form10-q.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
|
|
ý
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2007
|
|
|
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934 FOR THE TRANSITION PERIOD
FROM TO
|
|
COMMISSION
FILE NUMBER: 000-14879
Cytogen
Corporation
(EXACT
NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
Delaware
|
22-2322400
|
(State
of Incorporation)
|
(I.R.S.
Employer Identification No.)
|
650
College Road East, Suite 3100, Princeton, New Jersey 08540-5308
(Address
of principal executive offices)(Zip Code)
(609)
750-8200
(Registrant's
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to the filing requirements
for
at least the past 90 days. Yes ý No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer.
Large
Accelerated Filer o
|
Accelerated
Filer ý
|
Non-
Accelerated Filer o
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No ý
APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS
DURING THE PRECEDING FIVE YEARS
Indicate
by check mark whether the registrant has filed all documents and reports
required to be filed by Sections 12, 13 or 15(d)of the Securities Exchange
Act
of 1934 subsequent to the distribution of securities under a plan confirmed
by a
court.
o
Yes o No
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date.
Class:
Common Stock, $.01 par value
|
Outstanding
at August 6, 2007: 35,473,957
|
CYTOGEN
CORPORATION
QUARTERLY
REPORT ON FORM 10-Q
JUNE
30,
2007
TABLE
OF CONTENTS
|
Page
|
PART
I. FINANCIAL INFORMATION
|
1
|
Item
1. Consolidated
Financial Statements
(unaudited)
|
1
|
Consolidated
Balance Sheets as of June 30, 2007 and December 31,
2006
|
2
|
Consolidated
Statements of Operations for the Three Months and Six Months Ended
June
30, 2007 and 2006
|
3
|
Consolidated
Statements of Cash Flows for the Six Months Ended June 30, 2007 and
2006
|
4
|
Notes
to Consolidated Financial Statements
|
5
|
Item
2.
Management's Discussion and Analysis of Financial Condition and Results
of
Operations
|
15
|
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
|
36
|
Item
4. Controls
and Procedures
|
36
|
PART
II. OTHER INFORMATION
|
38
|
Item
1A. Risk
Factors
|
38
|
Item
2.
Unregistered Sales of Equity Securities and Use of
Proceeds
|
50
|
Item
4.
Submission of Matters to a Vote of Security Holders
|
50
|
Item
6.
Exhibits
|
52
|
SIGNATURES
|
53
|
PROSTASCINT®,
QUADRAMET® and CAPHOSOL® are registered United States trademarks of Cytogen
Corporation. All other trade names, trademarks or servicemarks
appearing in this Quarterly Report on Form 10-Q are the property of their
respective owners, and not the property of Cytogen Corporation or any of its
subsidiaries.
PART
I - FINANCIAL INFORMATION
Item
1. Consolidated Financial Statements
(unaudited)
CYTOGEN
CORPORATION AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(All
amounts in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
ASSETS:
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash
equivalents
|
|
$ |
16,095
|
|
|
$ |
32,507
|
|
Restricted
cash
|
|
|
--
|
|
|
|
1,100
|
|
Accounts
receivable,
net
|
|
|
2,145
|
|
|
|
2,113
|
|
Inventories
|
|
|
5,393
|
|
|
|
2,538
|
|
Inventories
at
wholesalers
|
|
|
24
|
|
|
|
93
|
|
Prepaid
expenses
|
|
|
1,411
|
|
|
|
1,571
|
|
Other
current
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current
assets
|
|
|
25,115
|
|
|
|
39,985
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, less accumulated depreciation and amortization of
$1,571
and $1,409 at
June 30, 2007 and December 31, 2006, respectively
|
|
|
1,051
|
|
|
|
691
|
|
Product
license fees, less accumulated amortization of $3,195 and $2,577
at June
30, 2007 and
December 31, 2006, respectively
|
|
|
10,994
|
|
|
|
11,612
|
|
Other
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Current
portion of long-term
liabilities
|
|
|
86
|
|
|
|
64
|
|
Accounts
payable and accrued
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current
liabilities
|
|
|
11,326
|
|
|
|
10,168
|
|
|
|
|
|
|
|
|
|
|
Warrant
liabilities
|
|
|
4,349
|
|
|
|
6,464
|
|
Other
long-term
liabilities
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock, $.01 par
value, 5,400,000 shares authorized-Series C Junior Participating
Preferred
Stock, $.01 par value, 200,000 shares authorized, none issued and
outstanding
|
|
|
--
|
|
|
|
--
|
|
Common
stock, $.01 par value,
100,000,000 and 50,000,000 shares authorized, 29,659,357 and
29,605,631
shares issued and outstanding at June 30, 2007 and December 31,
2006, respectively
|
|
|
297
|
|
|
|
296
|
|
Additional
paid-in
capital
|
|
|
465,921
|
|
|
|
465,016
|
|
Accumulated
other
comprehensive income
|
|
|
33
|
|
|
|
20
|
|
Accumulated
deficit
|
|
|
(442,898 |
) |
|
|
(427,670 |
) |
|
|
|
|
|
|
|
|
|
Total
stockholders'
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
The
accompanying notes are an integral
part of these statements.
CYTOGEN
CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(All
amounts in thousands, except per share data)
(Unaudited)
|
|
|
Three
Months
Ended
June 30,
|
|
Six
Months
Ended
June
30,
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
QUADRAMET
|
|
$ |
2,410
|
|
|
$ |
1,988
|
|
|
$ |
4,760
|
|
|
$ |
4,244
|
|
PROSTASCINT
|
|
|
2,508
|
|
|
|
2,180
|
|
|
|
4,964
|
|
|
|
4,364
|
|
CAPHOSOL
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
product
revenue
|
|
|
5,152
|
|
|
|
4,168
|
|
|
|
9,958
|
|
|
|
8,608
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue
|
|
|
2
|
|
|
|
4
|
|
|
|
4
|
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues
|
|
|
5,154
|
|
|
|
4,172
|
|
|
|
9,962
|
|
|
|
8,614
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of product
revenue
|
|
|
3,157
|
|
|
|
2,552
|
|
|
|
6,059
|
|
|
|
4,914
|
|
General
and
administrative
|
|
|
2,394
|
|
|
|
2,892
|
|
|
|
4,804
|
|
|
|
5,255
|
|
Selling
and
marketing
|
|
|
9,656
|
|
|
|
4,102
|
|
|
|
17,787
|
|
|
|
7,976
|
|
Research
and
development
|
|
|
1,624
|
|
|
|
1,505
|
|
|
|
3,228
|
|
|
|
4,541
|
|
Equity
in (income) loss of
joint venture
|
|
|
--
|
|
|
|
(13 |
) |
|
|
--
|
|
|
|
120
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating
expenses
|
|
|
16,831
|
|
|
|
11,038
|
|
|
|
31,878
|
|
|
|
22,806
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(11,677 |
) |
|
|
(6,866 |
) |
|
|
(21,916 |
) |
|
|
(14,192 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
285
|
|
|
|
392
|
|
|
|
661
|
|
|
|
689
|
|
Interest
expense
|
|
|
(24 |
) |
|
|
(6 |
) |
|
|
(34 |
) |
|
|
(12 |
) |
Advanced
Magnetics Inc. litigation settlement, net
|
|
|
--
|
|
|
|
--
|
|
|
|
3,946
|
|
|
|
--
|
|
Gain
on sale of equity interest in joint venture
|
|
|
--
|
|
|
|
12,873
|
|
|
|
--
|
|
|
|
12,873
|
|
Decrease
in value of warrant liabilities
|
|
|
1,020
|
|
|
|
813
|
|
|
|
2,115
|
|
|
|
182
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss)
|
|
$ |
(10,396 |
) |
|
$ |
7,206
|
|
|
$ |
(15,228 |
) |
|
$ |
(460 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net income (loss) per share
|
|
$ |
(0.35 |
) |
|
$ |
0.32
|
|
|
$ |
(0.51 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted weighted average common shares
outstanding
|
|
|
29,644
|
|
|
|
22,474
|
|
|
|
29,625
|
|
|
|
22,474
|
|
The
accompanying notes are an integral part of these statements.
CYTOGEN
CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(All
amounts in thousands)
(Unaudited)
|
|
Six
Months Ended June 30,
|
|
|
2007
|
|
|
2006
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(15,228 |
) |
|
$ |
(460 |
) |
Adjustments
to reconcile net loss to net cash used
|
|
|
|
|
|
|
|
in
operating
activities:
|
|
|
|
|
|
|
|
Depreciation
and
amortization
|
|
|
872
|
|
|
|
601
|
|
Decrease
in value of warrant
liabilities
|
|
|
(2,115 |
) |
|
|
(182 |
) |
Share-based
compensation
expense
|
|
|
847
|
|
|
|
772
|
|
Gain
on sale of equity interest
in joint venture
|
|
|
--
|
|
|
|
(12,873 |
) |
Other
|
|
|
51
|
|
|
|
12
|
|
Changes
in assets and
liabilities:
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(32 |
) |
|
|
(173 |
) |
Inventories
|
|
|
(2,854 |
) |
|
|
1,623
|
|
Other
assets
|
|
|
1,481
|
|
|
|
656
|
|
Accounts
payable and accrued
liabilities
|
|
|
2,143
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating
activities
|
|
|
(14,835 |
) |
|
|
(10,002 |
) |
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
Purchase
of product
rights
|
|
|
(1,000
|
) |
|
|
(2,000 |
) |
Purchases
of property and
equipment
|
|
|
(598 |
) |
|
|
(86 |
) |
Proceeds
from sale of equity interest in joint venture
|
|
|
--
|
|
|
|
13,132
|
|
|
|
|
|
|
|
|
|
Net
cash provided by (used in)
investing activities
|
|
|
(1,598 |
) |
|
|
11,046
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
Proceeds
from issuance of common stock
|
|
|
58
|
|
|
|
36
|
|
Payment
of long-term
liabilities
|
|
|
(37 |
) |
|
|
(17 |
) |
|
|
|
|
|
|
|
|
Net
cash provided by financing
activities
|
|
|
21
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
(16,412 |
) |
|
|
1,063
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, beginning of period
|
|
|
32,507
|
|
|
|
30,337
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, end of period
|
|
$ |
16,095
|
|
|
$ |
31,400
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of non-cash information:
|
|
|
|
|
|
|
|
Capital
lease of
equipment
|
|
$ |
84
|
|
|
$ |
96
|
|
Unrealized
holding gain on
marketable securities
|
|
$ |
13
|
|
|
$ |
41
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash information:
|
|
|
|
|
|
|
|
Cash
paid for
interest
|
|
$ |
17
|
|
|
$ |
12
|
|
The
accompanying notes are an integral part of these statements.
CYTOGEN
CORPORATION AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.
THE COMPANY
Background
Cytogen
Corporation (the "Company") is a specialty pharmaceutical company dedicated
to
advancing the treatment and care of patients by building, developing, and
commercializing a portfolio of oncology products. The Company's
specialized sales force currently markets three therapeutic products and one
diagnostic product to the U.S. oncology market. CAPHOSOL is an
electrolyte solution for the treatment of oral mucositis and dry mouth that
is
approved in the U.S. as a prescription medical device. QUADRAMET
(samarium Sm-153 lexidronam injection) is approved for the treatment of pain
in
patients whose cancer has spread to the bone. PROSTASCINT (capromab
pendetide) is a PSMA-targeting monoclonal antibody-based agent to image the
extent and spread of prostate cancer. SOLTAMOX (tamoxifen citrate) is
the first liquid hormonal therapy approved in the U.S. for the treatment of
breast cancer in adjuvant and metastatic settings. The Company is
also developing CYT-500, a third-generation radiolabeled antibody to treat
prostate cancer.
Cytogen
has a history of operating losses since its inception. The Company
currently relies on two products, PROSTASCINT and QUADRAMET, for substantially
all of its current revenues. The Company will depend on market
acceptance of CAPHOSOL and SOLTAMOX for potential new revenues. If
CAPHOSOL or SOLTAMOX does not achieve market acceptance, either because the
Company fails to effectively market such products or competitors introduce
competing products, the Company will not be able to generate sufficient revenue
to become profitable. The Company has, from time to time, stopped
selling certain products that the Company previously believed would generate
significant revenues. The Company's products are subject to
significant regulatory review by the FDA and other federal and state agencies,
which requires significant time and expenditures in seeking, maintaining and
expanding product approvals. In addition, the Company relies on
collaborative partners to a significant degree, among other things, to
manufacture its products, to secure raw materials, and to provide licensing
rights to their proprietary technologies for the Company to sell and market
to
others. The Company is also subject to revenue and credit
concentration risks as a small number of its customers account for a high
percentage of total revenues and corresponding receivables. The loss
of one of these customers or changes in their buying patterns could result
in
reduced sales, thereby adversely affecting the operating results.
The
Company has incurred negative cash flows from operations since its inception,
and has expended, and expects to continue to expend, substantial funds to
implement its planned product development efforts, including acquisition of
complementary clinical stage and marketed products, research and development,
clinical studies and regulatory activities, and to further the Company's
marketing and sales programs including new product launches. The
Company expects its existing capital resources at June 30, 2007, along with
the
net proceeds of approximately $9.1 million from the sale of equity in July
2007,
should be adequate to fund operations and commitments into 2008. The
Company cannot assure you that its business or
operations
will not change in a manner that would consume available resources more rapidly
than anticipated. The Company expects that it will have additional
requirements for debt or equity capital, irrespective of whether and when
profitability is reached, for further product development costs, product and
technology acquisition costs, and working capital.
Basis
of Consolidation
The
consolidated financial statements include the financial statements of Cytogen
and its subsidiaries. All intercompany balances and transactions have
been eliminated in consolidation.
Basis
of Presentation
The
consolidated financial statements and notes thereto of Cytogen are unaudited
and
include all adjustments which, in the opinion of management, are necessary
to
present fairly the financial condition and results of operations as of and
for
the periods set forth in the Consolidated Balance Sheets, Consolidated
Statements of Operations and Consolidated Statements of Cash
Flows. All such accounting adjustments are of a normal, recurring
nature. The consolidated financial statements do not include all of
the information and footnote disclosures normally included in financial
statements prepared in accordance with U.S. generally accepted accounting
principles and should be read in conjunction with the consolidated financial
statements and notes thereto included in the Company's Annual Report on Form
10-K, filed with the Securities and Exchange Commission (SEC), which includes
financial statements as of and for the year ended December 31,
2006. The results of the Company's operations for any interim period
are not necessarily indicative of the results of the Company's operations for
any other interim period or for a full year.
Summary
of Significant Accounting Policies
Use
of Estimates
The
preparation of financial statements in conformity with U.S. generally accepted
accounting principles requires management to make estimates and assumptions
that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those
estimates.
Cash
and Cash Equivalents
Cash
and
cash equivalents include cash in banks and all highly-liquid investments with
a
maturity of three months or less at the time of purchase.
Restricted
Cash
In
connection with the Company's license agreement with InPharma executed in
October 2006, the Company pledged $1.1 million as collateral to secure a letter
of credit for $1.0 million in favor of InPharma to guarantee Cytogen's payment
obligation of $1.0 million, which was paid on April 11, 2007 (see Note
6). The cash collateral was released from restriction upon the
expiration of the letter of credit on April 17, 2007.
Inventories
The
Company's inventories include PROSTASCINT, CAPHOSOL, and SOLTAMOX with the
majority of the inventories related to PROSTASCINT. Inventories are
stated at the lower of cost or market as determined using the first-in,
first-out method and consisted of the following (all amounts in
thousands):
|
|
|
|
|
|
|
Raw
materials
|
|
$ |
232
|
|
|
$ |
325
|
|
Work-in-process
|
|
|
2,875
|
|
|
|
1,296
|
|
Finished
goods
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Net
Loss Per Share
Basic
net
loss per common share is calculated by dividing the Company's net loss by the
weighted-average common shares outstanding during each period. Diluted net
loss
per common share is the same as basic net loss per share for each of the three
and six month periods ended June 30, 2007 and the six month period ended June
30, 2006, because the inclusion of common stock equivalents, which consist
of
nonvested shares, warrants and options to purchase shares of the Company's
common stock, would be antidilutive due to the Company's
losses. Diluted income per common share for the three months ended
June 30, 2006 is computed by dividing net income by the weighted-average common
shares outstanding during the period, increased to include all additional common
shares that would have been outstanding assuming potentially dilutive common
share equivalents had been issued. Dilutive common share equivalents include
the
dilutive effect of in-the-money shares, which is calculated, based on the
average share price for the three months ended June 30, 2006 using the treasury
stock method. Under the treasury stock method, the exercise price of
a security, the average amount of unrecognized compensation cost during the
period, if any, and the amount of tax benefits that would be recorded in
additional paid-in-capital, if any, when the security is exercised, are assumed
to be used to repurchase shares in the current period. Weighted-average common
stock equivalents to purchase 5,264,022 shares of the Company's common stock
were excluded from the computation of diluted net income per common share for
the three months ended June 30, 2006 because their effect would have been
antidilutive.
