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8-K - FORM 8-K - SPECTRUM PHARMACEUTICALS INC | c16069e8vk.htm |
Exhibit 99.1 |
COMPANY CONTACTS
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
SPECTRUM
PHARMACEUTICALS ANNOUNCES RECORD REVENUE AND RECORD PROFIT IN
FIRST QUARTER 2011
FIRST QUARTER 2011
| First Quarter 2011 Product Revenues in Excess of $40 Million as Compared to Approximately $7 Million in the First Quarter of 2010 | ||
| Anticipate Reporting a Record Quarterly Profit in the First Quarter 2011 |
| Second Consecutive Profitable Quarter |
| FUSILEV® sNDA For Use In Advanced Metastatic Colorectal Cancer is Currently Under Review by the FDA |
| PDUFA Action Date This Week April 29, 2011 |
| ZEVALIN® Prior Approval Supplement for the Removal of the Bioscan Requirement Currently Under Review by the FDA |
| PDUFA Action Date November 20, 2011 |
| Belinostat and Apaziquone Clinical Programs on Track for New Drug Application Filings in 2012 | ||
| Conference Call to be Held on Wednesday, May 4, 2011 |
IRVINE, California April 27, 2011 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development operations with a primary focus in
oncology, today announced preliminary unaudited first quarter 2011 product revenues and that it
anticipates reporting a record quarterly profit in the first quarter.
We are pleased with our record revenue and profit during the first quarter, said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. We
believe that our strategy of having multiple commercial drugs has been validated, and our ability
to respond to market developments has been demonstrated. While we expect ZEVALIN revenues to grow
gradually over time as we continue to focus on driving adoption of ZEVALIN as the treatment of
choice for appropriate patients, the revenue growth this quarter was driven by FUSILEV. There is
great anticipation around several events for Spectrum over the next two years. If approved for
colorectal cancer later this week, we believe it could represent a significant growth catalyst for
the company. The PDUFA action date for FUSILEVs use in colorectal cancer is this Friday, April
29th.
First Quarter 2011 Estimated Revenues (unaudited)
| First Quarter 2011 product revenues in excess of $40 million, a nearly six-fold increase as compared to approximately $7 million in the first quarter 2010 |
The Company plans to file its 10-Q for the first quarter ended March 31, 2011 on Tuesday, May 3,
after the market close, and host a conference call on Wednesday, May 4, 2011.
Conference Call
Wednesday, May 4, 2011 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic:
|
(877) 837-3910, Conference ID# 60326117 | |
International:
|
(973) 796-5077, Conference ID# 60326117 |
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI
2011/2012 Corporate Events and Valuation Catalysts
FUSILEV®
| FUSILEV sNDA for use in advanced metastatic colorectal cancer is currently under review by the FDA |
| PDUFA Action Date April 29, 2011 |
ZEVALIN®
| ZEVALIN bioscan removal is currently under review by the FDA |
| PDUFA Action Date November 20, 2011 |
Belinostat
| Complete enrollment in registrational study and file rolling NDA for Peripheral T-Cell Lymphoma in 2011/2012. |
Apaziquone
| Anticipate data from Phase 3 bladder cancer trials and filing NDA in 2012. |
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug
development operations with a primary focus in oncology. The Companys strategy is comprised of
acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and
commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two
drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of
novel drug candidates. The Company has assembled an integrated in-house scientific team, including
clinical development, medical research, regulatory affairs, biostatistics and data management,
formulation development, and has established a commercial infrastructure for the marketing of its
drug products. The Company also leverages the expertise of its worldwide partners to assist in the
execution of its strategy. For more information, please visit the Companys website at
www.sppirx.com.
Forward-looking statement This press release may contain forward-looking statements regarding
future events and the future performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially. These statements include but
are not limited to statements that relate to our business and its future, including certain company
milestones, Spectrums ability to identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and
employees, around the world to assist us in the execution of our strategy, 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 our existing and new drug candidates, may not prove safe or effective, the
possibility that our existing and new drug candidates may not receive approval from the FDA, and
other regulatory agencies 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 lack of revenues, our limited marketing experience, our dependence on
third parties for clinical trials, manufacturing, distribution and quality control and other risks
that are described in further detail in the Companys reports filed with the Securities and
Exchange Commission. We do not plan to update any such forward-looking statements and expressly
disclaim any duty to update the information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum
Pharmaceuticals, Inc. REDEFINING CANCER CARE and the Spectrum Pharmaceutical logos are trademarks
owned by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI