x |
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the fiscal year ended December 31,
2007.
|
¨ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the transition period from ________ to
________.
|
Delaware
|
13-4087132
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
750
Lexington Avenue
New
York, New York
|
10022
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Common
Stock, Par Value $0.001 Per Share
(Title
of Class)
|
NASDAQ
Global Market
(Name
of Each Exchange on Which
Registered)
|
Accelerated
filer x
|
|
Non-accelerated
filer o
|
Smaller
reporting company o
|
|
Page
|
|
SPECIAL
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
|
1
|
|
PART
I
|
||
ITEM
1
|
Business
|
2
|
ITEM
1A
|
Risk
Factors
|
24
|
ITEM
1B
|
Unresolved
Staff Comments
|
34
|
ITEM
2
|
Properties
|
34
|
ITEM
3
|
Legal
Proceedings
|
34
|
ITEM
4
|
Submission
of Matters to a Vote of Security Holders
|
35
|
PART
II
|
||
ITEM
5
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
35
|
ITEM
6
|
Selected
Financial Data
|
38
|
ITEM
7
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
39
|
ITEM
7A
|
Quantitative
and Qualitative Disclosure About Market Risk
|
49
|
ITEM
8
|
Financial
Statements and Supplementary Data
|
49
|
ITEM
9
|
Changes
in and Disagreements With Accountants on Accounting and Financial
Disclosures
|
50
|
ITEM
9A
|
Controls
and Procedures
|
50
|
ITEM
9B
|
Other
Information
|
50
|
PART
III
|
||
ITEM
10
|
Directors,
Executive Officers and Corporate Governance
|
50
|
ITEM
11
|
Executive
Compensation
|
50
|
ITEM
12
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
50
|
ITEM
13
|
Certain
Relationships and Related Transactions and Director
Independence
|
51
|
ITEM
14
|
Principal
Accountant Fees and Services
|
51
|
PART
IV
|
||
ITEM
15
|
Exhibits
and Financial Statement Schedules
|
52
|
·
|
expectations
for increases or decreases in expenses;
|
·
|
expectations
for the development, manufacturing, regulatory approval, and
commercialization of SulonexTM
(sulodexide), 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; and
|
·
|
expectations
for future capital requirements.
|
Product
candidate
|
Target
indication
|
Development
status
|
Endocrine/Renal
|
||
Sulonex™
(sulodexide)
|
Diabetic
nephropathy
|
Phase
3 & Phase 4
|
Zerenex™
(ferric citrate)
|
Hyperphosphatemia
in patients with
end-stage renal disease |
Phase
2
|
Oncology
|
||
KRX-0401
(perifosine)
|
Renal
cancer and other multiple forms of cancer
|
Phase
2
|
KRX-0402
(O6-benzylguanine)
or (O6-BG)
|
Brain
cancer
|
Phase
2
|
KRX-0601
(7-hydroxystaurosporine)
|
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
|
● |
seek
to acquire medically important, novel drug candidates in late pre-clinical
or early clinical development;
|
● |
utilize
our clinical development capabilities to manage and drive our drug
candidates through the clinical development process to approval;
and
|
● |
commercialize
our drug candidates, either alone or in partnership, which we believe
is
important to provide maximum shareholder
value.
|
● |
complete
the analysis of our pivotal Phase 3 trial and continue our Phase
4 program
for Sulonex;
|
● |
prepare
a New Drug Application for Sulonex (sulodexide) for filing with the
FDA;
|
● |
if
we meet the primary objective of our pivotal Phase 3 trial for Sulonex,
develop the commercial infrastructure required to manufacture, market
and
sell our drug candidates following approval, if any, by the
FDA;
|
● |
launch
a Phase 3 study for KRX-0401 (perifosine) in patients with advanced
renal
cell carcinoma;
|
● |
continue
to build our clinical development and regulatory capabilities and
conduct
additional pre-clinical, toxicology and clinical trials for our portfolio
products, including Zerenex, KRX-0401, KRX-0402, KRX-0501, KRX-0601
and
KRX-0701; and
|
● |
seek
to in-license or acquire additional compounds.
|
· |
The
delicate filtering membranes of the glomerular loops thicken and
their
crucial anionic glycosaminoglycan molecules are either depleted or
altered
and lose some or all of their negative charge. Since the negative
charge
of the glycosaminoglycan components is believed to provide selectivity
to
the filtration process by the glomerular membranes, this loss of
negative
charge results in the release of protein, usually albumin, from the
blood
into the filtrate and urine. The release of abnormal amounts of protein
or
albumin into the urine is called proteinuria or albuminuria,
respectively.
|
· |
In
addition, hyperglycemia induced overproduction of TGF beta, a regulatory
protein, by the kidney induces the accumulation of Type IV collagen
resulting in scar formation in the area surrounding the glomerular
capillaries. Over time, the extrinsic pressure of this scar tissue
causes
collapse of individual glomeruli, loss of functionality and release
of
albumin into the filtrate and
urine.
|
(1) |
50%
reduction in albumin to creatinine ratio or ACR (ACR is a standard
measurement used to assess the level of kidney disease in these patients.
ACR measures the level of albumin protein in urine, also referred
to as
albuminuria), or
|
(2) |
Normalization
of ACR with at least a 25% reduction in ACR (in this study the normal
laboratory range for albuminuria was defined as less than 20mg of
albumin
to 1g of creatinine).
|
Placebo
|
|
200
mg/day sulodexide
|
|
400
mg/day sulodexide
|
||||||
Number
of Patients
|
39
|
42
|
49
|
|||||||
Number
of Patients with Therapeutic Success at 6 Months
|
6
|
14
|
9
|
|||||||
Proportion
or Percentage
|
15.4%
|
|
33.3%
|
|
18.4%
|
|
||||
95%
Confidence Interval
|
6%
- 31%
|
|
20%
- 50%
|
|
9%
- 32%
|
|
Treatment
Comparison
|
Outcome
|
|
%
of
Outcome
Placebo
|
|
%
of
Outcome
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
|
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
|
Placebo
n=38
|
|
200
mg/day sulodexide
n=41
|
|
400
mg/day sulodexide
n=46
|
|
|||||
Proportion
or Percentage
|
7.9%
|
|
22.0%
|
|
13.0%
|
|
||||
95%
Confidence Interval
|
1.7%
- 21.4%
|
|
10.6%
- 37.6%
|
|
4.9%
- 26.3%
|
|
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
|
Placebo
(n=16)
|
|
2g/day
(n=31)
|
|
4g/day
(n=32)
|
|
6g/day
(n=32)
|
|
||||||
Day
0 (Baseline)*
|
7.2
(1.4
|
)
|
7.2
(1.2
|
)
|
7.1
(1.3
|
)
|
7.3
(1.3
|
)
|
|||||
Day
28 (End of Treatment Period)*
|
7.2
(1.2
|
)
|
6.9
(2.2
|
)
|
6.0
(1.3
|
)
|
5.8
(1.8
|
)
|
|||||
Placebo
Comparison:
|
|||||||||||||
Mean
Difference from Placebo
|
-0.02
|
-1.1
|
-1.5
|
||||||||||
P-value
|
NS
|
0.06
|
0.0119
|
||||||||||
Baseline
Comparison:
|
|||||||||||||
Mean
Difference from Baseline
|
-0.1
|
-0.3
|
-1.1
|
-1.5
|
|||||||||
P-value
|
NS
|
NS
|
NS
|
<0.01
|
|||||||||
*mean
(standard deviation)
|
Placebo
(n=16)
|
|
2g/day
(n=31)
|
|
4g/day
(n=32)
|
|
6g/day
(n=32)
|
|
||||||
Day
0 (Baseline)*
|
62.8
(13.9
|
)
|
62.9
(13.2
|
)
|
63.5
(10.7
|
)
|
65.8
(12.2
|
)
|
|||||
Day
28 (End of Treatment Period)*
|
63.2
(12.6
|
)
|
61.7
(21.3
|
)
|
55.4
(13.4
|
)
|
54.1
(17.7
|
)
|
|||||
Placebo
Comparison:
|
|||||||||||||
Mean
Difference from Placebo
|
-0.9
|
-7.91
|
-11.4
|
||||||||||
P-value
|
0.8950
|
0.1375
|
0.0378
|
||||||||||
Baseline
Comparison:
|
|||||||||||||
Mean
Difference from Baseline
|
-0.3
|
-1.1
|
-8.1
|
-11.7
|
|||||||||
P-value
|
NS
|
NS
|
NS
|
<0.01
|
|||||||||
*mean
(standard deviation)
|
Serum
Phosphorous
|
||||||||||
Baseline
(mg/dL)
|
|
End-Point
(Four
Weeks) (mg/dL)
|
|
Change
from
Baseline
|
|
|||||
Ferric
Citrate
(Zerenex™)
(4.5 g/day)
|
7.2
+/- 2.5
|
5.9
+/- 2.0
|
P<0.005
|
|||||||
Calcium
Acetate
(PhosLo®)
(4 g/day)
(1)
|
7.2
+/- 2.0
|
5.6
+/- 1.7
|
P<0.005
|
Serum
Phosphorous
|
||||||||||
Baseline
(mg/dL)
|
|
End-Point
(Four
Weeks) (mg/dL)
|
|
Change
from
Baseline
|
|
|||||
Ferric
Citrate
(Zerenex™)
(3 g/day)
|
6.7
+/- 1.9
|
5.7
+/- 1.6
|
P<0.001
|
|||||||
Calcium
Carbonate
(3
g/day)
(1)
|
7.2
+/- 1.9
|
5.2
+/- 1.5
|
P<0.001
|
Number
of Patients
|
||||||||||
All
Doses
|
|
Lower
Doses
50 or 100 mg Daily
|
|
Higher
Doses
900
or 1200 mg Weekly
|
|
|||||
Total
enrolled, all tumor types
|
416
|
205
|
211
|
|||||||
Renal
Cell Cancers
|
24
|
12
|
12
|
|||||||
Evaluable
for response*
|
13
|
7
|
6
|
|||||||
Partial
response (RECIST)
|
4
|
|
2
|
2
|
||||||
Durations
of response (months)
|
4,
7, 9, 12
|
7,
12
|
4,
9
|
|||||||
Stable
≥ 6 months
|
4
|
3
|
1
|
|||||||
Duration
stable disease (months)
|
10,
13, 14, 18+
|
10,
13, 14
|
18+
|
|||||||
Response
rate†
|
31%
|
|
29%
|
|
33%
|
|
||||
Clinical
benefit rate ††
|
62%
|
|
71%
|
|
50%
|
|
* |
Patients
with measurable disease on study for at least 2 months and at least
one
tumor measurement after initiation of
perifosine
|
+ |
Patient
had not yet progressed at the time of the
analysis
|
† |
RECIST
criteria
|
†† |
PR
or Stable for ≥6
months
|
Number
(%)
|
|
Duration of Response
(Weeks)
|
|
||||
Perifosine
Alone
|
|||||||
Evaluable
for response
|
50
|
||||||
