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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): February 2, 2007
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
incorporation)
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(Commission File Number)
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(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)) |
TABLE OF CONTENTS
Item 2.02 Results of Operations and Financial Condition
On February 2, 2007, MannKind Corporation issued a press release announcing its financial results
for the fourth 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 filed herewith:
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99.1 |
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Press Release of MannKind Corporation dated February 2, 2007,
reporting MannKinds financial results for the fourth 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: February 2, 2007
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 February 2, 2007, reporting MannKinds financial results for the fourth quarter of 2006. |
exv99w1
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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.com |
MANNKIND CORPORATION REPORTS FOURTH QUARTER AND FULL YEAR 2006 FINANCIAL RESULTS
- Conference Call to Begin Today at 9:00 a.m. ET -
VALENCIA, Calif., February 2, 2007 MannKind Corporation (Nasdaq: MNKD) today reported
financial results for the fourth quarter and year ended December 31, 2006.
For the fourth quarter of 2006, total operating expenses were $71.8 million, compared with $35.0
million for the fourth quarter of 2005. Research and development (R&D) expenses increased by $31.2
million to $59.7 million for the fourth quarter of 2006 compared to the fourth quarter of 2005,
primarily due to increased costs associated with the Companys expanded clinical development
program for Technosphere® Insulin. All of the pivotal Phase 3 trials are now under way
in the United States, Latin America and Europe. General and administrative (G&A) expenses
increased by $5.6 million to $12.1 million for the fourth quarter of 2006 compared to the fourth
quarter of 2005 primarily due to changes in stock-based compensation expense and increased
consulting and various other general and administrative expenses. The total number of employees
increased from 428 at the end of 2005 to 545 at the end of 2006.
The net loss applicable to common stockholders for the fourth quarter of 2006 was $71.3 million, or
$1.30 per share based on 54.7 million weighted average shares outstanding, compared with a net loss
applicable to common stockholders of $33.3 million, or $0.66 per share based on 50.3 million
weighted average shares outstanding, for the fourth quarter of 2005.
For the year ended December 31, 2006, total operating expenses were $233.8 million, compared with
$118.1 million for 2005. R&D expenses were $191.8 million in 2006, up $96.4 million from 2005,
primarily related to the expansion of clinical trials of the Technosphere Insulin program. G&A
expenses increased by $19.2 million to $42.0
million for 2006 as compared to 2005 primarily related to increased stock compensation expense and
increased legal, accounting and consulting fees. The net loss applicable to common stockholders
for 2006 was $230.5 million, or $4.52 per share based on 51.0 million weighted average shares
outstanding, compared with a net loss applicable to common stockholders of $114.3 million, or $2.87
per share based on 39.9 million weighted averages shares outstanding for 2005. In December 2006,
the Company sold 23.0 million shares of common stock and issued $115.0 million of convertible
notes, raising gross proceeds of $515.7 million. The resulting aggregate net proceeds from these
offerings after expenses was $495.9 million. The number of common shares outstanding at December
31, 2006 was 73,360,154.
Cash, cash equivalents and marketable securities were $436.5 million at December 31, 2006, $50.1
million at September 30, 2006, and $145.6 million at December 31, 2005.
2006 was another exceptional year for MannKind marked with significant growth and progress. We
continue to grow as an organization led by a team of very skilled and experienced managers. We
remain committed to our clinical progress and goals, reflecting our confidence in Technosphere
Insulin. New data continues to affirm the exciting attributes of Technosphere Insulin. In our
completed studies to date, we have seen little, if any, need for meal titration, significant
improvement in glycemic control overall and in post-meal profiles, virtually no risk of severe
hypoglycemia, no weight gain, and no adverse effect on pulmonary function, said Alfred Mann,
Chairman and Chief Executive Officer of MannKind Corporation. All of our pivotal trials are under
way and the two year pulmonary safety trial, the gating trial for filing, was fully enrolled with
2,051 patients in September 2006. We are continuing the expansion of our manufacturing operations
in Danbury, CT, and have completed a successful round of financing this year, and received
clearance from the FDA to begin a Phase 1 trial of our first cancer immunotherapy product. In 2007,
we will continue on our path to bring Technosphere Insulin to market as quickly as possible.
Conference Call
MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern
Standard 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. 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) 443-4144 or (203) 369-1112 and entering
conference number 2363265.
Presenting from the Company will be:
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Chairman and Chief Executive Officer Alfred Mann |
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Corporate Vice President and Chief Scientific Officer Peter Richardson |
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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 product, the Technosphere
Insulin System, is currently in Phase 3 clinical trials in the United States, Europe and Latin
America to study its safety and efficacy in the treatment of diabetes. For more information on
MannKind Corporation and its technology, visit http://www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to MannKinds
clinical trials, product candidates and organizational development 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 the Technosphere Insulin System, competition
from other pharmaceutical or biotechnology companies, MannKinds ability to enter into any
collaborations or strategic partnerships, intellectual property matters 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, 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 press 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 December 31, |
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Year Ended December 31, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenue |
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$ |
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$ |
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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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59,740 |
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28,589 |
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191,796 |
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95,347 |
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General and administrative |
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12,058 |
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6,457 |
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42,001 |
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22,775 |
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Total operating expenses |
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71,798 |
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35,046 |
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233,797 |
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118,122 |
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Loss from operations |
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(71,798 |
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(35,046 |
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(233,697 |
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(118,122 |
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Other income |
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48 |
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85 |
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208 |
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78 |
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Interest expense on note payable to
principal stockholder |
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(822 |
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(1,511 |
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Interest expense on convertible debt |
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(222 |
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(222 |
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Interest income |
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1,526 |
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1,669 |
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4,679 |
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3,707 |
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Loss before provision for income taxes |
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(71,268 |
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(33,292 |
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(230,543 |
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(114,337 |
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Income taxes |
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(5 |
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(1 |
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Net loss applicable to common
stockholders |
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$ |
(71,268 |
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$ |
(33,292 |
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$ |
(230,548 |
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$ |
(114,338 |
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Net loss per share applicable to
common stockholders basic and
diluted |
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$ |
(1.30 |
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$ |
(0.66 |
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$ |
(4.52 |
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$ |
(2.87 |
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Shares used to compute basic and
diluted net loss per share applicable
to common stockholders |
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54,684 |
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50,250 |
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50,970 |
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39,871 |
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MannKind Corporation
Condensed Balance Sheet
(Unaudited)
(in thousands)
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December 31, |
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December 31, |
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2006 |
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2005 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
319,555 |
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$ |
56,037 |
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Marketable securities |
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116,924 |
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89,597 |
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State research and development tax credit exchange
receivable current |
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2,418 |
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1,194 |
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Prepaid expenses and other current assets |
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10,650 |
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3,044 |
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Total current assets |
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449,547 |
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149,872 |
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Property and equipment net |
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88,328 |
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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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1,500 |
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2,031 |
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Other assets |
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362 |
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285 |
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Total |
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$ |
539,737 |
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$ |
228,371 |
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Liabilities and Stockholders Equity |
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Current liabilities |
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$ |
44,959 |
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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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Senior convertible notes |
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111,267 |
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Stockholders equity |
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383,487 |
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206,977 |
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Total |
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$ |
539,737 |
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$ |
228,371 |
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# # #