Development Highlights: 2 Near-term NDA’s and 2 Potential
Blockbusters
- SPI-2012, a novel long-acting
GCSF, demonstrated non-inferiority to pegfilgrastim at the 135
µg/kg dose (p= 0.002), and superiority at the 270 µg/kg dose (p=
0.023) in a randomized Phase 2 Study. Phase 3 protocols are being
finalized following productive meetings with regulatory agencies in
the U.S. and Europe.
- Poziotinib, a novel pan-HER
inhibitor, showed promising Phase 1 data (ORR= 60%) in heavily
pretreated breast cancer patients who had failed multiple other
HER2-directed therapies.
- Captisol-Enabled™ Melphalan, a
propylene-glycol free formulation with improved stability, accepted
for NDA review by FDA with a PDUFA action date of October 23,
2015.
- Apaziquone, a potent
tumor-activated pro-drug for non-muscle invasive bladder cancer,
showed statistically significant results in a post-hoc subgroup
analysis of two Phase 3 studies (p=0.001); Company plans NDA
submission this year.
Financial Highlights: Strong Growth in Sales and Non-GAAP
Earnings
- Total product sales for the year ended
December 31, 2014 were $186.5 million, a 30% increase year over
year.
- Total product sales for the three
months ended December 31, 2014 were $51.7 million.
- Non-GAAP diluted EPS was $0.09, and
GAAP EPS was ($0.05) during the three months ended December 31,
2014.
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 and
year ended December 31, 2014.
"2014 was a strong year of revenue and non-GAAP earnings growth,
and we now have one of the strongest pipelines in Spectrum's
history,” said Rajesh C. Shrotriya, MD, Chairman and Chief
Executive Officer of Spectrum Pharmaceuticals. “SPI-2012, our lead
drug being investigated for the treatment of neutropenia targets a
blockbuster market and has shown impressive Phase 2 data which we
are sharing at our Analyst Day today. We have recently acquired
Poziotinib, a novel Pan-HER inhibitor that has shown promising
efficacy in breast cancer patients who had failed multiple HER2
agents in Phase 1 studies. We believe this drug has the potential
to be best in class. Further, we expect an FDA decision on our next
hematology drug CE-Melphalan in October, and we expect to file an
NDA for Apaziquone later this year. I am excited about the
tremendous progress at Spectrum which has positioned us well for
long-term growth."
Three-Month Period Ended December 31,
2014 (All numbers are approximate)
GAAP Results
Total revenues were $51.9 million and product sales were $51.7
million in the fourth quarter of 2014. Total revenue increased 25%
from $41.5 million in the fourth quarter of 2013, while product
sales increased 28% from $40.5 million in the fourth quarter of
2013.
Product sales in the fourth quarter included: FUSILEV®
(levoleucovorin) net sales of $30 million, FOLOTYN® (pralatrexate
injection) net sales of $12.2 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $5 million, MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) net sales of $1.6 million and BELEODAQ®
(belinostat) for Injection nets sales of $2.9 million.
Spectrum recorded net loss of $3.0 million, or ($0.05) per basic
and diluted share in the three-month period ended December 31,
2014, compared to net loss of $39.4 million, or ($0.63) per basic
and diluted share in the comparable period in 2013. Total research
and development expenses were $14.4 million in the quarter, as
compared to $10.8 million in the same period in 2013. Selling,
general and administrative expenses were $24.5 million in the
quarter, compared to $25.7 million in the same period in 2013.
Non-GAAP Results
Spectrum recorded non-GAAP net income of $7.5 million, or $0.12
per basic share and $0.09 per diluted share in the three-month
period ended December 31, 2014, compared to non-GAAP net income of
$3.5 million, or $0.06 per basic share and $0.05 per diluted share
in the comparable period in 2013. Non-GAAP research and development
adjustments were $0.4 million, as compared to $0.5 million in the
same period of 2013. Non-GAAP selling, general and administrative
adjustments were $3.1 million, as compared to $4.3 million in the
same period in 2013.
Twelve-Month Period Ended December 31,
2014 (All numbers are Approximate)
GAAP Results
Consolidated revenue of $186.8 million for the twelve-month
period ending December 31, 2014 was comprised of product sales of
$186.5 million and $0.3 million from license fees and service
revenue.
Product sales in 2014 were comprised of: FUSILEV® sales of
$105.6 million, FOLOTYN® sales of $47.5 million, ZEVALIN® sales of
$22.2 million, Marqibo® sales of $6.3 million and BELEODAQ® sales
of $4.9 million.
