02.11.2007 11:00:00
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Immunicon Corporation Reports Results for the Three and Nine Months Ended September 30, 2007
Immunicon Corporation (Nasdaq-Global Market:IMMC), which is developing
and commercializing proprietary cell and molecular-based human
diagnostic and life-science research products with a primary focus on
cancer, today announced its results of operations for the three and nine
month periods ended September 30, 2007.
On May 31, 2007, Immunicon announced that it had filed a Demand for
Arbitration against Veridex, LLC, a wholly-owned subsidiary of Johnson
and Johnson, or Veridex, whereby Immunicon is seeking termination of the
20-year exclusive worldwide agreement with Veridex, which currently
grants Veridex the right to market, sell and distribute its cancer
diagnostic products; rescission of all licenses currently held by
Veridex under that agreement; and payment of compensatory and punitive
damages based on, "repudiation and fundamental
breaches by Veridex of its contractual, agency and other fiduciary
obligations to market, sell and distribute Immunicon's cancer diagnostic
products.” It is anticipated that this
arbitration will be completed before the end of the first quarter of
2008.
Immunicon reported product and service revenue of $4.7 million for the
three months ended September 30, 2007, which represented a 160% increase
over the $1.8 million in product and service revenue for the three
months ended September 30, 2006. Instrument revenue was $3.3 million in
the third quarter of 2007 compared to $1.0 million in the third quarter
of 2006. Reagent and consumable product sales were $743,000 in the three
months ended September 30, 2007 and $488,000 in the three months ended
September 30, 2006. Service revenue increased by 107% to $588,000 in the
third quarter of 2007 compared to $283,000 in the same period in 2006.
Immunicon delivered 22 CellTracks AutoPrep sample preparation
instruments and 23 CellTracks Analyzer II instruments to customers
during the quarter ended September 30, 2007 and now has 119 AutoPrep
instruments and 130 cell analyzers in service. An instrument system is
comprised of one cell analyzer plus one AutoPrep sample preparation
device. As of September 30, 2007, we have an instrument backlog of 10
instrument systems. Recognition of revenue related to instrument
shipments to customers typically is delayed for a period of several
months pending the final evaluation and acceptance of these instruments
by customers.
Costs of goods sold were $4.4 million for the three months ended
September 30, 2007 compared to $1.9 million for the three months ended
September 30, 2006. Immunicon reported a gross profit on product and
service sales of $252,000 in the third quarter of 2007 compared to a
loss on product sales of $151,000 in the quarter ended September 30,
2006. The gross profit on sales of products and services in the quarter
ended September 30, 2007 reflects margin on instrument sales of $233,000
and on services of $276,000 offset by a loss on reagent and consumable
sales of $257,000. We completed the outsourcing of our instrument
manufacturing activities in the third quarter. Effective April 1, 2007,
we increased the list prices for our instruments to $205,000 per
instrument system from $150,000. As a result, the gross profit per
instrument for the quarter was approximately $6,000.
Research and development expenses for the three months ended September
30, 2007 were $2.6 million compared to $3.1 million in the corresponding
three months in 2006. The reduction of $500,000 was principally a result
of the decrease in clinical trial and development costs and the
utilization of certain research and development personnel to support
pharma services activity. The salary cost related to support of pharma
services activity is charged to cost of goods sold.
General and administrative ("G&A”)
expenses for the quarter ended September 30, 2007 were $6.8 million,
compared to $2.7 million for the comparable quarter of 2006. This
increase is attributable principally to increases in legal and
professional fees of $4.5 million related to our arbitration against
Veridex. As of September 30, 2007, we have incurred $5.4 million in
costs related to the arbitration.
As disclosed previously, Immunicon issued an aggregate of $30,000,000 in
principal amount of unsecured subordinated convertible notes (the "Notes”)
and received $27.3 million in proceeds net of related fees and expenses
on December 5, 2006. As a result of this financing, Immunicon values
certain provisions of the Notes and the related warrants separately in
accordance with various accounting guidance documents, including
Statement of Financial Accounting Standards 133, "Accounting
for Derivative Instruments and Hedging Activities”,
and related interpretations including EITF 00-19, "Accounting
for Derivative Financial Instruments Indexed to, and Potentially Settled
in, a Company’s Own Stock.”
