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third avenue new york, ny 10022 tel (212) 918-3000 fax ( 212) 918-3100 WWW.HHLAW.COM |
Re: | Flamel Technologies S.A. Form 20-F for Fiscal Year Ended December 31, 2006 SEC File No. 000-28508 |
1. | Please explain to us why the impact of payables related to capital investments that were apparently used to complete the Micropump production facility had an impact on your operating cash flows as it appears this would be more of an investing activity. |
Response: The Company has historically not segregated payables related to investments in property and equipment from payables for goods and services when reconciling net income to operating cash flows for purposes of preparing our Statement of Cash Flows. However, information concerning payables relating to investments in property and equipment verses payables for goods and services has appeared in our Managements Discussion and Analysis. The impact of this classification is immaterial to the financial statements as a whole, as the impact for fiscal 2006 would have been an increase in operating cash flows of $3.0 million and a reduction in investing activities of $3.0 million. In the future, the Company will change its Statement of Cash Flows such that the movement in payables for significant capital investments for the years presented will be segregated from normal trade payables and classified as an investing cash flow. In addition, the Company will modify its discussion on Liquidity and Capital Resources prospectively to eliminate any impact from changes in accounts payable arising from amounts due for the purchase of property, plant and equipment. |
2. | Also explain to us why the amounts spent under the restricted funding from GSK are shown as uses of cash here and in your statement of cash flows. We note that paragraph 19(c) of SFAS 95 seems to designate the proceeds from these activities as financing, but the uses of these proceeds appear to be more investing activities under paragraph 17(c). Please provide any specific references to the applicable authoritative literature upon which you relied in making this determination. |
Response: The Company determined that the restricted funding received from GSK to purchase equipment on their behalf, but for which title does not pass to the Company during the course of a supply agreement, most closely resembles a financing and subsequent settling of the obligation as discussed in paragraph 18 of SFAS 95. As such, the Company relied on paragraph 20(b) of SFAS 95 and determined that the use of these proceeds to fund the purchase of equipment whose title remains with GSK for the duration of the supply agreement, to be the satisfaction of their obligation under the |
conditions stipulated by the funding by GSK, and therefore a financing activity. We believe the description within our Statement of Cash Flows and within the Notes to Consolidated Financial Statements describes the nature, source, and use of funds related to the GSK Supply Agreement, the initial term of which is four years. |
3. | Please provide us in disclosure-type format the disclosures required by paragraphs A240-A241 of SFAS 123R related to deferred compensation, the expected recognition period and intrinsic value. Refer to paragraphs A240(c)(2), A240(d), and A240(h) of SFAS 123R. |
Response: Please find below the disclosures as required by A240(c)(2), A240(d), and A240(h) of SFAS 123R. The Company proposes including this disclosure prospectively. |
Weighted-average expected life (years)
|
4.36 | |||
Expected volatility rate
|
52.5 | % | ||
Expected dividend yield
|
| |||
Risk-free interest rate
|
4.66 | % | ||
Forfeiture rate
|
5 | % |
2006 | ||||||||||||||||
Free of | ||||||||||||||||
charge share | ||||||||||||||||
(In thousands of U.S dollars except per share data) | Options | awards | Warrants | Total | ||||||||||||
Research and development |
3,662 | 56 | 203 | 3,921 | ||||||||||||
Cost of goods sold |
144 | 10 | 0 | 154 | ||||||||||||
Selling, general and administrative |
3,581 | 13 | 2,319 | 5,914 | ||||||||||||
Total stock-based compensation expense |
7,387 | 79 | 2,522 | 9,989 | ||||||||||||
Effect on earnings per share |
