SPPI Spectrum Pharmaceuticals Inc.

3.44
-0.04  -1%
Previous Close 3.48
Open 3.48
52 Week Low 2.6799
52 Week High 5.24
Market Cap $535,653,511
Shares 155,713,230
Float 125,463,286
Enterprise Value $363,401,040
Volume 2,937,207
Av. Daily Volume 2,778,270
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ROLONTIS (eflapegrastim)
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
Non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2
NDA Filing
NDA Filing
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

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. Poziotinib NDA on track for 2021 submission

    New poziotinib twice daily dosing (BID) data presented at AACR demonstrated improved anti-tumor activity and better tolerance

    FDA pre-approval inspection at the ROLONTIS® manufacturing facility scheduled for May 2021

    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, 2021 and provided a corporate update.

    "Our top priority is submission of the NDA to the FDA for poziotinib based on the positive data from Cohort 2 of the ZENITH20 clinical trial," said Joe Turgeon…

    Poziotinib NDA on track for 2021 submission

    New poziotinib twice daily dosing (BID) data presented at AACR demonstrated improved anti-tumor activity and better tolerance

    FDA pre-approval inspection at the ROLONTIS® manufacturing facility scheduled for May 2021

    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, 2021 and provided a corporate update.

    "Our top priority is submission of the NDA to the FDA for poziotinib based on the positive data from Cohort 2 of the ZENITH20 clinical trial," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The additional data on twice daily dosing presented at AACR has the potential to significantly expand the value of poziotinib. We also look forward to the FDA's pre-approval inspection of the ROLONTIS manufacturing facility which has been scheduled for later this month."

    Pipeline Updates

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

    • Spectrum is actively working on its new drug application (NDA) for the use of poziotinib in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. Submission of the NDA, based on the positive results of Cohort 2 from the ZENITH20 clinical trial, is planned for later this year.
    • New data was presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting 2021 from ZENITH20 Cohort 5 which demonstrated improved efficacy and tolerability for twice daily (BID) dosing. In the 38 patients, with EGFR or HER2 exon 20 insertion mutations, who received 16mg per day and randomized either to poziotinib 16mg once daily (QD) or 8mg BID in Cohort 5, improved responses were observed in the BID arm with 31.6% of patients reaching a partial response, and Grade 3 or higher related adverse events were reduced by approximately 60%. Additionally, the BID dosing allowed for an improved rate of dose reductions and interruptions relative to the QD dose.
    • Faster enrollment is expected in Cohort 5 which is now dosing exclusively at 8mg BID.
    • Enrollment of first-line patients with NSCLC HER2 exon 20 mutations is continuing for Cohort 4 of the ZENITH20 clinical trial. Poziotinib is being administered at a dose of 8mg BID in first line treatment.
    • A poster titled "CNS activity of poziotinib in NSCLC with exon 20 insertion mutations" based on data from Cohorts 1-3 has been accepted for presentation at ASCO.

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

    • The FDA's pre-approval inspection of the ROLONTIS manufacturing facility has been scheduled for later this month and pre-commercial preparation activities are underway.

    Three-Month Period Ended March 31, 2021 (All numbers are from Continuing Operations and are approximate)

    GAAP Results

    Spectrum recorded a net loss of $35.7 million, or $0.25 loss per basic and diluted share, in the three-month period ended March 31, 2021, compared to a net loss of $40.6 million, or $0.36 loss per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $19.4 million in the quarter, as compared to $16.0 million in the same period in 2020. Selling, general and administrative expenses were $14.3 million in the quarter, compared to $14.8 million in the same period in 2020.

    The company ended the quarter with cash, cash equivalents, and marketable securities of $162.9 million.

    Non-GAAP Results

    Spectrum recorded a non-GAAP net loss of $29.4 million, or $0.20 loss per basic and diluted share, in the three-month period ended March 31, 2021, compared to a non-GAAP net loss of $25.0 million, or $0.22 loss per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $18.0 million, as compared to $14.6 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $11.5 million, as compared to $10.8 million in the same period in 2020.

