Spectrum Pharmaceuticals Provides Third Quarter Financial and Pipeline Update
November 03 2016 - 4:05PM
Business Wire
- 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.
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
possible.
Pipeline Update:
- 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 toxicities.
- 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 million.
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.Shiv KapoorVice President,
Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Apr 2023 to Apr 2024