Other
Comprehensive Income or Loss
Other
comprehensive income consisted of unrealized holding gains on marketable
securities. For the three months ended June 30, 2007, the unrealized holding
gain for these securities was $3,000 and, as a result, the comprehensive loss
for the three months ended June 30, 2007 was $10,393,000. For the six months
ended June 30, 2007, the unrealized holding gain for these securities was
$13,000 and, as a result, the comprehensive loss for the six months ended June
30, 2007 was $15,215,000. For the three months ended June 30, 2006,
the unrealized holding loss for these securities was $55,000 and, as a result,
the comprehensive income for the three months ended June 30, 2006 was
$7,151,000. For the six months ended June 30, 2006, the unrealized holding
gain
of the securities was $41,000 and as a result, the comprehensive loss for the
six months ended June 30, 2006 was $419,000.
Recent
Accounting Pronouncements
Advance
Payments for Goods or Services
In
June
2007, the Financial Accounting Standards Board ("FASB") issued Emerging Issues
Task Force (EITF) Issue No. 07-3, "Accounting for Advance Payments for Goods
or
Services To Be Used in Future Research and Development" (EITF 07-3), which
is
effective for calendar year companies on January 1, 2008. The Task
Force concluded that nonrefundable advance payment for goods or services that
will be used or rendered for future research and development activities should
be deferred and capitalized. Such amounts should be recognized as an
expense as the related goods are delivered or the services are performed, or
when the goods or services are no longer expected to be provided. The
Company is currently assessing the potential impacts on the Company's
consolidated financial statements upon adoption of EITF 07-3.
Fair
Value Option
In
February 2007, the FASB issued Statement of Financial Accounting Standards
("SFAS") No. 159 "The Fair Value Option for Financial Assets and Financial
Liabilities, Including an Amendment of FASB Statement No. 115" (SFAS 159),
which will become effective for fiscal years beginning after November 15,
2007. SFAS 159 permits entities to measure eligible financial
assets and financial liabilities at fair value, on an instrument-by-instrument
basis, that are otherwise not permitted to be accounted for at fair value under
other generally accepted accounting principles. The fair value measurement
election is irrevocable and subsequent changes in fair value must be recorded
in
earnings. The Company will adopt SFAS 159 in fiscal year 2008
and is evaluating if it will elect the fair value option for any of its eligible
financial instruments.
Fair
Value Measurement
In
September 2006, the FASB finalized SFAS No. 157, "Fair Value Measurements"
(SFAS
157) which will become effective in 2008. This Statement defines fair
value, establishes a framework for measuring fair value and expands disclosures
about fair value measurements; however, it does not require any new fair value
measurements. The provisions of SFAS 157 will be applied
prospectively to fair value measurements and disclosures beginning in the first
quarter of 2008 and is not expected to have a material effect on the Company's
consolidated financial statements.
Income
Taxes
Effective
January 1, 2007, the Company adopted FASB Interpretation No. 48, "Accounting
for
Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109" ("FIN
48"). FIN 48 prescribes how a company should recognize, measure,
present and disclose an uncertain income tax position. A "tax
position" is a position taken on a previously filed tax return, or expected
to
be taken in a future tax return that is reflected in the measurement of current
and deferred tax assets or liabilities for interim or annual periods. A tax
position can result in a permanent reduction of income taxes payable, a deferral
of income taxes to future periods, or a change in the expected ability to
realize deferred tax assets. A change in net assets that results from
adoption of FIN 48 is recorded as an adjustment to retained earnings in
the
period
of
adoption. The adoption of FIN 48 did not have any impact on the
Company's consolidated financial statements.
On
May 2,
2007, the FASB Staff Position amended FIN 48 to provide guidance on how an
enterprise should determine whether a tax position is effectively settled for
the purpose of recognizing previously unrecognized tax benefits. This
guidance, which is effective immediately, had no impact on the Company's
consolidated financial statements as of and for the three and six month periods
ended June 30, 2007.
Reclassification
Certain
amounts in prior year's consolidated financial statements have been reclassified
to conform to the current year presentation.
2.
SHARE-BASED COMPENSATION
The
Company accounts for its share-based compensation according to the provisions
of
SFAS No. 123(R), "Share-Based Payment," which requires companies to measure
and
recognize compensation expense for all share-based payments at fair
value. The Company's share-based compensation costs are generally
based on the fair value of the option awards calculated using the Black-Scholes
option pricing model on the date of grant.
For
the
three months ended June 30, 2007, the Company recorded $419,000 of share-based
compensation expense, of which $314,000 was included in general and
administrative expenses, $51,000 was included in selling and marketing expenses,
and $54,000 was recorded in research and development expenses. For
the six months ended June 30, 2007, the Company recorded $847,000 of share-based
compensation expense, of which $548,000 was included in general and
administrative expenses, $175,000 was included in selling and marketing
expenses, and $124,000 was recorded in research and development
expenses. For the three months ended June 30, 2006, the Company
recorded $309,000 of share-based compensation expense, of which $311,000 was
included in general and administrative expenses, $5,000 was included in selling
and marketing expenses, and $7,000 of expense reversal was recorded in research
and development expenses to reflect actual forfeitures. For the six months
ended
June 30, 2006, the Company recorded $772,000 of share-based compensation
expense, of which $557,000 was included in general and administrative expenses,
$163,000 was included in selling and marketing expenses, and $52,000 was
recorded in research and development expenses.
The
weighted-average grant date fair value per share of the options granted under
the Cytogen stock option plans during the three and six months ended June 30,
2007 is estimated at $1.77 and $1.82 per share, respectively, as compared to
$2.79 and $2.77 per share in the same periods of 2006, respectively, using
the
Black-Scholes option pricing model with the following weighted average
assumptions:
|
|
Three
Months
Ended
June
30, 2007
|
|
|
Six
Months
Ended
June
30, 2007
|
|
|
|
|
|
|
|
|
Expected
life (years)
|
|
|
8.92
|
|
|
|
6.35
|
|
Expected
volatility
|
|
|
101% |
|
|
|
85% |
|
Dividend
yield
|
|
|
0% |
|
|
|
0% |
|
Risk-free
interest rate
|
|
|
5.25% |
|
|
|
4.77% |
|
Options
granted
|
|
|
103,000
|
|
|
|
816,500
|
|
Nonvested
shares granted
|
|
|
80,000
|
|
|
|
245,000
|
|
|
|
Three
Months
Ended
June
30, 2006
|
|
|
Six
Months
Ended
June
30, 2006
|
|
|
|
|
|
|
|
|
|
|
Expected
life (years)
|
|
|
6.53
|
|
|
|
6.51
|
|
Expected
volatility
|
|
|
97% |
|
|
|
97% |
|
Dividend
yield
|
|
|
0% |
|
|
|
0% |
|
Risk-free
interest rate
|
|
|
4.95% |
|
|
|
4.94% |
|
Options
granted
|
|
|
532,400
|
|
|
|
551,600
|
|
Nonvested
shares granted
|
|
|
69,800
|
|
|
|
71,800
|
|
The
compensation costs for nonvested share awards are based on the fair value of
Cytogen common stock on the date of grant. The weighted-average grant
date fair value per share of nonvested share awards granted during the three
and
six month periods ended June 30, 2007 was $1.99 and $2.33, respectively, as
compared to $3.58 and $3.56 in the same periods in 2006,
respectively.
On
June
13, 2007, the Company's stockholders approved an amendment to the Company's
2004 Non-Employee Director Stock Incentive Plan to increase the maximum
aggregate number of shares of common stock available for issuance under such
plan from 375,000 to 750,000. The Company has reserved an additional
375,000 shares of its common stock for issuance in connection with such
increase.
3.
LAUREATE PHARMA, L.P.
In
September 2006, the Company entered into a non-exclusive manufacturing agreement
with Laureate pursuant to which Laureate shall manufacture PROSTASCINT and
its
primary raw materials for Cytogen in Laureate's Princeton, New Jersey facility.
The agreement will terminate, unless terminated earlier pursuant to its terms,
upon Laureate's completion of the specified production campaign for PROSTASCINT
and shipment of the resulting products from Laureate's
facility. Under the terms of the agreement, the Company anticipates
it will pay at least an aggregate of $3.9 million through the end of the term
of
contract. Approximately $2.9 million has been incurred under this
agreement through June 30, 2007, and was recorded as inventory when purchased,
of which $1.0 million and $2.4 million were recorded during the three and six
month periods ended June 30, 2007, respectively.
4.
WARRANT LIABILITY
In
July
and August 2005, the Company sold to certain institutional investors shares
of
common stock and 776,096 warrants to purchase shares of its common stock
having
an exercise price of $6.00 per share. These warrants are exercisable
beginning six months and ending ten years
after their issuance. The shares of common stock underlying the
warrants were registered under the Company's existing shelf registration
statement. The Company is required to maintain the effectiveness of
the registration statement as long as any warrants are
outstanding.
Under
Emerging Issues Task Force No. 00-19 "Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company's Own Stock"
("EITF 00-19"), to qualify as permanent equity, the equity derivative must
permit the issuer to settle in unregistered shares. The Company does
not have that ability under the securities purchase agreement for the warrants
issued in July and August 2005 and, as EITF 00-19 considers the ability to
keep
a registration statement effective as beyond the Company's control, the warrants
cannot be classified as permanent equity and are instead classified as a
liability in the accompanying consolidated balance sheets.
In
November 2006, the Company sold to certain institutional investors shares of
its
common stock and 3,546,107 warrants to purchase shares of its common stock
with
an exercise price of $3.32 per share. These warrants are exercisable
beginning six months and ending five years after their issuance. The
warrant agreement contains a cash settlement feature, which is available to
the
warrant holders at their option, upon an acquisition in certain
circumstances. As a result, the warrants cannot be classified as
permanent equity and are instead classified as a liability at their fair value
in the accompanying consolidated balance sheet.
The
Company recorded the warrant liabilities at their fair value at each reporting
date using the Black-Scholes option-pricing model with the following
weighted-average assumptions:
|
|
|
|
|
|
|
Dividend
yield
|
|
|
0%
|
|
|
|
0%
|
|
Expected
volatility
|
|
|
75%
|
|
|
|
107%
|
|
Expected
life(1)
|
|
5.0
years
|
|
|
9.1
years
|
|
Risk-free
interest rate
|
|
|
5.0%
|
|
|
|
5.2%
|
|
Company
Common Stock Price
|
|
$ |
1.95
|
|
|
$ |
2.50
|
|
Outstanding
warrants
|
|
|
4,322,203
|
|
|
|
776,096
|
|
|
|
The
remaining expected life assumptions at June 30, 2007 and 2006 for
the
warrants issued in July and August 2005 were 8.1 years and 9.1
years,
respectively. The expected life assumption at June 30, 2007 for
the warrants issued in November
2006 was 4.4 years.
|
Equity
derivatives not qualifying for permanent equity accounting are recorded at
fair
value and are remeasured at each reporting date until the warrants are exercised
or expire. Changes in the fair value of the warrants issued as
described above will be reported in the consolidated statements of operations
as
non-operating income or expense. At June 30, 2007, the fair value of
the warrants decreased to approximately $4.3 million from $6.5 million at
December 31, 2006, resulting in gains of $1.0 million and $2.1 million for
the
three and six
months
ended June 30, 2007, respectively, compared to
$813,000 and $182,000 for the same periods in 2006, respectively.
In
connection with the sale of Cytogen shares and warrants in November 2006,
the
Company entered into a Registration Rights Agreement with the investors under
which the Company was obligated to file a registration statement with the
SEC
for the resale of Cytogen shares
sold to the investors and shares issuable upon exercise of the warrants within
a
specified time period. The Company is also required to use
commercially reasonable efforts to keep the registration statement
continuously effective with the SEC until such time when all of the registered
shares are sold or three years from closing date, whichever is
earlier. In the event the Company fails to keep the registration
statement effective, the Company is obligated to pay the investors liquidated
damages equal to 1% of the aggregate purchase price of $20 million for each
thirty-day period that the registration statement is not effective, up to
10%. On December 28, 2006, the SEC declared the registration
statement effective. The Company concluded that the contingent
obligation was not probable, and therefore no contingent liability was recorded
as of December 31, 2006 and June 30, 2007.
See
Note
11 for information concerning the warrants issues in connection with the sale
of
equity in July 2007.
5.
ONCOLOGY THERAPEUTICS NETWORK, J.V.
In
January 2007, the Company amended the revised purchase and supply agreement
with
Oncology Therapeutics Network, J.V. ("OTN") dated June 20, 2006, as revised
in
August 2006, appointing OTN as the exclusive warehousing agent and non-exclusive
distributor of CAPHOSOL, in addition to SOLTAMOX ("Products"). Under
the terms of the revised agreement, the Company pays OTN management fees based
upon a percentage of the value of Products shipped during the
period.
6.
INPHARMA AS
On
October 11, 2006, the Company and InPharma entered into a license agreement
granting the Company exclusive rights for CAPHOSOL in North America and options
to license the marketing rights for CAPHOSOL in Europe and
Asia. Under the terms of the Agreement, the Company was obligated to
pay InPharma $1.0 million upon the six-month anniversary of the execution of
the
agreement, which payment was made on April 11, 2007. In addition, the
Company is obligated to pay InPharma royalties based on a percentage of net
sales and future milestone payments of up to an aggregate of $49.0 million,
of
which payments totaling $35 million are based upon annual sales first reaching
levels in excess of $30 million. The Company is also obligated to pay
a finder's fee based upon a percentage of milestone payments made to
InPharma.
7.
HOLOPACK VERPACKUNGSTECHNIK GMBH
In
February 2007, the Company entered into a non-exclusive manufacturing agreement
with Holopack Verpackungstechnik GmbH for the manufacture of
CAPHOSOL. The agreement has a term of two years and automatically
renews for an additional year. The agreement is terminable by
Holopack or the Company with three months notice prior to the end of each term
period.
8.
LITIGATION
In
January 2006, the Company filed a complaint against Advanced Magnetics in
the
Massachusetts Superior Court for breach of contract, fraud, unjust enrichment,
and breach of the implied covenant of good faith and fair dealing in connection
with the parties' 2000 license agreement. The
complaint sought damages along with a request for specific performance requiring
Advanced Magnetics to take all reasonable steps to secure FDA approval of
COMBIDEX in compliance with the terms of the licensing agreement. In
February 2006, Advanced Magnetics filed an answer to the Company's complaint
and
asserted various counterclaims, including tortuous interference, defamation,
consumer fraud and abuse of process. In February 2007, the Company
settled its lawsuit against Advanced Magnetics, as well as Advanced Magnetics'
counterclaims against Cytogen, by mutual agreement. Under
the terms of the settlement agreement, Advanced Magnetics paid $4 million
to the
Company and will release 50,000 shares of Cytogen common stock currently
being
held in escrow. In addition, both parties agreed to early termination
of the licensing agreement that would have expired in August
2010. During the three months ended March 31, 2007, the Company
incurred $54,000 of legal fees related to the litigation.
In
addition, the Company is, from time to time, subject to claims and suits arising
in the ordinary course of business. In the opinion of management, the
ultimate resolution of any such current matters would not have a material effect
on the Company's financial condition, results of operations or
liquidity.
9.
INCOME TAXES
In
July
2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty
in Income Taxes (FIN 48), which is applicable for fiscal years beginning
after December 15, 2006. FIN 48 clarifies the accounting for uncertainty in
income taxes recognized in an enterprise's financial statements in accordance
with SFAS No. 109, Accounting for Income Taxes. FIN 48 prescribes a
recognition threshold and measurement for financial statement recognition and
measurement of a tax position reported or expected to be reported on a tax
return. FIN 48 also provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure, and transition. The
Company adopted the provisions of FIN 48 on January 1, 2007. Adoption
of FIN 48 had no impact on the Company's consolidated results of operations
and
financial position.
On
May 2,
2007, the FASB Staff Position amended FIN 48 to provide guidance on how an
enterprise should determine whether a tax position is effectively settled for
the purpose of recognizing previously unrecognized tax benefits. This
guidance, which is effective immediately, also had no impact on the Company's
consolidated financial statements as of and for the three and six month periods
ended June 30, 2007.