The Company recorded net loss of $45.7 million, or ($0.71) per
basic and diluted share in the twelve-month period ended December
31, 2014, compared to net loss of $62.1 million, or ($1.02) per
basic and diluted share in 2013. Total research and development
expenses were $69.7 million in 2014, as compared to $46.7 million
in 2013. Selling, general and administrative expenses were $97.4
million in 2014, compared to $99.3 million in 2013. The Company had
cash and equivalents and marketable securities of an aggregate
$133.2 million as of December 31, 2014.
Non-GAAP Results
The Company recorded non-GAAP net income of $21.4 million, or
$0.33 per basic share and $0.27 per diluted share in the
twelve-month period ended December 31, 2014, compared to net loss
of $5.6 million, or ($0.09) per basic and diluted share in the same
period in 2013. Non-GAAP research and development adjustments were
$19.6 million, as compared to $2.1 million in the same period of
2013. Non-GAAP selling, general and administrative adjustments were
$12.5 million, as compared to $19.3 million in the same period of
2013.
Development Highlights
SPI-2012: a novel, biologic GCSF that could expand
treatment options
- A Phase 2 randomized study demonstrated
SPI-2012 to be non-inferior to pegfilgrastim at the 135 µg/kg dose
(0.44 versus 0.31 days, respectively; p= 0.002), and superior at
the 270 µg/kg dose (0.03 versus 0.31 days, respectively, p= 0.023)
based on the primary endpoint, Mean Duration of Severe Neutropenia
(DSN).
- All SPI-2012 doses showed acceptable
safety profile with no significant dose-related or unexpected
toxicities, and AE incidences were comparable to pegfilgrastim;
there was a low incidence of immunogenicity.
- Company plans two randomized, active
controlled Phase 3 studies of SPI-2012 versus pegfilgrastim in
patients with breast cancer, one in North America and one
international, with a primary endpoint of DSN; study start-up is
ongoing.
Poziotinib: an oral, irreversible, pan-HER inhibitor
under development with best in class potential
- Poziotinib shows targeted activity to
HER1 (EGFR), HER2, HER4, and receptor mutations including EGFR
T790M in vitro.
- In vitro data demonstrates the superior
activity of poziotinib to neratinib and afatinib in several HER2
positive cell lines (SK-Br-3- IC50s: 1.0 versus 2.0 and 16.0
nM, respectively; MDA-MB-175- IC50s: 0.1 versus 2.5 and 2.4
nM, respectively; MDA-MB-453 (PIK3CA mutant)- IC50s: 5.4
versus 17.8 and 92.4 nM, respectively).
- Poziotinib has promising Phase 1 data
in heavily pretreated breast cancer patients who had failed other
HER2-directed therapies with an Overall Response Rate (ORR) of 60%
(n=10), and activity in other solid tumors.
- Poziotinib showed an acceptable safety
profile in Phase 1 with a treatment duration > 3 months in 42.9%
of patients, > 6 months in 22.2%, and > 12 months in 7.9%
patients (n=63).
- Additional Phase 2 studies are ongoing
in multiple tumor types.
Captisol-enabled Melphalan: a new melphalan formulation
with improved stability
- Captisol-enabled Melphalan (Propylene
Glycol-Free) 505(b)(2) NDA accepted for review with a PDUFA action
date of October 23, 2015.
- Proposed labeling includes current IV
melphalan indication for palliative treatment of patients with
multiple myeloma (MM), for whom oral therapy is not appropriate,
and also an additional indication as a high-dose conditioning
treatment prior to hematopoietic progenitor (stem) cell
transplantation in patients with MM.
- Phase 2 data met the primary endpoint
of bioequivalence for this new formulation to Alkeran® (melphalan
hydrochloride) for Injection. High-dose therapy with CE-Melphalan
(200 mg/m2) was associated with promising efficacy (ORR = 95%,
Complete Response Rate = 31%; Very Good Partial Response Rate or
better in 74% of patients), successful myeloablation, and
engraftment following HSCT.
- Safety profile comparable to IV
melphalan with no unexpected toxicities, and a low incidence of
Grade 3 mucositis (13%); and no Grade 4 mucositis.
Apaziquone: a tumor-activated pro-drug; potentially 1st
new drug for NMIBC in >40 years
- Adjuvant use of apaziquone for
immediate intravesical instillation following transuretheral
resection (TUR) of non-muscle invasive bladder cancer (NMIBC)
demonstrate a high response rate of marker lesions (69%) with
nearly 50% of patients remaining tumor-free after 18 months in
Phase 1/Phase 2 studies.
