UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): March 1, 2012
SPECTRUM PHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter)
Delaware | 001-35006 | 93-0979187 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
11500 S. Eastern Ave., Ste. 240, Henderson, NV 89052 |
(Address of principal executive offices, including zip code)
Registrants telephone number, including area code: (702) 835-6300
Not Applicable |
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 | Results of Operations and Financial Condition. |
On March 1, 2012, Spectrum Pharmaceuticals, Inc. issued a press release, which, among other matters, sets forth our results of operations for the year ended December 31, 2011. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing information, including Exhibit 99.1, is being furnished under Item 2.02 and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press Release dated March 1, 2012. |
2
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 1, 2012 |
SPECTRUM PHARMACEUTICALS, INC. | |||||
By: |
/s/ Brett L. Scott | |||||
Brett L. Scott | ||||||
Senior Vice President and Acting Chief | ||||||
Financial Officer |
3
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press Release dated March 1, 2012. |
4
Exhibit 99.1
COMPANY CONTACTS |
||
Shiv Kapoor |
Paul Arndt | |
Vice President, Strategic Planning & Investor Relations |
Senior Manager, Investor Relations | |
702-835-6300 |
702-835-6300 |
SPECTRUM PHARMACEUTICALS REPORTS RECORD REVENUES, PROFITS, AND CASH GENERATED FROM OPERATIONS FOR THE TWELVE-MONTH PERIOD ENDED DECEMBER 31, 2011
| Financial Highlights: |
| First Full Year of Profitability Since Inception in 2002 |
| Total Revenues of $193 Million in 2011, Up 160% From Previous Record Revenues of $74 Million in 2010, Comprised of Product Sales of $181 Million: |
| $153 Million From FUSILEV |
| $28 Million From ZEVALIN |
| Non-GAAP EPS of $1.25 Per Diluted Share in 2011, Up From a Loss of $0.87 in 2010 |
| $222 Million in Cash, Cash Equivalents, Investments and Receivables as of December 31, 2011, Compared to $125 Million as of December 31, 2010 |
| Stock Repurchase Program Initiated in 2011 Remains in Place |
| Two New Drug Applications on Track for Filing in 2012 |
| Apaziquone Pivotal, Registrational Data Expected Soon |
| Belinostat Pivotal, Registrational Data Expected Later in the Year |
| Stage Is Set For Long-Term ZEVALIN Growth |
| Worldwide Commercial Strategy Being Executed |
| Expanded Clinical Development Program Underway |
| Repositioning Campaign Capitalizes on the Bioscan Removal to Augment Market Penetration |
HENDERSON, Nevada March 1, 2012 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today reported financial results for the three- and twelve-month periods ended December 31, 2011.
A 160% increase in annual total revenues and a healthy year-end balance sheet made 2011 a landmark year, said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. Today, Spectrum Pharmaceuticals is in a strong position for solid growth over the next 5 years. We have two approved drugs with significant growth potential and two novel drugs in late-stages of development with pivotal data expected this year. We look forward to the results of our pivotal registrational program for apaziquone soon, and for belinostat later in the year. Based on our growing pipeline and product portfolio, we expect 2012 to be another transformational year for Spectrum.
11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405
www.sppirx.com NASDAQ: SPPI
Twelve-Month Period Ended December 31, 2011 (All #s are Approximate)
Consolidated revenue of $193 million was comprised of product sales of $181 million and $12 million from licensing fees. This represents a 160% increase from the $74 million in consolidated revenue recorded in the twelve-month period of 2010, which was comprised of product sales of $61 million and $13 million from licensing fees.
Non-GAAP Results
The Company recorded non-GAAP net income of $72 million, or $1.36 per basic share and $1.25 per diluted share in the twelve month period ended December 31, 2011, compared to a net loss of $43 million, or ($0.87) per basic and diluted share in 2010. Non-GAAP research and development expenses were $26 million, as compared to $55 million in the same period of 2010, which included the $30 million up-front licensing fee for belinostat. Non-GAAP selling, general and administrative expenses were $52 million, as compared to $43 million in the same period in 2010.
GAAP Results
The Company recorded net income of $49 million, or $0.91 per basic and $0.84 per diluted share in the twelve month period ended December 31, 2011, compared to a net loss of $49 million, or ($0.99) per basic and diluted share in 2010. Total research and development expenses were $28 million in 2011, as compared to $57 million in 2010, which included the $30 million up-front licensing fee for belinostat. Selling, general and administrative expenses were $73 million in 2011, which included non-cash charges of $21 million, compared to $49 million in 2010, which included non-cash charges of $6 million.
During the twelve-month period ended December 31, 2011, net cash provided by operations was approximately $43 million. Cash, equivalents, investments and receivables as of December 31, 2011 aggregated $222 million, as compared to $125 million as of December 31, 2010.
On June 15th, the Board of Directors of the Company authorized the repurchase up to $25 million of our common stock through the end of December 2012. Under the program the Company has repurchased approximately 363,000 shares of common stock.
