UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 27, 2006
MannKind Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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000-50865
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13-3607736 |
(State or other jurisdiction of
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(Commission File Number)
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(IRS Employer |
incorporation or organization)
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Identification No.) |
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28903 North Avenue Paine
Valencia, California
(Address of principal executive offices)
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91355
(Zip Code) |
Registrants telephone number, including area code: (661) 775-5300
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing
obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
TABLE OF CONTENTS
Section 2
Financial Information
Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance
Sheet Arrangement of a Registrant.
On November 27, 2006, the Company was advanced an additional $20.0 million under a loan arrangement
with its principal stockholder that was initially entered into on August 2, 2006 and amended on
October 30, 2006. Together with the $50.0 million advanced on August 2, 2006, the aggregate
principal outstanding following the November advance is $70.0 million.
Under this loan arrangement as amended, the Company can borrow funds 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
$10.0 million. Principal repayment is due and payable one year from the date of each advance. Any
principal repaid can be re-borrowed by the Company subject to the limitations above. Interest
accrues on each outstanding advance at a fixed 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 Companys 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.
Section 8 Other Events
Item 8.01 Other Events.
In the first half of 2006, the Company engaged a marketing research firm to assist it in developing
a brand strategy for its Technosphere Insulin System. As part of that engagement, the marketing
firm conducted several surveys, engaged in research activities and performed physician interviews,
all of which were primary designed to provide the marketing firm insight to assist it in developing
a branding strategy for the Companys Technosphere Insulin System. The survey conducted by the
marketing firm involved 425 physicians, including 150 general practitioners, 150 internists and 125
endocrinologists. Physicians were chosen from a pre-screened pool of physicians, which was further
reduced by various selection criteria including age, years of experience and the number of diabetic
patients treated in a typical month. Physicians participating in the survey went to a website,
hosted by the marketing firm, and there were able to view limited background information regarding
the Technosphere Insulin System. Following which they responded to numerous questions designed to
assist the marketing firm in developing the appropriate marketing strategy for the product. Among
the questions asked was When do you think you would prescribe Technosphere Insulin? Physicians
were asked to check each of the boxes that applied, with each box correlating to a patient stage
identified below.
The following table presents the results of the marketing survey. The percentages in each column
represent the percentage of physicians who indicated that they would prescribe their patients the
proposed drug during that patient stage:
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General |
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Patient Stage |
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Practitioners |
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Internists |
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Endocrinologists |
Prediabetes (before diet & exercise) |
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10 |
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7 |
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10 |
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After failing diet and exercise |
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37 |
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30 |
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21 |
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After failing 1 oral medication |
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47 |
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44 |
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35 |
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After failing 2 oral medications |
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64 |
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55 |
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52 |
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After failing 3 oral medications |
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49 |
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32 |
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44 |
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With oral medications |
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71 |
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59 |
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62 |
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With subcutaneous basal insulin |
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47 |
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39 |
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72 |
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This marketing survey was conducted solely for the purpose of evaluating a proposed product
positioning strategy and the reaction of physicians to the strategy. The information presented
above cannot be used forecast anticipated physician acceptance or use of the product. The
Technosphere Insulin System is not currently available and has not been approved by the FDA for
commercialization. The Company anticipates that the clinical trials necessary to support FDA
approval will not be completed for at least two years. The Company cannot assure you that
physicians would actually prescribe the Technosphere Insulin System, if it is approved, to their
patients at the stages indicated above, or at all. Moreover, other more favorable alternatives to
the Technosphere Insulin System may exist at the time the Companys product is approved and
physicians may prescribe that product in lieu of the Technosphere Insulin System. Physicians
responding to the survey above were basing their responses on data the Company supplied to them and
without the benefit of actual experience with the product and with limited clinical data. Any
long-term clinical data that Company produces may not support the physician decisions described
above and physicians may not adopt the use of the Technosphere Insulin System based on those
results. Additional risks associated with the development of the Technosphere Insulin System, its
approval by the FDA and other regulatory agencies and its adoption by physicians are set forth in
detail the Companys Form 10-K for the year ended December 31, 2005 and each of the Form 10-Qs for
the periods ended March 31, 2006, June 30, 2006 and September 30, 2006. You are encouraged to read
those risk factors in connection with the evaluation of the information presented in this Report.
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