x
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
|
SECURITIES
EXCHANGE ACT OF 1934
|
For
the quarterly period ended June 30, 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
|
2
|
|
PART
I
|
FINANCIAL
INFORMATION
|
3
|
Item
1
|
Financial
Statements
|
3
|
Consolidated
Balance Sheets as of June 30, 2007 (unaudited) and
December
31, 2006
|
3
|
|
Consolidated
Statements of Operations for the three and six months
ended
June 30, 2007 and 2006 (unaudited)
|
4
|
|
Consolidated
Statement of Changes in Stockholders’ Equity
for
the six months ended June 30, 2007 (unaudited)
|
5
|
|
Consolidated
Statements of Cash Flows for the six months
ended
June 30, 2007 and 2006 (unaudited)
|
6
|
|
Notes
to Consolidated Financial Statements (unaudited)
|
8
|
|
Item
2
|
Management's
Discussion and Analysis of Financial Condition and
Results
of Operations
|
15
|
Item
3
|
Quantitative
and Qualitative Disclosures About Market Risk
|
26
|
Item
4
|
Controls
and Procedures
|
26
|
PART
II
|
OTHER
INFORMATION
|
26
|
Item
1
|
Legal
Proceedings
|
26
|
Item
1A
|
Risk
Factors
|
27
|
Item
4
|
Submission
of Matters to a Vote of Security Holders
|
38
|
Item
6
|
Exhibits
|
39
|
· |
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.
|
June
30, 2007
|
December
31, 2006
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
24,420
|
$
|
48,736
|
|||
Short-term
investment securities
|
61,162
|
63,659
|
|||||
Accrued
interest receivable
|
382
|
525
|
|||||
Other
current assets
|
426
|
2,048
|
|||||
Total
current assets
|
86,390
|
114,968
|
|||||
Long-term
investment securities
|
2,294
|
12,690
|
|||||
Property,
plant and equipment, net
|
11,168
|
8,489
|
|||||
Goodwill
|
3,208
|
3,208
|
|||||
Other
assets, net
|
344
|
958
|
|||||
Total
assets
|
$
|
103,404
|
$
|
140,313
|
|||
Liabilities
and stockholders’ equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
10,212
|
$
|
10,460
|
|||
Accrued
compensation and related liabilities
|
606
|
1,534
|
|||||
Deferred
revenue
|
265
|
200
|
|||||
Total
current liabilities
|
11,083
|
12,194
|
|||||
Contingent
equity rights
|
4,004
|
4,004
|
|||||
Other
liabilities
|
248
|
294
|
|||||
Total
liabilities
|
15,335
|
16,492
|
|||||
Stockholders’
equity
|
|||||||
Common
stock, $0.001 par value per share (95,000,000 and 60,000,000 shares
authorized,
43,661,101
and 43,516,669 shares issued, 43,581,153 and 43,460,569 shares outstanding
at
June
30, 2007, and December 31, 2006, respectively)
|
44
|
44
|
|||||
Additional
paid-in capital
|
317,867
|
312,078
|
|||||
Treasury
stock, at cost, 79,948 and 56,100 shares at June 30, 2007, and December
31, 2006, respectively
|
(357
|
)
|
(89
|
)
|
|||
Deficit
accumulated during the development stage
|
(229,485
|
)
|
(188,212
|
)
|
|||
Total
stockholders’ equity
|
88,069
|
123,821
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
103,404
|
$
|
140,313
|
Three
months ended
June
30,
|
Six
months ended
June
30,
|
Amounts
accumulated
during
the
development
|
||||||||||||||
2007
|
2006
|
2007
|
2006
|
stage
|
||||||||||||
Revenue:
|
||||||||||||||||
Diagnostic
revenue
|
$
|
36
|
$
|
23
|
$
|
66
|
$
|
23
|
$
|
169
|
||||||
Service
revenue
|
14
|
224
|
26
|
336
|
1,840
|
|||||||||||
Management
fees from related party
|
--
|
--
|
--
|
--
|
300
|
|||||||||||
Total
revenue
|
50
|
247
|
92
|
359
|
2,309
