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 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.”
- SPI-2012 (eflapegrastim), a novel long-acting GCSF: A pivotal Phase 3 study was initiated under a Special Protocol Assessment (SPA) from the FDA in Q1 2016 to evaluate SPI-2012 in the management of chemotherapy-induced neutropenia in approximately 580 patients with breast cancer. Enrollment is on track and the company expects to file a BLA in 2018. Moderate to severe neutropenia is a serious side effect of certain chemotherapeutic agents which can lead to infection, hospitalization, and even death. The Phase 2 data demonstrated that SPI-2012 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. SPI-2012 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 program 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.
- Qapzola, a potent tumor-activated drug being investigated for non-muscle invasive bladder cancer: The FDA is expected to make a decision on Qapzola’s approval by the PDUFA date of December 11, 2016. The FDA plans to hold an advisory committee meeting on September 14, 2016. The Company is actively enrolling an additional randomized, placebo-controlled Phase 3 trial under a SPA agreement. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA.
Three-Month Period Ended June 30, 2016 (All numbers are approximate)
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.
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.
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)
Three Months Ended
Six Months Ended
|Product sales, net||$||30,887||$||35,144||$||66,129||$||73,557|
|License fees and service revenue||3,062||9,838||11,686||10,042|
|Operating costs and expenses:|
|Cost of product sales (excludes amortization and impairment charges of intangible assets)||5,609||5,990||11,212||13,061|
|Cost of service revenue||2,214||—||3,495||—|
|Selling, general and administrative||27,620||22,552||49,583||45,886|
|Research and development||14,281||9,558||29,744||25,409|
|Amortization and impairment charges of intangible assets||6,306||6,916||12,145||20,938|
Total operating costs and expenses
|Loss from operations||(22,081||)||(34||)||(28,364||)||(21,695||)|
|Other (expense) income:|
|Interest expense, net||(2,375||)||(2,258||)||(4,714||)||(4,486||)|
|Change in fair value of contingent consideration related to acquisitions||(285||)||(146||)||(1,327||)||(646||)|
|Other income (expense), net||340||69||618||(966||)|
|Total other expenses||(2,320||)||(2,335||)||(5,423||)||(6,098||)|
|Loss before income taxes||(24,401||)||(2,369||)||(33,787||)||(27,793||)|
|Benefit (provision) for income taxes||106||23||171||(115||)|
|Net loss per share:|
|Basic and diluted||$||(0.35||)||$||(0.04||)||$||(0.50||)||$||(0.43||)|
|Weighted average shares outstanding:|
|Basic and diluted||68,575,021||65,466,004||67,146,188||65,167,162|
|SPECTRUM PHARMACEUTICALS, INC.|
|Condensed Consolidated Balance Sheets|
(In thousands, expect per share and par value amounts)
|Cash and cash equivalents||$||155,759||$||139,741|
|Accounts receivable, net of allowance for doubtful accounts of $15 and $120, respectively||34,319||30,384|
|Prepaid expenses and other assets||2,954||3,507|
|Total current assets||206,652||190,625|
|Property and equipment, net of accumulated depreciation||643||918|
|Intangible assets, net of accumulated amortization and impairment charges||178,312||190,335|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and other accrued liabilities||$||48,208||$||56,539|
|Accrued payroll and benefits||6,496||8,188|
|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|
|Commitments and contingencies|
|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, $0.001 par value; 175,000,000 shares authorized; 75,902,704 and 68,228,935 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively||75||68|
|Additional paid-in capital||606,220||552,108|
|Accumulated other comprehensive loss||(2,651||)||(5,319||)|
|Total stockholders’ equity||235,899||212,857|
|Total liabilities and stockholders’ equity||$||429,204||$||419,049|
Non-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)
|Three months ended June 30,||Six months ended June 30,|
|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
|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:|
|Insurance reimbursement under D&O policy||—||365||—||1,746|
|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:|
|Other R&D milestone payments||(770||)||—||(2,826||)||(3,000||)|
Total adjustments to R&D
|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:|
|Impairment of FUSILEV distribution rights||—||—||—||(7,160||)|
Total adjustments to amortization and impairment charges of intangible assets
|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:|
|Weighted average shares outstanding:|