x
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
|
SECURITIES
EXCHANGE ACT OF 1934
|
For
the quarterly period ended March 31, 2007
|
OR
|
o
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
|
SECURITIES
EXCHANGE ACT OF 1934
|
For
the transition period from
to
.
|
Delaware
(State
or other jurisdiction of incorporation or organization)
|
13-4087132
(I.R.S.
Employer Identification No.)
|
|
Page
|
||
SPECIAL
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
|
3
|
|
PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1
|
Financial
Statements
|
4
|
Consolidated
Balance Sheets as of March 31, 2007 (unaudited) and December
31, 2006
|
4
|
|
Consolidated
Statements of Operations for the three months ended
March 31, 2007 and 2006 (unaudited)
|
5
|
|
Consolidated
Statement of Changes in Stockholders’ Equity for
the three months ended March 31, 2007 (unaudited)
|
6
|
|
Consolidated
Statements of Cash Flows for the three months ended
March 31, 2007 and 2006 (unaudited)
|
7
|
|
Notes
to Consolidated Financial Statements for the three
months ended
March 31, 2007 (unaudited)
|
9
|
|
Item
2
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
15
|
Item
3
|
Quantitative
and Qualitative Disclosures About Market Risk
|
22
|
Item
4
|
Controls
and Procedures
|
22
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1
|
Legal
Proceedings
|
23
|
Item
1A
|
Risk
Factors
|
24
|
Item
6
|
Exhibits
|
34
|
· |
expectations
for increases or decreases in expenses;
|
· |
expectations
for the development, manufacturing, regulatory approval, and
commercialization of SulonexTM,
ZerenexTM,
KRX-0401, and our additional product candidates or any other products
we
may acquire or in-license;
|
· |
expectations
for incurring capital expenditures to expand our research and development
and manufacturing capabilities;
|
· |
expectations
for generating revenue or becoming profitable on a sustained basis;
|
· |
expectations
or ability to enter into marketing and other partnership agreements;
|
· |
expectations
or ability to enter into product acquisition and in-licensing
transactions;
|
· |
expectations
or ability to build our own commercial infrastructure to manufacture,
market and sell our drug
candidates;
|
· |
estimates
of the sufficiency of our existing cash and cash equivalents and
investments to finance our business strategy;
|
· |
expected
losses; and
|
· |
expectations
for future capital requirements.
|
March
31, 2007
|
December
31,
2006
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
35,471
|
$
|
48,736
|
|||
Short-term
investment securities
|
57,181
|
63,659
|
|||||
Accrued
interest receivable
|
659
|
525
|
|||||
Other
current assets
|
829
|
2,048
|
|||||
Total
current assets
|
94,140
|
114,968
|
|||||
Long-term
investment securities
|
14,708
|
12,690
|
|||||
Property,
plant and equipment, net
|
10,965
|
8,489
|
|||||
Goodwill
|
3,208
|
3,208
|
|||||
Other
assets, net
|
344
|
958
|
|||||
Total
assets
|
$
|
123,365
|
$
|
140,313
|
|||
Liabilities
and stockholders’ equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
13,451
|
$
|
10,460
|
|||
Accrued
compensation and related liabilities
|
320
|
1,534
|
|||||
Deferred
revenue
|
197
|
200
|
|||||
Total
