- Total revenues for the year ended
December 31, 2013 were $155.9 million.Total revenues for the three
months ended December 31, 2013 were $41.5 million.
- Q4 Non-GAAP diluted EPS was $0.05, and
GAAP basic and diluted EPS was ($0.63); the difference is primarily
due to non-cash charges.
- SPI-2012 trial accruing well; the
Company expects to make a Phase 3 Go/No-Go decision in 2014.
- Top-line Data from Captisol-enabled®
Melphalan pivotal trial expected in the second quarter.
- Beleodaq™ NDA has been granted Priority
Review by the FDA with an action date of August 9, 2014.
Spectrum Pharmaceuticals (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, 2013.
“I am very pleased with the progress and milestones Spectrum
achieved in 2013, including the launch of our fourth oncology drug
Marqibo,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive
Officer, and President of Spectrum Pharmaceuticals. “Looking into
2014 and beyond, we could potentially have our fifth drug,
Beleodaq, on the market by the end of this year. We anticipate
top-line data for Captisol-enabled Melphalan’s pivotal trial in the
second quarter of 2014, and to file an NDA thereafter. In addition,
SPI-2012, our long-acting, proprietary conjugated GCSF, continues
to progress well and we expect to make a decision on a phase 3
study in 2014. We have a diversified revenue stream from multiple
oncology drugs and are well positioned for future growth.”
Three-Month Period Ended December 31,
2013 (All numbers are approximate)
GAAP Results
Consolidated revenues of $41.5 million were comprised of product
net sales of $40.5 million and $1.0 million from licensing fees.
This represents a 41% decrease from $70.1 million in consolidated
revenue, including product net sales of $66.7 million, recorded in
the three-month period ended December 31, 2012.
Product revenues in fourth quarter included: FUSILEV®
(levoleucovorin) net sales of $20.6 million, FOLOTYN® (pralatrexate
injection) net sales of $11.3 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $7.3 million, and Marqibo® (vinCRIStine
sulfate LIPOSOME injection) net sales of $1.3 million.
The Company recorded a net loss of $39.4 million, or ($0.63) per
basic and diluted share in the three-month period ended December
31, 2013, compared to net income of $7.5 million, or $0.13 per
basic and $0.12 per diluted share in the comparable period in 2012.
Total research and development expenses were $10.8 million in the
quarter, as compared to $13.7 million in the same period in 2012.
Selling, general and administrative expenses were $25.7 million in
the quarter, compared to $25.7 million in the same period in
2012.
Non-GAAP Results
The Company recorded non-GAAP net income of $3.5 million, or
$0.06 per basic share and $0.05 per diluted share in the
three-month period ended December 31, 2013, compared to net income
of $18.8 million, or $0.32 per basic and $0.29 per diluted share in
the comparable period in 2012. Non-GAAP research and development
adjustments were $0.5 million, as compared to $0.7 million in the
same period of 2012. Non-GAAP selling, general and administrative
adjustments were $4.3 million, as compared to $5.2 million in the
same period in 2012.
Twelve-Month Period Ended December 31,
2013 (All numbers are Approximate)
GAAP Results
Consolidated revenue of $155.9 million for the twelve-month
period ending December 31, 2013 was comprised of product sales of
$143.5 million and $12.4 million from license fees and service
revenue.
Product sales in 2013 were comprised of: FUSILEV® sales of $68.4
million, FOLOTYN® sales of $44.4 million, ZEVALIN® sales of $29.4
million and Marqibo® sales of $1.3 million.
The Company recorded net loss of $62.1 million, or ($1.02) per
basic and diluted share in the twelve-month period ended December
31, 2013, compared to net income of $94.2 million, or $1.61 per
basic and $1.46 per diluted share in 2012. Total research and
development expenses were $46.7 million in 2013, as compared to
$41.6 million in 2012. Selling, general and administrative expenses
were $99.3 million in 2013, which included non-cash charges of
$11.9 million, compared to $89.9 million in 2012, which included
non-cash charges of $13.4 million.
