SECURITIES AND EXCHANGE COMMISSION
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2002
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Anika Therapeutics, Inc. |
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(Exact Name of Registrant as Specified in Its Charter) |
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Massachusetts |
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04-3145961 |
(State or Other Jurisdiction of Incorporation or Organization) |
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(I.R.S. Employer Identification No.) |
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236 West Cummings Park, Woburn, Massachusetts |
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01801 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrants Telephone Number, Including Area Code: (781) 932-6616 |
Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the last 90 days. Yes ý No o
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the last practicable date.
At August 7, 2002 there were 9,934,280 outstanding shares of Common Stock, par value $.01 per share.
PART I: FINANCIAL INFORMATION
ITEM 1: FINANCIAL STATEMENTS
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
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June 30,
|
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December
31,
|
|
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ASSETS |
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(Unaudited) |
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Current assets: |
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|
|
|
|
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Cash and equivalents |
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$ |
7,477,859 |
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$ |
9,064,977 |
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Short-term marketable securities |
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4,500,000 |
|
3,994,401 |
|
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Accounts receivable, net of reserves of $25,000 |
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2,228,694 |
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2,240,929 |
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Inventories |
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2,786,648 |
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3,726,982 |
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Prepaid expenses and other current assets |
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455,603 |
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540,476 |
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Total current assets |
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17,448,804 |
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19,567,765 |
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Property and equipment, at cost |
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9,572,235 |
|
9,530,047 |
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Less: accumulated depreciation |
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(7,126,819 |
) |
(6,583,175 |
) |
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|
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2,445,416 |
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2,946,872 |
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Long-term deposits |
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143,060 |
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148,160 |
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Notes receivable from officers |
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178,000 |
|
253,000 |
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Total assets |
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$ |
20,215,280 |
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$ |
22,915,797 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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|
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|
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Accounts payable |
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$ |
765,938 |
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$ |
954,585 |
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Accrued expenses |
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1,740,923 |
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1,842,399 |
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Deferred revenue |
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566,010 |
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15,001 |
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Total current liabilities |
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3,072,871 |
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2,811,985 |
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Stockholders equity: |
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Redeemable convertible preferred stock, $.01 par value; 750,000 shares authorized, no shares issued and outstanding |
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Undesignated preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding |
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Common stock, $.01 par value; 30,000,000 shares authorized, 9,991,943 shares issued |
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99,919 |
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99,919 |
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Additional paid-in capital |
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31,640,234 |
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31,640,234 |
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Treasury stock (at cost, 57,663 shares) |
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(279,756 |
) |
(279,756 |
) |
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Accumulated deficit |
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(14,317,988 |
) |
(11,356,585 |
) |
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Total stockholders equity |
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17,142,409 |
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20,103,812 |
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Total liabilities and stockholders equity |
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$ |
20,215,280 |
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$ |
22,915,797 |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
2
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
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Quarter Ended June 30, |
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Six Months Ended June 30, |
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2002 |
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2001 |
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2002 |
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2001 |
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|
|
|
|
|
|
|
|
|
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Product revenue |
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$ |
3,415,877 |
|
$ |
2,919,034 |
|
$ |
5,800,594 |
|
$ |
5,097,652 |
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License revenue |
|
5,000 |
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|
|
10,000 |
|
|
|
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Total revenue |
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3,420,877 |
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2,919,034 |
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5,810,594 |
|
5,097,652 |
|
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Cost of product revenue |
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2,201,318 |
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2,109,049 |
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4,288,732 |
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4,077,997 |
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Gross profit |
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1,219,559 |
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809,985 |
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1,521,862 |
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1,019,655 |
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Operating expenses: |
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Research and development |
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1,050,426 |
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921,325 |
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2,140,300 |
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2,269,195 |
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Selling, general and administrative |
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1,388,837 |
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1,858,790 |
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2,468,332 |
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3,247,364 |
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Litigation settlement costs |
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886,480 |
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950,716 |
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Total operating expenses |
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2,439,263 |
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3,666,595 |
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4,608,632 |
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6,467,275 |
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Loss from operations |
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(1,219,704 |
) |
(2,856,610 |
) |
(3,086,770 |
) |
(5,447,620 |
) |
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Interest income, net |
|
62,508 |
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206,202 |
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125,367 |
|
478,781 |
|
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Net loss |
|
$ |
(1,157,196 |
) |
$ |
(2,650,408 |
) |
$ |
(2,961,403 |
) |
$ |
(4,968,839 |
) |
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|
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|
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Basic and diluted net loss per common share |
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$ |
(0.12 |
) |
$ |
(0.27 |
) |
$ |
(0.30 |
) |
$ |
(0.50 |
) |
Shares used to calculate basic and diluted net loss per common share |
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9,934,280 |
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9,934,280 |
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9,934,280 |
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9,934,280 |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
3
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
For the Six Months Ended
(Unaudited)
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June 30,
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June 30,
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Cash flows from operating activities: |
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Net loss |
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$ |
(2,961,403 |
) |
$ |
(4,968,839 |
) |
Adjustments to reconcile net loss to net cash used by operations: |
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|
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Depreciation |
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543,644 |
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471,360 |
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Amortization of deferred compensation |
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|
|
127,645 |
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Forgiveness of note receivable from officer |
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129,000 |
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Changes in operating assets and liabilities: |
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|
|
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|
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Accounts receivable |
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12,235 |
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486,309 |
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Inventories |
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940,334 |
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112,972 |
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Prepaid expenses and other current assets |
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84,873 |
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137,823 |
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Accounts payable |
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(188,647 |
) |
781,107 |
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Accrued expenses |
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(101,476 |
) |
485,363 |
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Deferred revenue |
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551,009 |
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237,657 |
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Net cash used in operating activities |
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(1,119,431 |
) |
(1,999,603 |
) |
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Cash flows from investing activities |
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|
|
|
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Proceeds from sale of short-term marketable securities |
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1,994,401 |
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12,001,865 |
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Purchase of short-term marketable securities |
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(2,500,000 |
) |
(9,383,839 |
) |
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Purchase of property and equipment |
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(42,188 |
) |
(626,355 |
) |
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Note receivable from officers |
|
75,000 |
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|
|
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Deposits |
|
5,100 |
|
5,940 |
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Net cash provided by (used in) investing activities |
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(467,687 |
) |
1,997,611 |
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|
|
|
|
|
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Decrease in cash and cash equivalents |
|
(1,587,118 |
) |
(1,992 |
) |
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Cash and cash equivalents at beginning of period |
|
9,064,977 |
|
8,265,936 |
|
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Cash and cash equivalents at end of period |
|
$ |
7,477,859 |
|
$ |
8,263,944 |
|
The accompanying notes are an integral part of these unaudited consolidated financial statements.
4
ANIKA THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of Business
Anika Therapeutics, Inc. (Anika or the Company) develops, manufactures and commercializes therapeutic products and devices intended to promote the protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Due to its unique biophysical and biochemical properties, HA plays an important role in a number of physiological functions such as the protection and lubrication of soft tissues and joints, the maintenance of the structural integrity of tissues, and the transport of molecules to and within cells. The Companys currently marketed products consist of ORTHOVISC ® , which is an HA product used in the treatment of some forms of osteoarthritis in humans, and HYVISC ® , which is an HA product used in the treatment of equine osteoarthritis. ORTHOVISC ® is currently approved for sale and is being marketed in Canada, parts of Europe, Turkey, and Israel. In the U.S., ORTHOVISC Ò is currently limited to investigational use. The Company manufactures AMVISC ® and AMVISC ® Plus for Bausch & Lomb Surgical, which are HA products used as viscoelastic supplements in ophthalmic surgery. The Company also manufactures CoEase Ô for Advanced Medical Optics, Inc., STAARVISC Ò II for STAAR Surgical Company and ShellGel Ô for Cytosol Ophthalmics, Inc. which are injectible ophthalmic viscoelastic products.
2. Basis of Presentation
The accompanying consolidated financial statements have been prepared by the Company without audit, pursuant to the rules and regulations of the Securities and Exchange Commission and in accordance with accounting principles generally accepted in the United States. In the opinion of management, these consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to fairly state the financial position of the Company as of June 30, 2002, the results of its operations for the quarter and six months ended June 30, 2002 and 2001 and its cash flows for the six months ended June 30, 2002 and 2001.
The accompanying consolidated financial statements and related notes should be read in conjunction with the Companys annual financial statements filed with the Annual Report on Form 10-K for the year ended December 31, 2001. The results of operations for the quarter and six months ended June 30, 2002 are not necessarily indicative of the results to be expected for the year ending December 31, 2002. See Risk Factors and Certain Factors Affecting Future Operating Results.
3. Summary of Significant Accounting Policies
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
5
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Anika Therapeutics, Inc. and its wholly owned subsidiaries, Anika Securities Corporation and Anika Therapeutics UK, Ltd. All intercompany transactions and balances have been eliminated in consolidation.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and investments with original maturities of 90 days or less.
Marketable Securities
The Company follows the provisions of Statement of Financial Accounting Standards (SFAS) No. 115, Accounting for Certain Investments in Debt and Equity Securities. Short-term marketable securities consist of investments with maturities within twelve months of the balance sheet date. The Company classifies these marketable securities as held to maturity, and accordingly they are carried at amortized cost. Aggregate fair value, amortized cost and average maturity for marketable securities held at June 30, 2002 and December 31, 2001 are as follows:
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June 30, 2002 |
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|
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Amortized Cost |
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Gross Unrealized
|
|
Fair Value |
|
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Commercial Bond (12 month maturity) |
|
$ |
2,000,000 |
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$ |
(3,040 |
) |
$ |
1,996,960 |
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Municipal Bond (12 month maturity) |
|
2,500,000 |
|
|
|
2,500,000 |
|
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Total |
|
$ |
4,500,000 |
|
$ |
(3,040 |
) |
$ |
4,496,960 |
|
|
|
December 31, 2001 |
|
|||||||
|
|
Amortized Cost |
|
Gross Unrealized
|
|
Fair Value |
|
|||
Commercial Paper (weighted average maturity of 5.5 months) |
|
$ |
3,994,401 |
|
$ |
39,802 |
|
$ |
4,034,203 |
|
During the six months ending June 30, 2002, securities classified as held to maturity, with an aggregate amortized cost of $2,032,000, including interest and realized gains of $37,599, matured.
Revenue Recognition
Product revenue is recognized upon shipment to the customer as long as there is persuasive evidence of an arrangement, the sales price is fixed or determinable and collection of the related receivable is probable. ORTHOVISC Ò has been sold through several distribution arrangements as well as two outsource order processing arrangements (logistics agents). Sales of product through third party logistics agents in certain markets are recognized as revenue upon shipment by the logistics agent to the customer. The Company recognizes non-refundable up-front or milestone payments received as part of supply, distribution, and marketing arrangements, ratably over the terms of the agreements to which the payments apply. Amounts received or billed prior to meeting the Companys revenue recognition criteria are recorded as deferred revenue in the accompanying balance sheet.
6
Reporting Comprehensive Income
SFAS No. 130, Reporting Comprehensive Income, establishes standards for reporting and display of comprehensive income (loss) and its components in the financial statements. Comprehensive income (loss) is the total of net income (loss) and all other non-owner changes in equity including such items as unrealized holding gains/losses on securities, foreign currency translation adjustments and minimum pension liability adjustments. The Company had no other items of comprehensive income (loss) for the quarter and six months ended June 30, 2002 and 2001 except for its reported net loss.
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-makers, in making decisions regarding how to allocate resources and assess performance. The Companys chief decision-making group consists of two individuals: the chief executive officer and president and the chief financial officer. Based on the criteria established by SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information , the Company has one reportable operating segment, the results of which are disclosed in the accompanying financial statements. Substantially all of the operations and assets of the Company have been derived from and are located in the United States.
Revenues by geographic location in total and as a percentage of total revenues are as follows:
|
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Quarter Ended June, |
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|
|
2002 |
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2001 |
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|
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Revenue |
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Percent of
|
|
Revenue |
|
Percent of
|
|
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United States |
|
$ |
2,688,277 |
|
78.6 |
% |
$ |
1,955,793 |
|
67.0 |
% |
Middle East |
|
30,000 |
|
0.9 |
|
|
|
|
|
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Other/Europe |
|
702,600 |
|
20.5 |
|
963,241 |
|
33.0 |
|
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Total |
|
$ |
3,420,877 |
|
100.0 |
% |
$ |
2,919,034 |
|
100.0 |
% |
|
|
Six Months Ended June 30, |
|
||||||||
|
|
2002 |
|
2001 |
|
||||||
|
|
Revenue |
|
Percent of
|
|
Revenue |
|
Percent of
|
|
||
United States |
|
$ |
4,551,380 |
|
78.3 |
% |
$ |
3,396,275 |
|
66.6 |
% |
Middle East |
|
89,115 |
|
1.5 |
|
11,950 |
|
0.2 |
|
||
Other/Europe |
|
1,170,099 |
|
20.2 |
|
1,689,427 |
|
33.1 |
|
||
Total |
|
$ |
5,810,594 |
|
100.0 |
% |
$ |
5,097,652 |
|
100.0 |
% |
Since early 2001, sales of product for the Turkish market have been made to a European-based entity and have accordingly been classified in the Other/Europe category since that time.
Product revenue by significant customers as a percent of total revenues is as follows:
|
|
Quarter Ended June 30, |
|
Six Months Ended June 30, |
|
||||
|
|
2002 |
|
2001 |
|
2002 |
|
2001 |
|
AMVISC â Bausch & Lomb |
|
42.2 |
% |
50.9 |
% |
47.1 |
% |
56.9 |
% |
HYVISC â Boehringer Ingelheim |
|
16.6 |
% |
9.8 |
% |
15.1 |
% |
7.9 |
% |
ORTHOVISC â Pharmaren AG |
|
11.6 |
% |
23.7 |
% |
8.9 |
% |
22.1 |
% |
|
|
70.4 |
% |
84.4 |
% |
71.1 |
% |
86.9 |
% |
7
4. Earnings Per Share
The Company reports earnings per share in accordance with SFAS No. 1 28, Earnings per Share , which establishes standards for computing and presenting earnings (loss) per share.
Basic earnings per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing net income (loss) by the weighted average number of common shares and dilutive potential common shares outstanding during the period. Under the treasury stock method, the dilutive unexercised options are assumed to be exercised at the beginning of the period or at issuance, if later. The assumed proceeds are then used to purchase common shares at the average market price during the period. For periods where the Company has incurred a loss, dilutive net loss per share is equal to basic net loss per share. Accordingly, the dilutive effect of outstanding options totaling 126,875 and 416,500, respectively, at June 30, 2002 and 2001, are excluded from the calculation of diluted weighted average shares outstanding because to include them would have been antidilutive for the periods presented.
5. Inventories
Inventories consist of the following:
|
|
June 30,
|
|
December 31,
|
|
||
Raw materials |
|
$ |
1,256,422 |
|
$ |
1,542,511 |
|
Work-in-process |
|
1,320,791 |
|
1,971,067 |
|
||
Finished goods |
|
209,435 |
|
213,404 |
|
||
Total |
|
$ |
2,786,648 |
|
$ |
3,726,982 |
|
Inventories are stated at the lower of cost or market, with cost being determined using the first-in, first-out (FIFO) method. Work-in-process and finished goods inventories include materials, labor, and manufacturing overhead.
