Flamel Technologies Announces Third Quarter 2009 Results; Additional New Projects; Cash Increases from $45.1 to $48.8 million
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FLML | Quote | Chart | News | PowerRating -- Flamel Technologies (Nasdaq:FLML) today announced its financial results
for the third quarter of 2009. Highlights in the third quarter included:
--
Significant technical and preclinical success in moving forward with
our existing projects.
--
the signing of two further projects, one for Medusa(R) for
potentially multiple molecules, and the other for a Micropump(R)
formulation; and
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an increase in the Company's cash and marketable securities from $45.1
million at the end of the first quarter to $48.8 MM.
Stephen H. Willard, Flamel's chief executive officer, commented, "In
addition to our continued success in attracting new projects and new
partners, we are reaching a stage where many of our existing projects
are generating positive results. This is important as they will create
the opportunities to move these formulations forward through the
regulatory pipeline. "
"This success is seen not only with delivery of proteins and peptides,
but also with the expansion into a variety of other types of therapeutic
agents. We are demonstrating the ability to show in vivo
success with therapies other than subcutaneous injection, as most
recently demonstrated in our recent agreement with Pfizer regarding
intravenous delivery using our Medusa(R) technology."
"Flamel is currently working on multiple projects, including those with
GSK, Merck Serono, Pfizer, and Baxter. We are diversified across both
new and existing molecules, in a variety of therapeutic areas. While we
will continue to seek new partners and new applications, I expect the
focus increasingly to shift to the success and ramp-up of some of our
most promising existing programs."
Flamel reported total revenues in the third quarter 2009 of $9.9
million, up from $9.1 million in the year-ago period. License and
research revenues grew to $4.7 million versus $3.1 million in the third
quarter of 2008. Product sales and services totaled $2.7 million during
the quarter versus $3.0 million in the third quarter, 2008. Other
revenues during the third quarter of 2009, including royalties on the
sale of Coreg CR(TM), were $2.5 million versus $3.0 million in the year-ago
period.
Costs and expenses during the third quarter of 2009 were $(15.0) million
versus $(13.8) million in the year-ago period. Costs of goods and
services sold in the quarter remained constant at $(2.6) million for the
third quarter of both 2008 and 2009. Research and development expenses
were $(9.3) million versus $(8.2) million in the third quarter of 2008.
SG&A increased to $(3.1) million from $(2.9) million in the year-ago
period.
Net loss in the third quarter of 2009 was $(3.4) million, compared to a
net loss of $(2.3) million in the third quarter of 2008. Net loss per
share (basic) for the third quarter of 2009 was ($0.14), compared to a
net loss per share (basic) in the year-ago period of ($0.10).
Cash and marketable securities at the end of the third quarter totaled
$48.8 million versus $45.1 million at the end of the second quarter,
2009. This marked the fourth consecutive quarter that the Company
increased its cash and marketable securities position.
For the nine months of 2009, Flamel reported total revenues of $31.5
million versus $29.2 million in the first nine months of 2008. License
and research revenues during the period were $16.2 million versus $9.8
million in the year-ago period. Product sales and services during the
first nine months of 2009 were $7.6 million versus $10.9 million in the
first nine months of 2008. Other revenues during the first nine months
of 2009 were $7.8 million versus $8.4 million in the year-ago period.
During the first nine months of 2009, total costs and expenses declined
to $(42.2) million, from $(44.4) million in the year-ago period. Costs
of goods and services sold in the first nine months of 2009 totaled
$(6.5) million versus $(7.3) million in the year-ago period. Research
and development expenses during the first nine months of 2009 were
$(26.3) million versus $(26.5) million during the year-ago period. SG&A
for the first nine months of 2009 amounted to $(9.4) million versus
$(10.7) million in the year-ago period.
Net loss in the first nine months of 2009 was $(5.7) million, compared
to a net loss of $(9.4) million in the first nine months of last year.
Net loss per share (basic) for the first nine months of 2009 was
$(0.24), compared to net loss per share (basic) in the year-ago period
of $(0.39).
A conference call to discuss earnings is scheduled for 8:30 AM EST
November 16, 2009. The dial-in number (for investors in the U.S. and
Canada) is 1-800-860-2442; the conference ID number is 435349.
International investors are invited to dial 1 412-858-4600.
Flamel Technologies, S.A. is a biopharmaceutical company principally
engaged in the development of two unique polymer-based delivery
technologies for medical applications. Micropump(R) is a
controlled release and taste-masking technology for the oral
administration of small molecule drugs. Flamel's Medusa(R)
technology is designed to deliver controlled-release formulations of
proteins, peptides, as well as other large and small molecules.
This document contains a number of matters, particularly as related
to the status of various research projects and technology platforms,
that constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. The document reflects
the current view of management with respect to future events and is
subject to risks and uncertainties that could cause actual results to
differ materially from those contemplated in such forward-looking
statements. These risks include risks that products in the development
stage may not achieve scientific objectives or milestones or meet
stringent regulatory requirements, uncertainties regarding market
acceptance of products in development, the impact of competitive
products and pricing, and the risks associated with Flamel's reliance on
outside parties and key strategic alliances. These and other risks are
described more fully in Flamel's Annual Report on the Securities and
Exchange Commission Form 20-F for the year ended December 31, 2008.
Schedule attached
Financial Statements (Unaudited)
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)
(Amounts in thousands of dollars except share data)
Three months ended September 30, Nine months ended September 30,
2008 2009 2008 2009
Revenue:
License and research revenue $3,140 $4,726 $9,841 $16,156
Product sales and services 3,023 2,651 10,918 7,602
Other revenues 2,972 2,521 8,394 7,769
Total revenue 9,135 9,898 29,153 31,527
Costs and expenses:
Cost of goods and services sold (2,613) (2,567) (7,263) (6,508)
Research and development (8,239) (9,305) (26,476) (26,288)
Selling, general and administrative (2,899) (3,138) (10,659) (9,371)
Total (13,751) (15,010) (44,398) (42,167)
Loss from operations (4,616) (5,112) (15,245) (10,640)
Interest income net 377 92 1,127 349
Foreign gain (loss) 220 (140) 76 (288)
Other income 58 4 159 13
Loss before income taxes (3,961) (5,156) (13,883) (10,566)
Income tax benefit 1,657 1,774 4,525 4,824
Net loss ($2,304) ($3,382) ($9,358) ($5,742)
Loss per share
Basic loss per ordinary share ($0.10) ($0.14) ($0.39) ($0.24)
Diluted loss per share ($0.10) ($0.14) ($0.39) ($0.24)
Weighted average number of shares outstanding (in thousands) :
Basic 24,077 24,225 24,066 24,217
Diluted 24,077 24,225 24,066 24,217
SOURCE: Flamel Technologies, S.A.
Flamel Technologies
Charles Marlio, + (33) (0)4-7278-3434
Director of Strategic Planning and Investor Relations
Fax: + (33) (0)4-7278-3435
Marlio@flamel.com
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