UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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): November 3, 2004
MannKind Corporation
Delaware | 000-50865 | 13-3607736 | ||
(State or other jurisdiction of incorporation or organization) |
(Commission File Number) | (IRS Employer Identification No.) |
28903 North Avenue Paine Valencia, California (Address of principal executive offices) |
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 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 CRF 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition | ||||||||
Item 9.01 Financial Statements and Exhibits | ||||||||
SIGNATURE | ||||||||
EXHIBIT INDEX | ||||||||
Exhibit 99.1 |
Section 2 Financial Information
Item 2.02 Results of Operations and Financial Condition
On November 3, 2004 MannKind Corporation issued a press release announcing its financial results for the third quarter of 2004. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
Section 9 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits
(c) Exhibits. The following exhibit is filed herewith:
99.1
|
Press Release of MannKind Corporation dated November 3, 2004, reporting MannKinds financial results for the third quarter of 2004. |
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: November 3, 2004
EXHIBIT INDEX
Number | Description | |
99.1
|
Press Release of MannKind Corporation dated November 3, 2004, reporting MannKinds financial results for the third quarter of 2004. |
Exhibit 99.1
Company Contact:
|
Investor Relations: | |
Dick Anderson
|
Ina McGuinness or Bruce Voss | |
Chief Financial Officer
|
Lippert/Heilshorn & Associates | |
661-775-5302
|
310-691-7100 | |
danderson@mannkindcorp.com
|
imcguinness@lhai.com |
MANNKIND REPORTS THIRD QUARTER FINANCIAL RESULTS
VALENCIA, Calif. (November 3, 2004) MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter and nine months ended September 30, 2004.
For the third quarter of 2004, total operating expenses were $20.5 million, compared with $14.0 million in the third quarter of 2003. Research and development (R&D) expenses increased by $0.9 million to $11.7 million, primarily due to increased expenses associated with expanded clinical trials and related support for the Companys Technosphere® Insulin program, offset by a $5.5 million R&D credit exchange recognized under a R&D credit exchange program in the State of Connecticut for qualified research and development expenses. Of this amount, approximately $1.5 million consisted of cash received during the third quarter of 2004. Without this offsetting credit, R&D expenses for the quarter would have been $17.2 million. General and administrative (G&A) expenses increased by $5.5 million to $8.8 million. Included in R&D and G&A expenses for the third quarter of 2004 are non-cash stock-based compensation expenses aggregating $7.0 million, compared with $0.2 million in the third quarter of 2003.
The net loss for the third quarter of 2004 was $20.2 million, versus a net loss of $13.9 million in the third quarter of 2003. Net loss per share was $1.40 in the third quarter of 2004 compared with a net loss per share of $0.72 for the comparable 2003 period. Net loss per share in the third quarter of 2004 includes a deemed dividend to Series B and C preferred stockholders of approximately $19.2 million, or $0.68 per share, which occurred as a consequence of the automatic conversion of the preferred stock into common stock at the close of the Companys recent initial public offering. Although the non-cash dividend had no effect on stockholders equity, it increased the net loss applicable to the common stockholders and the net loss per share. Since all of the preferred stock automatically converted into common stock at the close of the initial public offering in the third quarter of 2004, no further dividends on the preferred stock will be reflected in future periods. For the third quarter of 2003, the deemed dividend was $0.1 million.
During the third quarter of 2004 we continued to make clinical and regulatory progress toward our goal of commercializing a differentiated pulmonary insulin system. By approximating the bodys natural first-phase insulin release spike, our Technosphere® Insulin System has the potential to offer important clinical advantages over all other diabetes therapies, including those currently on the market or under development, said Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation. The active treatment portion of a Phase 2b study in the U.S. involving 123 patients with early- to mid-stage type 2 diabetes was recently completed. Top-line results from that study are expected to be released by the end of the year. A 200-patient Phase 2b study underway in Europe continues, with expected completion during the first half of 2005.
Dr. Wendell Cheatham, Corporate Vice President of MannKind Corporation, said that the Company was pleased with the response to the scientific information presented on the Technosphere® Insulin System at the meeting of the European Association for the Study of Diabetes in Munich, Germany and at the SMi Annual Conference on Diabetes in London, UK. At both meetings, the Company presented data from a Phase 2 study in type 2 diabetes. These patients were treated with either Technosphere® Insulin or subcutaneous insulin for one week before crossing over to the alternate treatment modality, thereby serving as their own control. Even though patients were exposed to virtually identical amounts of insulin in each of the two treatment modalities, the total glucose excursion during the post-meal period was 48% lower when Technosphere® Insulin was used as compared to subcutaneous insulin. These results added further support that the use of Technosphere® Insulin achieves significantly better post-prandial glucose control than subcutaneous insulin, commented Dr. Cheatham.
