS No. 123. Under the
provisions of SFAS No. 148, companies that choose to adopt the accounting
provisions of SFAS 123 will be permitted to select from three transition
methods: the prospective method, the modified prospective method and the
retroactive restatement method. SFAS No. 148 requires certain new disclosures
that are incremental to those required by SFAS No.123, which must also be made
in interim financial statements. The transition and annual disclosure provisions
of SFAS No. 148 are effective for fiscal years ending after December 15, 2002.
The impact on the Company's financial statements has not yet been determined.
Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations:
Statements in this Form 10-Q that are not statements or descriptions of
historical facts are "forward-looking" statements under Section 21E of the
Securities Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995 and are subject to numerous risks and
uncertainties. These and other forward-looking statements made by the Company in
reports that we file with the SEC, press releases, and public statements of our
officers, corporate spokespersons or our representatives are based on a number
of assumptions and relate to, without limitation: the Company's ability to
successfully develop, obtain regulatory approval for and commercialize any
products, including trospium; its ability to enter into corporate collaborations
or to obtain sufficient additional capital to fund operations; and the
Redux(TM)-related litigation. The words "believe," "expect," "anticipate,"
"intend," "plan," "estimate" or other expressions which predict or indicate
future events and trends and do not relate to historical matters identify
forward-looking statements. Readers are cautioned not to place undue reliance on
these forward-looking statements as they involve risks and uncertainties and
such forward-looking statements may turn out to be wrong. Actual results could
differ materially from those currently anticipated due to a number of factors,
including those set forth under "Risk Factors" and elsewhere in, or incorporated
by reference into, the Company's Form 10-K for its fiscal year ended September
30, 2002. These factors include, but are not limited to: dependence on the
success of trospium; the early stage of products under development;
uncertainties relating to clinical trials, regulatory approval and
commercialization of the Company's products; risks associated with contractual
arrangements; dependence on third parties for manufacturing and marketing;
competition; need for additional funds and corporate partners; history of
operating losses and expectation of future losses; product liability; risks
related to certain insurance-related litigation; risks relating to the
Redux-related litigation; limited patents and proprietary rights; dependence on
market exclusivity; valuation of our common stock; and other risks. The
forward-looking statements represent the Company's judgment and expectations as
of the date of this Form 10-Q. We assume no obligation to update any such
forward-looking statements.
The following discussion should be read in conjunction with the Company's
unaudited consolidated financial statements and notes thereto appearing
elsewhere in this report and audited consolidated financial statements and notes
thereto included in the Company's Annual Report on Form 10-K for the fiscal year
ended September 30, 2002. Unless the context indicates otherwise, "Indevus" or
the "Company" refer to Indevus Pharmaceuticals, Inc.
General
8
Description of the Company
Indevus is a biopharmaceutical company engaged in the development and
commercialization of a diversified portfolio of product candidates, including
multiple compounds in late-stage clinical development. The Company is currently
developing or has certain rights to five core compounds: trospium for overactive
bladder, pagoclone for panic and generalized anxiety disorders, citicoline for
ischemic stroke, IP 751 for pain and inflammatory disorders, and PRO 2000 for
the prevention of infection by HIV and other sexually transmitted pathogens.
Major Products
Trospium is a muscarinic receptor antagonist in development as a treatment
for overactive bladder. In September 2002, the Company announced that a
523-patient, double-blind, placebo-controlled Phase III clinical trial with
trospium met both of its primary endpoints and all of its overactive bladder
secondary endpoints. Based on the results of this Phase III trial and the
European clinical trials database, the Company plans to file a new drug
application ("NDA") for trospium during the second calendar quarter of 2003,
contingent upon discussions with the U.S. Food and Drug Administration ("FDA").
The Company is evaluating commercial opportunities for the drug. As of December
16, 2002, the Company entered into a manufacturing agreement with Madaus AG
("Madaus"), licensor of trospium to the Company, whereby Madaus will produce and
sell to the Company commercial quantities of trospium in bulk form. The
agreement provides for certain minimum purchases commencing in the year trospium
is first sold commercially.
Pagoclone is a novel GABA (gamma amino butyric acid) receptor agonist in
development for the treatment of anxiety disorders. The Company is pursuing a
new worldwide development partnership for the commercialization of pagoclone.
