UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 28, 2005
MannKind Corporation
(Exact name of registrant as specified in its charter)
| 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) |
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 July 28, 2005, MannKind Corporation issued a press release announcing its financial results for
the second quarter of 2005. 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 filed herewith:
99.1 |
Press Release of MannKind Corporation dated July 28, 2005, reporting MannKind’s financial results for the second quarter of 2005. | |||
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: July 28, 2005
EXHIBIT INDEX
| Number | Description | ||||
99.1 |
Press Release of MannKind Corporation dated July 28, 2005, reporting MannKind’s financial results for the second quarter of 2005. | ||||
\
Exhibit 99.1
| Company Contact: | Investor Relations: | |||
Dick Anderson |
Julie Huang | |||
Chief Financial Officer |
Financial Dynamics | |||
661-775-5302 |
212-850-5628 | |||
danderson@mannkindcorp.com |
jhuang@fd-us.com | |||
MANNKIND CORPORATION REPORTS SECOND QUARTER FINANCIAL RESULTS
Company to Review Clinical Trials, Manufacturing Process, and
Financial Outlook on Today’s 9:00 a.m. EDT Conference Call
Financial Outlook on Today’s 9:00 a.m. EDT Conference Call
VALENCIA, Calif. (July 28, 2005) – MannKind Corporation (Nasdaq NM: MNKD) today reported
financial results for the second quarter and six months ended June 30, 2005.
For the second quarter of 2005, total operating expenses were $27.6 million, compared with
$18.4 million for the second quarter of 2004. Research and development (R&D) expenses increased by
$9.3 million to $23.6 million, primarily due to increased costs associated with the Company’s
expanded clinical trials and related support for its Technosphere® Insulin program.
General and administrative (G&A) expenses decreased by $0.1 million to $4.0 million.
For the first six months of 2005, operating expenses totaled $50.2 million, compared with $35.0
million in the first half of 2004. R&D expenses were $42.3 million, up $15.2 million, again
primarily related to the expansion of clinical trials of MannKind’s Technosphere® Insulin program.
G&A expenses increased by $0.1 million to $7.9 million for the first half of 2005.
The net loss applicable to common stockholders for the first half of 2005 was $49.3 million, or
$1.50 per share based on 32.8 million shares outstanding, compared with a net loss applicable to
common stockholders of $35.3 million, or $1.77 per share based on 20.0 million shares outstanding,
for the first half of 2004.
Cash, cash equivalents and marketable securities were $42.4 million at June 30, 2005 and $90.5
million at December 31, 2004.
“During this past quarter, we achieved a significant milestone in the development of our inhaled
Technosphere® Insulin System as a unique and innovative treatment for diabetes. We initiated a
pivotal Phase 3 safety study in the United States, involving patients with type 1 and type 2
diabetes. This is our second Phase 3 trial, the first being an efficacy study that we have been
conducting in Europe since late 2004, in which
patient enrollment is ahead of schedule. We expect these studies to add to the growing evidence of
the safety and efficacy of inhaled Technosphere® Insulin, such as our completed phase 2b study in
which HbA1c levels decreased significantly within a three-month period compared to control with no
increase in the risk of hypoglycemia,” said Alfred Mann, Chairman and Chief Executive Officer of
MannKind Corporation.
Conference Call
MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern
Daylight Time. To participate in the call please dial (888) 935-0258 or listen to the call on the
Internet at www.mannkindcorp.com. A telephone replay will be accessible for approximately 48 hours
following completion of the call by dialing (866) 476-5481 and entering conference number 8860480.
The web site replay will be available for fourteen days.
