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): November 5, 2008
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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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))
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Item 2.02 |
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Results of Operations and Financial Condition |
On November 5, 2008, MannKind Corporation issued a press release announcing its financial results
for the third quarter of 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.
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Item 9.01 |
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Financial Statements and Exhibits |
(c) |
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Exhibits. The following exhibit is furnished herewith: |
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99.1 |
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Press Release of MannKind Corporation dated November 5, 2008,
reporting MannKinds financial results for the third quarter of 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: |
/s/ Matthew J. Pfeffer
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Name: |
Matthew J. Pfeffer |
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Title: |
Corporate Vice
President and Chief
Financial Officer |
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Dated: November 5, 2008
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 November 5, 2008,
reporting MannKinds financial results for the third quarter of 2008. |
exv99w1
Exhibit 99.1
Company Contact:
Matthew Pfeffer
Chief Financial Officer
661-295-4784
mpfeffer@mannkindcorp.com
MANNKIND CORPORATION REPORTS THIRD QUARTER FINANCIAL RESULTS
Conference Call Today at 9:00 a.m. EST
VALENCIA, Calif., November 5, 2008 MannKind Corporation (Nasdaq: MNKD) today reported
financial results for the third quarter ended September 30, 2008.
For the third quarter of 2008, total operating expenses were $69.1 million, compared to $75.6
million for the third quarter of 2007, primarily attributable to the $9.2 million reduction in
research and development (R&D) expenses which totaled $55.6 million for this quarter compared to
$64.8 million for the same quarter in 2007. The decrease in R&D expenses for the three months
ended September 30, 2008 as compared to the same period in the prior year was primarily due to
decreased costs associated with the clinical development of AFRESA (formerly identified as the
Technosphere Insulin System) and the related manufacturing costs associated with clinical trial
materials, partially offset by increased stock-based compensation expense and increased
facilities-related expenses. General and administrative (G&A) expenses increased by $2.7 million
to $13.4 million for the third quarter of 2008 compared to the third quarter of 2007. G&A expenses
for the three months ended September 30, 2008 increased as compared to the same period in the prior
year primarily due to increased employee-related and consulting expenses and increased stock-based
compensation expense.
For the first nine months of 2008, operating expenses totaled $224.0 million, compared to $228.3
million in the first nine months of 2007. R&D expenses for the first nine months were $181.7
million, compared to $190.1 million in 2007. The decrease in R&D expenses for the nine months
ended September 30, 2008, as compared to the same period in the prior year was primarily due to
decreased costs associated with the clinical development of AFRESA and the related manufacturing
costs associated with clinical trial materials, partially offset by increased stock-based
compensation expense and increased facilities-related expenses. G&A expenses increased by $4.2
million to $42.4 million for the first nine months of 2008 as compared to the same period in 2007.
G&A expenses for the nine months ended September 30, 2008 increased as compared to the same period
in the prior year primarily due to increased employee-related and
consulting expenses and increased stock-based compensation expense, offset by decreased
professional fees.
We anticipate that our R&D expenses associated with AFRESA will continue to decline as we close out
our pivotal clinical studies and complete preparations for the filing of our New Drug Application
(NDA) with the U.S. Food and Drug Administration (FDA). We expect G&A expenses, other than non-cash
stock-based compensation expense, to remain constant in the future.
The net loss for the third quarter of 2008 was $68.5 million, or $0.67 per share, based on 101.6
million weighted average shares outstanding. This compares to a net loss of $73.0 million, or
$0.99 per share, based on 73.5 million weighted average shares outstanding for the third quarter of
2007.
The net loss for the first nine months of 2008 was $219.7 million, or $2.17 per share based on
101.5 million shares outstanding, compared with a net loss of $218.2 million, or $2.97 per share
based on 73.4 million shares outstanding, for the first nine months of 2007.
Cash and cash equivalents and marketable securities were $95.2 million at September 30, 2008,
$180.5 million at June 30, 2008, and $368.3 million at December 31, 2007.
MannKind has made great progress this quarter, commented Alfred Mann, Chairman and Chief
Executive Officer. Our pivotal trials are completed and we are well along in preparation of the
AFRESA NDA submission to the FDA. We have completed and dedicated our new manufacturing facility
and equipped it with the first stage of the modular production systems that will be used to supply
commercial product. The emerging data support our belief that AFRESA will be a very important
prandial insulin for most people with type 1 and type 2 diabetes. We will soon be ready to
reinitiate discussions with potential partners.