6. Notes Receivable from Officers
Notes receivable from officers of $178,000 consists of loans made to one officer and one former officer. The note receivable from the officer accrues interest at 6.22%. The note receivable from the former officer is secured by a mortgage on his primary residence, accrues interest at an annual rate of 6.0% and is due on August 12, 2004. A note in the amount of $75,000 from the Companys former chief executive officer was repaid on June 12, 2002.
7. Licensing and Distribution Agreements
In July 2000, the Company entered into a seven-year supply agreement (the BLS Agreement) with Bausch & Lomb Surgical, a unit of Bausch & Lomb. Under the terms of the BLS Agreement, effective January 1, 2001, the Company became Bausch & Lombs exclusive provider of AMVISC ® and AMVISC ® Plus, ophthalmic viscoelastic products, in the U.S. and international markets. The BLS Agreement expires December 31, 2007, superceding an existing supply contract with Bausch & Lomb Surgical that was set to expire December 31, 2001 (the Old BLS Agreement). The BLS Agreement is subject to early termination and/or reversion to a non-exclusive basis under certain circumstances. The
8
BLS Agreement lifts contractual restrictions on the Companys sales of certain ophthalmic products to other companies contained in the Old BLS Agreement, subject to payment of royalties to Bausch & Lomb by the Company. The Company agreed to a reduction in unit selling prices effective April 1, 2000, and the elimination of minimum unit purchase obligations by Bausch & Lomb Surgical. Under the terms of the BLS Agreement, the price for units sold in a calendar year is dependent on total unit volume of sales of certain ophthalmic products during the year. Accordingly, unit prices for sales occurring in the six months ended June 30, 2002 are subject to possible retroactive price adjustments when the actual annual unit volume for 2002 becomes known. In accordance with the Companys revenue recognition policy, revenue is not recognized if the sale price is not fixed or determinable and any amounts received in excess of revenue recognized is recorded as deferred revenue. At June 30, 2002, the deferred revenue under the BLS Agreement amounted to approximately $488,000.
In April 2001, the Company entered into a five-year supply agreement with Cytosol Ophthalmics, Inc. Under the terms of the agreement, effective April 11, 2001, the Company became Cytosol Ophthalmics exclusive provider of sterile sodium hyaluronate ophthalmic viscoelastic products in the U.S. and international markets. Under the agreement, in lieu of up-front payments, the Company is entitled to an increase in the price per unit it charges Cytosol of $2 per unit for the initial 50,000 units purchased. As a result, revenue of $2 per unit for the initial 50,000 units purchased will be deferred at the time of shipment and recognized ratably over the remaining term of the agreement. The agreement expires April 11, 2006. The agreement is subject to early termination and/or reversion to a non-exclusive basis under certain circumstances. At June 30, 2002, deferred revenue under this agreement amounted to approximately $73,000. At June 30, 2002, deferred revenue also includes $5,000 relating to fees paid to the Company under its agreement with AMA Pharmaceuticals.
8. Legal Matters
Securities and Exchange Commission Investigation . The SEC has issued a formal order of investigation and has required the Company to provide information in connection with certain revenue recognition matters. The Company has been cooperating fully. These matters, relating to the Companys historical accounting for and disclosures concerning sales of ORTHOVISC Ò under a long-term supply and distribution agreement with Zimmer, were also the subject of the Companys March 15, 2000 disclosure concerning an informal SEC inquiry and the restatement of results for 1998 and the first three quarters of 1999. As reported on August 14, 2001, as a result of the SECs ongoing investigation, the Company, in conjunction with its independent auditors, determined to again restate its financial results for the fourth quarter of 1998 and the first quarter of 1999. As a result of the SECs investigation, the Company has been informed that the staff of the Boston District Office of the SEC (the Staff) is considering recommending that the SEC authorize civil injunctive actions against the Company and others, including former officers of the Company, concerning these matters. The Company was invited by the Staff to submit its views as to why a civil injunctive action against the Company should not be instituted, and the Company did so. The Company is currently in discussions with the Staff concerning possible resolution of the matter by settlement. The Company is not in a position to predict whether such a settlement will be reached. In addition, if the Company expends substantial additional costs and fees in responding to this matter, then the matter may have an adverse effect on the Companys financial position.
9
ITEM 2. MA NAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding:
our future sales and product revenues, including possible retroactive price adjustments, expectations regarding unit volumes or other offsets to price reductions;
our efforts to increase sales of ophthalmic viscoelastic products;
our manufacturing capacity and work-in-process manufacturing;
the timing, scope, and rates of patient enrollment in clinical trials and related costs;
FDA or other regulatory approvals and/or reimbursement approvals of new or potential products;
the development of possible new products;
the rate at which we use cash and the amounts used;
possible negotiations or renegotiations with existing or new distribution and collaboration partners; and
the possible resolution of the SEC investigation by settlement, and the effect of the SEC investigation on our financial position if we expend substantial additional costs and fees in our response to the investigation.
Statements identified by words such as will, likely, may, believe, expect, anticipate, intend, and other expressions, that are predictions of, or indicate future events and trends and which do not relate to historical matters, also identify forward-looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors, some of which are beyond our control, including those factors described in the section titled Risk Factors and Certain Factors Affecting Future Operating Results in this Quarterly Report on Form 10-Q. Our actual results, performance or achievement could differ materially from anticipated results, performance or achievement, expressed or implied in such forward-looking statements. Such forward looking statements are based upon the current assumptions and beliefs of management and are only expectations of future results. Additional factors that might cause such a difference are set forth herein and in the Managements Discussions and Analysis of Financial Condition and Results of Operations beginning on page 10 of this Quarterly Report on Form 10-Q, as well as factors described in our Annual Report on Form 10-K for the year ended December 31, 2001 and our press releases and other filings with the Securities and Exchange Commission. We undertake no obligation to publicly update or revise any forward-looking statement whether as a result of new information, future events or otherwise.
Results of Operations
Product revenue. Product revenue for the quarter ended June 30, 2002 was $3,415,877, an increase of $496,843, or 17.0%, from $2,919,034 for the quarter ended June 30, 2001. Product revenue for the six months ended June 30, 2002 was $5,800,594, an increase of $702,942, or 13.8%, from $5,097,652 for the six months ended June 30, 2001. The increase in product revenue for the quarter and six months ended June 30, 2002 compared to the same periods last year is primarily due to higher ophthalmic product sales and sales of HYVISC® partially offset by lower sales of ORTHOVISC®. Sales of ophthalmic products increased approximately $444,000 and $667,000 for the quarter and six months ended June 30, 2002, respectively, primarily due to new supply agreements with Cytosol Ophthalmics, Inc. and Advanced Medical Optics, Inc., and sales of HYVISC® increased approximately $283,000 and $476,000. The decrease in sales of ORTHOVISC® is primarily attributable to lower sales for the Turkish market.
We derive a substantial portion of our revenue from the sale of AMVISC â and AMVISC â Plus to Bausch & Lomb Surgical. For the quarter and six months ended June 30, 2002, AMVISC â and AMVISC â Plus sales accounted for 42.2% and 47.1% of product revenue, respectively, compared to 50.9% and 56.9% of product revenue for the quarter and six months ended June 30, 2001.
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Revenues by geographic location in total and as a percentage of total revenues are as follows:
|
|
Quarter Ended June, |
|
||||||||
|
|
2002 |
|
2001 |
|
||||||
|
|
Revenue |
|
Percent of Revenue |
|
Revenue |
|
Percent of Revenue |
|
||
United States |
|
$ |
2,688,277 |
|
78.6 |
% |
$ |
1,955,793 |
|
67.0 |
% |
Middle East |
|
30,000 |
|
0.9 |
|
|
|
|
|
||
Other/Europe |
|
702,600 |
|
20.5 |
|
963,241 |
|
33.0 |
|
||
Total |
|
$ |
3,420,877 |
|
100.0 |
% |
$ |
2,919,034 |
|
100.0 |
% |
|
|
Six Months Ended June 30, |
|
||||||||
|
|
2002 |
|
2001 |
|
||||||
|
|
Revenue |
|
Percent of
|
|
Revenue |
|
Percent of
|
|
||
United States |
|
$ |
4,551,380 |
|
78.3 |
% |
$ |
3,396,275 |
|
66.6 |
% |
Middle East |
|
89,115 |
|
1.5 |
|
11,950 |
|
0.2 |
|
||
Other/Europe |
|
1,170,099 |
|
20.2 |
|
1,689,427 |
|
33.1 |
|
||
Total |
|
$ |
5,810,594 |
|
100.0 |
% |
$ |
5,097,652 |
|
100.0 |
% |
Since early 2001, sales of product for the Turkish market have been made to a European-based entity and have accordingly been classified in the Other/Europe category since that time.
License revenue. License revenue was $5,000 and $10,000 for the quarter and six months ended June 30, 2002, related to an annual up-front payment associated with a five year supply agreement with a purchaser of our ophthalmic products.
Gross profit. Gross profit for the quarter ended June 30, 2002 was $1,219,559, or 35.7% of revenue, an increase of $409,574, or 50.6%, from a gross profit of $809,985, or 27.7% of revenue, for the quarter ended June 30, 2001. Gross profit for the six months ended June 30, 2002 was $1,521,862, or 26.2% of revenue, an increase of $502,207, or 49.3%, from a gross profit of $1,019,655, or 20.0% of revenue, for the six months ended June 30, 2001. Gross profit for the quarter and six months ended June 30, 2002, as compared with same periods last year, benefited from improved manufacturing cost performance resulting from our efforts over the past year to reduce work in process inventories combined with increase sales volumes.
Research and development. Research and development expenses for the quarter ended June 30, 2002 was $1,050,426, an increase of $129,101, or 14.0%, compared to $921,325 for the quarter ended June 30, 2001. Research and development expenses for the six months ended June 30, 2002 was $2,140,300, a decrease of $128,895, or 5.7%, compared to $2,269195 for the six months ended June 30, 2001. Research and development expenses include costs for the current Phase III clinical trial for ORTHOVISC®, our product for treatment of osteoarthritis of the knee, for which we are currently seeking FDA approval. The increase in research and development expense for the quarter ended June 30, 2002 compared to the same period last year is primarily due to higher costs related to the ORTHOVISC® clinical trial partially offset by a decrease in employee related costs due to lower headcount. The decrease in research and development expense for the six months ended June 30, 2002 compared to the same period last year is primarily due to a decrease in employee related costs due to lower headcount partially offset by higher costs related to the ORTHOVISC® clinical trial. The increase in costs related to the ORTHOVISC® clinical trial for the six months ended June 30, 2002 compared to the same period last year was partially offset by expenditures in the first quarter of last year related to the preparation for initiation of a clinical trial for INCERT®, a therapy
11
for preventing post-surgical adhesions. As previously disclosed, we determined not to commence a clinical trial for INCERT® during 2001.
Selling, general and administrative. Selling, general and administrative expenses for the quarter ended June 30, 2002 was $1,388,837, a decrease of $469,953, or 25.3%, compared to $1,858,790 for the quarter ended June 30, 2001. Selling, general and administrative expenses for the six months ended June 30, 2002 was $2,468,332, a decrease of $779,032, or 24.0%, compared to $3,247,364 for the six months ended June 30, 2001. The decrease is primarily attributable to separation costs of $515,000 incurred in the first six months of 2001 related to management changes we implemented in June 2001 combined with lower professional service fees and lower ORTHOVISC® selling expenses in foreign markets in 2002 compared to 2001.
Litigation settlement costs. Litigation settlement costs for the quarter and six months ended June 30, 2001 included a charge of $850,000, which is the amount of a $1.25 million settlement amount contributed by us related to a putative class action suit. For the quarter and six months ended June 30, 2001, professional fees related to the putative class action suit were $36,480 and $100,716, respectively.
Interest income, net. Interest income, net, for the quarter ended June 30, 2002 was $62,508, a decrease of $143,694, or 69.7%, compared to $206,202 for the quarter ended June 30, 2001. Interest income, net, for the six months ended June 30, 2002 was $125,367, a decrease of $353,414, or 73.8%, compared to $478,781 for the six months ended June 30, 2001. The decrease in interest income, net, is primarily due to lower interest rates on investments combined with lower average cash balances during the quarter and six months ended June 30, 2002, compared to the same periods last year.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity is defined as the ability to meet current and future financial obligations of a short-term nature. Historically, we have funded our cash requirements from available cash and short-term marketable securities.
At June 30, 2002, we had cash, cash equivalents and short-term marketable securities of $12.0 million and working capital of $14.4 million compared to cash, cash equivalents and short-term marketable securities of $13.1 million and working capital of $16.8 million at December 31, 2001. Short-term marketable securities at June 30, 2002 consist of a commercial bond and a municipal bond each with an original maturity of one year.
Aggregate cash used in operating activities was $1,119,431 for the six months ended June 30, 2002 and $1,999,603 for the six months ended June 30, 2001. Cash used in operating activities for the six months ended June 30, 2002 included net loss, adjusted for depreciation and amortization, of $2,417,759. This cash used in operating activities was partially offset by cash provided by a reduction in inventory of $940,334 and an increase in deferred revenue of $551,009. The increase in deferred revenue largely relates to unit pricing provisions under the Companys supply agreement with Bausch & Lomb (see Note 7). Cash used in operating activities for the six months ended June 30, 2001 included net loss, adjusted for depreciation and amortization, of $4,369,834. This cash used in operating activities was partially offset by cash provided by a reduction accounts receivable of $486,309, an increase in accounts payable and accrued expenses of $1,266,470 and an increase in deferred revenue of $237,657.
Capital expenditures were $42,188 for the six months ended June 30, 2002. Capital expenditures in 2002 are expected to include spending for small equipment, computers, and furniture and fixtures associated with normal operations. We anticipate that use of cash in 2002 will be significantly less than cash used in 2001.
12
Our future capital requirements and the adequacy of available funds will depend, on numerous factors, including:
market acceptance of its existing and future products;
the successful commercialization of products in development;
progress in its product development efforts;
the magnitude and scope of product development efforts;
progress with pre-clinical studies, clinical trials and product clearances by the FDA and other agencies;
the cost of maintaining adequate manufacturing capabilities;
the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
competing technological and market developments; and
the development of strategic alliances for the marketing of certain of its products.
We have historically derived the majority of our revenues from a small number of customers, most of whom resell our products to end users and most of whom are significantly larger companies than us. For the six months ended June 30, 2002, Bausch & Lomb accounted for 47.1% of product revenues and 46.4% of our accounts receivable balance and Boehringer Ingelheim accounted for 15.1% of product revenues and 25.6% of our accounts receivable balance. On March 11, 2002, Bausch & Lombs senior debt and short-term debt ratings were downgraded. Although Bausch & Lomb emphasized at that time it was not facing any issues with respect to liquidity, any such issues that impact their ability to pay their accounts with us could adversely impact future revenues.
