e10vq
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the quarterly period ended September 30, 2005. |
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the
transition period from
to |
Commission file number: 0-27718
NEOSE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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13-3549286 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
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102 Witmer Road
Horsham, Pennsylvania
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19044 |
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(Address of principal executive offices)
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(Zip Code) |
(215) 315-9000
(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 þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of
the Exchange Act).
Yes þ No o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date: 32,782,372 shares of common stock, $.01 par value, were outstanding
as of November 1, 2005.
NEOSE TECHNOLOGIES, INC.
INDEX
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Page |
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PART I. FINANCIAL INFORMATION: |
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Item 1. Financial Statements (unaudited)
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Balance Sheets as of September 30, 2005 and December 31, 2004 |
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3 |
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Statements of Operations for the three and nine months
ended September 30, 2005 and 2004 |
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4 |
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Statements of Cash Flows for the nine months ended September
30, 2005 and 2004 |
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5 |
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Notes to Financial Statements |
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6 |
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Item 2. Managements Discussion and Analysis of Financial Condition and
Results of Operations |
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22 |
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Item 4. Controls and Procedures |
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35 |
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PART II.
OTHER INFORMATION: |
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Item 6. Exhibits |
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36 |
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SIGNATURES |
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37 |
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2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Neose Technologies, Inc.
Balance Sheets
(unaudited)
(in thousands, except per share amounts)
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September 30, |
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December 31, |
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2005 |
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2004 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
35,476 |
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$ |
45,048 |
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Marketable securities |
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9,977 |
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Accounts receivable and other current assets |
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2,045 |
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2,768 |
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Total current assets |
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47,498 |
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47,816 |
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Property and equipment, net |
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25,010 |
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41,133 |
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Intangible and other assets, net |
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1,103 |
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1,782 |
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Total assets |
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$ |
73,611 |
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$ |
90,731 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Note payable |
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$ |
258 |
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$ |
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Current portion of long-term debt and capital lease obligations |
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4,417 |
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4,586 |
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Accounts payable |
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613 |
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1,783 |
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Accrued compensation |
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1,560 |
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1,916 |
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Accrued expenses |
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2,763 |
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2,052 |
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Deferred revenue |
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1,275 |
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1,560 |
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Total current liabilities |
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10,886 |
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11,897 |
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Long-term debt and capital lease obligations |
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11,284 |
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13,759 |
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Deferred revenue, net of current portion |
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3,316 |
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3,688 |
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Other liabilities |
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486 |
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533 |
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Total liabilities |
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25,972 |
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29,877 |
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Stockholders equity: |
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Preferred stock, par value $.01 per share, 5,000 shares
authorized, none issued |
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Common stock, par value $.01 per share, 50,000 shares
authorized; 32,782 and 24,717 shares issued and outstanding |
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328 |
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247 |
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Additional paid-in capital |
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278,875 |
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248,027 |
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Deferred compensation |
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(10 |
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(39 |
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Accumulated deficit |
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(231,554 |
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(187,381 |
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Total stockholders equity |
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47,639 |
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60,854 |
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Total liabilities and stockholders equity |
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$ |
73,611 |
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$ |
90,731 |
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The accompanying notes are an integral part of these financial statements.
3
Neose Technologies, Inc.
Statements of Operations
(unaudited)
(in thousands, except per share amounts)
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2005 |
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2004 |
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2005 |
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2004 |
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Revenue from collaborative agreements |
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$ |
1,503 |
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$ |
1,451 |
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$ |
4,271 |
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$ |
3,592 |
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Operating expenses: |
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Research and development |
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7,521 |
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9,305 |
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26,133 |
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24,971 |
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General and administrative |
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2,685 |
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2,861 |
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8,469 |
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9,047 |
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Restructuring charges |
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14,002 |
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14,002 |
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Total operating expenses |
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24,208 |
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12,166 |
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48,604 |
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34,018 |
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Operating loss |
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(22,705 |
) |
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(10,715 |
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(44,333 |
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(30,426 |
) |
Other income |
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22 |
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Interest income |
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415 |
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195 |
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1,138 |
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431 |
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Interest expense |
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(331 |
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(304 |
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(1,000 |
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(658 |
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Net loss |
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$ |
(22,621 |
) |
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$ |
(10,824 |
) |
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$ |
(44,173 |
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$ |
(30,653 |
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Basic and diluted net loss per share |
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$ |
(0.69 |
) |
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$ |
(0.44 |
) |
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$ |
(1.42 |
) |
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$ |
(1.38 |
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Weighted-average shares outstanding
used in computing basic and diluted
net loss per share |
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32,782 |
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24,712 |
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31,188 |
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22,284 |
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The accompanying notes are an integral part of these financial statements.
4
Neose Technologies, Inc.
Statements of Cash Flows
(unaudited)
(in thousands)
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Nine months ended |
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September 30, |
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2005 |
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2004 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(44,173 |
) |
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$ |
(30,653 |
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Adjustments to reconcile net loss to net cash used in
operating activities: |
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Impairment of property and equipment |
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13,187 |
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Depreciation and amortization expense |
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3,831 |
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4,433 |
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Non-cash compensation expense |
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484 |
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93 |
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Loss (gain) on disposition of property and equipment |
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(21 |
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5 |
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Changes in operating assets and liabilities: |
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Accounts receivable and other current assets |
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831 |
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(907 |
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Intangible and other assets |
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2 |
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Accounts payable |
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(1,054 |
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(551 |
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Accrued compensation |
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26 |
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(570 |
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Accrued expenses |
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774 |
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575 |
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Deferred revenue |
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(657 |
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387 |
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Other liabilities |
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(47 |
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129 |
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Net cash used in operating activities |
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(26,819 |
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(27,057 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(719 |
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(8,942 |
) |
Proceeds from sale of property and equipment |
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70 |
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Proceeds from settlement of property and equipment dispute |
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25 |
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Purchases of marketable securities |
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(9,845 |
) |
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Proceeds from maturities of marketable securities |
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5,000 |
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Net cash used in investing activities |
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(10,469 |
) |
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(3,942 |
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Cash flows from financing activities: |
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Proceeds from issuance of debt |
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1,484 |
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12,696 |
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Repayments of debt |
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(3,860 |
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(5,756 |
) |
Debt issuance costs |
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(103 |
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Restricted cash related to debt |
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901 |
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Proceeds from issuance of common stock, net |
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30,092 |
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30,103 |
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Proceeds from exercise of stock options |
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73 |
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Net cash provided by financing activities |
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27,716 |
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37,914 |
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Net increase (decrease) in cash and cash equivalents |
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(9,572 |
) |
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6,915 |
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Cash and cash equivalents, beginning of period |
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45,048 |
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48,101 |
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Cash and cash equivalents, end of period |
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$ |
35,476 |
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$ |
55,016 |
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The accompanying notes are an integral part of these financial statements.
5
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
1. Organization and Business Activities
Neose Technologies, Inc. is a biopharmaceutical company using its enzymatic technologies to
develop proprietary drugs, focusing primarily on therapeutic proteins.
Our revenue from collaborative agreements increased from $1,435 in the year ended December 31,
2003 to $5,070 in the year ended December 31, 2004. In April 2005, we entered into an agreement
with BioGeneriX AG for the use of our GlycoAdvance® and GlycoPEGylation technologies to develop a
long-acting version of a currently marketed therapeutic protein (see Note 12). We have partnered
five of the six proprietary drug programs that use our technologies and are in various stages of
research and preclinical development. We have an additional two proteins available for partnering.
Under our collaborative agreements, we have begun to receive significant revenues from our planned
principal operation of developing proprietary drugs. As a result of the revenue growth in the year
ended December 31, 2004 compared to the year ended December 31, 2003 and because we entered into
new collaborative agreements in 2004 and 2005, we are no longer considered a development-stage
company as we had been since our inception in January 1989, and all cumulative information reported
in prior years is no longer reported.
2. Interim Financial Information
The accompanying unaudited financial statements have been prepared in accordance with U.S.
generally accepted accounting principles for presentation of interim financial statements.
Accordingly, the unaudited financial statements do not include all the information and footnotes
necessary for a comprehensive presentation of the financial position, results of operations, and
cash flows for the periods presented. In our opinion, however, the unaudited financial statements
include all the normal recurring adjustments that are necessary for a fair presentation of the
financial position, results of operations, and cash flows for the periods presented. You should not
base your estimate of our results of operations for 2005 solely on our results of operations for
the nine months ended September 30, 2005. You should read these unaudited financial statements in
combination with the other Notes in this section; Managements Discussion and Analysis of
Financial Condition and Results of Operations appearing in Item 2; and the Financial Statements,
including the Notes to the Financial Statements, included in our Annual Report on Form 10-K for the
year ended December 31, 2004.
3. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles requires us to make estimates and assumptions. Those estimates and assumptions affect
the reported amounts of assets and liabilities as of the date of the financial statements, the
disclosure of contingent assets and liabilities as of the date of the financial
6
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
statements, and the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates.
Accounting for Restructuring Costs
In August 2005, we announced that we had implemented a restructuring of operations (see Note
13). Statement of Financial Accounting Standards (SFAS) No. 146, Accounting for Costs Associated
with Exit or Disposal Activities (SFAS No. 146), addresses financial accounting and reporting for
costs associated with exit or disposal activities. SFAS No. 146 requires a liability for a cost
associated with an exit or disposal activity be recognized and measured initially at fair value
only when the liability is incurred. SFAS No. 146 does not apply to costs associated with a
disposal activity covered by SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets. The restructuring charges recorded by us during the three months ended September 30, 2005
are comprised primarily of costs to write-off property and equipment and to reduce our workforce.
