x
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
|
SECURITIES
EXCHANGE ACT OF 1934
|
For
the quarterly period ended June 30, 2008
|
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.)
|
Large
accelerated filer £
|
Accelerated
filer x
|
Non-accelerated
filer £
(Do not check if smaller reporting company)
|
Smaller
reporting company £
|
Page
|
||
SPECIAL
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING
STATEMENTS
|
1
|
|
PART
I
|
FINANCIAL
INFORMATION
|
2
|
Item
1
|
Financial
Statements
|
2
|
Consolidated
Balance Sheets as of June 30, 2008 (unaudited) and December
31, 2007
|
2
|
|
Consolidated
Statements of Operations for the three and six months ended
June 30, 2008 and 2007 (unaudited)
|
3
|
|
Consolidated
Statement of Changes in Stockholders’ Equity for
the six months ended June 30, 2008 (unaudited)
|
4
|
|
Consolidated
Statements of Cash Flows for the six months ended
June 30, 2008 and 2007 (unaudited)
|
5
|
|
Notes
to Consolidated Financial Statements (unaudited)
|
7
|
|
Item
2
|
Management's
Discussion and Analysis of Financial Condition and Results
of Operations
|
17
|
Item
3
|
Quantitative
and Qualitative Disclosures About Market Risk
|
27
|
Item
4
|
Controls
and Procedures
|
28
|
PART
II
|
OTHER
INFORMATION
|
28
|
Item
1
|
Legal
Proceedings
|
28
|
Item
1A
|
Risk
Factors
|
30
|
Item
4
|
Submission
of Matters to a Vote of Security Holders
|
40
|
Item
6
|
Exhibits
|
40
|
·
|
expectations
for increases or decreases in expenses;
|
·
|
expectations
for the development, manufacturing, regulatory approval, and
commercialization of ZerenexTM
(ferric citrate), 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;
|
·
|
ability
to continue to satisfy the listing requirements of the NASDAQ Stock
Market; and
|
·
|
expectations
for future capital requirements.
|
June 30, 2008
|
December 31, 2007
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
14,037
|
$
|
19,065
|
|||
Short-term
investment securities
|
10,325
|
43,038
|
|||||
Interest
receivable
|
99
|
283
|
|||||
Other
current assets
|
1,201
|
1,330
|
|||||
Total
current assets
|
25,662
|
63,716
|
|||||
Long-term
investment securities
|
10,125
|
2,296
|
|||||
Property,
plant and equipment, net
|
254
|
11,497
|
|||||
Goodwill
|
3,208
|
3,208
|
|||||
Other
assets, net
|
102
|
344
|
|||||
Total
assets
|
$
|
39,351
|
$
|
81,061
|
|||
Liabilities
and stockholders’ equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
9,704
|
$
|
19,134
|
|||
Accrued
compensation and related liabilities
|
864
|
1,254
|
|||||
Current
portion of deferred revenue
|
1,495
|
1,023
|
|||||
Total
current liabilities
|
12,063
|
21,411
|
|||||
Deferred
revenue, net of current portion
|
17,962
|
11,022
|
|||||
Contingent
equity rights
|
4,004
|
4,004
|
|||||
Other
liabilities
|
156
|
202
|
|||||
Total
liabilities
|
34,185
|
36,639
|
|||||
Commitments
and contingencies (Note 6)
|
|||||||
Stockholders’
equity
|
|||||||
Preferred
stock, $0.001 par value per share (5,000,000 shares authorized,
no shares
issued and outstanding)
|
—
|
—
|
|||||
Common
stock, $0.001 par value per share (95,000,000 shares authorized,
