| - Conference Call to Begin Today at 4:00 PM EDT -
VALENCIA, Calif.--(BUSINESS WIRE)--May. 4, 2009--
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MannKind Corporation and Subsidiaries
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31,
|
|
|
|
Cumulative
period from
February 14,
1991 (date of
inception) to
March 31,
|
|
|
|
|
|
2009
|
|
|
|
|
2008
|
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
$
|
—
|
|
|
|
|
$
|
20
|
|
|
|
|
$
|
2,988
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
42,889
|
|
|
|
|
|
58,445
|
|
|
|
|
|
1,040,371
|
|
|
General and administrative
|
|
|
|
|
14,917
|
|
|
|
|
|
15,640
|
|
|
|
|
|
260,759
|
|
|
In-process research and development costs
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
19,726
|
|
|
Goodwill impairment
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
151,428
|
|
|
Total operating expenses
|
|
|
|
|
57,806
|
|
|
|
|
|
74,085
|
|
|
|
|
|
1,472,284
|
|
|
Loss from operations
|
|
|
|
|
(57,806
|
)
|
|
|
|
|
(74,065
|
)
|
|
|
|
|
(1,469,296
|
)
|
|
Other income (expense)
|
|
|
|
|
71
|
|
|
|
|
|
60
|
|
|
|
|
|
(1,872
|
)
|
|
Interest expense on note payable to related party
|
|
|
|
|
(593
|
)
|
|
|
|
|
—
|
|
|
|
|
|
(2,116
|
)
|
|
Interest expense on senior convertible notes
|
|
|
|
|
(1,115
|
)
|
|
|
|
|
(337
|
)
|
|
|
|
|
(7,072
|
)
|
|
Interest income
|
|
|
|
|
31
|
|
|
|
|
|
2,921
|
|
|
|
|
|
36,892
|
|
|
Loss before provision for income taxes
|
|
|
|
|
(59,412
|
)
|
|
|
|
|
(71,421
|
)
|
|
|
|
|
(1,443,464
|
)
|
|
Income taxes
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
(26
|
)
|
|
Net loss
|
|
|
|
|
(59,412
|
)
|
|
|
|
|
(71,421
|
)
|
|
|
|
|
(1,443,490
|
)
|
|
Deemed dividend related to beneficial conversion feature of
convertible preferred stock
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
(22,260
|
)
|
|
Accretion on redeemable preferred stock
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
|
(952
|
)
|
|
Net loss applicable to common stockholders
|
|
|
|
$
|
(59,412
|
)
|
|
|
|
$
|
(71,421
|
)
|
|
|
|
$
|
(1,466,702
|
)
|
|
Net loss per share applicable to common stockholders — basic and
diluted
|
|
|
|
$
|
(0.58
|
)
|
|
|
|
$
|
(0.70
|
)
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share
applicable to common stockholders
|
|
|
|
|
102,030
|
|
|
|
|
|
101,409
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MannKind Corporation and Subsidiaries
(A Development Stage Company)
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009
|
|
|
|
|
|
December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
27,114
|
|
|
|
|
|
$
|
27,648
|
|
Marketable securities
|
|
|
|
|
3,115
|
|
|
|
|
|
|
18,844
|
|
State research and development credit exchange receivable — current
|
|
|
|
|
—
|
|
|
|
|
|
|
1,500
|
|
Prepaid expenses and other current assets
|
|
|
|
|
4,907
|
|
|
|
|
|
|
5,983
|
|
Total current assets
|
|
|
|
|
35,136
|
|
|
|
|
|
|
53,975
|
|
Property and equipment — net
|
|
|
|
|
228,352
|
|
|
|
|
|
|
226,436
|
|
State research and development credit exchange receivable — net of
current portion
|
|
|
|
|
1,675
|
|
|
|
|
|
|
1,500
|
|
Other assets
|
|
|
|
|
10,548
|
|
|
|
|
|
|
548
|
|
Total
|
|
|
|
$
|
275,711
|
|
|
|
|
|
$
|
282,459
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
$
|
40,159
|
|
|
|
|
|
$
|
53,472
|
|
Senior convertible notes
|
|
|
|
|
112,378
|
|
|
|
|
|
|
112,253
|
|
Note payable to related party
|
|
|
|
|
90,000
|
|
|
|
|
|
|
30,000
|
|
Other liabilities
|
|
|
|
|
—
|
|
|
|
|
|
|
—
|
|
Stockholders’ equity
|
|
|
|
|
33,174
|
|
|
|
|
|
|
86,734
|
|
Total
|
|
|
|
$
|
275,711
|
|
|
|
|
|
$
|
282,459
|
Source: MannKind Corporation
MannKind Corporation Matthew J. Pfeffer Corporate Vice
President and Chief Financial Officer 661-775-5300 mpfeffer@mannkindcorp.com
|