UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2003
or
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from ___________ to ___________.
Commission file number: 000-23265
SALIX PHARMACEUTICALS, LTD.
(Exact name of Registrant as specified in its charter)
| Delaware |
|
94-3267443 |
| (State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
8540 Colonnade Center
Drive, Suite 501
Raleigh, North Carolina 27615
(Address of principal executive offices, including zip code)
(919)
862-1000
(Registrants telephone number, including area code)
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 past 90 days.
| YES x |
NO o |
The number of shares of the Registrants Common Stock outstanding as of May 12, 2003 was 21,459,904.
SALIX PHARMACEUTICALS, LTD.
TABLE OF CONTENTS
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Page No. | |
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| PART I. |
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| Item 1. |
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1 | |
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2 | |
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3 | |
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4 | |
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| Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations |
6 | |
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| Item 3. |
10 | ||
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| Item 4. |
10 | ||
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| PART II. |
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| Item 1. |
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| Item 6. |
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| 12 | |||
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| 13 | |||
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
SALIX PHARMACEUTICALS, LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars, in thousands, except share amounts)
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March 31, 2003 |
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December 31, 2002 |
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(unaudited) |
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(audited) |
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| ASSETS |
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| Current assets: |
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| Cash and cash equivalents |
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$ |
28,576 |
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$ |
34,531 |
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| Short-term investments |
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11,342 |
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14,165 |
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| Accounts receivable, net |
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7,655 |
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5,980 |
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| Inventory, net |
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9,424 |
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10,210 |
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| Prepaid and other current assets |
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2,177 |
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2,080 |
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| Total current assets |
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59,174 |
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66,966 |
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| Long-term investments |
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7,042 |
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7,052 |
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| Property and equipment, net |
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1,216 |
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1,284 |
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| Total assets |
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$ |
67,432 |
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75,302 |
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| LIABILITIES AND STOCKHOLDERS EQUITY |
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| Current liabilities: |
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| Accounts payable |
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$ |
1,577 |
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$ |
3,029 |
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| Accrued liabilities |
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7,731 |
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8,676 |
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| Deferred revenue |
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3,150 |
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3,208 |
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| Total current liabilities |
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12,458 |
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14,913 |
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| Commitments |
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| Stockholders equity: |
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| Preferred stock, $0.001 par value; 5,000,000 shares authorized, issuable in series, none outstanding |
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| Common stock, $0.001 par value; 80,000,000 shares authorized, 21,375,846 shares issued and outstanding at March 31, 2003 and December 31, 2002, respectively. |
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21 |
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21 |
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| Additional paid-in capital |
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131,298 |
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131,300 |
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| Accumulated other comprehensive loss |
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(248 |
) |
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(306 |
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| Accumulated deficit |
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(76,097 |
) |
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(70,626 |
) |
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| Total stockholders equity |
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54,974 |
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60,389 |
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| Total liabilities and stockholders equity |
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$ |
67,432 |
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$ |
75,302 |
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The accompanying notes are an integral part of these financial statements.
1
SALIX PHARMACEUTICALS, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(U.S. dollars, in thousands, except per share data)
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Three months ended |
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2003 |
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2002 |
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| Revenues: |
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| Product revenue |
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$ |
11,522 |
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$ |
6,211 |
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| Total revenues |
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11,522 |
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6,211 |
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| Costs and expenses: |
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| Cost of products sold |
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$ |
2,764 |
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$ |
1,566 |
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| License fees and costs related to collaborative agreements |
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31 |
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31 |
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| Research and development |
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5,150 |
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2,485 |
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| Selling, general and administrative |
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9,619 |
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6,978 |
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| Total cost and expenses |
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17,564 |
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11,060 |
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| Loss from operations |
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(6,042 |
) |
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(4,849 |
) |
| Interest, and other income (expense), net |
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570 |
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|
125 |
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| Net loss before tax |
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$ |
(5,472 |
) |
$ |
(4,724 |
) |
| Income tax |
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| Net loss |
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$ |
(5,472 |
) |
$ |
(4,724 |
) |
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| Net loss per share, basic and diluted |
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$ |
(0.26 |
) |
$ |
(0.26 |
) |
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| Shares used in computing net loss per share, basic and diluted |
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21,376 |
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17,895 |
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The accompanying notes are an integral part of these financial statements.
