- Conference Call to Begin Today at 6:00 P.M. ET -
VALENCIA, Calif.--(BUSINESS WIRE)--Nov. 1, 2012--
MannKind Corporation (Nasdaq: MNKD) today reported financial
results for the third quarter ended September 30, 2012.
For the third quarter of 2012, total operating expenses were $35.5
million compared to $32.8 million for the third quarter of 2011, an
increase of $2.7 million. Research and development (R&D) expenses were
$25.4 million for the third quarter of 2012 compared to $23.1 million
for the same quarter in 2011, an increase of $2.3 million. This 10.0%
increase was primarily due to an increase of $7.0 million in clinical
trial-related activities in the third quarter of 2012, offset in part by
a non-recurring $4.1 million expense recorded in the third quarter of
2011 in connection with the settlement of the terminated insulin supply
agreement. General and administrative (G&A) expenses were $10.1 million
for the third quarter of 2012 compared to $9.6 million for the same
quarter of 2011, an increase of $0.5 million. This 5.2% increase in G&A
expense was primarily due to an increase in the litigation settlement
accrual recorded in the third quarter of 2012.
For the first nine months of 2012, operating expenses totaled $113.5
million compared to $110.0 million in the first nine months of 2011, an
increase of $3.5 million. Total R&D expenses were $76.2 million for the
first nine months of 2012 compared to $79.7 million in the same period
in 2011, a decrease of $3.5 million. This 4.4% decrease was primarily
due to a non-recurring $16.0 million expense recorded during the first
nine months of 2011 in connection with the settlement of the terminated
insulin supply agreement and decreased salary-related expenses of $7.9
million resulting from the February 2011 restructuring, offset by $20.2
million in increased clinical trial-related expenses in the first nine
months of 2012. G&A expenses were $37.3 million for the first nine
months of 2012 as compared to $30.3 million in the same period in 2011,
an increase of $7.0 million. This 23.1% increase was primarily due to
the $8.6 million litigation settlement accrual recorded in the first
nine months of 2012, partially offset by decreased salary-related costs
as a result of the February 2011 reduction in force.
The net loss applicable to common stockholders for the third quarter of
2012 was $42.8 million, or $0.22 per share based on 190.5 million
weighted average shares outstanding, compared with a net loss applicable
to common stockholders of $38.4 million, or $0.31 per share based on
122.1 million weighted average shares outstanding, for the third quarter
of 2011. The number of common shares outstanding at September 30, 2012
was 199,767,463.
Cash and short-term investments were $3.2 million at December 31, 2011
and $2.1 million at September 30, 2012, not including total net proceeds
of $86.0 million from the underwritten public offering of common stock
and warrants in October 2012.
Conference Call
MannKind management will host a conference call to discuss these results
today at 6:00 p.m. Eastern Time. To participate in the call please dial
800-447-0521 or 847-413-3238 and use the participant passcode: 33432275.
To listen to the call via the Internet please visit http://www.mannkindcorp.com.
The website replay will be available for 14 days. A telephone replay
will be accessible for approximately 14 days following completion of the
call by dialing 888-843-7419 or 630-652-3042 and use the participant
passcode: 3343 2275#.
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
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 lead product candidate,
AFREZZA®, is in late stage clinical investigation for the treatment of
adults with type 1 or type 2 diabetes for the control of hyperglycemia.
MannKind maintains a website at http://www.mannkindcorp.com
to which MannKind regularly posts copies of its press releases as well
as additional information about MannKind. 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 that involve
risks and uncertainties. Words such as “believes”, “anticipates”,
“plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon MannKind’s 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, the progress, timing and results of clinical trials,
difficulties or delays in seeking or obtaining regulatory approval, the