Upon issuance of the Notes, Immunicon recorded a liability of $8.1
million related to the embedded conversion option in the Notes and a
liability of $1.9 million related to the value of the warrants. For the
quarter ended September 30, 2007, Immunicon has marked-to-market the
conversion option and the warrants and have recorded a non-cash increase
in income of $3.3 million in the Consolidated Statement of Operations
related to the change in valuation of the Notes and the related warrants
for the three months ended September 30, 2007. For further description
of the Notes and related warrants, please refer to the Current Report on
Form 8-K filed by Immunicon with the Securities and Exchange Commission
on December 5, 2006.
Interest expense was $1.5 million and $98,000 for the three months ended
September 30, 2007 and 2006, respectively. The increase is attributable
principally to the non-cash interest expense of $1.5 million related to
the issuance of the Notes and related warrants. Interest income was
$514,000 and $367,000 for the three months ended September 30, 2007 and
2006, respectively. The increase in 2007 was due to the higher available
cash balance for investment in 2007.
For the three months ended September 30, 2007, Immunicon’s
net loss was $6.7 million compared to a net loss of $5.6 million for the
three months ended September 30, 2006. The loss per share was $0.24 and
$0.20 for the three months ended September 30, 2007 and September 30,
2006, respectively. The weighted average common shares outstanding was
27.7 and 27.6 million, respectively, for the three month periods ended
September 30, 2007 and September 30, 2006, respectively.
As of September 30, 2007, Immunicon had cash, cash equivalents and
investments of $38.6 million.
Financial guidance update
Immunicon is updating its previously announced financial guidance for
the year ending December 31, 2007:
Instrument system placements (a system includes one CellTracks
Analyzer II and one CellTracks AutoPrep System) - range of between 65
and 75 system placements
CellTracks AutoPrep System and CellTracks Analyzer II Instrument
revenue - range of between $9 million and $10 million (excludes
estimated 2007 EasyCount System revenue)
Combined reagent, consumable and service revenue –
range of between $5 million and $6.5 million
Net cash expenditures – range of between
$20 million and $22 million
We are increasing the revenue guidance for instrument revenue from a
range of between $8 million and $9 million due to a higher than
previously anticipated rate of instrument placements in the second half
of 2007. We are increasing our guidance for cash expenditures from a
range of $17.5 million to $20 million to account for expenditures
related to the arbitration against Veridex. For the nine months ended
September 30, 2007, we have incurred $5.4 million in arbitration-related
expenses. While it is difficult to project the extent of arbitration
activities and costs, we expect that these activities and costs will
increase over the next 3 to 4 months.
The financial guidance estimates shown above reflect current
expectations of Immunicon’s management based
on available information. These statements are forward-looking and
actual results may differ materially, including as a result of the
factors more specifically referenced below in the discussion regarding "forward-looking
statements.” Estimating the items above is
inherently difficult.
A summary of instrument shipments and instruments sold for revenue
recognition purposes for the period from product launch to September 30,
2007 is shown below:
Cumulative as of Three months ended Cumulative as of June 30, 2007 September 30, 2007 September 30, 2007 Instrument shipments
Cell analyzers 107 23 130 CellTracks AutoPreps 97 22 119
Instruments sold (1)
Cell analyzers 102 21 123
CellTracks AutoPreps 87 20 107
(1) Represents instruments which were sold and revenue recorded
in the period indicated.
Conference Call
Byron D. Hewett, President and CEO, and other members of Immunicon’s
senior management will provide an update and discuss results via Webcast
and conference call on Friday, November 2, 2007, at 9:00 a.m. EDT. To
participate in the live call by telephone, the dial-in number for
domestic U.S. listeners is (866) 700-7101 using passcode: 20778396.
International callers may dial (617) 213-8837 using passcode: 20778396.
In addition, a live audio webcast of the call will be available online
at Immunicon’s corporate website at http://www.immunicon.com.
