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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Spectrum Pharmaceuticals Inc | NASDAQ:SPPI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 1.03 | 1.14 | 0.9785 | 0 | 01:00:00 |
Development Highlights: 2 Near-term NDA’s and 2 Potential Blockbusters
Financial Highlights: Strong Growth in Sales and Non-GAAP Earnings
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 today financial results for the three-month period and year ended December 31, 2014.
"2014 was a strong year of revenue and non-GAAP earnings growth, and we now have one of the strongest pipelines in Spectrum's history,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “SPI-2012, our lead drug being investigated for the treatment of neutropenia targets a blockbuster market and has shown impressive Phase 2 data which we are sharing at our Analyst Day today. We have recently acquired Poziotinib, a novel Pan-HER inhibitor that has shown promising efficacy in breast cancer patients who had failed multiple HER2 agents in Phase 1 studies. We believe this drug has the potential to be best in class. Further, we expect an FDA decision on our next hematology drug CE-Melphalan in October, and we expect to file an NDA for Apaziquone later this year. I am excited about the tremendous progress at Spectrum which has positioned us well for long-term growth."
Three-Month Period Ended December 31, 2014 (All numbers are approximate)
GAAP Results
Total revenues were $51.9 million and product sales were $51.7 million in the fourth quarter of 2014. Total revenue increased 25% from $41.5 million in the fourth quarter of 2013, while product sales increased 28% from $40.5 million in the fourth quarter of 2013.
Product sales in the fourth quarter included: FUSILEV® (levoleucovorin) net sales of $30 million, FOLOTYN® (pralatrexate injection) net sales of $12.2 million, ZEVALIN® (ibritumomab tiuxetan) net sales of $5 million, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) net sales of $1.6 million and BELEODAQ® (belinostat) for Injection nets sales of $2.9 million.
Spectrum recorded net loss of $3.0 million, or ($0.05) per basic and diluted share in the three-month period ended December 31, 2014, compared to net loss of $39.4 million, or ($0.63) per basic and diluted share in the comparable period in 2013. Total research and development expenses were $14.4 million in the quarter, as compared to $10.8 million in the same period in 2013. Selling, general and administrative expenses were $24.5 million in the quarter, compared to $25.7 million in the same period in 2013.
Non-GAAP Results
Spectrum recorded non-GAAP net income of $7.5 million, or $0.12 per basic share and $0.09 per diluted share in the three-month period ended December 31, 2014, compared to non-GAAP net income of $3.5 million, or $0.06 per basic share and $0.05 per diluted share in the comparable period in 2013. Non-GAAP research and development adjustments were $0.4 million, as compared to $0.5 million in the same period of 2013. Non-GAAP selling, general and administrative adjustments were $3.1 million, as compared to $4.3 million in the same period in 2013.
Twelve-Month Period Ended December 31, 2014 (All numbers are Approximate)
GAAP Results
Consolidated revenue of $186.8 million for the twelve-month period ending December 31, 2014 was comprised of product sales of $186.5 million and $0.3 million from license fees and service revenue.
Product sales in 2014 were comprised of: FUSILEV® sales of $105.6 million, FOLOTYN® sales of $47.5 million, ZEVALIN® sales of $22.2 million, Marqibo® sales of $6.3 million and BELEODAQ® sales of $4.9 million.
The Company recorded net loss of $45.7 million, or ($0.71) per basic and diluted share in the twelve-month period ended December 31, 2014, compared to net loss of $62.1 million, or ($1.02) per basic and diluted share in 2013. Total research and development expenses were $69.7 million in 2014, as compared to $46.7 million in 2013. Selling, general and administrative expenses were $97.4 million in 2014, compared to $99.3 million in 2013. The Company had cash and equivalents and marketable securities of an aggregate $133.2 million as of December 31, 2014.
Non-GAAP Results
The Company recorded non-GAAP net income of $21.4 million, or $0.33 per basic share and $0.27 per diluted share in the twelve-month period ended December 31, 2014, compared to net loss of $5.6 million, or ($0.09) per basic and diluted share in the same period in 2013. Non-GAAP research and development adjustments were $19.6 million, as compared to $2.1 million in the same period of 2013. Non-GAAP selling, general and administrative adjustments were $12.5 million, as compared to $19.3 million in the same period of 2013.
Development Highlights
SPI-2012: a novel, biologic GCSF that could expand treatment options
Poziotinib: an oral, irreversible, pan-HER inhibitor under development with best in class potential
Captisol-enabled Melphalan: a new melphalan formulation with improved stability
Apaziquone: a tumor-activated pro-drug; potentially 1st new drug for NMIBC in >40 years
Conference Call
Friday, March 13, 2015 @ 10:00 a.m. Eastern/7:00 a.m. Pacific
Domestic: (877) 837-3910, Conference ID# 82077760
International: (973) 796-5077, Conference ID# 82077760
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals' website: www.sppirx.com on March 13, 2015 at 10:00 a.m. Eastern/7:00 a.m. Pacific.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market five oncology drugs─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights; MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, for which the Company has worldwide marketing rights and BELEODAQ® (belinostat) for Injection in the U.S. Spectrum's strong track record in 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.
