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Share Name | Share Symbol | Market | Type |
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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 |
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 ended June 30, 2016.
“I am very pleased with the progress we have made on our pipeline and our commercial portfolio,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "Our advanced development pipeline includes treatments for chemotherapy-induced neutropenia, breast cancer, and bladder cancer. The success of any of these drugs could transform the company. We are currently enrolling patients in the pivotal program for SPI-2012, which we believe has shown a compelling clinical profile in Phase 2 studies. In addition, Poziotinib has the potential to be a best in class pan-HER inhibitor, and we recently started enrolling breast cancer patients who have failed other HER2-directed therapies in a Phase 2 trial. Qapzola for post-surgical treatment of non-muscle invasive bladder cancer is under FDA review and we look forward to presenting our case to an FDA advisory panel next month. We are making advances in our pipeline that could lead to novel cancer therapies that would benefit both patients and shareholders.”
Pipeline Update:
Three-Month Period Ended June 30, 2016 (All numbers are approximate)
GAAP Results
Total product sales were $30.9 million in the second quarter of 2016. Product sales in the second quarter included: FUSILEV® (levoleucovorin) net sales of $10.5 million, FOLOTYN® (pralatrexate injection) net sales of $11.0 million, ZEVALIN® (ibritumomab tiuxetan) net sales of $2.8 million, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) net sales of $2.1 million, BELEODAQ® (belinostat for injection) net sales of $3.7 million and EVOMELA® (melphalan) for injection net sales of $0.9 million.
Spectrum recorded net loss of $24.3 million, or $(0.35) per basic and diluted share in the three-month period ended June 30, 2016, compared to net loss of $2.3 million, or $(0.04) per basic and diluted share in the comparable period in 2015. Total research and development expenses were $14.3 million in the quarter, as compared to $9.6 million in the same period in 2015. Selling, general and administrative expenses were $27.6 million in the quarter, compared to $22.6 million in the same period in 2015.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $3.7 million, or $(0.05) per basic and diluted share in the three-month period ended June 30, 2016, compared to non-GAAP net loss of $0.5 million, or $(0.01) per basic and diluted share in the comparable period in 2015. Non-GAAP research and development expenses were $12.9 million, as compared to $9.1 million in the same period of 2015. Non-GAAP selling, general and administrative expenses were $16.1 million, as compared to $19.7 million in the same period in 2015.
Conference Call
Tuesday, August 9, 2016 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID# 49557622
International: (973) 796-5077, Conference ID# 49557622
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 August 9, 2016 at 4:30 p.m. Eastern/1:30 p.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 Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and expects an FDA decision on another drug in the second half of 2016. Additionally, Spectrum’s pipeline includes three drugs in advanced stages of clinical development that have 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 - 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 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. 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™ and QAPZOLA™ 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
SPECTRUM PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations(In thousands, except per share amounts)
(Unaudited)
Three Months EndedJune 30, Six Months EndedJune 30, 2016 2015 2016 2015 Revenues: Product sales, net $ 30,887 $ 35,144 $ 66,129 $ 73,557 License fees and service revenue 3,062 9,838 11,686 10,042 Total revenues $ 33,949 $ 44,982 $ 77,815 $ 83,599 Operating costs and expenses: Cost of product sales (excludes amortization and impairment charges of intangible assets) 5,609 5,990 11,212 13,061 Cost of service revenue 2,214 — 3,495 — Selling, general and administrative 27,620 22,552 49,583 45,886 Research and development 14,281 9,558 29,744 25,409 Amortization and impairment charges of intangible assets 6,306 6,916 12,145 20,938Total operating costs and expenses
56,030 45,016 106,179 105,294 Loss from operations (22,081 ) (34 ) (28,364 ) (21,695 ) Other (expense) income: Interest expense, net (2,375 ) (2,258 ) (4,714 ) (4,486 ) Change in fair value of contingent consideration related to acquisitions (285 ) (146 ) (1,327 ) (646 ) Other income (expense), net 340 69 618 (966 ) Total other expenses (2,320 ) (2,335 ) (5,423 ) (6,098 ) Loss before income taxes (24,401 ) (2,369 ) (33,787 ) (27,793 ) Benefit (provision) for income taxes 106 23 171 (115 ) Net loss $ (24,295 ) $ (2,346 ) $ (33,616 ) $ (27,908 ) Net loss per share: Basic and diluted $ (0.35 ) $ (0.04 ) $ (0.50 ) $ (0.43 ) Weighted average shares outstanding: Basic and diluted 68,575,021 65,466,004 67,146,188 65,167,162 SPECTRUM PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets(In thousands, expect per share and par value amounts)
(Unaudited)