current liabilities
|
13,968
|
12,194
|
|||||
Contingent
equity rights
|
4,004
|
4,004
|
|||||
Other
liabilities
|
271
|
294
|
|||||
Total
liabilities
|
18,243
|
16,492
|
|||||
Stockholders’
equity
|
|||||||
Common
stock, $0.001 par value per share (60,000,000 and 60,000,000 shares
authorized, 43,580,081 and 43,516,669 shares issued, 43,518,008 and
43,460,569 shares outstanding at March 31, 2007, and December 31,
2006,
respectively)
|
44
|
44
|
|||||
Additional
paid-in capital
|
315,262
|
312,078
|
|||||
Treasury
stock, at cost, 62,073 and 56,100 shares at March 31, 2007, and December
31, 2006, respectively
|
(159
|
)
|
(89
|
)
|
|||
Deficit
accumulated during the development stage
|
(210,025
|
)
|
(188,212
|
)
|
|||
Total
stockholders’ equity
|
105,122
|
123,821
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
123,365
|
$
|
140,313
|
Three
months ended
March
31,
|
Amounts
accumulated
during
the
development
|
|||||||||
2007
|
2006
|
stage
|
||||||||
Revenue:
|
||||||||||
Diagnostic
revenue
|
$
|
30
|
$
|
–
|
$
|
133
|
||||
Service
revenue
|
12
|
112
|
1,826
|
|||||||
Management
fees from related party
|
–
|
–
|
300
|
|||||||
Total
revenue
|
42
|
112
|
2,259
|
|||||||
Operating
expenses:
|
||||||||||
Cost
of diagnostics sold
|
22
|
–
|
162
|
|||||||
Cost
of services
|
32
|
171
|
2,076
|
|||||||
Research
and development:
|
||||||||||
Non-cash
compensation
|
995
|
2,724
|
15,233
|
|||||||
Non-cash
acquired in-process research and development
|
–
|
–
|
18,800
|
|||||||
Other
research and development
|
17,446
|
12,333
|
137,479
|
|||||||
Total
research and development
|
18,441
|
15,057
|
171,512
|
|||||||
Selling,
general and administrative:
|
||||||||||
Non-cash
compensation
|
2,006
|
2,817
|
15,855
|
|||||||
Other
selling, general and administrative
|
2,795
|
2,645
|
36,991
|
|||||||
Total
selling, general and administrative
|
4,801
|
5,462
|
52,846
|
|||||||
Total
operating expenses
|
23,296
|
20,690
|
226,596
|
|||||||
Operating
loss
|
(23,254
|
)
|
(20,578
|
)
|
(224,337
|
)
|
||||
Interest
and other income, net
|
1,441
|
982
|
14,803
|
|||||||
Net
loss before income taxes
|
(21,813
|
)
|
(19,596
|
)
|
(209,534
|
)
|
||||
Income
taxes
|
–
|
–
|
491
|
|||||||
Net
loss
|
$
|
(21,813
|
)
|
$
|
(19,596
|
)
|
$
|
(210,025
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.50
|
)
|
$
|
(0.51
|
)
|
$
|
(10.00
|
)
|
|
Weighted
average shares used in computing basic and
diluted
net loss
per common share
|
43,506,236
|
38,071,609
|
20,995,344
|
Common
stock
|
Additional
paid-in
|
|||||||||
Shares
|
Amount
|
capital
|
||||||||
Balance
at December 31, 2006
|
43,516,669
|
$
|
44
|
$
|
312,078
|
|||||
Changes
during the period:
|
||||||||||
Purchase
of common stock
|
–
|
–
|
–
|
|||||||
Exercise
of options
|
63,412
|
–*
|
183
|
|||||||
Compensation
in respect of options, restricted stock and warrants granted to employees,
directors and third-parties
|
–
|
–
|
3,001
|
|||||||
Net
loss
|
–
|
–
|
–
|
|||||||
Balance
at March 31, 2007
|
43,580,081
|
$
|
44
|
$
|
315,262
|
Treasury
stock
|
Deficit
accumulated
during
the
development
|
||||||||||||
Shares
|
Amount
|
Stage
|
Total
|
||||||||||
Balance
at December 31, 2006
|
56,100
|
$
|
(89
|
)
|
$
|
