SPPI Spectrum Pharmaceuticals Inc.

4.78
+0.01  (+0%)
Previous Close 4.77
Open 4.76
52 Week Low 1.7422
52 Week High 10.57
Market Cap $697,508,145
Shares 145,922,206
Float 111,247,031
Enterprise Value $477,504,591
Volume 1,334,499
Av. Daily Volume 2,343,317
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Upcoming Catalysts

Drug Stage Catalyst Date
SPI-2012 (ROLONTIS)
Chemotherapy-Induced Neutropenia
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Poziotinib - Zenith20
Non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Belinostat
Peripheral T-Cell Lymphoma cancer
Approved
Approved
Approved July 7, 2014.
EVOMELA (melphalan) for Injection
Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
Approved
Approved
CRL October 23 2015. Approved March 15 2016.
FUSILEV
Colorectal cancer
Approved
Approved
CRL received October 9, 2009. Approved April 29, 2011.
ZEVALIN
Non-Hodgkin’s lymphoma
CRL
CRL
CRL received July 5, 2009.

Latest News

  1. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will present an overview of the company's business strategy and development-stage programs at two upcoming virtual investor conferences:

    • Stifel Virtual Healthcare Conference, Monday, November 16th, 2020 at 2:40 p.m. ET.
    • Jefferies London Healthcare Conference, Wednesday, November 18th, 2020 at 2:20 p.m. ET.

    A live webcast of the presentations will be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations with a replay available shortly after each event.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will present an overview of the company's business strategy and development-stage programs at two upcoming virtual investor conferences:

    • Stifel Virtual Healthcare Conference, Monday, November 16th, 2020 at 2:40 p.m. ET.
    • Jefferies London Healthcare Conference, Wednesday, November 18th, 2020 at 2:20 p.m. ET.

    A live webcast of the presentations will be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations with a replay available shortly after each event.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals please visit 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 management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum's business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, 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 Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval 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 dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

    SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

    View Full Article Hide Full Article
  2. FDA deferred action on the BLA for ROLONTIS® (eflapegrastim) due to inability to conduct inspection of the manufacturing facility citing COVID-19 related travel restrictions

    Pre-NDA meeting with FDA is scheduled for poziotinib in NSCLC HER2 exon-20 insertion mutations in previously treated patients

    Management to host webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT

    Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period ended September 30, 2020.

    "The third quarter was marked by significant progress in our drug development programs and a strengthened financial position," said Joe Turgeon, President…

    FDA deferred action on the BLA for ROLONTIS® (eflapegrastim) due to inability to conduct inspection of the manufacturing facility citing COVID-19 related travel restrictions

    Pre-NDA meeting with FDA is scheduled for poziotinib in NSCLC HER2 exon-20 insertion mutations in previously treated patients

    Management to host webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT

    Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period ended September 30, 2020.

    "The third quarter was marked by significant progress in our drug development programs and a strengthened financial position," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "Our team is preparing for the upcoming pre-NDA meeting with the FDA for poziotinib and actively working to obtain an approval for ROLONTIS as soon as possible."

    Pipeline Updates

    Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

    • Spectrum has a pre-NDA meeting with the FDA to review the positive results from Cohort 2 and the path forward for poziotinib registration for the treatment of patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations.
    • Spectrum presented the results from Cohort 2 at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September. This marked the first presentation to the medical and scientific community of the positive results from this registrational cohort from the ZENITH20 clinical trial.
    • Spectrum expects to provide poziotinib update, including dosing strategy and topline results from Cohort 3 of the ZENITH20 trial in first-line EGFR NSCLC patients, by year-end 2020.

    ROLONTIS (eflapegrastim), a novel long-acting G-CSF

    • The FDA deferred its action on the BLA for ROLONTIS, due to an inability to inspect the Hanmi Bioplant in South Korea citing travel restrictions related to the COVID-19 pandemic.
    • Spectrum has confirmed with the FDA that the deferral is not a Complete Response Letter (CRL). The company is actively working to find a way to expedite the plant inspection.