45,163,007 and 43,751,101 shares issued, 45,083,059 and 43,671,153
shares
outstanding at June 30, 2008 and December 31, 2007,
respectively)
|
45
|
44
|
|||||
Additional
paid-in capital
|
325,985
|
323,009
|
|||||
Treasury
stock, at cost, 79,948 shares at June 30, 2008 and December 31,
2007,
respectively
|
(357
|
)
|
(357
|
)
|
|||
Deficit
accumulated during the development stage
|
(320,507
|
)
|
(278,274
|
)
|
|||
Total
stockholders’ equity
|
5,166
|
44,422
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
39,351
|
$
|
81,061
|
Three months ended
June 30,
|
Six months ended
June
30,
|
Amounts
accumulated
during the
development
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
stage
|
||||||||||||
Revenue:
|
||||||||||||||||
License
revenue
|
$
|
327
|
$
|
—
|
$
|
526
|
$
|
—
|
$
|
730
|
||||||
Diagnostic
revenue
|
—
|
36
|
—
|
66
|
169
|
|||||||||||
Service
revenue
|
62
|
14
|
62
|
26
|
1,928
|
|||||||||||
Other
revenue
|
—
|
—
|
—
|
—
|
1,027
|
|||||||||||
Total
revenue
|
389
|
50
|
588
|
92
|
3,854
|
|||||||||||
Operating
expenses:
|
||||||||||||||||
Cost
of diagnostics sold
|
—
|
16
|
—
|
38
|
178
|
|||||||||||
Cost
of services
|
14
|
30
|
14
|
62
|
2,182
|
|||||||||||
Research
and development:
|
||||||||||||||||
Non-cash
compensation
|
251
|
1,178
|
(729
|
)
|
2,173
|
17,083
|
||||||||||
Non-cash
acquired in-process research and development
|
—
|
—
|
—
|
—
|
18,800
|
|||||||||||
Other
research and development
|
4,243
|
15,685
|
35,071
|
33,131
|
229,993
|
|||||||||||
Total
research and development
|
4,494
|
16,863
|
34,342
|
35,304
|
265,876
|
|||||||||||
Selling,
general and administrative:
|
||||||||||||||||
Non-cash
compensation
|
1,767
|
1,407
|
3,484
|
3,413
|
24,419
|
|||||||||||
Other
selling, general and administrative
|
2,085
|
2,394
|
4,052
|
5,189
|
48,167
|
|||||||||||
Total
selling, general and administrative
|
3,852
|
3,801
|
7,536
|
8,602
|
72,586
|
|||||||||||
Total
operating expenses
|
8,360
|
20,710
|
41,892
|
44,006
|
340,822
|
|||||||||||
Operating
loss
|
(7,971
|
)
|
(20,660
|
)
|
(41,304
|
)
|
(43,914
|
)
|
(336,968
|
)
|
||||||
Interest
and other income (expense), net
|
274
|
1,200
|
(929
|
)
|
2,641
|
16,988
|
||||||||||
Net
loss before income taxes
|
(7,697
|
)
|
(19,460
|
)
|
(42,233
|
)
|
(41,273
|
)
|
(319,980
|
)
|
||||||
Income
taxes
|
—
|
—
|
—
|
—
|
527
|
|||||||||||
Net
loss
|
$
|
(7,697
|
)
|
$
|
(19,460
|
)
|
$
|
(42,233
|
)
|
$
|
(41,273
|
)
|
$
|
(320,507
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.17
|
)
|
$
|
(0.45
|
)
|
$
|
(0.96
|
)
|
$
|
(0.95
|
)
|
$
|
(13.66
|
)
|
|
Weighted
average shares used in computing basic and diluted net loss
per common share
|
44,095,873
|
43,556,475
|
43,906,974
|
43,531,495
|
23,469,443
|
Common
stock
|
Additional
paid-in
|
|||||||||
Shares
|
Amount
|
capital
|
||||||||
Balance
at December 31, 2007
|
43,751,101
|
$
|
44
|
$
|
323,009
|
|||||
Changes
during the period:
|
||||||||||
Issuance
of restricted stock
|
1,401,906
|
1
|
—
|
|||||||
Forfeiture
of restricted stock
|
(65,000
|
)
|
(—)
|
* |
—
|
|||||
Exercise
of options
|
75,000
