Spectrum Pharmaceuticals Reports Record Revenues and Profits for First Quarter of 2012
Financial Highlights of the Quarter
$0.71Per Diluted Share Compared to $0.23Per Diluted Share in the Same Quarter Last Year.
Total Revenues of
$60 MillionCompared to $44 Millionin the Same Quarter Last Year.
$253 Millionin Cash, Investments and Receivables as of March 31, 2012, Compared with $222 Millionin December 31, 2011.
- EPS of
FUSILEV® Gains Market Share and Grows
Record FUSILEV Revenues of
$51 MillionCompared to $35 Millionin the Same Quarter Last Year.
- 1,263 Accounts Ordered FUSILEV in the First Quarter Compared to 549 Accounts in the Previous Evidencing Strong User Pull Through.
- Current Trends Indicate Strong Demand Should Continue.
- Record FUSILEV Revenues of
Planned Acquisition of Allos Therapeutics Expected to be Accretive
to Spectrum in the Fourth Quarter of 2012
- FOLOTYN®, an Anti-Cancer Agent for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL), Achieved U.S. net Sales of $50 Million in 2011.
"The first quarter represents an unprecedented milestone in the history
of the company, with approximately
Three-Month Period Ended
Consolidated revenue of
The Company recorded net income of
The Company recorded non-GAAP net income of
During the three-month period ended
There were approximately 59.5 million shares of common stock issued and
outstanding as of
Domestic: (877) 837-3910, Conference ID# 72508257
International: (973) 796-5077, Conference ID# 72508257
For interested individuals unable to join the call, a replay will be
|Domestic Replay Dial-In #:||(855) 859-2056, Conference ID# 72508257|
|International Replay Dial-In #:||(404) 537-3406, Conference ID# 72508257|
This conference call will also be webcast. Listeners may access the
webcast, which will be available on the investor relations page of
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 Accomplishments For Early 2012
- Continued revenue and market share growth
- Strong end-user pull through
- Expanded manufacturing capacity assures reliable supply to meet increasing demand
Entered into an agreement to acquire licensing rights from
Bayer Healthcareto market ZEVALIN outside of the US
- Launched new patient-to-patient educational campaign for ZEVALIN on ZEVALIN.com
Publication: ZEVALIN Plus High Dose Chemotherapy (Z-BEAM) Highly
Effective in Aggressive Lymphoma; Randomized Study Reported in
Journal of the American Cancer Society
Planned Allos Therapeutics Acquisition
- Signed a definitive agreement and commenced a tender offer to acquire all of the outstanding shares of Allos Therapeutics
Upfront portion of the transaction valued at up to $206 million on a
fully-diluted basis, and approximately
$108million net of Allos'cash balance at the end of 2011
- FOLOTYN® marketed for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL); FOLOTYN generated more than $35 million in U.S. net sales in 2010 and $50 million in 2011
- Acquisition expected to be accretive to Spectrum on a cash basis in the fourth quarter of 2012
Catalysts for remainder of 2012
- Continue to expand market share
- Initiate additional clinical study to expand indications
- Initiate enrollment in the "ZEST" clinical study in diffuse large B-cell lymphoma
- Initiate trial in newly diagnosed follicular non-hodgkin's lymphoma patients
Conduct the "ZAR" trial, a head-to-head study vs. rituximab
maintenance in follicular non-hodgkin's lymphoma in
- Top line data from pivotal trial in relapsed refractory PTCL expected in Q4
- Initiate a Phase 2 study for SPI-1620
- Initiate a Phase 2 study for SPI-2012
- Initiate a Phase 2 study for Lucanthone in GBM
- Initiate a Phase I study for SPI-014 (f/k/a Renazorb)
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company committed to the
development and commercialization of innovative anti-cancer
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 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.
This press release may contain forward-looking statements regarding
future events and the future performance of
Additional risks that could cause actual results to differ include,
with respect to
The tender offer described herein commenced on
Non-GAAP Financial Measures
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.
|Consolidated Statements of Income and Reconciliation of Non-GAAP Adjustments|
|(In thousands, except share and per share data)|
Three Months Ended
Three Months Ended
|Product sales, net||$||56,784||$||-||$||56,784||$||40,523||$||-||$||40,523|
|License and contract revenue||3,075||-||3,075||3,075||-||3,075|
|Operating costs and expenses:|
|Cost of product sales (excludes amortization of purchased intangible assets)||8,673||8,673||6,580||-||6,580|
|Selling, general and administrative||18,262||(2,624||
|Research and development||8,891||(391||
|Amortization of purchased intangibles||930||-||930||930||-||930|
|Total operating costs and expenses||36,756||(5,117||)||31,639||26,091||(4,064||)||22,027|
|Income from operations||23,103||5,117||28,220||17,507||4,064||21,571|
|Change in fair value of common stock warrant liability||-||-||-||(5,250||)||
|Other income, net||138||-||138||520||-||520|
|Income before provision for income taxes||23,241||5,117||28,358||12,777||9,314||22,091|
|Benefit (provision) for income taxes||23,301||(25,609||)||(2,308||)||-||-||-|
|Net income per share:|
|Weighted average shares outstanding:|
|(1)||Adjustment for stock-based compensation expense recognized in the period|
|(2)||Add back the change in fair value of common stock warrant liability|
|(3)||Add back non-recurring payment related to co-development agreement|
Add back the legal and professional fees related to the
|(5)||Add back non-recurring costs associated with a reduction in staff|
|(6)||Adjustment for benefit of deferred tax valuation account offset by current taxes|
|SUMMARY CONSOLIDATED BALANCE SHEETS|
|Cash and equivalents||149,373||121,202|
|Accounts receivable, net||55,380||51,703|
|Prepaid expenses and other current assets||2,303||2,074|
|Deferred tax asset||10,000||-|
|Total current assets||262,866||225,801|
|Property and equipment, net||2,528||2,681|
|Intangible assets, net||40,231||41,654|
|Deferred tax asset||15,038||-|
|Deferred revenue and other credits — less current portion||11,268||14,029|
|Other long-term liabilities||467||307|
|Total stockholders' equity||239,451||187,907|
|Total liabilities and stockholders' equity||$||333,881||$||280,780|
Vice President, Strategic Planning & Investor Relations
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