Under SFAS No. 144, any impairment of property and equipment to be recognized is measured by
the amount by which the carrying amount of the assets exceeds the fair value of the assets. To
determine the fair value of assets that are not likely to be used over their remaining useful
economic life, we use a probability-weighted approach of estimated cash flows to be received upon a
range of possible disposition outcomes. In August 2005, we announced we would evaluate alternatives
relative to our current headquarters and pilot manufacturing facility (Witmer Road Facility), which
we own subject to a mortgage, including the potential disposition of the facility and further
consolidation of our research, development and administrative operations into a currently leased
facility also located in Horsham, Pennsylvania. As a result of the announcement, we concluded that
identifiable cash flows could be assigned to the Witmer Road Facility and related equipment. We
based our estimates of potential cash flows related to possible disposition outcomes on
conversations with commercial real estate firms that have both knowledge of recent history of sales
and expertise in marketing and selling similar facilities. These estimates may turn out to be
incorrect and our actual cash flows may be materially different from our estimates.
Under SFAS No. 146, any employee severance costs are determined based on the estimated
severance and fringe benefit charge for identified employees. In calculating the cost to exit
facilities, we estimate the future lease and operating costs to be paid until the lease is
terminated, the amount, if any, of sublease receipts, and real estate broker fees. This requires us
to estimate the timing and costs of the amount of operating costs and the timing and rate at which
we might be able to sublease the site. To form our estimates for these costs, we performed an
assessment of the affected facility and considered the current market conditions for the site. Our
assumptions on operating costs until terminated and offsetting sublease receipts may turn out to be
incorrect and our actual costs may be different from our estimates.
7
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
Our estimates of future liabilities may change, requiring us to record additional
restructuring charges or reduce the amount of liabilities recorded. At the end of each reporting
period, we evaluate the remaining accrued restructuring charges to ensure their adequacy, that no
excess accruals are retained and the utilization of the provisions are for their intended purposes
in accordance with developed exit plans. We periodically evaluate current available information and
adjust our accrued restructuring charges as necessary.
Stock-based Compensation
We apply the intrinsic value method of accounting for all stock-based employee compensation in
accordance with Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to
Employees, and related interpretations. We record deferred compensation for option grants to
employees for the amount, if any, by which the market price per share on the grant date exceeds the
exercise price per share. In addition, we apply fair value accounting for option grants to
non-employees in accordance with SFAS No. 123, Accounting for Stock-Based Compensation (SFAS No.
123), and Emerging Issues Task Force Issue 96-18, Accounting for Equity Instruments That Are Issued
to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.
We have elected to adopt only the disclosure provisions of SFAS No. 148, Accounting for
Stock-Based Compensation Transition and Disclosure, an amendment of FASB Statement No. 123. The
following table illustrates the effect on our net loss and basic and diluted net loss per share if
we had recorded compensation expense for the estimated fair value of our stock-based employee
compensation, consistent with SFAS No. 123:
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Three months ended |
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Nine months ended |
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|
September 30, |
|
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September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss as reported |
|
$ |
(22,621 |
) |
|
$ |
(10,824 |
) |
|
$ |
(44,173 |
) |
|
$ |
(30,653 |
) |
Add: Stock-based
employee
compensation
expense included
in reported net
loss |
|
|
(2 |
) |
|
|
11 |
|
|
|
820 |
|
|
|
89 |
|
Deduct: Total
stock-based
employee
compensation
expense determined
under fair
value-based method
for all awards |
|
|
(1,193 |
) |
|
|
(2,634 |
) |
|
|
(4,139 |
) |
|
|
(7,732 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss pro forma |
|
$ |
(23,816 |
) |
|
$ |
(13,447 |
) |
|
$ |
(47,492 |
) |
|
$ |
(38,296 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share as
reported |
|
$ |
(0.69 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.42 |
) |
|
$ |
(1.38 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share pro
forma |
|
$ |
(0.73 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.52 |
) |
|
$ |
(1.72 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
8
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted-average number of
common shares outstanding for the period. Diluted net loss per share is computed by dividing net
loss by the sum of weighted-average number of common shares outstanding for the period and the
number of additional shares that would have been outstanding if dilutive potential common shares
had been issued. Potential common shares are excluded from the calculation of diluted net loss per
share if the effect on net loss per share is antidilutive. Our diluted net loss per share is equal
to basic net loss per share for all reporting periods presented because giving effect in the
computation of diluted net loss per share to the exercise of outstanding options or granting of
restricted stock units would have been antidilutive.
Comprehensive Loss
Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income
(loss). Other comprehensive income (loss) includes changes to equity that are not included in net
income (loss). Our comprehensive loss for the three and nine months ended September 30, 2005 was
comprised only of our net loss, and was $22,621 and $44,173, respectively. Our comprehensive loss
for the three and nine months ended September 30, 2004 was comprised only of our net loss, and was
$10,824 and $30,653, respectively.
Fair Value of Financial Instruments
The fair value of financial instruments is the amount for which instruments could be exchanged
in a current transaction between willing parties. As of September 30, 2005, the carrying values of
cash and cash equivalents, marketable securities, accounts receivable and other current assets,
accounts payable, accrued expenses, and accrued compensation equaled or approximated their
respective fair values because of the short duration of these instruments. The fair value of our
debt and capital lease obligations was estimated by discounting the future cash flows of each
instrument at rates recently offered to us for similar debt instruments offered by our lenders. As
of September 30, 2005, the fair and carrying values of our debt and capital lease obligations were
$14,841 and $15,959, respectively.
Recent Accounting Pronouncements
In May 2005, the Financial Accounting Standards Board (FASB) issued SFAS No. 154, Accounting
Changes and Error Corrections a replacement of APB Opinion No. 20 and FASB Statement No. 3 (SFAS
No. 154), which replaces APB Opinion No. 20, Accounting Changes, and SFAS No. 3, Reporting
Accounting Changes in Interim Financial Statements, and changes the requirements for the accounting
for and reporting of a change in accounting principle. SFAS No. 154 applies to all voluntary
changes in accounting principle, and also applies to changes required by an accounting
pronouncement in the unusual instance that the pronouncement does not include specific transition
provisions. SFAS No. 154 will be effective for accounting changes
9
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
and corrections of errors made in fiscal years beginning after December 15, 2005. SFAS No. 154
does not change the transition provisions of any existing accounting pronouncements, including
those that are in a transition phase as of the effective date of SFAS No. 154. We do not believe
the adoption of SFAS No. 154 will have a material impact on our financial statements.
In March 2005, the FASB issued FASB Interpretation No. 47, Accounting for Conditional Asset
Retirement Obligations an interpretation of FASB Statement No. 143 (FIN 47), which will require
companies to recognize a liability for the fair value of a legal obligation to perform asset
retirement activities that are conditional on a future event if the amount can be reasonably
estimated. FIN 47 must be adopted no later than the end of the fiscal year ending after December
15, 2005. We have not completed an assessment of the impact that adoption of FIN 47 will have on
our financial statements.
In December 2004, the FASB issued SFAS No. 123R, Share-Based Payment (SFAS No. 123R), which
requires companies to expense the fair value of stock options and other equity-based compensation
to employees. SFAS No. 123R also provides guidance for determining whether an award is a
liability-classified award or an equity-classified award, and determining fair value. SFAS No. 123R
applies to all unvested stock-based payment awards outstanding as of the adoption date. Pursuant to
a rule announced by the Securities and Exchange Commission in April 2005, SFAS No. 123R must be
adopted no later than the beginning of the first fiscal year that begins after June 15, 2005. We
have not completed an assessment of the impact on our financial statements resulting from potential
modifications to our equity-based compensation structure or the use of an alternative fair value
model in anticipation of adopting SFAS No. 123R.
In December 2004, the FASB issued SFAS No. 153, Exchanges of Nonmonetary Assets an amendment
of APB Opinion No. 29 (SFAS No. 153). APB Opinion No. 29 requires a nonmonetary exchange of assets
be accounted for at fair value, recognizing any gain or loss, if the exchange meets a commercial
substance criterion and fair value is determinable. The commercial substance criterion is assessed
by comparing the entitys expected cash flows immediately before and after the exchange. SFAS No.
153 eliminates the similar productive assets exception, which accounts for the exchange of assets
at book value with no recognition of gain or loss. SFAS No. 153 is effective for nonmonetary asset
exchanges occurring in fiscal periods beginning after June 15, 2005. The adoption of SFAS No. 153
did not have an impact on our financial statements.
Reclassification
Certain prior year amounts have been reclassified to conform to current year presentation.
10
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
4. Supplemental Disclosure of Cash Flow Information
The following table contains additional cash flow information for the periods reported.
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
September 30, |
|
|
|
2005 |
|
|
2004 |
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross cash paid for interest |
|
$ |
986 |
|
|
$ |
533 |
|
|
|
|
|
|
|
|
|
|
Less capitalized interest |
|
|
|
|
|
|
(130 |
) |
|
|
|
|
|
|
|
Cash paid for interest, net of amounts capitalized |
|
$ |
986 |
|
|
$ |
403 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in accrued property and equipment |
|
$ |
(63 |
) |
|
$ |
(475 |
) |
|
|
|
|
|
|
|
Assets acquired under capital leases |
|
$ |
|
|
|
$ |
184 |
|
|
|
|
|
|
|
|
Decrease in acquisition value of property and
equipment related to cancellation of a vendor
invoice as partial settlement of dispute (see
Note 7) |
|
$ |
116 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Decrease in acquisition value of property and
equipment related to receivable from vendor as
partial settlement of dispute (see Note 7) |
|
$ |
50 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Decrease in acquisition value of property and
equipment due to decrease in amount of remaining
minimum lease payments under capital lease |
|
$ |
10 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash financing activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of accrued compensation from liability
to equity classified award upon grant of
restricted stock units (see Note 11) |
|
$ |
382 |
|
|
$ |
|
|
|
|
|
|
|
|
|
5. Marketable Securities
As of September 30, 2005, we held a marketable security that was an obligation of a U.S.
government agency. The security, which was classified as held-to-maturity, had an original maturity
of approximately six months. As of September 30, 2005, the amortized cost of the security was
$9,977, which included $132 of accrued interest, and the fair value was $9,980. We held no
marketable securities that matured during the nine months ended September 30, 2005. We received
proceeds of $5,000 during the nine months ended September 30, 2004 from the maturity of marketable
securities. As of December 31, 2004, we held no marketable securities.
