CEDAR KNOLLS, N.J., Nov. 6, 2008 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (Nasdaq:EMIS) today announced its financial results for the third quarter ended September 30, 2008. Emisphere will host a conference call to discuss third quarter results at 10:00 AM EST Thursday, November 6, 2008. A live Webcast of the conference call can be accessed through the company's web site at: www.emisphere.com. The live conference call dial-in number is: 1-800-762-9441 (United States and Canada) or 1-480-629-9570 (International). In addition, an archive of the Webcast can be accessed through the same link (www.emisphere.com); an audio replay of the call will be available following the conference call by calling 1-800-406-7325 (United States and Canada) or 1-303-590-3030 (International). The conference replay PIN is 3939833.
THIRD QUARTER FINANCIAL RESULTS
For the three months ended September 30, 2008
Emisphere reported a net loss of $5.1 million, or $0.17 cents per basic and diluted shares for the three months ended September 30, 2008, compared to net income of $3.0 million, or $0.10 cents per basic share and $0.09 cents per diluted share for the three months ended September 30, 2007, which included $11.9 million income (net) from the settlement of the lawsuit between Eli Lilly and the Company.
The operating loss for the three months ended September 30, 2008 was $5.7 million, compared to operating income of $3.5 million for the three months ended September 30, 2007.
Total operating expenses were $5.8 million for the three months ended September 30, 2008; a decrease of $3.2 million, or 35%, when compared to $9.0 million for the three months ended September 30, 2007.
Total operating expenses for the three months ended September 30, 2008 include research and development costs of $2.9 million and general and administrative expenses of $2.7 million compared to $5.4 million and $3.4 million respectively, for the three months ended September 30, 2007. Other income for the third quarter of 2008 was $0.6 million, compared to other expense of $0.5 million in the third quarter of 2007.
For the nine months ended September 30, 2008
Emisphere reported a net loss of $16.7 million, or $0.55 cents per basic and diluted shares for the nine months ended September 30, 2008, compared to a net loss of $13.0 million, or $0.46 cents per basic share and $0.50 cents per diluted share for the nine months ended September 30, 2007, which included $11.9 million income (net) from the settlement of the lawsuit between Eli Lilly and the Company.
The operating loss for the nine months ended September 30, 2008 was $18.1 million, compared to an operating loss of $13.2 million for the same period last year.
Total operating expenses were $18.3 million for the nine months ended September 30, 2008; a decrease of $10.6 million, or 36%, when compared to $28.9 million for the nine months ended September 30, 2007.
Total operating expenses for the nine months ended September 30, 2008 include research and development costs of $10.1 million and general and administrative expenses of $7.7 million compared to $16.8 million and $11.2 million respectively, in the nine months ended September 30, 2007. Other income for the nine months ended September 30, 2008 was $1.4 million, compared to other income of $0.2 million in the same period in 2007.
LIQUIDITY
Cash, cash equivalents, and investments as of September 30, 2008 were $11.0 million compared to $13.9 million at December 31, 2007.
The Company anticipates that its existing capital resources are sufficient to enable it to continue operations through April 2009. The Company continues to implement aggressive cost controls to conserve its cash and evaluate both non-dilutive and traditional financing options.
PRODUCT DEVELOPMENTS
Emisphere announced new human clinical data demonstrating a new, more bioavailable oral form of Vitamin B12 and a potential new avenue for addressing the problems of 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 formulations. By circumventing the current absorption process, Eligen(r) may present an opportunity to reduce the potential uncertainty associated with oral megadoses of Vitamin B12, and may prevent dependence on the substantial number of injections currently taken by millions of individuals.
CLINICAL STUDIES
During this quarter, Emisphere announced Novartis Pharma AG completed recruitment of two Phase III studies exploring the effects of Eligen(r) and Salmon Calcitonin on osteoporosis and osteoarthritis, respectively.
The Phase III study for the oral osteoporosis treatment is a multi-center study exploring the safety and efficacy of Oral Salmon Calcitonin in the treatment of vertebral fractures in postmenopausal women aged 60-80 with osteoporosis. The three year study includes 4,500+ patients, and will be conducted in North and South America, Europe and Asia.
The osteoarthritis Phase III study will explore the safety and efficacy of an oral formulation of salmon calcitonin to treat patients with osteoarthritis of the knee. This study, which will be used to support the filing with health authorities worldwide, includes more than 1,100 patients between 51 and 80 years of age with a medical history and symptoms of knee osteoarthritis. The study will be conducted mainly in Europe and is estimated to complete during the second half of 2010.
In October 2008, Emisphere also announced that Novartis Pharma AG and Nordic Bioscience initiated a second multi-center Phase III study exploring the safety and efficacy of an oral formulation of salmon calcitonin to treat patients with osteoarthritis of the knee. This second study, designed to meet FDA requirements for U.S. registration, will examine patients between 51 and 80 years of age suffering from painful symptoms of knee osteoarthritis. The study will be conducted in multiple sites, including the U.S., with an estimated completion during the second half of 2011.