Response
|
|||||||
MR
|
1
(2%)
|
|
24
|
||||
Stable
Disease*
|
33
(66%)
|
|
6
- 45+ (median 10)
|
|
|||
|
|||||||
Perifosine
+ Dexamethasone
|
|||||||
Evaluable
for response
|
29
|
||||||
Response
|
|||||||
PR
|
4(14%)
|
|
36,
39, 63+, 64+
|
||||
MR
|
6
(21%)
|
|
15,
18, 19, 28+, 30, 70
|
||||
Stable
Disease*
|
15
(52%)
|
|
6
- 31 (median 14)
|
|
Product
candidate
|
Target
indication |
Development
status |
Completion
of
phase
|
Estimated
cost
to complete phase |
Endocrine/Renal
|
||||
Sulonex™
(sulodexide)
|
Diabetic
nephropathy
|
Phase
3
|
1st
Qtr. 2008
|
Approximately
$3
million
|
Phase
4
|
Not
estimable
|
Not
estimable
|
||
Zerenex™
(ferric citrate)
|
Hyperphosphatemia
in
patients
with
end-stage
renal
disease
|
Phase
2
|
Late
2008 /
Early
2009
|
Approximately
$6
million
|
Oncology
|
||||
KRX-0401
(perifosine)
|
Renal
cancer and other multiple
forms of cancer |
Phase
2
|
Not
estimable
|
Not
estimable
|
KRX-0402
(O6-benzylguanine)
or
(O6-BG) |
Brain
cancer
|
Phase
2
|
Not
estimable
|
Not
estimable
|
KRX-0601
(7-hydroxystaurosporine)
|
Multiple
forms of cancer
|
Phase
2
|
Not
estimable
|
Not
estimable
|
KRX-0404
(ErPC)
|
Multiple
forms of cancer
|
Pre-clinical
|
Not
estimable
|
Not
estimable
|
Neurology
|
||||
KRX-0701
(dexlipotam)
|
Diabetic
neuropathy
|
Phase
2
|
Not
estimable
|
Not
estimable
|
KRX-0501
|
Neurological
disorders
|
Phase
1
|
2009
|
Approximately
$2
million
|
· |
that
the drug is intended to treat a serious or life-threatening
condition;
|
· |
that
the drug is intended to treat a serious aspect of the condition;
and
|
· |
that
the drug has the potential to address unmet medical needs, and this
potential is being evaluated in the planned drug development
program.
|
· |
Phase
1:
The drug is administered to a small group of humans, either healthy
volunteers or patients, to test for safety, dosage tolerance, absorption,
metabolism, excretion, and clinical pharmacology.
|
· |
Phase
2:
Studies are conducted on a larger number of patients to assess the
efficacy of the product, to ascertain dose tolerance and the optimal
dose
range, and to gather additional data relating to safety and potential
adverse events.
|
· |
Phase
3:
Studies establish safety and efficacy in an expanded patient population.
|
· |
Phase
4:
The FDA may require Phase 4 post-marketing studies to find out more
about
the drug’s long-term risks, benefits, and optimal use, or to test the drug
in different populations.
|
· |
slow
patient enrollment due to the nature of the clinical trial plan,
the
proximity of patients to clinical sites, the eligibility criteria
for
participation in the study or other
factors;
|
· |
inadequately
trained or insufficient personnel at the study site to assist in
overseeing and monitoring clinical trials or delays in approvals
from a
study site’s review board;
|
· |
longer
treatment time required to demonstrate efficacy or determine the
appropriate product dose;
|
· |
insufficient
supply of the drug candidates;
|
· |
adverse
medical events or side effects in treated patients;
and
|
· |
ineffectiveness
of the drug candidates.
|
● |
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.
|
Fiscal
Year Ended December 31, 2007
|
High
|
Low
|
|||||
Fourth
Quarter
|
$
|
11.14
|
$
|
8.40
|
|||
Third
Quarter
|
$
|
11.05
|
$
|
8.27
|
|||
Second
Quarter
|
$
|
11.64
|
$
|
9.77
|
|||
First
Quarter
|
$
|
13.27
|
$
|
10.19
|
Fiscal
Year Ended December 31, 2006
|
High
|
Low
|
|||||
Fourth
Quarter
|
$
|
14.77
|
$
|
11.96
|
|||
Third
Quarter
|
$
|
14.84
|
$
|
9.60
|
|||
Second
Quarter
|
$
|
18.19
|
$
|
12.54
|
|||
First
Quarter
|
$
|
19.16
|
$
|
14.95
|
Equity
Compensation Plan
Information
|
||||||||||
Plan
Category
|
Number of
securities to be
issued upon
exercise of
outstanding options
|
Weighted-average
exercise price of
outstanding
options
|
Number of
securities
remaining
available for
future issuance
under equity
compensation
plans (excluding
securities reflected
in column (a))
|
|||||||
(a)
|
(b)
|
(c)
|
||||||||
Equity
compensation plans approved by security holders
|
7,616,516
|
$
|
9.05
|
5,507,620
|
||||||
Equity
compensation plans not approved by security holders
|
3,252,657
|
$
|
4.49
|
—
|
||||||
Total
|
10,869,173
|
$
|
7.69
|
5,507,620
|
Years
ended December 31,
|
||||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
(in
thousands, except per share data)
|
||||||||||||||||
Statement
of Operations Data:
|
||||||||||||||||
License
revenue
|
$
|
204
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
Diagnostic
revenue
|
66
|
103
|
—
|
—
|
—
|
|||||||||||
Service
revenue
|
52
|
431
|
574
|
809
|
—
|
|||||||||||
Other
revenue
|
727
|
—
|
—
|
—
|
—
|
|||||||||||
Total
revenue
|
1,049
|
534
|
574
|
809
|
—
|
|||||||||||
Operating
expenses:
|
||||||||||||||||
Cost
of diagnostics sold
|
38
|
140
|
—
|
—
|
—
|
|||||||||||
Cost
of services
|
124
|
390
|
819
|
835
|
—
|
|||||||||||
Research
and development:
|
||||||||||||||||
Non-cash
compensation
|
3,574
|
6,504
|
594
|
413
|
(486
|
)
|
||||||||||
Non-cash
acquired in-process research and
development
|
—
|
—
|
—
|
18,800
|
—
|
|||||||||||
Other
research and development
|
74,889
|
56,139
|
24,182
|
9,805
|
5,996
|
|||||||||||
Total
research and development
|
78,463
|
62,643
|
24,776
|
29,018
|
5,510
|
|||||||||||
Selling,
general and administrative:
|
||||||||||||||||
Non-cash
compensation
|
7,086
|
8,408
|
775
|
1,087
|
188
|
|||||||||||
Other
selling, general and administrative
|
9,919
|
9,110
|
3,416
|
3,581
|
3,684
|
|||||||||||
Total
selling, general and administrative
|
17,005
|
17,518
|
4,191
|
4,668
|
3,872
|
|||||||||||
Total
operating expenses
|
95,630
|
80,691
|
29,786
|
34,521
|
9,382
|
|||||||||||
Operating
loss
|
(94,581
|
)
|
(80,157
|
)
|
(29,212
|
)
|
(33,712
|
)
|
(9,382
|
)
|
||||||
Other
income (expense):
|
||||||||||||||||
Interest
and other income, net
|
4,555
|
6,393
|
2,317
|
770
|
247
|
|||||||||||
Income
taxes
|
(36
|
)
|
—
|
—
|
(1
|
)
|
27
|
|||||||||
Net
loss
|
$
|
(90,062
|
)
|
$
|
(73,764
|
)
|
$
|
(26,895
|
)
|
$
|
(32,943
|
)
|
$
|
(9,108
|
)
|
|
Net
loss per common share
|
||||||||||||||||
Basic
and diluted
|
$
|
(2.07
|
)
|
$
|
(1.76
|
)
|
$
|
(0.78
|
)
|
$
|
(1.10
|
)
|
$
|
(0.43
|
)
|
|
|
As
of December 31,
|
|||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
|
(in
thousands)
|
|||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, interest receivable and
investment securities
|
$
|
64,682
|
$
|
125,610
|
$
|
100,733
|
$
|
49,878
|
$
|
31,414
|
||||||
Working
capital
|
42,305
|
102,774
|
83,890
|
46,538
|
30,982
|
|||||||||||
Total
assets
|
81,061
|
140,313
|
105,097
|
50,862
|
32,223
|
|||||||||||
Deferred
revenue, net of current portion
|
11,022
|
—
|
—
|
—
|
—
|
|||||||||||
Other
liabilities
|
202
|
294
|
322
|
92
|
—
|
|||||||||||
Contingent
equity rights
|
4,004
|
4,004
|
4,004
|
4,004
|
—
|
|||||||||||
Total
stockholders’ equity
|
44,422
|
123,821
|
94,678
|
42,804
|
31,226
|
Years
ended December 31,
|
|||||||||||||
2007
|
2006
|
2005
|
Amounts accumulated
during the
development stage
|
||||||||||
Sulonex
|
$
|
49,372,000
|
$
|
41,533,000
|
$
|
16,075,000
|
$
|
121,184,000
|
|||||
KRX-0401
|
15,210,000
|
8,508,000
|
5,394,000
|
31,342,000
|
|||||||||
Zerenex
|
4,825,000
|
1,531,000
|
450,000
|
—
|
|||||||||
Other
clinical stage compounds
|
3,990,000
|
2,410,000
|
1,143,000
|
14,972,000
|
|||||||||
Other
|
1,492,000
|
2,157,000
|
1,120,000
|
27,424,000
|
|||||||||
Total
|
$
|
74,889,000
|
$
|
56,139,000
|
$
|
24,182,000
|
$
|
194,922,000
|
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
|
$
|
46,529,000
|
$
|
23,910,000
|
$
|
22,619,000
|
$
|
--
|
$
|
--
|
||||||
Operating
leases
|
1,780,000
|
724,000
|
1,056,000
|
--
|
--
|
|||||||||||
Total
|
$
|
48,309,000
|
$
|
24,634,000
|
$
|
23,675,000
|
$
|
--
|
$
|
--
|
Contents
|
Page
|
Reports
of Independent Registered Public Accounting Firm
|
F-1
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-3
|
Consolidated
Statements of Operations for the years ended December 31, 2007, 2006
and
2005, and the period from December 3, 1996 to December 31,
2007
|
F-4
|
Consolidated
Statements of Changes in Stockholders’ Equity for the years ended December
31, 2007, 2006, and 2005, and the period from December 3, 1996 to
December
31, 2007
|
F-5
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2007, 2006
and
2005, and the period from December 3, 1996 to December 31,
2007
|
F-10
|
Notes
to the Consolidated Financial Statements
|
F-12
|
Exhibit
|
|
Number
|
Exhibit
Description
|
2.1
|
Agreement
and Plan of Merger by and among Keryx Biopharmaceuticals, Inc., AXO
Acquisition Corp., and ACCESS Oncology, Inc. dated as of January
7, 2004,
filed as Exhibit 2.1 to the Registrant’s Current Report on Form 8-K dated
January 8, 2004, filed on January 15, 2004 (File No. 000-30929), and
incorporated herein by reference.
