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
|
1
|
|
PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1
|
Financial
Statements
|
2
|
|
Consolidated
Balance Sheets as of September 30, 2007 (unaudited) and December
31, 2006
|
2
|
|
Consolidated
Statements of Operations for the three and nine months ended
September 30, 2007 and 2006 (unaudited)
|
3
|
Consolidated
Statement of Changes in Stockholders’ Equity for
the nine months ended September 30, 2007 (unaudited)
|
4
|
|
Consolidated
Statements of Cash Flows for the nine months ended
September 30, 2007 and 2006 (unaudited)
|
5
|
|
Notes
to Consolidated Financial Statements (unaudited)
|
7
|
|
Item
2
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
15
|
Item
3
|
Quantitative
and Qualitative Disclosures About Market Risk
|
24
|
Item
4
|
Controls
and Procedures
|
24
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1
|
Legal
Proceedings
|
24
|
Item
1A
|
Risk
Factors
|
25
|
Item
6
|
Exhibits
|
36
|
·
|
expectations
for increases or decreases in expenses;
|
·
|
expectations
for the development, manufacturing, regulatory approval, and
commercialization of SulonexTM,
ZerenexTM,
KRX-0401 (perifosine), 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.
|
September 30, 2007
|
December 31, 2006
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
28,640
|
$
|
48,736
|
|||
Short-term
investment securities
|
39,348
|
63,659
|
|||||
Accrued
interest receivable
|
453
|
525
|
|||||
License
receivable
|
12,000
|
--
|
|||||
Other
current assets
|
1,397
|
2,048
|
|||||
Total
current assets
|
81,838
|
114,968
|
|||||
Long-term
investment securities
|
2,295
|
12,690
|
|||||
Property,
plant and equipment, net
|
11,336
|
8,489
|
|||||
Goodwill
|
3,208
|
3,208
|
|||||
Other
assets, net
|
344
|
958
|
|||||
Total
assets
|
$
|
99,021
|
$
|
140,313
|
|||
Liabilities
and stockholders’ equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
10,343
|
$
|
10,460
|
|||
Accrued
compensation and related liabilities
|
1,109
|
1,534
|
|||||
Current
portion of deferred revenue
|
1,031
|
200
|
|||||
Total
current liabilities
|
12,483
|
12,194
|
|||||
Deferred
revenue, net of current portion
|
11,185
|
--
|
|||||
Contingent
equity rights
|
4,004
|
4,004
|
|||||
Other
liabilities
|
225
|
294
|
|||||
Total
liabilities
|
27,897
|
16,492
|
|||||
Stockholders’
equity
|
|||||||
Common
stock, $0.001 par value per share (95,000,000 and 60,000,000 shares
authorized,
43,731,101
and 43,516,669 shares issued, 43,651,153 and 43,460,569 shares outstanding
at
September 30, 2007, and December 31, 2006, respectively)
|
44
|
44
|
|||||
Additional
paid-in capital
|
320,450
|
312,078
|
|||||
Treasury
stock, at cost, 79,948 and 56,100 shares at September 30,
2007,
and
December 31, 2006, respectively
|
(357
|
)
|
(89
|
)
|
|||
Deficit
accumulated during the development stage
|
(249,013
|
)
|
(188,212
|
)
|
|||
Total
stockholders’ equity
|
71,124
|
123,821
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
99,021
|
$
|
140,313
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
Amounts
accumulated during the development |
||||||||||||||
2007
|
2006
|
2007
|
2006
|
stage
|
||||||||||||
Revenue:
|
||||||||||||||||
License
revenue
|
$
|
41
|
$
|
—
|
$
|
41
|
$
|
—
|
$
|
41
|
||||||
Diagnostic
revenue
|
—
|
35
|
66
|
58
|
169
|
|||||||||||
Service
revenue
|
11
|
39
|
37
|
375
|
1,851
|
|||||||||||
Management
fees from related party
|
—
|
—
|
—
|
—
|
300
|
|||||||||||
Total
revenue
|
52
|
74
|
144
|
433
|
2,361
|
|||||||||||
Operating
expenses:
|
||||||||||||||||
Cost
of diagnostics sold
|
—
|
50
|
38
|
69
|
178
|
|||||||||||
Cost
of services
|
28
|
29
|
90
|
298
|
2,134
|
|||||||||||
Research
and development:
|
||||||||||||||||
Non-cash