|
—
|
* |
222
|
||||||
Compensation
in respect of options and restricted stock granted to employees,
directors
and third-parties
|
—
|
—
|
2,754
|
|||||||
Net
loss
|
—
|
—
|
—
|
|||||||
Balance
at June 30, 2008
|
45,163,007
|
$
|
45
|
$
|
325,985
|
Treasury stock
|
Deficit
accumulated
during the
development
|
||||||||||||
Shares
|
Amount
|
Stage
|
Total
|
||||||||||
Balance
at December 31, 2007
|
79,948
|
$
|
(357
|
)
|
$
|
(278,274
|
)
|
$
|
44,422
|
||||
Changes
during the period:
|
|||||||||||||
Issuance
of restricted stock
|
—
|
—
|
—
|
1
|
|||||||||
Forfeiture
of restricted stock
|
—
|
—
|
—
|
(—)
|
* | ||||||||
Exercise
of options
|
—
|
—
|
—
|
222
|
|||||||||
Compensation
in respect of options and restricted stock granted to employees,
directors
and third-parties
|
—
|
—
|
—
|
2,754
|
|||||||||
Net
loss
|
—
|
—
|
(42,233
|
)
|
(42,233
|
)
|
|||||||
Balance
at June 30, 2008
|
79,948
|
$
|
(357
|
)
|
$
|
(320,507
|
)
|
$
|
5,166
|
Six months ended
June
30,
|
Amounts
accumulated
during the
development
stage
|
|||||||||
2008
|
2007
|
|||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(42,233
|
)
|
$
|
(41,273
|
)
|
$
|
(320,507
|
)
|
|
Adjustments
to reconcile net loss to cash flows used in operating activities:
|
||||||||||
Acquired
in-process research and development
|
—
|
—
|
18,800
|
|||||||
Stock
compensation expense
|
2,755
|
5,586
|
41,502
|
|||||||
Issuance
of common stock to technology licensor
|
—
|
—
|
359
|
|||||||
Interest
on convertible notes settled through issuance of preferred
shares
|
—
|
—
|
253
|
|||||||
Depreciation
and amortization
|
69
|
84
|
3,055
|
|||||||
(Gain)
loss on disposal of property, plant and equipment
|
—
|
(1
|
)
|
171
|
||||||
Impairment
of investment securities
|
1,875
|
—
|
1,875
|
|||||||
Other
impairment charges
|
11,037
|
600
|
14,119
|
|||||||
Exchange
rate differences
|
—
|
—
|
94
|
|||||||
Changes
in assets and liabilities, net of effects of acquisitions:
|
||||||||||
Decrease
(increase) in other current assets
|
129
|
1,622
|
(729
|
)
|
||||||
Decrease
(increase) in accrued interest receivable
|
184
|
143
|
(99
|
)
|
||||||
Decrease
(increase) in security deposits
|
242
|
—
|
(21
|
)
|
||||||
(Decrease)
increase in accounts payable and accrued expenses
|
(9,130
|
)
|
(248
|
)
|
7,959
|
|||||
(Decrease)
increase in accrued compensation and related liabilities
|
(390
|
)
|
(928
|
)
|
269
|
|||||
(Decrease)
increase in other liabilities
|
(46
|
)
|
(46
|
)
|
1
|
|||||
Increase
(decrease) in deferred revenue
|
7,412
|
65
|
19,001
|
|||||||
Net
cash used in operating activities
|
(28,096
|
)
|
(34,396
|
)
|
(213,898
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Purchases
of property, plant and equipment
|
(163
|
)
|
(2,763
|
)
|
(16,310
|
)
|
||||
Proceeds
from disposals of property, plant and equipment
|
—
|
15
|
740
|
|||||||
Increase
in note and accrued interest receivable from related party
|
—
|
—
|
(356
|
)
|
||||||
Payments
of transaction costs
|
—
|
—
|
(231
|
)
|
||||||
Increase
in other assets
|
—
|
—
|
(1,192
|
)
|
||||||
Investment
in held-to-maturity short-term securities
