e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
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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, 2010
Or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from
to
.
Commission file number: 000-50865
MannKind Corporation
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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13-3607736
(I.R.S. Employer
Identification No.) |
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28903 North Avenue Paine
Valencia, California
(Address of principal executive offices)
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91355
(Zip Code) |
(661) 775-5300
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
As of July 23, 2010, there were 113,760,415 shares of the registrants common stock, $.01 par value
per share, outstanding.
MANNKIND CORPORATION
Form 10-Q
For the Quarterly Period Ended June 30, 2010
TABLE OF CONTENTS
AFREZZATM and Technosphere® are our trademarks in the United States. We have also
applied for and have registered company trademarks in other jurisdictions, including Europe and
Japan.
2
PART 1: FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
MANNKIND CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands except share data)
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June 30, 2010 |
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December 31, 2009 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
28,358 |
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$ |
30,019 |
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Marketable securities |
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2,414 |
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2,475 |
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State research and development credit exchange current |
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1,500 |
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Prepaid expenses and other current assets |
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2,451 |
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3,672 |
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Total current assets |
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33,223 |
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37,666 |
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Property and equipment net |
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204,398 |
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208,229 |
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State research and development credit exchange receivable net of current portion |
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1,352 |
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918 |
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Other assets |
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584 |
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584 |
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Total |
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$ |
239,557 |
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$ |
247,397 |
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LIABILITIES AND STOCKHOLDERS DEFICIT |
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Current liabilities: |
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Accounts payable |
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$ |
2,365 |
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$ |
6,519 |
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Accrued expenses and other current liabilities |
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19,824 |
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22,334 |
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Total current liabilities |
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22,189 |
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28,853 |
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Senior convertible notes |
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113,030 |
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112,765 |
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Note payable to related party |
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242,000 |
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165,000 |
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Total liabilities |
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377,219 |
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306,618 |
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Commitments and contingencies |
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Stockholders deficit: |
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Undesignated preferred stock, $0.01 par value 10,000,000 shares authorized; no
shares issued or outstanding at June 30, 2010 and December 31, 2009 |
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Common stock, $0.01 par value 200,000,000 and 150,000,000 shares authorized at
June 30, 2010 and December 31, 2009, respectively; 113,674,221 and 113,025,291
shares issued and outstanding at June 30, 2010 and December 31, 2009,
respectively |
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1,137 |
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1,130 |
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Additional paid-in capital |
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1,552,335 |
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1,544,112 |
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Accumulated other comprehensive loss |
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(1 |
) |
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(281 |
) |
Deficit accumulated during the development stage |
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(1,691,133 |
) |
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(1,604,182 |
) |
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Total stockholders deficit |
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(137,662 |
) |
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(59,221 |
) |
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Total |
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$ |
239,557 |
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$ |
247,397 |
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See notes to condensed consolidated financial statements.
3
MANNKIND CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
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Cumulative period |
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from February 14, |
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1991 (date of |
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Three months ended |
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Six months ended |
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inception) to |
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June 30, |
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June 30, |
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June 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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2010 |
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Revenue |
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$ |
93 |
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$ |
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$ |
93 |
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$ |
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$ |
3,081 |
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Operating expenses: |
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Research and development |
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26,160 |
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39,849 |
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56,651 |
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82,738 |
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1,210,464 |
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General and administrative |
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11,196 |
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13,537 |
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21,306 |
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28,454 |
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320,595 |
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In-process research and development costs |
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19,726 |
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Goodwill impairment |
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151,428 |
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Total operating expenses |
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37,356 |
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53,386 |
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77,957 |
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111,192 |
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1,702,213 |
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Loss from operations |
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(37,263 |
) |
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(53,386 |
) |
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(77,864 |
) |
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(111,192 |
) |
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(1,699,132 |
) |
Other (expense) income |
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(1,257 |
) |
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|
283 |
|
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|
(2,047 |
) |
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353 |
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(3,939 |
) |
Interest expense on note payable to related
party |
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(2,523 |
) |
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(1,398 |
) |
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(4,625 |
) |
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(1,990 |
) |
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(11,827 |
) |
Interest expense on senior convertible notes |
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(1,211 |
) |
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(1,130 |
) |
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(2,421 |
) |
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(2,245 |
) |
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(13,146 |
) |
Interest income |
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3 |
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27 |
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6 |
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58 |
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36,937 |
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Loss before provision for income taxes |
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(42,251 |
) |
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|
(55,604 |
) |
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(86,951 |
) |
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(115,016 |
) |
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(1,691,107 |
) |
Income taxes |
|
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|
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|
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|
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(26 |
) |
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Net loss |
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(42,251 |
) |
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|
(55,604 |
) |
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(86,951 |
) |
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(115,016 |
) |
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(1,691,133 |
) |
Deemed dividend related to beneficial
conversion feature of convertible preferred
stock |
|
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(22,260 |
) |
Accretion on redeemable preferred stock |
|
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|
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|
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|
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(952 |
) |
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|
Net loss applicable to common stockholders |
|
$ |
(42,251 |
) |
|
$ |
(55,604 |
) |
|
$ |
(86,951 |
) |
|
$ |
(115,016 |
) |
|
$ |
(1,714,345 |
) |
|
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|
|
|
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|
|
|
|
|
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Net loss per share applicable to common
stockholders basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.77 |
) |
|
$ |
(1.13 |
) |
|
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|
|
|
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|
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|
|
|
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|
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|
Shares used to compute basic and diluted
net loss per share applicable to common
stockholders |
|
|
113,116 |
|
|
|
102,322 |
|
|
|
113,105 |
|
|
|
102,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
See notes to condensed consolidated financial statements.
4
MANNKIND CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
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Cumulative |
|
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|
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Period from |
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|
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|
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|
February 14, |
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|
|
|
|
|
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|
1991 (Date of |
|
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|
Six months ended |
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Inception) to |
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June 30, |
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June 30, |
|
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2010 |
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2009 |
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2010 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
|
$ |
(86,951 |
) |
|
$ |
(115,016 |
) |
|
$ |
(1,691,133 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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|
|
|
|
|
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|
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|
Depreciation and amortization |
|
|
8,607 |
|
|
|
9,233 |
|
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|
87,746 |
|
Stock-based compensation expense |
|
|
8,005 |
|
|
|
12,889 |
|
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|
107,847 |
|
Stock expense for shares issued pursuant to research agreement |
|
|
|
|
|
|
|
|
|
|
3,018 |
|
Loss on sale, abandonment/disposal or impairment of property and equipment |
|
|
|
|
|
|
|
|
|
|
23,575 |
|
Accrued interest on investments, net of amortization of discounts |
|
|
|
|
|
|
(12 |
) |
|
|
(191 |
) |
In-process research and development |
|
|
|
|
|
|
|
|
|
|
19,726 |
|
Goodwill impairment |
|
|
|
|
|
|
|
|
|
|
151,428 |
|
Loss on available-for-sale securities |
|
|
347 |
|
|
|
|
|
|
|
576 |
|
Other, net |
|
|
(6 |
) |
|
|
3 |
|
|
|
1,104 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
State research and development credit exchange receivable |
|
|
1,066 |
|
|
|
1,150 |
|
|
|
(1,352 |
) |
Prepaid expenses and other current assets |
|
|
1,221 |
|
|
|
1,450 |
|
|
|
(851 |
) |
Other assets |
|
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|
|
|
|
(7 |
) |
|
|
(584 |
) |
Accounts payable |
|
|
(3,810 |
) |
|
|
(3,259 |
) |
|
|
2,179 |
|
Accrued expenses and other current liabilities |
|
|
(3,313 |
) |
|
|
(11,453 |
) |
|
|
18,170 |
|
Other liabilities |
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
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|
|
|
|
|
|
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|
Net cash used in operating activities |
|
|
(74,834 |
) |
|
|
(105,022 |
) |
|
|
(1,278,744 |
) |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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|
|
|
|
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|
|
|
Purchase of marketable securities |
|
|
|
|
|
|
(2,000 |
) |
|
|
(792,601 |
) |
Sales/ maturities of marketable securities |
|
|
|
|
|
|
17,800 |
|
|
|
790,565 |
|
Purchase of property and equipment |
|
|
(4,052 |
) |
|
|
(12,548 |
) |
|
|
(314,761 |
) |
Proceeds from sale of property and equipment |
|
|
|
|
|
|
|
|
|
|
284 |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(4,052 |
) |
|
|
3,252 |
|
|
|
(316,513 |
) |
|
|
|
|
|
|
|
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|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock and warrants |
|
|
1,527 |
|
|
|
668 |
|
|
|
1,203,582 |
|
Collection of Series C convertible preferred stock subscriptions receivable |
|
|
|
|
|
|
|
|
|
|
50,000 |
|
Issuance of Series B convertible preferred stock for cash |
|
|
|
|
|
|
|
|
|
|
15,000 |
|
Cash received for common stock to be issued |
|
|
|
|
|
|
|
|
|
|
3,900 |
|
Repurchase of common stock |
|
|
|
|
|
|
|
|
|
|
(1,028 |
) |
Put shares sold to majority stockholder |
|
|
|
|
|
|
|
|
|
|
623 |
|
Borrowings under lines of credit |
|
|
|
|
|
|
|
|
|
|
4,220 |
|
Proceeds from notes receivables |
|
|
|
|
|
|
|
|
|
|
1,742 |
|
Borrowings on notes payable to related party |
|
|
77,000 |
|
|
|
105,000 |
|
|
|
312,000 |
|
Principal payments on notes payable to principal stockholder |
|
|
|
|
|
|
|
|
|
|
(70,000 |
) |
Borrowings on notes payable |
|
|
|
|
|
|
|
|
|
|
3,460 |
|
Principal payments on notes payable |
|
|
|
|
|
|
|
|
|
|
(1,667 |
) |
Proceeds from senior convertible notes |
|
|
|
|
|
|
|
|
|
|
111,267 |
|
Payment of employment taxes related to vested restricted stock units |
|
|
(1,302 |
) |
|
|
(218 |
) |
|
|
(9,484 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
77,225 |
|
|
|
105,450 |
|
|
|
1,623,615 |
|
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|
|
|
|
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|
5
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Cumulative |
|
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|
|
|
|
|
|
|
|
|
Period from |
|
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|
|
|
|
|
|
|
|
|
February 14, |
|
|
|
|
|
|
|
|
|
|
|
1991 (Date of |
|
|
|
Six months ended |
|
|
Inception) to |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
|
$ |
(1,661 |
) |
|
$ |
3,680 |
|
|
$ |
28,358 |
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
|
|
30,019 |
|
|
|
27,648 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
28,358 |
|
|
$ |
31,328 |
|
|
$ |
28,358 |
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH FLOWS DISCLOSURES: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
26 |
|
Interest paid in cash |
|
|
6,131 |
|
|
|
2,761 |
|
|
|
24,618 |
|
Accretion on redeemable convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
(952 |
) |
Issuance of common stock upon conversion of notes payable |
|
|
|
|
|
|
|
|
|
|
3,331 |
|
Increase in additional paid-in capital resulting from merger |
|
|
|
|
|
|
|
|
|
|
171,154 |
|
Issuance of common stock for notes receivable |
|
|
|
|
|
|
|
|
|
|
2,758 |
|
Issuance of put option by stockholder |
|
|
|
|
|
|
|
|
|
|
(2,949 |
) |
Put option redemption by stockholder |
|
|
|
|
|
|
|
|
|
|
1,921 |
|
Issuance of Series C convertible preferred stock subscriptions |
|
|
|
|
|
|
|
|
|
|
50,000 |
|
Issuance of Series A redeemable convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
4,296 |
|
Conversion of Series A redeemable convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
(5,248 |
) |
Non-cash construction in progress and property and equipment |
|
|
459 |
|
|
|
2,814 |
|
|
|
1,079 |
|
In connection with the Companys initial public offering, all shares of Series B and Series C
convertible preferred stock, in the amount of $15.0 million and $50.0 million, respectively,
automatically converted into common stock in August 2004.
See notes to condensed consolidated financial statements.
6
MANNKIND CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Description of business and basis of presentation
The accompanying unaudited condensed consolidated financial statements of MannKind Corporation and
its subsidiaries (the Company), have been prepared in accordance with generally accepted
accounting principles in the United States of America (GAAP) for interim financial information
and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and
Exchange Commission (the SEC). Accordingly, they do not include all of the information and
footnotes required by GAAP for complete financial statements. These statements should be read in
conjunction with the financial statements and notes thereto included in the Companys latest
audited annual financial statements. The audited statements for the year ended December 31, 2009
are included in the Companys annual report on Form 10-K for the fiscal year ended December 31,
2009 filed with the SEC on March 16, 2010 (the Annual Report).
In the opinion of management, all adjustments, consisting only of normal, recurring adjustments,
considered necessary for a fair presentation of the results of these interim periods have been
included. The results of operations for the three and six months ended June 30, 2010 may not be
indicative of the results that may be expected for the full year.
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of expenses during the reporting period. Actual results could differ from those estimates
or assumptions. The more significant estimates reflected in these accompanying financial statements
involve accrued expenses, the valuation of stock-based compensation and the determination of the
provision for income taxes and corresponding deferred tax assets and liabilities and any valuation
allowance recorded against net deferred tax assets.
Business The Company is a biopharmaceutical company focused on the discovery, development and
commercialization of therapeutic products for diseases such as diabetes and cancer. The Companys
lead product candidate, AFREZZA, is an ultra rapid-acting insulin. In March 2009, the Company
submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA)
requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the
control of hyperglycemia. In March 2010, the Company received a Complete Response letter regarding
this NDA from the FDA, requesting additional information. In July 2010, the FDA accepted the
Companys reply to the Complete Response letter and set a target action date of December 29, 2010.
AFREZZA consists of the Companys proprietary Technosphere particles onto which insulin molecules
are loaded. These loaded particles are then aerosolized and inhaled deep into the lung using the
Companys AFREZZA inhaler.