compensation
|
735
|
1,378
|
2,908
|
6,206
|
17,146
|
|||||||||||
Non-cash
acquired in-process research and development
|
—
|
—
|
—
|
—
|
18,800
|
|||||||||||
Other
research and development
|
15,967
|
14,950
|
49,098
|
39,635
|
169,131
|
|||||||||||
Total
research and development
|
16,702
|
16,328
|
52,006
|
45,841
|
205,077
|
|||||||||||
Selling,
general and administrative:
|
||||||||||||||||
Non-cash
compensation
|
1,780
|
1,481
|
5,193
|
7,839
|
19,042
|
|||||||||||
Other
selling, general and administrative
|
2,087
|
2,041
|
7,276
|
6,546
|
41,472
|
|||||||||||
Total
selling, general and administrative
|
3,867
|
3,522
|
12,469
|
14,385
|
60,514
|
|||||||||||
Total
operating expenses
|
20,597
|
19,929
|
64,603
|
60,593
|
267,903
|
|||||||||||
Operating
loss
|
(20,545
|
)
|
(19,855
|
)
|
(64,459
|
)
|
(60,160
|
)
|
(265,542
|
)
|
||||||
Interest
and other income, net
|
1,017
|
1,862
|
3,658
|
4,743
|
17,020
|
|||||||||||
Net
loss before income taxes
|
(19,528
|
)
|
(17,993
|
)
|
(60,801
|
)
|
(55,417
|
)
|
(248,522
|
)
|
||||||
Income
taxes
|
—
|
—
|
—
|
—
|
491
|
|||||||||||
Net
loss
|
$
|
(19,528
|
)
|
$
|
(17,993
|
)
|
$
|
(60,801
|
)
|
$
|
(55,417
|
)
|
$
|
(249,013
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.45
|
)
|
$
|
(0.42
|
)
|
$
|
(1.40
|
)
|
$
|
(1.34
|
)
|
$
|
(11.29
|
)
|
|
Weighted
average shares used in computing basic and diluted net loss
per common share
|
43,619,523
|
43,177,962
|
43,561,160
|
41,474,449
|
22,048,706
|
Common stock
|
Additional
paid-in |
|||||||||
Shares
|
Amount
|
capital
|
||||||||
Balance
at December 31, 2006
|
43,516,669
|
$
|
44
|
$
|
312,078
|
|||||
Changes
during the period:
|
||||||||||
Cancellation
of common stock held in escrow
|
(15,646
|
)
|
(—
|
)* |
—
|
|||||
Issuance
of restricted stock
|
175,000
|
—
|
* |
—
|
||||||
Forfeiture
of restricted stock
|
(83,334
|
)
|
(—
|
)* |
—
|
|||||
Surrender
of common stock for tax withholding
|
—
|
—
|
—
|
|||||||
Exercise
of options
|
138,412
|
—
|
* |
271
|
||||||
Compensation
in respect of options, restricted stock and warrants granted to
employees,
directors and third-parties
|
—
|
—
|
8,101
|
|||||||
Net
loss
|
—
|
—
|
—
|
|||||||
Balance
at September 30, 2007
|
43,731,101
|
$
|
44
|
$
|
320,450
|
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:
|
|||||||||||||
Cancellation
of common stock held in escrow
|
—
|
—
|
—
|
(—
|
)* | ||||||||
Issuance
of restricted stock
|
—
|
—
|
—
|
—
|
* | ||||||||
Forfeiture
of restricted stock
|
—
|
—
|
—
|
(—
|
)* | ||||||||
Surrender
of common stock for tax withholding
|
23,848
|
(268
|
)
|
—
|
(268
|
)
|
|||||||
Exercise
of options
|
—
|
—
|
—
|
271
|
|||||||||
Compensation
in respect of options, restricted stock and warrants granted to
employees,
directors and third-parties
|
—
|
—
|
—
|
8,101
|
|||||||||
Net
loss
|
—
|
—
|
(60,801
|
)
|
(60,801
|
)
|
|||||||
Balance
at September 30, 2007
|
79,948
|
$
|
(357
|
)
|
$
|
(249,013
|
)
|
$
|
71,124
|
Nine months ended
September 30, |
Amounts
accumulated
during the
development
|
|||||||||
2007
|
2006
|
stage
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(60,801
|
)
|
$
|
(55,417
|
)
|
$
|
(249,013
|
)
|
|
Adjustments
to reconcile cash flows used in operating activities:
|
||||||||||
Acquired
in-process research and development
|
—
|
—
|
18,800
|
|||||||
Stock
compensation expense
|
8,101
|
14,045
|
36,188
|
|||||||
Issuance
of common stock to technology licensor
|
—
|
—
|
359
|
|||||||
Interest
on convertible notes settled through issuance of preferred
shares
|
—
|
—
|
253
|
|||||||
Depreciation
and amortization
|
116
|
171
|
2,951
|
|||||||
(Gain)
loss on disposal of property, plant and equipment
|
(1
|
)
|
—
|
171
|
||||||
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
