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 4, 2009
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
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(State
or other jurisdiction of
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(Commission
File Number)
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(IRS
Employer
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incorporation)
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Identification
No.)
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28903
North Avenue Paine
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Valencia,
California
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91355
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
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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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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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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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
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On May 4,
2009, MannKind Corporation issued a press release announcing its financial
results for the first quarter of 2009. 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
(d) Exhibits.
The following exhibit is furnished herewith:
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99.1
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Press
Release of MannKind Corporation dated May 4, 2009, reporting MannKind’s
financial results for the first quarter of
2009.
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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:
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/s/ MATTHEW J.
PFEFFER
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Name:
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Matthew
J. Pfeffer
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Title:
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Corporate
Vice President and Chief
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Financial
Officer
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Dated:
May 4, 2009
EXHIBIT
INDEX
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Number
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Description
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99.1
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Press
Release of MannKind Corporation dated May 4, 2009, reporting MannKind’s
financial results for the first quarter of
2009.
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Exhibit 99.1
Company
Contact:
Matthew
J. Pfeffer
Corporate
Vice President and
Chief
Financial Officer
661-775-5300
mpfeffer@mannkindcorp.com
MANNKIND
CORPORATION REPORTS FIRST QUARTER OF 2009 FINANCIAL RESULTS
-
Conference Call to Begin Today at 4:00 PM EDT -
VALENCIA, Calif., May 4
/Business Wire/ -- MannKind Corporation (Nasdaq: MNKD) today
reported financial results for the first quarter ended March 31,
2009.
For the
first quarter of 2009, total operating expenses were $57.8 million, compared to
$74.1 million for the first quarter of 2008. Research and development (R&D)
expenses decreased by $15.6 million to $42.9 million for the first quarter of
2009 compared to the first quarter of 2008. This decrease in R&D
expenses as compared to the same period in the prior year was primarily due to
decreased costs associated with the clinical development of AFRESA® as well as
decreased manufacturing costs associated with raw material
purchases. General and administrative (G&A) expenses decreased by
$0.7 million to $14.9 million for the first quarter of 2009 compared to the
first quarter of 2008.
The net
loss applicable to common stockholders for the first quarter of 2009 was $59.4
million, or $0.58 per share, based on 102.0 million weighted average shares
outstanding, compared with a net loss applicable to common stockholders of $71.4
million, or $0.70 per share based on 101.4 million weighted average shares
outstanding, for the first quarter of 2008.
Cash,
cash equivalents and marketable securities were $30.2 million at March 31, 2009
compared to $46.5 million at December 31, 2008, and $269.1 million at March 31,
2008. Currently, the Company has $260.0 million of available borrowings under
the loan agreement with an entity controlled by the Company’s principal
stockholder.
"This
past quarter was extremely busy for MannKind," said Alfred Mann, Chairman and
Chief Executive Officer, "culminating in our submission to the FDA of a New Drug
Application for AFRESA. With this milestone accomplished, we are now
turning our attention to commercial readiness activities."
Conference
Call
MannKind
management will host a conference call to discuss these results today at 4:00 PM
EDT. To participate in the call, please dial (888) 677-5721 or (210) 839-8507.
To listen to the call via the internet, please visit
http://www.mannkindcorp.com. The web site replay will be available for 14 days.
A telephone replay will be accessible for approximately 14 days following
completion of the call by dialing (888) 566-0513 or (203) 369-3063.
Presenting
from the Company will be:
· Chairman
and Chief Executive Officer Alfred Mann
· President
and Chief Operating Officer Hakan Edstrom
· Corporate
Vice President and Chief Financial Officer Matthew Pfeffer
· Corporate
Vice President and Chief Scientific Officer Peter Richardson
About
MannKind Corporation
MannKind
Corporation (Nasdaq: MNKD) focuses on the discovery, development and
commercialization of therapeutic products for patients with diseases such as
diabetes and cancer. Its diabetes pipeline includes AFRESA, an ultra
rapid-acting insulin and MKC253, an inhaled formulation of human
GLP-1. MannKind also has two cancer immunotherapeutic products in
clinical development. MannKind maintains a website at
http://www.mannkindcorp.com to which the company regularly posts copies of its
press releases as well as additional information. Interested persons
can subscribe on the MannKind website to e-mail alerts that are sent
automatically when MannKind issues press releases, files its reports with the
Securities and Exchange Commission or posts certain other information to the
website.
