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 November 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 third quarter results, dated November 4,
2010.
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:
November 4, 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 third quarter results, dated November 4,
2010
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For
Immediate Release
Flamel
Technologies Announces Third Quarter Results; Achievement of Second Milestone in
Fourth Quarter with Merck Serono
LYON, France—November 4,
2010--Flamel Technologies (Nasdaq:FLML) today announced its financial
results for the third quarter of 2010.
The
Company also announced today that it has achieved a further milestone in its
development program with Merck Serono, a division of Merck KGaA, Darmstadt,
Germany, for an extended release formulation of interferon-beta
1-a. According to the terms of the original development agreement
negotiated in 2007, Flamel will receive € 1 million from Merck
Serono.
Other
recent highlights in the third quarter include:
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·
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Completion
of key steps in the Company’s development program with Merck Serono on an
extended release formulation of Interferon-beta 1-a, which led to last
month’s €3 million milestone announcement regarding clinical development;
and
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·
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Signing
of two further projects: one for Medusa and the other for a Micropump
formulation.
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Stephen
H. Willard, Flamel’s chief executive officer, commented, “Our achievements with
the Merck Serono project are the product of over two years of work and mark an
important point in the Company’s development of the Medusa
platform. These two most recent milestones are further steps in the
advancement of this program, which we believe demonstrates the continued growth
of Flamel and our Medusa Platform. We are pursuing multiple projects with the
Medusa platform which we believe will progress at a fast pace in the year
ahead.”
Mr.
Willard continued, “We are increasingly discussing opportunities to leverage our
expertise in the creation of improved formulations of already-marketed molecules
with interested parties, including the creation of bio-better
opportunities. We believe that the Company is uniquely positioned for
this opportunity, as the Medusa platform has been shown to deliver improved
efficacy and safety without chemical modification of the molecule being
delivered.”
Flamel
reported total revenues in the third quarter 2010 of $8.0 million, versus $9.9
million in the year-ago period. License and research revenues were
$4.1 million versus $4.7 million in the third quarter of
2009. Product sales and services totaled $1.8 million during the
quarter versus $2.7 million in the third quarter
2009. Other revenues during the third quarter of 2010,
composed primarily of royalties on the sale of Coreg CR™, were $2.1 million
versus $2.5 million in the year-ago period.
Costs and
expenses during the third quarter of 2010 were $(11.2) million versus $(13.2)
million in the year-ago period. Costs of goods and services sold in
the quarter were $(1.5) million versus $(2.6) million in the year-ago
period. Research and development expenses were $(6.7) million versus
$(7.5) million in the third quarter of 2009. SG&A declined to
$(2.9) million from $(3.1) million in the year-ago period.
Net loss
in the third quarter of 2010 was $(3.3) million, compared to a net loss of
$(3.4) million in the third quarter of 2009. Net loss per share
(basic) for the third quarter of 2010 was ($0.14), as it was in third quarter of
2009.
Cash and
marketable securities at the end of the third quarter totaled $32.1 million
versus $33.7 million at the end of the second quarter of 2010.
For the
first nine months of 2010, Flamel reported total revenues of $23.6 million
versus $31.5 million in the first nine months of 2009. License and research
revenues during the period were $10.9 million versus $16.2 million in the
year-ago period. Product sales and services during the first nine
months of 2010 were $6.0 million versus $7.6 million in the first nine months of
2009. Other revenues during the first nine months of 2010 were $6.8
million versus $7.8 million in the year-ago period.
During
the first nine months of 2010, total costs and expenses declined to $(35.5)
million, from $(37.3) million in the year-ago period. Costs of goods
and services sold in the first nine months of 2010 totaled $(5.0) million versus
$(6.5) million in the year-ago period. Research and development
expenses during the first nine months of 2010 were $(21.8) million versus
$(21.5) million during the year-ago period. SG&A for the first
nine months of 2010 amounted to $(8.7) million versus $(9.4) million in the
year-ago period.
