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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): May 11, 2007
MannKind Corporation
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction
of incorporation)
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000-50865
(Commission File Number)
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13-3607736
(IRS Employer
Identification No.) |
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28903 North Avenue Paine
Valencia, California
(Address of principal executive offices)
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91355
(Zip Code) |
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 filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition
On May 11, 2007, MannKind Corporation issued a press release announcing its financial results for
the first quarter of 2007. A copy of the press release is attached as Exhibit 99.1 to this Current
Report and is incorporated herein by reference.
The information in this Current Report is being furnished and shall not be deemed filed for the
purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject
to the liabilities of that Section. The information in this Current Report shall not be
incorporated by reference into any registration statement or other document pursuant to the
Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits
(c) Exhibits. The following exhibit is furnished herewith:
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99.1 |
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Press Release of MannKind Corporation dated May 11, 2007, reporting
MannKinds financial results for the first quarter of 2007. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MANNKIND CORPORATION
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By: |
/s/ Richard L. Anderson
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Name: |
Richard L. Anderson |
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Title: |
Chief Financial Officer |
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Dated: May 11, 2007
EXHIBIT INDEX
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Number |
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Description |
99.1
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Press Release of MannKind Corporation dated May 11, 2007, reporting
MannKinds financial results for the first quarter of 2007. |
exv99w1
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Company Contact:
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Financial Dynamics: |
Dick Anderson
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Evan Smith (investors) |
Chief Financial Officer
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Robert Stanislaro (media) |
661-775-5302
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212-850-5600 |
danderson@mannkindcorp.com
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mnkd@fd.com |
MANNKIND CORPORATION REPORTS FIRST QUARTER FINANCIAL RESULTS
Conference Call Today at 9:00 a.m. EDT
VALENCIA, Calif., May 11, 2007 MannKind Corporation (Nasdaq: MNKD) today reported
financial results for the first quarter ended March 31, 2007.
For the first quarter of 2007, total operating expenses were $77.3 million, compared with $45.1
million for the first quarter of 2006. A substantial proportion of this increase was attributed to
increased research and development (R&D) expenses which were $63.8 million for this quarter
compared to $36.0 million for the same quarter in 2006. These increased (R&D) costs were
associated with the Companys expanded clinical development program and manufacturing costs for
Technosphere® Insulin. General and administrative (G&A) expenses increased by $4.4
million to $13.6 million for the first quarter of 2007 compared to the first quarter of 2006. This
was due primarily to employee related expenses and professional fees.
The net loss applicable to common stockholders for the first quarter of 2007 was $73.1 million, or
$1.00 per share, based on 73.4 million weighted average shares outstanding. This compares to a net
loss applicable to common stockholders of $43.6 million, or $0.87 per share, based on 49.8 million
weighted average shares outstanding for the first quarter of 2006.
Cash, cash equivalents and marketable securities were $365.6 million at March 31, 2007, $436.5
million at December 31, 2006, and $102.6 million at March 31, 2006.
Technosphere Insulin continues to demonstrate significant differentiating qualities when compared
to other diabetes therapies. Technosphere Insulin produces a rapid elevation in insulin that peaks
within 12 to 14 minutes after inhalation. We believe the kinetics for Technosphere Insulin are much
faster than any other product in commercial development. The result of these kinetics in safety and
efficacy further strengthens our belief that Technosphere Insulin will emerge as the first in a new
class of diabetes products. said Alfred Mann, Chairman and Chief Executive Officer of MannKind
Corporation. We continue to meet our program milestones and remain on track to file our NDA
submission with the FDA for Technosphere Insulin in December 2008. All of our key Phase 3 trials
for Technosphere Insulin are progressing satisfactorily and I am pleased to announce today the
completion of enrollment for the 009 trial and anticipate we will complete enrollment for the 102
and the 103 trials around the end of this month.
MannKind also announced today that it has initiated a clinical trial in healthy individuals for a
second Technosphere product, MKC-253. This trial is being conducted in Europe. MKC-253 is a
formulation of GLP-1 delivered on Technosphere particles that MannKind is evaluating for safety,
tolerability, and pharmacokinetics. GLP-1 is a hormone secreted in the small intestine and colon in
response to food intake. GLP-1 in healthy individuals is known to stimulate insulin secretion and
slow gastric emptying. Patients with type 2 diabetes often exhibit a lower level of GLP-1
secretion. The initiation of this trial demonstrates our commitment to expand our proprietary
Technosphere formulation for the delivery of other drugs and develop Technosphere as a platform
technology, concluded Alfred Mann.
