form10-q_093007.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 SEPTEMBER 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)
(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 November 8, 2007: 35,512,651
|
CYTOGEN
CORPORATION
QUARTERLY
REPORT ON FORM 10-Q
SEPTEMBER
30, 2007
TABLE
OF CONTENTS
|
Page
|
PART
I.FINANCIAL INFORMATION
|
1
|
Item
1. Consolidated
Financial Statements
(unaudited)
|
1
|
Consolidated
Balance Sheets as of September 30, 2007 and December 31,
2006
|
2
|
Consolidated
Statements of Operations for the Three Months and Nine Months Ended
September 30, 2007 and 2006
|
3
|
Consolidated
Statements of Cash Flows for the Nine Months Ended September 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
|
17
|
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
|
38
|
Item
4. Controls
and Procedures
|
38
|
PART
II.OTHER INFORMATION
|
40
|
Item
1. Legal
Proceedings
|
40
|
Item
1A. Risk
Factors
|
40
|
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
|
53
|
|
53
|
Item
6. Exhibits
|
54
|
SIGNATURES
|
56
|
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
|
|
$ |
16,965
|
|
|
$ |
32,507
|
|
Restricted
cash
|
|
|
--
|
|
|
|
1,100
|
|
Accounts
receivable,
net
|
|
|
2,235
|
|
|
|
2,113
|
|
Inventories
|
|
|
5,632
|
|
|
|
2,538
|
|
Prepaid
expenses
|
|
|
1,328
|
|
|
|
1,571
|
|
Other
current
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current
assets
|
|
|
26,196
|
|
|
|
39,985
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, less accumulated depreciation and amortization of
$1,580
and $1,409 at September 30, 2007 and December 31, 2006,
respectively
|
|
|
1,033
|
|
|
|
691
|
|
Product
license fees, less accumulated amortization of $3,273 and $2,577
at
September 30, 2007 and December 31, 2006, respectively
|
|
|
8,916
|
|
|
|
11,612
|
|
Other
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Current
portion of long-term
liabilities
|
|
$ |
84
|
|
|
$ |
64
|
|
Accounts
payable and accrued
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current
liabilities
|
|
|
10,920
|
|
|
|
10,168
|
|
|
|
|
|
|
|
|
|
|
Warrant
liabilities
|
|
|
2,219
|
|
|
|
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, 35,512,651 and 29,605,631
shares issued and outstanding at September 30, 2007 and December
31, 2006,
respectively
|
|
|
355
|
|
|
|
296
|
|
Additional
paid-in
capital
|
|
|
472,521
|
|
|
|
465,016
|
|
Accumulated
other
comprehensive income
|
|
|
45
|
|
|
|
20
|
|
Accumulated
deficit
|
|
|
(448,016 |
) |
|
|
(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
September 30,
|
|
|
Nine
Months
Ended
September 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
QUADRAMET
|
|
$ |
2,482
|
|
|
$ |
1,998
|
|
|
$ |
7,242
|
|
|
$ |
6,242
|
|
PROSTASCINT
|
|
|
2,229
|
|
|
|
2,171
|
|
|
|
7,193
|
|
|
|
6,535
|
|
CAPHOSOL
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
product
revenue
|
|
|
5,120
|
|
|
|
4,169
|
|
|
|
15,078
|
|
|
|
12,777
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue
|
|
|
2
|
|
|
|
3
|
|
|
|
6
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues
|
|
|
5,122 |
|
|
|
4,172 |
|
|
|
15,084 |
|
|
|
12,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of product
revenue
|
|
|
3,174
|
|
|
|
2,631
|
|
|
|
9,233
|
|
|
|
7,545
|
|
Impairment
of intangible
asset
|
|
|
1,767
|
|
|
|
--
|
|
|
|
1,767
|
|
|
|
--
|
|
General
and
administrative
|
|
|
2,736
|
|
|
|
2,701
|
|
|
|
7,540
|
|
|
|
7,956
|
|
Selling
and
marketing
|
|
|
6,894
|
|
|
|
4,036
|
|
|
|
24,681
|
|
|
|
12,012
|
|
Research
and
development
|
|
|
1,466
|
|
|
|
1,040
|
|
|
|
4,694
|
|
|
|
5,581
|
|
Equity
in loss of joint
venture
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
120
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating
expenses
|
|
|
16,037
|
|
|
|
10,408
|
|
|
|
47,915
|
|
|
|
33,214
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(10,915 |
) |
|
|
(6,236 |
) |
|
|
(32,831 |
) |
|
|
(20,428 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
271
|
|
|
|
384
|
|
|
|
933
|
|
|
|
1,073
|
|
Interest
expense
|
|
|
(11 |
) |
|
|
(8 |
) |
|
|
(45 |
) |
|
|
(20 |
) |
Advanced
Magnetics, Inc. litigation settlement, net
|
|
|
--
|
|
|
|
--
|
|
|
|
3,946
|
|
|
|
--
|
|
Gain
on sale of equity interest in joint venture
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
12,873
|
|
Decrease
in value of warrant liabilities
|
|
|
5,536
|
|
|
|
122
|
|
|
|
7,651
|
|
|
|
304
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(5,119 |
) |
|
$ |
(5,738 |
) |
|
$ |
(20,346 |
) |
|
$ |
(6,198 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share
|
|
$ |
(0.15 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted weighted-average common shares
outstanding
|
|
|
35,099
|
|
|
|
22,494
|
|
|
|
31,483
|
|
|
|
22,481
|
|
The
accompanying notes are an integral part of these statements.