The
Company and its subsidiaries file income tax returns in the U.S. federal
jurisdiction and in various states. The Company has tax net operating
loss and credit carryforwards that are subject to examination for a number
of
years beyond the year in which they are utilized for tax purposes. Since a
portion of these carryforwards may be utilized in the future, many of these
attribute carryforwards will remain subject to examination.
The
Company's policy is to record interest and penalties on uncertain tax positions
as income tax expense. At June 30, 2007, the Company has no uncertain
tax positions, and no amounts recorded for interest or penalties included
in the
financial statements.
We
do not
anticipate any events in the next twelve month period that would require the
Company to record a liability related to any uncertain income tax positions
as
prescribed by FIN 48.
10.
INCREASE IN AUTHORIZED COMMON STOCK
On
June
13, 2007, the Company's stockholders approved an amendment to the Company's
Restated Certificate of Incorporation to increase the total authorized
shares of common stock of the Company from 50,000,000 to 100,000,000
shares.
11.
SALE OF COMMON STOCK AND WARRANTS
On
June
29, 2007, the Company entered into purchase agreements with certain
institutional investors for the sale of 5,814,600 shares of its common stock
and
2,907,301warrants to purchase shares of its common stock, through a private
placement offering. The warrants have an exercise price of $2.23 per
share and are exercisable beginning six months and ending five years after
their
issuance. The warrant agreement contains a cash settlement feature,
which is available to the warrant holders at their option, upon an acquisition
in certain circumstances. In exchange for $1.74, the purchasers
received one share of common stock and warrants to purchase .5 shares of common
stock. The transaction closed on July 6, 2007. The offering provided
net proceeds of approximately $9.1 million to the Company. The
placement agents in this transaction received (i) a cash fee equal to 6% of
the
aggregate gross proceeds and (ii) warrants to purchase 348,876 shares of Cytogen
common stock having an exercise price of $2.23 per share and exercisable
beginning six months and ending five years after their issuance. In
connection with this sale, the Company entered into a Registration Rights
Agreement with the investors under which the Company was obligated to file
a
registration statement with the SEC for the resale of Cytogen shares sold to
the
investors and shares issuable upon exercise of the warrants within a specified
time period. The Company is also required to use commercially
reasonable efforts to cause the registration to be declared effective by the
SEC
and to remain continuously effective until such time when all of the registered
shares are sold or two years from closing date, whichever is
earlier. In the event the Company fails to keep the registration
statement effective, the Company is obligated to pay the investors liquidated
damages equal to 1% of the purchase price paid by the investors ($10.1 million)
for each monthly period that the registration statement is not effective, up
to
10%. On July 23, 2007, the Company filed the registration statement
with the SEC. The Company is evaluating the accounting for this transaction
under EITF 00-19 and 00-19-2 and may be required to classify the fair value
of
the warrants or the liquidated damages as a liability.
Item
2. Management's Discussion and Analysis of Financial
Condition and Results of Operations
This
Quarterly Report on Form 10-Q contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 and Section
21E
of the Securities Exchange Act of 1934, as amended. These
forward-looking statements regarding future events and our future results are
based on current expectations, estimates, forecasts, and projections and the
beliefs and assumptions of our management including, without limitation, our
expectations regarding results of operations, selling, general and
administrative expenses, research and development expenses and the sufficiency
of our cash for future operations. Forward-looking statements may be
identified by the use of forward-looking terminology such as "may," "will,"
"expect," "estimate," "anticipate," "continue," or similar terms, variations
of
such terms or the negative of those terms. These forward-looking
statements include statements regarding the growth and market penetration for
CAPHOSOL, QUADRAMET, PROSTASCINT and SOLTAMOX, our ability to obtain favorable
coverage and reimbursement rates from government-funded and third party payors
for our products, increased expenses resulting from our sales force and
marketing expansion, including sales and marketing expenses for CAPHOSOL,
QUADRAMET, PROSTASCINT and SOLTAMOX, the sufficiency of our capital resources
and supply of products for sale, the continued cooperation of our contractual
and collaborative partners, our need for additional capital and other statements
included in this Quarterly Report on Form 10-Q that are not historical
facts. Such forward-looking statements involve a number of risks and
uncertainties and investors are cautioned not to put any undue reliance on
any
forward-looking statement. We cannot guarantee that we will actually
achieve the plans, intentions or expectations disclosed in any such
forward-looking statements. Factors that could cause actual results
to differ materially, include, our ability to launch a new product, market
acceptance of our products, the results of our clinical trials, our ability
to
raise additional capital, our ability to hire and retain employees, economic
and
market conditions generally, our receipt of requisite regulatory approvals
for
our products and product candidates, the continued cooperation of our marketing
and other collaborative and strategic partners, our ability to protect our
intellectual property, and the other risks identified under Item 1A "Risk
Factors" in this Quarterly Report on Form 10-Q and Item 1A "Risk Factors" in
our
Annual Report on Form 10-K for the year ended December 31, 2006, and those
under
the caption "Risk Factors," as included in certain of our other filings, from
time to time, with the Securities and Exchange Commission.
Any
forward-looking statements made by us do not reflect the potential impact of
any
future acquisitions, mergers, dispositions, joint ventures or investments we
may
make. We do not assume, and specifically disclaim, any obligation to
update any forward-looking statements, and these statements represent our
current outlook only as of the date given.
The
following discussion and analysis should be read in conjunction with the
consolidated financial statements and related notes thereto contained elsewhere
herein, as well as in our Annual Report on Form 10-K for the year ended December
31, 2006 and from time to time in our other filings with the Securities and
Exchange Commission.
Overview
We
are a
specialty pharmaceutical company dedicated to advancing the treatment and care
of patients by building, developing, and commercializing a portfolio of oncology
products. Our specialized sales force currently markets three
therapeutic products and one diagnostic product to the U.S. oncology
market. CAPHOSOL is an electrolyte solution for the treatment of oral
mucositis and dry mouth that is approved in the U.S. as a prescription medical
device. QUADRAMET is approved for the treatment of pain in patients
whose cancer has spread to the bone. PROSTASCINT is a PSMA-targeting
monoclonal antibody-based agent to image the extent and spread of prostate
cancer. SOLTAMOX is the first liquid hormonal therapy approved in the
U.S. for the treatment of breast cancer in adjuvant and metastatic
settings. We are also developing CYT-500, a third-generation
radiolabeled antibody to treat prostate cancer.
Significant
Events in 2007
Settlement Agreement
with Advanced Magnetics
In
February 2007, we announced the settlement of our lawsuit against Advanced
Magnetics, Inc., as well as Advanced Magnetics' counterclaims against Cytogen,
by mutual agreement. Under the terms of the settlement agreement,
Advanced Magnetics paid us $4 million and will release 50,000 shares of Cytogen
common stock currently being held in escrow. In addition, both parties agreed
to
early termination of the 10-year license and marketing agreement and supply
agreement established in August 2000, as amended, for two imaging agents being
developed by Advanced Magnetics, Combidex® (ferumoxtran-10) and ferumoxytol,
previously Code 7228. The license and marketing agreement and supply agreement
would have expired in August 2010.
Initiation
of Phase 1 Trial for Radiolabeled Antibody for the Treatment of
Hormone-Refractory Prostate Cancer
In
February 2007, we announced the initiation of the first human clinical study
of
CYT-500, a radiolabeled monoclonal antibody targeted to prostate-specific
membrane antigen (PSMA). The Phase 1 clinical trial will investigate the safety
and tolerability of CYT-500 and determine the optimal antibody mass and
therapeutic dose for further studies. The clinical trial is being conducted
at
Memorial Sloan-Kettering Cancer Center under a Cytogen-sponsored Investigational
New Drug (IND) application, which was approved by the United States Food and
Drug Administration ("FDA") in May 2006, and is expected to enroll up to 36
patients.
Introduction
of CAPHOSOL in the United States
In
March
2007, we introduced CAPHOSOL, an advanced electrolyte solution indicated in
the
U.S. as an adjunct to standard oral care in treating oral mucositis (OM) caused
by radiation or high dose chemotherapy. CAPHOSOL is also indicated for dryness
of the mouth or throat (hyposalivation, xerostomia), regardless of the cause
or
whether the conditions are temporary or permanent.
Addition
of Senior Vice President of Sales and Marketing
On
June
11, 2007 we announced that we had appointed Stephen A. Ross to the newly created
position of Senior Vice President, Sales and Marketing effective July 9,
2007. Mr. Ross has over 15 years of commercial pharmaceutical
industry experience, as well as numerous key achievements specific to the
oncology space. Mr. Ross joined Cytogen from GlaxoSmithKline (GSK)
where most recently he served as Vice President, Specialist Business Units
in
the UK. In that capacity, Mr. Ross led a team of more than 300
employees and together they established new oncology and cervical business
units
in the UK. Previously, Mr. Ross served as Vice President and General Manager
of
GSK Ireland. His experience at GSK also includes managing a portfolio
of eight cytotoxic agents and two anti-emetic agents.
Sale
of Common Stock and Warrants
On
June
29, 2007, we entered into purchase agreements with certain institutional
investors for the sale of 5,814,600 shares of our common stock and
2,907,301warrants to purchase shares of our common stock, through a private
placement offering. The transaction closed on July 6, 2007. The
warrants have an exercise price of $2.23 per share and are exercisable beginning
six months and ending five years after their issuance. In exchange
for $1.74, the purchasers received one share of common stock and warrants to
purchase .5 shares of common stock. The offering provided us with net
proceeds of approximately $9.1 million. The placement agents in this
transaction received (i) a fee equal to 6% of the aggregate gross proceeds
and
(ii) warrants to purchase 348,876 shares of our common stock having an exercise
price of $2.23 per share and exercisable beginning six months and ending five
years after their issuance. In connection with this sale, we entered into
a Registration Rights Agreement with the investors. We are evaluating
the proper accounting for this transaction and may be required to classify
the
fair value of the warrants or the liquidated damages as a
liability.
Results
of Operations
Three
Months Ended June 30, 2007 and 2006
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
%
|
|
|
|
(All
amounts in thousands, except percentage
data)
|
|
QUADRAMET
|
|
$ |
2,410
|
|
|
$ |
1,988
|
|
|
$ |
422
|
|
|
|
21 |
% |
PROSTASCINT
|
|
|
2,508
|
|
|
|
2,180
|
|
|
|
328
|
|
|
|
15 |
% |
CAPHOSOL
|
|
|
234
|
|
|
|
--
|
|
|
|
234
|
|
|
|
n/a
|
|
Contract
revenue
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
(50 |
)% |
Total
revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
24 |
% |
Total
revenues for the second quarter of 2007 were $5.2 million compared to $4.2
million for the same period in 2006. Beginning in the second quarter of 2007,
we
began recognizing revenue from CAPHOSOL. Product revenues, which were
comprised of sales from QUADRAMET, PROSTASCINT and CAPHOSOL in the second
quarter of 2007 and sales from
QUADRAMET
and PROSTASCINT in the second quarter of 2006, accounted for nearly all of
total
revenues for each of the second quarters of 2007 and 2006,
respectively. Contract revenues accounted for the remainder of
revenues. We did not recognize any revenue from SOLTAMOX which we
introduced to the U.S market in the second half of 2006, because shipments
of
this product did not meet the revenue recognition criteria under U.S. generally
accepted accounting principles (GAAP). We will defer recognition of
revenue until the right of return on this product no longer exists or until
we
develop sufficient historical experience to reliably estimate expected
returns. To date, we have shipped $719,000 of SOLTAMOX to
wholesalers, net of returns, which we have not recorded as
revenue. Due to the remaining shelf life of twelve months or less at
June 30, 2007, we believe there is a high likelihood that some or all of the
product will be returned, which would result in our inability to recognize
such
shipments as revenue. We cannot assure you that we will be able to
successfully market SOLTAMOX or that SOLTAMOX will achieve market penetration
on
a timely basis or result in significant revenues for us.
QUADRAMET. QUADRAMET
sales were $2.4 million for the second quarter of 2007, reflecting a 3% increase
over the amount reported in the first quarter of 2007 and a 21% increase over
the second quarter of 2006. Quarterly sales trends for QUADRAMET
typically exhibit variability. QUADRAMET sales accounted for 47% and
48% of product revenues for the second quarters of 2007 and 2006,
respectively. Unit sales for the second quarter of 2007 are
consistent with the first quarter of 2007, and increased 6% from the second
quarter of 2006. The sales increase from the second quarter of prior
year period was also due to price increases for QUADRAMET of 5% and 13% on
September 1, 2006 and January 1, 2007, respectively. Currently, we
market QUADRAMET only in the United States and have no rights to market
QUADRAMET in Europe. We are focusing on multiple key initiatives to
position QUADRAMET for future growth and market penetration, including: (i)
distinguishing the physical properties of QUADRAMET from first-generation agents
within its class; (ii) empowering and marketing to key prescribing audiences;
(iii) broadening palliative use within label beyond prostate cancer to include
breast, lung and multiple myeloma; and (iv) evaluating the role of QUADRAMET
in
combination with other commonly used oncology agents. We cannot assure you
that
we will be able to successfully market QUADRAMET or that QUADRAMET will achieve
greater market penetration on a timely basis or result in significant revenues
for us.
PROSTASCINT.
PROSTASCINT sales for the second quarter of 2007 were $2.5
million, reflecting a 2% increase over the amount reported in the first quarter
of 2007 and a 15% increase over the second quarter of
2006. PROSTASCINT sales accounted for 49% and 52% of product revenues
for the second quarters of 2007 and 2006, respectively. Unit sales
for the second quarter of 2007 are consistent with the first quarter of 2007
and
the second quarter of 2006. The sales increase from the second
quarter of prior year period was attributable to a higher average selling price
in 2007 due to price increases for PROSTASCINT of 9% and 10% on September 1,
2006 and January 1, 2007, respectively. We believe recent developments in
imaging resolution, emerging clinical data, and an increasing level of
recognition of the value of PROSTASCINT fusion imaging support an important
near- and long-term market opportunity for PROSTASCINT. We are
focusing on multiple key areas to position PROSTASCINT for future growth and
market penetration, including: (i) positioning PROSTASCINT fusion imaging as
the
standard of care for prostate cancer imaging; (ii) generating awareness of
the
prognostic value of the PSMA antigen; (iii) leveraging the publication and
presentation of outcomes data;
and (iv)
advancing image-guided applications including brachytherapy, intensity modulated
radiation therapy, surgery and cryotherapy. We cannot assure you that
we will be able to successfully market PROSTASCINT, or that PROSTASCINT will
achieve greater market penetration on a timely basis or result in significant
revenues for us.
CAPHOSOL. We
introduced CAPHOSOL to the U.S market in March 2007. CAPHOSOL
revenues for the second quarter of 2007 were $234,000, which was based on a
number of factors including product sales to end-users, on-hand inventory
estimates in the distribution channel, expiry dates, and data on product
acceptance in the marketplace. We have not recorded $111,000 of CAPHOSOL
inventory at wholesalers as revenue. We will defer recognition of
revenue until the right of return on this product no longer exists or until
we
develop sufficient historical experience to reliably estimate expected returns
and discounts. When inventories in the distribution channel do not
exceed targeted levels, and we have the ability to estimate product returns
and
discounts, we will recognize product sales upon shipment, net of discounts,
returns and allowances. We cannot assure you that we will be able to
successfully market CAPHOSOL or that CAPHOSOL will achieve greater market
penetration on a timely basis or result in significant revenues for
us.
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
%
|
|
|
|
(All
amounts in thousands, except percentage
data)
|
|
Cost
of product
revenue
|
|
$ |
3,157
|
|
|
$ |
2,552
|
|
|
$ |
605
|
|
|
|
24 |
% |
General
and
administrative
|
|
|
2,394
|
|
|
|
2,892
|
|
|
|
(498 |
) |
|
|
(17 |
)% |
Selling
and
marketing
|
|
|
9,656
|
|
|
|
4,102
|
|
|
|
5,554
|
|
|
|
135 |
% |
Research
and
development
|
|
|
1,624
|
|
|
|
1,505
|
|
|
|
119
|
|
|
|
8 |
% |
Equity
in (income) loss of joint venture
|
|
|
|
|
|
|
(13 |
) |
|
|
|
|
|
|
100 |
% |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
52 |
% |
Total
operating expenses for the second quarter of 2007 were $16.8 million compared
to
$11.0 million in the same quarter of 2006.
