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8-K - FORM 8-K - SPECTRUM PHARMACEUTICALS INCd381778d8k.htm
EX-3.2 - EX-3.2 - SPECTRUM PHARMACEUTICALS INCd381778dex32.htm

Exhibit 99.1

 

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COMPANY CONTACTS

Shiv Kapoor

Vice President, Strategic Planning & Investor Relations

702-835-6300

InvestorRelations@sppirx.com

Spectrum Pharmaceuticals Reports Record Revenues and Strong Profits for Second Quarter; Revenues of $68.7 Million up 51.5% over Last Year and Strong non-GAAP EPS of $0.37, up 48% over Last Year

 

   

Financial Highlights

 

   

$278.5 Million in Cash, Investments and Receivables as of June 30, 2012 — After Cash Payment of $25.4 Million for Ex-US ZEVALIN Rights — As Compared with $253 Million in March 31, 2012.

 

   

Three- and Six-Month Total Revenues of $68.7 Million and $128.6 Million, Respectively, Compared to $45.4 Million and $89.0 Million in the Same Periods Last Year.

 

   

Non-GAAP EPS of $0.37 per Diluted Share Compared to $0.25 Per Diluted Share in the Second Quarter Last Year. GAAP EPS of $0.29 per Diluted Share Compared to $0.12 Per Diluted Share in the Second Quarter Last Year.

 

   

Product Highlights

 

   

Record FUSILEV Revenues of $56.6 Million Compared to $33.9 Million in the Second Quarter Last Year. Current Trends Indicate Strong Demand Should Continue.

 

   

Company Poised to Grow ZEVALIN through Global Expansion.

 

   

Planned Acquisition of Allos Therapeutics, Inc. Would Add FOLOTYN® to Commercial Portfolio.

 

   

Spectrum Has 10 Drugs in Clinical Development. Several Near-Term Catalysts including Clinical Data from Late-Stage Trials.

HENDERSON, Nevada – August 8, 2012 – Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today financial results for the three-month and six-month periods ended June, 2012.

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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“The second quarter was a historic period for Spectrum, during which we had record revenues and strong profits,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “These are exciting times at Spectrum, and we expect several key catalysts before the end of the year. Based on our current product portfolio, strong financial position, robust pipeline and active business development, we are in a formidable position to further grow our company over the next 5 years.”

Three-Month Period Ended June 30, 2012 (All numbers are approximate)

Consolidated revenue of $68.7 million was comprised of product sales of $65.6 million and $3.1 million from licensing fees. This represents a 51.5% increase from the $45.4 million in consolidated revenue, including product sales of $42.3 million, recorded in the three-month period ending June 30, 2011.

GAAP Results

The Company recorded net income of $18.1 million, or $0.31 per basic and $0.29 per diluted share in the three-month period ended June 30, 2012, compared to a net income of $7.2 million, or $0.14 per basic and $0.12 per diluted share in the comparable period in 2011. Total research and development expenses were $9.6 million in the quarter, as compared to $7.7 million in the same period in 2011. Selling, general and administrative expenses were $23.3 million in the quarter, compared to $18.7 million in the same period in 2011.

Non-GAAP Results

The Company recorded non-GAAP net income of $23.5 million, or $0.40 per basic share and $0.37 per diluted share in the three-month period ended June 30, 2012, compared to a net income of $14.5 million, or $0.28 per basic and $0.25 per diluted share in the comparable period in 2011. Non-GAAP research and development adjustments were $397,000, as compared to $495,000 in the same period of 2011. Non-GAAP selling, general and administrative adjustments were $5.9 million, as compared to $6.3 million in the same period in 2011.

During the three-month period ended June 30, 2012, net cash provided by operations was approximately $18.0 million. Cash, equivalents, investments and receivables as of June 30, 2012 aggregated $279 million, as compared to $253 million as of March 31, 2011.

There were approximately 59.8 million shares of common stock issued and outstanding as of June 30, 2012.