There can be no assurance that we will record profits in future periods. However, we believe that our cash and investments on hand will be sufficient to meet our requirements at least through June 30, 2003. See Risk Factors and Certain Other Factors Affecting Future Operating Results History of Losses; Uncertainty of Future Profitability.
The terms of any future equity financings may be dilutive to our stockholders and the terms of any debt financings may contain restrictive covenants, which could limit our ability to pursue certain courses of action. Our ability to obtain financing is dependent on the status of our future business prospects as well as conditions prevailing in the relevant capital markets. No assurance can be given that any additional financing will be made available to us or will be available on acceptable terms should such a need arise.
Critical Accounting Policies
In December 2001, the SEC requested that reporting companies discuss their most critical accounting policies in managements discussion and analysis of financial condition and results of operations. The SEC indicated that a critical accounting policy is one that is important to the portrayal of a companys financial condition and operating results and requires managements most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
We have identified the policies below as critical to our business operations and the understanding of our results of operations. The impact and any associated risks related to these policies on our business operations is discussed throughout Managements Discussion and Analysis of Financial Condition and Results of Operations where such policies affect our reported and expected financial results. For a detailed discussion on the application of this and other accounting policies, see Note 2 in the Notes to the
13
Consolidated Financial Statements of our Annual Report on Form 10-K for the year ended December 31, 2001. Our preparation of this Quarterly Report on Form 10-Q requires us to make estimates and assumptions that affect the reported amount of assets and liabilities, disclosure of contingent assets and liabilities at the date of our financial statements, and we cannot make any assurances that actual results will not differ from those estimates.
Revenue Recognition. Product revenue is recognized upon shipment to the customer as long as there is (i) persuasive evidence of an arrangement, (ii) the sales price is fixed or determinable and (iii) collection of the related receivable is probable. Amounts billed or collected prior to recognition of revenue is classified as deferred revenue. Determination of criteria (ii) and (iii) are based on managements judgments regarding the fixed nature of the product fee and collectibility of those fees. Under our agreement with Bausch and Lomb, the price for units sold in a calendar year is dependent on total unit volume of sales of certain ophthalmic products during the year. Accordingly, unit prices for sales occurring in interim quarters are subject to possible retroactive price adjustments when the actual annual unit volume for the year becomes known. In accordance with our revenue recognition policy, the amount of revenue subject to the contracted price adjustment is recorded as deferred revenue until the annual unit volume becomes known and the sales price becomes fixed. ORTHOVISC® has been sold through several distribution arrangements as well as outsource order-processing arrangements (logistic agents.) Sales of product through third party logistics agents in certain markets are recognized as revenue upon shipment by the logistics agent to the customer. We recognize non-refundable upfront or milestone payments received as part of supply, distribution, and marketing arrangements, ratably over the terms of the arrangements to which the payments apply.
Reserve for Obsolete/Excess Inventory. Inventories are stated at the lower of cost or market. We regularly review raw materials and work-in-process inventories and record a provision for excess and obsolete inventory if the inventory has not progressed through the manufacturing process for a period of time in excess of the typical inventory cycle period. The reserve is adjusted in subsequent periods to reflect the current movement of the inventory through the manufacturing process.
RISK FACTORS AND CERTAIN FACTORS AFFECTING FUTURE OPERATING RESULTS
Our business is subject to comprehensive and varied government regulation and, as a result, failure to obtain FDA or other governmental approvals for our products may materially adversely affect our business, results of operations or financial condition.
Product development and approval within the Food & Drug Administration framework takes a number of years and involves the expenditure of substantial resources. There can be no assurance that the FDA will grant approval for our new products on a timely basis if at all, or that FDA review will not involve delays that will adversely affect our ability to commercialize additional products or expand permitted uses of existing products, or that the regulatory framework will not change, or that additional regulation will not arise at any stage of our product development process which may adversely affect approval of or delay an application or require additional expenditures by us. In the event our future products are regulated as human drugs or biologics, the FDAs review process of such products typically would be substantially longer and more expensive than the review process to which they are currently subject as devices.
Class III devices are those that generally must receive pre-market approval from the FDA (e.g. life-sustaining, life-supporting and implantable or new devices which have not been found to be substantially equivalent to legally marketed devices) and require clinical testing to ensure safety and effectiveness and FDA approval prior to marketing and distribution. In order for us to commercially distribute ORTHOVISC ® in the U.S., we must obtain a pre-market approval. The PMA process can be expensive, uncertain and lengthy. A number of devices for which PMAs have been sought have never
14
been approved for marketing. The review of an application often occurs over a protracted time period, potentially taking two years or more from the filing date to complete. We submitted a PMA application for ORTHOVISC® in December 1997. In October 1998, we were notified by the FDA that our PMA application for ORTHOVISC® was not approvable and that additional clinical data would be required to demonstrate the effectiveness of ORTHOVISC®. We submitted an IDE to the FDA in February 1999 and received approval in late March 1999 to commence a second Phase III clinical study. We received initial results from the Phase III clinical trial in late May 2000 that we determined did not show sufficient efficacy to support the filing of a PMA application. We have evaluated available information and in February 2001, we commenced another Phase III clinical trial of ORTHOVISC®. The trial is being conducted in up to 25 centers in the U.S. and Canada, with 360 patients expected to be enrolled, and with evaluation over a six-month period following treatment. There can be no assurances that:
any additional clinical data will support the efficacy of ORTHOVISC ® ;
we will complete any additional clinical trials of ORTHOVISC ® ;
we will be able to successfully complete the FDA approval process; or
any additional clinical trials will support a PMA application and/or FDA approval in a timely manner or at all.
There also can be no assurance that any delay in receiving FDA approvals will not continue to adversely affect our competitive position. Furthermore, even if we were to receive a PMA approval:
the approval may include significant limitations on the indications and other claims sought for use for which the product may be marketed;
the approval may include other significant conditions to approval such as post-market testing, tracking, or surveillance requirements; and
we may not be able to achieve meaningful sales of ORTHOVISC® in the U.S.
Once obtained, marketing approval can be withdrawn by the FDA for a number of reasons, including, among other things, the failure to comply with regulatory standards, or the occurrence of unforeseen problems following initial approval. We may be required to make further filings with the FDA under certain circumstances. The FDAs regulations require a PMA supplement for any changes that affect the safety and effectiveness of an approved device, including, but not limited to, new indications for use, labeling changes, the use of a different facility to manufacture, process or package the device, and changes in performance or design specifications. Changes in manufacturing that affect safety and effectiveness may be deemed approved after a 30-day notice unless the FDA requests a supplement. Our failure to receive approval of a PMA supplement regarding the use of a different manufacturing facility or any other change affecting the safety or effectiveness of an approved device on a timely basis, or at all, may have a material adverse effect on our business, financial condition, and results of operations. The FDA could also limit or prevent the manufacture or distribution of our products and has the power to require the recall of such products. Significant delay or cost in obtaining, or failure to obtain FDA approval to market products, any FDA limitations on the use of our products, or any withdrawal or suspension of approval or rescission of approval by the FDA could have a material adverse effect on our business, financial condition, and results of operations.
In addition, all FDA approved or cleared products manufactured by us must be manufactured in compliance with the FDAs Good Manufacturing Practices (GMP) regulations and, for medical devices, the FDAs Good Manufacturing Practices/Quality System Regulations (GMP/QSR). Ongoing compliance with GMP/QSR and other applicable regulatory requirements is enforced through periodic inspection by state and federal agencies, including the FDA. The FDA may inspect us and our facilities from time to time to determine whether we are in compliance with regulations relating to medical device
15
and manufacturing companies, including regulations concerning manufacturing, testing, quality control and product labeling practices. There can be no assurance that we will be able to comply with current or future FDA requirements applicable to the manufacture of products.
FDA regulations depend heavily on administrative interpretation and there can be no assurance that the future interpretations made by the FDA or other regulatory bodies, with possible retroactive effect, will not adversely affect us. In addition, changes in the existing regulations or adoption of new governmental regulations or policies could prevent or delay regulatory approval of our products.
Failure to comply with applicable regulatory requirements could result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the FDA to grant pre-market clearance or PMAs for devices, withdrawal of approvals and criminal prosecution.
In addition to regulations enforced by the FDA, we are subject to other existing and future federal, state, local and foreign regulations. International regulatory bodies often establish regulations governing product standards, packing requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. There can be no assurance that we will be able to achieve and/or maintain compliance required for CE marking or other foreign regulatory approvals for any or all of our products or that we will be able to produce our products in a timely and profitable manner while complying with applicable requirements. Federal, state, local and foreign regulations regarding the manufacture and sale of medical products are subject to change. We cannot predict what impact, if any, such changes might have on our business.
The process of obtaining approvals from the FDA and other regulatory authorities can be costly, time consuming, and subject to unanticipated delays. There can be no assurance that approvals or clearances of our products will be granted or that we will have the necessary funds to develop certain of its products. Any failure to obtain, or delay in obtaining such approvals or clearances, could adversely affect our ability to market our products.
We have historically incurred operating losses and we cannot make any assurances about our future profitability.
From our inception through December 31, 1996 and in 1999, 2000, and 2001, we have incurred annual operating losses. As of June 30, 2002, we had an accumulated deficit of approximately $14.3 million. The continued development of our products will require the commitment of substantial resources to conduct research and preclinical and clinical development programs, and to establish sales and marketing capabilities or distribution arrangements. Our ability to reach profitability is highly uncertain. To achieve profitability, we must, among other things, successfully complete development of certain of our products, obtain regulatory approvals and establish sales and marketing capabilities or distribution arrangements for certain of our products.
Substantial competition could materially affect our financial performance.
We compete with many companies, including, among others, large pharmaceutical companies and specialized medical products companies. Many of these companies have substantially greater financial and other resources, larger research and development staffs, more extensive marketing and manufacturing organizations and more experience in the regulatory process than us. We also compete with academic institutions, governmental agencies and other research organizations that may be involved in research, development and commercialization of products. Because a number of companies are developing or have developed HA products for similar applications, the successful commercialization of a particular product
16
will depend in part upon our ability to complete clinical studies and obtain FDA marketing and foreign regulatory approvals prior to our competitors, or, if regulatory approval is not obtained prior to competitors, to identify markets for our products that may be sufficient to permit meaningful sales of our products. For example, several of our competitors have already obtained FDA and foreign regulatory approvals for marketing HA products with applications similar to that of ORTHOVISC Ò . Thus, the successful commercialization of ORTHOVISC Ò will depend in part on our ability to effectively market ORTHOVISC Ò against more established products with a longer sales history. There can be no assurance that we will be able to compete against current or future competitors or that competition will not have a material adverse effect on our business, financial condition and results of operations. We are currently experiencing uncertainties in the Turkish market from economic, regional, political, and competitive factors. As a result, we are uncertain of the extent of our future sales in this market.
Our clinical trials may not support a PMA filing.
Several of our products, including ORTHOVISC Ò , will require clinical trials to determine their safety and efficacy for U.S. and international marketing approval by regulatory bodies, including the FDA. In late May 2000, our initial analysis of the results of our second Phase III clinical trial of ORTHOVISC Ò did not show sufficient efficacy to support the filing of a PMA application to obtain FDA approval. Although we have received (IDE) approval from the FDA for ORTHOVISC ® there can be no assurance that:
any additional clinical data will support the efficacy of ORTHOVISC®,
we will complete any additional clinical trials of ORTHOVISC®,
we will be able to successfully complete the FDA approval process for either ORTHOVISC®, or
additional ORTHOVISC® clinical trials will support a PMA application and/or FDA approval in a timely manner, or at all.
There can be no assurance that we will not encounter additional problems that will cause us to delay, suspend or terminate the clinical trials. In addition, we cannot make any assurance that such clinical trials, if completed, will ultimately demonstrate these products to be safe and efficacious.
We are dependent upon marketing and distribution partners and the failure to maintain strategic alliances on acceptable terms will have a material adverse effect on our business, financial condition and results of operations .
Our success will be dependent, in part, upon the efforts of our marketing partners and the terms and conditions of our relationships with such marketing partners.
We cannot assure you that such marketing partners will not seek to renegotiate their current agreements on terms less favorable to us. Under the terms of the BLS Agreement, effective January 1, 2001, we became Bausch & Lombs exclusive provider of AMVISC ® and AMVISC ® Plus ophthalmic viscoelastic products, in the U.S. and international markets. The BLS Agreement expires December 31, 2007, and superceded an existing supply contract with Bausch & Lomb that was set to expire December 31, 2001. The BLS Agreement is subject to early termination and/or reversion to a non-exclusive basis under certain circumstances. The BLS Agreement lifts contractual restrictions on our ability to sell certain ophthalmic products to other companies, subject to our payment of royalties. We agreed to a reduction in unit selling prices retroactively effective to April 1, 2000 and the elimination of minimum unit purchase obligations of Bausch & Lomb.
17
We have not achieved incremental sales of our ophthalmic products to Bausch & Lomb and/or other companies sufficient to offset the effects of the price reduction and royalties to Bausch & Lomb and there can be no assurances that we will be able to do so in the future. The reduction in unit prices resulted in a decrease in our revenue and gross profit from Bausch & Lomb. We expect revenue in 2002 to be consistent with 2001. In addition, under certain circumstances, Bausch & Lomb has the right to terminate the agreement, and/or the agreement may revert to a non-exclusive basis; in each case, we cannot make any assurances that such circumstances will not occur. For the years ended December 31, 2001 and 2000, sales of AMVISC ® products to Bausch & Lomb accounted for 65.2% and 54.1% of product revenues, respectively. For the six months ended June 30, 2002, sales to Bausch & Lomb amounted to 47.1% of our revenue. Although we intend to continue to seek new opthalmic product customers, there can be no assurances that we will be successful in obtaining new customers or to achieve meaningful sales to such new customers.
We have a relationship with a logistic agent (outsource order processing providers) to distribute ORTHOVISC ® to customers in certain European countries previously served by Zimmer. We have entered into new distribution agreements for ORTHOVISC ® in Canada and the U.K. We are seeking to establish long-term distribution and marketing relationships with new distribution partners in additional countries. There can be no assurance that we will be able to identify or engage appropriate distribution or collaboration partners or effectively transition to any such partners. There can be no assurance that we will obtain European or other reimbursement approvals or, if such approvals are obtained, they will be obtained on a timely basis or at a satisfactory level of reimbursement.
We will need to obtain the assistance of additional marketing partners to bring new and existing products to market. The failure to establish strategic partnerships for the marketing and distribution of our products on acceptable terms will have a material adverse effect on our business, financial condition, and results of operations.
Our future success depends upon market acceptance of our existing and future products .
Our success will depend in part upon the acceptance of our existing and future products by the medical community, hospitals and physicians and other health care providers, and third-party payors. Such acceptance may depend upon the extent to which the medical community perceives our products as safer, more effective or cost-competitive than other similar products. Ultimately, for our new products to gain general market acceptance, it will also be necessary for us to develop marketing partners for the distribution of our products. There can be no assurance that our new products will achieve significant market acceptance. Failure of some or all of our future products to achieve significant market acceptance could have a material adverse effect on our business, financial condition, and results of operations.