|
651
|
(404
|
)
|
(925
|
)
|
|||||
Decrease
(increase) in accrued interest receivable
|
72
|
(150
|
)
|
(453
|
)
|
|||||
(Increase)
in license receivable
|
(12,000
|
)
|
—
|
(12,000
|
)
|
|||||
(Increase)
in security deposits
|
—
|
(255
|
)
|
(263
|
)
|
|||||
(Decrease)
increase in accounts payable and accrued expenses
|
(117
|
)
|
3,002
|
8,598
|
||||||
(Decrease)
increase in accrued compensation and related liabilities
|
(425
|
)
|
(367
|
)
|
514
|
|||||
(Decrease)
increase in other liabilities
|
(69
|
)
|
(37
|
)
|
70
|
|||||
Increase
in deferred revenue
|
12,016
|
13
|
11,760
|
|||||||
Net
cash used in operating activities
|
(51,857
|
)
|
(39,399
|
)
|
(179,814
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Purchases
of property, plant and equipment
|
(2,963
|
)
|
(4,326
|
)
|
(15,951
|
)
|
||||
Proceeds
from disposals of property, plant and equipment
|
15
|
—
|
440
|
|||||||
Increase
in note and accrued interest receivable from related party
|
—
|
—
|
(356
|
)
|
||||||
Payments
of transaction costs
|
—
|
(231
|
)
|
(231
|
)
|
|||||
Decrease
(increase) in other assets
|
—
|
27
|
(1,192
|
)
|
||||||
Investment
in held-to-maturity short-term securities
|
(2,072
|
)
|
(4,049
|
)
|
(50,985
|
)
|
||||
Proceeds
from maturity of held-to-maturity short-term securities
|
20,006
|
6,573
|
72,027
|
|||||||
Investment
in available-for-sale short-term securities
|
(21,000
|
)
|
(36,375
|
)
|
(79,100
|
)
|
||||
Proceeds
from sale of available-for-sale short-term securities
|
40,100
|
5,225
|
56,500
|
|||||||
Investment
in held-to-maturity long-term securities
|
(2,330
|
)
|
(11,896
|
)
|
(40,277
|
)
|
||||
Proceeds
from maturity of held-to-maturity long-term securities
|
2
|
4
|
192
|
|||||||
Net
cash provided by (used in) investing activities
|
31,758
|
(45,048
|
)
|
(58,933
|
)
|
Nine months ended
September 30,
|
Amounts
accumulated
during the
development
|
|||||||||
2007
|
2006
|
stage
|
||||||||
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
|
—
|
82,696
|
158,487
|
|||||||
Proceeds
from private placements, net
|
—
|
—
|
45,795
|
|||||||
Proceeds
from exercise of options and warrants
|
271
|
1,481
|
9,120
|
|||||||
Purchase
of treasury stock
|
(268
|
)
|
—
|
(357
|
)
|
|||||
Net
cash provided by financing activities
|
3
|
84,177
|
267,382
|
|||||||
Cash
acquired in acquisition
|
—
|
5
|
99
|
|||||||
Effect
of exchange rate on cash
|
—
|
—
|
(94
|
)
|
||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(20,096
|
)
|
(265
|
)
|
28,640
|
|||||
Cash
and cash equivalents at beginning of year
|
48,736
|
68,175
|
—
|
|||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
28,640
|
$
|
67,910
|
$
|
28,640
|
||||
NON
- CASH TRANSACTIONS
|
||||||||||
Issuance
of common stock in connection with acquisition
|
$
|
—
|
$
|
3,310
|
$
|
9,635
|
||||
Contingent
equity rights in connection with acquisition
|
—
|
—
|
4,004
|
|||||||
Assumption
of liabilities in connection with acquisition
|
—
|
347
|
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
|
2,759,465
|
1,641,156
|
—
|
2,315,903
|
54,379
|
|||||||||||||||
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
|
3,648,507
|
131,037
|
66,666
|
1,556,149
|
153,790
|
|||||||||||||||
2006
CFO Incentive Plan
|
—
|
500,000
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
2007
CAO Inducement Plan
|
11.11
|
100,000
|
100,000
|
—
|
—
|
—
|
—
|
|||||||||||||||
2007
General Counsel Incentive Stock Option Plan
|
11.02
|
150,000
|
150,000
|
—
|
—
|
—
|
—
|
|||||||||||||||
2007
Incentive Plan
|
9.96
|
6,000,000
|
204,100
|
—
|
—
|
—
|
5,795,900
|
|||||||||||||||
22,677,657
|
10,542,724
|
5,436,198
|
66,666
|
7,052,704
|
6,004,069
|
* |
Exercise
price range excludes restricted
stock.