Webcast participants are encouraged to log on to the site at least 15
minutes prior to the scheduled start time to register, download, and
install any necessary audio software. Following the call, a webcast
audio replay will be available on Immunicon’s
website until Friday, November 30, 2007. In addition, a dial-in replay
will be maintained for five days through Wednesday, November 7, and can
be accessed by dialing (888) 286-8010 (U.S. listeners) or (617) 801-6888
(International dialers), using reservation code: 42668045.
The conference call audio will also be distributed over the Thomson/CCBN
Investor Distribution Network to both institutional and individual
investors. Individual investors can listen to the call through the
Thomson/CCBN individual investor center at www.earnings.com
or by visiting any of the investor sites in the Thomson/CCBN Individual
Investor Network. Institutional investors can access the call via the
Thomson/CCBN password-protected event management site, StreetEvents (www.streetevents.com).
About Immunicon Corporation
Immunicon Corporation is developing and commercializing proprietary
cell- and molecular-based human diagnostic and life science research
products with an initial focus on cancer disease management. Immunicon
has developed platform technologies for selection and analysis of rare
cells in blood, such as circulating tumor cells and circulating
endothelial cells that are important in many diseases and biological
processes. Immunicon’s products and
underlying technology platforms also have application in the clinical
development of cancer drugs and in cancer research and may have
applications in other fields of medicine, such as cardiovascular and
infectious diseases.
The information contained in this press release includes "forward-looking
statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are often preceded by words such as "hope,” "may,” "believe,” "anticipate,” "plan,” "expect,” "intend,” "assume,” "will”
and similar expressions. Forward-looking statements contained in this
press release include, among others, statements relating to Immunicon’s
anticipated business performance, the on-going arbitration with Veridex,
2007 anticipated instrument system placements, instrument revenue,
combined reagent, consumable and service revenue, net loss, net loss per
common share and net cash expenditures, Immunicon’s
funding strategy for commercialization activities and key product and
clinical development programs and other statements not of historical
fact, including those related to our financial guidance for 2007.
Immunicon cautions investors not to place undue reliance on the
forward-looking statements contained in this press release.
Forward-looking statements speak only as of the date of this press
release, reflect management’s current
expectations and involve certain factors, such as risks and
uncertainties that may cause actual results to be far different from
those suggested by Immunicon’s
forward-looking statements. These factors include, but are not limited
to, risks and uncertainties associated with: Immunicon’s
dependence on Veridex, LLC, a Johnson & Johnson company, in the field of
cancer cell analysis; the risks and uncertainties associated with the
arbitration proceeding with Veridex given Immunicon’s
dependence on Veridex; Immunicon’s capital
and financing needs; research and development and clinical trial
expenditures; commercialization of Immunicon’s
product candidates; Immunicon’s ability to
use licensed products and to obtain new licenses from third parties;
Immunicon’s ability to manage its growth;
obtaining necessary regulatory approvals; reliance on third party
manufacturers and suppliers; reimbursement by third party payors to
Immunicon’s customers for Immunicon’s
products; risks and uncertainties associated with Immunicon’s
outstanding convertible notes and warrants; compliance with applicable
manufacturing standards; the ability to earn license and milestone
payments under Immunicon’s agreement with
Veridex; retaining key management or scientific personnel; delays in the
development of new products or to planned improvements to Immunicon’s
products; effectiveness of Immunicon’s
products compared to competitors’ products;
protection of Immunicon’s intellectual
property and other proprietary rights; conflicts with the intellectual
property of third parties; product liability lawsuits that may be
brought against Immunicon; labor, contract or technical difficulties;
and competitive pressures in Immunicon’s
industry. These factors are discussed in more detail in Immunicon’s
filings with the Securities and Exchange Commission. Except as required
by law, Immunicon accepts no responsibility for updating the information
contained in this press release beyond the published date, whether as a
result of new information, future events or otherwise, or for
modifications made to this document by Internet or wire services.
