e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934. |
For the quarterly period ended June 30, 2008
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 No. 1-15803
AVANIR PHARMACEUTICALS
(Exact name of registrant as specified in its charter)
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California |
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(State or other jurisdiction of
incorporation or organization)
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33-0314804
(I.R.S. Employer Identification No.) |
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101 Enterprise Suite 300, Aliso Viejo, California
(Address of principal executive offices)
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92656
(Zip Code) |
(949) 389-6700
(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 and Exchange Act of 1934 during the preceding 12 months (or
for such shorter periods that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. YES
þ NO o
Indicate by check mark whether the registrant is 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
As of July 31, 2008, the registrant had 78,202,560 shares of common stock issued and outstanding.
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
AVANIR PHARMACEUTICALS
CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, |
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September 30, |
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2008 |
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2007 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
46,997,243 |
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$ |
30,487,962 |
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Short-term investments in marketable securities |
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1,747,761 |
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Receivables, net |
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1,710,980 |
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988,450 |
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Inventories |
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17,000 |
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17,000 |
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Prepaid expenses |
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745,007 |
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1,479,992 |
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Other current assets |
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636,053 |
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Current portion of restricted investments in marketable securities |
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388,122 |
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688,122 |
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Total current assets |
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50,494,405 |
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35,409,287 |
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Investments in marketable securities |
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249,078 |
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Restricted investments in marketable securities, net of current portion |
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468,475 |
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468,475 |
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Property and equipment, net |
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904,659 |
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1,215,666 |
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Intangible assets, net |
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21,005 |
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41,048 |
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Long-term inventories |
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1,316,277 |
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1,337,991 |
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Other assets |
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345,444 |
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374,348 |
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TOTAL ASSETS |
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$ |
53,550,265 |
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$ |
39,095,893 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,651,722 |
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$ |
307,700 |
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Accrued expenses and other liabilities |
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1,341,019 |
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2,050,864 |
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Accrued compensation and payroll taxes |
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955,294 |
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1,191,677 |
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Current portion of deferred revenues |
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2,571,103 |
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2,267,594 |
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Current portion of notes payable |
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46,818 |
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254,676 |
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Current liabilities of discontinued operations |
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1,351,649 |
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Total current liabilities |
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7,917,605 |
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6,072,511 |
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Accrued expenses and other liabilities, net of current portion |
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941,078 |
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1,170,396 |
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Deferred revenues, net of current portion |
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10,843,035 |
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13,052,836 |
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Notes payable, net of current portion |
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11,769,916 |
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Total liabilities |
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19,701,718 |
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32,065,659 |
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Commitments and contingencies (Note 13)
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Shareholders equity: |
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Preferred stock no par value, 10,000,000 shares authorized, no shares
issued or outstanding as of June 30, 2008 and September 30, 2007 |
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Common stock no par value, 200,000,000 shares authorized;
78,202,560 and 43,117,358 shares issued and outstanding as of
June 30, 2008 and September 30, 2007, respectively |
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284,626,146 |
|
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245,531,712 |
|
Accumulated deficit |
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(250,778,126 |
) |
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(238,498,733 |
) |
Accumulated other comprehensive income (loss) |
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527 |
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(2,745 |
) |
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Total shareholders equity |
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33,848,547 |
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7,030,234 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
53,550,265 |
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$ |
39,095,893 |
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The accompanying notes to condensed consolidated financial statements are an integral part of this statement.
3
AVANIR PHARMACEUTICALS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
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Three Months Ended June 30, |
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Nine Months Ended June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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REVENUES FROM PRODUCT SALES |
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Net revenues |
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$ |
3,550 |
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$ |
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$ |
129,820 |
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$ |
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Cost of revenues |
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21,714 |
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Product gross margin |
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3,550 |
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108,106 |
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REVENUES AND COST OF RESEARCH SERVICES AND OTHER |
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Revenues from research and development services |
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181,692 |
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2,372,384 |
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Revenues from government research grant services |
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527,517 |
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122,398 |
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1,006,922 |
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475,474 |
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Revenues from license agreements |
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1,534,552 |
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1,443,543 |
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1,648,459 |
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1,556,827 |
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Revenue from royalties |
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584,314 |
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453,091 |
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2,993,992 |
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1,955,804 |
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Revenues from research services and other |
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2,646,383 |
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2,200,724 |
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5,649,373 |
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6,360,489 |
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Cost of research and development services |
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(155,450 |
) |
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(1,202,476 |
) |
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(232,257 |
) |
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(2,973,715 |
) |
Cost of government research grant services |
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(358,028 |
) |
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(201,178 |
) |
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(915,563 |
) |
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(666,166 |
) |
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Research services and other gross margin |
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2,132,905 |
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797,070 |
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4,501,553 |
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2,720,608 |
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Total gross margin |
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2,136,455 |
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797,070 |
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4,609,659 |
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2,720,608 |
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OPERATING EXPENSES |
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Research and development |
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3,139,685 |
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2,604,294 |
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10,090,610 |
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13,769,286 |
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Selling, general and administrative |
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2,350,071 |
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7,469,784 |
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7,897,085 |
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18,885,623 |
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Total operating expenses |
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5,489,756 |
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10,074,078 |
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17,987,695 |
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32,654,909 |
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Loss from operations |
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(3,353,301 |
) |
|
|
(9,277,008 |
) |
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(13,378,036 |
) |
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(29,934,301 |
) |
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OTHER INCOME (EXPENSES) |
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Interest income |
|
|
315,818 |
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|
88,916 |
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|
1,026,204 |
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|
425,254 |
|
Interest expense |
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|
(114,375 |
) |
|
|
(232,939 |
) |
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|
(539,589 |
) |
|
|
(785,632 |
) |
Gain on early extinguishment of debt |
|
|
967,547 |
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|
|
|
|
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|
967,547 |
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|
Other, net |
|
|
1,249,764 |
|
|
|
1,418,725 |
|
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|
1,250,950 |
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1,614,048 |
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|
Loss from continuing operations before provision for income taxes |
|
|
(934,547 |
) |
|
|
(8,002,306 |
) |
|
|
(10,672,924 |
) |
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|
(28,680,631 |
) |
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|
|
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|
Provision for income taxes |
|
|
22,148 |
|
|
|
8,097 |
|
|
|
37,307 |
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|
21,501 |
|
|
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|
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|
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|
Loss before discontinued operations |
|
|
(956,695 |
) |
|
|
(8,010,403 |
) |
|
|
(10,710,231 |
) |
|
|
(28,702,132 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
(483,680 |
) |
|
|
(1,139,976 |
) |
|
|
(1,569,162 |
) |
|
|
(4,316,136 |
) |
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|
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|
Net loss |
|
$ |
(1,440,375 |
) |
|
$ |
(9,150,379 |
) |
|
$ |
(12,279,393 |
) |
|
$ |
(33,018,268 |
) |
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BASIC AND DILUTED NET LOSS PER SHARE: |
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|
Loss from continuing operations |
|
$ |
(0.01 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.81 |
) |
Loss from discontinued operations |
|
|
(0.01 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.12 |
) |
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|
Net loss per share |
|
$ |
(0.02 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.93 |
) |
|
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|
Basic and diluted weighted average number of common shares outstanding |
|
|
71,069,841 |
|
|
|
40,580,326 |
|
|
|
52,418,695 |
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|
|
35,546,976 |
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|
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|
The accompanying notes to condensed consolidated financial statements are an integral part of this statement.
4
AVANIR PHARMACEUTICALS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
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Nine Months Ended June 30, |
|
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|
2008 |
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|
2007 |
|
OPERATING ACTIVITIES: |
|
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|
|
|
|
|
|
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|
|
|
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|
|
Net loss |
|
$ |
(12,279,393 |
) |
|
$ |
(33,018,268 |
) |
Loss from discontinued operations |
|
|
1,569,162 |
|
|
|
4,316,136 |
|
Adjustments to reconcile loss before discontinued operations to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
335,049 |
|
|
|
2,718,065 |
|
Share-based compensation expense |
|
|
1,257,538 |
|
|
|
1,702,826 |
|
Amortization of debt discount |
|
|
232,776 |
|
|
|
183,000 |
|
Gain on extinguishment of debt |
|
|
(967,547 |
) |
|
|
|
|
Loss on disposal of assets |
|
|
638 |
|
|
|
163,570 |
|
Changes in operating assets and liabilities (net of effects of acquisition/disposition of FazaClo): |
|
|
|
|
|
|
|
|
Receivables |
|
|
(722,528 |
) |
|
|
375,998 |
|
Inventories |
|
|
21,714 |
|
|
|
(1,071,254 |
) |
Prepaid and other assets |
|
|
134,849 |
|
|
|
960,523 |
|
Accounts payable |
|
|
1,344,022 |
|
|
|
(9,622,311 |
) |
Accrued expenses and other liabilities |
|
|
(939,163 |
) |
|
|
2,514,054 |
|
Accrued compensation and payroll taxes |
|
|
(236,383 |
) |
|
|
(1,119,331 |
) |
Deferred revenue |
|
|
(1,906,292 |
) |
|
|
(3,303,885 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities of continuing operations |
|
|
(12,155,558 |
) |
|
|
(35,200,877 |
) |
Net cash (used in) provided by operating activities of discontinued operations |
|
|
(203,608 |
) |
|
|
3,706,605 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(12,359,166 |
) |
|
|
(31,494,272 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Investments in securities |
|
|
|
|
|
|
(351,403 |
) |
Proceeds from sales and maturities of investments in securities |
|
|
2,300,107 |
|
|
|
16,900,000 |
|
Purchase of property and equipment |
|
|
(16,550 |
) |
|
|
(137,254 |
) |
Proceeds from sales of fixed assets |
|
|
4,900 |
|
|
|
457,420 |
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
2,288,457 |
|
|
|
16,868,763 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from issuances of common stock and warrants, net of commissions
and offering costs |
|
|
37,851,772 |
|
|
|
30,829,882 |
|
Tax withholding payments reimbursed by restricted stock |
|
|
(28,779 |
) |
|
|
|
|
Payments on notes and capital lease obligations |
|
|
(11,243,003 |
) |
|
|
(6,694,582 |
) |
|
|
|
|
|
|
|
Net cash provided by financing activities of continuing operations |
|
|
26,579,990 |
|
|
|
24,135,300 |
|
Net cash used in financing activities of discontinued operations |
|
|
|
|
|
|
(6,869,435 |
) |
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
26,579,990 |
|
|
|
17,265,865 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
16,509,281 |
|
|
|
2,640,356 |
|
Cash and cash equivalents at beginning of period |
|
|
30,487,962 |
|
|
|
4,898,214 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
46,997,243 |
|
|
$ |
7,538,570 |
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
446,058 |
|
|
$ |
1,151,361 |
|
Income taxes paid |
|
$ |
37,307 |
|
|
$ |
21,501 |
|
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase price adjustment of assumed liabilities |
|
$ |
|
|
|
$ |
4,067,889 |
|
Issuance of note payable |
|
$ |
|
|
|
$ |
4,000,000 |
|
Accrued liabilities of discontinued operations in connection
with Net Working Capital Adjustment |
|
$ |
1,351,649 |
|
|
$ |
|
|
The accompanying notes to condensed consolidated financial statements are an integral part of this statement.
5
AVANIR PHARMACEUTICALS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements of Avanir
Pharmaceuticals (Avanir, we, or the Company) have been prepared in accordance with
the rules and regulations of the Securities and Exchange Commission (SEC) for interim reporting
including the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. These condensed statements
do not include all disclosures required by accounting principles generally accepted in the United
States of America (U.S. GAAP) for annual audited financial statements and should be read in
conjunction with the Companys audited consolidated financial statements and related notes included
in the Companys Annual Report on Form 10-K for the year ended September 30, 2007. The Company
believes these condensed consolidated financial statements reflect all adjustments (consisting only
of normal, recurring adjustments) that are necessary for a fair presentation of the financial
position and results of operations for the periods presented. Results of operations for the interim
periods presented are not necessarily indicative of results to be expected for the year. Certain
prior period amounts have been reclassified to conform to the current period presentation.
The preparation of financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amounts, and the disclosures of commitments and
contingencies in the financial statements and accompanying notes. Actual results could differ from
those estimates.
On August 3, 2007, the Company
sold its rights to the FazaClo® product and the related assets and
operations. The sale was made pursuant to an agreement entered into with Azur Pharma, Inc. (Azur)
in July 2007. In connection with the sale, the Company transferred certain assets and liabilities
related to FazaClo to Azur. The accompanying unaudited condensed consolidated financial statements
of Avanir Pharmaceuticals include adjustments to reflect the classification of the
Companys FazaClo business as discontinued operations. See Note 3 in the Notes to the Condensed
Consolidated Financial Statements for information on discontinued operations.
2. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of Business
Avanir Pharmaceuticals is a pharmaceutical company focused on acquiring, developing and
commercializing novel therapeutic products for the treatment of chronic diseases. The Companys
product candidates address therapeutic markets that include the central nervous system,
inflammatory diseases and infectious diseases. The Companys lead product candidate,
ZenviaTM (dextromethorphan hydrobromide/quinidine sulfate), is currently in Phase III
clinical development for the treatment of pseudobulbar affect (PBA) and diabetic peripheral
neuropathic pain (DPN pain). The Companys first commercialized product, docosanol 10% cream,
(sold as Abreva® by its marketing partner GlaxoSmithKline Consumer Healthcare in North America) is
the only over-the-counter treatment for cold sores that has been approved by the FDA. The Companys
inflammatory disease program, which targets macrophage migration inhibitory factor (MIF), is
currently partnered with Novartis. The Companys infectious disease program has historically been
focused primarily on anthrax antibodies. In March 2008, the Company sold the rights to its anthrax
antibody program to Emergent Biosolutions (see Note 15).
The Companys operations are subject to certain risks and uncertainties frequently encountered by
companies in similar stages of operations, particularly in the evolving market for small biotech
and specialty pharmaceuticals companies. Such risks and uncertainties include, but are not limited
to, timing and uncertainty of achieving milestones in clinical trials and in obtaining approvals by
the FDA and regulatory agencies in other countries. The Companys ability to generate
revenues in the future will depend principally on 1) ultimately attaining market acceptance of
Zenvia (formerly referred to as Neurodex) for the treatment of PBA, assuming the FDA approves the
Companys new drug application, 2) the timing and success of reaching development milestones, 3)
obtaining regulatory approvals and 4) license arrangements. The Companys operating expenses depend
substantially on the level of expenditures for clinical development activities for Zenvia for the
treatment of PBA and DPN pain, and program funding for Xenerex authorized by the Companys research
grant and the rate of progress being made on
6
such programs. The NIH/NIAID grant (NIH grant), which funded the anthrax antibody program,
expired on June 30, 2008. All work was completed under the grant. In connection with the anthrax
antibody program, we also ceased all future research and development work related to the Xenerex
program on June 30, 2008.
Concentrations
Substantially all of the Companys cash and cash equivalents are maintained with two major
financial institutions in the United States. Deposits held with banks may exceed the amount of
insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and,
therefore, bear minimal risk.
Financial instruments that potentially subject the Company to concentrations of credit risk consist
principally of cash and cash equivalents, interest rate instruments and accounts receivable. The
holder of the Companys interest rate instrument is a major financial institution of high credit
standing.
Income Taxes
On July 13, 2006, the Financial Accounting Standards Board (FASB) issued Financial Interpretation
(FIN) No. 48, Accounting for Uncertainty in Income Taxes An Interpretation of FASB Statement
No. 109 . FIN No. 48 clarifies the accounting for uncertainty in income taxes recognized in an
entitys financial statements in accordance with SFAS No. 109, Accounting for Income Taxes, and
prescribes a recognition threshold and measurement attributes for financial statement disclosure of
tax positions taken or expected to be taken on a tax return. Under FIN No. 48, the impact of an
uncertain income tax position on the income tax return must be recognized at the largest amount
that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An
uncertain income tax position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, FIN No. 48 provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure and transition. FIN No. 48 is effective
for fiscal years beginning after December 15, 2006.
The Company adopted the provisions of FIN No. 48 on October 1, 2007. The total amount of
unrecognized tax benefits as of the date of adoption was $3.0 million. As a result of the
implementation of FIN No. 48, the Company recognized a $2.6 million decrease in deferred tax assets
and a corresponding decrease in the valuation allowance. There are no unrecognized tax benefits
included in the consolidated balance sheet that would, if recognized, affect the effective tax
rate.
The Companys policy is to recognize interest and/or penalties related to income tax matters in
income tax expense. The Company had $0 accrued for interest and penalties on the Companys
condensed consolidated balance sheets at September 30, 2007 and at June 30, 2008, and has
recognized $0 in interest and/or penalties in the condensed consolidated statements of operations
for the three and nine months ended June 30, 2008.
The Company is subject to taxation in the U.S. and various state jurisdictions. The Companys tax
years for 1992 and forward are subject to examination by the U.S. and California tax authorities
due to the carryforward of unutilized net operating losses and research and development credits.
Revenue Recognition
The Company has historically generated revenues from product sales, collaborative research and
development arrangements, and other commercial arrangements such as, royalties, the sale of royalty
rights and sales of technology rights. Payments received under such arrangements may include
non-refundable fees at the inception of the arrangements, milestone payments for specific
achievements designated in the agreements, royalties on sales of products resulting from
collaborative arrangements, and payments for the sale of rights to future royalties.
The Company recognizes revenue in accordance with the SECs Staff Accounting Bulletin Topic 13
(Topic 13), Revenue Recognition. Revenue is recognized when all of the following criteria are
met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have
been rendered; (3) the sellers price to the buyer is fixed and determinable; and (4)
collectibility is reasonably assured. Certain product sales are subject to rights of return. In
accordance with Statement of Financial Accounting Standards No. 48, Revenue Recognition When Right
of Return Exists (FAS 48), the Company recognizes such product revenues at the time of sale only
if it has met
7
all the criteria of FAS 48, including the ability to reasonably estimate future returns. FAS 48
states that revenue from sales transactions where the buyer has the right to return the product
shall be recognized at the time of sale only if (1) the sellers price to the buyer is
substantially fixed or determinable at the date of sale, (2) the buyer has paid the seller, or the
buyer is obligated to pay the seller and the obligation is not contingent on resale of the product,
(3) the buyers obligation to the seller would not be changed in the event of theft or physical
destruction or damage of the product, (4) the buyer acquiring the product for resale has economic
substance apart from that provided by the seller, (5) the seller does not have significant
obligations for future performance to directly bring about resale of the product by the buyer, and
(6) the amount of future returns can be reasonably estimated. The Company recognizes such product
revenues when either it has met all the criteria of FAS 48, including that ability to reasonably
estimate future returns, when it can reasonably estimate that the return privilege has
substantially expired, or when the return privilege has substantially expired, whichever occurs
first.