2
SALIX PHARMACEUTICALS, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(U.S. dollars, in thousands)
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Three months ended |
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2003 |
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2002 |
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| Cash Flows From Operating Activities |
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| Net loss |
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$ |
(5,472 |
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$ |
(4,724 |
) |
| Adjustments to reconcile net loss to net cash used in operating activities: |
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| Depreciation and amortization |
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116 |
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90 |
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| Changes in assets and liabilities: |
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| Accounts receivable, inventory and other assets |
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(986 |
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(886 |
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| Accounts payable and other current liabilities |
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(2,397 |
) |
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(599 |
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| Deferred revenue |
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(58 |
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(50 |
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| Net cash used in operating activities |
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(8,797 |
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(6,169 |
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| Cash Flows From Investing Activities |
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| Purchases of property and equipment |
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(48 |
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(154 |
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| Proceeds from maturity of investments |
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2,834 |
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| Net cash provided by (used in) investing activities |
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2,786 |
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(154 |
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| Cash Flows From Financing Activities |
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| Proceeds from issuance of common stock |
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(2 |
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57,595 |
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| Net cash (used in) provided by financing activities |
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(2 |
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57,595 |
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| Effect of exchange rate changes on cash |
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58 |
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| Net (decrease) increase in cash and cash equivalents |
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(5,955 |
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51,272 |
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| Cash and cash equivalents at beginning of period |
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34,531 |
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27,868 |
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| Cash and cash equivalents at end of period |
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$ |
28,576 |
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$ |
79,140 |
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The accompanying notes are an integral part of these financial statements.
3
SALIX PHARMACEUTICALS, LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2003
(Unaudited)
| 1. |
Organization and Basis of Presentation |
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Salix Pharmaceuticals, Ltd., (the Company) became a Delaware corporation on December 31, 2001 pursuant to a reorganization and continuation of the Company as a domestic entity. |
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These statements are stated in United States dollars and are prepared under accounting principles generally accepted in the United States. The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries. All significant intercompany balances and transactions have been eliminated. |
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The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring items), which, in the opinion of management, are necessary for a fair presentation of financial position, results of operations and cash flows. These financial statements should be read in conjunction with Managements Discussion and Analysis of Financial Condition and Results of Operations included elsewhere in this Report and with the audited consolidated financial statements for the fiscal year ended December 31, 2002 included in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2002 filed with the Securities and Exchange Commission. The results of operations for interim periods are not necessarily indicative of results to be expected for a full year or any future period. |
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| 2. |
Commitments |
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At March 31, 2003, the Company had binding purchase order commitments for inventory purchases aggregating approximately $10.6 million over 10 months. |
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| 3. |
Investments |
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The Company considers all investments that have a maturity of greater than three months and less than one year to be short-term investments. All securities with maturities beyond one year are considered long-term investments. The Companys short-term and long-term investments consist of government agency and high-grade corporate bonds. The Company has the intent and ability to hold these investments until maturity; therefore, the investments are classified as held-to-maturity and are reported at amortized cost. |
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| 4. |
Inventory |
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Inventory at March 31, 2003 consisted of $6.8 million of raw materials and $2.6 million of finished goods. Inventory at December 31, 2002 consisted of $7.3 million of raw material and $2.9 million of finished goods. As of March 31, 2003, the Company had approximately $2.2 million in raw material inventories relating to products that had not been approved by the U.S. Food and Drug Administration. |