11
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
6. Accounts Receivable and Other Current Assets
Accounts receivable and other current assets consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Accounts receivable |
|
$ |
1,069 |
|
|
$ |
2,150 |
|
Prepaid insurance (see Note 9) |
|
|
287 |
|
|
|
102 |
|
Other prepaid expenses |
|
|
531 |
|
|
|
406 |
|
Receivable from related party |
|
|
30 |
|
|
|
31 |
|
Other current assets |
|
|
128 |
|
|
|
79 |
|
|
|
|
|
|
|
|
|
|
$ |
2,045 |
|
|
$ |
2,768 |
|
|
|
|
|
|
|
|
7. Property and Equipment
Property and equipment consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Building and facility improvements |
|
$ |
19,129 |
|
|
$ |
38,270 |
|
Laboratory, manufacturing, and office equipment |
|
|
9,691 |
|
|
|
19,364 |
|
Land |
|
|
357 |
|
|
|
700 |
|
Construction-in-progress |
|
|
|
|
|
|
157 |
|
|
|
|
|
|
|
|
|
|
|
29,177 |
|
|
|
58,491 |
|
Less accumulated depreciation and amortization |
|
|
(4,167 |
) |
|
|
(17,358 |
) |
|
|
|
|
|
|
|
|
|
$ |
25,010 |
|
|
$ |
41,133 |
|
|
|
|
|
|
|
|
As part of the restructuring announced in August 2005 (see Note 13), we decided to centralize
research activities in Horsham, Pennsylvania by ending operations in our leased facility in San
Diego, California. During the three months ended September 30, 2005, we recorded a non-cash
impairment charge of approximately $187 related to property and equipment located in the San Diego
facility. The aggregate acquisition value of the impaired assets was reduced by $745 and the
related accumulated depreciation and amortization was reduced by $558. This impairment charge was
included in restructuring charges on our statements of operations.
We also announced we would evaluate alternatives relative to our Witmer Road Facility, which
we own subject to a mortgage, including the potential disposition of the facility and further
consolidation of our research, development and administrative operations into a currently leased
facility that is also located in Horsham, Pennsylvania. As a result of the announcement, we
concluded that identifiable cash flows could be assigned to the Witmer Road Facility and
12
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
related equipment. To determine the appropriate carrying value of these assets, we used a probability-
weighted approach of estimated cash flows to be received upon a range of possible disposition
outcomes. We based our estimates of potential cash flows related to possible disposition outcomes
on conversations with commercial real estate firms that have both knowledge of recent history of
sales and expertise in marketing and selling similar facilities. Based on those estimates, we
recorded during the third quarter of 2005 a non-cash impairment charge of $13,000, which was
included in restructuring charges on our statements of operations, on our Witmer Road Facility and
related equipment. The aggregate acquisition value of the impaired assets was reduced by $29,007
and the related accumulated depreciation and amortization was reduced by $16,007.
Laboratory, manufacturing, and office equipment as of September 30, 2005 and December 31, 2004
included $530 and $1,021, respectively, of assets acquired under capital leases. Accumulated
depreciation and amortization as of September 30, 2005 and December 31, 2004 included $289 and
$429, respectively, related to assets acquired under capital leases. Depreciation expense, which
includes amortization of assets acquired under capital leases, was $3,391 and $3,680 for the nine
months ended September 30, 2005 and 2004, respectively. Research and development expenses on our
statements of operations include a gain of $21 during the three and nine months ended September 30,
2005 from the sale of assets that were held for sale as of December 31, 2004 and a loss of $5
during the nine months ended September 30, 2004 from the disposition of property and equipment.
During the nine months ended September 30, 2005 and 2004, we disposed of fully depreciated assets
that had an original acquisition value of $17 and $2, respectively.
During the three months ended September 30, 2005, we settled a dispute with a vendor from
which we had purchased property and equipment. The vendor agreed to pay us $75, of which $25 was
paid upon execution of the settlement agreement and the remaining $50 was due during the ensuing 60
days, and to cancel an outstanding invoice of $116. We reduced the acquisition cost of the property
and equipment by $191, reduced accounts payable by $116, and recorded a receivable of $50 as of
September 30, 2005.
13
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
8. Intangible and Other Assets
Intangible and other assets consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Acquired intellectual property,
net of accumulated amortization
of $3,686 and $3,238 as of
September 30, 2005 and December
31, 2004, respectively |
|
$ |
864 |
|
|
$ |
1,312 |
|
Non-competition agreement, net
of accumulated amortization of
$882 and $772 as of September
30, 2005 and December 31, 2004,
respectively |
|
|
|
|
|
|
110 |
|
Deferred financing costs, net of
accumulated amortization of $32
and $18 as of September 30, 2005
and December 31, 2004,
respectively |
|
|
149 |
|
|
|
163 |
|
Receivable from related party |
|
|
29 |
|
|
|
57 |
|
Deposits |
|
|
61 |
|
|
|
140 |
|
|
|
|
|
|
|
|
|
|
$ |
1,103 |
|
|
$ |
1,782 |
|
|
|
|
|
|
|
|
9. Debt and Capital Lease Obligations
Debt and capital lease obligations consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Term loan from bank |
|
$ |
7,334 |
|
|
$ |
8,000 |
|
Industrial development authority bond |
|
|
1,000 |
|
|
|
1,000 |
|
Term loan from landlord (unsecured),
annual interest at 13.00%, due June 2008 |
|
|
1,083 |
|
|
|
1,327 |
|
Notes payable to equipment lender,
secured by equipment and facility
improvements, interest rates from 8.00%
to 9.44%, due 2006 to 2009 |
|
|
5,943 |
|
|
|
7,463 |
|
Note payable, secured by insurance
policies, annual interest at 3.91%, due
January 2006 |
|
|
258 |
|
|
|
¾ |
|
|
|
|
|
|
|
|
Subtotal |
|
|
15,618 |
|
|
|
17,790 |
|
Capital lease obligations |
|
|
341 |
|
|
|
555 |
|
|
|
|
|
|
|
|
Total debt |
|
|
15,959 |
|
|
|
18,345 |
|
Less note payable |
|
|
(258 |
) |
|
|
¾ |
|
Less current portion of long-term debt |
|
|
(4,417 |
) |
|
|
(4,586 |
) |
|
|
|
|
|
|
|
Total debt, net of current portion |
|
$ |
11,284 |
|
|
$ |
13,759 |
|
|
|
|
|
|
|
|
14
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
Term Loan from Bank and Industrial Development Authority Bonds
During the first quarter of 2004, we and a bank entered into agreements under which the bank
acquired and reissued the $1,000 outstanding of our tax-exempt Industrial Development Authority
bonds. In addition, we borrowed $8,000 from the bank, of which $6,200 funded improvements to our
leased facility, which we occupied in April 2004, in Horsham, PA. The remaining $1,800 borrowed
from the bank was used to repay other debt.
The interest rate on the bond and bank debt varies quarterly, depending on 90-day LIBOR rates.
At September 30, 2005, the 90-day LIBOR was 4.07%. We have the option each quarter to incur
interest on the outstanding principal at the LIBOR-based variable interest rate or a fixed rate
offered by our bank.
For the $8,000 term loan, interest accrues at an interest rate equal to the 90-day LIBOR plus
3.0%. We made quarterly, interest-only payments prior to March 31, 2005. Commencing on March 31,
2005, we began to make quarterly principal payments of $222 plus interest. We are required to make
these payments over the remaining term of the ten-year loan period.
For the $1,000 Industrial Development Authority bond, we are making quarterly, interest-only
payments for ten years at an interest rate equal to the 90-day LIBOR plus 1.5%, followed by a
single repayment of principal at the end of the ten-year loan period. If the 90-day LIBOR at the
beginning of any calendar quarter is between 4.0% and 6.0%, the bond will bear interest at the
90-day LIBOR plus 1.25%. If the 90-day LIBOR at the beginning of any calendar quarter exceeds 6.0%,
the bond will bear interest at the 90-day LIBOR plus 1.0%.
To provide security for these borrowings, we granted a first mortgage to our bank on the land
and building where our present headquarters are located, as well as a security interest of first
priority on certain improvements, certain equipment, and other tangible personal property. Under
our agreements with the bank, if the bank determines a material adverse change has occurred in our
business, financial condition, results of operations, or business prospects, the bank in its sole
discretion may declare at any time an event of default, of which one potential outcome could be the
accelerated repayment of the loan balance, which was $8,334 as of September 30, 2005. Under our
agreements with the bank, we agreed to limit our total outstanding debt to $22,000. As of September
30, 2005, our total outstanding debt was $15,959. At any time after January 30, 2008, or if we fail
to maintain a minimum required cash and short-term investments balance of at least $22,000, our
bank has the option to require additional collateral from us in the form of a security interest in
certain cash and short-term investments, or in the form of a letter of credit, which may have the
effect of requiring us to repay the outstanding loan balance to the bank. The agreements with our
bank also contain covenants that, among other things, require us to obtain consent from the bank
prior to paying dividends, making certain investments, changing the nature of our business,
assuming or guaranteeing the indebtedness of another entity or individual, selling or otherwise
disposing of a substantial portion of our assets, and merging or consolidating with another entity.