Citicoline has been under development by the Company as a neuroprotective
treatment for ischemic stroke. Indevus has signed a non-binding memorandum of
agreement with a privately held biotechnology company to fund the further
development of citicoline. The finalization of this agreement is contingent upon
input from the FDA on the design and clinical endpoints of an additional large
Phase III trial and the negotiation of a definitive contract.
IP 751 is a compound in early clinical development to treat pain and
inflammatory disorders. In December 2002, the Company announced results of a
Phase II clinical trial in Germany showing that treatment with IP 751
significantly reduced neuropathic pain, with no significant adverse events and
psychoactive properties. An investigative new drug application ("IND") for IP
751 has been filed with the FDA, and an initial Phase I clinical trial designed
to assess its safety showed that it was well tolerated, with no clinically
significant adverse events and no evidence of psychotropic activity. The Company
is currently determining the optimal clinical and regulatory plan for advancing
this compound as a therapy for pain and inflammatory disorders.
PRO 2000 is a topical microbicide in development for the prevention of the
sexual transmission of HIV and other sexually-transmitted pathogens. A number of
clinical trials are ongoing or planned. These trials include a European
Commission-funded Phase II safety trial in at-risk African women planned to
begin in early 2003. The Company will owe its PRO 2000 licensor a $500,000
milestone payment subsequent to the initiation of this trial. In addition, an
National Institutes of Health-sponsored Phase II/III pivotal trial to determine
the safety and efficacy of PRO 2000 in blocking male to female HIV transmission
is planned to begin in 2003 in Africa and India. The study is expected to
involve approximately 10,000 HIV-uninfected women at risk for acquiring HIV by
virtue of living in countries where the risk of such infection is high.
The Company licensed to Lilly exclusive, worldwide rights to Indevus'
patent covering the use of fluoxetine to treat certain conditions and symptoms
associated with premenstrual syndrome. Lilly is marketing the drug under the
trade name Sarafem. The Company received royalties based on net sales of Sarafem
through December 2001. In
9
December 2002, the Company entered into an amended licensing agreement with
Lilly providing for a $777,000 initial payment to the Company upon the signing
of the agreement and royalty payments from Lilly to the Company based on net
sales of Sarafem in the U.S. from October 1, 2002 until the expiration of the
Company's patent. In addition, the agreement includes other potential milestone
payments to the Company from Lilly. On January 23, 2003, Galen Holdings PLC
announced the completion of its acquisition of the U.S. sales and marketing
rights to Sarafem from Lilly. Pursuant to our agreement with Lilly, the
remaining milestone payments of $2,184,000 were accelerated and received by the
Company from Lilly in February 2003. MIT, the Company's licensor, is entitled to
a portion of payments made to Indevus by Lilly.
Critical Accounting Policies and Significant Judgments and Estimates
The discussion and analysis of our financial condition and results of
operations is based upon our consolidated financial statements that have been
prepared in accordance with generally accepted accounting principles in the U.S.
The preparation of these financial statements requires us to make certain
estimates and assumptions that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at the date of
the consolidated financial statements and the reported amounts of revenue and
expense during the reported periods. These items are constantly monitored and
analyzed by management for changes in facts and circumstances, and material
changes in these estimates could occur in the future. Changes in estimates are
recorded in the period in which they become known. We base our estimates on
historical experience and various other assumptions that we believe to be
reasonable under the circumstances. Actual results may differ from our estimates
if past experience or other assumptions do not turn out to be substantially
accurate.
Critical Accounting Policies
In December 2001, the SEC requested that all registrants discuss their
"critical accounting policies" in management's discussion and analysis of
financial condition and results of operations. A critical accounting policy is a
policy that is both important to the portrayal of the Company's financial
conditions and results, and requires management's most difficult, subjective or
complex judgements and estimates. While our significant accounting policies are
more fully described in the notes to our audited consolidated financial
statements included in our Form 10-K for the fiscal year ended September 30,
2002, we consider our revenue recognition policy critical and therefore we state
it below.
Revenue Recognition
Contract and license fee revenue is primarily generated through
collaborative license and development agreements with strategic partners for the
development and commercialization of the Company's product candidates.
10
The terms of the agreements typically include non-refundable license fees,
funding of research and development, payments based upon achievement of certain
milestones and royalties on net product sales. Non-refundable license fees are
recognized as contract and license fee revenue when the Company has a
contractual right to receive such payment provided a contractual arrangement
exists, the contract price is fixed or determinable, the collection of the
resulting receivable is reasonably assured and the Company has no further
performance obligations under the license agreement.
