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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
|X| QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2003
|_| TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
COMMISSION FILE NUMBER 000-30929
KERYX BIOPHARMACEUTICALS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 13-4087132
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER IDENTIFICATION NO.)
INCORPORATION OR ORGANIZATION)
750 LEXINGTON AVENUE
NEW YORK, NEW YORK 10022
(ADDRESS INCLUDING ZIP CODE OF PRINCIPAL EXECUTIVE OFFICES)
212-531-5965
(REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE)
Indicate by an (X) 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 to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes |X| NO |_|
Indicate by an (X) whether the registrant is an accelerated filer (as defined in
Rule 12b-2 of the Exchange Act). Yes |_| NO |X|
As of May 6, 2003, the registrant had outstanding 20,322,710 shares of Common
Stock, $0.001 par value per share.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Interim Consolidated Balance Sheets as of March 31, 2003
and December 31, 2002........................................ 3
Interim Consolidated Statements of Operations for the
three months ended March 31, 2003 and 2002................... 4
Interim Consolidated Statements of Cash Flows for the
three months ended March 31, 2003 and 2002................... 5
Notes to Interim Consolidated Financial Statements
of March 31, 2003............................................ 7
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations.......................... 11
Item 3. Quantitative and Qualitative Disclosures About
Market Risk.................................................. 28
Item 4. Controls and Procedures........................................ 28
PART II. OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds...................... 29
Item 6. Exhibits and Reports on Form 8-K............................... 29
SIGNATURES.............................................................. 30
CERTIFICATIONS.......................................................... 31
2
ITEM 1. FINANCIAL STATEMENTS
Keryx Biopharmaceuticals, Inc. (A Development Stage Company)
Interim Consolidated Balance Sheets as of March 31, 2003 and December 31, 2002
- --------------------------------------------------------------------------------
(in thousands, except share amounts)
March 31 December 31
2003 2002
(Unaudited) (Audited)
----------- -----------
Assets
Current assets
Cash and cash equivalents $ 19,559 $ 13,350
Investment securities, held-to-maturity 2,760 10,575
Deposits in respect of employee severance
obligations (current portion) 340 299
Accrued interest receivable 66 206
Deferred tax asset -- 170
Other receivables and prepaid expenses 178 267
-------- --------
Total current assets 22,903 24,867
-------- --------
Deposits in respect of employee severance obligations -- 117
Property, plant and equipment, net 1,289 3,031
Other assets (primarily intangible assets), net 296 1,088
-------- --------
Total assets $ 24,488 $ 29,103
======== ========
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable and accrued expenses $ 753 $ 920
Income taxes payable 158 177
Accrued compensation and related liabilities 1,279 1,420
-------- --------
Total current liabilities 2,190 2,517
-------- --------
Liability in respect of employee severance obligations -- 188
Deferred tax liability, net -- 68
-------- --------
Total liabilities 2,190 2,773
-------- --------
Commitments and contingencies
Stockholders' equity
Common stock, $0.001 par value per share (40,000,000 and
40,000,000 shares authorized, 20,123,185 and 19,913,185
shares issued, 20,076,885 and 19,866,885 shares outstanding
at March 31, 2003 and December 31, 2002, respectively) 20 20
Additional paid-in capital 71,959 72,067
Treasury stock, at cost, 46,300 shares at March 31, 2003
and at December 31, 2002 (77) (77)
Unearned compensation (314) (178)
Deficit accumulated during the development stage (49,290) (45,502)
-------- --------
Total stockholders' equity 22,298 26,330
-------- --------
Total liabilities and stockholders' equity $ 24,488 $ 29,103
======== ========
The accompanying notes are an integral part of the consolidated financial
statements.
3
Keryx Biopharmaceuticals, Inc. (A Development Stage Company)
Interim Consolidated Statements of Operations for the Three Months Ended
March 31, 2003 and 2002
- --------------------------------------------------------------------------------
(in thousands, except share and per share amounts)
Amounts
Three months ended March 31, accumulated
------------------------------ during the
development
2003 2002 stage
(Unaudited) (Unaudited) (Unaudited)
------------ ------------ ------------
Management fees from related party $ -- $ -- $ 300
------------ ------------ ------------
Operating expenses
Research and development:
Non-cash compensation $ (266) $ (580) $ 6,947
Other research and development 3,371 2,943 27,282
------------ ------------ ------------
Total research and development expenses 3,105 2,363 34,229
------------ ------------ ------------
General and administrative:
Non-cash compensation 2 (6) 3,393
Other general and administrative 664 1,310 15,069
------------ ------------ ------------
Total general and administrative expenses 666 1,304 18,462
------------ ------------ ------------
Total operating expenses 3,771 3,667 52,691
------------ ------------ ------------
Operating loss (3,771) (3,667) (52,391)
Interest income, net 85 174 3,720
------------ ------------ ------------
Net loss before income taxes (3,686) (3,493) (48,671)
Income taxes 102 50 619
------------ ------------ ------------
Net loss $ (3,788) $ (3,543) $ (49,290)
============ ============ ============
Basic and diluted loss per common share $ (0.19) $ (0.18) $ (3.76)
============ ============ ============
Weighted average shares used in computing
basic and diluted net loss per common share 20,011,036 19,890,335 13,092,903
The accompanying notes are an integral part of the consolidated financial
statements.
4
Keryx Biopharmaceuticals, Inc. (A Development Stage Company)
Interim Consolidated Statements of Cash Flows for the Three Months Ended
March 31, 2003 and 2002
- --------------------------------------------------------------------------------
(in thousands)
Amounts
accumulated
Three months ended March 31, during the
---------------------------- development
2003 2002 stage
----------- ----------- -----------
(Unaudited) (Unaudited) (Unaudited)
----------- ----------- -----------
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $(3,788) $(3,543) $(49,290)
Adjustments to reconcile cash flows used in
operating activities:
Employee stock compensation expense 3 4 8,963
Consultants' and third-party stock compensation
expense (negative expense) (267) (590) 1,377
Issuance of common stock to technology licensor -- 359 359
Interest on convertible notes settled
through issuance of preferred shares -- -- 253
Depreciation and amortization 264 211 1,590
Loss on disposal of property, plant and equipment -- 2 84
Impairment charges 2,295 -- 2,295
Exchange rate differences (4) 11 80
Changes in assets and liabilities:
Decrease (increase) in other receivables
and prepaid expenses 89 128 (173)
Decrease (increase) in accrued interest
receivable 140 108 (66)
Changes in deferred tax provisions and
valuation allowance 102 (57) --
(Decrease) increase in accounts payable
and accrued expenses (119) (135) 751
(Decrease) increase in income taxes payable (19) 104 158
Increase (decrease) in accrued compensation
and related liabilities (141) (258) 1,279
Provision for employee severance obligations (188) 210 --
------- ------- --------
Net cash used in operating activities (1,633) (3,446) (32,340)
------- ------- --------
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment -- (693) (4,400)
Proceeds from disposals of property,
plant and equipment -- 33 37
Investment in other assets, net (74) (67) (1,197)
Proceeds from (additions to) deposits in
respect of employee severance obligations 117 (37) --
Deposits in respect of employee severance
obligations (current portion) (41) -- (340)
Proceeds from sale and maturity of
(investment in) short-term securities 7,815 4,771 (2,760)
------- ------- --------
Net cash provided by (used in)
investing activities $ 7,817 $ 4,007 $ (8,660)
------- ------- --------
The accompanying notes are an integral part of the consolidated financial
statements.
5
Keryx Biopharmaceuticals, Inc. (A Development Stage Company)
Interim Consolidated Statements of Cash Flows for the Three Months Ended
March 31, 2003 and 2002
- --------------------------------------------------------------------------------
(in thousands)
Amounts
accumulated
Three months ended March 31, during the
--------------------------------- development
2003 2002 stage
----------- ----------- -----------
(Unaudited) (Unaudited) (Unaudited)
----------- ----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from short-term loans $ -- $ -- $ 500
Proceeds from long-term loans -- -- 3,251
Issuance of convertible note, net -- -- 2,150
Issuance of preferred shares, net and
contributed capital -- -- 8,453
Receipts on account of shares previously
issued -- -- 7
Proceeds from initial public offering, net -- -- 46,298
Proceeds from exercise of options and warrants 21 -- 57
Purchase of treasury stock -- -- (77)
-------- --------- ---------
Net cash provided by financing activities 21 -- 60,639
-------- --------- ---------
Effect of exchange rate on cash 4 (11) (80)
-------- --------- ---------
NET INCREASE IN CASH AND CASH
EQUIVALENTS 6,209 550 19,559
Cash and cash equivalents at beginning
of period 13,350 23,345 --
-------- --------- ---------
CASH AND CASH EQUIVALENTS AT END OF
PERIOD $ 19,559 $ 23,895 $ 19,559
======== ========= =========
NON-CASH TRANSACTIONS
Conversion of short-term loans into
contributed capital $ -- $ -- $ 500
Conversion of long-term loans into
contributed capital -- -- 2,681
Conversion of long-term loans into
convertible notes of Partec -- -- 570
Conversion of convertible notes of Partec
and accrued interest into stock in Keryx -- -- 2,973
Issuance of warrants to related party
as finder's fee in private placement -- -- 114
Declaration of stock dividend -- -- 3
Conversion of Series A preferred stock to
common stock -- -- --*
Purchase of property, plant and equipment
and other assets on credit -- 136 --
SUPPLEMENTARY DISCLOSURES OF CASH FLOW
INFORMATION
Cash paid for interest $ --* $ --* $ 139
Cash paid for income taxes 19 -- 390
* Amount less than $1,000
The accompanying notes are an integral part of the consolidated financial
statements.
