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): September 1, 2004
MannKind Corporation
Delaware (State or other jurisdiction of incorporation) |
000-50865 (Commission File Number) |
13-3607736 (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
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 September 1, 2004 MannKind Corporation issued a press release announcing its financial results for the second 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. |
99.1
|
Press Release of MannKind Corporation dated September 1, 2004, reporting MannKinds financial results for the second 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: September 1, 2004
EXHIBIT INDEX
Number | Description | |
99.1
|
Press Release of MannKind Corporation dated September 1, 2004, reporting MannKinds financial results for the second 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 SECOND QUARTER FINANCIAL RESULTS
VALENCIA, Calif. (September 1, 2004) MannKind Corporation (Nasdaq: MNKD), today reported financial results for the second quarter and six months ended June 30, 2004.
For the second quarter of 2004, total operating expenses were $18.4 million, compared with $13.2 million in the second quarter of 2003. Research & Development (R&D) expenses increased by $5.0 million to $14.3 million primarily due to the increased expenses associated with expanded clinical trials and related support for the Companys Technosphere® Insulin product. General and administrative (G&A) expenses increased by $0.2 million to $4.1 million. The net loss for the second quarter of 2004 was $18.2 million versus a net loss of $13.1 million in the second quarter of 2003. Net loss per share was $0.91 in the second quarter of 2004 compared with a net loss of $0.79 for the comparable 2003 period. Net loss per share, when calculated on a pro forma basis to give effect to the conversion of preferred stock into common stock upon the closing of MannKinds initial public offering on August 2, 2004, was $0.73 in the second quarter of 2004.
For the first six months of 2004, operating expenses totaled $35.0 million compared with $33.6 million in the first half of 2003. R&D expenses were $27.1 million, up $6.2 million, again related primarily to the expansion of clinical trials of MannKinds Technosphere® Insulin program. G&A expenses were $7.8 million, a decrease of $4.9 million from the first half of 2003, when the Company consolidated its California operations into a single facility.
For the first half of 2004, the net loss was $34.7 million, versus a net loss of $33.4 million in the first half of 2003.
Cash, cash equivalents and marketable securities at June 30, 2004 were $41.3 million, compared with $55.9 million at December 31, 2003. Subsequent to June 30, 2004, MannKind completed its initial public offering, resulting in net proceeds of approximately $83.6 million, including $4.0 million in proceeds from the exercise of the underwriters over-allotment option.
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, which is currently in late Phase II clinical trials for the treatment of diabetes, consists of a proprietary dry powder Technosphere® formulation of insulin that is inhaled into the deep lung using MannKinds MedTone inhaler. Early indications show MannKinds proprietary Technosphere® Insulin Systems performance characteristics, convenience and ease of use have the potential to change the way diabetes is treated. 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 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 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. 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 share and per share amounts) |
Three Months Ended |
Six Months Ended |
||||||||||||||
June 30, | June 30, | June 30, | June 30, | |||||||||||||
2004 |
2003 |
2004 |
2003 |
|||||||||||||
Revenue |
$ | | $ | | $ | | $ | | ||||||||
OPERATING EXPENSES: |
||||||||||||||||
Research & development |
14,311 | 9,321 | 27,110 | 20,884 | ||||||||||||
General & administrative |
4,071 | 3,903 | 7,840 | 12,710 | ||||||||||||
Total operating expenses |
18,382 | 13,224 | 34,950 | 33,594 | ||||||||||||
Loss from operations |
(18,382 | ) | (13,224 | ) | (34,950 | ) | (33,594 | ) | ||||||||
Interest income |
123 | 119 | 221 | 204 | ||||||||||||
Other income (expense) |
14 | 17 | 75 | (33 | ) | |||||||||||
Loss before provision for income taxes |
(18,245 | ) | (13,088 | ) | (34,654 | ) | (33,423 | ) | ||||||||
Income taxes |
| | | | ||||||||||||
Net loss |
(18,245 | ) | (13,088 | ) | (34,654 | ) | (33,423 | ) | ||||||||
Deemed dividend related to beneficial
conversion feature of convertible preferred
stock |
| (875 | ) | (612 | ) | (875 | ) | |||||||||
Accretion on redeemable preferred stock |
4 | (63 | ) | (60 | ) | (123 | ) | |||||||||
Net loss applicable to common stockholders |
$ | (18,241 | ) | $ | (14,026 | ) | $ | (35,326 | ) | $ | (34,421 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic and diluted |
$ | (0.91 | ) | $ | (0.79 | ) | $ | (1.77 | ) | $ | (2.01 | ) | ||||
Basic and diluted pro forma |
$ | (0.73 | ) | $ | (1.44 | ) | ||||||||||
Shares used to compute basic and diluted
net loss per share: |
||||||||||||||||
Basic and diluted |
19,975 | 17,760 | 19,975 | 17,117 | ||||||||||||
Basic and diluted pro forma |
24,907 | 24,562 | ||||||||||||||
Condensed balance sheet data (in thousands): |
6/30/04 |
12/31/03 |
||||||
Cash, cash equivalents and marketable securities |
$ | 41,260 | $ | 55,945 | ||||
Working capital |
35,865 | 49,097 | ||||||
Total assets |
110,778 | 125,876 | ||||||
Deferred compensation and other liabilities |
130 | 404 | ||||||
Redeemable convertible preferred stock |
5,248 | 5,188 | ||||||
Deficit accumulated during the development stage |
(401,625 | ) | (366,971 | ) | ||||
Total stockholders equity |
97,352 | 111,577 |