Spectrum Pharmaceuticals Reports Fourth Quarter 2016 and Full Year 2016 Financial Results and Pipeline Update
- ROLONTIS™ (eflapegrastim) pivotal program is on track for Spectrum to file BLA next year.
-
Poziotinib study in non-small cell lung cancer patients with EGFR Exon
20 insertion mutations, being run in partnership with
The University of Texas MD Anderson Cancer Center , is expected to yield results before year end. -
Qapzola™ (apaziquone) receives a new Special Protocol Assessment (SPA)
from the
FDA that significantly reduces the number of patients required for NDA filing. -
Q4 revenues were
$35.2 million , including$32.2 million in product sales.
"We made significant advancements in our pipeline throughout 2016 and I
believe we are well positioned for transformational growth," said Rajesh
Pipeline Update:
-
ROLONTIS (eflapegrastim), a novel long-acting GCSF: A
pivotal Phase 3 study was initiated under a SPA from the
FDA in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer. The Company is actively enrolling breast cancer patients in the current trial, expects to initiate an additional smaller Phase 3 trial, and continues to expect to file a BLA next year.
-
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor:
In collaboration with
The University of Texas MD Anderson Cancer Center , an investigator sponsored trial is being initiated in non-small cell lung cancer patients with EGFR Exon 20 insertion mutations. The study is expected to yield results before year end. Spectrum is also conducting a Phase 2 breast cancer trial in theU.S. , based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. Further, multiple Phase 2 studies are being conducted inSouth Korea byHanmi Pharmaceuticals and National OncoVenture to study additional cancer indications. -
Qapzola, a potent tumor-activated drug being investigated for
non-muscle invasive bladder cancer: The Company received a new SPA
from the
FDA on a proposed Phase 3 study design. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous study, this study will use twice the dosage of Qapzola (8 mg), will evaluate approximately 70% fewer patients (n = 425), and will evaluate time-to-recurrence as the primary endpoint compared to recurrence at 2 years.
Three-Month Period Ended
GAAP Results
Total product sales were
Spectrum recorded net loss of
During the quarter the Company purchased
Non-GAAP Results
Spectrum recorded non-GAAP net loss of
Twelve-Month Period Ended
GAAP Results
Total product sales were
Product sales in 2016 included: FUSILEV® (levoleucovorin) net
sales of
Spectrum recorded net loss of
Non-GAAP Results
Spectrum recorded non-GAAP net loss of
Conference Call
Domestic: | (877) 837-3910, Conference ID# 67373281 | |||||
International: | (973) 796-5077, Conference ID# 67373281 |
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 8, 2017 at 4:30 p.m. Eastern/1:30 p.m. Pacific.
About
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 has an advanced stage pipeline that has 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
© 2017
|
||||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||||
(In thousands, except per share amounts) |
||||||||||||||||
(Unaudited) |
||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Revenues: | ||||||||||||||||
Product sales, net | $ | 32,195 | $ | 34,837 | $ | 128,596 | $ | 136,851 | ||||||||
License fees and service revenue | 3,041 | 15,494 | 17,848 | 25,705 | ||||||||||||
Total revenues | $ | 35,236 | $ | 50,331 | $ | 146,444 | $ | 162,556 | ||||||||
Operating costs and expenses: | ||||||||||||||||
Cost of product sales (excludes amortization and impairment charges of intangible assets) | 9,238 | 6,181 | 27,953 | 27,689 | ||||||||||||
Cost of service revenue | 2,174 | — | 7,890 | — | ||||||||||||
Selling, general and administrative | 18,300 | 21,218 | 87,347 | 86,514 | ||||||||||||
Research and development | 15,899 | 15,433 | 58,936 | 50,766 | ||||||||||||