We may be unable to adequately protect our intellectual property rights.
Our success will depend, in part, on our ability to obtain and enforce patents, protect trade secrets, obtain licenses to technology owned by third parties when necessary, and conduct our business without infringing on the proprietary rights of others. The patent positions of pharmaceutical, medical products and biotechnology firms, including ours, can be uncertain and involve complex legal and factual questions. There can be no assurance that any patent applications will result in the issuance of patents or, if any patents are issued, whether they will provide significant proprietary protection or commercial advantage, or will not be circumvented by others. In the event a third party has also filed one or more patent applications for any of its inventions, we may have to participate in interference proceedings declared by the PTO to determine priority of invention (see below), which could result in failure to obtain, or the loss of, patent protection for the inventions and the loss of any right to use the inventions. Even if the eventual outcome is favorable to us, such interference proceedings could result in substantial
18
cost to us, and diversion of managements attention away from our operations. Submission and prosecution of patent applications, litigation to establish the validity and scope of patents, assertion of patent infringement claims against others and the defense of patent infringement claims by others can be expensive and time consuming. There can be no assurance that in the event that any claims with respect to any of our patents, if issued, will not be challenged by one or more third parties, that any court or patent authority ruling on such challenge will determine that such patent claims are valid and enforceable. An adverse outcome in such litigation could cause us to lose exclusivity covered by the disputed rights. If a third party is found to have rights covering products or processes used by us, we could be forced to cease using the technologies or marketing the products covered by such rights, we could be subject to significant liabilities to such third party, or we could be required to license technologies from such third party. Furthermore, even if our patents are determined to be valid, enforceable, and broad in scope, there can be no assurance that competitors will not be able to design around such patents and compete with us using the resulting alternative technology.
We have a policy of seeking patent protection for patentable aspects of our proprietary technology. We intend to seek patent protection with respect to products and processes developed in the course of our activities when we believe such protection is in our best interest and when the cost of seeking such protection is not inordinate. However, no assurance can be given that any patent application will be filed, that any filed applications will result in issued patents or that any issued patents will provide us with a competitive advantage or will not be successfully challenged by third parties. The protections afforded by patents will depend upon their scope and validity, and others may be able to design around our patents. Our issued patents and any patents, which arise from our licensed application, would provide competitive protection, if at all, only in the United States.
Other entities have filed patent applications for or have been issued patents concerning various aspects of HA-related products or processes. There can be no assurance that the products or processes we develop will not infringe on the patent rights of others in the future. Any such infringement may have a material adverse effect on our business, financial condition, and results of operations. We received notice from the PTO in 1995 that a third party was attempting to provoke a patent interference with respect to one of our co-owned patents covering the use of INCERT ® for post-surgical adhesion prevention. It is unclear whether an interference will be declared. If an interference is declared, it is not possible at this time to determine the merits of the interference or the effect, if any, the interference will have on our development or marketing of INCERT ® for this use. No assurance can be given that we would be successful in any such interference proceeding. If the third-party interference were to be decided adversely to us, involved claims of our patent would be cancelled and the third party may enforce patent rights against us which could prohibit the sale and use of INCERT ® products.
We also rely upon trade secrets and proprietary know-how for certain non-patented aspects of our technology. To protect such information, we require all employees, consultants and licensees to enter into confidentiality agreements limiting the disclosure and use of such information. There can be no assurance that these agreements provide meaningful protection or that they will not be breached, that we would have adequate remedies for any such breach, or that our trade secrets, proprietary know-how, and our technological advances will not otherwise become known to others. In addition, there can be no assurance that, despite precautions taken by us, others have not and will not obtain access to our proprietary technology. Further, there can be no assurance that third parties will not independently develop substantially equivalent or better technology.
Pursuant to the BLS Agreement, we have agreed to transfer to Bausch & Lomb, upon expiration of the term of the BLS agreement on December 31, 2007, or in connection with earlier termination in certain circumstances, our manufacturing process, know-how and technical information, which relate to AMVISC ® products. Upon expiration of the BLS Agreement, there can be no assurance that Bausch &
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Lomb will continue to use us to manufacture AMVISC ® and AMVISC ® Plus. If Bausch & Lomb discontinues using us as a manufacturer after such time, our business, financial condition, and results of operations would likely be materially and adversely affected.
Our manufacturing processes involve inherent risks and disruption could materially adversely affect our business, financial condition and results of operations.
Our results of operations are dependent upon the continued operation of our manufacturing facility in Woburn, Massachusetts. The operation of biomedical manufacturing plants involves many risks, including the risks of breakdown, failure or substandard performance of equipment, the occurrence of natural and other disasters, and the need to comply with the requirements of directives of government agencies, including the FDA. In addition, we rely on a single supplier for syringes and a small number of suppliers for a number of other materials required for the manufacturing and delivery of our HA products. Furthermore, our manufacturing processes and research and development efforts involve animals and products derived from animals. The utilization of animals in research and development and product commercialization is subject to increasing focus by animal rights activists. The activities of animal rights groups and other organizations that have protested animal based research and development programs or boycotted the products resulting from such programs could cause an interruption in our manufacturing processes and research and development efforts. The occurrence of material operational problems, including but not limited to the events described above, could have a material adverse effect on our business, financial condition, and results of operations during the period of such operational difficulties.
Our financial performance depends on the continued growth and demand for our products and we may not be able to successfully manage the expansion of our operations
Our future success depends on substantial growth in product sales. There can be no assurance that such growth can be achieved or, if achieved, can be sustained. There can be no assurance that even if substantial growth in product sales and the demand for our products is achieved, we will be able to:
develop the necessary manufacturing capabilities;
obtain the assistance of additional marketing partners;
attract, retain and integrate the required key personnel; or
implement the financial, accounting and management systems needed to manage growing demand for our products
Our failure to successfully manage future growth could have a material adverse effect on our business, financial condition, and results of operations.
Sales of our products are largely dependent upon third party reimbursement and our performance may be harmed by health care cost containment initiatives.
In the U.S. and other markets, health care providers, such as hospitals and physicians, that purchase health care products, such as our products, generally rely on third party payors, including Medicare, Medicaid and other health insurance and managed care plans, to reimburse all or part of the cost of the health care product. We depend upon the distributors for our products to secure reimbursement and reimbursement approvals. Reimbursement by third party payors may depend on a number of factors, including the payors determination that the use of our products is clinically useful and cost-effective, medically necessary and not experimental or investigational. Since reimbursement approval is required from each payor individually, seeking such approvals can be a time consuming and costly process which, in the future, could require us or our marketing partners to provide supporting scientific, clinical and cost-
20
effectiveness data for the use of our products separately to each payor. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and third party payors are increasingly attempting to contain the costs of health care products and services by limiting both coverage and the level of reimbursement for new therapeutic products and by refusing in some cases to provide coverage for uses of approved products for disease indications for which the FDA has not granted marketing approval. In addition, Congress and certain state legislatures have considered reforms that may affect current reimbursement practices, including controls on health care spending through limitations on the growth of Medicare and Medicaid spending. There can be no assurance that third party reimbursement coverage will be available or adequate for any products or services we develop. Outside the U.S., the success of our products is also dependent in part upon the availability of reimbursement and health care payment systems. Lack of adequate coverage and reimbursement provided by governments and other third party payors for our products and services could have a material adverse effect on our business, financial condition, and results of operations.
We may seek financing in the future, which could be difficult to obtain and which could dilute your ownership interest or the value of your shares.
We had cash, cash equivalents and short-term marketable securities of approximately $12.0 million as of June 30, 2002. Our future capital requirements and the adequacy of available funds will depend, however, on numerous factors, including:
market acceptance of our existing and future products;
the successful commercialization of products in development;
progress in our product development efforts;
the magnitude and scope of such product development efforts,
progress with preclinical studies, clinical trials and product clearances by the FDA and other agencies;
the cost and timing of our efforts to manage our manufacturing capabilities and related costs;
the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
competing technological and market developments; and
the development of strategic alliances for the marketing of certain of our products.
To the extent that funds generated from our operations, together with our existing capital resources are insufficient to meet future requirements, we will be required to obtain additional funds through equity or debt financings, strategic alliances with corporate partners and others, or through other sources. The terms of any future equity financings may be dilutive to you and the terms of any debt financings may contain restrictive covenants, that limit our ability to pursue certain courses of action. Our ability to obtain financing is dependent on the status of our future business prospects, as well as conditions prevailing in the relevant capital markets. No assurance can be given that any additional financing will be made available to us or will be available on acceptable terms should such a need arise.
We could become subject to product liability claims, which, if successful, could materially adversely affect our business, financial condition and results of operations.
The testing, marketing and sale of human health care products entail an inherent risk of allegations of product liability, and there can be no assurance that substantial product liability claims will not be asserted against us. Although we have not received any material product liability claims to date and have an insurance policy of $5,000,000 per occurrence and $5,000,000 in the aggregate to cover such claims should they arise, there can be no assurance that material claims will not arise in the future or that our insurance
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will be adequate to cover all situations. Moreover, there can be no assurance that such insurance, or additional insurance, if required, will be available in the future or, if available, will be available on commercially reasonable terms. Any product liability claim, if successful, could have a material adverse effect on our business, financial condition and results of operations.
Our business is dependent upon hiring and retaining qualified management and scientific personnel.
We are highly dependent on the members of our management and scientific staff, the loss of one or more of whom could have a material adverse effect on us. In June 2001, Mr. Engle, the former Chief Executive Officer and Chairman of the Board of Directors, and Mr. Slater, the former Vice President of Operations, ceased to be employees. As of April 2, 2002, Mr. Sherwood, previously President and Chief Operating Officer succeeded Mr. Potter as the Chief Executive Officer of the Company. Mr. Potter agreed to remain the Chief Financial Officer until a new Chief Financial Officer was appointed in order to effect an orderly transition. As of March 25, 2002, we appointed a new Senior Vice President of Sales and Marketing. As of July 8, 2002, we appointed a new Chief Financial Officer to succeed Mr. Potter. There can be no assurances that such management changes will not adversely affect our business. In addition, we believe that our future success will depend in large part upon our ability to attract and retain highly skilled, scientific, managerial and manufacturing personnel. We face significant competition for such personnel from other companies, research and academic institutions, government entities and other organizations. There can be no assurance that we will be successful in hiring or retaining the personnel we require. The failure to hire and retain such personnel could have a material adverse effect on our business, financial condition and results of operations.
We are subject to environmental regulation and any failure to comply with applicable laws could subject us to significant liabilities and harm our business .
We are subject to a variety of local, state and federal government regulations relating to the storage, discharge, handling, emission, generation, manufacture and disposal of toxic, or other hazardous substances used in the manufacture of our products. Any failure by us to control the use, disposal, removal or storage of hazardous chemicals or toxic substances could subject us to significant liabilities, which could have a material adverse effect on our business, financial condition, and results of operations.
Our future operating results may be harmed by economic, political and other risks relating to international sales.
During the years ended December 31, 2001 and 2000, approximately, 27.9% and 20.2%, respectively, of our product sales were sold to international distributors. During the six months ended June 30, 2002 approximately 21.7% of our product sales were sold to international distributors. Our representatives, agents and distributors who sell products in international markets are subject to the laws and regulations of the foreign jurisdictions in which they operate and in which our products are sold. A number of risks are inherent in international sales and operations. For example, the volume of international sales may be limited by the imposition of government controls, export license requirements, political and/or economic instability, trade restrictions, changes in tariffs, difficulties in managing international operations, import restrictions and fluctuations in foreign currency exchange rates. We sell our ORTHOVISC ® product to a European sales and marketing company to supply the Turkish market. The Turkish economic situation has been volatile and the impacts of this volatility on future sales of ORTHOVISC ® are uncertain. Such changes in the volume of sales may continue to have adverse effects on our business, financial condition, and results of operations.
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Our stock price has been and may remain highly volatile, and we cannot assure you that market making in our common stock will continue .
The market price of shares of our common stock may be highly volatile. Factors such as announcements of new commercial products or technological innovations by us or our competitors, disclosure of results of clinical testing or regulatory proceedings, governmental regulation and approvals, developments in patent or other proprietary rights, public concern as to the safety of products developed by us and general market conditions may have a significant effect on the market price of our common stock. In particular, our stock price declined significantly in October 1998 following our announcement that the FDA had notified us that its PMA for ORTHOVISC® was not approvable and that additional clinical data would be required to demonstrate the effectiveness of ORTHOVISC®. The stock price declined again in May 2000 following our announcements that initial analysis of results from the Phase III clinical trial of ORTHOVISC® did not show sufficient efficacy to support the filing of a PMA application to obtain FDA approval, and that the SEC had issued a formal order of investigation and required us to provide information in connection with certain revenue recognition matters. The trading price of our common stock could be subject to wide fluctuations in response to quarter-to-quarter variations in our operating results, material announcements by us or our competitors, governmental regulatory action, conditions in the health care industry generally or in the medical products industry specifically, or other events or factors, many of which are beyond our control. In addition, the stock market has experienced extreme price and volume fluctuations which have particularly affected the market prices of many medical products companies and which often have been unrelated to the operating performance of such companies. Our operating results in future quarters may be below the expectations of equity research analysts and investors. In such event, the price of our common stock would likely decline, perhaps substantially.
No person is under any obligation to make a market in the common stock or to publish research reports on us, and any person making a market in the common stock or publishing research reports on us may discontinue market making or publishing such reports at any time without notice. There can be no assurance that an active public market in our common stock will be sustained.
There is a risk that we may be unable to maintain our listing on the Nasdaq National Market.
Our common stock is currently traded on the Nasdaq National Market. Under NASDAQs listing maintenance standards, if the minimum bid price of our Common Stock is under $1.00 per share for 30 consecutive trading days, NASDAQ may choose to notify us that it is delisting our common stock from its National Market. If the minimum bid price of our common stock does not thereafter regain compliance for a minimum of 10 consecutive trading days during the 90 days following notification by NASDAQ, our common stock may be delisted from trading on the NASDAQ. There is a risk that our common stock will not meet NASDAQs listing maintenance standards and fail to remain eligible for trading on the NASDAQ National Market. If our common stock is delisted, the delisting would most likely have a material adverse effect on the price and liquidity of our common stock and your ability to sell any of our Common Stock at all would be severely limited.
Our charter documents contain anti-takeover provisions that may prevent or delay any attempt to acquire us.
Certain provisions of our Restated Articles of Organization and Amended and Restated By-laws could have the effect of discouraging a third party from pursuing a non-negotiated takeover of us and preventing certain changes in control. These provisions include a classified Board of Directors, advance notice to the Board of Directors of stockholder proposals, limitations on the ability of stockholders to remove directors and to call stockholder meetings, and the provision that vacancies on the Board of Directors be filled by a majority of the remaining directors. In addition, the Board of Directors adopted a Shareholders Rights Plan in April 1998. We are also subject to Chapter 110F of the Massachusetts General
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Laws which, subject to certain exceptions, prohibits a Massachusetts corporation from engaging in any of a broad range of business combinations with any interested stockholder for a period of three years following the date that such stockholder became an interested stockholder. These provisions could discourage a third party from pursuing a takeover of us at a price considered attractive by many stockholders, since such provisions could have the effect of preventing or delaying a potential acquirer from acquiring control of us and our Board of Directors.
