form10-q_q12008.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2008
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE TRANSITION PERIOD
FROM TO
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COMMISSION
FILE NUMBER: 000-14879
Cytogen
Corporation
(EXACT
NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
Delaware
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22-2322400
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(State
or Other Jurisdiction of Incorporation or Organization)
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(I.R.S.
Employer Identification No.)
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650
College Road East, Suite 3100, Princeton, New Jersey 08540-5308
(Address
of principal executive offices)(Zip Code)
(609)
750-8200
(Registrant's
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to the filing requirements for
the past 90 days. Yes ý No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
Large
Accelerated Filer
¨
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Accelerated
Filer
¨
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Non-
Accelerated Filer
¨
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Smaller
Reporting Company x
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(Do
not check if a smaller reporting company)
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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 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, $0.01 par value
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Outstanding
at May 4, 2008: 35,593,633
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QUARTERLY
REPORT ON FORM 10-Q
MARCH 31,
2008
TABLE OF
CONTENTS
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Page
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1
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1
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2
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3
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4
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5
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17
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33
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34
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35
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35
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35
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48
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48
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48
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48
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49
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50
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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.
Item 1. Consolidated Financial
Statements (unaudited)
CONSOLIDATED
BALANCE SHEETS
(All
amounts in thousands, except share and per share data)
(Unaudited)
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ASSETS:
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Current
assets:
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Cash and cash
equivalents
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$ |
3,090 |
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$ |
8,914 |
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Accounts receivable,
net
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2,966 |
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2,747 |
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Inventories
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4,133 |
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4,635 |
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Prepaid
expenses
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1,379 |
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1,070 |
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Other current
assets
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262 |
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121 |
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Total current
assets
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11,830 |
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17,487 |
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Property
and equipment, less accumulated depreciation and amortization of $1,720
and $1,662 at March 31, 2008 and December 31, 2007,
respectively
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913 |
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1,046 |
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Product
license fees, less accumulated amortization of $3,821 and $3,547 at March
31, 2008 and December 31, 2007, respectively
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8,568 |
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8,842 |
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Other
assets
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1,948 |
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1,952 |
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$ |
23,259 |
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$ |
29,327 |
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LIABILITIES
AND STOCKHOLDERS' EQUITY:
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Current
liabilities:
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Current portion of long-term
liabilities
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80 |
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87 |
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Accounts payable and accrued
liabilities
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7,948 |
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8,490 |
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Total current
liabilities
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8,028 |
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8,577 |
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Warrant
liabilities
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965 |
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995 |
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Other
long-term
liabilities
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50 |
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66 |
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Total
liabilities
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9,043 |
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9,638 |
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Commitments
and contingencies
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Stockholders'
equity:
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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
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-- |
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-- |
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Common stock, $.01 par value,
100,000,000 shares authorized, 35,593,633 and 35,570,836 shares issued and
outstanding at March 31, 2008 and December 31, 2007,
respectively
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356 |
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356 |
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Additional paid-in
capital
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473,038 |
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472,648 |
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Accumulated other
comprehensive income
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42 |
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47 |
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Accumulated
deficit
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(459,220 |
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(453,362 |
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Total stockholders'
equity
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14,216 |
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19,689 |
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$ |
23,259 |
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$ |
29,327 |
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The accompanying notes are an integral
part of these statements.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(All
amounts in thousands, except per share data)
(Unaudited)
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Three
Months Ended March 31,
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Revenues:
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Product
revenue:
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QUADRAMET
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$ |
2,138 |
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$ |
2,350 |
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PROSTASCINT
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2,580 |
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2,456 |
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CAPHOSOL
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620 |
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-- |
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Total product
revenue
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5,338 |
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4,806 |
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Other
revenue
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1 |
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2 |
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Total
revenues
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5,339 |
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4,808 |
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Operating
expenses:
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Cost of product
revenue
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3,095 |
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2,902 |
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General and
administrative
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3,121 |
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2,410 |
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Selling and
marketing
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3,942 |
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8,131 |
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Research and
development
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1,120 |
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1,604 |
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Total operating
expenses
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11,278 |
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15,047 |
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Operating
loss
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(5,939 |
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(10,239 |
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Interest
income
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63 |
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376 |
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Interest
expense
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(12 |
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(10 |
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Advanced
Magnetics Inc. litigation settlement, net
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-- |
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3,946 |
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Decrease
in value of warrant
liabilities
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30 |
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1,095 |
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Net
loss
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$ |
(5,858 |
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$ |
(4,832 |
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Basic
and diluted net loss per share
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$ |
(0.16 |
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$ |
(0.16 |
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Weighted-average
common shares outstanding
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35,576 |
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29,606 |
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The
accompanying notes are an integral part of these statements.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(All
amounts in thousands)
(Unaudited)
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Three
Months Ended March 31,
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CASH
FLOWS FROM OPERATING ACTIVITIES:
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Net
loss
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$ |
(5,858 |
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$ |
(4,832 |
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Adjustments
to reconcile net loss to net cash used in
operating activities:
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Depreciation and
amortization
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393 |
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438 |
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Decrease in value of warrant
liabilities
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(30 |
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(1,095 |
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Share-based compensation
expense
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385 |
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428 |
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Other
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9 |
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(11 |
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Changes in assets and
liabilities:
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Accounts
receivables
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(220 |
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(57 |
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Inventories
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506 |
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(1,351 |
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Other
assets
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(451 |
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(1,099 |
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Accounts payable and accrued
liabilities
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(539 |
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792 |
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Net cash used in operating
activities
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(5,805 |
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(6,787 |
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CASH
FLOWS FROM INVESTING ACTIVITIES:
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Purchases
of property and
equipment
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- |
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(153 |
) |
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Net cash used in investing
activities
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- |
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(153 |
) |
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CASH
FLOWS FROM FINANCING ACTIVITIES:
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Proceeds
from issuances of common stock
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4 |
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34 |
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Payment
of long-term
liabilities
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(23 |
) |
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(16 |
) |
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Net cash provided by (used in)
financing activities
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(19 |
) |
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18 |
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Net
decrease in cash and cash equivalents
|
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(5,824 |
) |
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(6,922 |
) |
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Cash
and cash equivalents, beginning of period
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8,914 |
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32,507 |
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Cash
and cash equivalents, end of period
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$ |
3,090 |
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$ |
25,585 |
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Supplemental
disclosure of non-cash information:
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Capital
lease of equipment
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- |
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$ |
71 |
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Unrealized holding gain (loss)
on marketable securities
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$ |
(5 |
) |
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$ |
10 |
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Supplemental
disclosure of cash information:
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Cash paid for
interest
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$ |
10 |
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$ |
10 |
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The
accompanying notes are an integral part of these statements.
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 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.
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 new 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. Effective January 1, 2008, the Company ceased selling and
marketing SOLTAMOX, a liquid hormonal therapy approved in the U.S. for the
treatment of breast cancer in adjuvant and metastatic settings. The
Company's products are subject to significant regulatory review by the Food and
Drug Administration, or 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’s unaudited financial statements for the three months ended March 31,
2008, were prepared under the assumption that the Company will continue its
operations as a going concern. The Company incorporated in 1980, and
does not have a history of earnings. Continued operations are
dependent on the Company’s ability to complete equity or debt formation
activities or to generate profitable operations. Such capital
formation activities may not be available or may not be available on reasonable
terms. The Company’s financial statements do not include any
adjustments that may result from the outcome of this uncertainty. If
the Company cannot continue as a viable entity, its stockholders may lose some
or all of their investment in the Company.
