Immunomedics Announces Fiscal 2013 Results

Immunomedics Announces Fiscal 2013 Results

MORRIS PLAINS, N.J., Aug. 22, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc.
(Nasdaq:IMMU), a biopharmaceutical company primarily focused on the
development of monoclonal antibody-based products for the targeted treatment
of cancer, autoimmune and other serious diseases, today reported financial
results for the fourth quarter and fiscal year ended June 30, 2013. The
Company also highlighted recent key developments and planned activities for
its clinical pipeline.

Fourth Quarter Fiscal 2013 Results

Total revenues for the fourth quarter of fiscal year 2013, which ended on June
30, 2013, were $1.4 million as compared to total revenues of $1.0 million for
the same quarter last fiscal year. The increase of $0.4 million in total
revenues this quarter was primarily due to a $0.5 million increase in research
and development revenue from the increase in the number of National Cancer
Institute grants as well as the timing of research activities.

Net loss attributable to our stockholders this quarter was $7.7 million, or
$0.09 per basic share, compared with a net loss attributable to our
stockholders of $7.5 million, or $0.10 per basic share, for the same quarter
in fiscal 2012. The increase in net loss this quarter was primarily due to
$0.3 million higher cost in research and development from increased clinical
trial expenses.

Fiscal Year 2013 Results

Total revenues for fiscal year 2013 were $5.0 million, as compared to $32.7
million for fiscal year 2012. The decrease of $27.7 million this fiscal year
was primarily the result of $28.4 million of non-recurring license fee revenue
from an amendment to the Licensing Agreement with UCB earned in fiscal year
2012.

Net loss attributable to our stockholders for the fiscal year ended June 30,
2013 was $12.2 million, or $0.16 per diluted share, as compared to a net
income attributable to our stockholders of $0.8 million, or $0.01 per diluted
share, in fiscal year 2012. The change in net income of $13.0 million in
fiscal 2013 was primarily due to the non-recurring license fee revenue from
the UCB sublicensing amendment in fiscal 2012, partially offset in 2013 by the
$16.7 million net proceeds from a settlement in our arbitration proceeding
before the Financial Industry Regulatory Authority against a broker-dealer
relating to our prior investment in certain securities, and $2.6 million in
business insurance claims in fiscal 2013. In addition, in fiscal 2013 we
incurred $4.3 million of higher research and development expenses.

The increase in research and development expenses resulted primarily from a
$2.5 million increase in clinical trial expenses related to the Phase Ib study
of clivatuzumab in relapsed pancreatic cancer completed this year and the
ongoing antibody-drug conjugate clinical trials, as well as a decrease of $2.0
million of research and development expense reimbursements from the previous
year.

The Company has no long-term debt and as of June 30, 2013, cash and cash
equivalents totaled $41.3 million.

"We have made significant progress in clinical developments during fiscal year
2013," commented Gerard G. Gorman, Senior Vice President Finance and Chief
Financial Officer. "In order to continue the clinical development of our
antibody-drug conjugate programs in patients with solid tumors, which have
advanced into Phase II trials, and to pay for certain expenses to initiate the
planned clivatuzumab trial for the treatment of patients with pancreatic
cancer, which we anticipate to advance into Phase III in fiscal 2014, we
expect cash requirements in fiscal year 2014 to increase to $24 to $26
million. Furthermore, to complete the planned Phase III clinical trial with
clivatuzumab, we will require additional funding, and our potential licensing
opportunities could be a source of these funds," Mr. Gorman added.

The Company's key clinical developments and future planned activities:

Epratuzumab

  *New data from an open-label extension of the EMBLEM™ Phase IIb study
    evaluating the long-term effects of epratuzumab treatment in adult
    patients with moderate-to-severe systemic lupus erythematosus (SLE) were
    presented by lupus investigators at the European League Against Rheumatism
    2013 Congress. Please refer to the Company's press release at
    http://www.immunomedics.com/pdfs/news/2013/pr06132013a.pdf for more
    information.
    
  *UCB will continue to enroll patients with SLE into the Phase III program
    for epratuzumab throughout calendar year 2013. The slower than anticipated
    enrollment is due to the heterogeneous nature of SLE and the complex
    aspects of the diagnostic instruments. First results are now expected in
    the first quarter of calendar year 2015.