CYTOGEN
CORPORATION AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(All
amounts in thousands)
(Unaudited)
|
|
Nine
Months Ended September 30,
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(20,346 |
) |
|
$ |
(6,198 |
) |
Adjustments
to reconcile net loss to net cash used
|
|
|
|
|
|
|
|
|
in
operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and
amortization
|
|
|
1,300
|
|
|
|
933
|
|
Decrease
in value of warrant
liabilities
|
|
|
(7,651 |
) |
|
|
(304 |
) |
Share-based
compensation
expense
|
|
|
1,323
|
|
|
|
1,359
|
|
Increase
(decrease) in provision
for doubtful accounts
|
|
|
58
|
|
|
|
(4 |
) |
Gain
on sale of equity interest
in joint venture
|
|
|
--
|
|
|
|
(12,873 |
) |
Reserve
for excess
inventory
|
|
|
366
|
|
|
|
--
|
|
Impairment
of intangible
asset
|
|
|
1,767
|
|
|
|
--
|
|
Other
|
|
|
47
|
|
|
|
(14 |
) |
Changes
in assets and
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(180 |
) |
|
|
(55 |
) |
Inventories
|
|
|
(3,442 |
) |
|
|
1,808
|
|
Other
assets
|
|
|
1,598
|
|
|
|
(399 |
) |
Accounts
payable and accrued
liabilities
|
|
|
1,742
|
|
|
|
1,331
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating
activities
|
|
|
(23,418 |
) |
|
|
(14,416 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchases
of product rights
|
|
|
(1,000 |
) |
|
|
(2,000 |
) |
Purchases
of property and equipment
|
|
|
(711 |
) |
|
|
(103 |
) |
Proceeds
from sale of equity interest in joint venture
|
|
|
--
|
|
|
|
13,132
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by (used in)
investing activities
|
|
|
(1,711 |
) |
|
|
11,029
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of common stock
|
|
|
6,603
|
|
|
|
52
|
|
Proceeds
from issuance of warrants
|
|
|
3,041
|
|
|
|
--
|
|
Payment
of long-term liabilities
|
|
|
(57 |
) |
|
|
(30 |
) |
|
|
|
|
|
|
|
|
|
Net
cash provided by financing
activities
|
|
|
9,587
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
Net
decrease in cash and cash equivalents
|
|
|
(15,542 |
) |
|
|
(3,365 |
) |
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, beginning of period
|
|
|
32,507
|
|
|
|
30,337
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, end of period
|
|
$ |
16,965
|
|
|
$ |
26,972
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of non-cash information:
|
|
|
|
|
|
|
|
|
Capital
lease of
equipment
|
|
$ |
84
|
|
|
$ |
96
|
|
Unrealized
holding gain on
marketable securities
|
|
$ |
25
|
|
|
$ |
41
|
|
Issuance
of warrants to placement agents
|
|
$
|
365 |
|
|
$ |
-- |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash information:
|
|
|
|
|
|
|
|
|
Cash
paid for
interest
|
|
$ |
22
|
|
|
$ |
20
|
|
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 two 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. The Company also currently has
U.S. commercial rights to SOLTAMOX (tamoxifen citrate), a liquid hormonal
therapy approved in the U.S. for the treatment of breast cancer in adjuvant
and
metastatic settings (see Note 2).
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 for potential new revenues. If
CAPHOSOL does not achieve market acceptance, either because the Company fails
to
effectively market such product 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 September 30, 2007 should
be
adequate to fund operations and commitments into the first quarter of
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.
The
Company expects that it will need to raise additional capital by the end of
the
first quarter of 2008. If the Company is unable to raise
additional financing, it could be required to reduce its capital
expenditures, scale back its sales and marketing or research and development
plans, reduce its workforce, license to others products or technologies the
Company would otherwise seek to commercialize itself and sell certain
assets. There can be no assurance that the Company can obtain equity
financing, if at all, on terms acceptable to the Company.
On
November 5, 2007, the Company announced that it had engaged an investment
banking firm to assist the Company in identifying and evaluating strategic
alternatives intended to enhance the future growth potential of the Company’s
pipeline and maximize shareholder value. There can be no assurance
that this evaluation will lead to any specific action or transaction. There
can
be no assurance that the plan to identify and evaluate strategic alternatives
will provide greater value to the Company’s stockholders than that reflected in
the current stock price.
On
November 5, 2007, the Company received notification from The NASDAQ Stock
Market, or NASDAQ, that the Company is not in compliance with the $1.00 minimum
bid price requirement for continued inclusion on the NASDAQ Global Market
pursuant to Marketplace Rule 4450(a)(5). The closing price of
Cytogen’s common stock has been below $1.00 per share since September 24,
2007. The letter states that the Company has 180 calendar days, or
until May 5, 2008, to regain compliance with the minimum bid price requirement
of $1.00 per share. The Company can achieve compliance, if at any
time before May 5, 2008, its common stock closes at $1.00 per share or more
for
at least 10 consecutive business days. If compliance with NASDAQ’s
Marketplace Rules is not achieved by May 5, 2008, NASDAQ will provide notice
that the Company’s common stock will be delisted from the NASDAQ Global
Market. In the event of such notification, the Company would have an
opportunity to appeal NASDAQ’s determination. If faced with
delisting, the Company may submit an application to transfer the listing of
its
common stock to the NASDAQ Capital Market. There can be no assurance
that the Company will be able to maintain the listing of its Common Stock on
the
NASDAQ Global Market.
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
7). 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 and CAPHOSOL 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
|
|
$ |
82
|
|
|
$ |
325
|
|
Work-in-process
|
|
|
3,623
|
|
|
|
1,296
|
|
Finished
goods
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Due
to
short-dating of current product and limited end user demand, SOLTAMOX inventory
was fully reserved as of September 30, 2007 (see Note 2).
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 nine month periods ended September 30, 2007 and 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.
Other
Comprehensive Income or Loss
Other
comprehensive income consisted of unrealized holding gains on marketable
securities. For the three months ended September 30, 2007, the unrealized
holding gain for these securities was $12,000 and, as a result, the
comprehensive loss for the three months ended September 30, 2007 was $5,107,000.
For the nine months ended September 30, 2007, the unrealized holding gain for
these securities was $25,000 and, as a result, the comprehensive loss for the
nine months ended September 30, 2007 was $20,321,000. For the three
months ended September 30, 2006, there was no unrealized holding gain or loss
for these securities and, as a result, the comprehensive loss for the three
months ended September 30, 2006 was $5,738,000, the same as net loss. For the
nine months ended September 30, 2006, the unrealized holding gain of the
securities was $41,000 and as a result, the comprehensive loss for the nine
months ended September 30, 2006 was $6,157,000.
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 nine month periods
ended September 30, 2007.
Reclassification
Certain
amounts in prior year's consolidated financial statements have been reclassified
to conform to the current year presentation.
2.
IMPAIRMENT OF ASSETS
The
Company assesses the carrying value of its intangible assets when circumstances
indicate that the carrying amount of the underlying asset may not be
recoverable. Due to continued limited end-user demand, uncertainty regarding
future market penetration, the decision this quarter to
reallocate sales and marketing resources to other products, and inventory
dating issues, the Company assessed the recoverability of the carrying amount
of
its SOLTAMOX license and determined an impairment existed as of September 30,
2007. Accordingly, during the third quarter of 2007, Cytogen recorded a non-cash
impairment charge of approximately $1.8 million to write-down this asset to
zero. SOLTAMOX is a liquid hormonal therapy approved in the U.S. for the
treatment of breast cancer in adjuvant and metastatic settings.
In
addition, the Company recorded a reserve for excess SOLTAMOX inventory in the
amount of $84,000 and $298,000 during the three and nine month periods ended
September 30,
2007,
respectively. The Company also recorded
a charge of $64,000 relating to future estimated minimum royalty obligations
for
SOLTAMOX in the accompanying consolidated statement of operations for the three
months ended September 30, 2007.
3.
