e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2010
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 000-17758
EMISPHERE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
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13-3306985 |
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(State or jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification Number) |
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240 Cedar Knolls Rd, Suite 200 |
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Cedar Knolls, NJ
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07927 |
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(Address of principal executive offices)
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(Zip Code) |
(973) 532-8000
(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 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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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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
The number of shares of the Registrants common stock, $.01 par value, outstanding as of
May 1, 2010 was 42,927,109.
EMISPHERE TECHNOLOGIES, INC.
Index
All other items called for by the instructions to Form 10-Q have been omitted because the
items are not applicable or the relevant information is not material.
2
PART I
ITEM 1. FINANCIAL STATEMENTS
EMISPHERE TECHNOLOGIES, INC.
CONDENSED BALANCE SHEETS
March 31, 2010 and December 31, 2009
(in thousands, except share and per share data)
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March 31, 2010 |
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December 31, |
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(unaudited) |
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2009 |
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Assets: |
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Current assets: |
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Cash and cash equivalents |
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$ |
3,015 |
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$ |
3,566 |
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Accounts receivable, net |
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4 |
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158 |
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Inventories |
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233 |
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20 |
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Prepaid expenses and other current assets |
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142 |
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369 |
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Total current assets |
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3,394 |
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4,113 |
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Equipment and leasehold improvements, net |
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122 |
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138 |
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Purchased technology, net |
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1,017 |
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1,077 |
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Restricted cash |
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259 |
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259 |
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Deferred financing cost |
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324 |
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346 |
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Total assets |
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$ |
5,116 |
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$ |
5,933 |
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Liabilities and Stockholders Deficit: |
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Current liabilities: |
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Notes payable, including accrued interest and net of related discount |
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$ |
12,810 |
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$ |
12,588 |
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Accounts payable and accrued expenses |
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4,943 |
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4,975 |
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Derivative instruments |
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Related party |
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8,248 |
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3,205 |
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Others |
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7,830 |
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2,984 |
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Restructuring accrual, current |
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600 |
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750 |
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Other current liabilities |
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29 |
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52 |
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Total current liabilities |
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34,460 |
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24,554 |
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Notes payable, including accrued interest and net of related discount,
related party |
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14,324 |
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13,076 |
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Deferred revenue |
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13,501 |
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11,494 |
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Derivative instrument related party |
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8,669 |
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4,591 |
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Deferred lease liability and other liabilities |
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74 |
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82 |
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Total liabilities |
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71,028 |
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53,797 |
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Stockholders deficit: |
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Preferred stock, $.01 par value; authorized 1,000,000 shares; none
issued and outstanding |
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Common stock, $.01 par value; authorized 100,000,000 shares; issued
42,373,807 shares (42,084,075 outstanding) as of March 31, 2010 and
issued 42,360,133 shares (42,070,401 outstanding) as December 31, 2009 |
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424 |
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424 |
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Additional paid-in-capital |
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392,753 |
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392,335 |
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Accumulated deficit |
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(455,137 |
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(436,671 |
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Common stock held in treasury, at cost; 289,732 shares |
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(3,952 |
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(3,952 |
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Total stockholders deficit |
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(65,912 |
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(47,864 |
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Total liabilities and stockholders deficit |
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$ |
5,116 |
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$ |
5,933 |
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The accompanying notes are an integral part of the financial statements.
3
EMISPHERE TECHNOLOGIES, INC.
CONDENSED STATEMENT OF OPERATIONS
For the three months ended March 31, 2010 and 2009
(in thousands, except share and per share data)
(unaudited)
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For the three months ended |
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March 31, |
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2010 |
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2009 |
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Net Sales |
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$ |
12 |
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$ |
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Costs and expenses: |
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Research and development |
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562 |
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1,923 |
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General and administrative expenses |
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2,334 |
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2,921 |
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Restructuring costs |
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50 |
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(353 |
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Gain on disposal of fixed assets |
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(1 |
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(43 |
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Depreciation and amortization |
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75 |
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211 |
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Total costs and expenses |
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3,020 |
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4,659 |
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Operating loss |
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(3,008 |
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(4,659 |
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Other non-operating income (expense): |
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Other income |
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3 |
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41 |
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Sublease income |
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232 |
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Change in fair value of derivative instruments |
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Related party |
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(9,120 |
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113 |
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Other |
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(4,847 |
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35 |
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Interest expense |
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Related party |
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(1,271 |
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(1,044 |
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Other |
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(222 |
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(135 |
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Total other non-operating expense |
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(15,457 |
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(758 |
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Net loss |
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$ |
(18,465 |
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$ |
(5,417 |
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Net loss per share, basic and diluted |
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$ |
(0.44 |
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$ |
(0.18 |
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Weighted average shares outstanding, basic and diluted |
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42,077,334 |
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30,341,078 |
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The accompanying notes are an integral part of the financial statements.
4
EMISPHERE TECHNOLOGIES, INC.
CONDENSED STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2010 and 2009
(in thousands)
(unaudited)
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For the three months ended |
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March 31, |
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2010 |
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2009 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(18,465 |
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$ |
(5,417 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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15 |
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151 |
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Amortization |
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60 |
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60 |
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Change in fair value of derivative instruments |
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13,968 |
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(148 |
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Non-cash interest expense |
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1,493 |
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1,179 |
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Non-cash compensation expense |
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407 |
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238 |
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Gain on disposal of fixed assets |
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(1 |
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(43 |
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Changes in assets and liabilities excluding non-cash transactions: |
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Decrease in accounts receivable |
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154 |
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217 |
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Decrease in inventory |
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2 |
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Decrease (increase) in prepaid expenses and other current assets |
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12 |
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(27 |
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Increase (decrease) in deferred revenue |
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2,007 |
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186 |
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Increase (decrease) in accounts payable and accrued expenses |
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(1 |
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927 |
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Increase (decrease) in other current liabilities |
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(23 |
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2 |
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Decrease in deferred lease liability |
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(30 |
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(6 |
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Decrease in restructuring accrual |
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(150 |
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(627 |
) |
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Total adjustments |
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17,913 |
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2,109 |
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Net cash used in operating activities |
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(552 |
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(3,308 |
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Net cash provided by investing activities proceeds from sale of fixed assets |
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1 |
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45 |
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Net decrease in cash and cash equivalents |
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(551 |
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(3,263 |
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Cash and cash equivalents, beginning of period |
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3,566 |
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7,214 |
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Cash and cash equivalents, end of period |
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$ |
3,015 |
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$ |
3,951 |
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Schedule of non-cash financing |
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Common stock issued to settle accrued Directors compensation |
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$ |
11 |
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$ |
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The accompanying notes are an integral part of the financial statements.
5
EMISPHERE TECHNOLOGIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
1. Nature of Operations and Liquidity
Nature of Operations. Emisphere Technologies, Inc. (Emisphere, our, us, the Company or
we) is a biopharmaceutical company that focuses on our improved delivery of therapeutic molecules
and pharmaceutical compounds using its Eligen® Technology. These molecules and compounds
could be currently available or are in pre-clinical or clinical development.
Our core business strategy is to develop oral forms of drugs that are not currently
available or have poor bioavailability in oral form, either alone or with corporate partners, by
applying the Eligen® Technology to those drugs. Typically, the drugs that we target have
received regulatory approval, have demonstrated safety and efficacy, and are currently available on
the market. Since inception, we have no product sales from these product candidates. However, in
November 2009 the Company launched its first commercially available product, oral
Eligen® B12 (100mcg), which had been specifically developed to help improve Vitamin B12
absorption and bioavailability with a patented formulation.
Liquidity. As of March 31, 2010, we had approximately $3.3 million in cash and restricted
cash, approximately $31.1 million in working capital deficiency, a stockholders deficit of
approximately $65.9 million and an accumulated deficit of approximately $455.1 million. Our net
loss and operating loss for the three months ended March 31, 2010 were approximately $18.5 million
and $3.0 million, respectively. We anticipate that we will continue to generate significant losses
from operations for the foreseeable future, and that our business will require substantial
additional investment that we have not yet secured. As such, we anticipate that our existing cash
resources will enable us to continue operations only through approximately June 2010 or earlier if
unforeseen events arise that negatively affect our liquidity. Further, we have significant future
commitments and obligations. These conditions raise substantial doubt about our ability to continue
as a going concern. Consequently, the audit opinion issued by our independent registered public
accounting firm relating to our financial statements for the year ended December 31, 2009 contained
a going concern explanatory paragraph. We are pursuing new as well as enhanced collaborations and
exploring other financing options, with the objective of minimizing dilution and disruption.
Our plan is to raise capital when needed and/or to pursue product partnering
opportunities. We expect to continue to spend substantial amounts on research and development,
including amounts spent on conducting clinical trials for our product candidates. Expenses will be
partially offset with income-generating license agreements, if possible. Further, we will not have
sufficient resources to develop fully any new products or technologies unless we are able to raise
substantial additional financing on acceptable terms or secure funds from new or existing partners.
We cannot assure that financing will be available when needed, or on favorable terms or at all. If
additional capital is raised through the sale of equity or convertible debt securities, the
issuance of such securities would result in dilution to our existing stockholders. Our failure to
raise capital before June 2010 will adversely affect our business, financial condition and results
of operations, and could force us to reduce or cease our operations. No adjustment has been made in
the accompanying financial statements to the carrying amount and classification of recorded assets
and liabilities should we be unable to continue operations.
2. Basis of Presentation
The condensed balance sheet at December 31, 2009 was derived from audited financial
statements but does not include all disclosures required by accounting principles generally
accepted in the United States of America. The other information in these condensed financial
statements is unaudited but, in the opinion of management, reflects all adjustments necessary for a
fair presentation of the results for the periods covered. All such adjustments are of a normal
recurring nature unless disclosed otherwise. These condensed financial statements, including notes,
have been prepared in accordance with the applicable rules of the Securities and Exchange
Commission and do not include all of the information and disclosures required by accounting
principles generally accepted in the United States of America for complete financial statements.
These condensed financial statements should be read in conjunction with the financial statements
and additional information as contained in our Annual Report on Form 10-K for the year ended
December 31, 2009.