The Company allocates amounts to separate elements in multiple element arrangements in accordance
with Emerging Issues Task Force Issue No. 00-21 (EITF 00-21), Accounting for Revenue
Arrangements with Multiple Deliverables. Revenues are allocated to a delivered product or service
when all of the following criteria are met: (1) the delivered item has value to the customer on a
standalone basis; (2) there is objective and reliable evidence of the fair value of the undelivered
item; and (3) if the arrangement includes a general right of return relative to the delivered item,
delivery or performance of the undelivered item is considered probable and substantially in the
Companys control. The Company uses the relative fair values of the separate deliverables to
allocate revenue. For arrangements with multiple elements that are separated, the Company
recognizes revenues in accordance with Topic 13. Revenue is recognized when all of the following
criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or
services have been rendered; (3) the sellers price to the buyer is fixed and determinable; and (4)
collectibility is reasonably assured. Certain sales transactions include multiple deliverables.
Product Sales
Active Pharmaceutical Ingredient Docosanol (API Docosanol). Revenue from sales of the
Companys API Docosanol is recorded when title and risk of loss have passed to the buyer and
provided the criteria in SAB Topic 13 are met. The Company sells the API Docosanol to various
licensees upon receipt of a written order for the materials. Shipments generally occur fewer
than five times a year. The Companys contracts for sales of the API Docosanol include buyer
acceptance provisions that give the Companys buyers the right of replacement if the delivered
product does not meet specified criteria. That right requires that they give the Company notice
within 30 days after receipt of the product. The Company has the option to refund or replace any
such defective materials; however, it has historically demonstrated that the materials shipped
from the same pre-inspected lot have consistently met the specified criteria and no buyer has
rejected any of the Companys shipments from the same pre-inspected lot to date. Therefore, the
Company recognizes revenue at the time of delivery without providing any returns reserve.
FazaClo. (Sales from Discontinued Operations). In August 2007, the Company sold FazaClo and all
associated operations to Azur and as a result, all revenues, cost of revenues, and operating
expenses related to FazaClo for fiscal 2007 have been classified as discontinued operations in
the accompanying condensed consolidated financial statements (See Note 3 Acquisition of Alamo
Pharmaceuticals, Inc. / Sale of FazaClo).
As discussed in Note 3, Acquisition of Alamo Pharmaceuticals, Inc. / Sale of FazaClo , the
Company acquired Alamo Pharmaceuticals LLC (Alamo) on May 24, 2006, with one marketed product,
FazaClo (clozapine, USP), that began shipping to wholesale customers in July 2004 in 48-pill
boxes. At that time, FazaClo had a two-year shelf life. In June 2005, Alamo received FDA
approval to extend the product expiration date to three years. In October 2005, Alamo began
shipping 96-pill boxes and accepted returns of unsold or undispensed 48-pill boxes.
During fiscal 2007, the Company sold FazaClo to pharmaceutical wholesalers. They resold the
Companys product to outlets such as pharmacies, hospitals and other dispensing organizations.
The Company had agreements with its wholesale customers, various states, hospitals, certain
other medical institutions and third-party payers throughout the U.S. These agreements
frequently contained commercial incentives, which may have included pricing allowances and
discounts payable at the time the product was sold to the dispensing outlet or upon dispensing
the product to patients. Consistent with pharmaceutical industry practice, wholesale
8
customers can return purchased product during an 18-month period that begins six months prior to
the products expiration date and ends 12 months after the expiration date. Additionally,
several of the Companys dispensing outlets have the right to return expired product at any
time. Once products have been dispensed to patients the right of return expires. However, upon
the sale of the FazaClo assets, Azur assumed all future liabilities for returns and allowances
related to the FazaClo sales that were made by the Company. Therefore, as of the date of the
sale of the FazaClo assets, the Company no longer had responsibility for returns and allowances
related to its sales of FazaClo.
Beginning in the first quarter of fiscal 2007, the Company obtained third-party information
regarding certain wholesaler inventory levels, a sample of outlet inventory levels and
third-party market research data regarding FazaClo sales. The third-party data included, (i) IMS
Health Audit National Sales Perspective reports (NSP), which is a projection of near-census
data of wholesaler shipments of product to all outlet types, including retail and non-retail
and; (ii) IMS Health National Prescription Audit (NPA) Syndicated data, which captures
end-user consumption from retail dispensed prescriptions based upon projected data from
pharmacies estimated to represent approximately 60% to 70% of the U.S. prescription universe.
Further, the Company analyzed historical rebates and chargebacks earned by State Medicaid,
Medicare Part D and managed care customers. Based upon this additional information and analysis
obtained, the Company estimated the amount of product that was shipped that was no longer in the
wholesale or outlet channels, and hence no longer subject to a right of return. Therefore, the
Company began recognizing revenues, net of returns, chargebacks, rebates, and discounts, in the
first quarter of fiscal 2007, for product that it estimated had been sold to patients and that
was no longer subject to a right of return.
FazaClo product revenues were recorded net of provisions for estimated product pricing
allowances including: State Medicaid base and supplemental rebates, Medicare Part D discounts,
managed care contract discounts and prompt payment discounts were at an aggregate rate of
approximately 25.8% of gross revenues for the fiscal year ended September 30, 2007. Provisions
for these allowances were estimated based upon contractual terms and require management to make
estimates regarding customer mix to reach. The Company considered its current contractual rates
with States related to Medicaid base and supplemental rebates, with private organizations for
Medicare Part D discounts and contracts with managed care organizations.
Multiple Element Arrangements.
The Company has arrangements whereby it delivers to the customer multiple elements including
technology and/or services. Such arrangements have generally included some combination of the
following: antibody generation services; licensed rights to technology, patented products,
compounds, data and other intellectual property; and research and development services. In
accordance with EITF 00-21, the Company analyzes its multiple element arrangements to determine
whether the elements can be separated. The Company performs its analysis at the inception of the
arrangement and as each product or service is delivered. If a product or service is not separable,
the combined deliverables will be accounted for as a single unit of accounting.
When a delivered element meets the criteria for separation in accordance with EITF 00-21, the
Company allocates amounts based upon the relative fair values of each element. The Company
determines the fair value of a separate deliverable using the price it charges other customers when
it sells that product or service separately; however, if the Company does not sell the product or
service separately, it uses third-party evidence of fair value. The Company considers licensed
rights or technology to have standalone value to its customers if it or others have sold such
rights or technology separately or its customers can sell such rights or technology separately
without the need for the Companys continuing involvement.
License Arrangements. License arrangements may consist of non-refundable upfront license fees,
data transfer fees, research reimbursement payments, exclusive licensed rights to patented or
patent pending compounds, technology access fees, various performance or sales milestones.
These arrangements are often multiple element arrangements.
Non-refundable, up-front fees that are not contingent on any future performance by the Company,
and require no consequential continuing involvement on its part, are recognized as revenue when
the license term commences and the licensed data, technology and/or compound is delivered. Such
deliverables may include
9
physical quantities of compounds, design of the compounds and structure-activity relationships,
the conceptual framework and mechanism of action, and rights to the patents or patents pending
for such compounds. The Company defers recognition of non-refundable upfront fees if it has
continuing performance obligations without which the technology, right, product or service
conveyed in conjunction with the non-refundable fee has no utility to the licensee that is
separate and independent of the Companys performance under the other elements of the
arrangement. In addition, if the Company has required continuing involvement through research
and development services that are related to its proprietary know-how and expertise of the
delivered technology, or can only be performed by the Company, then such up-front fees are
deferred and recognized over the period of continuing involvement.
Payments related to substantive, performance-based milestones in a research and development
arrangement are recognized as revenues upon the achievement of the milestones as specified in
the underlying agreements when they represent the culmination of the earnings process.
Research Services Arrangements. Revenues from research services are recognized during the
period in which the services are performed and are based upon the number of
full-time-equivalent personnel working on the specific project at the agreed-upon rate.
Reimbursements from collaborative partners for agreed upon direct costs including direct
materials and outsourced services, or subcontracted, pre-clinical studies are classified as
revenues in accordance with EITF Issue No. 99-19, Reporting Revenue Gross as a Principal
versus Net as an Agent, and recognized in the period the reimbursable expenses are incurred.
Payments received in advance are deferred until the research services are performed or costs
are incurred. These arrangements are often multiple element arrangements.
Royalty Arrangements. The Company recognizes royalty revenues from licensed products when
earned in accordance with the terms of the license agreements. Net sales amounts generally
required to be used for calculating royalties include deductions for returned product, pricing
allowances, cash discounts, freight and warehousing. These arrangements are often multiple
element arrangements.
Certain royalty arrangements require that royalties are earned only if a sales threshold is
exceeded. Under these types of arrangements, the threshold is typically based on annual sales.
The Company recognizes royalty revenue in the period in which the threshold is exceeded.
When the Company sells its rights to future royalties under license agreements and also
maintain continuing involvement in earning such royalties, it defers recognition of any upfront
payments and recognize them as revenues over the life of the license agreement. The Company
recognizes revenues for the sale of an undivided interest of its Abreva® license agreement to
Drug Royalty USA under the units-of-revenue method. Under this method, the amount of deferred
revenues to be recognized in each period is calculated by multiplying the ratio of the royalty
payments due to Drug Royalty USA by GlaxoSmithKline for the period to the total remaining
royalties that is expected GlaxoSmithKline will pay Drug Royalty USA over the remaining term of
the agreement by the unamortized deferred revenues.
Government Research Grant Revenues. The Company recognizes revenues from federal research grants
during the period in which the related expenditures are incurred.
Cost of Revenues
Cost of revenues includes direct and indirect costs to manufacture product sold, including the
write-off of obsolete inventory, and to provide research and development services. Amortization of
acquired FazaClo product rights is classified within cost of revenues under discontinued
operations.
Recognition of Expenses in Outsourced Contracts
Pursuant to managements assessment of the services that have been performed on clinical trials and
other contracts, the Company recognizes expenses as the services are provided. Such management
assessments include, but are not limited to: (1) an evaluation by the project manager of the work
that has been completed during the period, (2) measurement of progress prepared internally and/or
provided by the third-party service provider, (3) analyses of data
10
that justify the progress, and (4) managements judgment. Several of the Companys contracts extend
across multiple reporting periods, including its largest contract, representing a $7.1 million
Phase III clinical trial contract that was entered into in the first fiscal quarter of 2008. A 3%
variance in the Companys estimate of the work completed in its largest contract could increase or
decrease its quarterly operating expenses by approximately $213,000.
Capitalization and Valuation of Long-Lived and Intangible Assets
In accordance with Statement of Financial Accounting Standards No. 141, Business Combinations
(FAS 141) and Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangible
Assets (FAS 142), goodwill and intangible assets acquired in a purchase business combination and
determined to have an indefinite useful life are not amortized, but instead are tested for
impairment on an annual basis or more frequently if certain indicators arise. Goodwill represents
the excess of purchase price of an acquired business over the fair value of the underlying net
tangible and intangible assets. The Company had no goodwill as of June 30, 2008 as a result of the
sale of FazaClo. (See Note 3 Acquisition of Alamo Pharmaceuticals, Inc. / Sale of FazaClo). There
was no impairment of goodwill for the nine month period ended June 30, 2007.
Intangible assets with finite useful lives are amortized over their respective useful lives and
reviewed for impairment in accordance with Statement of Financial Accounting Standards No. 144,
"Accounting for the Impairment or Disposal of Long-Lived Assets (FAS 144.) The method of
amortization shall reflect the pattern in which the economic benefits of the intangible asset are
consumed or otherwise used up. If that pattern cannot be reliably determined, a straight-line
amortization method will be used. Identifiable intangible assets acquired with the May 2006
purchase of Alamo represent expected benefits of the FazaClo product rights, customer
relationships, trade name and non-compete agreement. These acquired intangible assets were disposed
of in fiscal 2007 with the sale of FazaClo to Azur. As of June 30, 2008, intangible assets with
indefinite useful lives are comprised of trade names which are not amortized.
In accordance with FAS 144, intangible assets and other long-lived assets, except for goodwill, are
evaluated for impairment whenever events or changes in circumstances indicate that their carrying
value may not be recoverable. If the review indicates that intangible assets or long-lived assets
are not recoverable (i.e. the carrying amount is less than the future projected undiscounted cash
flows), their carrying amount would be reduced to fair value. Factors the Company considers
important that could trigger an impairment review include the following:
|
|
|
A significant underperformance relative to expected historical or projected future
operating results; |
|
|
|
|
A significant change in the manner of the Companys use of the acquired asset or the
strategy for its overall business; and/or |
|
|
|
|
A significant negative industry or economic trend. |
Legal expenses for patent related costs are expensed as incurred and classified as research and
development expenses in the Companys condensed consolidated statements of operations.
Share-Based Compensation
The Company accounts for awards of share-based compensation to employees under the fair value
method required by Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based
Payment (FAS 123R). The fair value of each award of share-based compensation is measured at the
date of grant. Share-based compensation awards generally vest over time, subject to continued
service to the Company and/or the satisfaction of certain performance conditions. The Company
recognizes the estimated fair value of employee stock options over the service period using the
straight-line method.
Share-based compensation expense recognized in the condensed consolidated statements of operations
is based on awards ultimately expected to vest, reduced for estimated forfeitures. FAS 123R
requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeiture rates differ from those estimates. The estimation of the number of
stock awards that will ultimately be forfeited requires judgment, and to the extent actual results
or updated estimates differ from the Companys current estimates, such amounts will be
11
recorded as a cumulative adjustment in the period in which estimates are revised. The Company
considers many factors when estimating expected forfeitures, including types of awards, employee
class and historical experience. During the second quarter of fiscal 2007, the Company updated its
projected forfeiture rates as it applies to stock-based compensation considering recent actual data
following the implementation of various restructuring initiatives earlier that year. Pre-vesting
forfeiture rates for the nine month periods ended June 30, 2008 and 2007 were estimated to be 30%
for all employees, officers and directors. Such estimates have been based on the Companys
historical experience. Future estimates and actual results may differ substantially from the
Companys current estimates.
Total compensation expense related to all of the Companys share-based awards, recognized under FAS
123R, for the three and nine month periods ended June 30, 2008 and 2007 was classified as selling
general and administrative expenses and research and development expenses and was comprised of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended |
|
|
For the nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
From Continuing Operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expense |
|
$ |
279,074 |
|
|
$ |
247,078 |
|
|
$ |
852,068 |
|
|
$ |
1,365,874 |
|
Research and development expense |
|
|
71,713 |
|
|
|
118,853 |
|
|
|
405,470 |
|
|
|
336,952 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense related
to continuing operations |
|
|
350,787 |
|
|
|
365,931 |
|
|
|
1,257,538 |
|
|
|
1,702,826 |
|
From Discontinued Operations: |
|
|
|
|
|
|
171,712 |
|
|
|
13,905 |
|
|
|
352,799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
350,787 |
|
|
$ |
537,643 |
|
|
$ |
1,271,443 |
|
|
$ |
2,055,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended |
|
|
For the nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Share-based compensation expense from: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
$ |
139,010 |
|
|
$ |
302,505 |
|
|
$ |
500,186 |
|
|
$ |
960,407 |
|
Restricted stock units |
|
|
200,066 |
|
|
|
199,708 |
|
|
|
642,878 |
|
|
|
670,028 |
|
Restricted stock awards |
|
|
11,711 |
|
|
|
35,430 |
|
|
|
128,379 |
|
|
|
425,190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
350,787 |
|
|
$ |
537,643 |
|
|
$ |
1,271,443 |
|
|
$ |
2,055,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Since the Company has a net operating loss carryforward as of June 30, 2008, no excess tax benefits
for the tax deductions related to share-based awards were recognized in the condensed consolidated
statements of operations. Additionally, no incremental tax benefits were recognized from stock
options exercised in the three and nine month periods ended June 30, 2008 and 2007 that would have
resulted in a reclassification to reduce net cash used in operating activities with an offsetting
increase in net cash provided by financing activities. (See Note 12 Employee Equity Incentive
Plans.)
Recently Issued Accounting Pronouncements
FASB Staff Position No. 142-3 (FSP 142-3). In April 2008, the FASB issued FSP 142-3,
Determination of the Useful Life of Intangible Assets". FSP 142-3 amends the factors that should
be considered in developing renewal or extension assumptions used to determine the useful life of a
recognized intangible asset under Financial Accounting Standard No. 142, Goodwill and Other
Intangible Assets". FSP 142-3 is effective for fiscal years beginning after December 15, 2008.
Therefore, the Company will be required to adopt FSP 142-3 for the fiscal year beginning October 1,
2009. The Company is currently evaluating the impact of FSP 142-3 on its consolidated financial
position and results of operations.
Financial Accounting Standards No. 161 (FAS 161). In March 2008, the FASB issued FASB Statement
No. 161, Disclosures about Derivative Instruments and Hedging Activities, an Amendment of FAS
133". The new standard is intended to improve financial reporting about derivative instruments and
hedging activities by requiring enhanced disclosures to enable investors to better understand their
effects on an entitys financial position, financial
12
performance and cash flows. FAS 161 is
effective for financial statements issued for fiscal years and interim periods beginning after
November 15, 2008. Therefore, the Company will be required to adopt FAS 161 for the fiscal year
beginning October 1, 2009.
