e8vk
UNITED STATES
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
Date of Report (Date of earliest event reported): October 24, 2005
MannKind Corporation
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation)
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000-50865
(Commission File Number)
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13-3607736
(IRS Employer
Identification No.) |
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28903 North Avenue Paine
Valencia, California
(Address of principal executive offices)
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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 filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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¨ 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 October 24, 2005, MannKind Corporation issued a press release announcing its financial results
for the third 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:
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99.1
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Press Release of MannKind Corporation dated October 24, 2005, reporting
MannKinds financial results for the third 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.
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MANNKIND CORPORATION
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By: |
/s/ Richard L. Anderson
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Name: |
Richard L. Anderson |
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Dated: October 24, 2005 |
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Title: |
Chief Financial Officer |
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EXHIBIT INDEX
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Number |
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Description |
99.1
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Press Release of MannKind Corporation dated October 24, 2005,
reporting MannKinds financial results for the third quarter of
2005. |
exv99w1
EXHIBIT
99.1
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Company Contact:
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Investor Relations: |
Dick Anderson
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Julie Huang |
Chief Financial Officer
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Financial Dynamics |
661-775-5302
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212-850-5628 |
danderson@mannkindcorp.com
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Julie.Huang@fd.com |
MANNKIND CORPORATION REPORTS THIRD QUARTER FINANCIAL RESULTS
Conference Call to Begin Today at 9:00 a.m. ET
VALENCIA, Calif. (October 24, 2005) MannKind Corporation (Nasdaq NM: MNKD) today reported
financial results for the third quarter and nine months ended September 30, 2005.
For the third quarter of 2005, total operating expenses were $32.9 million, compared with
$20.5 million for the third quarter of 2004. Research and development (R&D) expenses increased by
$12.7 million to $24.5 million for the third quarter of 2005 compared to the third quarter of
2004, primarily due to increased costs associated with the Companys expanded clinical development
program for Technosphere® Insulin, which is currently in Phase 3 clinical trials in the
U.S. and Europe. General and administrative (G&A) expenses decreased by $0.3 million to $8.4
million for the third quarter of 2005 compared to the third quarter of 2004.
The net loss applicable to common stockholders for the third quarter of 2005 was $31.7 million, or
$0.73 per share based on 43.5 million shares outstanding, compared with a net loss applicable to
common stockholders of $39.4 million, or $1.40 per share based on 28.1 million shares outstanding,
for the third quarter of 2004.
For the first nine months of 2005, operating expenses totaled $83.1 million, compared with $55.5
million in the first nine months of 2004. R&D expenses were $66.8 million for the first nine
months of 2005, up $27.9 million from the first nine months of 2004, primarily related to the
expansion of clinical trials of the Technosphere Insulin program. G&A expenses decreased by $0.2
million to $16.3 million for the first nine months of 2005 as compared to the first nine months of
2004.
The net loss applicable to common stockholders for the first nine months of 2005 was $81.0
million, or $2.23 per share based on 36.4 million shares outstanding, compared with a net loss
applicable to common stockholders of $74.7 million, or $3.29 per share based on 22.7 million shares
outstanding, for the first nine months of 2004.
We successfully completed one of the largest equity placements in our sector this year. As well,
our Technosphere Insulin (TI) System continues to gain recognition for being unlike any other
inhaled insulin therapy in registration or under development, said Alfred Mann, Chairman and Chief
Executive Officer of MannKind Corporation. With a strengthened balance sheet and operating team,
management continues to advance and execute its clinical development program for TI. We are
currently completing database lock on the results of our TI European Phase 2b trial (005) and
intend to announce the results in the next few months.
Financing Transaction
On August 5, 2005, MannKind completed a $175 million private placement of newly issued shares of
common stock and the concurrent issuance of warrants for the purchase of additional shares of
common stock. Net proceeds will be used primarily to fund the development of the Technosphere
Insulin System.
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) 282-8353 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 (888) 568-0414 and entering conference number 2891046.
The web site replay will be available for fourteen days.
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, Dick Anderson
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to MannKinds
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 Companys 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, risks related to intellectual property matters, difficulties or delays
in seeking or obtaining regulatory approval, risks related to manufacturing the Companys lead
product candidate, risks related to competition from other pharmaceutical or biotechnology
companies, risks related to the Companys ability to enter into any collaborations or strategic
partnerships or obtain additional financing to support the Companys operations, risks related to
the Companys ability to meet milestones and
other risks detailed in MannKinds 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)
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(In thousands, except per share |
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amounts) |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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September 30, |
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September 30, |
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2005 |
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2004 |
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2005 |
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2004 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Research and development |
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24,466 |
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11,790 |
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66,758 |
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38,901 |
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General and administrative |
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8,396 |
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8,713 |
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16,318 |
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16,552 |
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Total operating expenses |
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32,862 |
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20,503 |
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83,076 |
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55,453 |
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Loss from operations |
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(32,862 |
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(20,503 |
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(83,076 |
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(55,453 |
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Other income (expense) |
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(29 |
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37 |
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(8 |
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112 |
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Interest income |
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1,161 |
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278 |
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2,038 |
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499 |
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Loss before provision for income taxes |
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(31,730 |
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(20,188 |
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(81,046 |
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(54,842 |
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Income taxes |
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(1 |
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Net loss |
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(31,730 |
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(20,188 |
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(81,047 |
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(54,842 |
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Deemed dividend related to beneficial
conversion feature of convertible
preferred stock |
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(19,210 |
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(19,822 |
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Accretion on redeemable preferred
stock |
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(60 |
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Net loss applicable to common
stockholders |
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$ |
(31,730 |
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$ |
(39,398 |
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$ |
(81,047 |
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$ |
(74,724 |
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Net loss per share applicable to
common stockholders basic and
diluted |
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$ |
(0.73 |
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$ |
(1.40 |
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$ |
(2.23 |
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$ |
(3.29 |
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Shares used to compute basic and
diluted net loss per share applicable
to common stockholders |
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43,460 |
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28,051 |
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36,373 |
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22,687 |
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MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
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September 30, |
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December 31, |
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2005 |
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2004 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
69,238 |
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$ |
78,987 |
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Marketable securities |
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113,166 |
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11,546 |
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Restricted cash |
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18 |
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583 |
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State research and development tax credit exchange
receivable current |
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1,233 |
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1,500 |
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Prepaid expenses and other current assets |
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3,451 |
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3,265 |
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Total current assets |
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187,106 |
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95,881 |
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Property and equipment net |
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71,387 |
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66,511 |
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State research and development tax credit exchange receivable
- - net of current portion |
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1,249 |
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1,030 |
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Other assets |
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282 |
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61 |
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Total |
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$ |
260,024 |
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$ |
163,483 |
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Liabilities and Stockholders Equity |
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Current liabilities |
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$ |
18,960 |
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$ |
13,044 |
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Other liabilities |
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36 |
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76 |
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Stockholders equity |
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241,028 |
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150,363 |
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Total |
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$ |
260,024 |
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$ |
163,483 |
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# # #