(188,212
|
)
|
$
|
123,821
|
||||
Changes
during the period:
|
|||||||||||||
Purchase
of common stock
|
5,973
|
(70
|
)
|
–
|
(70
|
)
|
|||||||
Exercise
of options
|
–
|
–
|
–
|
183
|
|||||||||
Compensation
in respect of options, restricted stock and warrants granted to employees,
directors and third-parties
|
–
|
–
|
–
|
3,001
|
|||||||||
Net
loss
|
–
|
–
|
(21,813
|
)
|
(21,813
|
)
|
|||||||
Balance
at March 31, 2007
|
62,073
|
$
|
(159
|
)
|
$
|
(210,025
|
)
|
$
|
105,122
|
Three
months ended
March
31,
|
Amounts
accumulated
during
the
development
stage
|
|||||||||
2007
|
2006
|
|||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(21,813
|
)
|
$
|
(19,596
|
)
|
$
|
(210,025
|
)
|
|
Adjustments
to reconcile cash flows used in operating activities:
|
||||||||||
Acquired
in-process research and development
|
–
|
–
|
18,800
|
|||||||
Stock
compensation expense
|
3,001
|
5,541
|
31,088
|
|||||||
Issuance
of common stock to technology licensor
|
–
|
–
|
359
|
|||||||
Interest
on convertible notes settled through issuance of preferred
shares
|
–
|
–
|
253
|
|||||||
Depreciation
and amortization
|
49
|
52
|
2,884
|
|||||||
Loss
on disposal of property, plant and equipment
|
–
|
–
|
172
|
|||||||
Impairment
charges
|
600
|
–
|
3,082
|
|||||||
Exchange
rate differences
|
–
|
–
|
94
|
|||||||
Changes
in assets and liabilities, net of effects of acquisitions:
|
||||||||||
Decrease
(increase) in other current assets
|
1,219
|
(1,297
|
)
|
(357
|
)
|
|||||
(Increase)
decrease in accrued interest receivable
|
(134
|
)
|
140
|
(659
|
)
|
|||||
(Increase)
in security deposits
|
–
|
(241
|
)
|
(263
|
)
|
|||||
Increase
in accounts payable and accrued expenses
|
2,991
|
1,300
|
11,706
|
|||||||
(Decrease)
increase in accrued compensation and related liabilities
|
(1,214
|
)
|
1,276
|
(275
|
)
|
|||||
(Decrease)
increase in other liabilities
|
(23
|
)
|
(17
|
)
|
116
|
|||||
(Decrease)
increase in deferred revenue
|
(3
|
)
|
95
|
(259
|
)
|
|||||
Net
cash used in operating activities
|
(15,327
|
)
|
(12,747
|
)
|
(143,284
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Purchases
of property, plant and equipment
|
(2,511
|
)
|
(526
|
)
|
(15,499
|
)
|
||||
Proceeds
from disposals of property, plant and equipment
|
–
|
–
|
425
|
|||||||
(Increase)
in note and accrued interest receivable from related party
|
–
|
–
|
(356
|
)
|
||||||
Payments
of transaction costs
|
–
|
–
|
(231
|
)
|
||||||
Decrease
(increase) in other assets
|
–
|
27
|
(1,192
|
)
|
||||||
Investment
in held-to-maturity short-term securities
|
(22
|
)
|
(26
|
)
|
(48,935
|
)
|
||||
Proceeds
from maturity of held-to-maturity short-term securities
|
4,500
|
305
|
56,521
|
|||||||
Investment
in available-for-sale short-term securities
|
(500
|
)
|
(125
|
)
|
(58,600
|
)
|
||||
Proceeds
from sale of available-for-sale short-term securities
|
2,500
|
–
|
18,900
|
|||||||
Investment
in held-to-maturity long-term securities
|
(2,019
|
)
|
(3
|
)
|
(39,966
|
)
|
||||
Proceeds
from maturity of held-to-maturity long-term securities
|
1
|
2
|
191
|
|||||||
Net
cash used in investing activities
|
1,949
|
(346
|
)
|
(88,742
|
)
|
Three
months ended
March
31,
|
Amounts
accumulated
during
the