    Conference Call

    Thursday, May 13, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic: (877) 837-3910, Conference ID# 1373243

    International: (973) 796-5077, Conference ID# 1373243

    This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals' website https://investor.sppirx.com/events-and-presentations on May 13, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    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. Cohorts 3 (EGFR) and 4 (HER2) are 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 likelihood and timing of the FDA approval of poziotinib, the timing of an NDA submission for poziotinib based on the positive results of Cohort 2 from the ZENITH20 clinical trial, the potential for an increase in the value of poziotinib using BID dosing, the speed of enrollment in Cohort 5, the timing of the FDA's pre-approval inspection of the ROLONTIS manufacturing facility, whether the final safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial will continue to demonstrate similar results to the preliminary data, the future potential of Spectrum's existing drug pipeline, the progression of the poziotinib and ROLONTIS 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 preclinical and clinical data, the possibility that Spectrum's new and existing drug candidates, including 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, the possibility that the FDA postpones its pre-approval inspection of the ROLONTIS manufacturing facility past May 2021 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, 2021, 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.

    © 2021 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

    March 31,

     

    2021

     

    2020

    Revenues

    $

     

     

    $

     

    Operating costs and expenses:

     

     

     

    Selling, general and administrative

    14,315

     

     

    14,794

     

    Research and development

    19,371

     

     

    15,993

     

    Total operating costs and expenses

    33,686

     

     

    30,787

     

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

    (33,686

    )

     

    (30,787

    )

    Other income (expense):

     

     

     

    Interest income, net

    84

     

     

    704

     

    Other expense, net

    (2,081

    )

     

    (10,534

    )

    Total other expense

    (1,997

    )

     

    (9,830

    )

    Loss from continuing operations before income taxes

    (35,683

    )

     

    (40,617

    )

    Benefit for income taxes from continuing operations

    7

     

     

     

    Loss from continuing operations

    $

    (35,676

    )

     

    $

    (40,617

    )

    (Loss) income from discontinued operations, net of income taxes

    (21

    )

     

    45

     

    Net loss

    $

    (35,697

    )

     

    $

    (40,572

    )

     

     

     

     

    Basic and diluted loss per share:

     

     

     

    Loss from continuing operations

    $

    (0.25

    )

     

    $

    (0.36

    )

    (Loss) income from discontinued operations

    $

    0.00

     

     

    $

    0.00

     

    Net loss per share, basic and diluted

    $

    (0.25

    )

     

    $

    (0.36

    )

    Weighted average shares outstanding, basic and diluted

    145,371,657

     

     

    111,780,571

     

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and par value amounts)

    (Unaudited)

     

     

    March 31,

    2021

     

    December 31,

    2020

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    69,521

     

     

    $

    46,009

     

    Marketable securities

    93,336

     

     

    134,016

     

    Accounts receivable, net

    64

     

     

    67

     

    Other receivables

    2,795

     

     

    2,394

     

    Prepaid expenses and other current assets

    3,491

     

     

    4,161

     

    Total current assets

    169,207

     

     

    186,647

     

    Property and equipment, net

    3,613

     

     

    3,577

     

    Facility and equipment under lease

    1,824

     

     

    2,247

     

    Other assets

    4,363

     

     

    4,327

     

    Total assets

    $

    179,007

     

     

    $

    196,798

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    42,412

     

     

    $

    43,771

     

    Accrued payroll and benefits

    4,967

     

     

    9,375

     

    Total current liabilities

    47,379

     

     

    53,146

     

    Other long-term liabilities

    9,189

     

     

    9,409

     

    Total liabilities

    56,568

     

     

    62,555

     

    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; 153,728,336 and 146,083,110 issued and outstanding at March 31, 2021 and December 31, 2020, respectively

    154

     

     

    146

     

    Additional paid-in capital

    1,046,784

     

     

    1,021,221

     

    Accumulated other comprehensive loss

    (3,507

    )

     

    (1,829

    )

    Accumulated deficit

    (920,992

    )

     

    (885,295

    )

    Total stockholders' equity

    122,439

     

     

    134,243

     

    Total liabilities and stockholders' equity

    $

    179,007

     

