MannKind Corporation Reports 2010 First Quarter Financial Results

VALENCIA, Calif., Apr 30, 2010 (BUSINESS WIRE) --MannKind Corporation (Nasdaq:MNKD) today reported financial results for the first quarter ended March 31, 2010.

For the first quarter of 2010 total operating expenses were $40.6 million, compared to $57.8 million for the first quarter of 2009. Research and development (R&D) expenses were $30.5 million for the first quarter of 2010 compared to $42.9 million for the same quarter in 2009, a decrease of $12.4 million. This 29% decrease in R&D expense was primarily due to reduced costs associated with the clinical development of AFREZZA™ after the submission of its NDA in March 2009. General and administrative (G&A) expenses decreased by $4.8 million to $10.1 million for the first quarter of 2010 compared to $14.9 million in the first quarter of 2009. This 32% decrease in G&A expense was mainly due to decreased salary related costs resulting from the April 2009 reduction in force and the non-recurrence of costs related to the negotiation of the transaction with Pfizer, which occurred during the first quarter of 2009.

The net loss applicable to common stockholders for the first quarter of 2010 was $44.7 million, or $0.40 per share based on 113.1 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $59.4 million, or $0.58 per share based on 102.0 million weighted average shares outstanding for the first quarter of 2009. The number of common shares outstanding at March 31, 2010 was 113,449,327.

Cash, cash equivalents and marketable securities were $31.5 million at March 31, 2010 and $32.5 million at December 31, 2009. Currently, the Company has $145.0 million of available borrowings under the loan agreement with an entity controlled by the Company's principal stockholder.

"The most significant event of the first quarter was clearly the FDA's response to our NDA for AFREZZA," said Alfred Mann, Chairman and Chief Executive Officer. "Since that time, we have been preparing for an upcoming meeting with the agency and readying a submission that is intended to address the FDA's questions about AFREZZA. We also completed Study 117, an efficacy study in patients with type 1 diabetes, and are pleased to report that AFREZZA met the primary endpoint of non-inferiority in HbA1C levels compared to standard insulin therapy. This is a very busy time for MannKind Corporation."

Conference Call

MannKind management will host a conference call to discuss these results today at 9:00 a.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 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 (800) 216-2819 or (402) 220-3756.

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 Matthew Pfeffer
  • Corporate Vice President and Chief Scientific Officer Peter Richardson

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 diabetes pipeline includes AFREZZATM and MKC253. MKC253 is currently in phase 1 clinical trials. In March 2009, MannKind 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. In March 2010, MannKind received a Complete Response to this NDA from the FDA requesting additional information. Currently, AFREZZA remains under regulatory review. Other products in its pipeline include the cancer immunotherapy products MKC1106-PP and MKC1106-MT, which are currently in phase 1 clinical trials. MannKind maintains a website at 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 regulatory status of MannKind's 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, difficulties or delays in seeking or obtaining regulatory approval, MannKind's ability to manage its existing ash resources or raise additional cash resources, stock price volatility 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, 2009 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


(In thousands, except per share amounts)

Three months ended

March 31,

Cumulative period

from February 14,

1991 (date of

inception) to

March 31,

2010 2009 2010
Revenue $ -- $ -- $ 2,988
Operating expenses:
Research and development 30,491 42,889 1,184,304
General and administrative 10,110 14,917 309,399
In-process research and development costs -- -- 19,726
Goodwill impairment -- -- 151,428
Total operating expenses 40,601 57,806 1,664,857
Loss from operations (40,601 ) (57,806 ) (1,661,869 )
Other (expense) income (790 ) 71 (2,682 )
Interest expense on note payable to related party (2,102 ) (593 ) (9,304 )
Interest expense on senior convertible notes (1,210 ) (1,115 ) (11,935 )
Interest income 3 31 36,934
Loss before provision for income taxes (44,700 ) (59,412 ) (1,648,856 )
Income taxes -- -- (26 )
Net loss (44,700 ) (59,412 ) (1,648,882 )
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 $ (44,700 ) $ (59,412 ) $ (1,672,094 )
Net loss per share applicable to common stockholders -- basic and diluted $ (0.40 ) $ (0.58 )
Shares used to compute basic and diluted net loss per share applicable to common stockholders 113,095 102,030

MannKind Corporation

(A Development Stage Company)

Condensed Consolidated Balance Sheet


(in thousands)

March 31, 2010

December 31, 2009

Current assets:
Cash and cash equivalents $ 29,052 $ 30,019
Marketable securities 2,488 2,475
State research and development credit exchange receivable -- current -- 1,500
Prepaid expenses and other current assets 3,217 3,672
Total current assets 34,757 37,666
Property and equipment -- net 206,761 208,229
State research and development credit exchange receivable -- net of current portion 1,153 918
Other assets 584 584
Total $ 243,255 $ 247,397

Liabilities and Stockholders' Deficit

Current liabilities

$ 26,300 $ 28,853
Senior convertible notes 112,897 112,765
Note payable to principal stockholder 205,000 165,000
Stockholders' deficit (100,942 ) (59,221 )
Total $ 243,255 $ 247,397

SOURCE: MannKind Corporation

MannKind Corporation
Matthew J. Pfeffer
Chief Financial Officer


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