    Three-Month Period Ended September 30, 2020 (All numbers are from Continuing Operations and are approximate)

    GAAP Results

    Spectrum recorded a net loss of $48.5 million, or $0.37 loss per basic and diluted share, in the three-month period ended September 30, 2020, compared to a net loss of $26.6 million, or $0.24 loss per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $24.5 million in the quarter, as compared to $17.2 million in the same period in 2019. Selling, general and administrative expenses were $15.1 million in the quarter, compared to $13.1 million in the same period in 2019.

    The company ended the quarter with cash, cash equivalents, and marketable securities of $198.3 million.

    Non-GAAP Results

    Spectrum recorded a non-GAAP net loss of $35.2 million, or $0.27 loss per basic and diluted share, in the three-month period ended September 30, 2020, compared to a non-GAAP net loss of $24.5 million, or $0.22 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $23.3 million, as compared to $16.1 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $12.3 million, as compared to $9.9 million in the same period in 2019.

    Conference Call and Webcast

    Spectrum's management will host a webcast and conference call today, November 4, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 1281757. A live webcast of the call will be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations and will be archived there shortly after the live event.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals, please visit www.sppirx.com.

    About ZENITH20

    The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) have completed enrollment of previously treated NSCLC patients with exon 20 mutations. Cohort 3 (EGFR) has completed enrollment and Cohort 4 (HER2) is currently enrolling first-line NSCLC patients with exon 20 mutations. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.

    Notice Regarding Forward-Looking Statements

    Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Spectrum's business and its future, including the significance of Cohort 2's reported results; the outcome of the upcoming pre-NDA meeting with the FDA regarding poziotinib and the FDA's determination of a path forward for poziotinib; poziotinib's potential to significantly advance the treatment of NSCLC patients with HER2 exon 20 insertion mutations; the timing and results of future FDA decisions, including the timing of the FDA's inspection of the Hanmi Bioplant in South Korea and its action on the ROLONTIS BLA; the timing of the poziotinib update, including dosing strategy and topline results from Cohort 3; the overall progression of the poziotinib and ROLONTIS development programs; the company's ability to advance and fund the development and commercialization of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the future potential of the company's existing drug pipeline and its ability to transform the company in the near future; and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Spectrum and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Risks that could cause actual results to differ include, but are not limited to, the possibility that the different methodologies, assumptions and applications the company utilizes to assess particular safety or efficacy parameters may yield different statistical results, and even if the company believes the data collected from the clinical trials of its product candidates, including poziotinib, are positive, these data may not be sufficient to support approval by the FDA; the ongoing effects of the COVID-19 pandemic, including the duration of travel restrictions related thereto; the possibility that success in early clinical trials, especially if based on a small patient sample, might not result in success in later clinical trials, and other unforeseen events during clinical trials which could cause delays or other adverse consequences; other uncertainties inherent in new product development; the possibility that Spectrum's new and existing drug candidates, including ROLONTIS and poziotinib, may not ultimately prove to be safe or effective; the possibility that Spectrum's new and existing drug candidates, if approved, may not be more effective, safer, or more cost efficient than competing drugs; and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Spectrum in general, see the risk disclosures in the Annual Report on Form 10-K of Spectrum for the year ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Spectrum.

    SPECTRUM PHARMACEUTICALS, INC.® and ROLONTIS® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals' logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenues

    $

     

     

     

    $

     

     

     

    $

     

     

     

    $

     

     

    Operating costs and expenses:

     

     

     

     

     

     

     

    Selling, general and administrative

    15,116

     

     

     

    13,126

     

     

     

    44,654

     

     

     

    46,308

     

     

    Research and development

    24,453

     

     

     

    17,167

     

     

     

    62,192

     

     

     

    56,035

     

     

    Total operating costs and expenses

    39,569

     

     

     

    30,293

     

     

     

    106,846

     

     

     

    102,343

     

     

    Loss from continuing operations before other income (expense) and income taxes

    (39,569

    )

     

     

    (30,293

    )

     

     

    (106,846

    )

     

     

    (102,343

    )

     

    Other income (expense):

     

     

     

     

     

     

     

    Interest income, net

    188

     

     

     

    1,521

     

     

     

    1,217

     

     

     

    4,076

     

     

    Other income (expense), net

    (9,131

    )

     

     

    2,015

     

