- Company met with the FDA, made
significant progress, and is ready to initiate SPI-2012 Pivotal
clinical trial upon agreement on Special Protocol Assessment
(SPA)
- On track for apaziquone NDA filing by
year end based on previous Phase 3 studies; additional Phase 3
trial initiated under SPA
- Meeting with FDA scheduled on November
6, 2015 to address the Complete Response Letter on
EVOMELA™(melphalan) for injection
- Phase 2 poziotinib breast cancer study
designed, and will be submitted with IND by year end
- Spectrum raises guidance on year-end
cash to over $125 million, up from the Company’s previous guidance
of $110 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
September 30, 2015.
“The highest priority of the Company remains SPI-2012, which is
a late-stage drug that could compete in the multi-billion dollar
neutropenia market,” said Rajesh C. Shrotriya, MD, Chairman and
Chief Executive Officer of Spectrum Pharmaceuticals. “We had a
productive meeting last week with the FDA and expect to finalize
our SPA on SPI-2012 quickly. We have a meeting with the FDA this
Friday to discuss EVOMELA’s Complete Response Letter and we feel
confident in bringing EVOMELA to the market for patients. Before
the end of this year, we look forward to filing the NDA for our
bladder cancer drug apaziquone and initiating a Phase 2 breast
cancer trial for poziotinib in the U.S. shortly. We believe the
infrastructure that we have built over the years serves as a strong
foundation for continued future growth.”
Pipeline Update- Two Potential
Blockbusters and One Near-term NDA Submission:
- SPI-2012, a novel long-acting
GCSF: In a Phase 2 dose ranging study, SPI-2012 was shown to be
superior at the higher dose tested and non-inferior at the middle
dose in decreasing the duration of severe neutropenia 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. The Phase 2 data will be presented at the
San Antonio Breast Cancer Symposium. Spectrum has continued to have
productive discussions with the FDA, expects to finalize the
pivotal study design this year, and start the study shortly after
reaching SPA agreement with the Agency. Over 80 study sites have
already been qualified.
- Apaziquone, a potent tumor-activated
pro-drug for non-muscle invasive bladder cancer: By year end,
Spectrum expects to file the NDA based on the previous Phase 3
studies. The Company has also initiated enrollment in an additional
randomized, placebo-controlled Phase 3 trial under the SPA
agreement, and treated the first patient in late October. This
Phase 3 study has been specifically designed to address important
lessons learned from the previous apaziquone Phase 3 studies, as
well as recommendations made by the FDA.
- EVOMELA, a propylene-glycol free
melphalan formulation with improved stability: Spectrum is
actively addressing the non-clinical issues raised in the Complete
Response Letter regarding the EVOMELA NDA. FDA has granted a Type A
meeting for November 6, 2015 and the company believes these issues
can be swiftly resolved. Spectrum plans to launch this drug with
our existing sales force.
- Poziotinib, a potential
best-in-class, novel, pan-HER inhibitor: The Company plans to
initiate a breast cancer program in the U.S., based on compelling
Phase 1 efficacy data in breast cancer patients who had failed
multiple other HER-2 directed therapies. In addition, multiple
Phase 2 studies funded by our partner, Hanmi Pharmaceuticals, are
currently ongoing in South Korea.
Three-Month Period Ended
September 30, 2015 (All numbers are
approximate)
GAAP Results
Total product sales were $28.5 million in the third quarter of
2015. Total product sales decreased 41% from $47.9 million in the
third quarter of 2014.
Product sales in the third quarter included: FUSILEV®
(levoleucovorin) net sales of $11.1 million, FOLOTYN® (pralatrexate
injection) net sales of $8.7 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $4.8 million, MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) net sales of $1.3 million and BELEODAQ®
(belinostat for injection) net sales of $2.6 million.
Spectrum recorded net loss of $18.7 million, or $(0.28) per
basic and diluted share in the three-month period ended
September 30, 2015, compared to net loss of $11.5 million, or
$(0.18) per basic and diluted share in the comparable period in
2014. Total research and development expenses were $9.9 million in
the quarter, as compared to $14.4 million in the same period in
2014. Selling, general and administrative expenses were $19.4
million in the quarter, compared to $24.1 million in the same
period in 2014.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $7.9 million, or $(0.12)
per basic share and diluted share in the three-month period ended
September 30, 2015, compared to non-GAAP net income of $5.3
million, or $0.08 per basic and $0.07 per diluted share in the
comparable period in 2014. Non-GAAP research and development
expenses were $9.4 million, as compared to $14.0 million in the
same period of 2014. Non-GAAP selling, general and administrative
expenses were $17.2 million, as compared to $21.3 million in the
same period in 2014.