Conference Call
MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern
Daylight Time. To participate in the call please dial (888) 566-5775 or (210) 839-8503. To listen
to the call via the Internet please visit www.mannkindcorp.com. The web site replay will be
available for fourteen days. A telephone replay will be accessible for approximately 14 days
following completion of the call by dialing (888) 568-0920 or (203) 369-3791 and entering
conference number 2363283.
Presenting from the Company will be:
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Chairman and Chief Executive Officer Alfred Mann |
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President and Chief Operating Officer Hakan Edstrom |
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Corporate Vice President and Chief Financial Officer Dick Anderson |
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of
therapeutic products for diseases such as diabetes and cancer. Its lead product, the Technosphere
Insulin System, is currently in Phase 3 clinical trials in the United States, Europe and Latin
America to study its safety and efficacy in the treatment of diabetes. For more information on
MannKind Corporation and its technology, visit http://www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to MannKinds
clinical trials, product candidates and organizational development that involve risks and
uncertainties. Words such as believes, anticipates, plans, expects, intend, will,
goal, potential and similar expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon the Companys current expectations. Actual results
and the timing of events could differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include, without limitation, risks
related to the progress, timing and results of clinical trials, difficulties or delays in seeking
or obtaining regulatory approval, the manufacture of the Technosphere Insulin System, competition
from other pharmaceutical or biotechnology companies, MannKinds ability to enter into any
collaborations or strategic partnerships, intellectual property matters and other risks detailed in
MannKinds filings with the Securities and Exchange Commission, including the Annual Report on Form
10-K for the year ended December 31, 2006 and periodic reports on Form 10-Q and Form 8-K. You are
cautioned not to place undue reliance on these forward-looking statements, which speak only as of
the date of this press release. All forward-looking statements are qualified in their entirety by
this cautionary statement, and MannKind undertakes no obligation to revise or update any
forward-looking statements to reflect events or circumstances after the date of this press release.
(Tables to follow)
MannKind Corporation
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
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Three Months Ended March 31, |
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2007 |
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2006 |
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Revenue |
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$ |
10 |
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$ |
100 |
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Operating expenses: |
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Research and development |
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63,788 |
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35,950 |
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General and administrative |
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13,550 |
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9,138 |
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Total operating expenses |
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77,338 |
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45,088 |
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Loss from operations |
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(77,328 |
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(44,988 |
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Other income |
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52 |
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50 |
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Interest expense on senior convertible notes |
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(1,145 |
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Interest income |
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5,280 |
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1,380 |
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Loss before provision for income taxes |
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(73,141 |
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(43,558 |
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Income taxes |
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(1 |
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Net loss |
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$ |
(73,141 |
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$ |
(43,559 |
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Net loss basic and diluted |
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$ |
(1.00 |
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$ |
(0.87 |
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Shares used to compute basic and diluted net
loss per share |
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73,388 |
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49,787 |
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MannKind Corporation
Condensed Balance Sheet
(Unaudited)
(in thousands)
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March 31, |
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December 31, |
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Assets |
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2007 |
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2006 |
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Current assets: |
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Cash and cash equivalents |
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$ |
262,753 |
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$ |
319,555 |
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Marketable securities |
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102,824 |
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116,924 |
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State research and development tax credit exchange
receivable current |
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3,918 |
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2,418 |
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Prepaid expenses and other current assets |
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13,714 |
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10,650 |
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Total current assets |
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383,209 |
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449,547 |
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Property and equipment net |
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98,622 |
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88,328 |
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State research and development tax credit exchange receivable
net of current portion |
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375 |
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1,500 |
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Other assets |
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361 |
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362 |
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Total |
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$ |
482,567 |
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$ |
539,737 |
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Liabilities and Stockholders Equity |
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Current liabilities |
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$ |
55,853 |
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$ |
44,959 |
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Other liabilities |
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24 |
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24 |
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Senior convertible notes |
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111,406 |
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111,267 |
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Stockholders equity |
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315,284 |
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383,487 |
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Total |
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$ |
482,567 |
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$ |
539,737 |
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# # #