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 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. The closing price of Cytogen’s common
stock has been below $1.00 per share since September 24, 2007. On
April 17, 2008, the Company had submitted a request to NASDAQ to extend the
compliance period, which expired on May 5, 2008, to after the May 8th Special
Stockholders Meeting, when the stockholders will vote on the merger with EUSA
Pharma. On May 7, 2008, the Company received a determination letter
from NASDAQ indicating that trading of the Company’s common stock will be
suspended at the opening of business on May 16, 2008, unless the Company
requests an appeal. The Company plans to appeal NASDAQ’s
determination if the Company’s stockholders fail to approve the
merger. 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.
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. On March 11, 2008, the
Company announced that it entered into a definitive merger agreement with EUSA
Pharma Inc., pursuant to which all outstanding shares of the Company’s common
stock will be converted into $0.62 per share in cash, which represents a premium
of approximately 35% over the closing price of $0.46 on March 10,
2008. If, at closing of the merger, there are additional shares of
the Company’s common stock issued and outstanding which cause the total merger
consideration to exceed $22.6 million, then the per share merger consideration
may be reduced accordingly so that such maximum aggregate merger consideration
does not exceed $22.6 million. EUSA Pharma is a transatlantic
specialty pharmaceutical company focused on oncology, pain control and critical
care.
Closing
of the merger is conditioned on, among other things, the receipt of approval by
holders of a majority of the outstanding shares of Cytogen’s common stock
entitled to vote, and the parties entrance into a sublicense agreement for the
European and Asian rights to the Company’s CAPHOSOL product, which was finalized
in April 2008. It is also subject to certain regulatory review and
other customary closing conditions. The transaction is expected to
close in the second quarter of 2008. Upon closing of the merger, EUSA
Pharma intends to apply to delist all of Cytogen’s issued shares from the NASDAQ
Stock Market.
Our cash and cash
equivalents were $3.1 million as of March 31, 2008. During the first quarter
ended March 31, 2008, net cash used in operating activities was $5.8 million. We
expect that our existing capital resources at March 31, 2008 along with the net
receipt of $5.0 million in April 2008 for the sublicensing of the European and
Asian rights to CAPHOSOL, should be adequate to fund our operations and
commitments into the second quarter of 2008. In the event that
the Merger Agreement is terminated due to the consummation of a superior
proposal, as defined in the Merger Agreement, or a financing or asset sale
without EUSA Pharma’s approval which is deemed to be a breach by us under the
covenants of the Merger Agreement, EUSA Pharma will return to us the CAPHOSOL
marketing rights and we will pay EUSA Pharma $10.0 million plus interest
calculated at 4% per annum for either (i) the period of time between the
effective date and the
closing of the superior proposal, or (ii) the period of time between the
termination of the Merger Agreement and the closing of the financing or asset
sale, as applicable. 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 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.
If we are
unable to consummate the merger with EUSA Pharma, we will need to raise
additional capital in the second quarter of 2008. If we are unable to raise
additional financing, we will 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, sell certain assets, cease operations or declare
bankruptcy. There can be no assurance that we can obtain equity financing, if at
all, on terms acceptable to us. 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.
Additionally,
if we are unable to consummate the merger with EUSA Pharma, our common stock may
be delisted by NASDAQ. If delisted from the NASDAQ Global Market and unable to
transfer to the NASDAQ Capital Market, 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. There can be
no assurance that we will be able to maintain the listing of our
common
stock on NASDAQ. 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.
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,
2007. 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 as of 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.
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 |
|
|
$ |
82 |
|
Work-in-process
|
|
|
1,619 |
|
|
|
3,221 |
|
Finished
goods
|
|
|
2,432 |
|
|
|
1,332 |
|
|
|
$ |
4,133 |
|
|
$ |
4,635 |
|
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
month periods ended March 31, 2008 and 2007 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 or losses on
marketable securities. For the three months ended March 31, 2008, the
unrealized holding loss for these securities was $5,000 and, as a result, the
comprehensive loss for the three months ended March 31, 2008 was
$5,863,000. For the three months ended March 31, 2007, the unrealized
holding gain for these securities was $10,000 and, as a result, the
comprehensive loss for the three months ended March 31, 2007 was
$4,822,000.
Recent
Accounting Pronouncements
Advance
Payments for Goods or Services
In June
2007, FASB issued 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 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 adoption of EITF 07-03 had no impact on the
Company’s consolidated financial statements as of and for the three months ended
March 31, 2008.
Fair
Value Option
In
February 2007, the Financial Accounting Standards Board (“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 No. 159), which became effective for fiscal years
beginning after November 15, 2007. SFAS No. 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 adoption of SFAS 159 had no impact
on the Company’s consolidated financial statements.
Fair
Value Measurement
In
September 2006, the FASB issued SFAS No. 157 “Fair Value Measurements”.
Statement No. 157 defines fair value, establishes a framework for measuring
fair value under U.S. GAAP, and enhances disclosures about fair value
measurements. The Statement applies when other accounting
pronouncements require fair value measurements; it does not require new fair
value measurements. On February 12, 2008, the FASB issued FASB
Staff Position No. FAS 157-2, “Effective Date of FASB Statement No. 157”,
which amends FAS No. 157 by delaying its effective date by one year for
non-financial assets and non-financial liabilities, except for items that are
recognized or disclosed at fair value in the financial statements on a recurring
basis. The Company adopted SFAS No. 157 for financial assets and
liabilities on January 1, 2008. There was no impact to the
Company’s condensed consolidated financial statements upon adoption of SFAS No.
157. SFAS 157-2 for nonfinancial assets and liabilities is effective for the
Company starting in 2009. The Company is currently assessing the
potential impacts on its consolidated financial statements upon the adoption of
SFAS 157-2.
On March
11, 2008, the Company announced that it entered into a definitive merger
agreement with EUSA Pharma Inc. (the “Merger Agreement”), pursuant to which all
outstanding shares of the Company’s common stock will be converted into $0.62
per share in cash, which represents a premium of approximately 35% over the
closing price of $0.46 on March 10, 2008. If, at closing of the
merger, there are additional shares of the Company’s common stock issued and
outstanding which cause the total merger consideration to exceed $22.6 million,
then the per share merger consideration may be reduced accordingly so that such
maximum aggregate merger consideration does not exceed $22.6
million. EUSA Pharma is a transatlantic specialty pharmaceutical
company focused on oncology, pain control and critical care.
Closing
of the merger is conditioned on, among other things, the receipt of approval by
holders of a majority of the outstanding shares of Cytogen’s common stock
entitled to vote, and the parties entrance into a sublicense agreement for the
European and Asian rights to the Company’s Caphosol product, which was finalized
in April 2008. It is also subject to certain regulatory review and
other customary closing conditions. The transaction is expected to
close in the
second quarter of 2008. Upon closing of the merger, EUSA Pharma
intends to apply to delist all of Cytogen’s issued shares from the NASDAQ Stock
Market.