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 and nine months ended September 30, 2007 and 2006, the Company recorded
share-based compensation expenses as follows (all amounts in
thousands):
|
|
Three
Months
Ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
$ |
258
|
|
|
$ |
335
|
|
Selling
and marketing
|
|
|
55
|
|
|
|
147
|
|
Research
and development
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine
Months
Ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
$ |
807
|
|
|
$ |
892
|
|
Selling
and marketing
|
|
|
229
|
|
|
|
310
|
|
Research
and development
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
The
weighted-average grant date fair value per share of the options granted under
the Cytogen stock option plans during the three and nine months ended September
30, 2007 is estimated at $1.10 and $1.77 per share, respectively, as compared
to
$1.72 and $2.71 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
September
30,
|
|
|
Nine
Months Ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
life (years)
|
|
|
5.98
|
|
|
|
6.32
|
|
Expected
volatility
|
|
|
79 |
% |
|
|
85 |
% |
Dividend
yield
|
|
|
0 |
% |
|
|
0 |
% |
Risk-free
interest rate
|
|
|
5.03 |
% |
|
|
4.79 |
% |
Options
granted
|
|
|
59,000
|
|
|
|
875,500
|
|
Nonvested
shares granted
|
|
|
20,000
|
|
|
|
265,000
|
|
|
|
Three
Months Ended
September
30,
|
|
|
Nine
Months
Ended
September
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
life (years)
|
|
|
5.96
|
|
|
|
6.48
|
|
Expected
volatility
|
|
|
91 |
% |
|
|
97 |
% |
Dividend
yield
|
|
|
0 |
% |
|
|
0 |
% |
Risk-free
interest rate
|
|
|
4.92 |
% |
|
|
4.94 |
% |
Options
granted
|
|
|
33,750
|
|
|
|
585,350
|
|
Nonvested
shares granted
|
|
|
5,000
|
|
|
|
76,800
|
|
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
nine month periods ended September 30, 2007 was $1.59 and $2.28, respectively,
as compared to $2.18 and $3.47 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.
4.
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 $3.5 million has been incurred under this
agreement through September 30, 2007, and was recorded
as
inventory when purchased, of which $523,000 and $3.0 million were recorded
during the three and nine month periods ended September 30, 2007,
respectively.
5.
WARRANT LIABILITY
In
July
and August 2005, the Company sold to certain institutional investors shares
of
common stock and warrants to purchase 776,096 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 warrant 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 therefore the warrants are 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 warrants to purchase 3,546,107 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.
In
July
2007, the Company sold to certain institutional investors 5,814,600 shares
of
its common stock and warrants to purchase 2,907,301shares of its common stock
with an exercise price of $2.23 per share (see Note 12). The
Company also issued warrants to purchase 348,876 shares of its common stock
to
the placement agents, in addition to the cash
compensation. These warrants are exercisable beginning six months
after their issuance and ending five years after they become
exercisable. 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 |
% |
|
|
108 |
% |
Expected
life(1)
|
|
4.98
years
|
|
|
8.8
years
|
|
Risk-free
interest rate
|
|
|
4.29 |
% |
|
|
4.69 |
% |
Company
Common Stock Price
|
|
$ |
0.79
|
|
|
$ |
2.35
|
|
Outstanding
warrants
|
|
|
7,578,380
|
|
|
|
776,096
|
|
(1)
|
The
remaining expected life assumptions at September 30, 2007 and 2006
for the
warrants issued in July and August 2005 were 7.8 years and 8.8 years,
respectively. The expected life assumption at September 30,
2007 for the warrants issued in November 2006 was 4.1 years. The
expected
life assumption at September 30, 2007 for the warrants issued in
July 2007
was 5.2 years.
|
Warrants 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 September 30, 2007, the Company
reported gains of $5.5 million and $7.7 million for the three and nine months
ended September 30, 2007, respectively, compared to $122,000 and $304,000 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 September 30, 2007.
In
connection with the sale of Cytogen shares and warrants in July 2007, 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 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 aggregate purchase price of $10.1 million for each
monthly period that the registration statement is not effective, up to
10%. On August 22, 2007, 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 September 30, 2007.
6.
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. Under the terms of the revised agreement,
the Company pays OTN management
fees
based upon a percentage of the value of CAPHOSOL shipped during the
period. In November 2007, McKesson Corporation acquired
OTN. The Company does not anticipate any disruption in OTN's
performance of its obligation to warehouse and distribute CAPHOSOL.
7.
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 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. On August 30, 2007, the Company and InPharma amended the
license agreement to restructure the amounts payable by the Company upon the
exercise of the option for the European marketing
rights. The Company currently is seeking a strategic partner to
market CAPHOSOL in Europe.
8.
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.
9.
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 $4.0 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.
On
November 7, 2007, Eastern Virginia Medical School (“EVMS”) filed a complaint
against the Company in the United States District Court for the Eastern District
of Virginia. In the complaint, EVMS purports that the Company’s
PROSTASCINT product infringes a patent owned by EVMS and previously licensed
to
the Company under an agreement between EVMS
and
the Company entered into in 1991. The
Company is investigating the merits of these claims and intends to conduct
a
vigorous defense of such claims, if appropriate. However, given the
early stage of such litigation and the uncertainties associated with legal
proceedings, especially with patent litigation, the Company is unable to
estimate the ultimate financial impact, if any, to its results of operations
and
financial condition.
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.
10.
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 was effective immediately, also had no impact on the Company's
consolidated financial statements as of and for the three and nine month periods
ended September 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 September 30, 2007, the Company has no
uncertain tax positions, and no amounts recorded for interest or penalties
included in the financial statements.
The
Company does not anticipate any events in the next 12-month period that would
require it to record a liability related to any uncertain income tax positions
as prescribed by FIN 48.
11.
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.
12.
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
warrants to purchase 2,907,301shares 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 after their issuance and
ending
five years after they become exercisable. 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 (see Note 5). In exchange for
$1.74, the purchasers received one share of common stock and a warrant
to
purchase .5 share of common stock. The transaction closed on July 6,
2007. The offering provided net cash proceeds of approximately $9.3 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 after their issuance
and
ending five years after they become exercisable. 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
aggregate purchase price of $10.1 million for each monthly period that
the
registration statement is not effective, up to 10%. On August 22,
2007, 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 September 30,
2007.
13.
SUBSEQUENT EVENT
On
November 12, 2007, the Company announced that the Board of
Directors had accepted the resignation of Michael D. Becker, President, Chief
Executive Officer and director of the Company from his executive officer
and
director positions with the Company, effective November 9, 2007. Mr.
Becker has resigned to pursue another executive position, but will remain
an
employee of the Company through November 21, 2007. The Company also
announced the resignation of William J. Thomas, Senior Vice President and
General Counsel, from his executive officer positions, effective November
16,
2007. Mr. Thomas has resigned to pursue another general counsel
position. The two resignations are unrelated. Messrs.
Becker and Thomas are not receiving any severance payments.
On
November 12, 2007, the Board of Directors appointed Kevin G. Lokay, a current
member of the Company’s Board of Directors, to replace Mr. Becker and
immediately assume the position of President and Chief Executive
Officer. Mr. Lokay has served on the Company’s Board of Directors
since January 2001 and will remain a member of the
Board.