The SEC commenced an investigation concerning our revenue recognition matters .
The SEC has issued a formal order of investigation and has required us to provide information in connection with certain revenue recognition matters. We have been cooperating fully. These matters, relating to our historical accounting for and disclosures concerning sales of ORTHOVISC ® under a long-term supply and distribution agreement with Zimmer, were also the subject of our March 15, 2000 disclosure concerning an informal SEC inquiry and the restatement of results for 1998 and the first three quarters of 1999. On August 14, 2001, as a result of the SECs ongoing investigation, we, in conjunction with our independent auditors, determined to again restate our financial results for the fourth quarter of 1998 and the first quarter of 1999 as discussed in Note 15 of the consolidated financial statements included in the companys Annual Report on Form 10-K for the year ended December 31, 2001. As a result of the SECs investigation, we have been informed that the staff of the Boston District Office of the SEC (the Staff) is considering recommending that the SEC authorize civil injunctive actions against us and others, including former officers, concerning these matters. We were invited by the Staff to submit our views as to why a civil injunctive action against us should not be instituted, and we have done so. We are currently in discussions with the Staff concerning possible resolution of the matter by settlement. We are not in a position to predict whether such a settlement will be reached. In addition, if we expend substantial additional costs and fees in responding to this matter, then the matter may have an adverse effect on our financial position.
Our revenues are derived from a small number of customers, the loss of which could materially adversely affect our business, financial condition and results of operations .
We have historically derived the majority of our revenues from a small number of customers, most of whom resell our products to end users and most of who are significantly larger companies than us. For the six months ended June 30, 2002, Bausch & Lomb accounted for 47.1% of product revenues and 46.4% of our accounts receivable balance and Boehringer Ingelheim accounted for 15.1% of product revenues and 25.6% of our accounts receivable balance. Our failure to generate as much revenue as expected from these customers or the failure of these customers to purchase our products would adversely affect our business. On March 11, 2002, Bausch & Lombs senior debt and short-term debt ratings were downgraded. Although Bausch & Lomb emphasized at that time it was not facing any issues with respect to liquidity, any such issues that impact their ability to pay their accounts with us could adversely impact future revenues. In addition, if present and future customers terminate their purchasing arrangements with us, significantly reduce or delay their orders, or seek to renegotiate their agreements on terms less favorable to us, our business, financial condition, and results of operations will be adversely affected. If we accept terms less favorable than the terms of the current agreement, such renegotiations may have a material adverse effect on our business, financial condition, and/or results of operations. Furthermore, we may be subject to the perceived or actual advantage the customers may have given their relative size and importance to us in any future negotiations. Any termination, change, reduction or delay in orders could seriously harm our business, financial condition, and results of operations. Accordingly, unless and until we diversify and expand our customer base, our future success will significantly depend upon the timing and size of future purchases by our largest customers and the financial and operational success of these customers. Product revenue in the future may continue to be adversely impacted by economic uncertainties associated with the Turkish market.
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The loss of any one of our major customers or the delay of significant orders from such customers, even if only temporary, could reduce or delay our recognition of revenues, harm our reputation in the industry, and reduce our ability to accurately predict cash flow, and, as a consequence, could seriously harm our business, financial condition, and results of operations.
We, through our distributors, distribute ORTHOVISC ® in territories such as Canada, Spain, Portugal, Turkey, and Israel. Due to the result of the unfavorable results of the U.S. ORTHOVISC ® Phase III clinical trial announced on May 31, 2000, marketing efforts in these countries have been and may continue to be negatively affected. There can be no assurance that past ORTHOVISC ® sales levels will be maintained or that sales will occur at all in these countries.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of June 30, 2002, we do not participate in any derivative financial instruments or other financial and commodity instruments for which fair value disclosure would be required under SFAS No. 107. All of our investments consist of money market funds and commercial paper that are carried on our books at amortized cost, which approximates fair market value. Accordingly, we have no quantitative information concerning the market risk of participating in such investments.
Primary Market Risk Exposures
Our primary market risk exposures are in the areas of interest rate risk and foreign currency exchange rate risk. Our investment portfolio of cash equivalent and short-term investments is subject to interest rate fluctuations, but we believe this risk is immaterial due to the short-term nature of these investments. Our exposure to currency exchange rate fluctuations is specific to certain sales to a foreign customer and is expected to continue to be modest. The impact of currency exchange rate movements on sales to this foreign customer was immaterial for the quarter ended June 30, 2002. Currently, we do not engage in foreign currency hedging activities.
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
See Note 8, Legal Matters of the consolidated financial statements. The description of such matters is incorporated herein by reference to such financial statements.
Item 4. Submission of Matters to a Vote of Security Holders
On June 5, 2002, we held our 2002 Annual Meeting of Stockholders. At our annual meeting, stockholders were asked to consider a proposal to elect a Class III Director of Anika to serve until the 2005 annual meeting of stockholders and until his successors is duly elected and qualified (the Election Proposal).
With respect to the Election Proposal, Steven E. Wheeler was nominated as a Class III Director of Anika. Mr. Wheeler received 9,218,811shares voted in favor of his election and 244,087 votes were withheld. Mr. Wheeler was therefore elected as Class III Director. Joseph L. Bower and Eugene A. Davidson, Ph.D. (Class I Directors), and Samuel F. McKay and Harvey S. Sadow (Class II Directors) continued to serve their respective terms after the Annual Meeting.
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Item 6. Exhibits and Reports on Form 8-K
* filed herewith
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(b) |
Reports on Form 8-K: |
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The Registrant filed the following Reports on Form 8-K during the quarter ended June 30, 2002: |
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1. Current Report on Form 8-K filed June 10, 2002, as amended by Current Report on Form 8-K/A filed June 20, 2002, announcing that the Company had terminated Arthur Andersen LLP as independent auditor. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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 in Woburn, Massachusetts on August 14, 2002.
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Anika Therapeutics, Inc. |
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August 14, 2002 |
By: |
/s/ William J. Knight |
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William J. Knight |
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Chief Financial Officer and Treasurer |
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(Principal Financial Officer and Accounting Officer) |
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EXHIBIT 3.3
-0033257
Examiner |
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Name Approved |
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CPM R.A.
P.C. |
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NO. 04-3145961
THE COMMONWEALTH OF MASSACHUSETTS
WILLIAM FRANCIS GALVIN
Secretary of the Commonwealth
One Ashburton Place, Boston, Massachusetts 02108-1512
ARTICLES OF AMENDMENT
(GENERAL LAWS, CHAPTER 156B, SECTION 72)
We, J. Melville Engle, *President, and Sean F. Moran, *Clerk,
of |
Anika Research, Inc. , |
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(Exact name of corporation) |
located at |
236 West Cummings Park, Woburn, MA 01801 |
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(Street address of corporation in Massachusetts) |
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certify that these Articles of Amendment affecting articles numbered:
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Article 1 |
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(Number those articles 1, 2, 3, 4, 5 and/or 6 being amended) |
of the Articles of Organization were duly adopted at a meeting held on January 8, 1997, by vote of:
4,197,334 shares of Common of 4,917,023 shares outstanding, |
(type, class & series, if any) |
125,476 shares of Series A Preferred of 126,259 shares outstanding, and |
(type, class & series, if any) |
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shares of |
of |
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shares outstanding, |
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(type, class & series, if any) |
/1**/ being at least a majority of each type, class or series outstanding and entitled to vote thereon:
Changed name of corporation to Anika Therapeutics, Inc.
/*/ Delete the inapplicable words.
/**/ Delete the inapplicable clause.
/1/ For amendments adopted pursuant to Chapter 156B, Section 70.
/2/ For amendments adopted pursuant to Chapter 156B, Section 71.
NOTE: IF THE SPACE PROVIDED UNDER ANY ARTICLE OR ITEM ON THIS FORM IS INSUFFICIENT, ADDITIONS SHALL BE SET FORTH ON ONE SIDE ONLY OF SEPARATE 8 1/2 X 11 SHEETS OF PAPER WITH A LEFT MARGIN OF AT LEAST 1 INCH. ADDITIONS TO MORE THAN ONE ARTICLE MAY BE MADE ON A SINGLE SHEET SO LONG AS EACH ARTICLE REQUIRING EACH ADDITION IS CLEARLY INDICATED.
2
To change the number of shares and the par value (if any) of any type, class or series of stock which the corporation is authorized to issue, fill in the following:
The total presently authorized is:
WITHOUT PAR VALUE STOCKS |
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WITH PAR VALUE STOCKS |
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NUMBER OF SHARES |
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TYPE |
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NUMBER OF SHARES |
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PAR VALUE |
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Common: |
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N/A |
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Common: |
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N/A |
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Preferred: |
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N/A |
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Preferred: |
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N/A |
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Change the total authorized to:
WITHOUT PAR VALUE STOCKS |
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WITH PAR VALUE STOCKS |
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TYPE |
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NUMBER OF SHARES |
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TYPE |
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NUMBER OF SHARES |
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PAR VALUE |
Common: |
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N/A |
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Common: |
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N/A |
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Preferred: |
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N/A |
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Preferred: |
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N/A |
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The foregoing amendment(s) will become effective when these Articles of Amendment are filed in accordance with General Laws, Chapter 156B, Section 6 unless these articles specify, in accordance with the vote adopting the amendment, a later effective date not more than thirty days after such filing, in which event the Amendment will become effective on such later date.
SIGNED UNDER THE PENALTIES OF PERJURY, this 8th day of January, 1997,
/s/ J. Melville Engle, *President, |
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J. Melville Engle |
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/s/ Sean F. Moran, *Clerk. |
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Sean F. Moran |
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/*/ Delete the inapplicable words.
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Exhibit 3.6
AMENDED AND RESTATED BY-LAWS
OF
ANIKA THERAPEUTICS, INC.
Notwithstanding the foregoing provisions, the Board of Directors shall be obligated to include information as to any nominee for director in any proxy statement or other communication sent to stockholders.
The chairman of the meeting may, if the facts warrant, determine and declare to the meeting that any proposed item of business was not brought before the meeting in accordance with the foregoing procedure and, if he should so determined, he shall so declare to the meeting and the defective item of business shall be disregarded.
Any officer may be removed at any time, with or without cause, by vote of a majority of the entire number of Directors then in office. An officer may be removed for cause only after reasonable notice and opportunity to be heard by the Board of Directors prior to action thereon.
Except as the Board of Directors may otherwise determine, no officer who resigns or is removed shall have any right to any compensation as an officer for any period following his resignation or removal, or any right to damages on account of such removal, whether his compensation be by the month or the year or otherwise, unless such compensation is expressly provided in a duly authorized written agreement with the Corporation.
The Assistant Treasurers shall perform such duties and possess such powers as the Board of Directors, the President or the Treasurer may from time to time prescribe. In the event of the absence, inability or refusal to act of the Treasurer, the Assistant Treasurer (or if there shall be more than one, the Assistant Treasurers in the order determined by the Board of Directors) shall perform the duties and exercise the powers of the Treasurer.
Any Assistant Clerk shall perform such duties and possess such powers as the Board of Directors, the President or the Clerk may from time to time prescribe. In the event of the absence, inability or refusal to act of the Clerk, the Assistant Clerk (or if there shall be more than one, the Assistant Clerks in the order determined by the Board of Directors) shall perform the duties and exercise the powers of the Clerk.
In the absence of the Clerk or any Assistant Clerk at any meeting of stockholders or Directors, the person presiding at meeting shall designate a temporary clerk to keep a record of the meeting.
Every certificate for shares of stock which are subject to any restriction on transfer pursuant to the Articles of Organization, the By-Laws, applicable securities laws or any agreement to which the Corporation is a party, shall have conspicuously noted on the face or back of the certificate either the full text of the restriction or a Stockholder of the existence of such restrictions and a statement that the Corporation will furnish a copy of the restrictions to the holder of such certificate upon written request and without charge. Every certificate issued when the Corporation is authorized to issue more than one class or series of stock shall set forth on its face or back either the full text of the preferences, voting powers, qualifications and special and relative rights of the shares of each class and series authorized to be issued or a statement of the existence of such preferences, powers, qualifications and rights and a statement that the Corporation will furnish a copy thereof to the holder of such certificate upon written request and without charge.
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It shall be the duty of each stockholder to notify the Corporation of his post office address and of his taxpayer identification number.
If no record date is fixed and the transfer books are not closed, the record date for determining the stockholders having the right to notice of or to vote at a meeting of stockholders shall be at the close of business on the day before the day on which notice is given, and the record date for determining the stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors acts with respect to such purpose.
Unless otherwise provided for therein, these By-Laws may be amended by vote of the holders of a majority of the shares of each class of the capital stock at the time outstanding and entitled to vote at any annual or special meeting of stockholders, if notice of the substance of the proposed amendment is stated in the notice of such meeting. If authorized by the Articles of Organization and unless otherwise provided for therein, the Directors, by a majority of their number then in office, may also make, amend or repeal these By-Laws, in whole or in part, except with respect to (a) the provisions of these By-Laws governing (i) the removal of Directors and (ii) the amendment of these By-Laws and (b) any provision of these By-Laws which by law, the Articles of Organization or these By-Laws requires action by the stockholders.
Not later than the time of giving notice of the meeting of stockholders next following the making, amending or repealing by the Directors of any By-Law, notice stating the substance of such change shall be given to all stockholders entitled to vote on amending the By-Laws.
Any By-Law adopted by the Directors may be amended or repealed by the stockholders entitled to vote or amending the By-Law.
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Exhibit 10.1
[ANIKA THERAPEUTICS LETTERHEAD]
April 2, 2002
PERSONAL & CONFIDENTIAL
Mr. Edward Ross, Jr.
26 Locke Lane
Lexington, MA 02173
Dear Ed:
This letter notifies you in writing of the termination of your employment with Anika Therapeutics, Inc. (the Company). This letter also proposes an agreement between you and the Company.
Your employment will terminate effective March 22, 2002. The Company shall pay you your current base salary through March 22, 2002. In addition, the Company will pay you for all accrued but unused vacation time through March 22, 2002, which will be based on 270.91 hours of accrued but unused vacation time. The Company also will provide you with the right to continue group medical and dental insurance coverage under the terms of the law known as COBRA. The termination of other benefits will be addressed in separate correspondence. For further details refer to Section 3a.
The payment and other terms set forth above will not be affected by whether or not you agree to the terms set forth below.
The remainder of this letter proposes an agreement (the Agreement) between you and the Company. The purpose of this Agreement is to establish an amicable arrangement for ending your employment relationship, to release the Company and related persons or entities from any claims to establish a brief Consultancy Period (as defined herein) and to permit you to receive fair and reasonable separation pay and related benefits.
