Spectrum Pharmaceuticals Reports Continued Advancement of Robust, Late-Stage Pipeline and First Quarter 2015 Financial Results
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Significant Progress in Q1 on Two Potential Blockbusters and Two
Near-term NDA's
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SPI-2012, a novel long-acting GCSF: Positive Phase 2 data
presented at Analyst Day, and final Phase 3 protocols have been
sent to the
FDA - Poziotinib, a novel pan-HER inhibitor: Compelling Phase 1 data presented in breast cancer patients who had failed multiple other HER-2 directed therapies; multiple Phase 2 studies underway
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EVOMELA™(CE-Melphalan), a propylene-glycol free Melphalan
with improved stability; NDA review ongoing with positive
FDA discussions; on track for approval decision onOctober 23, 2015 - Apaziquone, a potent pro-drug for non-muscle invasive bladder cancer: Statistically significant results presented from an integrated analysis of two completed Phase 3 studies; NDA submission planned this year
-
SPI-2012, a novel long-acting GCSF: Positive Phase 2 data
presented at Analyst Day, and final Phase 3 protocols have been
sent to the
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Financial Highlights
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Total product sales for the three months ended
March 31, 2015 were$38.4 million (excluding$7.0 million in deferred revenue) compared to$40.1 million in the same period last year -
Non-GAAP EPS for the three months ended
March 31, 2015 was ($0.07 ), and GAAP EPS was ($0.39 ) -
The Company expects to exit 2015 with Cash and Cash Equivalents of
more than
$100 Million
-
Total product sales for the three months ended
"Spectrum has embarked upon 2015 with promising late-stage assets that
give me immense confidence in the future of our Company," said Rajesh C.
Shrotriya, MD, Chairman and Chief Executive Officer of
Three-Month Period Ended
GAAP Results
Total product sales were
Product sales in the first quarter included: FUSILEV®
(levoleucovorin) net sales of
Spectrum recorded net loss of
Non-GAAP Results
Spectrum recorded non-GAAP net loss of
2015 Financial Guidance
Spectrum projects 2015 year-end Cash and Cash Equivalents over
Conference Call
Domestic: (877) 837-3910, Conference ID# 22837264
International: (973) 796-5077, Conference ID# 22837264
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 May 7, 2015 at 4:30 p.m. Eastern/1:30 p.m. Pacific.
About
About Evomela™
Evomela, 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
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.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of
© 2015
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Consolidated Statement of Operations | ||||||||||
(In thousands, expect per share amounts) |
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(Unaudited) |
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Three Months Ended |
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2015 | 2014 | |||||||||
Revenues: | ||||||||||
Product sales, net | $ | 38,413 | $ | 40,096 | ||||||
License fees and service revenue | 205 | 28 | ||||||||
Total revenues | $ | 38,618 | $ | 40,124 | ||||||
Operating expenses: | ||||||||||
Cost of product sales (excludes amortization of purchased intangible assets) | 7,071 | 6,278 | ||||||||
Selling, general and administrative | 23,335 | 23,403 | ||||||||
Research and development | 15,851 | 29,497 | ||||||||
Amortization and impairment of intangible assets | 14,022 | 5,360 | ||||||||
Total operating expenses | 60,279 | 64,538 | ||||||||
Loss from operations | (21,661 | ) | (24,414 | ) | ||||||
Interest expense | (2,228 | ) | (2,067 | ) | ||||||
Change in fair value of contingent consideration related to acquisition | (500 | ) | (724 | ) | ||||||
Other expenses, net | (1,035 | ) | (358 | ) | ||||||
Loss before income taxes | (25,424 | ) | (27,563 | ) | ||||||
Provision for income taxes | (138 | ) | (78 | ) | ||||||
Net loss | $ | (25,562 | ) | $ | (27,641 | ) | ||||
Net loss per share: | ||||||||||
Basic | $ | (0.39 | ) | $ | (0.44 | ) | ||||
Diluted | $ | (0.39 | ) | $ | (0.44 | ) | ||||
Weighted average shares outstanding: | ||||||||||
Basic | 64,880,677 | 63,447,309 | ||||||||
Diluted | 64,880,677 | 63,447,309 | ||||||||
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Consolidated Balance Sheets | ||||||||
(In thousands, expect per share amounts) |
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(Unaudited) |
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2015 |
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ASSETS | ||||||||
Current Assets: | ||||||||
Cash and equivalents | $ | 123,365 | $ | 129,942 | ||||
Marketable securities | 3,308 | 3,306 | ||||||
Accounts receivable, net of allowance for doubtful accounts of |
68,755 | 70,758 | ||||||
Other receivables | 7,914 | 5,489 | ||||||
Inventories | 9,079 | 9,200 | ||||||
Prepaid expenses and other current assets | 3,375 | 3,774 | ||||||
Deferred income taxes | 170 | — | ||||||
Total current assets | 215,966 | 222,469 | ||||||
Property and equipment, net | 1,313 | 1,405 | ||||||
Intangible assets, net | 214,606 | 230,100 | ||||||
Goodwill | 17,949 | 18,195 | ||||||
Other assets | 18,808 | 17,864 | ||||||
Total assets | $ | 468,642 | $ | 490,033 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and other accrued obligations | $ | 82,153 | $ | 84,994 | ||||
Accrued payroll and related expenses | 4,378 | 8,444 | ||||||
Deferred revenue | 17,045 | 9,959 | ||||||
Drug development liability | 1,141 | 1,141 | ||||||
Acquisition related contingent obligations | 5,091 | 4,901 | ||||||
Total current liabilities | 109,808 | 109,439 | ||||||
Drug development liability, less current portion | 13,978 | 14,644 | ||||||
Deferred revenue, less current portion | 416 | — | ||||||
Acquisition related contingent obligations | 2,751 | 2,441 | ||||||
Deferred tax liability | 6,808 | 6,569 | ||||||
Other long-term obligations | 6,944 | 6,088 | ||||||
Convertible senior notes | 97,568 | 96,298 | ||||||
Total liabilities | 238,273 | 235,479 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, |
||||||||
Series B junior participating preferred stock, |
— | — | ||||||
Series E convertible voting preferred stock, |
123 | 123 | ||||||
Common stock, |
66 | 66 | ||||||
Additional paid-in capital | 541,157 | 538,553 | ||||||
Accumulated other comprehensive income | (2,077 | ) | (850 | ) | ||||
Accumulated deficit | (308,900 | ) | (283,338 | ) | ||||
Total stockholders' equity | 230,369 | 254,554 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 468,642 | $ | 490,033 |
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.
