Emisphere Technologies Announces Financial and Operational Results for the Third Quarter and First Nine Months of 2009

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Mon Nov 9, 2009 8:45am EST

http://www.businesswire.com/news/home/20091109005233/en

Conference Call/Webcast to be held today, November 9, 2009 at 10:00 AM EST
CEDAR KNOLLS, N.J.--(Business Wire)--
Emisphere Technologies, Inc. (OTC BB: EMIS) today announced financial and
operational results for the third quarter and nine months ended September 30,
2009. 

THIRD QUARTER FINANCIAL RESULTS

For the three months ended September 30, 2009, Emisphere reported a net loss of
$4.0 million, or $0.11 per basic and diluted share, compared to a net loss of
$5.1 million, or $0.17 per basic and diluted share for the same period last
year. 

The operating loss for the three months ended September 30, 2009 was $3.4
million, compared to an operating loss of $5.7 million in the same period last
year. Total operating expenses for the three months ended September 30, 2009
were $3.4 million; a decrease of approximately $2.4 million, or 42%, compared to
$5.8 million for the same period last year. Total operating expenses for the
three months ended September 30, 2009 include research and development costs of
$0.8 million and general and administrative expenses of $2.5 million, compared
to $2.9 million and $2.7 million respectively, for the same period last year. 

Other expense for the three months ended September 30, 2009 was $0.6 million,
compared to other income of $0.6 million for the same period last year. 

YEAR TO DATE FINANCIAL RESULTS

For the nine months ended September 30, 2009, Emisphere reported a net loss of
$13.6 million, or $0.42 per basic and diluted share, including a $1.2 million
one time favorable adjustment to the restructuring charge and gain on the
disposal of fixed assets associated with the closure of its research and
development facility in Tarrytown, New York in April 2009. This compares to a
net loss of $16.7 million, or $0.55 per basic and diluted share for the nine
months ended September 30, 2008. 

Total operating expenses for the nine months ended September 30, 2009 were $11.1
million, a decrease of approximately $7.3 million, or 40% compared to $18.3
million for the same period last year. Total operating expenses for the nine
months ended September 30, 2009 include research and development costs of $3.5
million and general and administrative expenses of $8.3 million and the $1.2
million one time favorable adjustment to the restructuring charge and gain from
the disposal of fixed assets, compared to $10.1 million and $7.7 million
respectively, for the same period last year. 

Other expense for the nine months ended September 30, 2009 was $2.6 million,
compared to other income of $1.4 million in the same period last year. 

LIQUIDITY

At September 30, 2009, Emisphere Technologies reported cash and restricted cash
of $7.2 million, compared to $1.5 million at June 30, 2009. Approximately $12.5
million is due as payment of the Novartis Note on December 1, 2009. Assuming we
will be able to satisfy our obligation under the Novartis Note by some means
other than the use of our existing capital resources, we anticipate that those
existing capital resources, without implementing additional cost reductions,
raising additional capital, or obtaining substantial cash inflows from potential
partners or our products, will enable us to continue operations through
approximately February 2010. 

The Company has implemented aggressive cost controls to conserve its cash and
continues to evaluate both non-dilutive and traditional financing options.
Management believes there are reasonable financing alternatives potentially
available to it that will enable it to meet its near term operating cash
requirements. Please refer to the Quarterly Report on Form 10Q for the quarter
ended September 30, 2009 for additional information. 

KEY PRODUCT AND CORPORATE DEVELOPMENTS

* Oral Eligen® B-12:

* On November 2, 2009, the Company announced that interim data from an ongoing
study demonstrated its high-dose oral Eligen® B12 (1000mcg) performed as well as
or better than B12 injections in individuals with Vitamin B12 deficiency. Normal
levels of serum B12 and active B12 were achieved by 100 percent of those study
participants who have currently taken Eligen® B12 (1000mcg) 15 days into the
90-day study when the first blood samples were taken. It is estimated that
between 30 and 40 million high dose injections of B12 are given each year in the
U.S. alone and over 250 million such injections are given worldwide. Emisphere`s
Eligen® B12 product (1000mcg) is planned to be available in 2010. 
* On October 8, 2009, the Company announced that it is introducing and launching
its first commercially available product, oral Eligen® B12 (100 mcg). Oral
Eligen® B12 (100 mcg), has been specifically developed to help improve Vitamin
B12 absorption and bioavailability with a patented formulation. Life Extension®
will have certain exclusivity in the U.S. for distribution via the internet and
also at specialty health food and nutritional retail outlets including; The
Vitamin Shoppe, GNC and Vitamin World. Oral Eligen® B12 (100mcg) tablets will be
available starting November of this year. Financial terms of the agreement were
not disclosed.