If you agree to the terms of this Agreement, you acknowledge that you are entering into this Agreement voluntarily. It is customary in employment separation agreements that provide for severance pay for the departing employee to release the employer from any possible claims, even if the employer believes, as is the case here, that no such claims exist. You understand that you are giving up your right to bring any and all possible legal claims against the Company. Neither the Company nor you want your employment relationship to end with a legal dispute. By entering into this Agreement, you understand that the Company is not admitting in any way that it violated any legal obligation that it owed to you. To the contrary, the Companys willingness to enter into this Agreement demonstrates that it is continuing to deal with you fairly and in good faith.
With those understandings, you and the Company agree as follows:
1. Termination
As we have discussed, you understand that your employment with the Company as its Vice President of Sales and Marketing and from any and all other positions that you may hold with the Company will terminate effective March 22, 2002 (the Termination Date). You agree that up to and including March 22, 2002, you shall work diligently and responsibly in performing the duties associated with your current position as Vice President of Sales and Marketing.
2. Severance Pay
If this Agreement becomes effective, the Company will not assert that your employment was terminated for cause due to non-performance and shall agree to provide severance pay (Severance Pay) to you consisting of the continuation of your current base salary rate of $166,049.00 per year for the six-month period plus 5-week consulting period (see paragraph 4) beginning March 23, 2002 (the Salary Continuation Period), payable on the Companys regular bi-weekly payroll dates. The Company will suspend the payment of Severance Pay until such time as the Agreement becomes effective in accordance with Section 15. If the Agreement becomes effective, the Company will reinstate you to the payroll and shall provide any suspended payroll payments to you no later than the second payroll date after this Agreement becomes effective.
3. Benefits
a. Medical and Dental Benefits
By agreeing to this Agreement, you elect to continue your medical and dental insurance coverage under COBRA. Your COBRA period will commence on March 23, 2002. Provided that you remain eligible for COBRA continuation coverage, the Company shall continue to pay the premiums for your group medical and dental insurance coverage on the same basis as if you continued to be employed during the Salary Continuation period. Thereafter, you may continue coverage at your own expense for the remainder of the COBRA period to the extent you remain eligible.
b. Stock and Stock Option Plans
Nothing in this Agreement is intended to reduce or expand your rights under the Companys Stock Option Plan dated March 3, 1993, as amended (the Plan), or the agreements you entered into pursuant to the Plan.
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c. Outplacement
The Company shall pay up to $10,000 to Stybell Peabody & Associates to assist you in your efforts to obtain new employment, provided that such outplacement services are provided on or prior to October 1, 2002.
d. Other Benefits
Your eligibility to participate in any other employee benefit plans and programs sponsored by or made available to employees of the Company or its affiliated or related entities ceases effective on or after your Termination Date in accordance with applicable benefit plan terms and benefit practices. Your rights to benefits, if any, are governed by the terms of those benefit plans and programs.
4. Consultancy Period
For the six-week period commencing on Monday, March 25, 2002 (the Consultancy Period), you agree that you shall perform for the Company any requested services that are reasonably performed by someone of your knowledge and skill level, including, but not limited to, services that will assist the Company in the transition from your position as Vice President of Sales and Marketing, and may include the application of any factual or scientific knowledge you may have related to the Companys business or products (the Consultancy), as follows:
Through April 5, 2002, you agree that you will report to the office for no fewer than 20 hours, but no more than 40 hours as requested by the Company.
From April 6, 2002 through April 26, 2002, you should not report to the office unless directed to do so by the Company. At its discretion, the Company will determine the number of hours to be worked and when those hours are to be worked, provided that such times are reasonable and do not unreasonably interfere with your search for new employment.
You agree that during the Consultancy Period, you shall perform the Consultancy in a responsible and diligent manner and that you will not take any actions intended to damage the Company or its products.
In the event that you sign this Agreement, the Company will pay your regular base pay as of the Termination Date for the Consultancy Period, payable on the Companys regular bi-weekly payroll dates after the Effective Date of this Agreement. If you do not sign this Agreement, the Company will compensate you for time actually spent by you consulting as contemplated in this paragraph 4 of the Agreement at a rate of $80.00 per hour, rounded to the nearest half hour.
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5. Tax Treatment
The Company shall undertake to make deductions, withholdings and tax reports with respect to payments and benefits under this Agreement to the extent that it reasonably and in good faith believes that it is required to make such deductions, withholdings and tax reports. Payments under this Agreement shall be in amounts net of any such deductions or withholdings. Nothing in this Agreement shall be construed to require the Company to make any payments to compensate you for any adverse tax effect associated with any payments or benefits or for any deduction or withholding from any payment or benefit.
6. Release of Claims
In consideration for, among other terms, the payments and benefits described in Sections 2, 3 (c) and 4, to which you otherwise would not be entitled, you voluntarily release and forever discharge the Company, its affiliated and related entities, its and their respective predecessors, successors and assigns, and each of their current and former officers, directors, shareholders, employees, attorneys, accountants and agents in their official and personal capacities (collectively referred to as the Releasees) generally from all claims, demands, debts, damages and liabilities of every name and nature, known or unknown, that, as of the date that you sign this Agreement, you now have, ever had, now claim to have or ever claimed to have had against any or all of the Releasees (Claims). This release includes, without limitation, all Claims relating to your employment by and termination of employment with the Company; all Claims of wrongful discharge; all Claims of breach of contract; all Claims of retaliation or discrimination under federal, state or local law (including, without limitation, Claims of age discrimination under the Age Discrimination in Employment Act); all Claims of defamation or other torts; all Claims of violation of public policy; all Claims for wages, bonuses, incentive compensation, vacation pay or any other compensation or benefits; and all Claims for damages of any sort, including, without limitation, compensatory damages, punitive damages and attorneys fees; provided, however, that this release shall not affect your right to enforce this Agreement.
You agree that you shall not seek or accept reinstatement with any Releasees. You also agree that you shall not seek damages of any nature, equitable or legal remedies, attorneys fees, or costs from any of the Releasees with respect to any Claim. As a material inducement to the Company to enter into this Agreement, you hereby represent that you have not heretofore assigned to any third party and you have not heretofore filed with any agency or court any Claim released by this Agreement.
7. Return of Property
You will return all Company property that is in your possession, custody or control, including, without limitation, computer equipment, software, cellular telephones, keys and access cards, credit cards, files and any other documents (including computerized data and any
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copies made of any computerized data or software) containing information concerning the Company, its business or customer relationships (in the latter two cases, actual or prospective), no later than the date when this Agreement becomes effective.
8. Cooperation
You agree that, at any time in the future, you shall cooperate fully with the Company as reasonably requested, consistent with your schedule, in all regulatory matters, in the gathering of information for the Companys annual reports, filings and statements with the Securities and Exchange Commission and the Nasdaq Stock Market, Inc. or exchange on which the Companys securities are listed, and in the defense or prosecution of any legal claims or actions that already have been brought or that may be brought in the future against or on behalf of the Company that related to events or occurrences that transpired during your employment with the Company. Your full cooperation in connection with such regulatory matters, information gathering claims, actions or disputes shall include, without limitation, being available to meet with representatives of the Company to prepare for regulatory processes and counsel to prepare for discovery or trial and to testify truthfully as a witness when reasonably requested by the Company. The Company will reimburse you for any reasonable out-of-pocket expenses (which shall not be construed to include your personal attorneys fees) that you incur in connection with such cooperation, provided that you provide the Company reasonable documentation of such out-of-pocket expenses. In addition, with the exception of any time spent by you actually testifying as a witness, the Company shall reimburse you at a rate of $100.00 per hour for each hour that you spend cooperating with the Company, or acting in furtherance thereof, in accordance with this Section.
9. Confidentiality of Agreement
You agree to keep the existence and terms of this Agreement in the strictest confidence and to not reveal, unless legally compelled to do so, the existence or terms of this Agreement to any persons except your attorney and your financial advisors, provided that they also agree to keep such information confidential. You shall be considered to have breached this Agreement if any of those individuals fails to keep such information completely confidential. Nothing in this Section 9 shall be construed to prevent you from disclosing such matters to the extent required by a lawfully issued subpoena or duly issued court order; provided that you provide the Company with advance written notice as soon as is practicable and a reasonable opportunity to contest such subpoena or court order. Nothing contained herein shall be deemed to limit your rights under applicable law, including 29 U.S.C. § 626(f)(4).
The Company agrees to keep the existence and terms of this Agreement in the strictest confidence and to not reveal, unless legally compelled to do so, the existence or terms of this Agreement to any persons except its attorney and its financial advisors, provided that they also agree to keep such information confidential.
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10. Validity of Non-Disclosure and Non-Competition Agreement
You acknowledge and agree that you remain bound by the terms of the Companys Non-Disclosure and Non-Competition Agreement that was executed by you on December 2, 1996.
11. Non-Disparagement
You will refrain from making any disparaging statements, taking any actions, or conducting yourself in any way that adversely affects the reputation or goodwill of the Company and/or its affiliated entities and the current and former officers, directors, shareholders, employees and agents of any of them. These non-disparagement obligations shall not in any way affect your obligation to testify truthfully in any legal proceeding.
The Company, as represented by the Anika management team as of the signature date of this agreement, will refrain from making any disparaging statements, taking any actions, or conducting itself in any way that adversely affects your reputation or goodwill. These non-disparagement obligations shall not in any way affect the Companys obligation to testify truthfully in any legal proceeding.
12. Treatment of Reference Inquiries
The Company agrees that any inquiries regarding your employment will be referred to the Human Resources Department which will respond to any such inquiries by stating the dates of your employment, the position held by you and that your termination followed changes in management.
13. Consideration of the Agreement
This Agreement is a legally binding document. Provided that you do not revoke this Agreement in accordance with Section 15 below, your signature will commit you to the terms of this Agreement. You acknowledge that you have been advised to discuss all aspects of this Agreement with your attorney, that you have carefully read and fully understand all of the provisions of this Agreement and that you are voluntarily entering into this Agreement.
14. Consent to Jurisdiction
You and the Company hereby consent to the jurisdiction of the Superior Court of the Commonwealth of Massachusetts and the United States District Court for the District of Massachusetts with respect to any claim of violation of this Agreement. With respect to any such court action you (a) submit to the jurisdiction of such courts, (b) consent to service of process, and (c) waive any other requirement (whether imposed by statute, rule of court or otherwise) with respect to personal jurisdiction or venue.
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15. Other Provisions
You acknowledge that you have been given the opportunity to consider this Agreement for twenty-one (21) days before signing it. You further acknowledge that any changes made to this Agreement since it was originally issued to you on March 22, 2002 are not material and do not restart the running of any period in which you are statutorily permitted to review this Agreement. If you sign this Agreement within less than twenty-one (21) days of the date of its delivery to you, you acknowledge that such decision was entirely voluntary and that you had the opportunity to consider this Agreement for the entire twenty-one (21) day period. To accept this Agreement, you must provide the fully signed Agreement to the undersigned by the end of the twenty-one (21) day period. For a period of seven (7) days from the date you sign this Agreement, you have the right to revoke this Agreement by written notice to the undersigned. If you do not revoke this Agreement, it shall become effective on the eighth (8th) day after you sign it. This Agreement shall not become effective or enforceable until the expiration of the seven (7) day revocation period (the Effective Date).
This Agreement constitutes the entire agreement regarding the termination of your employment with the Company. This Agreement supersedes any previous agreements or understandings between us, except for any agreements under the Companys Stock Option Plan, as described in Section 3(b) and the Non-Disclosure and Non-Competition Agreement described in Section 10. In signing this Agreement, you are not relying upon any oral promises or representations made by anyone at or on behalf of the Company.
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This Agreement will be interpreted and enforced under the laws of the Commonwealth of Massachusetts, without regard to conflict of law principles. In the event of any dispute, this Agreement will be construed as a whole, will be interpreted in accordance with its fair meaning, and will not be construed strictly for or against either you or the Company. This Agreement is executed under seal. Please indicate your agreement to the terms of this Agreement by signing and returning to me a copy of this letter. You are advised to consult with an attorney before signing this Agreement.
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Sincerely, |
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ANIKA THERAPEUTICS, INC. |
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By: |
/s/ Douglas R. Potter |
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Accepted and agreed to: |
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Douglas R. Potter |
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Chief Financial Officer |
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/s/ Edward Ross, Jr. |
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Edward Ross, Jr. |
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Date: April 9, 2002 |
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Exhibit 10.2
[ANIKA THERAPEUTICS LETTERHEAD]
June 25, 2002
Mr. William J. Knight
39 Bare Hill Road
Boxford, MA 01921
Dear Bill:
I am pleased to present our offer to you to join Anika Therapeutics, Inc. as an employee. The terms of our offer, subject to approval by the Compensation Committee of the Board of Directors, are outlined below:
Position : Chief Financial Officer.
Description of duties : You will have responsibility for all the financial activities of the Company including financial plans and policies, accounting practices and procedures, and the Companys relationship with its shareholders and the outside financial community.
Reporting to : Charles H. Sherwood, Ph.D., President and Chief Executive Officer.
Employment date : Your anticipated start date is no later than July 15, 2002.
Rate of pay : $6,923.08 per bi-weekly payroll (annualized $180,000).
Management bonus plan : Target 20% of salary at plan. Bonus is payable shortly after year-end based on Company performance and personal performance against key objectives. In accordance with the Management Bonus Plan, your bonus for 2002 will be prorated based on the number of months of your employment.
Stock options : 75,000 options. Options will vest over 4 years in accordance with the terms of the stock option agreement.
Benefits : You will be eligible to participate in the Anika employee benefit programs upon commencement of employment. This program currently covers comprehensive medical and dental benefits, life and disability insurance, supplemental disability insurance, and a Section 125 Plan. You will be eligible to participate in our 401(k) Savings and Investment Plan at the first enrollment date following your date of hire. Under the current terms, the 401(k) plan entitles you to contribute up to the maximum limit established by the IRS. The Company will match 100% of your contribution up to 5% of your salary. Your participation in the benefit plans will be governed by and subject to the plan terms as described in the official documents and Summary Plan Descriptions.
Vacation : You will accrue three weeks of vacation during your first year of employment and are subject to the terms of accrual and use set forth in Anikas policies. Presently, the policy allows the accrual of one additional day of vacation for each year of employment up to a maximum of four weeks.
Severance in the event of termination :
1) Termination without cause (non-performance related): If Anika terminates your employment without cause (as construed under Massachusetts common law for employment contracts), Anika will continue your base salary at its then current rate for six months, subject to your compliance with your obligations under your other agreements with the Company and your cooperation with any other reasonable requests by Anika for assistance during that period. In addition, in such circumstances the Company will also pay the premiums for continuation of medical and dental benefits under COBRA for you and your family for six months after termination of your employment (or until the end of COBRA eligibility, if earlier), subject to your premium payment of the active employee share of premium payments for such coverage.
