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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 5, 2006
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):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
TABLE OF CONTENTS
Item 2.02 Results of Operations and Financial Condition
On May 5, 2006, MannKind Corporation issued a press release announcing its financial results for
the first quarter of 2006. 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 May 5, 2006, reporting
MannKinds financial results for the first quarter of 2006. |
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/ Richard L. Anderson
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Name: |
Richard L. Anderson |
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Title: |
Chief Financial Officer |
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Dated: May 5, 2006
EXHIBIT INDEX
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Number |
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Description |
99.1
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Press Release of MannKind
Corporation dated May 5,
2006, reporting MannKinds
financial results for the
first quarter of 2006. |
exv99w1
EXHIBIT 99.1
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Company Contact:
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Financial Dynamics: |
Dick Anderson
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Julie Huang (investors) |
Chief Financial Officer
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Robert Stanislaro (media) |
661-775-5302
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212-850-5600 |
danderson@mannkindcorp.com
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mnkd@fd-us.com |
MANNKIND CORPORATION REPORTS FIRST QUARTER FINANCIAL RESULTS
- - Conference Call to Begin Today at 9:00 a.m. ET -
VALENCIA, Calif., May 5, 2006 MannKind Corporation (Nasdaq NM: MNKD) today reported
financial results for the three months ended March 31, 2006.
For the first quarter of 2006, total operating expenses were $45.1 million, compared with $22.6
million for the first quarter of 2005. Research and development (R&D) expenses increased by $17.3
million to $36.0 million for the first quarter of 2006 compared to the first quarter of 2005,
primarily due to increased costs associated with the Companys expanded clinical development
program for Technosphere® Insulin, which is currently in Phase 3 clinical trials in the
U.S. and Europe. General and administrative (G&A) expenses increased by $5.1 million to $9.1
million for the first quarter of 2006 compared to the first quarter of 2005 primarily due to an
increase in stock compensation expense and increased consulting and various other general and
administrative expenses, such as legal and accounting fees.
The net loss applicable to common stockholders for the first quarter of 2006 was $43.6 million, or
$0.87 per share based on 49.8 million shares outstanding, compared with a net loss applicable to
common stockholders of $22.2 million, or $0.68 per share based on 32.8 million shares outstanding,
for the first quarter of 2005.
Cash, cash equivalents and marketable securities were $102.6 million at March 31, 2006 and $145.6
million at December 31, 2005.
In first quarter of 2006, we announced the initiation of two pivotal Phase 3 clinical trials of
Technosphere Insulin in patients with type 1 and type 2 diabetes, said Alfred Mann, Chairman and
Chief Executive Officer of MannKind Corporation. We expect to initiate our last pivotal trial
shortly.
Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation added, In April we
announced the results of a study that demonstrated that patients with type 1 diabetes using
Technosphere Insulin can achieve much lower post meal glucose excursions and comparable levels of
HbA1c as patients
treated with an injected rapid-acting insulin analog. Our study also found that patients using
Technosphere Insulin experienced some weight loss in contrast to the weight gain experienced by
patients using the injected rapid-acting insulin analog. Furthermore, after twelve weeks of
treatment, pulmonary function did not differ between the two patient groups and there were no
incidents of severe hypoglycemia.
Conference Call
MannKind management will host a conference call to discuss the first quarter results today at 9:00
a.m. Eastern Time. To participate in the call please dial (888) 566-5775 or (210) 839-8503. To
listen to the call via the Internet please visit www.mannkindcorp.com. A telephone replay will be
accessible for approximately 48 hours following completion of the call by dialing (800) 234-3897 or
(402) 220-9689 and entering passcode MNKD. The web site replay will be available for fourteen
days.
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 Dick Anderson |
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of
therapeutic products for diseases such as diabetes and cancer. Its lead investigational product
candidate, the Technosphere® Insulin System, is currently in phase 3 clinical trials in the U.S.
and Europe to study its safety and efficacy in the treatment of diabetes. For more information on
MannKind Corporation and its technology, visit www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to MannKinds
clinical trials and product candidates 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, the risk that future safety and efficacy studies may not confirm
our past clinical results, risks related to intellectual property matters, difficulties or delays
in seeking or obtaining regulatory approval, risks related to manufacturing the Companys lead
product candidate, risks related to competition from other pharmaceutical or biotechnology
companies, risks related to the Companys ability to enter into any collaborations or strategic
partnerships or obtain additional financing to support the Companys operations, risks related to
the Companys ability to meet milestones and other risks detailed in MannKinds filings with the
SEC, including the Annual Report on Form 10-K for the year ended December 31, 2005 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
news release.
(Tables to follow)
MannKind Corporation
Consolidated Statements of Operations
(Unaudited)
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(In thousands, except per share |
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amounts) |
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Three Months Ended March 31, |
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2006 |
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2005 |
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Revenue |
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$ |
100 |
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$ |
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Operating expenses: |
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Research and development |
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35,950 |
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18,696 |
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General and administrative |
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9,138 |
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3,951 |
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Total operating expenses |
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45,088 |
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22,647 |
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Loss from operations |
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(44,988 |
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(22,647 |
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Other income |
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50 |
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14 |
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Interest income |
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1,380 |
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472 |
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Loss before provision for income taxes |
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(43,558 |
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(22,161 |
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Income taxes |
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(1 |
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(1 |
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Net loss applicable to common
stockholders |
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$ |
(43,559 |
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$ |
(22,162 |
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Net loss per share applicable to
common stockholders basic and
diluted |
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$ |
(0.87 |
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$ |
(0.68 |
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Shares used to compute basic and
diluted net loss per share applicable
to common stockholders |
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49,787 |
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32,764 |
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MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
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March 31, |
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December 31, |
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Assets |
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2006 |
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2005 |
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Current assets: |
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Cash and cash equivalents |
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$ |
45,889 |
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$ |
56,037 |
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Marketable securities |
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56,700 |
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89,597 |
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State research and development tax credit exchange
receivable current |
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1,044 |
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1,194 |
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Prepaid expenses and other current assets |
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5,907 |
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3,044 |
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Total current assets |
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109,540 |
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149,872 |
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Property and equipment net |
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80,289 |
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76,183 |
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State research and development tax credit exchange receivable
net of current portion |
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1,875 |
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2,031 |
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Other assets |
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287 |
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285 |
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Total |
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$ |
191,991 |
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$ |
228,371 |
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Liabilities and Stockholders Equity |
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Current liabilities |
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$ |
24,257 |
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$ |
21,365 |
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Other liabilities |
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24 |
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29 |
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Stockholders equity |
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167,710 |
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206,977 |
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Total |
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$ |
191,991 |
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$ |
228,371 |
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# # #