2015 Financial Guidance
Spectrum raises guidance on year-end cash to over $125 million,
up from the Company’s previous guidance of $110 million excluding
any new business development transactions.
Conference Call
Wednesday, November 4, 2015 @ 4:30 p.m.
Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID#
54872723
International: (973) 796-5077, Conference ID#
54872723
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 November 4,
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. Additionally, Spectrum's pipeline includes
three drugs targeting blockbuster markets in advanced stages of
clinical development. Spectrum's strong track record in-licensing
and acquiring differentiated drugs, expertise and proven track
record 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 is a new, propylene glycol-free melphalan formulation
that demonstrated bioequivalence to the standard melphalan
formulation (Alkeran) in a Phase 2 clinical study (Aljitawi et al,
Bone Marrow Transplant, 2014). EVOMELA has been granted Orphan Drug
Designation by the FDA for its use as a high-dose conditioning
regimen for patients with MM undergoing ASCT.
EVOMELA’s formulation eliminates the need to use a propylene
glycol containing custom diluent, which is required with other
intravenous melphalan formulations, and has been reported to cause
renal and cardiac side effects. The use of the Captisol® technology
to reformulate melphalan also improved its stability, extending its
use time to five hours, which is anticipated to simplify
preparation and administration logistics, and allow for slower
infusion rates and longer administration durations 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 Amgen’s 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.
Condensed Consolidated Statements of
Operations
(In thousands, except per share
amounts)
(Unaudited)
Three Months EndedSeptember 30, Nine
Months EndedSeptember 30, 2015 2014
2015 2014 Revenues: Product sales, net $
28,457 $ 47,916 $ 102,014 $ 134,867 License fees and service
revenue 170 74 10,212 102 Total
revenues $ 28,627 $ 47,990 $ 112,226 $ 134,969
Operating costs and expenses: Cost of product sales
(excludes amortization of intangible assets) 8,447 6,530 21,508
18,964 Selling, general and administrative 19,411 24,125 65,297
72,927 Research and development 9,924 14,420 35,333 55,252
Amortization and impairment of intangible assets 6,919 7,042
27,857 17,763 Total operating costs and
expenses 44,701 52,117 149,995 164,906
Loss from operations (16,074 ) (4,127 ) (37,769 ) (29,937 ) Other
expenses: Interest expense, net (2,274 ) (2,361 ) (6,760 ) (6,404 )
Change in fair value of contingent consideration related to
acquisitions 81 (181 ) (565 ) (1,910 ) Other expense, net (535 )
(1,393 ) (1,501 ) (2,238 ) Total other expenses (2,728 ) (3,935 )
(8,826 ) (10,552 ) Loss before income taxes (18,802 ) (8,062 )
(46,595 ) (40,489 ) Benefit (provision) for income taxes 78
(3,477 ) (37 ) (2,254 ) Net loss $ (18,724 ) $ (11,539 ) $ (46,632
) $ (42,743 ) Net loss per share: Basic $ (0.28 ) $ (0.18 )
$ (0.71 ) $ (0.66 ) Diluted $ (0.28 ) $ (0.18 ) $ (0.71 ) $ (0.66 )
Weighted average shares outstanding: Basic 65,855,727 64,765,072
65,457,060 64,369,466 Diluted 65,855,727 64,765,072 65,457,060
64,369,466
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Balance
Sheets
(In thousands, expect per share and par
value amounts)
(Unaudited)
September 30, 2015
December 31, 2014
ASSETS Current assets: Cash and cash equivalents 136,527
129,942 Marketable securities 245 3,306 Accounts receivable, net of
allowance for doubtful accounts of $131 and $120, respectively
48,150 70,758 Other receivables 12,347 5,489 Inventories 7,071
9,200 Prepaid expenses 3,963 3,774 Deferred tax assets 82 —
Total current assets 208,385 222,469 Property and equipment,
net of accumulated depreciation 1,079 1,405 Intangible assets, net
of accumulated amortization 201,184 230,100 Goodwill 18,023 18,195
Other assets 17,842 17,864 Total assets 446,513
490,033
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities: Accounts payable and other accrued liabilities
78,116 84,994 Accrued payroll and benefits 7,140 8,444 Deferred
revenue 9,990 9,959 Drug development liability 573 1,141
Acquisition-related contingent obligations 5,373 4,901
Total current liabilities 101,192 109,439 Drug development