development
stage
|
|||||||||
2007
|
2006
|
|||||||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||||
Proceeds
from short-term loans
|
$
|
–
|
$
|
–
|
$
|
500
|
||||
Proceeds
from long-term loans
|
–
|
–
|
3,251
|
|||||||
Payment
of assumed notes payable and accrued interest in connection with
the
ACCESS Oncology acquisition
|
–
|
–
|
(6,322
|
)
|
||||||
Issuance
of convertible note, net
|
–
|
–
|
2,150
|
|||||||
Issuance
of preferred shares, net
|
–
|
–
|
8,453
|
|||||||
Receipts
on account of shares previously issued
|
–
|
–
|
7
|
|||||||
Proceeds
from initial public offering, net
|
–
|
–
|
46,298
|
|||||||
Proceeds
from subsequent public offerings, net
|
–
|
82,741
|
158,487
|
|||||||
Proceeds
from private placements, net
|
–
|
–
|
45,795
|
|||||||
Proceeds
from exercise of options and warrants
|
183
|
1,203
|
9,032
|
|||||||
Purchase
of treasury stock
|
(70
|
)
|
–
|
(159
|
)
|
|||||
Net
cash provided by financing activities
|
113
|
83,944
|
267,492
|
|||||||
Cash
acquired in acquisition
|
–
|
–
|
99
|
|||||||
Effect
of exchange rate on cash
|
–
|
–
|
(94
|
)
|
||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(13,265
|
)
|
70,851
|
35,471
|
||||||
Cash
and cash equivalents at beginning of year
|
48,736
|
68,175
|
–
|
|||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
35,471
|
$
|
139,026
|
$
|
35,471
|
||||
NON
- CASH TRANSACTIONS
|
||||||||||
Issuance
of common stock in connection with acquisition
|
$
|
–
|
$
|
–
|
$
|
9,635
|
||||
Contingent
equity rights in connection with acquisition
|
–
|
–
|
4,004
|
|||||||
Assumption
of liabilities in connection with acquisition
|
–
|
–
|
9,068
|
|||||||
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
|
|||||||
SUPPLEMENTARY
DISCLOSURES OF CASH FLOW INFORMATION
|
||||||||||
Cash
paid for interest
|
$
|
–
|
$
|
–
|
$
|
1,166
|
||||
Cash
paid for income taxes
|
$
|
–
|
$
|
–
|
$
|
432
|
Plan
|
Exercise
price
|
Authorized
|
Outstanding
|
Exercised
|
Restricted
Stock
Vested
|
Exercisable
|
Available
for
grant
|
|||||||||||||||
1999
Stock Option Plan
|
$
|
0.10
- 1.30
|
4,230,000
|
617,995
|
3,506,505
|
–
|
617,995
|
–
|
||||||||||||||
2000
Stock Option Plan
|
1.10
- 14.64
|
4,455,000
|
2,869,465
|
1,566,156
|
–
|
2,257,007
|
19,379
|
|||||||||||||||
Non
Plan
|
0.33
|
240,000
|
60,000
|
157,500
|
–
|
60,000
|
–
|
|||||||||||||||
2002
CEO Incentive Stock
Option
Plan
|
1.30
|
2,002,657
|
2,002,657
|
–
|
–
|
2,002,657
|
–
|
|||||||||||||||
2004
President Incentive Plan
|
9.25
|
1,000,000
|
1,000,000
|
–
|
–
|
500,000
|
–
|
|||||||||||||||
2004
Long-Term Incentive Plan
|
7.13
- 18.06
|
* |
4,000,000
|
3,675,084
|
131,037
|
16,666
|
1,264,614
|
177,213
|
||||||||||||||
2006
CFO Incentive Plan
|
15.30
|
500,000
|
500,000
|
–
|
–
|
166,667
|
–
|
|||||||||||||||
2007
CAO Inducement Plan
|
11.11
|
100,000
|
100,000
|
–
|
–
|
–
|
–
|
|||||||||||||||
16,527,657
|
10,825,201
|
5,361,198
|
16,666
|
6,868,940
|
196,592
|
Outstanding
equity awards
|
||||||||||
Shares
available
|
Number
of
shares
|
Weighted-
average
exercise
price
|
||||||||
Balance,
December 31, 2006
|
152,158
|
10,849,713
|
$
|
7.82
|
||||||
Authorized
|
100,000
|
–
|
–
|
|||||||
Granted
|
(124,900
|
)
|
124,900
|
11.03
|