Cost
of Product Revenue. Cost of product revenue for the second
quarters of 2007 and 2006 were $3.2 million and $2.6 million, respectively,
and
primarily reflects: (i) manufacturing and distribution costs for PROSTASCINT
and
QUADRAMET; (ii) royalties on our sales of products; (iii) amortization of the
up-front payments to acquire the marketing rights to QUADRAMET in 2003, SOLTAMOX
in April 2006 and CAPHOSOL in October 2006; and (iv) $518,000 of costs
associated with shipments of SOLTAMOX and CAPHOSOL to wholesalers, including
a
reserve of $214,000 for excess SOLTAMOX inventory with short expiry dates,
and
minimum royalties for SOLTAMOX that we do not have the ability to recover,
if
and when products are returned. Recoverable costs related to SOLTAMOX
and CAPHOSOL shipments to wholesalers for which we have not recognized revenue
in accordance to GAAP, are deferred and will be recorded as cost of product
revenue when those units are sold through to customers and recognized as
revenue.
General
and Administrative. General and administrative expenses
for the second quarter of 2007 were $2.4 million compared to $2.9 million in
the
same period of 2006. The decrease from the prior year period is
primarily due to reduced spending in the second quarter of 2007 for professional
fees including audit, legal and consulting services.
Selling
and Marketing. Selling and marketing expenses for the second
quarter of 2007 were $9.7 million compared to $4.1 million in the same period
of
2006. The increase from the prior year period is primarily driven by:
(i) $2.7 million of costs associated with the launch of CAPHOSOL late in the
first quarter of 2007; (ii) a $614,000 expense increase in marketing initiatives
related to SOLTAMOX which we introduced in the second half of 2006; and (iii)
the expanded investment for our specialty sales force and commercial support
of
QUADRAMET and PROSTASCINT.
Research
and Development. Research and development expenses for the second
quarter of 2007 were $1.6 million compared to $1.5 million in the same period
of
2006. The increase from the prior year period is primarily due to the
timing of development expenditures for QUADRAMET and PROSTASCINT, partially
offset by preclinical expenditures for CYT-500 incurred in 2006.
Equity
(Income) in Loss of Joint Venture. Our share of the income of the
PSMA Development Company LLC (PDC), our former joint venture with Progenics
Pharmaceuticals Inc., was $13,000 for the three months ended June 30,
2006. Such amounts represented 50% of the joint venture's net
income. We equally shared ownership and costs of the joint venture
with Progenics and accounted for the joint venture using the equity method
of
accounting until April 20, 2006 when we sold our ownership interest in PDC
to
Progenics. Following the sale of our interest in the joint venture in
April 2006, we have no further obligations to the joint venture.
Interest
Income/Expense. Interest income for the second quarter of 2007 was
$285,000 compared to $392,000 in the same period of 2006. The
decrease in 2007 from the prior year period was due to higher average cash
balances in 2006 partially offset by higher average investment yields in
2007. Interest expense for the second quarter of 2007 was $24,000
compared to $6,000 in the same period in 2006. Interest expense
includes interest on finance charges related to various equipment leases that
are accounted for as capital leases and interest on amounts to be escrowed
in
connection with the license agreement with InPharma.
Gain
on Sale of Equity Interest in Joint Venture. On April
20, 2006, we entered into a Membership Interest Purchase Agreement with
Progenics providing for the sale to Progenics of our 50% ownership interest
in
PDC, our joint venture with Progenics for the development of in vivo
cancer immunotherapies based on PSMA. In addition, we entered into an
Amended and Restated PSMA/PSMP License Agreement with Progenics and PDC pursuant
to which we licensed PDC certain rights in PSMA technology. Under the
terms of such agreements, we sold our 50% interest in PDC for a cash payment
of
$13.2 million, potential future milestone payments totaling up to $52.0 million
payable upon regulatory approval and commercialization of PDC products, and
royalties on future PDC product sales, if any. As a result of the
transaction, for the three months ended June 30, 2006, we recorded $12.9 million
in gain on sale of equity interest in the joint venture, which represents the
net proceeds after transaction costs less the carrying value of our investment
in the joint venture at the time of sale.
Decrease
in Warrant Liability. In connection with the sale of our common
stock and warrants in July and August 2005 and November 2006, we recorded the
warrants as a liability at their fair value using the Black-Scholes
option-pricing model and will remeasure them at each reporting date until
exercised or expired. Changes in the fair value of the warrants are
reported in the statements of operations as non-operating income or
expense. For the three months ended June 30, 2007, we reported a gain
of $1.0 million related to the decrease in fair value of the outstanding
warrants since December 31, 2006, compared to a $813,000 gain for the three
months ended June 30, 2006 related to the decrease in fair value of the then
outstanding warrants since December 31, 2005. The market price for
our common stock has been and may continue to be
volatile. Consequently, future fluctuations in the price of our
common stock may cause significant increases or decreases in the fair value
of
these warrants.
Net
Income (Loss). We
had
net loss of $10.4 million for the second quarter of 2007, compared to net income
of $7.2 million reported in the second quarter of 2006. The
basic and diluted net loss per share for the second quarter of 2007 was
$0.35 based on 29.6 million weighted average common shares
outstanding, compared to a basic and diluted net income per share of $0.32 based
on 22.5 million weighted average common shares outstanding for the same period
in 2006. The significant
fluctuation in results was due to the gain on the sale of our equity interest
in
the joint venture in 2006.
Six
Months Ended June 30, 2007 and 2006
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
%
|
|
|
|
(All
amounts in thousands, except percentage
data)
|
|
QUADRAMET
|
|
$ |
4,760
|
|
|
$ |
4,244
|
|
|
$ |
516
|
|
|
|
12 |
% |
PROSTASCINT
|
|
|
4,964
|
|
|
|
4,364
|
|
|
|
600
|
|
|
|
14 |
% |
CAPHOSOL
|
|
|
234
|
|
|
|
--
|
|
|
|
234
|
|
|
|
n/a
|
|
Contract
revenue
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
(33 |
)% |
Total
revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
16 |
% |
Total
revenues for the first half of 2007 were $10.0 million compared to $8.6 million
for the same period in 2006. Commencing with the second quarter of
2007, we began recognizing revenue from CAPHOSOL. Product revenues,
which were comprised of sales from QUADRAMET, PROSTASCINT and CAPHOSOL in the
first half of 2007 and sales from QUADRAMET and PROSTASCINT in the first half
of
2006, accounted for nearly all of total revenues for the first half of each
of
2007 and 2006. Contract revenues accounted for the remainder of
revenues. We did not recognize any revenue from SOLTAMOX which we
introduced to the U.S market in the second half of 2006, because shipments
of
this product did not meet the revenue recognition criteria under
GAAP. We will defer recognition of revenue until the right of return
on this product no longer exists or until we develop sufficient historical
experience to reliably estimate expected returns. To date, we have
shipped $719,000 of SOLTAMOX to wholesalers, net of returns, which we have
not
recorded as revenue. Due to the remaining shelf life of twelve months
or less at June 30, 2007, we believe there is a high likelihood that the product
will be returned, which would result in our inability to recognize
such
shipments
as revenue. We cannot assure you that we will be able to successfully
market SOLTAMOX or that SOLTAMOX will achieve market penetration on a timely
basis or result in significant revenues for us.
QUADRAMET.
QUADRAMET sales were $4.8 million for the first half of 2007,
an
increase of $516,000 from $4.2 million in the first half of
2006. QUADRAMET sales accounted for 48% and 49% of product revenues
for the first half of 2007 and 2006, respectively. Unit sales for the
first half of 2007 were consistent with sales for the first half of
2006. The sales increase from the first half of the prior year period
was attributable to a higher average selling price in 2007 due to price
increases for QUADRAMET of 5% and 13% on September 1, 2006 and January 1, 2007,
respectively. Currently, we market QUADRAMET only in the United
States and have no rights to market QUADRAMET in Europe. We are
focusing on multiple key initiatives to position QUADRAMET for future growth
and
market penetration, including: (i) distinguishing the physical properties of
QUADRAMET from first-generation agents within its class; (ii) empowering and
marketing to key prescribing audiences; (iii) broadening palliative use within
label beyond prostate cancer to include breast, lung and multiple myeloma;
and
(iv) evaluating the role of QUADRAMET in combination with other commonly used
oncology agents. We cannot assure you that we will be able to successfully
market QUADRAMET or that QUADRAMET will achieve greater market penetration
on a
timely basis or result in significant revenues for us.
PROSTASCINT. PROSTASCINT
sales were $5.0 million for the first half of 2007, an increase of $600,000
from
$4.4 million in the first half of 2006. PROSTASCINT sales accounted
for 50% and 51% of product revenues for the second quarters of 2007 and 2006,
respectively. Unit sales for the first half of 2007 decreased 2% from
the first half of 2006. The sales increase from the first half of the
prior year period was attributable to a higher average selling price in 2007
due
to price increases for PROSTASCINT of 9% and 10% on September 1, 2006 and
January 1, 2007, respectively. We believe recent developments in imaging
resolution, emerging clinical data, and an increasing level of recognition
of
the value of PROSTASCINT fusion imaging support an important near- and long-term
market opportunity for PROSTASCINT. We are focusing on multiple key
areas to position PROSTASCINT for future growth and market penetration,
including: (i) positioning PROSTASCINT fusion imaging as the standard of care
for prostate cancer imaging; (ii) generating awareness of the prognostic value
of the PSMA antigen; (iii) leveraging the publication and presentation of
outcomes data; and (iv) advancing image-guided applications including
brachytherapy, intensity modulated radiation therapy, surgery and
cryotherapy. We cannot assure you that we will be able to
successfully market PROSTASCINT, or that PROSTASCINT will achieve greater market
penetration on a timely basis or result in significant revenues for
us.
CAPHOSOL. CAPHOSOL
sales for the first half of 2007 were $234,000, which was based on a number
of
factors including product sales to end-users, on-hand inventory estimates in
the
distribution channel, expiry dates, and data on product acceptance in the
marketplace. We introduced CAPHOSOL to the U.S market in March
2007. We have not recorded $111,000 of CAPHOSOL inventory at
wholesalers as revenue. We will defer recognition of revenue until
the right of return on this product no longer exists or until we develop
sufficient historical experience to reliably estimate expected
returns. When inventories in the distribution channel do not exceed
targeted levels, and we have the ability to estimate product returns and
discounts, we will recognize product sales upon shipment, net of discounts,
returns and allowances. We cannot
assure
you that we will be able to successfully market CAPHOSOL or that CAPHOSOL will
achieve greater market penetration on a timely basis or result in significant
revenues for us.
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
%
|
|
|
|
(All
amounts in thousands, except percentage
data)
|
|
Cost
of product
revenue
|
|
$ |
6,059
|
|
|
$ |
4,914
|
|
|
$ |
1,145
|
|
|
|
23 |
% |
General
and
administrative
|
|
|
4,804
|
|
|
|
5,255
|
|
|
|
(451 |
) |
|
|
(9 |
)% |
Selling
and
marketing
|
|
|
17,787
|
|
|
|
7,976
|
|
|
|
9,811
|
|
|
|
123 |
% |
Research
and
development
|
|
|
3,228
|
|
|
|
4,541
|
|
|
|
(1,313 |
) |
|
|
(29 |
)% |
Equity
in (income) loss of joint venture
|
|
|
|
|
|
|
|
|
|
|
(120 |
) |
|
|
(100 |
)% |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
40 |
% |
Total
operating expenses for the first half of 2007 were $31.9 million compared to
$22.8 million in the same period of 2006.
Cost
of Product Revenues. Cost of product revenues for the
first half of 2007 and 2006 were $6.1 million and $4.9 million, respectively,
and primarily reflects: (i) manufacturing and distribution costs for PROSTASCINT
and QUADRAMET; (ii) royalties on our sales of products; (iii) amortization
of
the up-front payments to acquire the marketing rights to QUADRAMET in 2003,
SOLTAMOX in April 2006 and CAPHOSOL in October 2006; and (iv) $836,000 of costs
associated with shipments of SOLTAMOX and CAPHOSOL to wholesalers, including
a
reserve of $214,000 for excess SOLTAMOX inventory with short expiry dates,
and
minimum royalties for SOLTAMOX that we do not have the ability to recover,
if
and when products are returned. Recoverable costs related to SOLTAMOX
and CAPHOSOL shipments to wholesalers for which we have not recognized revenue
in accordance to GAAP, are deferred and will be recorded as cost of product
revenue when those units are sold through to customers and recognized as
revenue.
General
and Administrative. General and administrative expenses
for the first half of 2007 were $4.8 million compared to $5.3 million in the
same period of 2006. The decrease from the prior year period is
primarily due to reduced spending in 2007 for professional fees including audit
and legal services.
Selling
and Marketing. Selling and marketing expenses for the
first half of 2007 were $17.8 million compared to $8.0 million in the same
period of 2006. The increase from the prior year period is primarily
driven by: (i) $4.4 million of costs in the first half of 2007 associated with
the launch of CAPHOSOL late in the first quarter of 2007; (ii) a $1.4 million
expense increase in marketing initiatives related to SOLTAMOX which we
introduced in the second half of 2006; and (iii) the expanded investment for
our
specialty sales force and commercial support of QUADRAMET and
PROSTASCINT.
Research
and Development. Research and development expenses for
the first half of 2007 were $3.2 million compared to $4.5 million in the same
period of 2006. The decrease from
the
prior
year period is primarily due to preclinical expenditures for CYT-500 incurred
in
2006, partially offset by the timing of development expenditures for
QUADRAMET.
Equity
in Loss of Joint Venture. Our share of the loss of the
PSMA Development Company LLC, our former venture with Progenics Pharmaceuticals
Inc., was $120,000 during the first half of 2006. Such amount
represented 50% of the joint venture's net losses. We equally shared
ownership and costs of the joint venture with Progenics and accounted for the
joint venture using the equity method of accounting until April 20, 2006 when
we
sold our ownership interest in PDC to Progenics. Following the sale
of our interest in the joint venture in April 2006, we have no further
obligations to the joint venture.
Interest
Income/Expense. Interest income for the first half of
2007 was $661,000 compared to $689,000 in the same period of
2006. The decrease in 2007 from the prior year period was due to
higher average cash balances in 2006 partially offset by higher average
investment yields in 2007. Interest expense for the first half of
2007 was $34,000 compared to $12,000 in the same period in
2006. Interest expense includes interest on finance charges related
to various equipment leases that are accounted for as capital leases and
interest on amounts to be escrowed in connection with the license agreement
with
InPharma.
Advanced
Magnetics, Inc. Litigation Settlement, Net. In February
2007, we settled our lawsuit against Advanced Magnetics, Inc., as well as
Advanced Magnetics' counterclaims against us, by mutual
agreement. Under the terms of the settlement agreement, Advanced
Magnetics paid us $4.0 million and will release 50,000 shares of Cytogen common
stock currently being held in escrow. As a result of the settlement,
for the six months ended June 30, 2007, we recorded a gain of $3.9 million,
net
of transaction costs.
Gain
on Sale of Equity Interest in Joint Venture. On April
20, 2006, we entered into a Membership Interest Purchase Agreement with
Progenics providing for the sale to Progenics of our 50% ownership interest
in
PDC, our joint venture with Progenics for the development of in vivo
cancer immunotherapies based on PSMA. In addition, we entered into an
Amended and Restated PSMA/PSMP License Agreement with Progenics and PDC pursuant
to which we licensed PDC certain rights in PSMA technology. Under the
terms of such agreements, we sold our 50% interest in PDC for a cash payment
of
$13.2 million, potential future milestone payments totaling up to $52.0 million
payable upon regulatory approval and commercialization of PDC products, and
royalties on future PDC product sales, if any. As a result of the
transaction, for the six months ended June 30, 2006, we recorded $12.9 million
in gain on sale of equity interest in the joint venture, which represents the
net proceeds after transaction costs less the carrying value of our investment
in the joint venture at the time of sale.
Decrease
in Warrant Liability. In connection with the sale of our common
stock and warrants in July and August 2005 and November 2006, we recorded the
warrants as a liability at their fair value using the Black-Scholes
option-pricing model and will remeasure them at each reporting date until
exercised or expired. Changes in the fair value of the warrants are
reported in the statements of operations as non-operating income or
expense. For the six months ended June 30, 2007, we reported a gain
of $2.1 million related to the decrease in fair value of these outstanding
warrants since December 31, 2006, compared to a $182,000 gain for the six months
ended June 30, 2006 related to the decrease in fair value of the then
outstanding warrants since December 31, 2005. The market price for
our common stock has been and may continue to be
volatile. Consequently,
future fluctuations in the price of our common stock may cause significant
increases or decreases in the fair value of these warrants.
