MIGENIX Reports Third Quarter Fiscal Year 2008 Financial Results



    VANCOUVER and SAN DIEGO, March 13 /CNW/ - MIGENIX Inc. (TSX: MGI; OTC:
MGIFF), a clinical-stage developer of drugs for infectious diseases, reports
financial results for the three and nine months ended January 31, 2008 and an
update on its programs.
    Jim DeMesa, M.D., President & CEO of MIGENIX stated, "With the conclusion
of our third fiscal quarter and now being halfway through our fourth quarter,
we are looking forward to the completion of enrollment in the Phase III
Omigard registration trial for preventing catheter-related infections being
conducted by our partner, Cadence Pharmaceuticals. With completion of this
trial, we expect to enter into a very important time of clinical results over
the next half of the year (with both Omigard and celgosivir, our Phase II
hepatitis C drug candidate) followed by our potential entry into the
regulatory approval process in 2009 with Omigard."

    UPDATE ON DRUG DEVELOPMENT PROGRAMS

    Omiganan 1% gel (Omigard(TM)/CPI-226/MX-226; topical cationic peptide;
prevention of catheter-related infections): A pivotal Phase III study being
conducted by our development and commercialization partner Cadence
Pharmaceuticals is in progress in the United States under a Special Protocol
Assessment (SPA) agreement with the US FDA and in Europe. Cadence expects they
will complete enrollment of the 1,850 patients planned for the trial in the
second quarter of 2008, with results available in the second half of 2008. If
the results of the trial are positive, Cadence expects to submit a New Drug
Application ("NDA") for omiganan 1% gel in the first half of 2009. Under the
terms of the agreement with Cadence, MIGENIX will receive up to US$27 million
in development and commercialization milestone payments, upon the achievement
of specified milestones, starting with the US and European regulatory
submission process; and a double-digit royalty on net sales. MIGENIX has been
and continues to be in discussions with potential partners for the rest of
world (territories outside North America and Europe) rights held by MIGENIX
although the timing and completion of such a partnership(s) is uncertain at
this time.
    Celgosivir (MX-3253; oral alpha-glucosidase I inhibitor; treatment of
chronic hepatitis C virus infections): A Phase II study is currently enrolling
patients to assess 600 mg celgosivir for tolerability, pharmacokinetics and
viral kinetics when combined with the standard of care drugs, pegylated
interferon alfa-2b plus ribavirin, as compared to the standard of care drugs
alone and to 400 mg celgosivir plus the standard of care for up to 12 weeks of
therapy. With 15 patients enrolled to date, it is planned that approximately
six additional patients will be enrolled. In February, one of the two contract
research organizations we were using to conduct this study shut down
operations unexpectedly. We are in the process of transferring the planned
operations at this site including patients that have been qualified for
enrollment to another clinical site, and obtaining the required Institutional
Review Board approval for this site. We maintain our expectation for results
from the study in the third calendar quarter of 2008. MIGENIX has been and
continues to be in discussions with potential partners for the further
clinical development of celgosivir although the timing and completion of a
partnership is uncertain at this time.
    Omiganan (CLS001; topical cationic peptide; treatment of dermatological
diseases): Based on positive results from a recently completed Phase II
clinical study for the treatment of rosacea, our partner in this program,
Cutanea Life Sciences intends to enter Phase III clinical development later
this calendar year.
    MX-2401 (IV lipopeptide; treatment of gram-positive bacterial
infections): MX-2401 is an injectable lipopeptide being developed for the
treatment of serious gram positive bacterial infections. To date, preclinical
studies conducted on MX-2401 have demonstrated very favorable activity with
low toxicity, a long half-life, and other positive pharmacological and
competitive features (with efficacy in multiple animal models, including
pneumonia). Good Laboratory Practices ("GLP") compliant non-clinical studies
were initiated in April 2007. Activities in the program are currently focused
on manufacturing process development and advancing the program into the clinic
in late 2009.
    SB 9000 (dinucleotide; treatment of chronic hepatitis B virus
infections): This preclinical program was out-licensed to Spring Bank
Technologies and is supported in part with NIH funding. Spring Bank has made
significant progress and plans to advance the program into the clinic in 2009.
We have a convertible preferred share ownership position in Spring Bank.
    MX-4565 (small molecule; treatment of neurodegenerative diseases): In
June 2007 we were awarded a grant from the Michael J. Fox Foundation to fund
research in our MX-4565 program. Studies funded by the grant are ongoing.
    Other Matters: We provided notice to the University of Florida Research
Foundation Inc. (UFRFI) of the termination of the license agreement between
the Company and UFRFI. The license agreement relates primarily to the
Company's MX-4509 program that was written off in the year ended April 30,
2007.