2) Termination for cause: Anika may terminate your employment at any time for cause by delivering to you a certified copy of a resolution of the Board of Directors on Anika finding that you committed an act of omission constituting cause hereunder and specifying the particulars thereof in detail, adopted at a meeting called and held for that purpose and of which you were provided not less than seven days advance notice, including notice of the agenda of such meeting. As used herein, the term cause shall mean :
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conviction of a felony involving the Company, |
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acting in a manner which is materially detrimental or materially damaging to the Companys reputation or business operations other than actions which involve your bad judgment or a decision which was taken in good faith, provided that you shall have failed to remedy such action within ten days after receiving written notice of the Companys position with respect to such action; or |
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committing any material breach of this agreement, provided that, if such breach is capable of being remedied, you shall have failed to remedy such breach within ten days after your receipt of written notice requesting that you remedy such breach. |
Change in Control, Bonus, and Severance Agreement : Subject to the approval of the Compensation Committee of the Board of Directors, an Agreement (attached) between you and Anika Therapeutics, Inc. shall be executed providing terms pertaining to a Change in Control. The purpose of this Agreement is to reinforce and encourage your continued attention and dedication to your assigned duties without distraction in the face of potentially disturbing circumstances arising from the possibility of a Change in Control.
Arbitration: In the event of any controversy or claim arising out of or relating to this letter agreement or otherwise arising out your employment or the termination of that employment (including, without limitation, any claims of unlawful employment discrimination whether based on age or otherwise), that controversy or claim shall, to the fullest extent permitted by law, be settled by arbitration under the auspices of the American Arbitration Association (AAA) in Boston, Massachusetts in accordance with the Employment Dispute Resolution Rules of the AAA, including, but not limited to, the rules and procedures applicable to the selection of
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arbitrators (or alternatively, in any other forum or in any other form agreed upon by the parties). In the event that any person or entity other than you or Anika may be a party with regard to any such controversy or claim, such controversy or claim shall be submitted to arbitration subject to such other person or entitys agreement. Judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. This provision shall be specifically enforceable. Notwithstanding the foregoing, this provision shall not preclude either party from pursuing a court action for the sole purpose of obtaining a temporary restraining order or a preliminary injunction in circumstances in which such relief is appropriate; provided that any other relief shall be pursued through an arbitration proceeding pursuant to this provision.
Contingency : This offer is contingent upon your execution of the Anika Non-Disclosure and Non-Competition Agreement as an employee of Anika Therapeutics. In addition, all employees are subject to a background check including verification of education.
You, like everyone else at Anika, will be an at-will employee. The terms of your employment will be interpreted in accordance with and governed by the laws of the Commonwealth of Massachusetts.
Finally, this offer is conditioned on your representation that you are not subject to any confidentiality or non-competition agreement or any other similar type of restriction that would affect your ability to devote full time and attention to your work at Anika Therapeutics, Inc. Upon commencement of your employment, you will be required to provide evidence that you are a U.S. citizen or national, a lawful permanent resident, or an alien authorized to work in the U.S.
If the terms of this offer are acceptable, please indicate your acceptance by signing both copies of this letter and the Anika Non-Disclosure and Non-Competition Agreement and return one copy of each to me. I am enthusiastic about Anikas future prospects and look forward to your leadership and contribution to the Anika team.
Sincerely,
/s/ Charles H. Sherwood |
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Charles H. Sherwood, Ph.D. |
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President and Chief Executive Officer |
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Agreed and accepted: |
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/s/ William J. Knight |
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William J. Knight |
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Date: June 27, 2002 |
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Enclosures |
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Exhibit 10.3
ANIKA THERAPEUTICS, INC.
Change in Control, Bonus and Severance Agreement
AGREEMENT made as of July 8, 2002 by and among Anika Therapeutics, Inc., a Massachusetts corporation with its principal place of business in Woburn, Massachusetts (the Company), and William J. Knight of Boxford, Massachusetts (the Executive), an individual presently employed as the Chief Financial Officer, Vice President of Finance, Treasurer and Clerk of the Company.
1. Purpose . The Company considers it essential to the best interests of its stockholders to foster the continuous employment of key management personnel. The Board of Directors of the Company (the Board) recognizes, however, that, as is the case with many publicly held corporations, the possibility of a Change in Control (as defined in Section 2 hereof) exists and that such possibility, and the uncertainty and questions which it may raise among management, may result in the departure or distraction of management personnel to the detriment of the Company and its stockholders. Therefore, the Board has determined that appropriate steps should be taken to reinforce and encourage the continued attention and dedication of members of the Companys management, including the Executive, to their assigned duties without distraction in the face of potentially disturbing circumstances arising from the possibility of a Change in Control. Nothing in this Agreement shall be construed as creating an express or implied contract of employment and, except as otherwise agreed in writing between the Executive and the Company, the Executive shall not have any right to be retained in the employ of the Company.
2. Change in Control . A Change in Control shall mean the occurrence of any one of the following events:
(a) any person, as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934 (the Act) (other than the Company, any of its subsidiaries, any trustee, fiduciary or other person or entity holding securities under any employee benefit plan or trust of the Company or any of its subsidiaries), together with all affiliates and associates (as such terms are defined in Rule 12b-2 under the Act) of such person, shall become the beneficial owner (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, of securities of the Company representing 51% or more of the combined voting power of the Companys then outstanding securities having the right to vote in an election of the Companys Board of Directors (Voting Securities); or
(b) persons who, as of the date hereof, constitute the Companys Board of Directors (the Incumbent Directors) cease for any reason, including, without limitation, as a result of a tender offer, proxy contest, merger or similar transaction, to constitute at least a majority of the Board, provided that any person becoming a director of the Company subsequent to the date hereof whose election or nomination for election was
approved by a vote of at least a majority of the Incumbent Directors shall, for purposes of this Agreement, be considered an Incumbent Director; or
(c) the stockholders of the Company shall approve (A) any consolidation or merger of the Company where the shareholders of the Company, immediately prior to the consolidation or merger, would not, immediately after the consolidation or merger, beneficially own (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, shares representing in the aggregate 51% of the voting shares of the corporation issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation, if any), (B) any sale, lease, exchange or other transfer (in one transaction or a series of transactions contemplated or arranged by any party as a single plan) of all or substantially all of the assets of the Company or (C) any plan or proposal for the liquidation or dissolution of the Company.
Notwithstanding the foregoing, a Change in Control shall not be deemed to have occurred for purposes of the foregoing clause (a) solely as the result of an acquisition of securities by the Company which, by reducing the number of shares of Voting Securities outstanding, increases the proportionate voting power represented by the Voting Securities beneficially owned by any person to 51% or more of the combined voting power of all then outstanding Voting Securities; provided , however , that if any person referred to in this sentence shall thereafter become the beneficial owner of any additional shares of Voting Securities (other than pursuant to a share split, stock dividend or similar transaction or direct purchase from the Company), then a Change in Control shall be deemed to have occurred for purposes of the foregoing clause (a).
3. Terminating Event . A Terminating Event shall mean any of the events provided in this Section 3 occurring within twelve (12) months subsequent to a Change in Control as defined in Section 2:
(a) termination by the Company of the employment of the Executive with the Company for any reason other than for Cause or the death of the Executive. Cause shall mean, and shall be limited to, the occurrence of any one or more of the following events:
(i) a willful act of dishonesty by the Executive with respect to any matter involving the Company;
(ii) conviction of the Executive of a crime involving moral turpitude; or
(iii) the deliberate or willful failure by the Executive (other than by reason of the Executive=s physical or mental illness, incapacity or disability) to substantially perform the Executives duties with the Company and the continuation of such failure for a period of 30 days after delivery by the Company
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to the Executive of written notice specifying the scope and nature of such failure and its intention to terminate the Executive for Cause.
A Terminating Event shall not be deemed to have occurred pursuant to this Section 3(a) solely as a result of the Executive being an employee of any direct or indirect successor to the business or assets of the Company, rather than continuing as an employee of the Company following a Change in Control.
(b) termination by the Executive of the Executives employment with the Company for Good Reason. Good Reason shall mean the occurrence of any of the following events:
(i) a substantial adverse change in the nature or scope of the Executives responsibilities or duties from the responsibilities or duties exercised by the Executive immediately prior to the Change in Control, it being understood by the parties hereto, that so long as the Executive retains primary sales and marketing responsibilities for the business conducted by Anika immediately prior to the Change in Control, Good Reason shall not exist under this Section 3(b)(i); or
(ii) a reduction in the Executive=s annual base salary and/or benefits as in effect on the date hereof or as the same may be increased from time to time except for across-the-board salary and/or benefits reductions similarly affecting all or substantially all management employees.
For purposes of this Section 3, unless the context otherwise requires, Company shall mean the Company or any successor thereto or to the business thereof in a transaction involving a Change in Control.
4. Special Termination Payments . In the event a Terminating Event occurs within twelve (12) months after a Change in Control in lieu of any payments under the Employment Letter (as hereinafter defined),
(a) the Company shall pay to the Executive, in addition to the payment, if any, required by Section 5, an amount equal to 100% of the Executives annual salary as in effect immediately prior to the Change in Control, said amount shall be paid in one lump sum payment no later than thirty-one (31) days following the Date of Termination (as such term is defined in Section 9(b)); and
(b) the Company shall continue to provide health, dental, long-term disability, life insurance and other fringe benefits to the Executive, on the same terms and conditions (including any required co-payments) as though the Executive had remained an active employee, for twelve (12) months; and
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(c) the Company shall provide COBRA benefits to the Executive following the end of the period referred to in Section 4(c) above, such benefits to be determined as though the Executives employment had terminated at the end of such period.
5. Payment Upon Effective Date of Change in Control . Upon the effective date of a Change in Control, regardless of whether a Terminating Event has occurred, in addition to any other payment required by Section 4, the Company shall pay the Executive an amount in cash representing fifty percent (50%) of the Executives annual salary as in effect immediately prior to the Change in Control. Said amount shall be paid in one lump sum payment no later than thirty-one (31) days following the effective date of a Change in Control.
6. Certain Limitations . It is the intention of the Executive and of the Company that no payments by the Company to or for the benefit of the Executive under this Agreement or any other agreement or plan, if any, pursuant to which the Executive is entitled to receive payments or benefits shall be nondeductible to the Company by reason of the operation of Section 280G of the Code relating to parachute payments or any like statutory or regulatory provision. Accordingly, and notwithstanding any other provision of this Agreement or any such agreement or plan, if by reason of the operation of said Section 280G or any like statutory or regulatory provision, any such payments exceed the amount which can be deducted by the Company, such payments shall be reduced to the maximum amount which can be deducted by the Company. To the extent that payments exceeding such maximum deductible amount have been made to or for the benefit of the Executive, such excess payments shall be refunded to the Company with interest thereon at the applicable Federal rate determined under Section 1274(d) of the Code, compounded annually, or at such other rate as may be required in order that no such payments shall be nondeductible to the Company by reason of the operation of said Section 280G or any like statutory or regulatory provision. To the extent that there is more than one method of reducing the payments to bring them within the limitations of said Section 280G or any like statutory or regulatory provision, the Executive shall determine which method shall be followed, provided that if the Executive fails to make such determination within forty-five (45) days after the Company has given notice of the need for such reduction, the Company may determine the method of such reduction in its sole discretion.
7. Term . This Agreement shall take effect on the date first set forth above and shall terminate upon the earliest of (a) the termination by the Company of the employment of the Executive for Cause; (b) the cessation of the Executives employment with the Company for any reason or the resignation or termination of the Executive for any reason, in each case, prior to a Change in Control; or (c) the resignation of the Executive after a Change in Control for any reason other than for Good Reason.
8. Withholding . All payments made by the Company under this Agreement shall be net of any tax or other amounts required to be withheld by the Company under applicable law.
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9. Notice and Date of Termination; Disputes; Etc.
(a) Notice of Termination . After a Change in Control and during the term of this Agreement, any purported termination of the Executives employment (other than by reason of death) shall be communicated by written Notice of Termination from one party hereto to the other party hereto in accordance with this Section 9. For purposes of this Agreement, a Notice of Termination shall mean a notice which shall indicate the specific termination provision in this Agreement relied upon and the Date of Termination. Further, a Notice of Termination for Cause is required to include a copy of a resolution duly adopted by the affirmative vote of not less than a majority of the entire membership of the Board (exclusive of the Executive) at a meeting of the Board (after reasonable notice to the Executive and an opportunity for the Executive, accompanied by the Executives counsel, to be heard before the Board) finding that, in the good faith opinion of the Board, the termination met the criteria for Cause set forth in Section 3(a) hereof.
(b) Date of Termination . Date of Termination, with respect to any purported termination of the Executives employment after a Change in Control and during the term of this Agreement, shall mean the date specified in the Notice of Termination. In the case of a termination by the Company other than a termination for Cause (which may be effective immediately), the Date of Termination shall not be less than 30 days after the Notice of Termination is given. In the case of a termination by the Executive, the Date of Termination shall not be less than 15 days from the date such Notice of Termination is given. Notwithstanding Section 3(a) of this Agreement, in the event that the Executive gives a Notice of Termination to the Company, the Company may unilaterally accelerate the Date of Termination and such acceleration shall not result in a second Terminating Event for purposes of Section 3(a) of this Agreement.
(c) No Mitigation . The Company agrees that, if the Executives employment by the Company is terminated during the term of this Agreement, the Executive is not required to seek other employment or to attempt in any way to reduce any amounts payable to the Executive by the Company pursuant to Sections 4 and 5 hereof. Further, the amount of any payment provided for in this Agreement shall not be reduced by any compensation earned by the Executive as the result of employment by another employer, by retirement benefits, by offset against any amount claimed to be owed by the Executive to the Company, or otherwise.
(d) Mediation of Disputes . The parties shall endeavor in good faith to settle within 90 days any controversy or claim arising out of or relating to this Agreement or the breach thereof through mediation with J.A.M.S./Endispute or similar organizations. If the controversy or claim is not resolved within 90 days, the parties shall be free to pursue other legal remedies in law or equity.
10. Assignment; Prior Agreements; Non-Solicitation . Except for an assignment by the Company in connection with a Change in Control in which the successor, if other than the Company, shall assume and agree to perform this Agreement in writing, neither the Company nor the Executive may make any assignment of this Agreement or any interest herein, by operation of law or otherwise, without the prior written consent of the other party, and without such consent
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any attempted transfer shall be null and void and of no effect. This Agreement shall inure to the benefit of and be binding upon the Company and the Executive, their respective successors, executors, administrators, heirs and permitted assigns. In the event of the Executives death after a Terminating Event but prior to the completion by the Company of all payments due him under Sections 4 and 5 of this Agreement, the Company shall continue such payments to the Executives beneficiary designated in writing to the Company prior to his death (or to his estate, if the Executive fails to make such designation). This Agreement supercedes all prior Agreements, whether written or oral with respect to the subject matter hereof. Notwithstanding the foregoing that certain Non-Disclosure and Non-Competition Agreement of June 27, 2002 by and between Executive and the Company shall remain in full force and effect in accordance with its terms.
Executive covenants to the Company that during his employment with the Company and until one (1) year from the date he is no longer employed by the Company, any affiliate thereof or any successor thereto, he will not in any manner, on his own behalf, or as a partner, officer, director, employee, agent or entity, directly or indirectly, induce or attempt to influence any person serving as an employee of the Company or any successor thereto to leave its employ or hire any such person.
11. Enforceability . If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law.
12. Waiver . No waiver of any provision hereof shall be effective unless made in writing and signed by the waiving party. The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.
