UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For the
month of May 2010
Commission
File Number 000-28508
Flamel
Technologies
(Translation
of registrant's name into English)
Parc
Club du Moulin à Vent
33
avenue du Dr. Georges Levy
69693
Vénissieux Cedex France
(Address
of principal executive offices)
Indicate by check mark whether the
registrant files or will file annual reports under cover of Form 20-F or Form
40-F.
Form 20-F
x Form 40-F
¨
Indicate by check mark whether
registrant by furnishing the information contained in this Form is also thereby
furnishing the information to the Commission pursuant to Rule 12g3-2(b) under
the Securities Exchange Act of 1934.
Yes ¨ No x
If "Yes" is marked, indicate below the
file number assigned to the registrant in connection with Rule
12g3-2(b): 82-____________
INFORMATION
FILED WITH THIS REPORT
Document
Index
99.1
Press Release regarding 2010 first quarter results, dated May 5, 2010,
issued by Flamel Technologies S.A.
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
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Flamel
Technologies, S.A.
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Dated:
5 May, 2010
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By:
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/s/ Stephen H. Willard |
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Name: Stephen
H. Willard
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Title: Chief
Executive Officer
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EXHIBIT INDEX
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Exhibit
Number
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Description
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99.1
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Press
Release regarding 2010 first quarter results, dated May 5, 2010,
issued by Flamel Technologies
S.A.
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Flamel
Technologies Announces Expanded Partnership Relations; First Quarter
Results
LYON, France – May 5, 2010 –
Flamel Technologies (Nasdaq: FLML) today announced its financial results for the
first quarter of 2010. Highlights from the first quarter and the
period since the Company’s last conference call included:
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·
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Entering
into three new feasibility relationships, including one with a new
top-five pharmaceutical partner;
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·
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Expiration
of Hatch Waxman exclusivity for Coreg CR® with no generic formulation yet
approved;
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·
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The
Company filed a citizen’s petition with the FDA requesting that any
generic formulation be held to the same standards regarding minimum blood
plasma concentrations over 24 hours (Cmin) as Coreg CR;
and
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·
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Continued
progress with existing programs with Pfizer, Merck-Serono, Baxter, and
other unnamed partners.
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For the
first quarter 2010, Flamel reported total revenues of $8.1 million versus $12.1
million in the year-ago period; first quarter revenues in the year-ago period
included a $4 million milestone from GlaxoSmithKline
(GSK). License and research revenues during the first quarter
of 2010 were $ 3.4 million versus $7.1 million in the first quarter
2009. Excluding milestones, license and research revenue grew by 10%
year-over-year. Product sales and services, pursuant to the Company’s
supply contract with GSK, were $2.3 million versus $2.4 million in the year-ago
quarter. Other revenues in the first quarter, consisting primarily of
royalty revenues from GSK related to sales of Coreg CR, were $2.3 million as
compared to $2.5 million in the year-ago quarter.
Operational
expenses in the first quarter 2010 were $12.1 million versus $10.9 million in
the year-ago quarter. Costs of goods and services sold in the quarter
were $1.9 million, as compared to $2.1 million in the first quarter of
2009. Costs and expenses of Flamel's research and development were
$7.3 million, compared to $5.9 million in the first quarter of
2009. SG&A expenses during the quarter remained constant at a
level of $2.9 million.
Net loss
for the first quarter 2010 was ($4.0) million as compared to a net gain of $1.2
million in the first quarter of 2009. Net loss per share
(basic) for the first quarter of 2010 was ($0.17), compared to a net gain per
share (diluted) in the year-ago period of $0.05. Cash and marketable
securities at the end of the first quarter totaled $35.3 million versus $39.1
million at the end of the first quarter 2009.
Stephen
H. Willard, Flamel’s Chief Executive Officer, stated, “We are pleased to have
expanded the list of partners with whom we are working during the first
quarter. We continue to focus on these relationships to ensure the
best possible level of diversification and potential catalysts as between our
various partners and platforms. The existing programs that we are
working on are progressing well and should provide possible milestones during
the rest of the year. Our financial results are proceeding according
to budget. Many programs are in the clinic or are moving into the
clinic. Coupled with the continued royalty stream from sales of Coreg
CR, we believe these programs offer a strong foundation for the Company’s
continued success.”
Flamel
Technologies, S.A. is a biopharmaceutical company principally engaged in the
development of two unique polymer-based delivery technologies for medical
applications. Micropump® is a
controlled release and taste-masking technology for the oral administration of
small molecule drugs. Flamel's Medusa®
technology is designed to deliver controlled-release formulations of therapeutic
proteins.
A
conference call to discuss earnings is scheduled for 8:30 AM EDT May 6, 2010.
The dial-in number (for investors in the U.S. and Canada) is 1-888-516-2435. The
conference ID number is 4602187. International investors are invited
to dial (1) 719-325-2133. The webcast of the conference call will be
available on the Company’s website: www.flamel.com.
Contact:
Charles
Marlio, Director of Strategic Planning and Investor Relations
FRANCE:
+ 33 (0) 4 7278-3434
Fax: +
33 (0) 4 7278-3435
Marlio@flamel.com
This
document contains “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including certain plans, expectations,
goals and projections regarding financial results, product developments and
technology platforms. All statements that are not clearly historical
in nature are forward-looking, and the words “anticipate,” “assume,” “believe,”
“expect,” “estimate,” “plan,” will,” and similar expressions are generally
intended to identify forward-looking statements. All forward-looking
statements involve risks, uncertainties and contingencies, many of which are
beyond our control, 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. All forward-looking
statements included in this release are based on information available at the
time of the release. We undertake no obligation to update or alter
our forward-looking statements as a result of new information, future events or
otherwise.
Schedule
Attached
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts
in thousands of dollars except share data)
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Three
months ended March 31,
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2009
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2010
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Revenue:
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License
and research revenue
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$ | 7,089 | $ | 3,441 | ||||
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Product
sales and services
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2,422 | 2,305 | ||||||
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Other
revenues
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2,543 | 2,341 | ||||||
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Total
revenue
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12,054 | 8,087 | ||||||
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Costs
and expenses:
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Cost
of goods and services sold
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(2,050 | ) | (1,925 | ) | ||||
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Research
and development
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(5,919 | ) | (7,261 | ) | ||||
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Selling,
general and administrative
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(2,946 | ) | (2,931 | ) | ||||
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Total
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(10,915 | ) | (12,117 | ) | ||||
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Profit (loss)
from operations
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1,139 | (4,030 | ) | |||||
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Interest
income net
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118 | 112 | ||||||
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Foreign
exchange gain (loss)
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(74 | ) | 14 | |||||
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Other
income (loss)
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7 | 3 | ||||||
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Income
(loss) before income taxes
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1,190 | (3,901 | ) | |||||
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Income
tax benefit (expense)
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0 | (123 | ) | |||||
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Net
income (loss)
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$ | 1,190 | $ | (4,024 | ) | |||
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Earnings
(loss) per share
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Basic
earnings (loss) per ordinary share
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$ | 0.05 | $ | (0.17 | ) | |||
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Diluted
earnings (loss) per share
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$ | 0.05 | $ | (0.17 | ) | |||
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Weighted
average number of shares outstanding (in thousands) :
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Basic
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24,205 | 24,343 | ||||||
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Diluted
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24,372 | 24,343 | ||||||