15
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
2005 Activity
During the three months ended September 30, 2005, we reduced the acquisition value of property
and equipment and the carrying value of capital lease obligations by $10 due to a decrease in the
amount of remaining minimum lease payments under a capital lease, which decrease resulted from the
move of equipment into a state in which the payments were no longer subject to sales tax.
In July 2005, we borrowed $783 secured by laboratory equipment and facility improvements. The
terms of the financing require us to pay monthly principal and interest payments over 48 months at
an interest rate of 9.44%.
In March 2005, we borrowed $701 to finance insurance policy premiums due on certain insurance
policies. The insurance policy premiums, net of amortization, are included in accounts receivable
and other current assets on our balance sheet at September 30, 2005 (see Note 6). We are required
to pay $65 of principal and interest during each of the 11 months beginning on March 15, 2005 and
ending on January 15, 2006. The interest is calculated based on an annual percentage rate of 3.91%.
To secure payment of the amounts financed, we granted the lender a security interest in all of our
right, title and interest to the insurance policies. Upon a default by us, the lender can demand,
and will have the right to receive, immediate payment of the total unpaid balance of the loan. In
the event of default and the demand for immediate payment by the lender, interest will accrue on
any unpaid amounts at the highest rate allowed by applicable law.
10. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2005 |
|
|
2004 |
|
Professional fees |
|
$ |
1,110 |
|
|
$ |
610 |
|
Sponsored research and contract
laboratory services |
|
|
430 |
|
|
|
557 |
|
Restructuring costs (see Note 13) |
|
|
273 |
|
|
|
¾ |
|
Employee relocation |
|
|
179 |
|
|
|
186 |
|
Preclinical studies |
|
|
102 |
|
|
|
126 |
|
Interest expense |
|
|
43 |
|
|
|
43 |
|
Property and equipment |
|
|
¾ |
|
|
|
63 |
|
Other expenses |
|
|
626 |
|
|
|
467 |
|
|
|
|
|
|
|
|
|
|
$ |
2,763 |
|
|
$ |
2,052 |
|
|
|
|
|
|
|
|
16
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
11. Stockholders Equity
Common Stock
In February 2005, we sold 8,050 shares of our common stock at a public offering price of $4.00
per share, generating net proceeds of $30,006.
In January 2005, participating employees purchased 15 shares of common stock pursuant to our
employee stock purchase plan, resulting in net proceeds of $86. Effective January 31, 2005, we
terminated the employee stock purchase plan due, in part, to the potential financial statement
impact resulting from the expected adoption of SFAS No. 123R in January 2006. During the nine
months ended September 30, 2005, there were no exercises of options to purchase shares of common
stock.
Restricted Stock Units
In May 2005, we granted restricted stock units (RSUs) to members of our board of directors in
lieu of cash payment for services. Because these RSUs vested immediately, we charged the fair value
of $107 relating to these RSUs to operating expenses on the date of grant.
In March 2005, in order to align the interests of management and stockholders, and as part of
a broader program to conserve cash, we modified our bonus program for 2004 for officers, adjusted
salaries for officers to reduce cash payments, and granted RSUs to officers. We also decided to pay
2005 bonuses for officers by the award of RSUs instead of cash. During the nine months ended
September 30, 2005, we recorded $688 of expense related to these awards, of which $362 was for
equity-classified awards.
Modification of 2004 Bonus Awards for Officers
In March 2005, the Compensation Committee of our Board of Directors (Compensation Committee)
decided that the 2004 bonus award to our Chief Executive Officer would be paid solely in RSUs
instead of cash, and that 2004 bonus awards to other officers would be payable 50% in cash and 50%
in RSUs. The liability associated with the cash portion of the 2004 bonus was $441 and was included
in accrued compensation at December 31, 2004 on our balance sheet. The number of RSUs granted was
determined by dividing the dollar amount of the 2004 bonus to be paid in the form of RSUs by the
fair market value of our common stock on the date of grant. Except for two officers that retired,
these RSUs will not vest until the first anniversary of the grant, and will not be distributed
until 18 months from grant, subject to the occurrence of certain events. The amount of the RSU
portion of the 2004 bonus for the retired officers was $67, which we charged to general and
administrative expenses on our statement of operations in 2004 because the RSUs were immediately
vested. The amount of the RSU portion of the 2004 bonus for other officers was $588, which we are
charging to operating expenses on our statements of operations on a straight-line basis over the
26-month period from January 2004 to the vesting
17
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
date of the RSUs (March 2006). As a result, at December 31, 2004, our accrued compensation
included $339 related to these RSUs. The liability classification of these RSUs continued until the
grant date, at which time the liability of $382 for the award became equity-classified.
Modification of 2005 Bonus Awards for Officers
Payment of 2005 bonuses, if any, for officers will be made in full by the award of RSUs
instead of cash in amounts determined by our Compensation Committee. For 2005 only, each officers
bonus target has been increased by 25% to compensate for the change from cash to RSUs. The number
of RSUs granted to each officer will be determined by dividing his or her 2005 bonus, as determined
by our Compensation Committee, by the average of our closing stock price on March 3, 2005 and our
closing stock price on the grant date, which we anticipate will occur during the first quarter of
2006. Because the RSUs will vest in equal amounts over the four quarters following the date of
grant, each RSU will be segregated into four tranches, and the value of each tranche will be
amortized to operating expenses on our statements of operations individually as though each is a
separate award.
For each quarter of 2005, we will calculate an estimated award value using the fair value of
our stock as of the most recent balance sheet date. The award value will be accrued over the period
from January 2005 until one year following the date of grant. The accrued award value as of each
balance sheet date will be classified as a liability until the grant date, at which time the award
will become equity-classified and the liability balance will be reclassified to additional
paid-in-capital. The accrued award value as of September 30, 2005 of $283 is included in accrued
compensation on our balance sheet.
Adjustment of Officer Base Salaries
In March 2005, the Compensation Committee reduced the base salary levels of all of the
Companys officers for the period from March 1, 2005 through February 28, 2006. The salary for each
officer is 10% lower than his or her base salary on February 28, 2005. In connection with these
reductions, each officer was granted a one-time award of RSUs. The number of RSUs granted for this
purpose was determined with reference to the 10% reduction and forgone merit increases, and the
closing price of our common stock on the date of grant. The grant date value of these RSUs, which
vest in equal amounts over four quarters following the date of grant, of $363 is being charged to
operating expenses on a straight-line basis over the 12-month period from March 2005 through
February 2006.
12. Collaborative Agreements and Significant Customer Concentration
BioGeneriX Agreements
On January 28, 2005, we entered into a Supply and Option Agreement (Option Agreement) with
BioGeneriX AG (BioGeneriX), a company of the ratiopharm Group, that
18
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
provided for BioGeneriX to pay us a non-refundable payment and to supply to us an undisclosed
protein for research purposes. The Option Agreement also granted BioGeneriX an exclusive option to
enter into a pre-negotiated Research, License and Option agreement (License Agreement) for the use
of our enzymatic technologies to develop a long-acting version of a currently marketed therapeutic
protein.
On April 28, 2005, we and BioGeneriX entered into the License Agreement following the exercise
by BioGeneriX of the option we granted to it under the Option Agreement. We received a
non-refundable payment in connection with the exercise of the option and execution of the License
Agreement.
Under the License Agreement, we are entitled to receive research payments for 12 months, and
potentially milestone payments of up to $61,500 as well as royalties on product sales. The License
Agreement provides that we will conduct research on behalf of BioGeneriX for approximately 12
months and grants to BioGeneriX the right to obtain an exclusive, worldwide license, upon specified
terms, to use our enzymatic technologies to develop and commercialize a long-acting version of the
undisclosed therapeutic protein that is the target of the research. If BioGeneriX exercises its
right to obtain this license, BioGeneriX will be responsible for the further development and
commercialization of the target protein. In addition, if requested by BioGeneriX, we will provide,
and be fully reimbursed for, any required technical assistance. We will also be entitled, at our
request, to supplies of some process reagents from BioGeneriX.
We also are collaborating with BioGeneriX on the development and commercialization of a
long-acting granulocyte colony stimulating factor, under a separate agreement, which was described
in the Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended
December 31, 2004.
Amendment to Novo Nordisk Agreement
In February 2005, we entered into an amendment (Amendment) to one of our two Research,
Development and License Agreements with Novo Nordisk A/S (Novo Nordisk) dated as of November 17,
2003, as previously amended (Novo Agreement). The Novo Agreement was described in the Notes to
Financial Statements, included in our Annual Report on Form 10-K for the year ended December 31,
2004.
Under the Novo Agreement, we are conducting work on next-generation versions of two proteins.
The Amendment provided for a change in the timing of one milestone payment, and a restructuring of
payment of certain project-related costs for one of the two proteins that is the subject of the
Novo Agreement.
19
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
Significant Customer Concentration
During the three and nine months ended September 30, 2005, one customer accounted for 39% and
43%, respectively, of total revenues. During the three and nine months ended September 30, 2004
that customer accounted for 42% and 76%, respectively, of total revenues. During the three and nine
months ended September 30, 2005, a second customer accounted for 61% and 57%, respectively, of
total revenues. During the three and nine months ended September 30, 2004, that second customer
accounted for 58% and 24%, respectively, of total revenues.
13. Restructuring
In August 2005, we announced that we had implemented a restructuring of operations to enable
an enhanced focus on next-generation proteins, to allow for the anticipated transfer of production
of proteins and reagents to our collaborative partners and contract manufacturers now that our
programs are more mature, and to reduce cash burn. Upon completion of the restructuring, we will
have reduced the size of our workforce by approximately 25% since the end of the first quarter of
2005. Our net loss for the three and nine months ended September 30, 2005 included $14,002 of
charges related to this restructuring, including $13,187 of non-cash property and equipment
impairment charges (see Note 7) and $815 of expected payments for employee severance.