Financial Accounting Standards No. 160 (FAS 160). In December 2007, the FASB issued FAS 160,
Noncontrolling Interests in Consolidated Financials, an
Amendment of ARB No. 51, which is
intended to improve the relevance, comparability and transparency of the financial information that
a reporting entity provides in its consolidated financial statements by establishing certain
required accounting and reporting standards. FAS 160 is effective for fiscal years beginning on or
after December 15, 2008. Therefore, the Company will be required to adopt FAS 160 for the fiscal
year beginning October 1, 2009. The Company is evaluating the options provided under FAS 160 and
their potential impact on its financial condition and results of operations if implemented. The
Company does not expect the adoption of FAS 160 to significantly affect its consolidated financial
condition or results of operations.
Financial Accounting Standards No. 141(R) (FAS 141R). In December 2007, the FASB issued FAS 141R,
Business Combinations: Applying the Acquisition Method, which retains the fundamental
requirements of FAS 141 but provides additional guidance on applying the acquisition method when
accounting for similar economic events by establishing certain principles and requirements. FAS
141R is effective for fiscal years beginning on or after December 15, 2008. Therefore, the Company
will be required to adopt FAS 141R for the fiscal year beginning October 1, 2009. The Company is
evaluating the options provided under FAS 141R and their potential impact on its financial
condition and results of operations when implemented. The Company does not expect the adoption of
FAS 141R to significantly affect its consolidated financial condition or results of operations.
EITF Issue No. 07-1. In November 2007, the FASBs Emerging Issues Task Force issued EITF Issue No.
07-1, Accounting for Collaborative Arrangements, (EITF 07-1) which defines collaborative
arrangements and establishes reporting and disclosure requirements for such arrangements. EITF 07-1
is effective for fiscal years beginning after December 15, 2008. Therefore, the Company will be
required to adopt EITF 07-1 for the fiscal year beginning October 1, 2009. The Company is
continuing to evaluate the impact of adopting the provisions of EITF 07-1; however, it does not
anticipate that adoption will have a material effect on its consolidated financial condition or
results of operations.
EITF Issue No. 07-3. In June 2007, the FASBs Emerging Issues Task Force reached a consensus on
EITF Issue No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to Be
Used in Future Research and Development Activities (EITF 07-3) that would require nonrefundable
advance payments made by the Company for future R&D activities to be capitalized and recognized as
an expense as the goods or services are received by the Company. EITF 07-3 is effective with
respect to new arrangements entered into beginning January 1, 2008. The Companys adoption of EITF
07-3 did not have a material impact on its consolidated financial condition or results of
operations.
Financial Accounting Standards No. 159 (FAS 159). In February 2007, the FASB issued FAS 159, The
Fair Value Option for Financial Assets and Financial Liabilities Including an amendment of FASB
Statement 115, which provides companies with an option to measure eligible financial assets and
liabilities in their entirety at fair value. The fair value option may be applied instrument by
instrument, and may be applied only to entire instruments. If a company elects the fair value
option for an eligible item, changes in the items fair value must be reported as unrealized gains
and losses in earnings at each subsequent reporting date. FAS 159 is effective for fiscal years
beginning after November 15, 2007. Therefore, the Company will be required to adopt FAS 159 for the
fiscal year beginning October 1, 2008. The Company is evaluating the options provided under FAS 159
and their potential impact on its financial condition and results of operations if implemented. The
Company does not expect the adoption of FAS 159 to significantly affect its consolidated financial
condition or results of operations.
Financial Accounting Standards No. 157 (FAS 157). In September 2006, the FASB issued FAS 157,
Fair Value Measurements. FAS 157 defines fair value, established a framework for measuring fair
value in generally accepted
accounting principles (GAAP) and expands disclosures about fair value measurements. FAS 157 is
effective for financial statements issued for fiscal years beginning after November 15, 2007.
Therefore, the Company will be required to adopt FAS 157 for the fiscal year beginning October 1,
2008. In February 2008, the FASB released FASB Staff Position 157-2, Effective Date of FASB
Statement No. 157 which delayed the effective date of FAS
13
157 for all nonfinancial assets and
nonfinancial liabilities, except those that are recognized or disclosed at fair value in the
financial statements on a recurring basis (at least annually) until the fiscal year beginning
October 1, 2009. The Company is currently evaluating the effect of FAS 157 on its consolidated
financial condition and results of operations.
3. ACQUISITION OF ALAMO PHARMACEUTICALS, INC. / SALE OF FAZACLO
On May 24, 2006, pursuant to a Unit Purchase Agreement dated May 22, 2006 (the Acquisition
Agreement), the Company acquired all of the outstanding equity interests in Alamo from the former
members of Alamo (the Selling Holders) for approximately $29.2 million in consideration,
consisting of approximately $4.0 million in cash, promissory notes with an aggregate face value of
$25.1 million and an estimated fair value of $24.3 million, and $912,000 in acquisition-related
transaction costs. The purchase price exceeded the net assets acquired, resulting in the Company
recording $22.1 million of goodwill. The results of operations of Alamo were included in the
Companys consolidated financial statements from the date of acquisition until the sale of the
Alamo assets in fiscal 2007, at which time the Alamo-related results of operations for all periods
presented were reclassified as discontinued operations. The Company intended to leverage the
FazaClo sales force to assist with the commercial launch of Zenvia, which was planned for early
2007; however, due to the receipt of the FDA approvable letter and resulting delay in the planned
launch of Zenvia, the Company entered into an agreement to sell FazaClo in July 2007. Details of
the sale of FazaClo are described below.
In connection with the Alamo acquisition, the Company also agreed to pay the selling holders up
to an additional $39,450,000 in revenue-based earn-out payments, based on future sales of
FazaClo (clozapine USP), an orally disintegrating drug for the treatment of refractory
schizophrenia. On May 15, 2007, the Company issued an additional $2,000,000 promissory note
based on FazaClo sales rates through that quarter and on August 15, 2007, the Company issued a
second promissory note, also in the principal amount of $2,000,000. The remaining earn-out
payments of $35,450,000 are based on the achievement of certain target levels of FazaClo sales
in the U.S. from the closing date of the acquisition through December 31, 2018. In connection
with the FazaClo sale, Azur assumed these remaining contingent payment obligations, however,
the Company is still contingently liable in the event of default by Azur.
The Company also previously agreed to pay the selling holders one-half of all net licensing
revenues that it may receive through December 31, 2018 from licenses of FazaClo outside of the
U.S., if any (Non-US Licensing Revenues). There were no Non-US Licensing Revenues through August
3, 2007, the date of sale of FazaClo, and these future obligations have been assumed by Azur as
described below.
In the first quarter of fiscal 2007, the Company recognized a reduction of $3.1 million to the
purchase price of Alamo as a result of a reduction in the estimated amount of certain assumed
liabilities acquired, and thereby reduced the carrying value of goodwill. Additionally, through the
sale of FazaClo in August 2007, the purchase price of Alamo was cumulatively increased by a net of
approximately $20,000, as a result of the issuance of additional notes payable in fiscal 2007
totaling $4.0 as additional consideration (see above), less cumulative reductions of $3.98 million
to the assumed liabilities.
In June 2008, the Company entered into an agreement which provided for the acceleration of the
payment of the outstanding principal under the senior notes with an outstanding balance of $12
million (net of unamortized discount of $140,000) for a total sum of $10.9 million in full
satisfaction of the Notes, recognizing a gain on extinguishment of debt of $968,000 (net of
unamortized discount of $140,000). The accelerated payment of the Notes represented an estimated
savings of approximately $1.2 million in principal and interest payments through the original
maturity date, net of estimated lost earnings on cash balances that would have been held through
the maturity date. (See Note 10 Notes Payable.)
Sale of FazaClo, Presentation of Discontinued Operations, and Working Capital Adjustment
In August 2007, the Company sold FazaClo and its related assets and operations to Azur. In
connection with the sale, the Company received approximately $43.9 million in upfront consideration
and has the right to receive up to an additional $10.0 million in contingent payments in 2009,
subject to the satisfaction of certain regulatory
14
conditions. In addition, Azur is obligated to
pay up to $2.0 million in royalties, based on 3% of annualized net product revenues in excess of
$17.0 million. The Companys earn-out obligations that would have been payable to the prior owner
of Alamo upon the achievement of certain milestones were assumed by Azur; however, the Company is
contingently liable in the event of default. The Company transferred all FazaClo related business
operations to Azur in August 2007.
In
accordance with FAS 144 Accounting for the Impairment or Disposal of Long-Lived Assets, the
financial results relating to FazaClo have been classified as discontinued operations in the
accompanying condensed consolidated statements of operations for all periods presented.
The Asset Purchase Agreement (the Agreement) with Azur provides for an adjustment to the sale
price of FazaClo in connection with the final determination of the amount of net working capital
(as defined in the Agreement) included as part of the sale (Net Working Capital Adjustment). The
Agreement also stipulates that an adjustment to net working capital shall only exist if the final
Net Working Capital Adjustment is greater than $250,000. As of September 30, 2007, based on the
knowledge and information that the Company had at the time, it estimated that the Net Working
Capital Adjustment was less than the $250,000 threshold. However, in January 2008, the Company
received claims from Azur that the Net Working Capital Adjustment should reduce the sale price of
FazaClo by approximately $2.0 million. The Company disputed the amount of Net Working Capital
Adjustment claimed by Azur. However, based upon new information and its own analysis, for the
quarter ended December 31, 2007, the Company accrued a liability of $868,000 and recognized a
charge in its statement of operations as a result of potential Net Working Capital Adjustment. On
August 1, 2008, the independent arbitrator engaged by the Company and Azur determined the Net
Working Capital Adjustment to be $1,352,000. As a result, for the quarter ended June 30, 2008, the
Company increased its accrual on the Net Working Capital Adjustment to $1,352,000, and recognized
an additional charge of $484,000 in its statement of operations. In accordance with FAS 154
Accounting for Changes and Error Corrections the Net Working Capital Adjustment is considered a
change in estimate and represents new information that was not available as of September 30, 2007.
The accrued liability related to the Net Working Capital Adjustment as of June 30, 2008 is included
in current liabilities of discontinued operations in the accompanying balance sheet, and the
charges in the statement of operations from the Net Working Capital Adjustment are included in loss
from discontinued operations in the accompanying statement of operations.
In addition to the accrued loss on the Net Working Capital Adjustment of $1.4 million, the Company
recognized an additional $217,000 of other costs related to the operations of FazaClo business
during the nine months ended June 30, 2008, which, the Company initially estimated were assumed by
Azur.
A summarized statement of operations for the discontinued operations for the three and nine months
ended June 30, 2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
For the three months |
|
|
For the nine months |
|
|
|
ended June 30, 2007 |
|
|
ended June 30, 2007 |
|
REVENUES FROM PRODUCT SALES |
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
4,938,708 |
|
|
$ |
15,038,523 |
|
Cost of revenues |
|
|
1,535,535 |
|
|
|
3,930,323 |
|
|
|
|
|
|
|
|
Product gross margin |
|
|
3,403,173 |
|
|
|
11,108,200 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,301,730 |
|
|
|
2,960,244 |
|
Selling, general and administrative |
|
|
3,058,497 |
|
|
|
11,915,325 |
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(957,054 |
) |
|
|
(3,767,369 |
) |
|
|
|
|
|
|
|
|
|
OTHER EXPENSE |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(182,922 |
) |
|
|
(548,767 |
) |
|
|
|
|
|
|
|
Loss before provision for income taxes |
|
|
(1,139,976 |
) |
|
|
(4,316,136 |
) |
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(1,139,976 |
) |
|
$ |
(4,316,136 |
) |
|
|
|
|
|
|
|
15
4. RELOCATION OF COMMERCIAL AND GENERAL AND ADMINISTRATIVE OPERATIONS
In fiscal 2006, the Company relocated all operations other than research from San Diego, California
to Aliso Viejo, California. In fiscal 2007, following the Companys receipt of a non-renewal and
termination notice from AstraZeneca and the successful completion of the development services under
an agreement with Novartis, the Board of Directors approved a plan of disposition to exit the
Companys facilities in San Diego. Pursuant to this plan, the Company subleased a total of
approximately 48,000 square feet of laboratory and office space in San Diego and relocated
remaining personnel and clinical trial support functions to the Companys offices in Orange County,
California.
The following table presents the restructuring activities for the nine months ended June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Payments/ |
|
|
June 30, |
|
|
|
2007 |
|
|
Adjustments |
|
|
2008 |
|
Accrued Restructuring: |
|
|
|
|
|
|
|
|
|
|
|
|
Employee severance and relocation benefits |
|
$ |
75,790 |
|
|
$ |
(75,790 |
) |
|
$ |
|
|
Lease restructuring liabilities |
|
|
2,223,802 |
|
|
|
(991,594 |
) |
|
|
1,232,208 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
2,299,592 |
|
|
$ |
(1,058,914 |
) |
|
|
1,240,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: current portion |
|
|
(1,163,627 |
) |
|
|
|
|
|
|
(346,765 |
) |
|
|
|
|
|
|
|
|
|
|
|
Non-current portion |
|
$ |
1,135,965 |
|
|
|
|
|
|
$ |
893,913 |
|
|
|
|
|
|
|
|
|
|
|
|
The current portion of the lease restructuring liabilities of $338,000 is included in Accrued
Expenses and Other Liabilities and the non-current portion of lease restructuring liability of
$894,000 is included in Accrued Expenses and Other Liabilities, net of Current Portion in the
accompanying condensed consolidated balance sheet at June 30, 2008.
5. INVENTORIES
The composition of inventories is as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
1,333,277 |
|
|
$ |
1,354,991 |
|
Less: current portion |
|
|
(17,000 |
) |
|
|
(17,000 |
) |
|
|
|
|
|
|
|
Long-term portion |
|
$ |
1,316,277 |
|
|
$ |
1,337,991 |
|
|
|
|
|
|
|
|
Inventories relate to the active pharmaceutical ingredients docosanol and Zenvia. The amount
classified as long-term inventories is comprised of docosanol and the raw material components for
Zenvia, dextromethorphan and quinidine, which will be used in the manufacture of Zenvia capsules in
the future.
16
6. ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued expenses and other liabilities are as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
September 30, 2007 |
|
Accrued research and development expenses |
|
$ |
629,775 |
|
|
$ |
419,989 |
|
Accrued general and administrative expenses |
|
|
283,993 |
|
|
|
287,517 |
|
Deferred rent |
|
|
47,166 |
|
|
|
34,432 |
|
Lease restructuring liabilities |
|
|
1,232,208 |
|
|
|
2,223,802 |
|
Other |
|
|
88,955 |
|
|
|
255,520 |
|
|
|
|
|
|
|
|
Total accrued expenses and other liabilities |
|
|
2,282,097 |
|
|
|
3,221,260 |
|
Less: current portion |
|
|
(1,341,019 |
) |
|
|
(2,050,864 |
) |
|
|
|
|
|
|
|
Non-current total accrued expenses and other liabilities |
|
$ |
941,078 |
|
|
$ |
1,170,396 |
|
|
|
|
|
|
|
|
See Note 3 for a description of current liabilities of discontinued operations.
7. DEFERRED REVENUES
The following table sets forth as of June 30, 2008 the deferred revenue balances for the Companys
sale of future Abreva® royalty rights to Drug Royalty USA and other agreements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Royalty |
|
|
|
|
|
|
|
|
|
USA |
|
|
Other |
|
|
|
|
|
|
Agreement |
|
|
Agreements |
|
|
Total |
|
Deferred revenues as of October 1, 2007 |
|
$ |
14,738,509 |
|
|
$ |
581,921 |
|
|
$ |
15,320,430 |
|
Changes during the period: |
|
|
|
|
|
|
|
|
|
|
|
|
Additions |
|
|
|
|
|
|
250,000 |
|
|
|
250,000 |
|
Recognized as revenues during period |
|
|
(1,915,469 |
) |
|
|
(240,823 |
) |
|
|
(2,156,292 |
) |
|
|
|
|
|
|
|
|
|
|
Deferred revenues as of June 30, 2008 |
|
$ |
12,823,040 |
|
|
$ |
591,098 |
|
|
$ |
13,414,138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Classified and reported as: |
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of deferred revenues |
|
$ |
2,093,912 |
|
|
$ |
477,191 |
|
|
$ |
2,571,103 |
|
Deferred revenues, net of current portion |
|
|
10,729,128 |
|
|
|
113,907 |
|
|
|
10,843,035 |
|
|
|
|
|
|
|
|
|
|
|
Total deferred revenues |
|
$ |
12,823,040 |
|
|
$ |
591,098 |
|
|
$ |
13,414,138 |
|
|
|
|
|
|
|
|
|
|
|
|
8. COMPUTATION OF NET LOSS PER COMMON SHARE
Basic net loss per common share is computed by dividing net loss by the weighted-average number of
common shares outstanding during the period, excluding restricted stock that has been issued but is
not yet vested. Diluted net loss per common share is computed by dividing net loss by the
weighted-average number of common shares outstanding during the period plus additional weighted
average common equivalent shares outstanding during the period. Common equivalent shares result
from the assumed exercise of outstanding stock options and warrants (the proceeds of which are then
presumed to have been used to repurchase outstanding stock using the treasury stock method) and the
vesting of restricted shares of common stock. In loss periods, certain of the common equivalent
shares have been excluded from the computation of diluted net loss per share, because their effect
would have been anti-dilutive. For the nine month period ended June 30, 2008, a total of 648,803
stock options, 12,509,742 stock warrants, 3,000 restricted stock awards and 2,296,809 restricted
stock units were excluded from the computation of diluted net loss per share. For the nine month
period ended June 30, 2007 a total of 1,011,544 stock options, 1,018,943 stock warrants and
2,107,703 restricted stock units were excluded from the computation of diluted net loss per share.
