Conference Call/Webcast to be Held Monday, August 11 at 10:00 AM EDT
CEDAR KNOLLS, N.J., Aug. 11 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. (Nasdaq: EMIS) today announced its financial results for
the second quarter ended June 30, 2008.
Emisphere will host a conference call to discuss second quarter results
at 10:00 AM EDT Monday, August 11, 2008. A live Webcast of the conference
call can be accessed through the company's website at: http://www.emisphere.com.
The live conference call dial-in number is: 1-800-894-5910 (United States
and Canada) or 1-785-424-1052 (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
1-800-283-5758 (United States and Canada) or 1-402-220-0863
(International).
SECOND QUARTER FINANCIAL RESULTS
Q2-2008 versus Q2-2007 - Prior Year Comparisons
Emisphere reported a net loss of $7.6 million, or $0.25 per basic and
diluted shares for the three months ended June 30, 2008, compared to a net
loss of $12.1 million, or $0.43 per basic and diluted shares for the three
months ended June 30, 2007. The operating loss was $5.9 million for the
three months ended June 30, 2008, compared to an operating loss of $9.5
million for the same period last year.
Total operating expenses were $5.9 million for the three months ended
June 30, 2008; a decrease of $4.0 million, or 41%, compared to $9.9 million
for the three months ended June 30, 2007.
Research and development costs decreased $2.7 million, or 45%, to $3.3
million for the three months ended June 30, 2008 compared to $6.0 million
for the three months ended June 30, 2007.
General and administrative costs decreased $1.2 million, or 35%, to
$2.4 million for the three months ended June 30, 2008 compared to $3.6
million for the three months ended June 30, 2007.
Q2-2008 versus Q1-2008 - Prior Quarter Comparisons
Total operating expenses of $5.9 million for the three months ended
June 30, 2008 decreased $0.7 million, or 11%, compared to $6.6 million for
the three months ended March 31, 2008.
Research and development costs decreased $0.5 million, or 13%, to $3.3
million for the three months ended June 30, 2008 compared to $3.8 million
for the three months ended March 31, 2008.
General and administrative costs decreased $ 0.3 million, or 12%, to
$2.4 million for the three months ended June 30, 2008 compared to $2.7
million for the three months ended March 31, 2008.
LIQUIDITY
Cash, cash equivalents, and investments as of June 30, 2008 were $15.4
million an increase of 11% as compared to $13.9 million as of December 31,
2007.
The Company anticipates that its existing capital resources are
sufficient to enable it to continue operations through March 2009.
"Throughout 2008, Emisphere continues to build value," said Michael V.
Novinski, President and Chief Executive Officer. "We have delivered
encouraging results with our Eligen(R) B12 formulation that could have a
significant impact on addressing the problems associated with B12
supplementation. At the same time, we are continuing to build high-value
partnerships, as seen with our license agreement with Novo Nordisk. Our
goal is to continue to drive the Eligen(R) Technology toward
commercialization using Eligen(R) B12 and use this exciting technology as a
platform to provide solutions to the hurdles associated with the delivery
of molecules that are difficult to absorb through additional high value
partnerships and exploration of other molecules and nutrients."
CORPORATE DEVELOPMENTS
Emisphere recently announced an exclusive Development and License
Agreement with Novo Nordisk A/S (NYSE: NVO) to develop and commercialize
oral formulations of Novo Nordisk's proprietary GLP-1 receptor agonists,
which have the potential of treating Type 2 diabetes, using Emisphere's
Eligen(R) Technology. The agreement includes at least $87 million in
contingent product development and sales milestone payments to Emisphere,
of which a $10 million non-refundable license fee was received during June
2008, as well as royalties on sales. The agreement also provides Novo
Nordisk with the option to develop oral formulations of Novo Nordisk
compounds other than GLP-1 receptor agonists using Emisphere's proprietary
carrier technology.
Under the new agreement, Novo Nordisk is responsible for the
development and commercialization of the product candidates. Novo Nordisk
and Emisphere have collaborated since 2007 on early stage preclinical
research that has preliminarily confirmed the utility of Emisphere's
carriers to provide bioavailable oral formulations of GLP-1 receptor
agonists.
PRODUCT DEVELOPMENTS
Emisphere also recently released human clinical data demonstrating a
new, more bioavailable oral form of Vitamin B12 and a potential new avenue
for addressing the problems with B12 supplementation. As demonstrated by
the data, the Eligen(R) B12 formulation avoids the normal specialized
absorption process that limits absorption of Vitamin B12 from current oral
formulations. This bypass of the normal absorption process may present
Eligen(R) B12 with an opportunity to reduce the potential uncertainty
associated with oral megadoses of Vitamin B12 and may prevent dependence on
the substantial number of injections being taken by millions of
individuals.
Emisphere's human study follows a number of animal studies that also
indicated the advantages of the Eligen(R) Technology when applied to a
poorly absorbed but essential nutrient such as Vitamin B12. The Company is
planning additional clinical studies, including pharmacokinetic studies and
safety and efficacy studies in vitamin B12 deficient people to further
elucidate the advantages of the Eligen(R) technology.
CLINICAL STUDIES
Novartis Pharma AG has launched a Phase I study in postmenopausal women
to determine the safety and tolerability of Oral PTH-1-34, a combination of
human PTH-1-34 and the absorption enhancer 5-CNAC using Emisphere's
proprietary Eligen(R) Technology, for the treatment of postmenopausal
osteoporosis. The study is designed to assess the bioavailability profile
of increasing doses of PTH-1-34 combined with different amounts of 5-CNAC
administered orally. The trial is being conducted in Switzerland and is
estimated to yield first interpretable results by the end of the year.
