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 1, 2010
MannKind
Corporation
(Exact
name of registrant as specified in its charter)
Delaware |
000-50865 |
13-3607736 |
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer 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):
⃞ 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))
Item 2.02 Results of Operations and Financial Condition
On February 1, 2010, MannKind Corporation issued a press release announcing its financial results for the fourth quarter and full year 2009. 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 February 1, 2010, reporting MannKind’s financial results for the fourth quarter and full year 2009. |
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 |
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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 |
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Chief Financial Officer |
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Dated: |
February 1, 2010 |
EXHIBIT INDEX
Number | Description |
99.1 |
Press Release of MannKind Corporation dated February 1, 2010, reporting MannKind’s financial results for the fourth quarter and full year 2009. |
Exhibit 99.1
MannKind Corporation Reports 2009 Fourth Quarter and Full Year Financial Results
- Conference Call to Begin Today at 5:00 PM EST -
VALENCIA, Calif.--(BUSINESS WIRE)--February 1, 2010--MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and year ended December 31, 2009.
For the fourth quarter of 2009, total operating expenses were $55.8 million, compared to $81.8 million for the fourth quarter of 2008. Research and development (R&D) expenses were $43.1 million for the fourth quarter of 2009 compared to $68.8 million for the same quarter in 2008, a decrease of $25.7 million. This 37% decrease was primarily due to reduced costs associated with the clinical development of AFREZZA™ as the Company completed its pivotal AFREZZA trials in 2008, including decreased raw material purchases and clinical supplies costs, offset by a loss on disposal of fixed assets of $12.8 million. General and administrative (G&A) expenses decreased by $0.3 million to $12.7 million for the fourth quarter of 2009 compared to $13.0 million in the fourth quarter of 2008.
The net loss applicable to common stockholders for the fourth quarter of 2009 was $59.5 million, or $0.53 per share based on 112.9 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $83.3 million, or $0.82 per share based on 101.8 million weighted average shares outstanding for the fourth quarter of 2008. The number of common shares outstanding at December 31, 2009 was 113,025,291.
For the year ended December 31, 2009, total operating expenses were $209.8 million, compared with $305.8 million for 2008. R&D expenses were $156.3 million in 2009, compared to $250.4 million in 2008, a decrease of $94.1 million. The 38% decrease mainly reflects decreased clinical development program expenses of AFREZZA including decreased raw material purchases and clinical supplies costs. G&A expenses decreased by $1.9 million to $53.4 million for 2009 as compared to $55.3 million for 2008 primarily due to the nonrecurrence of costs associated with the purchase of patents during the first quarter of 2008 as well as decreased stock compensation expense in 2009, which were partially offset by increased professional fees, including those related to the insulin acquisition transaction with Pfizer Inc. during the second quarter of 2009.
The net loss applicable to common stockholders for 2009 was $220.1 million, or $2.07 per share based on 106.5 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $303.0 million, or $2.98 per share based on 101.6 million weighted averages shares outstanding for 2008.
Cash, cash equivalents and marketable securities were $32.5 million at December 31, 2009 and $46.5 million at December 31, 2008. Currently, the Company has $185.0 million of available borrowings under the loan agreement with an entity controlled by the Company’s principal stockholder.
Alfred Mann, Chairman and Chief Executive Officer, commented, “2009 was a good year for MannKind Corporation. We submitted a comprehensive new drug application to the FDA and worked with the agency throughout the year to facilitate their review. We brought our manufacturing facility through a successful pre-approval inspection by the FDA and received two Facility of the Year category awards from the International Society for Pharmaceutical Engineering, INTERPHEX, and Pharmaceutical Processing magazine. We also completed much of the technical and clinical bioequivalency studies necessary for a supplemental NDA for our next-generation inhaler, which we expect to submit to the FDA in the second quarter of this year.”
Conference Call
MannKind management will host a conference call to discuss these results today at 5:00 p.m. Eastern Time. To participate in the call please dial (888) 677-5721 or (210) 839-8507 and use the participant passcode: MANNKIND. To listen to the call via the Internet please visit http://www.mannkindcorp.com. The web site replay will be available for 14 days. A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (866) 494-3185 or (203) 369-1752.
Presenting from the Company will be:
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 AFREZZA™ (formerly AFRESA®), MKC253, MKC1106-PP, and MKC1106-MT. MannKind has submitted an NDA to the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. The other three programs are currently in Phase 1 clinical trials. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential of the Company’s products, including AFREZZA, and our plans to submit a supplemental NDA in 2010, 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 inherent in the progress, timing and results of clinical trials, difficulties or delays in seeking or obtaining regulatory approval, intellectual property matters and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2008 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.
