Emisphere Technologies, Inc. Announces 2007 Fourth Quarter and Year End Financial Results
Â Â Conference Call/Webcast to be Held Wednesday, March 19 at 10:00 AM EDT
Â Â Â CEDAR KNOLLS, N.J., March 17 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. (Nasdaq: EMIS) today announced its financial results for
the fourth quarter and year ended December 31, 2007.
Â Â Â Emisphere will host a conference call to discuss fourth quarter results
at 10:00 AM EDT Wednesday, March 19, 2008. A live webcast of the conference
call can be accessed through the Company's web site at: http://www.emisphere.com.
The live conference call dial-in number is: 1-888-710-4011 (United States
and Canada) or 1-913-312-0947 (International). In addition, an archive of
the webcast can be accessed through the same link; an audio replay of the
call will be available following the conference call by calling
1-888-203-1112 (United States and Canada) or 1-719-457-0820
(International). The conference replay PIN is 3149335.
Â Â Â FOURTH QUARTER FINANCIAL RESULTS
Â Â Â Emisphere reported a net loss of $3.9 million, or $0.13 per basic and
$0.18 per diluted share for the quarter ended December 31, 2007, compared
to a net loss of $3.0 million, or $0.11 per basic and $0.30 diluted share
for the quarter ended December 31, 2006. The fourth quarter operating loss
was $7.5 million, compared to an operating loss of $8.4 million for the
same period last year.
Â Â Â Total operating expenses were $7.8 million for the 2007 fourth quarter,
a decrease of $0.9 million or 11% compared to the same period last year.
Total operating expenses include research and development costs of $4.2
million (a decrease of $0.5 million or 11% compared to last year's fourth
quarter) and general and administrative expenses of $3.3 million (an
increase of $0.2 million or 7% compared to the same period last year).
Other income for the fourth quarter of 2007 was $3.6 million, compared to
income of $5.4 million in the fourth quarter of 2006.
Â Â Â Cash, cash equivalents, restricted cash and investments held as of
December 31, 2007 were $14.1 million, a net decrease of $7.4 million from
such amounts held on December 31, 2006.
Â Â Â The Company anticipates that its existing capital resources are
sufficient to enable it to continue operations through July 2008.
Consequently, the audit opinion on its financial statements contained a
going concern explanatory paragraph again in 2007. NASDAQ Marketplace Rule
4350(B) requires companies to make a public announcement through the news
media disclosing the receipt of such opinion. However, the audit report
does not take into account any potential future cash inflows. "Emisphere
has implemented aggressive cost control initiatives and management
processes to extend our cash runway. We are also pursing new, as well as
enhanced, collaborations and are exploring other financing options with the
objective of minimizing shareholder dilution and business disruption," said
Michael V. Novinski, President and Chief Executive Officer.
Â Â Â YEAR END FINANCIAL RESULTS
Â Â Â Emisphere reported a net loss of $16.9 million, or $0.58 per basic
share and $0.76 per diluted, for the year ended December 31, 2007, compared
to a net loss of $41.8 million, or $1.58 for both basic and diluted shares
for the year ended December 31, 2006. Revenue for 2007 was $4.1 million,
compared to $7.3 million during 2006.
Â Â Â Total operating expenses, excluding the net proceeds from the
settlement of the Lilly litigation of $11.9 million, were $36.6 million for
the year ended December 31, 2007 (an increase of $2.2 million or 6%
compared to the year ended December 31, 2006). Total operating expenses
include research and development costs of $21.1 million (an increase of
$2.2 million or 12% compared to last year) and general and administrative
expenses of $14.5 million (an increase of $2.8 million or 24% compared to
last year). Other income for the year ended December 31, 2007 was $3.7
million, compared to other expense of $14.6 million in the year ended
December 31, 2006.
Â Â Â Weighted average basic shares outstanding for the year ended December
31, 2007 were 29 million and 29.1 diluted, versus 26.5 million for both
basic and diluted December 31, 2006.
Â Â Â CORPORATE AND PRODUCT DEVELOPMENTS
Â Â Â Emisphere recently announced that animal studies have demonstrated
proof of concept that absorption of oral Vitamin B12 using the Company's
proprietary eligen(R) Technology is 15-30 times greater than with the same
dose of oral Vitamin B12 administered alone. The Company believes this data
demonstrates a potential commercial avenue for its technology that can have
a positive impact on the lives of patients.