|
(32
|
)
|
(2,034
|
)
|
(55,081
|
)
|
||||
Proceeds
from maturity of held-to-maturity short-term securities
|
12,842
|
8,504
|
88,883
|
|||||||
Investment
in available-for-sale short-term securities
|
(12,000
|
)
|
(10,000
|
)
|
(126,800
|
)
|
||||
Proceeds
from sale of available-for-sale short-term securities
|
22,200
|
18,750
|
114,800
|
|||||||
Investment
in held-to-maturity long-term securities
|
(1
|
)
|
(2,329
|
)
|
(44,320
|
)
|
||||
Proceeds
from maturity of held-to-maturity long-term securities
|
—
|
2
|
193
|
|||||||
Net
cash provided by (used in) investing activities
|
22,846
|
10,145
|
(39,674
|
)
|
Six
months ended
June
30,
|
Amounts
accumulated
during
the
development
stage
|
|||||||||
2008
|
2007
|
|||||||||
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
|
—
|
—
|
158,487
|
|||||||
Proceeds
from private placements, net
|
—
|
—
|
45,795
|
|||||||
Proceeds
from exercise of options and warrants
|
222
|
203
|
9,342
|
|||||||
Purchase
of treasury stock
|
—
|
(268
|
)
|
(357
|
)
|
|||||
Net
cash provided by financing activities
|
222
|
(65
|
)
|
267,604
|
||||||
Cash
acquired in acquisition
|
—
|
—
|
99
|
|||||||
Effect
of exchange rate on cash
|
—
|
—
|
(94
|
)
|
||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(5,028
|
)
|
(24,316
|
)
|
14,037
|
|||||
Cash
and cash equivalents at beginning of period
|
19,065
|
48,736
|
—
|
|||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
14,037
|
$
|
24,420
|
$
|
14,037
|
||||
NON
- CASH TRANSACTIONS
|
||||||||||
Sale
of manufacturing facility assets
|
$
|
300
|
$
|
— |
$
|
300
|
||||
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
|
$
|
—
|
$
|
—
|
$
|
468
|
(in thousands)
|
June 30, 2008
|
December 31, 2007
|
|||||
Short-term
investment securities:
|
|||||||
Obligations
of domestic governmental agencies (mature between October 2008
and May
2009) (held-to-maturity)
|
$
|
10,325
|
$
|
20,838
|
|||
Auction
rate securities (mature between 2031 and 2047)
(available-for-sale)
|
—
|
22,200
|
|||||
Total
short-term investment securities
|
$
|
10,325
|
$
|
43,038
|
|||
Long-term
investment securities:
|
|||||||
Obligations
of domestic governmental agencies
(held-to-maturity)
|
$
|
—
|
$
|
2,296
|
|||
Auction
rate securities (mature between 2031 and 2047)
(available-for-sale)
|
10,125
|
—
|
|||||
Total
long-term investment securities
|
$
|
10,125
|
$
|
2,296
|
· |
Level
1 – quoted prices in active markets for identical assets and
liabilities;
|
· |
Level
2 – inputs other than Level 1 quoted prices that are directly or
indirectly observable; and
|
· |
Level
3 – unobservable inputs that are not corroborated by market
data.
|
Financial assets at fair value
as of June 30, 2008
|
||||||||||
(in thousands)
|
Level
1
|
Level
2
|
Level
3
|
|||||||
Money
market funds (1)
|
$
|
11,014
|
$
|
—
|
$
|
—
|
||||
Short-term
investment securities (held-to-maturity) (2)
|
10,325
|
—
|
—
|
|||||||
Auction
rate securities (3)
|
—
|
—
|
10,125
|
|||||||
Total
|
$
|
21,339
|
$
|
—
|
$
|
10,125
|
||||
(1)
|
Included
in cash and cash equivalents on the Company’s consolidated balance sheet.