6
Keryx Biopharmaceuticals, Inc. (A Development Stage Company)
Notes to the Interim Consolidated Financial Statements of March 31, 2003
- --------------------------------------------------------------------------------
NOTE 1 - GENERAL
BASIS OF PRESENTATION
Keryx Biopharmaceuticals, Inc. ("Keryx" or the "Company") is a biopharmaceutical
company focused on the acquisition, development and commercialization of novel
pharmaceutical products for the treatment of serious, life-threatening diseases,
including diabetes and cancer. The Company was incorporated in Delaware in
October 1998 (under the name Paramount Pharmaceuticals, Inc., which was later
changed to Lakaro Biopharmaceuticals, Inc. in November 1999, and finally to
Keryx Biopharmaceuticals, Inc. in January 2000). The Company commenced
activities in November 1999, and since then has operated in one segment of
operations, namely the development and commercialization of clinical compounds
and core technologies for the life sciences.
Until November 1999, most of the Company's activities were carried out by Partec
Limited, an Israeli corporation formed in December 1996, and its subsidiaries
SignalSite Inc. (85% owned) and its subsidiary, SignalSite Israel Ltd. (wholly
owned), and Vectagen Inc. (87.25% owned) and its subsidiary, Vectagen Israel
Ltd. (wholly owned) (hereinafter collectively referred to as "Partec"). In
November 1999, the Company acquired substantially all of the assets and
liabilities of Partec and, as of that date, the activities formerly carried out
by Partec are now performed by the Company. At the date of the acquisition,
Keryx and Partec were entities under common control (the controlling interest
owned approximately 79.7% of Keryx and approximately 76% of Partec) and
accordingly, the assets and liabilities were recorded at their historical cost
basis by means of an "as if" pooling and Partec is being presented as a
predecessor company. Consequently, these financial statements include the
activities performed in previous periods by Partec by aggregating the relevant
historical financial information with the financial statements of the Company as
if they had formed a discrete operation under common management for the entire
development stage.
The Company owns a 100% interest in Keryx (Israel) Ltd., organized in Israel,
Keryx Biomedical Technologies Ltd., organized in Israel, and Keryx Securities
Corp., a U.S. corporation incorporated in the Commonwealth of Massachusetts.
In March 2003, the Company gave notice of termination to employees in its
Jerusalem, Israel laboratory facility. As a result of such terminations, the
Company has indicated its intention to cease its research and development
activities in Israel and further decrease its administrative activities in its
Jerusalem facility. Substantially all of the biopharmaceutical development and
administrative activities during the quarter were conducted in the United
States, and therefore, the Company has one geographical segment. The majority of
the Company's fixed assets are still held in Israel, although the Company
intends to either sell or dispose of these assets.
The accompanying unaudited interim consolidated financial statements were
prepared in accordance with the instructions for Form 10-Q and, therefore, do
not include all disclosures necessary for a complete presentation of financial
condition, results of operations, and cash flows in conformity with generally
accepted accounting principles. All adjustments which are, in the opinion of
management, of a normal recurring nature and are necessary for a fair
presentation of the interim financial statements have been included.
Nevertheless, these financial statements should be read in conjunction with the
Company's audited financial statements contained in its Annual Report on Form
10-K for the year ended December 31, 2002. The results of operations for
7
the period ended March 31, 2003 are not necessarily indicative of the results
that may be expected for the entire fiscal year or any other interim period.
The Company has not had revenues from its planned principal operations and is
dependent upon significant financing to fund the working capital necessary to
execute its business plan. If the Company determines to seek additional funding,
there can be no assurance that the Company will be able to obtain any such
funding on terms that are acceptable to it, if at all.
STOCK - BASED COMPENSATION
The Company applies the intrinsic value-based method of accounting prescribed by
the Accounting Principles Board ("APB") Opinion No. 25, "Accounting for Stock
Issued to Employees," and related interpretations, to account for stock option
plans for employees and directors, as allowed by Statement of Financial
Accounting Standards ("SFAS") No. 123, "Accounting for Stock-based Compensation"
(SFAS No. 123). As such, compensation expense would be recorded on the
measurement date only if current market price of the underlying stock exceeded
the exercise price. SFAS No. 123 is applied to stock options and warrants
granted to other than employees and directors. The Company has adopted the
disclosure requirements of SFAS No. 123 and SFAS No. 148 for awards to its
directors and employees.
Had the compensation expenses for stock options granted under the Company's
stock option plans been determined based on fair value at the grant dates
consistent with the method of SFAS No. 123, the Company's net income and
earnings per share would have been reduced to the pro forma amount below:
Amounts
Accumulated
For the three months ended March 31, During the
------------------------------------- Development
2003 2002 Stage
----------- ----------- -----------
(Unaudited) (Unaudited) (Unaudited)
----------- ----------- -----------
Net loss, as reported $(3,788) $(3,543) $(49,290)
Add: Stock-based compensation expense
to employees and directors
determined under the intrinsic value-
based method, as included in reported net
loss, net of related tax effects 3 5 8,963
Deduct: Total stock-based compensation expense
to employees and directors
determined under fair value-based
method for all awards, net of
related tax effects (719) (338) (11,762)
------- ------- --------
Pro forma net loss $(4,564) $(3,876) $(52,089)
Losses per common share,
Basic and diluted:
As reported $ (0.19) $ (0.18) $ (3.76)
Pro forma $ (0.22) $ (0.19) $ (3.98)
LOSS PER SHARE
Basic net loss per share is computed by dividing the losses allocable to common
stockholders by the weighted average number of common shares outstanding for the
period. Diluted net loss per share does not reflect the effect of 4,384,715
common shares to be issued upon exercise of stock options and warrants, as their
inclusion would be anti-dilutive.
8
NOTE 2 - STOCKHOLDERS' EQUITY
The compensation committee of the Company's board of directors did not grant,
during the three months ended March 31, 2003, options to purchase any shares of
the Company's common stock to any of its employees, directors or consultants. In
addition, options for the purchase of 259,456 shares of the Company's common
stock were forfeited and options for the purchase of 210,000 shares of the
Company's common stock were exercised during the three months ended March 31,
2003.
The Company did not repurchase any shares of its common stock during the three
months ended March 31, 2003 pursuant to the stock repurchase program approved by
its board of directors in November 2002. Under its stock repurchase program the
Company was authorized to repurchase up to 2,453,700 additional Keryx shares as
of March 31, 2003.
NOTE 3 - INCOME TAXES
In September 2001, one of the Company's Israeli subsidiaries received the status
of an "Approved Enterprise" which grants certain tax benefits in Israel in
accordance with the "Law for the Encouragement of Capital Investments, 1959". In
June 2002, the subsidiary received formal temporary notification that it had met
the requirements for implementation of the benefits under this program.
Under its Approved Enterprise status, the subsidiary must maintain certain
conditions and submit periodic reports. Failure to comply with the conditions of
the Approved Enterprise status could cause the subsidiary to lose previously
accumulated tax benefits. Through March 31, 2003, our subsidiary has received
tax benefits of approximately $731,000. As a result of the restructuring
implemented in 2002, the staff and activity of this subsidiary were materially
reduced. In January 2003, the subsidiary notified the Israeli governmental
authority of such reductions and requested that the program instituted prior to
the cost reductions be approved. In February 2003, the Israeli governmental
authority informed the subsidiary that it may be in non-compliance with the
conditions of its Approved Enterprise program because of the indicated
reductions. As part of the restructuring implemented during the first quarter of
2003, as described in Note 4, the Company has decided to close down its
Jerusalem laboratory facility operated by the subsidiary. The subsidiary is
currently undergoing discussions with the Israeli governmental authority and at
this point, it is uncertain as to whether or not any past benefits will need to
be repaid. Accordingly, the Company has not recorded any charge with respect to
this potential liability.
NOTE 4 - RESTRUCTURING
2003 Restructuring
In March 2003, the Company gave notice of termination to four employees, all
based in its Jerusalem laboratory facility, and, in addition, the Company has
indicated its intention to cease its research and development activities and
further decrease its administrative activities in its Jerusalem facility (the
"current restructuring").
As a result of these actions, the Company reevaluated its long-lived assets in
accordance with SFAS No. 144, "Accounting for the Impairment or Disposal of
Long-Lived Assets," and took a non-cash impairment charge of approximately
$2,295,000, all of which was included in research and development expenses. The
impairment charge included a write-off of approximately $1,509,000 in fixed
assets and approximately $786,000 in other investments relating to intangible
assets.
9
The current restructuring included a four person, or approximately 18%,
reduction in the Company's work force. All of such persons were research
personnel involved in early stage projects. As of March 31, 2003, none of the
employees terminated under the current restructuring had left the Company, since
their final date of employment was subsequent to March 31, 2003.
Through March 31, 2003, the Company had total accumulated expenses of
approximately $35,000 for severance benefits for employees terminated under the
current restructuring, all of which had been previously expensed as part of the
Company's ongoing accrual for employee severance benefits in accordance with
Israeli law.
No severance benefits were paid during the period, because no employees have
left the Company under the current restructuring as of March 31, 2003, since
their final date of employment was subsequent to March 31, 2003.
As of March 31, 2003, approximately $35,000 in severance obligations related to
the current restructuring is included in accrued compensation and related
liabilities. A portion of this amount was formerly included in liability in
respect of employee severance obligations and was reclassified to current
liabilities after it became short-term in nature. With respect to this
liability, the Company had funded deposits in respect of employee severance
obligations of approximately $31,000 that were reclassified to current assets,
as they will be redeemed in the short-term. In addition, as a result of the
current restructuring, the Company reclassified its liability in respect of
employee severance obligations to a current liability and similarly reclassified
its deposits in respect of employee severance obligations to current assets.
The Company may also incur other costs related to the current restructuring of
its Jerusalem-based activities. (See Note 3 with regard to potential liability
in respect of tax benefits received by a subsidiary of the Company as an
Approved Enterprise.).