     

     

    (15,720

    )

     

     

    (5,547

    )

     

    Total other income (expense)

    (8,943

    )

     

     

    3,536

     

     

     

    (14,503

    )

     

     

    (1,471

    )

     

    Loss from continuing operations before income taxes

    (48,512

    )

     

     

    (26,757

    )

     

     

    (121,349

    )

     

     

    (103,814

    )

     

    (Provision) benefit for income taxes from continuing operations

    (6

    )

     

     

    200

     

     

     

    (15

    )

     

     

    8,628

     

     

    Loss from continuing operations

    $

    (48,518

    )

     

     

    $

    (26,557

    )

     

     

    $

    (121,364

    )

     

     

    $

    (95,186

    )

     

    Income from discontinued operations, net of income taxes

    66

     

     

     

    572

     

     

     

    255

     

     

     

    21,547

     

     

    Net loss

    $

    (48,452

    )

     

     

    $

    (25,985

    )

     

     

    $

    (121,109

    )

     

     

    $

    (73,639

    )

     

     

     

     

     

     

     

     

     

    Basic and diluted loss per share:

     

     

     

     

     

     

     

    Loss from continuing operations

    $

    (0.37

    )

     

     

    $

    (0.24

    )

     

     

    $

    (1.02

    )

     

     

    $

    (0.86

    )

     

    Income from discontinued operations

    $

    0.00

     

     

     

    $

    0.01

     

     

     

    $

    0.00

     

     

     

    $

    0.20

     

     

    Net loss per share, basic and diluted

    $

    (0.37

    )

     

     

    $

    (0.23

    )

     

     

    $

    (1.02

    )

     

     

    $

    (0.67

    )

     

    Weighted average shares outstanding, basic and diluted

    131,455,727

     

     

     

    111,178,880

     

     

     

    118,664,914

     

     

     

    110,291,090

     

     

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, expect per share and par value amounts)

    (Unaudited)

     

     

    September 30,

    2020

     

    December 31,

    2019

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    77,132

     

     

     

    $

    64,418

     

     

    Marketable securities

    121,179

     

     

     

    159,455

     

     

    Accounts receivable, net of allowance for credit losses of $43 and $43, respectively

    453

     

     

     

    441

     

     

    Other receivables

    3,186

     

     

     

    9,558

     

     

    Prepaid expenses and other current assets

    10,876

     

     

     

    10,148

     

     

    Total current assets

    212,826

     

     

     

    244,020

     

     

    Property and equipment, net

    18,456

     

     

     

    11,607

     

     

    Facility and equipment under lease

    2,662

     

     

     

    3,806

     

     

    Other assets

    3,994

     

     

     

    4,000

     

     

    Total assets

    $

    237,938

     

     

     

    $

    263,433

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    52,985

     

     

     

    $

    54,284

     

     

    Accrued payroll and benefits

    8,113

     

     

     

    7,686

     

     

    Total current liabilities

    61,098

     

     

     

    61,970

     

     

    Other long-term liabilities

    8,480

     

     

     

    11,070

     

     

    Total liabilities

    69,578

     

     

     

    73,040

     

     

    Commitments and contingencies

     

     

     

    Stockholders' equity:

     

     

     

    Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding

     

     

     

     

     

    Common stock, $0.001 par value; 300,000,000 shares authorized; 145,931,172 and 113,299,612 issued and outstanding at September 30, 2020 and December 31, 2019, respectively

    146

     

     

     

    113

     

     

    Additional paid-in capital

    1,016,474

     

     

     

    918,205

     

     

    Accumulated other comprehensive loss

    (2,724

    )

     

     

    (3,498

    )

     

    Accumulated deficit

    (845,536

    )

     

     

    (724,427

    )

     

    Total stockholders' equity

    168,360

     

     

     

    190,393

     

     

    Total liabilities and stockholders' equity

    $

    237,938

     

     

     

    $

    263,433

     

     

    Non-GAAP Financial Measures (from Continuing Operations)

