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Flamel Technologies Announces Fourth Quarter and Year-End Results ; 2001 Loss Per Share Narrows to $(0.18) Per Share

Lyon, France, March 12, 2002
2001 marks third year of reduced net loss per share.
Cash and account receivable increase year over year.
Flamel Technologies (Nasdaq:FLML) today announced its financial results for the fourth quarter and year ended December 31, 2001.

Flamel’s Fourth Quarter 2001 :

For the fourth quarter of 2001, Flamel reported total revenues of $4.6 million, compared to $2.5 million in the fourth quarter of 2000, including $1.4 million of income previously deferred from the initial payment Flamel received upon execution of a collaborative agreement with Novo Nordisk.
Products sales and services revenues in the fourth quarter, consisting largely of contract manufacturing income, were approximately $0.5 million, compared to $0.9 million in the fourth quarter of last year. Oter income totaled approximately $0.4 million, compared to $0.3 million.

Costs and expenses were $4.7 million in the quarter, compared to $4.1 million in the fourth quarter of the prior year. These results reflected an increase in research and development costs, while all other expenses categories declined in relation to the fourth quarter of 2000. Net loss was $(0.1) million for the fourth quarter of 2001, compared to $(1.6) million in the fourth quarter of 2000. On a per share basis, the net loss per odrinary share was $(0.00), compared with $(0.10) in the fourth quarter of 2000.

Flamel’s Calendar Year 2001 Results :

For the calendar year 2001, Flamel reported that its revenue grew to $13.1 million, an increase of 20% compared to revenues of $10.9 million in 2000. In 2001, license and research revenues totaled $9.9 million compared to $6.6 million in 2000. License and research revenues in 2001 included revenues from Novo Nordisk, Servier, Merck and Corning, as well as from other undisclosed partners. Revenues also included the recognition of $1.4 million of initial payments from Novo Nordisk which had previously been deferred and were recognized in the fourth quarter of 2001 upon termination of the licensing agreement between the two companies. Product sales and services for 2001 totaled $2.0 million, compared to $3.0 million in 2000. This revenue is the combined result of sales of photochromic materials to Corning and certain contract manufacturing for various parties, and reflected use of existing inventories of polymer dye by corning rather than the purchase of additional supplies. Other revenues in 2001 totaled $1.2 million, compared to $1.2 million reported in 2000. This largely reflects continuing royalties from Corning.

Total costs and expenses for the year were $16.2 million, compared to $16.1 million reported for the year ended December 31, 2000. Research and development expenses increased as Flamel obtained a number of new partnerships during the year and also began self-funded work on controlled-release formulations of a number of new proteins. Lower costs of goods sold related to the lower manufacturing volumes for Corning. Selling, general and administrative expenses remained constant at $3.4 million.

For the year ended December 31, 2001, the net resulting loss from operations was $2.9 million, compared to a loss from operations $4.9 million reported for the year ended December 31, 2000. In 2000, the company also recognized an accounting charge of $4.6 million ($0.30 per share) specifically related to a change in accounting principles regarding the initial payment received in December 1999 on signing a collaborative agreement with Novo Nordisk.

Net loss for Flamel in 2001 was $2.9 million, or $(0.18) per share, compared to a net loss of $9.5 million in 2000, or $(0.62) per share after accounting changes.

Cash on hand and accounts receivable totaled $12.9 million ($5.3 million and $7.6 million respectively), compared to $12.7 million at year end 2000 ($10.1 million and $2.6 million, respectively).

“We are pleased that we have ended 2001 with cash and accounts receivable at a level slightly higher than at the end of the previous year,” noted Stephen Willard, Chief Financial Officer. “We are reporting a 19% increase in revenues while holding expenses relatively constant. Our net operating loss for the year also declined 41% versus 2000, and marked the third year of decline in net loss. We remain committed to preserving a strong cash position as we exploit the results of our maturing technologies.”

“The year 2001 saw important progress with our core technologies,” reported Dr. Gerard Soula, Flamel's President and Chief Executive Officer. “With our Micropump® technology, we announced significant licensing deals with Merck & Co., Inc. and Servier, and partnerships with two other major pharmaceutical companies which remain undisclosed. We completed human proof of concept studies for a controlled-release antibiotic, a controlled-release antidiabetic (metformin) and a controlled-release ACE inhibitor, which has been licensed to Servier. Together with our controlled-release antiviral, Genvir™, we believe that we have a rich portfolioof proven applications for Micropump® which we will seek to license aggressively. With our controlled-release protein technology, Medusa®, we have completed an improved formulations of insulin which is ready for clinical trials and we have six other products in development either in partnership or in house. Together, we believe that our core technologies have wide potential applications and are becoming widely recognized among major worldwide pharmaceutical companies. We believe that this will ultimately result in potential benefits for our company and its stockholders.”

 

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(R) nano-encapsulation technology is designed to deliver therapeutic proteins. Micropump(R) is a controlled release and taste-masking technology for the oral administration of small molecule drugs.

Flamel's expertise in polymer science has also been instrumental in the development of a photochromic eyeglass lens product now marketed by Corning Inc. Additionally, Flamel has developed new herbicide delivery systems now being tested by Monsanto and has patented a biomaterial, ColCys(TM).

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 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, 1999.

FLAMEL TECHNOLOGIES S.A.
CONSOLIDATED STATEMENT OF OPERATIONS
(Amounts in thousands, except per share data)

 

Three months ended
December 31

Twelve months ended
December 31

2001
US
Dollars

2000
US
Dollars

2001
US Dollars

2000
US Dollars

REVENUES

       

License and research revenue

3,629

1,345

9,858

6,619

Product sales and services

516

859

2,009

3,034

Other revenues

406

271

1,220

1,249

Total Revenues

4,561

2,475

13,087

10,902

COSTS and EXPENSES

       

Cost of goods and services

(644)

(712)

(2,166)

(2,863)

Research and development

(3,055)

(2,375)

(10,662)

(9,789)

Selling, general and administrative

(957)

(980)

(3,391)

(3,435)

Stock compensation expense

(5)

(8)

(23)

(20)

Total Costs and expenses

(4,661)

(4,075)

(16,242)

(16,107)

PROFIT / (LOSS) FROM OPERATIONS

(100)

(1,600)

(3,155)

(5,205)

Interest income, net

27

30

240

322

Foreign exchange gain(loss)

8

26

55

49

Profit /(Loss) before income taxes

(65)

(1,544)

(2,860)

(4,834)

Income tax benefit (expense)

(14)

(50)

(14)

(50)

Cumulative effect of prior years (to December 31, 1999) of changing method of revenue recognition

-

-

-

(4,577)

NET INCOME / LOSS

(79)

(1,594)

(2,874)

(9,461)

NET INCOME / (LOSS) PER ORDINARY SHARE before cumulative effect of change in accounting principle

$   (0,00)

(0.10)

$   (0.18)

$   (0.32)

Cumulative effect per share of prior years of changin method of revenue recognition

-

-

-

$   (0.30)

NET INCOME / (LOSS) PER ORDINARY SHARE

$   (0,00)

(0.10)

$   (0.18)

$   (0.62)

Weighted average number of ordinary shares outstanding

16,198

16,198

16,198

15,331