Six-Month Period Ended June 30, 2012 (All numbers are approximate)

The Company recorded net income of $64.6 million, or $1.10 per basic and $1.01 per diluted share, compared to income of $20.0 million, or $0.39 per basic and $0.35 per diluted share, in the six-month period ended June 30, 2011. Consolidated revenue of $128.6 million was comprised of product sales of $122.4 million and $6.2 million from licensing fees. This represents a 44.5% increase from $89.0 million in consolidated revenue recorded in the first six months of 2011, comprised of product sales of $82.8 million and $6.2 million from licensing fees. Total research and development expenses were $18.5 million, as compared to $13.5 million in the same period of 2011. Selling, general and administrative expenses were $41.6 million, compared to $31.5 million in the same period in 2011.

 

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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Conference Call

 

Wednesday, August 8, 2012 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
    Domestic:    (877) 837-3910, Conference ID# 14285827
    International:    (973) 796-5077, Conference ID# 14285827

For interested individuals unable to join the call, a replay will be available from August 8, 2012 @ 4:30 p.m. ET/1:30 p.m. PT through August 22, 2012 until 11:59 p.m. ET/8:59 p.m. PT.

 

Domestic Replay Dial-In #:

   (855) 859-2056, Conference ID# 14285827
International Replay Dial-In #:    (404) 537-3406, Conference ID# 14285827

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on August 8, 2012 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 Accomplishments for the First Half of 2012

FUSILEV® (levoleucovorin) for Injection

 

   

Continued revenue and market penetration.

 

   

Expanded manufacturing capacity assures reliable supply to meet increasing demand.

ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use

 

   

Commenced ex-US operations. Outside U.S., incidence and prevalence of follicular NHL is higher than in the U.S., and research interest is strong, with presence at major ex-U.S. medical conferences.

 

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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Recent key data presentations have included:

 

   

Phase 2 data reported at the ASCO meeting suggested reduced need for standard chemotherapy when given in combination with ZEVALIN to patients with more advanced stage III/IV CD20+ diffuse large B-cell lymphoma (DLBCL).

 

   

Phase 2 data presented at the European Hematology Association meeting demonstrated 2-year overall survival rate of 91% for ZEVALIN plus high dose chemotherapy (Z-BEAM), vs. 61% for chemotherapy, i.e. BEAM, alone.

 

   

As part of a broad clinical program for ZEVALIN, Spectrum initiated a Phase 2 trial in rituximab-refractory low-grade or follicular B-cell non-Hodgkin’s lymphoma using ZEVALIN as part of a motexafin gadolinium combination regimen.

Earlier-stage Development Pipeline

 

   

Initiated a Phase 2 study for lucanthone in primary Glioblastoma Multiforme (GBM).

 

   

Initiated a Phase 1 study for RenaZorb® (also referred to as SPI-014).

Potential Catalysts for the Second Half of 2012

FUSILEV®

 

   

Continue to expand market penetration.

ZEVALIN®

 

   

Grow ZEVALIN sales through worldwide expansion.

 

   

Report early results from investigator-initiated study comparing ZEVALIN with rituximab maintenance in NHL (“ZAR” study).

 

   

Commence pivotal “ZEST” study assessing 2-year overall survival and progression-free survival in DLBCL patients 60 years and older.

 

   

Expand head-to-head study of a single ZEVALIN vs. rituximab maintenance in follicular non-Hodgkin’s lymphoma (“RoZetta” study).

Late-stage Drug Candidates

 

   

Belinostat: Topline data expected in Q4 from pivotal trial in relapsed refractory peripheral T-cell lymphoma (PTCL).

 

   

Apaziquone: Expect to meet with the FDA in Q4.

 

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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Earlier-stage Development Pipeline

 

   

Report topline clinical data from Renazorb®.

 

   

Initiate a Phase 2 study for SPI-1620.

 

   

Initiate a Phase 2 study for SPI-2012.