3. Stock-Based Compensation Plans
On April 20, 2007, the stockholders of the Company approved the 2007 Stock Award and
Incentive Plan (the 2007 Plan). The 2007 Plan provides for grants of options, stock appreciation
rights, restricted stock, deferred stock, bonus stock and awards in lieu of obligations, dividend
equivalents, other stock-based awards and performance awards to executive officers and other
employees of the Company, and non-employee directors, consultants and others who provide
substantial service to us. The 2007 Plan provides for the issuance of an aggregate 3,275,334 shares
as follows: 2,500,000 new shares, 374,264 shares remaining and transferred from the Companys 2000
Stock Option Plan (the 2000 Plan) (which was then replaced by the 2007 Plan) and 401,070 shares
remaining and transferred from the Companys Stock Option Plan for Outside Directors (the
Directors Stock Plan). In addition, shares canceled, expired, forfeited, settled in cash, settled
by delivery of fewer shares than the number underlying the award, or otherwise terminated under the
2000 Plan will become available for issuance under the 2007 Plan.
6
Prior to the adoption of the 2007 Plan, the Company granted stock-based compensation to
employees under the 2000 Plan and the 2002 Broad Based Plan (the 2002 Plan), and to non-employee
directors under the Directors Stock Plan. The Company also has grants outstanding under various
expired and terminated stock plans, including the 1991 Stock Option Plan, the 1995 Non-Qualified
Stock Option Plan, the Deferred Directors Compensation Stock Plan and Non-Plan Options. In January
2007, the Directors Stock Plan expired.
As of March 31, 2010, shares available for future grants under the Plans amounted to
1,572,798.
Total compensation expense recorded during the three months ended March 31, 2010 for
share-based payment awards was $0.4 million, of which $0.03 million is included in research and
development and $0.37 million is included in general and administrative expenses in the condensed
statement of operations for the three months ended March 31, 2010. Total compensation expense
recorded during the three months ended March 31, 2009 for share-based payment awards was $0.24
million, of which $0.03 million is included in research and development and $0.21 million is
included in general and administrative expenses in the condensed statement of operations for the
three months ended March 31, 2009. At March 31, 2010, total unrecognized estimated compensation
expense related to non-vested stock options granted prior to that date was $0.9 million, which is
expected to be recognized over a weighted-average period of approximately two years. No options
were exercised in the three months ended March 31, 2010 or 2009. No tax benefit was realized due to
a continued pattern of operating losses.
During the three months ended March 31, 2010, the Company granted options for 452,000
shares with a weighted average exercise price of $1.31.
4. Inventories
Inventories are stated at the lower of cost or market determined by the first in, first out
method. Inventories consist principally of finished goods at March 31, 2010 and December 31, 2009.
5. Fixed Assets
Fixed Assets. Equipment and leasehold improvements, net, consists of the following:
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Useful Lives |
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March 31, |
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December 31, |
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in Years |
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2010 |
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2009 |
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(in thousands) |
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Equipment |
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3-7 |
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$ |
1,370 |
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$ |
1,370 |
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Leasehold improvements |
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Term of lease |
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61 |
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61 |
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1,431 |
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1,431 |
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Less, accumulated depreciation and amortization |
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1,309 |
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1,293 |
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Equipment and leasehold improvements, net |
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$ |
122 |
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$ |
138 |
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6. Purchased Technology
Purchased technology represents the value assigned to patents and the rights to utilize,
sell or license certain technology in conjunction with our proprietary carrier technology. These
assets are utilized in various research and development projects. Purchased technology is amortized
over a period of 15 years, which represents the average life of the patents.
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March 31, |
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December 31, |
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2010 |
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2009 |
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(in thousands) |
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Gross carrying amount |
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$ |
4,533 |
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$ |
4,533 |
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Less, accumulated amortization |
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3,516 |
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3,456 |
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Net book value |
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$ |
1,017 |
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$ |
1,077 |
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Amortization expense for the purchased technology is approximately $60 thousand per
quarter in 2010 and in the remaining years through 2014.
7
7. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consist of the following:
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March 31, |
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December 31, |
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|
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2010 |
|
|
2009 |
|
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(In thousands) |
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Accounts payable and other accrued expenses |
|
$ |
1,783 |
|
|
$ |
1,979 |
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Accrued cost of lawsuit |
|
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2,333 |
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|
2,333 |
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Accrued bonus |
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|
438 |
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|
150 |
|
Accrued legal, professional fees and other |
|
|
234 |
|
|
|
302 |
|
Accrued vacation |
|
|
115 |
|
|
|
81 |
|
Clinical trial expenses and contract research |
|
|
40 |
|
|
|
130 |
|
|
|
|
|
|
|
|
|
|
$ |
4,943 |
|
|
$ |
4,975 |
|
|
|
|
|
|
|
|
8. Notes Payable
Notes payable consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(in thousands) |
|
MHR Convertible Notes |
|
$ |
14,324 |
|
|
$ |
13,076 |
|
Novartis Note |
|
|
12,810 |
|
|
|
12,588 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,134 |
|
|
$ |
25,664 |
|
|
|
|
MHR Convertible Notes. The MHR Convertible Notes are due on September 26, 2012,
bear interest at 11% and are secured by a first priority lien in favor of MHR Institutional
Partners IIA L.P. (together with its affiliates, MHR) on substantially all of our assets (the
MHR Notes). Interest is payable in the form of additional Convertible Notes issued monthly
through March 31, 2007 and then semi-annually beginning June 30, 2008, rather than in cash and we
have the right to call the MHR Notes after September 26, 2010 if certain conditions are satisfied.
The MHR Notes are convertible, at the sole discretion of MHR or any assignee thereof through
September 25, 2010, into shares of our common stock at a price per share of $3.78. At March 31,
2010, the MHR Notes were convertible into 6,149,196 shares of our common stock. In connection
with the convertible note transaction, we amended MHRs then existing warrants to purchase 387,374
shares of our common stock to provide for additional anti-dilution protection. MHR was also granted
the option to purchase warrants for up to an additional 617,211 shares of our common stock (the
Warrant Purchase Option) at a price per warrant equal to $0.01 per warrant for each of the first
67,084 warrants and $1.00 per warrant for each additional warrant. This option was exercised by MHR
in April 2006. See Note 8 for a further discussion of the liability related to these warrants.
The book value of the MHR Notes is comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(in thousands) |
|
Face Value of the notes |
|
$ |
23,244 |
|
|
$ |
22,616 |
|
Discount (related to the
embedded conversion
feature) |
|
|
(743 |
) |
|
|
(793 |
) |
Discount (related to
the warrant purchase
option) |
|
|
(7,337 |
) |
|
|
(7,848 |
) |
Lenders financing costs |
|
|
(840 |
) |
|
|
(899 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
14,324 |
|
|
$ |
13,076 |
|
|
|
|
The debt discount, lenders finance costs, deferred financing costs and amounts
attributed to derivative instruments are being amortized to interest expense over the life of the
MHR Notes using an interest method to yield an effective interest rate of 36.1%.
In connection with the MHR financing, the Company agreed to appoint a representative of
MHR (the MHR Nominee) and another person (the Mutual Director) to its Board of Directors.
Further, the Company amended its certificate of incorporation to
8
provide for continuity of the MHR Nominee and the Mutual Nominee on the Board, as described
therein, so long as MHR holds at least 2% of the outstanding common stock of the Company.
The MHR Notes provide for various events of default. On May 5, 2006, we received an
executed waiver from MHR providing for a temporary waiver of defaults, which were not
payment-related, under the Loan Agreement. We have received extensions of such waiver from time to
time, the latest being received May 12, 2010 and is in effect through May 18, 2011; as such the MHR
Notes have been classified as long-term. Effective January 1, 2009, the Company adopted the
provisions of the Financial Accounting Standards Board Accounting Codification Topic 815-40-15-5,
Evaluating Whether an Instrument Involving a Contingency is Considered Indexed to an Entitys Own
Stock (FASB ASC 815-40-15-5). Under FASB ASC 85-40-15-5, the conversion feature embedded in the
MHR notes have been bifurcated from the host contract and accounted for separately as a derivative.
The bifurcation of the embedded derivative increased the amount of debt discount thereby reducing
the book value of the MHR Notes and increasing prospectively the amount of interest expense to be
recognized over the life of the MHR Notes.
Novartis Note. The Convertible Promissory Note due originally on December 1, 2009,
issued by us to Novartis on December 1, 2004 (the Novartis Note), in accordance with and pursuant
to the terms and conditions therein. The Novartis Note was issued in a private placement
transaction pursuant to Section 4(2) of the Securities Act in connection with a new research
collaboration option relating to the development of PTH-1-34. The Novartis Note currently bears
interest at a rate of 7%. The Novartis Note is convertible at our option, if and when we elect to
so convert, at any time prior to maturity into that number of shares of our common stock equal to
the outstanding principal and accrued and unpaid interest thereon divided by the conversion price,
which conversion price is equal to the average of the highest bid and lowest ask prices of our
common stock as quoted on the Over-The-Counter Bulletin Board (OTCBB) averaged over a period of
twenty (20) days, consisting of the day on which the conversion price is being determined and the
nineteen (19) consecutive business days prior to such day, provided certain conditions contained in
the Novartis Note are met. Those conditions include that, at the time of such conversion, no event
of default under the Novartis Note has occurred and is continuing and that there is either an
effective registration statement in effect covering the resale of the shares issued in connection
with such conversion or the shares may be resold by Novartis pursuant to SEC Rule 144. Based on the
price per share of our common stock on March 31, 2010, the Novartis Note is convertible into
7,683,154 shares of our common stock, assuming Novartis does not exercise its right to limit the
number of shares issued to it upon conversion of the Novartis Note such that the shares of common
stock they receive upon conversion do not exceed 19.9% of the total shares of our common stock
outstanding.
The Novartis Note was originally due December 1, 2009. On November 30, 2009, Novartis agreed
to extend the maturity date to February 26, 2010. On February 23, 2010, Novartis agreed to extend
the maturity date to May 26, 2010. The Company continues to accrue interest at 7%.
