e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 |
For the quarterly period ended June 30, 2006
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
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13-3607736 |
(State or other jurisdiction of incorporation
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(I.R.S. Employer Identification No.) |
or organization) |
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28903 North Avenue Paine
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91355 |
Valencia, California
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(Zip Code) |
(Address of principal executive offices) |
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(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 is a large accelerated filer, an accelerated filer or
a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer 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 28, 2006, there were 49,701,099 shares of the registrants common stock, $.01 par value
per share, outstanding.
MANNKIND CORPORATION
Form 10-Q
For the Quarterly Period Ended June 30, 2006
TABLE OF CONTENTS
2
PART I: FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
MANNKIND CORPORATION AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(In thousands except share data)
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June 30, 2006 |
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December 31, 2005 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
27,056 |
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$ |
56,037 |
|
Marketable securities |
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23,800 |
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89,597 |
|
State research and development credit exchange receivable current |
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1,043 |
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|
1,194 |
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Prepaid expenses and other current assets |
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6,952 |
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|
3,044 |
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|
|
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Total current assets |
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58,851 |
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|
149,872 |
|
Property and equipment net |
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83,190 |
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76,183 |
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State research and development credit exchange receivable net of current portion |
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2,250 |
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|
2,031 |
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Other assets |
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288 |
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285 |
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Total |
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$ |
144,579 |
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$ |
228,371 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
2,586 |
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$ |
3,547 |
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Accrued expenses and other current liabilities |
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24,548 |
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17,818 |
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Total current liabilities |
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27,134 |
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21,365 |
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Other liabilities |
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24 |
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29 |
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Total liabilities |
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27,158 |
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21,394 |
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Commitments and contingencies |
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Stockholders equity: |
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Undesignated preferred stock, $0.01 par value 10,000,000 shares authorized; no
shares issued or outstanding at June 30, 2006 and December 31, 2005 |
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Common stock, $0.01 par value 90,000,000 shares authorized; 49,698,064 and
50,314,108 shares issued and outstanding at June 30, 2006 and December 31, 2005,
respectively |
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|
496 |
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|
503 |
|
Additional paid-in capital |
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|
772,536 |
|
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|
763,775 |
|
Deficit accumulated during the development stage |
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|
(655,611 |
) |
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|
(557,301 |
) |
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|
|
|
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Total stockholders equity |
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117,421 |
|
|
|
206,977 |
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|
|
|
|
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Total |
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$ |
144,579 |
|
|
$ |
228,371 |
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|
The accompanying notes are an integral part of these consolidated financial statements.
3
MANNKIND CORPORATION AND SUBSIDIARY
(A Development Stage Company)
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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2006 |
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2005 |
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2006 |
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2005 |
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2006 |
|
Revenue |
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$ |
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$ |
|
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|
$ |
100 |
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|
$ |
|
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$ |
2,958 |
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Operating expenses: |
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Research and development |
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45,321 |
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23,596 |
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81,271 |
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42,292 |
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379,671 |
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General and administrative |
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10,456 |
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3,971 |
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19,594 |
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7,922 |
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117,569 |
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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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|
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|
|
|
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|
|
|
|
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151,428 |
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|
|
|
|
|
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|
|
|
|
|
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Total operating expenses |
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|
55,777 |
|
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|
27,567 |
|
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|
100,865 |
|
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|
50,214 |
|
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668,394 |
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Loss from operations |
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(55,777 |
) |
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(27,567 |
) |
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(100,765 |
) |
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(50,214 |
) |
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(665,436 |
) |
Other income (expense) |
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59 |
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7 |
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|
109 |
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21 |
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(1,783 |
) |
Interest income |
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971 |
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405 |
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|
2,351 |
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|
877 |
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11,629 |
|
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|
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|
|
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|
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Loss before provision for
income taxes |
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(54,747 |
) |
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(27,155 |
) |
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(98,305 |
) |
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(49,316 |
) |
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|
(655,590 |
) |
Income taxes |
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(4 |
) |
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(5 |
) |
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(1 |
) |
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(21 |
) |
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|
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Net loss |
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(54,751 |
) |
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|
(27,155 |
) |
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(98,310 |
) |
|
|
(49,317 |
) |
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(655,611 |
) |
Deemed dividend related to
beneficial conversion feature
of convertible preferred
stock |
|
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|
|
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|
|
|
|
|
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(22,260 |
) |
Accretion on redeemable
preferred stock |
|
|
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|
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|
|
|
|
|
|
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(952 |
) |
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Net loss applicable to common
stockholders |
|
$ |
(54,751 |
) |
|
$ |
(27,155 |
) |
|
$ |
(98,310 |
) |
|
$ |
(49,317 |
) |
|
$ |
(678,823 |
) |
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|
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Net loss per share applicable
to common stockholders
basic and diluted |
|
$ |
(1.10 |
) |
|
$ |
(0.83 |
) |
|
$ |
(1.98 |
) |
|
$ |
(1.50 |
) |
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Shares used to compute basic
and diluted net loss per
share applicable to common
stockholders |
|
|
49,638 |
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32,777 |
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49,712 |
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32,771 |
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The accompanying notes are an integral part of these consolidated financial statements.
4
MANNKIND CORPORATION AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
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Cumulative |
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|
|
|
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|
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|
period from |
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|
|
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|
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|
February 14, |
|
|
|
|
|
|
|
|
|
|
|
1991 (date of |
|
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|
Six months ended |
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|
inception) to |
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|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(98,310 |
) |
|
$ |
(49,317 |
) |
|
$ |
(655,611 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
4,115 |
|
|
|
3,639 |
|
|
|
34,752 |
|
Stock-based compensation expense (benefit) |
|
|
7,497 |
|
|
|
(2,901 |
) |
|
|
30,015 |
|
Accrued interest on investments, net of amortization of premiums |
|
|
197 |
|
|
|
25 |
|
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|
51 |
|
(Gain)/loss on sale and abandonment/disposal of property and equipment |
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|
(14 |
) |
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(24 |
) |
|
|
3,353 |
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
19,726 |
|
Discount on stockholder notes below market rate |
|
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|
|
|
|
|
|
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|
241 |
|
Non-cash compensation expense of officer resulting from stockholder contribution |
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|
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70 |
|
Accrued interest expense on notes payable to stockholders |
|
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|
|
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|
1,538 |
|
Non-cash interest expense |
|
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|
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|
|
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|
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|
3 |
|
Accrued interest on notes |
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|
|
|
|
|
|
|
|
|
(747 |
) |
Goodwill impairment |
|
|
|
|
|
|
|
|
|
|
151,428 |
|
Loss on available-for-sale securities |
|
|
|
|
|
|
|
|
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|
229 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
State research and development credit exchange receivable |
|
|
(68 |
) |
|
|
1,180 |
|
|
|
(3,293 |
) |
Prepaid expenses and other current assets |
|
|
(3,908 |
) |
|
|
808 |
|
|
|
(6,952 |
) |
Other assets |
|
|
(3 |
) |
|
|
(142 |
) |
|
|
(288 |
) |
Accounts payable |
|
|
(962 |
) |
|
|
1,144 |
|
|
|
2,586 |
|
Accrued expenses and other current liabilities |
|
|
6,730 |
|
|
|
3,373 |
|
|
|
24,548 |
|
Other liabilities |
|
|
(5 |
) |
|
|
(33 |
) |
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|
21 |
|
Payment of deferred compensation |
|
|
|
|
|
|
(1,373 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(84,731 |
) |
|
|
(43,621 |
) |
|
|
(398,330 |
) |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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|
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|
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|
|
|
Purchase of marketable securities |
|
|
(23,950 |
) |
|
|
(69,550 |
) |
|
|
(426,668 |
) |
Sales of marketable securities |
|
|
89,550 |
|
|
|
58,195 |
|
|
|
402,590 |
|
Purchase of property and equipment |
|
|
(11,141 |
) |
|
|
(5,547 |
) |
|
|
(121,510 |
) |
Proceeds from sale of property and equipment |
|
|
32 |
|
|
|
90 |
|
|
|
214 |
|
Restricted cash |
|
|
|
|
|
|
565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
54,491 |
|
|
|
(16,247 |
) |
|
|
(145,374 |
) |
|
|
|
|
|
|
|
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CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock and warrants for cash |
|
|
1,259 |
|
|
|
433 |
|
|
|
494,510 |
|
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 |
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
period from |
|
|
|
|
|
|
|
|
|
|
|
February 14, |
|
|
|
|
|
|
|
|
|
|
|
1991 (date of |
|
|
|
Six months ended |
|
|
inception) to |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
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 |
|
Principal payments on notes payable |
|
|
|
|
|
|
|
|
|
|
(1,667 |
) |
Borrowings on notes payable |
|
|
|
|
|
|
|
|
|
|
3,460 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,259 |
|
|
|
433 |
|
|
|
570,760 |
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
(28,981 |
) |
|
|
(59,435 |
) |
|
|
27,056 |
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
|
|
56,037 |
|
|
|
78,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
27,056 |
|
|
$ |
19,552 |
|
|
$ |
27,056 |
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH FLOWS DISCLOSURES: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
5 |
|
|
$ |
1 |
|
|
$ |
21 |
|
Interest paid in cash |
|
|
|
|
|
|
|
|
|
|
80 |
|
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 |
|
Notes receivable by stockholder issued to officers |
|
|
|
|
|
|
|
|
|
|
|
|
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 |
) |
In connection with the Companys initial public offering, all shares of Series B and Series C
convertible preferred stock, in the amount of $15,000,000 and $50,000,000, respectively,
automatically converted into common stock in August 2004.