    FINANCIAL RESULTS

    For the three months ended January 31, 2008 ("Q3/08"), MIGENIX incurred a
loss of $3.4 million (Q3/07: $6.7 million) or $0.04 (Q3/07: $0.08) per common
share, and for the nine months ended January 31, 2008 ("YTD Fiscal 2008") the
loss is $9.5 million ($0.10 per common share) compared to a loss of
$12.9 million ($0.16 per common share) for the nine months ended January 31,
2007 ("YTD Fiscal 2007"). The YTD Fiscal 2008 loss includes $2.5 million in
non-cash expenses (YTD Fiscal 2007: $5.5 million). The $3.3 million decrease
in the Q3/08 loss compared to the Q3/07 loss is principally attributable to a
$2.8 million decrease in the write-down in intangible assets (see "Write-down
of Intangible Assets" below) and a $0.6 million decrease in research and
development expenses (see "Research and Development Expenses" below).

    Revenues

    During Q3/08 the Company had no revenues (Q3/07: (less than)
$0.1 million) and during YTD Fiscal 2008 research and development
collaboration revenue was nominal (i.e. (less than) $0.1 million) (YTD Fiscal
2007: nominal). This research and development collaboration revenue is
pursuant to the sale of omiganan drug substance to Cutanea Life Sciences.

    Research and Development Expenses

    The following table summarizes our research and development expenses for
the periods indicated:

    
                                 --------------------------------------------
                                  Three months ended       Nine months ended
                                          January 31              January 31
                                 --------------------------------------------
                                    2008        2007        2008        2007
                                 --------------------------------------------
    Program Expenses                       (Canadian dollars, millions)
      Omiganan 1% gel (partnered)   $0.0        $0.0        $0.0        $0.0
      Omiganan for dermatological
       diseases (partnered)          0.0         0.0         0.0         0.0
      Celgosivir                     0.3         0.5         1.0         1.1
      MX-2401 (net of government
       assistance)                   0.1         0.4         0.2         0.9
      MX-4509                        0.0         0.0         0.0         0.0
      Other projects                 0.1         0.1         0.1         0.2
                                 --------------------------------------------
    Total Program Expenses          $0.5        $1.0        $1.3        $2.2
                                 --------------------------------------------

    Unattributed Expenses
      Personnel                     $0.7        $0.7        $2.2        $2.0
      Patent costs                   0.1         0.2         0.7         0.6
      Other                          0.2         0.2         0.8         0.8
                                 --------------------------------------------
    Total Unattributed Expenses     $1.0        $1.1        $3.7        $3.4
                                 --------------------------------------------

    Total Research & Development
     Expenses                       $1.5        $2.1        $5.0        $5.6
                                 --------------------------------------------
                                 --------------------------------------------
    (1) Before amortization expense, technology and license acquisition
        costs, and write-downs of intangibles assets.
    (2) Value of $0.0 million represents $nil to ~$50,000 in expenses during
        the period.
    

    Our Omiganan programs are being advanced by development and
commercialization partners (Cadence Pharmaceuticals and Cutanea Life
Sciences).
    Celgosivir program costs were $0.3 million in Q3/08 (Q3/07: $0.4 million)
and were $1.0 million for YTD Fiscal 2008 (YTD Fiscal 2007: $1.1 million).
    Costs in the MX-2401 program in Q3/08 were $0.1 million (Q3/07:
$0.4 million) and were $0.2 million for YTD Fiscal 2008 (YTD Fiscal 2007:
$1.0 million). The decrease in Q3/08 and YTD Fiscal 2008 MX-2401 costs is
principally due to higher cost manufacturing activity in Q3/07 and YTD Fiscal
2007 in preparation for the GLP studies started in April 2007.
    Research and development costs not allocated to programs were
$1.0 million in Q3/08 (Q3/07: $1.1 million) and were $3.7 million for YTD
Fiscal 2008 (YTD Fiscal 2007: $3.4 million). The approximate $0.3 million
increase in these unallocated research and development costs in YTD Fiscal
2008 is spread out across personnel costs (increased headcount initiated last
year, particularly with respect to non-clinical work in the celgosivir
program) and patent costs (advancement of celgosivir patent applications).
    We anticipate that we will make determinations as to which programs to
pursue and how much funding to direct to each program on an ongoing basis. We
are currently focusing our resources on advancing the development of our
non-partnered programs: celgosivir and MX-2401.

