e8vk
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): February 17, 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 |
(State or other jurisdiction of
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(Commission File Number)
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(IRS Employer |
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 |
(Address of principal executive offices)
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(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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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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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 February 17, 2009, MannKind Corporation issued a press release announcing its financial results
for the fourth quarter and full year 2008. 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 February 17, 2009,
reporting MannKinds financial results for the fourth quarter and
full year 2008. |
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: February 17, 2009
EXHIBIT INDEX
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Number |
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Description |
99.1
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Press Release of MannKind Corporation dated February 17, 2009, reporting
MannKinds financial results for the fourth quarter and full year 2008. |
exv99w1
Exhibit 99.1
Company Contact:
Matthew J. Pfeffer
Corporate Vice President and
Chief Financial Officer
661-775-5300
mpfeffer@mannkindcorp.com
MANNKIND CORPORATION REPORTS FOURTH QUARTER AND FULL
YEAR 2008 FINANCIAL RESULTS
- Conference Call to Begin Today at 4:00 PM ET -
VALENCIA, Calif., February 17 /PRNewswire-FirstCall/ MannKind Corporation (Nasdaq: MNKD) today
reported financial results for the fourth quarter and year ended December 31, 2008.
For the fourth quarter of 2008, total operating expenses were $81.8 million, compared to $79.1
million for the fourth quarter of 2007. Research and development (R&D) expenses increased by $2.0
million to $68.8 million for the fourth quarter of 2008 compared to the fourth quarter of 2007.
This increase is primarily due to higher manufacturing costs (including clinical supplies) for
AFRESA®, offset in part by lower purchased services in the associated clinical development program,
and lower technology agreement costs in our oncology research programs. General and administrative
(G&A) expenses increased by $0.7 million to $13.0 million for the fourth quarter of 2008 compared
to the fourth quarter of 2007.
The net loss applicable to common stockholders for the fourth quarter of 2008 was $83.3 million, or
$0.82 per share based on 101.8 million weighted average shares outstanding, compared with a net
loss applicable to common stockholders of $75.0 million, or $0.75 per share based on 99.6 million
weighted average shares outstanding, for the fourth quarter of 2007.
For the year ended December 31, 2008, total operating expenses were $305.8 million, compared with
$307.4 million for 2007. R&D expenses were $250.4 million in 2008, down $6.4 million from 2007,
primarily related to lower technology agreement costs in our oncology research programs and
decreased clinical development program expenses, which were offset by increases in manufacturing
costs (including clinical supplies) for
AFRESA and associated clinical development program expenses. G&A expenses increased by $4.8 million
to $55.3 million for 2008 as compared to 2007 primarily due to salaries and stock compensation
expenses. The total number of employees decreased from 609 at the end of 2007 to 580 at the end of
2008.
The net loss applicable to common stockholders for 2008 was $303.0 million, or $2.98 per share
based on 101.6 million weighted average shares outstanding, compared with a net loss applicable to
common stockholders of $293.2 million, or $3.66 per share based on 80.0 million weighted averages
shares outstanding for 2007. The number of common shares outstanding at December 31, 2008 was
102,008,096.
Cash, cash equivalents and marketable securities were $46.5 million at December 31, 2008, $95.2
million at September 30, 2008, and $368.3 million at December 31, 2007. Currently, the Company has
additional financial resources of $320.0 million available under the loan arrangement with our
principal stockholder.
Our NDA for AFRESA is now almost finished, stated Alfred Mann, Chairman and Chief Executive
Officer. Little more than the hyperlinking of the electronic submission remains to be completed.
Our clinical, regulatory and CMC teams have done an extraordinary job assembling a comprehensive
document that describes the robust safety and efficacy data that we have collected for AFRESA. The
extensive clinical program that we conducted has provided evidence that AFRESA consistently
decreases A1C levels and additionally offers marked benefits for patients in terms of post-prandial
glucose control, fasting glucose control, weight loss and hypoglycemia. Moreover, the studies
indicate that AFRESA achieves these clinical benefits without any adverse effects on pulmonary
function. We look forward to the year ahead as we transition from the development of AFRESA into
commercial readiness.