|
|
|
2.2
|
First
Amendment to the Agreement and Plan of Merger by and among Keryx
Biopharmaceuticals, Inc., AXO Acquisition Corp., and ACCESS Oncology,
Inc.
dated as of February 5, 2004, filed as Exhibit 2.2 to the Registrant’s
Current Report on Form 8-K dated February 5, 2004, filed on February
20,
2004 (File No. 000-30929), and incorporated herein by
reference.
|
3.1
|
Amended
and Restated Certificate of Incorporation of Keryx Biopharmaceuticals,
Inc., filed as Exhibit 3.1 to the Registrant's Quarterly Report on
Form
10-Q for the quarter ended June 30, 2004, filed on August 12, 2004
(File
No. 000-30929), 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, 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.
|
4.1
|
Specimen
Common Stock Certificate, filed as Exhibit 4.1 to the Registrant’s First
Amendment to the Registration Statement on Form S-1 filed on June
30, 2000
(File No. 333-37402), and incorporated herein by
reference.
|
4.2
|
Form
of Warrant for the Purchase of Shares of Common Stock between certain
holders of Series A Preferred Stock and Keryx Biopharmaceuticals,
Inc.,
dated as of December 14, 1999, filed as Exhibit 4.9 to the Registrant’s
Registration Statement on Form S-1 filed on May 19, 2000 (File No.
333-37402), and incorporated herein by reference.
|
4.3
|
Form
of Common Stock Purchase Warrant dated November 20, 2003, issued
to the
purchasers under the Securities Purchase Agreement, filed as Exhibit
10.3
to the Registrant’s Registration Statement on Form S-3 filed on December
12, 2003 (File No. 333-111143), and incorporated herein by
reference.
|
4.4
|
Securities
Purchase Agreement dated November 12, 2003 among Keryx Biopharmaceuticals,
Inc. and the Purchasers identified on the signature pages thereof,
filed
as Exhibit 10.1 to the Company’s Registration Statement on Form S-3 filed
on December 12, 2003 (File No. 333-111143), and incorporated herein
by
reference.
|
|
|
4.5
|
Registration
Rights Agreement dated November 17, 2003 among Keryx Biopharmaceuticals,
Inc. and the Purchasers identified on the signature pages thereof,
filed
as Exhibit 10.2 to the Registrant’s Registration Statement on Form S-3
filed on December 12, 2003 (File No. 333-111143), and incorporated
herein
by reference.
|
4.6
|
Securities
Purchase Agreement dated February 12, 2004 among Keryx Biopharmaceuticals,
Inc. and the Purchasers identified on the signature pages thereof,
filed
as Exhibit 10.1 to the Company’s Registration Statement on Form S-3 filed
on March 16, 2004 (File No. 333-113654), and incorporated herein
by
reference.
|
|
|
4.7
|
Registration
Rights Agreement dated February 17, 2004 among Keryx Biopharmaceuticals,
Inc. and the Purchasers identified on the signature pages thereof,
filed
as Exhibit 10.2 to the Registrant’s Registration Statement on Form S-3
filed on March 16, 2004 (File No. 333-113654), and incorporated herein
by
reference.
|
10.1!
|
License
Agreement between Alfa Wassermann S.p.A. and Partec Ltd., dated as
of
November 12, 1998, filed as Exhibit 10.7 to the Registrant’s Second
Amendment to the Registration Statement on Form S-1 filed on July
24, 2000
(File No. 333-37402), and incorporated by reference.
|
|
|
10.2!
|
License
Agreement between Opocrin S.p.A. and Keryx Biopharmaceuticals, Inc.,
dated
September 25, 2002, filed as Exhibit 10.9 to the Registrant’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2002 filed
on
November 12, 2002 (File No. 000-30929), and incorporated herein by
reference.
|
|
|
10.3
|
Form
of Sulonex™ (KRX-101) Scientific Advisory Board Agreement, filed as
Exhibit 10.20 to the Registrant’s First Amendment to the Registration
Statement on Form S-1 filed on June 30, 2000 (File No. 333-37402),
and
incorporated herein be reference.
|
|
|
10.4†
|
Employment
Agreement between Keryx Biopharmaceuticals, Inc. and Michael S. Weiss
dated as of December 23, 2002, filed as Exhibit 10.1 to the Registrant’s
Quarterly Report of Form 10-Q for the quarter ended March 31, 2003
filed
on May 15, 2003 (File No. 000-30929), and incorporated herein by
reference.
|
|
|
10.5†
|
1999
Stock Option Plan, as amended, filed as Exhibit 10.2 to the Registrant’s
Quarterly Report of Form 10-Q for the quarter ended March 31, 2003
filed
on May 15, 2003 (File No. 000-30929) and incorporated herein by
reference.
|
|
|
10.6†
|
2000
Stock Option Plan, as amended, filed as Exhibit 10.3 to the Registrant’s
Quarterly Report of Form 10-Q for the quarter ended March 31, 2003
filed
on May 15, 2003 (File No. 000-30929) and incorporated herein by
reference.
|
|
|
10.7†
|
2002
CEO Incentive Stock Option Plan, filed as Exhibit 10.4 to the Registrant’s
Quarterly Report of Form 10-Q for the quarter ended March 31, 2003
filed
on May 15, 2003 (File No. 000-30929) and incorporated herein by
reference.
|
|
|
10.8
|
Sub-license
Agreement dated October 13, 2000 between Procept, Inc. and AOI
Pharmaceuticals, Inc.,
filed as Exhibit 10.32 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.9
|
Amendment
to Sub-license agreement dated February 28, 2002 between AOI
Pharmaceuticals, Inc. and Procept, Inc.,
filed as Exhibit 10.33 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.10
|
Patent
License Agreement dated February 28, 2002 between Procept, Inc. and
United
State Public Health Services, as amended,
filed as Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.11
|
Release
Agreement dated February 28, 2002 among AOI Pharmaceuticals, Inc.,
Procept, Inc., and United States Public Health Services,
filed as Exhibit 10.35 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.12
|
Comprehensive
Release Agreement dated May 29, 2002 among AOI Pharmaceuticals, Inc.,
Procept, Inc., United States Public Health Services and the University
of
Chicago,
filed as Exhibit 10.36 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.13!
|
Sub-license
Agreement between Prescient NeuroPharma, Inc. and ACCESS Oncology,
Inc.
dated December 24, 2001,
filed as Exhibit 10.37 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.14!
|
License
Agreement dated September 18, 2002 between Zentaris AG and AOI Pharma,
Inc,
filed as Exhibit 10.38 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.15!
|
Addendum
Agreement to License and Cooperation Agreement for Perifosine dated
December 3, 2003 between Zentaris AG and AOI Pharma, Inc.,
filed as Exhibit 10.39 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
|
|
10.16
|
Cooperative
Research and Development Agreement between the National Cancer Institute
and ASTA Medica Inc., as amended,
filed as Exhibit 10.40 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2003, filed on March 30, 2004, and
incorporated herein by reference.
|
10.17†
|
Keryx
Biopharmaceuticals, Inc. 2004 Long-Term Incentive Plan, filed with
the
Registrant’s Definitive Proxy Statement for the Annual Meeting of
Stockholders on June 10, 2004, filed on April 29, 2004, and incorporated
herein by reference.
|
10.18†
|
Employment
Agreement between Mark Stier and Keryx Biopharmaceuticals, Inc.,
dated as
of March 23, 2007, filed
as Exhibit 10.1 to the Registrant’s Annual Report on Form 10-Q for the
quarter ended March 31, 2007, filed on May 7, 2007, and incorporated
herein by reference.