In addition, the Company intends to further reduce its remaining activities in
its Jerusalem facility. The Company believes that these reductions, which will
include further personnel reductions and sales of fixed assets, will likely
require an asset impairment charge during the second and/or third quarters of
2003, although the amount of this impairment charge and other costs associated
with the further curtailment of its activities in its Jerusalem facility cannot
be determined at this time. The carrying value of the assets that could be
impaired, thus resulting in a non-cash write down, including fixed assets,
totals approximately $776,000. The Company may also incur other costs relating
to the further reduction of its Jerusalem-based activities. The portion of the
Company's lease obligations relating to its Jerusalem facility amounts to
approximately $1,052,000 through the end of 2005. Costs of severance benefits
for the employees who are likely to receive notice of termination as part of
this further reduction are accrued to the balance sheet date as part of the
liability in respect of employee severance benefits in accordance with Israeli
law.
2002 Restructuring
In 2002, the Company implemented a strategic reorganization (the "2002
restructuring"). The 2002 restructuring was designed to substantially reduce
early stage research expenditures so that the Company could focus primarily on
the development of its lead product candidate KRX-101 for the treatment of
diabetic nephropathy and on the acquisition of additional clinical stage
compounds. The 2002 restructuring included a 46 person, or approximate 70%,
reduction in the Company's work force, including senior management,
administrative staff, and research personnel involved in early stage projects.
As of March 31, 2003, 45 employees had left under the 2002 restructuring.
10
Through March 31, 2003, the Company had total accumulated expenses of
approximately $1,118,000 for severance benefits for employees terminated under
the 2002 restructuring, almost all of which had been expensed in prior periods.
As of March 31, 2003, 45 employees have left the Company under 2002
restructuring and approximately $389,000 of severance benefits have been paid.
As of March 31, 2003, approximately $729,000 in severance obligations related to
the 2002 restructuring is included in accrued compensation and related
liabilities. With respect to this liability, the Company had funded deposits in
respect to employee severance obligations of approximately $200,000.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion should be read in conjunction with the unaudited,
consolidated financial statements and the related footnotes thereto, appearing
elsewhere in this report.
OVERVIEW
We are a biopharmaceutical company focused on the acquisition, development and
commercialization of novel pharmaceutical products for the treatment of serious,
life-threatening diseases, including diabetes and cancer.
In the second half of 2002 and March of 2003, we undertook corporate
restructurings that have resulted in the reduction of staff and a re-focus of
our efforts primarily on the development of our lead compound, KRX-101, which
has completed a Phase 2 trial, and on the acquisition of additional late stage
clinical compounds. For a further discussion of these restructurings, see "-
Restructuring" below.
Our lead compound under development is sulodexide, or KRX-101, to which we have
an exclusive license in North America, Japan and other markets. In 2001, KRX-101
was granted Fast-Track designation for the treatment of diabetic nephropathy
and, in 2002, we announced that the FDA had agreed, in principle, to permit us
to avail ourselves of the accelerated approval process under subpart H of the
FDA's regulations governing applications for the approval to market a new drug.
To date, we have not received approval for the sale of any of our drug
candidates in any market.
We were incorporated as a Delaware corporation in October 1998. We commenced
operations in November 1999, following our acquisition of substantially all of
the assets and certain of the liabilities of Partec Ltd., our predecessor
company that began its operations in January 1997. Since commencing operations,
our activities have been primarily devoted to developing our technologies and
drug candidates, raising capital, purchasing assets for our corporate offices
and laboratory facilities and recruiting personnel. We are a development stage
company and have no product sales to date. Our major sources of working capital
have been proceeds from various private placements of equity securities and from
our initial public offering. We have two wholly owned operating subsidiaries,
Keryx Biomedical Technologies Ltd. and Keryx (Israel) Ltd., which have
historically engaged in research and development activities and administrative
activities in Israel. For a further discussion of our current research,
development and administrative activities in Israel, see "2003 Restructuring"
and "2002 Restructuring" below.
Research and development expenses consist primarily of salaries and related
personnel costs, fees paid to consultants and outside service providers for
11
laboratory development, facilities-related and other expenses relating to the
design, development, testing, and enhancement of our product candidates, as well
as expenses related to in-licensing or acquisition of new product candidates. We
expense our research and development costs as they are incurred.
General and administrative expenses consist primarily of salaries and related
expenses for executive, finance and other administrative personnel, recruitment
expenses, professional fees and other corporate expenses, including business
development, general legal activities and facilities related expenses.
Our results of operations include non-cash compensation expense as a result of
the grants of stock, stock options and warrants. We account for stock-based
employee and director compensation arrangements in accordance with the
provisions of Accounting Principles Board Opinion No. 25, "Accounting for Stock
Issued to Employees," and FASB issued Interpretation No. 44, "Accounting for
Certain Transactions Involving Stock Compensation," as allowed by Statement of
Financial Accounting Standards No. 123, "Accounting for Stock-Based
Compensation" (SFAS No. 123), and comply with the disclosure provisions of SFAS
No. 123 and SFAS No. 148. Compensation expense for options and warrants granted
to employees and directors represents the intrinsic value (the difference
between the stock price of the common stock and the exercise price of the
options or warrants) of the options and warrants at the date of grant, as well
as the difference between the stock price at reporting date and the exercise
price, in the case where a measurement date has not been reached. Compensation
for options and warrants granted to consultants and other third-parties has been
determined in accordance with SFAS No. 123, as the fair value of the equity
instruments issued, and according to the guidelines set forth in EITF 96-18,
"Accounting for Equity Instruments that are Issued to Other than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services." The compensation
cost is recorded over the respective vesting periods of the individual stock
options and warrants. The expense is included in the respective categories of
expense in the statement of operations. We expect to record additional non-cash
compensation expense in the future, which may be significant. However, because
some of the options and warrants issued to employees, consultants and other
third-parties either do not vest immediately or vest upon the achievement of
certain milestones, the total expense is uncertain.
We have incurred negative cash flow from operations since our inception. We
anticipate incurring negative cash flow from operations for the foreseeable
future. We have spent, and expect to continue to spend, substantial amounts in
connection with implementing our business strategy, including our planned
product development efforts and our clinical trials.
STOCK REPURCHASE PROGRAM
In November 2002, our board of directors authorized a stock repurchase program
of up to 2.5 million shares of our common stock. Purchases under the stock
repurchase program may be made in the open market or in private transactions
from time to time. The stock repurchase program is being funded using our
working capital. We did not repurchase any shares of our common stock during the
three months ended March 31, 2003 pursuant to the stock repurchase program.
Under the stock repurchase program, up to 2,453,700 shares of our common stock
remain available for repurchase as of March 31, 2003.
CRITICAL ACCOUNTING POLICIES
The discussion and analysis of our financial condition and results of operations
are based upon our consolidated financial statements, which have been prepared
in accordance with accounting principles generally accepted in the United
States. The preparation of these financial statements requires us
12
to make estimates and judgments that affect the reported amount of assets and
liabilities and related disclosure of contingent assets and liabilities at the
date of our financial statements and the reported amounts of revenues and
expenses during the applicable period. Actual results may differ from these
estimates under different assumptions or conditions.
We define critical accounting policies as those that are reflective of
significant judgments and uncertainties, and may potentially result in
materially different results under different assumptions and conditions. In
applying these critical accounting policies, our management uses its judgment to
determine the appropriate assumptions to be used in making certain estimates.
These estimates are subject to an inherent degree of uncertainty. Our critical
accounting policies include the following:
Foreign Currency Translation. In preparing our consolidated financial
statements, we translate non-US dollar amounts in the financial statements of
our Israeli subsidiaries into US dollars. Under the relevant accounting guidance
the treatment of any gains or losses resulting from this translation is
dependent upon management's determination of the functional currency. The
functional currency is determined based on management's judgment and involves
consideration of all relevant economic facts and circumstances affecting the
subsidiaries. Generally, the currency in which a subsidiary transacts a majority
of its transactions, including billings, financing, payroll and other
expenditures would be considered the functional currency. However, any
dependency upon the parent and the nature of the subsidiary's operations must
also be considered. If any subsidiary's functional currency is deemed to be the
local currency, then any gain or loss associated with the translation of that
subsidiary's financial statements would be included as a separate part of our
stockholders' equity under the caption "cumulative translation adjustment."
However, if the functional currency of the subsidiary is deemed to be the US
dollar then any gain or loss associated with the translation of these financial
statements would be included within our statement of operations. Based on our
assessment of the factors discussed above, we consider the US dollar to be the
functional currency for each of our Israeli subsidiaries because the majority of
the transactions of each subsidiary, including billings, payroll, taxes and
other major obligations, are conducted using the US dollar. Therefore all gains
and losses from translations are recorded in our statement of operations. Had we
used the Israeli currency as the functional currency of our subsidiaries,
exchange gains and losses would have been treated as a component of
stockholders' equity, as other comprehensive income, included in a statement of
comprehensive income. We believe that the amount of such comprehensive income
for the three months ended March 31, 2003 would not have been material.