The accompanying notes are an integral part of these consolidated financial statements.
6
MANNKIND CORPORATION AND SUBSIDIARY
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Description of business and basis of presentation
The accompanying unaudited consolidated financial statements of MannKind Corporation (the
Company), have been prepared in accordance with generally accepted accounting principles in the
United States of America 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 generally
accepted accounting principles in the United States of America for complete financial statements.
These statements should be read in conjunction with the consolidated financial statements and notes
thereto included in the Companys latest audited annual financial statements. The audited
statements for the year ended December 31, 2005 are included in the Companys annual report on Form
10-K for the fiscal year ended December 31, 2005 filed with the SEC on March 16, 2006 (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 six and three months ended June 30, 2006 may not be
indicative of the results that may be expected for the full year.
The preparation of financial statements in conformity with accounting principles generally accepted
in the United States of America 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 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 MannKind Corporation is a biopharmaceutical company focused on the development and
commercialization of therapeutic products for diseases such as diabetes and cancer. The Companys
lead investigational product candidate, the Technosphere Insulin System, is currently in Phase 3
clinical trials in the U.S. and Europe to study its safety and efficacy in the treatment of
diabetes. The Technosphere Insulin System consists of the Companys proprietary dry-powder
Technosphere formulation of insulin that is inhaled deep into the lung using the Companys MedTone
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, 2006 the Company has reported accumulated net
losses of $655.6 million, which include a goodwill impairment charge of $151.4 million, and
negative cash flow from operations of $398.3 million. It is costly to develop therapeutic products
and conduct clinical trials for these products. On August 2, 2006, the Company entered into a loan
arrangement with its principal stockholder to borrow up to a total of $150.0 million in one or more
advances at any time through August 2, 2007 that the Companys cash balance falls below its
projected cash requirements for the subsequent three months, provided that each advance be no less
than $50.0 million. The Company borrowed $50.0 million under the loan arrangement on August 2,
2006. See Note 10 Subsequent Event.
The Company believes that this loan arrangement with its principal stockholder will enable the
Company to continue funding operations through the second quarter of 2007. 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.
Accordingly, the Company expects that it will need to raise additional capital, either through the
sale of equity and/or debt securities, a strategic business collaboration with a pharmaceutical
company or the establishment of other funding facilities, in order to continue the development and
commercialization of its Technosphere Insulin System and other product candidates and to support
its other ongoing activities. If planned operating results are not
achieved or the Company is not successful in raising additional
capital, management believes that planned expenditures could be
reduced or eliminated in a relatively short period to continue
activities, on a reduced basis.
7
Reclassifications Certain reclassifications have been made to the prior years financial
statements to conform to the 2006 presentation.
Segment Information In accordance with Statement of Financial Accounting Standards (SFAS) No.
131, Disclosures about Segments of an Enterprise and Related Information, operating segments are
identified as components of an enterprise about which separate discrete financial information is
available for evaluation by the chief operating decision-maker in making decisions regarding
resource allocation and assessing performance. To date, the Company has viewed its operations and
manages its business as one segment operating entirely in the United States of America.
2. Investment in securities
The following is a summary of the available-for-sale securities classified as current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
June 30, 2006 |
|
December 31, 2005 |
(in thousands) |
|
Cost basis |
|
Fair value |
|
Cost basis |
|
Fair value |
Auction rate municipal bonds |
|
$ |
23,800 |
|
|
$ |
23,800 |
|
|
$ |
89,597 |
|
|
$ |
89,597 |
|
The Companys policy is to maintain a highly liquid short-term investment portfolio. The
contractual maturities for auction rate municipal bonds at June 30, 2006 are between 22 and 40
years. Despite the long-term nature of their stated contractual maturities, the Company has the
ability to quickly liquidate these securities. Proceeds from the sale and maturities of
available-for-sale securities amounted to approximately $89.6 million and $58.2 million for the six
months ended June 30, 2006 and 2005, respectively, and $40.6 million and $24.7 million for the
three months ended June 30, 2006 and 2005, respectively. Gross realized gains and losses for
available-for-sale securities were insignificant for the three and six months ended June 30, 2006 and 2005.
Gross realized gains and losses for available-for-sale securities are recorded as other income
(expense). The cost of securities sold is based on the specific identification method. Unrealized
gains and losses for available-for-sale securities as of the periods presented in the table above
were not material.
3. Accounting for stock-based compensation
On January 1, 2006, the Company adopted the provisions of SFAS No. 123R (SFAS No. 123R),
Share-based Payment: an Amendment of FASB Statements No. 123 and 95, which is a revision of SFAS
No. 123 (SFAS No. 123), Accounting for Stock-Based Compensation. Prior to January 1, 2006, the
Company accounted for employee stock options and the employee stock purchase plan using the
intrinsic value method in accordance with Accounting Principles Board (APB) Opinion No. 25 (APB
No. 25), Accounting for Stock Issued to Employees, and adopted the disclosure only alternative of
SFAS No. 123. SFAS No. 123R eliminated the intrinsic value method of accounting for stock options
which the Company followed until December 31, 2005. Further, SFAS No. 123R requires all share-based
payments to employees, including grants of stock options and the compensatory elements of employee
stock purchase plans, to be recognized in the income statement based upon the fair value of the
awards at the grant date.
Upon adoption of SFAS No. 123R, the Company selected the modified prospective transition method
whereby unvested awards at the date of adoption as well as awards that are granted, modified, or
settled after the date of adoption will be measured and accounted for in accordance with SFAS No.
123R. Measurement and attribution of compensation cost for awards unvested as of January 1, 2006 is
based on the same estimate of the grant-date or modification-date fair value and the same
attribution method (straight-line) used previously under SFAS No. 123.
In the
three and six months ended June 30, 2006, the Company recorded stock-based compensation expense
of $3.8 million and $7.5 million, respectively, which
caused loss before provision for income taxes to increase by
$3.8 million and $7.5 million, respectively, and
basic and diluted net loss per share applicable to common stockholders to increase by $0.08 and $0.15 per
share, respectively. The following table presents stock-based compensation expense included in operating expenses
for the three and six months ended June 30, 2006 and the pro forma stock-based compensation amounts
that would have been included in the statements of operations for three and six months ended June
30, 2005 had stock-based compensation expense been determined in accordance with the fair value
method prescribed by SFAS No. 123:
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands, except per share data) |
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Stock-based employee compensation expense
determined under the fair value based method for all
awards |
|
$ |
3,578 |
|
|
$ |
3,873 |
|
|
$ |
7,051 |
|
|
$ |
7,143 |
|
Fair value of discount on employee stock purchase plan |
|
|
114 |
|
|
|
106 |
|
|
|
212 |
|
|
|
176 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based employee compensation expense |
|
$ |
3,692 |
|
|
$ |
3,979 |
|
|
$ |
7,263 |
|
|
$ |
7,319 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss as reported |
|
|
|
|
|
$ |
(27,155 |
) |
|
|
|
|
|
$ |
(49,317 |
) |
Add: Stock-based employee compensation expense
(benefit) included in reported net loss |
|
|
|
|
|
|
(2,460 |
) |
|
|
|
|
|
|
(3,180 |
) |
Deduct: Stock-based compensation expense determined
under fair value method |
|
|
|
|
|
|
(3,979 |
) |
|
|
|
|
|
|
(7,319 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss pro forma |
|
|
|
|
|
$ |
(33,594 |
) |
|
|
|
|
|
$ |
(59,816 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share (basic and diluted): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
|
|
|
|
$ |
(0.83 |
) |
|
|
|
|
|
$ |
(1.50 |
) |
Pro forma |
|
|
|
|
|
$ |
(1.03 |
) |
|
|
|
|
|
$ |
(1.83 |
) |
The fair value of each option is estimated on the grant date or modification date, if any, using
the Black-Scholes option valuation model. The variables used by the Company for the three and six
months ended June 30, 2006 and 2005 are disclosed in the following table. The risk-free rate for
periods within the contractual life of the option is based on the U.S. Treasury yield curve in
effect at the time of grant. The stock price volatility used is based on the historical volatility
of the stock of several of the Companys peers. The weighted average expected life is calculated
using the simplified method, which is defined in Staff Accounting Bulletin No. 107, Topic 14:
Share-based Payment, and is equal to one-half of the sum of the weighted average time to vest and
the options contractual term.