Forward-Looking
Statements
This
press release contains forward-looking statements, including statements related
to MannKind’s commercial readiness activities. 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 MannKind's current expectations and
involve risks and uncertainties. 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 difficulties or delays in seeking or obtaining regulatory
approval, and other risks detailed in MannKind's filings with the Securities and
Exchange Commission, including the Annual Report on Form 10-K for the year ended
December 31, 2008 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 and Subsidiaries
(A
Development Stage Company)
Condensed
Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share
amounts)
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Three
months ended
March 31,
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Cumulative
period from
February
14,
1991
(date of
inception)
to
March 31,
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|||||||||||
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2009
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2008
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2009
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Revenue
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$ | — | $ | 20 | $ | 2,988 | ||||||
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Operating
expenses:
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||||||||||||
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Research
and development
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42,889 | 58,445 | 1,040,371 | |||||||||
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General
and administrative
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14,917 | 15,640 | 260,759 | |||||||||
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In-process
research and development costs
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— | — | 19,726 | |||||||||
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Goodwill
impairment
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— | — | 151,428 | |||||||||
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Total
operating expenses
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57,806 | 74,085 | 1,472,284 | |||||||||
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Loss
from operations
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(57,806 | ) | (74,065 | ) | (1,469,296 | ) | ||||||
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Other
income (expense)
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71 | 60 | (1,872 | ) | ||||||||
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Interest
expense on note payable to related party
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(593 | ) | — | (2,116 | ) | |||||||
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Interest
expense on senior convertible notes
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(1,115 | ) | (337 | ) | (7,072 | ) | ||||||
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Interest
income
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31 | 2,921 | 36,892 | |||||||||
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Loss
before provision for income taxes
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(59,412 | ) | (71,421 | ) | (1,443,464 | ) | ||||||
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Income
taxes
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— | — | (26 | ) | ||||||||
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Net
loss
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(59,412 | ) | (71,421 | ) | (1,443,490 | ) | ||||||
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Deemed
dividend related to beneficial conversion feature of convertible preferred
stock
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— | — | (22,260 | ) | ||||||||
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Accretion
on redeemable preferred stock
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— | — | (952 | ) | ||||||||
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Net
loss applicable to common stockholders
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$ | (59,412 | ) | $ | (71,421 | ) | $ | (1,466,702 | ) | |||
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Net
loss per share applicable to common stockholders — basic and
diluted
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$ | (0.58 | ) | $ | (0.70 | ) | ||||||
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Shares
used to compute basic and diluted net loss per share applicable to common
stockholders
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102,030 | 101,409 | ||||||||||
MannKind
Corporation and Subsidiaries
(A
Development Stage Company)
Condensed
Consolidated Balance Sheet
(Unaudited)
(in
thousands)
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March 31, 2009
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December 31, 2008
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Assets
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||||||||
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Current
assets:
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Cash
and cash equivalents
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$ | 27,114 | $ | 27,648 | ||||
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Marketable
securities
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3,115 | 18,844 | ||||||
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State
research and development credit exchange receivable —
current
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— | 1,500 | ||||||
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Prepaid
expenses and other current assets
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4,907 | 5,983 | ||||||
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Total
current assets
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35,136 | 53,975 | ||||||
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Property
and equipment — net
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228,352 | 226,436 | ||||||
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State
research and development credit exchange receivable — net of current
portion
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1,675 | 1,500 | ||||||
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Other
assets
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10,548 | 548 | ||||||
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Total
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$ | 275,711 | $ | 282,459 | ||||
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Liabilities
and Stockholders’ Equity
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||||||||
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Current
liabilities
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$ | 40,159 | $ | 53,472 | ||||
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Senior
convertible notes
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112,378 | 112,253 | ||||||
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Note
payable to related party
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90,000 | 30,000 | ||||||
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Other
liabilities
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— | — | ||||||
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Stockholders’
equity
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33,174 | 86,734 | ||||||
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Total
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$ | 275,711 | $ | 282,459 | ||||
###