Press Releases
Flamel Technologies Reports Third
Quarter 1998 Results
-Announces Clinical Trial Completion
for Genvir and Progress with Asacard-
LYON, FRANCE, October 27, 1998 – Flamel Technologies S.A. (Nasdaq: FLML) today announced financial results for the third quarter and nine-month period ended September 30, 1998.
Revenue for the quarter was $1.7 million, compared to $1.2 million for the third quarter of 1997. This increase was primarily due to contract research payments from Monsanto and French government programmes. Expenses in the quarter decreased to $4.2 million, as compared to $4.6 million in the same quarter last year, primarily due to lower external product development costs. The Company reported a net loss of $2.2 million, or $(0.17) per share, as compared to a net loss of $2.9 million, or $(0.27) per share, in the third quarter of 1997.
Total revenue for the nine months of 1998 was $6.6 million, compared to $4.7 million for the same period last year. Sales of proprietary photochromic material to Corning and additional contract research funding accounted for the increased revenues. Total costs and expenses for the nine-month period increased to $13.9 million, as compared to $12.7 million incurred last year. Higher manufacturing costs related to increased product sales and additional administrative expenses related to the financing transaction completed in June 1998 accounted for the increase in costs and expenses. The net loss for the nine month period 1998 was $6.2 million, or $(0.55) per share, versus the net loss of $6.9 million, or $(0.66) per share, reported last year. At September 30, 1998, the Company had $15.1 million in cash and investments.
"We are extremely pleased with our performance for the quarter. Favorable preliminary data for Genvir, formerly known as Viropump, and further development of applications for Asacard will contribute to Flamel’s future growth," said Gerard Soula, President and Chief Executive Officer. "Our efforts will now focus on bringing Genvir, a treatment for acute genital herpes, to a market where it could be attractively positioned compared with alternative drugs in terms of patient compliance and price. Additionally it is our intention to extend indications for Asacard beyond cardiovascular use to other traditional indications for aspirin," Soula concluded.
During the third quarter 1998, the Phase III study of Genvir was completed and initial analyses of resulting data are positive. Genvir is a controlled-release formulation of acyclovir, a twice-a-day treatment for acute genital herpes. Genvir utilizes Flamel’s proprietary Micropump™ technology that extends the duration of action of drugs best absorbed in the small intestine. The Company will file a dossier for European Union approval in the second half of 1999.
Additionally the Company realized progress with Asacard. Based on new data, Flamel now intends to extend the product to traditional indications for aspirin, such as analgesic and anti-inflammation usage. The Company believes that a high dosage form of Asacard can be used as an effective analgesic with a reduction in the gastrointestinal side-effects commonly associated with aspirin. Phase II clinical studies are underway to prove this concept.
A Phase I study of Asacard 325 mg for cardiovascular use has been completed in the US and resulting data, as expected, were consistent with the European data. However, because the US market for cardiovascular aspirin has now clearly evolved to much lower dosage forms, Flamel will defer development of Asacard 325mg for use in the US cardiovascular market. This deferment will not effect the European launch of Asacard 162.5 mg following completion of the Phase IV clinical study recently launched by G.D. Searle, Flamel’s European marketing partner.
Flamel Technologies is engaged in the development of advanced polymer technologies for unique life science applications. To meet important medical needs and develop commercially valuable products, the Company is building on its principal technology platforms: the controlled release of therapeutic drugs and proteins with its Micropump® and Medusa® system; the efficient delivery of agrochemical active ingredients with its Agsome™ system; ColCys™ biomaterial-based medical devices; and photochromic materials for eyeglass lenses.
Agsome™, Basulin™ and ColCys™ are trademarks, and Micropump® and Medusa® are registered trademarks of Flamel Technologies.
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 presentation reflects the current views of Flamel’s 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 Form 20-F dated December 31, 1997.
Flamel Technologies, Inc.
|
Nine months ended September 30 |
Nine months ended September 30 | |||
|
1997 |
1998 |
1997 |
1998 | |
| Revenue : | ||||
|
$ 1,173 |
$ 1,921 |
$ 251 |
$ 682 |
|
3,085 |
4,589 |
992 |
1,028 |
|
445 |
137 |
- |
- |
|
4,703 |
6,647 |
1,243 |
1,710 |
| Costs and expenses : |
|
|
|
|
|
(2,641) |
(3,479) |
(804) |
(940) |
|
(7,659) |
(7,544) |
(3,075) |
(2,367) |
|
(2,218) |
(2,828) |
(702) |
(861) |
|
(147) |
(72) |
(49) |
(24) |
|
(12,665) |
(13,923) |
(4,630) |
(4,192) |
|
|
|
|
| |
| Loss from operations |
(7,962) |
(7,276) |
(3,387) |
(2,482) |
|
|
|
|
| |
| Interest income, net |
426 |
244 |
201 |
72 |
| Foreign exchange gain (loss) |
28 |
(35) |
- |
(24) |
| Loss before income taxes |
(7,508) |
(7,067) |
(3,186) |
(2,434) |
| Income tax benefit |
652 |
824 |
250 |
254 |
| Net loss |
$ (6,856) |
$ (6,243) |
$ (2,936) |
$ (2,180) |
|
|
|
|
| |
|
Net loss per ordinary share |
$ (0.66) |
$ (0.55) |
$ (0.27) |
$ (0.17) |
|
|
|
|
| |
| Weighted average number of ordinary shares outstanding |
10,464 |
11,745 |
10,806 |
12,939 |