    General and Corporate Expenses

    General and corporate expenses in Q3/08 were $0.9 million (Q3/07:
$0.9 million) and were $2.7 million for YTD Fiscal 2008 (YTD Fiscal 2007:
$2.7 million). Personnel costs were $0.5 million in Q3/08 (Q3/07:
$0.7 million) and were $1.5 million for YTD Fiscal 2008 (YTD Fiscal 2007:
$1.8 million).

    Amortization

    Amortization expense for property and equipment was $0.2 million in YTD
Fiscal 2008 (YTD Fiscal 2007: $0.2 million).
    Amortization expense for intangible assets was $0.2 million in YTD Fiscal
2008 (YTD Fiscal 2007: $0.5 million).

    Write-down of Intangible Assets

    Pursuant to the quarterly review of intangible assets for Q3/08 the
Company determined that a $0.5 million write-down was appropriate in respect
of a technology acquired as part of our August 2004 merger with MitoKor. The
write-down of intangible assets in Q3/08 and YTD Fiscal 2008 was $0.5 million.
The $3.3 million write-down in Q3/07 and YTD Fiscal 2007 related to the
Company's MX-4509 program.

    Other Income and Expenses

    Interest income was $0.4 million for YTD Fiscal 2008 (YTD Fiscal 2007:
$0.4 million).
    Accretion expense related to the convertible royalty participation units
for Q3/08 was $0.5 million (Q3/07: $0.4 million) and is $1.3 million for YTD
Fiscal 2008 (YTD Fiscal 2007: $1.1 million). This accretion expense is a
non-cash expense resulting from (i) accreting the liability component of the
convertible royalty participation units to the maximum royalties payable of
$29.5 million (will be reduced for actual royalties paid, any units converted
into common shares, and should our estimate of the probable royalties payable
decline below $29.5 million) over the estimated royalty payment term using the
effective interest method; and (ii) amortizing the deferred financing costs
over the estimated royalty payment term using the effective interest method.
    The foreign exchange loss in Q3/08 was $0.1 million (Q3/07: nominal gain)
and a loss of $0.1 million for YTD Fiscal 2008 (YTD Fiscal 2007: nominal
loss).

    Property & Equipment and Intangible Asset Expenditures

    Property and equipment expenditures for Q3/08 were approximately
$0.1 million (Q3/07: nominal) and for YTD Fiscal 2008 were $0.3 million (YTD
Fiscal 2007: $0.2 million). The Q3/08 and YTD Fiscal 2008 expenditures are
principally for leasehold improvements for the Company's new Vancouver
facility occupied in November 2007.
    Intangible asset costs capitalized in Q3/08, Q3/07, YTD Fiscal 2008 and
YTD Fiscal 2007 were $nil.

    Liquidity and Capital Resources

    As of January 31, 2008, the Company had cash, cash equivalents and
short-term investments of $7.9 million (April 30, 2007: $15.3 million) and the
Company's net working capital was $7.1 million (April 30, 2007:
$14.6 million). The $7.5 million decrease in net working capital from
April 30, 2007 is primarily attributable to the cash loss of $7.0 million
(loss excluding non-cash expenses: amortization, stock-based compensation and
accretion of the convertible royalty participation units) for the nine months
ended January 31, 2008.
    MIGENIX believes that its funds on hand at January 31, 2008 are
sufficient to provide for operations into the fourth quarter of calendar 2008
before funds received, if any, from existing or new license agreements, the
exercise of warrants and options and financing activities. The Company will
continue advancing its highest priority programs (see "Research and
Development Expenses") while operating within an annual burn rate of
approximately $9 million to $10 million (reduced from previously expected
range of $11 million to $13 million principally due to delaying some
non-essential development activities). The magnitude of spending in the
Company's development programs will be dependent on the licensing status of
the celgosivir program and results in the various programs. We may need to
increase or decrease our annual burn rate in response to such results. MIGENIX
is likely to need to raise additional funds in support of its operations and
there is no assurance that such funds can be obtained.