17
9. COMPREHENSIVE LOSS
Comprehensive loss consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months |
|
|
For the nine months |
|
|
|
ended June 30, |
|
|
ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net loss |
|
$ |
(1,440,375 |
) |
|
$ |
(9,150,379 |
) |
|
$ |
(12,279,393 |
) |
|
$ |
(33,018,268 |
) |
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on available-for-sale securities |
|
|
|
|
|
|
3,042 |
|
|
|
3,272 |
|
|
|
82,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(1,440,375 |
) |
|
$ |
(9,147,337 |
) |
|
$ |
(12,276,121 |
) |
|
$ |
(32,935,927 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
10. NOTES PAYABLE
In June 2008, the Company accelerated the repayment of the outstanding principal under the
promissory notes issued in connection with the acquisition of Alamo (the Notes). At the time of
repayment, the Notes had an outstanding balance of $12 million (net of unamortized discount of
$140,000), which was retired early in consideration for a single payment of $10.9 million in full
satisfaction of the Notes. The Company recognized a gain on extinguishment of debt of $968,000 (net
of unamortized discount of $140,000). The accelerated repayment of the Notes represented an
estimated savings of approximately $1.2 million in principal and interest payments through the
original Maturity Date, net of estimated lost earnings on cash balances that would have been held
through the Maturity Date.
11. SHAREHOLDERS EQUITY
In April 2008, the Company closed a registered securities offering raising $40 million in gross
proceeds ($38 million after offering expenses) from a select group of institutional investors led
by ProQuest Investments and joined by Clarus Ventures, Vivo Ventures, and OrbiMed Advisors. In
connection with the offering, approximately 35 million shares of common stock were issued at a
price of $1.14 per share unit. Additionally, the Company issued warrants to acquire up to
approximately 12.2 million common shares at $1.43 per share. The warrants have a 5-year exercise
term, but can be called for redemption for a nominal price. The proceeds are expected to provide
adequate capital to ensure continuing operations through the anticipated timing of the FDA approval
decision for Zenvia for the PBA indication.
During the nine month period ended June 30, 2008, the Company issued 83,985 shares of common stock
in connection with the vesting of restricted stock units. In connection with the vesting, two
officers exercised their option to pay for minimum required withholding taxes associated with the
vesting of restricted stock by surrendering 15,779 shares of common stock at an average market
price of $1.46 per share.
Also during the nine months ended June 30, 2008, 2,000 shares of common stock, previously issued as
a restricted stock award, were surrendered upon the termination of an employee and 4,983 shares of
restricted stock were
surrendered to pay for the minimum required withholding taxes associated with the vesting of the
restricted stock award.
During January 2008, the Company sold and issued a total of 34,568 shares of its Class A common
stock for aggregate gross offering proceeds of $44,200 ($42,700 after offering expenses, including
underwriting discounts and commissions). In April 2008, the Company notified Brinson Patrick
Securities Corporation that it had terminated the outstanding financing facility with the
Corporation.
In November 2007, warrants to purchase 1,053,000 shares of the Companys common stock at an
exercise price of $3.30 per share expired unexercised. As of June 30, 2008, warrants to purchase
12,509,742 shares of the Companys common stock at a weighted-average exercise price per share of
$1.60 remained outstanding, all of which are exercisable.
18
12. EMPLOYEE EQUITY INCENTIVE PLANS
The Company currently has five equity incentive plans (the Plans), two of which are currently in
active use as described below. The Plans are: the 2005 Equity Incentive Plan (the 2005 Plan), the
2003 Equity Incentive Plan (the 2003 Plan), the 2000 Stock Option Plan (the 2000 Plan), the
1998 Stock Option Plan (the 1998 Plan) and the 1994 Stock Option Plan (the 1994 Plan), which
are described in the Companys Annual Report on Form 10-K for the year ended September 30, 2007.
All of the Plans were approved by the shareholders, except for the 2003 Equity Incentive Plan,
which was approved solely by the Board of Directors. Stock-based awards are subject to terms and
conditions established by the Compensation Committee of the Companys Board of Directors. The
Companys policy is to issue new common shares upon the exercise of stock options, conversion of
share units or purchase of restricted stock.
During the nine month periods ended June 30, 2008 and 2007, the Company granted share-based awards
under both the 2003 Plan and the 2005 Plan. Under the 2003 Plan and 2005 Plan, options to purchase
shares, restricted stock units, restricted stock and other share-based awards may be granted to the
Companys employees and consultants. Under the Plans, as of June 30, 2008, the Company had an
aggregate of 7,923,580 shares of its common stock reserved for future issuance. Of those shares,
2,948,613 were subject to outstanding options and other awards and 4,974,967 shares were available
for future grants of share-based awards. As of June 30, 2008, no options were outstanding to
consultants. The Company may also, from time to time, issue share-based awards outside of the Plans
to the extent permitted by NASDAQ rules. As of June 30, 2008, there were no options to purchase
shares of the Companys common stock that were issued outside of the Plans (inducement option
grants) outstanding. None of the share-based awards are classified as a liability as of June 30,
2008.
Stock Options. Stock options are granted with an exercise price equal to the current market price
of the Companys common stock at the grant date and have 10-year contractual terms. For option
grants to employees, 25% of the option shares vest and become exercisable on the first anniversary
of the grant date and the remaining 75% of the option shares vest and become exercisable quarterly
in equal installments thereafter over three years; for option grants to non-employee directors,
one-third of the option shares vest and become exercisable on the first anniversary of the grant
date and the remaining two-thirds of the option shares vest and become exercisable daily or
quarterly in equal installments thereafter over two years; and for certain option grants to
non-employee directors, options have been granted as fully vested and exercisable at the date of
grant. Certain option awards provide for accelerated vesting if there is a change in control (as
defined in the Plans).
Summaries of stock options outstanding and changes during the nine month period ended June 30, 2008
are presented below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
average |
|
|
|
|
|
|
|
|
|
|
average |
|
|
remaining |
|
|
|
|
|
|
|
|
|
|
exercise |
|
|
contractual |
|
|
Aggregate |
|
|
|
Number of |
|
|
price per |
|
|
term |
|
|
intrinsic |
|
|
|
shares |
|
|
share |
|
|
(in years) |
|
|
value |
|
Outstanding, October 1, 2007 |
|
|
1,040,581 |
|
|
$ |
7.69 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(391,778 |
) |
|
$ |
8.74 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, June 30, 2008 |
|
|
648,803 |
|
|
$ |
7.05 |
|
|
|
7.2 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest in the future, June 30, 2008 |
|
|
497,440 |
|
|
$ |
8.31 |
|
|
|
6.7 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, June 30, 2008 |
|
|
294,232 |
|
|
$ |
10.73 |
|
|
|
5.5 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no options granted during the nine month period ended June 30, 2008. The weighted
average grant-date fair values of options granted during the nine month period ended June 30, 2007
was $2.14 per share. There were no options exercised in the nine month period ended June 30, 2008.
The total intrinsic value of options exercised during the nine month period ended June 30, 2007 was
$271,000 based on the differences in market prices on the dates of exercise and the option exercise
prices. As of June 30, 2008, the total unrecognized compensation cost related to
19
unvested options
was $917,000 which is expected to be recognized over the weighted-average period of 1.9 years,
based on the vesting schedules.
The fair value of each option award is estimated on the date of grant using the
Black-Scholes-Merton option pricing model (Black-Scholes model), which uses the assumptions noted
in the following table. Expected volatilities are based on historical volatility of the Companys
common stock and other factors. The expected term of options granted is based on analyses of
historical employee termination rates and option exercises. The risk-free interest rate is based on
the U.S. Treasury yield for a period consistent with the expected term of the option in effect at
the time of the grant.
Assumptions used in the Black-Scholes model for options granted during the nine month period ended
June 30, 2007 were as follows:
|
|
|
|
|
|
|
2007 |
Expected volatility |
|
|
75%-103 |
% |
Weighted-average volatility |
|
|
88 |
% |
Average expected term in years |
|
|
6.0 |
|
Risk-fee interest rate (zero coupon U.S. Treasury Note) |
|
|
4.7 |
% |
Expected dividend yield |
|
|
0 |
% |
The following table summarizes information concerning outstanding and exercisable stock options as
of June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Remaining |
|
Average |
|
|
|
|
|
Average |
Range of |
|
Number |
|
Contractual |
|
Exercise |
|
Number |
|
Exercise |
Exercise Prices |
|
Outstanding |
|
Life in Years |
|
Price |
|
Exercisable |
|
Price |
$1.20 $1.29
|
|
|
150,960 |
|
|
|
8.7 |
|
|
$ |
1.28 |
|
|
|
6,250 |
|
|
$ |
1.20 |
|
$2.41 $2.88
|
|
|
128,504 |
|
|
|
8.7 |
|
|
$ |
2.44 |
|
|
|
7,723 |
|
|
$ |
2.88 |
|
$4.50 $6.80
|
|
|
68,251 |
|
|
|
5.4 |
|
|
$ |
5.72 |
|
|
|
50,126 |
|
|
$ |
5.60 |
|
$6.92 $9.92
|
|
|
47,125 |
|
|
|
7.0 |
|
|
$ |
7.91 |
|
|
|
31,500 |
|
|
$ |
8.41 |
|
$10.24 $11.76
|
|
|
151,688 |
|
|
|
6.6 |
|
|
$ |
11.66 |
|
|
|
114,847 |
|
|
$ |
11.63 |
|
$12.12 $16.60
|
|
|
89,000 |
|
|
|
6.0 |
|
|
$ |
14.34 |
|
|
|
70,511 |
|
|
$ |
14.04 |
|
$19.38 $19.38
|
|
|
13,275 |
|
|
|
0.9 |
|
|
$ |
19.38 |
|
|
|
13,275 |
|
|
$ |
19.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
648,803 |
|
|
|
7.2 |
|
|
$ |
7.05 |
|
|
|
294,232 |
|
|
$ |
10.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units. RSUs generally vest based on three years of continuous service. The
following table summarizes the RSU activities for the nine months ended June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
average grant |
|
|
|
shares |
|
|
date fair value |
|
Unvested, October 1, 2007 |
|
|
1,914,988 |
|
|
$ |
2.17 |
|
Granted |
|
|
867,351 |
|
|
$ |
1.49 |
|
Vested |
|
|
(254,279 |
) |
|
$ |
2.89 |
|
Forfeited |
|
|
(231,250 |
) |
|
$ |
1.75 |
|
|
|
|
|
|
|
|
|
Unvested, June 30, 2008 |
|
|
2,296,810 |
|
|
$ |
1.87 |
|
|
|
|
|
|
|
|
|
During the nine month period ended June 30, 2008, the Company awarded 867,351 shares of restricted
stock units to employees with a weighted average grant date fair value of $1.49 and exercisable at
a purchase price of $0.00 per share.
At June 30, 2008, there were 148,000 shares of restricted stock with a weighted-average grant date
fair value of $2.93 awarded to directors that have vested but are still restricted until the
directors resign.
20
The grant-date fair value of RSUs granted during the nine month periods ended June 30, 2008 and
2007 was $1,288,000 and $4,032,000, respectively. As of June 30, 2008, the total unrecognized
compensation cost related to unvested shares was $3,112,000 which is expected to be recognized over
a weighted-average period of 2.0 years, based on the vesting schedules.
Restricted stock awards. Restricted stock awards are grants that entitle the holder to acquire
shares of restricted common stock at a fixed price, which is typically nominal. Typically, the
shares are acquired shortly after the granting of the award and the shares are then subject to a
right of repurchase or forfeiture that lapses over time in accordance with a vesting schedule. The
shares of restricted stock cannot be sold, pledged or otherwise disposed of until the award vests,
and any unvested shares may be reacquired by us for the original purchase price following the
awardees termination of service. The restricted stock awards typically vest on the second or third
anniversary of the grant date or on a graded vesting schedule over three years of employment. A
summary of unvested restricted stock awards as of June 30, 2008 and changes during the nine month
periods ended June 30, 2008 are presented below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
average grant |
|
|
|
shares |
|
|
date fair value |
|
Unvested, October 1, 2007 |
|
|
22,500 |
|
|
$ |
11.87 |
|
Vested |
|
|
(17,500 |
) |
|
$ |
13.29 |
|
Forfeited |
|
|
(2,000 |
) |
|
$ |
6.91 |
|
|
|
|
|
|
|
|
|
Unvested, June 30, 2008 |
|
|
3,000 |
|
|
$ |
6.91 |
|
|
|
|
|
|
|
|
|
There were no restricted stock awards granted in the nine month period ended June 30, 2008. The
grant-date fair value of restricted stock awards granted in the nine month period ended June 30,
2007 was $110,000. As of June 30, 2008, the total unrecognized compensation cost related to
unvested shares was $11,000 which is expected to be recognized over a weighted-average period of
0.1 years.
The Company received no cash from exercised options and restricted stock awards under all
share-based payment arrangements during the nine month period ended June 30, 2008. During the nine
month period ended June 30, 2007, the Company received a total of $294,000 in cash from exercised
options and restricted stock awards under all share-based payment arrangements. No tax benefit was
realized for the tax deductions from option exercise of the share-base payment arrangements in the
nine month periods ended June 30, 2008 and 2007.
13. COMMITMENTS AND CONTINGENCIES
Center for Neurologic Study (CNS) The Company holds the exclusive worldwide marketing rights to
Zenvia for certain indications pursuant to an exclusive license agreement with CNS. The Company
will be obligated to pay CNS up to $400,000 in the aggregate in milestones to continue to develop
for both PBA and DPN pain, assuming they are both approved for marketing by the FDA. The Company is
not currently developing, nor does it have an obligation to develop, any other indications under
the CNS license agreement. In fiscal 2005, the Company paid $75,000 to CNS under the CNS license
agreement, and will need to pay a $75,000 milestone if the FDA approves
Zenvia for the treatment of PBA. In addition, the Company is obligated to pay CNS a royalty on
commercial sales of Zenvia with respect to each indication, if and when the drug is approved by the
FDA for commercialization. Under certain circumstances, the Company may have the obligation to pay
CNS a portion of net revenues received if it sublicenses Zenvia to a third party. Under the
agreement with CNS, the Company is required to make payments on achievements of up to a maximum of
ten milestones, based upon five specific medical indications. Maximum payments for these milestone
payments could total approximately $2.1 million if the Company pursued the development of Zenvia
for all of the licensed indications. Of the clinical indications that the Company currently plans
to pursue, expected milestone payments could total $800,000. In general, individual milestones
range from $150,000 to $250,000 for each accepted new drug application (NDA) and a similar amount
for each approved NDA. In addition the Company is obligated to pay CNS a royalty ranging from
approximately 5% to 8% of net revenues.
21
Eurand, Inc. In August 2006, the Company entered into a development and license agreement (Eurand
Agreement) with Eurand, Inc. (Eurand), under which Eurand will provide research and development
services using Eurands proprietary technology to develop a once-a-day controlled release capsule,
a new formulation of Zenvia for the treatment of PBA (Controlled-Release Zenvia). Under the terms
of the Eurand Agreement, the Company will pay Eurand for development services on a time and
material basis. The Company will be required to make payments up to $7.6 million contingent upon
achievement of certain development milestones and up to $14.0 million contingent upon achievement
of certain sales targets. In addition, the Company will be required to make royalty payments based
on sales of Controlled-Release Zenvia. No such payments were made in the first nine months of
fiscal 2008. In December 2006, the Company suspended further work under this agreement until
resolution of further development plans for Zenvia resulting from its meeting with the FDA in late
February 2007. All material remaining obligations would only be due in the event the Company
re-initiate the agreement in the future. As of June 30, 2008, the Company had not yet reinitiated
work under this agreement.
Contingencies. In the ordinary course of business, the Company may face various claims brought by
third parties and it may, from time to time, make claims or take legal actions to assert the
Companys rights, including intellectual property rights as well as claims relating to employment
and the safety or efficacy of its products. Any of these claims could subject the Company to costly
litigation and, while the Company generally believes that it has adequate insurance to cover many
different types of liabilities, the Companys insurance carriers may deny coverage or the Companys
policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to
happen, the payment of any such awards could have a material adverse effect on the Companys
operations, cash flows and financial position. Additionally, any such claims, whether or not
successful, could damage the Companys reputation and business. Management believes the outcome of
currently pending claims and lawsuits will not likely have a material effect on the Companys
operations or financial position.
In September 2007, a court awarded the Company reimbursement of attorneys fees spent over a
four-year period in connection with the enforcement of a settlement agreement entered into with a
former employee. In April 2008, the Company received the proceeds from the settlement in the amount
of $1.25 million. The proceeds were recorded as Other Income in the third fiscal quarter of 2008.
In addition, it is possible that the Company could incur termination fees and penalties if it
elected to terminate contracts with certain vendors, including clinical research organizations.
Guarantees and Indemnities. The Company indemnifies its directors and officers to the maximum
extent permitted under the laws of the State of California, and various lessors in connection with
facility leases for certain claims arising from such facilities or leases. Additionally, the
Company periodically enters into contracts that contain indemnification obligations, including
contracts for the purchase and sale of assets, clinical trials, pre-clinical development work and
securities offerings. These indemnification obligations provide the contracting parties with the
contractual right to have Avanir pay for the costs associated with the defense and settlement of
claims, typically in circumstances where Avanir has failed to meet its contractual performance
obligations in some fashion.
The maximum amount of potential future payments under such indemnifications is not determinable.
The Company has not incurred significant amounts related to these guarantees and indemnifications,
and no liability has been recorded in the condensed consolidated financial statements for
guarantees and indemnifications as of June 30, 2008.
14. SEGMENT INFORMATION
The Company operates its business on the basis of a single reportable segment, which is the
business of discovery, development and commercialization of novel therapeutics for chronic
diseases. The Companys chief operating decision-maker is the Chief Executive Officer, who
evaluates the Company as a single operating segment.
The Company categorizes revenues by geographic area based on selling location. All the Companys
operations are currently located in the U.S.; therefore, total revenues for the three and nine
month periods ended June 30, 2008 and 2007 are attributed to the U.S. All long-lived assets at June
30, 2008 and September 30, 2007 are located in the U.S.
22
For the three month periods ended June 30, 2008 and 2007, the revenues from prior sale of rights to
royalties under the GlaxoSmithKline (GSK) license agreement were 22% and 21% of total net
revenues, respectively. For the nine month periods ended June 30, 2008 and 2007, the sale of rights
to royalties under the GSK license agreement were 49% and 31% of total net revenues, respectively.