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free
interest
rate
|
|
4.96% |
|
3.66% |
|
4.59%-4.96%% |
|
3.43%-3.89% |
Dividend
yield
|
|
0% |
|
0% |
|
0% |
|
0% |
Volatility
factor
|
|
63% |
|
100% |
|
63% |
|
100% |
Weighted average
expected
life |
|
6.08 years |
|
4.00 years |
|
6.08 years |
|
4.00 years |
9
Total stock-based compensation expense (benefit) recognized in the accompanying statements of
operations is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Employee-related |
|
$ |
3,692 |
|
|
$ |
(2,460 |
) |
|
$ |
7,263 |
|
|
$ |
(3,180 |
) |
Non-Employee-related |
|
|
94 |
|
|
|
118 |
|
|
|
234 |
|
|
|
153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,786 |
|
|
$ |
(2,342 |
) |
|
$ |
7,497 |
|
|
$ |
(3,027 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Incentive Plan
The Companys 2004 Equity Incentive Plan (the Plan) provides for the granting of stock awards
including stock options and restricted stock units, to employees, directors and consultants.
The Companys board of directors determines eligibility, vesting schedules and exercise prices for
stock awards granted under the Plan. Options and other stock awards under the Plan expire not more
than ten years from the date of the grant and are exercisable upon vesting. Stock options generally
vest over four years. Current stock option grants vest and become exercisable at the rate of 25%
after one year and ratably on a monthly basis over a period of 36 months thereafter. Restricted
stock units generally vest over four years with consideration satisfied by service to the Company.
The Plan provides for full acceleration of vesting if an employee is terminated within thirteen
months of a change in control, as defined.
On February 16, 2006, the Company granted new hire stock options to purchase 153,480 shares of
common stock at an exercise price of $16.13 per share and granted 247,554 restricted stock units.
The options were valued at $10.03 per option share and restricted stock units were valued at $16.13
per share, which was the fair market value of the common stock on the grant date. The compensation
cost of the awards of approximately $5.1 million is being expensed over the requisite service
periods of the awards.
On May 25, 2006, the Companys board of directors approved new hire and promotion stock option
grants to purchase 221,330 shares of common stock at an exercise price of $17.00 per share. The
Companys board of directors also granted 177,703 restricted stock units. The options were valued
at $10.65 per option share and restricted stock units were valued at $17.00 per share, which was the fair
market value of the common stock on the grant date. The compensation cost of the awards of
approximately $5.4 million is being expensed over the requisite service periods of the awards.
In May 2006, the Companys stockholders approved an increase of 4.0 million shares in the number of
shares reserved under the Plan for future issuance. As of June 30, 2006, 4,291,127 options and
578,449 restricted stock units were outstanding under the Plan and an additional 3,805,176 shares
of common stock were available for issuance under the Plan.
During 2004, the Companys board of directors and stockholders approved the 2004 Non-Employee
Directors Stock Option Plan. The plan provides for the automatic, non-discretionary grant of
options to the Companys non-employee directors. Options to purchase 70,000 shares of common stock
were automatically granted on May 25, 2006, the day of the annual stockholders meeting, to
non-employee directors pursuant to the 2004 Non-Employee Directors Stock Option Plan. The
corresponding compensation cost of the awards approximated $0.7 million, which is being expensed
over the requisite service periods of the awards. As of June 30, 2006, 337,500 options were
outstanding under the plan and an additional 462,500 shares of common stock were available for
issuance under the plan.
The Company has two other stock award plans: the 1991 Stock Option Plan (the 1991 Plan) and the
1999 Stock Plan (the 1999 Plan). Both of these plans provide for the granting of stock options to
directors, employees and consultants. As of June 30, 2006, 73,084 options were outstanding under
the 1991 Plan and 170,695 options were outstanding under the 1999 Plan. There were no additional
shares available for issuance under the 1991 Plan or the 1999 Plan at June 30, 2006.
Prior to the merger of CTL and AlleCure into the Company, CTL had granted options to purchase
shares of its common stock under its 2000 Stock Option and Stock Plan (the CTL Plan). Similarly,
AlleCure had granted options to purchase shares of its common stock under its 2000 Stock Option and
Stock Plan (the AlleCure Plan). Pursuant to the plans of reorganization and agreements of merger
between the Company and each of CTL and AlleCure, the Company has assumed the obligation to issue
shares of the Companys common stock,
at the exchange ratio agreed to in the merger agreement, upon the exercise of options granted under
the CTL Plan and the AlleCure Plan. After the merger date, no further options were granted under
either the CTL Plan or AlleCure Plan. As of June 30, 2006 there were an aggregate of 45,801 options
outstanding under these plans.
10
During the year ended December 31, 2002, the Companys board of directors granted 240,972
options at an exercise price of $25.23 per share to an employee who is the principal stockholder.
The options vest annually over four years. These options, which were not under any plan, were
outstanding at June 30, 2006 and are included in the tables below.
A summary
of option activity as of March 31, 2006 and June 30, 2006,
and changes during each of the three months ended March 31, 2006
and June 30, 2006, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
Number |
|
|
Exercise |
|
|
Remaining |
|
|
Aggregate |
|
|
|
of |
|
|
Price Per |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Share |
|
|
Term (Years) |
|
|
Value ($000) |
|
Outstanding at January 1, 2006 |
|
|
4,985,831 |
|
|
$ |
12.40 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
153,480 |
|
|
|
16.13 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(59,878 |
) |
|
|
9.41 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(93,120 |
) |
|
|
12.79 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(37,903 |
) |
|
|
19.97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2006 |
|
|
4,948,410 |
|
|
|
12.48 |
|
|
|
7.3 |
|
|
$ |
39,389 |
|
Granted |
|
|
291,330 |
|
|
|
17.00 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(17,685 |
) |
|
|
10.74 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(53,412 |
) |
|
|
14.84 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(9,461 |
) |
|
|
11.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2006 |
|
|
5,159,182 |
|
|
|
12.72 |
|
|
|
7.2 |
|
|
$ |
44,321 |
|
Exercisable at June 30, 2006 |
|
|
2,180,972 |
|
|
|
11.81 |
|
|
|
|
|
|
|
|
|
11
A summary
of restricted stock units activity as of
March 31, 2006 and June 30, 2006, and changes during
each of the three months ended March 31, 2006 and June 30, 2006, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
Number |
|
|
Grant Date |
|
|
Remaining |
|
|
Aggregate |
|
|
|
of |
|
|
Fair Value |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Per Share |
|
|
Term (Years) |
|
|
Value ($000) |
|
Outstanding at January 1, 2006 |
|
|
164,901 |
|
|
$ |
11.00 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
247,554 |
|
|
|
16.13 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(6,719 |
) |
|
|
11.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2006 |
|
|
405,736 |
|
|
$ |
14.12 |
|
|
|
9.6 |
|
|
$ |
8,293 |
|
Granted |
|
|
177,703 |
|
|
|
17.00 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(4,990 |
) |
|
|
13.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2006 |
|
|
578,449 |
|
|
|
15.02 |
|
|
|
9.5 |
|
|
$ |
12,327 |
|
Exercisable at June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
weighted-average grant-date fair value per share of options granted during the three months ended June
30, 2005 and 2006 was $8.83 and $10.65, respectively. The total intrinsic value of options
exercised during the three months ended June 30, 2005 and 2006 was approximately $0.1 million and
$0.2 million, respectively. The total fair value of options vested during the three months ended
June 30, 2006 and 2005 was $2.3 million and $2.3 million, respectively. Cash received from the
exercise of options during the three months ended June 30, 2006 and 2005 was approximately $0.2
million and $0.1 million, respectively.