    Outstanding Shares

    There are currently 94,463,806 (January 31, 2008: 94,463,806; April 30,
2007: 94,237,205) common shares outstanding; 29,465 convertible royalty
participation units (January 31, 2008 and April 30, 2007: 29,465); and
5,250,000 (January 31, 2008: 5,250,000; April 30, 2007: 9,350,000) preferred
shares outstanding. During Q3/08 we redeemed 4,000,000 Series E preferred
shares for the aggregate sum of US$1 as the milestone obligations associated
with these shares expired August 31, 2007.

    -------------------------------------------------------------------------
    Conference Call

    Investors, analysts and the media are invited to participate in a
conference call and webcast on Thursday, March 13 at 11:00 a.m. ET (8:00 a.m.
PT) to discuss this announcement. An update on company activities will also be
provided. To participate in the conference call, please dial 416-644-3417 or
1-800-732-0232. The call will be available for replay until March 27, 2008 by
calling 416-640-1917 or 1-877-289-8525 and entering the pass code 21263848
followed by the number sign. The live and archived webcast will be accessible
through the company's website at www.migenix.com for the next 90 days.
    -------------------------------------------------------------------------

    

    Selected Financial Highlights

    BALANCE SHEETS                                    January 31,   April 30,
    Unaudited - In Thousands of Canadian dollars            2008        2007
    -------------------------------------------------------------------------
    Assets
    Cash and cash equivalents                             $1,864      $2,945
    Short-term investments                                 6,063      12,365
    Other current assets                                   1,335       1,245
    -------------------------------------------------------------------------
    Total current assets                                  $9,262     $16,555
    Long-term investments                                      1           1
    Property & equipment                                   1,088         881
    Intangible assets                                      1,006       1,671
    Deferred transaction costs(1)                              -         473
    -------------------------------------------------------------------------
    Total assets                                         $11,357     $19,581
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Liabilities and Shareholders' Equity
    Accounts payable and accrued liabilities              $2,124      $1,958
    -------------------------------------------------------------------------
    Total current liabilities                             $2,124      $1,958
    Convertible royalty participation units(1)             5,705       4,847
    Preferred shares                                           -         115
    -------------------------------------------------------------------------
    Total liabilities                                     $7,829      $6,920
    -------------------------------------------------------------------------

    Shareholders' equity
    Common shares                                       $125,156    $124,994
    Equity portion of convertible royalty
     participation units                                   4,554       4,554
    Contributed surplus                                    8,056       7,830
    Deficit                                             (134,238)   (124,717)
    -------------------------------------------------------------------------
    Total shareholders' equity                            $3,528     $12,661
    -------------------------------------------------------------------------
    Total liabilities and shareholders' equity           $11,357     $19,581
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------
    (1) As of May 1, 2007 pursuant to the adoption of new accounting
        standards Deferred transaction costs are netted against the
        convertible royalty participation units in liabilities.


    STATEMENTS OF LOSS,
     COMPREHENSIVE LOSS AND
     DEFICIT
    Unaudited - In Thousands      Three months ended       Nine months ended
     Canadian dollars (except          January 31,             January 31,
     per share amounts)             2008        2007        2008        2007
                               ----------------------------------------------
    Revenue
      Research and development
       collaboration                   -          19           6          19
    -------------------------------------------------------------------------
                                       -         $19          $6         $19
    -------------------------------------------------------------------------
    Expenses
      Research and development     1,558       2,118       5,015       5,624
      General and corporate          902         854       2,732       2,659
      Amortization                   173         234         427         693
      Write-down of intangible
       assets                        474       3,316         474       3,316
    -------------------------------------------------------------------------
                                  $3,107      $6,522      $8,648     $12,292
    -------------------------------------------------------------------------