Revenues from milestone payments related to arrangements under which the
Company has no continuing performance obligations are recognized upon
achievement of the related milestone. Revenues from milestone payments related
to arrangements under which the Company has continuing performance obligations
are recognized as revenue upon achievement of the milestone only if all of the
following conditions are met: the milestone payments are non-refundable;
achievement of the milestone was not reasonably assured at the inception of the
arrangement; substantive effort is involved in achieving the milestone; and the
amount of the milestone is reasonable in relation to the effort expended or the
risk associated with achievement of the milestone. If any of these conditions
are not met, the milestone payments are deferred and recognized as revenue over
the term of the arrangement as the Company completes its performance
obligations.
Royalty revenue consists of payments received from licensees for a portion
of sales proceeds from products that utilize the Company's licensed technologies
and is recognized when the amount of and basis for such royalty payments are
reported to the Company in accurate and appropriate form and in accordance with
the related license agreement.
Cash received in advance of revenue recognition is recorded as deferred
revenue.
Significant Judgments and Estimates
Insurance Claim Receivable
As of December 31, 2002, the Company had an outstanding insurance claim of
approximately $3,735,000, including $3,688,000 of which the Company paid through
December 31, 2002 to the group of law firms defending the Company in the
Redux-related product liability litigation, for services rendered by such law
firms through May 30, 2001. The full amount of the Company's current outstanding
insurance claim is made pursuant to the Company's product liability policy
issued to the Company by Reliance Insurance Company ("Reliance"), which is in
liquidation proceedings. Based upon discussions with its attorneys and other
consultants regarding the amount and timing of potential collection of its
claims on Reliance, the Company has recorded a reserve against its outstanding
and estimated claim receivable from Reliance to reduce the balance to the
estimated net realizable value of $1,258,000 reflecting the Company's best
estimate given the available facts and circumstances. The Company believes its
reserve of $2,477,000 against the $3,735,000 of insurance claims on Reliance as
of December 31, 2002 is a significant estimate reflecting management's
judgement. To the extent the Company does not collect the insurance claim
receivable of $1,258,000, the Company would be required to record additional
charges. Alternatively, if the Company collects amounts in excess of the current
receivable balance, the Company would record a credit for the additional funds
received in the statement of operations.
Redux-Related Liabilities
The Company also has an accrued liability of $1,242,000 for Redux-related
expenses, including legal expenses. The amounts the Company ultimately pays
could differ significantly from the amount currently accrued at December 31,
2002. To the extent the amounts paid differ from the amounts accrued, the
Company will record a charge or credit to the statement of operations.
Results of Operations
Total revenues decreased to $822,000 in the three month period ended
December 31, 2002 from $3,541,000 in
11
the three month period ended December 31, 2001. Contract and license fee revenue
of $822,000 in the first quarter of fiscal 2003 consisted primarily of $777,000
from an initial payment received from Lilly related to the amended agreement for
Sarafem. Contract and license fee revenue of $342,000 in the first quarter of
fiscal 2002 consisted primarily of revenue from a research grant related to
certain PRO 2000 development costs. Royalty revenue of $3,199,000 in the first
quarter of fiscal 2002 related to royalties received from Lilly related to sales
of Sarafem. Pursuant to its amended agreement, the Company expects to commence
receiving royalties from Lilly on sales of Sarafem in the second quarter of
fiscal 2003.
Cost of revenues of $210,000 and $838,000 in the three month periods ended
December 31, 2002 and 2001, respectively, consisted primarily of amounts due to
MIT for their portion of the contractual payments and royalties received from
Lilly.
Research and development expense increased $532,000, or 16%, to $3,777,000
in the three month period ended December 31, 2002 from $3,245,000 in the three
month period ended December 31, 2001. This increase is primarily due to expenses
incurred by the Company related to the development of, and preparation of an NDA
for, trospium.
General and administrative expense increased $879,000, or 56%, to
$2,457,000 in the three month period ended December 31, 2002 from $1,578,000 in
the three month period ended December 31, 2001. This increase was primarily due
to increased pre-marketing costs related to trospium and increased legal costs
related to the litigation with Columbia Casualty Company ("CNA"). In February
2003, CNA and the Company agreed to withdraw their respective claims against
each other and end the litigation.