Business Development

 

   

Anticipate Closing Allos Therapeutics, Inc. Acquisition.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum currently markets two oncology drugs — FUSILEV® (levoleucovorin) for Injection in the U.S. and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum’s strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

About Allos Therapeutics, Inc.

Allos Therapeutics is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN® (pralatrexate injection), a folate analog metabolic inhibitor. FOLOTYN is approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. Allos is also developing FOLOTYN in other hematologic malignancies and solid tumors. Allos is headquartered in Westminster, Colorado. For more information, please visit Allos’ website at www.allos.com.

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 the United States by Pfizer, Sanofi-Aventis, and Takeda.

 

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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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 Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.

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.

About FOLOTYN®

FOLOTYN, (pralatrexate injection), a folate analogue metabolic inhibitor, was discovered by Memorial Sloan-Kettering Cancer Center, SRI International and Southern Research Institute and developed by Allos Therapeutics. In September 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. FOLOTYN has been available to patients in the U.S. since October 2009. An updated analysis of data from PROPEL, the pivotal study of FOLOTYN in patients with relapsed or refractory PTCL, was published in the March 20, 2011 issue of the Journal of Clinical Oncology. FOLOTYN has patent protection through 2017, potentially through July 2022, assuming a five-year patent term extension through the Hatch-Waxman Act. Please see full Prescribing Information for FOLOTYN at www.FOLOTYN.com.

 

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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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.

 

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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This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals and Allos Therapeutics that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. Such forward-looking statements include statements relating to the ability of the Spectrum Pharmaceuticals and Allos Therapeutics to complete the transactions contemplated by the Agreement and Plan of Merger dated as of April 4, 2012 (the “Merger Agreement”), including the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions set forth in the Merger Agreement, the possibility of any termination of the Merger Agreement, and, if the transaction is completed, the success and strategic fit of the proposed combination of Spectrum Pharmaceuticals and Allos Therapeutics. The forward-looking statements contained in this document are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Actual results may differ materially from current expectations because of risks associated with uncertainties as to the timing of the tender offer and the subsequent merger; uncertainties as to how many of Allos’ stockholders will tender their shares of common stock in the tender offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the offer or the merger may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the offer or the merger; and the risk that shareholder litigation in connection with the tender offer or the merger may result in significant costs of defense, indemnification and liability. The success and strategic fit of the combined entities will depend on Spectrum Pharmaceuticals’ and Allos Therapeutics’ ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, and to leverage the expertise of partners and employees around the world to assist us in the execution of our combined strategy.

Additional risks that could cause actual results to differ include, with respect to Spectrum Pharmaceuticals, the possibility that existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA or other regulatory agencies may not receive approval in a timely manner or at all, the possibility that existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum Pharmaceuticals’ lack of sustained revenue history, Spectrum Pharmaceuticals’ limited marketing experience, Spectrum Pharmaceuticals’ dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Spectrum Pharmaceuticals’ reports filed with the Securities and Exchange Commission, and with respect to Allos Therapeutics, uncertainties pertaining to the business of Allos Therapeutics, including those set forth in Allos Therapeutics’ reports filed with the Securities and Exchange Commission. Neither Spectrum Pharmaceuticals nor Allos Therapeutics 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.

The tender offer described herein commenced on April 13, 2012. This press release is neither an offer to purchase nor a solicitation of an offer to sell securities. Spectrum Pharmaceuticals caused its subsidiary, Sapphire Acquisition Sub, Inc., to file a tender offer statement on Schedule TO with the Securities and Exchange Commission. Investors and Allos stockholders are strongly advised, prior to making any decisions with respect to whether to tender their shares of Allos into the tender offer or, if necessary, vote their shares in favor of the adoption of the Merger Agreement, to read carefully the tender offer statement (including an offer to purchase, letter of transmittal and related tender offer documents) and the related solicitation/recommendation statement on Schedule 14D-9, and if applicable, a proxy statement regarding the merger, that Allos filed with the Securities and Exchange Commission, and any amendments to the foregoing, because they contain and will contain important information about the tender offer and the merger. These documents are and will be available at no charge on the Securities and Exchange Commission’s website at www.sec.gov. In addition, a copy of the tender offer statement will be made available free of charge to all stockholders of Allos who direct a request to Spectrum at www.sppirx.com, and a copy of the tender offer statement and the solicitation/recommendation statement will be made available free of charge to all stockholders of Allos Therapeutics, Inc. at www.allos.com or by contacting Allos Therapeutics Inc. at 11080 CirclePoint Road, Suite 200, Westminster, Colorado 80020 (303) 426-6262.