Net
Income (Loss). We had net loss of $15.2 million for the
first half of 2007, compared to $460,000 reported for the first half of
2006. The basic and diluted net loss per share for the first half of
2007 was $0.51 based on 29.6 million weighted average
common shares outstanding, compared to a basic and diluted net loss per share
of
$0.02 based on 22.5 million weighted average common shares
outstanding for the same period in 2006. The significant fluctuation
in results was due to the gain on the sale of our equity interest in the joint
venture in 2006, increased selling and marketing expenses in 2007 for CAPHOSOL
and SOLTAMOX, partially offset by the Advanced Magnetics litigation settlement
in 2007.
COMMITMENTS
We
have
entered into various contractual and commercial commitments. The
following table summarizes our obligations with respect to theses commitments
as
of June 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(All
amounts in thousands)
|
|
Capital
lease obligations
|
|
$ |
86
|
|
|
$ |
84
|
|
|
$ |
--
|
|
|
$ |
--
|
|
|
$ |
170
|
|
Facility
leases
|
|
|
338
|
|
|
|
451
|
|
|
|
--
|
|
|
|
--
|
|
|
|
789
|
|
Research
and development
|
|
|
160
|
|
|
|
197
|
|
|
|
150
|
|
|
|
444
|
|
|
|
951
|
|
Marketing
and other obligations
|
|
|
1,486
|
|
|
|
2
|
|
|
|
--
|
|
|
|
--
|
|
|
|
1,488
|
|
Manufacturing
contracts(1)
|
|
|
4,961
|
|
|
|
4,859
|
|
|
|
--
|
|
|
|
--
|
|
|
|
9,820
|
|
Minimum
royalty payments(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
(1)
|
Effective
January 1, 2004, we entered into a manufacturing and supply agreement
with
Bristol-Myers Squibb Medical Imaging, Inc. ("BMSMI") for QUADRAMET
whereby
BMSMI manufactures, distributes and provides order processing and
customer
services for us relating to QUADRAMET. Under the terms of our
agreement, we are obligated to pay at least $4.9 million annually,
subject
to future annual price adjustment, through 2008, unless terminated
by
BMSMI or us on a two year prior written notice. This agreement
will automatically renew for five successive one-year periods unless
terminated by BMSMI or us on a two-year prior written
notice. Accordingly, we have not included commitments beyond
June 30, 2009.
|
|
(2)
|
We
acquired an exclusive license from The Dow Chemical Company for QUADRAMET
for the treatment of osteoblastic bone metastases in certain
territories. The agreement requires us to pay Dow royalties based on
a percentage of net sales of QUADRAMET, or a guaranteed contractual
minimum payment, whichever is greater, and future payments upon
achievement of certain milestones. Future annual minimum royalties
due to Dow are $1.0 million per year in 2007 through 2012 and $833,000
in
2013.
We acquired the exclusive marketing
rights
for SOLTAMOX in the United States under our distribution agreement
with
Rosemont. The agreements with Rosemont require us to pay
Rosemont quarterly minimum royalties based on an agreed upon percentage
of
total tamoxifen prescriptions in the United States through June 2018.
The
above table includes future estimated annual minimum royalties based
upon
tamoxifen prescriptions in the United States for the quarter ended
March
31, 2007.
|
In
addition to the above, we are obligated to make certain royalty payments based
on sales of the related product and certain milestone payments if we achieve
specific development milestones or commercial milestones. We are also
obligated to pay a finder's fee based upon a percentage of milestone payments
made to InPharma in connection with the licensing of CAPHOSOL. We did
not include in the table above any payments that do not represent fixed or
minimum
payments but are instead payable only upon the achievement of a milestone,
if
the achievement of that milestone is uncertain or the obligation amount is
not
determinable.
Liquidity
and Capital Resources
Condensed
Statement of Cash Flows:
|
|
Six
Months Ended
June
30, 2007
|
|
|
|
(All
amounts in thousands)
|
|
Net
loss
|
|
$ |
(15,228 |
) |
Adjustments
to reconcile net loss to net cash used in
operating
activities
|
|
|
393 |
|
Net
cash used in operating
activities
|
|
|
(14,835 |
) |
Net
cash used in investing
activities
|
|
|
(1,598 |
) |
Net
cash provided by financing activities
|
|
|
|
|
Net
decrease in cash and cash equivalents
|
|
$ |
(16,412 |
) |
Overview
Our
cash
and cash equivalents were $16.1 million as of June 30, 2007, compared to $32.5
million as of December 31, 2006. The amount of cash and cash
equivalents at June 30, 2007 does not include the net proceeds of $9.1 million
from the sale of equity in July 2007. During the six months ended
June 30, 2007 and 2006, net cash used in operating activities was $14.8 million
and $10.0 million, respectively. The increase in cash usage from the
prior year period was primarily due to the support of marketing initiatives
for
our marketed products, including the commercial launch of CAPHOSOL in 2007,
partially offset by the receipt of $4.0 million related to the Advanced
Magnetics, Inc. settlement agreement. We
expect
that our existing capital resources at June 30, 2007, along with the proceeds
received from the July 2007 sale of equity, should be adequate to fund our
operations and commitments into 2008.
Historically,
our primary sources of cash have been proceeds from the issuance and sale of
our
stock through public offerings and private placements, product-related revenues,
revenues from contract research services, fees paid under license agreements
and
interest earned on cash and short-term investments.
Our
long-term financial objectives are to meet our capital and operating
requirements through revenues from existing products and licensing arrangements.
To achieve these objectives, we may enter into research and development
partnerships and acquire, in-license and develop other technologies, products
or
services. Certain of these strategies may require payments by us in either
cash
or stock in addition to the costs associated with developing and marketing
a
product or technology. However, we believe that, if successful, such strategies
may increase long-term revenues. We cannot assure you of the success of such
strategies or that resulting funds will be sufficient to meet cash requirements
until product revenues are sufficient to cover operating expenses, if
ever. To fund these strategic and operating activities, we may sell
equity, debt or other securities as market conditions permit or enter into
credit facilities.
We
have
incurred negative cash flows from operations since our inception, and have
expended, and expect to continue to expend in the future, substantial funds
to
implement our planned product development efforts, including acquisition of
complementary clinical stage and marketed products, research and development,
clinical studies and regulatory activities, and to further our marketing and
sales programs. We expect that our existing capital resources at June
30, 2007, along with the proceeds received from the July 2007 sale of equity,
should be adequate to fund our operations and commitments into
2008. We cannot assure you that our business or operations will not
change in a manner that would consume available resources more rapidly than
anticipated. We expect that we will have additional requirements for
debt or equity capital, irrespective of whether and when we reach profitability,
for further product development costs, product and technology acquisition costs,
and working capital.
Our
future capital requirements and the adequacy of available funds will depend
on
numerous factors, including: (i) the successful commercialization of our
products; (ii) the costs associated with the acquisition of complementary
clinical stage and marketed products; (iii) progress in our product development
efforts and the magnitude and scope of such efforts; (iv) progress with clinical
trials; (v) progress with regulatory affairs activities; (vi) the cost of
filing, prosecuting, defending and enforcing patent claims and other
intellectual property rights; (vii) competing technological and market
developments; and (viii) the expansion of strategic alliances for the sales,
marketing, manufacturing and distribution of our products. To the
extent that the currently available funds and revenues are insufficient to
meet
current or planned operating requirements, we will be required to obtain
additional funds through equity or debt financing, strategic alliances with
corporate partners and others, or through other sources. We cannot
assure you that the financial sources described above will be available when
needed or at terms commercially acceptable to us. If adequate funds
are not available, we may be required to delay, further scale back or eliminate
certain aspects of our operations or attempt to obtain funds through
arrangements with collaborative partners or others that may require us to
relinquish rights to certain of our technologies, product candidates, products
or potential markets. If adequate funds are not available, our
business, financial condition and results of operations will be materially
and
adversely affected.
Other
Liquidity Events
On
June
29, 2007, we entered into purchase agreements with certain institutional
investors for the sale of 5,814,600 shares of our common stock and
2,907,301warrants to purchase shares of our common stock, through a private
placement offering. The warrants have an exercise price of $2.23 per
share and are exercisable beginning six months and ending five years after
their
issuance. The warrant agreement contains a cash settlement feature,
which is available to the warrant holders at their option, upon an acquisition
in certain circumstances. In exchange for $1.74, the purchasers
received one share of common stock and warrants to purchase .5 shares of common
stock. The transaction closed on July 6, 2007. The offering provided
us net proceeds of approximately $9.1 million to the Company. The
placement agents in this transaction received (i) a cash fee equal to 6% of
the
aggregate gross proceeds and (ii) warrants to purchase 348,876 shares of our
common stock having an exercise price of $2.23 per share and exercisable
beginning six months and ending five years after their issuance. In
connection with this sale, we entered into a Registration Rights Agreement
with
the investors
under
which we were obligated to file a registration statement with the SEC for the
resale of the shares sold to the investors and shares issuable upon exercise
of
the warrants within a specified time period. We are also required to
use commercially reasonable efforts to cause the registration to be declared
effective by the SEC and to remain continuously effective until such time when
all of the registered shares are sold or two years from closing date, whichever
is earlier. In the event we fail to keep the registration statement
effective, we are obligated to pay the investors liquidated damages equal to
1%
of the purchase price paid by the investors ($10.1 million) for each monthly
period that the registration statement is not effective, up to
10%. On July 23, 2007, we filed the registration statement with the
SEC. We are evaluating the accounting for this transaction under EITF 00-19
and 00-19-2 and may be required to classify the fair value of the warrants
or
liquidated damages as a liability.
On
November 10, 2006, we sold to certain institutional investors 7,092,203 shares
of our common stock and 3,546,107 warrants to purchase shares of our common
stock. The warrants have an exercise price of $3.32 per share and are
exercisable beginning six months and ending five years after their
issuance. The warrant agreement contains a cash settlement feature,
which is available to the warrant holders at their option, upon an acquisition
in certain circumstances. In connection with this sale, we entered
into a Registration Rights Agreement with the investors under which, we were
obligated to file a registration statement with the SEC for the resale of the
shares sold to the investors and shares issuable upon exercise of the warrants
within a specified time period. We are also required to use
commercially reasonable efforts to keep the registration statement continuously
effective with the SEC until such time when all of the registered shares are
sold or three years from closing date, whichever is earlier. In the
event we fail to keep the registration statement effective, we are obligated
to
pay the investors liquidated damages equal to 1% of the aggregate purchase
price
of $20 million for each thirty-day period that the registration statement is
not
effective, up to 10%. On December 28, 2006, the SEC declared the
registration statement effective. We concluded that the contingent
obligation was not probable, and therefore no contingent liability was recorded
as of June 30, 2007.
On
October 11, 2006, we entered into a license agreement with InPharma granting
us
exclusive rights for CAPHOSOL in North America and options to license the
marketing rights for CAPHOSOL in Europe and Asia. Under the terms of
the Agreement, we are obligated to pay InPharma $1.0 million after six months,
which was paid on April 11, 2007 and place $400,000 into an escrow
account. In addition, we are obligated to pay InPharma royalties
based on a percentage of net sales and future milestone payments of up to an
aggregate of $49.0 million, of which payments totaling $35 million are based
upon annual sales first reaching levels in excess of $30 million. For
six months ended June 30, 2007, we recorded $50,000 of royalties to
InPharma. We are also obligated to pay a finder's fee based upon a
percentage of milestone payments made to InPharma.
In
the
event we exercise the options to license marketing rights for CAPHOSOL in Europe
and Asia, we are obligated to pay InPharma additional fees and payments,
including sales-based milestone payments for the respective
territories. We also shall pay InPharma a portion of any up-front
license fees and milestone payments, but not royalties, received by us in
consideration of the grant by us to other parties of the right to market
CAPHOSOL in Europe and Asia, to the extent such up-front license fees and
milestone payments are in excess of the respective amounts paid by us to
InPharma for such rights.
In
September 2006, we entered into a non-exclusive manufacturing agreement with
Laureate pursuant to which Laureate shall manufacture PROSTASCINT and its
primary raw materials for Cytogen in Laureate's Princeton, New Jersey facility.
The agreement will terminate, unless terminated earlier pursuant to its terms,
upon Laureate's completion of the specified production campaign for PROSTASCINT
and shipment of the resulting products from Laureate's
facility. Under the terms of the agreement, we anticipate paying at
least an aggregate of $3.9 million through the end of the term of contract,
of
which $2.4 million of an aggregate $2.9 million, was incurred during the
six months ended June 30, 2007.
On
April
21, 2006, we entered into a distribution agreement with Savient granting us
exclusive marketing rights for SOLTAMOX in the United States. In
addition, we entered into a supply agreement with Savient and Rosemont for
the
manufacture and supply of SOLTAMOX. Our agreements with Savient were
subsequently assigned to Rosemont by Savient. Under the terms of the
agreements, we may pay contingent sales-based payments of up to a total of
$4.0
million to Rosemont. We are also required to pay Rosemont royalties
on net sales of SOLTAMOX. Beginning in 2007, we are obligated to pay
Rosemont quarterly minimum royalties based on an agreed upon percentage of
total
tamoxifen prescriptions in the United States. For the six months
ended June 30, 2007, we recorded $211,000 in royalties to Rosemont. Unless
terminated earlier, each of the distribution and supply agreements will
terminate upon the expiration of the last to expire patent covering SOLTAMOX
in
the United States, which is currently June 2018. In the event the
tamoxifen prescriptions for an agreed upon period of time are less than the
pre-established minimum, the agreement may be terminated if we are unable to
reach an agreement with Rosemont to amend the terms of the contract to account
for such impact.
On
May 6,
2005, we entered into a license agreement with The Dow Chemical Company to
create a targeted oncology product designed to treat prostate and other
cancers. The agreement applies proprietary MeO-DOTA bifunctional
chelant technology from Dow to radiolabel our PSMA antibody with a therapeutic
radionuclide. Under the agreement, proprietary chelation technology
and other capabilities, provided through ChelaMedSM
radiopharmaceutical services from Dow, will be used to attach a therapeutic
radioisotope to the 7E11-C5 monoclonal antibody utilized in our PROSTASCINT
molecular imaging agent. As a result of the agreement, we are
obligated to pay a minimal license fee and aggregate future milestone payments
of $1.9 million for each licensed product and royalties based on sales of
related products, if any. Unless terminated earlier, the Dow
agreement terminates at the later of (a) the tenth anniversary of the date
of
first commercial sale for each licensed product or (b) the expiration of the
last to expire valid claim that would be infringed by the sale of the licensed
product. We may terminate the license agreement with Dow on 90 days
written notice.
Effective
January 1, 2004, we entered into a manufacturing and supply agreement with
BMSMI
whereby BMSMI manufactures, distributes and provides order processing and
customer services for us relating to QUADRAMET. Under the terms of
the new agreement, we are obligated to pay at least $4.9 million annually,
subject to future annual price adjustment, through 2008, unless terminated
by
BMSMI or us on two years prior written notice. During the six months
ended June 30, 2007, we incurred $2.4 million of manufacturing costs for
QUADRAMET. This agreement will automatically renew for five
successive one-year periods unless terminated by BMSMI or us on a two year
prior
written notice. We also pay BMSMI a
variable
amount per month for each QUADRAMET order placed to cover the costs of customer
service.
We
acquired an exclusive license from The Dow Chemical Company for QUADRAMET for
the treatment of osteoblastic bone metastases in certain
territories. The agreement requires us to pay Dow royalties based on
a percentage of net sales of QUADRAMET, or a guaranteed contractual minimum
payment, whichever is greater, and future payments upon achievement of certain
milestones. Future annual minimum royalties due to Dow are $1.0
million per year in 2007 through 2012 and $833,000 in 2013.
CRITICAL
ACCOUNTING POLICIES AND ESTIMATES
Note
1 to
our Consolidated Financial Statements in our Annual Report on Form 10-K for
the
year ended December 31, 2006, includes a summary of our significant accounting
policies and methods used in the preparation of our Consolidated Financial
Statements. The following is a brief discussion of the more
significant accounting policies and methods used by us. The
preparation of our Consolidated Financial Statements requires us to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Our actual results could differ
materially from those estimates.
Revenue
Recognition
Product
revenues include product sales by us to our customers. We recognize revenues
in
accordance with SEC Staff Accounting Bulletin No. 104 ("SAB 104"), "Revenue
Recognition." We recognize product sales when substantially all the
risks and rewards of ownership have transferred to the customer, which generally
occurs on the date of shipment. Our revenue recognition policy has a
substantial impact on our reported results and relies on certain estimates
that
require subjective judgments on the part of management. We recognize product
sales net of allowances for estimated returns, rebates and
discounts. We estimate allowances based primarily on our past
experience and other available information pertinent to the use and marketing
of
the product.
