- SPI-2012, a novel long-acting
GCSF: A pivotal Phase 3 study was initiated under Special
Protocol Assessment (SPA) and is currently enrolling patients.
- Poziotinib, a novel pan-HER
inhibitor: A Phase 2 trial was initiated in breast cancer
patients who have failed other HER2-directed therapies.
- EVOMELA™ (melphalan)
for injection, a propylene-glycol free melphalan formulation:
The Company resubmitted the NDA and received a PDFUA date of May 9,
2016. If approved, the Company plans to launch this drug with its
existing sales force.
-
EOquin® (apaziquone for intravesical
instillation), a potent tumor-activated drug for non-muscle
invasive bladder cancer: Spectrum filed an NDA and the company
received a PDFUA date of December 11, 2016.
- Q4 revenues were $34.8 million driven
by strong demand for our oncology drugs and the Company ended 2015
with $139.7 million in cash.
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, 2015.
“We had solid operating performance this quarter and our
pipeline has never been stronger with multiple drugs enrolling in
late-stage trials,” said Rajesh C. Shrotriya, MD, Chairman and
Chief Executive Officer of Spectrum Pharmaceuticals. “We believe
each of our late-stage drugs have demonstrated strong clinical
data, and can be transformative to the Company. We just started
enrolling the pivotal Phase 3 study for SPI-2012 and a Phase 2
study for poziotinib. We have two drugs lined up for FDA decision
this year: Evomela in May, and EOquin in December. We remain
focused on bringing innovative oncology medicines to the
market.”
Pipeline Update:
- SPI-2012, a novel long-acting
GCSF: A pivotal Phase 3 study was initiated in Q1 2016 and will
evaluate SPI-2012 as a treatment for chemotherapy-induced
neutropenia in approximately 580 patients with breast cancer. In a
Phase 2 dose ranging study, SPI-2012 was shown to have a shorter
duration of severe neutropenia at the higher dose tested and
comparable at the middle dose compared to the blockbuster drug
pegfilgrastim. 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 initiated 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. The Company submitted the Phase 2
protocol to the FDA as part of an Investigational New Drug (IND)
application in November 2015. In addition, multiple Phase 2 studies
are being conducted by Hanmi Pharmaceuticals and National
OncoVenture in South Korea.
- EVOMELA, a propylene-glycol free
melphalan formulation: After receiving a Complete Response
Letter in October, Spectrum was granted a Type A meeting with the
FDA on November 6, 2015. Within days, the company resubmitted the
NDA and received a PDUFA date of May 9, 2016. If approved, we plan
to launch Evomela with our existing sales force.
- EOquin, a potent tumor-activated
drug for non-muscle invasive bladder cancer: Spectrum filed an
NDA based on the previous Phase 3 studies. The FDA accepted the NDA
and has given Spectrum a PDUFA date of December 11, 2016. The
FDA also indicated that it plans to hold an advisory committee
meeting regarding the NDA. The Company is actively enrolling an
additional randomized, placebo-controlled Phase 3 trial under the
SPA agreement. The Phase 3 study has been specifically designed to
build on learnings from the previous EOquin Phase 3 studies, as
well as recommendations from the FDA.
Three-Month Period Ended
December 31, 2015 (All numbers are approximate)
GAAP Results
Total product sales were $34.8 million in the fourth quarter of
2015. Total product sales decreased 33% from $51.7 million in the
fourth quarter of 2014.
Product sales in the fourth quarter included: FUSILEV®
(levoleucovorin) net sales of $15.1 million, FOLOTYN® (pralatrexate
injection) net sales of $10.3 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $3.7 million, BELEODAQ® (belinostat) for
injection net sales of $3.0 million, and MARQIBO® (vinCRIStine
sulfate LIPOSOME injection) net sales of $2.7 million. FUSILEV
sales exceeded our expectations in the fourth quarter, however, we
continue to expect significant declines in the future due to
additional competition and pricing pressure.
Spectrum recorded net loss of $4.2 million, or $0.06 per basic
and diluted share in the three-month period ended December 31,
2015, compared to net loss of $3.0 million, or $0.05 per basic and
diluted share in the comparable period in 2014. Total research and
development expenses were $15.4 million in the quarter, as compared
to $14.4 million in the same period in 2014. Selling, general and
administrative expenses were $21.2 million in the quarter, compared
to $24.5 million in the same period in 2014.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $4.6 million, or $0.07
per basic share and diluted share in the three-month period ended
December 31, 2015, compared to non-GAAP net income of $7.5
million, or $0.12 per basic and $0.09 per diluted share in the
comparable period in 2014. Non-GAAP research and development
expenses were $14.8 million as compared to $14.0 million in the
same period of 2014. Non-GAAP selling, general and administrative
expenses were $18.1 million, as compared to $21.4 million in the
same period in 2014.
Twelve-Month Period Ended
December 31, 2015 (All numbers are approximate)
GAAP Results
Total product sales were $136.9 million for the twelve months
ended December 31, 2015. Total product sales decreased 27%
from $186.5 million in the same period of 2014.
