- SPI-2012 (eflapegrastim) pivotal Phase
3 study is actively enrolling breast cancer patients in over 80
clinical sites in the U.S.
- Poziotinib Phase 2 trial is enrolling
breast cancer patients who have failed other HER2-directed
therapies.
- Qapzola™ (apaziquone) advisory panel
scheduled on September 14, 2016, and FDA decision expected on
December 11, 2016.
- Q2 revenues were $33.9 million,
including $30.9 million in product sales. The Company’s sixth FDA
approved drug EVOMELA® (melphalan) for injection was launched in
the second quarter; formulary access and adoption in top
institutions is encouraging.
- The Company raised $45.1 million in Q2,
and an additional $28.8 million in Q3, utilizing an at-the-market
security offering.
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.”
Pipeline Update:
- 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)
GAAP Results
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.
Non-GAAP Results
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.
Conference Call
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)
(Unaudited)
Three Months EndedJune 30, Six Months
EndedJune 30, 2016 2015 2016
2015 Revenues: Product sales, net $ 30,887 $ 35,144 $
66,129 $ 73,557 License fees and service revenue 3,062 9,838
11,686 10,042 Total revenues $ 33,949 $
44,982 $ 77,815 $ 83,599 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
56,030 45,016 106,179 105,294 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 $
(24,295 ) $ (2,346 ) $ (33,616 ) $ (27,908 ) 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)
(Unaudited)
June 30, 2016 December 31, 2015
ASSETS Current assets: Cash and cash equivalents $ 155,759 $
139,741 Marketable securities 247 245 Accounts receivable, net of
allowance for doubtful accounts of $15 and $120, respectively
34,319 30,384 Other receivables 6,968 12,572 Inventories 6,405
4,176 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
Goodwill 17,997 17,960 Other assets 25,600 19,211
Total assets $ 429,204 $ 419,049
LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and
other accrued liabilities $ 48,208 $ 56,539 Accrued payroll and
benefits 6,496 8,188 Deferred revenue 3,461 6,130 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 Total
liabilities 193,305 206,192 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; 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 ) Accumulated deficit (367,745 ) (334,123 ) 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)
(Unaudited)
Three months ended June 30, Six months ended June
30, 2016 2015 2016
2015 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
— (9,682 ) (6,000 ) (9,682 )
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:
Stock-based compensation (2,790 ) (3,087 ) (5,559 ) (5,116 )
Litigation expenses (8,518 ) 25 (10,813 ) 441 Insurance
reimbursement under D&O policy — 365 — 1,746 Depreciation
expense (164 ) (177 ) (329 ) (345 ) 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: Stock-based
compensation (637 ) (441 ) (1,045 ) (873 ) Depreciation expense (3
) (3 ) (6 ) (6 ) Other R&D milestone payments (770 ) —
(2,826 ) (3,000 )
Total adjustments to R&D
(1,410 ) (444 ) (3,877 ) (3,879 )
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: Amortization expense
(6,306 ) (6,916 ) (12,145 ) (13,778 ) Impairment of FUSILEV
distribution rights — — — (7,160 )
Total adjustments to amortization and
impairment charges of intangible assets
(6,306 ) (6,916 ) (12,145 ) (20,938 )
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: Basic $ (0.05 ) $ (0.01 ) $ (0.05 )
$ (0.08 ) Diluted $ (0.05 ) $ (0.01 ) $ (0.05 ) $ (0.08 )
Weighted average shares outstanding: Basic 68,575,021
65,466,004 67,146,188 65,167,162 Diluted 68,575,021 65,466,004
67,146,188 65,167,162
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160809006282/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
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