On April 11, 2008, EUSA
Pharma transferred $5.0 million in immediately available funds to both the
Company and InPharma for an aggregate total of $10.0 million, in connection with
the sublicensing of the European and Asian marketing rights to the CAPHOSOL
product (see Note 5). In the event that the Merger Agreement
is terminated due to the consummation of a superior proposal, as defined in the
Merger Agreement, or a financing or asset sale without EUSA Pharma’s approval
which is deemed to be a breach by the Company under the covenants of the Merger
Agreement, EUSA Pharma will return to the Company the CAPHOSOL marketing rights
and the Company will pay EUSA Pharma $10.0 million plus interest calculated at
4% per annum for either (i) the period of time between the effective date
and the closing of the superior proposal, or (ii) the period of time
between the termination of the Merger Agreement and the closing of the financing
or asset sale, as applicable.
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 months ended March 31, 2008 and 2007, the Company recorded share-based
compensation expenses as follows (all amounts in thousands):
|
|
Three
Months Ended
March
31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
$ |
226 |
|
|
$ |
234 |
|
Selling
and marketing
|
|
|
87 |
|
|
|
123 |
|
Research
and development
|
|
|
72 |
|
|
|
71 |
|
|
|
$ |
385 |
|
|
$ |
428 |
|
There
were no options granted under the Cytogen stock option plans during the three
months ended March 31, 2008. The weighted-average grant date fair
value per share of the options granted under the Cytogen stock option plans
during the three months ended March 31, 2007 is estimated at $1.83 per share
using the Black-Scholes option pricing model with the following weighted average
assumptions:
|
|
Three
Months
Ended
March 31,
2007
|
|
|
|
|
Expected
life (years)
|
|
|
5.98 |
Expected
volatility
|
|
|
83% |
Dividend
yield
|
|
|
0% |
Risk-free
interest rate
|
|
|
4.7% |
Option
granted
|
|
|
713,500 |
Nonvested
shares granted
|
|
|
165,000 |
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
months ended March 31, 2007 was $2.50. No nonvested share awards were
granted during the three months ended March 31, 2008.
On March 10, 2008, the Company’s Board
of Directors suspended the 2005 Employee Stock Purchase Plan (the “ESPP Plan”)
until December 31, 2008, as a result of the execution of the merger agreement
with EUSA Pharma. The Company’s Board of Directors has taken steps to
terminate the ESPP Plan upon consummation of the merger with EUSA
Pharma. The weighted-average fair value per share ascribed to the
shares purchased under the ESPP Plan during the three months ended March 31,
2008 and 2007 is estimated at $0.17 and $0.65 per share, respectively, on the
date of grant using the Black-Scholes option pricing model with the following
weighted-average assumptions:
|
|
Three
Months Ended
March
31,
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
life (months)
|
|
|
3 |
|
|
3 |
Expected
volatility
|
|
|
82% |
|
|
63% |
Dividend
yield
|
|
|
0% |
|
|
0% |
Risk-free
interest rate
|
|
|
3.26% |
|
|
5.02% |
ESPP
Options granted
|
|
|
39,516 |
|
|
18,764 |
4.
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 10 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 shares of its common
stock and warrants to purchase 2,907,301 shares of its common stock with an
exercise price of $2.23 per share. 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
|
|
72% |
|
82% |
Expected
life(1)
|
|
4.5
years
|
|
5.3
years
|
Risk-free
interest rate
|
|
2.4% |
|
4.6% |
Company
Common Stock Price
|
|
$0.57 |
|
$2.09 |
Outstanding
warrants
|
|
7,578,380 |
|
4,322,203 |
(1)
|
The
remaining expected life assumptions at March 31, 2008 and 2007 for the
warrants issued in July and August 2005 were 7.3 years and 8.3 years,
respectively. The remaining expected life assumption at March
31, 2008 and 2007 for the warrants issued in November 2006 was 3.6 years
and 4.6 years, respectively. The remaining expected life
assumption at March 31, 2008 for the warrants issued in July 2007 was 4.8
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 March 31, 2008 and 2007, the
Company reported gains of $30,000 and $1.1 million for the three months ended
March 31, 2008 and 2007, 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 $20.0 million for each
30-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, 2007 and March 31, 2008.
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 December
31, 2007 and March 31, 2008.
5.
INPHARMA AS
On
October 11, 2006, the Company and InPharma entered into a Product License and
Assignment Agreement (the “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 is obligated to pay InPharma $6.0 million in aggregate up-front
fees, of which $4.6 million was paid upon the execution of the agreement, $1.2
million in 2007 and $200,000 will be paid in October 2008 provided there are no
indemnification claims by the Company. In addition, the Company is
obligated to pay InPharma royalties based on a percentage of net
sales. The Company is also obligated to pay future payments to
InPharma based upon the achievement of certain sales-based milestones and a
finder's fee based upon a percentage of milestone payments paid to
InPharma.
In the
event the Company exercises the options to license marketing rights for CAPHOSOL
in Europe and Asia, the Company is obligated to pay InPharma additional fees and
payments, including sales-based milestone payments for the respective
territories.
The
Company is required to obtain consents from certain licensors, but not InPharma,
if the Company sublicenses the rights to market CAPHOSOL in Europe and Asia to
other parties. The Company is also required to pay those licensors royalties
based on a percentage of net sales in Europe and Asia, if
exercised.
On August
30, 2007, the Company and InPharma executed Amendment No. 1 to the License
Agreement to restructure the amounts payable by the Company upon the exercise of
the option for the European and Asian marketing rights. On February
14, 2008, the Company and InPharma executed Amendment No. 2 to the License
Agreement to restructure the amounts payable by Cytogen in connection with the
exercise of the option for the European and Asian marketing rights, including
milestone payments and royalties based on sales levels in North
America. In order to exercise this option, the Company is required to
pay InPharma an upfront payment of $5.0 million as well as three additional
one-time payments of $5.0 million due on the later of (i) each of the first
three anniversary dates of the option exercise date and (ii) April 1 in the
calendar year in which each such anniversary occurs. Such additional
one-time payments are subject to reduction if there is a launch of a similar
generic product during such three-year period.
In
addition to the Merger Agreement between the Company and EUSA Pharma dated March
10, 2008, the parties entered into a sublicense agreement for the European and
Asian rights to CAPHOSOL. Under the terms of this agreement, EUSA
Pharma is required to pay the Company a one-time payment of $10.0 million, $5.0
million of which will be used by the Company to exercise its option to the
European and Asian rights.
On April 11, 2008, the Company
exercised its option to license the marketing rights for CAPHOSOL in Europe and
Asia and EUSA Pharma transferred $5.0 million to InPharma in connection with the
exercise of the Company’s option.
6.
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. In February 2008, the parties executed a non-binding
term sheet setting forth mutually acceptable terms for settlement of the pending
litigation between the parties. Pursuant to the term sheet, Cytogen
and EVMS are currently working toward finalizing and executing a settlement
agreement, as well as a new license agreement. For the year ended
December 31, 2007, the Company recorded an estimated settlement amount of
$100,000 in cost of product revenue which represents the maximum obligation
related to this settlement.
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.
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, 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 risks of not consummating the merger
agreement with EUSA Pharma, 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, 2007, 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, 2007 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 cancer 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.