Basis of Presentation The Company is considered to be in the development stage as its primary
activities since incorporation have been establishing its facilities, recruiting personnel,
conducting research and development, business development, business and financial planning, and
raising capital. Since its inception through June 30, 2010 the Company has reported accumulated net
losses of $1.7 billion and cumulative negative cash flow from operations of $1.3 billion. It is
costly to develop therapeutic products and conduct clinical trials for these products. At June 30,
2010 the Companys capital resources consisted of cash, cash equivalents, and marketable securities
of $30.8 million (including a $2.0 million certificate of deposit held as collateral for foreign
exchange hedging instruments) and $108.0 million of available borrowings under the loan agreement
with an entity controlled by the Companys principal stockholder (see Note 12). Based upon the
Companys current expectations, management believes the Companys existing capital resources will
enable it to continue planned operations through the first quarter of 2011. However, the Company
cannot provide assurances that its plans will not change or that changed circumstances will not
result in the depletion of its capital resources more rapidly than it currently anticipates. On
April 30, 2010, the Company filed a shelf registration statement with the SEC providing for the
sale of up to $200 million of equity and debt securities from time to time in one or more
transactions. This registration statement was declared effective by the SEC on May 11, 2010. The
shelf registration is intended to provide the Company with the flexibility to take advantage of
potential financing opportunities when and if deemed appropriate by management of the Company. If
the Company is not successful in raising additional capital through equity or debt financing or
entering a business collaboration, the Company may be required to reduce expenses through the
delay, reduction or curtailment of its projects, including AFREZZA development activities, or
further reduction of costs for facilities and administration, and there will be substantial doubt
about its ability to continue as a going concern.
7
Fair Value of Financial Instruments The carrying amounts of financial instruments, which include
cash equivalents, marketable securities and accounts payable, approximate their fair values due to
their relatively short maturities. The fair value of the note payable to an entity controlled by
the Companys principal shareholder cannot be reasonably estimated as the Company would not be able
to obtain a similar credit arrangement in the current economic environment. The senior convertible
notes had a carrying value of $113.0 million and $112.8 million as of June 30, 2010 and December
31, 2009, respectively. The senior convertible notes had an estimated fair value of $67.3 million
as of June 30, 2010, calculated based on quoted prices in an inactive market (Level 2 in the fair
value hierarchy) and an estimated fair value of $80.3 million as of December 31, 2009, calculated
based on quoted prices in an active market (Level 1 in the fair value hierarchy). The Company had a
transfer of $67.3 million from Level 1 to Level 2 in the fair value hierarchy as its senior
convertible notes were previously being valued based on quoted prices in an active market. The
fair value of foreign exchange hedging contracts equals the carrying value at each balance sheet
date. The fair value of these contracts are determined using methodologies based on market
observable inputs (Level 2 in the fair value hierarchy), including foreign currency spot rates. The
Company recorded an unrealized loss on the foreign exchange hedging contracts of $1.8 million at
June 30, 2010 and $0.3 million at December 31, 2009.
Subsequent Events The Company has evaluated subsequent events through the date the financial
statements were issued.
Recently Issued Accounting Standards On April 29, 2010, the Financial Accounting Standards Board
(FASB) issued Accounting Standards Update (ASU) No. 2010-17, Milestone Method of Revenue
Recognition, which establishes a revenue recognition model for contingent consideration that is
payable upon the achievement of an uncertain future event, referred to as a milestone, which
requires an entity to record the milestone payment in its entirety in the period received if the
milestone meets all the necessary criteria to be considered substantive. The scope of the ASU is
limited to research and development arrangements. The ASU is effective for fiscal years beginning
on or after June 15, 2010, and interim periods within those years. Early application is permitted.
Adoption of this guidance is expected to have a significant effect on how certain future revenue
arrangements are reflected in the financial statements.
2. Investment in securities
The following is a summary of the available-for-sale securities classified as current assets (in
thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
|
|
|
|
Cost |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost Basis |
|
|
Loss |
|
|
Fair Value |
|
|
Basis |
|
|
Loss |
|
|
Value |
|
Available-for-sale securities |
|
$ |
2,414 |
|
|
$ |
|
|
|
$ |
2,414 |
|
|
$ |
2,761 |
|
|
$ |
(286 |
) |
|
$ |
2,475 |
|
The Companys available-for-sale securities at June 30, 2010 and December 31, 2009 consist
principally of a $2.0 million certificate of deposit with a maturity greater than 90 days, held as
collateral for foreign exchange hedging instruments, and a common stock investment. The certificate
of deposit is stated at fair value based on quoted prices for similar instruments in an active
market (Level 2 in the fair value hierarchy) and the common stock investment is stated at fair
value based on quoted prices in an active market (Level 1 in the fair value hierarchy). The
Companys policy is to maintain a highly liquid short-term investment portfolio. The common stock
investment was considered to be other than temporarily impaired as of June 30, 2010. As a result,
the Company recognized realized losses of $0.3 million and reduced the cost basis to $2.4 million
for its available-for-sale securities. Gross realized gains and losses for available-for-sale
securities for the three and six months ended June 30, 2009 were insignificant and recorded as
other income (expense). Gross unrealized gains and losses are included in other comprehensive
income (loss).
3. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities are comprised of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Salary and related expenses |
|
$ |
8,968 |
|
|
$ |
13,362 |
|
Research and clinical trial costs |
|
|
1,824 |
|
|
|
3,169 |
|
Accrued interest |
|
|
2,714 |
|
|
|
2,065 |
|
Construction in progress |
|
|
893 |
|
|
|
203 |
|
Other |
|
|
5,425 |
|
|
|
3,535 |
|
|
|
|
|
|
|
|
Accrued expenses and other current liabilities |
|
$ |
19,824 |
|
|
$ |
22,334 |
|
|
|
|
|
|
|
|
8
4. Accounting for stock-based compensation
Total stock-based compensation expense recognized in the accompanying condensed consolidated
statements of operations for the three and six months ended June 30, 2010 and 2009 was as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Stock-based compensation |
|
$ |
4,256 |
|
|
$ |
7,053 |
|
|
$ |
8,005 |
|
|
$ |
12,889 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2010, there were $9.6 million and $17.0 million of unrecognized compensation costs
related to options and restricted stock units, respectively, which are expected to be recognized
over the remaining weighted average vesting period of 2.3 years.
5. Comprehensive Loss
Accounting Standards Codification (ASC) 220-10-45 Comprehensive Income Other Presentation
requires reporting and displaying comprehensive income (loss) and its components, which, for the
Company, includes net loss and unrealized gains and losses on investments and cumulative
translation gains and losses. In accordance with this guidance, the accumulated balance of other
comprehensive income (loss) is disclosed as a separate component of stockholders equity. For the
three and six months ended June 30, 2010 and 2009, comprehensive loss consisted of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net loss |
|
$ |
(42,251 |
) |
|
$ |
(55,604 |
) |
|
$ |
(86,951 |
) |
|
$ |
(115,016 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain
(loss) on investments |
|
|
273 |
|
|
|
(476 |
) |
|
|
286 |
|
|
|
(417 |
) |
Cumulative
translation (loss)
gain |
|
|
(3 |
) |
|
|
3 |
|
|
|
(6 |
) |
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(41,981 |
) |
|
$ |
(56,077 |
) |
|
$ |
(86,671 |
) |
|
$ |
(115,430 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in the unrealized gain on investments for the three and six months ended June 30, 2010 is
a realized loss of $0.3 million due to the other than temporary impairment of marketable
securities.
6. Net loss per common share
Basic net loss per share excludes dilution for potentially dilutive securities and is computed by
dividing loss applicable to common stockholders by the weighted average number of common shares
outstanding during the period. Diluted net loss per share reflects the potential dilution that
could occur if securities or other contracts to issue common stock were exercised or converted into
common stock. Potentially dilutive securities are excluded from the computation of diluted net loss
per share for all of the periods presented in the accompanying statements of operations because the
reported net loss in each of these periods results in their inclusion being antidilutive.
Antidilutive securities, which consist of stock options, restricted stock units, warrants, and
shares that could be issued upon conversion of the senior convertible notes, that are not included
in the diluted net loss per share calculation consisted of an aggregate of 17,257,838 shares and
17,072,136 shares as of June 30, 2010 and 2009, respectively.
9
7. State research and development credit exchange receivable
The State of Connecticut provides certain companies with the opportunity to exchange certain
research and development income tax credit carryforwards for cash in exchange for forgoing the
carryforward of the research and development income tax credits. The program provides for an
exchange of research and development income tax credits for cash equal to 65% of the value of
corporation tax credit available for exchange. Estimated amounts receivable under the program are
recorded as a reduction of research and development expenses. At June 30, 2010, the estimated
amount receivable under the program was $1.4 million.
8. Property and equipment net
Property and equipment net consist of the following (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
|
|
Useful |
|
|
|
|
|
|
|
|
|
Life |
|
|
June 30, |
|
|
December 31, |
|
|
|
(Years) |
|
|
2010 |
|
|
2009 |
|
Land |
|
|
|
|
|
$ |
5,273 |
|
|
$ |
5,273 |
|
Buildings |
|
|
39-40 |
|
|
|
54,966 |
|
|
|
54,966 |
|
Building improvements |
|
|
5-40 |
|
|
|
113,320 |
|
|
|
113,188 |
|
Machinery and equipment |
|
|
3-15 |
|
|
|
74,044 |
|
|
|
72,958 |
|
Furniture, fixtures and office equipment |
|
|
5-10 |
|
|
|
5,369 |
|
|
|
5,312 |
|
Computer equipment and software |
|
|
3 |
|
|
|
15,999 |
|
|
|
15,840 |
|
Leasehold improvements |
|
|
|
|
|
|
172 |
|
|
|
172 |
|
Construction in progress |
|
|
|
|
|
|
9,256 |
|
|
|
6,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
278,399 |
|
|
|
273,970 |
|
Less accumulated depreciation and amortization |
|
|
|
|
|
|
(74,001 |
) |
|
|
(65,741 |
) |
|
|
|
|
|
|
|
|
|
|
|
Property and equipment net |
|
|
|
|
|
$ |
204,398 |
|
|
$ |
208,229 |
|
|
|
|
|
|
|
|
|
|
|
|
Leasehold improvements are amortized over the shorter of the term of the lease or the service lives
of the improvements.
Depreciation and amortization expense related to property and equipment for the three and six
months ended June 30, 2010 and 2009 was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Depreciation and amortization expense |
|
$ |
4,170 |
|
|
$ |
4,590 |
|
|
$ |
8,342 |
|
|
$ |
8,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9. Common and preferred stock
In May 2010, the Companys stockholders approved an increase in its authorized shares of common
stock from 150,000,000 to 200,000,000. As such, the Company is authorized to issue 200,000,000
shares of common stock, par value $0.01 per share, and 10,000,000 shares of undesignated preferred
stock, par value $0.01 per share, issuable in one or more series designated by the Companys board
of directors. No other class of capital stock is authorized. As of June 30, 2010 and December 31,
2009, 113,674,221 and 113,025,291 shares of common stock, respectively, were issued and
outstanding. No shares of preferred stock were issued and outstanding at June 30, 2010 or December
31, 2009.
10. Warrants
In connection with the sale of common stock in the private placement which closed in August 2005,
the Company concurrently issued warrants to purchase up to 3,426,000 shares of common stock at an
exercise price of $12.228 per share. These warrants became exercisable in February 2006 and expire
on August 5, 2010. During the six months ended June 30, 2010, no warrants were exercised. As of
June 30, 2010, warrants to purchase 2,882,873 shares of common stock remained outstanding.
10
11. Commitments and contingencies
Supply Commitments As of June 30, 2010, the Company had a binding annual commitment for insulin
purchases with Organon N.V. (Organon) aggregating approximately $82.0 million over the period
from 2010 through 2012. If the Company terminates the supply agreement following failure to obtain
or maintain regulatory approval of AFREZZA or either party terminates the agreement following the
parties inability to agree to changes to product specifications mandated after regulatory
approval, the Company will be required to pay Organon a specified termination fee if Organon is
unable to sell certain quantities of insulin to other parties.
Guarantees and Indemnifications In the ordinary course of its business, the Company makes certain
indemnities, commitments and guarantees under which it may be required to make payments in relation
to certain transactions. The Company, as permitted under Delaware law and in accordance with its
Bylaws, indemnifies its officers and directors for certain events or occurrences, subject to
certain limits, while the officer or director is or was serving at the Companys request in such
capacity. The term of the indemnification period is for the officers or directors lifetime. The
maximum amount of potential future indemnification is unlimited; however, the Company has a
director and officer insurance policy that may enable it to recover a portion of any future amounts
paid. The Company believes the fair value of these indemnification agreements is minimal. The
Company has not recorded any liability for these indemnities in the accompanying condensed
consolidated balance sheets. However, the Company accrues for losses for any known contingent
liability, including those that may arise from indemnification provisions, when future payment is
probable and the amount can be reasonably estimated. No such losses have been recorded to date.
Litigation From time to time, the Company becomes involved in various legal proceedings and other
matters. In accordance with general accounting guidance for recording contingencies, the Company
records a provision for a liability related to a legal proceeding when it is both probable that a
liability has been incurred and the amount of the loss can be reasonably estimated. The Company
does not believe that any liability from any reasonably foreseeable disposition of such claims and
litigation, individually or in the aggregate, would have a material adverse effect on its
consolidated financial position or results of operations.
12. Related-party loan arrangement
In October 2007, the Company entered into a $350.0 million loan arrangement with its principal
stockholder. Under the arrangement, the Company can borrow up to a total of $350.0 million. On
February 26, 2009, the promissory note underlying the loan arrangement was revised as a result of
the principal stockholder being licensed as a finance lender under the California Finance Lenders
Law. Accordingly, the lender was revised to The Mann Group LLC, an entity controlled by the
Companys principal stockholder. Interest will accrue on each outstanding advance at a fixed rate
equal to the one-year LIBOR rate as reported by the Wall Street Journal on the date of such advance
plus 3% per annum and will be payable quarterly in arrears. Principal repayment is due on December
31, 2011. At any time after January 1, 2010, the principal stockholder can require the Company to
prepay up to $200.0 million in advances that have been outstanding for at least 12 months. If the
principal stockholder exercises this right, the Company will have until the earlier of 180 days
after the principal stockholder provides written notice or December 31, 2011 to prepay such
advances. The principal stockholder has agreed not to exercise his prepayment right if such
prepayment would require the use of existing working capital resources to repay the loan. In the
event of a default, all unpaid principal and interest either becomes immediately due and payable or
may be accelerated at the principal stockholders option, and the interest rate will increase to
the one-year LIBOR rate calculated on the date of the initial advance or in effect on the date of
default, whichever is greater, plus 5% per annum. Any borrowings under the loan arrangement will be
unsecured. The loan arrangement contains no financial covenants. There are no warrants associated
with the loan arrangement, nor are advances convertible into the Companys common stock.