For
new
products launches such as CAPHOSOL and SOLTAMOX, which we introduced in March
2007 and August 2006, respectively, our policy is to recognize revenue based
on
a number of factors, including product sales to end-users, on-hand inventory
estimates in the distribution channel, and the data to determine product
acceptance in the marketplace to estimate product returns. When
inventories in the distribution channel do not exceed targeted levels, and
we
have the ability to estimate product returns and discounts, we will recognize
product sales upon shipment, net of discounts, returns and
allowances.
Provisions
for Estimated Reductions to Gross Sales
At
the
time product sales are made, we reduce gross sales through accruals for product
returns, rebates and volume discounts. We account for these reductions in
accordance with Emerging Issues Task Force Issue No. 01-9, ("EITF 01-9"),
Accounting for Consideration Given
by
a
Vendor to a Customer (Including a Reseller of the Vendor's Products) ("EITF
01-9"), and Statement of Financial Accounting Standard No. 48, Revenue
Recognition When Right of Return Exists ("SFAS 48"), as applicable.
Returns
QUADRAMET
is a radioactive product that is indicated for the relief of pain due to
metastatic bone disease arising from various types of cancer. Due to its rapid
rate of radioactive decay, QUADRAMET has a shelf life of only about 72
hours. For this reason, QUADRAMET is ordered for a specific patient
on a pre-scheduled visit, and, as such, our customers are unable to maintain
stock inventories of this product. In addition, because the product
is ordered for pre-scheduled visits for specific patients, product returns
are
very low. Our methodology to estimate sales returns is based on
historical experience that demonstrates that the vast majority of the returns
occur within one month of when product was shipped. At the time of
sale, we estimate the quantity and value of QUADRAMET that may ultimately be
returned. We generally have the exact number of returns related to prior month
sales in the current month, so the provision for returns is trued up to actual
quickly.
We
do not
allow product returns for PROSTASCINT.
Returns
from new products, like SOLTAMOX and CAPHOSOL, are more difficult to
assess. Since we have no historical return experience with these
products, we cannot reliably estimate expected returns of this new
product. Therefore, we will defer recognition of revenue until the
right of return no longer exists or until we have developed sufficient
historical experience to estimate sales returns. We may use
information from external sources to estimate our return
provisions.
Volume
Discounts
We
provide volume discounts to certain customers based on
sales levels of given products during each calendar month. We recognize revenue
net of these volume discounts at the end of each month. There are no
volume discounts based on cumulative sales over more than a one month
period. Accordingly, there is no current need to estimate volume
discounts.
Rebates
From
time
to time, we may offer rebates to our customers. We establish a rebate
accrual based on the specific terms in each agreement, in an amount equal to
our
reasonable estimate of the expected rebate claims attributable to the sales
in
the current period and adjust the accrual each reporting period to reflect
the
actual experience. If the amount of future rebates cannot be
reasonably estimated, a liability will be recognized for the maximum potential
amount of the rebates.
License
and contract revenues include milestone payments and fees under collaborative
agreements with third parties, revenues from research services, and revenues
from other miscellaneous sources. We defer non-refundable up-front
license fees and recognize them over the estimated performance period of the
related agreement, when we have continuing
involvement. Since
the term of the performance periods is subject to management's estimates, future
revenues to be recognized could be affected by changes in such
estimates.
Accounts
Receivable
Our
accounts receivable balances are net of an estimated allowance for uncollectible
accounts. We continuously monitor collections and payments from our
customers and maintain an allowance for uncollectible accounts based upon our
historical experience and any specific customer collection issues that we have
identified. While we believe our reserve estimate to be appropriate,
we may find it necessary to adjust our allowance for uncollectible accounts
if
the future bad debt expense exceeds our estimated reserve. We are
subject to concentration risks as a limited number of our customers provide
a
high percent of total revenues, and corresponding receivables.
Inventories
Inventories
are stated at the lower of cost or market, as determined using the first-in,
first-out method, which most closely reflects the physical flow of our
inventories. Our products and raw materials are subject to expiration
dating. We regularly review quantities on hand to determine the need
for reserves for excess and obsolete inventories based primarily on our
estimated forecast of product sales. Our estimate of future product
demand may prove to be inaccurate, in which case we may have understated or
overstated our reserve for excess and obsolete inventories.
Carrying
Value of Fixed and Intangible Assets
Our
fixed
assets and certain of our acquired rights to market our products have been
recorded at cost and are being amortized on a straight-line basis over the
estimated useful life of those assets. We also acquired an option to
purchase marketing rights to CAPHOSOL in Europe which was recorded as other
assets and will transfer the costs to the appropriate asset account, when and
if
exercised. If indicators of impairment exist, we assess the
recoverability of the affected long-lived assets by determining whether the
carrying value of such assets can be recovered through undiscounted future
operating cash flows. Regarding the option to purchase marketing
rights to CAPHOSOL in Europe, we also assess our intent and ability to exercise
the option, the option expiry date and market and product
competitiveness. If impairment is indicated, we measure the amount of
such impairment by comparing the carrying value of the assets to the present
value of the expected future cash flows associated with the use of the
asset. Adverse changes regarding future cash flows to be received
from long-lived assets could indicate that an impairment exists, and would
require the write down of the carrying value of the impaired asset at that
time.
Given
our
commitment to effectively managing our resources, we are continually assessing
our investments in product strategies. Based on our review
of our intangible assets as of June 30, 2007 in light of those strategies,
we did not recognize any impairment charges during the quarter ended June
30,
2007. We
continue to monitor product performance, especially as pertains to SOLTAMOX,
and
will reevaluate the expected cash flows and fair value of our intangible
assets
quarterly.
Warrant
Liability
We
follow
Emerging Issues Task Force (EITF) No. 00-19, "Accounting for Derivative
Financial Instruments Indexed to, and Potentially Settled in, a Company's
Own
Stock" which provides guidance for distinguishing between permanent equity,
temporary equity and assets and liabilities. Under EITF 00-19, to
qualify as permanent equity, the equity derivative must permit us
to
settle in unregistered shares. We do not have that ability under the
securities purchase agreement for the warrants issued in July and August
2005
and, as EITF 00-19 considers the ability to keep a registration statement
effective as beyond our control, the warrants cannot be classified as permanent
equity and are instead classified as a liability in the accompanying
consolidated balance sheet. Our warrants issued in November 2006
which permit net cash settlement at the option of the warrant holders also
require classification as a liability in accordance with EITF
00-19.
We
record
the warrant liability at its fair value using the Black-Scholes option-pricing
model and remeasure it at each reporting date until the warrants are exercised
or expire. Changes in the fair value of the warrants are reported in the
consolidated statements of operations as non-operating income or
expense. The fair value of the warrants is subject to significant
fluctuation based on changes in our stock price, expected volatility, expected
life, the risk-free interest rate and dividend yield. The market
price for our common stock has been and may continue to be
volatile. Consequently, future fluctuations in the price of our
common stock may cause significant increases or decreases in the fair value
of
the warrants issued.
We
follow
EITF No. 00-19-2 "Accounting for Registration Payment Arrangement" which
specifies that registration payment arrangements should play no part in
determining the initial classification and subsequent accounting for the
securities they related to. The Staff position requires the
contingent obligation in a registration payment arrangement to be separately
analyzed under FASB Statement No. 5, "Accounting for Contingencies" and FASB
Interpretation No. 14, "Reasonable Estimation of the Amount of a
Loss". Consequently, if payment in a registration payment arrangement
in connection with the warrants issued in November 2006 is probable and can
be
reasonably estimated, a liability will be recorded.
Share-Based
Compensation
We
account for share-based compensation in accordance with SFAS No. 123(R),
"Share-Based Payment." Under the fair value recognition provision of
this statement, the share-based compensation, which is generally based on the
fair value of the awards calculated using the Black-Scholes option pricing
model
on the date of grant, is recognized on a straight-line basis over the requisite
service period, generally the vesting period, for grants on or after January
1,
2006. For nonvested shares, we use the fair value of the underlying
common stock on the date of grant. Determining the fair value of
share-based awards at the grant date requires judgment, including estimating
expected dividend yield, expected forfeiture rates, expected volatility, the
expected term and expected risk-free interest rates. If we were to
use different estimates or a different valuation model, our share-based
compensation expense and our results of operations could be materially
impacted.
Recent
Accounting Pronouncements
Advance
Payments for Goods or Services
In
June
2007, the Financial Accounting Standards Board ("FASB") issued Emerging Issues
Task Force ("EITF") Issue No. 07-3, "Accounting for Advance Payments for Goods
or Services To Be Used in Future Research and Development" (EITF 07-03), which
is effective for calendar year companies on January 1, 2008. The Task
Force concluded that nonrefundable advance payment for goods or services that
will be used or rendered for future research and development activities should
be defined and capitalized. Such amounts should be recognized as an
expense as the related goods are delivered or the services are performed, or
when the goods or services are no longer expected to be provided. We
are currently assessing the potential impacts on our consolidated financial
statements upon adoption of EITF 07-03.
Fair
Value Option
In
February 2007, the Financial Accounting Standards Board ("FASB") issued SFAS
No.
159 "The Fair Value Option for Financial Assets and Financial Liabilities,
Including an Amendment of FASB Statement No. 115" (SFAS 159), which will
become effective for fiscal years beginning after November 15,
2007. SFAS 159 permits entities to measure eligible financial
assets and financial liabilities at fair value, on an instrument-by-instrument
basis, that are otherwise not permitted to be accounted for at fair value under
other generally accepted accounting principles. The fair value measurement
election is irrevocable and subsequent changes in fair value must be recorded
in
earnings. We will adopt SFAS 159 in fiscal year 2008 and are
evaluating if we will elect the fair value option for any of our eligible
financial instruments.
Fair
Value Measurement
In
September 2006, the FASB finalized SFAS No. 157, "Fair Value Measurements"
(SFAS
157) which will become effective in fiscal year 2008. This Statement
defines fair value, establishes a framework for measuring fair value and expands
disclosure about fair value measurements; however, it does not require any
new
fair value measurements. The provisions of SFAS 157 will be applied
prospectively to fair value measurements and disclosures beginning in the first
quarter of 2008 and is not expected to have a material effect on our
consolidated financial statements.
Income
Taxes
Effective
January 1, 2007, we adopted FASB Interpretation No. 48, "Accounting for
Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109" ("FIN
48"). FIN 48 prescribes how a company should recognize, measure,
present and disclose uncertain income position. A "tax position" is a
position taken on a previously filed tax return, or expected to be taken in
a
future tax return that is reflected in the measurement of current and deferred
tax assets or liabilities for interim or annual periods. A tax position can
result in a permanent reduction of income taxes payable, a deferral of income
taxes to future periods, or a change in the expected ability to realize deferred
tax assets. A change in net assets that results from adoption of FIN
48
is
recorded as an adjustment to retained earnings in the period of
adoption. The adoption of FIN 48 did not have any impact on our
consolidated financial statements.
On
May 2,
2007, the FASB Staff Position amended FIN 48 to provide guidance on how an
enterprise should determine whether a tax position is effectively settled for
the purpose of recognizing previously unrecognized tax benefits. This
guidance, which is effective immediately, also had no impact on our consolidated
financial statements as of and for the three and six month periods ended June
30, 2007.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
We
do not
have operations subject to risks of foreign currency fluctuations, nor do we
use
derivative financial instruments in our operations. Our exposure to
market risk is principally confined to interest rate sensitivity. Our
cash equivalents are conservative in nature, with a focus on preservation of
capital. Due to the short-term nature of our investments and our
investment policies and procedures, we have determined that the risks associated
with interest rate fluctuations related to these financial instruments are
not
material to our business.
We
are
exposed to certain risks arising from changes in the price of our common stock,
primarily due to potential effect of changes in fair value of the warrant
liabilities related to the warrants issued in 2005 and 2006. The
warrant liabilities are measured at fair value using the Black-Scholes
option-pricing model at each reporting date and are subject to significant
increases or decreases in value and a corresponding loss or gain in the
statement of operations due to the effects of changes in the price of common
stock at period end and the related calculation of volatility.
Item
4. Controls and Procedures
(a)
Disclosure Controls and Procedures
Our
management, with the participation of our chief executive officer and chief
financial officer, evaluated the effectiveness of our disclosure controls and
procedures as of June 30, 2007. The term "disclosure controls and
procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, means controls and other procedures of a company that
are
designed to ensure that information required to be disclosed by the Company
in
the reports that it files or submits under the Securities Exchange Act of 1934
is recorded, processed, summarized and reported, within the time periods
specified in the SEC's rules and forms. Disclosure controls and
procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed by a company in the reports
that it files or submits under the Securities Exchange Act of 1934 is
accumulated and communicated to the company's management, including its
principal executive and principal financial officers, as appropriate to allow
timely decisions regarding required disclosure. Management recognized
that any controls and procedures, no matter how well designed and operated,
can
provide only reasonable assurance of achieving their objectives and management
necessarily applied its judgment in evaluating the cost-benefit relationship
of
possible controls and procedures. Based on this evaluation, our chief
executive officer and chief financial officer concluded that, as of June 30,
2007, our controls and procedures were effective.
(b)
Changes in Internal Control Over Financial Reporting
No
change
in our internal control over financial reporting (as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended
as of June 30, 2007 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1A. Risk Factors
This
section sets forth changes in the risks factors previously disclosed in our
Annual Report on Form 10-K due to our activities during the quarter ended June
30, 2007.
Investing
in our common stock involves a high degree of risk. You should
carefully consider the risks and uncertainties described below together with
the
other risks described in our Annual Report on Form 10-K for the year ended
December 31, 2006 and the information included or incorporated by reference
in
this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the
year ended December 31, 2006 in your decision as to whether or not to invest
in
our common stock. If any of the risks or uncertainties described
below or in our Annual Report on Form 10-K for the year ended December 31,
2006
actually occur, our business, financial condition or results of operations
would
likely suffer. In that case, the trading price of our common stock
could fall, and you may lose all or part of the money you paid to buy our common
stock.
We
have a history of operating losses and an accumulated deficit and expect to
incur losses in the future.
Given
the
high level of expenditures associated with our business and our inability to
generate revenues sufficient to cover such expenditures, we have had a history
of operating losses since our inception. We had net losses of $10.4
million and $15.2 million for the three and six months ended June 30,
2007. We had an accumulated deficit of $443 million as of June 30,
2007. We
expect
that our existing capital resources at June 30, 2007, along with the proceeds
received from the July 2007 sale of equity, should be adequate to fund our
operations and commitments into 2008.
In
order
to develop and commercialize our technologies, particularly our
prostate-specific membrane antigen technology, and launch and expand our
products, we expect to incur significant increases in our expenses over the
next
several years. As a result, we will need to generate significant
additional revenue to become profitable.
To
date,
we have taken affirmative steps to address our trend of operating
losses. Such steps include, among other things:
|
·
|
undergoing
steps to realign and implement our focus as a product-driven
biopharmaceutical company;
|
|
·
|
establishing
and maintaining our in-house specialty sales force;
and
|
|
·
|
enhancing
our marketed product portfolio through marketing alliances and strategic
arrangements.
|
Although
we have taken these affirmative steps, we may never be able to successfully
implement them, and our ability to generate and sustain significant additional
revenues or
achieve
profitability will depend upon the risk
factors discussed elsewhere in this section entitled, "Risk Factors" or in
our
Annual Report on Form 10-K for the year ended December 31, 2006. As
a result, we may never be able to generate or sustain significant additional
revenue or achieve profitability.
We
depend on sales of QUADRAMET and PROSTASCINT for substantially all of our
near-term revenues.
We
expect
QUADRAMET and PROSTASCINT to account for substantially all of our product
revenues in the near future. For the quarter ended June 30, 2007,
revenues from QUADRAMET and PROSTASCINT accounted for approximately 47% and
49%,
respectively, of our product revenues. For the six months ended June 30, 2007,
revenues from QUADRAMET and PROSTASCINT accounted for approximately 48% and
50%,
respectively, of our product revenues. If QUADRAMET or PROSTASCINT
does not achieve broader market acceptance, either because we fail to
effectively market such products or our competitors introduce competing
products, we may not be able to generate sufficient revenue to become
profitable.
We
will depend on market acceptance of SOLTAMOX and CAPHOSOL for future
revenues.
On
April
21, 2006, we and Savient entered into a distribution agreement granting us
exclusive marketing rights for SOLTAMOX in the United States. We
introduced SOLTAMOX to the U.S. oncology market in the second half of
2006. Through
June 30, 2007, we have not recognized any revenues from
SOLTAMOX.