Conference Call
MannKind management will host a conference call to discuss these results today at 4:00 PM ET. 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 (800) 756-2759 or (402) 998-0791.
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 Matthew Pfeffer |
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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 pipeline includes AFRESA, which has completed Phase 3 clinical trials, and MKC253,
which is currently in Phase 1 clinical trials. Both of these investigational products are being
evaluated for their safety and efficacy in the treatment of diabetes. MannKind maintains a website
at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press release as
well as additional information about MannKind. Interested persons can subscribe on the MannKind
website to email alerts that are sent automatically when MannKind issues press releases, files its
reports with the SEC or posts certain other information to the website.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to
differentiating AFRESA from other insulins. 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 MannKinds 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 progress, timing
and results of clinical trials, difficulties or delays in seeking or obtaining regulatory approval,
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, 2007 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
(A Development Stage Company)
Condensed Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
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Cumulative |
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period from |
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February 14, |
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1991 (date of |
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Three months ended |
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Twelve months ended |
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inception) to |
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December 31, |
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December 31, |
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December 31, |
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2008 |
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2007 |
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2008 |
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2007 |
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2008 |
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Revenue |
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$ |
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$ |
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$ |
20 |
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$ |
10 |
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$ |
2,988 |
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Operating expenses: |
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Research and development |
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68,777 |
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66,751 |
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250,442 |
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256,844 |
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997,482 |
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General and administrative |
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12,978 |
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12,316 |
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55,343 |
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50,523 |
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245,842 |
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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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81,755 |
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79,067 |
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305,785 |
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307,367 |
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1,414,478 |
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Loss from operations |
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(81,755 |
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(79,067 |
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(305,765 |
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(307,357 |
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(1,411,490 |
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Other expense |
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(55 |
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(355 |
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(62 |
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(197 |
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(1,943 |
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Interest expense on note payable to
principal stockholder |
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(12 |
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(12 |
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(1,523 |
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Interest expense on senior convertible
notes |
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(1,742 |
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(584 |
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(2,327 |
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(3,408 |
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(5,957 |
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Interest income |
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271 |
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4,996 |
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5,129 |
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17,775 |
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36,861 |
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Loss before provision for income taxes |
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(83,293 |
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(75,010 |
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(303,037 |
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(293,187 |
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(1,384,052 |
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Income taxes |
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(2 |
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(3 |
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(2 |
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(3 |
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(26 |
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Net loss |
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(83,295 |
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(75,013 |
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(303,039 |
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(293,190 |
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(1,384,078 |
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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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$ |
(83,295 |
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$ |
(75,013 |
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$ |
(303,039 |
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$ |
(293,190 |
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$ |
(1,407,290 |
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Net loss per share applicable to
common stockholders basic and
diluted |
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$ |
(0.82 |
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$ |
(0.75 |
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$ |
(2.98 |
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$ |
(3.66 |
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Shares used to compute basic and
diluted net loss per share applicable
to common stockholders |
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101,758 |
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99,605 |
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101,561 |
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80,038 |
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MannKind Corporation
(A Development Stage Company)
Condensed Balance Sheet
(Unaudited)
(in thousands)
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December 31, 2008 |
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December 31, 2007 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
27,648 |
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$ |
368,285 |
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Marketable securities |
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18,844 |
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State research and development credit exchange receivable current |
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1,500 |
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831 |
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Prepaid expenses and other current assets |
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5,983 |
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9,596 |
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Total current assets |
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53,975 |
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378,712 |
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Property and equipment net |
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226,436 |
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162,683 |
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State research and development credit exchange receivable net of current portion |
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1,500 |
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1,500 |
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Other assets |
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548 |
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548 |
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Total |
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$ |
282,459 |
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$ |
543,443 |
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Liabilities and Stockholders Equity |
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Current liabilities |
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$ |
53,472 |
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$ |
67,558 |
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Senior convertible notes |
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112,253 |
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111,761 |
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Note payable to principal stockholder |
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30,000 |
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Other liabilities |
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24 |
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Stockholders equity |
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86,734 |
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364,100 |
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Total |
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$ |
282,459 |
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$ |
543,443 |
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