- SPI-2012: Pursuing Special
Protocol Assessment (SPA) before initiating a non-inferiority Phase
3 study, also powered at 80% for superiority to pegfilgrastim
- EVOMELA™ (melphalan
hydrochloride) for injection: On track for FDA decision (NDA PDUFA
date of October 23, 2015)
- Poziotinib: Expect to initiate
Phase 2 study in breast cancer
- Apaziquone: On track for NDA
filing by year end
- Company raises guidance following
better operating performance; now expects to exit 2015 with cash of
more than $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
June 30, 2015.
“The results from this quarter demonstrate our ability to
maintain financial discipline while continuing to fund our highest
priority projects,” said Rajesh C. Shrotriya, MD, Chairman and
Chief Executive Officer of Spectrum Pharmaceuticals. “The second
half of 2015 marks key milestones for several of Spectrum’s drugs.
With the potential approval of Evomela in October, we could have
six drugs on the market. Pending alignment with the FDA, we expect
to initiate a non-inferiority Phase 3 study for SPI-2012 which
would be powered at 80% to show superiority against pegfilgrastim.
Also, our potentially best-in-class novel pan-HER inhibitor,
poziotinib, will target breast cancer in a Phase 2 clinical
program. Additionally, with apaziquone, we plan to file an NDA and
initiate a confirmatory Phase 3 trial under a SPA by year end. Our
pipeline has never been as exciting as it is today, and provides a
sound foundation for future growth of the company.”
Pipeline Update:
Two Potential Blockbusters, One
Near-term FDA Decision and One Near-term NDA
Submission
- SPI-2012, a novel long-acting
GCSF: In Phase 2 trials earlier this year, SPI-2012’s efficacy was
shown to be non-inferior at the middle dose, and superior to the
blockbuster drug pegfilgrastim at the higher dose tested. Based on
discussion with the FDA, the Company plans to initiate a Phase 3
study this year, and is seeking an SPA for this study that would be
powered at over 90% to demonstrate non-inferiority and at 80% to
demonstrate superiority to pegfilgrastim.
- EVOMELA, a propylene-glycol free
formulation of melphalan with improved stability: NDA review is
ongoing and is on track for an FDA decision on October 23, 2015.
This drug is expected to be launched using Spectrum’s existing
sales force, and pre-launch activities have commenced.
- Poziotinib, a potential
best-in-class, novel, pan-HER inhibitor: The Company plans to
initiate a U.S. based breast cancer program based on compelling
Phase 1 efficacy data demonstrated in breast cancer patients who
had failed multiple other HER-2 directed therapies. In addition,
multiple Phase 2 studies funded by Hanmi Pharmaceuticals are
currently ongoing.
- Apaziquone, a potent pro-drug
being investigated for non-muscle-invasive bladder cancer:
Apaziquone is a bio-reductive agent activated by reductase enzymes,
such as DT-diaphorase, expressed by bladder tumor cells, to form a
cytotoxic alkylating agent. Spectrum expects to file an NDA by
year-end. Additionally, the Company is seeking an SPA with the FDA
before commencing an additional confirmatory Phase 3 Study.
Three-Month Period Ended June 30, 2015
(All numbers are approximate)
GAAP Results
Total product sales were $35.1 million in the second quarter of
2015. Total product sales decreased 25% from $46.9 million in the
second quarter of 2014.
Product sales in the second quarter included: FUSILEV®
(levoleucovorin) net sales of $14.3 million, FOLOTYN® (pralatrexate
injection) net sales of $12.2 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $4.8 million, MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) net sales of $2.1 million and BELEODAQ®
(belinostat for injection) net sales of $1.7 million.
Spectrum recorded net loss of $2.3 million, or $(0.04) per basic
and diluted share in the three-month period ended June 30,
2015, compared to net loss of $3.6 million, or $(0.06) per basic
and diluted share in the comparable period in 2014. Total research
and development expenses were $9.6 million in the quarter, as
compared to $11.3 million in the same period in 2014. Selling,
general and administrative expenses were $22.6 million in the
quarter, compared to $25.4 million in the same period in 2014.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $0.5 million, or $(0.01)
per basic share and diluted share in the three-month period ended
June 30, 2015, compared to non-GAAP net income of $6.8 million, or
$0.11 per basic share and $0.09 per diluted share in the comparable
period in 2014. Non-GAAP research and development expenses were
$9.1 million, as compared to $10.8 million in the same period of
2014. Non-GAAP selling, general and administrative expenses were
$19.7 million, as compared to $21.8 million in the same period in
2014.
