- Significant Progress in Q1 on Two
Potential Blockbusters and Two Near-term NDA’s
- 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
- EVOMELA™(CE-Melphalan), a
propylene-glycol free Melphalan with improved stability; NDA review
ongoing with positive FDA discussions; on track for approval
decision on October 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
- Financial Highlights
- 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
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, 2015.
“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 Spectrum Pharmaceuticals. “2015 will be a
pivotal year in the development of several of our assets. We
recently shared exciting Phase 2 data from SPI-2012 and are making
progress towards initiating a global pivotal trial for this
potential blockbuster product. Contingent on a positive FDA
decision later this year, we plan to launch EVOMELA with our
existing sales force. We are making progress towards filing an NDA
for Apaziquone, which targets a disease with high unmet need. I am
also very excited about our recent acquisition of Poziotinib, a
novel pan-HER inhibitor which has shown remarkable efficacy in
early clinical trials in patients with breast cancer. We have a lot
to be excited about and are invigorated to rapidly and efficiently
bring several exciting drugs to cancer patients.”
Three-Month Period Ended March 31, 2015
(All numbers are approximate)
GAAP Results
Total product sales were $38.4 million (excluding $7 million in
deferred revenue) in the first quarter of 2015. Total product sales
decreased 4% from $40.1 million in the first quarter of 2014.
Product sales in the first quarter included: FUSILEV®
(levoleucovorin) net sales of $20.2 million, FOLOTYN® (pralatrexate
injection) net sales of $9.3 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $4.2 million, MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) net sales of $1.9 million and BELEODAQ®
(belinostat) for Injection net sales of $2.8 million.
Spectrum recorded net loss of $25.6 million, or ($0.39) per
basic and diluted share in the three-month period ended March 31,
2015, compared to net loss of $27.6 million, or ($0.44) per basic
and diluted share in the comparable period in 2014. Total research
and development expenses were $15.9 million in the quarter, as
compared to $29.5 million in the same period in 2014 which included
a $17.8 million milestone payment. Selling, general and
administrative expenses were $23.3 million in the quarter, compared
to $23.4 million in the same period in 2014.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $4.7 million, or ($0.07)
per basic share and diluted share in the three-month period ended
March 31, 2015, compared to non-GAAP net income of $0.7 million, or
$0.01 per basic share and diluted share in the comparable period in
2014. Non-GAAP research and development expenses were $12.4
million, as compared to $11.2 million in the same period of 2014.
Non-GAAP selling, general and administrative expenses were $22.9
million, as compared to $20.7 million in the same period in
2014.
2015 Financial Guidance
Spectrum projects 2015 year-end Cash and Cash Equivalents over
$100 million, excluding any new business development
transactions.
Conference Call
Thursday, May 7, 2015 @ 4:30 p.m.
Eastern/1:30 p.m. Pacific
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 Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in oncology and hematology. Spectrum
and its affiliates market five oncology drugs─ FUSILEV®
(levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate
injection), also marketed in the U.S.; ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights; MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) for intravenous infusion, for which the Company has
worldwide marketing rights and BELEODAQ® (belinostat) for Injection
in the U.S. Spectrum's strong track record in 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.
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 FDA. This formulation eliminates the need
to use propylene glycol containing custom diluent, which has been
reported to cause renal and cardiac side effects, which in turn
limit the ability to deliver higher doses of therapeutic compounds.
The use of the Captisol® technology to reformulate melphalan also
improves its stability and is anticipated to allow for slower
infusion rates and longer administration durations, potentially
enabling clinicians to safely achieve a higher dose intensity for
pre-transplant chemotherapy.
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. Valentino Stella at the
University of Kansas’ Higuchi Biosciences Center for specific use
in drug development and formulation. This unique technology has
enabled six FDA-approved products, including Onyx Pharmaceuticals’
Kyprolis®, Baxter International’s Nexterone® and Merck’s NOXAFIL
IV. There are also more than 30 Captisol-enabled products currently
in clinical development.
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®, and BELEODAQ® 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.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
SPECTRUM PHARMACEUTICALS, INC. Consolidated
Statement of Operations
(In thousands, expect per share
amounts)
(Unaudited)
Three Months EndedMarch 31,
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
SPECTRUM PHARMACEUTICALS, INC. Consolidated
Balance Sheets
(In thousands, expect per share
amounts)
(Unaudited)
March 31,2015
December 31,2014
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 $164 and $120, respectively
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, $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, 2015 and December 31, 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; 66,905,839 and 65,969,699 shares
issued and outstanding at March 31, 2015 and December 31, 2014,
respectively 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.
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations and
Reconciliation of Non-GAAP Adjustments
(In thousands, except share and per share
data)
(Unaudited)
Three months ended
March 31,
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
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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