The increase in GSK royalties as a percentage of total revenue is attributed to royalty revenue of
$934,000 recorded in the first fiscal quarter of 2008, an increase of $720,000 from the royalty
received in fiscal 2007, pursuant to the GSK license agreement in which the Company is entitled to
receive 4% of all annual net sales of Abreva in North America in excess of $62 million during each
calendar year. For the nine month period ended June 30, 2007, 19% of the Companys total net
revenues were derived from its license agreement with AstraZeneca. No revenues were derived from
AstraZeneca in the three month period ended June 30, 2007. For the three and nine month periods
ended June 30, 2007, 8% and 18% of the Companys total net revenues, respectively, were derived
from its license agreement with Novartis. No revenues were derived from AstraZeneca or Novartis in
the three and nine month periods ended June 30, 2008.
Net trade-related receivables for docosanol product sales accounted for 2% of net receivables as
of June 30, 2008.
15. LICENSE AGREEMENTS
In March 2008, the Company entered into an Asset Purchase and License Agreement with Emergent
Biosolutions for the sale of the Companys anthrax antibodies and license to use its proprietary
Xenerex Technology platform. Under the terms of the Agreement, the Company is obligated to complete
the remaining work under the Companys NIH/NIAID grant (NIH grant). As such, revenue resulting
from upfront payments totaling $250,000 that were received in the second fiscal quarter of 2008
will be deferred until the remaining work is completed under the Asset Purchase and License
Agreement. The $2 million NIH grant was awarded to the Company in July 2006 in order to establish a
cGMP manufacturing process for the anthrax antibody and test efficacy of the fully human monoclonal
antibody in non-human primates. The NIH grant expired on June 30, 2008.
16. SUBSEQUENT EVENTS
In June 2008, the European Patent Office notified the Company of the approval of a new patent for
Zenvia, thereby protecting the Companys commercial exclusivity for Zenvia into 2023.
In January 2008, Azur made claims that the Net Working Capital Adjustment should reduce the sale
price by approximately $2.0 million, which was approximately $1.1 million more than the amount that
the Company had accrued. As a result, as provided by the Agreement, the Company and Azur engaged
the services of a U.S. national accounting firm to serve as an independent arbitrator to resolve
this dispute of the Net Working Capital Adjustment. The arbitrator rendered a decision in August
2008 resulting in an additional accrual of $484,000. The $484,000 is reflected in current
liabilities of discontinued operations at June 30, 2008. (see Note 3)
Item 2.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report on Form 10-Q contains forward-looking statements concerning future events and
performance of the Company. When used in this report, the words intend, estimate, anticipate,
believe, plan or
expect and similar expressions are included to identify forward-looking statements. These
forward-looking statements are based on our current expectations and assumptions and many factors
could cause our actual results to differ materially from those indicated in these forward-looking
statements. You should review carefully the factors identified in this report under the caption,
Risk Factors and in our most recent Annual Report on Form 10-K filed with the SEC. We disclaim
any intent to update or announce revisions to any forward-looking statements to reflect actual
events or developments. Except as otherwise indicated herein, all dates referred to in this report
represent periods or dates fixed with reference to the calendar year, rather than our fiscal year
ending September 30. The three month period ended June 30, 2008 may also be referred to as the
third quarter of fiscal 2008.
23
EXECUTIVE OVERVIEW
We are a pharmaceutical company focused on developing, acquiring and commercializing novel
therapeutic products for the treatment of chronic diseases. Our product candidates address
therapeutic markets in the areas of the central nervous system and inflammatory diseases. Our lead
product candidate, Zenvia (dextromethorphan hydrobromide/quinidine sulfate), is currently in Phase
III clinical development for the treatment of PBA and DPN pain. Our first commercialized product,
docosanol 10% cream, (sold as Abreva® by our marketing partner GlaxoSmithKline Consumer Healthcare
in North America) is the only over-the-counter treatment for cold sores that has been approved by
the FDA. Our inflammatory disease program, which targets macrophage migration inhibitory factor
(MIF), is currently partnered with Novartis. Our infectious disease program has historically been
focused primarily on anthrax antibodies and, in March 2008, we sold our rights to this program to
Emergent Biosolutions. Under the terms of the Emergent agreement, we were obligated to complete the
remaining work under our NIH/NIAID grant. The NIH/NIAID grant (NIH grant), which funded the
anthrax antibody program, expired on June 30, 2008. All work was completed under the grant. In
connection with the anthrax antibody program, we also ceased all future research and development
work related to the Xenerex program on June 30, 2008.
Zenvia Status
Zenvia is currently in Phase III clinical development for the treatment of two
conditions: (1) pseudobulbar affect (PBA), which is an involuntary emotional expression disorder
and (2) diabetic peripheral neuropathic (DPN pain).
In October 2006, we received an approvable letter from the FDA for Zenvia in the
treatment of patients with PBA. The approvable letter raised certain safety and efficacy concerns
and the safety concerns will require additional clinical development to resolve. Based on
discussions with the FDA, we were able to successfully resolve the outstanding efficacy concerns
relating to the original dose formulation that was tested in our earlier trials. However, to
address the remaining safety concerns, we agreed to re-formulate Zenvia and conduct one
additional confirmatory Phase III clinical trial using lower dose formulations. The goal of the
study is to demonstrate improved safety while maintaining significant efficacy at a lower dose. In
October 2007, we reached agreement with the FDA under the Special Protocol Assessment (SPA)
process, on the design of a single confirmatory Phase III clinical trial of Zenvia for
the treatment of patients with PBA. We enrolled our first patient in this trial in December 2007
and as of August 2008, we are on target with our expected enrollment numbers. In May 2008, we
informed the FDA of our intention to increase the planned patient enrollment numbers from 270 to
approximately 300 in order to provide additional statistical power to the trial and increase the
size of our safety database. We continue to expect this study to be completed (as defined as
top-line safety and efficacy data becomes available) during the second half of calendar 2009, even
after allowing for the increase in the size of the trial.
In April 2007, we announced positive top-line data results from our first Phase III clinical trial
of Zenvia for DPN pain. Before discussing a further Phase III trial with the FDA, we
made the decision to conduct a formal pharmacokinetic (PK) study to identify a lower quinidine
dose formulation that may have similar efficacy to the doses tested in the Phase III study. While
we have received no formal direction from the FDA to lower quinidine dose formulation for DPN pain,
we believe it is the most prudent course of action given the current regulatory environment and the
FDAs concerns raised over Zenvia for PBA. In May 2008, we reported a positive outcome
of the formal PK study and announced that we identified alternative lower-dose quinidine
formulations of Zenvia for DPN pain. The two new doses are intended to deliver similar efficacy and
improved safety/tolerability versus the
formulations previously tested for this indication. We intend to incorporate the PK study data
into the Zenvia patent portfolio, submit a Phase III protocol to FDA under Special Protocol
Assessment (SPA) process by year end calendar 2008 and evaluate strategic options for funding
further development in DPN pain.
Docosanol 10% Cream
Docosanol 10% cream is a topical treatment for cold sores. In 2000, we received FDA approval for
marketing docosanol 10% cream as an over-the-counter product. Since that time, docosanol 10% cream
has been approved by regulatory agencies in Canada, Denmark, Finland, Israel, Korea, Norway,
Portugal, Spain, Poland, Greece and Sweden and is sold by our marketing partners in these
territories. In 2000, we granted a subsidiary of
24
GlaxoSmithKline, SB Pharmco Puerto Rico, Inc.
(GlaxoSmithKline) the exclusive rights to market docosanol 10% cream in North America.
GlaxoSmithKline markets the product under the name Abreva® in the United States
and Canada. In fiscal 2003, we sold an undivided interest in our GlaxoSmithKline license agreement
for docosanol 10% cream to Drug Royalty USA, Inc. (Drug Royalty USA) for $24.1 million. We
retained the right to receive 50% of all royalties under the GlaxoSmithKline license agreement for
annual net sales of Abreva in North America in excess of $62 million. Starting in fiscal 2007,
annual Abreva sales exceeded this threshold and we began participating in the excess royalties at
that time.
Inflammation Program
In April 2005, we entered into an exclusive Research Collaboration and License Agreement with
Novartis regarding the license of certain compounds that regulate macrophage migration inhibitory
factor (MIF) in the treatment of various inflammatory diseases. We initially provided contract
research services to Novartis to support this program for two years and, in March 2007, Novartis
made the decision to continue the MIF research program internally and to allow the research
collaboration portion of this agreement to expire without renewal. Under the terms of the license
agreement, we are eligible to receive over $200 million in combined upfront and milestone payments
upon achievement of development, regulatory, and sales objectives. We are also eligible to receive
escalating royalties on any worldwide product sales generated from this program.
Xenerex Human Antibody Technology Anthrax/Other Infectious Diseases
Our patented Xenerex antibody technology can be used to develop human monoclonal antibodies for use
as prophylactic and therapeutic drugs, which may be used to prevent or treat anthrax and other
infectious diseases. This proprietary technology provides a platform for accessing human monoclonal
antibodies against disease antigens. The Xenerex technology is capable of generating fully human
antibodies to target antigens and draws on the natural diversity of the human donor population.
Using Xenerex technology, we have discovered a human monoclonal antibody, AVP-21D9, that provides
immediate post-exposure neutralization and immediate immunity to animals exposed to a lethal dose
of recombinant anthrax toxins.
In March 2008, we entered into an Asset Purchase and License Agreement with Emergent Biosolutions
for the sale of our anthrax antibodies and license to use our proprietary Xenerex Technology
platform. Under the terms of the Agreement, we are obligated to complete the remaining work
under our NIH/NIAID grant (NIH grant). As such, revenue resulting from upfront payments totaling
$250,000 that were received in the second fiscal quarter of 2008 will be deferred until the
remaining work is completed under the Agreement. The NIH/NIAID grant (NIH grant), which funded
the anthrax antibody program, expired on June 30, 2008. All work was completed under the grant. In
connection with the anthrax antibody program, we also ceased all future research and development
work related to the Xenerex program on June 30, 2008.
Restructuring Activities
In May 2006, we acquired FazaClo® (clozapine, USP), a product marketed for the management of
treatment-resistant schizophrenia and the reduction in the risk of recurrent suicidal behavior in
schizophrenia or schizoaffective disorders. We had intended to leverage the FazaClo sales force to
assist with the commercial launch of Zenvia for PBA, a launch that was planned for early
2007. However, due to the receipt of the approvable letter and the resulting delay in the planned
launch of Zenvia, the strategic rationale for continued marketing of FazaClo by Avanir no longer
existed. Therefore, we entered into an agreement in July 2007 to sell FazaClo to Azur Pharma.
The sale, which closed August 3, 2007, provided approximately $43.9 million in an up-front cash
payment and may provide up to an additional $10.0 million in contingent payments to be paid in
calendar year 2009, subject to certain regulatory conditions. In addition, we are eligible to
receive up to $2.0 million in royalties, based on 3% of annualized net product revenues in excess
of $17.0 million. Azur acquired the FazaClo sales force and support operations, representing
approximately 80 employees in total. As a result, we became a substantially smaller organization
following the sale of FazaClo, as well as the divestiture of our drug discovery operations in San
Diego, and will be principally focused over the next two to three years on seeking regulatory
approval of Zenvia for the treatment of patients with PBA and patients with DPN pain.
We have suspended all funding activities for our selective cytokine inhibitor program and have also
ended all further prosecution and maintenance of associated patents.
25
As a result of these initiatives, we have undergone significant organizational changes since fiscal
2007. Our principal focus is currently on gaining regulatory approval for Zenvia TM,
first for the treatment of patients with PBA and then for patients with DPN pain. We believe that
the proceeds from the sale of FazaClo and the proceeds from the April 2008 common stock offering
will be sufficient to fund our operations, including our ongoing confirmatory Phase III trial for
Zenvia in patients with PBA, through the date by which we expect that FDA will render an approval
decision with respect to Zenvia for PBA. For additional information about the risks and
uncertainties that may affect our business and prospects, please see Risk Factors.
Our principal executive offices are located at 101 Enterprise, Suite 300, Aliso Viejo, California
92656. Our telephone number is (949) 389-6700 and our e-mail address is info@avanir.com. Our
Internet website address is www.avanir.com. We make our periodic and current reports available on
our Internet website, free of charge, as soon as reasonably practicable after such material is
electronically filed with, or furnished to, the SEC. No portion of our website is incorporated by
reference into this Quarterly Report on Form 10-Q. The public may read and copy the materials we
file with the SEC at the SECs Public Reference Room, located at 100 F Street, NE, Washington, D.C.
20549. The public may obtain information regarding the operation of the Public Reference Room by
calling the SEC at 1-800-SEC-0330. The public may also read and copy the materials we file with the
SEC by visiting the SECs website, www.sec.gov.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
To understand our financial statements, it is important to understand our critical accounting
policies and estimates. The preparation of our financial statements in conformity with accounting
principles generally accepted in the United States requires us to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Significant estimates and assumptions are required in the
determination of revenue recognition and sales deductions for estimated chargebacks, rebates, sales
incentives and allowances, certain royalties and returns and losses. Significant estimates and
assumptions are also required in the appropriateness of capitalization and amortization periods for
identifiable intangible assets, inventories, the potential impairment of goodwill and other
intangible assets, income taxes, contingencies, estimate on net working capital adjustment and
stock-based compensation. Some of these judgments can be subjective and complex, and, consequently,
actual results may differ from these estimates. For any given individual estimate or assumption
made by us, there may also be other estimates or assumptions that are reasonable. Although we
believe that our estimates and assumptions are reasonable, they are based upon information
available at the time the estimates and assumptions are made. Actual results may differ
significantly from our estimates.
A summary of significant accounting policies and a description of accounting policies that are
considered critical may be found in Part II, Item 7 of our Annual Report on Form 10-K for the year
ended September 30, 2007 in the Critical Accounting Policies and Estimates section and in Note 2
of the Notes to our condensed consolidated financial statements included herein.
26
RESULTS OF OPERATIONS
COMPARISON OF THREE MONTHS ENDED JUNE 30, 2008 AND 2007
Revenues and Cost of Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
$ Change |
|
|
% Change |
|
PRODUCT SALES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
3,550 |
|
|
$ |
|
|
|
$ |
3,550 |
|
|
|
100 |
% |
Cost of revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
3,550 |
|
|
$ |
|
|
|
$ |
3,550 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LICENSES, RESEARCH SERVICES AND GRANTS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services |
|
$ |
|
|
|
$ |
181,692 |
|
|
$ |
(181,692 |
) |
|
|
-100 |
% |
Government research grant |
|
|
527,517 |
|
|
|
122,398 |
|
|
|
405,119 |
|
|
|
331 |
% |
License agreements |
|
|
1,534,552 |
|
|
|
1,443,543 |
|
|
|
91,009 |
|
|
|
6 |
% |
Royalty and sale of royalty rights |
|
|
584,314 |
|
|
|
453,091 |
|
|
|
131,223 |
|
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues from licenses, research services
and grants |
|
|
2,646,383 |
|
|
|
2,200,724 |
|
|
|
445,659 |
|
|
|
20 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services |
|
|
155,450 |
|
|
|
1,202,476 |
|
|
|
(1,047,026 |
) |
|
|
-87 |
% |
Government research grant |
|
|
358,028 |
|
|
|
201,178 |
|
|
|
156,850 |
|
|
|
78 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs from research services and grants |
|
|
513,478 |
|
|
|
1,403,654 |
|
|
|
(890,176 |
) |
|
|
-63 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services and other gross margin |
|
|
2,132,905 |
|
|
|
797,070 |
|
|
|
1,335,835 |
|
|
|
168 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total gross margin |
|
$ |
2,136,455 |
|
|
$ |
797,070 |
|
|
$ |
1,339,385 |
|
|
|
168 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
Net product revenues for the three months ended June 30, 2008 include sales of docosanol 10% cream
of $4,000. Revenues from licenses, royalties, research services and grants increased by $446,000 to
$2.6 million for the third quarter of fiscal 2008 compared to $2.2 million in the third quarter of
fiscal 2007. The increase in revenues is attributed to an increase of $405,000 in government grant
revenue related to our anthrax antibody program, which ended June 30, 2008. This increase is
offset by a decrease in research revenue of $182,000 primarily related to our research services
agreements with AstraZeneca and Novartis, neither of which are still active.
Potential revenue-generating contracts that remained active as of June 30, 2008 include several
docosanol 10% cream license agreements and our license agreement with Novartis for our MIF
technology. We may continue to seek partnerships with pharmaceutical companies that can help fund
our operations in exchange for sharing in the success of any licensed compounds or technologies.
Cost of Revenues
Cost of licenses, research services and grants declined to $513,000 or 19% of revenues for the
third quarter of fiscal 2008 compared with $1.4 million or 64% of revenues for the third quarter of
fiscal 2007. The decline in cost of revenues is primarily attributed to a 87% decline in the cost
of research services due to the termination of the
AstraZeneca agreement and non-renewal of the Novartis agreement. The cost of licenses, research
services and grants includes primarily direct and indirect payroll costs and the costs of outside
vendors.
27
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
$ Change |
|
|
% Change |
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,139,685 |
|
|
$ |
2,604,294 |
|
|
$ |
535,391 |
|
|
|
21 |
% |
Selling, general and administrative |
|
|
2,350,071 |
|
|
|
7,469,784 |
|
|
|
(5,119,713 |
) |
|
|
-69 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
$ |
5,489,756 |
|
|
$ |
10,074,078 |
|
|
$ |
(4,584,322 |
) |
|
|
-46 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development Expenses
Research and development expenses increased by $535,000 from $2.6 million in the third quarter of
fiscal 2007 to $3.1 million for the third quarter of fiscal 2008. The increase is primarily due to
increased costs incurred for Zenvia due to the confirmatory Phase III trial for the PBA indication
of Zenvia.
Over the next two years, we expect that our research and development costs will consist mainly of
expenses related to the confirmatory Phase III trial for Zenvia for PBA.
Selling, General and Administrative Expenses
Selling, general and administrative expenses decreased by $5.1 million from $7.5 million for the
third quarter of fiscal 2007 compared to $2.4 million for the third quarter of fiscal 2008. The
decrease is primarily attributed to a decrease in our overall selling, general and administrative
expenses as a result of the restructuring and the significant organizational changes that we made
to our infrastructure in the last half of fiscal 2007. Specifically, the decrease is primarily
attributed to expense reductions in personnel, legal and consulting expenses.