Investment income decreased $37,000, or 16%, to $191,000 in the three month
period ended December 31, 2002 from $228,000 in the three month period ended
December 31, 2001. This decrease resulted from reduced market interest rates on
higher weighted average invested cash balances.
For the three month period ended December 31, 2002, the Company had a net
loss of $5,431,000, or $(0.12) per share, basic and diluted, compared to a net
loss of $1,946,000, or $(0.04) per share, basic and diluted, for the three month
period ended December 31, 2001. The Company expects to report losses for its
consolidated operations for fiscal 2003.
Liquidity and Capital Resources
Cash, Cash Equivalents and Marketable Securities
At December 31, 2002, the Company had consolidated cash, cash equivalents
and marketable securities of $36,101,000 compared to $41,543,000 at September
30, 2002. This decrease of $5,442,000 primarily represents cash used in
operating activities.
The Company believes it has sufficient cash for currently planned
expenditures for at least the next twelve months. Based on certain assumptions
relating to operations and other factors, the Company may require additional
funds after such time. The Company does not currently have sufficient funds to
fully develop and commercialize any of its current products and product
candidates and will require additional funds or corporate collaborations for the
development and commercialization of its compounds in development, as well as
any new businesses, products or technologies acquired or developed in the
future. The Company has no commitments to obtain such funds. There can be no
assurance that the Company will be able to obtain additional financing to
satisfy future cash requirements on acceptable terms, or at all.
Product Development
The Company expects to continue to expend substantial additional amounts
for the development of its products. There can be no assurance that results of
any ongoing or future pre-clinical or clinical trials will be successful, that
additional trials will not be required, that any drug or product under
development will receive FDA approval in
12
a timely manner or at all, or that such drug or product could be successfully
manufactured in accordance with current Good Manufacturing Practices ("cGMP") or
successfully marketed in a timely manner, or at all, or that the Company will
have sufficient funds to develop or commercialize any of its products. The
Company expects to expend a substantial amount during the next twelve months to
fund development, regulatory and pre-marketing activities for trospium.
The Company expects to rely on Madaus to manufacture trospium for
commercial use. The Company believes that Madaus' manufacturing facility for
trospium does not currently meet cGMP requirements. Although Madaus is
endeavoring to bring its manufacturing facility into compliance with cGMP
requirements, failure to do so in a timely manner could cause a material delay
in the NDA submission, FDA approval, if any, and commercialization of trospium.
While the Company may seek a second source for trospium if Madaus is unable to
meet all regulatory requirements or provide the necessary quantities of trospium
in a timely manner, this could also cause a material delay in the NDA
submission, FDA approval, if any, and commercialization of trospium.
Total research and development expenses incurred by the Company through
December 31, 2002 on the major compounds currently being developed, including
allocation of corporate general and administrative expenses, are approximately
as follows: trospium $29,800,000, pagoclone $15,700,000, citicoline $77,000,000,
PRO 2000 $6,800,000, and IP 751 $600,000. In June 2002, the Company re-acquired
rights to pagoclone from Pfizer. During the period Pfizer had rights to
pagoclone, Pfizer conducted and funded all development activities for pagoclone.
Estimating costs and time to complete development of a compound is difficult due
to the uncertainties of the development process and the requirements of the FDA
which could necessitate additional and unexpected clinical trials or other
development, testing and analysis. Results of any testing could result in a
decision to alter or terminate development of a compound, in which case
estimated future costs could change substantially. Certain compounds could
benefit from subsidies, grants or government or agency-sponsored studies that
could reduce the Company's development costs. In the event the Company were to
enter into a licensing or other collaborative agreement with a corporate partner
involving sharing, funding or assumption by such corporate partner of
development costs, the estimated development costs to be incurred by the Company
could be substantially less than the estimates below. Additionally, research and
development costs are extremely difficult to estimate for early-stage compounds
due to the fact that there is generally less comprehensive data available for
such compounds to determine the development activities that would be required
prior to the filing of an NDA. Given these uncertainties and other risks,
variables and considerations related to each compound and regulatory
uncertainties in general, the Company estimates remaining research and
development costs, excluding allocation of corporate general and administrative
expenses, from December 31, 2002 through the preparation of an NDA for its major
compounds currently being developed as follows: approximately $4,000,000 for
trospium, approximately $15,000,000 for PRO 2000 and, approximately $40,000,000
for pagoclone. The Company does not plan to develop citicoline further without
project-specific funding. The Company cannot reasonably estimate date of
completion for any compound that is not at least in Phase III clinical
development due to the uncertainty of the number of required trials and size of
such trials and the duration of development. Actual costs and time to complete
may differ significantly from the estimates.