    Loss before other income
     (expense)                   $(3,107)    $(6,503)    $(8,642)   $(12,273)
      Accretion of convertible
       royalty participation
       units and amortization
       of transaction costs         (485)       (389)     (1,331)     (1,108)
      Interest income                106         170         376         444
      Foreign exchange gain
       (loss)                         62          (4)         76          13
    -------------------------------------------------------------------------
    Loss and comprehensive
     loss for the period         $(3,424)    $(6,726)    $(9,521)   $(12,924)
    Deficit, beginning of
     period                     (130,814)   (114,863)   (124,717)   (108,665)
    -------------------------------------------------------------------------
    Deficit, end of period     $(134,238)  $(121,589)  $(134,238)  $(121,589)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Basic and diluted loss
     per common share             $(0.04)     $(0.08)     $(0.10)     $(0.16)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------
    Weighted avg. common
     shares outstanding (000's)   94,464      87,497      94,464      78,767
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------


    STATEMENTS OF CASH FLOWS
    Unaudited - In Thousands
     of Canadian dollars

    Loss for the period          $(3,424)    $(6,726)    $(9,521)   $(12,924)
    Items not affecting cash:
      Amortization                   173         234         427         693
      Write-down of intangible
       assets                        474       3,316         474       3,316
      Stock-based compensation        51          47         236         282
      Issuance of deferred
       share units                     -           -           -          96
      Accretion of convertible
       royalty participation
       units and amortization
       of transaction costs          485         389       1,331       1,108
      Changes in non-cash
       working capital items
       relating to operating
       activities                   (207)        564          54        (112)
    -------------------------------------------------------------------------
    Cash used in operating
     activities                  $(2,448)    $(2,176)    $(6,999)    $(7,541)
    -------------------------------------------------------------------------

    Issuance of convertible
     royalty participation
     units                             -           -           -       7,732
    Issuance of common shares,
     net of issue costs                -      10,133           -      10,133
    Proceeds on exercise of
     stock options                     -           -           -          10
    Proceeds on exercise of
     warrants                          -          17          36         172
    Repayment of capital lease
     obligation                        -           -           -          (5)
    -------------------------------------------------------------------------
    Cash provided by financing
     activities                        -     $10,150         $36     $18,042
    -------------------------------------------------------------------------

    Funds from (purchases of)
     short-term investments       (1,427)     (8,286)      6,201     (11,097)
    Proceeds on disposal of
     equipment                         -           -          12           -
    Purchases of property and
     equipment                      (147)        (30)       (331)       (201)
    -------------------------------------------------------------------------
    Cash provided by (used in)
     investing activities        $(1,574)    $(8,316)     $5,882    $(11,298)
    -------------------------------------------------------------------------

    (Decrease) increase in
     cash and cash equivalents   $(4,022)      $(342)    $(1,081)      $(797)
    Cash and cash equivalents,
     beginning of period           5,886       5,288       2,945       5,743
    -------------------------------------------------------------------------
    Cash and cash equivalents,
     end of period                $1,864      $4,946      $1,864      $4,946
    -------------------------------------------------------------------------
    

    About MIGENIX

    MIGENIX is committed to advancing therapy, improving health, and
enriching life by developing and commercializing drugs primarily in the area
of infectious diseases. The Company's programs include drug candidates for:
the prevention of catheter-related infections (Phase III), the treatment of
chronic hepatitis C infections (Phase II and preclinical), the treatment of
dermatological diseases (end of Phase II), the treatment of serious gram
positive bacterial infections (preclinical) and the treatment of hepatitis B
infections (preclinical). MIGENIX is headquartered in Vancouver, British
Columbia, Canada with US operations in San Diego, California. Additional
information can be found at www.migenix.com.