Accounting For Income Taxes. As part of the process of preparing our
consolidated financial statements we are required to estimate our income taxes
in each of the jurisdictions in which we operate. This process involves
management estimating our actual current tax exposure together with assessing
temporary differences resulting from differing treatment of items for tax and
accounting purposes. These differences result in deferred tax assets and
liabilities, which are included within our consolidated balance sheet. We must
then assess the likelihood that our deferred tax assets will be recovered from
future taxable income and, to the extent we believe that recovery is not likely,
we must establish a valuation allowance. To the extent we establish a valuation
allowance or increase this allowance in a period, we must include an expense
within the tax provision in the statement of operations. Significant management
judgment is required in determining our provision for income taxes, our deferred
tax assets and liabilities and any valuation allowance recorded against our net
deferred tax assets. We have fully offset our US deferred tax asset with a
valuation allowance. Our lack of earnings history and the uncertainty
surrounding our ability to generate taxable income prior to the expiration of
such deferred tax assets were the primary factors considered by management in
establishing the valuation allowance. The deferred tax asset in
13
our financial statements for the comparative period relates to our wholly owned
Israeli subsidiaries. These subsidiaries have generated taxable income in
respect of services provided within the group, and therefore we believed in the
past that the deferred tax asset relating to the Israeli subsidiaries would be
realized. It should be noted that as the income has been derived from companies
within the consolidated group, it had been eliminated upon consolidation. During
the quarter, we decided to cease our research and development activities in
Israel and further decrease our administrative activities in our Jerusalem
facility. In addition, since the Israeli subsidiaries are no longer expected to
generate income, we do not believe that the deferred tax asset will be realized.
We therefore have decided to record a valuation allowance against the deferred
tax asset, resulting in an expense in the statement of operations for the three
months ended March 31, 2003.
In September 2001, one of our Israeli subsidiaries received the status of an
"Approved Enterprise" which grants certain tax benefits in Israel in accordance
with the "Law for the Encouragement of Capital Investments, 1959". Through March
31, 2003, this Israeli subsidiary will have received tax benefits of
approximately $731,000 as a result of the subsidiary's status as an "Approved
Enterprise." In June 2002, the subsidiary received formal temporary notification
that it had met the requirements for implementation of the benefits under this
program. In January 2003, the subsidiary notified the Israeli governmental
authority of reductions in its staff and operations that had formed the basis of
its Approved Enterprise program, and requested that the program instituted prior
to the cost reductions be approved. In February 2003, the Israeli governmental
authority informed this subsidiary that it may be in non-compliance with the
conditions of its Approved Enterprise program because of the indicated
reductions. As part of the restructuring implemented during the first quarter of
2003, as described below, we decided to close down our Jerusalem laboratory
facility. Our subsidiary is currently undergoing discussions with the Israeli
governmental authority and at this point we are uncertain as to whether or not
any of the past benefits will need to be repaid. Accordingly, we have not
recorded any charge with respect to this potential liability.
Stock Compensation. During historical periods, we have granted options to
employees, directors and consultants, as well as warrants to other third
parties. In applying SFAS No. 123, we use the Black-Scholes pricing model to
calculate the fair market value of our options and warrants. The Black-Scholes
model takes into account volatility in the price of our stock, the risk-free
interest rate, the estimated life of the option or warrant, the closing market
price of our stock and the exercise price. We have assumed for the purposes of
the Black-Scholes calculation that an option will be exercised one year after it
fully vests. We base our estimates of our stock price volatility on the
volatility during the year prior to the grant of the option or warrant. However,
this estimate is neither predictive nor indicative of the future performance of
our stock. For purposes of the calculation, it was assumed that no dividends
will be paid during the life of the options and warrants.
In accordance with EITF 96-18, "Accounting for Equity Instruments that are
Issued to Other than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services," total compensation expense for options issued to consultants
is determined at the "measurement date." The expense is recognized over the
vesting period for the options. Until the measurement date is reached, the total
amount of compensation expense remains uncertain. We record option compensation
based on the fair value of the options at the reporting date. These options are
then revalued, or the total compensation is recalculated based on the then
current fair value, at each subsequent reporting date. This results in a change
to the amount previously recorded in respect of the option grant and additional
expense or a negative expense may be recorded in subsequent periods based on
changes in the assumptions used to calculate fair value, such as changes in
market price, until the measurement date is reached and the compensation expense
is determined.
14
Impairment Of Long-Lived Assets And Long-Lived Assets To Be Disposed Of. We have
adopted SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived
Assets" (SFAS No. 144) from January 1, 2002. This Statement requires that
long-lived assets be 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 future cash flows expected to
be generated by the asset or used in its disposal. If the carrying amount of an
asset exceeds its estimated future cash flows, an impairment charge is
recognized. Assets to be disposed of are reported at the lower of the carrying
amount or fair value less costs to sell. We have conducted such a review in
light of our restructuring in 2003. Our review included estimating each drug
candidate's chance of continued development, partnering and FDA approval, its
estimated market size and share, and potential royalty rate. We believe, based
upon this review of our future net cash flow estimates for each of drug
candidates and the decision to close our laboratory facility in Jerusalem, that
an impairment charge should be recorded for the quarter ended March 31, 2003.
Any changes in any of these estimates could affect the need to record an
impairment charge or the amount of the charge thereof. See "- Restructuring"
below.
RESTRUCTURING
2003 Restructuring
In March 2003, we gave notice of termination to four employees, all based in our
Jerusalem laboratory facility, and, in addition, we indicated our intention to
cease our research and development activities and further decrease our
administrative activities in our Jerusalem facility (the "current
restructuring").
As a result of these actions, we reevaluated our long-lived assets in accordance
with SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived
Assets," and took a non-cash impairment charge of $2,295,000, all of which was
included in research and development expenses. The impairment charge included a
write-off of $1,509,000 in fixed assets and approximately $786,000 in other
investments relating to intangible assets.
The current restructuring included a four person, or approximately 18%,
reduction in our work force. All of such persons were research personnel
involved in early stage projects. As of March 31, 2003, none of the employees
terminated under our current restructuring had left us, since their final date
of employment was subsequent to March 31, 2003.
Through March 31, 2003, we had total accumulated expenses of $35,000 for
severance benefits for employees terminated under our current restructuring, all
of which had been previously expensed as part of our ongoing accrual for
employee severance benefits in accordance with Israeli law.
No severance benefits were paid during the period, because no employees have
left us under our current restructuring as of March 31, 2003, since their final
date of employment was subsequent to March 31, 2003.
As of March 31, 2003, $35,000 in severance obligations related to the current
restructuring is included in accrued compensation and related liabilities. A
portion of this amount was formerly included in liability in respect of employee
severance obligations and was reclassified to current liabilities after it
became short-term in nature. With respect to this liability, we had funded
deposits in respect of employee severance obligations of $31,000 that were
reclassified to current assets, as they will be redeemed in the short-term. In
addition, as a result of the current restructuring, we reclassified our
liability in respect of employee severance obligations to a current
15
liability and similarly reclassified our deposits in respect of employee
severance obligations to current assets.
We may also incur other costs related to the current restructuring of our
Jerusalem-based activities, with regard to potential liability in respect of tax
benefits received by our subsidiary as an Approved Enterprise.
In addition, we intend to further reduce our remaining activities in our
Jerusalem facility. We believe that these reductions, which are expected to
include further personnel reductions and sales of fixed assets, will likely
require an asset impairment charge during the second and/or third quarters of
2003, although the amount of this impairment charge and other costs associated
with the further curtailment of our activities in our Jerusalem facility cannot
be determined at this time. The carrying value of the assets that could be
impaired, thus resulting in a non-cash write down, including fixed assets,
totals approximately $776,000. We may also incur other costs relating to the
further reduction of our Jerusalem-based activities. For example, the portion of
our lease obligations relating to our Jerusalem facility amounts to
approximately $1,052,000 through the end of 2005. Costs of severance benefits
for the employees who are expected to receive notice of termination as part of
this further reduction are accrued to the balance sheet date as part of the
liability in respect of employee severance benefits in accordance with Israeli
law.
2002 Restructuring
In the second half of 2002, we implemented a strategic reorganization (the "2002
restructuring"). The 2002 restructuring was designed to substantially reduce
early stage research expenditures so that we could focus primarily on the
development of our lead product candidate KRX-101 for the treatment of diabetic
nephropathy and on the acquisition of additional clinical stage compounds. The
2002 restructuring included a 46 person, or approximate 70%, reduction in the
Company's work force, including senior management, administrative staff, and
research personnel involved in early stage projects. As of March 31, 2003, 45
employees had left under the 2002 restructuring.
Through March 31, 2003, we had total accumulated expenses of $1,118,000 for
severance benefits for employees terminated under our 2002 restructuring, almost
all of which had been expensed in prior periods.
As of March 31, 2003, 45 employees have left us under the 2002 restructuring and
$389,000 of severance benefits have been paid.
As of March 31, 2003, $729,000 in severance obligations related to the 2002
restructuring is included in accrued compensation and related liabilities. With
respect to this liability, we had funded deposits in respect to employee
severance obligations of $200,000.
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2003 COMPARED TO THE THREE MONTHS ENDED MARCH 31,
2002
Revenue. We did not have any revenue for the three months ended March 31, 2003
and March 31, 2002.
Research and Development Expenses. Research and development expenses, including
non-cash compensation expense related to stock option grants and warrant
issuances, increased by $742,000 to $3,105,000 for the three months ended March
31, 2003, as compared to expenses of $2,363,000 for the three months ended March
31, 2002. The increase in research and development expenses
16
was due primarily to the non-cash impairment charge associated with our decision
to cease our Jerusalem laboratory activities, as described above. These
increases were partially offset by a decline in early stage research and
development expenditures as a result of the 2002 restructuring.
We expect our research and development costs to decrease for the remainder of
2003 as the result of the implementation of the current and 2002 restructurings.
Non-cash compensation expense related to stock option grants and warrant
issuances was negative $266,000 for the three months ended March 31, 2003 as
compared to negative $580,000 for the three months ended March 31, 2002. This
negative non-cash compensation expense was primarily due to the revaluation of
previously issued options and warrants to consultants and other third parties as
a result of the decline in our stock price pursuant to the provisions of SFAS
No. 123 and EITF 96-18.