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 and PROSTASCINT, 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 and
PROSTASCINT, 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: the risk of not raising additional capital by the end
of
the first quarter of 2008, which may lead to reduced capital expenditures,
scaled back sales and marketing or research and development plans, workforce
reductions or the out-licensing or sale of certain proprietary assets; the
risk
of successfully identifying, evaluating, and executing strategic transactions
or
actions to enhance our future growth potential and maximize shareholder value;
the risk that we are not successful in achieving compliance with NASDAQ listing
requirements and our common stock is delisted from the NASDAQ Global Market;
our
ability to launch a new product; market acceptance of our products; the results
of our clinical trials; 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 two
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. We also currently have U.S. commercial rights to SOLTAMOX, a
liquid hormonal therapy approved in the U.S. for the treatment of breast cancer
in adjuvant and metastatic settings.
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.
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 warrants
to purchase 2,907,301shares 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 after their issuance and ending five years after they become
exercisable. In exchange for $1.74, the purchasers received one share
of common stock and a warrant to purchase .5 share of common
stock. The offering provided us with net cash proceeds of
approximately $9.3 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 after their issuance and ending
five years after they become exercisable. In connection with this sale, we
entered into a Registration Rights Agreement with the investors. On
August 22, 2007, the SEC declared the registration statement
effective. 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.
Engagement
of Investment Banking Firm to Identify and Evaluate Strategic
Alternatives
On
November 5, 2007, we announced that we engaged ThinkEquity Partners LLC to
assist us in identifying and evaluating strategic alternatives intended to
enhance the future growth potential of our pipeline and maximize shareholder
value. No assurances can be given that this evaluation will lead to
any specific action or transaction. There can be no assurance that
the plan to identify and evaluate strategic alternatives will provide greater
value to our stockholders than that reflected in the current stock
price.
Receipt
of
Nasdaq Notification Related to Minimum Bid Price
On
November 5, 2007, we received notification from The NASDAQ Stock Market, or
NASDAQ, that we are is not in compliance with the $1.00 minimum bid price
requirement for continued inclusion on the NASDAQ Global Market pursuant to
Marketplace Rule 4450(a)(5). The closing price of our common stock
has been below $1.00 per share since September 24, 2007. The letter
states that we have 180 calendar days, or until May 5, 2008, to regain
compliance with the minimum bid price requirement of $1.00 per
share. We can achieve compliance, if at any time before May 5, 2008,
our common stock closes at $1.00 per share or more for at least 10 consecutive
business days. If compliance with NASDAQ’s Marketplace Rules is not
achieved by May 5, 2008, NASDAQ will provide notice that our common stock will
be delisted from the NASDAQ Global Market. In the event of such
notification, we would have an opportunity to appeal NASDAQ’s
determination. If faced with delisting, we may submit an application
to transfer the listing of our common stock to the NASDAQ Capital
Market.
Kevin
Lokay appointed as President and Chief Executive Officer
On
November 12, 2007, we announced that Kevin G. Lokay, a current member of
the
Company’s Board of Directors, was appointed to the position of President and
Chief Executive Officer. Mr. Lokay has served on the Company’s Board
of Directors since January 2001 and will remain a member of the Board. Mr.
Lokay has more than 26 years of pharmaceutical industry experience, including
a
strong concentration in the successful sales and marketing of oncology
therapeutics and supportive care products. Mr. Lokay recently served
as Vice President and Business Unit Head, Oncology and Acute Care Business
Unit
at GlaxoSmithKline Pharmaceuticals (GSK). While at GSK, he successfully launched
three oncology and two acute care products and grew the business to over
$2.3
billion in sales.
Results
of Operations
Three
Months Ended September 30, 2007 and 2006
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
%
|
|
|
|
(All
amounts in thousands, except percentage
data)
|
|
QUADRAMET
|
|
$ |
2,482
|
|
|
$ |
1,998
|
|
|
$ |
484
|
|
|
|
24 |
% |
PROSTASCINT
|
|
|
2,229
|
|
|
|
2,171
|
|
|
|
58
|
|
|
|
3 |
% |
CAPHOSOL
|
|
|
409
|
|
|
|
--
|
|
|
|
409
|
|
|
|
n/a
|
|
Contract
revenue
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
|
(33 |
)% |
Total
revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
23 |
% |
Total
revenues for the third quarter of 2007 were $5.1 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. 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). Due to continued limited end-user demand and inventory dating
issues, we believe there is a high likelihood that substantially all of the
SOLTAMOX inventory at wholesalers will be returned, which would result in our
inability to recognize such shipments as revenue. We now believe that
SOLTAMOX has limited revenue potential that will not have a significant impact
on total revenues. See the discussion on Impairment of Intangible
Assets below.
QUADRAMET. QUADRAMET
sales were $2.5 million for the third quarter of 2007, reflecting a 3% increase
over the amount reported in the second quarter of 2007 and a 24% increase over
the third quarter of 2006. Quarterly sales trends for QUADRAMET
typically exhibit variability. QUADRAMET sales accounted for 48% of
product revenues for each quarter ended September 30, 2007 and
2006. Unit sales for the third quarter of 2007 increased 3% from the
second quarter of 2007, and increased 9% from the third quarter of
2006. In addition to the volume increase, the sales increase from the
third 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 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 third quarter of 2007 were $2.2 million,
reflecting a 11% decrease from the second quarter of 2007 and a 3% increase
over
the third quarter of 2006. PROSTASCINT sales accounted for 44% and
52% of product revenues for the third quarters of 2007 and 2006,
respectively. Unit sales for the third quarter of 2007 decreased 11%
from the second quarter of 2007 and decreased 13% as compared to the third
quarter of 2006. The sales increase from the third 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 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 third quarter of 2007 were $409,000, reflecting a 75% increase
over the amount reported in the second quarter of 2007. Unit sales
for the third quarter of 2007 increased 64% from the second quarter of
2007. Starting in the third quarter of 2007, we have had sufficient
evidence to reasonably estimate returns and chargebacks and have managed
inventories in the distribution channels to not exceed targeted
levels. As a result, we began to recognize revenues on CAPHOSOL based
on shipments to customers. CAPHOSOL revenues for the third quarter of
2007 included approximately $100,000 of revenues for products at wholesalers
at September 30, 2007. 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
|
|
$ |
3,174
|
|
|
$ |
2,631
|
|
|
$ |
543
|
|
|
|
21 |
% |
Impairment
of intangible assets
|
|
|
1,767
|
|
|
|
--
|
|
|
|
1,767
|
|
|
|
n/a
|
|
General
and
administrative
|
|
|
2,736
|
|
|
|
2,701
|
|
|
|
35
|
|
|
|
1 |
% |
Selling
and
marketing
|
|
|
6,894
|
|
|
|
4,036
|
|
|
|
2,858
|
|
|
|
71 |
% |
Research
and
development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41 |
% |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
54 |
% |
Cost
of Product Revenue. Cost of product revenue for the third quarters
of 2007 and 2006 were $3.2 million and $2.6 million, respectively, and primarily
reflects: (i) manufacturing and distribution costs for PROSTASCINT, QUADRAMET
and CAPHOSOL; (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) $200,000 of costs
associated with shipments of SOLTAMOX to wholesalers, including a reserve of
$84,000 for excess SOLTAMOX inventory with short expiry dates, and minimum
royalties for SOLTAMOX. The increase from the prior year period is
primarily due to costs
aggregating
$533,000 associated with CAPHOSOL and
SOLTAMOX which we introduced to the U.S. market in March 2007 and August 2006,
respectively. All
SOLTAMOX inventory is fully reserved as of September 30, 2007.