On
October 11, 2006, we entered into a license agreement with InPharma granting
us
exclusive marketing rights for CAPHOSOL in North America. We
introduced CAPHOSOL late in the first quarter of 2007. Through
June 30, 2007, we have recognized $234,000 of revenues from
CAPHOSOL.
Our
future growth and success will depend on market acceptance of SOLTAMOX and
CAPHOSOL by healthcare providers, third-party payors and
patients. Market acceptance will depend, in part, on our ability to
demonstrate to these parties the effectiveness of these
products. Sales of these products will also depend on the
availability of favorable coverage and reimbursement by governmental healthcare
programs such as Medicare and Medicaid as well as private health insurance
plans. If SOLTAMOX or CAPHOSOL does not achieve market acceptance,
either because we fail to effectively market such products or our competitors
introduce competing products, we may not be able to generate sufficient revenue
to become profitable.
A
small number of customers account for the majority of our sales, and the loss
of
one of them, or changes in their purchasing patterns, could result in reduced
sales, thereby adversely affecting our operating results.
We
sell
our products to a small number of radiopharmacy networks. During the
six months ended June 30, 2007, we received 63% of our total revenues from
three
customers, as follows: 41% from Cardinal Health (formerly Syncor International
Corporation); 15% from Mallinckrodt Inc.; and 7% from GE Healthcare (formerly
Amersham Health). During the year
ended
December 31, 2006, we received 64% of our total
revenues from three customers, as follows: 41% from Cardinal Health; 14% from
Mallinckrodt Inc.; and 9% from GE Healthcare. During the year ended
December 31, 2005, we received 67% of our total revenues from three
customers,
as follows: 47% from Cardinal Health; 11% from Mallinckrodt Inc.; and 9% from
GE
Healthcare.
The
small
number of radiopharmacies, consolidation in this industry or financial
difficulties of these radiopharmacies could result in the combination or
elimination of customers for our products. We anticipate that our
results of operations in any given period will continue to depend to a
significant extent upon sales to a small number of customers. As a
result of this customer concentration, our revenues from quarter to quarter
and
business, financial condition and results of operations may be subject to
substantial period-to-period fluctuations. In addition, our business,
financial condition and results of operations could be materially adversely
affected by the failure of customer orders to materialize as and when
anticipated. None of our customers have entered into an agreement
requiring on-going minimum purchases from us. We cannot assure you
that our principal customers will continue to purchase products from us at
current levels, if at all. The loss of one or more major customers
could have a material adverse effect on our business, financial condition and
results of operations.
There
are risks associated with the manufacture and supply of our
products.
If
we are
to be successful, our products will have to be manufactured by contract
manufacturers in compliance with regulatory requirements and at costs acceptable
to us. If we are unable to successfully arrange for the manufacture of our
products and product candidates, either because potential manufacturers are
not
cGMP compliant, are not available or charge excessive amounts, we will not
be
able to successfully commercialize our products and our business, financial
condition and results of operations will be significantly and adversely
affected.
PROSTASCINT
is currently manufactured at a current Good Manufacturing Practices, or cGMP,
compliant manufacturing facility operated by Laureate Pharma,
L.P. Although we entered into another agreement with Laureate in
September 2006 which provides for Laureate's manufacture of PROSTASCINT for
us,
our failure to maintain a long term supply agreement on commercially reasonable
terms will have a material adverse effect on our business, financial condition
and results of operations.
We
have
an agreement with BMSMI to manufacture QUADRAMET for us. Both primary
components of QUADRAMET, particularly Samarium-153 and EDTMP, are provided
to
BMSMI by outside suppliers. Due to radioactive decay, Samarium-153 must be
produced on a weekly basis. BMSMI obtains its requirements for Samarium-153
from
a sole supplier and EDTMP from another sole supplier. Alternative sources for
these components may not be readily available, and any alternative supplier
would have to be identified and qualified, subject to all applicable regulatory
guidelines. If BMSMI cannot obtain sufficient quantities of the components
on
commercially reasonable terms, or in a timely manner, it would be unable to
manufacture QUADRAMET on a timely and cost-effective basis, which would have
a
material adverse effect on our business, financial condition and results of
operations.
We
have a
supply agreement with Rosemont to manufacture SOLTAMOX for
us. The supply agreement with Rosemont will terminate upon the
expiration of the last to expire patent covering SOLTAMOX in the United States,
which is currently June 2018. Our failure to maintain
a long term supply agreement for SOLTAMOX on commercially reasonable terms
will
have a material adverse effect on our business, financial condition and results
of operations.
We
have a
manufacturing agreement with Holopack to manufacture CAPHOSOL for
us. The agreement has a term of two years and automatically renews
for an additional year. Such agreement is terminable by Holopack or
us on three months notice prior to the end of each term period. Our
failure to maintain a long term supply agreement for CAPHOSOL on commercially
reasonable terms will have a material adverse effect on our business, financial
condition and results of operations.
We,
along
with our contract manufacturers and testing laboratories are required to adhere
to FDA regulations setting forth requirements for cGMP, and similar regulations
in other countries, which include extensive testing, control and documentation
requirements. Ongoing compliance with cGMP, labeling and other applicable
regulatory requirements is monitored through periodic inspections and market
surveillance by state and federal agencies, including the FDA, and by comparable
agencies in other countries. Failure of our contract vendors or us to comply
with applicable regulations could result in sanctions being imposed on us,
including fines, injunctions, civil penalties, failure of the government to
grant pre-market clearance or pre-market approval of drugs, delays, suspension
or withdrawal of approvals, seizures or recalls of products, operating
restrictions and criminal prosecutions any of which could significantly and
adversely affect our business, financial condition and results of
operations.
We
rely heavily on our collaborative partners.
Our
success depends largely upon the success and financial stability of our
collaborative partners. We have entered into the following agreements
for the development, sale, marketing, distribution and manufacture of our
products, product candidates and technologies:
|
·
|
a
license agreement with The Dow Chemical Company relating to the QUADRAMET
technology;
|
|
·
|
a
manufacturing and supply agreement for the manufacture of QUADRAMET
with
BMSMI;
|
|
·
|
a
manufacturing agreement for the manufacture of PROSTASCINT with Laureate
Pharma, L.P.;
|
|
·
|
a
distribution services agreement with Cardinal Health 105, Inc. (formerly
CORD Logistics, Inc.) for
PROSTASCINT;
|
|
·
|
a
license agreement with The Dow Chemical Company relating to Dow's
proprietary MeO-DOTA bifunctional chelant technology for use with
our
CYT-500 program;
|
|
·
|
a
distribution agreement and a manufacture and supply agreement with
Rosemont Pharmaceuticals Limited related to the supply and marketing
of
SOLTAMOX;
|
|
·
|
a
purchase and supply agreement with OTN for the distribution of SOLTAMOX
and CAPHOSOL;
|
|
·
|
a
license agreement with InPharma AS for the marketing of CAPHOSOL;
and
|
|
·
|
a manufacturing
agreement with Holopack for the manufacturing and supply of
CAPHOSOL.
|
Because
our collaborative partners are responsible for certain manufacturing and
distribution activities, among others, these activities are outside our direct
control and we rely on our partners to perform their obligations. In
the event that our collaborative partners are entitled to enter into third
party
arrangements that may economically disadvantage us, or do not perform their
obligations as expected under our agreements, our products may not be
commercially successful. As a result, any success may be delayed and
new product development could be inhibited with the result that our business,
financial condition and results of operation could be significantly and
adversely affected.
If
our
collaborative agreements expire or are terminated and we cannot renew or replace
them on commercially reasonable terms, our business and financial results may
suffer. If the agreements described above expire or are terminated,
we may not be able to find suitable alternatives to them on a timely basis
or on
reasonable terms, if at all. The loss of the right to use these
technologies that we have licensed or the loss of any services provided to
us
under these agreements would significantly and adversely affect our business,
financial condition and results of operations.
Certain
of our products are in the early stages of development and commercialization
and
we may never achieve the revenue goals set forth in our business
plan.
We
began
operations in 1980 and have since been engaged primarily in research directed
toward the development, commercialization and marketing of products to improve
the diagnosis and treatment of cancer.
In
April
2006, we executed a distribution agreement with Savient granting us
exclusive marketing rights for SOLTAMOX in the United
States. SOLTAMOX, an oral liquid hormonal therapy, is approved for
marketing in the United States. We introduced SOLTAMOX in the United
States in the second half of 2006 and,
through June 30, 2007, we have not recognized any revenues from
SOLTAMOX.
In
October 2006, we entered into a license agreement with InPharma granting us
exclusive marketing rights for CAPHOSOL in North America. We
introduced CAPHOSOL late in the first quarter of 2007.
In
May
2006, the U.S. Food and Drug Administration cleared an Investigational New
Drug
application for CYT-500, our lead therapeutic candidate targeting
PSMA. In February
2007,
we announced the initiation of the first human
clinical study of CYT-500. CYT-500 uses the same monoclonal antibody
from our PROSTASCINT molecular imaging agent, but is linked through a higher
affinity linker than is used for PROSTASCINT to a therapeutic as opposed to
an
imaging radionuclide. This PSMA technology is still in the early
stages of development. We cannot assure you that we will be able to
commercialize this product.
In
July
2004, as part of our continuing efforts to reduce non-strategic expenses, we
initiated the closure of facilities at our AxCell Biosciences
subsidiary. Research projects through academic, governmental and
corporate collaborators will continue to be supported and additional
applications for the intellectual property and technology at AxCell are being
pursued. We may be unable to further develop or commercialize any of
these products and technologies in the future.
Our
business is therefore subject to the risks inherent in an early-stage
biopharmaceutical business enterprise, such as the need:
|
·
|
to
obtain sufficient capital to support the expenses of developing our
technology and commercializing our
products;
|
|
·
|
to
ensure that our products are safe and
effective;
|
|
·
|
to
obtain regulatory approval for the use and sale of our
products;
|
|
·
|
to
manufacture our products in sufficient quantities and at a reasonable
cost;
|
|
·
|
to
develop a sufficient market for our products;
and
|
|
·
|
to
attract and retain qualified management, sales, technical and scientific
staff.
|
The
problems frequently encountered using new technologies and operating in a
competitive environment also may affect our business, financial condition and
results of operations. If we fail to properly address these risks and
attain our business objectives, our business could be significantly and
adversely affected.
We
depend on attracting and retaining key personnel.
We
are
highly dependent on the principal members of our management and scientific
staff. The loss of their services might significantly delay or prevent the
achievement of development or strategic objectives. Our success depends on
our
ability to retain key employees and to attract additional qualified employees.
Competition for personnel is intense, and therefore we may not be able to retain
existing personnel or attract and retain additional highly qualified employees
in the future.
We
do not
carry key person life insurance policies and we do not typically enter into
long-term arrangements with our key personnel. If we are unable to
hire and retain personnel in key positions, our business, financial condition
and results of operations could be significantly and adversely affected unless
qualified replacements can be found.
Failure
of third party payors to provide adequate coverage and reimbursement for our
products could limit market acceptance and affect pricing of our products and
affect our revenues.
Sales
of
our products depend in part on the availability of favorable coverage and
reimbursement by governmental healthcare programs such as Medicare and Medicaid
as well as private health insurance plans. Each payor has its own
process and standards for determining whether and, if so, to what extent it
will
cover and reimburse a particular product or service. Whether and to
what extent a product may be deemed covered by a particular payor depends upon
a
number of factors, including the payor's determination that the product is
reasonable and necessary for the diagnosis or treatment of the illness or injury
for which it is administered according to accepted standards of medical
practice, cost effective, not experimental or investigational, not found by
the
FDA to be less than effective, and not otherwise excluded from coverage by
law,
regulation, or contract. There may be significant delays in obtaining
coverage for newly-approved products, and coverage may not be available or
could
be more limited than the purposes for which the product is approved by the
FDA.
Moreover,
eligibility for coverage does not imply that any product will be reimbursed
in
all cases or at a rate that allows us to make a profit or even cover our costs,
which include, for example, research, development, production, sales, and
distribution costs. Interim payments for new products, if applicable,
also may not be sufficient to cover our costs and may not be made
permanent. Reimbursement rates may vary according to the use of the
product and the clinical setting in which it is used, may be based on payments
allowed for lower-cost products that are already reimbursed, may be incorporated
into existing payments for other products or services, and may reflect budgetary
constraints and/or imperfections in Medicare or Medicaid data. Net
prices for products may be reduced by mandatory discounts or rebates required
by
government healthcare programs, or other payors, or by any future relaxation
of
laws that restrict imports of certain medical products from countries where
they
may be sold at lower prices than in the United States.
Third
party payors often follow Medicare coverage policy and payment limitations
in
setting their own coverage policies and reimbursement rates, and may have
sufficient market power to demand significant price reductions. Even
if successful, securing coverage at adequate reimbursement rates from government
and third party payors can be a time consuming and costly process that could
require us to provide supporting scientific, clinical and cost-effectiveness
data for the use of our products among other data and materials to each
payor. Our inability to promptly obtain favorable coverage and
profitable reimbursement rates from government-funded and private payors for
our
products could have a material adverse effect on our business, financial
condition and results of operations, and our ability to raise capital needed
to
commercialize products.
Our
business, financial condition and results of operations will continue to be
affected by the efforts of governmental and third-party payors to contain or
reduce the costs of healthcare. There have been, and we expect that
there will continue to be, a number of federal and state proposals to regulate
expenditures for medical products and services, which may affect payments for
therapeutic and diagnostic imaging agents such as our products. In
addition, an emphasis on managed care increases possible pressure on the pricing
of these products. While we cannot
predict
whether these legislative or regulatory
proposals will be adopted, or the effects these proposals
or managed care efforts may have on our business, the announcement of these
proposals and the adoption of these proposals or efforts could affect our stock
price or our business. Further, to the extent these proposals or
efforts have an adverse effect on other companies that are our prospective
corporate partners, our ability to establish necessary strategic alliances
may
be harmed.
We
will need to raise additional capital which may not be available or only
available on less favorable terms.
Our
cash
and cash equivalents were $16.1 million at June 30, 2007. We expect
that our existing capital resources at June 30, 2007, along with the net
proceeds of $9.1 million received from the July 2007 sale of equity, should
be
adequate to fund our operations and commitments into 2008.
Our
business or operations may change in a manner that would consume available
resources more rapidly than anticipated. We expect that we will have
additional requirements for debt or equity capital, irrespective of whether
and
when we reach profitability, for further product development costs, product
and
technology acquisition costs and working capital. To the extent that
our currently available funds and revenues are insufficient to meet current
or
planned operating requirements, we will be required to obtain additional funds
through equity or debt financing, strategic alliances with corporate partners
and others, or through other sources. These financial sources may not
be available when we need them or they may be available, but on terms that
are
not commercially acceptable to us. If adequate funds are not
available, we may be required to delay further scale back or eliminate certain
aspects of our operations or attempt to obtain funds through arrangements with
collaborative partners or others that may require us to relinquish rights to
certain of our technologies, product candidates, products or potential
markets. If adequate funds are not available, our business, financial
condition and results of operations will be materially and adversely
affected.
We
have
incurred negative cash flows from operations since our inception and have
expended, and expect to continue to expend in the future, substantial funds
based upon the:
|
·
|
success
of our product commercialization
efforts;
|
|
·
|
success
of any future acquisitions of complementary products and technologies
we
may make;
|
|
·
|
magnitude,
scope and results of our product development and research and development
efforts;
|
|
·
|
progress
of preclinical studies and clinical
trials;
|
|
·
|
progress
toward regulatory approval for our
products;
|
|
·
|
costs
of filing, prosecuting, defending and enforcing patent claims and
other
intellectual property rights;
|
|
·
|
competing
technological and market developments;
and
|
|
·
|
expansion
of strategic alliances for the sale, marketing and distribution of
our
products.
|
Our
capital raising efforts may dilute stockholder interests.
If
we
raise additional capital by issuing equity securities or convertible debentures,
such issuance will result in ownership dilution to our existing stockholders,
and new investors could have rights superior to those of our existing
stockholders. The extent of such dilution will vary based upon the
amount of capital raised.
We
have limited sales, marketing and distribution capabilities for our
products.
We
have
established an internal sales force that is responsible for marketing and
selling CAPHOSOL, QUADRAMET, PROSTASCINT and SOLTAMOX. Although we
are continuing to expand our internal sales force, it still has limited sales,
marketing and distribution capabilities compared to those of many of our
competitors. If our internal sales force is unable to successfully
market CAPHOSOL, QUADRAMET, PROSTASCINT and SOLTAMOX, our business and financial
condition may be adversely affected. If we are unable to establish
and maintain significant sales, marketing and distribution efforts within the
United States, either internally or through arrangements with third parties,
our
business may be significantly and adversely affected. In locations
outside of the United States, we have not established a selling
presence. To the extent that our sales force, from time to time,
markets and sells additional products, we cannot be certain that adequate
resources or sales capacity will be available to effectively accomplish these
tasks.