MannKind Corporation (A Development Stage Company) Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts) |
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Three months ended |
Twelve months ended |
Cumulative |
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2009 | 2008 | 2009 | 2008 | 2009 | |||||||||||||||||||||||||||||||
Revenue |
$ |
— |
$ |
— |
$ | — | $ | 20 | $ | 2,988 | |||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||||||||||
Research and development | 43,100 | 68,777 | 156,331 | 250,442 | 1,153,813 | ||||||||||||||||||||||||||||||
General and administrative |
12,719 |
12,978 | 53,447 | 55,343 |
299,289 |
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In-process research and development costs | — | — | — | — | 19,726 | ||||||||||||||||||||||||||||||
Goodwill impairment | — | — | — | — | 151,428 | ||||||||||||||||||||||||||||||
Total operating expenses | 55,819 | 81,755 | 209,778 | 305,785 | 1,624,256 | ||||||||||||||||||||||||||||||
Loss from operations | (55,819 | ) | (81,755 | ) | (209,778 | ) | (305,765 | ) | (1,621,268 | ) | |||||||||||||||||||||||||
Other income (expense) | (451 | ) | (55 | ) | 51 | (62 | ) | (1,892 | ) | ||||||||||||||||||||||||||
Interest expense on note payable to principal stockholder | (1,873 | ) | (12 | ) | (5,679 | ) | (12 | ) | (7,202 | ) | |||||||||||||||||||||||||
Interest expense on senior convertible notes | (1,393 | ) | (1,742 | ) | (4,768 | ) | (2,327 | ) | (10,725 | ) | |||||||||||||||||||||||||
Interest income | 3 | 271 | 70 | 5,129 | 36,931 | ||||||||||||||||||||||||||||||
Loss before provision for income taxes | (59,533 | ) | (83,293 | ) | (220,104 | ) | (303,037 | ) | (1,604,156 | ) | |||||||||||||||||||||||||
Income taxes | — | (2 | ) | — | (2 | ) | (26 | ) | |||||||||||||||||||||||||||
Net loss | (59,533 | ) | (83,295 | ) | (220,104 | ) | (303,039 | ) | (1,604,182 | ) | |||||||||||||||||||||||||
Deemed dividend related to beneficial conversion feature of convertible preferred stock | — | — | — | — | (22,260 | ) | |||||||||||||||||||||||||||||
Accretion on redeemable preferred stock | — | — | — | — | (952 | ) | |||||||||||||||||||||||||||||
Net loss applicable to common stockholders |
$ |
(59,533 |
) |
$ |
(83,295 |
) | $ | (220,104 | ) | $ | (303,039 | ) | $ | (1,627,394 | ) | ||||||||||||||||||||
Net loss per share applicable to common stockholders — basic and diluted |
$ |
(0.53 |
) |
$ |
(0.82 |
) | $ | (2.07 | ) | $ | (2.98 | ) | |||||||||||||||||||||||
Shares used to compute basic and diluted net loss per share applicable to common stockholders | 112,860 | 101,758 | 106,534 | 101,561 | |||||||||||||||||||||||||||||||
MannKind Corporation (A Development Stage Company) Condensed Consolidated Balance Sheet (Unaudited) (in thousands) |
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December 31, 2009 |
December 31, 2008 |
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Assets | |||||||||||||||
Current assets: | |||||||||||||||
Cash and cash equivalents |
$ |
30,019 |
$ | 27,648 | |||||||||||
Marketable securities | 2,475 | 18,844 | |||||||||||||
State research and development credit exchange receivable — current | 1,500 | 1,500 | |||||||||||||
Prepaid expenses and other current assets | 3,672 | 5,983 | |||||||||||||
Total current assets | 37,666 | 53,975 | |||||||||||||
Property and equipment — net | 208,229 | 226,436 | |||||||||||||
State research and development credit exchange receivable — net of current portion | 918 | 1,500 | |||||||||||||
Other assets | 584 | 548 | |||||||||||||
Total |
$ |
247,397 |
$ | 282,459 | |||||||||||
Liabilities and Stockholders’ Equity |
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Current liabilities |
$ 28,853 | $ | 53,472 | ||||||||||||
Senior convertible notes | 112,765 | 112,253 | |||||||||||||
Note payable to principal stockholder | 165,000 | 30,000 | |||||||||||||
Stockholders’ equity (deficit) | (59,221 | ) | 86,734 | ||||||||||||
Total |
$ |
247,397 |
$ | 282,459 |
CONTACT:
MannKind Corporation
Matthew J. Pfeffer
Chief
Financial Officer
661-295-4784
mpfeffer@mannkindcorp.com