About Captisol-Enabled Melphalan
Captisol-Enabled, Propylene Glycol -free Melphalan is a novel intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, for which it has been granted an Orphan Drug Designation by the FDA. This formulation eliminates the need to use propylene glycol containing custom diluent, which has been reported to cause renal and cardiac side effects, which in turn limit the ability to deliver higher doses of therapeutic compounds. The use of the Captisol® technology to reformulate melphalan also improves its stability and is anticipated to allow for slower infusion rates and longer administration durations, potentially enabling clinicians to safely achieve a higher dose intensity for pre-transplant chemotherapy.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis®, Baxter International’s Nexterone® and Merck’s NOXAFIL IV. There are also more than 30 Captisol-enabled products currently in clinical development.
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 are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to our 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, 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 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 lack of sustained revenue history, 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 Company's 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. ®, FUSILEV®, FOLOTYN®, ZEVALIN®, MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
SPECTRUM PHARMACEUTICALS, INC.Consolidated Statements of Operations(In thousands, except per share amounts)(Unaudited)
Three Months EndedDecember 31, Twelve Months EndedDecember 31, 2014 2013 2014 2013 Revenues: Product sales, net $ 51,670 $ 40,479 $ 186,537 $ 143,475 License fees and service revenue 191 1,039 293 12,379 Total revenues $ 51,861 $ 41,518 $ 186,830 $ 155,854 Operating expenses:Cost of product sales (excludes amortization of intangible assets)
8,073 6,309 27,037 28,580 Selling, general and administrative 24,485 25,714 97,412 99,315 Research and development 14,410 10,760 69,662 46,670 Amortization and impairment of intangible assets 6,525 5,245 24,288 20,074 Total operating expenses 53,493 48,028 218,399 194,639 (Loss) from operations (1,632) (6,510) (31,569) (38,785) Interest expense (2,180) (650) (8,584) (2,192) Change in fair value of contingent consideration related to acquisition 2,897 2,871 987 2,871 Other (expense) income, net (2,129) 666 (4,367) 1,470 Loss before income taxes (3,044) (3,623) (43,533) (36,636) (Provision) benefit for income taxes 68 (35,749) (2,186) (25,498) ,, Net loss $ (2,976) $ (39,372) $ (45,719) $ (62,134) Net loss per share: Basic $ (0.05) $ (0.63) $ (0.71) $ (1.02) Diluted $ (0.05) $ (0.63) $ (0.71) $ (1.02) Weighted average shares outstanding: Basic 65,054,236 62,851,660 64,708,163 60,729,128 Diluted 65,054,236 62,851,660 64,708,163 60,729,128SPECTRUM PHARMACEUTICALS, INC.Consolidated Balance Sheets(In thousands, expect per share amounts)(Unaudited)
December 31,2014December 31,2013
ASSETS Current Assets: Cash and equivalents $ 129,942 $ 156,306 Marketable securities 3,306 3,471 Accounts receivable, net of allowance for doubtful accounts of $120 and $206, respectively 70,758 49,483 Other Receivables 5,489 7,539 Inventories 9,200 13,519 Prepaid expenses and other current assets 3,774 3,213 Deferred income taxes — 1,659 Total current assets 222,469 235,190 Property and equipment, net 1,405 1,535 Intangible assets, net 230,100 231,352 Goodwill 18,195 18,501 Deferred tax assets — — Other assets 17,864 12,577 Total assets $ 490,033 $ 499,155 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and other accrued obligations $ 84,994 $ 79,837 Accrued payroll and related expenses 8,444 6,872 Deferred revenue 9,959 156 Drug development liability 1,141 3,119 Acquisition related contingent obligations 4,901 — Total current liabilities 109,439 89,984 Drug development liability, less current portion 14,644 14,623 Acquisition related contingent obligations 2,441 8,329 Deferred tax liability 6,569 7,168 Other long-term obligations 6,088 5,965 Convertible senior notes 96,298 91,480 Total liabilities 235,479 217,549 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized: Series B junior participating preferred stock, $0.001 par value; 1,500,000 shares authorized; no shares issued and outstanding — — Series E convertible voting preferred stock, $0.001 par value and $10,000 stated value; 2,000 shares authorized; 20 shares issued and outstanding at December 31, 2014 and December 31, 2013, respectively (convertible into 40,000 shares of common stock, with aggregate liquidation value of $240) 123 123 Common stock, $0.001 par value; 175,000,000 shares authorized; 65,969,699 and 64,104,173 shares issued and outstanding at December 31, 2014 and December 31, 2013, respectively 66 64 Additional paid-in capital 538,553 518,144 Accumulated other comprehensive income (850) 894 Accumulated deficit (283,338) (237,619) Total stockholders’ equity 254,554 281,606 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 490,033 $ 499,155Non-GAAP Financial Measures
In this press release, Spectrum reports certain historical and expected non-GAAP results. Non-GAAP financial measures are reconciled to the most directly comparable GAAP financial measure in the tables of this press release and the accompanying footnotes. The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the below table. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the Company's on-going core operating performance.