.
|
10.19!
|
License
Agreement between Keryx Biopharmaceuticals, Inc. and Panion & BF
Biotech, Inc. dated as of November 7, 2005, filed
as Exhibit 10.21 to the Registrant’s Annual Report on Form 10-K for the
year ended December 31, 2005, filed on March 8, 2005, and incorporated
herein by reference.
|
10.20*
|
License
Agreement by and between Kyowa Hakko Kogyo Co., Ltd. and Keryx
Biopharmaceuticals, Inc. dated as of September 29, 2006,
filed as Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q
for the quarter ended September 30, 2006, filed on November 8, 2006,
and
incorporated herein by reference.
|
10.21
|
Assignment
and Assumption Agreement (related to the License Agreement by and
between
Kyowa Hakko Kogyo Co., Ltd. and Keryx Biopharmaceuticals, Inc. dated
as of
September 29, 2006) by and among Keryx Biopharmaceuticals, Inc. and
AOI
Pharmaceuticals, Inc. dated as of October 25, 2006, filed
as Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2006, filed on November 8, 2006, and
incorporated herein by reference.
|
10.22†
|
Amendment
to the Keryx Biopharmaceuticals, Inc. 2004 Long-Term Incentive Plan
dated
April 11, 2006, filed
as Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2006, filed on August 9, 2006, and incorporated
herein by reference.
|
10.23*
|
Sub-license
Agreement by and among Keryx Biopharmaceuticals, Inc., Japan Tobacco
Inc.,
and Torii Pharmaceutical Co., Ltd. dated September 26, 2007, filed
as Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the
quarter ended September 31, 2007, filed on November 9, 2007, and
incorporated herein by reference.
|
10.24†
|
Employment
Agreement between Beth F. Levine and Keryx Biopharmaceuticals, Inc.,
dated
as of April 25, 2007, filed
as Exhibit 10.2 to the Registrant’s Annual Report on Form 10-Q for the
quarter ended March 31, 2007, filed on May 7, 2007, and incorporated
herein by reference.
|
10.25†
|
Employment
Agreement between Dr. I. Craig Henderson and Keryx Biopharmaceuticals,
Inc. dated April 25, 2007,
filed as Exhibit 10.3 to the Registrant’s Annual Report on Form 10-Q for
the quarter ended March 31, 2007, filed on May 7, 2007, and incorporated
herein by reference.
|
10.26†
|
2007
Chief Accounting Officer Inducement Stock Option Plan dated March
23,
2007,
filed as Exhibit 10.4 to the Registrant’s Annual Report on Form 10-Q for
the quarter ended March 31, 2007, filed on May 7, 2007, and incorporated
herein by reference.
|
10.27†
|
2007
General Counsel Incentive Stock Option Plan dated April 25,
2007,
filed as Exhibit 10.5 to the Registrant’s Annual Report on Form 10-Q for
the quarter ended March 31, 2007, filed on May 7, 2007, and incorporated
herein by reference.
|
21.1
|
List
of subsidiaries of Keryx Biopharmaceuticals, Inc.
|
|
|
23.1
|
Consent
of KPMG LLP.
|
24.1
|
Power
of Attorney of Director and Officers of Keryx Biopharmaceuticals,
Inc.
(included herein).
|
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
February 27, 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
February 27, 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
February
27, 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
February
27, 2008.
|
Contents
|
Page
|
Reports
of Independent Registered Public Accounting Firm
|
F-1
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-3
|
Consolidated
Statements of Operations for the years ended December 31, 2007, 2006
and
2005, and the period from December 3, 1996 to December 31,
2007
|
F-4
|
Consolidated
Statements of Changes in Stockholders’ Equity for the years ended December
31, 2007, 2006, and 2005, and the period from December 3, 1996 to
December
31, 2007
|
F-5
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2007, 2006
and
2005, and the period from December 3, 1996 to December 31,
2007
|
F-10
|
Notes
to the Consolidated Financial Statements
|
F-12
|
2007
|
2006
|
||||||
Assets
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
19,065
|
$
|
48,736
|
|||
Short-term
investment securities
|
43,038
|
63,659
|
|||||
Accrued
interest receivable
|
283
|
525
|
|||||
Other
current assets
|
1,330
|
2,048
|
|||||
Total
current assets
|
63,716
|
114,968
|
|||||
Long-term
investment securities
|
2,296
|
12,690
|
|||||
Property,
plant and equipment, net
|
11,497
|
8,489
|
|||||
Goodwill
|
3,208
|
3,208
|
|||||
Other
assets, net
|
344
|
958
|
|||||
Total
assets
|
$
|
81,061
|
$
|
140,313
|
|||
Liabilities
and stockholders’ equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
19,134
|
$
|
10,460
|
|||
Accrued
compensation and related liabilities
|
1,254
|
1,534
|
|||||
Current
portion of deferred revenue
|
1,023
|
200
|
|||||
Total
current liabilities
|
21,411
|
12,194
|
|||||
Deferred
revenue, net of current portion
|
11,022
|
--
|
|||||
Contingent
equity rights
|
4,004
|
4,004
|
|||||
Other
liabilities
|
202
|
294
|
|||||
Total
liabilities
|
36,639
|
16,492
|
|||||
Commitments
and contingencies (Note 13)
|
|||||||
Stockholders’
equity
|
|||||||
Common
stock, $0.001 par value per share (95,000,000 and 60,000,000 shares
authorized, 43,751,101 and 43,516,669 shares issued, 43,671,153 and
43,460,569 shares outstanding at December 31, 2007, and 2006,
respectively)
|
44
|
44
|
|||||
Additional
paid-in capital
|
323,009
|
312,078
|
|||||
Treasury
stock, at cost, 79,948 and 56,100 shares at December 31, 2007, and
2006,
respectively
|
(357
|
)
|
(89
|
)
|
|||
Deficit
accumulated during the development stage
|
(278,274
|
)
|
(188,212
|
)
|
|||
Total
stockholders’ equity
|
44,422
|
123,821
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
81,061
|
$
|
140,313
|
2007
|
2006
|
2005
|
Amounts
accumulated during the development
stage
|
||||||||||
Revenue:
|
|||||||||||||
License
revenue
|
$
|
204
|
$
|
—
|
$
|
—
|
$
|
204
|
|||||
Diagnostic
revenue
|
66
|
103
|
—
|
169
|
|||||||||
Service
revenue
|
52
|
431
|
574
|
1,866
|
|||||||||
Other
revenue
|
727
|
—
|
—
|
1,027
|
|||||||||
Total
revenue
|
1,049
|
534
|
574
|
3,266
|
|||||||||
Operating
expenses:
|
|||||||||||||
Cost
of diagnostics sold
|
38
|
140
|
—
|
178
|
|||||||||
Cost
of services
|
124
|
390
|
819
|
2,168
|
|||||||||
Research
and development:
|
|||||||||||||
Non-cash
compensation
|
3,574
|
6,504
|
594
|
17,812
|
|||||||||
Non-cash
acquired in-process research and development
|
—
|
—
|
—
|
18,800
|
|||||||||
Other
research and development
|
74,889
|
56,139
|
24,182
|
194,922
|
|||||||||
Total
research and development
|
78,463
|
62,643
|
24,776
|
231,534
|
|||||||||
Selling,
general and administrative:
|
|||||||||||||
Non-cash
compensation
|
7,086
|
8,408
|
775
|
20,935
|
|||||||||
Other
selling, general and administrative
|
9,919
|
9,110
|
3,416
|
44,115
|
|||||||||
Total
selling, general and administrative
|
17,005
|
17,518
|
4,191
|
65,050
|
|||||||||
Total
operating expenses
|
95,630
|
80,691
|
29,786
|
298,930
|
|||||||||
Operating
loss
|
(94,581
|
)
|
(80,157
|
)
|
(29,212
|
)
|
(295,664
|
)
|
|||||
Interest
and other income, net
|
4,555
|
6,393
|
2,317
|
17,917
|
|||||||||
Net
loss before income taxes
|
(90,026
|
)
|
(73,764
|
)
|
(26,895
|
)
|
(277,747
|
)
|
|||||
Income
taxes
|
36
|
—
|
—
|
527
|
|||||||||
Net
loss
|
$
|
(90,062
|
)
|
$
|
(73,764
|
)
|
$
|
(26,895
|
)
|
$
|
(278,274
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(2.07
|
)
|
$
|
(1.76
|
)
|
$
|
(0.78
|
)
|
$
|
(12.34
|
)
|
|
Weighted
average shares used in computing basic and diluted net loss per
common
share
|
43,583,950
|
41,919,741
|
34,384,576
|
22,543,474
|
Series
A convertible
preferred
stock
|
Common
stock
|
Additional
paid-in
|
||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
capital
|
||||||||||||
Balance
at December 31, 2004
|
—
|
$
|
—
|
31,373,280
|
$
|
31
|
$
|
132,643
|
||||||||
Changes
during the year:
|
||||||||||||||||
Issuance
of common stock in public offering (net of issuance expenses of
$5,419)
|
—
|
—
|
5,780,000
|
6
|
75,784
|
|||||||||||
Exercise
of warrants
|
—
|
—
|
157,647
|
1
|
946
|
|||||||||||
Exercise
of options
|
—
|
—
|
520,969
|
—*
|
663
|
|||||||||||
Compensation
in respect of options and warrants granted to employees, directors
and
third-parties
|
—
|
—
|
—
|
—
|
722
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Balance
at December 31, 2005
|
—
|
$
|
—
|
37,831,896
|
$
|
38
|
$
|
210,758
|
Treasury
stock
|
Unearned
|
Deficit
accumulated during the development
|
||||||||||||||
Shares
|
Amount
|
compensation
|
stage
|
Total
|
||||||||||||
Balance
at December 31, 2004
|
56,100
|
$
|
(89
|
)
|
$
|
(2,228
|
)
|
$
|
(87,553
|
)
|
$
|
42,804
|
||||
Changes
during the year:
|
||||||||||||||||
Issuance