A summary of the status of the Companys nonvested shares, excluding restricted stock units, as of
March 31, 2006 and June 30, 2006, and changes during each of the three months ended March 31, 2006 and June 30, 2006,
is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
Number |
|
|
Grant Date |
|
|
|
of |
|
|
Fair Value |
|
|
|
Shares |
|
|
Per Share |
|
Nonvested at January 1, 2006 |
|
|
3,048,631 |
|
|
$ |
13.06 |
|
Granted |
|
|
153,480 |
|
|
|
10.03 |
|
Vested |
|
|
(151,504 |
) |
|
|
12.86 |
|
Forfeited |
|
|
(93,120 |
) |
|
|
12.79 |
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2006 |
|
|
2,957,487 |
|
|
|
12.74 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
291,330 |
|
|
|
10.65 |
|
Vested |
|
|
(217,194 |
) |
|
|
13.99 |
|
Forfeited |
|
|
(53,413 |
) |
|
|
14.84 |
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2006 |
|
|
2,978,210 |
|
|
|
13.09 |
|
|
|
|
|
|
|
|
|
A summary
of the status of the Companys restricted stock units, as
of March 31, 2006 and June 30, 2006, and changes
during each of the three months ended March 31, 2006 and June 30, 2006, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
Number |
|
|
Grant Date |
|
|
|
of |
|
|
Fair Value |
|
|
|
Shares |
|
|
Per Share |
|
Nonvested at January 1, 2006 |
|
|
164,901 |
|
|
$ |
11.00 |
|
Granted |
|
|
247,554 |
|
|
|
16.13 |
|
Forfeited |
|
|
(6,719 |
) |
|
|
11.41 |
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2006 |
|
|
405,736 |
|
|
|
14.12 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
177,703 |
|
|
|
17.00 |
|
Forfeited |
|
|
(4,990 |
) |
|
|
13.06 |
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2006 |
|
|
578,449 |
|
|
|
15.02 |
|
|
|
|
|
|
|
|
|
As of June 30, 2006, there was $21.1 million and $6.9 million of unrecognized compensation cost
related to options and restricted stock units, respectively, which is expected to be recognized
over the weighted average vesting period of 2.7 years.
In March 2004, the Companys board of directors approved the 2004 Employee Stock Purchase Plan. The
aggregate number of shares that may be sold under the plan is 2,000,000 shares of common stock. On
January 1 of each year, for a period of ten years beginning
12
January 1, 2005, the share reserve automatically increases by the lesser of: 700,000 shares, 1% of
the total number of shares of common stock outstanding on that date, or an amount as may be
determined by the board of directors. However, under no event can the annual increase cause the
total number of shares reserved under the purchase plan to exceed 10% of the total number of shares
of capital stock outstanding on December 31 of the prior year. On January 1, 2005 and 2006, the
purchase plan share reserve was increased by 327,562 and 503,141 shares, respectively. For the six
months ended June 30, 2005 and 2006, the Company sold 28,878 and 50,894, respectively, of its
common stock to employees participating in the plan.
4. 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 and warrants, that
are not included in the diluted net loss per share calculation consisted of an aggregate of
5,750,067 shares and 4,497,904 shares as of June 30, 2006 and 2005, respectively.
5. State research and development credit exchange receivable
The State
of Connecticut provides certain companies with the opportunity to
exchange eligible
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, 2006, the estimated
amount receivable under the program was $3.6 million.
6. Property and equipment
Property and equipment consist of the following (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
|
|
Useful |
|
|
|
|
|
|
|
|
|
Life |
|
|
|
|
|
|
|
|
|
(years) |
|
|
June 30, 2006 |
|
|
December 31, 2005 |
|
Land |
|
|
|
|
|
$ |
5,273 |
|
|
$ |
5,273 |
|
Buildings |
|
|
39-40 |
|
|
|
9,566 |
|
|
|
9,566 |
|
Building improvements |
|
|
5-40 |
|
|
|
43,480 |
|
|
|
39,543 |
|
Machinery and equipment |
|
|
3-10 |
|
|
|
25,901 |
|
|
|
23,087 |
|
Furniture, fixtures and office equipment |
|
|
5-10 |
|
|
|
2,930 |
|
|
|
2,573 |
|
Computer equipment and software |
|
|
3 |
|
|
|
5,382 |
|
|
|
4,808 |
|
Leasehold improvements |
|
|
|
|
|
|
36 |
|
|
|
5 |
|
Construction in progress |
|
|
|
|
|
|
13,560 |
|
|
|
10,298 |
|
Deposits on equipment |
|
|
|
|
|
|
6,528 |
|
|
|
6,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,656 |
|
|
|
101,564 |
|
Less accumulated depreciation and amortization |
|
|
|
|
|
|
(29,466 |
) |
|
|
(25,381 |
) |
|
|
|
|
|
|
|
|
|
|
|
Property and equipment net |
|
|
|
|
|
$ |
83,190 |
|
|
$ |
76,183 |
|
|
|
|
|
|
|
|
|
|
|
|
7 Common and preferred stock
The Company is authorized to issue 90,000,000 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, 2006 and December 31, 2005, 49,698,064 and 50,314,108 shares of common
stock, respectively, were issued and outstanding. No shares of preferred stock were issued and
outstanding at June 30, 2006 and December 31, 2005.
Registration rights The holders of 17,132,000 shares of common stock together with warrants to
purchase up to 3,426,000 shares of common stock, all of which were issued in the August 2005
private placement, have rights that require the Company to keep the
13
registration of the shares of common stock purchased in the private placement or underlying
warrants continuously effective until at least August 2007.
As of June 30, 2006 the holders of 916,715 shares of the Companys common stock and the holders of
warrants to purchase 12,436 shares of the Companys common stock have rights, subject to some
conditions, to require the Company to file registration statements covering their shares or to
include their shares in registration statements that the Company may file for itself or other
stockholders.
8. Warrants
During 1995 and 1996, the Company issued warrants to purchase shares of common stock. The warrants
range in exercise price from $12.53 to $12.70 per share and expire at various dates through 2007.
The warrants contain provisions for the adjustment of the exercise price and the number of shares
issuable upon the exercise of the warrant in the event the Company declares any stock dividends or
effects any stock split, reclassification or consolidation of its common stock. The warrants also
contain a provision that provides for an adjustment to the exercise price and the number of shares
issuable in the event that the Company issues securities for a per share price less than a
specified price. As of June 30, 2006, warrants to purchase 12,436 shares of common stock at a
weighted average exercise price of $12.66 per share are outstanding and exercisable.
In connection with the sale of common stock in the private placement which closed on August 5,
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 on February 1, 2006
and expire in August 2010. In the three months ended March 31, 2006, warrants for 979 shares were
exercised for approximately $12,000 and 98,441 shares were issued upon the cashless warrant
exercise of 254,528 warrant shares.
9. Commitments and contingencies
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 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. No
such losses have been recorded to date.
Litigation The Company is involved in various legal proceedings and other matters. In accordance
with SFAS No. 5, Accounting for Contingencies, the Company would record a provision for a liability
when it is both probable that a liability has been incurred and the amount of the loss can be
reasonably estimated.
In May 2005, the Companys former Chief Medical Officer filed a complaint against the Company in
the California Superior Court, County of Los Angeles, Wayman Wendell Cheatham, M.D. v. MannKind
Corporation, Case No. BC333845. The complaint alleges causes of action for wrongful termination in
violation of public policy, breach of contract and retaliation, in connection with the Companys
termination of Dr. Cheathams employment. In the complaint, Dr. Cheatham seeks compensatory,
punitive and exemplary damages in excess of $2.0 million as well as reimbursement of attorneys
fees. In June 2005, the Company answered the complaint, generally denying each of Dr. Cheathams
allegations and asserting various defenses. The Company believes the allegations in the complaint
are without merit and is vigorously defending against them. The Company also filed a
cross-complaint against Dr. Cheatham, alleging claims for libel per se, trade libel, breach of
contract, breach of the implied covenant of good faith and fair dealing and breach of the duty of
loyalty. The libel claims allege that Dr. Cheatham made certain false and malicious statements
about the Company in a letter to the Food and Drug Administration (FDA) with regard to a request
by the Company to hold a meeting with the FDA. The remaining causes of action in the
cross-complaint arise out of the Companys allegations that Dr. Cheatham had an undisclosed
consulting relationship with a Company competitor during his employment with the Company, in
violation of his agreement with the Company. In July 2005, Dr. Cheatham filed a demurrer, and a
motion to strike the Companys cross-complaint under Californias anti-SLAPP statute. In September
2005, the California Superior Court overruled Dr. Cheathams demurrer and denied his motion to
strike the Companys cross-complaint. Dr. Cheatham has appealed the Courts ruling denying his
motion to strike. Discovery as to Dr. Cheathams claims against the Company is proceeding, and this
case is currently scheduled for trial to
14
commence in February 2007. The Company believes that the ultimate resolution of this matter will
not have a material impact on the Companys financial position or results of operations.