We
may need to raise funds other than through the issuance of equity
securities.
If
we
raise additional funds through collaborations and licensing arrangements, we
may
be required to relinquish rights to certain of our technologies or product
candidates or to grant licenses on unfavorable terms. If we
relinquish rights or grant licenses on unfavorable terms, we may not be able
to
develop or market products in a manner that is profitable to us.
A
significant portion of our total outstanding shares of common stock may be
sold
in the market in the near future, which could cause the market price of our
common stock to drop significantly.
As
of
August 1, 2007, we had 35,473,957 shares of our common stock issued and
outstanding, all of which are either eligible to be sold under SEC Rule 144
or
are in the public float or are in the process of being registered with the
SEC. In addition, we have registered shares of our Common Stock
underlying warrants previously issued on numerous Form S-3 registration
statements, and we have also registered shares of our common stock underlying
options granted or to be granted under our stock option
plans. Consequently, sales of substantial amounts of our common stock
in the public market, or the perception that such sales could occur, may have
a
material adverse effect on our stock price.
Our
common stock has a limited trading market, which could limit your ability to
resell your shares of common stock at or above your purchase
price.
Our
common stock is quoted on the NASDAQ Global Market and currently has a limited
trading market. The NASDAQ Global Market requires us to meet minimum
financial requirements in order to maintain our listing. Currently,
we believe that we meet the continued listing requirements of the NASDAQ Global
Market. We cannot assure you that an active trading market will
develop or, if developed, will be maintained. As a result, our
stockholders may find it difficult to dispose of shares of our common stock
and,
as a result, may suffer a loss of all or a substantial portion of their
investment.
Our
common stock may be subject to the "penny stock" regulations which may affect
the ability of our stockholders to sell their shares.
The
NASDAQ Global Market requires us to meet minimum financial requirements in
order
to maintain our listing. Currently, we believe we meet the continued
listing requirements of the NASDAQ Global Market. If we do not
continue to meet the continued listing requirements, we could be
delisted. If we are delisted from the NASDAQ Global Market, our
common stock likely will become a "penny stock." In general, regulations of
the
SEC define a "penny stock" to be an equity security that is not listed on a
national securities exchange or the NASDAQ Stock Market and that has a market
price of less than $5.00 per share or with an exercise price of less than $5.00
per share, subject to certain exceptions. If our common stock becomes
a penny stock, additional sales practice requirements would be imposed on
broker-dealers that sell such securities to persons other than certain qualified
investors. For transactions involving a penny stock, unless exempt, a
broker-dealer must make a special suitability determination for the purchaser
and receive the purchaser's written consent to the transaction prior to the
sale. In addition, the rules on penny stocks require delivery, prior
to and after any penny stock transaction, of disclosures required by the
SEC.
If
our
common stock were subject to the rules on penny stocks, the market liquidity
for
our common stock could be severely and adversely
affected. Accordingly, the ability of holders of our common stock to
sell their shares in the secondary market may also be adversely
affected.
The
liquidity of our common stock could be adversely affected if we are delisted
from the NASDAQ Global Market.
In
the
event that we are unable to maintain compliance with all relevant NASDAQ Listing
Standards, our securities may be subject to delisting from the NASDAQ Global
Market. If such delisting occurs, the market price and market
liquidity of our common stock may be adversely affected. Such listing
standards include, among other things, requirements related to the market value
of our listed securities and publicly-held shares, and the minimum bid price
for
such shares. The minimum bid requirement is $1.00 per
share. On August 6, 2007, the closing sale price of our common stock
as reported by NASDAQ was $1.32.
If
faced
with delisting, we may submit an application to transfer the listing of our
common stock to the NASDAQ Capital Market. Alternatively, if our
common stock is delisted by NASDAQ, our common stock would be eligible to trade
on the OTC Bulletin Board
maintained
by NASDAQ, another over-the-counter quotation system, or on the pink sheets
where an investor may find it more difficult to dispose of or obtain accurate
quotations as to the market value of our common stock. In addition,
we would be subject to a rule promulgated by the Securities and Exchange
Commission that, if we fail to meet criteria set forth in such rule, imposes
various practice requirements on broker-dealers who sell securities governed
by
the rule to persons other than established customers and accredited
investors. Consequently, such rule may deter broker-dealers from
recommending or selling our common stock, which may further affect the liquidity
of our common stock.
Delisting
from NASDAQ would make trading our common stock more difficult for investors,
potentially leading to further declines in our share price. It would
also make it more difficult for us to raise additional
capital. Further, if we are delisted, we would also incur additional
costs under state blue sky laws in connection with any sales of our
securities. These requirements could severely limit the market
liquidity of our common stock and the ability of our shareholders to sell our
common stock in the secondary market.
Our
stock price has been and may continue to be volatile, and your investment in
our
stock could decline in value or fluctuate significantly.
The
market prices for securities of biotechnology and pharmaceutical companies
have
historically been highly volatile, and the market has from time to time
experienced significant price and volume fluctuations that are unrelated to
the
operating performance of particular companies. The market price of
our common stock has fluctuated over a wide range and may continue to fluctuate
for various reasons, including, but not limited to, announcements concerning
our
competitors or us regarding:
|
Ÿ
|
results
of clinical trials;
|
|
Ÿ
|
technological
innovations or new commercial
products;
|
|
Ÿ
|
changes
in governmental regulation or the status of our regulatory approvals
or
applications;
|
|
Ÿ
|
changes
in health care policies and
practices;
|
|
Ÿ
|
developments
or disputes concerning proprietary
rights;
|
|
Ÿ
|
litigation
or public concern as to safety of the our potential products;
and
|
|
Ÿ
|
changes
in general market conditions.
|
These
fluctuations may be exaggerated if the trading volume of our common stock is
low. These fluctuations may or may not be based upon any of our
business or operating results. Our common stock may experience
similar or even more dramatic price and volume fluctuations which may continue
indefinitely.
We
will be obligated to pay liquidated damages if our recently filed registration
statement is not declared effective within a certain period of
time.
On
June
28, 2007, we entered into a securities purchase agreement with certain
purchasers for the sale of common stock and warrants to purchase our common
stock in a private placement. In connection with the securities purchase
agreement, we entered into a registration rights agreement in which we were
obligated to file a registration statement within 30 days after the date
of the
securities purchase agreement. Such registration statement was filed on July
23,
2007. We will be obligated to pay each purchaser liquidated damages
if:
|
Ÿ
|
the
registration statement is not declared effective by September
26,
2007;
|
|
Ÿ
|
we
fail to file with the SEC an acceleration request of the registration
statement within five trading days of the date that we are
notified by the
SEC that such registration statement will not be subject to
further
review;
|
|
Ÿ
|
we
fail to file a pre-effective amendment and otherwise respond
in writing to
comments made by the SEC in respect of such registration statement
within
15 trading days after the receipt of comments by or notice
from the SEC
that such amendment is required in order for such registration
statement
to be declared
effective;
|
|
Ÿ
|
all
of the securities sold in the private placement are not registered
for
resale pursuant to one or more effective registration statements
on or
before June 30, 2008; or
|
|
Ÿ
|
after
the effectiveness, such registration statement ceases for any
reason to
remain continuously effective as to all securities sold in
the private
placement for which it is required to be effective, or the
purchasers are
not permitted to utilize the prospectus in such registration
statement for
more than ten trading days or more than an aggregate of 20
trading days
during any 12-month
period.
|
The
liquidated damages are equal to 1% of the aggregate purchase price paid by
each
purchaser for any issued and outstanding unregistered securities then held
by
such purchaser. We are not liable for liquidated damages for shares
issued pursuant to the warrants sold in the private placement and the maximum
aggregate liquidated damages payable to a purchaser shall be 10% of the
aggregate amount invested by such purchaser.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
On
June
29, 2007, we entered into purchase agreements with certain institutional
investors for the sale of 5,814,600 shares of our common stock and
2,907,301warrants to purchase shares of our common stock, through a private
placement offering. The warrants have an exercise price of $2.23 per
share and are exercisable beginning six months and ending five years after
their
issuance. The warrant agreement contains a cash settlement feature,
which is available to the warrant holders at their option, upon an acquisition
in certain circumstances. In exchange for $1.74, the purchasers
received one share of common stock and warrants to purchase .5 shares of common
stock. The transaction closed on July 6, 2007. The offering provided
us with net proceeds of approximately $9.1 million. The placement
agents in this transaction received (i) a cash fee equal to 6% of the aggregate
gross proceeds and (ii) warrants to purchase 348,876 shares of Cytogen common
stock having an exercise price of $2.23 per share and exercisable beginning
six
months and ending five years after their issuance. We believe that the issuance
of the foregoing securities were exempt from registration under Section 4(2)
of
the Securities Act of 1933. In connection with this sale, we entered
into a Registration Rights Agreement with the investors under which we were
obligated to file a registration statement with the SEC for the resale of the
shares sold to the investors and shares issuable upon exercise of the warrants
within a specified time period. We are also required to use
commercially reasonable efforts to cause the registration to be declared
effective by the SEC and to remain continuously effective until such time when
all of the registered shares are sold or two years from closing date, whichever
is earlier. In the event we fail to keep the registration statement
effective, we are obligated to pay the investors liquidated damages equal to
1%
of the purchase price paid by the investors ($10.1 million) for each monthly
period that the registration statement is not effective, up to
10%. On July 23, 2007, we filed the registration statement with the
SEC.
Item
4. Submission of Matters to a Vote of Security
Holders
On
June 13, 2007, we held our annual
meeting of stockholders to: (i) elect nine directors; (ii) consider and vote
upon a proposal to amend our 2004 Non-Employee Director Stock Incentive Plan
to
increase the maximum aggregate number of shares of common stock available for
issuance thereunder from 375,000 to 750,000; (iii) consider and vote upon a
proposal to approve an amendment to our Certificate of Incorporation to increase
the total authorized shares of common stock, $0.01 par value per share, of
the
Company from 50,000,000 to 100,000,000; and (iv) transact such other business
as
may come before the meeting.
There
were represented at our annual meeting, either in person or by proxy,
22,344,095 shares of our common stock out of a total number of
29,623,985 shares of common stock issued and outstanding and entitled to vote
at
the meeting.
The
following tables set forth information regarding the number of votes cast for,
withheld, abstentions and broker non-votes, with respect to each matter
presented at the meeting.
(i) Election
of Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
John
E. Bagalay, Jr.
|
|
|
21,609,689
|
|
|
|
734,405
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Michael
D. Becker
|
|
|
21,761,090
|
|
|
|
583,004
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Allen
Bloom
|
|
|
21,608,936
|
|
|
|
735,158
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Stephen
K. Carter
|
|
|
21,779,870
|
|
|
|
564,224
|
|
|
|
N/A
|
|
|
|
N/A
|
|
James
A. Grigsby
|
|
|
21,764,116
|
|
|
|
579,978
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Robert
F. Hendrickson
|
|
|
21,600,598
|
|
|
|
743,496
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Dennis
H. Langer
|
|
|
21,601,037
|
|
|
|
743,057
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Kevin
G. Lokay
|
|
|
21,603,893
|
|
|
|
740,201
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Joseph
A. Mollica
|
|
|
21,784,058
|
|
|
|
560,036
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
(ii)
|
Proposal
to approve an amendment to our 2004 Non-Employee Director Stock Incentive
Plan to increase the maximum aggregate number of shares of common
stock
available for issuance thereunder from 375,000 to
750,000:
|
|
|
|
|
|
|
|
|
|
|
|
|
4,392,226
|
|
|
|
910,816
|
|
|
|
36,799
|
|
|
|
17,004,214
|
|
|
(iii)
|
Proposal
to approve an amendment to our Certificate of Incorporation to increase
the total authorized shares of common stock, $0.01 par value per
share, of
the Company from 50,000,000 to
100,000,000:
|
|
|
|
|
|
|
|
|
|
|
|
|
20,280,233
|
|
|
|
1,957,377
|
|
|
|
106,485
|
|
|
|
-0-
|
|
Item
6. Exhibits.
Exhibit
No.
|
Description
|
3.1
|
Certificate
of Amendment to Restated Certificate of Incorporation dated June
13,
2007. Filed herewith.
|
10.1
|
Securities
Purchase Agreement between the Company and each of the Purchasers
dated as
of June 28, 2007. Filed as an exhibit to the Company's Current
Report on
Form 8-K, filed with the Commission on July 2, 2007, and incorporated
herein by reference.
|
10.2
|
Form
of Common Stock Purchase Warrant issued by the Company in favor
of each
Purchaser. Filed as an exhibit to the Company's Current Report
on Form
8-K, filed with the Commission on July 2, 2007, and incorporated
herein by
reference.
|
10.3
|
Registration Rights Agreement
between the Company and each of the Purchasers dated as of June 28,
2007. Filed as an exhibit to the Company's Current Report on Form
8-K,
filed with the Commission on July 2, 2007, and incorporated herein
by
reference.
|
10.4
|
Engagement
Agreement between the Company, Rodman & Renshaw, LLC and Roth Capital
Partners, LLC. Filed as an exhibit to the Company's Current Report on
Form 8-K, filed with the Commission on July 11, 2007, and incorporated
herein by reference.
|
10.5
|
Cytogen
Corporation 2004 Non-Employee Director Stock Incentive Plan, as
amended. Filed herewith.
|
31.1
|
Certification
of President and Chief Executive Officer pursuant to Rule 13a-14(a)
or
15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant
to
Section 302 of the Sarbanes-Oxley Act of 2002. Filed
herewith.
|
31.2
|
Certification
of Senior Vice President, Finance, and Chief Financial Officer,
pursuant
to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of
1934, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. Filed herewith.
|
32.1
|
Certification
of President and Chief Executive Officer pursuant to 18 U.S.C.
Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of
2002. Furnished herewith.
|
32.2
|
Certification
of Senior Vice President, Finance, and Chief Financial Officer,
pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the
Sarbanes-Oxley Act of 2002. Furnished
herewith.
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Date:
August 9, 2007
|
CYTOGEN
CORPORATION
|
|
|
|
|
By:
|
|
|
|
Michael
D. Becker,
|
|
|
President
and Chief Executive Officer
|
Date:
August 9, 2007
|
CYTOGEN
CORPORATION
|
|
|
|
|
By:
|
|
|
|
Kevin
J. Bratton
|
|
|
Senior
Vice President, Finance, and
Chief
Financial
Officer
(Principal
Financial and Accounting Officer)
|
EXHIBIT
INDEX
Exhibit
No.
|
Description
|
3.1
|
Certificate
of Amendment to Restated Certificate of Incorporation dated June
13,
2007. Filed herewith.
|
10.1
|
Securities
Purchase Agreement between the Company and each of the Purchasers
dated as
of June 28, 2007. Filed as an exhibit to the Company's Current
Report on
Form 8-K, filed with the Commission on July 2, 2007, and incorporated
herein by reference.
|
10.2
|
Form
of Common Stock Purchase Warrant issued by the Company in favor
of each
Purchaser. Filed as an exhibit to the Company's Current Report
on Form
8-K, filed with the Commission on July 2, 2007, and incorporated
herein by
reference.
|
10.3
|
Registration Rights Agreement
between the Company and each of the Purchasers dated as of June 28,
2007. Filed as an exhibit to the Company's Current Report on Form
8-K,
filed with the Commission on July 2, 2007, and incorporated herein
by
reference.
|
10.4
|
Engagement
Agreement between the Company, Rodman & Renshaw, LLC and Roth Capital
Partners, LLC. Filed as an exhibit to the Company's Current Report on
Form 8-K, filed with the Commission on July 11, 2007, and incorporated
herein by reference.
|
10.5
|
Cytogen
Corporation 2004 Non-Employee Director Stock Incentive Plan, as
amended. Filed herewith.
|
31.1
|
Certification
of President and Chief Executive Officer pursuant to Rule 13a-14(a)
or
15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant
to
Section 302 of the Sarbanes-Oxley Act of 2002. Filed
herewith.
|
31.2
|
Certification
of Senior Vice President, Finance, and Chief Financial Officer,
pursuant
to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of
1934, as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. Filed herewith.
|
32.1
|
Certification
of President and Chief Executive Officer pursuant to 18 U.S.C.
Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of
2002. Furnished herewith.
|
32.2
|
Certification
of Senior Vice President, Finance, and Chief Financial Officer,
pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the
Sarbanes-Oxley Act of 2002. Furnished
herewith.
|