The Company had cash and equivalents and marketable securities
of an aggregate $159.8 million as of December 31, 2013.
Non-GAAP Results
The Company recorded non-GAAP net loss of $5.6 million, or
($0.09) per basic and diluted share in the twelve-month period
ended December 31, 2013, compared to net income of $94.9 million,
or $1.62 per basic share and $1.47 per diluted share in the same
period in 2012. Non-GAAP research and development adjustments were
$2.1 million, as compared to $4.3 million in the same period of
2012. Non-GAAP selling, general and administrative adjustments were
$19.3 million, as compared to $21.6 million in the same period of
2012.
Conference Call
Thursday, March 6, 2014 @ 4:30 p.m.
Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910,
Conference ID# 15616517 International: (973) 796-5077,
Conference ID# 15616517
This conference call will also be webcast. Listeners may access
the webcast, which will be available on the investor relations page
of Spectrum Pharmaceutical’s website:
www.sppirx.com on March 6, 2014 at 4:30
p.m. Eastern/1:30 p.m. Pacific.
On the conference call, management will review the financial
results, provide an update on the Company’s business and discuss
expectations for the future.
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 four 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; and MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) for intravenous infusion, for which the Company
has worldwide marketing rights. 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 FUSILEV® (levoleucovorin) for
injection
FUSILEV, a novel folate analog, is approved as a ready-to-use
solution (FUSILEV Injection), and as freeze-dried powder (FUSILEV
for Injection). FUSILEV is indicated for use in combination
chemotherapy with 5-fluorouracil in the palliative treatment of
patients with advanced metastatic colorectal cancer. FUSILEV is
also indicated for rescue after high-dose methotrexate therapy in
osteosarcoma. FUSILEV is also indicated to diminish the toxicity
and counteract the effects of impaired methotrexate elimination and
of inadvertent overdosage of folic acid antagonists. FUSILEV, under
various trade names, is marketed outside the United States by
Pfizer, Sanofi-Aventis, and Takeda.
Important FUSILEV® (levoleucovorin) Safety
Considerations
FUSILEV is dosed at one-half the usual dose of racemic
d,l-leucovorin. FUSILEV is contraindicated for patients who have
had previous allergic reactions attributed to folic acid or folinic
acid. Due to calcium content, no more than 16-mL (160-mg) of
levoleucovorin solution should be injected intravenously per
minute. FUSILEV enhances the toxicity of fluorouracil. Concomitant
use of d,l-leucovorin with trimethoprim-sulfamethoxazole for
pneumocystis carinii pneumonia in HIV patients was associated with
increased rates of treatment failure in a placebo-controlled study.
Allergic reactions were reported in patients receiving FUSILEV.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in
patients receiving FUSILEV as rescue after high dose methotrexate
therapy. The most common adverse reactions ( > 50%) in patients
with advanced colorectal cancer receiving FUSILEV in combination
with 5-fluorouracil were diarrhea, nausea and stomatitis. FUSILEV
may counteract the antiepileptic effect of phenobarbital, phenytoin
and primidone, and increase the frequency of seizures in
susceptible patients.
Full prescribing information for FUSILEV can be found at
www.FUSILEV.com.
About FOLOTYN®
FOLOTYN, (pralatrexate injection), a folate analogue metabolic
inhibitor, was discovered by Memorial Sloan-Kettering Cancer
Center, SRI International and Southern Research Institute and
developed by Allos Therapeutics. In September 2009, the U.S. Food
and Drug Administration (FDA) granted accelerated approval for
FOLOTYN for use as a single agent for the treatment of patients
with relapsed or refractory PTCL. This indication is based on
overall response rate. Clinical benefit such as improvement in
progression-free survival or overall survival has not been
demonstrated. FOLOTYN has been available to patients in the U.S.
since October 2009. An updated analysis of data from PROPEL, the
pivotal study of FOLOTYN in patients with relapsed or refractory
PTCL, was published in the March 20, 2011 issue of the Journal of
Clinical Oncology. FOLOTYN has patent protection through July 2022,
based on a five-year patent term extension through the Hatch-Waxman
Act.
