6-K 1 w89424e6vk.htm FORM 6-K e6vk
 

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

For the month of July 2003

Commission File Number 0-28508

Flamel Technologies
(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 Form 20-F or Form 40-F.

     
Form 20-F   [X]   Form 40-F   [ ]

     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 [ ]   No [X]

     If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-_________

 


 

INDEX

                 
            Page
           
Item. 1 Financial Statements (Unaudited)
       
 
 
(a)     Condensed Consolidated Statements of Operations
    3  
   
Six months ended June 30, 2003 and 2002
       
 
 
(b)     Condensed Consolidated Statements of Operations
    4  
   
Three months ended June 30, 2003 and 2002
       
 
 
(c)     Condensed Consolidated Balance Sheets
    5  
   
June 30, 2003 and December 31, 2002
       
 
 
(d)     Condensed Consolidated Statements of Cash Flows
    6  
   
Six months ended June 30, 2003 and 2002
       
 
 
(e)     Consolidated Statement of Shareholders’ Equity
    7  
 
 
(f)     Notes to Condensed Consolidated Financial Statements
    8  
 
Item. 2 Management’s Discussion and Analysis of
    9  
   
Financial Condition and Results of Operations
       

2


 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands of dollars except share data)

                     
        Six months ended
        June 30,
       
        2002   2003
       
 
Revenue:
               
 
License and research revenue
  $ 5,360     $ 6,259  
 
Product sales and services
    1,314       1,901  
 
Other revenue
    535       372  
 
   
     
 
   
Total revenue
    7,209       8,532  
 
   
     
 
Costs and expenses:
               
 
Cost of goods and services sold
    (1,081 )     (1,811 )
 
Research and development
    (5,695 )     (8,525 )
 
Selling, general and administrative
    (1,791 )     (2,351 )
 
Stock compensation expense
    (10 )     (4 )
 
   
     
 
   
Total costs and expenses
    (8,577 )     (12,691 )
 
   
         
Profit (loss) from operations
    (1,368 )     (4,159 )
Other income
    2,396       1,007  
Interest income, net
    78       142  
Foreign exchange gain (loss)
    (147 )     (293 )
 
   
     
 
Income tax benefit
          (21 )
Net profit (loss)
  $ 959     $ (3,324 )
 
   
     
 
Net profit (loss) per ordinary share
  $ 0.06     $ (0.20 )
 
   
     
 
Weighted average number of ordinary shares outstanding
    16,198       16,327  
 
   
     
 

See notes to unaudited condensed consolidated financial statements

3


 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands of dollars except share data)

                     
        Three months ended
        June 30,
       
        2002   2003
       
 
Revenue:
               
 
License and research revenue
  $ 2,994     $ 4,297  
 
Product sales and services
    1,094       864  
 
Other revenue
    268       (162 )
 
   
     
 
   
Total revenue
    4,356       4,999  
 
   
     
 
Costs and expenses:
               
 
Cost of goods and services sold
    (781 )     (717 )
 
Research and development
    (2,741 )     (4,682 )
 
Selling, general and administrative
    (860 )     (1,341 )
 
Stock compensation expense
    (5 )        
 
   
     
 
   
Total costs and expenses
    (4,387 )     (6,740 )
 
   
         
Profit (loss) from operations
    (31 )     (1,741 )
Other income
    54       260  
Interest income, net
    61       62  
Foreign exchange gain (loss)
    (152 )     (210 )
 
   
     
 
Income tax benefit
    (68 )     (21 )
Net profit (loss)
  $ 959     $ (1,650 )
 
   
     
 
Net profit (loss) per ordinary share
  $ (0.00 )   $ (0.10 )
 
   
     
 
Weighted average number of ordinary shares outstanding
    16,198       16,327  
 
   
     
 

4


 

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(Amounts in thousands of dollars)

                         
           
            December 31,   June 30,
            2002   2003
            (Note)   (Unaudited)
           
 
       
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 14,527     $ 11,649  
 
Accounts receivable
    3,462       6,008  
 
Inventory
    375       1,069  
 
Prepaid expenses and other current assets
    347       936  
 
   
     
 
     
Total current assets
    18,711       19,662  
 
   
     
 
Property and equipment, net
    3,405       3,431  
Other assets:
               
 
Research and development tax credit receivable
    890       686  
 
Other long-term assets
    70       77  
 
   
     
 
     
Total other assets
    960       763  
 
   
     
 
 
Total assets
  $ 23,076     $ 23,856  
 
   
     
 
   
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
 
Current liabilities:
               
 
Current portion of long-term debt
  $ 693     $ 99  
 
Current portion of capital lease obligations
    229       190  
 
Accounts payable
    1,322       2,388  
 
Current portion of deferred revenue
    1,805       2,826  
 
Accrued expenses
    2,028       1,897  
 
Advances from customers
    361       284  
 
Other current liabilities
    71       112  
 
   
     
 
     
Total current liabilities
    6,509       7,796  
 
   
     
