Exhibit 99.1
NEOPHARM, Inc. Announces First Quarter 2007 Financial Results
WAUKEGAN, Ill.--(BUSINESS WIRE)--May 10, 2007--NEOPHARM, Inc.
(NASDAQ: NEOL), today announced its first quarter 2007 financial
results.
For the first quarter ended March 31, 2007, NEOPHARM reported a
net loss of $5.5 million, or $0.19 per diluted share, as compared to
$7.7 million, or $0.28 per share, for the same period last year, which
represents a $2.2 million, or 29%, reduction. This reduction was
driven primarily by a $1.0 million decrease in project costs related
to CINTREDEKIN BESUDOTOX and decreased personnel costs in the first
quarter of 2007 compared to 2006 as a result of the restructuring
initiatives completed during 2006.
The Company continues to focus on its various strategic
alternatives that will allow it to best realize the value of its drug
candidate portfolio (see Drug Candidate Update table and narrative
discussion below), while minimizing its use of cash to fund
operations. As of March 31, 2007, the Company had cash and short-term
investments on hand of $28.9 million. In consideration of the
restructuring initiatives announced in April 2007, the
reprioritization of the Company's various liposome based drug product
candidates and the delay in commercialization efforts related to
CINTREDEKIN BESUDOTOX, NEOPHARM currently estimates that cash and
short-term investments currently on hand are sufficient to fund
expected operating activities into 2009. However, the date as to which
sufficient funds continue to be available for operations, without
additional financing, may vary depending upon the timing and
implementation of various strategies under consideration by the
Company.
Laurence Birch, President and Chief Executive Officer of NEOPHARM
commented, "Over the last several weeks, we have continued our
aggressive evaluation of the Company's operations and product
portfolio in an effort to identify the appropriate path for NEOPHARM
going forward. Thus far, we have made significant progress in reducing
our cash consumption rate, and have aligned our management team in
such a way that we are able to effectively operate through this
current transition. While we have not reached any final conclusions,
in the near-term this review remains our foremost priority."
Drug Candidate Update
Drug product Clinical 2007 Clinical Commercialization
candidate indication(s) development status rights
- ------------------ -------------- ------------------ -----------------
CINTREDEKIN Glioblastoma Completed Phase 3 World wide
BESUDOTOX multiforme
(IL13-PE38QQR) (brain
cancer)
LE-SN38 Colorectal Phase 2 World wide
(Liposomal SN-38) cancer and
other solid
tumors
LEP-ETU Breast cancer, Planning possible World wide
(Liposomal lung cancer, Phase 3
Paclitaxel) ovarian
cancer and
other solid
tumors
LE-DT Breast cancer, Pre-IND World wide
(Liposomal lung cancer,
Docetaxel) prostate
cancer and
other solid
tumors
CINTREDEKIN BESUDOTOX
On March 28, 2007, representatives of the FDA's Office of Oncology
indicated that an additional Phase 3 clinical trial for CINTREDEKIN
BESUDOTOX in the treatment of GBM would be required before the FDA
could accept the Company's Biologics License Application (BLA). As a
result, the Company continues to evaluate its options regarding
CINTREDEKIN BESUDOTOX.
Development and commercialization rights for Japan have been
sublicensed to Nippon Kayaku Co., Ltd.
NeoLipid(R) Platform
LE-SN38
NEOPHARM announced on March 30, 2007 that the interim analysis of
data following the completion of treatment of the first 21 patients
demonstrated disease stabilization, but did not achieve the primary
tumor response endpoint. The Company is reassessing the project's next
steps including additional data analyses and the possibility of other
studies related to lung and breast cancer.
LEP-ETU
The Company continues to remain in discussions with the FDA on its
clinical and regulatory plans for LEP-ETU, given the recent receipt of
communication from the FDA on its Phase 3 Special Protocol Assessment.
LE-DT
NEOPHARM anticipates filing an Investigational New Drug
Application, or IND, with the U.S. FDA for LE-DT in late 2007.