liability, less current portion 13,827 14,644 Deferred revenue,
less current portion 407 — Acquisition-related contingent
obligations, less current portion 2,534 2,441 Deferred tax
liability 6,659 6,569 Other long-term liabilities 6,963 6,088
Convertible senior notes 100,192 96,298 Total
liabilities 231,774 235,479 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 September 30, 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; 67,314,580 and 65,969,699
shares issued and outstanding at September 30, 2015 and December
31, 2014, respectively 66 66 Additional paid-in capital 548,232
538,553 Accumulated other comprehensive loss (3,712 ) (850 )
Accumulated deficit (329,970 ) (283,338 ) Total stockholders’
equity 214,739 254,554
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY 446,513 490,033
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 endedSeptember 30,
Nine months endedSeptember 30, 2015
2014 2015 2014 GAAP product sales,
net & license fees and service revenue $
28,627 $ 47,990 $ 112,226
$ 134,969 Non GAAP adjustments to product
sales, net & license fees and service revenue: — —
(9,681 ) — Total adjustments to product sales,
net & license fees and service revenues — —
(9,681 ) —
Non-GAAP product sales & license and
contract revenue 28,627 47,990
102,545 134,969 GAAP cost of product
sales (excludes amortization of intangible assets) 8,447
6,530 21,508 18,964 Non-GAAP adjustments to
cost of product sales — — — —
Non-GAAP cost of product sales (excludes amortization of
intangible assets) 8,447 6,530
21,508 18,964 GAAP selling, general
and administrative expenses 19,411 24,125
65,297 72,927 Non GAAP adjustments to SG&A:
Stock-based compensation (2,005 ) (2,653 ) (7,121 ) (7,223 )
Shareholder lawsuit expenses (67 ) (104 ) 9 (1,367 ) Insurance
reimbursement under D&O policy — — 2,111 — Depreciation expense
(176 ) (56 ) (521 ) (874 ) Total adjustments to SG&A (2,248 )
(2,813 ) (5,522 ) (9,464 )
Non-GAAP selling, general and
administrative 17,163 21,312
59,775 63,463 GAAP research and
development 9,924 14,420 35,333
55,252 Non-GAAP adjustments to R&D: Stock-based
compensation (495 ) (411 ) (1,369 ) (1,366 ) Depreciation expense
(9 ) (10 ) (15 ) (58 ) Beleodaq milestone cash payment & stock
issuance — — — (17,790 ) Other R&D milestone payments —
— (3,000 ) — Total adjustments to R&D (504 ) (421
) (4,384 ) (19,214 )
Non-GAAP research and development
9,420 13,999 30,949
36,038 GAAP amortization and impairment of
intangible assets 6,919 7,042 27,857
17,763 Non-GAAP adjustments to amortization and impairment
of intangible assets: Amortization expense (6,919 ) (7,042 )
(20,697 ) (17,763 ) Impairment of FUSILEV distribution rights —
— (7,160 ) — Total adjustments to
amortization and impairment of intangibles (6,919 ) (7,042 )
(27,857 ) (17,763 )
Non-GAAP amortization and impairment of
intangibles — — —
— GAAP loss from operations (16,074
) (4,127 ) (37,769 )
(29,937 ) Non-GAAP adjustments to loss from
operations 9,671 10,276 28,082 46,441
Non-GAAP income (loss) from operations (6,403
) 6,149 (9,687 ) 16,504
GAAP total other expenses, net (2,728 )
(3,935 ) (8,826 ) (10,552
) Realized gain on TopoTarget shares — (2,217 ) — (2,219 )
Market-to-market of contingent consideration (81 ) 181 565 1,910
Loss on foreign currency exchange 30 3,863 1,049 4,469 Accretion of
discount on 2018 Convertible Notes 1,326 1,224 3,895
3,556 Total adjustments to other expense, net 1,275
3,051 5,509 7,716
Non-GAAP total
other expenses, net (1,453 ) (884 )
(3,317 ) (2,836 ) GAAP benefit
(provision) for income taxes 78 (3,477 )
(37 ) (2,254 ) Adjustment to benefit
(provision) for income taxes (78 ) 3,477 37 2,254
Non-GAAP benefit (provision) for income taxes
— — — —
GAAP net loss (18,724 ) (11,539
) (46,632 ) (42,743 ) Total
non-GAAP adjustments 10,868 16,804 33,628
56,411
Non-GAAP net (loss) income $
(7,856 ) $ 5,265 $
(13,004 ) $ 13,668 Non-GAAP
(loss) income per share: Basic $ (0.12 ) $ 0.08 $ (0.20
) $ 0.21 Diluted $ (0.12 ) $ 0.07 $ (0.20 ) $ 0.17
Weighted average shares outstanding: Basic 65,855,727
64,765,072 65,457,060 64,369,466 Diluted 65,855,727 79,473,994
65,457,060 79,166,593
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151104006550/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
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