9. Derivative Instruments
Derivative instruments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(in thousands) |
|
Elan Warrants |
|
$ |
1,144 |
|
|
$ |
394 |
|
MHR Convertible Note |
|
|
8,669 |
|
|
|
4,591 |
|
MHR warrants |
|
|
649 |
|
|
|
213 |
|
August 2007 Equity financing
warrants |
|
|
464 |
|
|
|
141 |
|
August
2009 equity financing warrants |
|
|
12,891 |
|
|
|
5,092 |
|
August 2009 equity
financing warrants to placement
agent |
|
|
930 |
|
|
|
349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
24,747 |
|
|
$ |
10,780 |
|
|
|
|
|
|
|
|
Elan Warrant. In connection with a restructuring of debt in March 2005, we issued to Elan
Corporation, plc (Elan) a warrant to purchase up to 600,000 shares of our common stock at an
exercise price of $3.88 (the Elan Warrant). The Elan Warrant provides for adjustment of the
exercise price upon the occurrence of certain events, including the issuance by Emisphere of common
stock or common stock equivalents that have an effective price that is less than the exercise price
of the warrant. The anti-dilution feature of the Elan Warrant was triggered in connection with the
August 2007 financing, resulting in an adjustment to the exercise price to $3.76. The anti-dilution
feature of the Elan Warrant was triggered again in connection with the August 2009 financing,
resulting in an adjustment to the exercise price to $0.4635. As of March 31, 2010 the Elan Warrant was outstanding
and would expire on August 31, 2010. The Company adopted the provisions of FASB ASC 815-40-15-5
effective January 1, 2009. Under FASB ASC 815-40-15-5, the Elan Warrant is not considered indexed
to the Companys own stock and, therefore, does not meet the scope exception in FASB ASC 815-10-15
and thus needs to be accounted for as a derivative liability. The fair value of the Elan Warrant is
estimated, at the end of each quarterly reporting period, using the Black-Scholes option pricing
model. The assumptions used in computing the fair value as
9
of March 31, 2010 are a closing stock price of $2.37, expected volatility 86.62% over the remaining term of five months and a risk-free
rate of 0.16%. The fair value of the Elan Warrant increased by $0.8 million during the three months
ended March 31, 2010 which has been recognized in the accompanying statements of operations. On
April 20, 2010, Elan notified the Company of its intention to exercise the Elan Warrant using the
cashless exercise provision. The Company issued 518,206 shares of common stock to Elan on April
21, 2010. After the cashless exercise, the Elan Warrant is no longer outstanding.
Embedded Conversion Feature of MHR Convertible Note. The MHR Notes contain a provision whereby, the
conversion price is adjustable upon the occurrence of certain events, including the issuance by
Emisphere of common stock or common stock equivalents at a price which is lower than the current
conversion price of the MHR Notes and lower than the current market price. However, the adjustment
provision does not become effective until after the Company raises $10 million through the issuance
of common stock or common stock equivalents at a price which is lower than the current conversion
price of the MHR Notes and lower than the current market price during any consecutive 24 month
period. The Company adopted the provisions of FASB ASC 815-40-15-5 effective January 1, 2009. Under
FASB ASC 815-40-15-5, the embedded conversion feature is not considered indexed to the Companys
own stock and, therefore, does not meet the scope exception in FASB ASC 815-10-15 and thus needs to
be accounted for as a derivative liability. The liability has been presented as a non-current
liability to correspond with its host contract, the MHR Notes. The fair value of the embedded
conversion feature is estimated, at the end of each quarterly reporting period, using the
Black-Scholes option pricing model. The assumptions used in computing the fair value as of March
31, 2010 are a closing stock price of $2.37, expected volatility 105.03% over the remaining term of
two years and six months and a risk-free rate of 1.6%. The fair value of the embedded conversion
feature increased by $4.1 million during the three months ended March 31, 2010 which has been
recognized in the accompanying statements of operations. The embedded conversion feature will be
adjusted to fair value for each future period it remains outstanding.
MHR Warrants. In connection with the exercise in April 2006 of the Warrant Purchase Option
discussed in Note 8 above, the Company issued warrants for 617,211 shares to MHR for proceeds of
$0.6 million. The MHR 2006 Warrants have an original exercise price of $4.00 and are exercisable
through September 26, 2011. The MHR 2006 Warrants have the same terms as the August 2007 equity
financing warrants (see below), with no limit upon adjustments to the exercise price. The
anti-dilution feature of the MHR 2006 Warrants was triggered in connection with the August 2007
equity financing, resulting in an adjusted exercise price of $3.76. Based on the provisions of FASB
ASC 815, Derivatives and Hedging, the MHR 2006 Warrants have been determined to be an embedded
derivative instrument which must be separated from the host contract. The MHR 2006 Warrants contain
the same potential cash settlement provisions as the August 2007 equity financing warrants and
therefore they have been accounted for as a separate liability. The fair value of the warrants is
estimated, at the end of each quarterly period, using the Black-Scholes option pricing model. The
assumptions used in computing the fair value as of March 31, 2010 are a closing stock price of
$2.37, expected volatility of 118.24% over the remaining term of one and a half years and a
risk-free rate of 0.41%. The fair value of the MHR warrants increased by $0.4 million during the
three months ended March 31, 2010 which has been recognized in the accompanying statements of
operations. The MHR warrants will be adjusted to estimated fair value for each future period they
remain outstanding. See Note 8 for a further discussion of the MHR Note.
August 2007 Equity Financing Warrants. In connection with the August 2007 offering, Emisphere
sold warrants to purchase up to 400,000 shares of common stock (the 2007 Warrants). Of these
400,000 warrants, 91,073 were sold to MHR. Each of the 2007 Warrants were issued with an
exercise price of $3.948 and expire on August 21, 2012. The 2007 Warrants provide for certain
anti-dilution protection as provided therein. Under the terms of the 2007 Warrants, we have an
obligation to make a cash payment to the holders of the warrants for any gain that could have
been realized if the holders exercise the warrants and we subsequently fail to deliver a
certificate representing the shares to be issued upon such exercise by the third trading day
after such warrants have been exercised. Accordingly, the 2007 Warrants have been accounted
for as a liability. The fair value of the 2007 Warrants is estimated, at the end of each
quarterly reporting period, using the Black-Scholes option pricing model. The warrants were
accounted for with an initial value of $1.0 million on August 22, 2007. The assumptions used
in computing the fair value as of March 31, 2010 are a closing stock price of $2.37, expected
volatility of 107.12% over the remaining term of two years and five months and a risk-free
rate of 1.02%. The fair value of the 2007 Warrants increased by $0.3 million during the three
months ended March 31, 2010 and the fluctuations have been recorded in the statements of
operations. The 2007 Warrants will be adjusted to estimated fair value for each future period
they remain outstanding.
August 2009 Equity Financing Investors Warrants. In connection with the August 2009 offering,
Emisphere sold warrants to purchase 6.4 million shares of common stock (the 2009 Warrants),
consisting of warrants to purchase 3.7 million shares of common stock to MHR and warrants to
purchase 2.7 million shares of common stock to other unaffiliated investors. The 2009 Warrants
were issued with an exercise price of $0.70 and expire on August 21, 2014. Under the terms of the
2009 Warrants, we have an obligation to make a cash payment to the holders of the warrants for any
gain that could have been realized if the holders exercise the warrants and we subsequently fail to
deliver a certificate representing the shares to be issued upon such exercise by the third trading
day after such warrants have been exercised. Accordingly, the 2009 Warrants have been accounted for as a
liability. The fair value of the 2009 Warrants is estimated, at the end of each quarterly reporting
period, using the Black-Scholes option pricing model. The assumptions used in computing the fair
value as of March 31, 2010 are a closing stock price of $2.37, expected volatility of 92.19% over
the remaining term of four years and five months and a risk-free rate of 2.55%. The fair value of
the 2009 Warrants increased by $7.8
10
million through March 31, 2010 and the fluctuation has been
recorded in the statements of operations. The 2009 Warrants will be adjusted to estimated fair
value for each future period they remain outstanding.
August 2009 Equity Financing Placement Agent Warrants. In connection with the August 2009 offering,
Emisphere issued to Rodman & Renshaw, LLC (the Placement Agent), as part of the compensation for
acting as placement agent for the August 2009 financing, warrants to purchase 504,000 shares of
common stock (the Placement Agent Warrants). The Placement Agent Warrants were issued with an
exercise price of $0.875 and expire on October 1, 2012. Under the terms of the warrants, we have an
obligation to make a cash payment to the holders of the warrants for any gain that could have been
realized if the holders exercise the warrants and we subsequently fail to deliver a certificate
representing the shares to be issued upon such exercise by the third trading day after such
warrants have been exercised. Accordingly, the Placement Agent Warrants have been accounted for as
a liability. The fair value of the Placement Agent Warrants are estimated, at the end of each
quarterly reporting period, using the Black-Scholes option pricing model. The assumptions used in
computing the fair value as of March 31, 2010 are a closing stock price of $2.37, expected
volatility of 104.71% over the remaining term of two years and six months and a risk-free rate of
1.6%. The fair value of the Placement Agent Warrants increased by $0.6 million through March 31,
2010 and the fluctuation has been recorded in the statements of operations. The fair value of the
Placement Agent Warrants was deemed to be a cost of the financing and accounted for as a reduction
in the proceeds. The Placement Agent Warrants will be adjusted to estimated fair value for each
future period they remain outstanding. On April 5, 2010, the Placement Agent notified the Company
of its intention to exercise a portion of the Placement Agent Warrants using the cashless
exercise provision. The Company issued 297,636 shares of common stock to the Placement Agent on
April 5, 2010. After this cashless exercise, Placement Agent Warrants to purchase 37,800 share of
common stock remained outstanding. On April 30, 2010, the Placement Agent notified the Company of
its intention to exercise the remaining outstanding portion of the Placement Agent Warrants using
the cashless exercise provision. The Company issued an additional 27,192 shares of common stock
to the purchase agent on April 30, 2010. After this cashless exercise, the Placement Agent Warrants
are no longer outstanding.