 
Long-term debt, less current portion
    1,391       1,516  
Other long-term liabilities
    789       1,144  
Deferred revenue, less current portion
    1,952       2,678  
Capital lease obligation, less current portion
    149       81  
 
   
     
 
 
Total long-term liabilities
    4,281       5,419  
 
   
     
 
Shareholders’ equity:
               
 
Ordinary shares
    2,366       2,384  
 
Additional paid-in capital
    71,178       71,854  
 
Accumulated deficit
    (56,381 )     (59,704 )
 
Deferred compensation
    (14 )     (10 )
 
Cumulative other comprehensive income
    (4,863 )     (3,883 )
 
   
     
 
     
Total shareholders’ equity
    12,286       10,641  
 
   
     
 
 
Total liabilities and shareholders’ equity
  $ 23,076     $ 23,856  
 
   
     
 

    Note: The balance sheet at December 31, 2002 has been derived from the audited financial statements at that date.

See notes to unaudited condensed consolidated financial statements

5


 

                       
          Six months ended  
          June 30,
         
          2002   2003
         
 
Cash flows from operating activities :
               
Net profit, (loss)
  $ 959     $ (3,323 )
Adjustments to reconcile net loss to net cash provided by operating activities :
               
 
Depreciation and amortization
    619       604  
 
Stock compensation expense
    10       4  
 
(Gain) loss on disposal of property and equipment
            (362 )
 
(Gain) loss on recognition of grants
            (769 )
 
Increase (decrease) in cash from :
               
   
Accounts receivable
    4,596       (2,162 )
   
Inventory
    400       (638 )
   
Prepaid expenses and other current assets
    (75 )     (542 )
   
Deferred revenue
    (23 )     1,363  
   
Accounts payable
    (48 )     916  
   
Accrued expenses
    (1,616 )     (375 )
   
Research and development tax credit receivable
    1,416       274  
   
Other
    109       138  
 
   
     
 
     
Net cash from, (used by) operating activities
    6,346       (4,872 )
 
   
     
 
Cash flows from investing activities :
               
 
Purchases of property and equipment
    (817 )     (368 )
 
Disposal of property and equipment
            372  
 
   
     
 
     
Net cash used for investing activities
    (817 )     4  
 
   
     
 
Cash flows from financing activities :
               
 
Proceeds of loans
          135  
 
Cash proceeds from sale of ordinary shares
          694  
 
Principal payments on loans and capital lease obligations
    (212 )     (126 )
 
   
     
 
     
Net cash provided by financing activities
    (212 )     703  
 
   
     
 
Effect of exchange rate changes on cash and cash equivalents
    1,280       1,294  
Net increase (decrease) in cash and cash equivalents
    6,597       (2,871 )
Cash and cash equivalents, beginning of period
    5,309       14,527  
 
   
     
 
Cash and cash equivalents, end of period
  $ 11,906     $ 11,649  
 
   
     
 

6


 

CONDENSED CONSOLIDATED STATEMENTS
OF SHAREHOLDERS' EQUITY (UNAUDITED)
(Amounts in thousands of dollars except share data)

                                                         
    Ordinary Shares                                        
   
  Additional                   Cumulative        
                    Paid-In   Accumulated   Deferred   Translation   Shareholders'
    Shares   Amount   Capital   Deficit   Compensation   Adjustment   Equity
   
 
 
 
 
 
 
Balance January 1, 2003
    16,197,590     $ 2,366     $ 71,178     $ (56,381 )   $ (14 )   $ (4,863 )   $ 12,286  
Issuance of ordinary shares at 4.75 ($5.50)
    82,000       12       439                               451  
Issuance of ordinary shares at 2.78 ($3.21)
    2,500               8                               8  
Issuance of ordinary shares at 4.88 ($5.76)
    30,000       4       169                               173  
Issuance of ordinary shares at 5.95 ($7.02)
    5,000       1       34                               35  
Issuance of ordinary shares at 2 ($2.75)
    10,000       1       26                               27  
Amortization of deferred compensation
                                    4               4  
Net loss
                            (3,323 )                     (3,323 )
Other comprehensive income Translation adjustment
                                            980       980  
Comprehensive income
                                                    (2,343 )
 
   
     
     
     
     
     
     
 
Balance June 30, 2003
    16,327,090     $ 2,384     $ 71,854     $ (59,704 )   $ (10 )   $ (3,883 )   $ 10,641  
 
   
     
     
     
     
     
     
 

7


 

FLAMEL TECHNOLOGIES S.A.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTES

1. ACCOUNTING POLICIES

     The accompanying unaudited condensed consolidated financial statements were prepared in accordance with accounting principles for interim financial statements generally accepted in the United States. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of Flamel Technologies S.A. (the “Company”), all adjustments (consisting of only normal recurring accruals) considered necessary for a fair presentation have been included.