Important FOLOTYN® Safety Information
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and
omit or modify dose for hematologic toxicities.
Mucositis may occur. If greater-than or equal to Grade 2
mucositis is observed, omit or modify dose. Patients should be
instructed to take folic acid and receive vitamin B12 to
potentially reduce treatment-related hematological toxicity and
mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions
may be progressive and increase in severity with further treatment.
Patients with dermatologic reactions should be monitored closely,
and if severe, FOLOTYN should be withheld or discontinued. Tumor
lysis syndrome may occur. Monitor patients and treat if needed.
FOLOTYN can cause fetal harm. Women should avoid becoming
pregnant while being treated with FOLOTYN and pregnant women should
be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to
patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are greater-than
or equal to Grade 3, omit or modify dose.
Adverse Reactions
The most common adverse reactions were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events are pyrexia, mucositis, sepsis,
febrile neutropenia, dehydration, dyspnea, and
thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the
drug, taking into consideration the importance of the drug to the
mother.
Drug Interactions
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result
in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at
www.FOLOTYN.com.
About ZEVALIN® and the ZEVALIN Therapeutic
Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is
indicated for the treatment of patients with relapsed or
refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma
(NHL). ZEVALIN is also indicated for the treatment of patients with
previously untreated follicular non-Hodgkin’s Lymphoma who achieve
a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The
ZEVALIN therapeutic regimen consists of two components: rituximab,
and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN
builds on the combined effect of a targeted biologic monoclonal
antibody augmented with the therapeutic effects of a beta-emitting
radioisotope.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an
essential component of the ZEVALIN therapeutic regimen. These
fatalities were associated with hypoxia, pulmonary infiltrates,
acute respiratory distress syndrome, myocardial infarction,
ventricular fibrillation, or cardiogenic shock. Most (80%)
fatalities occurred with the first rituximab infusion. ZEVALIN
administration can result in severe and prolonged cytopenias in
most patients. Severe cutaneous and mucocutaneous reactions, some
fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including BOXED
WARNINGS, for ZEVALIN and rituximab. Full prescribing information
for ZEVALIN can be found at www.ZEVALIN.com.
About Marqibo®
Marqibo is a novel, sphingomyelin/cholesterol
liposome-encapsulated, formulation of vincristine sulfate.
Vincristine, a microtubule inhibitor, is FDA-approved for the
treatment of adult patients with Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia (ALL) in second or greater
relapse or whose disease has progressed following two or more
anti-leukemia therapies. (The encapsulation technology, utilized in
this formulation, has been shown to provide prolonged circulation
of vincristine in the blood).
Please see important safety information below and the full
prescribing information for Marqibo at
www.marqibo.com.
Indication and usage
Marqibo is a liposomal vinca alkaloid indicated for the
treatment of adult patients with Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia (ALL) in second or greater
relapse or whose disease has progressed following two or more
anti-leukemia therapies. This indication is based on overall
response rate. Clinical benefit such as improvement in overall
survival has not been verified.
Important safety information
CONTRAINDICATIONS
- Marqibo is contraindicated in patients
with demyelinating conditions including Charcot-Marie-Tooth
syndrome
- Marqibo is contraindicated in patients
with hypersensitivity to vincristine sulfate or any of the other
components of Marqibo (vinCRIStine sulfate LIPOSOME injection
- Marqibo is contraindicated for
intrathecal administration
WARNING
See full prescribing information for
complete boxed warning.
- For Intravenous Use Only — Fatal if
Given by Other Routes
- Death has occurred with intrathecal
use
- Marqibo (vinCRIStine sulfate
LIPOSOME injection) has different dosage recommendations than
vinCRIStine sulfate injection. Verify drug name and dose prior to
preparation and administration to avoid overdosage.
Warnings and Precautions
For Intravenous Use Only
For Intravenous use only. Fatal if given by other routes.
Extravasation Tissue Injury
Only administer through a secure and free-flowing venous access
line. If extravasation is suspected, discontinue infusion
immediately and consider local treatment measures.