Product sales in 2015 included: FUSILEV® (levoleucovorin) net
sales of $60.7 million, FOLOTYN® (pralatrexate injection) net sales
of $40.6 million, ZEVALIN® (ibritumomab tiuxetan) net sales of
$17.5 million, BELEODAQ® (belinostat) for injection net sales of
$10.1 million, and MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) net sales of $8.0 million.
Spectrum recorded net loss of $50.8 million, or $0.78 per basic
and diluted share in the twelve-month period ended
December 31, 2015, compared to net loss of $45.7 million, or
$0.71 per basic and diluted share in the comparable period in 2014.
Total research and development expenses were $50.8 million for the
year, as compared to $69.7 million in the same period in 2014.
Selling, general and administrative expenses were $86.5 million for
the year, compared to $97.4 million in the same period in 2014.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $17.6 million, or $0.27
per basic and diluted share in the twelve-month period ended
December 31, 2015, compared to non-GAAP net income of $21.4
million, or $0.33 per basic and $0.27 per diluted share in the
comparable period in 2014. Non-GAAP research and development
expenses were $45.7 million as compared to $50.0 million in the
same period of 2014. Non-GAAP selling, general and administrative
expenses were $77.9 million, as compared to $84.9 million in the
same period in 2014.
Conference Call
Wednesday, March 9, 2016 @ 4:30 p.m.
Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID#
51999726 International: (973) 796-5077, Conference ID#
51999726
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 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 five hematology/oncology drugs, and expects two
FDA decisions in 2016. 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 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 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®, BELEODAQ® and EOquin® are registered trademarks of
Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING
CANCER CARE™, EVOMELA™ 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 EndedDecember 31,
Twelve Months EndedDecember 31, 2015
2014 2015 2014 Revenues: Product sales,
net $ 34,837 $ 51,670 $ 136,851 $ 186,537 License fees and service
revenue 15,494 191 25,705 293 Total
revenues $ 50,331 $ 51,861 $ 162,556 $ 186,830
Operating costs and expenses: Cost of product sales
(excludes amortization and impairment of intangible assets) 6,181
8,073 27,689 27,037 Selling, general and administrative 21,218
24,485 86,514 97,412 Research and development 15,433 14,410 50,766
69,662 Amortization and impairment of intangible assets 10,462
6,525 38,319 24,288 Total operating
costs and expenses 53,294 53,493 203,288
218,399 Loss from operations (2,963 ) (1,632 ) (40,732 )
(31,569 ) Other (expense) income: Interest expense, net (2,314 )
(2,180 ) (9,074 ) (8,584 ) Change in fair value of contingent
consideration related to acquisitions 1,241 2,897 676 987 Other
(expense) income, net 251 (2,129 ) (1,249 ) (4,367 ) Total
other expense (822 ) (1,412 ) (9,647 ) (11,964 ) Loss before income
taxes (3,785 ) (3,044 ) (50,379 ) (43,533 ) (Provision) benefit for
income taxes (369 ) 68 (406 ) (2,186 ) Net loss $ (4,154 ) $
(2,976 ) $ (50,785 ) $ (45,719 ) Net loss per share: Basic $ (0.06
) $ (0.05 ) $ (0.78 ) $ (0.71 ) Diluted $ (0.06 ) $ (0.05 ) $ (0.78
) $ (0.71 ) Weighted average shares outstanding: Basic 65,370,371
65,054,236 64,882,417 64,708,163 Diluted 65,370,371 65,054,236
64,882,417 64,708,163
SPECTRUM PHARMACEUTICALS, INC. Condensed
Consolidated Balance Sheets
(In thousands, expect per share and par
value amounts)
(Unaudited)
December 31, 2015 December 31,
2014 ASSETS Current assets: Cash and cash equivalents
139,741 129,942 Marketable securities 245 3,306 Accounts
receivable, net of allowance for doubtful accounts of $120 and
$120, respectively 30,384 70,758 Other receivables 12,572 5,489
Inventories 4,176 9,200 Prepaid expenses and other assets 4,206
3,774 Total current assets 191,324 222,469 Property
and equipment, net of accumulated depreciation 918 1,405 Intangible
assets, net of accumulated amortization 190,335 230,100 Goodwill
17,960 18,195 Other assets 20,683 17,864 Total assets
421,220 490,033
LIABILITIES AND STOCKHOLDERS’
EQUITY Current liabilities: Accounts payable and other accrued
liabilities 56,539 84,994 Accrued payroll and benefits 8,188 8,444
Deferred revenue 6,130 9,959 Drug development liability 259 1,141
Acquisition-related contingent obligations 5,227 4,901
Total current liabilities 76,343 109,439 Drug development
liability, less current portion 14,427 14,644 Deferred revenue,
less current portion 383 — Acquisition-related contingent
obligations 1,439 2,441 Deferred tax liability 6,779 6,569 Other
long-term liabilities 7,444 6,088 Convertible senior notes 101,548
96,298 Total liabilities 208,363 235,479 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,
2015 and 2014, 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;
68,228,935 and 65,969,699 issued and outstanding at December 31,
2015 and 2014, respectively 68 66 Additional paid-in capital
552,108 538,553 Accumulated other comprehensive loss (5,319 ) (850
) Accumulated deficit (334,123 ) (283,338 ) Total stockholders’
equity 212,857 254,554 Total liabilities and
stockholders’ equity 421,220 490,033
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.
