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
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 6, 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 February 6, 2006, MannKind Corporation issued a press release announcing its financial results
for the fourth quarter of 2005. 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:
| 99.1 | Press Release of MannKind Corporation dated February 6, 2006, reporting MannKind’s financial results for the fourth quarter of 2005. |
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: February 6, 2006
Table of Contents
EXHIBIT INDEX
| Number | Description | |
99.1
|
Press Release of MannKind Corporation dated February 6, 2006, reporting MannKind’s financial results for the fourth quarter of 2005. |
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 FOURTH QUARTER AND FULL YEAR 2005
FINANCIAL RESULTS
FINANCIAL RESULTS
- Conference Call to Begin Today at 9:00 a.m. ET -
VALENCIA, Calif., February 6, 2006 — MannKind Corporation (Nasdaq NM: MNKD) today reported
financial results for the fourth quarter and year ended December 31, 2005.
For the fourth quarter of 2005, total operating expenses were $35.0 million, compared with $21.7
million for the fourth quarter of 2004. Research and development (R&D) expenses increased by $8.1
million to $28.6 million for the fourth quarter of 2005 compared to the fourth quarter of 2004,
primarily due to increased costs associated with the Company’s 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 $5.3 million to $6.5
million for the fourth quarter of 2005 compared to the fourth quarter of 2004 primarily due to
changes 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 fourth quarter of 2005 was $33.3 million, or
$0.66 per share based on 50.3 million shares outstanding, compared with a net loss applicable to
common stockholders of $21.2 million, or $0.65 per share based on 32.8 million shares outstanding,
for the fourth quarter of 2004.
For the year ended December 31, 2005, total operating expenses were $118.1 million, compared with
$77.1 million for 2004. R&D expenses were $95.3 million in 2005, up $35.9 million from 2004,
primarily related to the expansion of clinical trials of the Technosphere Insulin program. G&A
expenses increased by $5.1 million to $22.8 million for 2005 as compared to 2004 primarily related
to increased compensation and other employee related costs and increased legal, accounting and
consulting fees.
The net loss applicable to common stockholders for 2005 was $114.3 million, or $2.87 per share
based on 39.9 million shares outstanding, compared with a net loss applicable to common
stockholders of $95.9 million, or $3.80 per share based on 25.2 million shares outstanding for
2004.
“2005 was an exceptional year for MannKind,” said Alfred Mann, Chairman and Chief Executive Officer
of MannKind Corporation. “In addition to strengthening our balance sheet and expanding our
management team, we added to the growing evidence of the safety, efficacy, and other
differentiating qualities of our lead investigational product candidate, Technosphere Insulin, an
inhalable form of insulin for type 1 and type 2 diabetes.”
Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation added, “In recent
clinical trials, we observed that the Technosphere Insulin System reduces blood glucose excursions
following a meal compared to the effect seen with oral or injectable diabetes medications. At the
same time, Technosphere Insulin appears to reduce the risk of late postprandial hypoglycemia
commonly associated with other diabetes products, without any evidence of weight gain or
deterioration in pulmonary function.”
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. A telephone replay will be
accessible for approximately 48 hours following completion of the call by dialing (866) 350-6999 or
(203) 369-0042 and entering conference number 1437837. The web site replay will be available for
fourteen days.
Presenting from the Company will be:
| • | Chairman and Chief Executive Officer Alfred Mann | ||
| • | President and Chief Operating Officer Hakan Edstrom | ||
| • | 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 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, risks related to intellectual property matters,
difficulties or delays in seeking or obtaining regulatory approval, risks related to manufacturing
the Company’s lead product candidate, risks related to competition from other pharmaceutical or
biotechnology companies, risks related to the Company’s ability to enter into any collaborations or
strategic partnerships or obtain additional financing to support the Company’s operations, risks
related to 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, 2004 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)
Consolidated Statements of Operations
(Unaudited)
| (In thousands, except per share | ||||||||||||||||
| amounts) | Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2005 | 2004 | 2005 | 2004 | |||||||||||||
Revenue |
— | — | — | — | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
28,589 | 20,506 | 95,347 | 59,406 | ||||||||||||
General and administrative |
6,457 | 1,191 | 22,775 | 17,743 | ||||||||||||
Total operating expenses |
35,046 | 21,697 | 118,122 | 77,149 | ||||||||||||
Loss from operations |
(35,046 | ) | (21,697 | ) | (118,122 | ) | (77,149 | ) | ||||||||
Other income (expense) |
85 | 114 | 78 | 226 | ||||||||||||
Interest income |
1,669 | 433 | 3,707 | 932 | ||||||||||||
Loss before provision for income taxes |
(33,292 | ) | (21,150 | ) | (114,337 | ) | (75,991 | ) | ||||||||
Income taxes |
0 | 0 | (1 | ) | (1 | ) | ||||||||||
Net loss |
(33,292 | ) | (21,150 | ) | (114,338 | ) | (75,992 | ) | ||||||||
Deemed dividend related to beneficial
conversion feature of convertible
preferred stock |
0 | 0 | 0 | (19,822 | ) | |||||||||||
Accretion on redeemable preferred
stock |
0 | 0 | 0 | (60 | ) | |||||||||||
Net loss applicable to common
stockholders |
$ | (33,292 | ) | $ | (21,150 | ) | $ | (114,338 | ) | $ | (95,874 | ) | ||||
Net loss per share applicable to
common stockholders — basic and
diluted |
$ | (0.66 | ) | $ | (0.65 | ) | $ | (2.87 | ) | $ | (3.80 | ) | ||||
Shares used to compute basic and
diluted net loss per share applicable
to common stockholders |
50,250 | 32,768 | 39,871 | 25,221 | ||||||||||||
MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
| December 31, | December 31, | |||||||
| Assets | 2005 | 2004 | ||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 56,037 | $ | 78,987 | ||||
Marketable securities |
89,597 | 11,546 | ||||||
Restricted cash |
583 | |||||||
State research and development tax credit exchange
receivable — current |
1,194 | 1,500 | ||||||
Prepaid expenses and other current assets |
3,044 | 3,265 | ||||||
Total current assets |
149,872 | 95,881 | ||||||
Property and equipment — net |
76,183 | 66,511 | ||||||
State research and development tax credit exchange receivable — net of current portion |
2,031 | 1,030 | ||||||
Other assets |
285 | 61 | ||||||
Total |
$ | 228,371 | $ | 163,483 | ||||
Liabilities and Stockholders’ Equity |
||||||||
Current liabilities |
$ | 21,365 | $ | 13,044 | ||||
Other liabilities |
29 | 76 | ||||||
Stockholders’ equity |
206,977 | 150,363 | ||||||
Total |
$ | 228,371 | $ | 163,483 | ||||
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