of common stock in public offering (net of issuance expenses of
$5,419)
|
—
|
—
|
—
|
—
|
75,790
|
|||||||||||
Exercise
of warrants
|
—
|
—
|
—
|
—
|
947
|
|||||||||||
Exercise
of options
|
—
|
—
|
—
|
—
|
663
|
|||||||||||
Compensation
in respect of options and warrants granted to employees, directors
and
third-parties
|
—
|
—
|
647
|
—
|
1,369
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(26,895
|
)
|
(26,895
|
)
|
|||||||||
Balance
at December 31, 2005
|
56,100
|
$
|
(89
|
)
|
$
|
(1,581
|
)
|
$
|
(114,448
|
)
|
$
|
94,678
|
Series
A convertible
preferred
stock
|
Common
stock
|
Additional
paid-in
|
||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
capital
|
||||||||||||
Balance
at December 31, 2005
|
—
|
$
|
—
|
37,831,896
|
$
|
38
|
$
|
210,758
|
||||||||
Changes
during the year:
|
||||||||||||||||
Issuance
of common stock in public offering (net of issuance expenses of
$104)
|
—
|
—
|
4,500,000
|
5
|
82,692
|
|||||||||||
Issuance
of common stock in connection with acquisition
|
—
|
—
|
245,024
|
—*
|
3,310
|
|||||||||||
Issuance
of common stock held in escrow
|
—
|
—
|
15,646
|
—*
|
—
|
|||||||||||
Issuance
of restricted stock
|
—
|
—
|
100,000
|
—*
|
—
|
|||||||||||
Exercise
of options
|
—
|
—
|
824,103
|
1
|
1,987
|
|||||||||||
Reclassification
of unearned compensation upon adoption of SFAS No. 123R
|
—
|
—
|
—
|
—
|
(1,581
|
)
|
||||||||||
Compensation
in respect of options, restricted stock and warrants granted to
employees,
directors and third-parties
|
—
|
—
|
—
|
—
|
14,912
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Balance
at December 31, 2006
|
—
|
$
|
—
|
43,516,669
|
$
|
44
|
$
|
312,078
|
Treasury
stock
|
Unearned
|
Deficit
accumulated during the development
|
||||||||||||||
Shares
|
Amount
|
compensation
|
stage
|
Total
|
||||||||||||
Balance
at December 31, 2005
|
56,100
|
$
|
(89
|
)
|
$
|
(1,581
|
)
|
$
|
(114,448
|
)
|
$
|
94,678
|
||||
Changes
during the year:
|
||||||||||||||||
Issuance
of common stock in public offering (net of issuance expenses of
$104)
|
—
|
—
|
—
|
—
|
82,697
|
|||||||||||
Issuance
of common stock in connection with acquisition
|
—
|
—
|
—
|
—
|
3,310
|
|||||||||||
Issuance
of common stock held in escrow
|
—
|
—
|
—
|
—
|
—*
|
|||||||||||
Issuance
of restricted stock
|
—
|
—
|
—
|
—
|
—*
|
|||||||||||
Exercise
of options
|
—
|
—
|
—
|
—
|
1,988
|
|||||||||||
Reclassification
of unearned compensation upon adoption of SFAS No. 123R
|
—
|
—
|
1,581
|
—
|
—
|
|||||||||||
Compensation
in respect of options, restricted stock and warrants granted to
employees,
directors and third-parties
|
—
|
—
|
—
|
—
|
14,912
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(73,764
|
)
|
(73,764
|
)
|
|||||||||
Balance
at December 31, 2006
|
56,100
|
$
|
(89
|
)
|
$
|
—
|
$
|
(188,212
|
)
|
$
|
123,821
|
Series
A convertible
preferred
stock
|
Common
stock
|
Additional
paid-in
|
||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
capital
|
||||||||||||
Balance
at December 31, 2006
|
—
|
$
|
—
|
43,516,669
|
$
|
44
|
$
|
312,078
|
||||||||
Changes
during the year:
|
||||||||||||||||
Cancellation
of common stock held in escrow
|
—
|
—
|
(15,646
|
)
|
(—)*
|
—
|
||||||||||
Issuance
of restricted stock
|
—
|
—
|
195,000
|
—*
|
—
|
|||||||||||
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
|
—
|
—
|
—
|
—
|
10,660
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Balance
at December 31, 2007
|
—
|
$
|
—
|
43,751,101
|
$
|
44
|
$
|
323,009
|
Treasury
stock
|
Unearned
|
Deficit
accumulated during the development
|
||||||||||||||
Shares
|
Amount
|
compensation
|
stage
|
Total
|
||||||||||||
Balance
at December 31, 2006
|
56,100
|
$
|
(89
|
)
|
$
|
—
|
$
|
(188,212
|
)
|
$
|
123,821
|
|||||
Changes
during the year:
|
||||||||||||||||
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
|
—
|
—
|
—
|
—
|
10,660
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(90,062
|
)
|
(90,062
|
)
|
|||||||||
Balance
at December 31, 2007
|
79,948
|
$
|
(357
|
)
|
$
|
—
|
$
|
(278,274
|
)
|
$
|
44,422
|
Series
A convertible
preferred
stock
|
|
Common
stock
|
|
Additional
paid-in
|
|
|||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
||||||
Amounts
accumulated during the development stage (December 3, 1996 to December
31,
2007):
|
||||||||||||||||
Contributed
capital
|
—
|
$
|
—
|
—
|
$
|
—
|
$
|
3,181
|
||||||||
Conversion
of convertible notes of Partec into stock in Keryx
|
—
|
—
|
—
|
—
|
2,973
|
|||||||||||
Issuance
of Series A convertible preferred stock to investors at $100 per
share for
cash (net of issuance expenses of $552)
|
89,180
|
—*
|
—
|
—
|
8,338
|
|||||||||||
Issuance
of Series A convertible preferred stock at $0.001 par value to
note
holders in exchange for note of predecessor
|
29,465
|
—*
|
—
|
—
|
—
|
|||||||||||
Issuance
of common stock to technology licensors for technology
license
|
—
|
—
|
1,256,797
|
2
|
358
|
|||||||||||
Issuance
of common stock in public offering (net of issuance expenses of
$5,523)
|
—
|
—
|
10,280,000
|
11
|
158,476
|
|||||||||||
Issuance
of common stock in private placement (net of issuance expenses
of
$1,205)
|
—
|
—
|
6,729,412
|
6
|
45,789
|
|||||||||||
Issuance
of common stock in connection with acquisition
|
—
|
—
|
868,169
|
1
|
9,634
|
|||||||||||
Issuance
of common stock held in escrow
|
—
|
—
|
15,646
|
—*
|
—
|
|||||||||||
Cancellation
of common stock held in escrow
|
—
|
—
|
(15,646
|
)
|
(—)*
|
—
|
||||||||||
Issuance
of restricted stock
|
—
|
—
|
295,000
|
—*
|
—
|
|||||||||||
Forfeiture
of restricted stock
|
—
|
—
|
(83,334
|
)
|
(—)*
|
—
|
||||||||||
Receipt
on account of shares issued in prior years
|
—
|
—
|
6,900,000
|
7
|
—
|
|||||||||||
Conversion
of Series A convertible preferred stock to common stock
|
(118,645
|
)
|
(—)*
|
6,114,962
|
6
|
(6
|
)
|
|||||||||
Issuance
of common stock in initial public offering, including exercise
of
overallotment (net of issuance expenses of $5,702)
|
—
|
—
|
5,200,000
|
5
|
46,293
|
|||||||||||
Purchase
of common stock
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Surrender
of common stock for tax withholding
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Exercise
of warrants
|
—
|
—
|
753,897
|
1
|
3,050
|
|||||||||||
Exercise
of options
|
—
|
—
|
5,436,198
|
5
|
6,064
|
|||||||||||
Reclassification
of unearned compensation upon adoption of SFAS No. 123R
|
—
|
—
|
—
|
—
|
(1,581
|
)
|
||||||||||
Compensation
in respect of options, restricted stock and warrants granted to
employees,
directors and third-parties
|
—
|
—
|
—
|
—
|
39,738
|
|||||||||||
Warrants
of common stock issued to related party as finder’s fee in private
placement
|
—
|
—
|
—
|
—
|
114
|
|||||||||||
Warrants
for common stock issued to note holders in exchange for note of
predecessor
|
—
|
—
|
—
|
—
|
588
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Balance
at December 31, 2007
|
—
|
$
|
—
|
43,751,101
|
$
|
44
|
$
|
323,009
|
Treasury
stock
|
|
Unearned
|
|
Deficit
accumulated during the development
|
|
|
|
|||||||||
|
|
Shares
|
|
Amount
|
|
compensation
|
|
stage
|
|
Total
|
||||||
Amounts
accumulated during the development stage (December 3, 1996 to December
31,
2007):
|
||||||||||||||||
Contributed
capital
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
3,181
|
|||||||
Conversion
of convertible notes of Partec into stock in Keryx
|
—
|
—
|
—
|
—
|
2,973
|
|||||||||||
Issuance
of Series A convertible preferred stock to investors at $100 per
share for
cash (net of issuance expenses of $552)
|
—
|
—
|
—
|
—
|
8,338
|
|||||||||||
Issuance
of Series A convertible preferred stock at $0.001 par value to
note
holders in exchange for note of predecessor
|
—
|
—
|
—
|
—
|
—*
|
|||||||||||
Issuance
of common stock to technology licensors for technology
license
|
—
|
—
|
—
|
—
|
360
|
|||||||||||
Issuance
of common stock in public offering (net of issuance expenses of
$5,523)
|
—
|
—
|
—
|
—
|
158,487
|
|||||||||||
Issuance
of common stock in private placement (net of issuance expenses
of
$1,205)
|
—
|
—
|
—
|
—
|
45,795
|
|||||||||||
Issuance
of common stock in connection with acquisition
|
—
|
—
|
—
|
—
|
9,635
|
|||||||||||
Issuance
of common stock held in escrow
|
—
|
—
|
—
|
—
|
—*
|
|||||||||||
Cancellation
of common stock held in escrow
|
—
|
—
|
—
|
—
|
(—)*
|
|||||||||||
Issuance
of restricted stock
|
—
|
—
|
—
|
—
|
—*
|
|||||||||||
Forfeiture
of restricted stock
|
—
|
—
|
—
|
—
|
(—)*
|
|||||||||||
Receipt
on account of shares issued in prior years
|
—
|
—
|
—
|
—
|
7
|
|||||||||||
Conversion
of Series A convertible preferred stock to common stock
|
—
|
—
|
—
|
—
|
(—)*
|
|||||||||||