    In this press release, Spectrum reports certain historical results that have not been prepared in accordance with generally accepted accounting principles (GAAP), including non-GAAP selling, general and administrative expenses, non-GAAP research and development expenses, non-GAAP net loss and non-GAAP net loss per share. Non-GAAP financial measures are reconciled to the most directly comparable GAAP financial measures 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 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 these non-GAAP financial measures are useful to investors in providing greater transparency to the information used by management in its operational decision-making. Management believes that the use of these non-GAAP financial measures also facilitates a comparison of the company's underlying operating performance with that of other companies in its industry, which use similar non-GAAP measures to supplement their GAAP 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. In addition, other companies, including other companies in our industry, may calculate non-GAAP financial measures differently than we do, limiting their usefulness as a comparative tool. Investors and potential investors are encouraged to review the reconciliation of our non-GAAP financial measures contained within this news release with our GAAP financial results.

    SPECTRUM PHARMACEUTICALS, INC.

    Reconciliation of Non-GAAP Adjustments for Condensed Consolidated Statements of Operations

    (In thousands, expect per share amounts)

     

     

     

    CONTINUING OPERATIONS ONLY

    Three Months Ended

    September 30,

     

    CONTINUING OPERATIONS ONLY

    Nine Months Ended

    September 30,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    (1)

    GAAP selling, general and administrative

    $

    15,116

     

     

     

    $

    13,126

     

     

     

    $

    44,654

     

     

     

    $

    46,308

     

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (3,018

    )

     

     

    (3,155

    )

     

     

    (9,773

    )

     

     

    (10,254

    )

     

     

    Depreciation expense

    144

     

     

     

    (58

    )

     

     

    (74

    )

     

     

    (180

    )

     

     

    Lease expense

    23

     

     

     

     

     

     

    47

     

     

     

    (129

    )

     

     

    Severance expense

     

     

     

     

     

     

     

     

     

    (1,515

    )

     

     

    Non-GAAP selling, general and administrative

    $

    12,265

     

     

     

    $

    9,913

     

     

     

    $

    34,854

     

     

     

    $

    34,230

     

     

    (2)

    GAAP research and development

    $

    24,453

     

     

     

    $

    17,167

     

     

     

    $

    62,192

     

     

     

    $

    56,035

     

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (1,090

    )

     

     

    (1,030

    )

     

     

    (3,598

    )

     

     

    (3,190

    )

     

     

    Depreciation expense

    (33

    )

     

     

    (30

    )

     

     

    (98

    )

     

     

    (45

    )

     

     

    Severance expense

     

     

     

     

     

     

     

     

     

    (260

    )

     

     

    R&D milestones and in-license upfront fees

     

     

     

     

     

     

     

     

     

    (2,751

    )

     

     

    Non-GAAP research and development

    $

    23,330

     

     

     

    $

    16,107

     

     

     

    $

    58,496

     

     

     

    $

    49,789

     

     

    (3)

    GAAP net loss from continuing operations

    $

    (48,518

    )

     

     

    $

    (26,557

    )

     

     

    $

    (121,364

    )

     

     

    $

    (95,186

    )

     

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

     

     

     

     

    Adjustments to SG&A and R&D, as noted above

    3,974

     

     

     

    4,273

     

     

     

    13,496

     

     

     

    18,324

     

     

     

    Adjustments to other (income) expense

    9,317

     

     

     

    (1,979

    )

     

     

    15,899

     

     

     

    6,449

     

     

     

    Adjustments to provision (benefit) for income taxes

    6

     

     

     

    (200

    )

     

     

    15

     

     

     

    (8,628

    )

     

     

    Non-GAAP net loss from continuing operations

    $

    (35,221

    )

     

     

    $

    (24,463

    )

     

     

    $

    (91,954

    )

     

     

    $

    (79,041

    )

     

    (4)

    GAAP net loss from continuing operations - per basic and diluted share

    $

    (0.37

    )

     

     

    $

    (0.24

    )

     

     

    $

    (1.02

    )

     

     

    $

    (0.86

    )

     

     

    Non-GAAP net loss from continuing operations - per basic and diluted share

    $

    (0.27

    )

     

     

    $

    (0.22

    )

     

     

    $

    (0.77

    )

     

     

    $

    (0.72

    )

     

     

    Weighted average shares outstanding, basic and diluted

    131,455,727

     

     

     

    111,178,880

     

     

     

    118,664,914

     

     

     

    110,291,090

     

     

    (1) Non-GAAP selling, general and administrative expenses (from continuing operations): These amounts reflect adjustments to reverse allocated operating expenses for certain non-cash items (including stock-based compensation, depreciation and lease expense), as well as the reversal of non-recurring severance expenses. We believe the resulting non-GAAP SG&A value is reflective of the period-over-period success of our administrative expense control and more indicative of our normalized SG&A expense trends.