The principal amount outstanding under the arrangement was $242.0 million and $165.0 million at
June 30, 2010 and December 31, 2009, respectively. As of June 30, 2010, the Company had accrued
interest of $2.5 million related to the amount outstanding and had $108.0 million of available
borrowings under the arrangement.
13. Senior convertible notes
On December 12, 2006, the Company completed an offering of $115.0 million aggregate principal
amount of 3.75% Senior Convertible Notes due 2013 (the Notes). The Notes are governed by the
terms of an indenture dated as of November 1, 2006 and a First Supplemental Indenture, dated as of
December 12, 2006. The Notes bear interest at the rate of 3.75% per year on the principal amount of
the Notes, payable in cash semi-annually in arrears on June 15 and December 15 of each year,
beginning June 15, 2007. As
11
of both June 30, 2010 and December 31, 2009, the Company had accrued interest of $0.2 million
related to the Notes. The Notes are general, unsecured, senior obligations of the Company and
effectively rank junior in right of payment to all of the Companys secured debt, to the extent of
the value of the assets securing such debt, and to the debt and all other liabilities of the
Companys subsidiaries. The maturity date of the Notes is December 15, 2013 and payment is due in
full on that date for unconverted securities. Holders may convert, at any time prior to the close
of business on the business day immediately preceding the stated maturity date, any outstanding
Notes into shares of the Companys common stock at an initial conversion rate of 44.5002 shares per
$1,000 principal amount of Notes, which is equal to a conversion price of approximately $22.47 per
share, subject to adjustment. Except in certain circumstances, if the Company undergoes a
fundamental change: (1) the Company will pay a make-whole premium on the Notes converted in
connection with a fundamental change by increasing the conversion rate on such Notes, which amount,
if any, will be based on the Companys common stock price and the effective date of the fundamental
change, and (2) each holder of the Notes will have the option to require the Company to repurchase
all or any portion of such holders Notes at a repurchase price of 100% of the principal amount of
the Notes to be repurchased plus accrued and unpaid interest, if any. The Company incurred
approximately $3.7 million in issuance costs which are recorded as an offset to the Notes in the
accompanying condensed consolidated balance sheets. These costs are being amortized to interest
expense using the effective interest method over the term of the Notes.
Amortization of debt issuance expense in connection with the Notes during the three and six months
ended June 30, 2010 and 2009 was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
Three months ended |
|
|
Six months ended |
|
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|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Amortization expense |
|
$ |
133 |
|
|
$ |
127 |
|
|
$ |
265 |
|
|
$ |
253 |
|
|
|
|
|
|
|
|
|
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|
|
14. Income taxes
As discussed in Note 14 to the financial statements in the Companys Annual Report, management of
the Company has concluded, in accordance with applicable accounting standards, that it is more
likely than not that the Company may not realize the benefit of its deferred tax assets.
Accordingly, net deferred tax assets have been fully reserved.
ASC 740-10-25 Income Taxes Recognition clarifies the accounting and disclosure for uncertainty in
tax positions, as defined. This guidance seeks to reduce the diversity in practice associated with
certain aspects of the recognition and measurement related to accounting for income taxes. The
Company believes that its income tax filing positions and deductions will be sustained on audit and
does not anticipate any adjustments that will result in a material change to its financial
position. Therefore, no reserves for uncertain income tax positions have been recorded pursuant to
this guidance. Tax years since 1993 remain subject to examination by the major tax jurisdictions in
which the Company is subject to tax.
12
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion contains forward-looking statements, which involve risks and
uncertainties. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including those set forth below in Part
II, Item 1A Risk Factors and elsewhere in this quarterly report on Form 10-Q. These interim
condensed consolidated financial statements and this Managements Discussion and Analysis of
Financial Condition and Results of Operations should be read in conjunction with the financial
statements and notes for the year ended December 31, 2009 and the related Managements Discussion
and Analysis of Financial Condition and Results of Operations, both of which are contained in the
Annual Report. Readers are cautioned not to place undue reliance on forward-looking statements. The
forward-looking statements speak only as of the date on which they are made, and we undertake no
obligation to update such statements to reflect events that occur or circumstances that exist after
the date on which they are made.
OVERVIEW
We are a biopharmaceutical company focused on the discovery, development and commercialization of
therapeutic products for diseases such as diabetes and cancer. Our lead product candidate, AFREZZA
(insulin human [rDNA origin]) Inhalation Powder, is an ultra rapid-acting insulin that has
completed Phase 3 clinical trials that evaluated its safety and efficacy in the treatment of
diabetes. We submitted an NDA to the FDA in March 2009. In March 2010, we received a Complete
Response letter regarding this NDA from the FDA, seeking additional information about AFREZZA. In
July 2010, the FDA accepted our reply to the Complete Response letter and set a target action date
of December 29, 2010.
We are a development stage enterprise and have incurred significant losses since our inception in
1991. As of June 30, 2010, we have incurred a cumulative net loss of $1.7 billion and a
stockholders deficit of $137.7 million. To date, we have not generated any product revenues and
have funded our operations primarily through the sale of equity securities, convertible debt
securities and borrowings under our related party loan. As discussed below in Liquidity and
Capital Resources, if we are unable to obtain additional funding in the future, there will be
substantial doubt about our ability to continue as a going concern.
We have held extensive discussions with a number of pharmaceutical companies concerning a potential
strategic business collaboration for AFREZZA and recently initiated partnership discussions with a
number of pharmaceutical companies regarding our cancer immunotherapy and cancer drug programs.
There can be no assurance that any such collaboration will be available to us on a timely basis or
on acceptable terms, if at all.
We do not expect to record sales of any product prior to regulatory approval and commercialization
of AFREZZA. We currently do not have the required approvals to market any of our product
candidates, and we may not receive such approvals. We may not be profitable even if we succeed in
commercializing any of our product candidates. We expect to make substantial expenditures and to
incur additional operating losses for at least the next several years as we:
|
|
|
continue the clinical development of AFREZZA and new inhalation systems for the treatment
of diabetes; |
|
|
|
|
seek regulatory approval to sell AFREZZA in the United States and other markets; |
|
|
|
|
seek sales and marketing collaborations for AFREZZA; |
|
|
|
|
seek development collaborations for our cancer immunotherapy and cancer drug programs;
and |
|
|
|
|
develop additional applications of our proprietary Technosphere platform technology for
the pulmonary delivery of other drugs. |
Our business is subject to significant risks, including but not limited to the risks inherent in
our ongoing clinical trials and the regulatory approval process, the results of our research and
development efforts, competition from other products and technologies and uncertainties associated
with obtaining and enforcing patent rights.
13
RESEARCH AND DEVELOPMENT EXPENSES
Our research and development expenses consist mainly of costs associated with the clinical trials
of our product candidates that have not yet received regulatory approval for marketing and for
which no alternative future use has been identified. This includes the salaries, benefits and
stock-based compensation of research and development personnel, raw materials, such as insulin
purchases, laboratory supplies and materials, facility costs, costs for consultants and related
contract research, licensing fees, and depreciation of laboratory equipment. We track research and
development costs by the type of cost incurred. We partially offset research and development
expenses with the recognition of estimated amounts receivable from the State of Connecticut
pursuant to a program under which we can exchange qualified research and development income tax
credits for cash. There were no purchases of insulin included in research and development expenses
for the quarter ended June 30, 2010.
Our research and development staff conducts our internal research and development activities, which
include research, product development, clinical development, manufacturing and related activities.
This staff is located in our facilities in Valencia, California; Paramus, New Jersey; and Danbury,
Connecticut. We expense the majority of research and development costs as we incur them.
Clinical development timelines, likelihood of success and total costs vary widely. We are focused
primarily on advancing AFREZZA through regulatory filings. Based on the results of preclinical
studies, we plan to develop additional applications of our Technosphere technology. Additionally,
we anticipate that we will continue to determine which research and development projects to pursue,
and how much funding to direct to each project, on an ongoing basis, in response to the scientific
and clinical success of each product candidate. We cannot be certain when any revenues from the
commercialization of our products will commence.
At this time, due to the risks inherent in the clinical trial process and given the early stage of
development of our product candidates other than AFREZZA, we are unable to estimate with any
certainty the costs that we will incur in the continued development of our product candidates for
commercialization. The costs required to complete the development of AFREZZA will be largely
dependent on the cost and efficiency of our manufacturing process and discussions with the FDA
regarding its requirements.
GENERAL AND ADMINISTRATIVE EXPENSES
Our general and administrative expenses consist primarily of salaries, benefits and stock-based
compensation for administrative, finance, business development, human resources, legal and
information systems support personnel. In addition, general and administrative expenses include
professional service fees and business insurance costs.
CRITICAL ACCOUNTING POLICIES
There have been no material changes to our critical accounting policies as described in Item 7 of
our Annual Report.
RESULTS OF OPERATIONS
Three and six months ended June 30, 2010 and 2009
Revenues
During the three and six months ended June 30, 2010 we recognized revenue of $93,000 under a
license agreement, and we did not recognize any revenue during the same periods in 2009. We do not
anticipate sales of any product prior to regulatory approval and commercialization of AFREZZA.
Research and Development Expenses
The following tables provide a comparison of the research and development expense categories for
the three and six months ended June 30, 2010 and 2009 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
Clinical |
|
$ |
6,897 |
|
|
$ |
10,619 |
|
|
$ |
(3,722 |
) |
|
|
(35 |
%) |
Manufacturing |
|
|
12,849 |
|
|
|
19,890 |
|
|
|
(7,041 |
) |
|
|
(35 |
%) |
Research |
|
|
4,055 |
|
|
|
4,934 |
|
|
|
(879 |
) |
|
|
(18 |
%) |
Research and development tax credit |
|
|
(198 |
) |
|
|
(175 |
) |
|
|
(23 |
) |
|
|
13 |
% |
Stock-based compensation expense |
|
|
2,557 |
|
|
|
4,581 |
|
|
|
(2,024 |
) |
|
|
(44 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
26,160 |
|
|
$ |
39,849 |
|
|
$ |
(13,689 |
) |
|
|
(34 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
Clinical |
|
$ |
13,826 |
|
|
$ |
27,377 |
|
|
$ |
(13,551 |
) |
|
|
(49 |
%) |
Manufacturing |
|
|
30,835 |
|
|
|
37,355 |
|
|
|
(6,520 |
) |
|
|
(17 |
%) |
Research |
|
|
7,634 |
|
|
|
10,281 |
|
|
|
(2,647 |
) |
|
|
(26 |
%) |
Research and development tax credit |
|
|
(433 |
) |
|
|
(350 |
) |
|
|
(83 |
) |
|
|
24 |
% |
Stock-based compensation expense |
|
|
4,789 |
|
|
|
8,075 |
|
|
|
(3,286 |
) |
|
|
(41 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
56,651 |
|
|
$ |
82,738 |
|
|
$ |
(26,087 |
) |
|
|
(32 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in research and development expenses for the three and six months ended June 30, 2010,
as compared to the three and six months ended June 30, 2009, was primarily due to decreased costs
associated with the clinical development of AFREZZA compared to the first and second quarter in
2009 when we prepared for the submission of the NDA, decreased manufacturing costs due to the
timing of raw material purchases and decreased research expenses due to reduced salary-related and
other research costs as a result of a reduction in force that we implemented in April 2009. We
anticipate that our research and development expenses will decrease slightly in 2010 compared to
the prior year as reduced product development costs will be mostly offset by increased raw material
purchases.
General and Administrative Expenses
The following tables provide a comparison of the general and administrative expense categories for
the three and six months ended June 30, 2010 and 2009 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
Salaries, employee related and other general expenses |
|
$ |
9,497 |
|
|
$ |
11,065 |
|
|
$ |
(1,568 |
) |
|
|
(14 |
%) |
Stock-based compensation expense |
|
|
1,699 |
|
|
|
2,472 |
|
|
|
(773 |
) |
|
|
(31 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
$ |
11,196 |
|
|
$ |
13,537 |
|
|
$ |
(2,341 |
) |
|
|
(17 |
%) |
|
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|
|
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|
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|
|
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|
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|
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|
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|
Six months ended |
|
|
|
|
|
|
|
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|
June 30, |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
Salaries, employee related and other general expenses |
|
$ |
18,090 |
|
|
$ |
23,640 |
|
|
$ |
(5,550 |
) |
|
|
(23 |
%) |
Stock-based compensation expense |
|
|
3,216 |
|
|
|
4,814 |
|
|
|
(1,598 |
) |
|
|
(33 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
$ |
21,306 |
|
|
$ |
28,454 |
|
|
$ |
(7,148 |
) |
|
|
(25 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses for the three and six months ended June 30, 2010 decreased as
compared to the same periods in the prior year primarily due to decreased salary related costs
resulting from the April 2009 reduction in force as well as the non-recurrence of costs related to
the Pfizer transaction during the first half of 2009. Overall, we expect general and administrative
expenses to decrease in 2010 as a result of the April 2009 reduction in force and decreased
professional fees.
Interest Income and Expense
Interest income for the three and six months ended June 30, 2010 decreased by $24,000 and $52,000,
respectively, as compared to the same periods in the prior year primarily due to lower market
interest rates.
Interest expense for the three and six months ended June 30, 2010 increased by $1.2 million and
$2.8 million, respectively, as compared to the same period in the prior year primarily due to the
interest expense related to the greater amounts outstanding under the borrowing arrangement with an
entity controlled by our principal stockholder (See Note 12 Related-party loan arrangement, of
the Notes to the accompanying financial statements).