- Reanalysis of data from two completed
randomized, placebo-controlled Phase 3 studies demonstrates a lower
2 year recurrence rate with apaziquone compared to placebo in the
intent-to-treat (ITT) Population (Study 1 (n=802): 36.9%
versus 42.2%, respectively, p= 0.130; Study 2 (n=812): 40.0%
versus 46.1%, respectively, p= 0.082).
- Statistically significant differences
in 2 year recurrence rates shown in the subgroup of ITT patients
receiving apaziquone 30 to 90 minutes post-TUR (Study 1
(n=141): 24.4% versus 40.7%, respectively, p= 0.040; Study 2
(n=152): 32.9% versus 51.3%, respectively, p= 0.022) likely due to
less post-TUR bleeding.
- Integrated analyses of the two Phase 3
studies also demonstrate statistically significant differences in 2
year recurrence rates for apaziquone versus placebo in both the
overall TaG1G2 Population (n=1,146; 38.8% versus 45.5%,
respectively, p= 0.022) and in the combined subgroup analysis
(n=217; 28.2% versus 50.0%, respectively, p= 0.001).
- The drug is well tolerated with no
systemic toxicities.
- An NDA submission for apaziquone based
on the completed studies is planned for this year.
- A new Phase 3 study in NMIBC is planned
that will specifically focus on the administration of apaziquone to
all patients in the 31 to 90 minute window post-TUR, and will also
include a second intravesical administration 8 days later.
Conference Call
Friday, March 13, 2015 @ 10:00 a.m.
Eastern/7:00 a.m. Pacific
Domestic: (877) 837-3910, Conference ID#
82077760
International: (973) 796-5077, Conference ID#
82077760
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 March
13, 2015 at 10:00 a.m. Eastern/7:00
a.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 Captisol-Enabled Melphalan
Captisol-Enabled, 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™
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 Statements of Operations(In thousands,
except per share amounts)(Unaudited)
Three Months EndedDecember 31, Twelve
Months EndedDecember 31, 2014 2013
2014 2013 Revenues: Product sales, net $ 51,670 $
40,479 $ 186,537 $ 143,475 License fees and service revenue
191 1,039 293 12,379 Total revenues $
51,861 $ 41,518 $ 186,830 $ 155,854 Operating expenses:
Cost of product sales (excludes
amortization of intangible assets)
8,073 6,309 27,037 28,580 Selling, general and administrative
24,485 25,714 97,412 99,315 Research and development 14,410 10,760
69,662 46,670 Amortization and impairment of intangible assets
6,525 5,245 24,288 20,074 Total
operating expenses 53,493 48,028 218,399
194,639 (Loss) from operations (1,632) (6,510)
(31,569) (38,785) Interest expense (2,180) (650) (8,584) (2,192)
Change in fair value of contingent consideration related to
acquisition 2,897 2,871 987 2,871 Other (expense) income, net
(2,129) 666 (4,367) 1,470 Loss
before income taxes (3,044) (3,623) (43,533) (36,636) (Provision)
benefit for income taxes 68 (35,749) (2,186)
(25,498) ,, Net loss $ (2,976) $ (39,372) $ (45,719) $
(62,134) Net loss per share: Basic $ (0.05) $ (0.63) $
(0.71) $ (1.02) Diluted $ (0.05) $ (0.63) $ (0.71) $ (1.02)
Weighted average shares outstanding: Basic 65,054,236
62,851,660 64,708,163 60,729,128 Diluted
65,054,236 62,851,660 64,708,163 60,729,128
SPECTRUM PHARMACEUTICALS,
INC.Consolidated Balance Sheets(In thousands, expect per
share amounts)(Unaudited)
December 31,2014
December 31,2013
ASSETS Current Assets: Cash and equivalents $ 129,942 $
156,306 Marketable securities 3,306 3,471 Accounts receivable, net
of allowance for doubtful accounts of $120 and $206, respectively
70,758 49,483 Other Receivables 5,489 7,539 Inventories 9,200
13,519 Prepaid expenses and other current assets 3,774 3,213
Deferred income taxes — 1,659 Total current
assets 222,469 235,190 Property and equipment, net 1,405 1,535
Intangible assets, net 230,100 231,352 Goodwill 18,195 18,501
Deferred tax assets — — Other assets 17,864 12,577
Total assets $ 490,033 $ 499,155
LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and
other accrued obligations $ 84,994 $ 79,837 Accrued payroll and
related expenses 8,444 6,872 Deferred revenue 9,959 156 Drug
development liability 1,141 3,119 Acquisition related contingent
obligations 4,901 — Total current liabilities
