- SPI-2012 (eflapegrastim), a novel
long-acting GCSF: A pivotal Phase 3 study was initiated and is
currently enrolling patients with approximately 60 clinical sites
open for enrollment in the U.S.
- Poziotinib, a novel pan-HER
inhibitor: A Phase 2 trial was initiated and is enrolling
breast cancer patients who have failed other HER2-directed
therapies.
- Apaziquone for non-muscle invasive
bladder cancer: FDA accepted NDA and assigned a PDFUA date of
December 11, 2016.
- EVOMELA™ (melphalan)
for injection: Company recently launched the drug and early
indicators are positive.
- Q1 revenues were $43.9 million,
including $35.2 million in product sales.
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
March 31, 2016.
“We are pleased to report strong revenues in the first quarter
and solid progress in our product pipeline,” said Rajesh C.
Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “Spectrum now has six FDA approved drugs on the
market, revenues from which continues to help fuel our pipeline. We
initiated a Phase 3 trial for our lead pipeline drug SPI-2012 and
now have approximately 60 U.S. sites open for enrollment. SPI-2012
has shown strong clinical data in Phase 2 studies and targets a
multi-billion dollar market. We also initiated a Phase 2 trial for
our breast cancer drug poziotinib, which we believe has the
potential to be best in-class among small molecule HER2-directed
therapies. Additionally, we expect a response from the FDA on the
NDA for apaziquone later this year. We remain focused on these
three programs, each of which we believe has the potential to
transform the Company.”
Pipeline Update:
- SPI-2012, a novel long-acting
GCSF: A pivotal Phase 3 study was initiated in Q1 2016 to
evaluate SPI-2012 as a treatment for chemotherapy-induced
neutropenia in approximately 580 patients with breast cancer.
Neutropenia, a possible side effect of chemotherapy, is a condition
where the number of neutrophils or white blood cells are too low,
and 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 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. In addition, multiple Phase 2
studies are being conducted by Hanmi Pharmaceuticals and National
OncoVenture in South Korea.
- Apaziquone, a potent tumor-activated
drug being investigated for non-muscle invasive bladder cancer:
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 an 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.
- EVOMELA, a propylene-glycol free
melphalan formulation: The FDA approved EVOMELA on March 10,
2016, two months ahead of the PDUFA date. Soon after, Spectrum
launched EVOMELA with its existing sales force in a market
estimated at approximately $100 million.
Three-Month Period Ended March 31,
2016 (All numbers are approximate)
GAAP Results
Total product sales were $35.2 million in the first quarter of
2016. Total product sales decreased 8.3% from $38.4 million in the
first quarter of 2015.
Product sales in the first quarter included: FUSILEV®
(levoleucovorin) net sales of $15.2 million, FOLOTYN® (pralatrexate
injection) net sales of $13.3 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $2.8 million, MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) net sales of $0.9 million and BELEODAQ®
(belinostat for injection) net sales of $3.0 million.
Spectrum recorded net loss of $9.3 million, or $(0.14) per basic
and diluted share in the three-month period ended March 31,
2016, compared to net loss of $25.6 million, or $(0.39) per basic
and diluted share in the comparable period in 2015. Total research
and development expenses were $15.5 million in the quarter, as
compared to $15.9 million in the same period in 2015. Selling,
general and administrative expenses were $22.0 million in the
quarter, compared to $23.3 million in the same period in 2015.
Non-GAAP Results
Spectrum recorded non-GAAP net income of $0.3 million, or $0.01
per basic share and less than $0.01 per diluted share in the
three-month period ended March 31, 2016, compared to non-GAAP
net loss of $4.7 million, or $(0.07) per basic and diluted share in
the comparable period in 2015. Non-GAAP research and development
expenses were $13.0 million, as compared to $12.4 million in the
same period of 2015. Non-GAAP selling, general and administrative
expenses were $16.7 million, as compared to $22.9 million in the
same period in 2015.
Conference Call
Thursday, May 5, 2016 @ 4:30 p.m.
Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID#
84912945
International: (973) 796-5077, Conference ID#
84912945
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 5,
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 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.® is a registered trademark of
Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER
CARE™ 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 EndedMarch
31,
2016 2015 Revenues: Product sales, net
$ 35,241 $ 38,413 License fees and service revenue 8,625 205
Total revenues $ 43,866 $ 38,618 Operating
costs and expenses: Cost of product sales (excludes amortization
and impairment charges of intangible assets) 5,604 7,071 Cost of
service revenue 1,282 — Selling, general and administrative 21,962
23,335 Research and development 15,462 15,851 Amortization and
impairment charges of intangible assets 5,839 14,022
Total operating costs and expenses 50,149 60,279 Loss
from operations (6,283 ) (21,661 ) Other (expense) income: Interest
expense, net (2,340 ) (2,228 ) Change in fair value of contingent
consideration related to acquisitions (1,042 ) (500 ) Other income
(expense), net 278 (1,035 ) Total other expenses (3,104 )
(3,763 ) Loss before income taxes (9,387 ) (25,424 ) Benefit
(provision) for income taxes 66 (138 ) Net loss $ (9,321 ) $
(25,562 ) Net loss per share: Basic and diluted $ (0.14 ) $ (0.39 )
Weighted average shares outstanding: Basic and diluted 65,597,261
64,880,677
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(In thousands, expect per share and par
value amounts)
(Unaudited)
March 31, 2016
December 31, 2015 ASSETS Current assets: Cash
and cash equivalents $ 132,306 $ 139,741 Marketable securities 246
245 Accounts receivable, net of allowance for doubtful accounts of
$15 and $120, respectively 19,248 30,384 Other receivables 15,175
12,572 Inventories 3,155 4,176 Prepaid expenses and other assets
2,352 3,507 Total current assets 172,482 190,625
Property and equipment, net of accumulated depreciation 810 918
Intangible assets, net of accumulated amortization and impairment
charges 184,753 190,335 Goodwill 18,044 17,960 Other assets 25,304
19,211 Total assets $ 401,393 $ 419,049
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable and other accrued liabilities $ 47,503 $ 56,539
Accrued payroll and benefits 4,555 8,188 Deferred revenue 1,312
6,130 Drug development liability 156 259 Acquisition-related
contingent obligations 6,000 5,227 Total current
liabilities 59,526 76,343 Drug development liability, less current
portion 14,354 14,427 Deferred revenue, less current portion 1,596
383 Acquisition-related contingent obligations, less current
portion 1,708 1,439 Deferred tax liability 6,849 6,779 Other
long-term liabilities 8,109 7,444 Convertible senior notes 100,933
99,377 Total liabilities 193,075 206,192 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; 20 shares issued and
outstanding at March 31, 2016 and December 31, 2015, 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; 68,942,042 and 68,228,935 shares
issued and outstanding at March 31, 2016 and December 31, 2015,
respectively 68 68 Additional paid-in capital 555,056 552,108
Accumulated other comprehensive loss (3,485 ) (5,319 ) Accumulated
deficit (343,444 ) (334,123 ) Total stockholders’ equity 208,318
212,857 Total liabilities and stockholders’ equity $
401,393 $ 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)
(Unaudited)
Three months endedMarch
31,
2016 2015 GAAP product sales, net
& license fees and service revenue $ 43,866
$ 38,618 Non GAAP adjustments to product sales, net
& license fees and service revenue: (6,000 ) — Total
adjustments to product sales, net & license fees and service
revenue (6,000 ) —
Non-GAAP product sales & license
and contract revenue 37,866 38,618
GAAP cost of product sales (excludes amortization and impairment
of intangible assets) 5,604 7,071 Non-GAAP
adjustments to cost of product sales — —
Non-GAAP
cost of product sales (excludes amortization and impairment of
intangible assets) 5,604 7,071
GAAP cost of service revenue 1,282 — Non-GAAP
adjustments to cost of service revenue — —
Non-GAAP cost of service revenue 1,282
— GAAP selling, general and administrative
expenses 21,962 23,335 Non GAAP adjustments to
SG&A: Stock-based compensation (2,769 ) (2,029 ) Litigation
expenses (2,295 ) 1,797 Depreciation expense (166 ) (168 ) Total
adjustments to SG&A (5,230 ) (400 )
Non-GAAP selling,
general and administrative 16,732 22,935
GAAP research and development 15,462
15,851 Non-GAAP adjustments to R&D: Stock-based
compensation (407 ) (433 ) Depreciation expense (3 ) (3 ) Other
R&D milestone payments (2,056 ) (3,000 ) Total adjustments to
R&D (2,466 ) (3,436 )
Non-GAAP research and development
12,996 12,415 GAAP amortization and
impairment of intangible assets 5,839 14,022
Non-GAAP adjustments to amortization and impairment charges of
intangible assets: Amortization expense (5,839 ) (6,862 )
Impairment of FUSILEV distribution rights — (7,160 ) Total
adjustments to amortization and impairment charges of intangible
assets (5,839 ) (14,022 )
Non-GAAP amortization and impairment
of intangibles — — GAAP loss
from operations (6,283 ) (21,661 )
Non-GAAP adjustments to loss from operations 7,535 17,858
Non-GAAP income (loss) from operations 1,252
(3,803 ) GAAP total other (expenses)
income, net (3,104 ) (3,763 )
Market-to-market of contingent consideration 1,042 501 (Gain) Loss
on foreign currency exchange (227 ) 1,145 Accretion of discount on
2018 Convertible Notes 1,385 1,270 Total adjustments
to other (expenses) income, net 2,200 2,916
Non-GAAP total other expenses, net (904 )
(847 ) GAAP benefit (provision) for income
taxes 66 (138 ) Adjustment to benefit
(provision) for income taxes (66 ) 138
Non-GAAP benefit
(provision) for income taxes — —
GAAP net loss (9,321 ) (25,562 )
Total non-GAAP adjustments 9,669 20,912
Non-GAAP
net loss $ 348 $ (4,650
) Non-GAAP loss per share: Basic $ 0.01 $
(0.07 ) Diluted $ 0.00 $ (0.07 )
Weighted average shares
outstanding: Basic 65,597,261 64,880,677 Diluted 80,613,907
64,880,677
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160505006478/en/
Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice
President, Strategic Planning & Investor RelationsInvestorRelations@sppirx.com
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