General and Administrative Expenses. General and administrative expenses,
including non-cash compensation expense related to stock option grants and
warrant issuances, decreased by $638,000 to $666,000 for the three months ended
March 31, 2003, as compared to expenses of $1,304,000 for the three months ended
March 31, 2002. The decrease in general and administrative expenses was due
primarily to reduced personnel and related costs associated with the 2002
restructuring.
We expect our general and administrative costs to decrease for the remainder of
2003 as the result of the implementation of the current and 2002 restructurings.
Non-cash compensation expense related to stock option grants was $2,000 for the
three months ended March 31, 2003 as compared to negative $6,000 for the three
months ended March 31, 2002.
Interest Income (Expense), Net. Interest income, net, decreased by $89,000 to
$85,000 for the three months ended March 31, 2003, as compared to income of
$174,000 for the three months ended March 31, 2002. The decrease resulted from a
lower level of invested funds and the general decline in market interest rates
when compared to the comparable period last year.
Income Taxes. Income tax expense increased by $52,000 to $102,000 for the three
months ended March 31, 2003, as compared to an expense of $50,000 for three
months ended March 31, 2002. The increase in income tax expense was primarily
due to the creation of a valuation allowance against the deferred tax asset and
the deferred tax liability of our Israeli subsidiaries, associated with the
cessation of our research and development activities and further decrease in
administrative activities in our Jerusalem facility. Income tax expense for the
comparative period is attributable to taxable income from the continuing
operations of our subsidiaries in Israel. This income is eliminated upon
consolidation of our financial statements.
Impact of Inflation. The effects of inflation and changing prices on our
operations were not significant during the periods presented.
LIQUIDITY AND CAPITAL RESOURCES
We have financed our operations from inception primarily through various private
and public financings. As of March 31, 2003, we had received net proceeds of
$46.3 million from our initial public offering, and $11.6 million from private
placement issuances of common and preferred stock, including $2.9 million raised
through the contribution by holders of their notes issued by our predecessor
company.
17
As of March 31, 2003, we had $22.4 million in cash, cash equivalents, interest
receivable and short-term securities, a decrease of $1.7 million from December
31, 2002. Cash used in operating activities for the three months ended March 31,
2003 was $1.6 million as compared to $3.4 million for the three months ended
March 31, 2002. This decrease in cash used in operating activities was due
primarily to reduced early stage research activities and associated personnel
and general and administrative expenses. For the three months ended March 31,
2003, net cash provided by investing activities of $7.8 million was primarily
the result of the maturity of short-term securities.
As of March 31, 2003, we have known contractual obligations, commitments and
contingencies of $1,444,000. Of this amount, $218,000 relates to research and
development agreements, all of which is due within the next year, and $48,000
relates to other agreements due within the next year. The additional $1,178,000
relates to operating lease obligations, of which $506,000 is due within the next
year, with the remaining $672,000 due within one to three years.
- -----------------------------------------------------------------------------------------------------------------------
Payments Due By Period
- -----------------------------------------------------------------------------------------------------------------------
Contractual Obligations Total Less than 1 Year 1-3 Years 4-5 Years After 5 Years
- -----------------------------------------------------------------------------------------------------------------------
Research and Development Agreements $ 218,000 $218,000 -- -- --
- -----------------------------------------------------------------------------------------------------------------------
Operating Leases 1,178,000 506,000 672,000 -- --
- -----------------------------------------------------------------------------------------------------------------------
Other Agreements 48,000 48,000 -- -- --
- -----------------------------------------------------------------------------------------------------------------------
Total Contractual Cash Obligations $1,444,000 $772,000 $672,000 -- --
- -----------------------------------------------------------------------------------------------------------------------
Additionally, we have undertaken to make contingent milestone payments to
certain of our licensors of up to approximately $5.0 million over the life of
the licenses, which expire from 2017 to 2023. In certain cases, such payments
will reduce any royalties due on sales of related products. In the event that
the milestones are not achieved, we remain obligated to pay one licensor $50,000
annually until the license expires.
We believe that our $22.4 million in cash, cash equivalents, interest receivable
and short-term securities as of March 31, 2003 will be sufficient to enable us
to meet our planned operating needs and capital expenditures for at least the
next 24 months. Our cash and cash equivalents as of March 31, 2003 are invested
in highly liquid investments such as cash, money market accounts and short-term
US corporate debt securities. As of March 31, 2003, we are unaware of any known
trends or any known demands, commitments, events, or uncertainties that will, or
that are reasonably likely to, result in a material increase or decrease in our
required liquidity. We expect that our liquidity needs throughout 2003 will
continue to be funded from existing cash, cash equivalents, and short-term
securities.
Our forecast of the period of time through which our cash, cash equivalents and
short-term securities will be adequate to support our operations is a
forward-looking statement that involves risks and uncertainties. The actual
amount of funds we will need to operate is subject to many factors, some of
which are beyond our control.
These factors include the following:
18
o the timing of expenses associated with product development of our
proprietary product candidates, especially KRX-101, and including
those expected to be in-licensed, partnered or acquired;
o the timing of the in-licensing, partnering and acquisition of new
product opportunities;
o the progress of the development efforts of parties with whom we have
entered or intend to enter into research and development agreements;
o our ability to achieve our milestones under licensing arrangements;
o the costs involved in prosecuting and enforcing patent claims and
other intellectual property rights; and
o the amount of any funds expended to repurchase our common stock.
We have based our estimate on assumptions that may prove to be wrong. We may
need to obtain additional funds sooner or in greater amounts than we currently
anticipate. Potential sources of financing include strategic relationships,
public or private sales of our stock or debt and other sources. We may seek to
access the public or private equity markets when conditions are favorable due to
our long-term capital requirements. We do not have any committed sources of
financing at this time, and it is uncertain whether additional funding will be
available when we need it on terms that will be acceptable to us, or at all. If
we raise funds by selling additional shares of common stock or other securities
convertible into common stock, the ownership interest of our existing
stockholders will be diluted. If we are not able to obtain financing when
needed, we may be unable to carry out our business plan. As a result, we may
have to significantly limit our operations and our business, financial condition
and results of operations would be materially harmed.
RISK FACTORS THAT MAY AFFECT RESULTS
This Quarterly Report on Form 10-Q contains forward-looking statements,
including statements about our future operating results, our drug development
programs and potential strategic alliances. For this purpose, any statement that
is not a statement of historical fact should be considered a forward-looking
statement. We often use the words "believe," "anticipate," "plan," "expect,"
"intend" and similar expressions to help identify forward-looking statements.
There are a number of important factors that could cause our actual results to
differ materially from those indicated or implied by forward-looking statements.
Factors that could cause or contribute to such differences include those
discussed below, as well as those discussed elsewhere in this Form 10-Q. We
disclaim any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
RISKS RELATED TO OUR BUSINESS
WE HAVE A LIMITED OPERATING HISTORY AND HAVE INCURRED SUBSTANTIAL OPERATING
LOSSES SINCE OUR INCEPTION. WE EXPECT TO CONTINUE TO INCUR LOSSES IN THE FUTURE
AND MAY NEVER BECOME PROFITABLE.
We have a limited operating history. You should consider our prospects in light
of the risks and difficulties frequently encountered by early stage companies.
In addition, we have incurred operating losses since our inception, expect to
continue to incur operating losses for the foreseeable future and may never
become profitable. As of March 31, 2003, we had an accumulated deficit of
approximately $49.3 million. As we expand our
19
development efforts, we will incur increasing losses. We may continue to incur
substantial operating losses even if we begin to generate revenues from our drug
candidates or technologies.
We have not yet commercialized any products or technologies and cannot be sure
we will ever be able to do so. Even if we commercialize one or more of our drug
candidates or technologies we may not become profitable. Our ability to achieve
profitability depends on a number of factors, including our ability to complete
our development efforts, obtain regulatory approval for our drug candidates and
successfully commercialize our drug candidates and technologies.
IF WE ARE UNABLE TO SUCCESSFULLY BEGIN OR COMPLETE OUR CLINICAL TRIALS OF
KRX-101, OUR ABILITY TO ACHIEVE OUR CURRENT BUSINESS STRATEGY WILL BE ADVERSELY
AFFECTED.
Whether or not and how quickly we complete clinical trials is dependent in part
upon the rate at which we are able to engage clinical trial sites and,
thereafter, the rate of enrollment of patients. Patient enrollment is a function
of many factors, including the size of the patient population, the proximity of
patients to clinical sites, the eligibility criteria for the study and the
existence of competitive clinical trials. If we experience delays in identifying
and contracting with sites and/or in patient enrollment in our clinical trial
program, we may incur additional costs and delay our development program for
KRX-101.
Additionally, we have submitted a subpart H clinical development plan to the FDA
for the clinical development of KRX-101 for diabetic nephropathy. A final
agreement on the specifics of our clinical program for that development plan has
not been agreed to with the FDA and we cannot give any assurance that an
acceptable final agreement on the specifics of such clinical program will ever
be reached with the FDA. In fact, based on the FDA's comments to our most recent
submission, we believe that additional discussions with the FDA will be required
prior to final agreement on the specifics of our subpart H accelerated approval
clinical program. We cannot assure you that those discussions will take place
or, if they do take place, the timing of such discussions, or that the results
of such discussions will be satisfactory to us. Additionally, the FDA has stated
that based on the novelty of the approach that we have discussed with them, they
would want to refer our proposed approach to the Cardio-Renal Advisory
Committee.
Moreover, even if we are able to reach final agreement with the FDA regarding
the specifics of an accelerated approval approach, no assurance can be given
that we will be able to meet the requirements set forth in such agreement. The
subpart H process is complex and requires flawless execution. Many companies who
have been granted the right to utilize an accelerated approval approach have
failed to obtain approval. The clinical timeline, scope and consequent cost for
the development of KRX-101 will depend, in part, on the final outcome of our
discussions with the FDA. Moreover, negative or inconclusive results from the
clinical trials we hope to conduct or adverse medical events could cause us to
have to repeat or terminate the clinical trials. Accordingly, we may not be able
to complete the clinical trials within an acceptable time frame, if at all.