Impairment
of Intangible Assets. We assess the carrying
value of our intangible assets when circumstances indicate that the carrying
amount of the underlying asset may not be recoverable. Due to continued limited
end-user demand, uncertainty regarding future market
penetration, the decision this quarter to reallocate sales and
marketing resources to other products, and inventory dating issues, we assessed
the recoverability of the carrying amount of our SOLTAMOX license and determined
an impairment existed. Accordingly, during the third quarter of 2007, we
recorded a non-cash impairment charge of approximately $1.8 million to
write-down this asset to zero.
General
and Administrative. General and administrative expenses
were $2.7 million for each of the third quarters in 2007 and
2006. The 2007 expenses included $341,000 of transaction costs
related to the issuance of warrants in July 2007, partially offset by reduced
spending in legal fees and corporate relation activities, when compared to
the
same period in 2006.
Selling
and Marketing. Selling and marketing expenses for the third
quarter of 2007 were $6.9 million compared to $4.0 million in the same period
of
2006. The increase from the prior year period is primarily driven by
$1.5 million of costs associated with the launch of CAPHOSOL in 2007, the
expanded investment for our specialty sales force, commercial support of
QUADRAMET and PROSTASCINT and $355,000 in managed care initiatives primarily
related to CAPHOSOL.
Research
and Development. Research and development expenses for the third
quarter of 2007 were $1.5 million compared to $1.0 million in the same period
of
2006. The increase from the prior year period is primarily due to
increased development expenditures for QUADRAMET and employment
costs.
Interest
Income/Expense. Interest income for the third quarter of 2007 was
$271,000 compared to $384,000 in the same period of 2006. The
decrease in 2007 from the prior year period was due to higher average cash
balances in 2006. Interest expense for the third quarter of 2007 was
$11,000 compared to $8,000 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.
Decrease
in Value of Warrant Liability. In connection with the sale of our
common stock and warrants in July and August 2005, November 2006 and July 2007,
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 September 30, 2007, we reported a
non-cash unrealized gain of $5.5 million related to the decrease in fair value
of the outstanding warrants during the period, compared to a $122,000 gain
for the three months ended September 30, 2006. 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
Loss. We had net loss of $5.1 million for the third
quarter of 2007, compared to net loss of $5.7 million reported in the third
quarter of 2006. The basic
and
diluted net loss per share for the third quarter of 2007 was $0.15 based
on 35.1
million weighted average common shares outstanding, compared to a basic and
diluted net loss per share of $0.26 based
on 22.5
million weighted average common shares outstanding for the same period in
2006. The fluctuation in results was primarily attributable to the
gain related to the decrease in fair value of the outstanding warrants,
partially offset by the increased selling and marketing expenses for CAPHOSOL
and the impairment charge for SOLTAMOX.
Nine
Months Ended September 30, 2007 and 2006
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
%
|
|
|
|
(All
amounts in thousands, except percentage
data)
|
|
QUADRAMET
|
|
$ |
7,242
|
|
|
$ |
6,242
|
|
|
$ |
1,000
|
|
|
|
16 |
% |
PROSTASCINT
|
|
|
7,193
|
|
|
|
6,535
|
|
|
|
658
|
|
|
|
10 |
% |
CAPHOSOL
|
|
|
643
|
|
|
|
--
|
|
|
|
643
|
|
|
|
n/a
|
|
Contract
revenue
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
(33 |
)% |
Total
revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
18 |
% |
Total
revenues for the first nine months of 2007 were $15.1 million compared to $12.8
million for the same period in 2006. Commencing with the second
quarter of 2007, we began recognizing revenue from CAPHOSOL. 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. Due to continued limited
end-user demand and inventory dating issues, we believe there is a high
likelihood that substantially all of the SOLTAMOX inventory at wholesalers
will
be returned, which would result in our inability to recognize such shipments
as
revenue. We now believe that SOLTAMOX has limited revenue potential
that will not have a significant impact on total revenues.
QUADRAMET.
QUADRAMET sales were $7.2 million for the first nine months of
2007, an increase of $1.0 million from $6.2 million in the first nine months
of
2006. QUADRAMET sales accounted for 48% and 49% of product revenues
for the first nine months of 2007 and 2006, respectively. Unit sales
for the first nine months of 2007 increased 3% from the first nine months of
2006. In addition to the volume increase, the sales increase from the
first nine months of the prior year period was also 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 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 $7.2 million for the first nine months of 2007, an increase of
$658,000 from $6.5 million in the first nine months of 2006. PROSTASCINT
sales accounted for 48% and 51% of product revenues for the first nine months
of
2007 and 2006, respectively. Unit sales for the first nine months of
2007 decreased 5% from the first nine months of 2006. The sales
increase from the first nine months 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
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 nine months of 2007 were $643,000. We introduced
CAPHOSOL to the U.S market in March 2007. We began to recognize
CAPHOSOL revenues in the second quarter of 2007, 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. Starting in the third quarter of 2007, we had sufficient
evidence to reasonably estimate returns and chargebacks and have managed
inventories in the distribution channels to not exceed targeted
levels. As a result, we began to recognize revenues on CAPHOSOL based
on shipments to customers. 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
|
|
$ |
9,233
|
|
|
$ |
7,545
|
|
|
$ |
1,688
|
|
|
|
22 |
% |
Impairment
of intangible assets
|
|
|
1,767
|
|
|
|
--
|
|
|
|
1,767
|
|
|
|
n/a
|
|
General
and
administrative
|
|
|
7,540
|
|
|
|
7,956
|
|
|
|
(416 |
) |
|
|
(5 |
)% |
Selling
and
marketing
|
|
|
24,681
|
|
|
|
12,012
|
|
|
|
12,669
|
|
|
|
105 |
% |
Research
and
development
|
|
|
4,694
|
|
|
|
5,581
|
|
|
|
(887 |
) |
|
|
(16 |
)% |
Equity
in loss of joint venture
|
|
|
|
|
|
|
|
|
|
|
(120 |
) |
|
|
(100 |
)% |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
44 |
% |
Cost
of Product Revenues. Cost of product revenues for the
first nine months of 2007 and 2006 were $9.2 million and $7.5 million,
respectively, and primarily reflects: (i) manufacturing and distribution costs
for PROSTASCINT, QUADRAMET and CAPHOSOL; (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) $640,000 of costs associated with shipments of SOLTAMOX to
wholesalers, including a reserve of $298,000 for excess SOLTAMOX inventory
with
short expiry dates, and minimum royalties for SOLTAMOX. The increase
from the prior year period is primarily due to costs aggregating $1.4 million
associated with CAPHOSOL and SOLTAMOX which we introduced to the U.S. market
in
March 2007 and August 2006, respectively. All SOLTAMOX inventory is fully
reserved as of September 30, 2007.