For the first nine months of 2004, operating expenses totaled $55.5 million, compared with $47.6 million for the first nine months of 2003. R&D expenses were $38.8 million, up $7.2 million, from the prior-year period, again related primarily to the expansion of clinical trials of MannKinds Technosphere® Insulin program. R&D expenses for the nine months of 2004 are offset by a $5.5 million R&D credit exchange recognized under a R&D credit exchange program in the State of Connecticut for qualified research and development expenses. Of this amount, approximately $1.5 million consisted of cash received during the third quarter of 2004. Without this offsetting credit, R&D expenses for the first nine months would have been $44.3 million. Year-to-date 2004 G&A expenses were $16.6 million, an increase of $0.7 million from the comparable 2003 period. Included in R&D and G&A expenses for the first nine months of 2004 are non-cash stock-based compensation expenses aggregating $9.4 million, compared with $3.3 million for the first nine months of 2003. For the first nine months of 2004, the net loss was $54.8 million, versus a net loss of $47.3 million for the comparable 2003 period.
Cash, cash equivalents and marketable securities at September 30, 2004 were $108.9 million, which includes net proceeds of approximately $83.6 million upon completion of the Companys initial public offering including approximately $4.0 million from the exercise of the underwriters over-allotment option. Cash, cash equivalents and marketable securities at December 31, 2003 were $55.9 million.
About MannKind Corporation
MannKind focuses on the discovery, development and commercialization of therapeutic products for diseases including diabetes, cancer, inflammatory and autoimmune diseases. The Companys lead product, the Technosphere® Insulin System, currently is in late Phase II clinical trials for the treatment of diabetes. This therapy consists of a proprietary dry powder Technosphere® formulation of insulin that is inhaled into the deep lung using MannKinds MedTone inhaler. Clinical indications show MannKinds proprietary Technosphere® Insulin Systems performance characteristics, unique kinetics, convenience and ease of use may have the potential to change the current diabetes treatment paradigm. 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 our clinical trials and product candidates. 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 our current expectations. Forward-looking statements 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, intellectual property matters, difficulties or delays in obtaining regulatory approval, manufacturing our lead product candidate, competition from other pharmaceutical or biotechnology companies, our ability to enter into any collaborations or strategic partnerships or obtain additional financing to support our operations and other risks detailed in our filings with the SEC, including our Registration Statement on Form S-1 and our quarterly reports on Form 10-Q. 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 release.
MannKind Corporation
Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data) | Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, | September 30, | September 30, | September 30, | |||||||||||||
2004 | 2003 | 2004 | 2003 | |||||||||||||
Revenue |
$ | | $ | | $ | | $ | | ||||||||
OPERATING EXPENSES: |
||||||||||||||||
Research and development |
11,695 | 10,764 | 38,805 | 31,648 | ||||||||||||
General and administrative |
8,808 | 3,261 | 16,648 | 15,971 | ||||||||||||
Total operating expenses |
20,503 | 14,025 | 55,453 | 47,619 | ||||||||||||
Loss from operations |
(20,503 | ) | (14,025 | ) | (55,453 | ) | (47,619 | ) | ||||||||
Interest income |
275 | 104 | 496 | 307 | ||||||||||||
Other income (expense) |
40 | 29 | 115 | (2 | ) | |||||||||||
Loss before provision for income
taxes |
(20,188 | ) | (13,892 | ) | (54,842 | ) | (47,314 | ) | ||||||||
Income taxes |
0 | 0 | 0 | 0 | ||||||||||||
Net loss |
(20,188 | ) | (13,892 | ) | (54,842 | ) | (47,314 | ) | ||||||||
Deemed dividend related to
beneficial conversion feature of
convertible preferred stock |
(19,210 | ) | (143 | ) | (19,822 | ) | (1,017 | ) | ||||||||
Accretion on redeemable preferred
stock |
0 | (65 | ) | (60 | ) | (188 | ) | |||||||||
Net loss applicable to common
stockholders |
$ | (39,398 | ) | $ | (14,100 | ) | $ | (74,724 | ) | $ | (48,519 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic and diluted |
$ | (1.40 | ) | $ | (0.72 | ) | $ | (3.29 | ) | $ | (2.70 | ) | ||||
Shares used to compute basic and
diluted net loss per share: |
||||||||||||||||
Basic and diluted |
28,051 | 19,697 | 22,687 | 17,986 | ||||||||||||
Condensed balance sheet data (in thousands): | September 30, 2004 | December 31, 2003 | ||||||
Cash, cash equivalents and marketable securities |
$ | 108,871 | $ | 55,945 | ||||
Working capital |
105,759 | 49,097 | ||||||
Total assets |
181,753 | 125,876 | ||||||
Deferred compensation and other liabilities |
58 | 404 | ||||||
Series A redeemable convertible preferred stock |
| 5,188 | ||||||
Deficit accumulated during the development stage |
(421,813 | ) | (366,971 | ) | ||||
Total stockholders equity |
172,555 | 111,577 |