OUR DRUG CANDIDATES ARE IN EARLY STAGES OF DEVELOPMENT AND MAY NEVER RECEIVE THE
NECESSARY REGULATORY APPROVALS.
Our drug candidates are in early stages of development. We have not received,
and may never receive, regulatory approval for clinical trials for any of our
drug candidates. We will need to conduct significant additional research and
human testing before we can apply for product approval with the FDA or with
regulatory authorities of other countries. Preclinical testing and clinical
development are long, expensive and uncertain processes. Satisfaction of
20
regulatory requirements typically depends on the nature, complexity and novelty
of the product and requires the expenditure of substantial resources. Data
obtained from preclinical and clinical tests can be interpreted in different
ways, which could delay, limit or prevent regulatory approval. It may take us
many years to complete the testing of our drug candidates and failure can occur
at any stage of this process. Negative or inconclusive results or medical events
during a clinical trial could cause us to delay or terminate our development
efforts.
Clinical trials also have a high risk of failure. A number of companies in the
pharmaceutical industry, including biotechnology companies, have suffered
significant setbacks in advanced clinical trials, even after achieving promising
results in earlier trials. If we experience delays in the testing or approval
process or if we need to perform more or larger clinical trials than originally
planned, our financial results and the commercial prospects for our drug
candidates may be materially impaired. In addition, we have limited experience
in conducting and managing the clinical trials necessary to obtain regulatory
approval in the United States and abroad and, accordingly, may encounter
unforeseen problems and delays in the approval process.
BECAUSE WE LICENSE OUR PROPRIETARY TECHNOLOGIES, TERMINATION OF THESE AGREEMENTS
WOULD PREVENT US FROM DEVELOPING OUR DRUG CANDIDATES.
We do not own KRX-101, our KinAce platform, or the SIB technology. We have
licensed these technologies from others. These license agreements require us to
meet development or financing milestones and impose development and
commercialization due diligence on us. In addition, under these agreements we
must pay royalties on sales of products resulting from licensed technologies and
pay the patent filing, prosecution and maintenance costs related to the
licenses. If we do not meet our obligations in a timely manner or if we
otherwise breach the terms of our agreements, our licensors could terminate the
agreements and we would lose the rights to KRX-101 and the KinAce and SIB
technologies.
BECAUSE OUR REVISED BUSINESS MODEL IS BASED, IN PART, ON THE ACQUISITION OR
IN-LICENSING OF ADDITIONAL CLINICAL PRODUCT CANDIDATES, IF WE FAIL TO ACQUIRE OR
IN-LICENSE SUCH CLINICAL PRODUCT CANDIDATES, OUR LONG TERM BUSINESS PROSPECTS
WILL BE SUBSTANTIALLY IMPAIRED.
As a major part of our business strategy, we plan to acquire or in-license
clinical stage product candidates. If we fail to acquire or in-license such
product candidates, we may not achieve expectations of our future performance.
Because we do not intend to engage in significant discovery research, we must
rely on third parties to sell or license new product opportunities to us. Other
companies, including some with substantially greater financial, development,
marketing and sales resources, are competing with us to acquire or in-license
such products or product candidates. We may not be able to acquire or in-license
rights to additional products or product candidates on acceptable terms, if at
all.
IF WE DO NOT ESTABLISH OR MAINTAIN DRUG DEVELOPMENT AND MARKETING ARRANGEMENTS
WITH THIRD PARTIES, WE MAY BE UNABLE TO COMMERCIALIZE OUR TECHNOLOGIES INTO
PRODUCTS.
We are an emerging company and do not possess all of the capabilities to fully
commercialize our product candidates on our own. From time to time, we may need
to contract with third parties to:
o assist us in developing, testing and obtaining regulatory approval
for and commercializing some of our compounds and technologies; and
21
o market and distribute our drug candidates.
For example, we are currently seeking third party partners to conduct further
preclinical development of the KinAce platform and other early stage programs.
There can be no assurance that we will be able to successfully enter into
agreements with such partners on terms that are acceptable to us. If we are
unable to successfully contract with third parties for these services when
needed, or if existing arrangements for these services are terminated, whether
or not through our actions, or if such third parties do not fully perform under
these arrangements, we may have to delay, scale back or end one or more of our
drug development programs or seek to develop or commercialize our technologies
independently, which could result in delays. Further, such failure could result
in the termination of license rights to one or more of our technologies.
Moreover, if these development or marketing agreements take the form of a
partnership or strategic alliance, such arrangements may provide our
collaborators with significant discretion in determining the efforts and
resources that they will apply to the development and commercialization of
products based on our technologies. Accordingly, to the extent that we rely on
third parties to research, develop or commercialize products based on our
technologies, we are unable to control whether such products will be
scientifically or commercially successful.
WE RELY ON THIRD PARTIES TO MANUFACTURE OUR PRODUCTS. IF THESE THIRD PARTIES DO
NOT SUCCESSFULLY MANUFACTURE OUR PRODUCTS OUR BUSINESS WILL BE HARMED.
We have no experience in manufacturing products for clinical or commercial
purposes and do not have any manufacturing facilities. We intend to use third
parties to manufacture our products for use in clinical trials and for future
sales. We may not be able to enter into third party contract manufacturing
agreements on acceptable terms, if at all.
Contract manufacturers often encounter difficulties in scaling up production,
including problems involving production yields, quality control and assurance,
shortage of qualified personnel, compliance with FDA and foreign regulations,
production costs and development of advanced manufacturing techniques and
process controls. Our third party manufacturers may not perform as agreed or may
not remain in the contract manufacturing business for the time required by us to
successfully produce and market our drug candidates. In addition, our contract
manufacturers will be subject to ongoing periodic, unannounced inspections by
the FDA and corresponding foreign governmental agencies to ensure strict
compliance with, among other things, current good manufacturing practices, in
addition to other governmental regulations and corresponding foreign standards.
We will not have control over, other than by contract, third party
manufacturers' compliance with these regulations and standards. Switching or
engaging multiple manufacturers may be difficult because the number of potential
manufacturers is limited and, particularly in the case of KRX-101, the process
by which multiple manufacturers make the drug substance must be identical at
each manufacturing facility. It may be difficult for us to find and engage
replacement or multiple manufacturers quickly and on terms acceptable to us if
at all. Moreover, if we need to change manufacturers, the FDA and corresponding
foreign regulatory agencies must approve these manufacturers in advance, which
will involve testing and additional inspections to ensure compliance with these
regulations and standards.
If third-party manufacturers fail to deliver the required quantities of our drug
candidates on a timely basis and at commercially reasonable prices, and if we
fail to find replacement or multiple manufacturers on acceptable terms, our
ability to develop and deliver products on a timely and competitive basis may be
adversely impacted and our business, financial condition or results of
operations will be materially harmed.
In the event that we are unable to obtain or retain third party manufacturers,
we will not be able to commercialize our products as planned. The manufacture
22
of our products for clinical trials and commercial purposes is subject to FDA
and foreign regulations. No assurance can be given that our third party
manufacturers will comply with these regulations or other regulatory
requirements now or in the future.
While we currently have a contract manufacturing relationship for KRX-101, we do
not believe that this relationship will be sufficient to meet our needs for
clinical and commercial supplies. Accordingly, we are currently seeking to
establish an alternative contract manufacturing relationship which we believe
will be adequate to satisfy our current clinical and commercial supply needs. As
we seek to transition our manufacturing of KRX-101 to a new contract
manufacturer, we will need to create a reproducible manufacturing process that
will ensure consistent manufacture of KRX-101 across multiple batches and
sources. As with all heparin-like compounds, the end product is highly sensitive
to the manufacturing process utilized. Slight changes in process will often
result in a different end product. Accordingly, the creation of a reproducible
process will be required for the successful commercialization of KRX-101. There
can be no assurance that we will be successful in this endeavor.
IF WE ARE NOT ABLE TO OBTAIN THE RAW MATERIAL REQUIRED FOR THE MANUFACTURE OF
OUR LEAD PRODUCT CANDIDATE, KRX-101, OUR ABILITY TO DEVELOP AND MARKET THIS
PRODUCT CANDIDATE WILL BE SUBSTANTIALLY HARMED.
Source materials for KRX-101, our lead product candidate, are derived from
porcine intestines. Long-term supplies for KRX-101 could be affected by
limitations in the supply of porcine intestines, over which we will have no
control. Additionally, diseases affecting the world supply of pigs could have an
actual or perceived negative impact on our ability, or the ability of our
contract manufacturers, to source, make and/or sell KRX-101. Such negative
impact could materially adversely affect the commercial success of KRX-101.
IF OUR COMPETITORS DEVELOP AND MARKET PRODUCTS THAT ARE MORE EFFECTIVE THAN
OURS, OUR COMMERCIAL OPPORTUNITY MAY BE REDUCED OR ELIMINATED.
Our commercial opportunity will be reduced or eliminated if our competitors
develop and market products that are more effective, have fewer side effects or
are less expensive than our drug candidates. Other companies have products or
drug candidates in various stages of preclinical or clinical development to
treat diseases for which we are seeking to discover and develop drug candidates.
Some of these potential competing drugs are further advanced in development than
our drug candidates and may be commercialized earlier. Even if we are successful
in developing effective drugs, our products may not compete successfully with
products produced by our competitors.
Our competitors include pharmaceutical companies and biotechnology companies, as
well as universities and public and private research institutions. In addition,
companies active in different but related fields represent substantial
competition for us. Many of our competitors have significantly greater capital
resources, larger research and development staffs and facilities and greater
experience in drug development, regulation, manufacturing and marketing than we
do. These organizations also compete with us to recruit qualified personnel,
attract partners for joint ventures or other collaborations, and license
technologies that are competitive with ours. As a result, our competitors may be
able to more easily develop technologies and products that would render our
technologies or our drug candidates obsolete or noncompetitive.