Issuance
of common stock in initial public offering, including exercise
of
overallotment (net of issuance expenses of $5,702)
|
—
|
—
|
—
|
—
|
46,298
|
|||||||||||
Purchase
of common stock
|
56,100
|
(89
|
)
|
—
|
—
|
(89
|
)
|
|||||||||
Surrender
of common stock for tax withholding
|
23,848
|
(268
|
)
|
—
|
—
|
(268
|
)
|
|||||||||
Exercise
of warrants
|
—
|
—
|
—
|
—
|
3,051
|
|||||||||||
Exercise
of options
|
—
|
—
|
—
|
—
|
6,069
|
|||||||||||
Reclassification
of unearned compensation upon adoption of SFAS No. 123R
|
—
|
—
|
1,581
|
—
|
—
|
|||||||||||
Compensation
in respect of options and warrants granted to employees, directors
and
third-parties
|
—
|
—
|
(1,581
|
)
|
—
|
38,157
|
||||||||||
Warrants
of common stock issued to related party as finder’s fee in private
placement
|
—
|
—
|
—
|
—
|
114
|
|||||||||||
Warrants
for common stock issued to note holders in exchange for note of
predecessor
|
—
|
—
|
—
|
—
|
588
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(278,274
|
)
|
(278,274
|
)
|
|||||||||
Balance
at December 31, 2007
|
79,948
|
$
|
(357
|
)
|
$
|
—
|
$
|
(278,274
|
)
|
$
|
44,422
|
2007
|
2006
|
2005
|
Amounts
accumulated
during
the
development
stage
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||||||||
Net
loss
|
$
|
(90,062
|
)
|
$
|
(73,764
|
)
|
$
|
(26,895
|
)
|
$
|
(278,274
|
)
|
|
Adjustments
to reconcile net loss to cash flows used in operating activities:
|
|||||||||||||
Acquired
in-process research and development
|
—
|
—
|
—
|
18,800
|
|||||||||
Stock
compensation expense
|
10,660
|
14,912
|
1,369
|
38,747
|
|||||||||
Issuance
of common stock to technology licensor
|
—
|
—
|
—
|
359
|
|||||||||
Interest
on convertible notes settled through issuance of preferred
shares
|
—
|
—
|
—
|
253
|
|||||||||
Depreciation
and amortization
|
151
|
224
|
190
|
2,986
|
|||||||||
(Gain)
loss on disposal of property, plant and equipment
|
(1
|
)
|
—
|
2
|
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
|
718
|
1,253
|
(2,578
|
)
|
(858
|
)
|
|||||||
Decrease
(increase) in accrued interest receivable
|
242
|
(189
|
)
|
(192
|
)
|
(283
|
)
|
||||||
(Increase)
in security deposits
|
—
|
(255
|
)
|
(8
|
)
|
(263
|
)
|
||||||
Increase
in accounts payable and accrued expenses
|
8,674
|
4,974
|
1,975
|
17,389
|
|||||||||
(Decrease)
increase in accrued compensation and related liabilities
|
(280
|
)
|
575
|
193
|
659
|
||||||||
(Decrease)
increase in other liabilities
|
(92
|
)
|
(28
|
)
|
230
|
47
|
|||||||
Increase
(decrease) in deferred revenue
|
11,845
|
97
|
(37
|
)
|
11,589
|
||||||||
Net
cash used in operating activities
|
(57,545
|
)
|
(52,201
|
)
|
(25,751
|
)
|
(185,502
|
)
|
|||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||||||||
Purchases
of property, plant and equipment
|
(3,159
|
)
|
(7,597
|
)
|
(964
|
)
|
(16,147
|
)
|
|||||
Proceeds
from disposals of property, plant and equipment
|
15
|
—
|
1
|
440
|
|||||||||
(Increase)
in note and accrued interest receivable from related party
|
—
|
—
|
—
|
(356
|
)
|
||||||||
Payments
of transaction costs
|
—
|
(231
|
)
|
—
|
(231
|
)
|
|||||||
Decrease
(increase) in other assets
|
—
|
27
|
(23
|
)
|
(1,192
|
)
|
|||||||
Investment
in held-to-maturity short-term securities
|
(6,136
|
)
|
(4,080
|
)
|
(1,122
|
)
|
(55,049
|
)
|
|||||
Proceeds
from maturity of held-to-maturity short-term securities
|
24,020
|
8,275
|
15,045
|
76,041
|
|||||||||
Investment
in available-for-sale short-term securities
|
(56,700
|
)
|
(38,375
|
)
|
(13,700
|
)
|
(114,800
|
)
|
|||||
Proceeds
from sale of available-for-sale short-term securities
|
76,200
|
6,725
|
8,675
|
92,600
|
|||||||||
Investment
in held-to-maturity long-term securities
|
(6,372
|
)
|
(16,677
|
)
|
(21,270
|
)
|
(44,319
|
)
|
|||||
Proceeds
from maturity of held-to-maturity long-term securities
|
3
|
5
|
185
|
193
|
|||||||||
Net
cash provided by (used in) investing activities
|
27,871
|
(51,928
|
)
|
(13,173
|
)
|
(62,820
|
)
|
2007
|
2006
|
2005
|
Amounts
accumulated
during
the
development
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
|
—
|
82,697
|
75,790
|
158,487
|
|||||||||
Proceeds
from private placements, net
|
—
|
—
|
—
|
45,795
|
|||||||||
Proceeds
from exercise of options and warrants
|
271
|
1,988
|
1,610
|
9,120
|
|||||||||
Purchase
of treasury stock
|
(268
|
)
|
—
|
—
|
(357
|
)
|
|||||||
Net
cash provided by financing activities
|
3
|
84,685
|
77,400
|
267,382
|
|||||||||
Cash
acquired in acquisition
|
—
|
5
|
—
|
99
|
|||||||||
Effect
of exchange rate on cash
|
—
|
—
|
—
|
(94
|
)
|
||||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(29,671
|
)
|
(19,439
|
)
|
38,476
|
19,065
|
|||||||
Cash
and cash equivalents at beginning of year
|
48,736
|
68,175
|
29,699
|
—
|
|||||||||
CASH
AND CASH EQUIVALENTS AT END OF YEAR
|
$
|
19,065
|
$
|
48,736
|
$
|
68,175
|
$
|
19,065
|
|||||
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
|
—
|
345
|
—
|
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
|
$
|
36
|
$
|
—
|
$
|
—
|
$
|
468
|
|
Estimated
useful
life
(years)
|
Lab
equipment
|
4
|
Office
furniture and equipment
|
3-7
|
Computers,
software and related equipment
|
3
|
(in
thousands)
|
December 31, 2007
|
|
December 31, 2006
|
||||
Money
market funds
|
$
|
14,457
|
$
|
14,733
|
|||
Checking
and bank deposits
|
4,608
|
34,003
|
|||||
Total
|
$
|
19,065
|
$
|
48,736
|
December
31,
2007
|
|||||||||||||
(in thousands)
|
Amortized cost
|
Gross
unrealized
holding gains
|
Gross
unrealized
holding losses
|
Estimated
fair
value
|
|||||||||
Short-term
investments:
|
|||||||||||||
Obligations
of domestic governmental agencies (mature between April and October
2008)
(Held-to-maturity)
|
$
|
20,838
|
$
|
91
|
$
|
—
|
$
|
20,929
|
|||||
Auction
notes (Available-for-sale) *
|
22,200
|
—
|
—
|
22,200
|
|||||||||
$
|
43,038
|
$
|
91
|
$
|
—
|
$
|
43,129
|
||||||
Long-term
investments:
|
|||||||||||||
Obligations
of domestic governmental agencies (mature May 2009)
(Held-to-maturity)
|
$
|
2,296
|
$
|
54
|
$
|
—
|
$
|
2,350
|
December
31,
2006
|
|||||||||||||
(in thousands)
|
Amortized cost
|
Gross
unrealized
holding
gains
|
Gross
unrealized
holding losses
|
Estimated
fair
value
|
|||||||||
Short-term
investments:
|
|||||||||||||
Obligations
of domestic governmental agencies (mature between January and October
2007) (Held-to-maturity)
|
$
|
21,959
|
$
|
—
|
$
|
(73
|
)
|
$
|
21,886
|
||||
Auction
notes (Available-for-sale) *
|
41,700
|
—
|
—
|
41,700
|
|||||||||
$
|
63,659
|
$
|
—
|
$
|
(73
|
)
|
$
|
63,586
|
|||||
Long-term
investments:
|
|||||||||||||
Obligations
of domestic governmental agencies (mature between April and May
2008)
(Held-to-maturity)
|
$
|
12,690
|
$
|
2
|
$
|
(19
|
)
|
$
|
12,673
|
||||
$
|
12,690
|
$
|
2
|
$
|
(19
|
)
|
$
|
12,673
|
(in thousands)
|
December 31, 2007
|
|
December 31, 2006
|
||||
Manufacturing
suite and equipment
|
$
|
11,224
|
$
|
8,162
|
|||
Lab
equipment
|
19
|
38
|
|||||
Leasehold
improvements
|
36
|
16
|
|||||
Office
furniture and equipment
|
315
|
311
|
|||||
Computers,
software and related equipment
|
391
|
318
|
|||||
11,985
|
8,845
|
||||||
Accumulated
depreciation and amortization
|
(488
|
)
|
(356
|
)
|
|||
Net
book value
|
$
|
11,497
|
$
|
8,489
|
For the year ended December 31
|
||||||||||
(in
thousands)
|
2007
|
2006
|
2005
|
|||||||
Depreciation
expense:
|
||||||||||
Cost
of services
|
$
|
—
|
$
|
2
|
$
|
4
|
||||
Research
and development
|
92
|
90
|
72
|
|||||||
General
and administrative
|
45
|
47
|
26
|
|||||||
Total
|
$
|
137
|
$
|
139
|
$
|
102
|
(in thousands)
|
|
December 31, 2007
|
|
December 31, 2006
|
|||
Patents
and other intangible assets
|
$
|
352
|
$
|
1,007
|
|||
Long-term
deposits
|
322
|
322
|
|||||
Deferred
registration fees
|
22
|
22
|
|||||
696
|
1,351
|
||||||
Accumulated
amortization
|
(352
|
)
|
(393
|
)
|
|||
$
|
344
|
$
|
958
|
(in
thousands, except share and per share amounts)
|
|||||||
Assumed
liabilities
|
$
|
345
|
|||||
Number
of shares of Keryx common stock issued
|
245,024
|
||||||
Multiplied
by Keryx’s average closing bid price per share as quoted on NASDAQ over a
period of 5 trading days (2 days prior to the Effective Date, the
Effective Date, and 2 days after the Effective Date)
|
$
|
13.51
|
3,310
|
||||
Other
transaction costs and cash settlement costs
|
341
|
||||||
Total
purchase price
|
$
|
3,996
|
(in
thousands)
|
||||
Allocation
of purchase price:
|
||||
Tangible
assets acquired
|
$
|
132
|
||
Amortizable
intangibles (over 12 years - patent life)
|
656
|
|||
Goodwill
|
3,208
|
|||
Purchase
price
|
$
|
3,996
|
· |
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.