    (2) Non-GAAP research and development expenses (from continuing operations): These amounts reflect adjustments to reverse allocated operating expenses for certain non-cash items (including stock-based compensation and depreciation), as well as the reversal of non-recurring severance expenses and R&D milestone achievements and in-license upfront fees that we record to this expense caption. We believe this resulting non-GAAP R&D value is more indicative of our normalized R&D expense trends.

    (3) Non-GAAP net loss (from continuing operations): These amounts reflect all non-GAAP adjustments described in (1) through (2) above, plus other non-cash and/or non-recurring items, including: (i) adjustments to reverse the impact of income taxes; (ii) reversal of foreign exchange gains and losses (non-cash); (iii) reversal of the mark-to-market adjustment (non-cash) on our equity securities holdings; and (iv) reversal of realized gain recorded on the sales of our equity holdings.

    (4) Non-GAAP net loss per share (from continuing operations): These amounts reflect all non-GAAP adjustments in (1) through (3) above to present our overall non-GAAP financial results for each period on a per-share basis.

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  3. Spectrum Pharmaceuticals (NASDAQ:SPPI) a biopharmaceutical company focused on novel and targeted oncology therapies, today announced it will host a conference call to discuss the third quarter 2020 financial results and provide a corporate update on Wednesday, November 4, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Wednesday, November 4, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 1281757

    International:

    (973) 796-5077, Conference ID# 1281757

    The conference call will also be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations and will be archived there shortly after the live event…

    Spectrum Pharmaceuticals (NASDAQ:SPPI) a biopharmaceutical company focused on novel and targeted oncology therapies, today announced it will host a conference call to discuss the third quarter 2020 financial results and provide a corporate update on Wednesday, November 4, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Wednesday, November 4, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 1281757

    International:

    (973) 796-5077, Conference ID# 1281757

    The conference call will also be available from the Investor Relations section of the company's website at http://investor.sppirx.com/events-and-presentations and will be archived there shortly after the live event.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals please visit 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 management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum's business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, 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 Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval 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 dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

    SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  4. Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that an inspection of the Hanmi Bioplant in South Korea is required before the FDA can approve the company's Biologics License Application (BLA) for ROLONTIS. The FDA was unable to conduct an inspection during the current review cycle due to restrictions on travel related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until an inspection can be completed. The company will continue to work actively with the FDA to define an approach for scheduling…

    Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that an inspection of the Hanmi Bioplant in South Korea is required before the FDA can approve the company's Biologics License Application (BLA) for ROLONTIS. The FDA was unable to conduct an inspection during the current review cycle due to restrictions on travel related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until an inspection can be completed. The company will continue to work actively with the FDA to define an approach for scheduling the required inspection. Spectrum has confirmed with the FDA that this is not a Complete Response Letter.

    "We are actively working with the FDA to find a way to expedite the plant inspection," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible."

    About ROLONTIS

    ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals, please visit www.sppirx.com.

    Notice Regarding Forward-Looking Statements — Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "seek," "look forward," "believe," "committed," "investigational," "pipeline," "launch," and similar terms, or by express or implied discussions relating to Spectrum's business and its future, including the timing and outcome of the FDA's inspection of the Hanmi Bioplant in South Korea, the FDA's ability to complete the inspection using alternative means, the overall likelihood of success and timing of the company's BLA for ROLONTIS, the future potential of Spectrum's existing drug pipeline, including ROLONTIS, and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Spectrum and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Risks that could cause actual results to differ include, but are not limited to, the possibility that Spectrum's existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

    SPECTRUM PHARMACEUTICALS, INC.® and ROLONTIS® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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  5. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented additional results from its pivotal Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). The on-demand mini oral session is part of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 Science Weekend being held September 19 – 21, 2020.

