- Conference Call/Webcast to be Held This Morning at 10:00 a.m. EDT -
TARRYTOWN, N.Y., May 4 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. (Nasdaq: EMIS) today announced its financial results for
the first quarter ended March 31, 2007. The Company also provided an update
on product and corporate developments that occurred during the first
quarter.
First Quarter Financial Results
The Company reported 2007 first quarter revenues of $2.8 million,
compared to $1.7 million in the first quarter of 2006. This increase was
due to the commencement of the Phase III testing on Oral Salmon Calcitonin
by Novartis under the Company's collaboration with them. The Company
reported an operating loss of $7.1 million for the quarter ended March 31,
2007, compared to an operating loss of $6.6 million for the first quarter
of 2006. The Company reported a net loss of $3.9 million, or $0.14 per
basic and $0.26 per diluted share, for the quarter ended March 31, 2007,
compared to a net loss of $26.8 million, or $1.13 per basic and diluted
share for the quarter ended March 31, 2006. Included in net loss is the
change in fair value of the derivatives, which resulted in a $3.5 million
gain compared to a loss of $7.6 million for the quarters ended March 31,
2007 and 2006, respectively. The net loss in the first quarter of fiscal
2006 included a one-time non-cash charge of $12.2 million for the
beneficial conversion feature of the convertible security.
Total operating expenses were $9.9 million for the 2007 first quarter,
an increase of $1.6 million compared to the same period last year. Total
operating expenses include research and development costs of $5.5 million,
an increase of $0.9 million compared to last year's first quarter, and
general and administrative expenses of $4.1 million, an increase of $1.3
million compared to the same period last year.
Cash, cash equivalents, restricted cash and investments held as of
March 31, 2007 were $15.6 million, a net decrease of $5.9 million from such
amounts held on December 31, 2006. Weighted average shares outstanding on a
diluted basis for the quarters ended March 31, 2007 and 2006, were 28.6
million and 23.7 million, respectively. The Company is currently evaluating
various financing options to address its future cash needs that will enable
the Company to continue operations beyond September 2007 and into the
future.
"Emisphere was successful in achieving progress in its primary clinical
development programs during the first quarter," said Lewis Bender, interim
President and CEO. "Our oral salmon calcitonin product, partnered with
Novartis Pharma AG and Nordic Bioscience, has entered a Phase 3 clinical
trial, and a well-respected Scientific Advisory Board was established to
provide guidance on oral insulin. The Company also reported statistically
significant results from studies conducted on oral formulations of GLP-1
and PYY. With regard to oral heparin, during the first quarter the Company
met with the FDA to determine a registration pathway for oral heparin
including the design for a phase 3 study. We believe that all remaining
questions on the Phase 3 study have been answered and a protocol can be
submitted.
"Finally, subsequent to the end of the first quarter, Emisphere
appointed Michael Novinski as the Company's President and CEO. We believe
Michael's extensive background in leading a respected pharmaceutical
company and bringing products through the FDA approval process will have a
significant beneficial impact on all our programs," said Bender.
Some of the recent corporate and product developments include:
Appointment of Michael Novinski as President and CEO
Appointment of new President and CEO. On April 10, 2007 the Company
announced the appointment of Michael V. Novinski to the position of
President and Chief Executive Officer, effective immediately. Mr. Novinski,
who will assume his duties at the Company beginning early May, will replace
Mr. Bender, who was appointed interim Chief Executive Officer on January
12, 2007. Mr. Bender will continue in the role of acting CEO until Mr.
Novinski is on board full time. Previously, Mr. Novinski was President of
Organon USA Inc., a business unit of Organon BioSciences Inc, for the last
four years. During his tenure as President, Organon USA received FDA
approval for a number of ethical pharmaceutical products in the areas of
Women's Healthcare, Fertility, Neuroscience, Anti-thrombotics and
Anesthesia.
Oral Salmon Calcitonin
Commencement of Phase 3 clinical trial for the treatment of
osteoporosis. The Company announced that Novartis Pharma AG and Nordic
Bioscience initiated a Phase 3 clinical trial for the treatment of
osteoporosis with an oral form of salmon calcitonin referred to as SMC021,
a new drug candidate using the Company's eligen (R) delivery technology.