|
|||||||||||
Operating
expenses:
|
||||||||||||||||
Cost
of diagnostics sold
|
16
|
19
|
38
|
19
|
178
|
|||||||||||
Cost
of services
|
30
|
98
|
62
|
269
|
2,106
|
|||||||||||
Research
and development:
|
||||||||||||||||
Non-cash
compensation
|
1,178
|
2,104
|
2,173
|
4,828
|
16,411
|
|||||||||||
Non-cash
acquired in-process research
and
development
|
--
|
--
|
--
|
--
|
18,800
|
|||||||||||
Other
research and development
|
15,685
|
12,352
|
33,131
|
24,685
|
153,164
|
|||||||||||
Total
research and development
|
16,863
|
14,456
|
35,304
|
29,513
|
188,375
|
|||||||||||
Selling,
general and administrative:
|
||||||||||||||||
Non-cash
compensation
|
1,407
|
3,541
|
3,413
|
6,358
|
17,262
|
|||||||||||
Other
selling, general and administrative
|
2,394
|
1,860
|
5,189
|
4,505
|
39,385
|
|||||||||||
Total
selling, general and administrative
|
3,801
|
5,401
|
8,602
|
10,863
|
56,647
|
|||||||||||
Total
operating expenses
|
20,710
|
19,974
|
44,006
|
40,664
|
247,306
|
|||||||||||
Operating
loss
|
(20,660
|
)
|
(19,727
|
)
|
(43,914
|
)
|
(40,305
|
)
|
(244,997
|
)
|
||||||
Interest
and other income, net
|
1,200
|
1,899
|
2,641
|
2,881
|
16,003
|
|||||||||||
Net
loss before income taxes
|
(19,460
|
)
|
(17,828
|
)
|
(41,273
|
)
|
(37,424
|
)
|
(228,994
|
)
|
||||||
Income
taxes
|
--
|
--
|
--
|
--
|
491
|
|||||||||||
Net
loss
|
$
|
(19,460
|
)
|
$
|
(17,828
|
)
|
$
|
(41,273
|
)
|
$
|
(37,424
|
)
|
$
|
(229,485
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.45
|
)
|
$
|
(0.41
|
)
|
$
|
(0.95
|
)
|
$
|
(0.92
|
)
|
$
|
(10.66
|
)
|
|
Weighted
average shares used in
computing
basic and diluted net
loss
per common share
|
43,556,475
|
43,117,656
|
43,531,495
|
40,608,571
|
21,530,982
|
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
|
165,000
|
--*
|
--
|
|||||||
Forfeiture
of restricted stock
|
(83,334
|
)
|
(--)*
|
--
|
||||||
Surrender
of common stock for tax withholding
|
--
|
--
|
--
|
|||||||
Exercise
of options
|
78,412
|
--*
|
203
|
|||||||
Compensation
in respect of options,
restricted
stock and warrants granted
to
employees, directors and third-parties
|
--
|
--
|
5,586
|
|||||||
Net
loss
|
--
|
--
|
--
|
|||||||
Balance
at June 30, 2007
|
43,661,101
|
$
|
44
|
$
|
317,867
|
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
|
--
|
--
|
--
|
203
|
|||||||||
Compensation
in respect of options,
restricted
stock and warrants granted
to
employees, directors and third-parties
|
--
|
--
|
--
|
5,586
|
|||||||||
Net
loss
|
--
|
--
|
(41,273
|
)
|
(41,273
|
)
|
|||||||
Balance
at June 30, 2007
|
79,948
|
$
|
(357
|
)
|
$
|
(229,485
|
)
|
$
|
88,069
|
Six
months ended
June
30,
|
Amounts
accumulated
during
the
development
|
|||||||||
2007
|
2006
|
stage
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(41,273
|
)
|
$
|
(37,424
|
)
|
$
|
(229,485
|
)
|
|
Adjustments
to reconcile cash flows used in operating activities:
|
||||||||||
Acquired
in-process research and development
|
--
|
--
|
18,800
|
|||||||
Stock
compensation expense
|
5,586
|
11,186
|
33,673
|
|||||||
Issuance
of common stock to technology licensor
|
--
|
--
|
359
|
|||||||
Interest
on convertible notes settled through issuance of preferred shares
|
--
|
--
|
253
|
|||||||
Depreciation
and amortization
|
84
|
120
|
2,919
|
|||||||