|
· |
500,000
shares of the Company’s common stock upon enrollment of the first patient
in a Keryx-sponsored Phase 3 (or other pivotal) clinical trial for
any of
the acquired ACCESS Oncology drug candidates;
|
· |
750,000
shares of the Company’s common stock upon the first new drug application
acceptance by the Food and Drug Administration, or FDA, for any of
the
acquired ACCESS Oncology drug candidates;
|
· |
1,750,000
shares of the Company’s common stock upon the first FDA approval of any of
the acquired ACCESS Oncology drug candidates;
and
|
· |
372,422
shares of the Company’s common stock following the first 12-month period
that sales of all of the acquired ACCESS Oncology drug candidates
combined
exceeds $100 million.
|
|
|
Number
of
shares
|
|
Weighted-
average
exercise
price
|
|
Weighted-
average
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|
||||
|
|
|
|
|
|
(in
years)
|
|
(in
millions)
|
|||||
Outstanding
at December 31, 2006
|
10,784,713
|
$
|
7.87
|
||||||||||
Granted
|
1,235,769
|
9.67
|
|||||||||||
Exercised
|
(138,412
|
)
|
1.96
|
$
|
1.3
|
||||||||
Forfeited
|
(544,730
|
)
|
14.48
|
||||||||||
Expired
|
(468,167
|
)
|
11.31
|
||||||||||
Outstanding
at December 31, 2007
|
10,869,173
|
$
|
7.69
|
6.9
|
$
|
31.1
|
|||||||
Vested
and expected to vest at December 31, 2007
|
10,768,822
|
$
|
7.65
|
6.9
|
$
|
31.1
|
|||||||
Exercisable
at December 31, 2007
|
7,306,546
|
$
|
5.71
|
6.2
|
$
|
31.1
|
Options
outstanding
|
|
Options
exercisable
|
||||||||||||||
Range
of
exercise
prices
|
Number
outstanding
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighed-
average
exercise
price
|
Number
exercisable
|
Weighed-
average
exercise
price
|
|||||||||||
$
0.10 - $ 2.14
|
4,175,987
|
5.7
|
$
|
1.24
|
4,175,987
|
$
|
1.24
|
|||||||||
3.01 - 8.98
|
926,599
|
8.3
|
7.18
|
346,911
|
5.02
|
|||||||||||
9.25 -
12.81
|
2,890,878
|
7.1
|
10.47
|
1,432,998
|
10.64
|
|||||||||||
13.00
- 18.06
|
2,875,709
|
8.2
|
14.42
|
1,350,650
|
14.50
|
|||||||||||
$
0.10 -$18.06
|
10,869,173
|
6.9
|
$
|
7.69
|
7,306,546
|
$
|
5.71
|
Number
of
Shares
|
Weighted
Average
Grant
Date
Fair
Value
|
Aggregate
Intrinsic
Value
|
||||||||
|
(in millions)
|
|||||||||
Outstanding
at December 31, 2006
|
100,000
|
$
|
15.30
|
|||||||
Granted
|
195,000
|
10.28
|
||||||||
Vested
|
(73,332
|
)
|
11.77
|
$
|
0.8
|
|||||
Forfeited
|
(83,334
|
)
|
15.30
|
|||||||
Outstanding
at December 31, 2007
|
138,334
|
$
|
10.09
|
$
|
1.2
|
Warrants
|
Weighted-
average
exercise price
|
Aggregate
Intrinsic
Value
|
||||||||
(in
millions)
|
||||||||||
Outstanding
at December 31, 2006
|
321,976
|
$
|
4.65
|
|||||||
Issued
|
—
|
—
|
||||||||
Exercised
|
—
|
—
|
$
|
—
|
||||||
Canceled
|
—
|
—
|
||||||||
Outstanding
at December 31, 2007
|
321,976
|
$
|
4.65
|
$
|
1.2
|
|||||
Warrants
outstanding
|
Warrants
exercisable
|
|||||||||||||||
Range
of
exercise
prices
|
Number
outstanding
|
Weighted-
average
remaining
contractual
life
(years)
|
Weighed-
average
exercise
price
|
Number
exercisable
|
Weighed-
average
exercise
price
|
|||||||||||
$ 0.01
|
72,564
|
2.0
|
$
|
0.01
|
72,564
|
$
|
0.01
|
|||||||||
6.00
|
249,412
|
0.9
|
6.00
|
249,412
|
6.00
|
|||||||||||
321,976
|
1.1
|
$
|
4.65
|
321,976
|
$
|
4.65
|
Black-Scholes
Option Valuation Assumptions
|
2007
|
|
2006
|
|
2005
|
|||||
Risk-free
interest rates
|
4.1%
|
|
4.7%
|
|
3.7%
|
|
||||
Dividend
yield
|
—
|
—
|
—
|
|||||||
Volatility
|
68.4%
|
|
78.3%
|
|
84.9%
|
|
||||
Weighted-average
expected term
|
4.8
years
|
3.1
years
|
4.9
years
|
Year
ended
|
Year
ended
|
||||||
(in
thousands)
|
December 31, 2007
|
December 31, 2006
|
|||||
Stock-based
compensation expense associated with restricted stock
|
$
|
1,028
|
$
|
189
|
|||
Stock-based
compensation expense associated with option grants +
|
9,632
|
14,723
|
|||||
Stock-based
compensation expense associated with warrants
|
—
|
—
|
|||||
$
|
10,660
|
$
|
14,912
|
+ |
Includes
additional non-cash compensation expense during the year ended
December
31, 2006 of $1,697, relating to previous grants made to a former
officer
and two former directors. The Board of Directors agreed to modify
their
option agreements in 2006 such that their vesting and exercisability
has
been extended beyond the terms of their original
agreements.
|
For the year
ended
December 31,
|
Amounts
accumulated
during the
development
stage through
December 31,
|
||||||
(in thousands, except
per share amounts)
|
2005
|
2005
|
|||||
Net
loss, as reported
|
$
|
(26,895
|
)
|
$
|
(114,448
|
)
|
|
Add:
Stock-based compensation expense to employees and directors determined
under the intrinsic value-based method, as included in reported
net
loss
|
445
|
10,179
|
|||||
Deduct:
Stock-based compensation expense to employees and directors determined
under fair value based method
|
(3,797
|
)
|
(20,216
|
)
|
|||
Pro
forma net loss
|
$
|
(30,247
|
)
|
$
|
(124,485
|
)
|
|
Basic
and diluted loss per common share:
|
|||||||
As
reported
|
$
|
(0.78
|
)
|
$
|
(6.34
|
)
|
|
Pro
forma
|
$
|
(0.88
|
)
|
$
|
(6.89
|
)
|
For
the year ended December 31,
|
||||||||||
(in thousands)
|
2007
|
2006
|
2005
|
|||||||
Losses
before taxes on income, as reported in the consolidated statements
of
operations
|
$
|
(90,026
|
)
|
$
|
(73,764
|
)
|
$
|
(26,895
|
)
|
|
Computed
“expected” tax benefit
|
(31,509
|
)
|
(25,817
|
)
|
(9,413
|
)
|
||||
Increase
(decrease) in income taxes resulting from:
|
||||||||||
Expected
benefit from state & local taxes
|
(4,624
|
)
|
(8,154
|
)
|
(3,379
|
)
|
||||
Change
in state and local effective tax rate
|
4,555
|
(831
|
)
|
(3,130
|
)
|
|||||
Unrecognized
compensation deduction
|
7,053
|
—
|
—
|
|||||||
Permanent
differences
|
447
|
1,067
|
(571
|
)
|
||||||
Witholding
tax
|
36 |
—
|
—
|
|||||||
Other
|
159
|
—
|
—
|
|||||||
Change
in the balance of the valuation allowance for deferred tax assets
allocated to income tax expense
|
23,919
|
33,735
|
16,493
|
|||||||
|
$ | 36 |
$
|
—
|
$
|
—
|
For
the year ended December 31,
|
||||||||||
(in
thousands)
|
2007
|
2006
|
2005
|
|||||||
Deferred
tax benefit
|
$
|
(24,186
|
)
|
$
|
(37,129
|
)
|
$
|
(18,931
|
)
|
|
Federal
deferred tax benefit relating to the exercise of stock
options
|
267
|
3,394
|
2,438
|
|||||||
Increase
in the valuation allowance for deferred tax assets
|
23,919
|
33,735
|
16,493
|
|||||||
|
$ | — |
$
|
—
|
$
|
—
|
(in
thousands)
|
December
31, 2007
|
December
31, 2006
|
|||||
Deferred
tax assets/(liabilities):
|
|||||||
Net
operating loss carryforwards
|
$
|
94,315
|
$
|
78,235
|
|||
Net
operating loss carryforwards (ACCESS Oncology)
|
6,128
|
6,128
|
|||||
Non-cash
compensation
|
10,980
|
7,843
|
|||||
Deferred
revenue
|
5,069
|
—
|
|||||
Research
and development
|
1,397
|
1,977
|
|||||
Intangible
assets due to different amortization methods
|
1,203
|
730
|
|||||
Accrued
compensation
|
30
|
19
|
|||||
Other
temporary differences
|
67
|
72
|
|||||
Net
deferred tax asset, excluding valuation allowance
|
119,189
|
95,004
|
|||||
Less
valuation allowance
|
(119,189
|
)
|
(95,004
|
)
|
|||
