SPPI Spectrum Pharmaceuticals Inc.

3.43
-0.26  -7%
Previous Close 3.69
Open 3.75
52 Week Low 1.7422
52 Week High 10.57
Market Cap $399,486,859
Shares 116,468,472
Float 81,793,297
Enterprise Value $255,681,661
Volume 1,206,317
Av. Daily Volume 1,365,362
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Upcoming Catalysts

Drug Stage Catalyst Date
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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SPI-2012 (ROLONTIS)
Chemotherapy-Induced Neutropenia
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
Belinostat
Peripheral T-Cell Lymphoma cancer
Approved
Approved
Approved July 7, 2014.
QAPZOLA - Apaziquone
Bladder cancer
Phase 3
Phase 3
Failed to meet primary endpoint in Phase 3 trial - Apr 2012. PDUFA date December 11 2016. Advisory Committee Meeting September 14 2016 voted 14 - 0 against approval. CRL issued November 17, 2016. New Phase 3 trial initiation announced August 14, 2017.
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, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced preclinical data evaluating the administration of ROLONTIS® (eflapegrastim) on the same day as chemotherapy. The duration of neutropenia in a rat model of chemotherapy induced neutropenia (CIN) was observed to be significantly shorter with eflapegrastim versus pegfilgrastim, regardless of the timing of administration: concomitantly or on the same day post-chemotherapy at 2, 5 or 24 hours post-chemotherapy.

    The poster titled "Chemotherapy induced neutropenia in rats following administration of eflapegrastim or pegfilgrastim on the same day at three different time points and at 24 hours post-chemotherapy…

    Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced preclinical data evaluating the administration of ROLONTIS® (eflapegrastim) on the same day as chemotherapy. The duration of neutropenia in a rat model of chemotherapy induced neutropenia (CIN) was observed to be significantly shorter with eflapegrastim versus pegfilgrastim, regardless of the timing of administration: concomitantly or on the same day post-chemotherapy at 2, 5 or 24 hours post-chemotherapy.

    The poster titled "Chemotherapy induced neutropenia in rats following administration of eflapegrastim or pegfilgrastim on the same day at three different time points and at 24 hours post-chemotherapy" was part of today's Special Populations, Survivorship, Outcomes, and Supportive Care session at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. ROLONTIS is an investigational drug not approved by the U.S. Food and Drug Administration (FDA) and the BLA (Biologics License Application) is currently under active review by the agency for the treatment of chemotherapy induced neutropenia with a PDUFA date of October 24, 2020.

    "These data in rats suggest that eflapegrastim administered at the time of chemotherapy, rather than waiting 24 hours, may be able to provide prophylaxis against chemotherapy induced neutropenia," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "Based on these preclinical results, we recently initiated a Phase 1 clinical trial to compare the effect of same day dosing of eflapegrastim on the duration of neutropenia in patients with early-stage breast cancer when administered on the same day, at varying intervals following docetaxel and cyclophosphamide chemotherapy."

    The poster is available on the company's website at: https://investor.sppirx.com/index.php/events-and-presentations.

    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 Spectrum's business and its future, including the company's ability to advance development of its late-stage pipeline assets and such assets' ability to serve areas of unmet need; the potential for same-day dosing of ROLONTIS® to provide prophylaxis against CIN in humans; the timing and results of FDA approvals; the future potential of Spectrum'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 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 the possibility that Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that same-day dosing of ROLONTIS® in humans does not provide prophylaxis against CIN, 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. 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

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  2. Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation of the results for preclinical studies evaluating the administration of ROLONTIS on the same day as chemotherapy in a rodent model. The abstract titled "Chemotherapy induced neutropenia in rats following administration of eflapegrastim or pegfilgrastim on the same day at three different timepoints and at 24 hours post-chemotherapy" will be part of the Special Populations, Survivorship, Outcomes, and Supportive Care session at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, to be held June 22-24, 2020. Full details of the poster are as follows:

    Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation of the results for preclinical studies evaluating the administration of ROLONTIS on the same day as chemotherapy in a rodent model. The abstract titled "Chemotherapy induced neutropenia in rats following administration of eflapegrastim or pegfilgrastim on the same day at three different timepoints and at 24 hours post-chemotherapy" will be part of the Special Populations, Survivorship, Outcomes, and Supportive Care session at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, to be held June 22-24, 2020. Full details of the poster are as follows:

    Abstract Title: Chemotherapy induced neutropenia in rats following administration of eflapegrastim or pegfilgrastim on the same day at three different timepoints and at 24 hours post-chemotherapy

    Authors: Yu-Yon Kim., et al.