(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
|
1,622
|
(1,524
|
)
|
46
|
||||||
Decrease
(increase) in accrued interest receivable
|
143
|
(86
|
)
|
(382
|
)
|
|||||
(Increase)
in security deposits
|
--
|
(241
|
)
|
(263
|
)
|
|||||
(Decrease)
increase in accounts payable and accrued expenses
|
(248
|
)
|
625
|
8,467
|
||||||
(Decrease)
increase in accrued compensation and related liabilities
|
(928
|
)
|
(558
|
)
|
11
|
|||||
(Decrease)
increase in other liabilities
|
(46
|
)
|
(34
|
)
|
93
|
|||||
Increase
(decrease) in deferred revenue
|
65
|
81
|
(191
|
)
|
||||||
Net
cash used in operating activities
|
(34,396
|
)
|
(27,855
|
)
|
(162,353
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Purchases
of property, plant and equipment
|
(2,763
|
)
|
(1,798
|
)
|
(15,751
|
)
|
||||
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
|
--
|
(145
|
)
|
(231
|
)
|
|||||
Decrease
(increase) in other assets
|
--
|
27
|
(1,192
|
)
|
||||||
Investment
in held-to-maturity short-term securities
|
(2,034
|
)
|
(4,011
|
)
|
(50,947
|
)
|
||||
Proceeds
from maturity of held-to-maturity short-term securities
|
8,504
|
1,071
|
60,525
|
|||||||
Investment
in available-for-sale short-term securities
|
(10,000
|
)
|
(30,825
|
)
|
(68,100
|
)
|
||||
Proceeds
from sale of available-for-sale short-term securities
|
18,750
|
175
|
35,150
|
|||||||
Investment
in held-to-maturity long-term securities
|
(2,329
|
)
|
(7,822
|
)
|
(40,276
|
)
|
||||
Proceeds
from maturity of held-to-maturity long-term securities
|
2
|
4
|
192
|
|||||||
Net
cash provided by (used in) investing activities
|
10,145
|
(43,324
|
)
|
(80,546
|
)
|
Six
months ended
June
30,
|
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
|
--
|
82,696
|
158,487
|
|||||||
Proceeds
from private placements, net
|
--
|
--
|
45,795
|
|||||||
Proceeds
from exercise of options and warrants
|
203
|
1,361
|
9,052
|
|||||||
Purchase
of treasury stock
|
(268
|
)
|
--
|
(357
|
)
|
|||||
Net
cash (used in) provided by financing activities
|
(65
|
)
|
84,057
|
267,314
|
||||||
Cash
acquired in acquisition
|
--
|
5
|
99
|
|||||||
Effect
of exchange rate on cash
|
--
|
--
|
(94
|
)
|
||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(24,316
|
)
|
12,883
|
24,420
|
||||||
Cash
and cash equivalents at beginning of year
|
48,736
|
68,175
|
--
|
|||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
24,420
|
$
|
81,058
|
$
|
24,420
|
||||
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
|
2,819,465
|
1,581,156
|
--
|
2,291,455
|
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
|
3,721,445
|
131,037
|
66,666
|
1,444,615
|
80,852
|
|||||||||||||||
2006
CFO Incentive Plan
|
15.30
|
500,000
|
180,556
|
--
|
--
|
180,556
|
--
|
|||||||||||||||
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
|
--
|
6,000,000
|
--
|
--
|
--
|
--
|
6,000,000
|
|||||||||||||||
22,677,657
|
10,652,118
|
5,376,198
|
66,666
|
7,097,278
|
6,135,231
|
Outstanding
equity awards
|
||||||||||
Shares
available
|
Number
of
shares
|
Weighted-
average
exercise
price
|
||||||||
Balance,
December 31, 2006
|
152,158
|
10,849,713
|
$
|
7.82
|
||||||
Authorized
|
6,250,000
|
--
|
--
|
|||||||
Granted
|
(651,200
|
)
|
651,200
|
8.05
|
||||||
Exercised
|
--
|
(78,412
|
)
|
2.59
|
||||||
Restricted
stock vested
|
--
|
(66,666
|
)
|
--
|
||||||