     The reporting currency of the Company is the U.S. dollar. The financial statements of the Company, whose functional currency is the Euro, have been translated into U.S. dollar equivalents using the period-end rate for asset and liability accounts, the weighted average rate for income and expense accounts, and historical rates for shareholders’ equity accounts. Corresponding translation gains or losses are recorded in shareholders’ equity.

     Operating results for the three months ended June 30, 2003 are not necessarily indicative of the results that may be expected for the year ending December 31, 2003. These condensed consolidated financial statements should be read in conjunction with the Company’s audited annual financial statements.

2. REVENUES

     2.1 LICENSE RESEARCH AND CONSULTING AGREEMENTS

     In accordance with the long-term research and product development agreement signed with Corning in December 1998, the Company received research and development payments of $192,000 during the first six months of 2003.

     In accordance with the license agreement signed with Servier in December 2001, the Company recognized research and development revenues of $895,000 and licensing fees of $1,100,000 for the first six months of 2003. The licensing fees include a milestone payment for $427,000 for results achieved in June 2003.

     In accordance with the license agreement signed with Beecham Pharmaceuticals (Pte) Limited in June 2002, the Company recognized licensing fees of $281,000 for the first 2003 six months of 2003.

     In accordance with the license agreement signed with SB Pharma Puerto Rico Inc. in March 2003, the Company recognized research and development revenues of $1,584,000 and licensing fees of $1,114,000 for the first six months of 2003. The licensing fees include a milestone payment for $943,000 for results achieved in June 2003.

     In accordance with the license agreement signed with Biovail in February 2003, the Company recognized licensing fees of $47,000 for the first six months of 2003.

     The Company received research and development payments on three feasibility studies with undisclosed partners for an amount of $989,000 for the first six months of 2003.

     2.2 OTHER REVENUES

     In accordance with the long-term research and product development agreement signed with Corning in December 1998, the Company recognized revenue of $313,000 corresponding to the royalties for the six months period ended June 30, 2003.

3. OTHER INCOME

     The Company recognized in February 2003 revenue of $376,000 from the sale of the equipments of its pilot plant of Vénissieux.

     The Company recognized in March 2003 a revenue of $768,000 from grants made by French public agencies linked to investments in the development of the Pessac facility, following the achievement of the conditions of those grants.

8


 

Item. 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Results of Operations

Revenues for the six months ended June 30, 2003 increased to $8.5 million, compared to $7.2 million for the first half of 2002.

License and research revenue for the six months ended June 30, 2003 of $6.3 million included $2.7 million revenue from GlaxoSmithKline, $2.0 million from Servier, $1.0 million from feasibility studies with other partners and $0.2 million from the on going research collaboration with Corning. License and research revenue for the first half of 2002 largely consisted of revenues from Novo-Nordisk, Corning, and various undisclosed partners.

Other revenues for the six months ended June 30, 2003 consisted of royalties from Corning and the sale of equipment from the Company’s pilot plant in Venissieux. Other income included $0.7 million in French government grants. Other revenue in the first quarter of 2002 included $2.3 million received in settlement of litigation with the Welcome Foundation regarding Flamel’s long acting acyclovir product Genvir. Revenues from product sales and services were $1.9 million in the six months ended June 30, 2003, compared to $1.3 million in the first quarter of 2002, largely as a result of increased toll manufacturing.

Total operating costs for the six months ended June 30, 2003 amounted to $12.7 million, up from $8.6 million in the comparable half of 2002, largely as a result of the increased value of the Euro to the dollar and increases in clinical and preclinical studies. Research and Development costs for the first six months of 2003 increased to $8.5 million from $5.7 million in the first half of 2002, largely as a result of the exchange rate and clinical and preclinical trial expenses. Sales, General and Administrative costs increased to $2.4 million from $1.8 million in the first half of 2002, largely due to variation in exchange rates.

Overall, the Company had a loss of $3.3 million for the six months ended June 30, 2004, compared to a gain of $1.0 million in the comparable period in 2002.

As a result of fluctuations in the amount of quarterly revenues, which may arise from the signing of research collaborations, license agreements or other extraordinary transactions, interim results are not necessarily indicative of the operating results for the full year.

9


 

Liquidity and Capital Resources

On June 30, 2003, the Company had $11.6 million in cash, compared to $11.9 million in cash at the end of the first half of 2002.

Net cash from operating activities amounted to a decline of $2.9 million for the first six months of 2003 which is due primarily to the loss for the period, offset by increases in deferred revenue from the recent licensing agreements and exchange rates.

10


 

INFORMATION FILED WITH THIS REPORT

Document Index

3.1   Bylaws of Flamel Technologies as amended July 31, 2003.
 
99.1   Press release dated July 30, 2003 (“Flamel Technologies Announces Second Quarter Results, Achievement of Two Additional Milestones from Partners Due to Operating Success”).

11


 

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.
     
    Flamel Technologies
 
Dated: August 15, 2003   By: /s/ Stephen H. Willard

Name: Stephen H. Willard
Title: Executive Vice President,
Chief Financial Officer and General
Counsel

12