Novartis has received CHMP advice on the Phase 3 trial design and clearance
from FDA to proceed with the study under a special protocol assessment
(SPA). As a result of the initiation of the trial, Emisphere received a
milestone payment from Novartis. This development reflects the potential
that for the first time, salmon calcitonin may also be effective as a
convenient oral medication, rather than the currently available injectable
or intranasal options.
Oral Heparin
Meeting with FDA on Oral Heparin. The company met with the FDA on March
23, 2007. As a result of that meeting, the Company believes that the key
elements of the registration pathway for oral heparin have been defined. In
addition, the company believes that all aspects of a pivotal phase 3 trial
for oral heparin have been agreed to with FDA.
Oral Insulin
Formulation of Scientific Advisory Board (SAB) for Oral Insulin. The
Company announced the formation of a SAB to provide guidance for the
Company's oral insulin clinical development program. The SAB is comprised
of six independent scientific experts in several fields related to diabetes
research. New clinical studies with improved formulations are planned.
Oral GLP-1 and PYY
Favorable results from Oral GLP-1 and PYY studies. The Company reported
the results of two clinical studies evaluating oral formulations of GLP-1
and PYY. The results of those studies showed that Emisphere's eligen (R)
technology can orally deliver those hormones. The oral administration of
both peptides induced a rapid and dose-dependent, statistically significant
increase in plasma drug concentrations (p<0.05) at all doses tested versus
placebo. Additionally, the orally delivered GLP-1 induced a statistically
significant effect on insulin release in all healthy male volunteers
(p<0.05) at all doses tested versus placebo. Emisphere will seek to publish
these results in a leading peer-reviewed scientific journal later this
year.
Conference Call Information
The Company will hold a conference call to discuss its 2007 first
quarter financial results today at 10:00 a.m. EDT. A replay of the
teleconference will be accessible approximately two hours following the end
of the call and will be archived through June 4, 2007.
The live conference call dial-in number is: 1-800-811-8845 (U.S./Canada)
1-913-981-4905 (International)
To access a replay of the call: 1-888-203-1112 (U.S./Canada)
1-719-457-0820 (International)
Conference replay PIN number is: 9100469
Emisphere will simultaneously webcast 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 http://www.emisphere.com/ir.asp.
Please visit the site at least five minutes prior to start time for
instructions.
About Emisphere Technologies, Inc.
Emisphere Technologies, Inc. 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 the Emisphere website,
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 (Commission File no. 1-10615) Annual Report
on Form 10-K (File 000-17758) filed on March 6, 2007.
EMISPHERE TECHNOLOGIES, INC.
Selected Financial Information
For the three months ended March 31, 2007 and 2006
(in thousands, except share and per share data)
Condensed Statements of Operations
For the three months ended
March 31,
2007 2006
(unaudited) (unaudited)
Revenue $2,809 $1,696
Costs and expenses:
Research and development 5,451 4,517
General and administrative expenses 4,145 2.802
Depreciation and amortization 315 990
Total costs and expenses 9,911 8,309
Operating loss (7,102) (6,613)
Other income and (expense):
Beneficial conversion of convertible security - (12,215)
Investment and other income 314 123
Change in fair value of derivative instruments 3,524 (7,564)
Interest expense (624) (567)
Total other income and (expense) 3,214 (20,223)
Net loss $(3,888) $(26,836)
Net loss per share, basic $(0.14) $(1.13)
Net loss per share, diluted $(0.26) $(1.13)
Weighted average shares outstanding, basic 28,311,744 23,666,389
Weighted average shares outstanding, diluted 28,618,574 23,666,389
Condensed Balance Sheets
March 31, December 31,
2007 2006
(unaudited) (unaudited)
Assets:
Cash, cash equivalents, and investments $15,615 $21,533
Accounts receivable 2,731 216
Prepaid expenses and other current assets 977 1,082
Total current assets 19,323 22,831
Equipment and leasehold improvements, net 2,413 2,652
Purchased technology, net 1,735 1,794
Other assets 807 815
Total assets $24,278 $28,092
Liabilities and stockholders' deficit:
Current liabilities $8,041 $9,454
Notes payable 25,360 24,744
Stockholders' deficit (9,123) (6,106)
Total liabilities and stockholders' deficit $24,278 $28,092
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
http://www.emisphere.com/ir.asp
CONTACT:
Stewart Siskind, Emisphere Technologies,
Inc., Investor Relations, +1-914-785-4742; or Media, Dan Budwick,
BMC Communications, +1-212-477-9007, ext. 14
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