The following table reflects the employee severance charges recorded, payments made, and
liability remaining as of September 30, 2005. We expect to pay our remaining obligations by the
third quarter of 2006. The estimates below have been made based upon our best estimate of the
amounts and timing of certain events included in the restructuring plan that will occur in the
future. It is possible that the actual outcome of certain events may differ from the estimates.
Changes will be made to the restructuring accrual at the point that the differences become
determinable.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Facility |
|
|
|
|
|
|
severance |
|
|
closure |
|
|
|
|
|
|
costs |
|
|
costs |
|
|
Total |
|
Initial provision |
|
$ |
815 |
|
|
$ |
¾ |
|
|
$ |
815 |
|
Cash payments |
|
|
(542 |
) |
|
|
¾ |
|
|
|
(542 |
) |
|
|
|
|
|
|
|
|
|
|
Balance as of
September 30, 2005 |
|
$ |
273 |
|
|
$ |
¾ |
|
|
$ |
273 |
|
|
|
|
|
|
|
|
|
|
|
During the three months ending December 31, 2005, we expect to record a non-cash charge of
approximately $152 in our statements of operations for the remaining required
20
NEOSE TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
(unaudited)
(in thousands, except per share amounts)
minimum payments under the operating lease for our facility in San Diego, California. This amount will be
included in facility closure costs in the above table. Because the remaining lease term
extends for only five months beyond our cease-use date of the facility, we have assumed no sublease
income in our calculation. During the three months ending December 31, 2005, we also expect to
record a restructuring charge of $52 relating to severance payments that are contingent upon
continued employment by certain employees of at least 60 days following notice of their
termination.
14. Commitments and Contingencies
In connection with the restructuring announced in August 2005 (see Note 13), we committed to
pay future cash retention bonuses to certain employees that were not given notice of termination in
August 2005, contingent upon such employees not voluntarily terminating their employment prior to
the payment date. The total potential value of these payments is $763, of which $317 was accrued
during the three months ended September 30, 2005. We expect to record additional accrued
compensation related to these retention bonuses of up to $271, $127, and $48 during the three
months ending December 31, 2005, March 31, 2006, and June 30, 2006, respectively. We also committed
to these employees, that if they were involuntarily terminated in the future, the termination
benefit offered would be no less favorable than offered to employees terminated in the August 2005
restructuring. As a result, accrued compensation on our balance sheet as of September 30, 2005
includes an additional $240 related to these potential payments.
In October 2005, we entered into separation agreements with certain officers. Under these
agreements, we agreed to pay an aggregate of $21 per month and provide medical benefits over a
12-month period commencing in November 2005. We also committed to award any bonus earned by the
individuals for 2005, as determined using the same criteria as if they were employed as of the time
of the award. As described in Note 11, payment of 2005 bonuses, if any, for officers will be made
in full by the award of restricted stock units instead of cash in amounts determined by our
Compensation Committee. In addition, we extended for twelve months the period during which each
officer may exercise stock options that were vested and outstanding as of each individuals
separation date, except for one individual that will provide consulting services following such
individuals separation date. Stock options will continue to vest while the individual provides
consulting services, and the twelve-month period during which the individual may exercise stock
options will commence upon the conclusion of the individuals provision of consulting services.
Because the stock options had no intrinsic value as of the modification date, there will be no
charge associated with the option modifications.
21
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
CAUTIONARY STATEMENT PURSUANT TO SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION ACT OF
1995:
This report and the documents incorporated by reference herein contain forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). When used in this
report and the documents incorporated herein by reference, the words anticipate, believe,
estimate, may, expect, intend, and similar expressions are generally intended to identify
forward-looking statements. These forward-looking statements include, among others, the statements
in Managements Discussion and Analysis of Financial Condition and Results of Operations about our:
|
|
|
estimate of the length of time that our existing cash and cash equivalents,
marketable securities, expected revenue, and interest income will be adequate to
finance our operating and capital requirements; |
|
|
|
|
expectations as to the costs and benefits of our August 2005 restructuring of
operations; |
|
|
|
|
expected losses; |
|
|
|
|
expectations for future capital requirements; |
|
|
|
|
expectations for increases in operating expenses; |
|
|
|
|
expectations for increases in research and development, and general and
administrative expenses in order to develop products, manufacture commercial
quantities of reagents and products, and commercialize our technology; |
|
|
|
|
expectations for the development of, the timing of regulatory filings related
to, and the ability to commence clinical trials for, our proprietary drug
candidates; |
|
|
|
|
expectations for generating revenue; |
|
|
|
|
expectations regarding the timing and structure of new or expanded
collaborations; and |
|
|
|
|
expectations regarding the success of existing collaborations for the
development and commercialization of products using our technologies. |
Our actual results could differ materially from the results expressed in, or implied by, these
forward-looking statements. Potential risks and uncertainties that could affect our actual results
include the following:
|
|
|
our ability to obtain the funds necessary for our operations; |
|
|
|
|
our ability to meet forecasted project timelines due to internal or external
causes; |
|
|
|
|
our ability to satisfy the FDAs request for additional information and obtain
clearance from the FDA to commence the Phase I clinical trial for NE-180; |
|
|
|
|
our ability to develop commercial-scale manufacturing processes for our products
and reagents, either independently or in collaboration with others; |
22
|
|
|
the risk that we will incur unexpected charges or will have unexpected
expenditures related to the restructuring upon the completion of further analysis
with respect to the restructuring generally and our assets specifically; |
|
|
|
|
our ability to enter into and maintain collaborative arrangements; |
|
|
|
|
our ability to obtain adequate sources of proteins and reagents either
manufactured internally or externally sourced; |
|
|
|
|
our ability to expand and protect our intellectual property and to operate
without infringing the rights of others; |
|
|
|
|
our ability to develop and commercialize therapeutic proteins and to
commercialize our technologies; |
|
|
|
|
our ability to attract and retain key personnel; |
|
|
|
|
our ability to compete successfully in an intensely competitive field; |
|
|
|
|
our ability to renovate our facilities as required for our operations; and |
|
|
|
|
general economic conditions. |
These and other risks and uncertainties that could affect our actual results are discussed in
this report and in our other filings with the Securities and Exchange Commission (SEC),
particularly the section entitled Factors Affecting The Companys Prospects of our Annual Report
on Form 10-K for the year ended December 31, 2004. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot guarantee future results,
events, levels of activity, performance, or achievements. We do not assume responsibility for the
accuracy and completeness of the forward-looking statements other than as required by applicable
law.
We do not undertake any duty to update after the date of this report any of the
forward-looking statements in this report to conform them to actual results.
You should read this section in combination with the section entitled Managements Discussion
and Analysis of Financial Condition and Results of Operations for the year ended December 31, 2004,
included in our Annual Report on Form 10-K for the year ended December 31, 2004 and in our 2004
Annual Report to Stockholders.
Overview
We are a biopharmaceutical company using our enzymatic technologies to develop proprietary
drugs, focusing primarily on therapeutic proteins. We believe that our core enzymatic technologies,
GlycoAdvance and GlycoPEGylation, improve the drug properties of therapeutic proteins by building
out, and attaching polyethylene glycol (PEG) to, carbohydrate structures on the proteins. We are
using our technologies to develop proprietary versions of protein drugs with proven safety and
efficacy and to improve the therapeutic profiles of proteins being developed by our partners. We
expect these modified proteins to offer significant advantages, including less frequent dosing and
possibly improved efficacy, over the original versions of the drugs now on the market, as well as
to meet or exceed the pharmacokinetic profile of next-generation versions of the drugs now on the
market. We believe this strategy of targeting drugs with proven safety and efficacy allows us to
lower the risk profile of our proprietary development portfolio as compared to de novo protein drug
development.
23
We have incurred operating losses each year since our inception. As of September 30, 2005, we
had an accumulated deficit of $231,554,000. We expect additional losses in 2005 and over the next
several years as we continue product research and development efforts and expand our intellectual
property portfolio. We have financed our operations through private and public offerings of equity
securities, proceeds from debt financings, and revenues from our collaborative agreements.
We believe that our existing cash and cash equivalents, marketable securities, expected
revenue from collaborations and license arrangements, and interest income should be sufficient to
meet our operating and capital requirements at least through the third quarter of 2006, although
changes in our collaborative relationships or our business, whether or not initiated by us, may
cause us to deplete our cash, cash equivalents, and marketable securities sooner than the above
estimate. Under agreements we entered into with a bank during the first quarter of 2004, we have
agreed to limit our total outstanding debt to $22,000,000. As of September 30, 2005, our total
outstanding debt was $15,959,000. At any time after January 30, 2008, or if we fail to maintain a
minimum required cash and short-term investments balance of at least $22,000,000, the bank has the
option to require additional collateral from us in the form of a security interest in certain cash
and short-term investments, or in the form of a letter of credit, which may have the effect of
requiring us to repay the outstanding loan balance to the bank. See Financing Activities Debt
Financing Activities Term Loan from Bank and Industrial Development Authority Bonds in the
Liquidity and Capital Resources section of this Form 10-Q for a description of the material
features of this borrowing.
Liquidity and Capital Resources
Overview
We had $45,453,000 in cash, cash equivalents, and marketable securities as of September 30,
2005, compared to $45,048,000 in cash and cash equivalents as of December 31, 2004. The increase
during the nine months ending September 30, 2005 was attributable to the net proceeds from our
public offering in February 2005, offset by the use of cash during the nine months ended September
30, 2005 to fund our operating activities, capital expenditures, and debt repayments.
In February 2005, we offered and sold 8,050,000 shares of our common stock at a public
offering price of $4.00 per share, generating net proceeds of $30,006,000.