10. Subsequent Event
On August 2, 2006 the Company entered into a loan arrangement with its principal stockholder to
borrow up to a total of $150.0 million in one or more advances at any time through August 2, 2007
that the Companys cash balance falls below its projected cash requirements for the subsequent
three month period, provided that each advance be no less than $50.0 million. The Company
borrowed $50.0 million under the loan arrangement on August 2, 2006. Interest accrues on
each outstanding advance at a rate equal to the one year LIBOR rate in effect on the day of such
advance plus 3% per annum and is payable quarterly in arrears. The loan
is unsecured and contains no financial covenants. There are no
warrants associated with the loan nor is the loan convertible into the
Company's stock. In the event of a default, all unpaid principal and
interest becomes immediately due and payable and the interest rate
increases to one year LIBOR calculated on the date of the initial
advance or in effect on the date of default, whichever is greater,
plus 5% per annum. Upon the closing of certain
financing events, including equity and debt financings or strategic transactions with third
parties, in which the Company receives cash proceeds of at least $100.0 million, the Company is
required to repay all or a portion of the principal and accrued and unpaid interest under the note
equal to the difference between the Companys cash balance immediately following the financing
event and its projected cash requirements for the six month period following the financing event.
15
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 (this Quarterly
Report). The interim 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, 2005 and the related Managements Discussion
and Analysis of Financial Condition and Results of Operations, both of which are contained in our
Annual Report on Form 10-K filed pursuant to Section 13 of the Securities Exchange Act of 1934.
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
MannKind Corporation is a biopharmaceutical company focused on the discovery, development and
commercialization of therapeutic products for diseases such as diabetes and cancer. Our lead
investigational product candidate, the Technosphere Insulin System, is currently in Phase 3
clinical trials in the United States and Europe to study its safety and efficacy in the treatment
of diabetes. This therapy consists of a proprietary dry powder formulation of insulin that is
inhaled into the deep lung using our proprietary inhaler. We believe that the performance
characteristics, unique kinetics, convenience and ease of use of the Technosphere Insulin System
may have the potential to change the way diabetes is treated.
In particular, we have observed in our clinical trials to date that the Technosphere Insulin System
produces a profile of insulin levels in the bloodstream that approximates the insulin profile
normally seen in healthy individuals immediately following the beginning of a meal, but which is
absent in all patients with diabetes. As a result, we believe that our Technosphere Insulin System
will be beneficial not only for insulin-using diabetes patients but also for patients with type 2
diabetes who are currently using conventional therapies other than insulin. If further clinical
trials support our initial observations, we believe the Technosphere Insulin System has the
potential to be indicated for the treatment of type 2 diabetes after a patient has failed to
respond adequately to diet and exercise. The use of insulin early in the progression of diabetes
would represent a paradigm shift in the treatment of this disease.
In a Phase 2 clinical trial conducted in the United States, the use of Technosphere Insulin at
mealtimes significantly lowered blood glucose levels in patients with type 2 diabetes who
previously were experiencing inadequate control of their disease. Even in patients with only mildly
elevated blood glucose levels, we observed in this study that the typical risks of frequent or
severe hypoglycemia generally associated with insulin therapy appear not to be associated with
Technosphere Insulin, suggesting that our therapy may have a potential safety advantage over other
currently available insulin therapies. In a European Phase 2 dosage-tolerance study, Technosphere
Insulin was observed to improve glycemic control in a dose-dependent manner as measured by
decreases in HbA1c levels and by reductions in glucose excursions following a meal. In addition,
there was no indication of a negative effect on pulmonary function and no weight gain at any dose
of Technosphere Insulin over 12 weeks of treatment.
Currently, we are enrolling patients in four major Phase 3 clinical trials, including a two-year
pulmonary safety study that will compare the pulmonary function of patients with type 1 or type 2
diabetes randomized to either Technosphere Insulin or standard diabetes care. Based on our
discussions with the Food and Drug Administration (the FDA), we plan to accumulate two years of
controlled safety data from patients with type 1 diabetes as well as patients with type 2 diabetes
before we file a new drug application for the Technosphere Insulin System. We anticipate that our
entire clinical trial program will involve more than 3,200 patients. Larger populations and longer
durations of exposure may be necessary depending on the safety profile of our product.
Our Technosphere Insulin System utilizes our proprietary Technosphere formulation technology, which
is based on a class of organic molecules that are designed to self-assemble into small particles
onto which drug molecules can be loaded. We are also developing additional Technosphere-based
products for the delivery of other drugs. We plan to initiate Phase 1
clinical trials of a
therapeutic cancer vaccine by the end of 2006.
We are a development stage enterprise and have incurred significant losses since our inception in
1991. As of June 30, 2006, we have incurred a cumulative net loss of $655.6 million. To date, we
have not generated any product revenues and have funded our operations primarily through the sale
of equity securities.
16
We do not anticipate sales of any product prior to regulatory approval and commercialization of our
Technosphere Insulin System. 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 and
increasing expenditures and to incur additional operating losses for at least the next several
years as we:
|
|
|
continue the clinical development and commercialization of our Technosphere Insulin
System for the treatment of diabetes; |
|
|
|
|
expand our manufacturing operations for our Technosphere Insulin System to meet our
currently anticipated commercial production needs; |
|
|
|
|
expand our other research, discovery and development programs; |
|
|
|
|
expand our proprietary Technosphere platform technology and develop additional
applications for the pulmonary delivery of other drugs; and |
|
|
|
|
enter into sales and marketing collaborations with other companies, if available on
commercially reasonable terms, or develop these capabilities ourselves. |
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.
CLINICAL DEVELOPMENT ACTIVITIES
The Technosphere Insulin System
We are currently conducting a number of studies of the safety and efficacy of the Technosphere
Insulin System, including the following trials that are underway or planned for 2006:
Study 010
This ongoing trial is a three-year evaluation of the safety and tolerability of Technosphere
Insulin in patients with type 2 diabetes who have participated in study 008 or study 005. The
primary objective is to evaluate pulmonary function with secondary objectives to examine changes in
HbA1c levels, insulin antibodies, frequency of adverse events and quality of life.
Study 030
This is a two-year, prospective, multi-site study that incorporates two design strategies. The
first component is a randomized, open-label trial comparing pulmonary function in two groups of
patients with diabetes. One group of approximately 625 patients is being treated with Technosphere
Insulin in combination with other antidiabetic therapy and the other group of approximately 625
patients is being treated with existing oral and/or injectable therapies. The second component is a
comparison of pulmonary function in the patients with diabetes who are not treated with
Technosphere Insulin to a group of 125 subjects without any abnormalities in glucose control.
Enrollment for this study began in June 2005 and is expected to be completed later in 2006.
Study 014
This study compared the efficacy of mealtime use of Technosphere Insulin plus basal insulin to
mealtime use of rapid-acting, subcutaneous insulin plus basal insulin in approximately 240 patients
with type 2 diabetes who had a baseline HbA1c level greater than 7.0% and less than 11.5%. The
primary efficacy endpoint for this study was mean change in HbA1c levels from baseline to treatment
week 24. Enrollment was completed in July 2005 and the treatment period completed in February 2006.
We plan to present data from Study 014 at the European Association for the Study of Diabetes in
September.
Study 101
This trial compared mealtime use of Technosphere Insulin to mealtime use of rapid-acting,
subcutaneous insulin in 110 patients with type 1 diabetes, who were evaluated over a 12-week
period. The primary efficacy endpoint was the change in blood glucose levels
17
following a standard meal. In April 2006 we announced that this was the first study that
demonstrated that patients with Type 1 diabetes using Technosphere Insulin can achieve comparable
levels of control in HbA1c as patients treated with an injected rapid-acting insulin analog.
