Spectrum Pharmaceuticals Reports Record Revenues, Profits, and Cash Generated from Operations for the Twelve-Month Period Ended December 31, 2012
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Total GAAP revenue for 2012 was
$267.7 million ; pro forma revenue (including ex-US ZEVALIN® and FOLOTYN® for the entire year) was$302 million . - GAAP Product revenues were up 41% and net income increased by 95% in 2012.
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The Company reported GAAP Diluted EPS of
$1.46 and Non-GAAP Diluted EPS of$1.42 compared to last year GAAP EPS of$0.84 and non-GAAP of$1.31 . - FUSILEV® unit volume was higher in the fourth quarter compared to the third quarter and end user sales trends are stable year-to-date.
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Significant cost synergies have been achieved in a short period
following the
Allos acquisition. FOLOTYN® shows strong sales growth in the most recent quarter. -
The Company ended the year with a strong balance sheet with
$143 million in cash, cash equivalents and investments after paying$133 million for theAllos acquisition, net of Allos' cash. - The Company expects revenues and operating income to increase in 2013.
"With substantial year-over-year sales growth, 2012 stands out as a
transformational year for Spectrum and provides a solid platform for
anticipated strong growth in sales and operating income in 2013," stated
Twelve-Month Period Ended
GAAP Results
Consolidated revenue of
Product revenues in 2012 comprised: FUSILEV® sales of
The Company recorded net income of
The Company had cash, cash equivalents and securities of approximately
On
There were approximately 60.0 million shares of common stock issued and
outstanding as of
Non-GAAP Results
The Company recorded non-GAAP net income of
Three-Month Period Ended
GAAP Results
Consolidated revenue of
The Company recorded net income of
Non-GAAP Results
The Company recorded non-GAAP net income of
Conference Call
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| Domestic: | (877) 837-3910, Conference ID# 94256900 | |||||
| International: | (973) 796-5077, Conference ID# 94256900 | |||||
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 Catalysts
FUSILEV® (levoleucovorin) for injection
- Continue to gain market share and grow revenue
- Initiate additional clinical studies to expand indications
FOLOTYN® (pralatrexate injection)
- Continue to grow the market for this recent addition to the Spectrum product portfolio
- Explore synergies, including clinical studies for combined treatment with FUSILEV
ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use
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Continue progress of Spectrum-sponsored or supported studies,
including:
- Phase 3 ZEST clinical trial in patients with Diffuse Large B-Cell Lymphoma (DLBCL);
- International SPINOZA (IIS) trial in patients with relapsed DLBCL who receive autologous stem cell transplantation (ASCT), and
- RoZetta study, a head-to-head evaluation of ZEVALIN consolidation treatment vs. rituximab maintenance in previously untreated patients with follicular non-Hodgkin's lymphoma.
Robust Pipeline
- Plan to file 2 NDAs in the next the 12 months
- Plan Phase 2 program for RenaZorb® (an orally available, lanthanum-based nanotechnology compound with potent phosphate-binding properties), based on positive Phase 1 clinical data
- Continue Phase 2 study for SPI-2012
- Initiate Phase 2 trials for SPI-1620
About
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
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 FOLOTYN®
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.