Presenting from the Company will be:
• Chairman of the Board and Chief Executive Officer, Alfred E. Mann
• President and Chief Operating Officer, Hakan Edstrom
• Corporate Vice President and Chief Financial Officer, Dick Anderson
• Sr. Vice President Clinical, Scientific & Medical Affairs, Anders Boss
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of
therapeutic products for diseases such as diabetes and cancer. The Company is currently in phase 3
clinical trials of its lead product, the Technosphere® Insulin System, in the U.S. and Europe to
study its potential for the treatment of diabetes. 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 MannKind’s
clinical trials and 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, risks related to the progress, timing
and results of clinical trials, the risk that future safety and efficacy studies may not confirm
our past clinical results, intellectual property matters, difficulties or delays in seeking or
obtaining regulatory approval, manufacturing the Company’s lead product candidate, competition from
other pharmaceutical or biotechnology companies, the Company’s ability to enter into any
collaborations or strategic partnerships or obtain additional financing to support the Company’s
operations, the Company’s ability to meet milestones and other risks detailed in MannKind’s filings
with the SEC, including the Annual Report on Form 10-K
for the year ended December 31, 2004 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 news release.
(Tables to follow)
MannKind Corporation
Consolidated Statements of Operations
(Unaudited)
Consolidated Statements of Operations
(Unaudited)
| (In thousands, except per share | ||||||||||||||||
| amounts) | Three Months Ended | Six Months Ended | ||||||||||||||
| June 30, | June 30, | June 30, | June 30, | |||||||||||||
| 2005 | 2004 | 2005 | 2004 | |||||||||||||
Revenue |
$ | — | $ | — | $ | — | $ | — | ||||||||
Operating expenses: |
||||||||||||||||
Research and development |
23,596 | 14,311 | 42,292 | 27,110 | ||||||||||||
General and administrative |
3,971 | 4,071 | 7,922 | 7,840 | ||||||||||||
Total operating expenses |
27,567 | 18,382 | 50,214 | 34,950 | ||||||||||||
Loss from operations |
(27,567 | ) | (18,382 | ) | (50,214 | ) | (34,950 | ) | ||||||||
Other income |
7 | 14 | 21 | 75 | ||||||||||||
Interest income |
405 | 123 | 877 | 221 | ||||||||||||
Loss before provision for income taxes |
(27,155 | ) | (18,245 | ) | (49,316 | ) | (34,654 | ) | ||||||||
Income taxes |
(1 | ) | ||||||||||||||
Net loss |
(27,155 | ) | (18,245 | ) | (49,317 | ) | (34,654 | ) | ||||||||
Deemed dividend related to beneficial
conversion feature of convertible
preferred stock |
— | — | — | (612 | ) | |||||||||||
Accretion on redeemable preferred
stock |
— | 4 | — | (60 | ) | |||||||||||
Net loss applicable to common
stockholders |
$ | (27,155 | ) | $ | (18,241 | ) | $ | (49,317 | ) | $ | (35,326 | ) | ||||
Net loss per share applicable to
common stockholders — basic and
diluted |
$ | (0.83 | ) | $ | (0.91 | ) | $ | (1.50 | ) | $ | (1.77 | ) | ||||
Shares used to compute basic and
diluted net loss per share applicable
to common stockholders |
32,777 | 19,975 | 32,777 | 19,975 | ||||||||||||
MannKind Corporation
Condensed Balance Sheet
(Unaudited)
(in thousands)
Condensed Balance Sheet
(Unaudited)
(in thousands)
| June 30, | December 31, | |||||||
| 2005 | 2004 | |||||||
Assets
|
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 19,552 | $ | 78,987 | ||||
Marketable securities |
22,884 | 11,546 | ||||||
Restricted cash |
18 | 583 | ||||||
State research and development tax credit exchange
receivable – current |
537 | 1,500 | ||||||
Prepaid expenses and other current assets |
2,457 | 3,265 | ||||||
Total current assets |
45,448 | 95,881 | ||||||
Property and equipment – net |
68,353 | 66,511 | ||||||
State research and development tax credit exchange receivable
- - net of current portion |
813 | 1,030 | ||||||
Other assets |
203 | 61 | ||||||
Total |
$ | 114,817 | $ | 163,483 | ||||
Liabilities and Stockholders’ Equity |
||||||||
Current liabilities |
$ | 16,188 | $ | 13,044 | ||||
Other liabilities |
43 | 76 | ||||||
Stockholders’ equity |
98,586 | 150,363 | ||||||
Total |
$ | 114,817 | $ | 163,483 | ||||
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