Amortization and impairment charges of intangible assets | 6,894 | 10,462 | 25,946 | 38,319 | ||||||||||||
Total operating costs and expenses | 52,505 | 53,294 | 208,072 | 203,288 | ||||||||||||
Loss from operations | (17,269 | ) | (2,963 | ) | (61,628 | ) | (40,732 | ) | ||||||||
Other (expense) income: | ||||||||||||||||
Interest expense, net | (2,348 | ) | (2,314 | ) | (9,435 | ) | (9,074 | ) | ||||||||
Change in fair value of contingent consideration related to acquisitions | 600 | 1,241 | (649 | ) | 676 | |||||||||||
Other (expense) income, net | (102 | ) | 251 | 887 | (1,249 | ) | ||||||||||
Total other expenses | (1,850 | ) | (822 | ) | (9,197 | ) | (9,647 | ) | ||||||||
Loss before income taxes | (19,119 | ) | (3,785 | ) | (70,825 | ) | (50,379 | ) | ||||||||
Benefit (provision) for income taxes | 1,677 | (369 | ) | 2,313 | (406 | ) | ||||||||||
Net loss | $ | (17,442 | ) | $ | (4,154 | ) | $ | (68,512 | ) | $ | (50,785 | ) | ||||
Net loss per share: | ||||||||||||||||
Basic and diluted | $ | (0.22 | ) | $ | (0.06 | ) | $ | (0.94 | ) | $ | (0.78 | ) | ||||
Weighted average shares outstanding: | ||||||||||||||||
Basic and diluted | 78,401,381 | 65,370,371 | 72,824,070 | 64,882,417 | ||||||||||||
|
||||||||
Condensed Consolidated Balance Sheets | ||||||||
(In thousands, expect per share and par value amounts) |
||||||||
(Unaudited) |
||||||||
2016 |
2015 |
|||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 158,222 | $ | 139,741 | ||||
Marketable securities | 247 | 245 | ||||||
Accounts receivable, net of allowance for doubtful accounts of |
39,782 | 30,384 | ||||||
Other receivables | 5,754 | 12,572 | ||||||
Inventories | 8,715 | 4,176 | ||||||
Prepaid expenses and other assets | 3,930 | 3,507 | ||||||
Total current assets | 216,650 | 190,625 | ||||||
Property and equipment, net of accumulated depreciation | 449 | 918 | ||||||
Intangible assets, net of accumulated amortization and impairment charges | 164,234 | 190,335 | ||||||
|
17,886 | 17,960 | ||||||
Other assets | 29,549 | 19,211 | ||||||
Total assets | $ | 428,768 | $ | 419,049 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and other accrued liabilities | $ | 52,483 | $ | 56,539 | ||||
Accrued payroll and benefits | 8,981 | 8,188 | ||||||
Deferred revenue | 3,188 | 6,130 | ||||||
Drug development liability | 861 | 259 | ||||||
Acquisition-related contingent obligations | — | 5,227 | ||||||
Total current liabilities | 65,513 | 76,343 | ||||||
Drug development liability, less current portion | 12,269 | 14,427 | ||||||
Deferred revenue, less current portion | 323 | 383 | ||||||
Acquisition-related contingent obligations, less current portion | 1,315 | 1,439 | ||||||
Deferred tax liability | 6,675 | 6,779 | ||||||
Other long-term liabilities | 9,604 | 7,444 | ||||||
Convertible senior notes | 97,043 | 99,377 | ||||||
Total liabilities | 192,742 | 206,192 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, |
— | — | ||||||
Series B Junior Participating Preferred Stock, |
— | — | ||||||
Series E Convertible Voting Preferred Stock, |
— | 123 | ||||||
Common stock, |
80 | 68 | ||||||
Additional paid-in capital | 640,166 | 552,108 | ||||||
Accumulated other comprehensive loss | (1,579 | ) | (5,319 | ) | ||||
Accumulated deficit | (402,641 | ) | (334,123 | ) | ||||
Total stockholders' equity | 236,026 | 212,857 | ||||||
Total liabilities and stockholders' equity | $ | 428,768 | $ | 419,049 | ||||
Non-GAAP Financial Measures
In this press release, Spectrum reports certain historical "non-GAAP
financial measures," as defined in Regulation G of the Securities
Exchange Act of 1934. Non-GAAP financial measures differ from financial
statements reported in conformity to
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.
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 reported under 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.