Technosphere Insulin has a more rapid onset of action and a shorter duration of action than the
injected rapid-acting insulin analog. In this study, the peak of the mean blood glucose values
following a standardized meal test were lower for patients on Technosphere Insulin than those
receiving injections of rapid-acting insulin analog. The study also found that patients using
Technosphere Insulin did not gain weight during the study in contrast to patients using the
injected rapid-acting insulin analog. Furthermore, after twelve weeks of treatment, pulmonary
function did not differ between the two patient groups.
Study 009
This study will evaluate Technosphere Insulin to prandial insulin analog both used in combination
with basal insulin in approximately 500 patients with type 1 diabetes for a 12-month period.
Efficacy will be evaluated on the basis of changes in HbA1c levels as well as changes in blood
glucose levels after a standardized mixed meal. We began enrolling patients in this study in the
first quarter of 2006.
Study 102
This study will compare the efficacy of mealtime use of Technosphere Insulin together with basal
insulin to the twice-daily use of premixed insulin, a mixture of intermediate acting insulin and a
rapid-acting insulin analog, in a population of approximately 500 patients with type 2 diabetes.
Efficacy will be evaluated on the basis of changes in HbA1c levels as well as changes in blood
glucose levels after a standardized mixed meal. We began enrolling patients in this study in the
first quarter of 2006.
Study 103
This study will evaluate the efficacy of Technosphere Insulin alone and in combination with
metformin, an oral medication, in approximately 500 patients with type 2 diabetes who are not
achieving desired glucose control with a combination of metformin and sulphonylurea, another oral
medication. Efficacy will be evaluated on the basis of changes in HbA1c levels after 26 weeks of
treatment as well as changes in blood glucose levels after a standardized mixed meal. We began enrolling patients in this study in the second quarter of 2006.
Special population studies
We have two ongoing special population studies: one examining the impact of asthma and the other
examining the impact of chronic smoking on the pharmacokinetics associated with Technosphere
Insulin. We plan to use the results of these studies to conduct safety studies in patients with
asthma and in chronic smokers that also have diabetes. We also plan to conduct a safety study in
patients with both diabetes and chronic obstructive pulmonary disease. Other special population
studies include a trial that will examine the elimination of Technosphere Insulin in patients with
kidney disease and a trial that will examine the effect of Technosphere Insulin in patients with
liver disease.
Cancer immunotherapy program
We are also developing therapies for the treatment of solid tumor cancers. The lead product
candidate in this program, MKC1106, is intended for the treatment of several solid-tumor cancers,
including ovarian, colorectal, pancreatic, renal, breast and prostate carcinomas. We plan to
commence clinical trials for MKC1106 late in the fourth quarter of 2006.
Our cancer therapy program utilizes the bodys immune system to help eradicate tumor cells. The
immune system is a network of cells and organs that defends the body against infection and abnormal
cells, such as cancer. A key element of the immune system is its ability to distinguish between
healthy cells and foreign or diseased cells that do not belong in the body. The immune system
accomplishes this task by recognizing distinctive molecules called epitopes found on the surface of
each cell as either normal or abnormal, and responding to them appropriately. Any substance capable
of triggering an immune response is known as an antigen. An antigen can be all or part of a
pathogenic organism or it can be a by-product of diseased cells. Certain specialized cells of the
immune system sample antigens present in the body and present the epitopes associated with foreign
antigens to other cells of the immune system whose function is to destroy any cell that expresses
the same epitope; this is known as cell-mediated immunity. In this way, the immune system can
launch a very specific response to infection or disease.
Our approach uses DNA- and peptide-based compounds that correspond to tumor-associated antigens
that are expressed in a range of solid-tumor cancers. A patient is first primed by DNA-based
compounds, or plasmids, that are injected directly into the patients lymph nodes. This is designed
to sensitize the immune system to the tumor-associated antigens encoded by the plasmids. After a
18
period of time, the patients lymph nodes are then injected with synthetic peptides that are
designed to boost or greatly amplify the immune response to the target antigens. This prime-boost
regimen is designed to provoke a potent cell-mediated immune response that destroys cancer cells
along with the underlying blood supply to a tumor.
We believe that our therapeutic approach addresses several deficiencies inherent in earlier
approaches to cancer immunotherapy, including:
|
|
|
Specificity. We target cancer epitopes to which the immune system has not developed a
tolerance, instead of targeting the dominant epitopes expressed by cancerous cells, many of
which are tolerated by the immune system. We have developed technology designed to identify
the non-tolerated epitopes on the cancer cell surface, and we have developed a method of
modifying these epitopes that is designed to activate an immune response. Through this
process, we believe that the bodys tolerance of the cancer cells can be broken, leading to
the destruction of the cancer by the immune system. |
|
|
|
|
Administration. In contrast to the conventional subcutaneous or intramuscular route of
administration, our compounds are delivered directly into the patients lymph nodes, where
studies have shown they will have the greatest impact. We believe that the direct delivery
of our compounds will bring local high concentrations of the active components of our
compounds into contact with high concentrations of the cells needed to generate a potent
cell-mediated immune response. |
|
|
|
|
Selectivity, potency and duration of response. We deliver our therapeutic compounds in a
manner that we believe primes the immune system to respond to cancer cells expressing
specific epitopes, in much the same way that a chronic infection evokes a progressively
increased immune response to invading bacteria. Our administrative regimen is designed to
boost the immune response over the course of a treatment cycle so that it becomes
increasingly potent and long acting. |
RESEARCH AND DEVELOPMENT EXPENSES
Our research and development expenses consist mainly of costs associated with the clinical trials
of our product candidates which 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, 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.
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 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 the Technosphere Insulin System through Phase 3 clinical trials and
regulatory filings. We plan to commercialize our lead product as a treatment for diabetes. 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 the Technosphere Insulin System, we are unable to
estimate with any certainty the costs we will incur in the continued development of our product
candidates for commercialization. The costs required to complete the development of our
Technosphere Insulin System will be largely dependent on the scope of our clinical trials, the cost
and efficiency of our manufacturing process and discussions with the FDA on its requirements. We
anticipate that our research and development expenses, particularly for the Technosphere Insulin
System, will increase significantly with the continuation of existing clinical trials, the
initiation of new trials, the resulting manufacturing costs associated with producing clinical
trial materials, and the expansion, qualification and validation of our commercial manufacturing
processes and facilities. Additionally, we expect non-cash stock-based compensation expense
resulting from the adoption of SFAS No. 123R, Share-based Payment: an Amendment of FASB Statement
123 and 95 (SFAS No. 123R), effective as of
January 1, 2006, to be higher in future periods as compared to
periods prior to January 1, 2006. See
Critical Accounting Policies below and Note 3 Accounting for Stock-Based Compensation in the
notes to our financial statements.
19
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
business insurance and professional services costs.
We expect general and administrative expenses other than non-cash stock-based compensation expense
to increase slightly in the future as a result of increased headcount, public company compliance
and establishment of investor relations and marketing programs. We expect overall general and
administrative expenses to be higher in future periods as compared to
periods prior to the adoption of SFAS No. 123R. See Critical Accounting Policies
below and Note 3 Accounting for Stock-Based Compensation in the notes to our financial
statements.
CRITICAL ACCOUNTING POLICIES
Other than the adoption of SFAS No. 123R, there have been no material changes to our critical
accounting policies as described in Item 7 to our Annual Report.
Stock-based Compensation
Prior to January 1, 2006, we accounted for employee stock options and the employee stock purchase
plan using the intrinsic value method in accordance with APB No. 25 and adopted the disclosure only
alternative of SFAS No. 123. Upon adoption of SFAS No. 123R, we selected the modified prospective
transition method whereby we recognized share-based employee costs from the beginning of 2006 as if
the fair value accounting method had been used to account for all employee awards granted,
modified, or settled after January 1, 2006 and to any awards that were not fully vested as of
January 1, 2006. The measurement and attribution of compensation cost for awards that are unvested
as of January 1, 2006 are based on the same estimate of the grant-date and the same attribution
method used previously under SFAS No. 123. Including the effects of adoption of SFAS No. 123R, we
recognized stock-based compensation expense of $7.5 million for the six months ended June 30, 2006.
