Spectrum Pharmaceuticals Provides Third Quarter Financial and Pipeline Update
Financial Update: Q3 revenues were $33.4 million, including
$30.3 million in product sales, with recently launched drug EVOMELA® (melphalan)
for injection contributing $5.9 million. The Company ended the quarter
with Cash and Cash Equivalents of $171.9 million.
Earnings Call Update: Spectrum is re-examining the accounting
treatment of the 2013 acquisition of the rights to CE Melphalan from
Ligand Pharmaceuticals. This re-examination is not expected to impact
reported revenue or cash balance for this or prior periods. The
previously scheduled earnings conference call for the third quarter
2016 will not take place today and the Company plans to release full
financial results as soon as possible.
ROLONTISTM (eflapegrastim): The
Company received conditional acceptance of ROLONTIS as the trade name
for SPI-2012 from the FDA. The pivotal Phase 3 study is actively
enrolling breast cancer patients. The Company is initiating an
additional Phase 3 study to enroll patients primarily in Europe.
Spectrum continues to expect to file a BLA in 2018.
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company
with fully integrated commercial and drug development operations with a
primary focus in Hematology and Oncology announced that the earnings
conference call for the third quarter 2016 will not take place to allow
for more time to finalize financial results. The Company is re-examining
the accounting treatment of the 2013 acquisition of the rights to CE
Melphalan from Ligand Pharmaceuticals. This re-examination is not
expected to impact reported revenue or cash balance for this or prior
periods. The Company plans to release full financial results as soon as
ROLONTIS (eflapegrastim), a novel long-acting GCSF: A
pivotal non-inferiority Phase 3 study was initiated under a Special
Protocol Assessment (SPA) from the FDA in 2016 to evaluate ROLONTIS in
the management of chemotherapy-induced neutropenia in patients with
breast cancer. The Company is initiating an additional Phase 3 study
to enroll patients primarily in Europe. The Company is actively
enrolling breast cancer patients in the current trial and expects to
file a BLA in 2018. The Phase 2 data demonstrated that ROLONTIS was
non-inferior to pegfilgrastim at the middle dose tested, and
statistically superior in terms of duration of severe neutropenia at
the highest dose tested. ROLONTIS was also shown to have an acceptable
safety profile with no significant dose-related or unexpected
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor:
Spectrum is continuing to enroll a Phase 2 breast cancer trial in
the U.S., based on promising Phase 1 efficacy data in breast cancer
patients who had failed multiple other HER2-directed therapies. In
addition, multiple Phase 2 studies are being conducted in South Korea
by Hanmi Pharmaceuticals and National OncoVenture.
Financial Update for Q3 2016:
Total product sales were $30.3 million in the third quarter of 2016.
Product sales in the third quarter included: FUSILEV®
(levoleucovorin) net sales of $4.9 million, FOLOTYN® (pralatrexate
injection) net sales of $11.3 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $2.6 million, MARQIBO® (vinCRIStine
sulfate LIPOSOME injection) net sales of $1.9 million, BELEODAQ®
(belinostat for injection) net sales of $3.6 million, and EVOMELA®
(melphalan) for injection net sales of $5.9 million.
The Company ended the quarter with Cash and Cash Equivalents of $171.9
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in Hematology and Oncology. Spectrum currently markets six
hematology/oncology drugs, and has an advanced stage pipeline that has
the potential to transform the Company. Spectrum's strong track record
for in-licensing and acquiring differentiated drugs, and expertise in
clinical development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase 3
studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement - Certain statements contained in this
press release constitute "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements are predictions based on expectations and projections about
future events, and are not statements of historical fact. You can
identify forward-looking statements by the use of forward-looking
terminology such as "plan", "continue", "expect", "anticipate",
"intend", "predict", "project", "estimate", "likely", "believe",
"might", "seek", "may", "remain", "potential", "can", "should", "could",
"future" and similar expressions, or the negative of those expressions.
These forward-looking statements include Spectrum's beliefs or
expectations relating to Spectrum's expectations relating to the filing
of the Form 10-Q and the results of the ongoing review. These statements
include, but are not limited to, statements that relate to Spectrum's
expectations relating to the filing of the Form 10-Q and the results of
the ongoing review, Spectrum's business and its future, including
certain company milestones, Spectrum's ability to identify, acquire,
develop and commercialize a broad and diverse pipeline of late-stage
clinical and commercial products, the timing and results of FDA
decisions, and any statements that relate to the intent, belief, plans
or expectations of Spectrum or its management, or that are not a
statement of historical fact. Risks that could cause actual
results to differ include the possibility that Spectrum's existing and
new drug candidates may not prove safe or effective, the possibility
that our existing and new applications to the FDA and other regulatory
agencies may not receive approval in a timely manner or at all, the
possibility that our existing and new drug candidates, if approved, may
not be more effective, safer or more cost efficient than competing
drugs, the possibility that our efforts to acquire or in-license and
develop additional drug candidates may fail, our dependence on third
parties for clinical trials, manufacturing, distribution and quality
control and other risks that are described in further detail in the
Company's reports filed with the Securities and Exchange Commission. Such
forward-looking statements involve known and unknown risks,
uncertainties, and other factors which may cause the actual results to
be materially different from any future results expressed or implied by
such forward-looking statements. Such factors include a material delay
in Spectrum's financial reporting, including the possibility that
Spectrum will not be able to file its Form 10-Q in a timely manner, the
possibility that one or more material weaknesses in Spectrum's internal
control over financial reporting may be identified in connection with
the ongoing review, the possibility that the ongoing review may identify
errors, which could be material, in Spectrum's accounting, whether
investors should no longer rely upon previously issued financial
statements, and the risk that Spectrum may need to restate its financial
statements. As a result of the foregoing and other factors, no assurance
can be given as to the future results, levels of activity and
achievements of Spectrum, and neither Spectrum nor any person assumes
responsibility for the accuracy and completeness of these statements.
The Company does not plan to update any such forward-looking statements
and expressly disclaims any duty to update the information contained in
this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®,FUSILEV®,
FOLOTYN®, ZEVALIN®, MARQIBO®,BELEODAQ®
, and EVOMELA® are registered trademarks of
Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING
CANCER CARE™ , QAPZOLA™, ROLONTIS™ and the Spectrum Pharmaceuticals'
logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any
other trademarks are the property of their respective owners.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source version on businesswire.com: http://www.businesswire.com/news/home/20161103006633/en/
Spectrum Pharmaceuticals, Inc.
Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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