Our financial
statements for the three months ended March 31, 2008, were prepared under the
assumption that we will continue our operations as a going
concern. We incorporated in 1980, and do not have a history of
earnings. As a result, our independent registered accountants in
their audit report for the fiscal year ended December 31, 2007 have expressed
substantial doubt about our ability to continue as a going
concern. Continued operations are dependent on our ability to
complete equity or debt formation activities or to generate profitable
operations. Such capital formation activities may not be available or
may not be available on reasonable terms. Our financial statements do
not include any adjustments that may result from the outcome of this
uncertainty. If we cannot continue as a viable entity, our
stockholders may lose some or all of their investment in the Company.
Significant
Events in 2008
Merger
Agreement with EUSA Pharma Inc.
On March
11, 2008, we announced that we entered into a definitive merger agreement with
EUSA Pharma, Inc. (the “Merger Agreement”), pursuant to which all of the
outstanding shares of Cytogen common stock will be converted into $0.62 per
share in cash, which represents a premium of approximately 35% over the closing
price of $0.46 on March 10, 2008. If, at closing of the merger, there
are additional shares of Cytogen’s common stock issued and outstanding which
cause the total merger consideration to exceed $22.6 million, then the per share
merger consideration may be reduced accordingly so that such maximum aggregate
merger consideration does not exceed $22.6 million. EUSA Pharma is a
transatlantic specialty pharmaceutical company focused on oncology, pain control
and critical care.
Closing
of the merger is conditioned on, among other things, the receipt of approval by
holders of a majority of the outstanding shares of Cytogen’s common stock
entitled to vote, and the parties entrance into a sublicense agreement for the
European and Asian rights to our Caphosol product, which was finalized in April
2008 (see below). It is also subject to certain regulatory review and
other customary closing conditions. The transaction is expected to
close in the second quarter of 2008. Upon closing of the merger, EUSA
Pharma intends to apply to delist all of Cytogen’s issued shares from the NASDAQ
Stock Market.
Sublicense
of the European and Asian Marketing Rights to CAPHOSOL Product
In
addition to the Merger Agreement between us and EUSA Pharma dated March 10,
2008, we entered into a sublicense agreement for the European and Asian
marketing rights to CAPHOSOL. Under the terms of this agreement, EUSA
Pharma was required to pay us a one-time payment of $10.0 million, $5.0 million
of which is used by us to exercise our option to the European and Asian
marketing rights from InPharma.
On April 11, 2008, EUSA
Pharma transferred $5.0 million to both us and InPharma for an aggregate total
of $10.0 million, in connection with the sublicensing of CAPHOSOL’s marketing
rights in Europe and Asia. In the event that the Merger
Agreement is terminated due to the consummation of a superior proposal, as
defined in the Merger Agreement, or a financing or asset sale without EUSA
Pharma’s approval which is deemed to be a breach by us under the covenants of
the Merger Agreement, EUSA Pharma will return to us the CAPHOSOL marketing
rights and we will pay EUSA Pharma $10.0 million plus interest calculated at 4%
per annum for either (i) the period of time between the effective date and
the closing of the superior proposal, or (ii) the period of time between
the termination of the Merger Agreement and the closing of the financing or
asset sale, as applicable.
Exercise
of Option for the European and Asian Marketing Rights to CAPHOSOL
Product
On
February 14, 2008, we entered into Amendment No. 2 to the CAPHOSOL license
agreement with InPharma to restructure the amounts payable by us in connection
with the exercise of the option for the European and Asian marketing rights,
including milestone payments and royalties based on sales levels in North
America. In order to exercise this option, we are required to pay
InPharma an upfront payment of $5.0 million as well as three additional one-time
payments of $5.0 million due on the later of (i) each of the first three
anniversary dates of the option exercise date and (ii) April 1 in the calendar
year in which each such anniversary occurs. Such additional one-time
payments are subject to reduction if there is a launch of a similar generic
product during such three-year period.
On April 11, 2008 we exercised our
option to license the marketing rights to CAPHOSOL in Europe and Asia and EUSA
Pharma transferred $5.0 million to InPharma on our behalf in connection with the
exercise of the option.
Results
of Operations
Three
Months Ended March 31, 2008 and 2007
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
% |
|
|
(All
amounts in thousands, except percentage data)
|
QUADRAMET
|
|
$ |
2,138 |
|
|
$ |
2,350 |
|
|
$ |
(212 |
) |
|
|
(9 |
%) |
PROSTASCINT
|
|
|
2,580 |
|
|
|
2,456 |
|
|
|
124 |
|
|
|
5 |
% |
CAPHOSOL
|
|
|
620 |
|
|
|
- |
|
|
|
620 |
|
|
|
n/a |
|
Other
revenue
|
|
|
1 |
|
|
|
2 |
|
|
|
(1 |
) |
|
|
(50 |
%) |
Total
revenues
|
|
$ |
5,339 |
|
|
$ |
4,808 |
|
|
$ |
531 |
|
|
|
11 |
% |
Total
revenues for the first quarter of 2008 were $5.3 million compared to $4.8
million for the same period in 2007. Product revenues accounted for nearly all
of total revenues for each of the first quarters of 2008 and 2007,
respectively. We did not recognize any revenue in the first quarter
of 2007 from CAPHOSOL which we introduced to the U.S market in March 2007,
because shipments of these products did not meet the revenue recognition
criteria under the U.S. generally accepted accounting principles
(GAAP). Commencing with the second quarter of 2007, we began
recognizing revenue from CAPHOSOL. 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, and if we
fail to successfully grow sales of CAPHOSOL, we may not be able to generate
sufficient revenue to become profitable.
QUADRAMET. QUADRAMET
sales for the first quarter of 2008 were $2.1 million, compared to $2.1 million
reported for the fourth quarter of 2007 and $2.4 million for the first quarter
of 2007. Unit sales for the first quarter of 2008 increased 3% over
the fourth quarter of 2007, but decreased 11% from the first quarter of
2007. Quarterly sales trends for QUADRAMET typically exhibit
variability. QUADRAMET sales accounted for 40% and 49% of product
revenues for the first quarters of 2008 and 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 first quarter of 2008 were $2.6 million, compared to $2.4 million
reported for the fourth quarter of 2007 and $2.5 million for the first quarter
of 2007. Unit sales for the first quarter of 2008 increased 5% from
the fourth quarter of 2007 and 1% from the first quarter of
2007. Quarterly sales trends for PROSTASCINT typically exhibit
variability. PROSTASCINT sales accounted for 48% and 51% of product
revenues for the first quarters of 2008 and 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 quarter of 2008 were $620,000. We introduced
CAPHOSOL to the U.S market in March 2007 and began recognizing CAPHOSOL revenues
in the second quarter of 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
|
|
$ |
3,095 |
|
|
$ |
2,902 |
|
|
$ |
193 |
|
|
|
7 |
% |
General
and
administrative
|
|
|
3,121 |
|
|
|
2,410 |
|
|
|
711 |
|
|
|
30 |
% |
Selling
and
marketing
|
|
|
3,942 |
|
|
|
8,131 |
|
|
|
(4,189 |
) |
|
|
(52 |
%) |
Research
and
development
|
|
|
1,120 |
|
|
|
1,604 |
|
|
|
(484 |
) |
|
|
(30 |
%) |
|
|
$ |
11,278 |
|
|
$ |
15,047 |
|
|
$ |
(3,769 |
) |
|
|
(25 |
%) |
Total
operating expenses for the first quarter of 2008 were $11.3 million compared to
$15.0 million in the same quarter of 2007.