Neurologic Toxicity
Sensory and motor neuropathies are common and are cumulative.
Monitor patients for symptoms of neuropathy, such as hypoesthesia,
hyperesthesia, paresthesia, hyporeflexia, areflexia, neuralgia, jaw
pain, decreased vibratory sense, cranial neuropathy, ileus, burning
sensation, arthralgia, myalgia, muscle spasm, or weakness, both
before and during treatment. Orthostatic hypotension may occur. The
risk of neurologic toxicity is greater if Marqibo is administered
to patients with preexisting neuromuscular disorders or when other
drugs with risk of neurologic toxicity are being given. In the
studies of relapsed and/or refractory adult ALL patients, Grade ≥ 3
neuropathy events occurred in 32.5% of patients. Worsening
neuropathy requires dose delay, reduction, or discontinuation of
Marqibo.
Myelosuppression
Monitor complete blood counts prior to each dose of Marqibo. If
Grade 3 or 4 neutropenia, thrombocytopenia, or anemia develops,
consider Marqibo dose modification or reduction as well as
supportive care measures.
Tumor Lysis Syndrome
Tumor lysis syndrome (TLS) may occur in patients with ALL
receiving Marqibo. Anticipate, monitor for, and manage.
Constipation and Bowel Obstruction
Ileus, bowel obstruction, and colonic pseudo-obstruction have
occurred. Marqibo can cause constipation. Institute a prophylactic
bowel regimen to mitigate potential constipation, bowel
obstruction, and/or paralytic ileus, considering adequate dietary
fiber intake, hydration, and routine use of stool softeners, such
as docusate. Additional treatments, such as senna, bisacodyl, milk
of magnesia, magnesium citrate, and lactulose may be
considered.
Fatigue
Marqibo can cause severe fatigue. Marqibo dose delay, reduction,
or discontinuation may be necessary.
Hepatic Toxicity
Fatal liver toxicity and elevated levels of aspartate
aminotransferase have occurred. Elevated levels of aspartate
aminotransferase of Grade ≥3 occurred in 6-11% of patients in
clinical trials. Monitor hepatic function tests. Reduce or
interrupt Marqibo for hepatic toxicity.
Embryofetal Toxicity
Marqibo can cause fetal harm when administered to a pregnant
woman. Vincristine sulfate liposome injection was teratogenic or
caused embryo-fetal death in animals. Women of childbearing
potential should avoid becoming pregnant while being treated with
Marqibo. There are no adequate and well-controlled studies of
Marqibo in pregnant women and there were no reports of pregnancy in
any of the clinical studies in the Marqibo clinical development
program. If this drug is used during pregnancy, or if the patient
becomes pregnant while taking this drug, the patient should be
apprised of the potential hazard to a fetus [see Use in Specific
Populations].
Adverse Reactions
The most common adverse reactions ( > 30%) were constipation
(57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral
neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia
(34%), decreased appetite (33%), and insomnia (32%).
The most commonly reported SAEs included febrile neutropenia
(20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress
(6.0%), and cardiac arrest (6.0%).
Twenty-eight percent of patients experienced adverse reactions
leading to treatment discontinuation. The most common adverse
reactions that caused treatment discontinuation were peripheral
neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome
(2%).
Deaths occurred in 23% of patients in study 1. The non-leukemia
related causes of deaths were brain infarct (1), intracerebral
hemorrhage (2), liver failure (1), multi-system organ failure (2),
pneumonia and septic shock (3), respiratory failure (4), pulmonary
hemorrhage (1), and sudden cardiac death (1).
Drug Interactions
No formal drug interaction studies have been conducted with
Marqibo. Marqibo is expected to interact with drugs known to
interact with non-liposomal vincristine sulfate.
Simultaneous oral or intravenous administration of phenytoin and
antineoplastic chemotherapy combinations that included
non-liposomal vincristine sulfate has been reported to reduce blood
levels of phenytoin and to increase seizure activity.
