- Conference Call to Begin Today at 4:00 PM ET -
VALENCIA, Calif., Feb. 17 /PRNewswire-FirstCall/ -- MannKind Corporation today reported financial results for the fourth quarter and year ended December 31, 2008.
For the fourth quarter of 2008, total operating expenses were $81.8 million, compared to $79.1 million for the fourth quarter of 2007. Research and development (R&D) expenses increased by $2.0 million to $68.8 million for the fourth quarter of 2008 compared to the fourth quarter of 2007. This increase is primarily due to higher manufacturing costs (including clinical supplies) for AFRESA(R), offset in part by lower purchased services in the associated clinical development program, and lower technology agreement costs in our oncology research programs. General and administrative (G&A) expenses increased by $0.7 million to $13.0 million for the fourth quarter of 2008 compared to the fourth quarter of 2007.
The net loss applicable to common stockholders for the fourth quarter of 2008 was $83.3 million, or $0.82 per share based on 101.8 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $75.0 million, or $0.75 per share based on 99.6 million weighted average shares outstanding, for the fourth quarter of 2007.
For the year ended December 31, 2008, total operating expenses were $305.8 million, compared with $307.4 million for 2007. R&D expenses were $250.4 million in 2008, down $6.4 million from 2007, primarily related to lower technology agreement costs in our oncology research programs and decreased clinical development program expenses, which were offset by increases in manufacturing costs (including clinical supplies) for AFRESA and associated clinical development program expenses. G&A expenses increased by $4.8 million to $55.3 million for 2008 as compared to 2007 primarily due to salaries and stock compensation expenses. The total number of employees decreased from 609 at the end of 2007 to 580 at the end of 2008.
The net loss applicable to common stockholders for 2008 was $303.0 million, or $2.98 per share based on 101.6 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $293.2 million, or $3.66 per share based on 80.0 million weighted averages shares outstanding for 2007. The number of common shares outstanding at December 31, 2008 was 102,008,096.
Cash, cash equivalents and marketable securities were $46.5 million at December 31, 2008, $95.2 million at September 30, 2008, and $368.3 million at December 31, 2007. Currently, the Company has additional financial resources of $320.0 million available under the loan arrangement with our principal stockholder.
“Our NDA for AFRESA is now almost finished,” stated Alfred Mann, Chairman and Chief Executive Officer. “Little more than the hyperlinking of the electronic submission remains to be completed. Our clinical, regulatory and CMC teams have done an extraordinary job assembling a comprehensive document that describes the robust safety and efficacy data that we have collected for AFRESA. The extensive clinical program that we conducted has provided evidence that AFRESA consistently decreases A1C levels and additionally offers marked benefits for patients in terms of post-prandial glucose control, fasting glucose control, weight loss and hypoglycemia. Moreover, the studies indicate that AFRESA achieves these clinical benefits without any adverse effects on pulmonary function. We look forward to the year ahead as we transition from the development of AFRESA into commercial readiness.”
Conference Call
MannKind management will host a conference call to discuss these results today at 4:00 PM ET. To participate in the call, please dial (888) 677-5721 or (210) 839-8507. 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 (800) 756-2759 or (402) 998-0791.
Presenting from the Company will be:
About MannKind Corporation
MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its pipeline includes AFRESA, which has completed Phase 3 clinical trials, and MKC253, which is currently in Phase 1 clinical trials. Both of these investigational products are being evaluated for their safety and efficacy in the treatment of diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press release as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to email alerts that are sent automatically when MannKind issues press releases, files its reports with the SEC or posts certain other information to the website.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to differentiating AFRESA from other insulins. 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 MannKind’s current expectations and involve risks and uncertainties. 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, 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, 2007 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.
CONTACT: Matthew J. Pfeffer, Corporate Vice President and Chief Financial
Officer of MannKind Corporation, +1-661-775-5300, mpfeffer@mannkindcorp.com
Web site: http://www.mannkindcorp.com/