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 (
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.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of
© 2013
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CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) |
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| Three Months Ended | Year Ended | ||||||||||||||||||||||
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| (unaudited) | (unaudited) | ||||||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Product sales, net | $ | 66,710 | $ | 49,904 | $ | 254,992 | $ | 180,663 | |||||||||||||||
| License and contract revenue | 3,394 | 3,075 | 12,715 | 12,300 | |||||||||||||||||||
| Total revenues | $ | 70,104 | $ | 52,979 | $ | 267,707 | $ | 192,963 | |||||||||||||||
| Operating costs and expenses: | |||||||||||||||||||||||
| Cost of product sales (excludes amortization of purchased intangible assets) | 15,231 | 10,283 | 46,633 | 33,838 | |||||||||||||||||||
| Selling, general and administrative | 27,242 | 25,292 | 91,965 | 72,553 | |||||||||||||||||||
| Research and development | 13,887 | 6,816 | 42,544 | 27,720 | |||||||||||||||||||
| Amortization of purchased intangibles | 2,341 | 930 | 6,741 | 3,720 | |||||||||||||||||||
| Total operating costs and expenses | 58,701 | 43,321 | 187,883 | 137,831 | |||||||||||||||||||
| Income from operations | 11,403 | 9,658 | 79,824 | 55,132 | |||||||||||||||||||
| Change in fair value of common stock warrant liability | — | — | — | (3,488) | |||||||||||||||||||
| Other income (expense), net | 232 | 27 | (844) | 577 | |||||||||||||||||||
| Income before provision for income taxes | 11,635 | 9,685 | 78,980 | 52,221 | |||||||||||||||||||
| Benefit (provision) for income taxes | (3,014) | (1,404) | 15,565 | (3,704) | |||||||||||||||||||
| Net income | $ | 8,621 | $ | 8,281 | $ | 94,545 | $ | 48,517 | |||||||||||||||
| Net income per share: | |||||||||||||||||||||||
| Basic | $ | 0.15 | $ | 0.15 | $ | 1.61 | $ | 0.91 | |||||||||||||||
| Diluted | $ | 0.13 | $ | 0.13 | $ | 1.46 | $ | 0.84 | |||||||||||||||
| Weighted average shares outstanding: | |||||||||||||||||||||||
| Basic | 58,628,963 | 56,916,064 | 58,588,916 | 53,272,767 | |||||||||||||||||||
| Diluted | 64,020,783 | 63,313,226 | 64,637,256 | 57,959,714 | |||||||||||||||||||
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SUMMARY CONSOLIDATED BALANCE SHEETS (In thousands) |
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December 31, | ||||||||||||
| 2012 | 2011 | ||||||||||||
| (unaudited) | |||||||||||||
| Cash, cash equivalents | $ | 139,698 | $ | 121,202 | |||||||||
| Marketable securities | 3,310 | 40,060 | |||||||||||
| Accounts receivable, net | 92,169 | 51,703 | |||||||||||
| Inventories, net | 14,478 | 10,762 | |||||||||||
| Prepaid expenses and other current assets | 2,745 | 2,074 | |||||||||||
| Deferred tax asset | 12,473 | — | |||||||||||
| Total current assets | 264,873 | 225,801 | |||||||||||
| Investments | — | 9,283 | |||||||||||
| Property and equipment, net | 2,548 | 2,681 | |||||||||||
| Intangible assets, net | 202,311 | 41,654 | |||||||||||
| Goodwill | 28,973 | — | |||||||||||
| Other assets | 7,569 | 1,361 | |||||||||||
| Total Assets | $ | 506,274 | $ | 280,780 | |||||||||
| Current liabilities | $ | 128,397 | $ | 78,537 | |||||||||
| Deferred revenue and other credits — less current portion | 2,937 | 14,029 | |||||||||||
| Deferred development costs — less current portion | 11,377 | — | |||||||||||
| Deferred payment contingency | 2,287 | — | |||||||||||
| Other long-term liabilities | 1,430 | 307 | |||||||||||
| Revolving line of credit | 75,000 | — | |||||||||||
| Total liabilities | 221,428 | 92,873 | |||||||||||
| Total stockholders' equity | 284,846 | 187,907 | |||||||||||
| Total liabilities and stockholders' equity | $ | 506,274 | $ | 280,780 | |||||||||
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.