There were approximately 59 million shares of common stock issued and outstanding as of December 31, 2011.
Conference Call
Thursday, March 1, 2012 @ 10:30 a.m. Eastern/7:30 a.m. Pacific | ||||
Domestic: | (877) 837-3910, Conference ID# 50311145 | |||
International: |
(973) 796-5077, Conference ID# 50311145 |
On the conference call, management will review the financial results, provide an update on the Companys business and discuss expectations for the future.
Key Catalysts For 2012
FUSILEV®
| Continue to gain market share and grow revenue; and, |
| Initiate additional clinical studies to expand indications. |
11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405
www.sppirx.com NASDAQ: SPPI
ZEVALIN®
| Execute worldwide commercial strategy; |
| Initiate enrollment in the ZEST clinical study in Diffuse Large B-Cell Lymphoma; and, |
| Expand the ZAR head-to-head study vs. rituximab maintenance in follicular non-Hodgkin lymphoma. |
Apaziquone
| Results of pivotal registrational clinical trial, and |
| File NDA. |
Belinostat
| Results of pivotal registrational clinical trial, and |
| File NDA. |
Robust Pipeline
| Initiate a Phase 2 study for SPI-1620 |
| Initiate a Phase 2 study for SPI-2012 |
| Initiate a Phase I study for SPI-014 (f/k/a Renazorb) |
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® (levoleucovorin) for Injection and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, apaziquone and belinostat, in late stage development with a goal of filing New Drug Applications (NDAs) with the U.S. Food & Drug Administration in 2012. The Company also has a diversified pipeline of novel drug candidates. The Companys strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Companys website at www.sppirx.com.
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 managements current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrums 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 may not receive approval, and other regulatory agencies 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 dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Companys 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.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405
www.sppirx.com NASDAQ: SPPI
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 Companys on-going core operating performance.
Management uses non-GAAP net income (loss) in its evaluation of the Companys 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 Companys 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 Companys 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.
11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405
www.sppirx.com NASDAQ: SPPI
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Reconciliation of Non-GAAP Adjustments
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended December 31, 2011 |
Three Months Ended December 31, 2010 |
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GAAP | Non-GAAP Adjustments |
Non-GAAP | GAAP | Non-GAAP Adjustments |
Non-GAAP | |||||||||||||||||||
Revenues: |
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Product sales, net |
$ | 49,904 | $ | | $ | 49,904 | $ | 30,871 | $ | | $ | 30,871 | ||||||||||||
License and contract revenue |
3,075 | | 3,075 | 3,075 | | 3,075 | ||||||||||||||||||
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Total revenues |
$ | 52,979 | $ | | $ | 52,979 | $ | 33,946 | $ | | $ | 33,946 | ||||||||||||
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Operating costs and expenses: |
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Cost of product sales (excludes amortization of purchased intangible assets) |
10,283 | 10,283 | 6,813 | | 6,813 | |||||||||||||||||||
Selling, general and administrative |
25,292 | (6,572 | )(1) | 18,720 | 12,475 | (1,645 | )(1) | 10,830 | ||||||||||||||||
Research and development |
6,816 | (449 | )(1) | 6,367 | 6,986 | (373 | )(1) | 6,613 | ||||||||||||||||
Amortization of purchased intangibles |
930 | | 930 | 930 | | 930 | ||||||||||||||||||
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Total operating costs and expenses |
43,321 | (7,021 | ) | 36,300 | 27,204 | (2,018 | ) | 25,186 | ||||||||||||||||
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Income (loss) from operations |
9,658 | 7,021 | 16,679 | 6,742 | 2,018 | 8,760 | ||||||||||||||||||
Change in fair value of common stock warrant liability |
| | | (3,300 | ) | 3,300 | (2) | | ||||||||||||||||
Other income, net |
27 | | 27 | 1,034 | | 1,034 | ||||||||||||||||||
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Income (loss) before provision for income taxes |
9,685 | 7,021 | 16,706 | 4,476 | 5,318 | 9,794 | ||||||||||||||||||
(Provision) benefit for income taxes |
(1,404 | ) | | (1,404 | ) | (36 | ) | | (36 | ) | ||||||||||||||
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Net income (loss) |
$ | 8,281 | $ | 7,021 | $ | 15,302 | $ | 4,440 | $ | 5,318 | $ | 9,758 | ||||||||||||
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Net income (loss) per share: |
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Basic |
$ | 0.15 | $ | 0.27 | $ | 0.09 | $ | 0.19 | ||||||||||||||||
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Diluted |
$ | 0.13 | $ | 0.24 | $ | 0.08 | $ | 0.19 | ||||||||||||||||
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Weighted average shares outstanding: |
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Basic |