Share-Based Compensation
During the second quarter of fiscal 2007, we updated our projected forfeiture rates as it applies
to stock-based compensation considering recent actual data. Forfeiture rates for the nine month
periods ended June 30, 2008 and 2007 were estimated to be approximately 30% based on our historical
experience. Future estimates may differ substantially from our current estimates.
Total compensation expense for our share-based payments in the three month period ended June 30,
2008 and the same period in 2007 was $351,000 and $538,000, respectively. Selling, general and
administrative expense in the three month periods ended June 30, 2008 and 2007 include share-based
compensation expense of $279,000 and $247,000, respectively. Research and development expense in
the three month periods ended June 30, 2008 and 2007 include share-based compensation expense of
$72,000 and $119,000, respectively. As of June 30, 2008, $4.0 million of total unrecognized
compensation costs related to nonvested options and awards is expected to be recognized over a
weighted average period of 2.0 years. See Note 12, Employee Equity Incentive Plans in the Notes
to Condensed Consolidated Financial Statements (Unaudited) for further discussion.
Other Income (Expenses)
For the three month period ended June 30, 2008, interest expense decreased to $114,000, compared to
$233,000 for the same period in the prior year. The decrease in interest expense in 2008 is
primarily due to a 3% decrease in the interest rate applied to Senior Notes as compared to the
prior year. In addition, the balance on the Notes decreased as compared to the prior year, mostly
attributed to the $11 million payment made in August 2007. The Seller Notes were issued in
connection with the purchase of Alamo.
For the three month period ended June 30, 2008, interest income increased to $316,000, compared to
$89,000 for the same period in the prior year. The increase is due to approximately a 500% increase
in the average balance of cash, cash equivalents and investments in securities for the quarter
ended June 30, 2008, compared to the same period in the prior year.
28
In the third fiscal quarter of 2008, a gain on extinguishment of debt was recorded in the amount of
$968,000 resulting from the Companys accelerated re-payment of the outstanding principal under the
Senior Notes. The Company paid $10.9 million in full satisfaction of the Notes. The accelerated
repayment of the Notes represented an estimated savings of approximately $1.2 million in principal
and interest payments through the original Maturity Date, net of estimated lost earnings on cash
balances that would have been held through the Maturity Date.
In September 2007, a court awarded us reimbursement of attorneys fees spent over a four-year period
in connection with the enforcement of a settlement agreement entered into with a former
employee. In April 2008, we received the settlement in the amount of $1.25 million. The settlement
was recorded in Other Income in the third quarter of fiscal 2008.
Loss from Discontinued Operations
Loss from discontinued operations was $484,000 in the three month period ended June 30, 2008,
compared to loss from discontinued operations of $1.1 million for the three month period ended June
30, 2007. The loss recognized in the three month period ended June 30, 2008 is attributed to the
accrual for the Net Working Capital Adjustment of $484,000.
Net Loss
Net loss was $1.4 million, or $0.02 per share, in the three month period ended June 30, 2008,
compared to a net loss of $9.2 million, or $0.23 per share for the three month period ended June
30, 2007.
COMPARISON OF NINE MONTHS ENDED JUNE 30, 2008 AND 2007
Revenues and Cost of Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
$ Change |
|
|
% Change |
|
PRODUCT SALES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
129,820 |
|
|
$ |
|
|
|
$ |
129,820 |
|
|
|
100 |
% |
Cost of revenues |
|
|
21,714 |
|
|
|
|
|
|
|
21,714 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
108,106 |
|
|
$ |
|
|
|
$ |
108,106 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LICENSES, RESEARCH SERVICES AND GRANTS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services |
|
$ |
|
|
|
$ |
2,372,384 |
|
|
$ |
(2,372,384 |
) |
|
|
-100 |
% |
Government research grant |
|
|
1,006,922 |
|
|
|
475,474 |
|
|
|
531,448 |
|
|
|
112 |
% |
License agreements |
|
|
1,648,459 |
|
|
|
1,556,827 |
|
|
|
91,632 |
|
|
|
6 |
% |
Royalty and sale of royalty rights |
|
|
2,993,992 |
|
|
|
1,955,804 |
|
|
|
1,038,188 |
|
|
|
53 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues from licenses, research services and grants |
|
|
5,649,373 |
|
|
|
6,360,489 |
|
|
|
(711,116 |
) |
|
|
-11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services |
|
|
232,257 |
|
|
|
2,973,715 |
|
|
|
(2,741,458 |
) |
|
|
-92 |
% |
Government research grant |
|
|
915,563 |
|
|
|
666,166 |
|
|
|
249,397 |
|
|
|
37 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs from research services and grants |
|
|
1,147,820 |
|
|
|
3,639,881 |
|
|
|
(2,492,061 |
) |
|
|
-68 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research services and other gross margin |
|
|
4,501,553 |
|
|
|
2,720,608 |
|
|
|
1,780,945 |
|
|
|
65 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total gross margin |
|
$ |
4,609,659 |
|
|
$ |
2,720,608 |
|
|
$ |
1,889,051 |
|
|
|
69 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
Net product revenues for the nine months ended June 30, 2008 include sales of docosanol 10% cream
of $130,000. Revenues from licenses, royalties, research services and grants declined by $700,000
to $5.6 million for the first nine months of fiscal 2008 compared to $6.4 million in the first nine
months of fiscal 2007. The decrease in revenues is attributed to a decline in revenue of $2.4
million from research services from our agreements with AstraZeneca and Novartis. In the second
fiscal quarter of 2008, neither of the collaboration services agreements with
29
AstraZeneca or
Novartis were still active, although our license agreement with Novartis remained in effect at that
time.
The revenue decrease was partially offset by an increase in revenue from royalties of $1 million.
The increase in royalty revenue is related to royalty revenue from GSK of $934,000 recorded in the
first quarter of 2008 an increase of $720,000 from the prior year, pursuant to the royalty sale
arrangement relating to our GSK license agreement in which we are entitled to receive 4% of all
annual net sales of Abreva in North America in excess of $62 million.
Potential revenue-generating contracts that remained active as of June 30, 2008 include several
docosanol 10% cream license agreements and our license agreement with Novartis for our MIF
technology. Partnering, licensing and research collaborations have been, and may continue to be, an
important part of our business development strategy. We may continue to seek partnerships with
pharmaceutical companies that can help fund our operations in exchange for sharing in the success
of any licensed compounds or technologies.
Cost of Revenues
Cost of product revenues for the nine months ended June 30, 2008 include the cost of docosanol 10%
cream. Cost of licenses, research services and grants declined to $1.2 million or 20% of revenues
for the first nine months of fiscal 2008 compared with $3.6 million or 57% of revenues for the
first nine months of fiscal 2007. The decline in cost of revenues is primarily attributed to a 92%
decline in the cost of research services due to the termination of the AstraZeneca agreement and
non-renewal of the Novartis agreement. The cost of licenses, research services and grants includes
primarily direct and indirect payroll costs and the costs of outside vendors.
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
$ Change |
|
|
% Change |
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
10,090,610 |
|
|
$ |
13,769,286 |
|
|
$ |
(3,678,676 |
) |
|
|
-27 |
% |
Selling, general and administrative |
|
|
7,897,085 |
|
|
|
18,885,623 |
|
|
|
(10,988,538 |
) |
|
|
-58 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
$ |
17,987,695 |
|
|
$ |
32,654,909 |
|
|
$ |
(14,667,214 |
) |
|
|
-45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development Expenses
Research and development expenses decreased by $3.7 million from $13.8 million in the first nine
months of fiscal 2007 to $10.1 million for the first nine months of fiscal 2008. The decrease is
primarily due to decreased costs incurred for Zenvia as we were conducting a study in the first six
months of fiscal 2007 for the DPN pain indication of Zenvia.
Over the next two years, we expect that our research and development costs will consist mainly of
expenses related to the confirmatory Phase III trial for Zenvia for PBA.
Selling, General and Administrative Expenses
Selling, general and administrative expenses decreased by $11.0 million from $18.9 million for the
first nine months of fiscal 2007 compared to $7.9 million for the first nine months of fiscal 2008.
The decrease resulted primarily from expenses incurred in the first fiscal quarter of 2007 in
preparation for commercial readiness for the launch of Zenvia which were not repeated in the first
fiscal quarter of 2008. In addition, the decrease is also attributed to a decrease in our overall
selling, general and administrative expenses as a result of the restructuring and the significant
organizational changes that we made to our infrastructure in the last half of fiscal 2007.
Share-Based Compensation
During the second quarter of fiscal 2007, we updated our projected forfeiture rates as it applies
to stock-based compensation considering recent actual data. Forfeiture rates for the nine month
periods ended June 30, 2008 and
30
2007 were estimated to be approximately 30% based on our historical
experience. Future estimates may differ substantially from our current estimates.
Total compensation expense for our share-based payments in the nine month period ended June 30,
2008 and the same period in 2007 was $1.3 million and $2.1 million, respectively. Selling, general
and administrative expense in the nine month periods ended June 30, 2008 and 2007 include
share-based compensation expense of $852,000 and $1.4 million, respectively. Research and
development expense in the nine month periods ended June 30, 2008 and 2007 include share-based
compensation expense of $405,000 and $337,000, respectively. As of June 30, 2008, $4.0 million of
total unrecognized compensation costs related to nonvested options and awards is expected to be
recognized over a weighted average period of 2.0 years. See Note 12, Employee Equity Incentive
Plans in the Notes to Condensed Consolidated Financial Statements (Unaudited) for further
discussion.
Other Income (Expenses)
For the nine month period ended June 30, 2008, interest expense decreased to $540,000, compared to
$786,000 for the same period in the prior year. The decrease in interest expense in 2008 is
primarily due to a decrease in the interest rate applied to the Seller Notes. The average interest
rate applied to the Senior Notes decreased by 1% from the first nine months of fiscal 2008 compared
to the same period in 2007. In addition, the balance on the Notes decreased as compared to the
prior year mostly due to the $11 million payment made in August 2007. The Seller Notes were issued
in connection with the purchase of Alamo.
For the nine month period ended June 30, 2008, interest income increased to $1 million, compared to
$425,000 for the same period in the prior year. The increase is due to approximately a 174%
increase in the average balance of cash, cash equivalents and investments in securities for the
nine months ended June 30, 2008, compared to the same period in the prior year.
In the third fiscal quarter of 2008, a gain on extinguishment of debt was recorded in the amount of
$968,000 resulting from the Companys accelerated re-payment of the outstanding principal under the
Senior Notes. The Company paid $10.9 million in full satisfaction of the Notes. The accelerated
repayment of the Notes represented an estimated savings of approximately $1.2 million in principal
and interest payments through the original Maturity Date, net of estimated lost earnings on cash
balances that would have been held through the Maturity Date.
In September 2007, a court awarded us reimbursement of attorneys fees spent over a four-year period
in connection with the enforcement of a settlement agreement entered into with a former
employee. In April 2008, we received the settlement in the amount of $1.25 million. The settlement
is recorded in Other Income in the third quarter of fiscal 2008.
Loss from Discontinued Operations
Loss from discontinued operations was $1.6 million in the nine month period ended June 30, 2008,
compared to loss from discontinued operations of $4.3 million for the nine month period ended June
30, 2007. The loss recognized in the nine month period ended June 30, 2008 is attributed to the
accrual for the Net Working Capital Adjustment of $1.4 million as well as additional costs related
to the operations of FazaClo during the nine months ended June 30, 2008.
Net Loss
Net loss was $12.3 million, or $0.23 per share, in the nine months ended June 30, 2008, compared to
a net loss of $33.0 million, or $0.93 per share for the nine months ended June 30, 2007.
LIQUIDITY AND CAPITAL RESOURCES
We assess our liquidity by our ability to generate cash to fund future operations. Key factors in
the management of our liquidity are: cash required to fund operating activities including expected
operating losses and the levels of accounts receivable, inventories, accounts payable and capital
expenditures; the timing and extent of cash received from milestone payments under license
agreements; funds required for acquisitions; funds required to repay notes
31
payable and capital
lease obligations as they become due; adequate credit facilities; and financial flexibility to
attract long-term equity capital on favorable terms. Historically, cash required to fund on-going
business operations has been provided by financing activities and used to fund operations and net
working capital requirements and investing activities.
Cash, cash equivalents and investments, as well as, net cash provided by or used for operating,
investing and financing activities are summarized in the table below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
|
|
|
June 30, |
|
(Decrease) |
|
September 30, |
|
|
2008 |
|
During Period |
|
2007 |
Cash, cash equivalents and investment in securities |
|
$ |
47,853,840 |
|
|
$ |
14,212,442 |
|
|
$ |
33,641,398 |
|
Cash and cash equivalents |
|
$ |
46,997,243 |
|
|
$ |
16,509,281 |
|
|
$ |
30,487,962 |
|
Net working capital |
|
$ |
42,576,800 |
|
|
$ |
13,240,024 |
|
|
$ |
29,336,776 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months |
|
|
|
|
|
|
Nine Months |
|
|
|
Ended |
|
|
Change |
|
|
Ended |
|
|
|
June 30, |
|
|
Between |
|
|
June 30, |
|
|
|
2008 |
|
|
Periods |
|
|
2007 |
|
Net cash used in operating activities |
|
$ |
(12,359,166 |
) |
|
$ |
19,135,106 |
|
|
$ |
(31,494,272 |
) |
Net cash provided by investing activities |
|
|
2,288,457 |
|
|
|
(14,580,306 |
) |
|
|
16,868,763 |
|
Net cash provided by financing activities |
|
|
26,579,990 |
|
|
|
9,314,125 |
|
|
|
17,265,865 |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
$ |
16,509,281 |
|
|
$ |
13,868,925 |
|
|
$ |
2,640,356 |
|
|
|
|
|
|
|
|
|
|
|
Operating activities. Net cash used in operating activities amounted to $12.4 million in the first
nine months of fiscal 2008 compared to $31.5 million in the first nine months of fiscal 2007. The
decrease in cash used in operating activities as a result of the various restructuring activities
described above in Executive Overview, which resulted in a $20.7 million decrease in net loss
coupled with a $11.0 million decrease in cash used for accounts payable.
Investing activities. Net cash provided by investing activities was $2.3 million in the first nine
months of fiscal 2008, compared to $16.9 million provided in the first nine months of fiscal 2007.
The decrease in cash provided by investing activities is primarily related to the decrease in
proceeds from the sale of securities which provided $16.9 million in the first nine months of
fiscal 2007 compared to $2.3 million in the same period in 2008.
Financing activities. Net cash provided by financing activities was $26.6 million in the first nine
months of fiscal 2008 compared to net cash provided by financing activities of $17.3 million in the
first nine months of fiscal 2007. The increase in net cash provided by financing activities is
primarily related to approximately $40.0 million of gross proceeds received from the sale of our
common stock through a registered common stock offering in April 2008 (before commissions and
offering costs) as compared to private placements totaling approximately $30.8 million in the first
nine months of fiscal 2007.
In June 2005, we filed a shelf registration statement on Form S-3 with the SEC to sell an aggregate
of up to $100 million in Class A common stock and preferred stock, depositary shares, debt
securities and warrants. This shelf registration statement was declared effective on August 3,
2005. In February 2008, we filed a shelf registration statement on Form S-3 with the SEC to sell an
aggregate of up to $25 million in Class A common stock and preferred stock, depositary shares, debt
securities and warrants. This shelf registration statement was declared effective on February 19,
2008. Through June 30, 2008, we had sold a total of 14,441,323 shares of Class A common stock under
the 2005 registration statement, raising gross offering proceeds of approximately $71.5 million and
net offering proceeds of approximately $69.6 million. We have also issued under the 2005
registration statement common stock warrants to purchase a total of 1,053,000 shares of our Class A
common stock at an exercise price of $3.30 per share. The warrants expired in November 2007
unexercised. As of June 30, 2008, no new securities offerings could be made under either of these
registration statements.
In December 2006 we entered into a financing facility with Brinson Patrick Securities Corporation
(Brinson Patrick). Under this facility, through July 31, 2008, we have offered and sold an
aggregate of 6,160,200 shares of
32
Class A common stock, which resulted in net proceeds of $16.2
million. In April 2008, we terminated our financing facility with the Corporation.
In April 2008, we closed a registered securities offering raising $40 million in gross proceeds
($38 million net of offering costs) from a select group of institutional investors led by ProQuest
Investments and joined by Clarus Ventures, Vivo Ventures, and OrbiMed Advisors. In connection with
the offering, we issued approximately 35 million shares of common stock were issued at a price of
$1.14 per share. We also issued warrants to purchase up to approximately 12.2 million shares of
common stock at a price of $1.43 per share. These warrants have a 5 year minimum period of time.
The proceeds from this offering are expected to provide us with adequate capital to allow
continuing operations through the date by which we expect to receive an approval decision from the
FDA for Zenvia for the PBA indication.
As of June 30, 2008, we have contractual obligations for long-term debt, capital (finance) lease
obligations and operating lease obligations, as summarized in the table that follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
|
|
Total |
|
|
1 Year |
|
|
1-3 Years |
|
|
3-5 Years |
|
|
5 Years |
|
Long-term debt (principal and interest) |
|
$ |
46,818 |
|
|
$ |
46,818 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating lease obligations |
|
|
6,567,098 |
|
|
|
1,605,808 |
|
|
|
3,089,282 |
|
|
|
1,872,008 |
|
|
|
|
|
Purchase obligations (1) |
|
|
1,719,782 |
|
|
|
1,719,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
8,333,698 |
|
|
$ |
3,372,408 |
|
|
$ |
3,089,282 |
|
|
$ |
1,872,008 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Purchase obligations consist of the total of trade accounts payable and trade related accrued
expenses at June 30, 2008 which approximates our contractual commitments for goods and
services in the normal course of our business. |
As part of the purchase consideration of the Alamo acquisition, we initially issued three
promissory notes in the principal amounts of $14,400,000, $6,675,000 and $4,000,000 (the First
Note, Second Note and Third Note, respectively) (collectively, the Notes).