In August 2005, we implemented a restructuring of operations to enable an enhanced focus on
next-generation proteins, to allow for the anticipated transfer of production of proteins and
reagents to our collaborative partners and contract manufacturers now that our programs are more
mature, and to reduce cash burn. The restructuring supplemented measures that we implemented in
March 2005 to reduce the rate of our cash utilization. The actions taken in March 2005 included
modifying the bonus program for officers, reducing officers base salaries for one year, and
reducing planned operating expenses and capital expenditures. The restructuring reduced the size of
our workforce by approximately 25%, as compared to the size of our workforce at the end of the
first quarter of 2005. After achieving the full benefits of the restructuring during the fourth
quarter of 2005, we expect to realize annualized savings of between $6,000,000 and $8,000,000. Net
cash utilization for the fourth quarter of 2005 is
24
expected to be between $7,500,000 and $8,500,000, which includes the cash effect of
restructuring costs but does not take into account any new partnering activities. Our average
net cash utilization during the first half of 2005 was approximately $10,500,000 per quarter,
excluding the effect of proceeds from equity issuances and purchases of marketable securities.
As part of the restructuring, we centralized research activities in Horsham, Pennsylvania by
ending operations in our leased facility in San Diego, California. Our future requirements for
internally manufactured products will be substantially lower than the capacity of our 24,000
square-foot pilot manufacturing facility. Therefore, we commenced efforts to evaluate the
disposition of our current headquarters and pilot manufacturing facility, which we own subject to a
mortgage. Our net loss for the three and nine months ended September 30, 2005 included $14,002,000
of charges related to this restructuring, including $13,187,000 of non-cash property and equipment
impairment charges and $815,000 of expected payments for employee severance.
The development of next-generation proprietary protein therapeutics, which we are pursuing
both independently and in collaboration with selected partners, will require substantial
expenditures by us and our collaborators. We plan to continue financing our operations through
private and public offerings of equity securities, proceeds from debt financings, and revenues from
existing and future collaborative agreements. Because our remaining 2005 revenues could be
substantially affected by entering into new collaborations and on the financial terms of any new
collaborations, we cannot estimate our remaining 2005 revenues. Other than revenues from our
collaborations with Novo Nordisk and BioGeneriX, and any future collaborations with others, we do
not expect to generate significant revenues until such time as products using our technologies are
commercialized, which is not expected during the next several years. We expect an additional
several years to elapse before we can expect to generate sufficient cash flow from operations to
fund our operating and investing requirements. We believe that our existing cash and cash
equivalents, marketable securities, expected revenue from collaborations and license arrangements,
and interest income should be sufficient to meet our operating and capital requirements at least
through the third quarter of 2006. Accordingly, we will need to raise substantial additional funds
to continue our business activities and fund our operations until we are generating sufficient cash
flow from operations.
Operating Activities
Net cash used in operating activities was $26,819,000 and $27,057,000 for the nine months
ending September 30, 2005 and 2004, respectively. Although our net loss for the 2005 period was
$13,520,000 greater than the net loss for the 2004 period, there was little change to our net cash
used in operating activities for the 2005 period compared to the 2004 period, because the increased
net loss was primarily due to the non-cash impairment charges of $13,187,000 recognized during the
third quarter of 2005 in connection with the restructuring discussed above.
Investing Activities
During the nine months ended September 30, 2005 and 2004, we invested $719,000 and $8,942,000,
respectively, in property, equipment, and building improvements. Of the 2004 amount, $5,085,000 was
invested in leasehold improvements that are described below.
25
During the three months ended September 30, 2005, we recorded proceeds of $25,000
from the settlement of a dispute with a vendor from which we had purchased property and
equipment. Under the settlement agreement, the vendor agreed to pay us $75,000, of which $25,000
was paid upon execution of the settlement agreement and the remaining $50,000 was due during the
ensuing 60 days, and to cancel an outstanding invoice of $116,000. During the nine months ended
September 30, 2005, we received proceeds of $70,000 upon the sale of equipment that we included in
assets held for sale in accounts receivable and other current assets on our balance sheet as of
December 31, 2004. The carrying value of the equipment was $49,000 and, therefore, we recognized a
gain on the sale of the equipment of $21,000. During the nine months ended September 30, 2004, we
entered into capital lease obligations for equipment with an aggregate book value of $184,000. We
did not enter into any capital lease obligations during the nine months ended September 30, 2005.
We had accrued property and equipment of $380,000 as of September 30, 2004. We had no accrued
property and equipment as of September 30, 2005.
We entered into a lease agreement in 2002 for a 40,000 square foot building. We converted
25,000 square feet into laboratory and office space. In April 2004, we occupied that finished
portion of the facility, and began amortizing the cost of those improvements. We expended
$10,175,000 for this project, of which $5,085,000 was expended during the nine months ended
September 30, 2004. During the first quarter of 2004, we entered into agreements with a bank for
the purpose of funding these improvements. See Financing Activities Debt Financing Activities
Term Loan from Bank and Industrial Development Authority Bonds in the Liquidity and Capital
Resources section of this Form 10-Q for a description of the material features of this borrowing.
In addition, pursuant to the lease, we received $250,000 from the landlord in September 2004 as a
partial reimbursement for improvements we made to the facility. This landlord incentive, which is
included in other liabilities on our balance sheet, is being amortized ratably as a reduction to
rental expense over the lease term.
We anticipate additional capital expenditures during the fourth quarter of 2005 of
approximately $200,000. We may finance some or all of these capital expenditures through capital
leases or the issuance of new debt or equity. We would prefer to finance capital expenditures
through the issuance of new debt, to the extent that we are allowed to do so under our existing
bank covenants. The terms of new debt could require us to maintain a minimum cash and investments
balance, or to transfer cash into an escrow account to collateralize some portion of the debt, or
both.
Financing Activities
Equity Financing Activities
In February 2005, we offered and sold 8,050,000 shares of our common stock at a public
offering price of $4.00 per share, generating net proceeds of $30,006,000.
During the nine months ended September 30, 2005 and 2004, participating employees purchased
15,201 and 23,564 shares, respectively, of common stock pursuant to our employee stock purchase
plan, resulting in net proceeds of $86,000 and $175,000, respectively. Effective January 31, 2005,
we terminated the employee stock purchase plan due, in part, to the potential
26
financial statement impact resulting from the expected adoption of SFAS No. 123R in January 2006. During the nine
months ended September 30, 2004, we received proceeds of $73,000 upon the exercise of options to
purchase 24,766 shares of common stock. There were no exercises of
options during the nine months ended September 30, 2005.
Debt Financing Activities
Our total debt decreased by $2,386,000 to $15,959,000 at September 30, 2005, compared to
$18,345,000 at December 31, 2004. This decrease primarily resulted from debt principal repayments
of $3,860,000, partially offset by $1,484,000 in proceeds from the issuance of debt.
Note Payable Secured by Insurance Policies
In March 2005, we borrowed $701,000 to finance the insurance policy premiums due on certain
insurance policies. As of September 30, 2005, the outstanding principal balance under this
agreement was $258,000. We are required to pay $65,000 of principal and interest during each of the
11 months beginning on March 15, 2005 and ending on January 15, 2006. The interest is calculated
based on an annual percentage rate of 3.91%. To secure payment of the amounts financed, we granted
the lender a security interest in all of our right, title and interest to the insurance policies.
Upon a default by us, the lender can demand, and will have the right to receive, immediate payment
of the total unpaid balance of the loan. In the event of default and the demand for immediate
payment by the lender, interest will accrue on any unpaid amounts at the highest rate allowed by
applicable law.
Term Loan from Bank and Industrial Development Authority Bonds
During the first quarter of 2004, we and a bank entered into agreements under which the bank
acquired and reissued the $1,000,000 outstanding of our tax-exempt Industrial Development Authority
bonds. In addition, we borrowed $8,000,000 from the bank, of which $1,800,000 was combined with
$1,100,000 of our restricted cash for the purpose of paying in full the $2,900,000 outstanding of
our taxable Industrial Development Authority bonds. The remaining $6,200,000 borrowed funded
improvements to our leased facility, which we occupied in April 2004, in Horsham, PA.
During the twelve months ending September 30, 2006, we will be required to make principal
payments totaling $889,000 under these agreements. The interest rate on the bond and bank debt
varies quarterly, depending on 90-day LIBOR rates. At September 30, 2005, the 90-day LIBOR was
4.07%. We have the option each quarter to incur interest on the outstanding principal at the
LIBOR-based variable interest rate or a fixed rate offered by our bank.
For the $8,000,000 term loan, interest accrues at an interest rate equal to the 90-day LIBOR
plus 3.0%. We made quarterly, interest-only payments prior to March 31, 2005. Commencing on March
31, 2005, we began to make quarterly principal payments of $222,000 plus interest. We are required
to make these payments over the remaining term of the ten-year loan period.
For the $1,000,000 Industrial Development Authority bond, we are making quarterly,
interest-only payments for ten years at an interest rate equal to the 90-day LIBOR plus 1.5%,
27
followed by a single repayment of principal at the end of the ten-year loan period. If the 90-day
LIBOR at the beginning of any calendar quarter is between 4.0% and 6.0%, the bond will bear
interest at the 90-day LIBOR plus 1.25%. If the 90-day LIBOR at the beginning of any calendar
quarter exceeds 6.0%, the bond will bear interest at the 90-day LIBOR plus 1.0%.
