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

Flamel Technologies, S.A.

(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 þ                    Form 40-F o

     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 o                    No þ

     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 2007 Fourth Quarter and Year End Results, dated March 3, 2008
99.2		Press Release regarding board and management changes, dated March 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.

Exhibit 99.1

For Immediate Release

Flamel Technologies Announces Fourth Quarter and
Year-End Results

Fourth quarter includes strong clinical results; new agreements;
and cash maintained at $41 million.

Lyon, France — March 3, 2008 — Flamel Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarter and year ended December 31, 2007. The major achievements of the fourth quarter were the completion of clinical trials on FT-105 basal insulin and IFN-Alpha XL, as well as the announcement that Flamel and Merck Serono had entered into a development agreement on a Merck Serono therapeutic protein.

Stephen H. Willard, Flamel’s chief executive officer, stated, “From both the business development and the scientific perspective, 2007 was an important year for Flamel. In March, our partner GSK launched Coreg CR™, the first marketed drug using Flamel’s drug delivery technology. We believe that COREG CR is well positioned to be a significant contributor to our future results because of its strengths as a product.”

Mr. Willard continued, “During 2007, a major focus of our Company was to establish new relationships with interested partners and to develop our internal projects and technology platforms. We succeeded in re-establishing and strengthening the Medusa^® platform by creating 10 new Medusa relationships, including those with Merck Serono and Wyeth. These relationships are a strong, well-diversified foundation for us to build the Medusa platform. Most importantly, the results of the two clinical trials we completed in October on FT-105 basal insulin and Interferon Alpha XL are compelling proof of concept for those two products and we are actively seeking to license these products.”

Flamel’s Fourth Quarter Results

Flamel reported total revenues for the fourth quarter 2007 of $10.6 million, versus total revenues of $7.8 million in the year-ago period. License and research revenue totaled $3.4 million during the fourth quarter versus $5.6 million during the year-ago period. Fourth quarter license and research revenue in 2006 included the receipt of a $3 million milestone from GSK; license and research revenue in Q4 2007 included receipt of $2 million in milestone payments from GSK. Product sales and services during the period were $4.7 million versus $2.1 million during the year-ago period. Other revenues were $2.4 million and consisted primarily of royalty income from GSK on the sales of COREG CR; other revenues in the fourth quarter of 2006 were $0.1 million.

Total costs and expenses during the quarter were $18.1 million and included FAS 123R options-related expense of $2.2 million; total costs and expenses in the fourth quarter of 2006 were $16.2 million. Costs of goods and services sold were $4.9 million in the fourth quarter of 2007 versus $1.4 million in the year-ago period. Research and development costs in the fourth quarter totaled $9.6 million versus $10.3 million in the year-ago period. Selling, general, and administrative costs declined to $3.6 million in the period from $4.6 million in the fourth quarter of 2006.

Net loss for the fourth quarter of 2007 was ($5.4 million) versus a net loss of ($5.9 million) in the year-ago period. Net loss per share (basic) was ($0.23) versus ($0.25) in the fourth quarter of 2006.

Flamel’s cash and marketable securities were $41.1 million at the end of the fourth quarter.

Flamel’s 2007 Annual Results

For the calendar year 2007, Flamel reported operating revenue of $36.7 million, as compared to $23.0 million in 2006. License and research revenue was $10.3 million in 2007, as compared to $20.3 million in 2006. Product sales and services for the year 2007 were $19.8 million, compared to $2.1 million in the year-ago period. Other revenues, consisting primarily of royalty income from sales of COREG CR by GlaxoSmithKline, were $6.6 million in 2007; other revenues in 2006 totaled $0.7 million.

Expenses in 2007 were $77.0 million and included FAS 123R options-related expenses of $11.5 million. Total costs and expenses in 2006 totaled $61.9 million. The increase in expenses was largely due to costs associated with the manufacture of COREG CR microparticles, pursuant to the Company’s supply agreement with GSK. Costs of goods and services sold were $17.3 million in 2007 versus $6.2 million in 2006.