15
LIQUIDITY AND CAPITAL RESOURCES
We have funded our operations primarily through the sale of equity securities, convertible debt
securities and borrowings under our related party note.
In October 2007, we entered into a loan arrangement with our principal stockholder allowing us to
borrow up to a total of $350.0 million. In February 2009, as a result of our principal stockholder
being licensed as a finance lender under the California Finance Lenders Law, the promissory note
underlying the loan arrangement was revised to reflect the lender as The Mann Group LLC, an entity
controlled by our principal stockholder. Interest will accrue on each outstanding advance at a
fixed rate equal to the one-year LIBOR rate as reported by the Wall Street Journal on the date of
such advance plus 3% per annum and will be payable quarterly in arrears. Principal repayment is due
on December 31, 2011. At any time after January 1, 2010, the lender can require us to prepay up to
$200.0 million in advances that have been outstanding for at least 12 months. If the lender
exercises this right, we will have until the earlier of 180 days after the lender provides written
notice or December 31, 2011 to prepay such advances. The principal stockholder has agreed not to
exercise his prepayment right if such prepayment would require the use of existing working capital
resources to repay the loan. In the event of a default, all unpaid principal and interest either
becomes immediately due and payable or may be accelerated at the lenders option, and the interest
rate will increase to the one-year LIBOR rate calculated on the date of the initial advance or in
effect on the date of default, whichever is greater, plus 5% per annum. Any borrowings under the
loan arrangement will be unsecured. The loan arrangement contains no financial covenants. There are
no warrants associated with the loan arrangement, nor are advances convertible into our common
stock. As of June 30, 2010, the amount borrowed and outstanding under the arrangement was $242.0
million.
During the six months ended June 30, 2010, we used $74.8 million of cash for our operations
compared to using $105.0 million for our operations in the six months ended June 30, 2009. We had a
net loss of $87.0 million for the six months ended June 30, 2010, of which $17.0 million consisted
of non-cash charges such as depreciation and amortization, and stock-based compensation. We expect
our negative operating cash flow to continue at least until we obtain regulatory approval and
achieve commercialization of AFREZZA.
We used $4.1 million of cash for investing activities during the six months ended June 30, 2010,
compared to $3.3 million of cash provided by investing activities for the six months ended June 30,
2009. For the six months ended June 30, 2010 and 2009, $4.1 million and $12.5 million,
respectively, were used to purchase machinery and equipment to expand our manufacturing operations
and our quality systems that support clinical trials for AFREZZA.
Our financing activities generated $77.2 million of cash for the six months ended June 30, 2010,
compared to $105.5 million for the same period in 2009. For the six months ended June 30, 2010,
cash from financing activities was primarily from the related party borrowings, as well as the
exercise of stock options.
As of June 30, 2010, we had $30.8 million in cash, cash equivalents and marketable securities
(including a $2.0 million certificate of deposit held as collateral for foreign exchange hedging
instruments). Although we believe our existing cash resources, including the $108.0 million
remaining available under our loan arrangement with an entity controlled by our principal
stockholder, will be sufficient to fund our anticipated cash requirements through the first quarter
of 2011, we will require significant additional financing in the future to fund our operations and
if we are unable to do so, there will be substantial doubt about our ability to continue as a going
concern. Accordingly, we expect that we will need to raise additional capital, either through the
sale of equity and/or debt securities, the entry into a strategic business collaboration with a
pharmaceutical or biotechnology company or the establishment of other funding facilities, in order
to continue the development and commercialization of AFREZZA and other product candidates and to
support our other ongoing activities. On April 30, 2010, we filed a shelf registration statement
with the SEC providing for the sale of up to $200 million of equity and debt securities from time
to time in one or more transactions. This registration statement was declared effective by the SEC
on May 11, 2010. However, we cannot provide assurances that we will be able to raise capital on
favorable terms, if at all.
We intend to use our capital resources to continue the development and commercialization of
AFREZZA, if approved, and to develop additional applications for our proprietary Technosphere
platform technology. In addition, portions of our capital resources will be devoted to expanding
our other product development programs for the treatment of different types of cancers. We are
expending a
16
portion of our capital to scale up our manufacturing capabilities in our Danbury facilities. We
also intend to use our capital resources for general corporate purposes, which may include
in-licensing or acquiring additional technologies.
We have held extensive discussions with a number of pharmaceutical companies concerning a potential
strategic business collaboration for AFREZZA. We cannot predict when, if ever, we could conclude an
agreement with a partner. There can be no assurance that any such collaboration will be available
to us on a timely basis or on acceptable terms, if at all.
If we enter into a strategic business collaboration with a pharmaceutical or biotechnology company,
we would expect, as part of the transaction, to receive additional capital. In addition, we expect
to pursue the sale of equity and/or debt securities, or the establishment of other funding
facilities. On April 30, 2010, we filed a shelf registration statement with the SEC providing for
the sale by us of up to $200 million of our equity and debt securities from time to time in one or
more transactions. This registration statement was declared effective by the SEC on May 11, 2010.
The shelf registration is intended to provide us with the flexibility to take advantage of
potential financing opportunities when and if deemed appropriate by our management.
Issuances of debt or additional equity could impact the rights of our existing stockholders, dilute
the ownership percentages of our existing stockholders and may impose restrictions on our
operations. These restrictions could include limitations on additional borrowing, specific
restrictions on the use of our assets as well as prohibitions on our ability to create liens, pay
dividends, redeem our stock or make investments. We also may seek to raise additional capital by
pursuing opportunities for the licensing, sale or divestiture of certain intellectual property and
other assets, including our Technosphere technology platform. There can be no assurance, however,
that any strategic collaboration, sale of securities or sale or license of assets will be available
to us on a timely basis or on acceptable terms, if at all. If we are unable to raise additional
capital, we may be required to enter into agreements with third parties to develop or commercialize
products or technologies that we otherwise would have sought to develop independently, and any such
agreements may not be on terms as commercially favorable to us.
However, we cannot provide assurances that our plans will not change or that changed circumstances
will not result in the depletion of our capital resources more rapidly than we currently
anticipate. If we are not successful in raising additional capital through equity or debt financing
or entering a business collaboration, we may be required to reduce expenses through the delay,
reduction or curtailment of our projects, including AFREZZA development activities, or further
reduction of costs for facilities and administration, and there will be substantial doubt about our
ability to continue as a going concern.
Off-Balance Sheet Arrangements
As of June 30, 2010 we did not have any off-balance sheet arrangements.
Contractual Obligations
The only material change to our contractual obligations disclosed in Item 7 of our Annual Report
was the additional borrowing of $77.0 million from an entity controlled by our principal
stockholder during the six months ended June 30, 2010. (See Note 12 Related-party loan
arrangement of the Notes to the accompanying financial statements.)
Recent Accounting Pronouncements
On April 29, 2010, the FASB issued ASU No. 2010-17, Milestone Method of Revenue Recognition, which
establishes a revenue recognition model for contingent consideration that is payable upon the
achievement of an uncertain future event, referred to as a milestone, which requires an entity to
record the milestone payment in its entirety in the period received if the milestone meets all the
necessary criteria to be considered substantive. The scope of the ASU is limited to research and
development arrangements. The ASU is effective for fiscal years beginning on or after June 15,
2010, and interim periods within those years. Early application is permitted. Adoption of this
guidance is expected to have a significant effect on how certain future revenue arrangements are
reflected in the financial statements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk related to changes in interest rates impacting our short-term
investment portfolio as well as the interest rate on our credit facility with an entity controlled
by our principal stockholder. The interest rate on our credit facility with an entity
17
controlled by our principal stockholder is a fixed rate equal to the one-year LIBOR rate as
reported by the Wall Street Journal on the date of such advance plus 3% per annum. Our current
policy requires us to maintain a highly liquid short-term investment portfolio consisting mainly of
U.S. money market funds and investment-grade corporate, government and municipal debt. None of
these investments is entered into for trading purposes. Our cash is deposited in and invested
through highly rated financial institutions in North America. Our short-term investments at June
30, 2010 are comprised mainly of a certificate of deposit and a common stock investment. We have
entered into a foreign exchange hedging transaction as part of our risk management program. We
continue to utilize our $350.0 million credit facility to fund operations. As of June 30, 2010, the
amount borrowed and outstanding under the credit facility was $242.0 million. The interest rate is
fixed at the time of the draw. If interest rates were to increase from levels at June 30, 2010 we
could experience a higher level of interest expense than assumed in our current operating plan.
ITEM 4. CONTROLS AND PROCEDURES
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as
amended, or the Exchange Act, is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms and that such information is accumulated and
communicated to our management, including our chief executive officer and chief financial officer,
as appropriate, to allow for timely decisions regarding required disclosure. In designing and
evaluating the disclosure controls and procedures, management recognizes that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management is required to apply its judgment in
evaluating the cost-benefit relationship of possible controls and procedures.
Our chief executive officer and chief financial officer performed an evaluation under the
supervision and with the participation of our management, of our disclosure controls and procedures
(as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of June 30, 2010. Based on
that evaluation, our chief executive officer and chief financial officer concluded that our
disclosure controls and procedures were effective at the reasonable assurance level.
There has been no change in our internal control over financial reporting during the fiscal quarter
ended June 30, 2010 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
None.
Item 1A. Risk Factors
You should consider carefully the following information about the risks described below, together
with the other information contained in this quarterly report on Form 10-Q before you decide to buy
or maintain an investment in our common stock. We believe the risks described below are the risks
that are material to us as of the date of this quarterly report. Additional risks and uncertainties
that we are unaware of may also become important factors that affect us. The risk factors set forth
below with an asterisk (*) next to the title contain changes to the description of the risk factors
previously disclosed in Item 1A to our annual report on Form 10-K. If any of the following risks
actually occur, our business, financial condition, results of operations and future growth
prospects would likely be materially and adversely affected. In these circumstances, the market
price of our common stock could decline, and you may lose all or part of the money you paid to buy
our common stock.
RISKS RELATED TO OUR BUSINESS
We depend heavily on the successful development and commercialization of our lead product
candidate, AFREZZA, which is not yet approved, and our other product candidates, which are in early
clinical or preclinical development.*
18
To date, we have not commercialized any product candidates. In March 2009, we submitted an NDA to
the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes
for the control of hyperglycemia. In March 2010, we received a Complete Response letter regarding
this NDA from the FDA. A Complete Response letter is issued by the FDAs Center for Drug Evaluation
and Research when the review of a submitted file is completed and questions remain that preclude
the approval of the NDA in its current form. In July 2010, the FDA accepted our reply to the
Complete Response letter and set a target action date of December 29, 2010. There can be no
assurance that the FDA will find our proposed approach for addressing its questions acceptable. The
FDA could also request that we conduct additional clinical trials to provide sufficient data for
approval of the NDA. There can be no assurance that we will obtain approval of the NDA in a timely
manner or at all.
Our other product candidates are generally in early clinical or preclinical development. We
anticipate that in the near term, our ability to generate revenues will depend solely on the
successful development and commercialization of AFREZZA.
We have expended significant time, money and effort in the development of our lead product
candidate, AFREZZA, which has not yet received regulatory approval and which may not be approved by
the FDA in a timely manner, or at all. We must receive the necessary approvals from the FDA and
similar foreign regulatory agencies before AFREZZA can be marketed and sold in the United States or
elsewhere. Even if we were to receive regulatory approval, we ultimately may be unable to gain
market acceptance of AFREZZA for a variety of reasons, including the treatment and dosage regimen,
potential adverse effects, the availability of alternative treatments and cost effectiveness. If we
fail to commercialize AFREZZA, our business, financial condition and results of operations will be
materially and adversely affected.
We are seeking to develop and expand our portfolio of product candidates through our internal
research programs and through licensing or otherwise acquiring the rights to therapeutics in the
areas of cancer and other indications. All of these product candidates will require additional
research and development and significant preclinical, clinical and other testing prior to seeking
regulatory approval to market them. Accordingly, these product candidates will not be commercially
available for a number of years, if at all.
A significant portion of the research that we are conducting involves new and unproven compounds
and technologies, including AFREZZA, Technosphere platform technology and immunotherapy product
candidates. Research programs to identify new product candidates require substantial technical,
financial and human resources. Even if our research programs identify candidates that initially
show promise, these candidates may fail to progress to clinical development for any number of
reasons, including discovery upon further research that these candidates have adverse effects or
other characteristics that indicate they are unlikely to be effective. In addition, the clinical
results we obtain at one stage are not necessarily indicative of future testing results. If we fail
to successfully complete the development and commercialization of AFREZZA or develop or expand our
other product candidates, or are significantly delayed in doing so, our business and results of
operations will be harmed and the value of our stock could decline.
We have a history of operating losses, we expect to continue to incur losses and we may never
become profitable.*
We are a development stage company with no commercial products. All of our product candidates are
still being developed, and all but AFREZZA are still in the early stages of development. Our
product candidates will require significant additional development, clinical trials, regulatory
clearances and additional investment before they can be commercialized. We cannot be certain when
AFREZZA may be approved, or if it will be approved.
We have never been profitable and, as of June 30, 2010, we had incurred a cumulative net loss of
$1.7 billion. The cumulative net loss has resulted principally from costs incurred in our research
and development programs, the write-off of goodwill and general operating expenses. We expect to
make substantial expenditures and to incur increasing operating losses in the future in order to
further develop and commercialize our product candidates, including costs and expenses to complete
clinical trials, seek regulatory approvals and market our product candidates, including AFREZZA.
This cumulative net loss may increase significantly as we continue development and clinical trial
efforts.
Our losses have had, and are expected to continue to have, an adverse impact on our working
capital, total assets and stockholders equity. As of June 30, 2010, we had a stockholders deficit
of $137.7 million. Our ability to achieve and sustain profitability depends upon obtaining
regulatory approvals for and successfully commercializing AFREZZA, either alone or with third
parties. We do not currently have the required approvals to market any of our product candidates,
and we may not receive them. We may not be profitable even if we succeed in commercializing any of
our product candidates. As a result, we cannot be sure when we will become profitable, if at all.