To provide security for these borrowings, we granted a first mortgage to our bank on the land
and building where our present headquarters are located, as well as a security interest of first
priority on certain improvements, certain equipment, and other tangible personal property. Under
our agreements with the bank, if the bank determines a material adverse change has occurred in our
business, financial condition, results of operations, or business prospects, the bank in its sole
discretion may declare at any time an event of default, of which one potential outcome could be the
accelerated repayment of the loan balance, which was $8,334,000 as of September 30, 2005. Under our
agreements with the bank, we agreed to limit our total outstanding debt to $22,000,000. As of
September 30, 2005, our total outstanding debt was $15,959,000. At any time after January 30, 2008,
or if we fail to maintain a minimum required cash and short-term investments balance of at least
$22,000,000, our bank has the option to require additional collateral from us in the form of a
security interest in certain cash and short-term investments, or in the form of a letter of credit,
which may have the effect of requiring us to repay the outstanding loan balance to the bank. The
agreements with our bank also contain covenants that, among other things, require us to obtain
consent from the bank prior to paying dividends, making certain investments, changing the nature of
our business, assuming or guaranteeing the indebtedness of another entity or individual, selling or
otherwise disposing of a substantial portion of our assets, and merging or consolidating with
another entity.
Term Loan from Landlord
In May 2004, we borrowed $1,500,000 from the landlord of our leased facilities in Horsham,
Pennsylvania. As of September 30, 2005, the outstanding principal balance under this agreement was
$1,083,000. The terms of the financing require us to pay monthly principal and interest payments
over 48 months at an interest rate of 13%. During the twelve months ending September 30, 2006, we
will be required to make principal and interest payments totaling $443,000 under this agreement.
Equipment Loans
In July 2005, we borrowed $783,000 secured by laboratory equipment and facility improvements.
The terms of the financing require us to pay monthly principal and interest payments over 48 months
at an interest rate of 9.44%. As of September 30, 2005, we owe $5,943,000 to an equipment lender
that financed the purchase of certain equipment and facility improvements, which collateralize the
amounts borrowed. The terms of the financings require us to make monthly principal and interest
payments through August 2009 at interest rates ranging from 8.00% to 9.44%. During the twelve
months ending September 30, 2006, we will make principal and interest payments totaling $3,341,000
under these agreements.
28
Capital Lease Obligations
The terms of our capital leases require us to make monthly payments through February 2009.
Under these agreements, we will be required to make principal and interest payments totaling
$241,000 during the twelve months ending September 30, 2006.
Operating Leases
We lease laboratory, office, warehouse facilities, and equipment under operating lease
agreements. In April 2001, we entered into a lease agreement for approximately 10,000 square feet
of laboratory and office space in San Diego, California. The initial term of the lease ends in
March 2006. As part of the restructuring announced in August 2005 and described in the Liquidity
and Capital Resources section of this Form 10-Q, we have centralized research activities in
Horsham, Pennsylvania by ending operations in our leased facility in San Diego, California.
We lease approximately 5,000 square feet of office and warehouse space in Horsham,
Pennsylvania under a lease agreement that expires April 2007. In February 2002, we entered into a
lease agreement for approximately 40,000 square feet of laboratory and office space in Horsham,
Pennsylvania. The initial term of the lease ends in July 2022, at which time we have an option to
extend the lease for an additional five years, followed by another option to extend the lease for
an additional four and one-half years. Pursuant to the lease, we received $250,000 from the
landlord in September 2004 as a partial reimbursement for improvements we made to the facility.
This landlord incentive, which is included in other liabilities on our accompanying balance sheets,
is being amortized ratably as a reduction to rental expense over the lease term. Our laboratory,
office, and warehouse facility leases contain escalation clauses, under which the base rent
increases annually by 2% to 4%.
Summary of Contractual Obligations
A summary of our obligations to make future payments under contracts existing as of December
31, 2004 is included in Item 7, Managements Discussion and Analysis of Financial Condition and
Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2004. The
Liquidity and Capital Resources section of this Form 10-Q describes obligations from material
contracts entered into during the nine months ended September 30, 2005.
Off-Balance Sheet Arrangements
We are not involved in any off-balance sheet arrangements that have or are reasonably likely
to have a current or future effect that is material to investors on our financial condition,
changes in financial condition, revenues or expenses, results of operations, liquidity, capital
expenditures, or capital resources.
29
Critical Accounting Policies and Estimates
A discussion of our critical accounting policies and estimates is included in Item 7,
Managements Discussion and Analysis of Financial Condition and Results of Operations, of our
Annual Report on Form 10-K for the year ended December 31, 2004. Other than as described below,
there have not been any changes or additions to our critical accounting policies during the nine
months ended September 30, 2005.
Accounting for Restructuring Costs
To account for exit or disposal activities, such as the restructuring described in Overview
in the Liquidity and Capital Resources section of this Form 10-Q, we apply Statement of Financial
Accounting Standards (SFAS) No. 146, Accounting for Costs Associated with Exit or Disposal
Activities (SFAS No. 146), which requires a liability for a cost associated with an exit or
disposal activity be recognized and measured initially at fair value only when the liability is
incurred. It does not apply to costs associated with a disposal activity covered by SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets (SFAS No. 144). The restructuring
charges recorded by us during the three months ended September 30, 2005 are comprised primarily of
costs to write-off property and equipment and reduce our workforce. Our net loss for the three and
nine months ended September 30, 2005 included $14,002,000 of charges related to this restructuring,
including $13,187,000 of non-cash property and equipment impairment charges and $815,000 of
expected payments for employee severance costs.
Under SFAS No. 144, any impairment of property and equipment to be recognized is measured by
the amount by which the carrying amount of the assets exceeds the fair value of the assets. To
determine the fair value of assets that are not likely to be used over their remaining useful
economic life, we use a probability-weighted approach of estimated cash flows to be received upon a
range of possible disposition outcomes. In August 2005, we announced we would evaluate alternatives
relative to our current headquarters and pilot manufacturing facility (Witmer Road Facility), which
we own subject to a mortgage, including the potential disposition of the facility and further
consolidation of our research, development and administrative operations into a currently leased
facility that is also located in Horsham, Pennsylvania. As a result of the announcement, we
concluded that identifiable cash flows could be assigned to the Witmer Road Facility and related
equipment. We based our estimates of potential cash flows related to possible disposition outcomes
on conversations with commercial real estate firms that have both knowledge of recent history of
sales and expertise in marketing and selling similar facilities. These estimates may turn out to be
incorrect and our actual cash flows may be materially different from our estimates.
Our estimates of future liabilities may change, requiring us to record additional
restructuring charges or reduce the amount of liabilities recorded. At the end of each reporting
period, we evaluate the remaining accrued balances to ensure their adequacy, that no excess
accruals are retained and the utilization of the provisions are for their intended purposes in
accordance with developed exit plans. We periodically evaluate current available information and
adjust our restructuring reserve as necessary.
30
Results of Operations
We recorded a net loss of $22,621,000 and $44,173,000 for the three and nine months ended
September 30, 2005, respectively. For the three and nine months ended September 30, 2004, we
recorded a net loss of $10,824,000 and $30,653,000, respectively. The following section explains
the changes between the reporting periods in each component of net loss.
Revenue from Collaborative Agreements
Revenue from collaborative agreements for the three and nine months ended September 30, 2005
was $1,503,000 and $4,271,000, respectively, compared to $1,451,000 and $3,592,000 for the
corresponding periods in 2004. Our revenue from collaborative agreements has historically been
derived from a few major collaborators. Our collaborative agreements have had some or all of the
following elements: upfront fees, research and development funding, milestone revenues, and
royalties on product sales.
During the three and nine months ended September 30, 2005, one customer accounted for 39% and
43%, respectively, of total revenues. During the three and nine months ended September 30, 2004
that customer accounted for 42% and 76%, respectively, of total revenues. During the three and nine
months ended September 30, 2005, a second customer accounted for 61% and 57%, respectively, of
total revenues. During the three and nine months ended September 30, 2004, that second customer
accounted for 58% and 24%, respectively, of total revenues.
Because our remaining 2005 revenues could be substantially affected by entering into new
collaborations and by the financial terms of any new collaborations, we cannot estimate our
remaining 2005 revenues. Material cash inflows from proprietary drug development projects are
highly uncertain, and we cannot reasonably estimate the period in which we will begin to receive
material net cash inflows from our major research and development projects. Cash inflows from
products in development are dependent on several factors, including entering into collaborative
agreements, the achievement of certain milestones, and regulatory approvals. We may not receive
milestone payments from any existing or future collaborations if a product in development fails to
meet technical or performance targets or fails to obtain the required regulatory approvals.
Further, our revenues from collaborations will be affected by the levels of effort committed and
made by our collaborative partners. Even if we achieve technical success in developing drug
candidates, our collaborative partners may discontinue development, may not devote the resources
necessary to complete development and commence marketing of these products, or they may not
successfully market potential products.
Research and Development Expense
Our proprietary drug development portfolio consists of two therapeutic protein candidates:
GlycoPEG-EPO (NE-180) and GlycoPEG-GCSF. Erythropoietin (EPO) is prescribed to stimulate production
of red blood cells, and is approved for sale in major markets around the world for the treatment of
chemotherapy-induced anemia and anemia associated with chronic renal failure. Based on early
preclinical studies, we believe it is feasible to develop a long-acting EPO through
GlycoPEGylation. We submitted an investigational new drug application (IND) for NE-180 to the U.S.
Food and Drug Administration (FDA) during the second quarter of 2005. In
31
August 2005, the FDA advised us that it requires additional manufacturing and preclinical
information in order to complete its review of the IND and that our proposed Phase I clinical
trial of NE-180 has been placed on hold. We have established a target of the fourth quarter of 2005
to submit a complete response to the FDA. In addition, as an alternative to approval in the U.S.,
we are exploring the possibility of early clinical development of NE-180 in a European regulatory
jurisdiction.
Granulocyte colony stimulating factor (G-CSF) is prescribed to stimulate production of
neutrophils (a type of white blood cell), and is approved for sale in major markets around the
world for treatment of neutropenia associated with myelosuppressive chemotherapy. Based on
proof-of-concept data and preclinical development activities conducted during 2004, we believe it
is feasible to develop a long-acting G-CSF through GlycoPEGylation. We and BioGeneriX plan to
continue preclinical development activities for GlycoPEG-GCSF through the end of 2005. Such
activities include requesting scientific advice from regulatory authorities in Europe. We have
established a target of the first quarter of 2006 for the submission of an Investigational
Medicinal Product Dossier or its equivalent to a European country.