|
Outstanding
equity awards
|
||||||||||
Shares
available
for grant
|
Number
of shares
|
Weighted-
average
exercise price
|
||||||||
Balance,
December 31, 2006
|
152,158
|
10,849,713
|
$
|
7.82
|
||||||
Authorized
|
6,250,000
|
—
|
—
|
|||||||
Granted
|
(855,300
|
)
|
855,300
|
8.39
|
||||||
Exercised
|
—
|
(138,412
|
)
|
1.96
|
||||||
Restricted
stock vested
|
—
|
(66,666
|
)
|
—
|
||||||
Canceled
|
(500,000
|
)
|
—
|
—
|
||||||
Forfeited
and expired
|
957,211
|
(957,211
|
)
|
12.63
|
||||||
Balance,
September 30, 2007
|
6,004,069
|
10,542,724
|
$
|
7.56
|
||||||
Exercisable
at December 31, 2006
|
6,178,994
|
$
|
3.92
|
|||||||
Exercisable
at September 30, 2007
|
7,052,704
|
$
|
5.38
|
Number of
options
|
Exercise
price per
share
|
Weighted-average
exercise price
|
Weighted-average
remaining
contractual term
(years)
|
Aggregate
intrinsic value
|
||||||||||||
Outstanding
at December 31, 2006
|
10,749,713
|
$
|
0.10 –
$ 18.06
|
$
|
7.90
|
7.6
|
$
|
58,048,000
|
||||||||
Granted
|
680,300
|
9.96
– 11.11
|
10.54
|
|||||||||||||
Exercised
|
(138,412
|
)
|
0.10
– 9.25
|
1.96
|
||||||||||||
Forfeited
and expired
|
(873,877
|
)
|
1.92
– 18.00
|
13.83
|
||||||||||||
Outstanding
at September 30, 2007
|
10,417,724
|
$
|
0.10
– 18.06
|
$
|
7.65
|
7.0
|
$
|
23,857,000
|
||||||||
Vested
and expected to vest at
September
30, 2007
|
10,323,355
|
$
|
0.10
– 18.06
|
$
|
7.61
|
7.0
|
$
|
24,053,000
|
||||||||
Exercisable
at September 30, 2007
|
7,052,704
|
$
|
0.10
– 18.06
|
$
|
5.38
|
6.4
|
$
|
32,160,000
|
Number of
shares
|
Average
grant date
fair value
|
||||||
Nonvested
at December 31, 2006
|
100,000
|
$
|
15.30
|
||||
Granted
|
175,000
|
10.47
|
|||||
Vested
|
(66,666
|
)
|
12.09
|
||||
Forfeited
|
(83,334
|
)
|
15.30
|
||||
Nonvested
at September 30, 2007
|
125,000
|
$
|
10.26
|
Warrants
|
Weighted-
average
exercise price
|
||||||
Outstanding
at December 31, 2006
|
321,976
|
$
|
4.65
|
||||
Issued
|
—
|
—
|
|||||
Exercised
|
—
|
—
|
|||||
Canceled
|
—
|
—
|
|||||
Outstanding
at September 30, 2007
|
321,976
|
$
|
4.65
|
Revenue
|
||||||||||||||||
Three months ended September 30,
|
Nine months ended September 30,
|
Amounts
accumulated
during the development
|
||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
stage
|
|||||||||||
Diagnostics
|
$
|
—
|
$
|
35
|
$
|
66
|
$
|
58
|
$
|
169
|
||||||
Services
|
11
|
39
|
37
|
375
|
1,851
|
|||||||||||
Products
|
41
|
—
|
41
|
—
|
41
|
|||||||||||
Total
|
$
|
52
|
$
|
74
|
$
|
144
|
$
|
433
|
$
|
2,061
|
Operating
loss
|
||||||||||||||||
Three months ended September 30,
|
Nine months ended September 30,
|
Amounts
accumulated
during the development
|
||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
Stage
|
|||||||||||
Diagnostics
|
$
|
(26
|
)
|
$
|
(348
|
)
|
$
|
(722
|
)
|
$
|
(762
|
)
|
$
|