manufacture of AFREZZA, competition from other pharmaceutical or
biotechnology companies, MannKind’s ability to enter into any
collaborations or strategic partnerships, intellectual property matters,
stock price volatility and other risks detailed in MannKind’s filings
with the Securities and Exchange Commission, including its Annual Report
on Form 10-K for the year ended December 31, 2011 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
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
|
|
Nine months ended
September 30,
|
|
|
|
Cumulative period
from February 14, 1991
(date of inception)
to September 30,
|
|
|
|
|
|
2012
|
|
|
2011
|
|
|
|
2012
|
|
|
2011
|
|
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
$
|
35
|
|
|
|
$
|
—
|
|
|
|
|
$
|
35
|
|
|
|
$
|
50
|
|
|
|
|
$
|
3,166
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
25,453
|
|
|
|
|
23,132
|
|
|
|
|
|
76,247
|
|
|
|
|
79,717
|
|
|
|
|
|
1,442,298
|
|
|
General and administrative
|
|
|
|
|
10,069
|
|
|
|
|
9,641
|
|
|
|
|
|
37,262
|
|
|
|
|
30,293
|
|
|
|
|
|
417,493
|
|
|
In-process research and development costs
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
19,726
|
|
|
Goodwill impairment
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
151,428
|
|
|
Total operating expenses
|
|
|
|
|
35,522
|
|
|
|
|
32,773
|
|
|
|
|
|
113,509
|
|
|
|
|
110,010
|
|
|
|
|
|
2,030,945
|
|
|
Loss from operations
|
|
|
|
|
(35,487
|
)
|
|
|
|
(32,773
|
)
|
|
|
|
|
(113,474
|
)
|
|
|
|
(109,960
|
)
|
|
|
|
|
(2,027,779
|
)
|
|
Other income (expense)
|
|
|
|
|
(2,651
|
)
|
|
|
|
79
|
|
|
|
|
|
12,078
|
|
|
|
|
1,476
|
|
|
|
|
|
11,002
|
|
|
Interest expense on note payable to related party
|
|
|
|
|
(2,245
|
)
|
|
|
|
(2,863
|
)
|
|
|
|
|
(8,321
|
)
|
|
|
|
(7,849
|
)
|
|
|
|
|
(36,655
|
)
|
|
Interest expense on senior convertible notes
|
|
|
|
|
(2,859
|
)
|
|
|
|
(2,845
|
)
|
|
|
|
|
(8,278
|
)
|
|
|
|
(8,092
|
)
|
|
|
|
|
(37,072
|
)
|
|
Interest income
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
2
|
|
|
|
|
18
|
|
|
|
|
|
36,991
|
|
|
Loss before provision for income taxes
|
|
|
|
|
(43,242
|
)
|
|
|
|
(38,402
|
)
|
|
|
|
|
(117,993
|
)
|
|
|
|
(124,407
|
)
|
|
|
|
|
(2,053,513
|
)
|
|
Income tax benefit
|
|
|
|
|
(408
|
)
|
|
|
|
—
|
|
|
|
|
|
(408
|
)
|
|
|
|
—
|
|
|
|
|
|
(382
|
)
|
|
Net loss
|
|
|
|
|
(42,834
|
)
|
|
|
|
(38,402
|
)
|
|
|
|
|
(117,585
|
)
|
|
|
|
(124,407
|
)
|
|
|
|
|
(2,053,131
|
)
|
|
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
|
|
|
|
$
|
(42,834
|
)
|
|
|
$
|
(38,402
|
)
|
|
|
|
$
|
(117,585
|
)
|
|
|
$
|
(124,407
|
)
|
|
|
|
$
|
(2,076,343
|
)
|
|
Net loss per share applicable to common stockholders — basic and
diluted
|
|
|
|
$
|
(0.22
|
)
|
|
|
$
|
(0.31
|
)
|
|
|
|
$
|
(0.71
|
)
|
|
|
$
|
(1.02
|
)
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share
applicable to common stockholders
|
|
|
|
|
190,534
|
|
|
|
|
122,130
|
|
|
|
|
|
164,611
|
|
|
|
|
121,636
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MannKind Corporation
(A Development Stage Company)
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2012
|
|
|
|
|
|
|
|
|
December 31, 2011
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
1,765
|
|
|
|
|
|
|
|
|
|
$
|
2,681
|
|
|
Available for sale securities and certificate of deposit
|
|
|
|
|
350
|
|
|
|
|
|
|
|
|
|
|
515
|
|
|
Prepaid expenses and other current assets
|
|
|
|
|
21,082
|
|
|
|
|
|
|
|
|
|
|
2,625
|
|
|
Total current assets
|
|
|
|
|
23,197
|
|
|
|
|
|
|
|
|
|
|
5,821
|
|
|
Property and equipment — net
|
|
|
|
|
186,611
|
|
|
|
|
|
|
|
|
|
|
193,029
|
|
|
State research and development credit exchange receivable — net of
current portion
|
|
|
|
|
293
|
|
|
|
|
|
|
|
|
|
|
473
|
|
|
Other assets
|
|
|
|
|
230
|
|
|
|
|
|
|
|
|
|
|
230
|
|
|
Total
|
|
|
|
$
|
210,331
|
|
|
|
|
|
|
|
|
|
$
|
199,553
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
$
|
51,764
|
|
|
|
|
|
|
|
|
|
$
|
25,360
|
|
|
Senior convertible notes
|
|
|
|
|
211,673
|
|
|
|
|
|
|
|
|
|
|
210,642
|
|
|
Note payable to principal stockholder
|
|
|
|
|
223,142
|
|
|
|
|
|
|
|
|
|
|
277,203
|
|
|
Stockholders’ deficit
|
|
|
|
|
(276,248
|
)
|
|
|
|
|
|
|
|
|
|
(313,652
|
)
|
|
Total
|
|
|
|
$
|
210,331
|
|
|
|
|
|
|
|
|
|
$
|
199,553
|
|

Source: MannKind Corporation
MannKind Corporation Matthew J. Pfeffer Chief Financial Officer 661-775-5300 mpfeffer@mannkindcorp.com
|