||||||||||||||||
Basic |
0.31 | 0.00 | 0.11 | 0.42 | ||||||||||||
Diluted |
0.31 | 0.00 | 0.11 | 0.42 |
Year Ended December 31, | ||||||||
(In thousands of U.S. dollars except share data) | 2004 | 2005 | ||||||
Net income (loss), as reported |
12,499 | (27,377 | ) | |||||
Add: Stock-based employee compensation expense
included in reported net income (loss), net of
related tax effects |
1,619 | 335 | ||||||
Deduct: Total stock-based employee compensation
expense determined under fair value based method
for all awards, net of related tax effects |
(7,254 | ) | (2,220 | ) | ||||
Pro forma net income (loss) |
6,864 | (29,262 | ) | |||||
Year Ended December 31, | ||||||||
(In thousands of U.S. dollars except share data) | 2004 | 2005 | ||||||
Earnings per share: |
||||||||
Basic, as reported |
0.58 | (1.19 | ) | |||||
Basic, pro forma |
0.31 | (1.27 | ) | |||||
Diluted, as reported |
0.53 | (1.19 | ) | |||||
Diluted, pro forma |
0.28 | (1.27 | ) |
Year Ended December 31 | ||||||||||||||||||||||||
(In U.S. dollars) | 2004 | 2005 | 2006 | |||||||||||||||||||||
Weighted avg. | Weighted avg. | Weighted avg. | Weighted avg. | Weighted avg. | Weighted avg. Fair | |||||||||||||||||||
value1 | Exer. Price1 | Fair value1 | Exer. Price1 | Fair value1 | Exer. Price1 | |||||||||||||||||||
Options or warrants whose price equaled
market
price of the underlying shares on the date of
grant |
10.96 | 12.83 | 9.61 | 16.82 | 14.39 | 25.67 | ||||||||||||||||||
Options or warrants whose price was less than
the market price of the underlying shares on
the date of grant |
| | | | | | ||||||||||||||||||
Options or warrants whose price was more than
the market price of the underlying shares on
the date of grant |
13.38 | 20.43 | | | | |
[1] Historical exchange rate at date of grant |
Weighted | Weighted | |||||||||||
Average | Average | |||||||||||
Warrants | Exercise Price | Exercise Price | ||||||||||
Outstanding | in U.S. dollars [1] | in Euros | ||||||||||
Balance at January 1, 2004 |
1,195,000 | $ | 6.55 | | 6.52 | |||||||
Warrants granted |
80,000 | $ | 26.27 | | 21.73 | |||||||
Balance at December 31, 2004 |
1,275,000 | $ | 7.79 | | 7.47 | |||||||
Warrants granted |
40,000 | $ | 16.18 | | 12.34 | |||||||
Warrants exercised |
1,125,000 | $ | 6.34 | | 6.37 | |||||||
Warrants cancelled |
150,000 | $ | 18.68 | | 15.70 | |||||||
Balance at December 31, 2005 |
40,000 | $ | 16.18 | | 12.34 | |||||||
Warrants granted |
365,000 | $ | 19.25 | | 15.78 | |||||||
Warrants exercised |
27,000 | $ | 17.44 | | 14.24 | |||||||
Balance at December 31, 2006 |
378,000 | $ | 19.05 | | 15.53 |
[1] Historical exchange rate at date of grant |
Warrants Outstanding | Warrants Exercisable | ||||||||||||||||||||||||||||||
Weighted | Weighted | Weighted | Weighted | Weighted | |||||||||||||||||||||||||||
average | average | average | average | average | |||||||||||||||||||||||||||
Range of | remaining | exercise | intrinsic | exercise | intrinsic | ||||||||||||||||||||||||||
exercise prices | Number of | contractual | price in | value in | Number of | price in | value in | ||||||||||||||||||||||||
in euros | shares | life | euros | euros | shares | euros | euros | ||||||||||||||||||||||||
0 to 12.34 |
33,000 | 3.01 | 12.34 | 9.84 | 13,000 | 12.34 | 9.84 | ||||||||||||||||||||||||
14.60 to 14.91 |
275,750 | 2.12 | 14.77 | 7.41 | 150,750 | 14.91 | 7.27 | ||||||||||||||||||||||||
20.07 |
69,250 | 2.17 | 20.07 | 2.11 | | | | ||||||||||||||||||||||||
378,000 | 2.20 | 15.53 | 6.65 | 163,750 | 14.71 | 7.47 | |||||||||||||||||||||||||
Weighted Average | Weighted Average | |||||||||||||||
Shares Available | Options Granted | Exercise Price in | Exercise Price | |||||||||||||
for Grant | and Outstanding | U.S dollars[1] | in Euros | |||||||||||||
Balance at January 1, 2004 |
772,500 | 3,220,000 | $ | 8.65 | | 7.68 | ||||||||||
Granted |
(926,500 | ) | 926,500 | $ | 20.75 | | 16.15 | |||||||||
Exercised |
| (360,000 | ) | $ | 1.55 | | 1.72 | |||||||||
Forfeited |
203,000 | (203,000 | ) | $ | 25.27 | | 20.81 | |||||||||
Balance at December 31, 2004 |
49,000 | 3,583,500 | $ | 11.55 | | 9.72 | ||||||||||
Options authorized |
1,500,000 | |||||||||||||||
Granted |