SPECTRUM PHARMACEUTICALS, INC. Reconciliation of
Non-GAAP Adjustments for Condensed Consolidated Statements of
Operations
(In thousands, expect per share
amounts)
(Unaudited)
Three Months EndedDecember 31,
Year Ended
December 31,
2015 2014 2015 2014
GAAP product sales, net & license fees and service
revenue $ 50,331 $ 51,861 $
162,556 $ 186,830 Non GAAP adjustments
to product sales, net & license fees and service revenue:
(15,000 ) — (24,681 ) — Total adjustments to
product sales, net & license fees and service revenues (15,000
) — (24,681 ) —
Non-GAAP product sales &
license and contract revenue 35,331 51,861
137,875 186,830 GAAP cost of
product sales (excludes amortization of intangible assets)
6,181 8,073 27,689 27,037 Non-GAAP
adjustments to cost of product sales — — — —
Non-GAAP cost of product sales (excludes amortization of
intangible assets) 6,181 8,073
27,689 27,037 GAAP selling, general
and administrative expenses 21,218 24,485
86,514 97,412 Non GAAP adjustments to SG&A:
Stock-based compensation (2,928 ) (2,831 ) (10,049 ) (10,054 )
Shareholder lawsuit expenses (15 ) (136 ) (7 ) (1,503 ) Insurance
reimbursement under D&O policy — — 2,111 — Depreciation expense
(170 ) (123 ) (691 ) (992 ) Total adjustments to SG&A (3,113 )
(3,090 ) (8,636 ) (12,549 )
Non-GAAP selling, general and
administrative 18,105 21,395
77,878 84,863 GAAP research and
development 15,433 14,410 50,766
69,662 Non-GAAP adjustments to R&D: Stock-based
compensation (666 ) (389
)
(2,035 ) (1,756 ) Depreciation expense (3 ) (13 )
(18 ) (72 ) Beleodaq milestone cash payment & stock issuance —
— — (17,790 ) Other R&D milestone payments — —
(3,000 ) — Total adjustments to R&D (669 ) (402 ) (5,053
) (19,618 )
Non-GAAP research and development 14,764
14,008 45,713 50,044
GAAP amortization and impairment of intangible assets
10,462 6,525 38,319 24,288 Non-GAAP
adjustments to amortization and impairment of intangible assets:
Amortization expense (10,462 ) (6,525 ) (31,159 ) (24,288 )
Impairment of FUSILEV distribution rights — — (7,160
) — Total adjustments to amortization and impairment
of intangibles (10,462 ) (6,525 ) (38,319 ) (24,288 )
Non-GAAP
amortization and impairment of intangibles —
— — — GAAP loss from
operations (2,963 ) (1,632 )
(40,732 ) (31,569 ) Non-GAAP
adjustments to loss from operations (756 )
10,017
27,327
56,455
Non-GAAP (loss) income from operations
(3,719 ) 8,385 (13,405 )
24,886 GAAP total other expenses, net
(822 ) (1,412 ) (9,647 )
(11,964 ) Realized gain on TopoTarget shares — — —
(2,219 ) Market-to-market of contingent consideration (1,241 )
(2,897 ) (676 ) (987 ) Loss on foreign currency exchange (161 )
2,186 889 6,824 Accretion of discount on 2018 Convertible Notes
1,356 1,261 5,250 4,818 Total
adjustments to other expense, net (46 ) 550 5,463
8,436
Non-GAAP total other expenses, net (868
) (862 ) (4,184 ) (3,528
) GAAP (provision) benefit for income taxes
(369 ) 68 (406 ) (2,186
) Adjustment to (provision) benefit for income taxes 369
(68 ) 406 2,186
Non-GAAP (provision)
benefit for income taxes — —
— — GAAP net loss (4,154
) (2,976 ) (50,785 )
(45,719 ) Total non-GAAP adjustments (433 ) 10,499
33,196 67,077
Non-GAAP net (loss)
income $ (4,587 ) $ 7,523
$ (17,589 ) $ 21,358
Non-GAAP (loss) income per share: Basic $ (0.07 ) $
0.12 $ (0.27 ) $ 0.33 Diluted $ (0.07 ) $ 0.09
$ (0.27 ) $ 0.27
Weighted average shares outstanding:
Basic 65,370,371 65,054,236 64,882,417 64,708,163 Diluted
65,370,371 79,354,398 64,882,417 79,268,282
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160309006210/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
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