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Part I – FINANCIAL INFORMATION
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Item 1. Condensed Consolidated Financial Statements (unaudited)
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a) Condensed Consolidated Statement of Operations for the Three months ended March 31, 2011 and 2010
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2
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b) Condensed Consolidated Balance Sheet as of March 31, 2011 and December 31, 2010
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3
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c) Condensed Consolidated Statement of Cash Flows for the Three months ended March 31, 2011 and 2010
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4
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d) Consolidated Statement of Shareholders’ Equity for the Three months ended March 31, 2011
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5
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e) Notes to Condensed Consolidated Financial Statements
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6
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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9
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PART II – OTHER INFORMATION
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Item 1. Legal Proceedings
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12
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Item 1A. Risk Factors
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12
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Item 5. Other Information
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15
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Three months ended March 31,
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2010
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2011
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Revenue:
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License and research revenue
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$ | 3,441 | $ | 3,214 | ||||
Product sales and services
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2,305 | 1,624 | ||||||
Other revenues
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2,341 | 1,926 | ||||||
Total revenue
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8,087 | 6,764 | ||||||
Costs and expenses:
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Cost of goods and services sold
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(1,925 | ) | (1,371 | ) | ||||
Research and development
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(7,261 | ) | (7,758 | ) | ||||
Selling, general and administrative
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(2,931 | ) | (2,526 | ) | ||||
Total
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(12,117 | ) | (11,655 | ) | ||||
Profit (loss) from operations
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(4,030 | ) | (4,891 | ) | ||||
Interest income net
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112 | 128 | ||||||
Foreign exchange gain (loss)
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14 | (240 | ) | |||||
Other income (loss)
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3 | 99 | ||||||
Income (loss) before income taxes
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(3,901 | ) | (4,904 | ) | ||||
Income tax
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(123 | ) | (23 | ) | ||||
Net income (loss)
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$ | (4,024 | ) | $ | (4,927 | ) | ||
Earnings (loss) per share
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Basic earnings (loss) per ordinary share
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$ | (0.17 | ) | $ | (0.20 | ) | ||
Diluted earnings (loss) per share
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$ | (0.17 | ) | $ | (0.20 | ) | ||
Weighted average number of shares outstanding (in thousands) :
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Basic
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24,343 | 24,646 | ||||||
Diluted
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24,343 | 24,646 |
ASSETS
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December 31,
2010
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March 31,
2011
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Current assets:
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Cash and cash equivalents
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$ | 8,184 | $ | 5,831 | ||||
Marketable securities
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23,160 | 20,172 | ||||||
Accounts receivable
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7,480 | 7,398 | ||||||
Inventory
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862 | 854 | ||||||
Research and development tax credit receivable short term
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2,304 | 87 | ||||||
Prepaid expenses and other current assets
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3,372 | 2,571 | ||||||
Total current assets
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45,362 | 36,913 | ||||||
Property and equipment, net
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21,425 | 22,744 | ||||||
Other assets:
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Research and development tax credit receivable long term
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7,641 | 10,126 | ||||||
Other long-term assets
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186 | 197 | ||||||
Total other assets
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7,827 | 10,323 | ||||||
Total assets
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$ | 74,614 | $ | 69,980 | ||||
LIABILITIES
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Current liabilities:
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Current portion of long-term debt
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2,317 | 2,463 | ||||||
Current portion of capital lease obligations
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59 | 94 | ||||||
Accounts payable
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4,941 | 4,705 | ||||||
Current portion of deferred revenue
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2,528 | 2,182 | ||||||
Advances from customers
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139 | 129 | ||||||
Accrued expenses
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6,004 | 5,069 | ||||||
Other current liabilities
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3,433 | 3,819 | ||||||
Total current liabilities
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19,421 | 18,461 | ||||||
Long-term debt, less current portion
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1,547 | 1,646 | ||||||
Capital lease obligations, less current portion
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133 | 252 | ||||||
Deferred revenue, less current portion
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3,247 | 3,038 | ||||||
Other long-term liabilities
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13,961 | 12,564 | ||||||
Total long-term liabilities
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18,888 | 17,500 | ||||||
Commitments and contingencies:
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- | - | ||||||
Shareholders' equity:
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Ordinary shares: 24,645,650 issued and outstanding at December 31, 2010 and March 31, 2011 (shares authorised 29,426,040) at nominal value of 0.122 euro
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3,589 | 3,589 | ||||||
Additional paid-in capital
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202,462 | 202,998 | ||||||
Accumulated deficit
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(180,619 | ) | (185,546 | ) | ||||
Accumulated other comprehensive income (loss)
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10,873 | 12,978 | ||||||
Total shareholders' equity
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36,305 | 34,019 | ||||||
Total liabilities and shareholders' equity
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$ | 74,614 | $ | 69,980 |
Three months ended March 31,
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2010
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2011
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Cash flows from operating activities:
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Net income (loss)
