NeoPharm, Inc. (NASDAQ:NEOL), Waukegan, Ill., has announced its
fourth quarter and full year 2007 financial results.
For the fourth quarter ended December 31, 2007, NeoPharm reported a
net loss of $1.1 million, or ($0.04) per basic and diluted share, as
compared to a net loss of $7.7 million, or ($0.28) per share, for the
same period last year. The net loss for the quarter includes a credit to
research and development expenses of $0.9 million, or $0.03 per diluted
share, related to an adjustment to reduce accrued clinical trial
expenses for the PRECISE trial from the estimated costs provided as
patients were enrolled in the trial to the actual final trial costs.
Excluding this one-time credit, the loss for the fourth quarter would
have been $2.0 million, or ($0.07) per share, which represents a 74%
reduction year-over-year.
Absent the one-time credit of $0.9 million in the fourth quarter of
2007, and a one-time credit of $2.0 million in the third quarter related
to the recognition of the deferred revenue for the Nippon-Kayaku license
agreement, the $2.0 million net loss for the fourth quarter favorably
compared to the $2.9 million net loss incurred in the third quarter of
2007, representing a reduction of $0.9 million, or 31%.
During the fourth quarter, the company held its cash consumption to
a level consistent with the prior quarter, allocating $2.1 million in
cash to its operations, excluding non-recurring payments of a deposit on
its new office lease and of previous trial obligations, versus $2.2
million in the third quarter of 2007. While NeoPharm anticipates future
cash consumption levels to be in-line with spending during the fourth
quarter, obligations related to previous drug product candidates'
trials are likely to be paid in the coming quarters. Despite these
anticipated disbursements, with $20.8 million in cash and other
investments at the end of the fourth quarter, the company reaffirmed its
estimate that it has adequate resources to fund its operations through
most of 2009.
For the year ended December 31, 2007, NeoPharm reported a net loss
of $11.0 million, or ($0.39) per basic and diluted share, which includes
the one-time credit related to the termination of the Nippon-Kayaku
license agreement and the credit to reduce accrued clinical trial
expenses, as compared to a loss of $33.2 million, or ($1.20) per share,
for the same period last year. The decline in the company's net
loss can be primarily attributed to continued efforts to reduce costs in
all areas of the company that are not directly related to its focus on
optimizing NeoPharm's drug development activities. With recent
cost-savings initiatives now largely completed, the company has
concentrated primarily on moving its current drug compounds to their
next stage of development.
"Through our aggressive reorganization of our business and
evaluation of our drug candidate portfolio, we have identified
meaningful opportunities to reduce inefficiencies and re-position
NeoPharm to more appropriately focus on the development of drugs for
patients suffering from a variety of cancers," commented Laurence
Birch, president and CEO of NeoPharm. "We are pleased with our
achievements to date. Most notably, we have put in place a management
team with the expertise necessary to progress our drug product
candidates to their next signal events. Additionally, through our
restructuring, we are now operating at an optimal cost structure and
believe we have the resources necessary to fund our operations well into
2009."
Drug Candidate Pipeline Update
Birch continued, "We continue to make great strides in the
development of our pipeline and we are approaching many noteworthy
milestones for our drug candidates. We have begun to accelerate the
efforts to conduct a Phase III Confirmatory Trial for Cintredekin
Besudotox, IL-13-PE38, for the Treatment of Recurrent Glioblastoma
Multiforme. Additionally, in the second quarter of 2008, we anticipate
patient enrollment to begin for our multi-center, open-label Phase II
clinical trial for LEP-ETU, Liposomal Paclitaxel, as well as our Phase I
clinical trial for LE-DT, Liposomes Encapsulated Taxotere."
Cintredekin Besudotox, IL13-PE38
NeoPharm has elected to explore the possibility of conducting an
initial Phase III confirmatory trial for Cintredekin Besudotox, IL
13-PE38, for the treatment of Recurrent Glioblastoma Multiforme, or GBM.
In such a confirmatory trial, the primary objectives would be
overall survival against standard of care as suggested by the FDA, as
well as Progression Free Survival, or PFS, for patients with GBM.
NeoPharm would use the results from such a confirmatory trial to decide
whether to thereafter expand the Phase III trial to meet the FDA's
requirements for Cintredekin Besudotox. The company believes it has the
resources necessary to complete the initial confirmatory trial and
complete a preliminary analysis and evaluation of drug activity.
If satisfactory results are obtained, the company will require
additional resources to expand the Phase III trial to satisfy the
requirements for submission of a possible biologic license application,
or BLA, which is necessary to obtain approval from the FDA. The company
will continue to update the progression of this trial on a timely basis.
LEP-ETU, Liposomal Paclitaxel The company expects to begin patient
enrollment early in the second quarter of 2008 for its multi-center
open-label, Phase II clinical trial of for efficacy and safety in
patients with Metastatic Breast Cancer.
LE-DT, Liposomes Encapsulated Taxotere
NeoPharm has received regulatory acceptance of its Investigational
New Drug (IND) submission for a novel, proprietary liposomal delivery
system of docetaxel, the active ingredient of Taxotere (docetaxel)
Injection Concentrate Intravenous Infusion, for the treatment of
patients with locally advanced or metastatic solid tumor after failure
of prior chemotherapy. NeoPharm currently anticipates the commencement
of its Phase I trial early in the second quarter of 2008.
Other Projected 2008 Milestone Events
--LE-rafAON - designed and developed to inhibit activated c- raf-1
gene, which has been associated with radiation and chemotherapy
resistance, c-raf gene-specific antisense
-- IND submission currently anticipated in mid-2008
--IL13-PE38, or Cintredekin Besudotox, for the treatment of
Idiopathic Pulmonary Fibrosis
-- IND submission currently expected in late 2008
BBB--LE-SN38, liposomal SN38 - for the treatment of colorectal
cancer. Other possible indications for breast, ovarian, prostate, and
non-small cell lung cancers
-- The company continues to evaluate next steps for its SN38
program. This evaluation includes investigating alternative indications,
as well as initiating additional preclinical studies
About NeoPharm, Inc.
NeoPharm, Inc., based in Waukegan, Illinois, is a publicly traded
biopharmaceutical company dedicated to the research, development and
commercialization of new and innovative cancer and other drugs for
therapeutic applications.
For more information, visit http://www.neopharm.com or call
847/887-0800.
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