23
IF WE LOSE OUR KEY PERSONNEL OR ARE UNABLE TO ATTRACT AND RETAIN ADDITIONAL
PERSONNEL, OUR OPERATIONS COULD BE DISRUPTED AND OUR BUSINESS COULD BE HARMED.
Subsequent to the current and 2002 restructurings, we currently have 17 full and
part-time employees and several other persons working under research agreements
or consulting agreements. To successfully develop our drug candidates, we must
be able to attract and retain highly skilled personnel. In addition, if we lose
the services of our current personnel, in particular, Michael S. Weiss, our
Chairman and Chief Executive Officer, our ability to continue to develop our
lead drug candidates could be materially impaired. In addition, while we have
employment agreements with Mr. Weiss and our other key executives, these
agreements would not prevent any of them from terminating their employment with
us.
ANY ACQUISITIONS WE MAKE MAY NOT BE SCIENTIFICALLY OR COMMERCIALLY SUCCESSFUL.
As part of our business strategy, we may effect acquisitions to obtain
additional businesses, products, technologies, capabilities and personnel. If we
make one or more significant acquisitions in which the consideration includes
stock or other securities, your equity in us may be significantly diluted. If we
make one or more significant acquisitions in which the consideration includes
cash, we may be required to use a substantial portion of our available cash.
Acquisitions involve a number of operational risks, including:
o difficulty and expense of assimilating the operations, technology
and personnel of the acquired business;
o inability to retain the management, key personnel and other
employees of the acquired business;
o inability to maintain the acquired company's relationship with key
third parties, such as alliance partners;
o exposure to legal claims for activities of the acquired business
prior to acquisition;
o diversion of management attention; and
o potential impairment of substantial goodwill and write-off of
in-process research and development costs, adversely affecting our
reported results of operations.
RISKS RELATED TO OUR FINANCIAL CONDITION
IF WE ARE UNABLE TO OBTAIN ADDITIONAL FUNDS ON TERMS FAVORABLE TO US, OR AT ALL,
OUR BUSINESS WOULD BE HARMED.
We expect to use rather than generate funds from operations for the foreseeable
future. Based on our current plans, we believe our existing cash and cash
equivalents will be sufficient to fund our operating expenses and capital
requirements for at least the next two years. However, the actual amount of
funds that we will need prior to or after that date will be determined by many
factors, some of which are beyond our control. As a result, we may need funds
sooner or in different amounts than we currently anticipate. These factors
include:
o the progress of our development activities;
o the progress of our research activities;
24
o the number and scope of our development programs;
o our ability to establish and maintain current and new licensing or
acquisition arrangements;
o our ability to achieve our milestones under our licensing
arrangements;
o the costs involved in enforcing patent claims and other intellectual
property rights; and
o the costs and timing of regulatory approvals.
If our capital resources are insufficient to meet future capital requirements,
we will have to raise additional funds. If we are unable to obtain additional
funds on terms favorable to us or at all, we may be required to cease or reduce
our operating activities or sell or license to third parties some or all of our
technology. If we raise additional funds by selling additional shares of our
capital stock, the ownership interests of our stockholders will be diluted. If
we raise additional funds through the sale or license of our technology, we may
be unable to do so on terms favorable to us.
OUR RESTRUCTURINGS MAY NOT ACHIEVE THE RESULTS WE INTEND AND MAY HARM OUR
BUSINESS.
Since mid-2002, we have been restructuring the company, including the current
and 2002 restructurings. Our workforce reduction consisted principally of
research personnel primarily involved in early-stage projects, along with
certain managerial and administrative staff. The implementation of our
restructurings has placed, and may continue to place, a significant strain on
our managerial, operational, financial and other resources. If we are unable to
implement our restructurings effectively, we may not successfully achieve our
business strategy or reduce our costs. Moreover, we may be required to further
reduce our headcount and/or program-specific expenditures, which could require
us to further scale back or abandon any of our development activities, or
license to others products or technologies we would otherwise have sought to
commercialize ourselves.
DUE TO THE RECENT REDUCTIONS IN STAFF AND ACTIVITY AT OUR RESEARCH AND
DEVELOPMENT SUBSIDIARY LOCATED IN ISRAEL, CERTAIN TAX BENEFITS WE HAD RECEIVED
FROM THE ISRAELI GOVERNMENT MAY BE REVOKED AND WE MAY BE REQUIRED TO REPAY SOME
OR ALL OF SUCH TAX BENEFITS PREVIOUSLY RECEIVED.
In September 2001, one of our Israeli subsidiaries received the status of an
"Approved Enterprise," a status which grants certain tax benefits in Israel in
accordance with the "Law for the Encouragement of Capital Investments, 1959".
Through March 31, 2003, our Israeli subsidiary will have received tax benefits
of approximately $731,000 as a result of our subsidiary's status as an "Approved
Enterprise." As a result of recent cost reductions, the staff and activity of
this subsidiary have been materially reduced. In January 2003, the subsidiary
notified the Israeli governmental authority of reductions in its staff and
operations that had formed the basis of its Approved Enterprise program, and
requested that the program instituted prior to the cost reductions be approved.
In February 2003, the Israeli governmental authority informed this subsidiary
that it may be in non-compliance with the conditions of its Approved Enterprise
program because of the indicated reductions. As part of the restructuring
implemented during the first quarter of 2003, we decided to close down our
Jerusalem laboratory facility. Our subsidiary is currently undergoing
discussions with the Israeli governmental authority and at this point we are
uncertain as to whether or not any of the past benefits will need to be repaid.
Accordingly, we have not recorded any charge with respect to this
25
potential liability. It is possible that as a result of these cost reductions
and the close down of the Jerusalem laboratory facility, some or all of the tax
benefits received to date will need to be repaid, which could adversely affect
our cash flow and results of operations.
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
IF WE ARE UNABLE TO ADEQUATELY PROTECT OUR INTELLECTUAL PROPERTY THIRD PARTIES
MAY BE ABLE TO USE OUR TECHNOLOGY, WHICH COULD ADVERSELY AFFECT OUR ABILITY TO
COMPETE IN THE MARKET.
Our commercial success will depend in part on our ability and the ability of our
licensors to obtain and maintain patent protection on our drug products and
technologies and successfully defend these patents and technologies against
third-party challenges. The patent positions of pharmaceutical and biotechnology
companies can be highly uncertain and involve complex legal and factual
questions. No consistent policy regarding the breadth of claims allowed in
biotechnology patents has emerged to date. Accordingly, the patents we use may
not be sufficiently broad to prevent others from practicing our technologies or
from developing competing products. Furthermore, others may independently
develop similar or alternative technologies or design around our patented
technologies. The patents we use may be challenged, invalidated or fail to
provide us with any competitive advantage.
Moreover, we rely on trade secrets to protect technology where we believe patent
protection is not appropriate or obtainable. However, trade secrets are
difficult to protect. While we require our employees, collaborators and
consultants to enter into confidentiality agreements, this may not be sufficient
to adequately protect our trade secrets or other proprietary information. In
addition, we share ownership and publication rights to data relating to some of
our drug candidates with our research collaborators and scientific advisors. If
we cannot maintain the confidentiality of this information, our ability to
receive patent protection or protect our proprietary information will be at
risk.
LITIGATION OR THIRD-PARTY CLAIMS OF INTELLECTUAL PROPERTY INFRINGEMENT COULD
REQUIRE US TO SPEND SUBSTANTIAL TIME AND MONEY DEFENDING SUCH CLAIMS AND
ADVERSELY AFFECT OUR ABILITY TO DEVELOP AND COMMERCIALIZE OUR PRODUCTS.
Third parties may assert that we are using their proprietary technology without
authorization. In addition, third parties may have or obtain patents in the
future and claim that our technologies infringe their patents. If we are
required to defend against patent suits brought by third parties, or if we sue
third parties to protect our patent rights, we may be required to pay
substantial litigation costs, and our management's attention may be diverted
from operating our business. In addition, any legal action against our licensors
or us that seeks damages or an injunction of our commercial activities relating
to the affected technologies could subject us to monetary liability and require
our licensors or us to obtain a license to continue to use the affected
technologies. We cannot predict whether our licensors or we would prevail in any
of these types of actions or that any required license would be made available
on commercially acceptable terms, if at all.
RISKS RELATED TO OUR COMMON STOCK
CONCENTRATION OF OWNERSHIP OF OUR COMMON STOCK AMONG OUR EXISTING EXECUTIVE
OFFICERS, DIRECTORS AND PRINCIPAL STOCKHOLDERS MAY PREVENT NEW INVESTORS FROM
INFLUENCING SIGNIFICANT CORPORATE DECISIONS.
As of March 31, 2003, our executive officers, directors and principal
stockholders (including their affiliates) beneficially own, in the aggregate,
approximately 37.6% of our outstanding common stock, including, for this
purpose, currently exercisable options and warrants held by our executive
26
officers, directors and principal stockholders. As a result, these persons,
acting together, may have the ability to effectively determine the outcome of
all matters submitted to our stockholders for approval, including the election
and removal of directors and any merger, consolidation or sale of all or
substantially all of our assets. In addition, such persons, acting together, may
have the ability to effectively control our management and affairs. Accordingly,
this concentration of ownership may harm the market price of our common stock by
discouraging a potential acquirer from attempting to acquire us.
OUR STOCK PRICE COULD BE VOLATILE AND YOUR INVESTMENT COULD DECLINE IN VALUE.