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$ | (4,024 | ) | $ | (4,927 | ) | ||
Adjustments to reconcile net income (loss)
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to net cash provided by (used in) operating activities:
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Depreciation of property and equipment
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1,247 | 1,028 | ||||||
Loss (gain) on disposal of property and equipment
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- | (11 | ) | |||||
Gains on sales of marketable securities
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(22 | ) | (12 | ) | ||||
Grants recognized in other income and income from operations
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(599 | ) | (50 | ) | ||||
Stock compensation expense
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875 | 519 | ||||||
Increase (decrease) in cash from:
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Accounts receivable
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920 | 535 | ||||||
Inventory
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182 | 60 | ||||||
Prepaid expenses and other current assets
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(666 | ) | 1,025 | |||||
Research and development tax credit receivable
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666 | 347 | ||||||
Accounts payable
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(682 | ) | (463 | ) | ||||
Deferred revenue
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(928 | ) | (886 | ) | ||||
Accrued expenses
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(377 | ) | (1,283 | ) | ||||
Other current liabilities
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233 | 163 | ||||||
Other long-term assets and liabilities
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(241 | ) | (375 | ) | ||||
Net cash provided by (used in) operating activities
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(3,416 | ) | (4,330 | ) | ||||
Cash flows from investing activities:
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Purchases of property and equipment
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(736 | ) | (901 | ) | ||||
Proceeds from disposal of property and equipment
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- | 11 | ||||||
Purchase of marketable securities
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(34,755 | ) | (3,689 | ) | ||||
Proceeds from sales of marketable securities
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33,444 | 7,985 | ||||||
Net cash provided by (used in) investing activities
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(2,047 | ) | 3,406 | |||||
Cash flows from financing activities:
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reimbursment of loans or conditional grants
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(1,879 | ) | (1,818 | ) | ||||
Principal payments on capital lease obligations
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(9 | ) | (20 | ) | ||||
Net cash provided by (used in) financing activities
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(1,888 | ) | (1,838 | ) | ||||
Effect of exchange rate changes on cash and cash equivalents
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(370 | ) | 409 | |||||
Net increase (decrease) in cash and cash equivalents
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(7,721 | ) | (2,353 | ) | ||||
Cash and cash equivalents, beginning of period
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8,716 | 8,184 | ||||||
Cash and cash equivalents, end of period
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$ | 995 | $ | 5,831 |
Additional
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Accumulated Other Comprehensive
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Ordinary Shares
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Paid-in |
Accumulated
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Income |
Shareholders'
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Shares
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Amount
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Capital | Deficit | (Loss) | Equity | |||||||||||||||||||
Balance at January 1, 2011
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24,645,650 | $ | 3,589 | $ | 202,462 | $ | (180,619 | ) | $ | 10,873 | $ | 36,305 | ||||||||||||
Stock-based compensation expense
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536 | 536 | ||||||||||||||||||||||
Net loss.
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(4,927 | ) | (4,927 | ) | ||||||||||||||||||||
Foreign currency translation adjustment
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2,105 | 2,105 | ||||||||||||||||||||||
Comprehensive loss
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$ | (2,822 | ) | |||||||||||||||||||||
Balance at March 31, 2011
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24,645,650 | $ | 3,589 | $ | 202,998 | $ | (185,546 | ) | $ | 12,978 | $ | 34,019 |
Three months ended
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(in thousands except per share data)
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March 31, 2010
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March 31, 2011
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Net income (loss)
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(4,024 | ) | (4,927 | ) | ||||
Net income (loss) per share
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Basic
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$ | (0.17 | ) | $ | (0.20 | ) | ||
Diluted
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$ | (0.17 | ) | $ | (0.20 | ) | ||
Number of shares used for computing
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Basic
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24,343 | 24,646 | ||||||
Diluted
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24,343 | 24,646 | ||||||
Stock-based compensation (ASC 718)
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Cost of products and services sold
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36 | 18 | ||||||
Research and development
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314 | 206 | ||||||
Selling, general and administrative
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525 | 295 | ||||||
Total
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875 | 519 | ||||||
Net income (loss) before stock-based compensation
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(3,149 | ) | (4,408 | ) | ||||
Net income (loss) before stock-based compensation per share
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Basic
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$ | (0.13 | ) | $ | (0.18 | ) | ||
Diluted
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$ | (0.13 | ) | $ | (0.18 | ) |
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-
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a cash outflow from financing activities ($1.8 million), related to the reimbursement to OSEO for the advance OSEO provided secured against the R&D tax credit from 2007, and
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-
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a cash inflow from operating activities ($2.3 million), corresponding to the R&D credit tax from 2007 paid by the tax authorities (and a corresponding decrease in the amount of the R&D tax credit receivable).
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·
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sales of products that incorporate our drug delivery technologies;
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financial terms of collaborative, technology access, license or other commercial agreements we enter into;
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results of research and development efforts;
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changes in the focus and direction of our business strategy;
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technological advances;
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results of clinical testing, requirements of the US Food and Drug Administration (FDA) and comparable foreign regulatory agencies;
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availability and terms of financing alternatives; and
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investments in complementary businesses, products or technologies
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we depend on a few customers for the majority of our revenues, and the loss of any one of these customers could reduce our revenues significantly.