Cost of Product
Revenue. Cost of product revenue for each of the first quarters of 2008
and 2007 was $3.1 million and $2.9 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 and
CAPHOSOL in October 2006. The increase from the prior year period is
primarily due to costs associated with higher revenues from PROSTASCINT and
CAPHOSOL but partially offset by the 2007 costs aggregating $166,000 associated
with SOLTAMOX. Effective January 1, 2008, the Company ceased selling
and marketing SOLTAMOX.
General and
Administrative. General and administrative expenses for the first quarter
of 2008 were $3.1 million compared to $2.4 million in the same period of
2007. The increase from the prior year period is primarily driven by
the $1.3 million of transaction costs associated with the merger with EUSA
Pharma in 2008, partially offset by a decrease in expenses related to a
reduction in headcounts and decreased investor and public relations
activities.
Selling and
Marketing. Selling and marketing expenses for the first
quarter of 2008 were $3.9 million compared to $8.1 million in the same period of
2007. The decrease from the prior year period is primarily driven by
costs incurred in 2007 associated with the launch of CAPHOSOL and increased
marketing support for QUADRAMET, PROSTASCINT and SOLTAMOX
initiatives.
Research and
Development. Research and development expenses for the first quarter of
2008 were $1.1 million compared to $1.6 million in the same period of 2007. The
decrease from the prior year period is primarily due to our continued strategic
realignment of research and development priorities.
Interest
Income/Expense. Interest income for the first quarter of 2008 was $63,000
compared to $376,000 in the same period of 2007. The decrease from
the prior year period was due to lower cash balances in
2008. Interest expense for the first quarter of 2008 was $12,000
compared to $10,000 in the same period in 2007. Interest expense
includes interest on finance charges related to various equipment leases that
are accounted for as capital leases and interest on amount 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
released 50,000 shares of Cytogen common stock held in escrow. As a
result of the settlement, we recorded a gain of $3.9 million, net of transaction
costs in 2007.
Decrease in
Warrant Liability. In connection with the sale of our common stock and
warrants in 2005, 2006 and 2007, we recorded the warrants as a liability at
their fair value using the Black-Scholes option-pricing model and re-measure
them at each reporting date until the warrants are exercised or
expire. 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 March 31, 2008, we reported a non-cash unrealized gain of
$30,000 related to the decrease in fair value of these outstanding warrants
during the period, compared to a $1.1 million non-cash unrealized gain for the
same period in 2007. 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.
Net loss for the first quarter of 2008 was $5.9 million compared to $4.8
million reported in the first quarter of 2007. The basic and diluted net loss
per share for the first quarter of 2008 was $0.16 based on 35.6 million
weighted average common shares outstanding, compared to a basic and diluted net
loss per share of $0.16 based on 29.6 million
weighted average common shares outstanding for the same period in
2007.
COMMITMENTS
We have
entered into various contractual and commercial commitments. The
following table summarizes our obligations with respect to theses commitments as
of March 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(All
amounts in thousands)
|
|
Capital
lease obligations
|
|
$ |
80 |
|
|
$ |
50 |
|
|
$ |
-- |
|
|
$ |
-- |
|
|
$ |
130 |
|
Facility
leases
|
|
|
338 |
|
|
|
197 |
|
|
|
-- |
|
|
|
-- |
|
|
|
535 |
|
Research
and development
|
|
|
177 |
|
|
|
150 |
|
|
|
150 |
|
|
|
387 |
|
|
|
864 |
|
Marketing
and other obligations
|
|
|
904 |
|
|
|
538 |
|
|
|
-- |
|
|
|
-- |
|
|
|
1,442 |
|
Manufacturing
contracts(1)
|
|
|
5,714 |
|
|
|
5,077 |
|
|
|
-- |
|
|
|
-- |
|
|
|
10,791 |
|
Minimum
royalty payments(2)
|
|
|
1,000 |
|
|
|
2,000 |
|
|
|
2,000 |
|
|
|
622 |
|
|
|
5,622 |
|
Total(3)
|
|
$ |
8,213 |
|
|
$ |
8,012 |
|
|
$ |
2,150 |
|
|
$ |
1,009 |
|
|
$ |
19,384 |
|
(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 $5.1 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
March 31, 2010.
|
(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 2008 through 2012 and $833,000 in
2013.
|
(3)
|
At
March 31, 2008, we have no uncertain tax positions. We do not
anticipate any events in the next 12-months that would require us to
record a liability related to any uncertain income tax positions as
prescribed by FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes (FIN 48).
|
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 Pharmaceuticals Limited. The agreement with Rosemont
required us to pay Rosemont quarterly minimum royalties based on an agreed upon
percentage of total tamoxifen prescriptions in the United States through June
2018. On April 4, 2008, we entered into a termination agreement with
Rosemont to terminate all agreements, including the minimum royalty
obligation. We have recorded a charge of $125,000 in 2007 for the
full settlement amount and have not included any further commitment beyond
December 31, 2007.
LIQUIDITY
AND CAPITAL RESOURCES
Our
financial statements for the three months ended March 31, 2008, were prepared
under the assumption that we will continue our operations as a going
concern. We were incorporated in 1980, and do not have a history of
earnings. As a result, our registered independent accountants in
their audit report for the fiscal year ended December 31, 2007 have expressed
substantial doubt about our ability to continue as a going
concern. Continued
operations
are dependent on our ability to complete equity or debt formation activities or
to generate profitable operations. Such capital formation activities
may not be available or may not be available on reasonable terms. Our
financial statements do not include any adjustments that may result from the
outcome of this uncertainty. If we cannot continue as a viable
entity, our stockholders may lose some or all of their investment in the
Company.
Condensed
Statement of Cash Flows:
|
|
Three
Months Ended
March
31, 2008
|
|
|
|
(All
amounts in thousands)
|
Net
loss
|
|
$ |
(5,858 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|
|
53 |
|
Net
cash used in operating
activities
|
|
|
(5,805 |
) |
Net
cash used in financing
activities
|
|
|
(19 |
) |
Net
decrease in cash and cash equivalents
|
|
$ |
(5,824 |
) |
Our cash
and cash equivalents were $3.1 million as of March 31, 2008, compared to $8.9
million as of December 31, 2007. For the three months ended March 31,
2008 and 2007, net cash used in operating activities was $5.8 million and $6.8
million, respectively. The decrease in cash usage from the prior year
period was primarily due to increased spending in 2007 for the marketing
initiatives on our marketed products including the commercial launch of
CAPHOSOL, and the 2007 receipt of $4.0 million related to the Advanced
Magnetics, Inc. settlement agreement. We expect that our existing
capital resources at March 31, 2008, along with the net receipt of $5.0
million in April 2008 for the sublicensing of CAPHOSOL’s European and Asian
marketing rights, should be adequate to fund our operations and commitments into
the second 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 revenues,
revenues from contract research services, fees paid under license agreements,
sale of assets, and interest earned on cash and short-term
investments.
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
products and complementary technologies, research and development, clinical
studies and regulatory activities, and to further our marketing and sales
programs. We expect that our existing capital resources at March 31,
2008, along with the net receipt of $5.0 million in April 2008 for the
sublicensing of CAPHOSOL’s European and Asian marketing rights, should be
adequate to fund our operations and commitments into the second 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.