In June 2008, the Company accelerated the repayment of the outstanding principal under the Notes,
which was then $12 million (net of unamortized discount of $140,000). In exchange for the early
repayment of Notes, we negotiated for a repayment discount of $968,000 (net of unamortized discount
of $140,000), which resulted in the full repayment of the Notes for a total sum of approximately
$10.9 million. The accelerated repayment of the Notes represented an estimated savings of
approximately $1.2 million in principal and interest payments through the original Maturity Date,
net of estimated lost earnings on cash balances that would have been held through the Maturity
Date.
Net Working Capital Adjustment.
The Asset Purchase Agreement (the Agreement) with Azur provides for an adjustment to the sale
price of FazaClo in connection with the final determination of the amount of net working capital
(as defined in the Agreement) included as part of the sale (Net Working Capital Adjustment). The
Agreement also stipulates that an adjustment to net working capital shall only exist if the final
Net Working Capital Adjustment is greater than $250,000. As of September 30, 2007, we estimated
that there would not be a Net Working Capital Adjustment. However, based upon current information
following the recent arbitration ruling, we have accrued a $1.4 million liability for the Net
Working Capital Adjustment which represents a reduction in the sale price of FazaClo which will be
an additional use of working capital.
Alamo Earn-Out Payments. In connection with the Alamo acquisition, we agreed to pay up to an
additional $39,450,000 in revenue-based earn-out payments, based on future sales of FazaClo. These
earn-out payments are based on FazaClo sales in the U.S. from the closing date of the acquisition
through December 31, 2018 (the Contingent Payment Period). Based on the results of the quarters
ended March 31, 2007 and June 30, 2007, we issued the first and second of these revenue-based
payments through the issuance of additional promissory notes in the principal amount of $2,000,000
per note. As previously discussed in this filing, we sold the FazaClo product line to Azur Pharma.
Our future earn-out obligations that would have been payable to the prior owner of Alamo
33
Pharmaceuticals upon the achievement of certain milestones were assumed by Azur Pharma; however, we
are still contingently liable in the event of default by Azur.
Eurand Milestone and Royalty Payments. In August 2006, we entered into a development and license
agreement (Eurand Agreement) with Eurand, Inc. (Eurand), under which Eurand will provide R&D
services using Eurands proprietary technology to develop a once-a-day controlled release capsule,
a new formulation, of Zenvia for the treatment of PBA (Controlled-Release Zenvia). Under the
terms of the Eurand Agreement, we will pay Eurand for development services on time and material
basis. We will be required to make payments up to $7.6 million contingent upon achievement of
certain development milestones and up to $14.0 million contingent upon achievement of certain sales
targets. In addition, we will be required to make royalty payments based on sales of
Controlled-Release Zenvia, if it is approved for commercialization. Development milestone events
include program initiation, delivery of prototypes, delivery of clinical trial material for phase
1, achieving target PK Profile in the pilot clinical study, delivery of clinical trial material for
phase 3, filing of the first NDA for the Product with the FDA, completion of manufacturing
validation and approval of the NDA with the FDA. Sales target milestones are $2.0 million upon
achieving $100 million of U.S. net revenues, $4.0 million upon achieving $200 million of U.S. net
revenues and $8.0 million upon achieving $400 million of U.S. net revenues. The agreement remains
in effect on a country-by-country basis for the longer of 10 years after first commercial sale or
the life of any Eurand patent, unless earlier terminated in accordance with the agreement. In
December 2006, we provided Eurand with notification to suspend activity on this project until
further notice. We may terminate the agreement upon 30 days notice in the event we receive a
response from the FDA that is something other than an unconditional approval of the original
formulation of Zenvia. Upon expiration of the agreement we shall own a fully-paid irrevocable
license. Effective December 2006, we suspended further work under this agreement until resolution
of further development plans for Zenvia resulting from our meeting with the FDA in late February
2007. All material remaining obligations would only be due in the event we re-initiate the
agreement in the future.
Zenvia License Milestone Payments. We hold the exclusive worldwide marketing rights to Zenvia for
certain indications pursuant to an exclusive license agreement with the Center for Neurologic Study
(CNS). We will be obligated to pay CNS up to $400,000 in the aggregate in milestones to continue
to develop both indications, assuming they are both approved for marketing by the FDA. We are not
currently developing, nor do we have an obligation to develop, any other indications under the CNS
license agreement. In fiscal 2005, we paid $75,000 to CNS under the CNS license agreement, and will
need to pay a $75,000 milestone if the FDA approves our NDA for Zenvia for the treatment of PBA. In
addition, we are obligated to pay CNS a royalty on commercial sales of Zenvia with respect to each
indication, if and when the drug is approved by the FDA for commercialization. Under certain
circumstances, we may have the obligation to pay CNS a portion of net revenues received if we
sublicense Zenvia to a third party.
Under our agreement with CNS, we are required to make payments on achievements of up to a maximum
of ten milestones, based upon five specific medical indications. Maximum payments for these
milestone payments could total approximately $2.1 million if we pursued the development of Zenvia
for all of the licensed indications. Of the clinical indications that we currently plan to pursue,
expected milestone payments could total $800,000. In general, individual milestones range from
$150,000 to $250,000 for each accepted NDA and a similar amount for each approved NDA. In addition,
we are obligated to pay CNS a royalty ranging from approximately 5% to 8% of net revenues.
Management Outlook
Following the completion of our $40 million common stock offering, in April 2008, we believe that
cash and investments in securities of approximately $47.9 million at June 30, 2008 will be
sufficient to sustain our planned level of operations through the clinical development of Zenvia
and the anticipated FDA approval decision for Zenvia for PBA. However, we cannot provide assurances
that our plans will not change, or that changed circumstances or delays in clinical development
will not result in the depletion of capital resources more rapidly than anticipated.
For information regarding the risks associated with our need to raise capital to fund our ongoing
and planned operations, please see Risk Factors.
34
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As described below, we are exposed to market risks related to changes in interest rates. Because
substantially all of our revenue, expenses and capital purchasing activities are transacted in U.S.
dollars, our exposure to foreign currency exchange rates is immaterial. However, in the future we
could face increasing exposure to foreign currency exchange rates as we expand international
distribution of docosanol 10% cream and purchase additional services from outside the U.S. Until
such time as we are faced with material amounts of foreign currency exchange rate risks, we do not
plan to use derivative financial instruments, which can be used to hedge such risks. We will
evaluate the use of derivative financial instruments to hedge our exposure as the needs and risks
should arise.
Interest rate sensitivity
Our investment portfolio consists primarily of fixed income instruments with an average duration of
approximately 9-12 months. The primary objective of our investments in debt securities is to
preserve principal while achieving attractive yields, without significantly increasing risk. We
classify our restricted investments in securities as of June 30, 2008 as held-to-maturity. Based on
the average duration of our investments as of June 30, 2008 and 2007, an increase of one percentage
point in the interest rates would have resulted in increases in interest income of approximately
$464,000 and $29,000, respectively.
Item 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer and Vice President, Finance, after evaluating the effectiveness of our
disclosure controls and procedures (as defined in the Securities Exchange Act of 1934, Rules
13a-15(e) and 15d-15(e), as of
the end of the period covered by this report, have concluded that, based on such evaluation, as of
June 30, 2008 our disclosure controls and procedures were effective and designed to provide
reasonable assurance that the information required to be disclosed is recorded, processed,
summarized and reported within the time periods specified in the SEC rules and forms. In designing
and evaluating the disclosure controls and procedures, our management recognized that any controls
and procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and our management necessarily was required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes in Internal Controls over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rule
13a-15(f) under the Exchange Act) during our fiscal quarter ended June 30, 2008, that has
materially affected, or is reasonably likely to materially affect our internal control over
financial reporting.
PART II OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
In the ordinary course of business, we may face various claims brought by third parties. Any of
these claims could subject us to costly litigation. Management believes the outcome of currently
identified claims and lawsuits will not have a material adverse effect on our financial condition
or results of operations.
35
Item 1A. RISK FACTORS
Risks Relating to Our Business
We must conduct additional clinical trials for Zenvia and there can be no assurance that the FDA
will approve Zenvia or that an approval, if granted, will be on terms we may seek.
In October 2006, we received an approvable letter from the FDA for our new drug application
(NDA) submission for Zenvia in the treatment of patients with PBA. The approvable letter raised
certain safety and efficacy concerns and the safety concerns will require additional clinical
development to resolve. Based on discussions with the FDA, we were able to successfully resolve the
outstanding efficacy concerns of the original dose formulation that was tested in earlier trials.
In order to address the safety concerns, however, we agreed to re-formulate Zenvia and conduct one
additional confirmatory Phase III clinical trial using lower dose formulations. The goal of the
study is to demonstrate improved safety while maintaining a significant degree of the efficacy seen
in our earlier trials testing higher doses. The study is expected to be completed (as defined as
top-line safety and efficacy data becomes available) during the second half of calendar 2009. It is
possible that the efficacy will be so reduced that we will not be able to satisfy the FDAs
efficacy requirements and there can be no assurance that the FDA will approve Zenvia for
commercialization.
Even if the confirmatory trial is successful, the additional development work will be costly
and time consuming. Because our patents covering Zenvia expire at various times from 2011 through
2019 (up to 2023 in Europe) (without accounting for potential extensions that might be available or
new patents that may be issued), any substantial delays in regulatory approval would negatively
affect the commercial potential for Zenvia for this indication. Additionally, it is possible that
Zenvia may not be approved with the labeling claims or for the patient population that we consider
most desirable for the promotion of the product. Less desirable labeling claims could adversely
affect the commercial potential for the product and could also affect our long-term prospects.
Additionally, although we have a Special Protocol Assessment (SPA) from the FDA for our
recently completed Phase III trial for DPN pain and for our confirmatory Phase III trial for Zenvia
for PBA, there can be no assurance that the terms of the SPA will ultimately be binding on the FDA.
An SPA is intended to serve as a binding agreement from the FDA on the adequacy of the design of a
planned clinical trial. Even where an SPA has been granted, however, additional data may
subsequently become available that causes the FDA to reconsider the
previously agreed upon scope of review and the FDA may have subsequent safety or efficacy
concerns that override the SPA. For example, it is possible that we will not obtain enough data on
cardiac risks in our ongoing Phase III trials to satisfy FDA safety concerns, which could
necessitate further clinical trials. Additionally, because we expanded the planned number of
patients to be enrolled in the ongoing PBA Phase III trial, the FDA may request other amendments to
the trial design including changes in the statistical analyses plan that could add to the trials
cost and/or time, as well as degree of difficulty in reaching clinical endpoints. As a result, even
with an SPA, we cannot be certain that the trial results will be found to be adequate to support an
efficacy claim and product approval.
The FDAs safety concerns regarding Zenvia for the treatment of PBA may extend to other clinical
indications that we are pursuing, including DPN pain. Due to these concerns, we expect to develop
Zenvia for other indications using alternative doses, which may negatively affect efficacy.
We are currently developing Zenvia for the treatment of DPN pain, for which we have completed
a Phase III trial. Although the FDA has not expressly stated that the safety concerns and questions
raised in the PBA approvable letter would apply to other indications such as DPN pain, we believe
that it is possible that the FDA will raise similar concerns for this indication. Accordingly, we
are investigating the potential use of alternative formulations with lower doses of quinidine and
various DM levels in the next Phase III trial for Zenvia for this indication. Although we achieved
positive results in our initial Phase III trial, an alternative lower dose may not yield the same
levels of efficacy as seen in the earlier trials and any drop in efficacy may be so great that the
drug does not demonstrate a statistically significant improvement over placebo. Additionally, any
alternative dose that we develop may not sufficiently satisfy the FDAs safety concerns. If this
were to happen, we may not be able to pursue the development of Zenvia for other indications or may
need to undertake significant additional clinical trials, which would be costly and cause
potentially substantial delays. There is also a risk that due to the change in dosage levels, the
FDA may require two additional Phase III trials for regulatory approval, which would be costly and
delay the potential commercial launch of this drug.
We have limited capital resources and will need to raise additional funds to support our
operations.
We have experienced significant operating losses in funding the research, development and
clinical testing of our drug candidates, accumulating operating losses totaling $251 million as of
June 30, 2008, and we expect to continue to incur substantial operating losses for the foreseeable
future. As of June 30, 2008, we had approximately
36
$48 million in cash, cash equivalents,
investments in marketable securities and restricted investments in marketable securities.
Additionally, we currently do not have any meaningful sources of recurring revenue or cash flow.
In light of our current capital resources, lack of near-term revenue opportunities and
substantial long-term capital needs, we will need to raise additional capital in the future to
finance our long-term operations until we expect to be able to generate meaningful amounts of
revenue from product sales. Based on our current loss rate and existing capital resources as of the
date of this filing, we estimate that we have sufficient funds to sustain our operations at their
current levels through [the anticipated timing of the FDA approval decision (at least 24 months).
Although we expect to be able to raise additional capital and/or curtail current levels of
operations to be able to continue to fund our operations beyond that time, there can be no
assurance that we will be able to do so or that the available terms of any financing would be
acceptable to us. If we are unable to raise additional capital to fund future operations, then we
may be unable to fully execute our development plans for Zenvia and DPN pain. This may result in
significant delays in our planned clinical trial of Zenvia for PBA and may force us to further
curtail our operations.
Any transactions that we may engage in to raise capital could dilute our shareholders and diminish
certain commercial prospects.
Although we have adequate capital reserves to fund operations through the anticipated timing
of the FDA approval decision for Zenvia in PBA, we expect that we will need to raise additional
capital in the future. We may do so through various financing alternatives, including licensing or
sales of our technologies, drugs and/or drug candidates, selling shares of common or preferred
stock, or through the issuance of debt. Each of these financing alternatives carries certain risks.
Raising capital through the issuance of common stock may depress the market price of our stock. Any
such financing will dilute our existing shareholders and, if our stock price is relatively
depressed at the time of any such offering, the levels of dilution would be greater. If we instead
seek to raise capital through
licensing transactions or sales of one or more of our technologies, drugs or drug candidates,
as we have previously done with certain investigational compounds and docosanol 10% cream, then we
will likely need to share a significant portion of future revenues from these drug candidates with
our licensees. Additionally, the development of any drug candidates licensed or sold to third
parties will no longer be in our control and thus we may not realize the full value of any such
relationships.
We have licensed out or sold most of our non-core drug development programs and related assets and
these and other possible future dispositions carry certain risks.
We have entered into agreements for the licensing out or sale of most of our non-core drug
development programs, including FazaClo, macrophage migration inhibitory factor (MIF), and our
anthrax antibody program, as well as docosanol in major markets worldwide. We may also out-license
or otherwise partner Zenvia for PBA and/or DPN pain indications if we are able to find a licensee /
partner willing to offer attractive terms. These transactions involve numerous risks, including:
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Diversion of managements attention from normal daily operations of the business; |
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Disputes over earn-outs, working capital adjustments or contingent payment obligations; |
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Insufficient proceeds to offset expenses associated with the transactions; and |
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The potential loss of key employees following such a transaction. |
Transactions such as these may result in disputes regarding representations and warranties,
indemnities, earn-outs, and other provisions in the transaction agreements. If disputes are
resolved unfavorably, our financial condition and results of operations may be adversely affected
and we may not realize the anticipated benefits from the transactions.
In addition, our financial projections are based on the receipt of contingent payment
obligations. Should we encounter difficulty with our partners in receiving timely payments, our
projections could vary from what has been
37
stated. For example, our contract with Azur Pharma
includes $10 million in contingent payment obligation to Avanir in calendar year 2009.
Disputes relating to these transactions can lead to expensive and time-consuming litigation
and may subject us to unanticipated liabilities or risks, disrupt our operations, divert
managements attention from day-to-day operations, and increase our operating expenses.
Our patents may be challenged and our patent applications may be denied. Either result would
seriously jeopardize our ability to compete in the intended markets for our proposed products.
We have invested in an extensive patent portfolio and we rely substantially on the protection
of our intellectual property through our ownership or control of issued patents and patent
applications. Such patents and patent applications cover Zenvia, docosanol 10% cream and other
potential drug candidates that could come from our technologies such as anti-inflammatory compounds
and antibodies. Because of the competitive nature of the biopharmaceutical industry, we cannot
assure you that:
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The claims in any pending patent applications will be allowed or that patents will be
granted; |
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Competitors will not develop similar or superior technologies independently, duplicate
our technologies, or design around the patented aspects of our technologies; |
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Our technologies will not infringe on other patents or rights owned by others, including
licenses that may not be available to us; |
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Any of our issued patents will provide us with significant competitive advantages; or |
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Challenges will not be instituted against the validity or enforceability of any patent
that we own or, if instituted, that these challenges will not be successful. |
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We will be able to secure additional worldwide intellectual property protection for our
Zenvia patent portfolio. |
Even if we successfully preserve our intellectual property rights, third parties, including
other biotechnology or pharmaceutical companies, may allege that our technology infringes on their
rights. Intellectual property litigation is costly, and even if we were to prevail in such a
dispute, the cost of litigation could adversely affect our business, financial condition, and
results of operations. Litigation is also time-consuming and would divert managements attention
and resources away from our operations and other activities. If we were to lose any litigation, in
addition to any damages we would have to pay, we could be required to stop the infringing activity
or obtain a license. Any required license might not be available to us on acceptable terms, or at
all. Some licenses might be non-exclusive, and our competitors could have access to the same
technology licensed to us. If we were to fail to obtain a required license or were unable to design
around a competitors patent, we would be unable to sell or continue to develop some of our
products, which would have a material adverse effect on our business, financial condition and
results of operations.
We currently have only a limited term of patent coverage for Zenvia in the U.S., which could result
in the introduction of generic competition within in a few years of product launch.
Our PBA related patents for Zenvia in the U.S. expire at various times from 2011 through 2012
and our DPN pain patents for Zenvia expires in 2016(we have longer patent protection for Zenvia in
certain European markets). These expirations do not account for any potential patent term
restoration nor does this account for the issuance of any patents pending. If Zenvia is approved,
we can apply for an up to five-year extension to one patent covering Zenvia; however, as Zenvia is
not a new chemical entity, it is unknown whether or not Zenvia will qualify for patent term
restoration under the U.S. Patent and Trademark Office guidelines. Once the patents covering Zenvia
expire or the three-year Hatch Waxman exclusivity period has passed, generic drug companies would
be able to introduce competing versions of the drug. Although we have filed additional new patents
for Zenvia, there can be no
38
assurance that these patents will issue or that any patents will have
claims that are broad enough to prevent generic competition. If we are unsuccessful in
strengthening our patent portfolio, our long-term revenues from Zenvia sales may be less than
expected.