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If we fail to raise additional capital our financial condition and business would suffer.*
It is costly to develop therapeutic product candidates and conduct clinical trials for these
product candidates. Although we are currently focusing on AFREZZA as our lead product candidate, we
have begun to conduct clinical trials for additional product candidates. Our existing capital
resources will not be sufficient to support the expense of fully commercializing AFREZZA or
developing any of our product candidates.
Based upon our current expectations, we believe that our existing capital resources, including the
loan arrangement with an entity controlled by our principal stockholder, will enable us to continue
planned operations through the first quarter of 2011. However, we cannot assure you that our plans
will not change or that changed circumstances will not result in the depletion of our capital
resources more rapidly than we currently anticipate. Accordingly, we plan to raise additional
capital, either through the sale of equity and/or debt securities, the entry into a strategic
business collaboration, or the establishment of other funding facilities, in order to continue the
development and commercialization of AFREZZA and other product candidates and to support our other
ongoing activities. On April 30, 2010, we filed a shelf registration statement with the SEC
providing for the sale by us of up to $200 million of our equity and debt securities from time to
time in one or more transactions. This registration statement was declared effective by the SEC on
May 11, 2010. The shelf registration is intended to provide us with the flexibility to take
advantage of potential financing opportunities when and if deemed appropriate by our management.
However, it may be difficult for us to raise additional capital through the sale of equity or debt
securities. As of June 30, 2010, we had a stockholders deficit of $137.7 million which may affect
our ability to raise additional capital. The amount of additional funds we need will depend on a
number of factors, including:
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the rate of progress and costs of our clinical trials and research and development
activities, including costs of procuring clinical materials and expanding our own
manufacturing facilities; |
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our success in establishing strategic business collaborations and the timing and amount
of any payments we might receive from any collaboration we are able to establish; |
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actions taken by the FDA and other regulatory authorities affecting our products and
competitive products; |
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our degree of success in commercializing AFREZZA; |
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the emergence of competing technologies and products and other adverse market
developments; |
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the timing and amount of payments we might receive from potential licensees; |
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the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and
other intellectual property rights or defending against claims of infringement by others; |
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the costs of discontinuing projects and technologies or decommissioning existing
facilities, if we undertake those activities; and |
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the costs of performing additional clinical trials to demonstrate safety and efficacy if
our current trials do not deliver results sufficient for FDA approval and commercialization. |
We have raised capital in the past primarily through the sale of equity and debt securities. We may
in the future pursue the sale of additional equity and/or debt securities, or the establishment of
other funding facilities. Issuances of additional debt or equity securities or the conversion of
any of our currently outstanding convertible debt securities into shares of our common stock could
impact your rights as a holder of our common stock and may dilute your ownership percentage.
Moreover, the establishment of other funding facilities may impose restrictions on our operations.
These restrictions could include limitations on additional borrowing and specific restrictions on
the use of our assets, as well as prohibitions on our ability to create liens, pay dividends,
redeem our stock or make investments.
We also may seek to raise additional capital by pursuing opportunities for the licensing or sale of
certain intellectual property and other assets, including our Technosphere technology platform. We
cannot offer assurances, however, that any strategic collaborations, sales of securities or sales
or licenses of assets will be available to us on a timely basis or on acceptable terms, if at all.
We may be
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required to enter into relationships with third parties to develop or commercialize products
or technologies that we otherwise would have sought to develop independently, and any such
relationships may not be on terms as commercially favorable to us as might otherwise be the case.
In the event that sufficient additional funds are not obtained through strategic collaboration
opportunities, sales of securities, credit facilities, licensing arrangements and/or asset sales on
a timely basis, we may be required to reduce expenses through the delay, reduction or curtailment
of our projects, including AFREZZA commercialization, or further reduction of costs for facilities
and administration. Moreover, if we do not obtain such additional funds, there will be substantial
doubt about our ability to continue as a going concern.
Deteriorating global economic conditions may have an adverse impact on the loan facility with an
entity controlled by our principal stockholder, which we currently cannot predict.
As widely reported, financial markets in the United States, Europe and Asia have been experiencing
a period of unprecedented turmoil and upheaval characterized by extreme volatility and declines in
security prices, severely diminished liquidity and credit availability, inability to access capital
markets, the bankruptcy, failure, collapse or sale of various financial institutions and an
unprecedented level of intervention from the United States federal government and other
governments. We cannot predict the impact of these events on the loan facility with an entity
controlled by our principal stockholder. If we are unable to draw on this financial resource, our
business and financial condition will be adversely affected.
If we do not achieve our projected development and commercialization goals in the timeframes we
announce and expect, our business would be harmed and the market price of our common stock could
decline.
For planning purposes, we estimate the timing of the accomplishment of various scientific,
clinical, regulatory and other product development goals, which we sometimes refer to as
milestones. These milestones may include the commencement or completion of scientific studies and
clinical trials and the submission of regulatory filings. From time to time, we publicly announce
the expected timing of some of these milestones. All of these milestones are based on a variety of
assumptions. The actual timing of the achievement of these milestones can vary dramatically from
our estimates, in many cases for reasons beyond our control, depending on numerous factors,
including:
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the rate of progress, costs and results of our clinical trial and research and
development activities, which will be impacted by the level of proficiency and experience of
our clinical staff; |
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our ability to identify and enroll patients who meet clinical trial eligibility criteria; |
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our ability to access sufficient, reliable and affordable supplies of components used in
the manufacture of our product candidates, including insulin and other materials for
AFREZZA; |
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the costs of expanding and maintaining manufacturing operations, as necessary; |
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the extent of scheduling conflicts with participating clinicians and clinical
institutions; |
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the receipt of approvals by our competitors and by us from the FDA and other regulatory
agencies; and |
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other actions by regulators. |
In addition, if we do not obtain sufficient additional funds through sales of securities, strategic
collaborations or the license or sale of certain of our assets on a timely basis, we may be
required to reduce expenses by delaying, reducing or curtailing our development of AFREZZA or other
product development activities, which would impact our ability to meet milestones. If we fail to
commence or complete, or experience delays in or are forced to curtail, our proposed clinical
programs or otherwise fail to adhere to our projected development goals in the timeframes we
announce and expect, our business and results of operations will be harmed and the market price of
our common stock may decline.
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We face substantial competition in the development of our product candidates and may not be able to
compete successfully, and our product candidates may be rendered obsolete by rapid technological
change.
A number of established pharmaceutical companies have or are developing technologies for the
treatment of diabetes. We also face substantial competition for the development of our other
product candidates.
Many of our existing or potential competitors have, or have access to, substantially greater
financial, research and development, production, and sales and marketing resources than we do and
have a greater depth and number of experienced managers. As a result, our competitors may be better
equipped than we are to develop, manufacture, market and sell competing products. In addition,
gaining favorable reimbursement is critical to the success of AFREZZA. Many of our competitors have
existing infrastructure and relationships with managed care organizations and reimbursement
authorities which can be used to their advantage.
The rapid rate of scientific discoveries and technological changes could result in one or more of
our product candidates becoming obsolete or noncompetitive. Our competitors may develop or
introduce new products that render our technology and AFREZZA less competitive, uneconomical or
obsolete. Our future success will depend not only on our ability to develop our product candidates
but to improve them and keep pace with emerging industry developments. We cannot assure you that we
will be able to do so.
We also expect to face increasing competition from universities and other non-profit research
organizations. These institutions carry out a significant amount of research and development in the
areas of diabetes and cancer. These institutions are becoming increasingly aware of the commercial
value of their findings and are more active in seeking patent and other proprietary rights as well
as licensing revenues.
If we fail to enter into a strategic collaboration with respect to AFREZZA, we may not be able to
execute on our business model.
We have held extensive discussions with a number of pharmaceutical companies concerning a potential
strategic business collaboration for AFREZZA. To date we have not reached an agreement with any of
these companies on a collaboration. We cannot predict when, if ever, we could conclude an agreement
with a partner. There can be no assurance that any such collaboration will be available to us on a
timely basis or on acceptable terms. If we are not able to enter into a collaboration on terms that
are favorable to us, we may be unable to undertake and fund product development, clinical trials,
manufacturing and marketing activities at our own expense. Accordingly, we may have to
substantially reduce our development efforts, which would delay or otherwise impede the
commercialization of AFREZZA.
We will face similar challenges as we seek to develop our other product candidates. Our current
strategy for developing, manufacturing and commercializing our other product candidates includes
evaluating the potential for collaborating with pharmaceutical and biotechnology companies at some
point in the drug development process and for these collaborators to undertake the advanced
clinical development and commercialization of our product candidates. It may be difficult for us to
find third parties that are willing to enter into collaborations on economic terms that are
favorable to us, or at all. Failure to enter into a collaboration with respect to any other product
candidate could substantially increase our requirements for capital and force us to substantially
reduce our development effort.
If we enter into collaborative agreements with respect to AFREZZA and if our third-party
collaborators do not perform satisfactorily or if our collaborations fail, development or
commercialization of AFREZZA may be delayed and our business could be harmed.
We may enter into license agreements, partnerships or other collaborative arrangements to support
the financing, development and marketing of AFREZZA. We may also license technology from others to
enhance or supplement our technologies. These various collaborators may enter into arrangements
that would make them potential competitors. These various collaborators also may breach their
agreements with us and delay our progress or fail to perform under their agreements, which could
harm our business.
If we enter into collaborative arrangements, we will have less control over the timing, planning
and other aspects of our clinical trials, and the sale and marketing of AFREZZA and our other
product candidates. We cannot offer assurances that we will be able to enter into satisfactory
arrangements with third parties as contemplated or that any of our existing or future
collaborations will be successful.
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Continued testing of AFREZZA or our other product candidate may not yield successful results, and
even if it does, we may still be unable to commercialize our product candidate.
Our research and development programs are designed to test the safety and efficacy of AFREZZA and
our other product candidates through extensive nonclinical and clinical testing. We may experience
numerous unforeseen events during, or as a result of, the testing process that could delay or
prevent commercialization of AFREZZA or any of our other product candidates, including the
following:
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safety and efficacy results obtained in our nonclinical and initial clinical testing may
be inconclusive or may not be predictive of results obtained in later-stage clinical trials
or following long-term use, and we may as a result be forced to stop developing product
candidates that we currently believe are important to our future; |
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the data collected from clinical trials of our product candidates may not be sufficient
to support FDA or other regulatory approval; |
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after reviewing test results, we or any potential collaborators may abandon projects that
we previously believed were promising; and |
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our product candidates may not produce the desired effects or may result in adverse
health effects or other characteristics that preclude regulatory approval or limit their
commercial use if approved. |
Forecasts about the effects of the use of drugs, including AFREZZA, over terms longer than the
clinical trials or in much larger populations may not be consistent with the clinical results. If
use of AFREZZA results in adverse health effects or reduced efficacy or both, the FDA or other
regulatory agencies may terminate our ability to market and sell AFREZZA, may narrow the approved
indications for use or otherwise require restrictive product labeling or marketing, or may require
further clinical trials, which may be time-consuming and expensive and may not produce favorable
results.
As a result of any of these events, we, any collaborator, the FDA, or any other regulatory
authorities, may suspend or terminate clinical trials or marketing of AFREZZA at any time. Any
suspension or termination of our clinical trials or marketing activities may harm our business and
results of operations and the market price of our common stock may decline.
If we are unable to transition successfully from a development company to a company that
commercializes therapeutics, our business would suffer.*
We require a well-structured plan to make the transition from the development stage to being a
company with commercial operations. In order to implement our commercialization strategy, we will
need to:
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align our management structure to accommodate the increasing complexity of our
operations; |
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develop comprehensive and detailed commercialization, clinical development and regulatory
plans; and |
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implement standard operating procedures. |
If we are unable to accomplish these measures in a timely manner, we would be at considerable risk
of failing to develop the capabilities necessary for commercial operations.
If our suppliers fail to deliver materials and services needed for the production of AFREZZA in a
timely and sufficient manner, or they fail to comply with applicable regulations, our business and
results of operations would be harmed and the market price of our common stock could decline.*
For AFREZZA to be commercially viable, we need access to sufficient, reliable and affordable
supplies of insulin, our AFREZZA inhaler, the related cartridges and other materials. We have a
long-term agreement with N.V. Organon for the supply of insulin. In June 2009, we purchased from
Pfizer, a portion of its inventory of bulk insulin and acquired an option to purchase the remainder
of Pfizers insulin inventory, in whole or in part, at a specified price to the extent that Pfizer
has not otherwise disposed of or used the retained insulin.
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We obtain FDKP, the precursor raw material for AFREZZA, from a major multinational chemical
manufacturer. We have completed a successful validation campaign of FDKP at commercial scale. We
can also utilize our in-house chemical manufacturing plant for supplemental capacity. We believe
our contract manufacturer has the capacity to supply our current and future commercial
requirements. We obtain our intended commercial AFREZZA inhaler and cartridges from a plastic
molding company located in the United States.
We must rely on our suppliers to comply with relevant regulatory and other legal requirements,
including the production of insulin in accordance with the FDAs current good manufacturing
practices, or cGMP for drug products, and the production of the AFREZZA inhaler and related
cartridges in accordance with Quality System Regulations or QSR. The supply of any of these
materials may be limited or any of the manufacturers may not meet relevant regulatory requirements,
and if we are unable to obtain any of these materials in sufficient amounts, in a timely manner and
at reasonable prices, or if we should encounter delays or difficulties in our relationships with
manufacturers or suppliers, the development or manufacturing of AFREZZA may be delayed. Any such
events could delay market introduction and subsequent sales of AFREZZA and, if so, our business and
results of operations will be harmed and the market price of our common stock may decline.