56,916,064 | 56,916,064 | 50,344,177 | 50,344,177 | ||||||||||||||||||||
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Diluted |
63,313,226 | 63,313,226 | 52,268,739 | 52,268,739 | ||||||||||||||||||||
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(1) | Adjustment for stock-based compensation expense recognized in the period |
(2) | Add back the change in fair value of common stock warrant liability |
11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405
www.sppirx.com NASDAQ: SPPI
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Reconciliation of Non-GAAP Adjustments
(In thousands, except share and per share data)
(Unaudited)
Twelve Months Ended December 31, 2011 |
Twelve Months Ended December 31, 2010 |
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GAAP | Non-GAAP Adjustments |
Non-GAAP | GAAP | Non-GAAP Adjustments |
Non-GAAP | |||||||||||||||||||
Revenues: |
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Product sales, net |
$ | 180,663 | $ | | $ | 180,663 | $ | 60,921 | $ | | $ | 60,921 | ||||||||||||
License and contract revenue |
12,300 | | 12,300 | 13,192 | | 13,192 | ||||||||||||||||||
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Total revenues |
$ | 192,963 | $ | | $ | 192,963 | $ | 74,113 | $ | | $ | 74,113 | ||||||||||||
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Operating costs and expenses: |
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Cost of product sales (excludes amortization of purchased intangible assets) |
33,838 | | 33,838 | 17,439 | | 17,439 | ||||||||||||||||||
Selling, general and administrative |
72,553 | (20,609 | )(1) | 51,944 | 48,550 | (5,801 | )(1) | 42,749 | ||||||||||||||||
Research and development |
27,720 | (1,628 | )(1) | 26,092 | 57,301 | (2,484 | )(1) | 54,817 | ||||||||||||||||
Amortization of purchased intangibles |
3,720 | | 3,720 | 3,720 | | 3,720 | ||||||||||||||||||
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Total operating costs and expenses |
137,831 | (22,237 | ) | 115,594 | 127,010 | (8,285 | ) | 118,725 | ||||||||||||||||
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Income (loss) from operations |
55,132 | 22,237 | 77,369 | (52,897 | ) | 8,285 | (44,612 | ) | ||||||||||||||||
Change in fair value of common stock warrant liability |
(3,488 | ) | 3,488 | (2) | | 2,731 | (2,731 | )(2) | | |||||||||||||||
Other income, net |
577 | | 577 | 1,279 | | 1,279 | ||||||||||||||||||
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Income (loss) before provision for income taxes |
52,221 | 25,725 | 77,946 | (48,887 | ) | 5,554 | (43,333 | ) | ||||||||||||||||
(Provision) benefit for income taxes |
(3,704 | ) | (1,896 | ) | (5,600 | ) | 43 | | 43 | |||||||||||||||
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Net income (loss) |
$ | 48,517 | $ | 23,829 | $ | 72,346 | $ | (48,844 | ) | $ | 5,554 | $ | (43,290 | ) | ||||||||||
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Net income (loss) per share: |
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Basic |
$ | 0.91 | $ | 1.36 | $ | (0.99 | ) | $ | (0.87 | ) | ||||||||||||||
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Diluted |
$ | 0.84 | $ | 1.25 | $ | (0.99 | ) | $ | (0.87 | ) | ||||||||||||||
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Weighted average shares outstanding: |
||||||||||||||||||||||||
Basic |
53,272,767 | 53,272,767 | 49,502,854 | 49,502,854 | ||||||||||||||||||||
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Diluted |
57,959,714 | 57,959,714 | 49,502,854 | 49,502,854 | ||||||||||||||||||||
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(1) | Adjustment for stock-based compensation expense recognized in the period |
(2) | Add back the change in fair value of common stock warrant liability |
11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405
www.sppirx.com NASDAQ: SPPI
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
SUMMARY CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
December 31, 2011 |
December 31, 2010 |
|||||||
Cash and equivalents |
121,202 | 53,557 | ||||||
Marketable securities |
40,060 | 42,117 | ||||||
Accounts receivable, net |
51,703 | 21,051 | ||||||
Inventories, net |
10,762 | 4,234 | ||||||
Prepaid expenses and other current assets |
2,074 | 906 | ||||||
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Total current assets |
225,801 | 121,865 | ||||||
Investments |
9,283 | 8,569 | ||||||
Property and equipment, net |
2,681 | 3,158 | ||||||
Intangible assets, net |
41,654 | 29,605 | ||||||
Other assets |
1,361 | 434 | ||||||
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Total Assets |
$ | 280,780 | $ | 163,631 | ||||
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Current liabilities |
$ | 78,537 | $ | 63,322 | ||||
Deferred revenue and other credits less current portion |
14,029 | 25,495 | ||||||
Other long-term liabilities |
307 | 338 | ||||||
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Total liabilities |
92,873 | 89,155 | ||||||
Total stockholders equity |
187,907 | 74,476 | ||||||
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Total liabilities and stockholders equity |
$ | 280,780 | $ | 163,631 | ||||
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11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405
www.sppirx.com NASDAQ: SPPI
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