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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 2008
Commission File Number 000-28508
Flamel Technologies S.A.
(Translation of registrants 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.
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.
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 third quarter 2008 results, dated November 3, 2008.
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 3, 2008
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By:
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/s/ Stephen H. Willard
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Name:
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Stephen H. Willard
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Title:
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Chief Executive Officer |
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EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
99.1
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Press release regarding third quarter 2008 results, dated November 3, 2008. |
exv99w1
Exhibit 99.1
Flamel Technologies Announces Third Quarter Results and
New Medusa Agreement
LYON, France November 3, 2008 Flamel Technologies (NASDAQ: FLML) today announced its financial
results for the third quarter of 2008.
For the third quarter of 2008, Flamel reported total revenues of $9.1 million, compared to $9.0
million in the year-ago period. Flamels total costs and expenses during the quarter declined 25%
to $13.8 million from $18.3 million in the third quarter of 2007.
Total net loss for the third quarter 2008 was ($2.3) million, as compared to ($9.1) million in the
third quarter of 2007. Net loss in the quarter, excluding non-cash FAS 123R compensation-related
expenses, was ($1.1) million; the comparable loss in 2007 was ($6.3) million. Net loss per share
(basic) for the quarter was ($0.10), compared to a net loss per share (basic) in the year-ago
quarter of ($0.38).
Cash and marketable securities at the end of the third quarter totalled $32.8 million, versus $34.5
million at the end of the second quarter. The decline was entirely due to currency translation
effects; virtually all cash and marketable securities are held in Euros and increased during the
quarter by 1.1 million.
License and research revenues increased during the quarter to $3.1 million from $2.0 million in the
third quarter of 2007. Product sales during the quarter were $3.0 million, a decline from $4.8
million in the third quarter 2007. Other revenues, which include royalties from Coreg CR, were
$3.0 million versus $2.2 million in the third quarter 2007.
Research and development expenses were $8.2 million versus $9.9 million in the year-ago quarter.
Selling, general, and administrative expenses during the quarter were reduced to $2.9 million from
$4.1 million in the third quarter of 2007. Costs of goods and services sold in the third quarter
were $2.6 million versus $4.3 million in the third quarter 2007.
For the first nine months of 2008, Flamel total revenues grew to $29.2 million, from $26.1 million
in the year-ago period. Expenses were reduced by 25% during this period, from $58.9 million in the
first three quarters of 2007 to $44.4 million in the same period of 2008.
Net loss in the first three quarters of 2008 was ($9.4) million compared to a net loss of ($31.8)
million in the first three quarters of last year. Excluding non-cash compensation expense, the net
loss was ($3.1 million) as compared to ($22.5) million in the first three quarters of 2007. Net
loss per share (basic) for the first nine months of 2008 was ($0.39), compared to net loss per
share (basic) in the year-ago period of ($1.32).
Flamels license and research revenues increased during the first nine months of 2008 to $9.8
million, versus $6.9 million in the year-ago period. Product sales and services during the period declined to $10.9 million, from $15.0 million in the first three quarters of 2007. Other
revenues, which are composed primarily of royalties from the sale of Coreg CR, were $8.4 million
during the period, as compared to $4.1 million in the first three quarters of 2007.
Flamels research and development expenses in the first three quarters of 2008 were $26.5 million,
as compared to $33.7 million in the year-ago period. Cost of goods and services sold were $7.3
million, as compared to $12.4 million in the first three quarters of 2007. SG&A declined to $10.7
million from $12.8 million during the first three quarters of 2007.
Since our last conference call, Flamel has continued to expand the portfolio of development
agreements with partner companies by signing a further Medusa feasibility project, said Stephen H.
Willard, chief executive officer of Flamel Technologies. The agreement is with a top five pharma
company, based on revenue, with whom we had not previously had a relationship. We also received a
payment from Wyeth Pharmaceuticals and have had good scientific progress in the feasibility studies
we had commenced earlier, including the program that we signed late last year with Merck Serono.
We now have 15 ongoing projects and are working with five of the top ten pharma companies in the
world, and seven of the top twenty. Three of these relationships involve multiple projects in
multiple indications, which serve to further diversify our growth prospects.
A conference call to discuss earnings is scheduled for 8:30 AM ET November 4, 2008. The dial-in
number (for investors in the US and Canada) is 1-800-374-1498; the conference ID number is
71106766. International investors are invited to dial 1-706-634-7261.
Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of
two unique polymer-based delivery technologies for medical applications. Flamels Medusa®
technology is designed to deliver controlled-release formulations of therapeutic proteins and
peptides. Micropump® is a controlled release and taste-masking technology for the oral
administration of small molecule drugs.
Contact:
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 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 Flamels 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. You should not place undue reliance on these
forward-looking statements. These and other risks are described more fully in Flamels Annual Report on the Securities and Exchange
Commission Form 20-F for the year ended December 31, 2007.
Financial Statements (Unaudited)
CONDENSED CONSOLIDATED STATEMENTS 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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2007 |
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2008 |
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2007 |
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2008 |
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Revenue: |
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License and research revenue |
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$ |
1,973 |
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$ |
3,140 |
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$ |
6,891 |
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$ |
9,841 |
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Product sales and services |
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4,824 |
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3,023 |
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15,042 |
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10,918 |
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Other revenues |
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2,222 |
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2,972 |
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4,160 |
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8,394 |
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Total revenue |
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9,019 |
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9,135 |
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26,093 |
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29,153 |
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Costs and expenses: |
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Cost of goods and services sold |
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(4,251 |
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(2,613 |
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(12,430 |
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(7,263 |
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Research and development |
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(9,908 |
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(8,239 |
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(33,666 |
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(26,476 |
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Selling, general and administrative |
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(4,124 |
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(2,899 |
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(12,787 |
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(10,659 |
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Total |
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(18,283 |
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(13,751 |
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(58,883 |
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(44,398 |
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Profit (loss) from operations |
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(9,264 |
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(4,616 |
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(32,790 |
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(15,245 |
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Interest income net |
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411 |
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377 |
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1,305 |
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1,127 |
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Foreign exchange gain (loss) |
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(229 |
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220 |
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(311 |
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76 |
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Other income (loss) |
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16 |
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58 |
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54 |
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159 |
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Income (loss) before income taxes |
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(9,066 |
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(3,961 |
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(31,742 |
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(13,883 |
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Income tax benefit (expense) |
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(40 |
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1,657 |
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(58 |
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4,525 |
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Net income (loss) |
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$ |
(9,106 |
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$ |
(2,304 |
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$ |
(31,800 |
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$ |
(9,358 |
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Earnings (loss) per share |
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Basic earnings (loss) per ordinary share |
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$ |
(0.38 |
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$ |
(0.10 |
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$ |
(1.32 |
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$ |
(0.39 |
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Diluted earnings (loss) per share |
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$ |
(0.38 |
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$ |
(0.10 |
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$ |
(1.32 |
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$ |
(0.39 |
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Weighted average number of shares outstanding (in thousands) : |
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Basic |
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24,042 |
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24,077 |
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24,017 |
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24,066 |
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Diluted |
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24,042 |
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24,077 |
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24,017 |
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24,066 |
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