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 stockholder value. On March
11, 2008, the Company announced that it entered into a definitive merger
agreement with EUSA Pharma, Inc., pursuant to which all outstanding shares of
the Company’s common stock will be converted into $0.62 per share in cash, which
represents a premium of approximately 35% over the closing price of $0.46 on
March 10, 2008. If, at closing of the merger, there are additional
shares of the Company’s common stock issued and outstanding which cause the
total merger consideration to exceed $22.6 million, then the per share merger
consideration may be reduced accordingly so that such maximum aggregate merger
consideration does not exceed $22.6 million. EUSA Pharma is a
transatlantic specialty pharmaceutical company focused on oncology, pain control
and critical care.
Closing
of the merger is conditioned on, among other things, the receipt of approval by
holders of a majority of the outstanding shares of Cytogen’s common stock
entitled to vote, and the parties entrance into a sublicense agreement for the
European and Asian rights to the Company’s Caphosol product, which was finalized
in April 2008. It is also subject to certain regulatory review and
other customary closing conditions. The transaction is expected to
close in the second quarter of 2008. Upon closing of the merger, EUSA
Pharma intends to apply to delist all of Cytogen’s issued shares from the NASDAQ
Stock Market.
If we are
unable to consummate the merger with EUSA Pharma, we will need to raise
additional capital in the second quarter of 2008. If we are unable to raise
additional financing, we will 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, sell certain assets, cease operations or declare
bankruptcy. There can be no assurance that we can obtain equity financing, if at
all, on terms acceptable to us. 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.
On
November 5, 2007, we received notification from The NASDAQ Stock Market, or
NASDAQ, that we are 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 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. The closing price of
Cytogen’s common stock has been below $1.00 per share since September 24,
2007. On April 17, 2008, the Company had submitted a request to
NASDAQ to extend the compliance period which expired on May 5, 2008, to after
the May 8th Special Stockholders Meeting, when the stockholders will vote on the
merger with EUSA Pharma. On May 7, 2008, the Company received a
determination letter from NASDAQ indicating that trading of the Company’s common
stock will be suspended at the opening of business on May 16, 2008, unless the
Company requests an appeal. The Company plans to appeal NASDAQ’s
determination if the Company’s stockholders fail to approve the
merger. If faced with delisting, we may submit an application to
transfer the listing of our common stock to the NASDAQ Capital
Market.
Additionally,
if we are unable to consummate the merger with EUSA Pharma, our common stock may
be delisted by NASDAQ. If delisted from the NASDAQ Global Market and unable to
transfer to the NASDAQ Capital Market, 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. There can be
no assurance that we will be able to maintain the listing of our common stock on
NASDAQ. 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.
Other
Liquidity Events
On April 11, 2008, we
exercised our option to license the marketing rights to CAPHOSOL in Europe and
Asia and EUSA Pharma transferred $5.0 million in immediately available funds to
both us and InPharma for an aggregate total of $10.0 million in connection with
the marketing rights. In the event that the Merger Agreement
is terminated due to the consummation of a superior proposal, as defined in the
Merger Agreement, or a financing or
asset
sale without EUSA Pharma’s approval which is deemed to be a breach by us under
the covenants of the Merger Agreement, EUSA Pharma will return to us the
CAPHOSOL marketing rights and we will pay EUSA Pharma $10.0 million plus
interest calculated at 4% per annum for either (i) the period of time
between the effective date and the closing of the superior proposal, or
(ii) the period of time between the termination of the Merger Agreement and
the closing of the financing or asset sale, as applicable.
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 2,907,301 shares of our common stock, through a private placement
offering. The placement agents in this transaction received warrants
to purchase 348,876 shares of our common stock. 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 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 the 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 March 31,
2008.
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 the 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 $20.0 million for each 30-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 March 31, 2008.
In
October 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. In accordance with
the terms of the License Agreement,
we are
obligated to pay an additional $200,000 in October 2008 contingent upon certain
conditions, royalties on net sales to certain other licensors and a finder's fee
based upon a percentage of milestone payments made to InPharma. Until
April 11, 2008, we were also obligated to pay InPharma royalties based on a
percentage of net sales and future milestone. On August 30, 2007, we
executed Amendment No. 1 to the License Agreement with InPharma that
restructured the amounts payable by us upon the exercise of the option for
European marketing rights. On February 14, 2008, we executed
Amendment No. 2 to the License Agreement with InPharma to restructure the
amounts payable by us in connection with the exercise of the options for the
European and Asian marketing rights, including milestone payments and royalties
based on sales levels in North America. Pursuant to the Sublicense
Agreement between EUSA Pharma and us dated March 10, 2008, EUSA Pharma
sublicenses the CAPHOSOL marketing rights to Europe and Asia. Under
the terms of the sublicense agreement EUSA Pharma is required to pay us a
one-time payment of $10.0 million, $5.0 million of which is used by us to
exercise the option for the European and Asian marketing rights to
CAPHOSOL.
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 $5.1 million annually,
subject to future annual price adjustment, through 2008, unless terminated by
BMSMI or us on a two year prior written notice. For the three months
ended March 31, 2008, we incurred $1.3 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. In January 2008, BMSMI was acquired by Avista Capital
Partners. Since our agreement requires two years’ prior written
notice to terminate and we have not received any termination notice from BMSMI,
we do not expect any disruption in BMSMI’s performance of its obligations under
our agreement through March 31, 2010. We currently have no
alternative manufacturer or supplier for QUADRAMET and any of its
components.
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 2008 through 2012 and $833,000 in 2013.
CRITICAL
ACCOUNTING POLICIES AND ESTIMATES
Financial
Reporting Release No. 60 requires all companies to include a discussion of
critical accounting policies or methods used in the preparation of financial
statements. Note 1 to our Consolidated Financial Statements in our
Annual Report on Form 10-K for the year ended December 31, 2007 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
product launches such as CAPHOSOL, which we introduced in March 2007, 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 “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 short half-life 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 has been carefully monitored to not
exceed targeted levels.
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
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 at March 31, 2008, we also assessed 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 relate 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 of 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. No liability was recorded as of December 31, 2007 or March
31, 2008.
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.
New
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 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
adoption of EITF 07-03 had no impact on our consolidated financial statements as
of and for the three months ended March 31, 2008.
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 became
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. The adoption of SFAS 159 had no impact in our
consolidated financial statements.
Fair
Value Measurement
In
September 2006, the FASB issued SFAS No. 157 “Fair Value Measurements”.
Statement No. 157 defines fair value, establishes a framework for measuring
fair value under U.S. GAAP, and enhances disclosures about fair value
measurements. The Statement applies when other accounting
pronouncements require fair value measurements; it does not require new fair
value measurements. On February 12, 2008, the FASB issued FASB
Staff Position No. FAS 157-2, “Effective Date of FASB Statement No. 157”,
which amends FAS No. 157 by delaying its effective date by one year for
non-financial assets and non-financial liabilities, except for items that are
recognized or disclosed at fair value in the financial statements on a recurring
basis. We adopted SFAS No. 157 for financial assets and liabilities
on January 1, 2008. There was no impact to our condensed
consolidated financial statements upon adoption of SFAS No. 157. SFAS 157-2 for
nonfinancial assets and liabilities is effective for us starting in
2009. We are currently assessing the potential impacts on our
consolidated financial statements upon the adoption of SFAS 157-2.
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 the 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.