2015 Financial Guidance
Spectrum projects year-end aggregate cash and cash equivalents
and marketable securities of over $110 million, up from the
Company’s previous guidance of $100 million excluding any new
business development transactions.
Conference Call
Thursday, August 6, 2015 @ 4:30 p.m.
Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID#
85787537
International: (973) 796-5077, Conference ID#
85787537
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 6,
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 hematology and oncology. Spectrum
markets five hematology/oncology drugs, and expects an FDA decision
on another hematology drug later this year. Additionally,
Spectrum's pipeline includes three drugs targeting blockbuster
markets in advanced stages of clinical development. 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, a propylene glycol-free formulation of melphalan,is
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. Condensed
Consolidated Statements of Operations
(In thousands, except per share
amounts)
(Unaudited)
Three Months EndedJune 30, Six Months
EndedJune 30, 2015 2014 2015
2014 Revenues: Product sales, net $ 35,144 $ 46,855 $
73,557 $ 86,951 License fees and service revenue 9,838 —
10,042 28 Total revenues $ 44,982 $
46,855 $ 83,599 $ 86,979 Operating
expenses: Cost of product sales (excludes amortization of purchased
intangible assets) 5,990 6,156 13,061 12,434 Selling, general and
administrative 22,552 25,399 45,886 48,802 Research and development
9,558 11,335 25,409 40,832 Amortization and impairment of
intangible assets 6,916 5,361 20,938 10,721
Total operating costs and expenses 45,016 48,251
105,294 112,789 Loss from operations (34 )
(1,396 ) (21,695 ) (25,810 ) Other Expenses: Interest expense
(2,258 ) (1,976 ) (4,486 ) (4,043 ) Change in fair value of
contingent consideration related to acquisitions (146 ) (1,005 )
(646 ) (1,729 ) Other income (expense), net 69 (487 ) (966 )
(845 ) Total other expenses (2,335 ) (3,468 ) (6,098 ) (6,617 )
Loss before income taxes (2,369 ) (4,864 ) (27,793 ) (32,427 )
Benefit (provision) for income taxes 23 1,301 (115 )
1,223 Net loss $ (2,346 ) $ (3,563 ) $ (27,908 ) $ (31,204 )
Net loss per share: Basic $ (0.04 ) $ (0.06 ) $ (0.43 ) $
(0.49 ) Diluted $ (0.04 ) $ (0.06 ) $ (0.43 ) $ (0.49 )
Weighted average shares outstanding: Basic 65,466,004 64,609,197
65,167,162 64,119,441 Diluted 65,466,004 64,609,197 65,167,162
64,119,441
SPECTRUM PHARMACEUTICALS,
INC. Condensed Consolidated Balance Sheets
(In thousands, expect per share and par
value amounts)
(Unaudited)
June 30, 2015 December 31, 2014
ASSETS Current assets: Cash and equivalents $ 142,271 $
129,942 Marketable securities 3,308 3,306 Accounts receivable, net
of allowance for doubtful accounts of $120 and $120, respectively
41,684 70,758 Other receivables 8,245 5,489 Inventories 8,794 9,200
Prepaid expenses 2,688 3,774 Deferred tax assets 172 —
Total current assets 207,162 222,469 Property and equipment,
net of accumulated depreciation 1,265 1,405 Intangible assets, net
of accumulated amortization 207,955 230,100 Goodwill 17,995 18,195
Other assets 19,952 17,864 Total assets $ 454,329
$ 490,033
LIABILITIES AND STOCKHOLDERS’
EQUITY Current liabilities: Accounts payable and other accrued
obligations $ 71,823 $ 84,994 Accrued payroll and benefits 5,777
8,444 Deferred revenue 7,087 9,959 Drug development liability 573
1,141 Acquisition-related contingent obligations 5,243 4,901
Total current liabilities 90,503 109,439 Drug development
liability, less current portion 13,916 14,644 Deferred revenue,
less current portion 414 — Acquisition-related contingent
obligations, less current portion 2,745 2,441 Deferred tax
liability 6,753 6,569 Other long-term liabilities 6,994 6,088
Convertible senior notes 98,866 96,298 Total
