"I am very pleased with the progress and milestones Spectrum achieved in
2013, including the launch of our fourth oncology drug Marqibo," said
Three-Month Period Ended
Consolidated revenues of
Product revenues in fourth quarter included: FUSILEV® (levoleucovorin)
net sales of
The Company recorded a net loss of
The Company recorded non-GAAP net income of
Twelve-Month Period Ended
Consolidated revenue of
Product sales in 2013 were comprised of: FUSILEV® sales of
The Company recorded net loss of
The Company had cash and equivalents and marketable securities of an
The Company recorded non-GAAP net loss of
|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 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
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.
FOLOTYN, (pralatrexate injection), a folate analogue metabolic
inhibitor, was discovered by
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.
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.
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
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.
Marqibo is a novel, sphingomyelin/cholesterol liposome-encapsulated,
formulation of vincristine sulfate. Vincristine, a microtubule
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
Important safety information
See full prescribing information for complete boxed warning.
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.
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.
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.
Marqibo can cause severe fatigue. Marqibo dose delay, reduction, or discontinuation may be necessary.
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.
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].
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).
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.
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).
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 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.
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.
The safety and effectiveness of Marqibo in pediatric patients have not been established.
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.
The influence of renal impairment on the safety, efficacy, and pharmacokinetics of Marqibo has not been evaluated.
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
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.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
|Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|Three Months Ended||Twelve Months Ended|
|Product sales, net||$||40,479||$||66,710||$||143,475||$||254,992|
|License fees and service revenue||1,039||3,394||12,379||12,715|
|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:|
|Weighted average shares outstanding:|
|Consolidated Balance Sheets|
|(In thousands, expect per share amounts)|
|Cash and equivalents||$||156,306||$||139,698|
Accounts receivable, net of allowance for doubtful accounts of
|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|
|Deferred tax assets||—||23,276|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and other accrued obligations||$||73,404||$||93,811|
|Accrued payroll and related expenses||6,872||4,835|
|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||—|
|Other long-term obligations||4,315||2,937|
|Revolving line of credit||—||75,000|
|Convertible senior notes||91,480||—|
|Commitments and contingencies|
Series B junior participating preferred stock,
Series E convertible voting preferred stock,
|Additional paid-in capital||518,144||463,710|
|Accumulated other comprehensive income||894||273|
|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)|
|Three months ended||
Twelve months ended
|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
|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||)||--|
|Legal and professional fees in connection with acquisitions||(67||)||(108||)||(3,444||)||(6,333||)|
Legal and professional fees for shareholder lawsuit
|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||)|
|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
|Non-GAAP amortization and impairment of purchased intangibles||$||--||$||--||$||--||$||--|
GAAP other income (expense)
|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 net (loss) income||$||3,472||$||18,777||$||(5,641||)||$||94,865|
|Non-GAAP (loss) income per share:|
|Non-GAAP weighted average shares outstanding:|
Vice President, Strategic Planning & Investor Relations
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