13. Notices . Any notices, requests, demands, and other communications provided for by this Agreement shall be sufficient if in writing and delivered in person or sent by registered or certified mail, postage prepaid, to the Executive at the last address the Executive has filed in writing with the Company, or to the Company at its main office, attention of the Board of Directors.
14. Effect on Other Plans . Except as provided in Section 10 hereof, nothing in this Agreement shall be construed to limit the rights of the Executive under the Companys benefit plans, programs or policies.
15. Amendment . This Agreement may be amended or modified only by a written instrument signed by the Executive and by a duly authorized representative of the Company.
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16. Governing Law . This is a Massachusetts contract and shall be construed under and be governed in all respects by the laws of the Commonwealth of Massachusetts.
17. Obligations of Successors . In addition to any obligations imposed by law upon any successor to the Company, the Company will use its commercially reasonable efforts to require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company to expressly assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place.
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IN WITNESS WHEREOF, this Agreement has been executed as a sealed instrument by the Company by their duly authorized officers and by the Executive, as of the date first above written.
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COMPANY : |
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ANIKA THERAPEUTICS, INC. |
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By: |
/s/ Charles H. Sherwood |
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Charles H. Sherwood, Ph.D. |
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President and Chief Executive Officer |
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EXECUTIVE : |
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/s/ William J. Knight |
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William J. Knight |
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Exhibit 10.4
ANIKA THERAPEUTICS, INC.
First Amended and Restated
Change in Control, Bonus and Severance Agreement
FIRST AMENDMENT AND RESTATEMENT, dated as of July 8, 2002 to that certain AGREEMENT made as of April 26, 2000 by and among Anika Therapeutics, Inc., a Massachusetts corporation with its principal place of business in Woburn, Massachusetts (the Company), and Charles H. Sherwood of Sudbury, Massachusetts (the Executive), an individual presently employed as the President and Chief Executive Officer of the Company.
1. Purpose . The Company considers it essential to the best interests of its stockholders to foster the continuous employment of key management personnel. The Board of Directors of the Company (the Board) recognizes, however, that, as is the case with many publicly held corporations, the possibility of a Change in Control (as defined in Section 2 hereof) exists and that such possibility, and the uncertainty and questions which it may raise among management, may result in the departure or distraction of management personnel to the detriment of the Company and its stockholders. Therefore, the Board has determined that appropriate steps should be taken to reinforce and encourage the continued attention and dedication of members of the Companys management, including the Executive, to their assigned duties without distraction in the face of potentially disturbing circumstances arising from the possibility of a Change in Control. Nothing in this Agreement shall be construed as creating an express or implied contract of employment and, except as otherwise agreed in writing between the Executive and the Company, the Executive shall not have any right to be retained in the employ of the Company.
2. Change in Control . A Change in Control shall mean the occurrence of any one of the following events:
(a) any person, as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934 (the Act) (other than the Company, any of its subsidiaries, any trustee, fiduciary or other person or entity holding securities under any employee benefit plan or trust of the Company or any of its subsidiaries), together with all affiliates and associates (as such terms are defined in Rule 12b-2 under the Act) of such person, shall become the beneficial owner (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, of securities of the Company representing 51% or more of the combined voting power of the Companys then outstanding securities having the right to vote in an election of the Companys Board of Directors (Voting Securities); or
(b) persons who, as of the date hereof, constitute the Companys Board of Directors (the Incumbent Directors) cease for any reason, including, without limitation, as a result of a tender offer, proxy contest, merger or similar transaction, to constitute at
least a majority of the Board, provided that any person becoming a director of the Company subsequent to the date hereof whose election or nomination for election was approved by a vote of at least a majority of the Incumbent Directors shall, for purposes of this Agreement, be considered an Incumbent Director; or
(c) the stockholders of the Company shall approve (A) any consolidation or merger of the Company where the shareholders of the Company, immediately prior to the consolidation or merger, would not, immediately after the consolidation or merger, beneficially own (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, shares representing in the aggregate 51% of the voting shares of the corporation issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation, if any), (B) any sale, lease, exchange or other transfer (in one transaction or a series of transactions contemplated or arranged by any party as a single plan) of all or substantially all of the assets of the Company or (C) any plan or proposal for the liquidation or dissolution of the Company.
Notwithstanding the foregoing, a Change in Control shall not be deemed to have occurred for purposes of the foregoing clause (a) solely as the result of an acquisition of securities by the Company which, by reducing the number of shares of Voting Securities outstanding, increases the proportionate voting power represented by the Voting Securities beneficially owned by any person to 51% or more of the combined voting power of all then outstanding Voting Securities; provided , however , that if any person referred to in this sentence shall thereafter become the beneficial owner of any additional shares of Voting Securities (other than pursuant to a share split, stock dividend or similar transaction or direct purchase from the Company), then a Change in Control shall be deemed to have occurred for purposes of the foregoing clause (a).
3. Terminating Event . A Terminating Event shall mean any of the events provided in this Section 3 occurring within twelve (12) months subsequent to a Change in Control as defined in Section 2:
(a) termination by the Company of the employment of the Executive with the Company for any reason other than for Cause or the death of the Executive. Cause shall mean, and shall be limited to, the occurrence of any one or more of the following events:
(i) a willful act of dishonesty by the Executive with respect to any matter involving the Company;
(ii) conviction of the Executive of a crime involving moral turpitude; or
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(iii) the deliberate or willful failure by the Executive (other than by reason of the Executives physical or mental illness, incapacity or disability) to substantially perform the Executives duties with the Company and the continuation of such failure for a period of 30 days after delivery by the Company to the Executive of written notice specifying the scope and nature of such failure and its intention to terminate the Executive for Cause.
A Terminating Event shall not be deemed to have occurred pursuant to this Section 3(a) solely as a result of the Executive being an employee of any direct or indirect successor to the business or assets of the Company, rather than continuing as an employee of the Company following a Change in Control.
(b) termination by the Executive of the Executives employment with the Company for Good Reason. Good Reason shall mean the occurrence of any of the following events:
(i) a substantial adverse change in the nature or scope of the Executives responsibilities or duties from the responsibilities or duties exercised by the Executive immediately prior to the Change in Control, it being understood by the parties hereto, that so long as the Executive retains primary management responsibilities for the business conducted by the Company immediately prior to the Change in Control, Good Reason shall not exist under this Section 3(b)(i); or
(ii) a reduction in the Executives annual base salary and/or benefits as in effect on the date hereof or as the same may be increased from time to time except for across-the-board salary and/or benefits reductions similarly affecting all or substantially all management employees.
For purposes of this Section 3, unless the context otherwise requires, Company shall mean the Company or any successor thereto or to the business thereof in a transaction involving a Change in Control.
4. Special Termination Payments . In the event a Terminating Event occurs within twelve (12) months after a Change in Control in lieu of any payments under the Employment Letter (as hereinafter defined),
(a) the Company shall pay to the Executive, in addition to the payment, if any, required by Section 5, an amount equal to 100% of the Executives annual salary as in effect immediately prior to the Change in Control, said amount shall be paid in one lump sum payment no later than thirty-one (31) days following the Date of Termination (as such term is defined in Section 9(b)); and
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(b) the Company shall continue to provide health, dental, long-term disability, life insurance and other fringe benefits to the Executive, on the same terms and conditions (including any required co-payments) as though the Executive had remained an active employee, for twelve (12) months; and
(c) the Company shall provide COBRA benefits to the Executive following the end of the period referred to in Section 4(c) above, such benefits to be determined as though the Executives employment had terminated at the end of such period.
5. Payment Upon Effective Date of Change in Control . Upon the effective date of a Change in Control, regardless of whether a Terminating Event has occurred, in addition to any other payment required by Section 4, the Company shall pay the Executive an amount in cash representing one hundred percent (100%) of the Executives annual salary as in effect immediately prior to the Change in Control. Said amount shall be paid in one lump sum payment no later than thirty-one (31) days following the effective date of a Change in Control.
6. Certain Limitations . It is the intention of the Executive and of the Company that no payments by the Company to or for the benefit of the Executive under this Agreement or any other agreement or plan, if any, pursuant to which the Executive is entitled to receive payments or benefits shall be nondeductible to the Company by reason of the operation of Section 280G of the Code relating to parachute payments or any like statutory or regulatory provision. Accordingly, and notwithstanding any other provision of this Agreement or any such agreement or plan, if by reason of the operation of said Section 280G or any like statutory or regulatory provision, any such payments exceed the amount which can be deducted by the Company, such payments shall be reduced to the maximum amount which can be deducted by the Company. To the extent that payments exceeding such maximum deductible amount have been made to or for the benefit of the Executive, such excess payments shall be refunded to the Company with interest thereon at the applicable Federal rate determined under Section 1274(d) of the Code, compounded annually, or at such other rate as may be required in order that no such payments shall be nondeductible to the Company by reason of the operation of said Section 280G or any like statutory or regulatory provision. To the extent that there is more than one method of reducing the payments to bring them within the limitations of said Section 280G or any like statutory or regulatory provision, the Executive shall determine which method shall be followed, provided that if the Executive fails to make such determination within forty-five (45) days after the Company has given notice of the need for such reduction, the Company may determine the method of such reduction in its sole discretion.
7. Term . This Agreement shall take effect on the date first set forth above and shall terminate upon the earliest of (a) the termination by the Company of the employment of the Executive for Cause; (b) the cessation of the Executives employment with the Company for any reason or the resignation or termination of the Executive for any reason, in each case, prior to a Change in Control; or (c) the resignation of the Executive after a Change in Control for any reason other than for Good Reason.
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8. Withholding . All payments made by the Company under this Agreement shall be net of any tax or other amounts required to be withheld by the Company under applicable law.
9. Notice and Date of Termination; Disputes; Etc.
(a) Notice of Termination . After a Change in Control and during the term of this Agreement, any purported termination of the Executives employment (other than by reason of death) shall be communicated by written Notice of Termination from one party hereto to the other party hereto in accordance with this Section 9. For purposes of this Agreement, a Notice of Termination shall mean a notice which shall indicate the specific termination provision in this Agreement relied upon and the Date of Termination. Further, a Notice of Termination for Cause is required to include a copy of a resolution duly adopted by the affirmative vote of not less than a majority of the entire membership of the Board (exclusive of the Executive) at a meeting of the Board (after reasonable notice to the Executive and an opportunity for the Executive, accompanied by the Executives counsel, to be heard before the Board) finding that, in the good faith opinion of the Board, the termination met the criteria for Cause set forth in Section 3(a) hereof.
(b) Date of Termination . Date of Termination, with respect to any purported termination of the Executives employment after a Change in Control and during the term of this Agreement, shall mean the date specified in the Notice of Termination. In the case of a termination by the Company other than a termination for Cause (which may be effective immediately), the Date of Termination shall not be less than 30 days after the Notice of Termination is given. In the case of a termination by the Executive, the Date of Termination shall not be less than 15 days from the date such Notice of Termination is given. Notwithstanding Section 3(a) of this Agreement, in the event that the Executive gives a Notice of Termination to the Company, the Company may unilaterally accelerate the Date of Termination and such acceleration shall not result in a second Terminating Event for purposes of Section 3(a) of this Agreement.
(c) No Mitigation . The Company agrees that, if the Executives employment by the Company is terminated during the term of this Agreement, the Executive is not required to seek other employment or to attempt in any way to reduce any amounts payable to the Executive by the Company pursuant to Sections 4 and 5 hereof. Further, the amount of any payment provided for in this Agreement shall not be reduced by any compensation earned by the Executive as the result of employment by another employer, by retirement benefits, by offset against any amount claimed to be owed by the Executive to the Company, or otherwise.
(d) Mediation of Disputes . The parties shall endeavor in good faith to settle within 90 days any controversy or claim arising out of or relating to this Agreement or the breach thereof through mediation with J.A.M.S./Endispute or similar organizations. If
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the controversy or claim is not resolved within 90 days, the parties shall be free to pursue other legal remedies in law or equity.
10. Assignment; Prior Agreements; NonSolicitation . Except for an assignment by the Company in connection with a Change in Control in which the successor, if other than the Company, shall assume and agree to perform this Agreement in writing, neither the Company nor the Executive may make any assignment of this Agreement or any interest herein, by operation of law or otherwise, without the prior written consent of the other party, and without such consent any attempted transfer shall be null and void and of no effect. This Agreement shall inure to the benefit of and be binding upon the Company and the Executive, their respective successors, executors, administrators, heirs and permitted assigns. In the event of the Executives death after a Terminating Event but prior to the completion by the Company of all payments due him under Sections 4 and 5 of this Agreement, the Company shall continue such payments to the Executives beneficiary designated in writing to the Company prior to his death (or to his estate, if the Executive fails to make such designation). This Agreement supercedes all prior Agreements, whether written or oral with respect to the subject matter hereof. Notwithstanding the foregoing: (A) that certain Employment Letter dated April 15, 1998 by and between the Company and the Executive, (the Employment Letter), shall govern any termination of the Executives employment with the Company (i) prior to the effective date of a Change in Control or (ii) following the expiration of twelve (12) months after a Change in Control; this Agreement shall govern in the event of any termination of Executives employment with the Company within twelve (12) months after a Change in Control; and (B) that certain Non-Disclosure and Non-Competition Agreement of May 4, 1998 by and between Executive and the Company shall remain in full force and effect in accordance with its terms.
Executive covenants to the Company that during his employment with the Company and until one (1) year from the date he is no longer employed by the Company, any affiliate thereof or any successor thereto, he will not in any manner, on his own behalf, or as a partner, officer, director, employee, agent or entity, directly or indirectly, induce or attempt to influence any person serving as an employee of the Company or any successor thereto to leave its employ or hire any such person.
11. Enforceability . If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law.
12. Waiver . No waiver of any provision hereof shall be effective unless made in writing and signed by the waiving party. The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this
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Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.
13. Notices . Any notices, requests, demands, and other communications provided for by this Agreement shall be sufficient if in writing and delivered in person or sent by registered or certified mail, postage prepaid, to the Executive at the last address the Executive has filed in writing with the Company, or to the Company at its main office, attention of the Board of Directors.
14. Effect on Other Plans . Except as provided in Section 10 hereof, nothing in this Agreement shall be construed to limit the rights of the Executive under the Companys benefit plans, programs or policies.
15. Amendment . This Agreement may be amended or modified only by a written instrument signed by the Executive and by a duly authorized representative of the Company.
16. Governing Law . This is a Massachusetts contract and shall be construed under and be governed in all respects by the laws of the Commonwealth of Massachusetts.
17. Obligations of Successors . In addition to any obligations imposed by law upon any successor to the Company, the Company will use its commercially reasonable efforts to require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company to expressly assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place.
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IN WITNESS WHEREOF, this Agreement has been executed as a sealed instrument by the Company by their duly authorized officers and by the Executive, as of the date first above written.
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COMPANY : |
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ANIKA THERAPEUTICS, INC. |
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By: |
/s/ William J. Knight |
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Name: |
William J. Knight |
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Title: |
Chief Financial Officer |
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EXECUTIVE : |
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/s/ Charles H. Sherwood |
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Charles H. Sherwood |
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