liabilities 220,191 235,479 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 June 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; 67,245,602 and 65,969,699 shares
issued and outstanding at June 30, 2015 and December 31, 2014,
respectively 66 66 Additional paid-in capital 545,359 538,553
Accumulated other comprehensive loss (165 ) (850 ) Accumulated
deficit (311,245 ) (283,338 ) Total stockholders’ equity 234,138
254,554
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY $ 454,329 $ 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 ended
June 30, 2015
Six months ended
June 30, 2015
2015 2014 2015 2014
GAAP product sales, net & license fees and service
revenue $ 44,982 $ 46,855 $
83,599 $ 86,979 Non GAAP adjustments to
product sales, net & license fees and service revenue: (9,682 )
— (9,682 ) — Total adjustments to product
sales, net & license fees and service revenues (9,682 ) —
(9,682 ) —
Non-GAAP product sales & license
and contract revenue 35,300 46,855
73,917 86,979 GAAP cost of product
sales (excludes amortization of intangible assets) 5,990
6,156 13,061 12,434 Non-GAAP adjustments to
cost of product sales — — — —
Non-GAAP cost of product sales (excludes amortization of
intangible assets) 5,990 6,156
13,061 12,434 GAAP selling, general
and administrative expenses 22,552 25,399
45,886 48,802 Non GAAP adjustments to SG&A:
Stock-based compensation (3,087 ) (2,163 ) (5,116 ) (4,570 )
Shareholder lawsuit expenses 25 (884 ) 441 (1,263 ) Insurance
reimbursement under D&O policy 365 — 1,746 — Depreciation
expense (177 ) (572 ) (345 ) (817 ) Total adjustments to SG&A
(2,874 ) (3,619 ) (3,274 ) (6,650 )
Non-GAAP selling, general
and administrative 19,678 21,780
42,612 42,152 GAAP research and
development 9,558 11,335 25,409
40,832 Non-GAAP adjustments to R&D: Stock-based
compensation (441 ) (511 ) (873 ) (955 ) Depreciation expense (3 )
(11 ) (6 ) (49 ) Beleodaq milestone cash payment & stock
issuance — — — (17,790 ) Other R&D milestone payments —
— (3,000 ) — Total adjustments to R&D (444 ) (522
) (3,879 ) (18,794 )
Non-GAAP research and development
9,114 10,813 21,530
22,038 GAAP amortization and impairment of
intangible assets 6,916 5,361 20,938
10,721 Non-GAAP adjustments to amortization and impairment
of intangible assets: Amortization expense (6,916 ) (5,361 )
(13,778 ) (10,721 ) Impairment of FUSILEV distribution rights —
— (7,160 ) — Total adjustments to
amortization and impairment of intangibles (6,916 ) (5,361 )
(20,938 ) (10,721 )
Non-GAAP amortization and impairment of
intangibles — — —
— GAAP loss from operations (34
) (1,396 ) (21,695 )
(25,810 ) Non-GAAP adjustments to loss from
operations 552 9,502 18,409 36,165
Non-GAAP income (loss) from operations 518
8,106 (3,286 ) 10,355
GAAP total other expenses, net (2,335 )
(3,468 ) (6,098 ) (6,617
) Market-to-market of contingent consideration 146 1,005 646
1,729 Loss on foreign currency exchange (127 ) — 1,019 — Accretion
of discount on 2018 Convertible Notes 1,298 1,185
2,569 2,332 Total adjustments to other expense, net
1,317 2,190 4,234 4,061
Non-GAAP
total other expenses, net (1,018 ) (1,278
) (1,864 ) (2,556 ) GAAP
benefit (provision) for income taxes 23 1,301
(115 ) 1,223 Adjustment to benefit (provision)
for income taxes (23 ) (1,301 ) 115 (1,223 )
Non-GAAP
benefit (provision) for income taxes — —
— — GAAP net loss
(2,346 ) (3,563 ) (27,908
) (31,204 ) Total non-GAAP adjustments 1,846
10,391 22,758 39,003
Non-GAAP net
(loss) income $ (500 ) $
6,828 $ (5,150 ) $
7,799 Non-GAAP (loss) income per share: Basic
$ (0.01 ) $ 0.11 $ (0.08 ) $ 0.12 Diluted $ (0.01 ) $
0.09 $ (0.08 ) $ 0.10
Weighted average shares
outstanding: Basic 65,466,004 64,609,197 65,167,162 64,119,441
Diluted 65,466,004 79,260,064 65,167,162 79,012,587
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150806006369/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
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