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Condensed Consolidated Statements of Operations and Reconciliation of Non-GAAP Adjustments | |||||||||||
(In thousands, except share and per share data) |
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(Unaudited) |
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Three months ended
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2015 | 2014 | ||||||||||
GAAP product sales, net & license fees and service revenue | $ | 38,618 | $ | 40,124 | |||||||
Non GAAP adjustments to product sales, net & license fees and service revenue: | -- | -- | |||||||||
Total adjustments to product sales, net & license fees and service revenues | -- | -- | |||||||||
Non-GAAP product sales & license and contract revenue | 38,618 | 40,124 | |||||||||
GAAP cost of product sales (excludes amortization of intangible assets) | 7,071 | 6,278 | |||||||||
Non-GAAP adjustments to cost of product sales | -- | -- | |||||||||
Non-GAAP cost of product sales (excludes amortization of intangible assets) | 7,071 | 6,278 | |||||||||
GAAP selling, general and administrative expenses | 23,335 | 23,403 | |||||||||
Non GAAP adjustments to SG&A: | |||||||||||
Stock-based compensation | (2,029 | ) | (2,127 | ) | |||||||
Shareholder lawsuit expenses, net of reimbursements | 1,797 | (379 | ) | ||||||||
Depreciation expense | (168 | ) | (245 | ) | |||||||
Total adjustments to SG&A | (400 | ) | (2,751 | ) | |||||||
Non-GAAP selling, general and administrative | 22,935 | 20,652 | |||||||||
GAAP research and development | 15,851 | 29,497 | |||||||||
Non-GAAP adjustments to R&D: | |||||||||||
Stock-based compensation | (433 | ) | (444 | ) | |||||||
Depreciation expense | (3 | ) | (38 | ) | |||||||
TopoTarget milestone cash payment & stock issuance | -- | (17,790 | ) | ||||||||
Other R&D milestone payments | (3,000 | ) | -- | ||||||||
Total adjustments to R&D | (3,436 | ) | (18,272 | ) | |||||||
Non-GAAP research and development | 12,415 | 11,225 | |||||||||
GAAP amortization and impairment of intangibles |
14,022 | 5,360 | |||||||||
Non-GAAP adjustments to amortization and impairment of intangibles: | |||||||||||
Amortization expense | (6,862 | ) | (5,360 | ) | |||||||
Impairment of FUSILEV distribution rights | (7,160 | ) | -- | ||||||||
Total adjustments to amortization and impairment of intangibles | (14,022 | ) | (5,360 | ) | |||||||
Non-GAAP amortization and impairment of intangibles | -- | -- | |||||||||
GAAP (loss) income from operations | (21,661 | ) | (24,414 | ) | |||||||
Non-GAAP adjustments to (loss) income from operations | 17,858 | 26,383 | |||||||||
Non-GAAP (loss) income from operations | (3,803 | ) | 1,969 | ||||||||
GAAP other expense net | (3,763 | ) | (3,149 | ) | |||||||
Market-to-market of contingent consideration | 501 | 724 | |||||||||
Loss on foreign currency exchange on intercompany loans | 1,145 | -- | |||||||||
Accretion of discount on 2018 Convertible Notes | 1,270 | 1,147 | |||||||||
Total adjustments to other expense, net | 2,916 | 1,871 | |||||||||
Non-GAAP other expense, net | (847 | ) | (1,278 | ) | |||||||
GAAP provision for income taxes | (138 | ) | (78 | ) | |||||||
Adjustment to provision for income taxes | 138 | 78 | |||||||||
Non-GAAP provision for income taxes | -- | -- | |||||||||
GAAP net (loss) income | (25,562 | ) | (27,641 | ) | |||||||
Non-GAAP adjustments | 20,912 | 28,332 | |||||||||
Non-GAAP net (loss) income | (4,650 | ) | 691 | ||||||||
Non-GAAP (loss) income per share: | |||||||||||
Basic | $ | (0.07 | ) | $ | 0.01 | ||||||
Diluted | $ | (0.07 | ) | $ | 0.01 | ||||||
Weighted average shares outstanding: | |||||||||||
Basic | 64,880,677 | 63,447,309 | |||||||||
Diluted | 64,880,677 | 78,746,903 | |||||||||
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
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