Conference Call
MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern
Time. 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 fourteen days. A telephone replay will be accessible for approximately 14 days
following completion of the call by dialing (866) 411-1707 or (203) 369-0654 and entering
conference number 4423761.
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 https://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 MannKinds
expected R&D and G&A expenses, clinical trials, product candidates, regulatory submissions,
manufacturing facility and partnership opportunities 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 AFRESA, competition from other pharmaceutical or
biotechnology companies, MannKinds ability to enter into any collaborations or strategic
partnerships, intellectual property matters, stock price volatility 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 data)
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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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Nine months ended |
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inception) to |
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September 30, |
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September 30, |
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September 30, |
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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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55,645 |
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64,825 |
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181,665 |
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190,093 |
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928,705 |
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General and administrative |
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13,435 |
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10,744 |
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42,365 |
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38,207 |
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232,864 |
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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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69,080 |
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75,569 |
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224,030 |
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228,300 |
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1,332,723 |
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Loss from operations |
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(69,080 |
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(75,569 |
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(224,010 |
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(228,290 |
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(1,329,735 |
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Other income (expense) |
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(7 |
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62 |
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(7 |
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158 |
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(1,888 |
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Interest expense on note payable to
principal stockholder |
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(1,511 |
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Interest expense on senior convertible
notes |
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(124 |
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(778 |
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(585 |
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(2,824 |
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(4,215 |
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Interest income |
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715 |
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3,238 |
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4,858 |
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12,779 |
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36,590 |
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Loss before provision for income taxes |
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(68,496 |
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(73,047 |
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(219,744 |
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(218,177 |
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(1,300,759 |
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Income taxes |
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(24 |
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Net loss |
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(68,496 |
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(73,047 |
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(219,744 |
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(218,177 |
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(1,300,783 |
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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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$ |
(68,496 |
) |
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$ |
(73,047 |
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$ |
(219,744 |
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$ |
(218,177 |
) |
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$ |
(1,323,995 |
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Net loss per share applicable to
common stockholders basic and
diluted |
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$ |
(0.67 |
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$ |
(0.99 |
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$ |
(2.17 |
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$ |
(2.97 |
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Shares used to compute basic and
diluted net loss per share applicable
to common stockholders |
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101,647 |
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73,520 |
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101,495 |
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73,444 |
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MANNKIND CORPORATION
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Unaudited)
(In thousands except share data)
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September 30, 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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$ |
31,582 |
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$ |
368,285 |
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Marketable securities |
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63,651 |
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State research and development credit exchange |
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831 |
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Prepaid expenses and other current assets |
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7,709 |
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9,596 |
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Total current assets |
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102,942 |
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378,712 |
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Property and equipment net |
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225,515 |
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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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2,625 |
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1,500 |
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Other assets |
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550 |
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548 |
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Total |
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$ |
331,632 |
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$ |
543,443 |
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities: |
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Accounts payable |
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$ |
19,992 |
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$ |
35,463 |
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Accrued expenses and other current liabilities |
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36,087 |
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32,095 |
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Total current liabilities |
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56,079 |
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67,558 |
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Senior convertible notes |
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112,128 |
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111,761 |
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Other liabilities |
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24 |
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Total liabilities |
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168,207 |
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179,343 |
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Commitments and contingencies |
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Stockholders equity: |
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Undesignated preferred stock, $0.01 par value 10,000,000 shares authorized; no
shares issued or outstanding at September 30, 2008 and December 31, 2007 |
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Common stock, $0.01 par value 150,000,000 shares authorized; 101,710,590 and
101,380,823 shares issued and outstanding at September 30, 2008 and December 31,
2007, respectively |
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1,017 |
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1,014 |
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Additional paid-in capital |
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1,463,191 |
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1,444,125 |
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Deficit accumulated during the development stage |
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(1,300,783 |
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(1,081,039 |
) |
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Total stockholders equity |
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163,425 |
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364,100 |
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Total |
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$ |
331,632 |
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$ |
543,443 |
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