Table of Contents
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
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 3, 2006
MannKind Corporation
(Exact name of registrant as specified in its charter)
| Delaware | 000-50865 | 13-3607736 | ||
| (State or other jurisdiction of | (Commission File Number) | (IRS Employer | ||
| incorporation) | Identification No.) |
| 28903 North Avenue Paine | ||||
| Valencia, California | 91355 | |||
| (Address of principal executive offices) | (Zip Code) |
Registrant’s 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):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 Results of Operations and Financial Condition | ||||||||
| Item 9.01 Financial Statements and Exhibits | ||||||||
| SIGNATURE | ||||||||
| EXHIBIT INDEX | ||||||||
| EXHIBIT 99.1 | ||||||||
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Item 2.02 Results of Operations and Financial Condition
On August 3, 2006, MannKind Corporation issued a press release announcing its financial results for
the second 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:
| 99.1 | Press Release of MannKind Corporation dated August 3, 2006, reporting MannKind’s financial results for the second quarter of 2006. |
Table of Contents
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.
| MANNKIND CORPORATION |
||||
| By: | /s/ Richard L. Anderson | |||
| Name: | Richard L. Anderson | |||
| Title: | Chief Financial Officer | |||
Dated: August 3, 2006
Table of Contents
EXHIBIT INDEX
| Number | Description | |
99.1
|
Press Release of MannKind Corporation dated August 3, 2006, reporting MannKind’s financial results for the second quarter of 2006. |
EXHIBIT 99.1
Company Contact:
|
Financial Dynamics: | |
Dick Anderson
|
Julie Huang (investors) | |
Chief Financial Officer
|
Robert Stanislaro (media) | |
661-775-5302
|
212-850-5600 | |
danderson@mannkindcorp.com
|
mnkd@fd-us.com |
MannKind Corporation Reports Second Quarter Financial Results
Company to Host Conference Call at 8:00 a.m. EDT
VALENCIA, Calif., August 3, 2006 — MannKind Corporation (Nasdaq: MNKD) today reported financial
results for the second quarter and six months ended June 30, 2006.
For the second quarter of 2006, total operating expenses were $55.8 million, compared with $27.6
million for the second quarter of 2005. Research and development (R&D) expenses increased by $21.7
million to $45.3 million, primarily due to increased costs associated with the Company’s expanded
clinical trials and related support for its Technosphere(R) Insulin program. General and
administrative (G&A) expenses increased by $6.5 million to $10.5 million 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.
For the first six months of 2006, operating expenses totaled $100.9 million, compared with $50.2
million in the first half of 2005. R&D expenses were $81.3 million, up $39.0 million, again
primarily related to the expansion of clinical trials of MannKind’s Technosphere(R) Insulin
program. G&A expenses increased by $11.7 million to $19.6 million for the first half of 2006
primarily related to increased stock compensation expense, compensation and other employee related
costs and increased legal, accounting and consulting fees.
The net loss applicable to common stockholders for the second quarter of 2006 was $54.8 million, or
$1.10 per share based on 49.6 million shares outstanding, compared with a net loss applicable to
common stockholders of $27.2 million, or $0.83 per share based on 32.8 million shares outstanding,
for the second quarter of 2005.
The net loss applicable to common stockholders for the first half of 2006 was $98.3 million, or
$1.98 per share based on 49.7 million shares outstanding, compared with a net loss applicable to
common stockholders of $49.3 million, or $1.50 per share based on 32.8 million shares outstanding,
for the first half of 2005.
Cash, cash equivalents and marketable securities were $50.9 million at June 30, 2006 and $102.6
million at March 31, 2006.
“During the second quarter of this year, MannKind announced additional data on our lead
investigational compound, Technosphere(R) Insulin, and its novel effect on the treatment of
diabetes,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation.
“Importantly, Study 101 demonstrated that patients with Type 1 diabetes who switched from meal time
rapid acting insulin analog injections to Technosphere(R) Insulin achieved comparable levels of
control in HbA1c and superior effects on post prandial glucose excursions. We plan to present data
from our Phase 3 results from Study 014 at the European Association for the Study of Diabetes in
September. During the second quarter, we also initiated an additional major Phase 3 trial, Study
103. Overall, we believe this has been another strong period for the continuous advancement of
Technosphere(R) Insulin.”