* Oral Salmon Calcitonin:

* On October 15, 2009, Emisphere Technologies announced that Novartis and its
partner, Nordic Bioscience, issued study results in which twice-daily oral
salmon calcitonin using Emisphere`s proprietary Eligen® Drug Delivery Technology
significantly suppressed markers of cartilage and bone degradation versus
placebo in men and women with osteoarthritis, the most common form of arthritis.
The study, a Phase I, placebo-controlled, double-blind, double-dummy,
randomized, gender-stratified clinical trial, was conducted on behalf of
Emisphere`s partner Novartis Pharma AG by Nordic Bioscience, and published
online in the September 2009 issue of Osteoarthritis and Cartilage. Emerging
data continue to indicate oral salmon calcitonin in combination with the
Company`s absorption-enhancing Eligen® Technology may be a potential therapeutic
option for women and men with osteoarthritis, which affects more than 20 million
people in the United States.

* Oral PTH:

* On October 20, 2009, Emisphere Technologies announced study results
demonstrating that a single dose of the novel oral parathyroid hormone PTH1-34,
which utilizes Emisphere`s proprietary Eligen® Drug Delivery Technology and
absorption-enhancer carrier molecule 5-CNAC, achieved potentially
therapeutically relevant exposure and safety profiles similar to those of the
currently available injectable formulation in healthy postmenopausal women. The
results of the study, conducted by Emisphere`s partner Novartis Pharma AG, were
presented Monday, October 19, 2009 in a poster session at the 73rd Annual
Scientific Meeting of the American College of Rheumatology in Philadelphia, PA.
The results of this study indicate we may be able to provide women with
postmenopausal osteoporosis a more convenient oral option for parathyroid
hormone therapy, which is now available only as an injection.

* Oral Glucagon-Like Peptide-1 (GLP-1):

* On September 8, 2009, Emisphere Technologies announced that an article
published in the September 2009 issue of Clinical Pharmacology and Therapeutics,
describes previously reported findings of an independent clinical study designed
to assess the pharmacokinetics, pharmacodynamics (PK/PD) and safety of oral
administration of the peptide GLP-1 utilizing Emisphere`s Eligen® carrier
technology. The study was conducted at the University Hospital in Basel,
Switzerland by Professor Christoph Beglinger, of the Clinical Research Center,
Department of Biomedicine Division of Gastroenterology, and Department of
Clinical Pharmacology and Toxicology at the hospital. The published data show
that the orally administered peptide, when administered with Emisphere`s SNAC®
carrier, is rapidly absorbed from the gut, leading to tenfold higher plasma
concentrations compared to control. The pharmacodynamic effects were consistent
with the known pharmacology of GLP-1, resulting in significantly increased basal
insulin release (P< 0.027), and marked effects on glucose levels. The
postprandial glucose peak was delayed with GLP-1, suggesting an effect on
gastric emptying. No adverse events were reported.

The live webcast of today`s scheduled 10AM EST conference call can be accessed
through the company`s web site at: www.emisphere.com. The live conference call
dial-in number is: 1-877-852-6579(United States and Canada) or 1-719-325-4772
(International). In addition, an archive of the webcast can be accessed through
the same link; an audio replay of the call will be available beginning at 1:00
PM EST through midnight on November 23, 2009 by calling 1-888-203-1112(United
States and Canada) or 1-719-457-0820(International). The conference replay PIN
is 3548334. 

About Emisphere Technologies, Inc.

Emisphere is a biopharmaceutical company that focuses on a unique and improved
delivery of therapeutic molecules or nutritional supplements using its Eligen®
Technology. These molecules and compounds could be currently available or in
development. Such molecules are usually delivered by injection; in many cases,
their benefits are limited due to poor bioavailability, slow on-set of action or
variable absorption. The Eligen® Technology can be applied to the oral route of
administration as well other delivery pathways, such as buccal, rectal,
inhalation, intra-vaginal or transdermal. The company`s website is:
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 for the fiscal year ended December
331, 2008 (file no. 000-17758) filed on March 16, 2009 and as amended on Form
10-K/A as filed on April 30, 2009, and our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2009, and as amended on Form 10-Q/A asfiled on October
21, 2009.

-Financial Tables to Follow-

                                                                                                                                                                                                                                                           
 EMISPHERE TECHNOLOGIES INC.                                                                                                                                                                                                                                   
 
                                                                                                                                                                                                                                                             
 
BALANCE SHEETS                                                                                                                                                                                                                                               
 
September 30, 2009 and December 31, 2008                                                                                                                                                                                                                     
 
(in thousands, except share and per share data)                                                                                                                                                                                                              
                                                                                                                                                                                                                                                           