Canceled
|
(319,444
|
)
|
--
|
--
|
||||||
Forfeited
and expired
|
703,717
|
(703,717
|
)
|
12.18
|
||||||
Balance,
June 30, 2007
|
6,135,231
|
10,652,118
|
$
|
7.64
|
||||||
Exercisable
at December 31, 2006
|
6,178,994
|
$
|
3.92
|
|||||||
Exercisable
at June 30, 2007
|
7,097,278
|
$
|
5.36
|
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
|
486,200
|
10.12
- 11.11
|
10.78
|
|||||||||||||
Exercised
|
(78,412
|
)
|
0.10
- 9.25
|
2.59
|
||||||||||||
Forfeited
and expired
|
(620,383
|
)
|
1.92
- 18.00
|
13.82
|
||||||||||||
Outstanding
at June 30, 2007
|
10,537,118
|
$
|
0.10
- 18.06
|
$
|
7.72
|
7.0
|
$
|
21,601,000
|
||||||||
Vested
and expected to vest at June 30,
2007
|
10,441,030
|
$
|
0.10
- 18.06
|
$
|
7.68
|
7.0
|
$
|
21,822,000
|
||||||||
Exercisable
at June 30, 2007
|
7,097,278
|
$
|
0.10
- 18.06
|
$
|
5.36
|
6.4
|
$
|
31,299,000
|
Number
of shares
|
Average
grant
date
fair
value
|
||||||
Nonvested
at December 31, 2006
|
100,000
|
$
|
15.30
|
||||
Granted
|
165,000
|
10.50
|
|||||
Vested
|
(66,666
|
)
|
12.09
|
||||
Forfeited
|
(83,334
|
)
|
15.30
|
||||
Nonvested
at June 30, 2007
|
115,000
|
$
|
10.28
|
Warrants
|
Weighted-
average
exercise
price
|
||||||
Outstanding
at December 31, 2006
|
321,976
|
$
|
4.65
|
||||
Issued
|
--
|
--
|
|||||
Exercised
|
--
|
--
|
|||||
Canceled
|
--
|
--
|
|||||
Outstanding
at June 30, 2007
|
321,976
|
$
|
4.65
|
Revenue
|
||||||||||||||||
Three
months ended June 30,
|
Six
months ended June 30,
|
Amounts
accumulated during the development
|
||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
stage
|
|||||||||||
Diagnostics
|
$
|
36
|
$
|
23
|
$
|
66
|
$
|
23
|
$
|
169
|
||||||
Services
|
14
|
224
|
26
|
336
|
1,840
|
|||||||||||
Products
|
--
|
--
|
--
|
--
|
--
|
|||||||||||
Total
|
$
|
50
|
$
|
247
|
$
|
92
|
$
|
359
|
$
|
2,009
|
Operating
loss
|
||||||||||||||||
Three
months ended June 30,
|
Six
months ended June 30,
|
Amounts
accumulated during the development
|
||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
stage
|
|||||||||||
Diagnostics
|
$
|
(21
|
)
|
$
|
(414
|
)
|
$
|
(695
|
)
|
$
|
(414
|
)
|
$
|
(1,712
|
)
|
|
Services
|
(16
|
)
|
126
|
(36
|
)
|
67
|
(266
|
)
|
||||||||
Products
|
(20,623
|
)
|
(19,439
|
)
|
(43,183
|
)
|
(39,958
|
)
|
(243,019
|
)
|
||||||
Total
|
$
|
(20,660
|
)
|
$
|
(19,727
|
)
|
$
|
(43,914
|
)
|
$
|
(40,305
|
)
|
$
|
(244,997
|
)
|
Net
loss
|
||||||||||||||||
Three
months ended June 30,
|
Six
months ended June 30,
|
Amounts
accumulated during the development
|
||||||||||||||
(in
thousands)
|
2007
|
2006
|
2007
|
2006
|
stage
|
|||||||||||
Operating
loss of
reportable
segments
|
$
|
(20,660
|
)
|
$
|
(19,727
|
)
|
$
|
(43,914
|
)
|
$
|
(40,305
|
)
|
$
|
(244,997
|
)
|
|
Interest
and other income
|
1,200
|
1,899
|
2,641
|
2,881
|
16,003
|
|||||||||||
Income
taxes
|
--
|
--
|
--
|
--
|
(491
|
)
|
||||||||||
Consolidated
net loss
|
$
|
(19,460
|
)
|
$
|
(17,828
|
)
|
$
|
(41,273
|
)
|
$
|
(37,424
|
)
|
$
|
(229,485
|
)
|
Goodwill
|
|||||||
(in
thousands)
|
June
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
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-0701
|
Diabetic
neuropathy
|
Phase
II
|
KRX-0501
|
Neurological
disorders
|
Phase
I
|
Placebo
|
200
mg/day
sulodexide
|
400
mg/day
sulodexide
|
|
Number
of Patients
|
39
|
42
|
49