CYP3A Interactions
Vincristine sulfate, the active agent in Marqibo, is a substrate
for cytochrome P450 3A isozymes (CYP3A); therefore, the concomitant
use of strong CYP3A inhibitors should be avoided (e.g.,
ketoconazole, itraconazole, voriconazole, posaconazole,
clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir,
ritonavir, saquinavir, telithromycin). Similarly, the concomitant
use of strong CYP3A inducers should be avoided (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin,
rifapentine, phenobarbital, St. John’s Wort).
P-glycoprotein Interactions
Vincristine sulfate, the active agent in Marqibo, is also a
substrate for P-glycoprotein (P-gp). The effect of concomitant use
of potent P-gp inhibitors or inducers has not been investigated; it
is likely that these agents will alter the pharmacokinetics or
pharmacodynamics of Marqibo. Therefore the concomitant use of
potent P-gp inhibitors or inducers should be avoided.
Use in Specific Populations
Pregnancy
Pregnancy Category D [see Warnings and Precautions]
Based on its mechanism of action and findings from animal
studies, Marqibo can cause fetal harm when administered to pregnant
women.
If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential hazard to a fetus. In an embryofetal developmental
study, pregnant rats were administered vincristine sulfate liposome
injection intravenously during the period of organogenesis at
vincristine sulfate doses of 0.022 to 0.09 mg/kg/day. Drug-related
adverse effects included fetal malformations (skeletal and
visceral), decreases in fetal weights, increased numbers of early
resorptions and post-implantation losses, and decreased maternal
body weights Malformations were observed at doses ≥ 0.044 mg/kg/day
in animals at systemic exposures approximately 20-40% of those
reported in patients at the recommended dose.
Nursing Mothers
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk and because of the
potential for serious adverse reactions in nursing infants, a
decision should be made whether to discontinue nursing or
discontinue the drug taking into account the importance of the drug
to the mother.
Pediatric Use
The safety and effectiveness of Marqibo in pediatric patients
have not been established.
Geriatric Use
Safety and effectiveness in elderly individuals have not been
established. In general, dose selection for an elderly patient
should be cautious, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy.
Renal Impairment
The influence of renal impairment on the safety, efficacy, and
pharmacokinetics of Marqibo has not been evaluated.
Hepatic Impairment
Non-liposomal vincristine sulfate is excreted primarily by the
liver. The influence of severe hepatic impairment on the safety and
efficacy of Marqibo has not been evaluated. The pharmacokinetics of
Marqibo was evaluated in patients with moderate hepatic dysfunction
(Child-Pugh B) secondary to melanoma liver metastases. The
dose-adjusted maximum plasma concentration (Cmax) and area under
the concentration-time curve (AUC) of Marqibo in patients with
moderate hepatic impairment was comparable to the Cmax and AUC of
patients with ALL who had otherwise normal hepatic function.
About Captisol-Enabled Melphalan
Captisol-enabled®, PG-free melphalan is a intravenous
formulation of melphalan being investigated for the multiple
myeloma transplant setting, which has been granted Orphan drug
designation by the FDA. This formulation avoids the use of
propylene glycol, which has been reported to cause renal and
cardiac side effects that limit the ability to deliver higher doses
of therapeutic compounds. The use of the Captisol technology to
reformulate melphalan is anticipated to allow for longer
administration durations and slower infusion rates, potentially
enabling clinicians to safely achieve a higher dose intensity of
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, and is owned by Ligand
Pharmaceuticals.