||||||
Exercised
|
–
|
(63,412
|
)
|
2.88
|
||||||
Restricted
stock vested
|
–
|
(16,666
|
)
|
–
|
||||||
Forfeited
and expired
|
69,334
|
(69,334
|
)
|
13.54
|
||||||
Balance,
March 31, 2007
|
196,592
|
10,825,201
|
7.87
|
|||||||
Exercisable
at December 31, 2006
|
6,178,994
|
3.92
|
||||||||
Exercisable
at March 31, 2007
|
6,868,940
|
5.05
|
Number
of Options
|
Exercise
price
per
share
|
Weighted-average
exercise
price
|
Weighted-average
remaining
contractual term
(years)
|
Aggregate
intrinsic value
|
||||||||||||
Outstanding
at January 1, 2007
|
10,749,713
|
$
|
0.10
- $ 18.06
|
7.90
|
7.6
|
$58,048,000
|
||||||||||
Granted
|
124,900
|
10.67
- 11.11
|
11.03
|
|||||||||||||
Exercised
|
(63,412
|
)
|
0.10
- 9.25
|
2.88
|
||||||||||||
Forfeited
and expired
|
(69,334
|
)
|
4.59
- 17.16
|
13.54
|
||||||||||||
Outstanding
at March 31, 2007
|
10,741,867
|
0.10
- 18.06
|
7.93
|
7.4
|
27,821,000
|
|||||||||||
Vested
and expected to vest at March 31, 2007
|
10,688,941
|
0.10
- 18.06
|
7.92
|
7.4
|
27,791,000
|
|||||||||||
Exercisable
at March 31, 2007
|
6,868,940
|
0.10
- 18.06
|
5.05
|
6.7
|
37,573,000
|
Number
of
Shares
|
Average
Grant Date
Fair
Value
|
||||||
Nonvested
at January 1, 2007
|
100,000
|
$
|
15.30
|
||||
Granted
|
|
–
|
–
|
||||
Vested
|
16,666
|
$
|
15.30
|
||||
Forfeited
|
–
|
–
|
|||||
Nonvested
at March 31, 2007
|
83,334
|
$
|
15.30
|
Warrants
|
Weighted-
average
exercise
price
|
||||||
Outstanding
at January 1, 2007
|
321,976
|
$
|
4.65
|
||||
Issued
|
–
|
–
|
|||||
Exercised
|
–
|
–
|
|||||
Canceled
|
–
|
–
|
|||||
Outstanding
at March 31, 2007
|
321,976
|
$
|
4.65
|
Revenue
|
||||||||||
Three
months ended March 31,
|
Amounts
accumulated
during
the
development
|
|||||||||
(in
thousands)
|
2007
|
2006
|
Stage
|
|||||||
Diagnostics
|
$
|
30
|
$
|
–
|
$
|
133
|
||||
Services
|
12
|
112
|
1,826
|
|||||||
Products
|
–
|
–
|
–
|
|||||||
Total
|
$
|
42
|
$
|
112
|
$
|
1,959
|
Operating
loss
|
||||||||||
Three
months ended March 31,
|
Amounts
accumulated
during
the
development
|
|||||||||
(in
thousands)
|
2007
|
2006
|
Stage
|
|||||||
Diagnostics
|
$
|
(674
|
)
|
$
|
–
|
$
|
(1,690
|
)
|
||
Services
|
(20
|
)
|
(59
|
)
|
(250
|
)
|
||||
Products
|
(22,560
|
)
|
(20,519
|
)
|
(222,397
|
)
|
||||
Total
|
$
|
(23,254
|
)
|
$
|
(20,578
|
)
|
$
|
(224,337
|
)
|
Net
loss
|
||||||||||
Three
months ended March 31,
|
Amounts
accumulated
during
the
development
|
|||||||||
(in
thousands)
|
2007
|
2006
|
Stage
|
|||||||
Operating
losses of reportable segments
|
$
|
(23,254
|
)
|
$
|
(20,578
|
)
|
$
|
(224,337
|
)
|
|
Interest
and other income
|
1,441
|
982
|
14,803
|
|||||||
Income
taxes
|
–
|
–
|
(491
|
)
|
||||||
Consolidated
net loss
|
$
|
(21,813
|
)
|
$
|
(19,596
|
)
|
$
|
(210,025
|
)
|
Goodwill
|
|||||||
(in
thousands)
|
March
31, 2007
|
December
31, 2006
|
|||||
Diagnostics
|
–
|
–
|
|||||
Services
|
–
|
–
|
|||||
Products
|
$
|
3,208
|
$
|
3,208
|
|||
Total
|
$
|
3,208
|
$
|
3,208
|
Product
candidate
|
Target
indication
|
Development
status
|
Endocrine/Renal
|
||
Sulonex™
|
Diabetic
nephropathy
|
Phase
III & Phase IV
|
Zerenex™
|
Hyperphosphatemia
in patients with
end-stage
renal disease
|
Phase
II
|
Oncology
|
||
KRX-0401
|
Multiple