The carrying amount of money market funds is a reasonable estimate
of fair
value.
|
(2)
|
Amortized cost approximates fair value. |
(3)
|
Included
in long-term investment securities on the Company’s consolidated balance
sheet.
|
(in thousands)
|
Available-for-sale
long-term
investments
|
|||
Balance
at January 1, 2008
|
$
|
—
|
||
Transfer
into Level 3 (1)
|
12,000
|
|||
Total
unrealized losses included in net loss
|
(1,811
|
)
|
||
Balance
at March 31, 2008
|
$
|
10,189
|
||
Total
unrealized losses included in net loss
|
(64
|
)
|
||
Balance
at June 30, 2008
|
$
|
10,125
|
(1) |
Based
on deteriorated market conditions experienced in the first quarter
of
2008, the Company changed the fair value measurement methodology
of its
auction rate securities portfolio that the Company classifies as
available-for-sale from quoted prices in active markets to a discounted
cash flow model. Accordingly, these securities were re-classified
from
Level 1 to Level 3.
|
Number
of shares
|
Weighted-
average
exercise price
|
Weighted-
average
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||||||||
(in
years)
|
|||||||||||||
Outstanding
at December 31, 2007
|
10,869,173
|
$
|
7.69
|
||||||||||
Granted
|
243,800
|
4.28
|
|||||||||||
Exercised
|
(75,000
|
)
|
2.96
|
$
|
259,900
|
||||||||
Forfeited
|
(1,205,214
|
)
|
10.35
|
||||||||||
Expired
|
(308,119
|
)
|
8.54
|
||||||||||
Outstanding
at June 30, 2008
|
9,524,640
|
$
|
7.27
|
6.0
|
$
|
119,804
|
|||||||
Vested
and expected to vest at June 30, 2008
|
9,466,026
|
$
|
7.25
|
6.0
|
$
|
119,794
|
|||||||
Exercisable
at June 30, 2008
|
7,644,167
|
$
|
6.24
|
5.4
|
$
|
119,504
|
Number
of
Shares
|
Weighted
Average
Grant
Date
Fair
Value
|
Aggregate
Intrinsic
Value
|
||||||||
Outstanding
at December 31, 2007
|
138,334
|
$
|
10.09
|
|||||||
Granted
|
1,401,906
|
0.52
|
||||||||
Vested
|
(50,000
|
)
|
10.17
|
$
|
24,500
|
|||||
Forfeited
|
(65,000
|
)
|
10.37
|
|||||||
Outstanding
at June 30, 2008
|
1,425,240
|
$
|
0.66
|
$
|
698,368
|
Warrants
|
Weighted-
average
exercise
price
|
Aggregate
Intrinsic
Value |
||||||||
Outstanding
at December 31, 2007
|
321,976
|
$
|
4.65
|
|||||||
Issued
|
—
|
—
|
||||||||
Exercised
|
—
|
—
|
||||||||
Canceled
|
—
|
—
|
||||||||
Outstanding
at June 30, 2008
|
321,976
|
$
|
4.65
|
$
|
35,070
|
Black-Scholes
Option Valuation Assumptions
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Risk-free
interest rates
|
2.9%
|
|
4.7%
|
|
2.6%
|
|
4.7%
|
|
|||||
Dividend
yield
|
—
|
—
|
—
|
—
|
|||||||||
Volatility
|
111.0%
|
|
71.4%
|
|
76.3%
|
|
71.6%
|
|
|||||
Weighted-average
expected term
|
2.0
years
|
4.4
years
|
4.3
years
|
4.5
years
|
Six months ended
|
||||
(in thousands)
|
June
30, 2008
|
|||
Research
and development
|
||||
Impairment
of manufacturing facility
|
$
|
11,037
|
||
Manufacturing
facility restoration
|
2,063
|
|||
Severance
|
624
|
|||
Non-cash
compensation
|
(1,569
|
)
|
||
Total
research and development
|
12,155
|
|||
Selling,
general and administrative
|
||||
Severance
|
99
|
|||