109,439 89,984 Drug development liability, less current portion
14,644 14,623 Acquisition related contingent obligations 2,441
8,329 Deferred tax liability 6,569 7,168 Other long-term
obligations 6,088 5,965 Convertible senior notes 96,298
91,480 Total liabilities 235,479 217,549 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 December 31,
2014 and December 31, 2013, 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; 65,969,699 and 64,104,173 shares issued and outstanding
at December 31, 2014 and December 31, 2013, respectively 66 64
Additional paid-in capital 538,553 518,144 Accumulated other
comprehensive income (850) 894 Accumulated deficit (283,338)
(237,619) Total stockholders’ equity 254,554
281,606
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY $ 490,033 $ 499,155
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 December
31,
Year ended December 31,
2014 2013
2014 2013
GAAP product sales & license and contract revenue $
51,861 $ 41,516 $ 186,830 $ 155,854 Non GAAP adjustments to product
sales & license and contract revenue: -- --
--
(7,608)
Total adjustments to product sales & license and contract
revenues -- --
--
(7,608)
Non-GAAP product sales & license and contract revenue
51,861 41,516 186,830 148,246 GAAP cost
of product sales 8,073 6,309 27,037 28,580 Non-GAAP adjustments to
cost of product sales -- -- -- --
Non-GAAP cost of product sales 8,073 6,309
27,037 28,580 GAAP selling, general and
administrative expenses 24,485 25,714 97,412 99,315 Non GAAP
adjustments to SG&A: Stock-based compensation (2,831) (3,667)
(10,054) (10,762) Shareholder lawsuit (136) (290) (1,503) (1,781)
Talon acquisition legal & professional fees -- (67) -- (3,444)
Reduction of Staff -- (12) -- (1,984) Loan modification expense --
-- -- (183) Depreciation expense (123) (220)
(992) (1,105) Total adjustments to SG&A (3,090) (4,256)
(12,549) (19,259) Non-GAAP selling, general and administrative
21,395 21,458 84,863 80,056 GAAP
research and development 14,410 10,760 69,662 46,670 Non-GAAP
adjustments to R&D: Stock-based compensation (389) (449)
(1,756) (2,016) Depreciation expense (13) (12) (72) (81) TopoTarget
milestone payment & stock issuance -- -- (17,790) -- Reduction
in staff -- (4) -- (1,375) Amendment of Mundipharma agreement
resulting in write off of deferred payment contingency -- --
--
2,431
Non-recurring payment related to co-development agreement --
--
--
(1,100)
Total adjustments to R&D (402) (465) (19,618) (2,141) Non-GAAP
research and development 14,008 10,295 50,044
44,529
GAAP amortization of intangibles
6,525 5,245
24,288
20,074
Non-GAAP adjustments to amortization of intangibles: Amortization
(6,525) (5,245) (24,288) (20,074) Total
adjustments to amortization of intangibles (6,525) (5,245)
(24,288)
(20,074)
Non-GAAP amortization of intangibles -- -- --
-- GAAP loss from operations (1,632) (6,512) (31,569)
(38,784) Non-GAAP adjustments to income from operations
10,017 9,966 56,455 33,866 Non-GAAP income
(loss) from operations 8,385 3,454 24,886
(4,919) GAAP other expense, net (1,412) 2,887
(11,964) 2,149 Non-GAAP adjustments to other expense Realized gain
on TopoTarget shares -- -- (2,219) -- Loss on foreign currency
exchange 2,186 -- 6,824 -- Market-to-market of contingent
consideration (2,897) (2,871) (987) (2,871) Accretion of discount
on 2018 Convertible Notes 1,261 -- 4,818
-- Total adjustments to other expense, net 550
(2,871) 8,436 (2,871) Non-GAAP other expense, net
(862) 16 (3,528) (722) GAAP
(provision)/benefit for income taxes 68 (35,749) (2,186) (25,498)
Adjustment to (provision)/benefit for income taxes (68)
35,749 2,186 25,498 Non-GAAP provision for
income taxes -- -- -- -- GAAP
net loss (2,976) (39,374) (45,719) (62,134) Non-GAAP adjustments
10,499 42,844 67,077 56,493 Non-GAAP
net income 7,523 3,470 21,358 (5,641)
Non-GAAP income per share:
Basic $ 0.12 $ 0.06
$
0.33
$
(0.09)
Diluted $ 0.09 $ 0.05 $ 0.27 $ (0.09) Weighted average
shares outstanding: Basic 65,054,236 62,851,660
64,708,163 60,729,128 Diluted 79,354,398
68,211,929 79,268,282 60,729,128
Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice
President, Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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