forms of cancer
|
Phase
II
|
KRX-0402
|
Brain
cancer
|
Phase
II
|
KRX-0601
|
Multiple
forms of cancer
|
Phase
II
|
KRX-0404
|
Multiple
forms of cancer
|
Pre-clinical
|
Neurology
|
||
KRX-0501
|
Neurological
disorders
|
Pre-clinical
|
· |
revenue
that is likely to result from the asset, including estimated selling
price, estimated market share and year-over-year growth
rates;
|
· |
operating
margin; and
|
· |
sales
and marketing and general and administrative expenses using historical
and
industry or other sources of market
data;
|
● |
manufacture
our product candidates;
|
● |
assist
us in developing, testing and obtaining regulatory approval for and
commercializing some of our compounds and technologies;
and
|
● |
market
and distribute our drug products.
|
● |
perceptions
by members of the health care community, including physicians, of
the
safety and efficacy of our product
candidates;
|
● |
the
rates of adoption of our products by medical practitioners and the
target
populations for our products;
|
● |
the
potential advantages that our products offer over existing treatment
methods;
|
● |
the
cost-effectiveness of our products relative to competing
products;
|
● |
the
availability of government or third-party payor reimbursement for
our
products;
|
● |
the
side effects or unfavorable publicity concerning our products or
similar
products; and
|
● |
the
effectiveness of our sales, marketing and distribution efforts.
|
● |
difficulty
and expense of assimilating the operations, technology and personnel
of
the acquired business;
|
● |
our
inability to retain the management, key personnel and other employees
of
the acquired business;
|
● |
our
inability to maintain the acquired company's relationship with key
third
parties, such as alliance partners;
|
● |
exposure
to legal claims for activities of the acquired business prior to
the
acquisition;
|
● |
the
diversion of our management's attention from our core business;
and
|
● |
the
potential impairment of goodwill and write-off of in-process research
and
development costs, adversely affecting our reported results of
operations.
|
● |
government
and health administration authorities;
|
● |
private
health insurers;
|
● |
managed
care programs; and
|
● |
other
third-party payors.
|
● |
decreased
demand for a product;
|
● |
injury
to our reputation;
|
● |
our
inability to continue to develop a drug candidate;
|
● |
withdrawal
of clinical trial volunteers; and
|
● |
loss
of revenues.
|
● |
the
timing of completion and results from clinical trials for our drug
candidates, especially Sulonex;
|
● |
the
timing of expenses associated with manufacturing and product development
of the proprietary drug candidates within our portfolio and those
that may
be in-licensed, partnered or
acquired;
|
● |
the
timing of the in-licensing, partnering and acquisition of new product
opportunities;
|
● |
the
progress of the development efforts of parties with whom we have
entered,
or may enter, into research and development
agreements;
|
● |
our
ability to achieve our milestones under our licensing arrangements;
and
|
● |
the
costs involved in prosecuting and enforcing patent claims and other
intellectual property rights.