SG&A in 2007 declined to $16.4 million versus $17.4 million in 2006. Research & Development expenses were $43.3 million versus $38.2 million in 2006. At a comparable exchange rate, SG&A and Research and Development Expense respectively would have been $15.0 million and $39.7 million, representing a reduction of $2.4 million in SG&A and an increase of $1.4 million in Research and Development.

The Company reported a net loss for the year 2007 of ($37.2 million), or ($1.55) per share, as compared with a net loss of ($35.2 million) in 2006, or ($1.48) per share.

About Flamel Technologies

Flamel Technologies is a drug delivery company with two intellectual property platforms: Micropump, for the controlled release of drugs best absorbed in the small intestine; and Medusa, for the controlled release of proteins, peptides, and other molecules injected subcutaneously. Both of these platforms offer advantages with respect to efficacy and the reduction of side-effects, in addition to the obvious benefits associated with more convenient dosing regimens. For detailed company information, including copies of this and other press releases, see Flamel’s web site www.flamel.com.

A conference call to discuss these results is scheduled for 8:30 AM Eastern Standard Time March 4, 2008. The dial-in number is (1) 800-374-1498 (Conference ID number: 36447833). International callers are invited to dial-in (1) 706-634-7261.

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. For further information on the Company, please review Flamel’s Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2006.

Contact:

Stephen H. Willard, Chief Executive Officer
Tel: (33) 4-7278-3434
Fax: (33) 4-7278-3435
Willard@Flamel.com

Charles Marlio, Director of Strategic Planning and Investor Relations
Tel: (011) (33) 4-7278-3434
Fax: (011) (33) 4-7278-3435
Marlio@flamel.com

Condensed Consolidated Statements of Operations
(amounts in thousands, except per share data)

		Three months ended								Twelve months ended
		December 31,								December 31,
		2006				2007				2006				2007
Revenue:
License and research revenue		$	5,586			$	3,416			$	20,263			$	10,307
Product sales and services			2,064				4,726				2,083				19,768
Other revenues			132				2,419				674				6,579
Total revenue			7,782				10,561				23,020				36,654
Costs and expenses:
Cost of goods and services sold			(1,355	)			(4,877	)			(6,250	)			(17,307	)
Research and development			(10,322	)			(9,648	)			(38,233	)			(43,314	)
Selling, general and administrative			(4,571	)			(3,603	)			(17,375	)			(16,390	)
Total			(16,248	)			(18,128	)			(61,858	)			(77,011	)
Profit (loss) from operations			(8,466	)			(7,567	)			(38,838	)			(40,357	)
Interest income net			623				370				1,987				1,675
Foreign exchange gain (loss)			(196	)			(143	)			(599	)			(454	)
Other income (loss)			30				143				131				197
Income (loss) before income taxes			(8,009	)			(7,197	)			(37,319	)			(38,939	)
Income tax benefit (expense)			2,152				1,752				2,118				1,694
Net income (loss)		$	(5,857	)		$	(5,445	)		$	(35,201	)		$	(37,245	)
Earnings (loss) per share
Basic earnings (loss) per ordinary share		$	(0.25	)		$	(0.23	)		$	(1.48	)		$	(1.55	)
Diluted earnings (loss) per share		$	(0.25	)		$	(0.23	)		$	(1.48	)		$	(1.55	)
Weighted average number of shares outstanding (in thousands) :
Basic			23,812				24,024				23,812				24,024
Diluted			23,812				24,024				23,812				24,024

Exhibit 99.2

For Immediate Release

Flamel Technologies Announces Nomination of Dr. Frank Fildes to
Board of Directors

Flamel Technologies also announces departure of Michel Finance and
appointment of Sian Crouzet

Lyon, France — March 3, 2008 — Flamel Technologies (Nasdaq: FLML) announced today that the Board of Directors has elected Dr. Frank J. Fildes, PhD to serve as a member of the Company’s Board of Directors. Dr. Fildes was elected to replace Cor Boonstra, who is retiring from his position with Flamel. Dr. Fildes will also assume Mr. Boonstra’s position on the Audit Committee of the Company.