    Session: Special Populations, Survivorship, Outcomes, and Supportive Care

    Date and Time: June 22, 2020, 9 a.m. - 6 p.m. EDT

    Poster Number: 2044 / 22

    Location:
    Access to the AACR Virtual Annual Meeting II will be free to everyone. While access will be free, attendees will be required to register to view the meeting. Registration for the meeting is available through the myAACR portal.

    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.

    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

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  3. Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that Lyndah K. Dreiling, M.D., MBA, has been named Senior Vice President, Clinical Development.

    "We are excited to welcome Dr. Lyndah Dreiling, a proven world-class leader with broad expertise in drug development and a track record of success," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "Her depth of experience in hematology and oncology drug development from preclinical to Phase 1-4 studies will be highly valuable as we approach our PDUFA date for ROLONTIS®, continue to execute our updated poziotinib development strategy, and further advance our emerging pipeline…

    Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that Lyndah K. Dreiling, M.D., MBA, has been named Senior Vice President, Clinical Development.

    "We are excited to welcome Dr. Lyndah Dreiling, a proven world-class leader with broad expertise in drug development and a track record of success," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "Her depth of experience in hematology and oncology drug development from preclinical to Phase 1-4 studies will be highly valuable as we approach our PDUFA date for ROLONTIS®, continue to execute our updated poziotinib development strategy, and further advance our emerging pipeline."

    Dr. Dreiling brings 25 years of experience in hematology and oncology drug development, most recently serving as Vice President, Head of Clinical Development at Five Prime Therapeutics. Prior to that, Dr. Dreiling served as Senior Director, Clinical Research Oncology at Gilead Sciences from October 2013 through November 2017, where she was the project leader for Zydelig® (idelalisib) that received U.S. and EMA regulatory approvals in 2014 for relapsed chronic lymphocytic leukemia (CLL) and follicular lymphoma. Prior to Gilead, Dr. Dreiling spent 10 years at Amgen, in roles of increasing responsibility in the hematology and oncology division, with her latest role as Vice President Global Development, Hematology/Oncology. She has also served as an Associate Director, Gene Therapy Clinical Research for Aventis Pharmaceuticals, formerly Gencell, a division of Rhone-Poulenc Rorer.

    Dr. Dreiling holds a B.S. in business administration and an MBA from the University of Colorado, a B.A in biology from the University of Denver, and an M.D. from the University of Colorado Health Sciences.

    In connection with Dr. Dreiling's employment, the Compensation Committee of the Board of Directors of the company granted to Dr. Dreiling a restricted stock award of 80,000 shares of the company's common stock. The restricted stock award has a value equal to $2.94, the closing price of the company's common stock as quoted on The NASDAQ Stock Market on the day preceding the grant date. The shares of restricted stock vest over the course of three years, with one-third of the shares of restricted stock vesting on each anniversary of the grant date from the first anniversary of the grant date until the third anniversary of the grant date. The shares of restricted stock are subject to the terms and conditions of the company's 2018 Long-Term Incentive Plan and were granted as a material inducement to Dr. Dreiling's acceptance of employment with the company in accordance with NASDAQ Listing Rule 5635(c)(4).

    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, the potential impact of Dr. Dreiling's future contributions to Spectrum's business, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the value of such pipeline and its ability to transform the company in the near future, 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 impact of the COVID-19 pandemic on Spectrum's business, a change to the PDUFA date for ROLONTIS®, 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.® 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

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  4. BLA for ROLONTIS® (eflapegrastim) under active FDA review - PDUFA date on October 24, 2020

    ROLONTIS same day dosing study initiated

    Updated Poziotinib strategy implemented to include new dosing regimens

    Poziotinib ZENITH20 Cohort 3 fully enrolled

    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 March 31, 2020.

    "The progress in our development pipeline speaks to the investigator interest and the commitment of our team during these unprecedented times," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals…

    BLA for ROLONTIS® (eflapegrastim) under active FDA review - PDUFA date on October 24, 2020

    ROLONTIS same day dosing study initiated

    Updated Poziotinib strategy implemented to include new dosing regimens

    Poziotinib ZENITH20 Cohort 3 fully enrolled

    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 March 31, 2020.

    "The progress in our development pipeline speaks to the investigator interest and the commitment of our team during these unprecedented times," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "The PDUFA date for ROLONTIS remains October 24, 2020 and our updated poziotinib strategy is well under way. We continue to drive the business forward and remain focused on achieving our milestones this year."