10. Net loss per share
The following table sets forth the information needed to compute basic earnings per
share:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2010 |
|
2009 |
|
|
(in thousands except per share data) |
Basic net loss |
|
$ |
(18,465 |
) |
|
$ |
(5,417 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
42,077,334 |
|
|
|
30,341,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per share |
|
$ |
(0.44 |
) |
|
$ |
(0.18 |
) |
For the three months ended March 31, 2010 and 2009, certain potential shares of common
stock have been excluded from diluted loss per share because the exercise price was greater than
the average market price of our common stock, and therefore, the effect on diluted loss per share
would have been anti-dilutive. The following table sets forth the number of potential shares of
common stock that have been excluded from diluted net loss per share because their effect was
anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
Options to purchase common shares |
|
|
3,168,716 |
|
|
|
2,230,559 |
|
Outstanding warrants |
|
|
8,536,248 |
|
|
|
2,972,049 |
|
Novartis convertible note payable |
|
|
7,683,154 |
|
|
|
7,537,921 |
|
MHR note payable |
|
|
6,149,196 |
|
|
|
5,511,423 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,537,314 |
|
|
|
18,251,952 |
|
|
|
|
|
|
|
|
11
11. Commitments and Contingencies
Commitments. At the beginning of 2009 we had leased approximately 80,000 square feet of
office space at 765 Old Saw Mill River Road, Tarrytown, NY for use as administrative offices and
laboratories. The lease for our administrative and laboratory facilities had been set to expire on
August 31, 2012. However, on April 29, 2009, the Company entered into a Lease Termination Agreement
(the Agreement) with BMR-Landmark at Eastview, LLC, a Delaware limited liability company (BMR)
pursuant to which the Company and BMR terminated the lease of space at 765 Old Saw Mill River Road
in Tarrytown, NY. Pursuant to the Agreement, the Lease was terminated effective as of April 1,
2009. The Agreement provided that the Company make the following payments to BMR: (a) $1 million,
paid upon execution of the Agreement, (b) $0.5 million, paid six months after the execution date of
the Agreement, and (c) $0.75 million, payable twelve months after the execution date of the
Agreement. Initial and six months payments were made on schedule. Although the final payment was
due originally on April 29, 2010, on March 17, 2010 the Company and BMR agreed to amend the
Agreement (the Amendment). According to the Amendment, the final payment was modified as follows:
the Company will pay Eight Hundred Thousand Dollars ($800,000), as follows: (i) Two Hundred
Thousand Dollars ($200,000) within five (5) days after the Execution Date and (ii) One Hundred
Thousand Dollars ($100,000) on each of the following dates: July 15, 2010, August 15, 2010,
September 15, 2010, October 15, 2010, November 15, 2010, and December 15, 2010.
We continue to lease office space at 240 Cedar Knolls Road, Cedar Knolls, NJ under a
non-cancellable operating lease expiring in 2013.
On April 6, 2007, the Board of Directors appointed Michael V. Novinski to the position of
President and Chief Executive Officer. Pursuant to his appointment, the Company has entered into a
three year employment agreement with Mr. Novinski. Mr. Novinskis employment agreement renews
automatically in one year increments unless either party notifies the other at least 60 days prior
to the date of expiration of their intention to terminate. If Mr. Novinskis contract is terminated
without cause by the Board of Directors or at any time by the executive for good reason as defined
in his contract, we are obligated to make severance payments to Mr. Novinski.
In April 2005, the Company entered into an amended and restated employment agreement with its
then Chief Executive Officer, Dr. Michael M. Goldberg, for services through July 31, 2007. On
January 16, 2007, the Board of Directors terminated Dr. Goldbergs services. On April 26, 2007, the
Board of Directors held a special hearing at which it determined that Dr. Goldbergs termination
was for cause. On March 22, 2007, Dr. Goldberg, through his counsel, filed a demand for arbitration
asserting that his termination was without cause and seeking $1,048,000 plus attorneys fees,
interest, arbitration costs and other relief alleged to be owed to him in connection with his
employment agreement with the Company. During the arbitration, Dr. Goldberg sought a total damage
amount of at least $9,223,646 plus interest. On February 11, 2010, the arbitrator issued the final
award in favor of Dr. Goldberg for a total amount of approximately $2,333,115 as full and final
payment for all claims, defenses, counterclaims, and related matters. As a result of the
February 11, 2010 final award, the Company adjusted its estimate of costs to settle this matter to
$2,333,115. If the awards are upheld and confirmed in court, the Company will be required to pay
the final amount due to Dr. Goldberg.
The Company evaluates the financial consequences of legal actions periodically or as facts
present themselves and books accruals to account for its best estimate of future costs accordingly.
Contingencies. In the ordinary course of business, we enter into agreements with third
parties that include indemnification provisions which, in our judgment, are normal and customary
for companies in our industry sector. These agreements are typically with business partners,
clinical sites, and suppliers. Pursuant to these agreements, we generally agree to indemnify, hold
harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified
parties with respect to our product candidates, use of such product candidates, or other actions
taken or omitted by us. The maximum potential amount of future payments we could be required to
make under these indemnification provisions is unlimited. We have not incurred material costs to
defend lawsuits or settle claims related to these indemnification provisions. As a result, the
estimated fair value of liabilities relating to these provisions is minimal. Accordingly, we have
no liabilities recorded for these provisions as of March 31, 2010.
In the normal course of business, we may be confronted with issues or events that may result
in a contingent liability. These generally relate to lawsuits, claims, environmental actions or the
action of various regulatory agencies. If necessary, management consults with counsel and other
appropriate experts to assess any matters that arise. If, in our opinion, we have incurred a
probable loss as set forth by accounting principles generally accepted in the U.S., an estimate is
made of the loss and the appropriate accounting entries are reflected in our financial statements.
After consultation with legal counsel, we do not anticipate that liabilities arising out of
currently pending or threatened lawsuits and claims will have a material adverse effect on our
financial position, results of operations or cash flows.
Restructuring Expense
On December 8, 2008, as part of our efforts to improve operational efficiency we decided
to close our research and development facilities in Tarrytown to reduce costs and improve operating
efficiency which resulted in a restructuring charge of approximately $3.8 million in the fourth
quarter, 2008. On April 29, 2009, the Company entered into the Lease Termination Agreement with
BMR, and credited the restructuring charge $0.35 million in accordance with the terms of the
Agreement. On March 17, 2010 the Company
12
and BMR amended the Agreement as described in this Note (above). Consequently, the
restructuring liability was readjusted to reflect the terms of the Amendment accordingly.
Adjustments to the restructuring liability are as follows ($ thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability at |
|
|
Cash |
|
|
Adjustment to |
|
|
Liability at |
|
|
|
December 31, 2009 |
|
|
Payments |
|
|
the Liability |
|
|
March 31, 2010 |
|
Lease restructuring expense |
|
$ |
750 |
|
|
$ |
(200 |
) |
|
$ |
50 |
|
|
$ |
600 |
|
12. Income Taxes
The Company is primarily subject to United States federal and New Jersey state income
tax. The Companys policy is to recognize interest and penalties related to income tax matters in
income tax expense. As of December 31, 2009 and March 31, 2010, the Company had no accruals for
interest or penalties related to income tax matters. For the three months ended March 31, 2010 and
2009, the effective income tax rate was 0%. The difference between the Companys effective income
tax rate and the Federal statutory rate of 35% is attributable to state tax benefits and tax
credits offset by changes in the deferred tax valuation allowance.
13. New Accounting Pronouncements
In October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue Arrangements,
(amendments to FASB ASC Topic 605, Revenue Recognition ) (ASU 2009-13). ASU 2009-13 requires
entities to allocate revenue in an arrangement using estimated selling prices of the delivered
goods and services based on a selling price hierarchy. The amendments eliminate the residual method
of revenue allocation and require revenue to be allocated using the relative selling price method.
ASU 2009-13 should be applied on a prospective basis for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010, with early adoption
permitted. The Company does not expect adoption of ASU 2009-13 to have a material impact on the
Companys results of operations or financial condition.
In April 2010, the FASB issue ASU 2010-17, Revenue Recognition Milestone Method (ASU
2010-17). ASU 2010-17 provides guidance on the criteria that should be met for determining
whether the milestone method of revenue recognition is appropriate. A vendor can recognize
consideration that is contingent upon achievement of a milestone in its entirety as revenue in the
period in which the milestone is achieved only if the milestone meets all criteria to be considered
substantive. The following criteria must be met for a milestone to be considered substantive. The
consideration earned by achieving the milestone should 1. be commensurate with either the level of
effort required to achieve the milestone or the enhancement of the value of the item delivered as a
result of a specific outcome resulting from the vendors performance to achieve the milestone; 2.
be related solely to past performance; and 3. be reasonable relative to all deliverables and
payment terms in the arrangement. No bifurcation of an individual milestone is allowed and there
can be more than one milestone in an arrangement. Accordingly, an arrangement may contain both
substantive and nonsubstantive milestones. ASU 2010-17 is effective on a prospective basis for
milestones achieved in fiscal years, and interim periods within those years, beginning on or after
June 15, 2010. Management is currently evaluating the potential impact of ASU 2010-17 on our
financial statements.
Management does not believe there would have been a material effect on the accompanying
financial statements had any other recently issued, but not yet effective, accounting standards
been adopted in the current period.
14. Fair Value
In accordance with FASB ASC 820, Fair Value Measurements and Disclosures, the following
table represents the Companys fair value hierarchy for its financial assets and liabilities
measured at fair value on a recurring basis as of March 31, 2010
and December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
Level 2 |
|
|
Level 2 |
|
|
|
March 31, 2010 |
|
|
December 31, 2009 |
|
|
|
($ thousands) |
|
|
($ thousands) |
|
Derivative instruments (short term) |
|
$ |
16,078 |
|
|
$ |
6,189 |
|
Derivative instruments (long term) |
|
|
8,669 |
|
|
|
4,591 |
|
|
|
|
|
|
|
|
Total |
|
$ |
24,747 |
|
|
$ |
10,780 |
|
|
|
|
|
|
|
|
Some of the Companys financial instruments are not measured at fair value on a recurring basis but
are recorded at amounts that approximate fair value due to their liquid or short-term nature, such
as cash and cash equivalents, receivables and payables.