Dr. Fildes is the former Senior Vice President: Head of Global Development for AstraZeneca, PLC, where he was responsible for the development, registration, and technical support of AstraZeneca products worldwide. He currently serves as a director of ProStrakan Group PLC and Piramed, Ltd. He also serves as a member of the Scientific Advisory Board of UCB Pharmaceuticals; as a member of the Portfolio Review Board of Ferring Pharmaceuticals; and as a member of the New Agents Development Committee for Cancer Research UK, the United Kingdom’s leading cancer charity. Dr. Fildes is a Fellow of the Royal Society of Medicine and the Royal Society of Chemistry.

Dr. Fildes commented, “In recent months, I have had the opportunity for an in-depth review of Flamel’s technology platforms with its scientists and technologists, and I believe that Flamel offers clinically and commercially compelling drug delivery solutions to pharmaceutical and biotechnology companies. I am delighted to be asked to serve as a member of Flamel’s Board of Directors.”

“The Board of Directors and the entire Flamel team are looking forward to working more closely with Dr. Fildes, who adds a further wealth of pharmaceutical experience and scientific knowledge to our Board,” said Elie Vannier, the chairman of the Board of Directors of Flamel Technologies. Stephen H. Willard, Flamel’s chief executive officer added: “Dr. Fildes’ drug development roles at AstraZeneca are of obvious help to us in every aspect of our work. Furthermore, as a Ph.D in polymer chemistry, he intimately understands the fundamental science that underpins our technology offerings to clients. Dr. Fildes has developed a close relationship with many of our top scientists. We all are pleased and honored that he has agreed to be nominated to serve the Company as a member of our Board of Directors.”

Mr. Vannier and Mr. Willard continued: “We would also like to express our deep appreciation and that of our fellow directors for the intelligence, no-nonsense approach, and time that Cor Boonstra has dedicated to Flamel Technologies since 2005. He has been a wonderful resource of business acumen and has contributed in many ways to our Company over the past few years. He will always have our thanks for all his efforts on our behalf, and our board will sincerely miss him.”

Flamel Technologies also announced today that Michel Finance, Executive Vice President and Chief Financial Officer, will be leaving the Company to pursue other interests. Sian Crouzet, Flamel’s Financial Controller will assume the role of Principal Financial Officer.

Mrs. Crouzet has served the company as Flamel’s Financial Controller since 2005. Mrs. Crouzet previously worked as Financial Controller France for McCormick & Company Inc. Previous to that, she was an external auditor with Ernst and Young. She is a UK Chartered Accountant and a graduate of Bradford University.

Mr. Willard stated, “I wish to thank Michel Finance for his work over the past two and a half years and wish him well in his future endeavors. We are very fortunate to have Sian’s experience and practical knowledge of the Company which has been developed as our Controller over the past two and a half years. I am looking forward to working with her in her new role as Principal Financial Officer.”

A conference call to discuss Flamel’s fourth quarter and 2007 annual results is scheduled for 8:30 AM Eastern Standard Time March 4, 2008. The dial-in number is (1) 800-374-1498 (Conference ID number: 36447833). International callers are invited to dial-in (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. Flamel’s Medusa^® technology is designed to deliver controlled-release formulations of therapeutic proteins and peptides, without reduction in bioactivity. Micropump^® is a controlled release and taste-masking technology for the oral administration of small molecule drugs; it is the intellectual platform licensed by GlaxoSmithKline for the development of COREG CR™.

Contact:

Stephen H. Willard, Chief Executive Officer
Tel: (33) 4-7278-3434
Fax: (33) 4-7278-3435
Willard@Flamel.com

Charles Marlio, Director of Strategic Planning and Investor Relations
Tel: (33) 4-7278-3434
Fax: (33) 4-7278-3435
Marlio@flamel.com

This document contains a number of matters, particularly as related to financial projections and 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 presentation 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, 2006.