    "This is the first presentation to the medical and scientific community of the positive results from our registrational Cohort 2 from the ZENITH20 clinical trial," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented additional results from its pivotal Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2). The on-demand mini oral session is part of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 Science Weekend being held September 19 – 21, 2020.

    "This is the first presentation to the medical and scientific community of the positive results from our registrational Cohort 2 from the ZENITH20 clinical trial," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "There is no approved treatment for NSCLC patients with HER2 exon 20 insertion mutations, and we look forward to sharing this data with the FDA and discussing the path forward for poziotinib registration."

    The presentation titled "ZENITH20, a multinational, multi-cohort Phase 2 study of poziotinib in NSCLC patients with EGFR or HER2 Exon 20 mutations" is available to members of ESMO and can be accessed on the meeting website here: https://cslide.ctimeetingtech.com/esmo2020/attendee/confcal_1/session/list?q=poziotinib&r=st%7E12. A copy of the slides can also be found at: https://investor.sppirx.com/index.php/events-and-presentations.

    ZENITH20 Trial Design and Results for Cohort 2

    Cohort 2 of the ZENITH20 trial enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% CI, 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. The disease control rate (DCR) was 70% while tumor reduction occurred in 67 patients (74%), with median tumor reduction of 22%. The evaluable patient analysis (n=74) demonstrated a confirmed ORR of 35.1% (95% CI, 24.4% – 47.1%) with a disease control rate of 82.4%.

    The median duration of response was 5.1 months (range 1 to >12.3), with a median follow up of 8.3 months and the median progression free survival was 5.5 months (range 0 to >13.1). 13 patients (14%) had treatment-related serious adverse events and 11 patients (12%) permanently discontinued due to adverse events. Grade 3 treatment related rash was observed in 27 patients (30%) with diarrhea in 23 patients (26%). Stomatitis/mucosal inflammation Grades 3 and 4 occurred in 21 patients (23%). Dose interruptions were reported in 78 patients (87%), and dose reductions in 70 patients (78%), which was similar to the rates in Cohort 1.

    Cohort 2 was designed to be a registrational study. Based on these results, Spectrum has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and its plans for a New Drug Application (NDA) submission.

    The ZENITH20 trial is comprised of 7 independent cohorts. Cohorts 1 - 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 - 7 are exploratory. In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice-daily dosing regimens as well as lower single daily dosage. This amendment did not impact Cohorts 2 and 3 as these cohorts were fully enrolled. Top line results from Cohort 3 are expected by the end of the year.

    About Poziotinib

    Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

    About Spectrum Pharmaceuticals, Inc.

    Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals, please visit www.sppirx.com.

    Notice Regarding Forward-Looking Statements

    Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to the company's business and its future, including the significance of Cohort 2's reported results; the timing and outcome of a potential meeting with the FDA regarding poziotinib and the FDA's determination of a path forward for poziotinib; poziotinib's potential to significantly advance the treatment of NSCLC patients with HER2 exon 20 insertion mutations; the timing and result of future FDA approvals; the timing of the results of Cohort 3; the overall progression of the poziotinib development program; the company's ability to advance development of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the future potential of the company's existing drug pipeline; and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of the company and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Risks that could cause actual results to differ include the possibility that the different methodologies, assumptions and applications the company utilizes to assess particular safety or efficacy parameters may yield different statistical results, and even if the company believes the data collected from the clinical trials of its product candidates, including poziotinib, are positive, these data may not be sufficient to support approval by the FDA; the possibility that success in early clinical trials, especially if based on a small patient sample, might not result in success in later clinical trials, and other unforeseen events during clinical trials which could cause delays or other adverse consequences; the company's existing and new drug candidates, including poziotinib, may not prove safe or effective; the possibility that the company's existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all; the possibility that the company's existing and new drug candidates, including poziotinib, if approved, may not be more effective, safer or more cost efficient than competing drugs; the possibility that the company's efforts to acquire or in-license and develop additional drug candidates may fail; the company's dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the risk disclosures in the company's Annual Report on Form 10-K for the year ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by the company.

    SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

    © 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved

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