June 30, 2016 December 31, 2015 ASSETS Current assets: Cash and cash equivalents $ 155,759 $ 139,741 Marketable securities 247 245 Accounts receivable, net of allowance for doubtful accounts of $15 and $120, respectively 34,319 30,384 Other receivables 6,968 12,572 Inventories 6,405 4,176 Prepaid expenses and other assets 2,954 3,507 Total current assets 206,652 190,625 Property and equipment, net of accumulated depreciation 643 918 Intangible assets, net of accumulated amortization and impairment charges 178,312 190,335 Goodwill 17,997 17,960 Other assets 25,600 19,211 Total assets $ 429,204 $ 419,049 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and other accrued liabilities $ 48,208 $ 56,539 Accrued payroll and benefits 6,496 8,188 Deferred revenue 3,461 6,130 Drug development liability 156 259 Acquisition-related contingent obligations — 5,227 Total current liabilities 58,321 76,343 Drug development liability, less current portion 14,227 14,427 Deferred revenue, less current portion 750 383 Acquisition-related contingent obligations, less current portion 1,993 1,439 Deferred tax liability 6,831 6,779 Other long-term liabilities 8,661 7,444 Convertible senior notes 102,522 99,377 Total liabilities 193,305 206,192 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; 0 and 20 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively (the prior year balance relates to the 20 shares of preferred stock which were converted into 40,000 shares of common stock in the current year) — 123 Common stock, $0.001 par value; 175,000,000 shares authorized; 75,902,704 and 68,228,935 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively 75 68 Additional paid-in capital 606,220 552,108 Accumulated other comprehensive loss (2,651 ) (5,319 ) Accumulated deficit (367,745 ) (334,123 ) Total stockholders’ equity 235,899 212,857 Total liabilities and stockholders’ equity $ 429,204 $ 419,049Non-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. Reconciliation of Non-GAAP Adjustments for Condensed Consolidated Statements of Operations(In thousands, expect per share amounts)
(Unaudited)
Three months ended June 30, Six months ended June 30, 2016 2015 2016 2015 GAAP product sales, net & license fees and service revenue $ 33,949 $ 44,982 $ 77,815 $ 83,599 Non GAAP adjustments to product sales, net & license fees and service revenue: — (9,682 ) (6,000 ) (9,682 )Total adjustments to product sales, net & license fees and service revenue
— (9,682 ) (6,000 ) (9,682 ) Non-GAAP product sales & license and contract revenue 33,949 35,300 71,815 73,917 GAAP cost of product sales (excludes amortization and impairment of intangible assets) 5,609 5,990 11,212 13,061 Non-GAAP adjustments to cost of product sales — — — — Non-GAAP cost of product sales (excludes amortization and impairment of intangible assets) 5,609 5,990 11,212 13,061 GAAP cost of service revenue 2,214 — 3,495 — Non-GAAP adjustments to cost of service revenue — — — Non-GAAP cost of service revenue 2,214 — 3,495 — GAAP selling, general and administrative expenses 27,620 22,552 49,583 45,886 Non GAAP adjustments to SG&A: Stock-based compensation (2,790 ) (3,087 ) (5,559 ) (5,116 ) Litigation expenses (8,518 ) 25 (10,813 ) 441 Insurance reimbursement under D&O policy — 365 — 1,746 Depreciation expense (164 ) (177 ) (329 ) (345 ) Total adjustments to SG&A (11,472 ) (2,874 ) (16,701 ) (3,274 ) Non-GAAP selling, general and administrative 16,148 19,678 32,882 42,612 GAAP research and development 14,281 9,558 29,744 25,409 Non-GAAP adjustments to R&D: Stock-based compensation (637 ) (441 ) (1,045 ) (873 ) Depreciation expense (3 ) (3 ) (6 ) (6 ) Other R&D milestone payments (770 ) — (2,826 ) (3,000 )Total adjustments to R&D
(1,410 ) (444 ) (3,877 ) (3,879 ) Non-GAAP research and development 12,871 9,114 25,867 21,530 GAAP amortization and impairment of intangible assets 6,306 6,916 12,145 20,938 Non-GAAP adjustments to amortization and impairment charges of intangible assets: Amortization expense (6,306 ) (6,916 ) (12,145 ) (13,778 ) Impairment of FUSILEV distribution rights — — — (7,160 )Total adjustments to amortization and impairment charges of intangible assets
(6,306 ) (6,916 ) (12,145 ) (20,938 ) Non-GAAP amortization and impairment of intangibles — — — — GAAP loss from operations (22,081 ) (34 ) (28,364 ) (21,695 ) Non-GAAP adjustments to loss from operations 19,188 552 26,723 18,409 Non-GAAP income (loss) from operations (2,893 ) 518 (1,641 ) (3,286 ) GAAP total other (expenses) income, net (2,320 ) (2,335 ) (5,423 ) (6,098 ) Market-to-market of contingent consideration 285 146 1,327 646 (Gain) Loss on foreign currency exchange (206 ) (127 ) (433 ) 1,019 Accretion of discount on 2018 Convertible Notes 1,416 1,298 2,800 2,569 Total adjustments to other (expenses) income, net 1,495 1,317 3,694 4,234 Non-GAAP total other expenses, net (825 ) (1,018 ) (1,729 ) (1,864 ) GAAP benefit (provision) for income taxes 106 23 171 (115 ) Adjustment to benefit (provision) for income taxes (106 ) (23 ) (171 ) 115 Non-GAAP benefit (provision) for income taxes — — — — GAAP net loss (24,295 ) (2,346 ) (33,616 ) (27,908 ) Total non-GAAP adjustments 20,577 1,846 30,246 22,758 Non-GAAP net loss $ (3,718 ) $ (500 ) $ (3,370 ) $ (5,150 ) Non-GAAP loss per share: Basic $ (0.05 ) $ (0.01 ) $ (0.05 ) $ (0.08 ) Diluted $ (0.05 ) $ (0.01 ) $ (0.05 ) $ (0.08 ) Weighted average shares outstanding: Basic 68,575,021 65,466,004 67,146,188 65,167,162 Diluted 68,575,021 65,466,004 67,146,188 65,167,162
View source version on businesswire.com: http://www.businesswire.com/news/home/20160809006282/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President, Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
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