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FLAMEL TECHNOLOGIES REPORTS FIRST QUARTER 1998 RESULTS

LYON, FRANCE, April 28, 1998 -- Flamel Technologies S.A. (NASDAQ: FLML) today announced financial results for the first quarter ended March 31, 1998.

Total revenue of $2.2 million for the quarter included a milestone payment from G.D. Searle & Co. for the UK approval of AsacardÔ, manufacturing revenues from the sale of photochromic material to Corning Incorporated, the sale of cimetidine formulations to SmithKline Beecham, an initial shipment of Asacard microparticles to Searle, and research and development funding from Monsanto Company and Corning. In 1997, total revenue in the first quarter was $2.1 million and included a research milestone payment from SmithKline, sales of cimetidine formulations and other revenue associated with the Company’s arrangements related to its purchase of a pharmaceutical manufacturing facility from SmithKline, and research and development funding from Corning.

Total costs and expenses were $4.9 million in the first quarter of 1998, compared to $4.1 million reported in the first quarter of 1997. An increase in research and development personnel, an increase in clinical trial expenses and new product manufacturing start-up costs account for the overall increase in total expenses. For the quarter, the Company reported a net loss of $2.4 million, or $0.22 per share, compared to a net loss of $1.7 million, or $0.16 per share, in the same quarter last year. The Company ended the quarter with $9.3 million in cash and investments.

"During the first quarter of 1998, we began to see tangible results from our efforts of the past year. The January receipt of the UK regulatory approval for Asacard, our controlled-release cardiovascular aspirin, was a significant event in Flamel’s history. This approval paves the way for the launching of the Company’s first commercial product by G.D. Searle, our European licensee. Additionally, in the quarter, we began manufacturing the second generation photochromic eyeglass lens material developed through our collaborative relationship with Corning," commented Dr. Gerard Soula, President and Chief Executive Officer.

 Flamel Technologies is engaged in the development of advanced polymer technologies for unique drug delivery and biomaterial applications. The Company is building on its principal technology platforms — the delivery of active ingredients with its Micropump® and Medusa® drug delivery systems, its AgsomeÔ delivery system for agrochemical active ingredients, its ColcysÔ biomaterial-based medical devices, and photochromic materials for ophthalmic lens products — to meet important medical needs and develop other commercially valuable products.

AsacardÔ, AgsomeÔ, BasulinÔ and ColcysÔ are trademarks, and Micropump® and Medusa® are registered trademarks of Flamel Technologies.

Note: This press release contains statements which may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to the risks and uncertainties, including, but not limited to, the risk associated with the Company’s limited history of operations and historic and future losses, the risk that products in the development stage may not achieve scientific objectives or milestones or meet regulatory requirements, uncertainties regarding market acceptance of products in development, the impact of competitive products and pricing, reliance on outside parties including the risks associated with key strategic alliances, and other risks detailed in the Company’s filings with the Securities and Exchange Commission.

FLAMEL TECHNOLOGIES S.A.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands of dollars except share data)

 

Three months ended
March 31

Three months ended
March 31

 

1997

1998

Revenue:    
License and research revenue $ 584 $ 985
Product sales and services 1,084 1,235
Other revenues 461 -
Total revenue 2,129 2,220
     
Costs and expenses:    
Cost of goods and services (952) (1,265)
Research and development (2,380) (2,821)
Selling, general and administrative (719) (840)
Stock compensation expense (49) (20)
Total costs and expenses (4,100) (4,946)
     
Loss from operations (1,971) (2,726)
     
Interest income (expense), net 87 149
Foreign exchange gain (loss) - 8 -
Loss before income taxes (1,876) (2,577)
Income tax benefit 174 156
Net loss $ (1,702) $ (2,421)
     
Net loss per ordinary share $ (0.16) $ (0.22)
     
Weighted average number of ordinary shares outstanding 10,278 10,924