Spectrum Pharmaceuticals Reports Financial Results for First Quarter 2013
Total revenue for the three months ending
March 31, 2013was $38.7 million. The company recorded a GAAP EPS of ( $0.05).
- Pivotal data in relapsed/refractory peripheral T-cell lymphoma from late-stage drug Belinostat to be presented as an oral presentation at ASCO 2013; the company expects to submit an NDA this summer.
- Company expects enrollment in the Captisol-enabled® melphalan study in multiple myeloma to be completed in 2013, with NDA submission in 2014.
$163.4 millioncash, cash equivalents, and investments as of March 31, 2013, as compared to $143.0 millionas of December 31, 2012.
"As a diversified company with three marketed oncology products and a
maturing pipeline, I am proud to say Spectrum is well positioned for
future growth," said
Three-Month Period Ended
Consolidated revenue of
Product revenues in first quarter included: FUSILEV® (levoleucovorin)
net sales of
The Company recorded net loss of
The Company recorded non-GAAP net loss of
During the three-month period ended
There were approximately 60.0 million shares of common stock issued and
outstanding as of
|Domestic: (877) 837-3910, Conference ID# 34586964|
|International: (973) 796-5077, Conference ID# 34586964|
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 May 9, 2013 at 1:30 p.m. Eastern/10:30 a.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.
Key Potential Growth Catalysts
- Pivotal Data from belinostat in relapsed/refractory PTCL to be presented as an oral presentation at ASCO 2013
- Belinostat NDA submission in summer 2013
- Pivotal data and Captisol-enabled melphalan NDA submission in 2014
- Apaziquone NDA submission in 2014
Continued progress of Spectrum-sponsored or supported ZEVALIN studies,
- Phase 3 ZEST clinical trial in patients with Diffuse Large B-Cell Lymphoma (DLBCL)
- An international investigator initiated study, the SPINOZA trial in patients with relapsed DLBCL who receive autologous stem cell transplantation (ASCT)
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.
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.
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 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Three Months Ended
|Product sales, net||$||29,346||$||56,784|
|License and contract revenue||9,321||3,075|
|Operating costs and expenses:|
|Cost of product sales (excludes amortization of purchased intangible assets)||6,782||8,673|
|Selling, general and administrative||22,347||18,262|
|Research and development||11,981||8,891|
|Amortization of purchased intangibles||2,368||930|
|Total operating costs and expenses||43,478||36,756|
|(Loss) income from operations||(4,811||)||23,103|
|Other (expense) income, net||(1,318||)||138|
|(Loss) income before provision for income taxes||(6,129||)||23,241|
|Benefit from income taxes||3,340||23,301|
|Net (loss) income||$||(2,789||)||$||46,542|
|Net (loss) income per share:|
|Weighted average shares outstanding:|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents||160,073||139,698|
|Accounts receivable, net||39,432||92,169|
|Prepaid expenses and other current assets||3,126||2,745|
|Total current assets||239,035||264,873|
|Property and equipment, net||2,227||2,548|
|Intangible assets, net||206,593||202,311|
|Deferred revenue and other credits — less current portion||3,456||2,937|
|Deferred development costs — less current portion||11,337||11,377|
|Deferred payment contingency||2,374||2,287|
|Other long-term liabilities||6,130||1,430|
|Revolving line of credit||75,000||75,000|
|Total stockholders' equity||284,378||284,846|
|Total liabilities and stockholders' equity||$||486,128||$||506,274|
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
|GAAP license and contract revenue||9,321||3,075|
Non GAAP adjustments to license and contract revenue:
Amendment of the Allergan agreement
|Total adjustments to license and contract revenues||6,225||--|
|Non-GAAP license and contract revenue||3,096||3,075|
|GAAP selling, general and administrative expenses||22,347||18,262|
|Non GAAP adjustments to SG&A:|
|Reduction in staff||--||272|
|Legal and professional fees for shareholder lawsuit||336||--|
|Total adjustments to SG&A||2,409||3,726|
|Non-GAAP selling, general and administrative||19,938||14,536|
|GAAP research and development||11,981||8,891|
|Non-GAAP adjustments to R&D:|
|One-time payment for co-development agreement||1,100||1,000|
|Total adjustments to R&D||1,774||1,391|
|Non-GAAP research and development||10,207||7,500|
GAAP amortization of purchased intangibles
|Non-GAAP adjustments to purchased intangibles:|
|Total adjustments to amortization of purchased intangibles||2,368||930|
|Non-GAAP amortization of purchased intangibles||--||--|
|GAAP (loss) income before income taxes||(6,129||)||23,241|
|Total non-GAAP adjustments||326||6,047|
|Non-GAAP income before income taxes||(5,803||)||29,288|
|GAAP benefit for income taxes||3,340||23,301|
|Adjustment to benefit for income taxes||(957||)||(25,609||)|
|Non-GAAP benefit/(provision) for income taxes||2,383||(2,308||)|
|GAAP net (loss) income||(2,789||)||46,542|
|Non-GAAP net income||(3,420||)||26,980|
Non-GAAP income per share:
|Weighted average shares outstanding:|
Vice President, Strategic Planning & Investor Relations
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