Osteoporosis is a disease associated with a gradual thinning and
weakening of the bones, occurring most frequently in women after menopause.
Thinner and weaker bones are increasingly susceptible to fractures.
Untreated postmenopausal osteoporosis can lead to chronic back pain,
disabling fractures and lost mobility.
Emisphere also announced findings from a clinical study assessing the
oral delivery of GLP-1 peptide safely and effectively. The study used a
delivery- agent-based approach using Emisphere's Eligen(R) Technology, and
was conducted at University Hospital in Basel, Switzerland by Christoph
Beglinger, M.D., of the Clinical Research Center, Department of Biomedicine
Division of Gastroenterology, and Department of Clinical Pharmacology and
Toxicology at the hospital.
Professor Beglinger's study, conducted in 16 healthy male subjects, was
designed to explore the pharmacodynamic effects of a single oral dose of
GLP-1 administered 15 minutes prior to an oral glucose tolerance test. The
study demonstrated that the oral formulation of GLP-1 stimulated an early
increase in fasting insulin and a decrease in fasting glucose as compared
to placebo. This study provides further evidence of the application of the
Eligen(R) Technology, and its use as a solution to the hurdles of
pharmaceutical development.
ABOUT EMISPHERE TECHNOLOGIES, INC.
Emisphere Technologies, Inc. is a biopharmaceutical company that
focuses on a unique and improved delivery of therapeutic molecules,
pharmaceutical compounds and nutritional supplements using its Eligen(R)
Technology. Some of these molecules or compounds can only be given by
injection; when combined with our technology convenient oral versions may
be safe, effective and provide significant advantages. The benefits of
other compounds are limited due to poor bioavailability, slow on-set of
action or variable absorption. In those cases, use of Emisphere's
technology can improve the therapeutic effectiveness of the compounds. 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 website is: http://www.emisphere.com.
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 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 17, 2008 and our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2008, filed on May 7, 2008.
PART 1
ITEM 1. FINANCIAL STATEMENTS
EMISPHERE TECHNOLOGIES, INC.
CONDENSED BALANCE SHEETS
June 30, 2008 and December 31, 2007
(in thousands, except share and per share data)
June 30, December 31,
2008 2007
(unaudited)
Assets:
Current assets:
Cash and cash equivalents $10,951 $3,938
Short-term investments 4,414 9,916
Accounts receivable 318 292
Prepaid expenses and other current assets 561 983
Total current assets 16,244 15,129
Equipment and leasehold improvements, net 1,812 2,074
Purchased technology, net 1,435 1,555
Restricted cash 246 246
Other assets 453 477
Total assets $20,190 $19,481
Liabilities and Stockholders' Deficit:
Current liabilities:
Accounts payable and accrued expenses $2,912 $2,874
Derivative instruments 2,285 2,487
Deferred revenue, current 137 73
Other current liabilities 78 73
Total current liabilities 5,412 5,507
Notes payable, including accrued interest and
net of related discount 28,727 27,320
Deferred revenue, non-current 10,305 -
Deferred lease and other liabilities 336 328
Total liabilities 44,780 33,155
Stockholders' deficit:
Preferred stock, $.01 par value; authorized
1,000,000 shares; none issued and
outstanding - -
Common stock, $.01 par value; authorized
100,000,000 shares; issued 30,626,660 shares
(30,336,928 outstanding) as of June 30, 2008,
and December 31, 2007 306 306
Additional paid-in capital 399,937 399,282
Accumulated deficit (420,885) (409,300)
Accumulated other comprehensive gain (loss) 4 (10)
Common stock held in treasury, at cost;
289,732 shares (3,952) (3,952)
Total stockholders' deficit (24,590) (13,674)
Total liabilities and stockholders' deficit $20,190 $19,481
EMISPHERE TECHNOLOGIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
For the three months and six months ended June 30, 2008 and 2007
(in thousands, except share and per share data)
(unaudited)
For the three months For the six months
ended June 30, ended June 30,
2008 2007 2008 2007
Revenue $14 $398 $169 $3,207
Costs and expenses:
Research and development 3,323 6,032 7,156 11,484
General and administrative
expenses 2,363 3,638 5,057 7,784
Gain on disposal of fixed
assets - - (135) -
Depreciation and
amortization 223 270 449 583
Total costs and expenses 5,909 9,940 12,527 19,851
Operating loss (5,895) (9,542) (12,358) (16,644)
Other income and (expense):
Change in fair value of
derivative instruments (1,291) (2,401) 202 1,123
Investment and other income 270 482 503 797
Sale of patents - - 1,500 -
Interest expense, net (727) (643) (1,432) (1,267)
Total other income
(expense) (1,748) (2,562) 773 653
Net loss $(7,643) $(12,104) $(11,585) $(15,991)
Net loss per share, basic $(0.25) $(0.43) $(0.38) $(0.57)
Net loss per share, diluted $(0.25) $(0.43) $(0.38) $(0.60)
Weighted average shares
outstanding, basic 30,336,928 28,313,056 30,336,928 28,305,810
Weighted average shares
outstanding, diluted 30,336,928 28,313,056 30,336,928 28,403,507
SOURCE Emisphere Technologies, Inc.
 back to top
Related links:
http://www.emisphere.com
CONTACT:
Bob Madison, Senior Director Corporate
Communications, +1-973-532-8001, bmadison@emisphere.com; Adam
Friedman, Adam Friedman Associates, +1-212-981-2529, ext. 18,
adam@adam-friedman.com
|