13
We have determined that it is not practical to estimate the fair value of our notes
payable because of their unique nature and the costs that would be incurred to obtain an
independent valuation. We do not have comparable outstanding debt on which to base an estimated
current borrowing rate or other discount rate for purposes of estimating the fair value of the
notes payable and we have not been able to develop a valuation model that can be applied
consistently in a cost efficient manner. These factors all contribute to the impracticability of
estimating the fair value of the notes payable. At March 31, 2010, the carrying value of the notes
payable and accrued interest was $27.1 million. The MHR Convertible Notes, which are due on
September 26, 2012, yield an effective interest rate of 36.1%. The Novartis Note, which is due
December 1, 2009, currently bears interest at a rate of 7%. Refer to Note 8 of these financial
statements for more information about the Companys notes payable.
15. Sale of Patents
On February 8, 2008, the Company sold to MannKind Corporation (Mannkind) certain
patents and a patent application relating to diketopiperazine technology for a total purchase price
of $2.5 million. An initial payment of $1.5 million was received in February 2008 and recognized as
other income. An additional $0.5 million was paid in May 2009 with the remaining $0.5 million
payment to be made no later than October 5, 2010. We will recognize as revenue the additional
amounts due from Mannkind when payment becomes reasonably assured.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
SAFE HARBOR CAUTIONARY STATEMENT
Certain statements in this Managements Discussion and Analysis of Financial Conditions
and Results of Operations and elsewhere in this report as well as statements made from time to time
by our representatives may constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These forward looking statements include (without
limitation) statements regarding planned or expected studies and trials of oral formulations that
utilize our Eligen® Technology; the timing of the development and commercialization of
our product candidates or potential products that may be developed using our Eligen®
Technology; the potential market size, advantages or therapeutic uses of our potential products;
variation in actual savings and operational improvements resulting from restructurings; and the
sufficiency of our available capital resources to meet our funding needs. We do not undertake any
obligation to publicly update any forward-looking statement, whether as a result of new
information, future events, or otherwise, except as required by law. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors which may cause our
actual results, performance or achievements to be materially different from any future results or
achievements expressed or implied by such forward-looking statements. Such factors include the
factors described under Part II, Item 1A. Risk Factors and other factors discussed in connection
with any forward looking statements.
General
Emisphere Technologies, Inc. is a biopharmaceutical company that focuses on a unique and
improved delivery of therapeutic molecules or nutritional supplements using its Eligen®
Technology. These molecules could be currently available or are under development. Such molecules
are usually delivered by injection; in many cases, their benefits are limited due to poor
bioavailability, slow on-set of action or variable absorption. In those cases, our technology may
increase the benefit of the therapy by improving bioavailability or absorption or by increasing the
onset of action. The Eligen® Technology can be applied to the oral route of
administration as well other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal
or transdermal. The Eligen® Technology can make it possible to orally deliver certain
therapeutic molecules without altering their chemical form or biological integrity.
Eligen® delivery agents, or carriers, facilitate or enable the transport of
therapeutic molecules across the mucous membranes of the gastrointestinal tract, to reach the
tissues of the body where they can exert their intended pharmacological effect.
Since our inception in 1986, substantial efforts and resources have been devoted to
understanding the Eligen® Technology and establishing a product development pipeline
that incorporated this technology with selected molecules. Since 2007, Emisphere has undergone many
positive changes. A new senior management team, led by Michael V. Novinski, was hired; the
Eligen® Technology was reevaluated and our corporate strategy was refocused on
commercializing the Eligen® Technology as quickly as possible, building high-value
partnerships and reprioritizing the product pipeline. Spending was redirected and aggressive cost
control initiatives were implemented. These changes resulted in redeployment of resources to
programs, one of which, yielded the introduction of our first commercial product during 2009. We
continue to develop potential product candidates in-house and we demonstrated and enhanced the
value of the Eligen® Technology as evident in the progress made by our development
partners Novo Nordisk A/S (Novo Nordisk) and Novartis Pharma AG (Novartis) on their respective
product development programs. Further development, exploration and commercialization of the
technology entail risk and operational expenses. However, we have made significant progress on
14
refocusing our efforts on strategic development initiatives and cost control and continue to
aggressively seek to reduce non-strategic spending.
The application of the Eligen® Technology is potentially broad and may provide
for a number of opportunities across a spectrum of therapeutic modalities or nutritional
supplements. During the first quarter 2010, we continued to develop our product pipeline utilizing
the Eligen® Technology with prescription and nonprescription product candidates. We
prioritized our development efforts based on overall potential returns on investment, likelihood of
success, and market and medical need. Our goal is to implement our Eligen® Technology to
enhance overall healthcare, including patient accessibility and compliance, while benefiting the
commercial pharmaceutical marketplace and driving company valuation. Investments required to
continue developing our product pipeline may be partially paid by income-generating license
arrangements whose value tends to increase as product candidates move from pre-clinical into
clinical development. It is our intention that incremental investments that may be required to fund
our research and development will be approached incrementally in order to minimize disruption or
dilution.
We plan to attempt to expand our current collaborative relationships to take advantage of
the critical knowledge that others have gained by working with our technology. We will also
continue to pursue product candidates for internal development and commercialization. We believe
that these internal candidates must be capable of development with reasonable investments in an
acceptable time period and with a reasonable risk-benefit profile.
Our product pipeline includes prescription, medical food, and nutritional supplements
candidates. On the nutritional supplements side, during November 2009, the Company launched its
first commercially available product, oral Eligen® B12 (100 mcg), which was specifically
developed to help improve Vitamin B12 absorption and bioavailability with a patented formulation.
The Company also reported progress on its planned second product, a higher dose formulation of
Eligen® B12 for use by B12 deficient individuals. During April 2010, the Company
announced that interim data from an ongoing study demonstrated that its high-dose oral
Eligen® B12 (1000mcg) given to individuals with low B12 levels restores normal B12 serum
concentrations. Normal levels of serum B12 were achieved by all study participants who had taken
Eligen® B12 (1000mcg) 15 days into the 90-day study when the first blood samples were
taken. These data, in Abstract Number 8370, were presented at the Experimental Biology 2010
Conference in Anaheim, California. In this open-label, randomized, 90-day study, serum cobalamin
(B12) and holotranscobalamin (active B12) were collected and measured at Baseline, Day 15, Day 31,
Day 61 and Day 91. A total of 49 study participants were enrolled (26 on IM injection and 23 on
oral) and received either nine 1000mcg intramuscular injections of Vitamin B12 or once daily
tablets of oral Eligen® B12 (1000 mcg). The results from an interim analysis showed that
serum cobalamin and active B12 returned to the normal range with both products and normalization
was maintained. This clinical study with Eligen® B12 (1000mcg) is expected to be completed
shortly. With participants in the oral Eligen® B12 (1000mcg) group showing the ability
to rapidly achieve normalized serum and active B12 levels, the study illustrates the potential of
the Eligen® Technology and of the high dose, oral Eligen® B12 (1000mcg)
formulation to offer a much needed medical food alternative to painful and inconvenient IM
injections. As a medical food, Emispheres Eligen® B12 (1000 mcg) is designed as a
specially formulated and processed oral formulation for the specific dietary management of patients
under medical supervision who, because of a limited or impaired capacity to absorb Vitamin B12 ,
have a diagnosed Vitamin B12 deficiency. It is planned to be available later in 2010. It is
estimated that as many as 10 million people in the U.S. and over 100 million people worldwide may
be B12 deficient. Oral Eligen® B12 and the foregoing statements have not been evaluated
by the Food and Drug Administration. Oral Eligen® B12 is not intended to diagnose,
treat, cure, or prevent any disease.
On the prescription side, our licensees include Novartis, which is using our drug delivery
technology in combination with salmon calcitonin, parathyroid hormone, and human growth hormone.
Their most advanced program is testing an oral formulation of calcitonin to treat osteoarthritis
and osteoporosis. Novartis is conducting two Phase III clinical studies for osteoarthritis and one
Phase III clinical study for osteoporosis. Now that these Phase III studies are fully enrolled,
over 5,500 clinical study patients used the Eligen® Technology during 2009 and continue
to use it during 2010. During December 2009, the Company announced that an independent Data
Monitoring Committee (DMC) informed Novartis and its partner Nordic Bioscience about their
recommendation to proceed with the Osteoporosis Phase III Study 2303 and the Osteoarthritis
Phase III Study 2301 exploring the safety and efficacy of an oral formulation of salmon calcitonin
to treat patients with osteoporosis and osteoarthritis of the knee. This recommendation is based on
a futility analysis of one-year data for all patients enrolled in the study for 12 months and
includes both an assessment of safety and efficacy parameters. Based on this interim analysis, the
DMC is of the opinion that there are no major or unexpected safety concerns and recommended
proceeding with the studies to evaluate the efficacy and safety profile of oral calcitonin at two
years as planned.
Also during December 2009, the Company announced a meta-analysis published in the December
2009 edition of Rheumatology Reports examining independent evidence of the analgesic action
of the hormone calcitonin. This publication restated the potential of calcitonin in filling a
significant unmet need for alternative treatments for persistent musculoskeletal pain. Scientists
from Nordic Bioscience were involved in the preparation of this meta-analysis. Non-malignant
musculoskeletal pain is the most common clinical symptom that causes patients to seek medical
attention and is a major cause of disability in the world. Musculoskeletal pain can arise from a
variety of common conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, surgery,
low back pain and bone
15
fracture. The meta-analysis, conducted by researchers at the Center for Sensory-Motor
Interaction in the Department of Health Science and Technology at Aalborg University in Denmark,
examined independent pre-clinical and clinical studies spanning nearly 45 years of the possible
intrinsic analgesic properties of calcitonin, with special focus on the challenges in the
musculoskeletal system. The authors concluded that well-designed clinical trials should be
conducted to further validate evidence of calcitonins analgesic action and its promising potential
role in the management of musculoskeletal pain. The effects of calcitonin on clinical pain
conditions have received increasing attention in the past decades, although a consensus on
mechanism-of-action and potential indications has not been reached. The analgesic activity of oral
salmon calcitonin has been shown in several controlled prospective double-blind studies; besides
pain management in osteoporosis, calcitonin has shown analgesic action in painful conditions such
as phantom limb pain, diabetic neuropathy, complex regional pain syndrome, adhesive capsulitis,
rheumatoid arthritis, vertebral crush fractures, spondylitis, tumor metastasis, cancer pain,
migraine, Pagets disease of bone as well as post-operative pain. An ideal treatment with an
optimal efficacy, safety and convenience profile is not available for the musculoskeletal pain
associated with such conditions as osteoporosis and osteoarthritis. This review of the literature
highlights the clear unmet medical need that could be addressed by Emispheres oral salmon
calcitonin product.