We have never manufactured AFREZZA or any other product candidates in commercial quantities, and if
we fail to develop an effective manufacturing capability for our product candidates or to engage
third-party manufacturers with this capability, we may be unable to commercialize these products.*
We use our Danbury facility to formulate AFREZZA, fill plastic cartridges with AFREZZA and blister
package the cartridges for use in our clinical trials. This facility has been fully qualified and
undergone inspection by the FDA. The manufacture of pharmaceutical products requires significant
expertise and capital investment, including the development of advanced manufacturing techniques
and process controls. Manufacturers of pharmaceutical products often encounter difficulties in
production, especially in scaling up initial production. These problems include difficulties with
production costs and yields, quality control and assurance and shortages of qualified personnel, as
well as compliance with strictly enforced federal, state and foreign regulations. If we engage a
third-party manufacturer, we would need to transfer our technology to that third-party manufacturer
and gain FDA approval, potentially causing delays in product delivery. In addition, our third-party
manufacturer may not perform as agreed or may terminate its agreement with us.
Additionally, when we manufacture commercial material on a significantly larger production scale
than the production scale for clinical trial materials, we are required by the FDA to establish
that the results obtained from the clinical trials may reasonably be extrapolated to such
commercial material. We have submitted documentation to the FDA to show correlation to the
clinical-scale production materials but can provide no assurance that approval will be obtained.
Any of these factors could cause us to delay or suspend clinical trials, regulatory submissions,
required approvals or commercialization of our product candidates, entail higher costs and result
in our being unable to effectively commercialize our products. Furthermore, if we or a third-party
manufacturer fail to deliver the required commercial quantities of any product on a timely basis,
and at commercially reasonable prices and acceptable quality, and we were unable to promptly find
one or more replacement manufacturers capable of production at a substantially equivalent cost, in
substantially equivalent volume and quality on a timely basis, we would likely be unable to meet
demand for such products and we would lose potential revenues.
We deal with hazardous materials and must comply with environmental laws and regulations, which can
be expensive and restrict how we do business.*
Our research and development work involves the controlled storage and use of hazardous materials,
including chemical, radioactive and biological materials. In addition, our manufacturing operations
involve the use of a chemical that is stable and non-hazardous under normal storage conditions, but
may form an explosive mixture under certain conditions. Our operations also produce hazardous waste
products. We are subject to federal, state and local laws and regulations governing how we use,
manufacture, store, handle and dispose of these materials. Moreover, the risk of accidental
contamination or injury from hazardous materials cannot be completely eliminated, and in the event
of an accident, we could be held liable for any damages that may result, and any liability could
fall outside the coverage or exceed the limits of our insurance. Currently, our general liability
policy provides coverage up to $1 million per occurrence and $2 million in the aggregate and is
supplemented by an umbrella policy that provides a further $4 million of coverage; however, our
insurance policy excludes pollution coverage and we do not carry a separate hazardous materials
policy. In addition, we
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could be required to incur significant costs to comply with environmental laws and regulations in
the future. Finally, current or future environmental laws and regulations may impair our research,
development or production efforts.
When we purchased the facilities located in Danbury, Connecticut in 2001, there was a soil cleanup
plan in process. As part of the purchase, we obtained an indemnification from the seller related to
the remediation of the soil for all known environmental conditions that existed at the time the
seller acquired the property. The seller is, in turn, indemnified for these known environmental
conditions by the previous owner. We also received an indemnification from the seller for
environmental conditions created during its ownership of the property and for environmental
problems unknown at the time that the seller acquired the property. These additional indemnities
are limited to the purchase price that we paid for the Danbury facilities.
During the construction of our expanded manufacturing facility, we completed the final stages of
the soil cleanup plan in the third quarter of 2008, at a cost of approximately $2.25 million. We
have reached an agreement with the party responsible for their contribution to past clean-up costs
and were reimbursed $1.625 million in July 2010. The responsible party has agreed to pay for or
indemnify us for any future costs and expenses directly related to the final closure of the
environmental remediation. If we are unable to collect these future costs and expenses, if any,
from the responsible party, our business and results of operations may be harmed.
If we fail to enter into collaborations with third parties, we would be required to establish our
own sales, marketing and distribution capabilities, which could impact the commercialization of our
products and harm our business.*
Our products are intended to be used by a large number of healthcare professionals who will require
substantial education and support. For example, a broad base of physicians, including primary care
physicians and endocrinologists, treat patients with diabetes. A large sales force will be required
in order to educate these physicians about the benefits and advantages of AFREZZA and to provide
adequate support for them. Therefore, we plan to enter into collaborations with one or more
pharmaceutical companies to market, distribute and sell AFREZZA, if it is approved. If we fail to
enter into collaborations, we would be required to establish our own direct sales, marketing and
distribution capabilities. Establishing these capabilities can be time-consuming and expensive.
Because we lack experience in selling pharmaceutical products to the diabetes market, we would be
at a disadvantage compared to our potential competitors, all of whom have substantially more
resources and experience than we do. For example, several other companies selling products to treat
diabetes have existing sales forces in excess of 1,500 sales representatives. We, acting alone,
would not initially be able to field a sales force as large as our competitors or provide the same
degree of marketing support. Also, we would not be able to match our competitors spending levels
for pre-launch marketing preparation, including medical education. We cannot assure you that we
will succeed in entering into acceptable collaborations, that any such collaboration will be
successful or, if not, that we will successfully develop our own sales, marketing and distribution
capabilities.
If any product that we may develop does not become widely accepted by physicians, patients,
third-party payers and the healthcare community, we may be unable to generate significant revenue,
if any.*
AFREZZA and our other product candidates are new and unproven. Even if any of our product
candidates obtain regulatory approval, they may not gain market acceptance among physicians,
patients, third-party payers and the healthcare community. Failure to achieve market acceptance
would limit our ability to generate revenue and would adversely affect our results of operations.
The degree of market acceptance of AFREZZA and our other product candidates will depend on many
factors, including the:
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perceived advantages and disadvantages of competitive products; |
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willingness of the healthcare community and patients to adopt new technologies; |
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ability to manufacture the product in sufficient quantities with acceptable quality and
cost; |
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perception of patients and the healthcare community, including third-party payers,
regarding the safety, efficacy and benefits compared to competing products or therapies; |
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convenience and ease of administration relative to existing treatment methods; |
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pricing and reimbursement relative to other treatment therapeutics and methods; and |
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marketing and distribution support. |
Because of these and other factors, any product that we may develop may not gain market acceptance,
which would materially harm our business, financial condition and results of operations.
If third-party payers do not reimburse consumers for our products, our products might not be used
or purchased, which would adversely affect our revenues.
Our future revenues and potential for profitability may be affected by the continuing efforts of
governments and third-party payers to contain or reduce the costs of healthcare through various
means. For example, in certain foreign markets the pricing of prescription pharmaceuticals is
subject to governmental control. In the United States, there has been, and we expect that there
will continue to be, a number of federal and state proposals to implement similar governmental
controls. We cannot be certain what legislative proposals will be adopted or what actions federal,
state or private payers for healthcare goods and services may take in response to any drug pricing
reform proposals or legislation. Such reforms may make it difficult to complete the development and
testing of AFREZZA and our other product candidates, and therefore may limit our ability to
generate revenues from sales of our product candidates and achieve profitability. Further, to the
extent that such reforms have a material adverse effect on the business, financial condition and
profitability of other companies that are prospective collaborators for some of our product
candidates, our ability to commercialize our product candidates under development may be adversely
affected.
In the United States and elsewhere, sales of prescription pharmaceuticals still depend in large
part on the availability of reimbursement to the consumer from third-party payers, such as
governmental and private insurance plans. Third-party payers are increasingly challenging the
prices charged for medical products and services. In addition, because each third-party payer
individually approves reimbursement, obtaining these approvals is a time-consuming and costly
process. We would be required to provide scientific and clinical support for the use of any product
to each third-party payer separately with no assurance that approval would be obtained. This
process could delay the market acceptance of any product and could have a negative effect on our
future revenues and operating results. Even if we succeed in bringing one or more products to
market, we cannot be certain that any such products would be considered cost-effective or that
reimbursement to the consumer would be available, in which case our business and results of
operations would be harmed and the market price of our common stock could decline.
If product liability claims are brought against us, we may incur significant liabilities and suffer
damage to our reputation.
The testing, manufacturing, marketing and sale of AFREZZA and our other product candidates expose
us to potential product liability claims. A product liability claim may result in substantial
judgments as well as consume significant financial and management resources and result in adverse
publicity, decreased demand for a product, injury to our reputation, withdrawal of clinical trial
volunteers and loss of revenues. We currently carry worldwide liability insurance in the amount of
$10 million. We believe these limits are reasonable to cover us from potential damages arising from
current and previous clinical trials of AFREZZA. In addition, we carry local policies per trial in
each country in which we conduct clinical trials that require us to carry coverage based on local
statutory requirements. We intend to obtain product liability coverage for commercial sales in the
future if AFREZZA is approved. However, we may not be able to obtain insurance coverage that will
be adequate to satisfy any liability that may arise, and because insurance coverage in our industry
can be very expensive and difficult to obtain, we cannot assure you that we will be able to obtain
sufficient coverage at an acceptable cost, if at all. If losses from such claims exceed our
liability insurance coverage, we may ourselves incur substantial liabilities. If we are required to
pay a product liability claim our business and results of operations would be harmed and the market
price of our common stock may decline.
If we lose any key employees or scientific advisors, our operations and our ability to execute our
business strategy could be materially harmed.
In order to commercialize our product candidates successfully, we will be required to expand our
work force, particularly in the areas of manufacturing, clinical trials management, regulatory
affairs, business development, and sales and marketing. These activities will require the addition
of new personnel, including management, and the development of additional expertise by existing
personnel. We face intense competition for qualified employees among companies in the biotechnology
and biopharmaceutical industries. Our
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success depends upon our ability to attract, retain and motivate highly skilled employees. We may
be unable to attract and retain these individuals on acceptable terms, if at all.
The loss of the services of any principal member of our management and scientific staff could
significantly delay or prevent the achievement of our scientific and business objectives. All of
our employees are at will and we currently do not have employment agreements with any of the
principal members of our management or scientific staff, and we do not have key person life
insurance to cover the loss of any of these individuals. Replacing key employees may be difficult
and time-consuming because of the limited number of individuals in our industry with the skills and
experience required to develop, gain regulatory approval of and commercialize our product
candidates successfully.
We have relationships with scientific advisors at academic and other institutions to conduct
research or assist us in formulating our research, development or clinical strategy. These
scientific advisors are not our employees and may have commitments to, and other obligations with,
other entities that may limit their availability to us. We have limited control over the activities
of these scientific advisors and can generally expect these individuals to devote only limited time
to our activities. Failure of any of these persons to devote sufficient time and resources to our
programs could harm our business. In addition, these advisors are not prohibited from, and may have
arrangements with, other companies to assist those companies in developing technologies that may
compete with our product candidates.
If our Chief Executive Officer is unable to devote sufficient time and attention to our business,
our operations and our ability to execute our business strategy could be materially harmed.
Alfred Mann, our Chairman and Chief Executive Officer, is involved in many other business and
charitable activities. As a result, the time and attention Mr. Mann devotes to the operation of our
business varies, and he may not expend the same time or focus on our activities as other, similarly
situated chief executive officers. If Mr. Mann is unable to devote the time and attention necessary
to running our business, we may not be able to execute our business strategy and our business could
be materially harmed.
If our internal controls over financial reporting are not considered effective, our business and
stock price could be adversely affected.
Section 404 of the Sarbanes-Oxley Act of 2002 requires us to evaluate the effectiveness of our
internal controls over financial reporting as of the end of each fiscal year, and to include a
management report assessing the effectiveness of our internal controls over financial reporting in
our annual report on Form 10-K for that fiscal year. Section 404 also requires our independent
registered public accounting firm to attest to, and report on, our internal controls over financial
reporting.
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect
that our internal controls over financial reporting will prevent all errors and all fraud. A
control system, no matter how well designed and operated, can provide only reasonable, not
absolute, assurance that the control systems objectives will be met. Further, the design of a
control system must reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute assurance that all control issues
and instances of fraud involving a company have been, or will be, detected. The design of any
system of controls is based in part on certain assumptions about the likelihood of future events,
and we cannot assure you that any design will succeed in achieving its stated goals under all
potential future conditions. Over time, controls may become inadequate because of changes in
conditions or deterioration in the degree of compliance with policies or procedures. Because of the
inherent limitations in a cost-effective control system, misstatements due to error or fraud may
occur and not be detected. We cannot assure you that we or our independent registered public
accounting firm will not identify a material weakness in our internal controls in the future. A
material weakness in our internal controls over financial reporting would require management and
our independent registered public accounting firm to evaluate our internal controls as ineffective.
If our internal controls over financial reporting are not considered effective, we may experience a
loss of public confidence, which could have an adverse effect on our business and on the market
price of our common stock.
RISKS RELATED TO REGULATORY APPROVALS
Our product candidates must undergo rigorous nonclinical and clinical testing and we must obtain
regulatory approvals, which could be costly and time-consuming and subject us to unanticipated
delays or prevent us from marketing any products.*
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Our research and development activities, as well as the manufacturing and marketing of our product
candidates, including AFREZZA, are subject to regulation, including regulation for safety, efficacy
and quality, by the FDA in the United States and comparable authorities in other countries. FDA
regulations and the regulation of comparable foreign regulatory authorities are wide-ranging and
govern, among other things:
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product design, development, manufacture and testing; |
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product labeling; |
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product storage and shipping; |
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pre-market clearance or approval; |
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advertising and promotion; and |
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product sales and distribution. |
Clinical testing can be costly and take many years, and the outcome is uncertain and susceptible to
varying interpretations. We cannot be certain if or when the FDA might request additional studies,
under what conditions such studies might be requested, or what the size or length of any such
studies might be. The clinical trials of our product candidates may not be completed on schedule,
the FDA or foreign regulatory agencies may order us to stop or modify our research, or these
agencies may not ultimately approve any of our product candidates for commercial sale. The data
collected from our clinical trials may not be sufficient to support regulatory approval of our
various product candidates, including AFREZZA. Even if we believe the data collected from our
clinical trials are sufficient, the FDA has substantial discretion in the approval process and may
disagree with our interpretation of the data. Our failure to adequately demonstrate the safety and
efficacy of any of our product candidates would delay or prevent regulatory approval of our product
candidates, which could prevent us from achieving profitability.