Management uses non-GAAP net income (loss) in its evaluation of the Company's core after-tax results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that providing these non-GAAP financial measures allows investors to view the Company's financial results in the way that management views the financial results.
The non-GAAP financial measures presented herein have certain limitations in that they do not reflect all of the costs associated with the operations of the Company's business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.
SPECTRUM PHARMACEUTICALS, INC.Condensed Consolidated Statements of Operations and Reconciliation of Non-GAAP Adjustments(In thousands, except share and per share data)(Unaudited)
Three months ended December 31,
Year ended December 31,
2014 2013 2014 2013 GAAP product sales & license and contract revenue $ 51,861 $ 41,516 $ 186,830 $ 155,854 Non GAAP adjustments to product sales & license and contract revenue: -- ----
(7,608)
Total adjustments to product sales & license and contract revenues -- ----
(7,608)
Non-GAAP product sales & license and contract revenue 51,861 41,516 186,830 148,246 GAAP cost of product sales 8,073 6,309 27,037 28,580 Non-GAAP adjustments to cost of product sales -- -- -- -- Non-GAAP cost of product sales 8,073 6,309 27,037 28,580 GAAP selling, general and administrative expenses 24,485 25,714 97,412 99,315 Non GAAP adjustments to SG&A: Stock-based compensation (2,831) (3,667) (10,054) (10,762) Shareholder lawsuit (136) (290) (1,503) (1,781) Talon acquisition legal & professional fees -- (67) -- (3,444) Reduction of Staff -- (12) -- (1,984) Loan modification expense -- -- -- (183) Depreciation expense (123) (220) (992) (1,105) Total adjustments to SG&A (3,090) (4,256) (12,549) (19,259) Non-GAAP selling, general and administrative 21,395 21,458 84,863 80,056 GAAP research and development 14,410 10,760 69,662 46,670 Non-GAAP adjustments to R&D: Stock-based compensation (389) (449) (1,756) (2,016) Depreciation expense (13) (12) (72) (81) TopoTarget milestone payment & stock issuance -- -- (17,790) -- Reduction in staff -- (4) -- (1,375) Amendment of Mundipharma agreement resulting in write off of deferred payment contingency -- ----
2,431
Non-recurring payment related to co-development agreement -- ----
(1,100)
Total adjustments to R&D (402) (465) (19,618) (2,141) Non-GAAP research and development 14,008 10,295 50,044 44,529GAAP amortization of intangibles
6,525 5,24524,288
20,074
Non-GAAP adjustments to amortization of intangibles: Amortization (6,525) (5,245) (24,288) (20,074) Total adjustments to amortization of intangibles (6,525) (5,245)(24,288)
(20,074)
Non-GAAP amortization of intangibles -- -- -- -- GAAP loss from operations (1,632) (6,512) (31,569) (38,784) Non-GAAP adjustments to income from operations 10,017 9,966 56,455 33,866 Non-GAAP income (loss) from operations 8,385 3,454 24,886 (4,919) GAAP other expense, net (1,412) 2,887 (11,964) 2,149 Non-GAAP adjustments to other expense Realized gain on TopoTarget shares -- -- (2,219) -- Loss on foreign currency exchange 2,186 -- 6,824 -- Market-to-market of contingent consideration (2,897) (2,871) (987) (2,871) Accretion of discount on 2018 Convertible Notes 1,261 -- 4,818 -- Total adjustments to other expense, net 550 (2,871) 8,436 (2,871) Non-GAAP other expense, net (862) 16 (3,528) (722) GAAP (provision)/benefit for income taxes 68 (35,749) (2,186) (25,498) Adjustment to (provision)/benefit for income taxes (68) 35,749 2,186 25,498 Non-GAAP provision for income taxes -- -- -- -- GAAP net loss (2,976) (39,374) (45,719) (62,134) Non-GAAP adjustments 10,499 42,844 67,077 56,493 Non-GAAP net income 7,523 3,470 21,358 (5,641)
Non-GAAP income per share:
Basic $ 0.12 $ 0.06$
0.33
$
(0.09)
Diluted $ 0.09 $ 0.05 $ 0.27 $ (0.09) Weighted average shares outstanding: Basic 65,054,236 62,851,660 64,708,163 60,729,128 Diluted 79,354,398 68,211,929 79,268,282 60,729,128
Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice President, Strategic Planning & Investor RelationsInvestorRelations@sppirx.com
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