(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 March 31, 2008. 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 March 31,
2008, 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 March 31, 2008 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
On November 7, 2007, Eastern Virginia
Medical School (“EVMS”) filed a complaint against us in the United States
District Court for the Eastern District of Virginia. In the
complaint, EVMS purported that our PROSTASCINT product infringed a patent owned
by EVMS and previously licensed to us under an agreement entered into in 1991
between EVMS and us. In February 2008, the parties executed a
non-binding term sheet setting forth mutually acceptable terms for settlement of
the pending litigation between the parties. Pursuant to the term
sheet, Cytogen and EVMS are currently working toward finalizing and executing a
settlement agreement, as well as a new license agreement.
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 March
31, 2008.
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, 2007 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, 2007 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, 2007
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 $3.1 million as of March 31, 2008. During
the three months ended March 31, 2008, net cash used in operating activities was
$5.8 million. We expect that our existing capital resources at March 31,
2008, along with the net receipt of $5.0 million in April 2008 for the
sublicensing of CAPHOSOL’s European and Asian marketing rights, should be
adequate to fund our operations and commitments into the second quarter of 2008.
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 March 31,
2008, along with the net receipt of $5.0 million in April 2008 for the
sublicensing of CAPHOSOL’s European and Asian marketing rights, should be
adequate to fund our operations and commitments into the second quarter of 2008.
However, 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.
If we are
unable to consummate the merger with EUSA Pharma, we will need to raise
additional capital in the second quarter of 2008. If we are unable to raise
additional financing, we will 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, sell certain assets, cease operations or declare
bankruptcy. There can be no assurance that we can obtain equity financing, if at
all, on terms acceptable to us. 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.
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 $5.9
million, $25.7 million, $15.1 million and $26.3 million for the three months
ended March 31, 2008 and for the years ended December 31, 2007, 2006 and 2005,
respectively. We had an accumulated deficit of $459.2 million as of
March 31, 2008. We expect that our existing capital resources at
March 31, 2008, along with the net receipt of $5.0 million in April 2008 for the
sublicensing of CAPHOSOL’s European and Asian marketing rights, should be
adequate to fund our operations and commitments into the second quarter of
2008.
We will
need to raise additional capital before the available resources at March
31, 2008 and the net receipt of $5.0 million in April 2008 for the
sublicensing of CAPHOSOL’s European and Asian marketing rights, are consumed,
which is expected to be in the second 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,
sell certain assets, cease operations or declare bankruptcy. 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 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:
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undergoing
steps to realign and implement our focus as a product-driven
biopharmaceutical company;
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establishing
and maintaining our in-house specialty sales force;
and
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enhancing
our marketed product portfolio through marketing alliances and strategic
arrangements.
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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". As a result, we
may never be able to generate or sustain significant additional revenue or
achieve profitability.
Our
auditors have expressed substantial doubt about our ability to continue as a
going concern.
Our
financial statements for the three months ended March 31, 2008, were prepared
under the assumption that we will continue our operations as a going
concern. We were incorporated in 1980, and do not have a history of
earnings. As a result, our registered independent accountants in
their audit report for the fiscal year ended December 31, 2007 have expressed
substantial doubt about our ability to continue as a going
concern. Continued operations are dependent on our ability to
complete equity or debt formation activities or to generate profitable
operations. Such capital formation activities may not be available or
may not be available on reasonable terms. Our financial statements do
not include any adjustments that may result from the outcome of this
uncertainty. If we cannot continue as a viable entity, our
stockholders may lose some or all of their investment in the
Company.
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 stockholder
value.
On March
11, 2008, the Company announced that it has entered into a definitive merger
agreement with EUSA Pharma Inc., pursuant to which all outstanding shares of the
Company will be converted into $0.62 per share in cash, which represents a
premium of approximately 35% over the closing price of $0.46 on March 10,
2008. EUSA Pharma is a transatlantic specialty pharmaceutical company
focused on oncology, pain control and critical care.
Closing
of the merger is conditioned on, among other things, the receipt of approval by
holders of a majority of the outstanding shares of Cytogen’s common stock, and
the parties entrance into a sublicense agreement for the European and Asian
rights to the Company’s Caphosol product, which was finalized in April
2008. It is also subject to certain regulatory review and other
customary closing conditions. The transaction is expected to close in
the second quarter of 2008. Upon closing of the merger, EUSA Pharma
intends to apply to delist all of Cytogen’s issued shares from the NASDAQ Stock
Market.
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 three months ended March 31,
2008, revenues from QUADRAMET and PROSTASCINT accounted for approximately 40%
and 48%, respectively, of our product revenues. If QUADRAMET or
PROSTASCINT do 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. For the three
months ended March 31, 2008, we have recognized $620,000 of revenues from
CAPHOSOL. For the fiscal year ended December 31, 2007, we recognized
$1.3 million 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 this
product. Sales of this product 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
three months ended March 31, 2008, we received 66% of our total
revenues from three customers as
follows: 46%
from Cardinal Health; 13% from Mallinckrodt; and 7% from GE
Healthcare. During the year ended December 31, 2007, we received 63%
of our total revenues from three customers, as follows: 43% from Cardinal
Health; 14% from Mallinckrodt Inc.; and 6% from Anazao Health
Corporation.
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
a current Good Manufacturing Practices or 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 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. During 2007,
the Company recorded a charge of $765,000 for costs related to a failed
ProstaScint batch. There were no failed ProstaScint batches in
2008. We cannot be certain that future PROSTASCINT batches produced
by Laureate will not have similar problems.
We have
an agreement with Bristol-Myers Squibb Medical Imaging, Inc., or BMSMI, to
manufacture QUADRAMET for us. Both primary components of QUADRAMET,
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.
In
January 2008, BMSMI was acquired by Avista Capital Partners. Since
our agreement requires two years prior written notice to terminate and we have
not received any termination notice from BMSMI, we do not expect any disruption
in BMSMI’s performance of its obligations under our agreement for 2008 and
2009. We currently have no alternative manufacturer or supplier for
QUADRAMET and any of its components.
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:
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a
license agreement with The Dow Chemical Company relating to the QUADRAMET
technology;
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a
manufacturing and supply agreement for the manufacture of QUADRAMET with
BMSMI;
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a
manufacturing agreement for the manufacture of PROSTASCINT with Laureate
Pharma, L.P.;
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a
distribution services agreement with Cardinal Health 105, Inc. (formerly
CORD Logistics, Inc.) for
PROSTASCINT;
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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;
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a
purchase and supply agreement with OTN for the distribution of
CAPHOSOL;
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a
license agreement with InPharma AS for the marketing of CAPHOSOL;
and
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a
manufacturing agreement with Holopack for the manufacturing and supply of
CAPHOSOL.
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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.
In
addition to the agreements described above, we currently depend on the following
agreements for our present and future operating results:
Agreement with Dr. Horosziewicz
regarding PROSTASCINT. In 1989, we entered into an agreement
with Dr. Julius S. Horosziewicz. Under this agreement, we were
assigned certain rights to the patent claiming the 7E11 antibody, as well as
additional patents relating to the PROSTASCINT product and commercialization
rights thereto. Under this agreement, we have made, and may continue
to make, certain payments to Dr. Horosziewicz, which obligation will remain in
effect until the expiration of the last related patent on October 28,
2010.