|
● |
the
timing of completion and results from clinical trials for our drug
candidates, especially Sulonex;
|
● |
the
progress of our development activities;
|
● |
the
progress of our research activities;
|
● |
the
number and scope of our development programs;
|
● |
the
costs associated with commercialization activities, including
manufacturing, marketing and sales;
|
● |
our
ability to establish and maintain current and new licensing or acquisition
arrangements;
|
● |
our
ability to achieve our milestones under our licensing
arrangements;
|
● |
the
costs involved in enforcing patent claims and other intellectual
property
rights; and
|
● |
the
costs and timing of regulatory approvals.
|
● |
developments
concerning our drug candidates;
|
● |
announcements
of technological innovations by us or our competitors;
|
● |
introductions
or announcements of new products by us or our
competitors;
|
● |
announcements
by us of significant acquisitions, strategic partnerships, joint
ventures
or capital commitments;
|
● |
changes
in financial estimates by securities analysts;
|
● |
actual
or anticipated variations in quarterly operating results;
|
● |
expiration
or termination of licenses, research contracts or other collaboration
agreements;
|
● |
conditions
or trends in the regulatory climate and the biotechnology and
pharmaceutical industries;
|
● |
changes
in the market valuations of similar companies; and
|
● |
additions
or departures of key personnel.
|
3.1
|
Amended
and Restated Certificate of Incorporation of Keryx Biopharmaceuticals,
Inc., filed as Exhibit 3.1 to the Registrant's Annual Report on Form
10-Q
for the quarter ended September 30, 2004, filed on August 12, 2004,
and
incorporated herein by reference.
|
3.2
|
Amended
and Restated Bylaws of Keryx Biopharmaceuticals, Inc., filed as Exhibit
3.2 to the Registrant’s Annual Report on Form 10-K for the year ended
December 31, 2001, filed on March 26, 2002 (File No. 000-30929),
and
incorporated herein by reference.
|
10.1†
|
Employment
Arrangement between Mark Stier and Keryx Biopharmaceuticals, Inc.,
dated
as of March 23, 2007
|
10.2†
|
Employment
Agreement between Beth F. Levine and Keryx Biopharmaceuticals, Inc.
dated
April 25, 2007
|
10.3†
|
Employment
Agreement between Dr. I. Craig Henderson and Keryx Biopharmaceuticals,
Inc. dated April 25, 2007
|
10.4†
|
2007
Chief Accounting Officer Inducement Stock Option Plan dated March
23,
2007
|
10.5†
|
2007
General Counsel Incentive Stock Option Plan dated April 25,
2007
|
31.1
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a),
as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated
May 7, 2007.
|
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a),
as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated
May 7, 2007.
|
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. §1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated
May 7,
2007.
|
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated
May 7,
2007.
|
KERYX
BIOPHARMACEUTICALS, INC.
|
||
|
|
|
Date:
May 7, 2007
|
By: | /s/ Ronald C. Renaud, Jr. |
|
||
Senior
Vice President, Chief Financial Officer, and
Treasurer
Principal
Financial Officer
|
10.1†
|
Employment
Arrangement between Mark Stier and Keryx Biopharmaceuticals, Inc.,
dated
as of March 23, 2007
|
10.2†
|
Employment
Agreement between Beth F. Levine and Keryx Biopharmaceuticals, Inc.
dated
April 25, 2007
|
10.3†
|
Employment
Agreement between Dr. I. Craig Henderson and Keryx Biopharmaceuticals,
Inc. dated April 25, 2007
|
10.4†
|
2007
Chief Accounting Officer Inducement Stock Option Plan dated March
23,
2007
|
|
|
10.5†
|
2007
General Counsel Incentive Stock Option Plan dated April 25,
2007
|
31.1
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a),
as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated
May
7, 2007.
|
31.2
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a),
as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated
May
7, 2007.
|
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. §1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated
May 7,
2007.
|
32.2
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated
May 7,
2007.
|