During April 2010, the Company announced the publication of a research study entitled,
Investigation of the Direct Effect of Salmon Calcitonin on Human Osteoarthritic Chondrocytes, by
Nordic Bioscience in the April 5, 2010 edition of the publication BMC Musculoskeletal
Disorders. Oral salmon calcitonin, which uses Emispheres proprietary Eligen®
Technology, is currently being studied in osteoarthritis and osteoporosis by Novartis Pharma AG and
Nordic Bioscience. The study was conducted in vitro on cartilage samples obtained from female
patients undergoing total knee arthroplasty surgery for the treatment of osteoarthritis. The
article describes the growth promoting effects of salmon calcitonin on these cartilage samples. The
study shows that treatment with pharmacological concentrations of calcitonin increases synthesis of
both proteoglycan (proteins and sugars which interweave with collagen) and collagen type II the
key components of articular cartilage. This research is unique and significant as it represents the
first work to look chiefly at the ability of salmon calcitonin to stimulate cartilage synthesis.
These findings provide evidence to substantiate the theory that calcitonin may exert a positive
effect on joint health through its dual action of promoting both bone and cartilage formation.
Novartis is also engaged in research using the Eligen® Technology and PTH1-34 to
develop a safe and effective oral formulation of PTH for the treatment of postmenopausal
osteoporosis, PTH is produced by the parathyroid glands to regulate the amount of calcium and
phosphorus in the body. When used therapeutically, it increases bone density and bone strength to
help prevent fractures. It is approved to treat osteoporosis, a disease associated with a gradual
thinning and weakening of the bones that occurs most frequently in women after menopause. Untreated
postmenopausal osteoporosis can lead to chronic back pain, disabling fractures, and lost mobility.
Novartis conducted a Phase I study in postmenopausal women to determine the safety and tolerability
of oral PTH1-34, a combination of human PTH1-34 and Emispheres delivery agent 5-CNAC, for the
treatment of postmenopausal osteoporosis. The study was designed to assess the bioavailability
profile of increasing doses of PTH1-34 combined with different amounts of 5-CNAC administered
orally. The results, from the single-center, partially-blinded, incomplete cross-over study were
presented October 19, 2009 in a poster session at the 73rd Annual Scientific Meeting of the
American College of Rheumatology in Philadelphia. Study results demonstrated that a single dose of
the novel oral parathyroid hormone PTH1-34, which utilizes Emispheres proprietary
Eligen® Drug Delivery Technology and absorption-enhancing carrier molecule 5-CNAC,
achieved potentially therapeutically relevant exposure and safety profiles similar to those of the
currently available injectable formulation in healthy postmenopausal women.
During April 2010, the Company announced that Novartis Pharma AG initiated a second Phase I
trial for an oral PTH1-34 which uses Emispheres Eligen® Technology, and is in
development for the treatment of postmenopausal osteoporosis. The study is a partially blinded,
placebo controlled, active comparator study to explore the safety, tolerability, pharmacokinetics
and pharmacodynamics in postmenopausal women after daily oral doses of PTH1-34. The study has two
parts (A and B) and will enroll a total of approximately up to 120 postmenopausal women. In Part A
of the trial, ascending doses of oral PTH1-34 using the Eligen® Technology will be
tested for safety, tolerability and pharmacokinetics and compared to Forsteo®. In Part
B, in addition to safety and tolerability of oral PTH1-34 using the Eligen® Technology,
pharmacodynamic responses will be measured by bone biomarker levels and bone mineral density, and
compared to Forsteo®. The first patient was enrolled in April.
Research using the Eligen® Technology and GLP-1, a potential treatment for Type 2
Diabetes is being conducted by Novo Nordisk A/S (Novo Nordisk) and by Dr. Christoph
Beglinger, M.D., of the Clinical Research Center, Department of Biomedicine Division of
Gastroenterology, and Department of Clinical Pharmacology and Toxicology at University Hospital in
Basel, Switzerland. We had previously conducted extensive tests on oral insulin for Type 1 Diabetes
and concluded that a more productive pathway is to move forward with GLP-1 and its analogs, an oral
form of which might be used to treat Type 2 Diabetes and related conditions. Consequently, on
June 21, 2008 we entered into an exclusive Development and License Agreement with Novo Nordisk
focused on the development of oral formulations of Novo Nordisks proprietary GLP-1 receptor
agonists.
During January 2010, we announced that Novo Nordisk had initiated its first Phase I clinical
trial with a long-acting oral GLP-1 analogue (NN9924). This milestone released a $2 million payment
to Emisphere, whose proprietary Eligen® Technology is used in the formulation of NN9924.
GLP-1 (Glucagon-Like Peptide-1) is a natural hormone involved in controlling blood sugar levels. It
16
stimulates the release of insulin only when blood sugar levels become too high. GLP-1
secretion is often impaired in people with Type 2 Diabetes. The aim of this trial, which is being
conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in
healthy volunteers. The trial will enroll approximately 155 individuals and results from the trial
are expected in 2011. There are many challenges in developing an oral formulation of GLP-1, in
particular obtaining adequate bioavailability. NN9924 addresses some of these key challenges by
utilizing Emispheres Eligen® Technology to facilitate absorption from the
gastrointestinal tract.
Our other product candidates in development are in earlier or preclinical research phases, and
we continue to assess them for their compatibility with our technology and market need. Our intent
is to seek partnerships with pharmaceutical and biotechnology companies for certain of these
products. We plan to expand our pipeline with product candidates that demonstrate significant
opportunities for growth. During March 2010, the Company and Alchemia Ltd. (ASX:ACL) announced that
they would join efforts to develop an oral formulation of the anti-coagulant drug fondaparinux with
Emispheres Eligen® Technology. Fondaparinux, an anti-coagulant used for the prevention
of deep vein thrombosis, is marketed in injectable form as Arixtra® by GlaxoSmithKline.
Arixtra® has been off patent since 2002 but, due to the complexity of its synthesis,
there is currently no approved generic or alternative source of commercial scale active
pharmaceutical ingredient (API). Alchemia has developed a novel, patent protected, synthesis for
the manufacture of fondaparinux at commercial scale. In March 2009, Alchemias manufacturing and
U.S. marketing partner, Dr Reddys Laboratories (NYSE: RDY) submitted an ANDA to the U.S. FDA for a
generic version of the injectable form of fondaparinux. The Company believes an oral formulation of
fondaparinux could dramatically increase the market potential for fondaparinux. Based on what we
know from our experience with other chemically-related anti-coagulants, the profile of fondaparinux
should fit very well with the Eligen® Technology given its half life and safety profile.
Although developing an oral formulation of an injectable compound is always challenging, this
project could produce substantial benefits for the medical community. The combination of
Emispheres delivery technology and Alchemias fondaparinux may ultimately allow us to bring an
oral anti-coagulant to market in an accelerated fashion. Alchemia has already seen preclinical data
suggesting that enhanced levels of oral absorption can be achieved for fondaparinux. If the dose
formulated with the Eligen® Technology can be successfully optimized, it could open up a
host of medically and commercially compelling opportunities for fondaparinux, Alchemia plans to
evaluate a number of different formulations initially in order to optimize oral bioavailability and
pharmacokinetics, with the aim of then rapidly moving into human clinical studies.
By focusing on improving operational efficiency, the Company has strengthened its financial
foundation while maintaining its focus on advancing and commercializing the Eligen®
Technology. By closing our research and development facility in Tarrytown, NY and utilizing
independent contractors to conduct essential research and development, we reduced our annual
operating costs by approximately 55% from 2008 levels. Annual cash expenditures were reduced by
approximately $11 million, and the resulting cash burn rate to support continuing operations is
approximately $8 million per year. Additionally, we expect to accelerate the commercialization of
the Eligen® Technology in a cost effective way and to gain operational efficiencies by
tapping into more advanced scientific processes independent contractors can provide.
Results of Operations
Three Months Ended March 31, 2010 Compared to Three Months Ended March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
2010 |
|
|
(in thousands) |
|
|
Change |
|
|
|
|
Revenue |
|
$ |
12 |
|
|
$ |
|
|
|
$ |
12 |
|
Operating expenses |
|
$ |
3,020 |
|
|
$ |
4,659 |
|
|
$ |
(1,639 |
) |
Operating loss |
|
$ |
(3,008 |
) |
|
$ |
(4,659 |
) |
|
$ |
1,651 |
|
Other income (expense) |
|
$ |
(15,457 |
) |
|
$ |
(758 |
) |
|
$ |
(14,699 |
) |
Net loss |
|
$ |
(18,465 |
) |
|
$ |
(5,417 |
) |
|
$ |
(13,048 |
) |
Revenue increased $0.01 million for the three months ended March 31, 2010 compared to the
same period last year due to commercial sales of low dose Eligen® B-12.
Operating expenses decreased $1.6 million or 35% for the three months ended March 31,
2010 in comparison to the same period last year. Details of these changes are highlighted in the
table below:
|
|
|
|
|
|
|
(in thousands) |
Increase in human resources costs |
|
$ |
299 |
|
Decrease in professional fees |
|
|
(895 |
) |
Decrease in occupancy costs |
|
|
(823 |
) |
Decrease in clinical costs |
|
|
(450 |
) |
Decrease in depreciation and amortization |
|
|
(136 |
) |
Increase in other costs |
|
|
366 |
|
|
|
$ |
(1,639 |
) |
17
Human resource costs increased $299 thousand, or 23%, due primarily to a $168 thousand
increase in non-cash compensation and the award of a $150 thousand bonus to the Companys CEO.
