EXHIBIT 99.1
For further information contact:
AT EMISPHERE TECHNOLOGIES, INC. Investors
Elliot M. Maza, CPA, J.D. Betsy Brod/Jonathan Schaffer
Chief Financial Officer Brod & Schaffer, LLC
(914) 785-4703 (212) 750-5800
Gillian Racine Media
Investor Relations Dan Budwick
(914) 785-4742 BMC Communications
(212) 477-9007 ext.14
EMISPHERE TECHNOLOGIES ANNOUNCES 2004 SECOND QUARTER RESULTS
Tarrytown, NY - August 4, 2004 --- Emisphere Technologies, Inc. (NASDAQ: EMIS)
today announced results for the second quarter ended June 30, 2004. The Company
also highlighted its progress in development programs using its proprietary
eligen(R) drug delivery technology.
Emisphere reported a net loss of $8.8 million, or $0.48 per share, for the
quarter ended June 30, 2004, as compared to a net loss of $11.4 million, or
$0.63 per share for the quarter ended June 30, 2003.
Total operating expenses were $7.7 million for the 2004 second quarter, a
decrease of $3.0 million, or 28%, compared to the same period last year. Total
operating expenses include research and development costs of $3.7 million, a
decrease of $1.7 million or 31%, compared to last year's second quarter. General
and administrative expenses were $2.8 million, essentially equal to general and
administrative expenses for the same period last year.
Depreciation and amortization expenses were lower in the second quarter than
last year due to the surrender of a portion of the leased space at the Tarrytown
facility and the resultant reduction in the cost basis of leasehold
improvements.
For the quarter ended June 30, 2004, other expense, which includes investment
income, interest expense and loss on sale of fixed assets, was $1.2 million
compared to $0.9 million for the same period last year.
Weighted average shares outstanding for the quarter ended June 30, 2004 and June
30, 2003, were 18.4 million and 18.0 million, respectively.
As of June 30, 2004, Emisphere held cash, cash equivalents and investments
totaling $30.2 million.
Emisphere filed a shelf registration with the Securities and Exchange Commission
on July 8, 2004, to sell in one or more offerings up to five million shares of
its common stock. The Company plans to use the proceeds from the shelf offering
for general corporate purposes, including further development of its lead
clinical programs.
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere
Technologies, Inc., commented, "We made significant progress during the second
quarter in our research and development efforts, both internally and in
collaboration with our partners. Our heparin program has advanced, and we are
now preparing to initiate discussions with the U.S. Food and Drug Administration
(FDA) for a new pivotal clinical trial comparing our soft gelatin capsule
formulation with the current injectable treatment. In addition, other research
programs we have undertaken, both with and without potential partners, have led
to licensing discussions and new relationships with other major pharmaceutical
companies. We consider these ongoing discussions and interest as validation of
our proprietary eligen(R) technology."
PRODUCT DEVELOPMENT UPDATE FOR SECOND QUARTER 2004
Oral Heparin
During the second quarter, Emisphere initiated a clinical trial in the United
States as part of its oral heparin program, with the purpose of selecting an
oral solid formulation of unfractionated heparin (UFH), an
antithrombotic/anticoagulant, for use in late-stage clinical trials. In a
separate release issued today, the Company announced that it has selected a soft
gelatin capsule formulation from the aforementioned trial to move forward into
broad clinical testing. With this formulation, Emisphere plans to initiate
discussions with the U.S. Food and Drug Administration (FDA) to outline an
aggressive clinical development program, comparing the selected formulation with
the currently marketed injectable low molecular weight heparin product.
Oral Insulin
On June 5th, Emisphere presented the results from a multiple-dose clinical study
of an oral insulin tablet using its eligen(R) technology at the 64th Scientific
Sessions of the American Diabetes Association. The study was conducted at PROFIL
institute, an internationally recognized diabetes research center in Germany.
The results from this study indicated that treatment with Emisphere's oral
insulin over a fourteen day period was well-tolerated, led to improvements in
post-prandial blood glucose concentrations and tended to improve fasting blood
glucose concentrations and insulin resistance with no hypoglycemic events, an
adverse complication that is often associated with injected insulin and other
anti-diabetic treatments. Emisphere continues discussions with several potential
partners for its oral insulin program while simultaneously continuing to advance
the program's development.
THE ELIGEN(R) TECHNOLOGY
Emisphere's broad-based oral drug delivery technology platform, known as the
eligen(R) technology, is based on the use of proprietary, synthetic chemical
compounds, known as EMISPHERE(R) delivery agents, or "carriers". These molecules
facilitate or enable the transport
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of the therapeutic macromolecules across biological membranes such as those of
the gastrointestinal tract, and exert their desired pharmacological effect.
Emisphere's eligen(R) technology makes it possible to orally deliver a
therapeutic molecule without altering its chemical form or biological integrity.