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| 5. |
Revenue Recognition |
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In December 1999, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, which among other guidance clarifies conditions to be met in order to recognize revenue. SAB 101 requires companies to recognize certain up-front non-refundable fees over the term of the related agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process. |
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Due to the uniqueness of each of its licensing arrangements, the Company analyzes each element of each contract, including milestone payments, to determine the appropriate revenue recognition. In accordance with |
4
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SAB 101, the Company recognizes revenue upon achievement of contractual milestones only when and to the extent the Company concludes that a separate earnings process has been culminated or the milestone is representative of the level of effort and progress toward completion of a long-term contract. |
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| 6. |
Research and Development |
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Research and development costs, both internal and externally contracted, are expensed as incurred. These costs include direct expenditures for goods and services, as well as indirect expenditures such as salaries, administrative expenses and various allocated costs. |
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| 7. |
Equity Offering |
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On March 15, 2002, the Company completed a public offering of its common stock. The Company raised approximately $57.4 million, net of offering costs, through the issuance of 4,600,000 shares of common stock. |
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| 8. |
Recent Accounting Pronouncements |
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In April 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities (SFAS 146). SFAS 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring) (Issue 94-3). SFAS 146 addresses the accounting and reporting for costs associated with exit or disposal activities resulting from entities increasingly engaging in exit and disposal activities where certain costs associated with those activities were recognized as liabilities at a plan (commitment) date under Issue 94-3 but did not meet the definition of a liability in FASB Concepts Statement No. 6, Elements of Financial Statements. The standard became effective for us beginning January 1, 2003. The adoption of SFAS 146 had no impact on our results of operations or financial position. |
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In November 2002, the FASB issued FASB Interpretation No. 45, Guarantors Accounting and Disclosure Requirements for Guarantees, Including Guarantees of Indebtedness of Others (an interpretation of FAS No. 5, 57 and 107 and rescission of FAS Interpretation No. 34) (FIN 45), which modifies the accounting and enhances the disclosure of certain types of guarantees. FIN 45 requires that upon issuance of certain guarantees, the guarantor must recognize a liability for the fair value of the obligation it assumes under the guarantee. The provisions of FIN 45 for the initial recognition and measurement are to be applied to guarantees issued or modified after December 31, 2002. The disclosure requirements are effective for financial statements of annual periods that end after December 15, 2002. The adoption of FIN 45 had no impact on our results of operations or financial position for the three months ending, nor as of, March 31, 2003. |
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| 9. |
Comprehensive Loss |
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Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss includes certain changes in the shareholders equity of the Company that are excluded from net loss. Specifically, other comprehensive loss includes foreign currency translation adjustments. |
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Comprehensive loss for the three months ended March 31, 2003 and 2002 was as follows: |
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Three months ended March 31, |
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2003 |
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2002 |
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| Net loss |
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$ |
(5,472 |
) |
$ |
(4,724 |
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| Cumulative foreign currency translation adjustments |
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58 |
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| Comprehensive loss |
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$ |
(5,414 |
) |
$ |
(4,724 |
) |
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5
10. Stock-Based Compensation
The Company accounts for stock-based awards to employees under the intrinsic value method in accordance with Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and has adopted the disclosure-only alternative of Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation. Under APB 25, the Company generally recognizes no compensation expense with respect to such awards.
In December 2002, the Financial Accounting Standards Board issued SFAS No. 148, Account for Stock Based Compensation-Transition and Disclosure and amendment of FASB Statement No. 123. This statement amends FASB Statement No. 123 Accounting for Stock Based Compensation, to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock based employee compensation. In addition, this statement amends the disclosure requirements of Statement 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock based employee compensation and the effects of the method used on reported results (see below). The standard is effective beginning with these financial statements and the provisions have been adopted herein.
Had compensation cost for the Companys stock-based compensation plan been determined based on fair value at the grant dates for awards under those plans consistent with the method of SFAS No. 123, the Companys net loss and loss per share would have been increased to the pro forma amounts indicated below for the periods ended March 31, 2003 and 2002, respectively.
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March 31, |
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2003 |
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2002 |
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| Net loss: |
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| As reported |
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$ |
(5,472 |
) |
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