Epratuzumab tetraxetan

  *The Phase I study of ^90Y-labeled epratuzumab tetraxetan combined with
    veltuzumab in patients with aggressive lymphoma was updated at the 2013
    Annual Meeting of the Society of Nuclear Medicine & Molecular Imaging
    (SNMMI). For more information, please refer to the Company's press release
    at http://www.immunomedics.com/pdfs/news/2013/pr06112013.pdf.
    
  *At the 2013 SNMMI Annual Meeting, updated results from a multicenter,
    Phase II trial evaluating yttrium-90-labeled epratuzumab tetraxetan as a
    consolidation therapy following standard-of-care treatment in elderly
    patients with previously-untreated diffuse large B-cell lymphoma were
    reported in an oral presentation. Please refer to the Company's press
    release at http://www.immunomedics.com/pdfs/news/2013/pr06102013b.pdf for
    more information.

Clivatuzumab tetraxetan

  *First results from a Phase Ib trial of ^90Y-labeled clivatuzumab
    tetraxetan in patients with pancreatic cancer who have failed at least two
    prior therapies were reported in an oral presentation at the European
    Society for Medical Oncology 15^th World Congress on Gastrointestinal
    Cancer. For more information, please refer to the Company's press release
    at http://www.immunomedics.com/pdfs/news/2013/pr07032013.pdf.
    
  *The Phase Ib trial will be updated in an oral presentation at the 26^th
    Annual Congress of the European Association of Nuclear Medicine in Lyon,
    France, on Wednesday, October 23, 2013.
    
  *Based on the encouraging results from the Phase Ib trial, a Phase III
    registration trial in patients with pancreatic cancer who have received at
    least 2 prior therapies is planned for the end of calendar year 2013 or
    the beginning of 2014.

Milatuzumab

  *A Phase I study to assess the safety and tolerability of milatuzumab when
    added to a standard regimen to prevent acute graft-versus-host disease in
    patients with hematologic malignancies undergoing stem cell transplant is
    expected to begin patient enrollment before the end of calendar year 2013.

Labetuzumab-SN-38

  *A Phase II proof-of-concept trial of labetuzumab-SN-38 (IMMU-130) in
    patients with colorectal cancer is expected to begin in the first quarter
    of fiscal 2014. A second Phase I/II trial testing two different dose
    schedules of IMMU-130 also is planned to commence in the first quarter of
    2014.

hRS7-SN-38

  *hRS7-SN-38 (IMMU-132) will be evaluated in patients with solid cancers in
    a Phase I/II proof-of-concept trial planned for patient enrollment in the
    first quarter of 2014.

IMMU-114

  *A Phase I dose-escalation study of subcutaneously administered IMMU-114, a
    humanized anti-HLA-DR antibody, as a monotherapy for patients with
    relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic
    leukemia is planned for the second half of calendar year 2013. An IND for
    this trial has been accepted by the FDA.

Conference Call

The Company will host a conference call and live audio webcast on Friday,
August 23, 2013 at 10:00 a.m. Eastern Time to discuss financial results for
the fourth quarter and fiscal year 2013, and review key clinical developments
and future planned activities. To access the conference call, please dial
(877) 303-2523 or (253) 237-1755 using the Conference ID 18199814. The
conference call will be webcast via the Investors page on the Company's
website at www.immunomedics.com. Approximately two hours following the live
event, a webcast replay of the conference call will be available on the
Company's website for 30 days through September 22, 2013.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company primarily focused
on the development of monoclonal antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases.We have developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or
toxins, in each case to create highly targeted agents.Using these
technologies, we have built a pipeline of therapeutic product candidates that
utilize several different mechanisms of action.Our lead product candidate,
epratuzumab, is currently in two Phase III clinical trials in lupus. In
oncology, we are planning to launch a Phase III pivotal trial for clivatuzumab
labeled with a radioisotope in advanced pancreatic cancer patients. Other
solid tumor therapeutics in Phase II clinical development include 2
antibody-drug conjugates, labetuzumab-SN-38 (IMMU-130) and hRS7-SN-38
(IMMU-132).We also have a majority ownership in IBC Pharmaceuticals, Inc.,
which is developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making
fusion proteins and multifunctional antibodies. DNL™ is being used
particularly to make bispecific antibodies targeting cancers and infectious
diseases as a T-cell redirecting immunotherapy, as well as bispecific
antibodies for next-generation cancer and autoimmune disease therapies. We
believe that our portfolio of intellectual property, which includes
approximately 227 active patents in the United States and more than 400
foreign patents, protects our product candidates and technologies.Our
strength in intellectual property has resulted in the top-10 ranking in the
2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology and
Pharmaceuticals category.For additional information on us, please visit our
website at www.immunomedics.com. The information on our website does not,
however, form a part of this press release.