Impairment
of Intangible Assets. We assess the carrying
value of our intangible assets when circumstances indicate that the carrying
amount of the underlying asset may not be recoverable.
Due to continued limited end-user demand, uncertainty regarding future market
penetration, the decision in the third quarter of 2007 to
reallocate sales and marketing resources to other products, and inventory
dating issues, we assessed the recoverability of the carrying amount of our
SOLTAMOX license and determined an impairment existed. Accordingly, during
the
third quarter of 2007, we recorded a non-cash impairment charge of approximately
$1.8 million to write-down this asset to zero.
General
and Administrative. General and administrative expenses
for the first nine months of 2007 were $7.5 million compared to $8.0 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, partially offset
by
$341,000 of transaction costs related to the issuance of warrants in July
2007.
Selling
and Marketing. Selling and marketing expenses for the
first nine months of 2007 were $24.7 million compared to $12.0 million in the
same period of 2006. The increase from the prior year period is
primarily driven by: (i) a $5.9 million expense increase associated with the
launch of CAPHOSOL late in the first quarter of 2007; (ii) a $1.3 million
expense increase in marketing initiatives related to SOLTAMOX which we
introduced in the second half of 2006; (iii) a $2.0 million expanded investment
in our specialty sales force; (iv) commercial support of QUADRAMET and
PROSTASCINT; and (v) $1.0 million in managed care related expenses primarily
related to SOLTAMOX and CAPHOSOL.
Research
and Development. Research and development expenses for
the first nine months of 2007 were $4.7 million compared to $5.6 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 increased development expenditures for QUADRAMET and
employment costs.
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 nine months 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 nine
months of 2007 was $933,000 compared to $1.1 million in the same period of
2006. The decrease in 2007 from the prior year period was due to
higher average cash balances in 2006. Interest expense for the first
nine months of 2007 was $45,000 compared to $20,000 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 nine months ended
September 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. During the nine months ended September 30, 2006, we recorded a
gain of $12.9 million on the sale of our equity interest in the joint
venture. This amount 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 Value of Warrant Liability. In connection with the sale of our
common stock and warrants in July and August 2005, November 2006 and July 2007,
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 nine months ended September 30, 2007, we reported a
non-cash unrealized gain of $7.7 million related to the decrease in fair value
of these outstanding warrants during the period, compared to a $304,000
gain for the nine months ended September 30, 2006. 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
Loss. We had net loss of $20.3 million for the first
nine months of 2007, compared to $6.2 million reported for the first nine months
of 2006. The basic and diluted net loss per share for the first nine
months of 2007 was $0.65 based on 31.5 million weighted
average common shares outstanding, compared to a basic and diluted net loss
per
share of $0.28 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 and the gain related to the decrease in fair
value
of the outstanding warrants.
COMMITMENTS
We
have
entered into various contractual and commercial commitments. The
following table summarizes our obligations with respect to theses commitments
as
of September 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(All
amounts in thousands)
|
|
Capital
lease obligations
|
|
$ |
84
|
|
|
$ |
66
|
|
|
$ |
--
|
|
|
$ |
--
|
|
|
$ |
150
|
|
Facility
leases
|
|
|
338
|
|
|
|
366
|
|
|
|
--
|
|
|
|
--
|
|
|
|
704
|
|
Research
and development
|
|
|
243
|
|
|
|
150
|
|
|
|
150
|
|
|
|
425
|
|
|
|
968
|
|
Marketing
and other obligations
|
|
|
1,035
|
|
|
|
1
|
|
|
|
--
|
|
|
|
--
|
|
|
|
1,036
|
|
Manufacturing
contracts(1)
|
|
|
4,859
|
|
|
|
4,859
|
|
|
|
--
|
|
|
|
--
|
|
|
|
9,718
|
|
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
September 30, 2009. We owe at least $1.1 million during the fourth
quarter of 2007.
|
(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 owe $285,000 during the fourth quarter of
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.
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. As a
result of our decision to reallocate resources to
our
other products, we have recorded $64,000 in the third quarter of 2007 for future
estimated minimum royalties through June 30, 2008. Such
accrual represents the maximum financial obligation
to Rosemont in accordance with certain termination provisions in the
agreement. Accordingly, we have not included any further commitment
beyond June 30, 2008.
Liquidity
and Capital Resources
Condensed
Statement of Cash Flows:
|
|
Nine
Months Ended
September
30, 2007
|
|
|
|
(All
amounts in thousands)
|
|
Net
loss
|
|
$ |
(20,346 |
) |
Adjustments
to reconcile net loss to net cash used in
operating
activities
|
|
|
(3,072 |
) |
Net
cash used in operating
activities
|
|
|
(23,418 |
) |
Net
cash used in investing
activities
|
|
|
(1,711 |
) |
Net
cash provided by financing activities
|
|
|
|
|
Net
decrease in cash and cash equivalents
|
|
$ |
(15,542 |
) |
Overview
Our
cash
and cash equivalents were $17.0 million as of September 30, 2007, compared
to
$32.5 million as of December 31, 2006. During the nine months ended
September 30, 2007 and 2006, net cash used in operating activities was $23.4
million and $14.4 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 also received net
cash proceeds of $9.3 million from our securities purchase agreement with
certain institutional investors in July 2007. We expect that our
existing capital resources at September 30, 2007, should be adequate to fund
our
operations and commitments into the first quarter of 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
September 30, 2007, should be adequate to fund our operations and commitments
into the first quarter of 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.
We
expect
that we will need to raise additional capital by the end of the first quarter
of
2008. If we are unable to raise additional financing, we could be
required to reduce our capital expenditures, scale back our sales and marketing
or research and development plans, reduce our workforce, license to others
products or technologies we would otherwise seek to
commercialize ourselves and sell certain assets. There can
be no assurance that we can obtain equity financing, if at all, on terms
acceptable to us.
On
November 5, 2007, we announced that we had engaged an investment banking
firm to
assist us in identifying and evaluating strategic alternatives intended to
enhance the future growth potential of our pipeline and maximize shareholder
value. There can be no assurance that this evaluation will lead to
any specific action or transaction. There can be no assurance that the plan
to
identify and evaluate strategic alternatives will provide greater value to
our
stockholders than that reflected in the current stock price.
On
November 5, 2007, we received notification from The NASDAQ Stock Market, or
NASDAQ, that we are is not in compliance with the $1.00 minimum bid price
requirement for continued inclusion on the NASDAQ Global Market pursuant to
Marketplace Rule 4450(a)(5). The closing price of our common stock
has been below $1.00 per share since September 24, 2007. The letter
states that we have 180 calendar days, or until May 5, 2008, to regain
compliance with the minimum bid price requirement of $1.00 per
share. We can achieve compliance, if at any time before May 5, 2008,
our common stock closes at $1.00 per share or more for at least 10 consecutive
business days. If compliance with NASDAQ’s Marketplace Rules is not
achieved by May 5, 2008, NASDAQ will provide notice that our common stock will
be delisted from the NASDAQ Global Market. In the event of such
notification, we would have an opportunity to appeal NASDAQ’s
determination. If faced with delisting, we may submit an application
to transfer the listing of our common stock to the NASDAQ Capital
Market.