Total
selling, general and administrative
|
99
|
|||
Total
restructuring costs
|
$
|
12,254
|
(in thousands)
|
||||
Restructuring
liabilities at December 31, 2007
|
$
|
—
|
||
Manufacturing
facility restoration
|
2,063
|
|||
Accrued
severance
|
723
|
|||
Restructuring
liabilities at March 31, 2008
|
$
|
2,786
|
||
Payment
of manufacturing facility restoration
|
(2,063
|
)
|
||
Payment
of severance
|
(395
|
)
|
||
Restructuring
liabilities at June 30, 2008
|
$
|
328
|
Payment
due by period
|
||||||||||||||||
Contractual
obligations
|
Total
|
Less than
1 year
|
1-3
years
|
3-5
years
|
More than
5 years
|
|||||||||||
Research
and development agreements
|
$
|
1,290,000
|
$
|
1,290,000
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
Operating
leases
|
1,386,000
|
629,000
|
757,000
|
—
|
—
|
|||||||||||
Total
|
$
|
2,676,000
|
$
|
1,919,000
|
$
|
757,000
|
$
|
—
|
$
|
—
|
Revenue
|
||||||||||||||||
Three months ended June 30,
|
Six months ended June 30,
|
Amounts
accumulated
during the
development
|
||||||||||||||
(in thousands)
|
2008
|
2007
|
2008
|
2007
|
Stage
|
|||||||||||
Diagnostics
|
$
|
—
|
$
|
36
|
$
|
—
|
$
|
66
|
$
|
169
|
||||||
Services
|
62
|
14
|
62
|
26
|
1,928
|
|||||||||||
Products
|
327
|
—
|
526
|
—
|
1,757
|
|||||||||||
Total
|
$
|
389
|
$
|
50
|
$
|
588
|
$
|
92
|
$
|
3,854
|
Operating
loss
|
||||||||||||||||
Three months ended June 30,
|
Six months ended June 30,
|
Amounts
accumulated
during the
development
|
||||||||||||||
(in thousands)
|
2008
|
2007
|
2008
|
2007
|
Stage
|
|||||||||||
Diagnostics
|
$
|
(8
|
)
|
$
|
(21
|
)
|
$
|
(89
|
)
|
$
|
(695
|
)
|
$
|
(1,861
|
)
|
|
Services
|
48
|
(16
|
)
|
48
|
(36
|
)
|
(254
|
)
|
||||||||
Products
|
(8,011
|
)
|
(20,623
|
)
|
(41,263
|
)
|
(43,183
|
)
|
(334,852
|
)
|
||||||
Total
|
$
|
(7,971
|
)
|
$
|
(20,660
|
)
|
$
|
(41,304
|
)
|
$
|
(43,914
|
)
|
$
|
(336,967
|
)
|
Net
loss
|
||||||||||||||||
Three months ended June 30,
|
Six months ended June 30,
|
Amounts
accumulated
during the
development
|
||||||||||||||
(in thousands)
|
2008
|
2007
|
2008
|
2007
|
Stage
|
|||||||||||
Operating
losses of reportable segments
|
$
|
(7,971
|
)
|
$
|
(20,660
|
)
|
$
|
(41,304
|
)
|
$
|
(43,914
|
)
|
$
|
(336,968
|
)
|
|
Interest
and other income (expense), net
|
274
|
1,200
|
(929
|
)
|
2,641
|
16,988
|
||||||||||
Income
taxes
|
—
|
—
|
—
|
—
|
(527
|
)
|
||||||||||
Consolidated
net loss
|
$
|
(7,697
|
)
|
$
|
(19,460
|
)
|
$
|
(42,233
|
)
|
$
|
(41,273
|
)
|
$
|
(320,507
|
)
|
Assets
(1)
|
|||||||
As of
|
As of
|
||||||
(in thousands)
|
June 30,
2008
|
December 31, 2007
|
|||||
Diagnostics
|
$
|
84
|
$
|
87
|
|||
Services
|
—
|
—
|
|||||
Products
|
4,681
|
16,293
|
|||||
Total
assets of reportable segments
|
4,765
|
16,380
|
|||||
Cash,
cash equivalents, interest receivable and investment
securities
|
34,586
|
64,681
|
|||||
Consolidated
total assets
|
$
|
39,351
|
$
|
81,061
|
(1)
|
Assets
for our reportable segments include fixed assets, goodwill, as
well as
accounts receivable and inventory.