    Pipeline Updates

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

    • FDA is actively reviewing the BLA for ROLONTIS for the treatment of chemotherapy-induced neutropenia. The PDUFA target action date for the ROLONTIS BLA is October 24, 2020.
    • Company-sponsored study evaluating the administration of ROLONTIS on the same day as chemotherapy, dosed its first patient. The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer.

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

    • Spectrum presented additional results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations at a plenary session of the virtual American Association for Cancer Research annual meeting on April 27, 2020. The podium presentation included additional safety and efficacy data. Although the results for Cohort 1 did not meet the primary endpoint, as previously announced, poziotinib demonstrated a 68.7% disease control rate.
    • Spectrum provided an update on its ZENITH20 trial evaluating poziotinib in NSCLC patients with EGFR and HER2 exon 20 insertion mutations. The protocol has been amended to explore additional dosing regimens and the earlier use of corticosteroids in an effort to increase drug compliance.
    • Cohort 2 of the ZENITH20 trial enrolling previously treated HER2 NSCLC patients is fully accrued as previously announced and is expected to have topline results released in mid-2020. Cohort 3 of the ZENITH20 trial enrolling first-line EGFR NSCLC patients is now fully enrolled and is expected to have topline results in the second half of 2020. Either cohort has the potential to support a future NDA submission.

    Three-Month Period Ended March 31, 2020 (All numbers are from Continuing Operations and are approximate)

    GAAP Results

    Spectrum recorded a net loss of $40.6 million, or $0.36 loss per basic and diluted share, in the three-month period ended March 31, 2020, compared to net loss of $39.8 million, or $0.36 loss per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $16.0 million in the quarter, as compared to $21.9 million in the same period in 2019. Selling, general and administrative expenses were $14.8 million in the quarter, compared to $16.0 million in the same period in 2019.

    The company ended the quarter with cash, cash equivalents, and marketable securities of $177.8 million.

    Non-GAAP Results

    Spectrum recorded a non-GAAP net loss of $25.0 million, or $0.22 per basic and diluted share, in the three-month period ended March 31, 2020, compared to a non-GAAP net loss of $29.2 million, or $0.27 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $14.6 million, as compared to $20.4 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $10.8 million, as compared to $10.7 million in the same period in 2019.

    Conference Call and Webcast

    Spectrum's management will host a webcast and conference call today, May 7, 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#: 8470139. 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 company's ability to advance development of its late-stage pipeline assets and the potential of such assets to transform the company in the near future; the likelihood of the company achieving its milestones this year; the timing of the results of cohort 2 and cohort 3 in Spectrum's ZENITH20 study, and the potential of either cohort to support a future NDA submission; the timing and results of FDA decisions, including its approval of the ROLONTIS BLA; the ability of Spectrum's pipeline to serve areas of unmet medical need; the progression of the ROLONTIS and poziotinib development programs; 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 uncertainties inherent in new product development, including clinical trial results and additional analysis of existing pre-clinical and clinical data, 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 per share amounts)

    (Unaudited)

     

    Three Months Ended

    March 31,

     

    2020

     

     

    2019

     

    Revenues

    $

     

     

     

    $

     

     

    Operating costs and expenses:

     

     

     

    Selling, general and administrative

    14,794

     

     

     

    15,952

     

     

    Research and development

    15,993

     

     

     

    21,886

     

     

    Total operating costs and expenses

    30,787

     

     

     

    37,838

     

     

    Loss from continuing operations before other expense and income taxes

    (30,787

    )

     

     

    (37,838

    )

     

     

    Other (expense) income:

     

     

     

    Interest income, net

    704

     

     

     

    1,061

     

     

    Other expense, net

    (10,534

    )

     

     

    (11,285

    )

     

    Total other expense

    (9,830

    )

     

     

    (10,224

    )

     

    Loss from continuing operations before income taxes

    (40,617

    )

     

     

    (48,062

    )

     

    Benefit for income taxes from continuing operations

     

     

     

    8,216

     

     

    Loss from continuing operations

    $

    (40,617

    )

     

     

    $

    (39,846

    )

     

    Income from discontinued operations, net of income taxes

    45

     

     

     

    20,587

     

     

    Net loss

    $

    (40,572

    )

     

     

    $

    (19,259

    )

     

     

     

     

     

    Basic and diluted loss per share:

     

     

     

    Loss per common share from continuing operations

    $

    (0.36

    )

     

     

    $

    (0.36

    )

     

    Income per common share from discontinued operations

     

     

     

    0.19

     

     