Net
deferred tax assets
|
$
|
—
|
$
|
—
|
For
the year ended December 31,
|
||||||||||
(in
thousands)
|
2007
|
2006
|
2005
|
|||||||
Interest
income
|
$
|
4,550
|
$
|
6,378
|
$
|
2,317
|
||||
Other
income
|
5
|
15
|
—
|
|||||||
$
|
4,555
|
$
|
6,393
|
$
|
2,317
|
(in
thousands)
|
2008
|
2009
|
2010
|
2011
|
2012
|
|||||||||||
Research
and development agreements
|
$
|
23,910
|
$
|
19,210
|
$
|
3,409
|
—
|
—
|
(in
thousands)
|
2008
|
2009
|
2010
|
2011
|
2012
|
|||||||||||
Operating
leases
|
$
|
724
|
$
|
597
|
$
|
459
|
—
|
—
|
Revenue
|
|||||||||||||
Amounts
accumulated during the development
|
|||||||||||||
(in
thousands)
|
2007
|
2006
|
2005
|
Stage
|
|||||||||
Diagnostics
|
$
|
66
|
$
|
103
|
$
|
—
|
$
|
169
|
|||||
Services
|
52
|
431
|
574
|
1,866
|
|||||||||
Products
|
931
|
—
|
—
|
931
|
|||||||||
Total
|
$
|
1,049
|
$
|
534
|
$
|
574
|
$
|
2,966
|
Operating
loss
|
|||||||||||||
Amounts
accumulated
during
the development
|
|||||||||||||
(in
thousands)
|
2007
|
2006
|
2005
|
Stage
|
|||||||||
Diagnostics
|
$
|
(756
|
)
|
$
|
(1,016
|
)
|
$
|
—
|
$
|
(1,772
|
)
|
||
Services
|
(72
|
)
|
41
|
(245
|
)
|
(302
|
)
|
||||||
Products
|
(93,753
|
)
|
(79,182
|
)
|
(28,967
|
)
|
(293,590
|
)
|
|||||
Total
|
$
|
(94,581
|
)
|
$
|
(80,157
|
)
|
$
|
(29,212
|
)
|
$
|
(295,664
|
)
|
Net
loss
|
|||||||||||||
Amounts
accumulated
during
the development
|
|||||||||||||
(in
thousands)
|
2007
|
2006
|
2005
|
Stage
|
|||||||||
Operating
losses of reportable segments
|
$
|
(94,581
|
)
|
$
|
(80,157
|
)
|
$
|
(29,212
|
)
|
$
|
(295,664
|
)
|
|
Interest
and other income
|
4,555
|
6,393
|
2,317
|
17,917
|
|||||||||
Income
taxes
|
(36
|
)
|
—
|
—
|
(527
|
)
|
|||||||
Consolidated
net loss
|
$
|
(90,062
|
)
|
$
|
(73,764
|
)
|
$
|
(26,895
|
)
|
$
|
(278,274
|
)
|
Assets
(1)
|
|||||||
As
of December 31,
|
|||||||
(in
thousands)
|
2007
|
2006
|
|||||
Diagnostics
|
$
|
87
|
$
|
734
|
|||
Services
|
—
|
116
|
|||||
Products
|
16,293
|
13,853
|
|||||
Total
assets of reportable segments
|
16,380
|
14,703
|
|||||
Cash
and cash equivalents (2)
|
64,681
|
125,610
|
|||||
Consolidated
total assets
|
$
|
81,061
|
$
|
140,313
|
(1)
|
Assets
for our reportable segments include fixed and intangible assets,
including
goodwill, as well as accounts receivable and
inventory.
|
(2)
|
Includes
cash, cash equivalents, interest receivable and investment securities.
|
Goodwill
|
|||||||
(in
thousands)
|
December 31, 2007
|
December 31, 2006
|
|||||
Diagnostics
|
—
|
—
|
|||||
Services
|
—
|
—
|
|||||
Products
|
$
|
3,208
|
$
|
3,208
|
|||
Total
|
$
|
3,208
|
$
|
3,208
|
2007
|
|||||||||||||
Mar.
31
|
June
30
|
Sept.
30
|
Dec.
31
|
||||||||||
(in
thousands, except per share data)
|
|||||||||||||
Revenue:
|
|||||||||||||
License
revenue
|
$
|
—
|
$
|
—
|
$
|
41
|
$
|
163
|
|||||
Diagnostic
revenue
|
30
|
36
|
—
|
—
|
|||||||||
Service
revenue
|
12
|
14
|
11
|
15
|
|||||||||
Other
revenue
|
—
|
—
|
—
|
727
|
|||||||||
Total
revenue
|
42
|
50
|
52
|
905
|
|||||||||
Operating
expenses:
|
|||||||||||||
Cost
of diagnostics sold
|
22
|
16
|
—
|
—
|
|||||||||
Cost
of services
|
32
|
30
|
28
|
34
|
|||||||||
Research
and development:
|
|||||||||||||
Non-cash
compensation
|
995
|
1,178
|
735
|
666
|
|||||||||
Other
research and development
|
17,446
|
15,685
|
15,967
|
25,791
|
|||||||||
Total
research and development
|
18,441
|
16,863
|
16,702
|
26,457
|
|||||||||
Selling,
general and administrative:
|
|||||||||||||
Non-cash
compensation
|
2,006
|
1,407
|
1,780
|
1,893
|
|||||||||
Other
selling, general and administrative
|
2,795
|
2,394
|
2,087
|
2,643
|
|||||||||
Total
selling, general and administrative
|
4,801
|
3,801
|
3,867
|
4,536
|
|||||||||
Total
operating expenses
|
23,296
|
20,710
|
20,597
|
31,027
|
|||||||||
Operating
loss
|
(23,254
|
)
|
(20,660
|
)
|
(20,545
|
)
|
(30,122
|
)
|
|||||
Other
income (expense)
|
|||||||||||||
Interest
and other income, net
|
1,441
|
1,200
|
1,017
|
897
|
|||||||||
Income
taxes
|
—
|
—
|
—
|
36
|
|||||||||
Net
loss
|
$
|
(21,813
|
)
|
$
|
(19,460
|
)
|
$
|
(19,528
|
)
|
$
|
(29,261
|
)
|
|
Net
loss per common share
|
|||||||||||||
Basic
and diluted
|
$
|
(0.50
|
)
|
$
|
(0.45
|
)
|
$
|
(0.45
|
)
|
$
|
(0.67
|
)
|
2006
|
|||||||||||||
Mar.
31
|
June
30
|
Sept.
30
|
Dec.
31
|
||||||||||
(in
thousands, except per share data)
|
|||||||||||||
Revenue:
|
|||||||||||||
Diagnostic
revenue
|
$
|
—
|
$
|
23
|
$
|
35
|
$
|
45
|
|||||
Service
revenue
|
112
|
224
|
39
|
56
|
|||||||||
Total
revenue
|
112
|
247
|
74
|
101
|
|||||||||
Operating
expenses:
|
|||||||||||||
Cost
of diagnostics sold
|
—
|
19
|
50
|
71
|
|||||||||
Cost
of services
|
171
|
98
|
29
|
92
|
|||||||||
Research
and development:
|
|||||||||||||
Non-cash
compensation
|
2,724
|
2,104
|
1,378
|
298
|
|||||||||
Other
research and development
|
12,333
|
12,352
|
14,950
|
16,504
|
|||||||||
Total
research and development
|
15,057
|
14,456
|
16,328
|
16,802
|
|||||||||
Selling,
general and administrative:
|
|||||||||||||
Non-cash
compensation
|
2,817
|
3,541
|
1,481
|
569
|
|||||||||
Other
selling, general and administrative
|
2,645
|
1,860
|
2,041
|
2,564
|
|||||||||
Total
selling, general and administrative
|
5,462
|
5,401
|
3,522
|
3,133
|
|||||||||
Total
operating expenses
|
20,690
|
19,974
|
19,929
|
20,098
|
|||||||||
Operating
loss
|
(20,578
|
)
|
(19,727
|
)
|
(19,855
|
)
|
(19,997
|
)
|
|||||
Other
income (expense)
|
|||||||||||||
Interest
and other income, net
|
982
|
1,899
|
1,862
|
1,650
|
|||||||||
Net
loss
|
$
|
(19,596
|
)
|
$
|
(17,828
|
)
|
$
|
(17,993
|
)
|
$
|
(18,347
|
)
|
|
Net
loss per common share
|
|||||||||||||
Basic
and diluted
|
$
|
(0.51
|
)
|
$
|
(0.41
|
)
|
$
|
(0.42
|
)
|
$
|
(0.42
|
)
|
KERYX
BIOPHARMACEUTICALS, INC.
|
|
By:
|
/s/
Michael S. Weiss
|
Michael
S. Weiss
Chairman
and Chief Executive
Officer
|
Signatures
|
Title
|
|
/s/
Michael S. Weiss
|
Chairman
and Chief Executive Officer
|
|
Michael
S. Weiss
|
(principal
executive officer)
|
|
/s/
Mark Stier
|
Chief
Accounting Officer
|
|
Mark
Stier
|
(principal
financial officer)
|
|
/s/
I. Craig Henderson, M.D.
|
President
and Director
|
|
I.
Craig Henderson, M.D.
|
||
/s/
Kevin
Cameron
|
Director
|
|
Kevin
Cameron
|
||
/s/
Senator Wyche Fowler, Jr.
|
Director
|
|
Senator
Wyche Fowler, Jr.
|
||
/s/
Malcolm
Hoenlein
|
Director
|
|
Malcolm
Hoenlein
|
||
/s/
Jack Kaye, CPA
|
Director
|
|
Jack
Kaye, CPA
|
||
/s/
Eric A. Rose, M.D.
|
Director
|
|
Eric
A. Rose, M.D.
|
||
/s/
Michael
P. Tarnok
|
Director
|
|
Michael
P. Tarnok
|
Exhibit
|
||
Number
|
Exhibit
Description
|
|
21.1
|
List
of subsidiaries of Keryx Biopharmaceuticals, Inc.
|
|
|
|
|
23.1
|
Consent
of KPMG LLP.
|
|
24.1
|
Power
of Attorney of Director and Officers of Keryx Biopharmaceuticals,
Inc.
(included herein).
|
|
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
February 27, 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
February 27, 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
February
27, 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
February
27, 2008.
|