Net loss
in the first nine months of 2010 was $(11.7) million, compared to a net loss of
$(5.7) million in the first nine months of last year. Net loss per
share (basic) for the first nine months of 2010 was $(0.48), compared to net
loss per share (basic) in the year-ago period of $(0.24).
A
conference call to discuss earnings is scheduled for 8:30 AM EDT on November 5,
2010. The dial-in number (for investors in the U.S. and Canada) is
(1) 877-719-9799; the conference ID number is 3279524. International
investors are invited to dial (1) 719-325-4857.
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 proteins,
peptides, as well as other large and small molecules.
Charles
Marlio, Director of Strategic Planning and Investor Relations
Tel: +
(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 U.S.
federal securities laws, including statements regarding the status of various
research and development projects and technology platforms. These
statements are identified by terms such as “anticipate,” “believe,” “could,”
“estimate,” “expect,” “intend,” “may,” “should,” “plan,” “predict,” “project,”
“will,” “continue” and other similar expressions and speak as of the date they
are made. 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. We undertake no obligation to update these forward-looking statements
as a result of new information, future events or otherwise, and you should not
place undue reliance on such statements. 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, 2009.
Schedule
attached
Financial Statements
(Unaudited)
CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)
(Amounts
in thousands of dollars except share data)
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Three
months ended
September
30,
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Nine months
ended
September
30,
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2009
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2010
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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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$ | 4,726 | $ | 4,119 | $ | 16,156 | $ | 10,865 | ||||||||
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Product
sales and services
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2,651 | 1,805 | 7,602 | 5,970 | ||||||||||||
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Other
revenues
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2,521 | 2,117 | 7,769 | 6,808 | ||||||||||||
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Total
revenue
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9,898 | 8,041 | 31,527 | 23,643 | ||||||||||||
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Costs
and expenses:
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Cost
of goods and services sold
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(2,567 | ) | (1,535 | ) | (6,508 | ) | (5,045 | ) | ||||||||
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Research
and development
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(7,531 | ) | (6,702 | ) | (21,464 | ) | (21,824 | ) | ||||||||
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Selling,
general and administrative
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(3,138 | ) | (2,931 | ) | (9,371 | ) | (8,659 | ) | ||||||||
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Total
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(13,236 | ) | (11,168 | ) | (37,343 | ) | (35,528 | ) | ||||||||
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Loss
from operations
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(3,338 | ) | (3,127 | ) | (5,816 | ) | (11,885 | ) | ||||||||
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Interest
income net
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92 | 109 | 349 | 326 | ||||||||||||
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Foreign
exchange gain (loss)
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(140 | ) | (302 | ) | (288 | ) | (87 | ) | ||||||||
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Other
income
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4 | 5 | 13 | 93 | ||||||||||||
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Loss
before income taxes
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(3,382 | ) | (3,315 | ) | (5,742 | ) | (11,553 | ) | ||||||||
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Income
tax benefit (expense)*
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- | (24 | ) | - | (100 | ) | ||||||||||
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Net
loss
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$ | (3,382 | ) | $ | (3,339 | ) | $ | (5,742 | ) | $ | (11,653 | ) | ||||
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Loss
per share
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Basic
loss per ordinary share
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$ | (0.14 | ) | $ | (0.14 | ) | $ | (0.24 | ) | $ | (0.48 | ) | ||||
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Diluted
loss per share
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$ | (0.14 | ) | $ | (0.14 | ) | $ | (0.24 | ) | $ | (0.48 | ) | ||||
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Weighted
average number of shares outstanding (in thousands) :
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Basic
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24,225 | 24,423 | 24,217 | 24,391 | ||||||||||||
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Diluted
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24,225 | 24,423 | 24,217 | 24,391 | ||||||||||||
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*
Research tax credit reclassified in operational expenses for
2009
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