This release, in addition to historical information, may contain
forward-looking statements made pursuant to the Private Securities Litigation
Reform Act of 1995. Such statements, including statements regarding clinical
trials, out-licensing arrangements (including the timing and amount of
contingent payments), forecasts of future operating results, potential
collaborations, and capital raising activities, involve significant risks and
uncertainties and actual results could differ materially from those expressed
or implied herein. Factors that could cause such differences include, but are
not limited to, risks associated with any cash payment that the Company might
receive in connection with a sublicense involving a third party and UCB, which
is not within the Company's control, new product development (including
clinical trials outcome and regulatory requirements/actions), our dependence
on our licensing partners for the further development of epratuzumab and
veltuzumab for non-cancer indications, competitive risks to marketed products
and availability of required financing and other sources of funds on
acceptable terms, if at all, as well as the risks discussed in the Company's
filings with the Securities and Exchange Commission.The Company is not under
any obligation, and the Company expressly disclaims any obligation, to update
or alter any forward-looking statements, whether as a result of new
information, future events or otherwise.

IMMUNOMEDICS, INC.
Condensed Consolidated Balance Sheets

                                               June 30,       June 30,
                                                  2013           2012
ASSETS                                                        
Current Assets:                                               
Cash and cash equivalents                        $ 41,326,000  $32,838,096
Accounts receivable, net of allowance for         622,830       659,958
doubtful accounts
Inventory                                        1,030,480     415,876
Other receivables                                 627,757       389,002
Prepaid expenses                                 432,660       582,601
Other current assets                             1,175,883     593,900
                                               45,215,610    35,479,433
                                                             
Property and equipment, net                      2,086,911     2,527,500
Value of life insurance policies                 594,832       598,288
Other long-term assets                            30,000        30,000
                                                             
                                               $ 47,927,353  $38,635,221
                                                             
LIABILITIES AND
STOCKHOLDERS'                                                 
EQUITY
Accounts payable and accrued expenses             $7,164,946   $5,412,169
Deferred revenues                                2,780,309     182,631
Other long-term liabilities                       1,400,728     1,301,212
Stockholders' equity                             36,581,370    31,739,209
                                                             
                                               $ 47,927,353  $38,635,221
                                                             
Condensed Consolidated Statements of Operations
                                               
                   Three Months Ended           Year Ended
                    June 30,                     June 30,
                   2013         2012         2013         2012
Revenues:                                                     
License fee and     $--         $--         $126,667     $28,418,000
other revenues
Product sales       772,332       825,084       2,991,129     3,517,739
Research &          589,630       137,956       1,844,201     798,088
development
Total Revenues      1,361,962     963,040       4,961,997     32,733,827
Costs and Expenses  9,012,657     8,515,474     36,538,422    31,859,660
Operating (Loss)    (7,650,695)   (7,552,434)   (31,576,425)  874,167
Income
Interest and Other  (8,608)       (3,466)       19,350,284    31,996
Income
(Loss) Income
before Income Tax   (7,659,303)   (7,555,900)   (12,226,141)  906,163
Expense
Income Tax Expense  (24,574)      10,215        (44,070)      (209,785)
Net (Loss) Income   (7,683,877)   (7,545,685)   (12,270,211)  696,378
Less Net Loss
attributable on     (27,716)      (29,158)      (104,761)     (113,574)
noncontrolling
interest
                                                             
Net (Loss) Income
attributable to     $ (7,656,161) $ (7,516,527) $(12,165,450) $809,952
Immunomedics, Inc.
stockholders
                                                             
Net (Loss) Income
per Common Share
attributable to                                               
Immunomedics, Inc.
stockholders:
Basic               $(0.09)      $(0.10)      $(0.16)      $0.01
Diluted             $(0.09)      $(0.10)      $(0.16)      $0.01
                                                             
Weighted average
number of common                                              
shares outstanding:
Basic               82,737,251    75,540,438     78,040,005    75,481,007
Diluted             82,737,251    75,540,438     78,040,005    76,174,377

CONTACT: For More Information:
         Dr. Chau Cheng
         Senior Director, Investor Relations & Grant Management
         (973) 605-8200, extension 123
         ccheng@immunomedics.com
 
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