Analysis of Cash Flows
Cash used in operating activities during the three month period ended
December 31, 2002 of $5,436,000 consisted primarily of the net loss of
$5,431,000.
Cash provided by investing activities during the three month period ended
December 31, 2002 of $1,683,000 consisted primarily of $1,693,000 of net inflows
from maturities and sales of marketable securities.
Commitments and Contingencies
At September 30, 2002, the Company's future minimum payments under
non-cancelable lease arrangements are as follows:
13
Operating
Fiscal Year Leases
----------- ------
2003 ....................................................... $ 543,000
2004 ....................................................... 560,000
2005 ....................................................... 555,000
2006 ....................................................... 568,000
2007 ....................................................... 312,000
Thereafter ................................................. -
----------
Total lease payments ................................. $2,538,000
==========
Pursuant to certain of the Company's in-licensing arrangements, the
Company will owe payments to its licensors upon achievement of certain
development and regulatory milestones; the Company cannot predict if or when
such events will occur.
Other
Recent Accounting Pronouncements
In June 2001, the FASB issued SFAS No. 141, "Business Combinations" ("SFAS
No. 141") and SFAS No. 142, "Goodwill and Other Intangible Assets" ("SFAS No.
142"). SFAS No. 141 requires that all business combinations be accounted for
under the purchase method only and that certain acquired intangible assets in a
business combination be recognized as assets apart from goodwill. SFAS No. 142
requires that ratable amortization of goodwill be replaced with periodic tests
of the goodwill's impairment and that intangible assets other than goodwill be
amortized over their useful lives. SFAS No. 141 is effective for all business
combinations initiated after June 30, 2001 and for all business combinations
accounted for by the purchase method for which the date of acquisition is after
June 30, 2001. The provisions of SFAS No. 142 are effective for fiscal years
beginning after December 15, 2001. The Company's adoption of SFAS Nos. 141 and
142 in fiscal year 2003 did not have a material effect on the Company's
financial condition or results of operations.
In October 2001, the FASB issued SFAS No. 144, "Accounting for the
Impairment or Disposal of Long-Lived Assets" ("SFAS No. 144"). SFAS No. 144
supercedes FASB Statement No. 121, "Accounting for the Impairment of Long-Lived
Assets and for Long-Lived Assets to be Disposed of", and provides a single
accounting model for long-lived assets to be disposed of by sale, whether
previously held and used or newly acquired. The provisions of SFAS No. 144 are
effective for fiscal years beginning after December 15, 2001, and, generally,
its provisions are to be applied prospectively. The Company's adoption of SFAS
No. 144 in fiscal year 2003 did not have a material effect on its financial
position or results of operations.
In September 2002, the FASB issued SFAS No. 146, "Accounting for Costs
Associated with Exit or Disposal Activities," ("SFAS No. 146") which supersedes
Emerging Issues Task Force ("EITF') Issue No. 94-3, "Liability Recognition for
Certain Employee Termination Benefits and Other Costs to Exit an Activity
(including Certain Costs incurred in a Restructuring)." The standard affects the
accounting for restructuring charges and related activities. The provisions of
this statement are required to be adopted for exit or disposal activities that
are initiated after December 31, 2002. The Company does not expect the adoption
of SFAS No. 146 to have an impact on its financial position and results of
operations.
In July 2000, the EITF released EITF 00-21, "Accounting for Revenue
Arrangements with Multiple Deliverables" ("EITF 00-21") for comment. EITF 00-21
addresses revenue recognition for arrangements with multiple deliverables. The
draft of EITF 00-21 was approved in November 2002 and is effective for revenue
arrangements entered into in fiscal years beginning after June 15, 2003, with
early adoption permitted. The impact of EITF 00-21 on the Company's financial
statements has not yet been determined.