    Net loss per common share

    $

    (0.36

    )

     

     

    $

    (0.18

    )

     

     

     

     

     

    Weighted average shares outstanding:

     

     

     

    Basic

    111,780,571

     

     

     

    109,552,602

     

     

    Diluted

    111,780,571

     

     

     

    109,552,602

     

     

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

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

    (Unaudited)

     

    March 31,

    2020

     

    December 31,

    2019

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    70,352

     

     

     

    $

    64,418

     

     

    Marketable securities

    107,441

     

     

     

    159,455

     

     

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

    435

     

     

     

    441

     

     

    Other receivables

    8,789

     

     

     

    9,558

     

     

    Prepaid expenses and other assets

    10,263

     

     

     

    10,148

     

     

    Total current assets

    197,280

     

     

     

    244,020

     

     

    Property and equipment, net of accumulated depreciation

    12,058

     

     

     

    11,607

     

     

    Other assets

    3,187

     

     

     

    4,000

     

     

    Facility and equipment under lease

    3,467

     

     

     

    3,806

     

     

    Total assets

    $

    215,992

     

     

     

    $

    263,433

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    49,130

     

     

     

    $

    54,284

     

     

    Accrued payroll and benefits

    4,568

     

     

     

    7,686

     

     

    Total current liabilities

    53,698

     

     

     

    61,970

     

     

    Other long-term liabilities

    8,526

     

     

     

    11,070

     

     

    Total liabilities

    62,224

     

     

     

    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; 114,774,079 and 113,299,612 issued and outstanding at March 31, 2020 and December 31, 2019, respectively

    114

     

     

     

    113

     

     

    Additional paid-in capital

    923,480

     

     

     

    918,205

     

     

    Accumulated other comprehensive loss

    (4,827

    )

     

     

    (3,498

    )

     

    Accumulated deficit

    (764,999

    )

     

     

    (724,427

    )

     

    Total stockholders' equity

    153,768

     

     

     

    190,393

     

     

    Total liabilities and stockholders' equity

    $

    215,992

     

     

     

    $

    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

    March 31,

     

     

    2020

     

     

    2019

     

    (1)

    GAAP selling, general and administrative

    $

    14,794

     

     

     

    $

    15,952

     

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

    Stock-based compensation expense

    (3,878

    )

     

     

    (3,450

    )

     

     

    Depreciation expense

    (106

    )

     

     

    (66

    )

     

     

    Lease expense

    9

     

     

     

    (129

    )

     

     

    Severance expense

     

     

     

    (1,641

    )

     

     

    Non-GAAP selling, general and administrative

    $

    10,819

     

     

     

    $

    10,666

     

     

    (2)

    GAAP research and development

    $

    15,993

     

     

     

    $

    21,886

     

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

    Stock-based compensation expense

    (1,398

    )

     

     

    (908

    )

     

     

    Depreciation expense

    (33

    )

     

     

    (2

    )

     

     

    Severance expense

     

     

     

    (547

    )

     

     

    Non-GAAP research and development

    $

    14,562

     

     

     

    $

    20,429

     

     

    (3)

    GAAP net loss from continuing operations

    $

    (40,617

    )

     

     

    $

    (39,846

    )

     

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

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

    5,406

     

     

     

    6,743

     

     

     

    Adjustments to other expense

    10,249

     

     

     

    12,140

     

     

     

    Adjustments to benefit for income taxes

     

     

     

    (8,216

    )

     

     

    Non-GAAP net loss from continuing operations

    $

    (24,962

    )

     

     

    $

    (29,179

    )

     

    (4)

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

    $

    (0.36

    )

     

     

    $

    (0.36

    )

     

     

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

    $

    (0.22

    )

     

     

    $

    (0.27

    )

     

     

     

     

     

     

     

    Weighted average shares outstanding:

     

     

     

     

    Basic

    111,780,571

     

     

    109,552,602

     

     

    Diluted

    111,780,571

     

     

    109,552,602

     

    (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. 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); and (iii) reversal of the mark-to-market adjustment (non-cash) on our equity securities 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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  5. 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 first quarter 2020 financial results and provide a corporate update on Thursday, May 7, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Thursday, May 7, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic: (877) 837-3910, Conference ID# 8470139

    International: (973) 796-5077, Conference ID# 8470139

    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

    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 first quarter 2020 financial results and provide a corporate update on Thursday, May 7, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Thursday, May 7, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic: (877) 837-3910, Conference ID# 8470139

    International: (973) 796-5077, Conference ID# 8470139

    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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