MannKind also announced today that it has entered into a loan agreement with Mr. Mann under which
the Company may borrow up to $150 million and has initiated the first borrowing under that
agreement in the amount of $50 million.
Conference Call
MannKind management will host a conference call to discuss these results today at 8:00 a.m. Eastern
Daylight Time. To participate in the call please dial (888) 566-5775 or listen to the call on the
Internet at www.mannkindcorp.com. A telephone replay will be accessible until August 10, 2006 by
dialing (800) 884-1524. The web site replay can be accessed at www.mannkindcorp.com and will be
available for fourteen days.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of
therapeutic products for diseases such as diabetes and cancer. The Company is currently in phase 3
clinical trials of its lead product, the Technosphere(R) Insulin System, in the U.S. and Europe to
study its potential for 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 MannKind’s
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 Company’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, 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, intellectual property matters, difficulties or delays in seeking or
obtaining regulatory approval, manufacturing the Company’s lead product candidate, competition from
other pharmaceutical or biotechnology companies, the Company’s ability to enter into any
collaborations or strategic partnerships or obtain additional financing to support the Company’s
operations, the Company’s ability to meet milestones and other risks detailed in MannKind’s 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)
| (In thousands, except per share amounts) | Three Months Ended | Six Months Ended | ||||||||||||||
| June 30, | June 30, | June 30, | June 30, | |||||||||||||
| 2006 | 2005 | 2006 | 2005 | |||||||||||||
Revenue |
$ | — | $ | — | $ | 100 | $ | — | ||||||||
Operating expenses: |
||||||||||||||||
Research and development |
45,321 | 23,596 | 81,271 | 42,292 | ||||||||||||
General and administrative |
10,456 | 3,971 | 19,594 | 7,922 | ||||||||||||
Total operating expenses |
55,777 | 27,567 | 100,865 | 50,214 | ||||||||||||
Loss from operations |
(55,777 | ) | (27,567 | ) | (100,765 | ) | (50,214 | ) | ||||||||
Other income |
59 | 7 | 109 | 21 | ||||||||||||
Interest income |
971 | 405 | 2,351 | 877 | ||||||||||||
Loss before provision for income taxes |
(54,747 | ) | (27,155 | ) | (98,305 | ) | (49,316 | ) | ||||||||
Income taxes |
(4 | ) | — | (5 | ) | (1 | ) | |||||||||
Net loss applicable to common stockholders |
$ | (54,751 | ) | $ | (27,155 | ) | $ | (98,310 | ) | $ | (49,317 | ) | ||||
Net loss per share applicable to common
stockholders — basic and diluted |
$ | (1.10 | ) | $ | (0.83 | ) | $ | (1.98 | ) | $ | (1.50 | ) | ||||
Shares used to compute basic and diluted net
loss per share applicable to common
stockholders |
49,638 | 32,777 | 49,712 | 32,771 | ||||||||||||
MannKind Corporation
Condensed Balance Sheet
(Unaudited)
(in thousands)
Condensed Balance Sheet
(Unaudited)
(in thousands)
| June 30, | December 31, | |||||||
Assets |
2006 |
2005 | ||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 27,056 | $ | 56,037 | ||||
Marketable securities |
23,800 | 89,597 | ||||||
State research and development tax credit exchange
receivable – current |
1,043 | 1,194 | ||||||
Prepaid expenses and other current assets |
6,952 | 3,044 | ||||||
Total current assets |
58,851 | 149,872 | ||||||
Property and equipment – net |
83,190 | 76,183 | ||||||
State research and development tax credit exchange receivable
- - net of current portion |
2,250 | 2,031 | ||||||
Other assets |
288 | 285 | ||||||
Total |
$ | 144,579 | $ | 228,371 | ||||
Liabilities and Stockholders’ Equity |
||||||||
Current liabilities |
$ | 27,134 | $ | 21,365 | ||||
Other liabilities |
24 | 29 | ||||||
Stockholders’ equity |
117,421 | 206,977 | ||||||
Total |
$ | 144,579 | $ | 228,371 | ||||
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