We expect expensing of stock-based compensation will continue to have an impact on our statement of
operations. As of June 30, 2006, there was $21.1 million and $6.9 million of unrecognized
compensation cost related to options and restricted stock units, respectively, granted by the
Company which is expected to be recognized over the weighted average vesting period of 2.7 years.
RESULTS OF OPERATIONS
The discussion and analysis of our financial condition and results of operations for the three
months ended June 30, 2006 and 2005 are based upon our consolidated interim financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United
States of America. The preparation of these consolidated financial statements requires us to make
estimates and judgments that affect the reported amount of assets, liabilities, revenues and
expenses, and as a result, actual condition or results may differ from our estimates under
different assumptions or conditions.
Revenues
During the six months ended June 30, 2006, we recognized $0.1 million in revenue under a license
agreement. There were no revenues recorded for the six months ended June 30, 2005. We do not
anticipate sales of any product prior to regulatory approval and commercialization of our
Technosphere Insulin System.
Research and Development Expense
The following table provides a comparison of the research and development expense categories for
the three and six months ended June 30, 2006 and 2005 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
Clinical |
|
$ |
28,092 |
|
|
$ |
12,768 |
|
|
$ |
15,324 |
|
|
|
120 |
% |
Manufacturing |
|
|
8,906 |
|
|
|
6,021 |
|
|
|
2,885 |
|
|
|
48 |
% |
Research |
|
|
6,708 |
|
|
|
5,350 |
|
|
|
1,358 |
|
|
|
25 |
% |
Stock-based compensation expense |
|
|
1,615 |
|
|
|
(543 |
) |
|
|
2,158 |
|
|
|
397 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
45,321 |
|
|
$ |
23,596 |
|
|
$ |
21,725 |
|
|
|
92 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
Clinical |
|
$ |
46,762 |
|
|
$ |
21,596 |
|
|
$ |
25,166 |
|
|
|
117 |
% |
Manufacturing |
|
|
18,129 |
|
|
|
11,269 |
|
|
|
6,860 |
|
|
|
61 |
% |
Research |
|
|
13,126 |
|
|
|
9,937 |
|
|
|
3,189 |
|
|
|
32 |
% |
Stock-based compensation expense |
|
|
3,254 |
|
|
|
(510 |
) |
|
|
3,764 |
|
|
|
738 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
81,271 |
|
|
$ |
42,292 |
|
|
$ |
38,979 |
|
|
|
92 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
increase in research and development expenses for the three and six months ended June 30, 2006, as
compared to the same periods in the prior year was primarily due to ongoing expenses related to the
clinical development of our Technosphere Insulin System. The expansion of our Phase 3 clinical
trial program for our Technosphere Insulin System and the continuation of other preclinical studies
increased our clinical research expenditures in 2006 as compared to the same period in 2005. This
also resulted in increased Technosphere Insulin manufacturing costs to supply clinical trial
materials. We also continue to expand our qualification and validation of our manufacturing system.
Additionally, research activities related to toxicology studies for our Technosphere Insulin
System, expanding our proprietary Technosphere platform technology, developing additional
applications for the pulmonary delivery of other drugs and the discovery and development of
programs primarily focused on cancer therapies resulted in increased research expenditures. We
anticipate that our research and development expenses associated with our Technosphere Insulin
System, expanding our Technosphere platform technology and the pursuit of cancer therapies will
continue to increase in 2006. Specifically, we anticipate increased expenses related to the
continuation of existing and initiation of new clinical trials, and the resulting manufacturing
costs associated with producing clinical trial materials.
The
increase in stock-based compensation expense for the three and six
months ended June 30, 2006 compared
to the same periods in the prior year primarily resulted from the adoption of SFAS No. 123R which
requires all share-based payments to employees, including grants of stock options and the
compensatory elements of employee stock purchase plans, to be recognized in the income statement
based upon the fair value of the awards at the grant date. As described in the Critical Accounting
Policies above, we have adopted SFAS No. 123R as of the effective date of January 1, 2006. As a result
of our adoption of SFAS No. 123R, we expect non-cash stock-based
compensation expense to be higher in future periods as compared to
periods prior to January 1, 2006. See Note 3 Accounting for Stock-Based Compensation in the footnotes
to our financial statements.
General and Administrative Expense
The following table provides a comparison of the general and administrative expense categories for
the three and six months ended June 30, 2006 and 2005 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
Salaries, employee related and other general expenses |
|
$ |
8,285 |
|
|
$ |
5,644 |
|
|
$ |
2,641 |
|
|
|
47 |
% |
Stock-based compensation expense |
|
|
2,171 |
|
|
|
(1,673 |
) |
|
|
3,844 |
|
|
|
230 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
$ |
10,456 |
|
|
$ |
3,971 |
|
|
$ |
6,485 |
|
|
|
163 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Salaries, employee related and other general expenses |
|
$ |
15,351 |
|
|
$ |
10,312 |
|
|
$ |
5,039 |
|
|
|
49 |
% |
Stock-based compensation expense |
|
|
4,243 |
|
|
|
(2,391 |
) |
|
|
6,635 |
|
|
|
277 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
$ |
19,594 |
|
|
$ |
7,921 |
|
|
$ |
11,673 |
|
|
|
147 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses for the three and six months ended June 30, 2006 increased as
compared to the same period in the prior year. Increased administrative services resulted in
increased headcount, compensation adjustments and other employee
21
related expenses. Additionally, litigation, public company compliance (including the Sarbanes-Oxley
Act) and our establishment of a marketing function in late 2005 increased both professional fees and
consulting expenses. Stock-based compensation expense also increased for the three and six months
ended June 30, 2006 compared to the three and six months ended June 30, 2005 upon the adoption of
SFAS No. 123R. We expect general and administrative expenses other than non-cash stock-based
compensation expense to increase slightly in the future as a result of increased headcount, public
company compliance and establishment of investor relations and marketing programs. We expect
non-cash stock-based compensation expense to be higher in future periods as compared to periods prior to January 1, 2006 as a result of the adoption
of SFAS No. 123R. See Critical Accounting Policies above and Note 3 Accounting for Stock-Based
Compensation in the footnotes to our financial statements.
LIQUIDITY AND CAPITAL RESOURCES
We have funded our operations primarily through the sale of equity securities. We do not anticipate
sales of any product prior to regulatory approval and commercialization of our Technosphere Insulin
System. We currently rely on cash resources to maintain adequate working capital levels. At June
30, 2006, we had $50.9 million in cash, cash equivalents and marketable securities, which we
believed was sufficient to fund our anticipated cash requirements into the third quarter of 2006.
To help us meet future funding needs, on August 2, 2006 we entered into a loan arrangement with our
principal stockholder, Alfred Mann, pursuant to which we are able to borrow up to a total of $150.0
million in one or more advances at any time over the next year should our cash balance fall below
our projected cash requirements for the subsequent three month period, provided that each advance
be no less than $50.0 million. We borrowed $50.0 million
under the loan arrangement on
August 2, 2006. Interest accrues on each outstanding advance at a rate equal to the one year LIBOR
rate in effect on the day of such advance plus 3% per annum and is payable quarterly in arrears. The loan is unsecured and contains no financial
covenants. There are no warrants associated with the loan nor is the
loan convertible into our stock. In the event of a default,
all unpaid principal and interest becomes immediately due and payable and the interest rate increases to one year LIBOR calculated
on the date of the initial advance or in effect on the date of default, whichever is greater, plus 5% per annum.
Upon the closing of certain financing events, including equity and debt financings or strategic
transactions with third parties, in which we receive cash proceeds of at least $100.0 million, we
are required to repay all or a portion of the principal and accrued and unpaid interest under the
note equal to the difference between our cash balance immediately following the financing event and
our projected cash requirements for the six month period following the financing event. We believe
that this loan arrangement with Mr. Mann will enable us to continue funding our
operations through the second quarter of 2007.
Notwithstanding our loan arrangement with Mr. Mann, we will require significant additional
financing in the future to fund our operations. If adequate funds are not available, we may be
required to delay, reduce or eliminate expenditures for certain of our programs, including our
Technosphere Insulin System development activities.
During the six months ended June 30, 2006, we used $84.7 million of cash for our operations. We had
a net loss of $98.3 million for the six months ended June 30, 2006, of which $11.6 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 our Technosphere Insulin System.