We
have
not yet determined what action, if any, we will take in response to the notice
from NASDAQ, although we intend to monitor the closing bid price of our common
stock between now and May 5, 2008, and to consider available options if our
common stock does not
trade
at
a level likely to result in the Company regaining compliance with the NASDAQ
minimum closing bid price requirement.
There
can
be no assurance that we will be able to maintain the listing of our common
stock
on the NASDAQ Global Market. 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
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 andwarrants
to
purchase 2,907,301shares 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 after their issuance and ending five years
after they become exercisable. 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 a warrant to purchase
.5
share of common stock. The transaction closed on July 6, 2007. The
offering provided us net cash proceeds of approximately $9.3
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 our common stock having an exercise price of $2.23 per share
and exercisable beginning six months after their issuance and ending five years
after they become exercisable. 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 aggregate purchase
price
of $10.1 million for each monthly period that the registration statement is
not
effective, up to 10%. On August 22, 2007, the registration statement
was declared effective by the SEC. We concluded that the contingent
obligation was not probable, and therefore no contingent liability was recorded
as of September 30, 2007.
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 September 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,
of
which $200,000 was paid on October 18, 2007. 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 nine months ended September 30, 2007,
we recorded $93,000 of royalties to InPharma. We are also obligated
to pay a finder's fee based upon a percentage of milestone payments made to
InPharma. On August 30, 2007, we executed an amendment to the license
agreement with InPharma that restructured the amounts payable by us upon
the exercise of the option for European marketing rights. We are
currently seeking a strategic partner to market CAPHOSOL in Europe.
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 or
Asia. For
Asia, such amounts are only payable to the extent such up-front license fees
and
milestone payments are in excess of the amount paid by us to InPharma for the
marketing rights in Asia.
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 $3.0 million of an aggregate $3.5 million, was incurred during the
nine
months ended September 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 nine months
ended September 30, 2007, we recorded $315,000 in royalties to
Rosemont. As a result of our reallocation of resources to our other
products, we have recorded $64,000 in the third quarter of 2007 for future
estimated minimum royalties through June 30, 2008. Such
accrual represents the maximum financial obligation
to Rosemont in accordance with certain termination provisions in the
agreement. We do not believe that we will have any further commitment
beyond June 30, 2008.
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
nine
months
ended September 30, 2007, we incurred $3.6 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.
Starting
in the third quarter of 2007, we have had sufficient evidence to reasonably
estimate returns and chargebacks for CAPHOSOL and have monitored inventories
in
the
distribution
channels to not exceed targeted levels. As a result we began
recognizing CAPHOSOL revenues based on shipments to customers.
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.
We
estimate returns on CAPHOSOL based on historical experience. To date,
returns have been minimal since the product has a three-year shelf life, a
majority of our customers do not stock the product due to its size and the
inventory in the distribution channels have been carefully monitored to not
exceed targeted levels.
Returns
from SOLTAMOX, 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. Due to continued limited end-user demand and inventory
dating issues, we believe there is a high likelihood that substantially all
of
the SOLTAMOX inventory at wholesalers will be returned. These returns will
have no financial impact on the results of our financial
statements.
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.
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 warrants 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
therefore the warrants are classified as a liability in the
accompanying consolidated balance sheet. Our warrants issued in
November 2006 and July 2007, 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 and July 2007 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. 07-03, "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 nine month periods ended
September 30, 2007.
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
Except
for purchases of CAPHOSOL which is manufactured in Europe and paid for in Euros,
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, 2006 and
2007. 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 September 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 September 30, 2007 that has materially affected, or is reasonably likely
to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
Item
1. Legal
Proceedings
On
November 7, 2007, Eastern Virginia Medical School (“EVMS”) filed a complaint
against the Company in the United States District Court for the Eastern District
of Virginia. In the complaint, EVMS purports that our PROSTASCINT
product infringes a patent owned by EVMS and previously licensed to us under
an
agreement between EVMS and the Company entered into in 1991. We are
investigating the merits of these claims and intend to conduct a vigorous
defense of such claims, if appropriate. However, given the early
stage of such litigation and the uncertainties associated with legal
proceedings, especially with patent litigation, we are unable to estimate
the
ultimate financial impact, if any, to our results of operations and financial
condition.
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
September 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
will need to raise additional capital which may not be available or only
available on less favorable terms.
Our
operations to date have required significant cash expenditures. Our
cash and cash equivalents were $17.0 million at September 30,
2007. We expect that our existing capital resources at September 30,
2007 should be adequate to fund our operations and commitments into
2008. However, we expect that we will need to raise additional
capital by the end of the first quarter of 2008 to continue our operations
as
they currently run. If we are unable to raise additional financing
when needed, we could be required to reduce our capital expenditures, scale
back
our sales and marketing or research and development plans, reduce our workforce,
license to others products or technologies we would otherwise seek to
commercialize ourselves and sell certain assets in order to continue
our operations. There can be no assurance that we can obtain equity
financing, if at all, on terms acceptable to us.
Additionally,
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 in the
future. 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, 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.
|
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 $5.1
million and $20.3 million for the three and nine months ended September 30,
2007. We had an accumulated deficit of $448 million as of September
30, 2007. We expect that our existing capital resources at September
30, 2007, should be adequate to fund our operations and commitments into
2008.
We
expect
that we will need to raise additional capital by the end of the first quarter
of
2008. If we are unable to raise additional financing, we could be
required to reduce our capital
expenditures, scale back our sales and marketing or research
and development plans, reduce our workforce, license to
others products or technologies we would otherwise seek to
commercialize ourselves and sell certain assets. There can
be no assurance that we can obtain equity financing, if at all, on terms
acceptable to us.
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.
Our
efforts to enhance the value of the Company for our stockholders may not be
successful. There is no guarantee that our stockholders will realize greater
value for, or preserve existing value of, their shares of the
Company.
On
November 5, 2007, we announced that we engaged an investment banking firm to
assist us in identifying and evaluating strategic alternatives intended to
enhance the future growth potential of our pipeline and maximize shareholder
value. No assurances can be given that this evaluation will lead to
any specific action or transaction. There can be no assurance that our plan
to
identify and evaluate strategic alternatives will provide greater value to
our
stockholders than that reflected in the current stock price.
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 September 30,
2007, revenues from QUADRAMET and PROSTASCINT accounted for approximately 48%
and 44%, respectively, of our product revenues. For the nine months ended
September 30, 2007, revenues from each of
QUADRAMET and PROSTASCINT accounted for approximately 48%
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 CAPHOSOL for future
revenues.
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
September 30, 2007, we have recognized $643,000 of revenues from
CAPHOSOL.