The trading price of our common stock is likely to be highly volatile and
subject to wide fluctuations in price in response to various factors, many of
which are beyond our control. These factors include:
o developments concerning our drug candidates;
o announcements of technological innovations by us or our competitors;
o new products introduced or announced by us or our competitors;
o changes in financial estimates by securities analysts;
o actual or anticipated variations in quarterly operating results;
o expiration or termination of licenses, research contracts or other
collaboration agreements;
o conditions or trends in the regulatory climate and the
biotechnology, pharmaceutical and genomics industries;
o changes in the market valuations of similar companies; and
o additions or departures of key personnel.
In addition, equity markets in general, and the market for biotechnology and
life sciences companies in particular, have experienced extreme price and volume
fluctuations that have often been unrelated or disproportionate to the operating
performance of companies traded in those markets. These broad market and
industry factors may materially affect the market price of our common stock,
regardless of our development and operating performance. In the past, following
periods of volatility in the market price of a company's securities, securities
class-action litigation has often been instituted against that company. Such
litigation, if instituted against us, could cause us to incur substantial costs
to defend such claims and divert management's attention and resources, which
could seriously harm our business.
THE GENERAL BUSINESS CLIMATE IS UNCERTAIN AND WE DO NOT KNOW HOW THIS WILL
IMPACT OUR BUSINESS OR OUR STOCK PRICE.
Over the past several years, there have been dramatic changes in economic
conditions, and the general business climate has been negatively impacted.
Indices of the U.S. stock markets have fallen significantly and consumer
confidence has waned. Compounding the general unease about the current business
climate are the still unknown economic and political impacts of the September
11, 2001 terrorist attacks and hostilities abroad. We are unable to predict how
any of these factors may affect our business or stock price.
27
ANTI-TAKEOVER PROVISIONS IN OUR CHARTER DOCUMENTS AND DELAWARE LAW COULD MAKE A
THIRD-PARTY ACQUISITION OF US DIFFICULT. THIS COULD LIMIT THE PRICE INVESTORS
MIGHT BE WILLING TO PAY IN THE FUTURE FOR OUR COMMON STOCK.
Provisions in our certificate of incorporation and bylaws could have the effect
of making it more difficult for a third party to acquire, or of discouraging a
third party from attempting to acquire, or control us. These provisions could
limit the price that certain investors might be willing to pay in the future for
shares of our common stock. Our certificate of incorporation allows us to issue
preferred stock with rights senior to those of the common stock without any
further vote or action by the stockholders and our bylaws eliminate the right of
stockholders to call a special meeting of stockholders, which could make it more
difficult for stockholders to effect certain corporate actions. These provisions
could also have the effect of delaying or preventing a change in control. The
issuance of preferred stock could decrease the amount of earnings and assets
available for distribution to the holders of our common stock or could adversely
affect the rights and powers, including voting rights, of such holders. In
certain circumstances, such issuance could have the effect of decreasing the
market price of our common stock.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk. The primary objective of our investment activities is to
preserve principal while at the same time maximizing the income we receive from
our investments without significantly increasing risk. Some of the securities
that we invest in may have market risk. This means that a change in prevailing
interest rates may cause the principal amount of the investment to fluctuate.
For example, if we hold a security that was issued with a fixed interest rate at
the then-prevailing rate and the prevailing interest rate later rises, the
principal amount of our investment will probably decline. We maintain our
portfolio in cash equivalents and short- and long-term interest bearing
securities, including corporate debt, money market funds and government debt
securities. The average duration of all of our investments held in the first
quarter of 2003 was less than one year. Due to the short-term nature of these
investments, we believe we have no material exposure to interest rate risk
arising from our investments. Therefore, no quantitative tabular disclosure is
required.
Foreign Currency Rate Fluctuations. While our Israeli subsidiaries transact
business in New Israel Shekels or NIS, most operating expenses and commitments
are linked to the US dollar. As a result, there is currently minimal exposure to
foreign currency rate fluctuations. Any foreign currency revenues and expenses
are translated using the daily average exchange rates prevailing during the year
and any transaction gains and losses are included in net income. In the future,
our subsidiaries may enter into NIS-based commitments that may expose us to
foreign currency rate fluctuations.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures. Based on their evaluations
as of a date within 90 days of the filing date of this report, our principal
executive officer and principal financial officer have concluded that our
disclosure controls and procedures (as defined in Rules 13a-14(c) and 15d-14(c)
under the Securities Exchange Act) are effective to ensure that information
required to be disclosed by us in reports that we file or submit under the
Securities Exchange Act is recorded, processed, summarized and reported within
the time periods specified in the rules and forms of the SEC.
28
(b) Changes in internal controls. There were no significant changes in our
internal controls or in other factors that could significantly affect these
internal controls subsequent to the date of their most recent evaluation.
PART II. OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
(d) Use of Proceeds From Registered Securities
We received net proceeds (after deducting underwriting discounts and commissions
and offering expenses) of $46.3 million from the sale of 5,200,000 shares of
common stock in our initial public offering in July 2000. As of March 31, 2003,
we have used the net proceeds of this offering as follows:
o approximately $5.6 million to fund the development of KRX-101
for diabetic nephropathy;
o approximately $3.8 million to fund the development of KRX-123
for hormone-resistant prostate cancer;
o approximately $10.3 million to fund expansion of our KinAce
platform and to further develop the compounds we have
generated with it; and
o approximately $14.2 million to use as working capital,
in-licensing development activities and for general corporate
purposes.
We intend to use our current capital resources primarily to advance KRX-101 and
to in-license, acquire and develop novel clinical stage compounds. The timing
and amounts of our actual expenditures will depend on several factors, including
the timing of our entry into collaboration agreements, the progress of our
clinical trials, the progress of our research and development programs, the
results of other pre-clinical and clinical studies and the timing and costs of
regulatory approvals.
Until we use the net proceeds, we intend to invest the funds in short and
long-term, investment-grade, interest-bearing instruments.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
The exhibits listed on the Exhibit Index are included with this
report.
10.1 - Employment Agreement between Keryx Biopharmaceuticals, Inc.
and Michael S. Weiss dated as of December 23, 2002
10.2 - 1999 Stock Option Plan (as amended)
10.3 - 2000 Stock Option Plan (as amended)
10.4 - 2002 CEO Incentive Stock Option Plan
99.1 - Certifications pursuant to 18 U.S.C. Section 1350
99.2 - Certifications pursuant to 18 U.S.C. Section 1350
29
(b) Reports on Form 8-K
On April 7, 2003, the Company furnished a Current Report on Form 8-K
under Items 7, 9 and 12, containing a copy of its earnings release
for the period ended December 31, 2002 (including financial
statements) pursuant to Item 12 (Results of Operations and Financial
Condition).
On May 14, 2003, the Company furnished a Current Report on Form 8-K
under Item 9, containing a copy of its earnings release for the
period ended March 31, 2003 (including financial statements)
pursuant to Item 12 (Results of Operations and Financial Condition).
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.
KERYX BIOPHARMACEUTICALS, INC.
Date: May 15, 2003 /s/ Ira Weinstein
--------------------------------------------
Ira Weinstein
Interim Chief Financial Officer & Treasurer
(Principal Financial and Accounting Officer)
30
CERTIFICATIONS
I, Michael S. Weiss, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Keryx
Biopharmaceuticals, Inc.;
2. Based on my knowledge, this annual 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 quarterly report;
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in all
material respects the financial condition, results of operations and cash
flows of the registrant as of, and for, the periods presented in this
quarterly report;
4. The registrant's other certifying officers 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 registrant and
have:
a) designed such disclosure controls and procedures to ensure that
material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this
quarterly report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls
and procedures as of a date within 90 days prior to the filing date
of this quarterly report (the "Evaluation Date"); and
c) presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures based on our
evaluation as of the Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on
our most recent evaluation, to the registrant's auditors and the audit
committee of the registrant's board of directors (or persons performing
the equivalent functions):
a) all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to
record, process, summarize and report financial data and have
identified for the registrant'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 registrant's
internal controls; and
6. The registrant's other certifying officers and I have indicated in this
quarterly report whether 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.
Date: May 15, 2003 /s/ Michael S. Weiss
------------------------------
Michael S. Weiss
Chief Executive Officer
(Principal Executive Officer)
31
I, Ira Weinstein, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Keryx
Biopharmaceuticals, Inc.;
2. Based on my knowledge, this quarterly 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 quarterly report;
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in all
material respects the financial condition, results of operations and cash
flows of the registrant as of, and for, the periods presented in this
quarterly report;
4. The registrant's other certifying officers 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 registrant and
have;
a) designed such disclosure controls and procedures to ensure that
material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this
quarterly report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls
and procedures as of a date within 90 days prior to the filing date
of this quarterly report (the "Evaluation Date"); and
c) presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures based our
evaluation as of the Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on
our most recent evaluation, to the registrant's auditors and the audit
committee of the registrant's board of directors (or persons performing
the equivalent functions):
a) all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to
record, process, summarize and report financial data and have
identified for the such 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 registrant's
internal controls; and
6. The registrant's other certifying officers and I have indicated in this
quarterly report whether 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.
/s/ Ira Weinstein
--------------------------------------------
Ira Weinstein
Dated: May 15, 2003 Interim Chief Financial Officer
(Principal Financial and Accounting Officer)
32
EXHIBIT INDEX
The following exhibits are filed as part of this Quarterly Report on Form 10-Q:
10.1 - Employment Agreement between Keryx Biopharmaceuticals, Inc. and Michael
S. Weiss dated as of December 23, 2002.
10.2 - 1999 Stock Option Plan (as amended)
10.3 - 2000 Stock Option Plan (as amended)
10.4 - 2002 CEO Incentive Stock Option Plan
99.1 - Certification pursuant to 18 U.S.C. Section 1350
99.2 - Certification pursuant to 18 U.S.C. Section 1350
33