    "Jim DeMesa"
    ------------
    James M. DeMesa, M.D.
    President & CEO

    FORWARD-LOOKING STATEMENTS

    This news release contains forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of 1995, and
forward-looking information within the meaning of applicable securities laws
in Canada, (collectively referred to as "forward-looking statements").
Statements, other than statements of historical fact, are forward-looking
statements and include, without limitation, statements regarding our strategy,
future operations, timing and completion of clinical trials, prospects, plans
and objectives of management. The words "anticipates", "believes", "budgets",
"could", "estimates", "expects", "forecasts", "intends", "may", "might",
"plans", "projects", "schedule", "should", "will", "would" and similar
expressions are often intended to identify forward-looking statements, which
include underlying assumptions, although not all forward-looking statements
contain these identifying words. By their nature, forward-looking statements
involve numerous assumptions, known and unknown risks and uncertainties, both
general and specific, that contribute to the possibility that the predictions,
forecasts, projections and other things contemplated by the forward-looking
statements will not occur.
    Although our management believes that the expectations represented by
such forward-looking statements are reasonable, there is significant risk that
the forward-looking statements may not be achieved, and the underlying
assumptions thereto will not prove to be accurate. Forward-looking statements
in this news release include, but are not limited to, statements concerning
our expectations for: Cadence Pharmaceuticals completing enrollment of 1,850
patients in the Omigard(TM) pivotal Phase III trial in the second quarter of
2008, with results available in the second half of 2008 and if the results of
this trial are positive, Cadence submitting a new drug application (NDA) for
Omigard(TM) in the first half of 2009; our plans to add approximately six
patients at 600 mg dose in the celgosivir Phase II viral kinetics study and
having results from the study in the third quarter of 2008; Cutanea Life
Sciences' plans to advance omiganan for the treatment of rosacea into Phase
III clinical development in 2008, our estimate of the probable royalties
payable to the holders of the convertible royalty participation units; our
plans to advance MX-2401 into the clinic in late 2009; Spring Bank's plans to
advance the SB 9000 program into the clinic in 2009; the Company continuing to
advance its highest priority programs while operating within an annual burn
rate of $9 million to $10 million; and the Company's financial resources being
sufficient to fund operations into the fourth quarter of 2008.
    With respect to the forward-looking statements contained in this news
release, we have made numerous assumptions regarding, among other things:
Cadence's ability to enroll sufficient patients to complete the Omigard(TM)
Phase III trial; the adequacy of the Omigard(TM) Phase III trial design to
generate data that are deemed sufficient by regulatory authorities to support
potential regulatory filings, including an NDA, for Omigard(TM); our ability
to enroll approximately six patients at the 600 mg dose in the celgosivir
Phase II viral kinetics study and having results from the study in the third
quarter of 2008; Cutanea's ability to manage, fund and advance omiganan for
dermatological applications into Phase III, the adequacy of Cutanea's Phase II
results for regulatory authorities to support advancing to Phase III; Spring
Bank's ability to manage, fund and advance SB 9000 into clinical development;
our ability to manage licensing opportunities; our ability to initiate, fund
and complete non-clinical studies, clinical studies, manufacturing and all
ancillary activities within our expected timelines; and future expense levels
being within our current expectations.
    Actual results or events could differ materially from the plans,
intentions and expectations expressed or implied in any forward-looking
statements, including the underlying assumptions thereto, as a result of
numerous risks, uncertainties and other factors including: dependence on
corporate collaborations; potential delays; uncertainties related to early
stage of technology and product development; uncertainties as to the
requirement that a drug be found to be safe and effective after extensive
clinical trials and the possibility that the results of such trials, if
completed, will not establish the safety or efficacy of our products;
uncertainties as to future expense levels and the possibility of unanticipated
costs or expenses or cost overruns; the possibility that opportunities will
arise that require more cash than presently anticipated and other
uncertainties related to predictions of future cash requirements; and other
risks and uncertainties which may not be described herein. Certain of these
factors and other factors are described in detail in the Company's Annual
Information Form and Annual Report on Form 20-F for and other filings with the
Canadian securities regulatory authorities and the U.S. Securities & Exchange
Commission.
    Forward-looking statements are based on our current expectations and
MIGENIX assumes no obligations to update such information to reflect later
events or developments.

    The Toronto Stock Exchange has not reviewed and does not accept
    responsibility for the adequacy or accuracy of this release.





For further information:

For further information: Art Ayres, MIGENIX Inc., Tel: (604) 221-9666
Ext. 233, aayres@migenix.com; Dian Griesel, Ph.D., Investor Relations, Group
Tel: (212) 825-3210, Theproteam@aol.com

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MIGENIX INC.

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