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
sales of Spectrum’s drug products, 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 customer
concentration, the possibility for fluctuations in customer orders,
evolving market dynamics, our dependence on third parties for
clinical trials, manufacturing, distribution, information 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®
and MARQIBO® are registered trademarks of Spectrum Pharmaceuticals,
Inc and its affiliates. BELEODAQ™, 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.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
SPECTRUM PHARMACEUTICALS, INC. Consolidated
Statements of Operations (In thousands, except per share
amounts) (Unaudited)
Three Months Ended
Twelve Months Ended December 31,
December 31, 2013 2012 2013
2012 Revenues: Product sales, net $ 40,479 $ 66,710 $
143,475 $ 254,992 License fees and service revenue 1,039
3,394 12,379 12,715
Total revenues $ 41,518 $ 70,104 $ 155,854
$ 267,707 Operating costs and expenses: Cost of
product sales (excludes amortization of purchased intangible
assets) 6,309 15,231 28,580 46,633 Selling, general and
administrative 25,714 25,692 99,315 89,922 Research and development
10,760 13,722 46,670 41,560 Amortization and impairment of
intangible assets 5,245 4,418
20,074 8,818 Total operating costs and
expenses 48,028 59,063 194,639
186,933 (Loss) income from operations (6,510 )
11,041 (38,785 ) 80,774 Change in fair value of contingent
consideration related to acquisition 2,871 — 2, 871 — Other income
(expense), net 16 232 (722 )
(844 ) (Loss) income before income taxes (3,623 ) 11,273
(36,636 ) 79,930 (Provision) benefit for income taxes
(35,749 ) (3,783 ) (25,498 ) 14,271 Net
(loss) income $ (39,372 ) $ 7,490 $ (62,134 ) $ 94,201
Net (loss) income per share: Basic $ (0.63 ) $ 0.13 $
(1.02 ) $ 1.61 Diluted $ (0.63 ) $ 0.12 $ (1.02 ) $
1.46 Weighted average shares outstanding: Basic
62,851,660 58,628,963 60,729,128
58,588,916 Diluted 62,851,660
64,020,783 60,729,128 64,637,256
SPECTRUM PHARMACEUTICALS, INC. Consolidated
Balance Sheets (In thousands, expect per share amounts)
(Unaudited)
December 31,
December 31, 2013 2012 ASSETS Current
Assets: Cash and equivalents $ 156,306 $ 139,698 Marketable
securities 3,471 3,310 Accounts receivable, net of allowance for
doubtful accounts of $206 and $228, respectively 49,483 92,169
Inventories 13,519 14,478 Prepaid expenses and other current assets
3,213 2,745 Income tax receivable 7,539 — Deferred income taxes
1,659 12,473 Total current assets
235,190 264,873 Property and equipment, net 1,535 2,548 Intangible
assets, net 231,352 200,234 Goodwill 18,501 7,279 Deferred tax
assets — 23,276 Other assets 12,577 6,745
Total assets $ 499,155 $ 504,955
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable and other accrued obligations $ 73,404 $ 93,811
Accrued payroll and related expenses 6,872 4,835 Deferred revenue
156 12,300 Drug development liability 9,552
12,297 Total current liabilities 89,984 123,243 Drug
development liability, less current portion 14,623 11,377 Deferred
payment contingency — 2,287 Acquisition related contingent
obligations 8,627 — Tax liabilities 8,520 1,430 Other long-term
obligations 4,315 2,937 Revolving line of credit — 75,000
Convertible senior notes 91,480 — Total
liabilities 217,549 216,274 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, 2013 and December 31,
2012, 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; 64,104,177 and
60,026,675 shares issued and outstanding at December 31, 2013 and
December 31, 2012, respectively 64 60 Additional paid-in capital
518,144 463,710 Accumulated other comprehensive income 894 273
Accumulated deficit (237,619 ) (175,485 ) Total
stockholders’ equity 281,606 288,681
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 499,155
$ 504,955
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.