(1,545,500 | ) | 1,545,500 | $ | 16.83 | | 13.64 | |||||||||
Exercised |
| (830,000 | ) | $ | 4.12 | | 4.26 | |||||||||
Forfeited |
794,000 | (874,000 | ) | $ | 19.60 | | 15.69 | |||||||||
Balance at December 31, 2005 |
797,500 | 3,425,000 | $ | 13.69 | | 11.31 | ||||||||||
Options authorized |
| |||||||||||||||
Granted |
(483,750 | ) | 483,750 | $ | 28.81 | | 22.33 | |||||||||
Exercised |
| (257,000 | ) | $ | 4.74 | | 4.39 | |||||||||
Forfeited |
32,500 | (122,500 | ) | $ | 18.82 | | 14.95 | |||||||||
Balance at December 31, 2006 |
346,250 | 3,529,250 | $ | 16.23 | | 13.18 | ||||||||||
[1] | Historical exchange rate at date of grant |
The total intrinsic value of options exercised during 2006 amounted to 3,891,000 or $4,936,000 (historical exchange rate at date of exercise). |
Stock options outstanding at December 31, 2006, which expire from 2010 to 2016 had exercise prices ranging from 1.36 to 25.39. The weighted average remaining contractual life of all options is 7.74 years. As of December 31, 2006, there were 3,529,250 outstanding options at a weighted average exercise price of 13.18, of which 1,654,250 were exercisable at a weighted average price of 9.37. |
Stock Options Outstanding | Stock Options Exercisable | |||||||||||||||||||||||||||
Weighted | Weighted | |||||||||||||||||||||||||||
average | Weighted | average | Weighted | Weighted | ||||||||||||||||||||||||
Range of exercise | Number of | remaining | average | intrinsic | Number of | average | average | |||||||||||||||||||||
prices in euros | shares | contractual | exercise price | value in | shares | exercise price | intrinsic value | |||||||||||||||||||||
life | in euros | euros | in euros | in euros | ||||||||||||||||||||||||
0 to 1.36 |
108,000 | 5.01 | 1.19 | 20.99 | 108,000 | 1.19 | 20.99 | |||||||||||||||||||||
2.33 to 2.77 |
285,000 | 5.12 | 2.47 | 19.71 | 285,000 | 2.47 | 19.71 | |||||||||||||||||||||
4.11 to 4.86 |
305,000 | 5.77 | 4.35 | 17.83 | 305,000 | 4.35 | 17.83 | |||||||||||||||||||||
6.40 to 7.58 |
125,000 | 3.89 | 6.78 | 15.40 | 125,000 | 6.78 | 15.40 | |||||||||||||||||||||
9.88 to 12.02 |
325,000 | 7.75 | 11.19 | 10.99 | 145,000 | 10.78 | 11.40 | |||||||||||||||||||||
12.86 to 16.23 |
1,684,000 | 8.70 | 14.32 | 7.86 | 501,250 | 14.20 | 7.97 | |||||||||||||||||||||
19.2 to 25.39 |
697,250 | 8.46 | 22.61 | 1.70 | 185,000 | 20.57 | 1.61 | |||||||||||||||||||||
3,529,250 | 7.74 | 13.18 | 10.14 | 1,654,250 | 9.37 | 12.81 | ||||||||||||||||||||||
The total fair value of options vested during 2006 amounted to 5,317,000 or $6,676,000 (average exchange rate of the year). |
The aggregate intrinsic value of options outstanding amounted to 35,787,000 or $47,131,000 (exchange rate at date of balance sheet). |
The aggregate intrinsic value of options exercisable amounted to 21,191,000 or $27,908,000 (exchange rate at date of balance sheet). |
4. | Please amend your certifications to include the following changes: |
| A conformed signature above the signature line at the end of the certifications. | ||
| Remove the title of the certifying individual at the beginning of the certifications. | ||
| Replace the word annual report with report in paragraphs 2, 3 and 4. | ||
| Revise the first sentence of paragraph 4 to reference internal control over financial reporting. | ||
| Revise paragraph 4(b) to reference generally accepted accounting rather than according principles. |
Response: We will amend the certifications in accordance with the Comment Letter in our amended Form 20-F. |
Sincerely, /s/ Amy Bowerman Freed Amy Bowerman Freed |
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cc: | Ms. Vanessa Robertson, Securities and Exchange Commission | |
Mr. Jim Atkinson, Securities and Exchange Commission | ||
Mr. Stephen Willard, Flamel Technologies S.A. |
Re: | Flamel Technologies S.A. Form 20-F for the Fiscal Year Ended December 31, 2006 File no.: 000-28508 |
| Flamel Technologies S.A. (the Company) is responsible for the adequacy and accuracy of the disclosure in the filings; | ||
| staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and | ||
| the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. |
Sincerely, |
||||
/s/ Stephen H Willard | ||||
Chief Executive Officer |