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. In February 2008, the parties executed a
non-binding term sheet setting forth mutually acceptable terms for settlement of
the pending litigation between the parties. Pursuant to the term
sheet, Cytogen and EVMS are currently working toward finalizing and executing a
settlement agreement, as well as a new license agreement.
Sloan-Kettering Institute for Cancer
Research. In 1993, we began a development program with SKICR
involving PSMA and our proprietary monoclonal antibody. In November
1996, we exercised an option for, and obtained, an exclusive worldwide license
from the SKICR to its PSMA-related technology. The license will
terminate on the date of expiration of the last to expire of the licensed
patents unless it is terminated earlier.
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. We
introduced SOLTAMOX in the United States in the second half of 2006 and have
only recognized a nominal amount in revenues from SOLTAMOX. Due to
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. Effective January 1, 2008, we ceased
selling and marketing SOLTAMOX.
In
October 2006, we entered into a license agreement with InPharma granting us
exclusive marketing rights for CAPHOSOL in North America. We
introduced CAPHOSOL late in the first quarter of 2007.
In May
2006, the U.S. Food and Drug Administration cleared an Investigational New Drug
application for CYT-500, our lead therapeutic candidate targeting
PSMA. In February 2007, we announced the initiation of the first
human clinical study of CYT-500. CYT-500 uses the same monoclonal
antibody from our PROSTASCINT molecular imaging agent, but is linked through a
higher affinity linker than is used for PROSTASCINT to a therapeutic as opposed
to an imaging radionuclide. This PSMA technology is still in the
early stages of development. We cannot assure you that we will be
able to commercialize this product.
Our
business is therefore subject to the risks inherent in an early-stage
biopharmaceutical business enterprise, such as the need:
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to
obtain sufficient capital to support the expenses of developing our
technology and commercializing our
products;
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to
ensure that our products are safe and
effective;
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to
obtain regulatory approval for the use and sale of our
products;
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to
manufacture our products in sufficient quantities and at a reasonable
cost;
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to
develop a sufficient market for our products;
and
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to
attract and retain qualified management, sales, technical and scientific
staff.
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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.
Failure
of third party payors to provide adequate coverage and reimbursement for our
products could limit market acceptance and affect pricing of our products and
affect our revenues.
Sales of
our products depend in part on the availability of favorable coverage and
reimbursement by governmental healthcare programs such as Medicare and Medicaid
as well as private health insurance plans. Each payor has its own
process and standards for determining whether and, if so, to what extent it will
cover and reimburse a particular product or service. Whether and to
what extent a product may be deemed covered by a particular payor depends upon a
number of factors, including the payor's determination that the product is
reasonable and necessary for the diagnosis or treatment of the illness or injury
for which it is administered according to accepted standards of medical
practice, cost effective, not experimental or investigational, not found by the
FDA to be less than effective, and not otherwise excluded from coverage by law,
regulation, or contract. There may be significant delays in obtaining
coverage for newly-approved products, and coverage may not be available or could
be more limited than the purposes for which the product is approved by the
FDA.
Moreover,
eligibility for coverage does not imply that any product will be reimbursed in
all cases or at a rate that allows us to make a profit or even cover our costs,
which include, for example, research, development, production, sales, and
distribution costs. Interim payments for new products, if applicable,
also may not be sufficient to cover our costs and may not be made
permanent. Reimbursement rates may vary according to the use of the
product and the clinical setting in which it is used, may be based on payments
allowed for lower-cost products that are already reimbursed, may be incorporated
into existing payments for other products or services, and may reflect budgetary
constraints and/or imperfections in Medicare or Medicaid data. Net
prices for products may be reduced by mandatory discounts or rebates required by
government healthcare programs, or other payors, or by any future relaxation of
laws that restrict imports of certain medical products from countries where they
may be sold at lower prices than in the United States.
Third
party payors often follow Medicare coverage policy and payment limitations in
setting their own coverage policies and reimbursement rates, and may have
sufficient market power to demand significant price reductions. Even
if successful, securing coverage at adequate reimbursement rates from government
and third party payors can be a time consuming and costly process that could
require us to provide supporting scientific, clinical and cost-effectiveness
data for the use of our products among other data and materials to each
payor. Our inability to promptly obtain favorable coverage and
profitable reimbursement rates from government-funded and private payors for our
products could have a material adverse effect on our business,
financial
condition and results of operations, and our ability to raise capital needed to
commercialize products.
Our
business, financial condition and results of operations will continue to be
affected by the efforts of governmental and third-party payors to contain or
reduce the costs of healthcare. There have been, and we expect that
there will continue to be, a number of federal and state proposals to regulate
expenditures for medical products and services, which may affect payments for
therapeutic and diagnostic imaging agents such as our products. In
addition, an emphasis on managed care increases possible pressure on the pricing
of these products. While we cannot predict whether these legislative
or regulatory proposals will be adopted, or the effects these proposals or
managed care efforts may have on our business, the announcement of these
proposals and the adoption of these proposals or efforts could affect our stock
price or our business. Further, to the extent these proposals or
efforts have an adverse effect on other companies that are our prospective
corporate partners, our ability to establish necessary strategic alliances may
be harmed.
We
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.
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 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
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
March 31, 2008, we had 35,593,633 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. If we
are unable to consummate the merger with EUSA Pharma, 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. On May 7, 2008, the Company received a
determination letter from NASDAQ indicating that trading of the Company’s common
stock will be suspended at the opening of business on May 16, 2008, unless the
Company requests an appeal. The Company plans to appeal NASDAQ’s
determination if the Company’s stockholders fail to approve the merger. 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 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. The closing price of
Cytogen’s common stock has been below $1.00 per share since September 24,
2007. On April 17, 2008, the Company had submitted a request to
NASDAQ to extend the compliance period which expired on May 5, 2008, to after
the May 8th Special Stockholders Meeting, when the stockholders will vote on the
merger with EUSA Pharma. On May 7, 2008, the Company received a
determination letter from NASDAQ indicating that trading of the Company’s common
stock will be suspended at the opening of business on May 16, 2008, unless the
Company requests an appeal. The Company plans to appeal NASDAQ’s
determination if the Company’s stockholders fail to approve the
merger.
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, 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. 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.
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 stockholders to sell our
common stock in the secondary market.
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:
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results
of clinical trials;
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technological
innovations or new commercial
products;
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changes
in governmental regulation or the status of our regulatory approvals or
applications;
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changes
in health care policies and
practices;
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developments
or disputes concerning proprietary
rights;
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litigation
or public concern as to safety of the our potential products;
and
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changes
in general market conditions.
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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 the 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 $20.0 million for each 30-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 the 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.
None.
Item 3. Defaults Upon Senior
Securities
None.
Item 4. Submission of Matters to a Vote of
Security Holders
None.
None.
Exhibit
No.
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Description
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10.1
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Amendment
No. 2 to Product License and Assignment Agreement dated as of February 14,
2008 by and between Cytogen Corporation and InPharma AS. Filed
herewith.*
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31.1
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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.
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31.2
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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.
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32.1
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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.
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32.2
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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.
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*
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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.
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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:
May 7, 2008
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CYTOGEN
CORPORATION
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By:
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Kevin
G. Lokay
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President
and Chief Executive Officer
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Date:
May 7, 2008
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CYTOGEN
CORPORATION
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By:
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Kevin
J. Bratton
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Senior
Vice President, Finance, and
Chief Financial
Officer
(Principal
Financial and Accounting Officer)
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-50-