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FLAMEL TECHNOLOGIES S.A. REPORTS SECOND QUARTER 1997 RESULTS

LYON, FRANCE, JULY 31, 1997 -- Flamel Technologies S.A. (NASDAQ: FLML) today announced financial results for the second quarter ended June 30, 1997. For the second quarter, the Company had a net loss of $2.2 million, compared with $2.4 million in the comparable quarter of 1996. The net loss per share for the second quarter of 1997 was $0.22, compared to $0.28 for the same period a year ago.

Revenues for the quarter ended June 30, 1997 were $1.3 million, up from $0.9 million in the second quarter of 1996. Revenues for the second quarter of 1997 included $1.0 million from the sales of Cimetidine formulations to SmithKline Beecham Laboratoires Pharmaceutiques in accordance with the subcontracting agreement signed as a part of the purchase by the Company of SmithKline's Pessac, France, manufacturing plant, effective January 1, 1997.

For the first six months of 1997 the Company had a net loss of $3.9 million, or $0.38 per share, compared to $3.9 million, or $0.51 per share, in the first six months of 1996. Revenues for the first six months of 1997 were $3.5 million, compared to $3.0 million in the first six months of 1996. The revenues for 1997 include $2.0 million from the sales of Cimetidine formulations to SmithKline, while the revenues for 1996 included a payment of $1.5 million received from G.D. Searle & Co., in the first quarter of 1996 as a non-recurring licensing fee. Dr. Gérard Soula, President and Chief Executive Officer of Flamel, noted that, "Research and development costs for the second quarter of 1997 were $2.2 million, an increase of $0.7 million over the same period a year ago. This increase, reflects both the higher level of spending on clinical trials -- principally the cost of conducting a Phase III study with Viropump, Flamel's twice-daily controlled-relief acyclovir -- and the increase in research and development staff between the two periods. This significantly higher internal R&D effort reflects a strong push by the Company on our Medusa® protein and peptide delivery system, principally focused on preclinical development of our Basulin™ long-acting insulin formulation for the treatment of diabetes."

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 -- through programs including Micropump and Medusa in drug-delivery, ColCys in biomaterial-based medical devices, and new materials for ophthalmic lens products -- to meet important unmet medical needs and develop other commercially valuable products.

NOTE: This press release contains statements which constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties, including but not limited to, the risk associated with the Company's limited history of operations and historic and future losses, and the risk 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, reliance on outside parties and 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.
CONSOLIDATED STATEMENT OF OPERATIONS
(In thousands, except per share data)

 

Three months ended
June 30,

Six months ended
June 30,

 

1997

1996

1997

1996

Revenue:
 
 
 
 
License and research revenue
$ 322
$ 560
$ 906
$2,580
Product sales
951
322
1,956
321
Laboratory analysis services
58
17
137
119
Other revenues
--
--
461
5
Total revenue
1,331
899
3,460
3,025
 
 
 
 
 
Costs and expenses:
 
 
 
 
Cost of goods sold
(834)
(232)
(1,729)
(232)
Cost of laboratory analysis services
(51)
(15)
(108)
(65)
Research and development
(2,204)
(1,485)
(4,584)
(4,070)
Selling, general and administrative
(797)
(678)
(1,516)
(1,225)
Stock compensation expense
(49)
(1,051)
(98)
(1,643)
Total cost and expenses
(3,935)
(3,461)
(8,035)
(7,235)
 
 
 
 
 
Loss from operations
(2,604)
(2,562)
(4,575)
(4,210)
 
 
 
 
 
Interest income (expense), net
138
(5)
225
(10)
Foreign exchange gain
20
21
28
76
Loss before income taxes
(2,446)
(2,546)
(4,322)
(4,144)
Income tax benefit
228
123
402
233
Net loss
$ (2,218)
$ (2,423)
$ (3,920)
$ (3,911)
 
 
 
 
 
Net loss per ordinary share
$ (0.22)
$ (0.28)
$ (0.38)
$ (0.51)
 
 
 
 
 
Weighted average number of ordinary and ordinary equivalent shares outstanding
10,301
8,721
10,290
7,724