If we fail to obtain regulatory approval in foreign jurisdictions, we would not be able to market
our products abroad and our revenue prospects would be limited.
We may seek to have our products or product candidates marketed outside the United States. In
order to market our products in the European Union and many other foreign jurisdictions, we must
obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.
The approval procedure varies among countries and jurisdictions and can involve additional testing.
The time required to obtain approval may differ from that required to obtain FDA approval. The
foreign regulatory approval process may include all of the risks associated with obtaining FDA
approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. For example,
our development partner in Japan has encountered significant difficulty in seeking approval of
Docosanol in that country and we may be forced to abandon efforts to seek approval in that country.
Approval by the FDA does not ensure approval by regulatory authorities in other countries or
jurisdictions, and approval by one foreign regulatory authority does not ensure approval by
regulatory authorities in other foreign countries or jurisdictions or by the FDA. We may not be
able to file for regulatory approvals and may not receive necessary approvals to commercialize our
products in any market. The failure to obtain these approvals could materially adversely affect our
business, financial condition and results of operations.
We have experienced turnover in senior management.
In the past 12 months, we have experienced turnover in our senior management team, including
the departures of our Interim Chief Financial Officer. Changes in management are disruptive to the
organization and any further changes may slow the Companys progress toward its goals. Changes in
Board composition may also be
disruptive and the loss of the experience and capabilities of any of our Board members may
reduce the effectiveness of the Board.
We face challenges retaining members of management and other key personnel.
The industry in which we compete has a high level of employee mobility and aggressive
recruiting of skilled employees. This type of environment creates intense competition for qualified
personnel, particularly in clinical and regulatory affairs, sales and marketing and accounting and
finance. Because we have a relatively small organization, the loss of any executive officers or
other key employees could adversely affect our operations. For example, if we were to lose one or
more of the senior members of our clinical and regulatory affairs team, the pace of clinical
development for Zenvia could be slowed significantly. We have experienced employee turnover and
the loss of key employees could adversely affect our business and cause significant disruption in
our operations.
Risks Relating to Our Industry
There are a number of difficulties and risks associated with clinical trials and our trials may not
yield the expected results.
There are a number of difficulties and risks associated with conducting clinical trials. For
instance, we may discover that a product candidate does not exhibit the expected therapeutic
results, may cause harmful side effects or have other unexpected characteristics that may delay or
preclude regulatory approval or limit commercial use if approved. It typically takes several years
to complete a late-stage clinical trial, such as the ongoing Phase III confirmatory trial for
Zenvia for PBA, and a clinical trial can fail at any stage of testing. If clinical trial
difficulties or failures arise, our product candidates may never be approved for sale or become
commercially viable.
In addition, the possibility exists that:
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the results from earlier clinical trials may not be statistically significant or
predictive of results that will be obtained from subsequent clinical trials, particularly
larger trials; |
39
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institutional review boards or regulators, including the FDA, may hold, suspend or
terminate our clinical research or the clinical trials of our product candidates for
various reasons, including noncompliance with regulatory requirements or if, in their
opinion, the participating subjects are being exposed to unacceptable health risks; |
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subjects may drop out of our clinical trials; |
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our preclinical studies or clinical trials may produce negative, inconsistent or
inconclusive results, and we may decide, or regulators may require us, to conduct
additional preclinical studies or clinical trials; and |
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the cost of our clinical trials may be greater than we currently anticipate. |
It is possible that earlier clinical and pre-clinical trial results may not be predictive of
the results of subsequent clinical trials. If earlier clinical and/or pre-clinical trial results
cannot be replicated or are inconsistent with subsequent results, our development programs may be
cancelled or deferred. In addition, the results of these prior clinical trials may not be
acceptable to the FDA or similar foreign regulatory authorities because the data may be incomplete,
outdated or not otherwise acceptable for inclusion in our submissions for regulatory approval.
Additionally, the FDA has substantial discretion in the approval process and may reject our
data or disagree with our interpretations of regulations or our clinical trial data or ask for
additional information at any time during their review. For example, the use of different
statistical methods to analyze the efficacy data from our recent Phase III trial of Zenvia in DPN
pain results in significantly different conclusions about the efficacy of the drug. Although we
believe we have legitimate reasons to use the methods that we have adopted as outlined in our SPA
with the FDA, the FDA may not agree with these reasons and may disagree with our conclusions
regarding the results of these trials.
Although we would work to be able to fully address any such FDA concerns, we may not be able
to resolve all such matters favorably, if at all. Disputes that are not resolved favorably could
result in one or more of the following:
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delays in our ability to submit an NDA; |
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the refusal by the FDA to accept for file any NDA we may submit; |
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requests for additional studies or data; |
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delays of an approval; or |
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the rejection of an application. |
If we do not receive regulatory approval to sell our product candidates or cannot successfully
commercialize our product candidates, we would not be able to generate meaningful levels of
sustainable revenues.
Clinical trials can be delayed for a variety of reasons. If we experience any such delays, we would
be unable to commercialize our product candidates on a timely basis, which would materially harm
our business.
Clinical trials may not begin on time or may need to be restructured after they have begun.
Additionally, clinical trials can experience delays for a variety of other reasons, including
delays related to:
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identifying and engaging a sufficient number of clinical trial sites; |
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negotiating acceptable clinical trial agreement terms with prospective trial sites; |
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obtaining institutional review board approval to conduct a clinical trial at a
prospective site; |
40
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recruiting eligible subjects to participate in clinical trials; |
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competition in recruiting clinical investigators or patients, particularly if others are
pursuing trials at the same time in the same patient population (whether or not for the
same indication); |
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shortage or lack of availability of supplies of drugs for clinical trials; |
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the need to repeat clinical trials as a result of inconclusive results or poorly
executed testing; |
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the placement of a clinical hold on a study; |
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the failure of third parties conducting and overseeing the operations of our clinical
trials to perform their contractual or regulatory obligations in a timely fashion; and |
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exposure of clinical trial subjects to unexpected and unacceptable health risks or
noncompliance with regulatory requirements, which may result in suspension of the trial. |
If we experience significant delays in or termination of clinical trials, our financial
results and the commercial prospects for our product candidates or any other products that we may
develop will be adversely impacted. In addition, our product development costs would increase and
our ability to generate revenue could be impaired.
The pharmaceutical industry is highly competitive and most of our competitors are larger and have
greater resources. As a result, we face significant competitive hurdles.
The pharmaceutical and biotechnology industries are highly competitive and subject to
significant and rapid technological change. We compete with hundreds of companies that develop and
market products and technologies in similar areas as our research. For example, we expect that
Zenvia will compete against antidepressants, atypical anti-psychotic agents and other agents.
Our competitors may have specific expertise and development technologies that are better than
ours and many of these companies, either alone or together with their research partners, have
substantially greater financial resources, larger research and development staffs and substantially
greater experience than we do. Accordingly, our competitors may successfully develop competing
products. We are also competing with other companies and their products with respect to
manufacturing efficiencies and marketing capabilities, areas where we have limited or no direct
experience.
If we fail to comply with regulatory requirements, regulatory agencies may take action against us,
which could significantly harm our business.
Marketed products, along with the manufacturing processes, post-approval clinical data,
labeling, advertising and promotional activities for these products, are subject to continual
requirements and review by the FDA and other regulatory bodies. Even if we receive regulatory
approval for one of our product candidates, the approval may be subject to limitations on the
indicated uses for which the product may be marketed or to the conditions of approval or contain
requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy
of the product.
In addition, regulatory authorities subject a marketed product, its manufacturer and the
manufacturing facilities to ongoing review and periodic inspections. We will be subject to ongoing
FDA requirements, including required submissions of safety and other post-market information and
reports, registration requirements, current Good Manufacturing Practices (cGMP) regulations,
requirements regarding the distribution of samples to physicians and recordkeeping requirements.
The cGMP regulations also include requirements relating to quality control and quality
assurance, as well as the corresponding maintenance of records and documentation. We rely on the
compliance by our contract
41
manufacturers with cGMP regulations and other regulatory requirements
relating to the manufacture of products. We are also subject to state laws and registration
requirements covering the distribution of our products. Regulatory agencies may change existing
requirements or adopt new requirements or policies. We may be slow to adapt or may not be able to
adapt to these changes or new requirements.
Developing and marketing pharmaceutical products for human use involves product liability risks,
for which we currently have limited insurance coverage.
The testing, marketing and sale of pharmaceutical products involves the risk of product
liability claims by consumers and other third parties. Although we maintain product liability
insurance coverage, product liability claims can be high in the pharmaceutical industry and our
insurance may not sufficiently cover our actual liabilities. If product liability claims were made
against us, it is possible that our insurance carriers may deny, or attempt to deny, coverage in
certain instances. If a lawsuit against us is successful, then the lack or insufficiency of
insurance coverage could affect materially and adversely our business and financial condition.
Furthermore, various distributors of pharmaceutical products require minimum product liability
insurance coverage before their purchase or acceptance of products for distribution. Failure to
satisfy these insurance requirements could impede our ability to achieve broad distribution of our
proposed products and the imposition of higher insurance requirements could impose additional costs
on us.
Risks Related to Reliance on Third Parties
Because we depend on clinical research centers and other contractors for clinical testing and for
certain research and development activities, the results of our clinical trials and such research
activities are, to a certain extent, beyond our control.
The nature of clinical trials and our business strategy of outsourcing a substantial portion
of our research require that we rely on clinical research centers and other contractors to assist
us with research and development, clinical testing activities, patient enrollment and regulatory
submissions to the FDA. As a result, our success depends partially on the success of these third
parties in performing their responsibilities. Although we pre-qualify our contractors and we
believe that they are fully capable of performing their contractual obligations, we cannot directly
control the adequacy and timeliness of the resources and expertise that they apply to these
activities. If our contractors do not perform their obligations in an adequate and timely manner,
the pace of clinical development, regulatory approval and commercialization of our drug candidates
could be significantly delayed and our prospects could be adversely affected.
We depend on third parties to manufacture, package and distribute compounds for our drugs and drug
candidates. The failure of these third parties to perform successfully could harm our business.
We have utilized, and intend to continue utilizing, third parties to manufacture, package and
distribute Zenvia and the Active Pharmaceutical Ingredient (API) for docosanol 10% cream and
supplies for our drug candidates. We have no experience in manufacturing and do not have any
manufacturing facilities. Currently, we have sole suppliers for the API for docosanol and Zenvia,
and a sole manufacturer for the finished form of Zenvia. Any material disruption in manufacturing
could cause a delay in shipments and possible loss of sales. We do not have any long-term
agreements in place with our current docosanol supplier or Zenvia supplier. Any delays or
difficulties in obtaining APIs or in manufacturing, packaging or distributing our products and
product candidates could delay Zenvia clinical trials for PBA and/or DPN pain. Additionally, the
third parties we rely on for manufacturing and packaging are subject to regulatory review, and any
regulatory compliance problems with these third parties could significantly delay or disrupt our
commercialization activities.
We generally do not control the development of compounds licensed to third parties and, as a
result, we may not realize a significant portion of the potential value of any such license
arrangements.
Under our license arrangement for our MIF compound, we have no direct control over the
development of this drug candidate and have only limited, if any, input on the direction of
development efforts. These development efforts are ongoing by our licensing partner and if the
results of their development efforts are negative or
42
inconclusive, it is possible that our
licensing partner could elect to defer or abandon further development of these programs, as was the
case in early 2007 when AstraZeneca terminated our license and collaboration agreement for our RCT
mechanism technology. We similarly rely on licensing partners to obtain regulatory approval for
Docosanol in foreign jurisdictions. Because much of the potential value of these license
arrangements is contingent upon the successful development and commercialization of the licensed
technology, the ultimate value of these licenses will depend on the efforts of licensing partners.
If our licensing partners do not succeed in developing the licensed technology for whatever reason,
or elect to discontinue the development of these programs, we may be unable to realize the
potential value of these arrangements.
We expect to rely entirely on third parties for international sales and marketing efforts.
In the event that we attempt to enter into international markets, we expect to rely on
collaborative partners to obtain regulatory approvals and to market and sell our product(s) in
those markets. We have not yet entered into any collaborative arrangement with respect to marketing
or selling Zenvia, with the exception of one such agreement relating to Israel. We may be unable to
enter into any other arrangements on terms favorable to us, or at all, and even if we are able to
enter into sales and marketing arrangements with collaborative partners, we cannot assure you that
their sales and marketing efforts will be successful. If we are unable to enter into favorable
collaborative arrangements with respect to marketing or selling Zenvia in international markets, or
if our collaborators efforts are unsuccessful, our ability to generate revenue from international
product sales will suffer.
Risks Relating to Our Stock
Our common stock could be delisted from The NASDAQ Global Market, which could negatively impact the
price of our common stock and our ability to access the capital markets.
Our common stock is currently listed on The NASDAQ Global Market. The listing standards of The
NASDAQ Global Market provide, among other things, that a company may be delisted if the bid price
of its stock drops below $1.00 for a period of 30 consecutive business days. Recently our stock has
traded below $1.00. If the bid price of our stock stays below $1.00 for a period of 30 consecutive
business days, we may receive a NASDAQ Staff Determination Letter informing us that we must regain
compliance with listing requirements or face delisting. Announcements by us of potential or pending
NASDAQ delisting actions could further depress our stock price.
If we fail to comply with the listing standards, our common stock listing may be moved to the
NASDAQ Capital Market, which is a lower tier market, or our common stock may be delisted and traded
on the over-the-counter bulletin board network. Moving our listing to the NASDAQ Capital Market
could adversely affect the liquidity of our common stock and the delisting of our common stock
would significantly affect the ability of investors to trade our securities and could significantly
negatively affect the value and liquidity of our common stock. In addition, the delisting of our
common stock could materially adversely affect our ability to raise capital on terms acceptable to
us or at all. Delisting from NASDAQ could also have other negative results, including the potential
loss of confidence by suppliers and employees, the loss of institutional investor interest and
fewer business development opportunities.
Our stock price has historically been volatile and we expect that this volatility will continue for
the foreseeable future.
The market price of our Class A common stock has been, and is likely to continue to be, highly
volatile. This volatility can be attributed to many factors independent of our operating results,
including the following:
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Announcements by us regarding our non-compliance with continued listing standards on the
NASDAQ stock market; |
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Comments made by securities analysts, including changes in their recommendations; |
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Short selling activity by certain investors, including any failures to timely settle
short sale transactions; |
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Announcements by us of financing transactions and/or future sales of equity or debt
securities; |
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Sales of our Class A common stock by our directors, officers, or significant
shareholders; |
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Announcements by our competitors of clinical trial results or product approvals; and |
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Market and economic conditions. |
Additionally, our stock price has been volatile as a result of announcements of regulatory
actions and decisions relating to our product candidates, including Zenvia, and periodic variations
in our operating results. We expect that our operating results will continue to vary from
quarter-to-quarter. Our operating results and prospects may also vary depending on our partnering
arrangements for our MIF technology, which has been licensed to a third party that controls the
continued progress and pace of development, meaning that the achievement of development milestones
is outside of our control.
As a result of these factors, we expect that our stock price may continue to be volatile and
investors may be unable to sell their shares at a price equal to, or above, the price paid.
Additionally, any significant drops in our stock price, such as the one we experienced following
the announcement of the Zenvia approvable letter, could give rise to shareholder lawsuits, which
are costly and time consuming to defend against and which may adversely affect our ability to raise
capital while the suits are pending, even if the suits are ultimately resolved in favor of the
Company.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The Companys equity incentive plans permit the net issuance of common stock upon the vesting
of restricted stock awards (including restricted stock units) to satisfy individual tax withholding
requirements. During the quarter ended June 30, 2008, the Company effectively redeemed, through a
net issuance process, the shares presented in the table below upon the vesting of awards granted
under these plans.
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Maximum Number (or |
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Total Number of |
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Approximate Dollar |
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Shares (or Units) |
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Value) of Shares |
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Purchased as Part |
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(or Units) that May |
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Total Number of |
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of Publicly |
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Yet Be Purchased |
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Shares (or Units) |
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Average Price Paid |
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Announced Plans or |
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Under the Plans or |
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Period |
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Purchased(1) |
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per Share (or Unit) |
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Programs |
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Programs |
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April 1 to 30, 2008 |
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0 |
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$ |
0 |
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N/A |
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N/A |
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May 1 to 31, 2008 |
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0 |
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$ |
0 |
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N/A |
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N/A |
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June 1 to 30, 2008 |
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2,504 |
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$ |
1.11 |
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N/A |
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N/A |
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Total |
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2,504 |
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$ |
1.11 |
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N/A |
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N/A |
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(1) |
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Includes the redemption of 1,287 shares from Keith Katkin at $1.11 per
share on June 13, 2008 and 1,217 shares from Randall Kaye at $1.11 per
share on June 13, 2008. |
Item 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable.
Item 5. OTHER INFORMATION
Not applicable.
Item 6. EXHIBITS
Exhibits
10.1 Payoff letter between Neal R. Cutler and Avanir Pharmaceuticals
31.1 Certification of Principal Executive Officer Required Under Rule 13a-14(a) of the Securities
Exchange Act of 1934, as amended.
31.2 Certification of Principal Financial Officer Required Under Rule 13a-14(a) of the Securities
Exchange Act of 1934, as amended.
32.0 Certification of Principal Executive Officer and Principal Financial Officer Required Under
Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. 1350.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Signature |
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Title |
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Date |
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/s/ Keith A. Katkin
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President and Chief Executive Officer
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August 8, 2008 |
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Keith A. Katkin
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(Principal Executive Officer) |
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/s/ Christine G. Ocampo
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Vice President, Finance |
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Christine G. Ocampo
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(Principal Financial and Accounting Officer)
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August 8, 2008 |
45