In December 2002, the FASB issued SFAS No. 148, "Accounting for
Stock-Based Compensation -- Transition
14
and Disclosure -- an amendment of SFAS 123" ("SFAS No. 148"). SFAS No. 148
provides additional transition guidance for companies that elect to voluntarily
adopt the accounting provisions of SFAS No. 123, "Accounting for Stock-Based
Compensation" ("SFAS No. 123") and is intended to encourage the adoption of the
accounting provisions of SFAS No. 123. Under the provisions of SFAS No. 148,
companies that choose to adopt the accounting provisions of SFAS 123 will be
permitted to select from three transition methods: the prospective method, the
modified prospective method and the retroactive restatement method. SFAS No. 148
requires certain new disclosures that are incremental to those required by SFAS
No.123, which must also be made in interim financial statements. The transition
and annual disclosure provisions of SFAS No. 148 are effective for fiscal years
ending after December 15, 2002. The impact on the Company's financial statements
has not yet been determined.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Indevus owns financial instruments that are sensitive to market risks as
part of its investment portfolio. The investment portfolio is used to preserve
Indevus' capital until it is required to fund operations, including Indevus'
research and development activities. None of these market-risk sensitive
instruments are held for trading purposes. Indevus does not own derivative
financial instruments in its investment portfolio.
Interest Rate Risk
Indevus invests its cash in a variety of financial instruments,
principally securities issued by the U.S. government and its agencies,
investment grade corporate and money market instruments. These investments are
denominated in U.S. dollars. These bonds are subject to interest rate risk, and
could decline in value if interest rates fluctuate. Indevus' investment
portfolio includes only marketable securities with active secondary or resale
markets to help ensure portfolio liquidity. Also, Indevus has implemented
guidelines limiting the duration of its investments. Due to the conservative
nature of these instruments, Indevus does not believe that it has a material
exposure to interest rate risk.
Item 4. Controls and Procedures
Within 90 days prior to the date of this report, we carried out an
evaluation, under the supervision and with the participation of our principal
executive officer and principal financial officer, of the effectiveness of the
design and operation of our disclosure controls and procedures. Based on this
evaluation, our principal executive officer and principal financial officer
concluded that our disclosure controls and procedures are effective for the
purpose of timely alerting the appropriate individuals of the material
information required to be included in our periodic SEC reports. It should be
noted that the design of any system of controls is based in part upon certain
assumptions about the likelihood of future events, and there can be no assurance
that any design will succeed in achieving its stated goals under all potential
future conditions, regardless of how remote.
In addition, we reviewed our internal controls, and there have been no
significant changes in our internal controls or in other factors that could
significantly affect those controls subsequent to the date of our last
evaluation.
PART II. Other Information
Item 1. Legal Proceedings
Product Liability Litigation: Subsequent to the market withdrawal of
Redux in September 1997, the Company had been named, together with other
pharmaceutical companies, as a defendant in approximately 3,200 legal actions,
many of which purport to be class actions, in federal and state courts relating
to the use of Redux. The actions generally have been brought by individuals in
their own right or on behalf of putative classes of persons who claim to have
suffered injury or who claim that they may suffer injury in the future due to
use of one or more weight loss drugs including Pondimin (fenfluramine),
phentermine and Redux. Plaintiffs' allegations of liability are based on various
theories of recovery, including, but not limited to, product liability, strict
liability, negligence, various breaches of warranty, conspiracy, fraud,
misrepresentation and deceit. These lawsuits typically allege that the short or
long-
15
term use of Pondimin and/or Redux, independently or in combination (including
the combination of Pondimin and phentermine popularly known as "fen-phen"),
causes, among other things, PPH, valvular heart disease and/or neurological
dysfunction. In addition, some lawsuits allege emotional distress caused by the
purported increased risk of injury in the future. Plaintiffs typically seek
relief in the form of monetary damages (including economic losses, medical care
and monitoring expenses, loss of earnings and earnings capacity, other
compensatory damages and punitive damages), generally in unspecified amounts, on
behalf of the individual or the class. In addition, some actions seeking class
certification ask for certain types of purportedly equitable relief, including,
but not limited to, declaratory judgments and the establishment of a research
program or medical surveillance fund. On December 10, 1997, the federal Judicial
Panel on Multidistrict Litigation issued an Order allowing for the transfer or
potential transfer of the federal actions to the Eastern District of
Pennsylvania for coordinated or consolidated pretrial proceedings. To date,
there have been no judgments against the Company, nor has the Company paid any
amounts in settlement of any of these claims.