The requirements governing the conduct of clinical trials and manufacturing and marketing of our
product candidates, including AFREZZA, outside the United States vary widely from country to
country. Foreign approvals may take longer to obtain than FDA approvals and can require, among
other things, additional testing and different clinical trial designs. Foreign regulatory approval
processes include essentially all of the risks associated with the FDA approval processes. Some of
those agencies also must approve prices of the products. Approval of a product by the FDA does not
ensure approval of the same product by the health authorities of other countries. In addition,
changes in regulatory policy in the United States or in foreign countries for product approval
during the period of product development and regulatory agency review of each submitted new
application may cause delays or rejections.
The process of obtaining FDA and other required regulatory approvals, including foreign approvals,
is expensive, often takes many years and can vary substantially based upon the type, complexity and
novelty of the products involved. We are not aware of any precedent for the successful
commercialization of products based on our technology. In January 2006, the FDA approved the first
pulmonary insulin product, Exubera. This approval has had an impact on and, notwithstanding the
voluntary withdrawal of the product from the market by its manufacturer, could still impact the
development and registration of AFREZZA in different ways. For example, Exubera may be used as a
reference for safety and efficacy evaluations of AFREZZA, and the approval standards set for
Exubera may be applied to other products that follow, including AFREZZA.
In March 2009, we submitted an NDA for AFREZZA. The FDA has advised us that it will regulate
AFREZZA as a combination product because of the complex nature of the system that includes the
combination of a new drug (AFREZZA) and a new medical device (the AFREZZA inhaler used to
administer the insulin). The FDAs review of our NDA for AFREZZA involves several separate review
groups of the FDA including: (1) the Metabolic and Endocrine Drug Products Division; (2) the
Pulmonary Drug Products Division; and (3) the Center for Devices and Radiological Health, which
reviews medical devices. The Metabolic and Endocrine Drug Products Division is the lead group and
obtains consulting reviews from the other two FDA groups. We can make no assurances at this time
about what impact FDA review by multiple groups will have on the approvability of our product.
In March 2010, we received a Complete Response letter regarding this NDA from the FDA. A Complete
Response letter is issued by the FDAs Center for Drug Evaluation and Research when the review of a
submitted file is completed and questions remain that
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preclude the approval of the NDA in its current form. In July 2010, the FDA accepted our reply to
the Complete Response letter and set a target action date of December 29, 2010. There can be no
assurance that the FDA will find our proposed approach for addressing its questions acceptable. The
FDA could also request that we conduct additional clinical trials to provide sufficient data for
approval of the NDA. There can be no assurance that we will obtain approval of the NDA in a timely
manner or at all.
Also, questions that have been raised about the safety of marketed drugs generally, including
pertaining to the lack of adequate labeling, may result in increased cautiousness by the FDA in
reviewing new drugs based on safety, efficacy, or other regulatory considerations and may result in
significant delays in obtaining regulatory approvals. Such regulatory considerations may also
result in the imposition of more restrictive drug labeling or marketing requirements as conditions
of approval, which may significantly affect the marketability of our drug products. FDA review of
AFREZZA as a combination product may lengthen the product development and regulatory approval
process, increase our development costs and delay or prevent the commercialization of AFREZZA.
We are developing AFREZZA as a new treatment for diabetes utilizing unique, proprietary components.
As a combination product, any changes to either the AFREZZA inhaler, or AFREZZA, including new
suppliers, could possibly result in FDA requirements to repeat certain clinical studies. For
example, we plan to launch AFREZZA with our next-generation inhaler rather than the device that was
used in pivotal clinical studies, and in our July 2010 reply to the FDAs Complete Response letter,
we submitted information on the comparability of our next-generation inhaler to the device that was
used in pivotal clinical studies. As a result of our change to our next-generation inhaler, the
FDA could yet require us to undertake additional clinical trials and other studies, which could
significantly delay the development and commercialization of AFREZZA. Our product candidates that
are currently in development for the treatment of cancer also face similar obstacles and costs.
We also must obtain final approval from the FDA for the trade name of our product. In September
2009, we proposed AFREZZA as a trade name, which the FDA found conditionally acceptable in December
2009.
We have only limited experience in filing and pursuing applications necessary to gain regulatory
approvals, which may impede our ability to obtain timely approvals from the FDA or foreign
regulatory agencies, if at all.*
We will not be able to commercialize AFREZZA or any other product candidates until we have obtained
regulatory approval. Until we prepared and submitted our NDA for AFREZZA, we had no experience as a
company in late-stage regulatory filings, such as preparing and submitting NDAs, which may place us
at risk of delays, overspending and human resources inefficiencies. Any delay in obtaining, or
inability to obtain, regulatory approval could harm our business.
If we do not comply with regulatory requirements at any stage, whether before or after marketing
approval is obtained, we may be subject to criminal prosecution, fined or forced to remove a
product from the market or experience other adverse consequences, including restrictions or delays
in obtaining regulatory marketing approval.
Even if we comply with regulatory requirements, we may not be able to obtain the labeling claims
necessary or desirable for product promotion. We may also be required to undertake post-marketing
trials. In addition, if we or other parties identify adverse effects after any of our products are
on the market, or if manufacturing problems occur, regulatory approval may be withdrawn and a
reformulation of our products, additional clinical trials, changes in labeling of, or indications
of use for, our products and/or additional marketing applications may be required. If we encounter
any of the foregoing problems, our business and results of operations will be harmed and the market
price of our common stock may decline.
Even if we obtain regulatory approval for our product candidates, such approval may be limited and
we will be subject to stringent, ongoing government regulation.
Even if regulatory authorities approve any of our product candidates, they could approve less than
the full scope of uses or labeling that we seek or otherwise require special warnings or other
restrictions on use or marketing or could require potentially costly post-marketing follow-up
clinical trials. Regulatory authorities may limit the segments of the diabetes population to which
we or others may market AFREZZA or limit the target population for our other product candidates.
Based on currently available clinical studies, we believe that AFREZZA may have certain advantages
over currently approved insulin products including its approximation of the natural early insulin
secretion normally seen in healthy individuals following the beginning of a meal. Nonetheless,
there are no assurances that these or any other advantages of AFREZZA will be agreed to by the FDA
or otherwise included in product labeling or advertising and, as a result, AFREZZA may not have our
expected competitive advantages when compared to other insulin products.
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The manufacture, marketing and sale of any of our product candidates will be subject to stringent
and ongoing government regulation. The FDA may also withdraw product approvals if problems
concerning safety or efficacy of a product occurs following approval. We cannot be sure that FDA
and United States Congressional initiatives pertaining to ensuring the safety of marketed drugs or
other developments pertaining to the pharmaceutical industry will not adversely affect our
operations.
We also are required to register our establishments and list our products with the FDA and certain
state agencies. We and any third-party manufacturers or suppliers must continually adhere to
federal regulations setting forth requirements, known as cGMP (for drugs) and QSR (for medical
devices), and their foreign equivalents, which are enforced by the FDA and other national
regulatory bodies through their facilities inspection programs. If our facilities, or the
facilities of our manufacturers or suppliers, cannot pass a preapproval plant inspection, the FDA
will not approve the marketing of our product candidates. In complying with cGMP and foreign
regulatory requirements, we and any of our potential third-party manufacturers or suppliers will be
obligated to expend time, money and effort in production, record-keeping and quality control to
ensure that our products meet applicable specifications and other requirements. QSR requirements
also impose extensive testing, control and documentation requirements. State regulatory agencies
and the regulatory agencies of other countries have similar requirements. In addition, we will be
required to comply with regulatory requirements of the FDA, state regulatory agencies and the
regulatory agencies of other countries concerning the reporting of adverse events and device
malfunctions, corrections and removals (e.g., recalls), promotion and advertising and general
prohibitions against the manufacture and distribution of adulterated and misbranded devices.
Failure to comply with these regulatory requirements could result in civil fines, product seizures,
injunctions and/or criminal prosecution of responsible individuals and us. Any such actions would
have a material adverse effect on our business and results of operations.
Our insulin supplier does not yet supply human recombinant insulin for an FDA-approved product.*
Our insulin supplier for purposes of the AFREZZA NDA sells its product outside of the United
States. The FDA has inspected this supplier and found it to be acceptable. If we were required to
find a new or additional supplier of insulin, we would be required to evaluate the new suppliers
ability to provide insulin that meets our specifications and quality requirements, which would
require significant time and expense and could delay the manufacturing and future commercialization
of AFREZZA. We also depend on suppliers for other materials that comprise AFREZZA, including our
AFREZZA inhaler and cartridges. Each device supplier must comply with relevant regulatory
requirements including QSR and is subject to inspection by the FDA. There can be no assurance, in
the conduct of an inspection of any of our suppliers, that the agency would find that the supplier
substantially complies with the QSR or cGMP requirements, where applicable. If we or any potential
third-party manufacturer or supplier fails to comply with these requirements or comparable
requirements in foreign countries, regulatory authorities may subject us to regulatory action,
including criminal prosecutions, fines and suspension of the manufacture of our products.
Reports of side effects or safety concerns in related technology fields or in other companies
clinical trials could delay or prevent us from obtaining regulatory approval or negatively impact
public perception of our product candidates.
At present, there are a number of clinical trials being conducted by us and other pharmaceutical
companies involving insulin delivery systems. If we discover that AFREZZA is associated with a
significantly increased frequency of adverse events, or if other pharmaceutical companies announce
that they observed frequent adverse events in their trials involving the pulmonary delivery of
insulin, we could encounter delays in the timing of our clinical trials or difficulties in
obtaining approval of AFREZZA. As well, the public perception of AFREZZA might be adversely
affected, which could harm our business and results of operations and cause the market price of our
common stock to decline, even if the concern relates to another companys products or product
candidates.
There are also a number of clinical trials being conducted by other pharmaceutical companies
involving compounds similar to, or competitive with, our other product candidates. Adverse results
reported by these other companies in their clinical trials could delay or prevent us from obtaining
regulatory approval or negatively impact public perception of our product candidates, which could
harm our business and results of operations and cause the market price of our common stock to
decline.
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RISKS RELATED TO INTELLECTUAL PROPERTY
If we are unable to protect our proprietary rights, we may not be able to compete effectively, or
operate profitably.
Our commercial success depends, in large part, on our ability to obtain and maintain intellectual
property protection for our technology. Our ability to do so will depend on, among other things,
complex legal and factual questions, and it should be noted that the standards regarding
intellectual property rights in our fields are still evolving. We attempt to protect our
proprietary technology through a combination of patents, trade secrets and confidentiality
agreements. We own a number of domestic and international patents, have a number of domestic and
international patent applications pending and have licenses to additional patents. We cannot assure
you that our patents and licenses will successfully preclude others from using our technologies,
and we could incur substantial costs in seeking enforcement of our proprietary rights against
infringement. Even if issued, the patents may not give us an advantage over competitors with
similar alternative technologies.
Moreover, the issuance of a patent is not conclusive as to its validity or enforceability and it is
uncertain how much protection, if any, will be afforded by our patents. A third party may challenge
the validity or enforceability of a patent after its issuance by various proceedings such as
oppositions in foreign jurisdictions or re-examinations in the United States. If we attempt to
enforce our patents, they may be challenged in court where they could be held invalid,
unenforceable, or have their breadth narrowed to an extent that would destroy their value.
We also rely on unpatented technology, trade secrets, know-how and confidentiality agreements. We
require our officers, employees, consultants and advisors to execute proprietary information and
invention and assignment agreements upon commencement of their relationships with us. We also
execute confidentiality agreements with outside collaborators. There can be no assurance, however,
that these agreements will provide meaningful protection for our inventions, trade secrets,
know-how or other proprietary information in the event of unauthorized use or disclosure of such
information. If any trade secret, know-how or other technology not protected by a patent were to be
disclosed to or independently developed by a competitor, our business, results of operations and
financial condition could be adversely affected.
If we become involved in lawsuits to protect or enforce our patents or the patents of our
collaborators or licensors, we would be required to devote substantial time and resources to
prosecute or defend such proceedings.
Competitors may infringe our patents or the patents of our collaborators or licensors. To counter
infringement or unauthorized use, we may be required to file infringement claims, which can be
expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a
patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using
the technology at issue on the grounds that our patents do not cover its technology. A court may
also decide to award us a royalty from an infringing party instead of issuing an injunction against
the infringing activity. An adverse determination of any litigation or defense proceedings could
put one or more of our patents at risk of being invalidated or interpreted narrowly and could put
our patent applications at risk of not issuing.
Interference proceedings brought by the U.S. Patent and Trademark Office may be necessary to
determine the priority of inventions with respect to our patent applications or those of our
collaborators or licensors. Litigation or interference proceedings may fail and, even if
successful, may result in substantial costs and be a distraction to our management. We may not be
able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary
rights, particularly in countries where the laws may not protect such rights as fully as in the
United States. We may not prevail in any litigation or interference proceeding in which we are
involved. Even if we do prevail, these proceedings can be very expensive and distract our
management.
Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation. In addition, during the course of this
kind of litigation, there could be public announcements of the results of hearings, motions or
other interim proceedings or developments. If securities analysts or investors perceive these
results to be negative, the market price of our common stock may decline.
If our technologies conflict with the proprietary rights of others, we may incur substantial costs
as a result of litigation or other proceedings and we could face substantial monetary damages and
be precluded from commercializing our products, which would materially harm our business.*
Over the past three decades the number of patents issued to biotechnology companies has expanded
dramatically. As a result it is not always clear to industry participants, including us, which
patents cover the multitude of biotechnology product types. Ultimately, the courts must determine
the scope of coverage afforded by a patent and the courts do not always arrive at uniform
conclusions.
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A patent owner may claim that we are making, using, selling or offering for sale an invention
covered by the owners patents and may go to court to stop us from engaging in such activities.
Such litigation is not uncommon in our industry.