Professional fees decreased $895 thousand, or 50%, due primarily to a $703 thousand decreases in
legal fees primarily in connection with the completion of the arbitration with the Companys former
CEO and a $185 thousand decrease in consulting costs.
Occupancy costs decreased $823 thousand, or 90%, due to the closure of our laboratory facilities in
Tarrytown, NY.
Clinical costs decreased $450 thousand, or 78%, due primarily to a $247 thousand decrease in
clinical trial costs, a $175 thousand decrease in outside lab fees associated with the completion
of clinical testing programs and outside lab fees related to oral formulations of the PYY and GLP-1
combination and B12.
Depreciation and amortization costs decreased $136 thousand, or 64%, due to the sales of laboratory
equipment and the write off of certain equipment in connection with the above referenced closure of
the Tarrytown facility.
Other costs increased $403 thousand, or 276%, due primarily to a $353 thousand credit adjustment to
restructuring expense taken during the first quarter 2009 in connection with the closure of the
Tarrytown facility, and a $50 thousand charge to restructuring expense in the first quarter 2010 in
connection with the Amendment to the Lease Termination Agreement for the Tarrytown facility.
Our principal operating costs include the following items as a percentage of total
operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
Human resource costs, including benefits |
|
|
53 |
% |
|
|
28 |
% |
Professional fees for legal, intellectual property, accounting and consulting |
|
|
30 |
% |
|
|
39 |
% |
Occupancy for our laboratory and operating space |
|
|
3 |
% |
|
|
19 |
% |
Clinical costs |
|
|
4 |
% |
|
|
11 |
% |
Depreciation and amortization |
|
|
2 |
% |
|
|
5 |
% |
Other |
|
|
8 |
% |
|
|
-2 |
% |
Other expense increased $14.7 million for the three months ended March 31, 2010 in
comparison to the same period last year primarily due to a $14.1 million increase in the fair value
of derivative instruments due to relative changes in stock price during the three months ended
March 31, 2010 and March 31, 2009 respectively; an increase of $0.3 million in interest expense and
a decrease of $0.3 million in other income due primarily from a $0.2 million decrease in sublease
income in connection with the closure of our Tarrytown facility during 2009.
As a result of the above factors, we had a net loss of $18.5 million for the three months
ended March 31, 2010, compared to a net loss of $5.4 million for the three months ended March 31,
2009.
Liquidity and Capital Resources
Since our inception in 1986, we have generated significant losses from operations and we
anticipate that we will continue to generate significant losses from operations for the foreseeable
future. As of March 31, 2010, our accumulated deficit was approximately $455.1 million and our
stockholders deficit was approximately $65.9 million. Our net loss and operating loss was $18.5
million and $3.0 million, respectively for the three months ended March 31, 2010 and $5.4 million
and $4.7 million respectively for the year ended December 31, 2009.
We have limited capital resources and operations to date have been funded primarily with
the proceeds from collaborative research agreements, public and private equity and debt financings
and income earned on investments. As of March 31, 2010 total cash was $3.3 million including
restricted cash of $0.26 million. The change in cash relates to the net loss offset by changes in
accounts payable and non-cash items. We anticipate that our existing capital resources, without
implementing cost reductions, raising additional capital, or obtaining substantial cash inflows from potential partners for our products, will enable us to continue
operations through approximately June 2010. However, this expectation is based on the current
operating plan that could change as a result of many
18
factors and additional funding may be required sooner than anticipated. These conditions
raise substantial doubt about our ability to continue as a going concern. The audit reports
prepared by our independent registered public accounting firms relating to our financial statements
for the years ended December 31, 2009, 2008 and 2007 include an explanatory paragraph expressing
substantial doubt about our ability to continue as a going concern.
Our business will require substantial additional investment that has not yet been
secured. While our plan is to raise capital when needed and/or to pursue partnering opportunities,
we cannot be sure how much we will need to spend in order to develop, market and manufacture new
products and technologies in the future. We expect to continue to spend substantial amounts on
research and development, including amounts spent on conducting clinical trials for our product
candidates. Further, we will not have sufficient resources to develop fully any new products or
technologies unless we are able to raise substantial additional financing on acceptable terms or
secure funds from new or existing partners. We cannot assure that financing will be available on
favorable terms or at all. Additionally, these conditions may increase the cost to raise capital
and/or result in further dilution. Our failure to raise capital when needed would adversely affect
our business, financial condition and results of operations, and could force us to reduce or cease
our operations.
However, we have implemented aggressive cost control initiatives and management processes
to extend our cash runway. The Company realized a critical milestone in its cost control plan which
will contribute to meeting its cash burn target of between $7 and $8 million per year. We are also
pursing new as well as enhanced collaborations and exploring other financing options, with the
objective of minimizing dilution and disruption.
Off-Balance Sheet Arrangements
As of March 31, 2010, we had no off-balance sheet arrangements, other than operating
leases. There were no changes in significant contractual obligations during the three months ended
March 31, 2010.
Critical Accounting Estimates
Please refer to the Companys Annual Report on Form 10-K filed with the SEC on March 25,
2010 for detailed explanations of its critical accounting estimates which have not changed
significantly during the period ended March 31, 2010.
New Accounting Pronouncements
In October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue Arrangements,
(amendments to FASB ASC Topic 605, Revenue Recognition) (ASU 2009-13). ASU 2009-13 requires
entities to allocate revenue in an arrangement using estimated selling prices of the delivered
goods and services based on a selling price hierarchy. The amendments eliminate the residual method
of revenue allocation and require revenue to be allocated using the relative selling price method.
ASU 2009-13 should be applied on a prospective basis for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010, with early adoption
permitted. The Company does not expect adoption of ASU 2009-13 to have a material impact on the
Companys results of operations or financial condition.
In April 2010, the FASB issue ASU 2010-17, Revenue Recognition Milestone Method (ASU
2010-17). ASU 2010-17 provides guidance on the criteria that should be met for determining
whether the milestone method of revenue recognition is appropriate. A vendor can recognize
consideration that is contingent upon achievement of a milestone in its entirety as revenue in the
period in which the milestone is achieved only if the milestone meets all criteria to be considered
substantive. The following criteria must be met for a milestone to be considered substantive. The
consideration earned by achieving the milestone should 1. Be commensurate with either the level of
effort required to achieve the milestone or the enhancement of the value of the item delivered as a
result of a specific outcome resulting from the vendors performance to achieve the milestone. 2,
Related solely to past performance. 3. Be reasonable relative to all deliverables and payment
terms in the arrangement. No bifurcation of an individual milestone is allowed and there can be
more than one milestone in an arrangement. Accordingly, an arrangement may contain both
substantive and nonsubstantive milestones. ASU 2010-17 is effective on a prospective basis for
milestones achieved in fiscal years, and interim periods within those years, beginning on or after
June 15, 2010. Management is currently evaluating the potential impact of ASU 2010-17 on our
financial statements.
Management does not believe there would have been a material effect on the accompanying
financial statements had any other recently issued, but not yet effective, accounting standards
been adopted in the current period.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Fair Value of Warrants and Derivative Liabilities. At March 31, 2010, the estimated fair
value of derivative instruments was $24.2 million. We estimate the fair values of these instruments
using the Black-Scholes option pricing model which takes into account a variety of factors,
including historical stock price volatility, risk-free interest rates, remaining maturity and the
closing price of our
19
common stock. We believe that the assumption that has the greatest impact on the determination of
fair value is the closing price of our common stock. The following table illustrates the potential
effect of changes in the assumptions used to calculate fair value:
|
|
|
|
|
|
|
Derivatives |
|
|
|
(in thousands) |
|
25% increase in stock price |
|
$ |
7,873 |
|
50% increase in stock price |
|
|
15,901 |
|
5% increase in assumed volatility |
|
|
685 |
|
|
|
|
|
|
25% decrease in stock price |
|
|
(7,478 |
) |
50% decrease in stock price |
|
|
(14,559 |
) |
5% decrease in assumed volatility |
|
|
(600 |
) |
ITEM 4T. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The Companys senior management is responsible for establishing and maintaining a system of
disclosure controls and procedures (as defined in Rule 13a-15 and 15d-15 under the Securities
Exchange Act of 1934 (the Exchange Act)) designed to ensure that information required to be
disclosed by the Company in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the Securities
and Exchange Commissions rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by
an issuer in the reports that it files or submits under the Exchange Act is accumulated and
communicated to the issuers management, including its principal executive officer or officers and
principal financial officer or officers, or persons performing similar functions, as appropriate to
allow timely decisions regarding required disclosure.
The Company has evaluated the effectiveness of the design and operation of its disclosure
controls and procedures under the supervision of and with the participation of management,
including the Chief Executive Officer and Chief Financial Officer, as of the end of the period
covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial
Officer have concluded that our disclosure controls and procedures are effective.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during the three
month period ended March 31, 2010 that materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
PART II
ITEM 1. LEGAL PROCEEDINGS
In April 2005, the Company entered into an amended and restated employment agreement with
its then Chief Executive Officer, Dr. Michael M. Goldberg, for services through July 31, 2007. On
January 16, 2007, the Board of Directors terminated Dr. Goldbergs services. On April 26, 2007, the
Board of Directors held a special hearing at which it determined that Dr. Goldbergs termination
was for cause. On March 22, 2007, Dr. Goldberg, through his counsel, filed a demand for arbitration
asserting that his termination was without cause and seeking $1,048,000 plus attorneys fees,
interest, arbitration costs and other relief alleged to be owed to him in connection with his
employment agreement with the Company. During the arbitration, Dr. Goldberg sought a total damage
amount of at least $9,223,646 plus interest. On February 11, 2010, the arbitrator issued the final
award in favor of Dr. Goldberg for a total amount of approximately $2,333,115 as full and final
payment for all claims, defenses, counterclaims, and related matters. As a result of the February
11, 2010 final award, the Company adjusted its estimate of costs to settle this matter to
$2,333,115. If the awards are upheld and confirmed in court, the Company will be required to make
final payment to Dr. Goldberg.