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Condensed Consolidated Statements of Income and Reconciliation of Non-GAAP Adjustments (In thousands, except share and per share data) (Unaudited) |
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| Three months ended | Year ended | ||||||||||||||||||
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December 31, | ||||||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||||||
| GAAP cost of product sales | 15,231 | 10,283 | 46,633 | 33,838 | |||||||||||||||
| Non GAAP adjustments to cost of product sales: | |||||||||||||||||||
| Zevalin tech transfer | 3,826 | -- | 3,826 | -- | |||||||||||||||
| Total adjustments to cost of product sales | 3,826 | -- | 3,826 | -- | |||||||||||||||
| Non-GAAP cost of product sales | 11,405 | 10,283 | 42,807 | 33,838 | |||||||||||||||
| GAAP selling, general and administrative expenses | 27,242 | 25,292 | 91,965 | 72,553 | |||||||||||||||
| Non GAAP adjustments to G&A: | |||||||||||||||||||
| Reduction in staff | 51 | -- | 1,925 | -- | |||||||||||||||
| Stock-based compensation | 4,932 | 6,572 | 13,041 | 20,609 | |||||||||||||||
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108 | -- | 6,333 | -- | |||||||||||||||
| Total adjustments to G&A | 5,091 | 6,572 | 21,299 | 20,609 | |||||||||||||||
| Non-GAAP selling, general and administrative | 22,151 | 18,720 | 70,666 | 51,944 | |||||||||||||||
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GAAP research and development |
13,887 | 6,816 | 42,544 | 27,720 | |||||||||||||||
| Non-GAAP adjustments to R&D: | |||||||||||||||||||
| Stock-based compensation | 527 | 449 | 1,843 | 1,628 | |||||||||||||||
| Reduction in staff | (28) | -- | 519 | -- | |||||||||||||||
| One-time payment for co-development agreement | -- | -- | 1,000 | -- | |||||||||||||||
| Total adjustments to R&D | 499 | 449 | 3,362 | 1,628 | |||||||||||||||
| Non-GAAP research and development | 13,388 | 6,367 | 39,182 | 26,092 | |||||||||||||||
| GAAP amortization of purchased intangibles | 2,341 | 930 | 6,741 | 3,720 | |||||||||||||||
| Non-GAAP adjustments to purchased intangibles: | |||||||||||||||||||
| Amortization | 2,341 | 930 | 6,741 | 3,720 | |||||||||||||||
| Total adjustments to amortization of purchased intangibles | 2,341 | 930 | 6,741 | 3,720 | |||||||||||||||
| Non-GAAP amortization of purchased intangibles | -- | -- | -- | -- | |||||||||||||||
| GAAP change in fair value of common stock warrant liability | -- | -- | -- | (3,488) | |||||||||||||||
| Non-GAAP adjustments to change in fair value of common stock warrant liability: | |||||||||||||||||||
| Change in fair value of common stock warrant liability | -- | -- | -- | (3,488) | |||||||||||||||
| Non-GAAP change in fair value of common stock warrant liability | -- | -- | -- | -- | |||||||||||||||
| GAAP income before income taxes | 11,635 | 9,685 | 78,980 | 52,221 | |||||||||||||||
| Total non-GAAP adjustments | 11,757 | 7,951 | 35,228 | 29,445 | |||||||||||||||
| Non-GAAP income before income taxes | 23,392 | 17,636 | 114,208 | 81,666 | |||||||||||||||
| GAAP (provision)/benefit for income taxes | (3,014) | (1,404) | 15,565 | (3,704) | |||||||||||||||
| Adjustment to (provision)/benefit for income taxes | (2,794) | -- | (37,851) | (1,896) | |||||||||||||||
| Non-GAAP (provision)/benefit for income taxes | (5,808) | (1,404) | (22,286) | (5,600) | |||||||||||||||
| GAAP net income | 8,621 | 8,281 | 94,545 | 48,517 | |||||||||||||||
| Non-GAAP adjustments | 8,963 | 7,951 | (2,623) | 27,549 | |||||||||||||||
| Non-GAAP net income | 17,584 | 16,232 | 91,922 | 76,066 | |||||||||||||||
| Non-GAAP income per share: | |||||||||||||||||||
| Basic | 0.30 | 0.29 | 1.57 | 1.43 | |||||||||||||||
| Diluted | 0.27 | 0.26 | 1.42 | 1.31 | |||||||||||||||
| Weighted average shares outstanding: | |||||||||||||||||||
| Basic | 58,628,963 | 56,916,064 | 58,588,916 | 53,272,767 | |||||||||||||||
| Diluted | 64,020,783 | 63,313,226 | 64,637,256 | 57,959,714 | |||||||||||||||
Vice President, Strategic Planning &
Investor Relations
InvestorRelations@sppirx.com
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