(1,738
|
)
|
|
Services
|
(17
|
)
|
10
|
(53
|
)
|
77
|
(283
|
)
|
||||||||
Products
|
(20,502
|
)
|
(19,517
|
)
|
(63,684
|
)
|
(59,475
|
)
|
(263,521
|
)
|
||||||
Total
|
$
|
(20,545
|
)
|
$
|
(19,855
|
)
|
$
|
(64,459
|
)
|
$
|
(60,160
|
)
|
$
|
(265,542
|
)
|
Net
loss
|
||||||||||||||||
Three months ended September 30,
|
Nine months ended September 30,
|
Amounts
accumulated
during the
development
|
||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
stage
|
|||||||||||
Operating
loss of reportable segments
|
$
|
(20,545
|
)
|
$
|
(19,855
|
)
|
$
|
(64,459
|
)
|
$
|
(60,160
|
)
|
$
|
(265,542
|
)
|
|
Interest
and other income
|
1,017
|
1,862
|
3,658
|
4,743
|
17,020
|
|||||||||||
Income
taxes
|
—
|
—
|
—
|
—
|
(491
|
)
|
||||||||||
Consolidated
net loss
|
$
|
(19,528
|
)
|
$
|
(17,993
|
)
|
$
|
(60,801
|
)
|
$
|
(55,417
|
)
|
$
|
(249,013
|
)
|
Goodwill
|
|||||||
(in
thousands)
|
September 30, 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
3 & Phase 4
|
||
Zerenex™
|
Hyperphosphatemia
in patients with end-stage
renal disease
|
Phase
2
|
||
Oncology
|
||||
KRX-0401
|
Multiple
forms of cancer
|
Phase
2
|
||
KRX-0402
|
Brain
cancer
|
Phase
2
|
||
KRX-0601
|
Multiple
forms of cancer
|
Phase
2
|
||
KRX-0404
|
Multiple
forms of cancer
|
Pre-clinical
|
||
Neurology
|
||||
KRX-0701
|
Diabetic
neuropathy
|
Phase
2
|
||
KRX-0501
|
Neurological
disorders
|
Phase
1
|
· |
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, and incorporated herein
by
reference.
|
3.3
|
Amendment
to Amended and Restated Certificate of Incorporation of Keryx
Biopharmaceuticals, Inc., dated July 24, 2007. Filed as Exhibit 3.3
to the
Registrant's Quarterly Report on Form 10-Q for the quarter ended
June 30,
2007, filed on August 9, 2007 and incorporated herein by
reference.
|
|
10.1*
|
Sub-license
Agreement by and among Keryx Biopharmaceuticals, Inc., Japan Tobacco
Inc.,
and Torii Pharmaceutical Co., Ltd. dated September 26,
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
November 9, 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
November 9, 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
November
9,
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
November
9,
2007.
|
|
KERYX
BIOPHARMACEUTICALS, INC.
|
|
|
|
|
Date:
November
9, 2007
|
By:
|
/s/
Mark Stier
|
|
Chief
Accounting Officer
|
|
|
Principal
Financial Officer
|
10.1*
|
Sub-license
Agreement by and among Keryx Biopharmaceuticals, Inc., Japan Tobacco
Inc.,
and Torii Pharmaceutical Co., Ltd. dated September 26,
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
November 9, 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
November 9,
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
November
9,
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
November 9,
2007.
|