Patent lawsuits can be expensive and would consume time and other resources. There is a risk that a
court would decide that we are infringing a third partys patents and would order us to stop the
activities covered by the patents, including the commercialization of our products. In addition,
there is a risk that we would have to pay the other party damages for having violated the other
partys patents (which damages may be increased, as well as attorneys fees ordered paid, if
infringement is found to be willful), or that we will be required to obtain a license from the
other party in order to continue to commercialize the affected products, or to design our products
in a manner that does not infringe a valid patent. We may not prevail in any legal action, and a
required license under the patent may not be available on acceptable terms or at all, requiring
cessation of activities that were found to infringe a valid patent. We also may not be able to
develop a non-infringing product design on commercially reasonable terms, or at all.
Moreover, certain components of AFREZZA and/or our cancer vaccines may be manufactured outside the
United States and imported into the United States. As such, third parties could file complaints
under 19 U.S.C. Section 337(a)(1)(B), or a 337 action, with the International Trade Commission, or
the ITC. A 337 action can be expensive and would consume time and other resources. There is a risk
that the ITC would decide that we are infringing a third partys patents and either enjoin us from
importing the infringing products or parts thereof into the United States or set a bond in an
amount that the ITC considers would offset our competitive advantage from the continued importation
during the statutory review period. The bond could be up to 100% of the value of the patented
products. We may not prevail in any legal action, and a required license under the patent may not
be available on acceptable terms, or at all, resulting in a permanent injunction preventing any
further importation of the infringing products or parts thereof into the United States. We also may
not be able to develop a non-infringing product design on commercially reasonable terms, or at all.
Although we own a number of domestic and foreign patents and patent applications relating to
AFREZZA and cancer vaccine products under development, we have identified certain third-party
patents having claims relating to pulmonary insulin delivery that may trigger an allegation of
infringement upon the commercial manufacture and sale of AFREZZA as well as third-party patents
disclosing methods of use and compositions of matter related to cancer vaccines that also may
trigger an allegation of infringement upon the commercial manufacture and sale of our cancer
immunotherapy. If a court were to determine that our insulin products or cancer therapies were
infringing any of these patent rights, we would have to establish with the court that these patents
were invalid or unenforceable in order to avoid legal liability for infringement of these patents.
However, proving patent invalidity or unenforceability can be difficult because issued patents are
presumed valid. Therefore, in the event that we are unable to prevail in an infringement or
invalidity action we will have to either acquire the third-party patents outright or seek a
royalty-bearing license. Royalty-bearing licenses effectively increase production costs and
therefore may materially affect product profitability. Furthermore, should the patent holder refuse
to either assign or license us the infringed patents, it may be necessary to cease manufacturing
the product entirely and/or design around the patents, if possible. In either event, our business
would be harmed and our profitability could be materially adversely impacted.
Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation. In addition, during the course of this
kind of litigation, there could be public announcements of the results of hearings, motions or
other interim proceedings or developments. If securities analysts or investors perceive these
results to be negative, the market price of our common stock may decline.
In addition, patent litigation may divert the attention of key personnel and we may not have
sufficient resources to bring these actions to a successful conclusion. At the same time, some of
our competitors may be able to sustain the costs of complex patent litigation more effectively than
we can because they have substantially greater resources. An adverse determination in a judicial or
administrative proceeding or failure to obtain necessary licenses could prevent us from
manufacturing and selling our products or result in substantial monetary damages, which would
adversely affect our business and results of operations and cause the market price of our common
stock to decline.
We may not obtain trademark registrations for our potential trade names.
We have not selected trade names for some of our products and product candidates; therefore, we
have not filed trademark registrations for our potential trade names for our products in all
jurisdictions, nor can we assure that we will be granted registration of
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those potential trade names for which we have filed. Although we intend to defend any opposition to
our trademark registrations, no assurance can be given that any of our trademarks will be
registered in the United States or elsewhere or that the use of any of our trademarks will confer a
competitive advantage in the marketplace. Furthermore, even if we are successful in our trademark
registrations, the FDA has its own process for drug nomenclature and its own views concerning
appropriate proprietary names. It also has the power, even after granting market approval, to
request a company to reconsider the name for a product because of evidence of confusion in the
marketplace. We cannot assure you that the FDA or any other regulatory authority will approve of
any of our trademarks or will not request reconsideration of one of our trademarks at some time in
the future.
RISKS RELATED TO OUR COMMON STOCK
Our stock price is volatile. *
The current turbulence in the U.S. and global financial markets could adversely affect our stock
price and our ability to raise additional capital through the sale of equity and/or debt
securities. The stock market, particularly in recent years, has experienced significant volatility
particularly with respect to pharmaceutical and biotechnology stocks, and this trend may continue.
The volatility of pharmaceutical and biotechnology stocks often does not relate to the operating
performance of the companies represented by the stock. Our business and the market price of our
common stock may be influenced by a large variety of factors, including:
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the progress and results of our clinical trials; |
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general economic, political or stock market conditions; |
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legislative developments; |
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announcements by us or our competitors concerning clinical trial results, acquisitions,
strategic alliances, technological innovations, newly approved commercial products, product
discontinuations, or other developments; |
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the availability of critical materials used in developing and manufacturing AFREZZA or
other product candidates; |
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developments or disputes concerning our patents or proprietary rights; |
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the expense and time associated with, and the extent of our ultimate success in, securing
regulatory approvals; |
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announcements by us concerning our financial condition or operating performance; |
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changes in securities analysts estimates of our financial condition or operating
performance; |
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general market conditions and fluctuations for emerging growth and pharmaceutical market
sectors; |
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sales of large blocks of our common stock, including sales by our executive officers,
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discussion of AFREZZA, our other product candidates, competitors products, or our stock
price by the financial and scientific press, the healthcare community and online investor
communities such as chat rooms. In particular, statements about us and our investigational
products that appear on interactive websites that permit users to generate content
anonymously or under a pseudonym may be difficult to verify and statements attributed to
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Any of these risks, as well as other factors, could cause the market price of our common stock to
decline.
If other biotechnology and biopharmaceutical companies or the securities markets in general
encounter problems, the market price of our common stock could be adversely affected.
Public companies in general and companies included on the Nasdaq Stock Market in particular have
experienced extreme price and volume fluctuations that have often been unrelated or
disproportionate to the operating performance of those companies. There has been particular
volatility in the market prices of securities of biotechnology and other life sciences companies,
and the market prices
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of these companies have often fluctuated because of problems or successes in a given market segment
or because investor interest has shifted to other segments. These broad market and industry factors
may cause the market price of our common stock to decline, regardless of our operating performance.
We have no control over this volatility and can only focus our efforts on our own operations, and
even these may be affected due to the state of the capital markets.
In the past, following periods of large price declines in the public market price of a companys
securities, securities class action litigation has often been initiated against that company.
Litigation of this type could result in substantial costs and diversion of managements attention
and resources, which would hurt our business. Any adverse determination in litigation could also
subject us to significant liabilities.
Our Chief Executive Officer and principal stockholder can individually control our direction and
policies, and his interests may be adverse to the interests of our other stockholders. After his
death, his stock will be left to his funding foundations for distribution to various charities, and
we cannot assure you of the manner in which those entities will manage their holdings.*
At July 23, 2010, Mr. Mann beneficially owned approximately 42.1% of our outstanding shares of
capital stock. We believe members of Mr. Manns family beneficially owned approximately an
additional 1% of our outstanding shares of common stock, although Mr. Mann does not have voting or
investment power with respect to these shares. By virtue of his holdings, Mr. Mann can and will
continue to be able to effectively control the election of the members of our board of directors,
our management and our affairs and prevent corporate transactions such as mergers, consolidations
or the sale of all or substantially all of our assets that may be favorable from our standpoint or
that of our other stockholders or cause a transaction that we or our other stockholders may view as
unfavorable.
Subject to compliance with United States federal and state securities laws, Mr. Mann is free to
sell the shares of our stock he holds at any time. Upon his death, we have been advised by Mr. Mann
that his shares of our capital stock will be left to the Alfred E. Mann Medical Research
Organization, or AEMMRO, and AEM Foundation for Biomedical Engineering, or AEMFBE, not-for-profit
medical research foundations that serve as funding organizations for Mr. Manns various charities,
including the Alfred Mann Foundation, or AMF, and the Alfred Mann Institutes at the University of
Southern California, the Technion-Israel Institute of Technology, and Purdue University, and that
may serve as funding organizations for any other charities that he may establish. The AEMMRO is a
membership foundation consisting of six members, including Mr. Mann, his wife, three of his
children and Dr. Joseph Schulman, the chief scientist of the AEMFBE. The AEMFBE is a membership
foundation consisting of five members, including Mr. Mann, his wife, and the same three of his
children. Although we understand that the members of AEMMRO and AEMFBE have been advised of Mr.
Manns objectives for these foundations, once Mr. Manns shares of our capital stock become the
property of the foundations, we cannot assure you as to how those shares will be distributed or how
they will be voted.
The future sale of our common stock or the conversion of our senior convertible notes into common
stock could negatively affect our stock price.
Substantially all of the outstanding shares of our common stock are available for public sale,
subject in some cases to volume and other limitations or delivery of a prospectus. If our common
stockholders sell substantial amounts of common stock in the public market, or the market perceives
that such sales may occur, the market price of our common stock may decline. Likewise the issuance
of additional shares of our common stock upon the conversion of some or all of our senior
convertible notes could adversely affect the trading price of our common stock. In addition, the
existence of these notes may encourage short selling of our common stock by market participants.
Furthermore, if we were to include in a company-initiated registration statement shares held by our
stockholders pursuant to the exercise of their registrations rights, the sale of those shares could
impair our ability to raise needed capital by depressing the price at which we could sell our
common stock.
In addition, we will need to raise substantial additional capital in the future to fund our
operations. If we raise additional funds by issuing equity securities or additional convertible
debt, the market price of our common stock may decline and our existing stockholders may experience
significant dilution.
34
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition
of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our
stockholders to replace or remove our current management.
We are incorporated in Delaware. Certain anti-takeover provisions under Delaware law and in our
certificate of incorporation and amended and restated bylaws, as currently in effect, may make a
change of control of our company more difficult, even if a change in control would be beneficial to
our stockholders. Our anti-takeover provisions include provisions such as a prohibition on
stockholder actions by written consent, the authority of our board of directors to issue preferred
stock without stockholder approval, and supermajority voting requirements for specified actions. In
addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law,
which generally prohibits stockholders owning 15% or more of our outstanding voting stock from
merging or combining with us in certain circumstances. These provisions may delay or prevent an
acquisition of us, even if the acquisition may be considered beneficial by some of our
stockholders. In addition, they may frustrate or prevent any attempts by our stockholders to
replace or remove our current management by making it more difficult for stockholders to replace
members of our board of directors, which is responsible for appointing the members of our
management.
Because we do not expect to pay dividends in the foreseeable future, you must rely on stock
appreciation for any return on your investment.
We have paid no cash dividends on any of our capital stock to date, and we currently intend to
retain our future earnings, if any, to fund the development and growth of our business. As a
result, we do not expect to pay any cash dividends in the foreseeable future, and payment of cash
dividends, if any, will also depend on our financial condition, results of operations, capital
requirements and other factors and will be at the discretion of our board of directors.
Furthermore, we may in the future become subject to contractual restrictions on, or prohibitions
against, the payment of dividends. Accordingly, the success of your investment in our common stock
will likely depend entirely upon any future appreciation. There is no guarantee that our common
stock will appreciate in value after the offering or even maintain the price at which you purchased
your shares, and you may not realize a return on your investment in our common stock.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
There were no sales of equity securities by us that were not registered under the Securities Act of
1933, as amended, during the second quarter of 2010.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. (REMOVED AND RESERVED)
ITEM 5. OTHER INFORMATION
None.
35
ITEM 6. EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
3.1(1)
|
|
Restated Certificate of Incorporation. |
|
|
|
3.2(2)
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation. |
|
|
|
3.3
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation. |
|
|
|
3.4(3)
|
|
Amended and Restated Bylaws. |
|
|
|
4.1(4)
|
|
Indenture, by and between MannKind and Wells Fargo Bank, N.A., dated November 1, 2006. |
|
|
|
4.2(5)
|
|
First Supplemental Indenture, by and between MannKind and Wells Fargo Bank, N.A., dated December 12, 2006. |
|
|
|
4.3(5)
|
|
Form of 3.75% Senior Convertible Note due 2013. |
|
|
|
4.4(1)
|
|
Form of common stock certificate. |
|
|
|
4.5(1)
|
|
Registration Rights Agreement, dated October 15, 1998 by and among CTL ImmunoTherapies Corp., Medical
Research Group, LLC, McLean Watson Advisory Inc. and Alfred E. Mann, as amended. |
|
|
|
31.1
|
|
Certification of the Chief Executive Officer Pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities
Exchange Act of 1934, as amended. |
|
|
|
31.2
|
|
Certification of the Chief Financial Officer Pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities
Exchange Act of 1934, as amended. |
|
|
|
32
|
|
Certifications of the Chief Executive Officer and Chief Financial Officer Pursuant to Rules 13a-14(b) or
15d-14(b) of the Securities Exchange Act of 1934, as amended and Section 1350 of Chapter 63 of Title 18
of the United States Code (18 U.S.C. § 1350). |
|
|
|
(1) |
|
Incorporated by reference to MannKinds registration statement on Form S-1 (File No.
333-115020), filed with the SEC on April 30, 2004, as amended. |
|
(2) |
|
Incorporated by reference to MannKinds quarterly report on Form 10-Q, filed with the SEC on
August 9, 2007. |
|
(3) |
|
Incorporated by reference to MannKinds current report on Form 8-K, filed with the SEC on
November 19, 2007. |
|
(4) |
|
Incorporated by reference to MannKinds registration statement on Form S-3 (File No.
333-138373) filed with the SEC on November 2, 2006. |
|
(5) |
|
Incorporated by reference to MannKinds current report on Form 8-K filed with the SEC on
December 12, 2006. |
36
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
Dated: August 2, 2010 |
MANNKIND CORPORATION
|
|
|
By: |
/s/ Matthew J. Pfeffer
|
|
|
|
Matthew J. Pfeffer |
|
|
|
Corporate Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
37