Â Â Â There are at least five million people in the United States receiving
40 million B12 injections annually to treat a variety of debilitating
medical conditions, and at least an additional five million people are
consuming over 600 million tablets of B12 of various strengths annually.
The Company believes that 40 million injections suggests a need for an oral
B12 preparation that can deliver therapeutic levels of B12, and that the
megadoses being consumed as tablets are further evidence of this need. The
Company's current timeline includes conducting clinical human trials
beginning as early as the third quarter of 2008.
Â Â Â Emisphere has two Phase III product candidates based on the compound
Salmon Calcitonin in collaboration with Novartis Pharma AG and its
development partner, Nordic Bioscience. One product relates to the
prevention of osteoporosis and the other product relates to the prevention
of osteoarthritis. The osteoarthritis product has the potential to be the
first disease-modifying drug that could halt progression of the illness,
rather than treating symptoms. Both product candidates use Emisphere's
eligen(R) delivery technology to provide Salmon Calcitonin as a convenient
Â Â Â Emisphere has two product candidates in Phase II, oral Heparin and oral
Insulin, about which the Company is conducting an ongoing evaluation of all
strategic options. The Company will provide specific conclusions as more
Â Â Â Emisphere has six product candidates in Phase I:
Â Â Â -- An Investigational New Drug ("IND") application was filed by Genta
Â Â Â Â Â Â Incorporated with the FDA on Gallium on July 31, 2007; a Gallium Phase
Â Â Â Â Â Â I study began in third quarter 2007
Â Â Â -- An Acyclovir study will generate data in the second quarter 2008 that
Â Â Â Â Â Â we and a partner will review
Â Â Â -- Satiety and oral glucose challenge studies for both GLP-1 and PYY were
Â Â Â Â Â Â started in humans with data expected during the second quarter of this
Â Â Â Â Â Â year
Â Â Â -- Parathyroid Hormone and Recombinant Human Growth Hormone continue on a
Â Â Â Â Â Â development path in collaboration with Novartis Pharma AG
Â Â Â Emisphere conducts a variety of preclinical research and development
programs, both in collaboration with pharmaceutical and biotechnology
companies and independently. These programs are subject to continuous
review to determine whether the collaborative projects should continue and
whether the independent projects are appropriate for further development or
Â Â Â "Our goal is to bring our technology to a commercial level as soon as
possible," said Mr. Novinski. "We believe that Vitamin B12 presents an
ideal opportunity to drive early commercialization while we continue to
explore other compounds in our pipeline."
Â Â Â ABOUT EMISPHERE TECHNOLOGIES, INC.
Â Â Â Emisphere Technologies, Inc. is a biopharmaceutical company that
focuses on a unique and improved delivery of therapeutic molecules and
pharmaceutical compounds using its eligen(R) Technology. These molecules
and compounds could be currently available or are in preclinical or
clinical development. Such molecules or compounds usually cannot be
delivered by the oral route of administration or the benefits of these
compounds are limited due to poor bioavailability, slow on-set of action or
variable absorption. The eligen(R) Technology can be applied to the oral
route of administration as well other delivery pathways, such as buccal,
per rectum, pulmonary, intra-vaginal or transdermal. The web site is:
Â Â Â Safe Harbor Statement Regarding Forward-Looking Statements
Â Â Â The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding future performance or
financial results, the timing or potential outcomes of research
collaborations or clinical trials, any market that might develop for any of
Emisphere's product candidates and the sufficiency of Emisphere's cash and
other capital resources) are forward-looking statements that involve risks
and uncertainties, including, but not limited to, the likelihood that
actual performance or results could materially differ, that future research
will prove successful, the likelihood that any product in the research
pipeline will receive regulatory approval in the United States or abroad,
the ability of Emisphere and/or its partners to develop, manufacture and
commercialize products using Emisphere's drug delivery technology, or
Emisphere's ability to fund such efforts with or without partners.
Emisphere undertakes no obligation to update any of these statements.
Readers are cautioned not to place undue reliance on these forward-looking
statements, which speak only as to the date hereof. Accordingly any
forward-looking statements should be read in conjunction with the
additional risks and uncertainties detailed in Emisphere's filings with the
Securities and Exchange Commission, including those factors discussed under
the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K for
the fiscal year ended December 31, 2007, filed on March 17, 2008, and our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2007, filed
on May 7, 2007 (file no. 000-17758), for the quarter ended June 30, 2007,
filed on August 7, 2007 (file No. 000-17758), and for the quarter ended
September 30, 2007, filed on November 6, 2007 (000-17758).