"Immunicon” and
the Immunicon Corporation logo are registered trademarks of Immunicon
Corporation. "CellSpotter,” "CellTracks” and "AutoPrep”
are registered trademarks of Immunivest Corporation, a wholly-owned
subsidiary of Immunicon Corporation. "CellTracks
Analyzer II” is a trademark of Immunivest
Corporation. "CellSearch”
is a trademark of Johnson & Johnson. All other trademarks or
servicemarks appearing herein are the property of their respective
holders. ALL RIGHTS RESERVED.
IMMUNICON CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS - UNAUDITED
(In thousands, except share amounts)
September 30,
December 31, 2007 2006 ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
23,300
$
36,132
Short-term investments
15,323
15,401
Receivable from related party
1,120
409
Accounts receivable, net
1,641
1,402
Inventory
2,978
3,966
Prepaid expenses
398
613
Other current assets
572
861
Total current assets
45,332
58,784
Property and equipment, net
2,795
4,011
Deferred financing fees
2,043
2,616
Other assets
835
362
TOTAL ASSETS
$ 51,005
$ 65,773
LIABILITIES AND STOCKHOLDERS’
EQUITY
CURRENT LIABILITIES:
Current portion of long-term debt
$
1,717
$
1,781
Accounts payable
4,859
1,743
Payable to related party
1,355
792
Accrued expenses
4,764
4,304
Current portion of deferred revenue
Related party
1,228
1,821
Other
329
438
Detachable warrants
228
2,181
Conversion option related to convertible debt
699
9,286
Total current liabilities
15,179
22,346
Convertible subordinated notes payable, net of discount
24,033
20,313
Long-term debt
1,750
2,256
Deferred revenue
Related party
446
234
Other
944
423
Commitments and Contingencies
STOCKHOLDERS’ EQUITY:
Common stock, $.001 par value—100,000,000
authorized, 27,714,266 and 27,667,769 shares issued and
outstanding as of September 30, 2007 and December 31, 2006,
respectively
28
28
Additional paid-in capital
163,499
162,596
Currency translation adjustment
31
22
Accumulated deficit
(154,905 )
(142,445 )
Total stockholders’ equity
8,653
20,201
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 51,005
$ 65,773
IMMUNICON CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF OPERATIONS
FOR THE THREE AND NINE MONTHS ENDED
SEPTEMBER 30, 2007 COMPARED TO
SEPTEMBER 30, 2006
(in thousands, except for per share and per share data) UNAUDITED
Three Months Ended
Nine Months Ended September 30, September 30,
2007 2006 2007 2006
Product and service revenue
Related party product revenue
$
2,727
$
659
$
5,554
$
1,373
Third party customer product revenue
1,355
855
3,658
2,843
Service revenue
588
283
1,767
960
Total product and service revenue
4,670
1,797
10,979
5,176
Cost of goods sold
4,418
1,948
10,946
5,897
Income, (loss) on product and service revenue
252
(151
)
33
(721
)
Milestone, license and other revenue
142
138
409
539
Total revenue
4,812
1,935
11,388
5,715
Operating expenses:
Research & development
2,645
3,129
8,434
9,507
General & administrative
6,771
2,683
12,407
7,501
Total operating expenses
9,416
5,812
20,841
17,008
Operating (loss)
(9,022
)
(5,825
)
(20,399
)
(17,190
)
Other income (expense)
Interest and other income, net
514
367
1,689
1,177
Change in fair value of detachable warrant and conversion right
3,316
-
10,539
-
Interest expense
(1,535
)
(98
)
(4,555
)
(314
)
Other income (expense), net
2,295
269
7,673
863
(Loss) before income tax benefit
(6,727
)
(5,556
)
(12,726
)
(16,327
)
Income tax (benefit)
-
-
(266 )
-
Net (loss)
$
(6,727
)
$
(5,556
)
$
(12,460
)
$
(16,327
)
Net (loss) per common share - basic and diluted
$
(0.24
)
$
(0.20
)
$
(0.45
)
$
(0.59
)
Weighted average common shares oustanding- basic and diluted
27,714,266
27,645,607
27,699,561
27,616,724
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