During October 2008, Emisphere announced the results of a study conducted by Professor Christoph Beglinger at the University Hospital in Basel, Switzerland, assessing the oral delivery of GLP-1 and PYY3-36 using Emisphere's proprietary delivery technology. The study showed, for the first time in 12 healthy subjects, that satiety peptides such as GLP-1 and PYY3-36 can be delivered orally in humans with safety and efficiency.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of therapeutic molecules using its Eligen(r) 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(r) 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 (file no. 1-10615) filed on March 13, 2008 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, filed on August 11, 2008.
EMISPHERE TECHNOLOGIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
For the three months and nine months ended September 30, 2008 and 2007
(in thousands, except share and per share data)
(unaudited)
For the three months For the nine months
ended September 30, ended September 30,
2008 2007 2008 2007
---------- ---------- ---------- ----------
Revenue $ 77 $ 571 $ 246 $ 3,778
Costs and
expenses:
Research and
development 2,945 5,364 10,101 16,848
General and
administrative
expenses 2,680 3,412 7,736 11,196
Loss on
disposal of
fixed assets -- -- (135) --
Depreciation
and amortiza-
tion 192 232 641 815
---------- ---------- ---------- ----------
Total costs
and expenses 5,817 9,008 18,343 28,859
---------- ---------- ---------- ----------
Income from
settlement of
lawsuit:
Proceeds from
settlement of
lawsuit -- 18,000 -- 18,000
Expenses from
settlement of
lawsuit -- (6,110) -- (6,110)
---------- ---------- ---------- ----------
Income from
settlement
of lawsuit -- 11,890 -- 11,890
---------- ---------- ---------- ----------
Operating
(loss) income (5,740) 3,453 (18,097) (13,191)
---------- ---------- ---------- ----------
Other income
and (expense):
Change in fair
value of
derivative
instruments 1,040 (21) 1,242 1,102
Investment and
other income 350 188 852 985
Sale of
patents -- -- 1,500 --
Interest
expense, net (750) (664) (2,182) (1,931)
---------- ---------- ---------- ----------
Total other
income
(expense) 640 (497) 1,412 156
---------- ---------- ---------- ----------
Net (loss)
income $ (5,100) $ 2,956 $ (16,685) $ (13,035)
---------- ---------- ---------- ----------
Net (loss)
income per
share, basic $ (0.17) $ 0.10 $ (0.55) $ (0.46)
---------- ---------- ---------- ----------
Net (loss)
income per
share, diluted $ (0.17) $ 0.09 $ (0.55) $ (0.50)
---------- ---------- ---------- ----------
Weighted
average shares
outstanding,
basic 30,338,174 29,187,151 30,337,442 28,602,819
---------- ---------- ---------- ----------
Weighted
average shares
outstanding,
diluted 30,338,174 32,375,805 30,337,442 28,728,063
---------- ---------- ---------- ----------
EMISPHERE TECHNOLOGIES, INC.
CONDENSED BALANCE SHEETS
September 30, 2008 and December 31, 2007
(in thousands, except share and per share data)
Sept. 30, 2008 Dec. 31, 2007
(unaudited)
Assets:
Current assets:
Cash and cash equivalents $ 9,528 $ 3,938
Short-term investments 1,498 9,916
Accounts receivable 456 292
Prepaid expenses and other
current assets 412 983
---------- ----------
Total current assets 11,894 15,129
Equipment and leasehold
improvements, net 1,682 2,074
Purchased technology, net 1,376 1,555
Restricted cash 246 246
Other assets 437 477
---------- ----------
Total assets $ 15,635 $ 19,481
---------- ----------
Liabilities and Stockholders'
Deficit:
Current liabilities:
Accounts payable and accrued
expenses $ 3,057 $ 2,874
Derivative instruments 1,245 2,487
Deferred revenue, current 23 73
Other current liabilities 80 73
---------- ----------
Total current liabilities 4,405 5,507
Notes payable, including accrued
interest and net of related
discount 29,463 27,320
Deferred revenue, non-current 10,831 --
Deferred lease and other liabilities 316 328
---------- ----------
Total liabilities 45,015 33,155
---------- ----------
Stockholders' deficit:
Preferred stock, $.01 par value;
authorized 1,000,000 shares; none
issued -- --
Common stock, $.01 par value;
authorized 100,000,000 shares;
issued 30,630,810 shares (30,341,078
outstanding) as of September 30,
2008; and issued 30,626,660
shares (30,336,928 outstanding)
as of December 31, 2007 306 306
Additional paid-in capital 400,253 399,282
Accumulated deficit (425,985) (409,300)
Accumulated other comprehensive
gain (loss) (2) (10)
Common stock held in treasury,
at cost; 289,732 shares (3,952) (3,952)
---------- ----------
Total stockholders' deficit (29,380) (13,674)
---------- ----------
Total liabilities and
stockholders' deficit $ 15,635 $ 19,481
---------- ----------