We conduct exploratory research, both independently and with collaborators, on therapeutic
candidates, primarily proteins, for development using our enzymatic technologies. Successful
candidates may be advanced for development through our own proprietary drug program or through our
partnering and licensing program, or a combination of the two. Although our primary focus is the
development of long-acting proteins, we are also conducting research to assess opportunities to use
our enzymatic technologies in other areas, such as glycopeptides and glycolipids. We expect to
continue this research during the remainder of 2005.
Our current research and development projects are divided between two categories: (i)
GlycoAdvance and GlycoPEGylation and (ii) Other Glycotechnology Programs, which includes projects
investigating other applications of our intellectual property. The following chart sets forth our
projects in each of these categories and the stage to which each has been developed:
|
|
|
|
|
|
|
|
|
|
|
Development |
|
|
|
|
Stage |
|
Status |
GlycoAdvance and GlycoPEGylation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NE-180 |
|
Preclinical |
|
Active |
GlycoPEG-GCSF |
|
Preclinical |
|
Active |
Other protein projects |
|
Research |
|
Active |
|
|
|
|
|
|
|
|
|
Other Glycotechnology Programs
|
|
|
|
|
Non-protein therapeutic applications |
|
Research |
|
Active |
The process of bringing drugs from the preclinical research and development stage through
Phase I, Phase II, and Phase III clinical trials to FDA approval is time consuming and expensive.
Because our announced product candidates are currently in the preclinical stage and there are a
variety of potential intermediate clinical and non-clinical outcomes that are inherent in drug
development, we cannot reasonably estimate either the timing or costs we will incur to complete
these research and development projects. In addition, the timing and costs to complete our research
and development projects will be affected by the timing and structure of any
32
collaboration agreements we may enter into with a third party, neither of which we can currently estimate.
For each of our research and development projects, we incur both direct and indirect expenses.
Direct expenses include salaries and other costs of personnel, raw materials, and supplies for each
project. We may also incur third-party costs related to these projects, such as contract research,
consulting and preclinical development costs. Indirect expenses include depreciation expense and
the costs of operating and maintaining our facilities, property, and equipment, to the extent used
for our research and development projects, as well as the costs of general management of our
research and development projects.
Our research and development expenses for the three and nine months ended September 30, 2005
were $7,521,000 and $26,133,000, respectively, compared to $9,305,000 and $24,971,000 for the
corresponding periods in 2004. The following table illustrates research and development expenses
incurred during the three and nine months ended September 30, 2005 and 2004 for our significant
groups of research and development projects (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
GlycoAdvance and
GlycoPEGylation |
|
$ |
3,843 |
|
|
$ |
4,386 |
|
|
$ |
13,992 |
|
|
$ |
11,254 |
|
Other Glycotechnology Programs |
|
|
237 |
|
|
|
19 |
|
|
|
766 |
|
|
|
141 |
|
Indirect expenses |
|
|
3,441 |
|
|
|
4,900 |
|
|
|
11,375 |
|
|
|
13,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,521 |
|
|
$ |
9,305 |
|
|
$ |
26,133 |
|
|
$ |
24,971 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GlycoAdvance and GlycoPEGylation
Our GlycoAdvance and GlycoPEGylation expenses result primarily from the development and
preclinical activities, including process development and pilot plant activities, associated with
our proprietary drug development programs. These expenses decreased during the third quarter of
2005 due primarily to a reduction in the purchase of supplies and raw materials as compared to the
third quarter of 2004. During the nine months ended September 30, 2005, these amounts increased
compared to the same period in 2004 due to the conduct of preclinical studies on NE-180 and
increased external costs associated with the development of reagents for GlycoPEG-GCSF.
Other Glycotechnology Programs
Research and development expenses related to our Other Glycotechnology Programs increased
during the 2005 periods, compared to the 2004 period, as we conducted more research on glycolipids
during the 2005 periods.
33
Indirect expenses
Our indirect research and development expenses decreased during the 2005 periods, compared to
the 2004 periods, primarily due to a decrease in consulting and outside research expenses as well
as a decrease in indirect labor efforts and personnel related costs, as more labor was focused on
the GlycoPEGylation and Glycotechnology programs. Further contributing to the 2005 decrease is a
reduction in depreciation expense in the third quarter of 2005 due to the impairment of our Witmer
Road facility and subsequent cessation of depreciation as of August 2005.
General and Administrative Expense
General and administrative expenses for the three and nine months ended September 30, 2005
were $2,685,000 and $8,469,000, respectively, compared to $2,861,000 and $9,047,000 for the
corresponding periods in 2004. The decrease for the 2005 periods was primarily due to lower
salaries and consulting expenses, partially offset by an increase in legal costs associated with
our intellectual property portfolio.
Restructuring Charges
Restructuring charges for the nine months ended September 30, 2005 were $14,002,000, which
included including $13,187,000 of non-cash property and equipment impairment charges and $815,000
of expected payments for employee severance costs. We did not incur any restructuring charges
during the three and nine months ended September 30, 2004.
During the three months ending December 31, 2005, we expect to record a non-cash restructuring
charge of approximately $152,000 in our statements of operations for the remaining required minimum
payments under the operating lease related to our facility in San Diego, California. Because the
remaining lease term extends for only five months beyond our cease-use date of the facility, we
have assumed no sublease income in our calculation. During the three months ending December 31,
2005, we also expect to record a restructuring charge of $52,000 relating to severance payments
that are contingent upon continued employment by certain employees of at least 60 days following
notice of their termination.
Other Income and Expense
Other income for the nine months ended September 30, 2005 was $22,000, and related to payments
received during the first quarter of 2005 in excess of the carrying value of accounts receivable
due to currency fluctuations. We do not expect any such other income during the remainder of 2005.
We had no other income during the three months ended September 30, 2005 or the three and nine
months ended September 30, 2004.
Interest income for the three and nine months ended September 30, 2005 was $415,000 and
$1,138,000, respectively, compared to $195,000 and $431,000 for the corresponding periods in 2004.
The increases were primarily due to higher interest rates during the 2005 periods. Our interest
income during the remainder of 2005 is difficult to project, and will depend largely on
34
prevailing interest rates and whether we receive cash from entering into any new collaborative
agreements or by completing any additional equity or debt financings during the year.
Interest expense for the three and nine months ended September 30, 2005 was $331,000 and
$1,000,000, respectively, compared to $304,000 and $658,000 for the corresponding periods in 2004.
The increases were primarily due to higher interest rates on our variable rate debt. The increase
during the nine months ended September 30, 2005 period was also due to the capitalization of
$130,000 of interest incurred during 2004 associated with leasehold improvements that we placed in
service in April 2004. Our interest expense during the remainder of 2005 is difficult to project
and will depend largely on prevailing interest rates and whether we enter into any new debt
agreements. See Financing Activities Debt Financing Activities in the Liquidity and Capital
Resources section of this Form 10-Q for a description of the material features of our debt
financings.
Item 4. Controls and Procedures
We carried out an evaluation, under the supervision and with the participation of our
management, including our principal executive officer and principal financial officer, of the
effectiveness of the design and operation of our disclosure controls and procedures as such term is
defined under Rule 13a-15(e) promulgated under the Exchange Act, for financial reporting as of
September 30, 2005. Based on that evaluation, our principal executive officer and principal
financial officer concluded that these controls and procedures are effective to ensure that
information required to be disclosed by us in reports that we file or submit under the Exchange Act
is recorded, processed, summarized and reported as specified in SEC rules and forms.
Our internal controls and procedures for financial reporting are designed to provide
reasonable assurance, and management believes that they provide such reasonable assurance, that our
transactions are properly authorized, our assets are safeguarded against unauthorized or improper
use, and our transactions are properly recorded and reported, in order to permit the preparation of
our financial statements in conformity with U.S. generally accepted accounting principles. There
were no changes in these controls or procedures identified in connection with the evaluation of
such controls or procedures that occurred during our last fiscal quarter, or in other factors that
have materially affected, or are reasonably likely to materially affect, these controls or
procedures.
Our management group, including our principal executive officer and principal financial
officer, does not expect that our disclosure controls and internal controls and related procedures
will prevent all error and all fraud. A control system, no matter how well designed and
implemented, can provide only reasonable assurance that the objectives of the control system are
met. In addition, the design and implementation of a control system must reflect the fact that
there are resource constraints, and the benefits of controls must be considered in relation to
their costs. The design of any system of controls is based, in part, upon certain assumptions about
the likelihood of future events, which may prove to be incorrect. Due to the limitations of all
control systems, no evaluation of controls can provide absolute assurance that all control issues
and instances of fraud, if any, within an organization have been detected or prevented.
35
PART II. OTHER INFORMATION
Item 6. Exhibits
|
10.1 |
|
Promissory Note of Neose Technologies, Inc. to General Electric Capital
Corporation, dated July 12, 2005. |
|
|
31.1 |
|
Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
31.2 |
|
Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
32.1 |
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
32.2 |
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002. |
36
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
NEOSE TECHNOLOGIES, INC.
|
|
Date: November 2, 2005 |
By: |
/s/ A. Brian Davis
|
|
|
|
A. Brian Davis |
|
|
|
Senior Vice President and Chief Financial Officer
(Principal Financial Officer and Duly Authorized
Signatory) |
|
37
Exhibit Index
|
|
|
Exhibit |
|
Description |
10.1
|
|
Promissory Note of Neose Technologies, Inc. to General Electric Capital
Corporation, dated July 12, 2005. |
|
|
|
31.1
|
|
Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002. |