 

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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SPECTRUM PHARMACEUTICALS, INC®, ZEVALIN®, FUSILEV®, and RenaZorb® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Allos Therapeutics, Inc.® and FOLOTYN® are registered trademarks of Allos Therapeutics, Inc.

© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

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.

 

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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Condensed Consolidated Statements of Income and Reconciliation of Non-GAAP Adjustments

(In thousands, except share and per share data)

(Unaudited)

 

     Three Months Ended
June 30, 2012
    Three Months Ended
June 30, 2011
 
     GAAP     Non-GAAP
Adjustments
    Non-GAAP     GAAP     Non-GAAP
Adjustments
    Non-GAAP  

Revenues:

            

Product sales, net

   $ 65,627      $ —        $ 65,627      $ 42,287      $ —        $ 42,287   

License and contract revenue

     3,075        —          3,075        3,075        —          3,075   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

   $ 68,702      $ —        $ 68,702      $ 45,362      $ —        $ 45,362   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating costs and expenses:

            

Cost of product sales (excludes amortization of purchased intangible assets)

     11,574        —          11,574        8,130        —          8,130   

Selling, general and administrative

     23,347        (2,685 )(1)         
       (3,228 )(4)      17,434        18,699        (6,321 )(1)      12,378   

Research and development

     9,583        (397 )(1)      9,186        7,686        (495 )(1)      7,191   

Amortization of purchased intangibles

     1,636        (1,636 )(5)      —          930        (930 )(5)      —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs and expenses

     46,140        (7,946     38,194        35,445        (7,746     27,699   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income from operations

     22,562        7,946        30,508        9,917        7,746        17,663   

Change in fair value of common stock warrant liability

     —          —          —          (1,237     1,237 (2)      —     

Other income (expense), net

     (1,507     —          (1,507     174        —          174   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income before provision for income taxes

     21,055        7,946        29,001        8,854        8,983        17,837   

Provision for income taxes

     (2,985     (2,787     (5,772     (1,650     (1,725     (3,375
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 18,070      $ 5,159      $ 23,229      $ 7,204      $ 7,258      $ 14,462   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income per share:

            

Basic

   $ 0.31        $ 0.40      $ 0.14        $ 0.28   
  

 

 

     

 

 

   

 

 

     

 

 

 

Diluted

   $ 0.29        $ 0.37      $ 0.12        $ 0.25   
  

 

 

     

 

 

   

 

 

     

 

 

 

Weighted average shares outstanding:

            

Basic

     58,763,700          58,763,700        52,257,049          52,257,049   
  

 

 

     

 

 

   

 

 

     

 

 

 

Diluted

     63,387,003          63,387,003        58,265,264          58,265,264   
  

 

 

     

 

 

   

 

 

     

 

 

 

 

(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 one-time payment related to co-development agreement
(4) Add back the legal and professional fees related to the Allos tender offer and the Bayer agreement licensing rights to market Zevalin outside the U.S.
(5) Add back amortization of certain acquired intangible assets related to business combinations

 

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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Condensed Consolidated Statements of Income and Reconciliation of Non-GAAP Adjustments

(In thousands, except share and per share data)

(Unaudited)

 

     Six Months Ended
June 30, 2012
    Six Months Ended
June 30, 2011
 
     GAAP     Non-GAAP
Adjustments
    Non-GAAP     GAAP     Non-GAAP
Adjustments
    Non-GAAP  