The Company entered into the AHP Indemnity and Release Agreement on May
30, 2001 pursuant to which Wyeth agreed to indemnify the Company against certain
classes of product liability cases filed against Indevus related to Redux. The
Company's indemnification covers existing plaintiffs who have already opted out
of Wyeth's national class action settlement of diet drug claims and claimants
alleging primary pulmonary hypertension. In addition, Wyeth has agreed to fund
all future legal costs related to the Company's defense of Redux-related product
liability cases. The agreement also provides for Wyeth to fund additional
insurance coverage to supplement the Company's existing product liability
insurance. The Company believes this total insurance coverage is sufficient to
address its potential remaining Redux product liability exposure. However, there
can be no assurance that uninsured or insufficiently insured Redux-related
claims or Redux-related claims for which the Company is not otherwise
indemnified or covered under the AHP Indemnity and Release Agreement will not
have a material adverse effect on the Company's future business, results of
operations or financial condition or that the potential of any such claims would
not adversely affect the Company's ability to obtain sufficient financing to
fund operations. Up to the date of the AHP Indemnity and Release Agreement, the
Company's defense costs were paid by, or subject to reimbursement to the Company
from, the Company's product liability insurers. To date, there have been no
Redux-related product liability settlements or judgments paid by the Company or
its insurers. In exchange for the indemnification, defense costs, and insurance
coverage provided to Indevus by Wyeth, the Company agreed to dismiss its suit
against Wyeth filed in January 2000, its appeal from the order approving Wyeth's
national class action settlement of diet drug claims, and its cross-claims
against Wyeth related to Redux product liability legal actions.
Complaint Against Wyeth: On January 24, 2000, the Company announced it had
filed a complaint against Wyeth in the Superior Court of the Commonwealth of
Massachusetts. The complaint sought unspecified but substantial damages and
attorneys' fees pursuant to common and statutory law for Wyeth's knowing and
willful deceptive acts and practices, fraud and misrepresentations and breach of
contract. Wyeth filed an answer denying the allegations of such complaint.
Pursuant to the AHP Indemnity and Release Agreement, described above, such
complaint was dismissed on June 28, 2001.
Insurance Litigation: In February 2003, CNA agreed to dismiss, with
prejudice, its lawsuit against the Company and the Company in turn agreed to
dismiss, with prejudice, its claims against CNA, without costs or fees to either
side. In August 2001, CNA, one of the Company's insurers for the period May 1997
through May 1998, filed an action in the United States District Court for the
District of Columbia against the Company. The lawsuit was based upon a claim for
breach of contract and declaratory judgment, seeking damages against the Company
in excess of $20,000,000, the amount that CNA had paid to the Company under its
insurance policy. CNA alleged that under the policy it was subrogated to any
claim for indemnification that Indevus may have had against Wyeth related to
Redux and that such claim was compromised without its consent when the Company
entered into the AHP Indemnity and Release Agreement. On March 8, 2002, the
Company filed an Answer, Affirmative Defenses and Counterclaims to the action,
including counterclaims for breach of contract, breach of the implied covenant
of good faith and fair dealing, declaratory judgment pursuant to 28 U.S.C.
Sections 2201 and 2202, and unfair or deceptive acts and/or unfair claims
settlement practices.
16
General: Pursuant to agreements between the parties, under certain
circumstances, the Company may be required to indemnify Servier, Boehringer and
other parties.
Although the Company maintains certain product liability and director and
officer liability insurance and intends to defend these and similar actions
vigorously, the Company has been required and may continue to be required to
devote significant management time and resources to these legal actions. In the
event of successful uninsured or insufficiently insured claims, or in the event
a successful indemnification claim were made against the Company and its
officers and directors, the Company's business, financial condition and results
of operations could be materially adversely affected. The uncertainties and
costs associated with these legal actions have had, and may continue to have, an
adverse effect on the market price of the Company's Common Stock and on the
Company's ability to obtain corporate collaborations or additional financing to
satisfy cash requirements, to retain and attract qualified personnel, to develop
and commercialize products on a timely and adequate basis, to acquire rights to
additional products, or to obtain product liability insurance for other products
at costs acceptable to the Company, or at all, any or all of which may
materially adversely affect the Company's business, financial condition and
results of operations. See "Management's Discussion and Analysis of Financial
Condition and Results of Operations."