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our revenues depend on pharmaceutical and biotechnology companies successfully developing products that incorporate our drug delivery technologies.
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although products that incorporate our drug delivery technologies may appear promising at their early stages of development and in clinical trials, none of these potential products may reach the commercial market for a number of reasons.
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we must invest substantial sums in research and development in order to remain competitive, and we may not fully recover these investments.
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we depend on key personnel to execute our business plan. If we cannot attract and retain key personnel, we may not be able to successfully implement our business plan.
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if we cannot keep pace with the rapid technological change in our industry, we may lose business, and our drug delivery systems could become obsolete or noncompetitive.
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if we cannot adequately protect our technology and proprietary information, we may be unable to sustain a competitive advantage.
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our products and technologies may not gain market acceptance.
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our collaborative arrangements may give rise to disputes over commercial terms, contract interpretation and ownership of our intellectual property and may adversely affect the commercial success of our products.
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third parties have claimed, and may claim in the future, that our technologies, or the products in which they are used, infringe on their rights and we may incur significant costs resolving these claims.
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we can offer no assurance that any patents issued to us will provide us with competitive advantages or will not be infringed, challenged, invalidated or circumvented by others, or that the patents or proprietary rights of others will not have an adverse effect on our ability to do business.
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if our third party collaborative partners face generic competition for their products, our revenues and royalties from such products may be adversely affected.
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healthcare reform and restrictions on reimbursements may limit our financial returns.
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products that incorporate our drug delivery technologies are subject to regulatory approval. If our pharmaceutical and biotechnology company partners do not obtain such approvals, or if such approvals are delayed, our revenues may be adversely affected.
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we may face product liability claims related to participation in clinical trials or the use or misuse of our products or third party products that incorporate our technologies.
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if we use biological and hazardous materials in a manner that causes injury, we may be liable for significant damages.
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our share price has been volatile and may continue to be volatile.
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because we have a limited operating history, investors in our shares may have difficulty evaluating our prospects.
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if we are not profitable in the future, the value of our shares may fall.
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our operating results may fluctuate, which may adversely affect our share price.
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we currently do not intend to pay dividends, and cannot assure shareholders that we will make dividend payments in the future.
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our largest shareholders own a significant percentage of the share capital and voting rights of the Company
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a) On Friday, June 24, 2011, we held our annual shareholders’ meeting to vote on sixteen proposals.
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b) The following matters were voted upon at the annual meeting:
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Proposal
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Votes For
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Votes Against/Abstain
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Broker Non-Votes
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Approval of Statutory Accounts for year ended December 31, 2010.
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23,207,241
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1,090,089
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0
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Allocation of results to retained earnings.
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23,975,438
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321,892
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0
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Renewal of Mr. Elie Vannier as Director.
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23,836,350
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460,980
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0
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Renewal of Mr. Lodewijk J.R. De Vink as Director.
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23,839,531
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457,799
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0
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Renewal of Mr. John L. Vogelstein as Director.
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23,851,751
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445,579
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0
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Renewal of Mr. Francis JT Fildes as Director.
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23,841,031
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456,299
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0
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Renewal of Mr. Stephen H. Willard as Director.
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22,550,057
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1,747,273
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0
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Appointment of Ambassador. Craig Stapleton as Director.
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23,854,344
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442,986
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0
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Appointment of Mrs. Catherine Bréchignac as Director.
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23,842,707
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454,623
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0
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Appointment of Mr. Guillaume Cerutti as Director.
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23,843,294
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454,036
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0
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Determination of the annual amount of Directors’ attendance fees.
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23,778,908
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518,422
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0
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Approval of agreements referred to in article L. 225-38 et seq. of the Commercial Code
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21,813,805
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2,483,525
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0
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Authorization to be granted to the Board of Directors to allocate two hundred thousand (200,000) shares at no cost (“free shares”) and taking note of the resulting capital increases.
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20,393,036
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3,904,294
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0
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Authorization to be granted to the Board of Directors for issue of a maximum number of three hundred and fifty thousand (350,000) stock warrants (BSA) reserved for a category of persons consisting of the company’s directors who are neither legal representatives nor employees of the Company, but including the Chairman of the Board of Directors; authorization to be granted to the Board of Directors for carrying out the resulting capital increases.
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20,389,869
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3,907,461
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0
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Authorization to be granted to the Board of Directors for increasing the share capital by issues of shares reserved for the members of a company saving plan established in application of Articles L.3332-18 et seq. of the Labour Code.
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1,754,992
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22,542,338
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0
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Powers for formalities.
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23,857,200
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440,130
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0
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Flamel Technologies, S.A.
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Dated: July 29, 2011 | /s/ Stephen H. Willard |
Stephen H. Willard
Chief Executive Officer
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