|
||||||||||||||||||||
Reconciliation of Non-GAAP Adjustments for Condensed Consolidated Statements of Operations | ||||||||||||||||||||
(In thousands, expect per share amounts) |
||||||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||
(1) | GAAP product sales, net & license fees and service revenue | $ | 35,236 | $ | 50,331 | $ | 146,444 | $ | 162,556 | |||||||||||
Non-GAAP adjustments to product sales, net & license fees and service revenue: | — | (15,000 | ) | (6,000 | ) | (24,681 | ) | |||||||||||||
Non-GAAP product sales, net & license fees and service revenue | $ | 35,236 | $ | 35,331 | $ | 140,444 | $ | 137,875 | ||||||||||||
(2) | GAAP selling, general and administrative expenses | $ | 18,300 | $ | 21,218 | $ | 87,347 | $ | 86,514 | |||||||||||
Non-GAAP adjustments to SG&A: | ||||||||||||||||||||
Stock-based compensation | (2,201 | ) | (2,928 | ) | (10,410 | ) | (10,049 | ) | ||||||||||||
Litigation expenses | (387 | ) | (15 | ) | (12,333 | ) | (7 | ) | ||||||||||||
Insurance reimbursement under D&O policy | — | — | — | 2,111 | ||||||||||||||||
Depreciation expense | (103 | ) | (170 | ) | (535 | ) | (691 | ) | ||||||||||||
Non-GAAP selling, general and administrative | $ | 15,609 | $ | 18,105 | $ | 64,069 | $ | 77,878 | ||||||||||||
(3) | GAAP research and development | $ | 15,899 | $ | 15,433 | $ | 58,936 | $ | 50,766 | |||||||||||
Non-GAAP adjustments to R&D: | ||||||||||||||||||||
Stock-based compensation | (457 | ) | (666 | ) | (2,002 | ) | (2,035 | ) | ||||||||||||
Depreciation expense | (3 | ) | (3 | ) | (11 | ) | (18 | ) | ||||||||||||
Other R&D milestone payments | — | — | (2,826 | ) | (3,000 | ) | ||||||||||||||
Non-GAAP research and development | $ | 15,439 | $ | 14,764 | $ | 54,097 | $ | 45,713 | ||||||||||||
(4) | GAAP net loss | $ | (17,442 | ) | $ | (4,154 | ) | $ | (68,512 | ) | $ | (50,785 | ) | |||||||
Non-GAAP adjustments to net loss: | ||||||||||||||||||||
Adjustments to product sales, net & license fees and service revenue, SG&A, and R&D as noted above | 3,151 | (11,218 | ) | 22,117 | (10,992 | ) | ||||||||||||||
Amortization and impairment charges of intangible assets | 6,894 | 10,462 | 25,946 | 38,319 | ||||||||||||||||
Adjustments to other (expense) income | 959 | (46 | ) | 6,011 | 5,463 | |||||||||||||||
Adjustments to benefit (provision) for income taxes | (1,677 | ) | 369 | (2,313 | ) | 406 | ||||||||||||||
Non-GAAP net loss | $ | (8,115 | ) | $ | (4,587 | ) | $ | (16,751 | ) | $ | (17,589 | ) | ||||||||
(5) | GAAP loss per share (Basic and Diluted) | $ | (0.22 | ) | $ | (0.06 | ) | $ | (0.94 | ) | $ | (0.78 | ) | |||||||
Non-GAAP loss per share (Basic and Diluted) | $ | (0.10 | ) | $ | (0.07 | ) | $ | (0.23 | ) | $ | (0.27 | ) | ||||||||
Weighted average shares outstanding: | ||||||||||||||||||||
Basic and Diluted | 78,401,381 | 65,370,371 | 72,824,070 | 64,882,417 | ||||||||||||||||
(1) Non-GAAP product sales, net & license fees and service revenue: These amounts reflect adjustments to reverse revenue recognition for upfront revenue from out-licenses and revenue from milestone achievement(s) that do not consistently recur. The resulting non-GAAP revenue solely consists of our (i) product sales, (ii) percentage-based royalties from our licensees' sales, and (iii) on-going service revenue. We believe this measure of non-GAAP revenue is more indicative of the period-over-period success of our core ongoing product sales and service revenue.
(2) Non-GAAP selling, general and administrative: These amounts reflect adjustments to reverse allocated operating expenses for certain non-cash items (including stock-based compensation and depreciation), as well as the reversal of irregular operating expense items such as non-recurring legal fees and settlements. We believe the resulting non-GAAP SG&A value is more indicative of the period-over-period success of our administrative expense control, and more reflective of our normalized SG&A expense trends.
(3) Non-GAAP research and development: These amounts reflect adjustments to reverse allocated operating expenses for certain non-cash items (including stock-based compensation and depreciation), as well as non-recurring R&D milestone achievements that we record to expense for our in-licenses. We believe the resulting non-GAAP R&D value is more reflective of our true R&D expense trends.
(4) Non-GAAP net loss: These amounts reflect all non-GAAP adjustments described in (1) through (3) above, plus other non-cash and/or non-recurring items, including: (i) adjustments to reverse cost of service expense recognition for certain service arrangements that do not consistently recur (which corresponds with our non-GAAP reversal of license and contract revenue, as discussed in (1) above); (ii) adjustments to reverse operating expenses for non-cash amortization and impairment of intangible assets (the reversal of these non-cash expenses allows for a clearer representation of the period-over-period success of our overall financial results and future working capital requirements); (iii) adjustments to reverse the impact of income taxes; and (iv) adjustments to reverse the impact of mark-to-market contingent consideration (although our contingent consideration results from prior acquisitions and is a part of our business strategy, these adjustments through earnings typically result from variables other than our current commercial activity or other operating performance measures that are a focus of our management), (v) reversal of foreign exchange gains and losses (non-cash), and (vi) debt discount accretion expense (non-cash) for our convertible notes.
(5) Non-GAAP loss per share: These amounts reflect all non-GAAP adjustments in (1) through (4) above to present our overall non-GAAP financial results for each period on a per-share basis.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170308006331/en/
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
Source:
News Provided by Acquire Media