|
Number
of Patients with Therapeutic
Success
|
6
|
14
|
9
|
Proportion
or Percentage
|
15%
|
33%
|
18%
|
95%
Confidence Interval
|
6%
- 31%
|
20%
- 50%
|
9%
- 32%
|
Treatment
Comparison
|
Outcome
|
%
of Events
Placebo
|
%
of Events
200
mg/day
|
Odds
Ratio
|
p
Values
|
200
mg/day vs. Placebo
|
Normalization
|
7.7%
|
16.7%
|
2.40
|
0.315
|
200
mg/day vs. Placebo
|
50%
Reduction
|
12.8%
|
28.6%
|
2.72
|
0.105
|
200
mg/day vs. Placebo
|
Therapeutic
Success
|
15.4%
|
33.3%
|
2.75
|
0.075
|
Placebo
|
200
mg/day
sulodexide
|
400
mg/day
sulodexide
|
|
Proportion
or Percentage
|
7.9%
|
22.0%
|
13.0%
|
95%
Confidence Interval
|
1.7%
- 21.4%
|
10.6%
- 37.6%
|
4.9%
- 26.3%
|
Treatment
Group
|
Baseline
|
2-Month
|
4-Month
|
6-Month
(End
of
Treatment)
|
Post-Treatment
|
Placebo
(n= 39)
|
73
|
70
|
78
|
85
|
87
|
200
mg/day (n= 42)
|
74
|
58
|
65
|
57
|
66
|
400
mg/day (n= 49)
|
67
|
70
|
67
|
73
|
74
|
Any
Adverse Event
|
Serious
Adverse Event
|
Possibly
Related Adverse Event
|
||||||||||
Treatment
|
N
|
%
of
Patients
|
N
of Events
|
N
|
%
of
Patients
|
N
of Events
|
N
|
%
of
Patients
|
N
of Events
|
|||
Placebo
(n= 47)
|
38
|
81%
|
102
|
4
|
9%
|
4
|
5
|
11%
|
9
|
|||
200
mg/d (n= 50)
|
46
|
92%
|
174
|
16
|
36%
|
20
|
7
|
14%
|
11
|
|||
400
mg/d (n= 52
|
42
|
81%
|
114
|
4
|
10%
|
4
|
11
|
21%
|
14
|
· |
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.
|
● |
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.
|
● |
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.
|
Nominee
|
Total
Votes For
|
Total
Votes Withheld
|
|||||
Kevin
J. Cameron
|
35,006,731
|
1,698,997
|
|||||
Wyche
Fowler, Jr.
|
32,015,455
|
4,750,273
|
|||||
I.
Craig Henderson, M.D.
|
26,178,380
|
10,587,348
|
|||||
Malcolm
Hoenlein
|
31,861,536
|
4,904,192
|
|||||
Jack
Kaye, CPA
|
35,006,831
|
1,698,897
|
|||||
Eric
Rose, M.D.
|
35,068,956
|
1,696,772
|
|||||
Michael
S. Weiss
|
26,310,648
|
10,455,080
|
Total
Votes For
|
|
Total
Votes Against
|
|
Abstention
and Broker Non-Votes
|
|||
36,494,013
|
266,175
|
5,540
|
Total
Votes For
|
|
Total
Votes Against
|
|
Abstention
and Broker Non-Votes
|
|||
33,832,449
|
2,925,829
|
7,447
|
Total
Votes For
|
|
Total
Votes Against
|
|
Abstention
and Broker Non-Votes
|
|||
15,509,140
|
12,730,425
|
8,526,163
|
The
exhibits listed on the Exhibit Index are included with this report.
|
||
|
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.
|
|
3.3
|
Amendment
to Amended and Restated Certificate of Incorporation of Keryx
Biopharmaceuticals, Inc., dated July 24, 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
August 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
August 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
August
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
August
9,
2007.
|
|
|
|
|
KERYX
BIOPHARMACEUTICALS, INC.
|
|
|
|
|
Date:
August 9,
2007
|
By:
|
/s/
Mark Stier
|
|
Chief
Accounting Officer
|
|
|
Principal
Financial Officer
|
3.3
|
Amendment
to Amended and Restated Certificate of Incorporation of Keryx
Biopharmaceuticals, Inc., dated July 24, 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
August
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
August
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
August
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
August
9,
2007.
|