Conference Call
The Company will not hold a conference call to discuss its first
quarter results as the new management team continues its assessment of
NEOPHARM's current projects and operations. Following the conclusion
of this strategic review, the Company will update its stakeholders on
the current state of affairs.
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 drugs for therapeutic
applications. Additional information can be obtained by visiting
NEOPHARM's Web site at www.neopharm.com.
Forward Looking Statements - This press release contains
"forward-looking statements" within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934. The Company has tried to identify such forward-looking
statements by use of such words as "expects," "intends," "hopes,"
"anticipates," "believes," "could," "may," "evidences" and
"estimates," and other similar expressions, but these words are not
the exclusive means of identifying such statements. Such statements
include, but are not limited to, any statements relating to the
Company's strategic review of projects and operations, the Company's
drug development programs, the initiation, progress and outcomes of
clinical trials of the Company's drug product candidates, projections
regarding cash used in operations, financial projections, and any
other statements that are not historical facts. Such statements
involve risks and uncertainties, including, but not limited to, those
risks and uncertainties relating to difficulties or delays in
financing, development, testing, regulatory approval, production, and
marketing of the Company's drug and non-drug compounds including, but
not limited to the Company's ability to pursue additional testing of
CINTREDEKIN BESUDOTOX and the liposomal technology drug product
candidates including, but not limited to, LEP-ETU, uncertainty
regarding the outcomes of ongoing or proposed FDA studies, uncertainty
regarding the availability of third party production capacity, the
Company's financial guidance and projections, the Company's ability to
evaluate the strategic alternatives available to the Company and to
cut back on its funding of certain of its development projects in
order to conserve its cash resources, the ability of the Company to
procure additional future sources of financing, unexpected adverse
side effects or inadequate therapeutic efficacy of the Company's drug
and non-drug compounds, including, but not limited to, CINTREDEKIN
BESUDOTOX and the liposomal technology drug product candidates, that
could slow or prevent products coming to market, uncertainty regarding
the Company's ability to market its drug and non-drug products,
including, but not limited to, CINTREDEKIN BESUDOTOX and the liposomal
technology drug product candidates, the uncertainty of patent
protection for the Company's intellectual property or trade secrets,
and other risks detailed from time to time in filings the Company
makes with the Securities and Exchange Commission. Such statements are
based on management's current expectations, but actual results may
differ materially due to various factors, including those risks and
uncertainties mentioned or referred to in this press release, and in
the Company's most recent annual report on Form 10-K for the calendar
year ended December 31, 2006, as updated in its quarterly reports on
Form 10-Q. Accordingly, you should not rely on these forward-looking
statements as a prediction of actual future results.
NEOPHARM, INC.
Condensed Consolidated Statements of Operations
Three Months Ended March 31, 2007 and March 31, 2006
(Unaudited)
Three Months Ended
-----------------------------
March 31, 2007 March 31, 2006
-------------- --------------
Product revenue $- $1,000
-------------- --------------
Total revenue - 1,000
Expenses:
Research and development 3,007,000 5,844,000
Selling, general, and administrative 2,859,000 3,045,000
Change in fair value of derivative
financial instruments 2,000 (543,000)
-------------- --------------
Total expenses 5,868,000 8,346,000
-------------- --------------
Loss from operations (5,868,000) (8,345,000)
Interest income 415,000 666,000
-------------- --------------
Net loss $(5,453,000) $(7,679,000)
============== ==============
Net loss per share --
Basic and diluted $(0.19) $(0.28)
============== ==============
Weighted average shares outstanding --
Basic and diluted 28,080,478 27,317,829
============== ==============
Balance Sheet Data:
(Unaudited)
March 31, December 31,
2007 2006
-------------- --------------
Cash, cash equivalents and short-term
investments $28,854,000 $38,587,000
Total assets $30,754,000 $40,689,000
Current liabilities $4,967,000 $9,577,000
Accumulated deficit $(266,686,000) $(261,233,000)
Total stockholders' equity $23,558,000 $28,871,000
CONTACT: Ashton Partners
Victoria Paris
vparis@ashtonpartners.com
312-553-6715