Investing activities provided $54.5 million of cash during the six months ended June 30, 2006. Cash
provided by investing activities was from net sales of marketable securities of $65.6 million
offset by $11.1 million used to purchase machinery and equipment to expand our manufacturing
operations and quality systems in support of our expansion of clinical trials for Technosphere
Insulin System. We expect to make significant purchases of equipment in the foreseeable future.
Our financing activities provided cash of $1.3 million for the six months ended June 30, 2006. Cash
from financing activities was primarily from the exercise of stock options and warrants.
We intend to use our capital resources to continue the development of our Technosphere Insulin
System 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 solid-tumor cancers. We anticipate that we will expend a
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 discussions with a number of pharmaceutical companies concerning a potential strategic
business collaboration for our Technosphere Insulin System. We have narrowed the list of potential
collaborative partners but are not disclosing the number of potential partners or their identities.
To date, we have neither concluded these discussions nor reached an agreement concerning such a
collaboration. There can be no assurance that any strategic collaboration will be available to us
on a timely basis or on acceptable
22
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 and reimbursements for a portion of the costs associated
with the development, manufacture and commercialization of our Technosphere Insulin System. In addition, we expect to
pursue the sale of equity and/or debt securities, or the establishment of other funding facilities.
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 planned operating results are not achieved or we are not successful in raising
additional equity financing or entering a business collaboration, we may be required to reduce
expenses through the delay, reduction or curtailment of our projects, including our Technosphere
Insulin System development activities, or further reduction of costs for facilities and
administration.
Off-Balance Sheet Arrangements
As of June 30, 2006, we did not have any off-balance sheet arrangements.
Contractual Obligations
There have been no material changes to our contractual obligations disclosed in Item 7 to our
Annual Report other than those in the ordinary course of our business, such as contracts related to
the continuation of existing clinical trials, the initiation of new trials and the expansion,
qualification and validation of our commercial manufacturing processes and facilities.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We have not used derivative financial instruments. However, we are exposed to market risk related
to changes in interest rates. Our current policy is 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. Our cash is deposited in and invested through highly rated financial
institutions in North America. Our short-term investments are subject to interest rate risk and
will fall in value if market interest rates increase. If market interest rates were to increase
immediately and uniformly by ten percent from levels at June 30, 2006, we estimate that the fair
value of our investment portfolio would decline by an immaterial amount.
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 Securities Exchange Act, is recorded, processed, summarized and reported within the
time periods specified in the Securities and Exchange Commissions 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 Rule 13a-15(b) of the Securities Exchange Act) as of June 30, 2006. 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.
23
There has been no change in our internal control over financial reporting during the fiscal quarter
ended June 30, 2006 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
As previously disclosed in our Annual Report, in May 2005, our former Chief Medical Officer, Wayman
Wendell Cheatham, M.D., filed a complaint against us in the California Superior Court, County of
Los Angeles in the case styled, Wayman Wendell Cheatham, M.D. v. MannKind Corporation, Case No.
BC333845. The complaint alleges causes of action for wrongful termination in violation of public
policy, breach of contract and retaliation, in connection with our termination of Dr. Cheathams
employment. In the complaint, Dr. Cheatham seeks compensatory, punitive and exemplary damages in
excess of $2.0 million, as well as reimbursement of attorneys fees. In June 2005, we answered the
complaint, generally denying each of Dr. Cheathams allegations and asserting various defenses. We
believe the allegations in the complaint are without merit and intend to vigorously defend against
them. We also filed a cross-complaint against Dr. Cheatham, alleging claims for libel per se, trade
libel, breach of contract, breach of the implied covenant of good faith and fair dealing and breach
of the duty of loyalty. The libel claims allege that Dr. Cheatham made certain false and malicious
statements about us in a letter to the FDA with regard to a request by us to hold a meeting with
the FDA. The remaining causes of action in the cross-complaint arise out of our allegations that
Dr. Cheatham had an undisclosed consulting relationship with a competitor during his employment
with us, in violation of our agreement. In July 2005, Dr. Cheatham filed a demurrer and motion to
strike our cross-complaint under Californias anti-SLAPP statute. On September 28, 2005, the
California Superior Court overruled Dr. Cheathams demurrer and denied his motion to strike our
cross-complaint. On November 4, 2005, Dr. Cheatham filed a notice of appeal of the Courts ruling
denying his motion to strike. Discovery as to Dr. Cheathams claims against us is proceeding, and
this case is currently scheduled for trial to commence in February 2007. We believe that the
ultimate resolution of this matter will not have a material impact on our financial position or
results of operations.
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 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 associated with our
business as previously disclosed in Item 1A to our annual report on Form 10-K for the year
ended December 31, 2005. 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 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 our Technosphere Insulin System are still in 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
anticipate that our Technosphere Insulin System will not be commercially available for several
years, if at all.
We have never been profitable, and, as of June 30, 2006, we had an accumulated deficit of $655.6
million. The accumulated deficit 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. This accumulated deficit may
increase significantly as we expand 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. Our ability to achieve and sustain profitability
depends upon obtaining regulatory approvals for and successfully commercializing our Technosphere
Insulin System, either alone or with third parties. We do not currently have the required approvals
24
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.
If we
fail to raise additional capital, our financial condition and business would suffer.*
It is costly to develop therapeutic products and conduct clinical trials for these products.
Although we currently are focusing on our Technosphere Insulin System as our lead product
candidate, we may in the future conduct clinical trials for a number of additional product
candidates. Our future revenues may not be sufficient to support the expense of these activities.
On
August 2, 2006, we entered into a loan arrangement with
our principal stockholder to borrow up to a total of
$150.0 million in one or more advances at any time through
August 2, 2007 should our cash balance fall below
its projected cash requirements for the subsequent three months,
provided that each advance be no less than $50.0 million. We borrowed $50.0 million under the loan arrangement on
August 2, 2006. We believe that this loan arrangement
with our principal stockholder will enable us to continue
funding operations through the second quarter of 2007. 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 expect that we will
need to raise additional capital, either through the sale of equity and/or debt securities, a
strategic business collaboration or the establishment of other funding facilities, in order to
continue the development and commercialization of our Technosphere Insulin System and other product
candidates and to support our other ongoing activities. The amount of additional funds we need will
depend on a number of factors, including:
|
|
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; |
|
|
|
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; |
|
|
|
actions taken by the FDA and other regulatory authorities affecting our products and competitive products; |
|
|
|
our degree of success in commercializing our Technosphere Insulin System or our other product candidates; |
|
|
|
the emergence of competing technologies and products and other adverse market developments; |
|
|
|
the timing and amount of payments we might receive from potential licensees; |
|
|
|
the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other intellectual property rights
or defending against claims of infringement by others; and |
|
|
|
the costs of discontinuing projects and technologies or decommissioning existing facilities, if we undertake those activities. |
We have raised capital in the past primarily through the sale of equity securities. We may in the
future pursue the sale of equity and/or debt securities, or the establishment of other funding
facilities. Issuances of debt or additional equity could impact your rights as a holder of our
common stock, may dilute your ownership percentage and 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, sale or
divestiture 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 sale or license of assets will be available to us on a timely basis or on
acceptable terms, if at all. We may be 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, licensing arrangements, sales of securities 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 our Technosphere Insulin System development activities, or further reduction of costs for
facilities and administration.
We depend heavily on the successful development and commercialization of our lead product
candidate, the Technosphere Insulin System, which is still under development, and our other product
candidates, which are in preclinical development.*
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To date, we have not completed the development of any products through to commercialization. Only
our Technosphere Insulin System is currently undergoing clinical trials, while our other product
candidates are in research 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 our Technosphere Insulin System.
We have expended significant time, money and effort in the development of our lead product
candidate, the Technosphere Insulin System, which has not yet received regulatory approval and
which may never be commercialized. Before we can market and sell our Technosphere Insulin System,
we will need to advance our Technosphere Insulin System through Phase 3 clinical trials and
demonstrate in these trials that our Technosphere Insulin System is safe and effective. We
initiated an additional major Phase 3 clinical trial this past quarter. Also, we currently
anticipate conducting several special population studies which will require additional time and
substantial expenditure of resources. We must also receive the necessary approvals from the FDA and
similar foreign regulatory agencies before this product can be marketed in the United States or
elsewhere. Even if we were to receive regulatory approval, we ultimately may be unable to gain
market acceptance of our Technosphere Insulin System 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 our Technosphere Insulin System, 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 areas. 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 our Technosphere Insulin System, 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 our Technosphere Insulin System 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.
If we do not achieve our projected development 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
compared to 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 our
Technosphere Insulin System; |
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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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