Revenues:

            

Product sales, net

   $ 122,411      $ —        $ 122,411      $ 82,810      $ —        $ 82,810   

License and contract revenue

     6,150        —          6,150        6,150        —          6,150   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

   $ 128,561      $ —        $ 128,561      $ 88,960      $ —        $ 88,960   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating costs and expenses:

            

Cost of product sales (excludes amortization of purchased intangible assets)

     20,247        —          20,247        14,710        —          14,710   

Selling, general and administrative

     41,609        (5,309 )(1)         
       (272 )(5)         
       (4,059 )(4)      31,969        31,450        (9,981 )(1)      21,469   

Research and development

     18,474        (788 )(1)         
       (1,000 )(3)      16,686        13,516        (899 )(1)      12,617   

Amortization of purchased intangibles

     2,566        (2,566 )(6)      —          1,860        (1,860 )(6)      —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs and expenses

     82,896        (13,994     68,902        61,536        (12,740     48,796   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income from operations

     45,665        13,994        59,659        27,424        12,740        40,164   

Change in fair value of common stock warrant liability

     —          —          —          (6,487     6,487 (2)      —     

Other income, net

     (1,369     —          (1,369     694        —          694   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income before provision for income taxes

     44,296        13,994        58,290        21,631        19,227        40,858   

Benefit (provision) for income taxes

     20,316        (28,472     (8,156     (1,650     (1,650     (3,300
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 64,612      $ (14,478   $ 50,134      $ 19,981      $ 17,577      $ 37,558   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income per share:

            

Basic

   $ 1.10        $ 0.86      $ 0.39        $ 0.72   
  

 

 

     

 

 

   

 

 

     

 

 

 

Diluted

   $ 1.01        $ 0.79      $ 0.35        $ 0.66   
  

 

 

     

 

 

   

 

 

     

 

 

 

Weighted average shares outstanding:

            

Basic

     58,617,530          58,617,530        51,814,122          51,814,122   
  

 

 

     

 

 

   

 

 

     

 

 

 

Diluted

     63,666,546          63,666,546        56,845,371          56,845,371   
  

 

 

     

 

 

   

 

 

     

 

 

 

 

(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 one-time payment related to co-development agreement
(4) Add back the legal and professional fees related to the Allos tender offer and the Bayer agreement licensing rights to market Zevalin outside the U.S.
(5) Add back the costs associated with a reduction in staff in Q1
(6) Add back amortization of certain acquired intangible assets related to business combinations

 

11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405 www.sppirx.com NASDAQ: SPPI


LOGO

 

SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

SUMMARY CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

     June  30,
2012
     December  31,
2011
 

Cash and equivalents

     190,154         121,202   

Marketable securities

     3,550         40,060   

Accounts receivable, net

     84,839         51,703   

Inventories, net

     7,686         10,762   

Prepaid expenses and other current assets

     1,800         2,074   

Deferred tax asset

     10,532         —     
  

 

 

    

 

 

 

Total current assets

     298,561         225,801   

Investments

     —           9,283   

Property and equipment, net

     2,488         2,681   

Intangible assets, net

     60,327         41,654   

Goodwill

     2,389         —     

Deferred tax asset

     20,961         —     

Other assets

     2,846         1,361   
  

 

 

    

 

 

 

Total Assets

   $ 387,572       $ 280,780   
  

 

 

    

 

 

 

Current liabilities

   $ 116,025       $ 78,537   

Deferred revenue and other credits – less current portion

     8,329         14,029   

Other long-term liabilities

     467         307   
  

 

 

    

 

 

 

Total liabilities

     124,821         92,873   

Total stockholders’ equity

     262,751         187,907   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 387,572       $ 280,780   
  

 

 

    

 

 

 

 

11500 S. Eastern Ave., Ste. 240 Henderson, Nevada 89052 Tel: 702-835-6300 Fax: 702-260-7405 www.sppirx.com NASDAQ: SPPI