- Conference Call/Webcast To Be Held Today at 10:00 a.m. EDT -
TARRYTOWN, N.Y., Aug. 7 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. (Nasdaq: EMIS) today announced its financial results for
the second quarter ended June 30, 2007.
"Emisphere's product pipeline is growing increasingly robust," said
Michael V. Novinski, President/Chief Executive Officer of Emisphere
Technologies, Inc. "In addition to the 10 products we have in various
stages of clinical development, we have an additional 11 pre-clinical
projects in our pipeline, six with partners and five without established
collaborations. We are seeking to move our patented technology into a broad
array of disease states, including obesity, osteoporosis, infectious
disease, diabetes, CNS, erectile dysfunction and fertility treatment, among
others."
Emisphere Technologies, Inc. will host a conference call to discuss
second quarter results at 10:00 AM EDT today. 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:
1-800-819-9193 (US and Canada) or 1- 913-981-4911 (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 (US and Canada) or 1- 719-457-0820
(International). The conference replay PIN is 9045496.
Second Quarter Financial Results
-- Operating expenses for the second quarter of 2007 were $9.9 million
compared to $8.6 million in the second quarter of 2006
* $1.3 million increase in operating expenses is primarily the result
of non-cash charges related to share-based payments
-- Other expense second quarter 2007 were $2.6 million, compared to $0.3
million in the second quarter of 2006
* $2.3 million increase in other expenses is primarily the result of
non-cash charges related to the change in fair value of derivative
instruments
-- Second quarter 2007 revenues were $0.4 million, compared to the $5.2
million in the second quarter of 2006
-- Second quarter 2007 operating loss of $9.5 million, compared to an
operating loss of $3.4 million for the first quarter of 2006
-- Second quarter 2007 net loss was $12.1 million, or $0.43 per basic and
diluted share, compared to a net loss of $3.8 million, or $0.14 per
basic and diluted share for the second quarter of 2006
-- As of June 30, 2007, Emisphere has $8.9 million in cash and
investments. The Company is currently evaluating various financing
options to address its future cash needs that will enable the Company
to continue operations through the fourth quarter of 2007 and beyond.
Corporate and Product Developments
Emisphere has two Phase III products based on the compound salmon
calcitonin in partnership 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
-- Osteoarthritis product has the potential to be the first disease-
modifying drug that halts progression of the illness rather than
treating symptoms
-- Both products use Emisphere's eligen(R) delivery technology to provide
salmon calcitonin for the first time as a convenient oral medication
Emisphere has three products in Phase II:
-- Development of recombinant human growth hormone ("rhGH") in
collaboration with Novartis Pharma AG
-- Continuing the development of oral heparin; discussions with the US
Food and Drug Administration (FDA) has established a pathway for
registration to proceed into complete Phase III for the use of oral
heparin in the prevention of deep-vein thrombosis following elective
total hip replacement. Emisphere is in current discussions with
potential partners to complete the development of oral heparin in a
collaborative arrangement.
-- Continuing clinical development of oral insulin; an insulin/glucose
clamp study with a new formulation is being planned over a three-month
period starting early in the first quarter, which will provide further
data and information on the dosage. Collaborative partnerships will
then be investigated
Emisphere has five products in Phase I:
-- An Investigational New Drug application (IND) was filed by Genta
Incorporated on gallium nitrate on July 31, 2007
-- A program continues on an improved oral formulation of the antiviral
compound acyclovir with a pharmaceutical company outside of the United
States
-- A food-intake study for both GLP-1 and PYY will be undertaken later
this year at University Hospital, Switzerland
-- Parathyroid hormone continues on a progressive clinical development
path in collaboration with Novaris Pharma AG
Emisphere has 11 products in preclinical development:
-- Six projects with partners in obesity, osteoporosis, infectious
disease, diabetes, and CNS
-- Five projects without established collaborations for the therapies of
CNS, erectile dysfunction, cardiovascular disease, inflammation and
pain, and fertility treatment
-- Following completion of these pre-clinical projects, decisions would
then be taken to possibly proceed into future collaborations with each
of the partners for further pre-clinical or clinical development;
projects without established collaborations will be assessed for
continued development to the next step with or without a partner
About Emisphere Technologies, Inc.
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 pre-clinical 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:
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 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 (file
no. 000-17758) filed on March 6, 2007, and our Quarterly Report on Form
10-Q for the quarter ended March 31, 2007, filed on May 7, 2007 (file no.
000-17758).
EMISPHERE TECHNOLOGIES, INC.
Condensed Statements of Operations (Unaudited)
For the three and six months ended June 30, 2007 and 2006
(in thousands, except share and per share data)
For the three months For the six months
ended ended
June 30, June 30,
2007 2006 2007 2006
Revenue $398 $5,220 $3,207 $6,916
Costs and expenses:
Research and development 6,032 4,858 11,484 9,375
General and administrative
expenses 3,638 2,812 7,784 5,614
Depreciation and
amortization 270 972 583 1,962
Total costs and expenses 9,940 8,642 19,851 16,951
Operating loss (9,542) (3,422) (16,644) (10,035)
Other (expense) and income:
Beneficial conversion of
convertible security - - - (12,215)
Investment and other income 482 294 797 417
Change in fair value of
derivative instruments (2,401) (56) 1,123 (7,620)
Interest expense (643) (573) (1,267) (1,140)
Total other (expense)
and income (2,562) (335) 653 (20,558)
Net (loss) income $(12,104) $(3,757) $(15,991) $(30,593)
Net (loss) income per
share, basic $(0.43) $(0.14) $(0.57) $(1.23)
Net (loss) income per
share, diluted $(0.43) $(0.14) $(0.60) $(1.23)
Weighted average shares
outstanding, basic 28,313,056 25,952,342 28,305,810 24,815,680
Weighted average shares
outstanding, diluted 28,313,056 25,952,342 28,403,507 24,815,680
EMISPHERE TECHNOLOGIES, INC.
Condensed Balance Sheets (Unaudited)
As of June 30, 2007 and December 31, 2006
(in thousands)
June 30, December 31,
2007 2006
Assets:
Cash, cash equivalents, restricted cash and
investments $8,939 $21,533
Accounts receivable 487 216
Prepaid expenses and other current assets 893 1,082
Total current assets 10,319 22,831
Equipment and leasehold improvements, net 2,247 2,652
Purchased technology, net 1,675 1,794
Other assets 798 815
Total Assets $15,039 $28,092
Liabilities and stockholders' deficit:
Current liabilities $9,016 $9,454
Notes payable 25,994 24,744
Other long-term liabilities 172 -
Stockholders' deficit (20,143) (6,106)
Total liabilities and stockholders' deficit $15,039 $28,092
SOURCE Emisphere Technologies, Inc.
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Related links: http://www.emisphere.com/
CONTACT: Bob Madison of Emisphere Technologies, Inc., +1-914-593-8360
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