Our
future growth and success will depend on market acceptance of 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 CAPHOSOL does not achieve market
acceptance, either because we fail to effectively market such product 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
nine months ended September 30, 2007, we received 63% of our total revenues
from
three customers, as follows: 42% from Cardinal Health (formerly Syncor
International Corporation); 14% 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 Bristol-Myers Squibb Medical Imaging, Inc., or 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
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
purchase and supply agreement with OTN for the distribution of
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 September 30, 2007, we have
not
recognized
any revenues from SOLTAMOX. Due to continued limited end-user demand,
uncertainty regarding future market penetration, the decision this
quarter to reallocate sales and marketing resources to other products, and
inventory dating issues, we assessed the recoverability of the carrying amount
of our SOLTAMOX license and determined an impairment existed. Accordingly,
during the third quarter of 2007, we recorded a non-cash impairment charge
of
approximately $1.8 million to write-down this asset to zero. We
believe that SOLTAMOX has limited revenue potential that will not have a
significant impact on total revenues.
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.
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,
new investors could have rights superior to those of our existing stockholders
and our stock price may decline. The extent of such dilution will
vary based upon the amount of capital raised and the terms on which it is
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 and PROSTASCINT. 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 and PROSTASCINT, 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
November 8, 2007, we had 35,512,651 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. Because the average daily trading volume of our
common stock on the NASDAQ Global Market is low, liquidity of our common stock
is impaired. As a result, the price of our common stock may be lower
then it might otherwise be if trading volumes were greater. The NASDAQ
Global Market requires us to meet minimum financial requirements in order to
maintain our listing. On November 5, 2007, we received notification
from The NASDAQ Stock Market that the Company is not in compliance with the
$1.00 minimum bid price requirement for continued inclusion on 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.
The
liquidity of our common stock could be adversely affected if we are delisted
from the NASDAQ Global Market.
On
November 5, 2007 we received notification from The NASDAQ Stock Market, or
NASDAQ, that the Company is not in compliance with the $1.00 minimum bid price
requirement for continued inclusion on the NASDAQ Global
Market pursuant to Marketplace Rule 4450(a)(5). The closing price of
our common stock has been below $1.00 per share since September 24,
2007. The letter states that we have 180 calendar days, or until May
5, 2008, to regain compliance with the minimum bid price requirement of $1.00
per share. We can achieve compliance, if at any time before May 5,
2008, our common stock closes at $1.00 per share or more for at least 10
consecutive business days.
If
compliance with NASDAQ’s Marketplace Rules is not achieved by May 5, 2008,
NASDAQ will provide notice that our common stock will be delisted from the
NASDAQ Global Market. In the event of such notification, we would
have an opportunity to appeal NASDAQ’s determination. 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 “penny stock” regulations
promulgated by the Securities and Exchange Commission that, if we fail to meet
criteria set forth in such regulations, imposes various practice requirements
on
broker-dealers who sell securities governed by the regulations to persons other
than established customers and accredited investors. Consequently,
such regulations may deter broker-dealers from recommending or selling our
common stock, which may further affect the liquidity of our common stock.We
cannot assure you that our common stock if delisted from the NASDAQ Global
Market will be listed on a national securities exchange, a national quotation
service, the OTC Bulletin Board or the pink sheets.
We
have
not yet determined what action, if any, we will take in response to the notice
from NASDAQ, although we intend to monitor the closing bid price of our common
stock between now and May 5, 2008, and to consider available options if our
common stock does not trade at a level likely to result in the Company regaining
compliance with the NASDAQ minimum closing bid price requirement.
There
can
be no assurance that we will be able to maintain the listing of our common
stock
on the NASDAQ Global Market. Delisting from NASDAQ would make trading
our common stock more difficult for investors, potentially leading to further
declines in our share price. Without a NASDAQ listing, stockholders may
have a difficult time getting a quote for the sale or purchase of our stock,
the
sale or purchase of our stock would likely be made more difficult and the
trading volume and liquidity of our stock would likely decline. Delisting
from NASDAQ would also result in negative publicity and would also make it
more
difficult for us to raise additional capital. The absence of such a
listing may adversely affect the acceptance of our common stock as currency
or
the value accorded it by other parties. 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
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. On November 5, 2007, we received
notification from The NASDAQ Stock Market that the Company is not in compliance
with the $1.00 minimum bid price requirement for continued inclusion on 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 and we are not able to transfer the listing of our
common stock to the NASDAQ Capital 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, 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.
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 we do not keep certain
registration statement effective for a certain period of time.
In
connection with the sale of Cytogen shares and warrants in November 2006, 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
Cytogen 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.
In
connection with the sale of Cytogen shares and warrants in July 2007, 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
Cytogen 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 aggregate purchase price of $10.1 million for each monthly period that
the registration statement is not effective, up to 10%. On August 22,
2007, the SEC declared the registration statement effective.
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 warrants
to
purchase 2,907,301shares 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 a warrant to purchase .5 share of common
stock. The transaction closed on July 6, 2007. The offering provided
us with net proceeds of approximately $9.3 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 they become exercisable. 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 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 aggregate purchase price of
$10.1 million for each monthly period that the registration statement is not
effective, up to 10%. On August 22, 2007, the registration
statement was declared effective by the SEC.
Item
5. Other
Events.
On
November 12,
2007, we announced that the Board of Directors had
accepted the resignation of Michael D. Becker, President, Chief Executive
Officer and director of the Company from his executive officer and director
positions with the Company, effective November 9, 2007. Mr. Becker
has resigned to pursue another executive position, but will remain an employee
of the Company through November 21, 2007. We also announced the
resignation of William J. Thomas, Senior Vice President and General Counsel,
from his executive officer positions, effective November 16,
2007. Mr. Thomas has resigned to pursue another general counsel
position. The two resignations are unrelated. Messrs.
Becker and Thomas are not receiving any severance payments.
On
November 12, 2007, the Board of
Directors appointed Kevin G. Lokay, a current member of our Board, to replace
Mr. Becker and immediately assume the position of President and Chief Executive
Officer. Mr. Lokay has served on our Board since January 2001
and will remain a member of the Board.
Item
6. Exhibits.
Exhibit
No.
|
Description
|
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
|
Amendment
No. 1 to Product License and Assignment Agreement dated August
30, 2007
between the Company and InPharma AS.* 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.
|
* The
Company has submitted an application for confidential treatment with the
Securities and Exchange Commission with respect to certain provisions contained
in this exhibit. The copy filed as an exhibit omits the information
subject to the confidentiality application.
SIGNATURES
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:
November 14, 2007
|
CYTOGEN
CORPORATION
|
|
|
|
|
By:
|
|
|
|
Kevin
G. Lokay,
|
|
|
President
and Chief Executive Officer
|
Date:
November 14, 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
|
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
|
Amendment
No. 1 to Product License and Assignment Agreement dated August
30, 2007
between the Company and InPharma AS.* 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.
|
* The
Company has submitted an application for confidential treatment with the
Securities and Exchange Commission with respect to certain provisions contained
in this exhibit. The copy filed as an exhibit omits the information
subject to the confidentiality application.