Condensed Consolidated Statements of
Operations and Reconciliation of Non-GAAP Adjustments
(In thousands, except share and per share data) (Unaudited)
Three months ended
Twelve months ended
December 31, December 31, 2013
2012 2013
2012 GAAP license and service revenue $ 1,039
$ 3,394 $ 12,379 $ 12,715
Non-GAAP
adjustments to license and service revenue: Amendment of the
Allergan agreement -- -- (7,608
) --
Non-GAAP license and service
revenue $ 1,039 $ 3,394 $ 4,771 $ 12,715
GAAP cost of product sales $ 6,309 $ 15,231
$ 28,580 $ 46,633
Non-GAAP adjustments to
cost of product sales:
ZEVALIN technology transfer
-- (3,826 ) -- (3,826 )
Non-GAAP cost of product sales $ 6,309 $
11,405 $ 28,580 $ 42,807 GAAP selling,
general and administrative expenses $ 25,714 $ 25,692
$ 99,315 $ 89,922
Non-GAAP adjustments to
SG&A: Severance costs associated with acquisition (12 ) (51
) (1,984 ) (1,925 ) Credit facility modification expense -- -- (183
) -- Stock-based compensation (3,667 ) (4,932 ) (10,762 ) (13,041 )
Depreciation (220 ) (79 ) (1,105 ) (315 ) Legal and professional
fees in connection with acquisitions (67 ) (108 ) (3,444 ) (6,333 )
Legal and professional fees for
shareholder lawsuit
(290 ) -- (1,781 ) --
Total adjustments to SG&A (4,256 ) (5,170 ) (19,259 ) (21,614 )
Non-GAAP selling, general and administrative $ 21,458
$ 20,522 $ 80,056 $ 68,308 GAAP
research and development $ 10,760 $ 13,722 $ 46,670
$ 41,560
Non-GAAP adjustments to R&D:
Severance costs associated with acquisition (4 ) 28 (1,375 ) (519 )
Stock-based compensation (449 ) (528 ) (2,016 ) (1,843 )
Depreciation (12 ) (167 ) (81 ) (895 ) Amendment of Mundipharma
agreement -- -- 2,431 -- Payments for clinical data access
-- -- (1,100 ) (1,000 ) Total
adjustments to R&D (465 ) (667 ) (2,141 ) (4,257 )
Non-GAAP research and development $ 10,295 $ 13,055
$ 44,529 $ 37,303 GAAP amortization and
impairment of purchased intangibles $ 5,245 $ 4,418 $
20,074 $ 8,818
Non-GAAP adjustments to purchased
intangibles:
Amortization and impairment of purchased
intangibles
(5,245 ) (4,418 ) (20,074 ) (8,818 )
Non-GAAP amortization and impairment of purchased
intangibles $ -- $ -- $ -- $ --
GAAP other income (expense)
$ 2,887 $ 232 $ 2,149 $ (844 )
Non-GAAP
adjustments to other income (expense): Change in fair value of
contingent consideration related to acquisition (2,871 )
-- (2,871 ) -- Total adjustments
to other income (expense) (2,871 ) -- (2,871 ) --
Non-GAAP other
income (expense) $ 16 $ 232 $ (722 ) $ (844 )
GAAP (loss) income before income taxes $ (3,623 ) $ 11,273
$ (36,636 ) $ 79,930 Total non-GAAP adjustments
7,095 14,081 30,995
38,515 Non-GAAP (loss) income before income taxes $
3,472 $ 25,354 $ (5,641 ) $ 118,445
GAAP (provision)/benefit for income taxes $ (35,749 ) $ (3,783 ) $
(25,498 ) $ 14,271 Adjustment to (provision)/benefit for
income taxes 35,749 (2,794 ) 25,498
(37,851 ) Non-GAAP (provision)/benefit for income
taxes $ -- $ (6,577 ) $ -- $ (23,580 ) GAAP
net (loss) income $ (39,372 ) $ 7,490 $ (62,134 ) $ 94,201
Non-GAAP adjustments 42,844 11,287
56,493 664 Non-GAAP net (loss)
income $ 3,472 $ 18,777 $ (5,641 ) $ 94,865
Non-GAAP (loss) income per share: Basic $ 0.06 $ 0.32
$ (0.09 ) $ 1.62 Diluted $ 0.05 $ 0.29
$ (0.09 ) $ 1.47 Non-GAAP weighted average shares
outstanding: Basic 62,851,660 58,628,963
60,729,128 58,588,916 Diluted
68,211,929 64,020,783 60,729,128
64,637,256
Spectrum PharmaceuticalsShiv Kapoor, 702-835-6300Vice President,
Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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