ITEM 1A. RISK FACTORS
The following risk factors should be read carefully in connection with evaluating our
business and the forward-looking statements that we make in this Report and elsewhere (including
oral statements) from time to time. Any of the following risks could materially and adversely
affect our business, our operating results, our financial condition and the actual outcome of
matters as to which forward-looking statements are made in this Report. Our business is subject to
many risks, which are detailed further in our Annual Report on Form 10-K , including:
20
Financial Risks
|
|
|
We have a history of operating losses and we may never achieve
profitability. If we continue to incur losses or we fail to raise
additional capital or receive substantial cash inflows from our
partners by June 2010, we may be forced to cease operations. |
|
|
|
|
We may not be able to make the payments we owe to Novartis Pharma AG. |
|
|
|
|
The audit opinion issued by our independent registered public
accounting firm relating to our financial statements for the year
ended December 31, 2009 contained a going concern explanatory
paragraph. |
|
|
|
|
We may not be able to meet the covenants detailed in the Convertible
Notes with MHR Institutional Partners IIA LP, which could result in
an increase in the interest rate on the Convertible Notes and/or
accelerated maturity of the Convertible Notes, which we would not be
able to satisfy. |
|
|
|
|
Our stock was de-listed from NASDAQ. |
Risks Related to our Business
|
|
|
Our business will suffer if we fail or are delayed in developing and commercializing an improved oral form of
Vitamin B12. |
|
|
|
|
We are highly dependent on the clinical success of our product candidates. |
|
|
|
|
We are highly dependent upon collaborative partners to develop and commercialize compounds using our delivery agents. |
|
|
|
|
Our collaborative partners control the clinical development of certain of our drug candidates and may terminate
their efforts at will. |
|
|
|
|
Our product candidates are in various stages of development, and we cannot be certain that any will be suitable for
commercial purposes. |
|
|
|
|
Our collaborative partners are free to develop competing products. |
|
|
|
|
Our business will suffer if we cannot adequately protect our patent and proprietary rights. |
|
|
|
|
We may be at risk of having to obtain a license from third parties making proprietary improvements to our technology. |
|
|
|
|
We are dependent on third parties to manufacture and, in some cases, test our products. |
|
|
|
|
We are dependent on our key personnel and if we cannot recruit and retain leaders in our research, development,
manufacturing, and commercial organizations, our business will be harmed. |
Risks Related to our Industry
|
|
|
Our future business success depends heavily upon regulatory approvals, which can be difficult to obtain
for a variety of reasons, including cost. |
|
|
|
|
We may face product liability claims related to participation in clinical trials for future products. |
|
|
|
|
We are subject to environmental, health and safety laws and regulations for which we incur costs to comply. |
|
|
|
|
We face rapid technological change and intense competition. |
Other Risks
|
|
|
Provisions of our corporate charter documents, Delaware law, our financing documents and our
stockholder rights plan may dissuade potential acquirers, prevent the replacement or removal of our
current management and members of our Board of Directors and may thereby affect the price of our
common stock. |
21
|
|
|
Our stock price has been and may continue to be volatile. |
|
|
|
|
Future sales of common stock or warrants, or the prospect of future sales, may depress our stock price. |
For a more complete listing and description of these and other risks that the
Company faces, please see our Annual Report for 2009 on Form 10-K as filed with the SEC on
March 25, 2010.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On April 5, 2010, Rodman & Renshaw, LLC (Rodman) notified the Company of its intention to
exercise part of its warrants to purchase 504,000 shares of common stock at an exercise price of
$0.875, using the cashless exercise provision. The Company issued 297,636 shares of common stock
to Rodman on April 5, 2010. On April 30, 2010, Rodman notified the Company of its intention to
exercise the remaining outstanding portion of the Warrant using the cashless exercise provision.
The Company issued an additional 27,192 shares of common stock to the purchase agent on April 30,
2010. After this cashless exercise, the August 2009 Equity Financing Placement Agent Warrants are
no longer outstanding.
On April 20, 2010, Elan Corporation, plc (Elan) notified the Company of its intention to
exercise its warrant to purchase up to 600,000 shares of the Companys common stock at an exercise
price of $0.4635 (as adjusted pursuant to the terms of the warrant) using the cashless exercise
provision. On April 21, 2010, the Company issued 518,206 shares of common stock to Elan.
For these issuances, the Company is relying on the exemption from federal registration under
Section 4(2) of the Securities Act of 1933, as amended.
ITEM 5. OTHER EVENTS
The Compensation Committee of Emisphere Technologies, Inc. (Emisphere) approved, pursuant to
the terms of its 2007 Stock Award and Incentive Plan (the 2007 Plan) new forms of incentive stock
option and non-qualified option agreements (the New Form Agreements) in order to provide for
accelerated vesting of options issued pursuant to the 2007 Plan upon a change in control of
Emisphere (as defined therein). The Compensation Committee also approved, pursuant to the terms of
its 2000 Stock Option Plan (the 2000 Plan and together with the 2007 Plan the Plans) and the
2007 Plan, that the terms of all unvested options currently outstanding under the Plans are amended
to provide for acceleration of vesting of such options upon such a change of control of Emisphere.
Such amendments to the outstanding options shall be effective upon acceptance by the individual
option holders.
22
ITEM 6. EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibit |
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Emisphere
Technologies, Inc., as amended by the Certificate of Amendment
of Amended and Restated Certificate of Incorporation of
Emisphere Technologies, Inc., dated April 20, 2007 (filed as
Exhibit 3.1 to the Quarterly Report on Form 10-Q for the
fiscal quarter ended March 31, 2007 and incorporated herein by
reference). |
|
|
|
3.2
|
|
By-Laws of Emisphere Technologies, Inc., as amended
December 7, 1998 (filed as Exhibit 3(ii) to the Quarterly
Report on Form 10-Q for the quarterly period ended January 31,
1999) and as further amended on September 23, 2005 (filed as
Exhibit 3.1 to the Current Report on Form 8-K filed on
September 30, 2005 and incorporated herein by reference). |
|
|
|
3.3
|
|
Amendment, effective as of September 11, 2007, to the Amended
By-Laws of Emisphere Technologies, Inc. (filed as Exhibit 3.1
to the Current Report on Form 8-K filed on September 14, 2007
and incorporated herein by reference). |
|
|
|
4.1
|
|
Restated Rights Agreement dated as of April 7, 2006 between
Emisphere Technologies, Inc. and Mellon Investor Services, LLC
(filed as Exhibit 1.1 to the Current Report on Form 8-K filed
on April 10, 2006 and incorporated herein by reference. |
|
|
|
10.1
|
|
Agreement to Extend the Maturity Date of the Convertible
Promissory Note Due December 1, 2009, between Emisphere
Technologies and Novartis Pharma AG dated February 23, 2010
(filed as Exhibit 10.68 to the Annual Report on Form 10-K
filed on March 25, 2010 and incorporated herein by reference). |
|
|
|
10.2
|
|
Form of Incentive Stock Option Agreement under the Emisphere
Technologies, Inc. 2007 Stock Award and Incentive Plan. |
|
|
|
10.3
|
|
Form of Non-Qualified Stock Option Agreement under the
Emisphere Technologies, Inc. 2007 Stock Award and Incentive
Plan. |
|
|
|
31.1
|
|
Certification of the 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 (filed herewith). |
|
|
|
31.2
|
|
Certification of the 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 (filed herewith). |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to section 906 of the Sarbanes- Oxley Act of 2002
(furnished herewith). |
23
SIGNATURES
Pursuant to the requirement 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.
|
|
|
|
|
|
Emisphere Technologies, Inc.
|
|
Date: May 17, 2010 |
/s/ Michael V. Novinski
|
|
|
Michael V. Novinski |
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
Date: May 17, 2010 |
/s/ Michael R. Garone
|
|
|
Michael R. Garone |
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
24
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibit |
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Emisphere
Technologies, Inc., as amended by the Certificate of Amendment
of Amended and Restated Certificate of Incorporation of
Emisphere Technologies, Inc., dated April 20, 2007 (filed as
Exhibit 3.1 to the Quarterly Report on Form 10-Q for the
fiscal quarter ended March 31, 2007 and incorporated herein by
reference). |
|
|
|
3.2
|
|
By-Laws of Emisphere Technologies, Inc., as amended
December 7, 1998 (filed as Exhibit 3(ii) to the Quarterly
Report on Form 10-Q for the quarterly period ended January 31,
1999) and as further amended on September 23, 2005 (filed as
Exhibit 3.1 to the Current Report on Form 8-K filed on
September 30, 2005 and incorporated herein by reference). |
|
|
|
3.3
|
|
Amendment, effective as of September 11, 2007, to the Amended
By-Laws of Emisphere Technologies, Inc. (filed as Exhibit 3.1
to the Current Report on Form 8-K, filed on September 14, 2007
and incorporated herein by reference). |
|
|
|
4.1
|
|
Restated Rights Agreement dated as of April 7, 2006 between
Emisphere Technologies, Inc. and Mellon Investor Services, LLC
(filed as Exhibit 1.1 to the Current Report on Form 8-K filed
April 10, 2006 and incorporated herein by reference. |
|
|
|
10.1
|
|
Agreement to Extend the Maturity Date of the Convertible
Promissory Note Due December 1, 2009, between Emisphere
Technologies and Novartis Pharma AG dated February 23, 2010
(filed as Exhibit 10.68 to the Annual Report on Form 10-K
filed on March 25, 2010 and incorporated herein by reference). |
|
|
|
10.2
|
|
Form of Incentive Stock Option Agreement under the Emisphere
Technologies, Inc. 2007 Stock Award and Incentive Plan. |
|
|
|
10.3
|
|
Form of Non-Qualified Stock Option Agreement under the
Emisphere Technologies, Inc. 2007 Stock Award and Incentive
Plan. |
|
|
|
31.1
|
|
Certification of the 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 (filed herewith). |
|
|
|
31.2
|
|
Certification of the 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 (filed herewith). |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to section 906 of the Sarbanes- Oxley Act of 2002
(furnished herewith). |
25