                                                                                                                                                                                                     September 30,               December 31,              
                                                                                                                                                                                                            2009                      2008             
                                                                                                                                                                                                     (unaudited)                                           
 Assets:                                                                                                                                                                                                                                                   
 Current assets:                                                                                                                                                                                                                                           
 Cash and cash equivalents                                                                                                                                                                           $      6,975              $      7,214            
 Accounts receivable, net of allowance of $9 in September 2009 and December 2008                                                                                                                            21                        232              
 Prepaid expenses and other current assets                                                                                                                                                                  253                       273              
 Total Current Assets                                                                                                                                                                                       7,249                     7,719            
 Equipment and leasehold improvements, net                                                                                                                                                                  161                       465              
 Purchased technology, net                                                                                                                                                                                  1,137                     1,316            
 Restricted cash                                                                                                                                                                                            255                       255              
 Other assets                                                                                                                                                                                               367                       421              
 Total assets                                                                                                                                                                                        $      9.169              $      10,176           
 Liabilities and Stockholders` Deficit:                                                                                                                                                                                                                    
 Current liabilities:                                                                                                                                                                                                                                      
 Notes payable, including accrued interest and net of related discount                                                                                                                               $      12,422             $      12,011           
 Accounts payable and accrued expenses                                                                                                                                                                      4,511                     2,361            
 Deferred revenue, current                                                                                                                                                                                  9                         87               
 Derivative instruments                                                                                                                                                                                                                                    
 Related party                                                                                                                                                                                              2,179                     153              
 Others                                                                                                                                                                                                     2,042                     114              
 Restructuring accrual, current                                                                                                                                                                             1,253                     927              
 Other current liabilities                                                                                                                                                                                  51                        20               
 Total current liabilities                                                                                                                                                                                  22,467                    15,673           
 Notes payable, including accrued interest and net of related discount                                                                                                                                      11,883                    18,209           
 Restructuring accrual                                                                                                                                                                                      -                         1,953            
 Deferred revenue                                                                                                                                                                                           11,467                    11,240           
 Derivative instruments - related party                                                                                                                                                                     3,800 90                  129              
 Deferred lease liability and other liabilities                                                                                                                                                                                                        
 Total liabilities                                                                                                                                                                                          49,707                    47,204           
 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 42,360,133 shares (42,070,401 outstanding) as of September 30, 2009; issued 30,630,810 shares (30,341,078 outstanding) as of                                                          
 December 31, 2008                                                                                                                                                                                          424                       306              
 Additional paid-in-capital                                                                                                                                                                                 392,059                   400,306          
 Accumulated deficit                                                                                                                                                                                        (429,069  )               (433,688  )      
 Common stock held in treasury, at cost; 289,732 shares                                                                                                                                                     (3,952    )               (3,952    )      
 Total stockholders` deficit                                                                                                                                                                                (40,538   )               (37,028   )      
 Total liabilities and stockholders` deficit                                                                                                                                                         $      9,169              $      10,176           
                                                                                                                                                                                                                                                       


 EMISPHERE TECHNOLOGIES, INC.                                                                                                                                                            
 
                                                                                                                                                                                       
 
STATEMENT OF OPERATIONS                                                                                                                                                                
 
For the three and nine months ended September 30, 2009 and 2008                                                                                                                        
 
(in thousands, except share and per share data)                                                                                                                                        
 
(unaudited)                                                                                                                                                                            
                                                                                                                                                                                     
                                                           For the three months ended                                    For the nine months ended                                   
                                                           September 30,                                                 September 30,                                               
                                                                 2009                          2008                      2009                          2008              
 Revenue                                                   $     -                       $     77                  $     -                       $     246               
 Costs and expenses:                                                                                                                                                             
 Research and development                                        782                           2,945                     3,452                         10,101            
 General and administrative expenses                             2,493                         2,680                     8,348                         7,736             
 Restructuring costs                                             -                             -                         (353        )                 -                 
 Gain on disposal of fixed assets                                (2          )                 -                         (824        )                 (135        )     
 Depreciation and amortization                                   120                           192                       427                           641               
 Total costs and expenses                                        3,393                         5,817                     11,050                        18,343            
 Operating loss                                                  (3,393      )                 (5,740      )             (11,050     )                 (18,097     )     
                                                                                                                                                                                 
 Other non-operating income (expense):                                                                                                                                           
 Other income (expense)                                          24                            87                        91                            310               
 Sublease income                                                 -                             263                       232                           542               
 Sale of patents                                           ___                                   -                         500                           1,500             
 Change in fair value of derivative instruments                                                                                                                                  
 Related party                                                   45                            467                       (35         )                 662               
 Other                                                           576                           573                       322                           580               
 Interest expense                                                                                                                                                                
 Related party                                                   (1,150      )                 (618        )             (3,290      )                 (1,789      )     
 Other                                                           (139        )                 (132        )             (411        )                 (393        )     
 Total other non-operating income (expense)                      (644        )                 640                       (2,591      )                 1,412             
 Net loss                                                  $     (4,037      )           $     (5,100      )       $     (13,641     )           $     (16,685     )     
 Net loss per share, basic and diluted                     $     (0.11       )           $     (0.17       )       $     (0.42       )           $     (0.55       )     
 Weighted average shares outstanding, basic and diluted          35,695,769                    30,338,174                32,188,553                    30,337,442        


Emisphere Technologies, Inc.
Michael R. Garone, 973-532-8005
Chief Financial Officer
mgarone@emisphere.com
or
Rx Communications Group
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
or
West Mill Marketing (for media only)
Jeff Winton, 908-872-2682
jeffwmm@aol.com



Copyright Business Wire 2009

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