17
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
10.128 Amendment No.1 to Licensing Agreement by and between Eli Lilly and
Company, Eli Lilly S.A., and Indevus Pharmaceuticals, Inc. effective as
of October 1, 2002 (1)
10.129 Supply Agreement as of December 16, 2002 by and between Madaus AG and
Indevus Pharmaceuticals, Inc. (1)
99.1 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, by Glenn L. Cooper,
Chief Executive Officer
99.2 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, by Michael W. Rogers,
Chief Financial Officer
------------
(1) Confidential treatment requested for a portion of this Exhibit
(b) Reports on Form 8-K
The Company did not file any reports on Form 8-K in the three month period ended
December 31, 2002.
18
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
INDEVUS PHARMACEUTICALS, INC.
Date: February 14, 2003 By: /s/ Glenn L. Cooper
--------------------------------------------
Glenn L. Cooper, M.D., Chairman, President,
and Chief Executive Officer
(Principal Executive Officer)
Date: February 14, 2003 By: /s/ Michael W. Rogers
--------------------------------------------
Michael W. Rogers, Executive Vice President,
Chief Financial Officer and Treasurer
(Principal Financial Officer)
Date: February 14, 2003 By: /s/ Dale Ritter
--------------------------------------------
Dale Ritter, Senior Vice President, Finance
(Principal Accounting Officer)
19
CERTIFICATION PURSUANT TO
SECURITIES EXCHANGE ACT RULES 13a-14 AND 15d-14,
AS PROMULGATED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Glenn L. Cooper, Chief Executive Officer of Indevus Pharmaceuticals, Inc.
certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Indevus
Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the issuer as of, and for, the periods presented in this report;
4. The issuer's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-14 and 15d-14) for the issuer and have:
(a) designed such disclosure controls and procedures to ensure that
material information relating to the issuer, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report was
being prepared;
(b) evaluated the effectiveness of the issuer's disclosure controls and
procedures as of a date within 90 days prior to the filing date of
this report ("Evaluation Date"); and
(c) presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of
the Evaluation Date;
5. The issuer's other certifying officer and I have disclosed, based on our
most recent evaluation, to the issuer's auditors and the audit committee of
the board of directors:
(a) all significant deficiencies in the design or operation of internal
controls which could adversely affect the issuer's ability to record,
process, summarize and report financial data and have identified for
the issuer's auditors any material weaknesses in internal controls;
and
(b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the issuer's internal
controls; and
6. The issuer's other certifying officer and I have indicated in this report
whether or not there were significant changes in internal controls or in
other factors that could significantly affect internal controls subsequent
to the date of our most recent evaluation, including any corrective actions
with regard to significant deficiencies and material weaknesses.
By: /s/ Glenn L. Cooper
-----------------------------
Chief Executive Officer
February 14, 2003
20
CERTIFICATION PURSUANT TO
SECURITIES EXCHANGE ACT RULES 13a-14 AND 15d-14,
AS PROMULGATED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael W. Rogers, Chief Financial Officer of Indevus Pharmaceuticals, Inc.
certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Indevus
Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the issuer as of, and for, the periods presented in this report;
4. The issuer's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-14 and 15d-14) for the issuer and have:
(a) designed such disclosure controls and procedures to ensure that
material information relating to the issuer, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report was
being prepared;
(b) evaluated the effectiveness of the issuer's disclosure controls and
procedures as of a date within 90 days prior to the filing date of
this report ("Evaluation Date"); and
(c) presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of
the Evaluation Date;
5. The issuer's other certifying officer and I have disclosed, based on our
most recent evaluation, to the issuer's auditors and the audit committee of
the board of directors:
(a) all significant deficiencies in the design or operation of internal
controls which could adversely affect the issuer's ability to record,
process, summarize and report financial data and have identified for
the issuer's auditors any material weaknesses in internal controls;
and
(b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the issuer's internal
controls; and
6. The issuer's other certifying officer and I have indicated in this report
whether or not there were significant changes in internal controls or in
other factors that could significantly affect internal controls subsequent
to the date of our most recent evaluation, including any corrective actions
with regard to significant deficiencies and material weaknesses.
By: /s/ Michael W. Rogers
--------------------------------
Chief Financial Officer
February 14, 2003
21