ABOUT EMISPHERE TECHNOLOGIES, INC.
Emisphere Technologies, Inc. (Nasdaq: EMIS) is a biopharmaceutical company
pioneering the oral delivery of otherwise injectable drugs. Emisphere's business
strategy is to develop oral forms of injectable drugs, either alone or with
corporate partners, by applying its proprietary eligen(R) technology to those
drugs or licensing its eligen(R) technology to partners who typically apply it
directly to their marketed drugs. Emisphere's eligen(R) technology has enabled
the oral delivery of proteins, peptides, macromolecules and charged organics.
Emisphere and its partners have advanced oral formulations or prototypes of
salmon calcitonin, heparin, insulin, parathyroid hormone, human growth hormone
and cromolyn sodium into clinical trials. Emisphere has strategic alliances with
world-leading pharmaceutical companies. For further information, please visit
www.emisphere.com.
Emisphere will hold a teleconference to discuss its second quarter 2004
financial results on August 4, 2004 beginning at 10:30 a.m. Eastern Time (7:30
a.m. Pacific Time). A replay of the teleconference will be made available for
one week and will be accessible two hours following the end of the call.
The live conference call dial-in number is: 800-231-5571 (U.S./Canada)
973-582-2703 (international)
To access a replay of the call: 877-519-4471 (U.S./Canada)
973-341-3080 (international)
Conference ID: 4919762
Emisphere will simultaneously be webcasting this teleconference. To access the
live broadcast in listen-only mode or the subsequently archived recording please
go to the investor relations portion of the Company's website at
www.emisphere.com or to http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=
EMIS&script=1010&item_id=920511. Please visit these sites at least five minutes
prior to start time for instructions.
Safe Harbor Statement Regarding Forward-looking Statements
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 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 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, Emisphere's
ability to fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with
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the Securities and Exchange Commission, including those factors discussed under
the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K (file no.
1-10615) filed on March 29, 2004.
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For additional information, please visit Emisphere's web site at
www.emisphere.com.
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EMISPHERE TECHNOLOGIES, INC.
Selected Financial Information
For the three and six months ended June 30, 2004 and 2003
(in thousands, except share and per share data)
Condensed Statements of Operations
FOR THE THREE MONTHS ENDED FOR THE SIX MONTHS ENDED
JUNE 30, JUNE 30,
--------------------------- ---------------------------
2004 2003 2004 2003
------------ ------------ ------------ ------------
(unaudited) (unaudited) (unaudited) (unaudited)
Revenue ...................................... $ 147 $ 246 $ 147 $ 272
------------ ------------ ------------ ------------
Costs and expenses:
Research and development ................... 3,750 5,430 8,631 10,394
General and administrative expenses ........ 2,772 2,806 5,358 5,345
Restructuring .............................. -- (73) -- (73)
Loss on impairment of long-lived assets .... -- 1,036 -- 1,040
Depreciation and amortization .............. 1,224 1,562 2,450 3,079
------------ ------------ ------------ ------------
Total costs and expenses ................. 7,746 10,761 16,439 19,785
------------ ------------ ------------ ------------
Operating loss ............................... (7,599) (10,515) (16,292) (19,513)
------------ ------------ ------------ ------------
Other (expense) and income:
Investment income and other ................ 216 380 498 758
Interest expense ........................... (1,450) (1,245) (2,902) (2,489)
Loss on sale of fixed assets ............... (2) (66) -- (66)
------------ ------------ ------------ ------------
Total other (expense) and income ......... (1,236) (931) (2,404) (1,797)
Net Loss ..................................... $ (8,835) $ (11,446) $ (18,696) $ (21,310)
============ ============ ============ ============
Net loss per share, basic and diluted ........ $ (0.48) $ (0.63) $ (1.02) $ (1.18)
============ ============ ============ ============
Weighted average shares outstanding, basic and
diluted ..................................... 18,404,000 18,048,000 18,334,000 18,034,000
============ ============ ============ ============
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Condensed Balance Sheets
JUNE 30, DECEMBER 31,
2004 2003
----------- -------------
Assets:
Cash, cash equivalents, and investments $ 30,216 $ 43,008
Prepaid expenses and other current assets 1,175 1,424
Equipment and leasehold improvements, net 11,520 13,324
Land, building and equipment held for sale, net 3,584 3,618
Assets under capital lease 563 681
Purchased technology, net 2,393 2,512
Other assets 1,512 1,482
----------- -------------
Total Assets $ 50,963 $ 66,049
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Liabilities and Stockholders' Equity:
Current liabilities $ 3,270 $ 3,371
Notes payable 41,220 38,345
Capital lease obligation -L/T 359 469
Deferred lease liability - L/T 859 1,057
Stockholders' equity 5,255 22,807
----------- -------------
Total liabilities and stockholders' equity $ 50,963 $ 66,049
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