|
Goodwill
|
|||||||
(in thousands)
|
June 30, 2008
|
December 31, 2007
|
|||||
Diagnostics
|
$
|
—
|
$
|
—
|
|||
Services
|
—
|
—
|
|||||
Products
|
3,208
|
3,208
|
|||||
Total
|
$
|
3,208
|
$
|
3,208
|
|||
Product
candidate
|
Target
indication
|
Development
status
|
Endocrine/Renal
|
||
Zerenex™
(ferric citrate)
|
Hyperphosphatemia
in patients with
end-stage
renal disease
|
Phase
2
|
Oncology
|
||
KRX-0401
(perifosine)
|
Multiple
forms of cancer
|
Phase
2
|
KRX-0404
(ErPC)
|
Multiple
forms of cancer
|
Pre-clinical
|
Neurology
|
||
KRX-0701
(dexlipotam)
|
Diabetic
neuropathy
|
Phase
2
|
KRX-0501
|
Neurological
disorders
|
Phase
1
|
Response
|
N
|
Median Duration of Therapy (wks)
|
|||||
Partial
Response
|
2 (5%)
|
|
60+,
24+
|
||||
Minimal
Response
|
10 (28%)
|
|
36
(range 9 - 68+
|
)
|
|||
ORR
(PR + MR)
|
12 (33%)
|
|
|||||
Stable
Disease
|
22 (61%)
|
|
|||||
Progression
|
2 (5%)
|
|
Payment due by period
|
||||||||||||||||
Contractual obligations
|
Total
|
Less than
1 year
|
1-3
years
|
3-5
years
|
More than
5 years
|
|||||||||||
Research
and development agreements
|
$
|
1,290,000
|
$
|
1,290,000
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
Operating
leases
|
1,386,000
|
629,000
|
757,000
|
—
|
—
|
|||||||||||
Total
|
$
|
2,676,000
|
$
|
1,919,000
|
$
|
757,000
|
$
|
—
|
$
|
—
|
· |
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;
|
● |
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.
|
● |
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.
|
Nominee
|
Total Votes For
|
Total Votes Withheld
|
|||||
Kevin J.
Cameron
|
27,657,806
|
2,040,434
|
|||||
Wyche
Fowler, Jr.
|
27,610,045
|
2,088,195
|
|||||
Malcolm
Hoenlein
|
27,613,104
|
2,085,136
|
|||||
Jack
Kaye, CPA
|
27,524,902
|
2,173,338
|
|||||
Eric
Rose, M.D.
|
27,618,865
|
2,079,375
|
|||||
Michael
P. Tarnok
|
27,657,690
|
2,040,550
|
|||||
Michael
S. Weiss
|
26,017,050
|
3,681,190
|
Total
Votes For
|
Total
Votes Against
|
Abstention
and Broker Non-Votes
|
|||||
1,541,526
|
5,233,440
|
22,923,270
|
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, 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.
|
|
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 11, 2008.
|
|
|
|
|
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 11, 2008.
|
|
|
|
|
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
11, 2008.
|
|
|
|
|
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
11, 2008.
|
|
KERYX BIOPHARMACEUTICALS, INC.
|
|
|
|
|
Date:
August
11, 2008
|
By:
|
/s/
James F. Oliviero
|
|
Vice
President, Finance
|
|
|
Principal Financial and Accounting Officer
|
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 11, 2008.
|
|
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 11, 2008.
|
|
|
|
|
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
11, 2008.
|
|
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
11, 2008.
|