     

    $

    196,798

     

    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 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, except share and per share amounts)

     

     

     

    CONTINUING OPERATIONS

    ONLY

    Three Months Ended

    March 31,

     

     

    2021

     

    2020

    (1)

    GAAP selling, general and administrative

    $

    14,315

     

     

    $

    14,794

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

    Stock-based compensation expense

    (2,799

    )

     

    (3,878

    )

     

    Depreciation expense

    (63

    )

     

    (106

    )

     

    Lease expense

    23

     

     

    9

     

     

    Non-GAAP selling, general and administrative

    $

    11,476

     

     

    $

    10,819

     

    (2)

    GAAP research and development

    $

    19,371

     

     

    $

    15,993

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

    Stock-based compensation expense

    (1,414

    )

     

    (1,398

    )

     

    Depreciation expense

    (2

    )

     

    (33

    )

     

    Non-GAAP research and development

    $

    17,955

     

     

    $

    14,562

     

    (3)

    GAAP net loss from continuing operations

    $

    (35,676

    )

     

    $

    (40,617

    )

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

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

    4,255

     

     

    5,406

     

     

    Adjustments to other expense

    2,072

     

     

    10,249

     

     

    Adjustments to benefit for income taxes

    (7

    )

     

     

     

    Non-GAAP net loss from continuing operations

    $

    (29,356

    )

     

    $

    (24,962

    )

    (4)

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

    $

    (0.25

    )

     

    $

    (0.36

    )

     

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

    $

    (0.20

    )

     

    $

    (0.22

    )

     

    Weighted average shares outstanding, basic and diluted

    145,371,657

     

     

    111,780,571

     

    (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. 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. 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.

    View Full Article Hide Full Article
  2. 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 2021 financial results and provide a corporate update on Thursday, May 13, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Thursday, May 13, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 1373243

    International:

    (973) 796-5077, Conference ID# 1373243

    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 (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 2021 financial results and provide a corporate update on Thursday, May 13, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    Conference Call and Webcast:

    Thursday, May 13, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 1373243

    International:

    (973) 796-5077, Conference ID# 1373243

    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.

    © 2021 Spectrum Pharmaceuticals, Inc. All Rights Reserved

    View Full Article Hide Full Article
  3. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented a data update on the safety and tolerability of twice daily (BID) administered poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations. These preliminary data, from Cohort 5 of the ZENITH20 clinical trial, continue to show improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrate improved anti-tumor activity with 8mg BID dosing. The presentation is part of the AACR Virtual Meeting 2021 taking place April 10-15, 2021.

    "The 8mg BID dosing arm…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented a data update on the safety and tolerability of twice daily (BID) administered poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations. These preliminary data, from Cohort 5 of the ZENITH20 clinical trial, continue to show improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrate improved anti-tumor activity with 8mg BID dosing. The presentation is part of the AACR Virtual Meeting 2021 taking place April 10-15, 2021.

    "The 8mg BID dosing arm is showing the best performance we have seen across the various dosing arms for a mixed population of EGFR and HER2 exon 20 insertion mutations in NSCLC patients. There is clearly an improved therapeutic effect and a lower adverse event rate which is highly encouraging," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "We are currently expanding the 8mg BID dataset and look forward to evaluating this dose in additional NSCLC patients and other solid tumors."

    A copy of the AACR presentation titled "Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations" is available on Spectrum's website at https://investor.sppirx.com/events-and-presentations.

    ZENITH20 Trial Design and Preliminary Safety and Efficacy Data for Cohort 5

    Cohort 5 of the ZENITH20 trial includes previously treated NSCLC patients with EGFR or HER2 exon 20 insertion mutations. This cohort is investigating the efficacy of poziotinib with various dosing levels including BID administration. For the 38 patients randomized to poziotinib 16mg QD or 8mg BID in Cohort 5, improved responses were reported in the BID arm with 31.6% of patients (6/19) reaching a partial response. For the 38 patients randomized to poziotinib 12mg QD or 6mg BID, these dosing levels were not as active as 8mg BID but showed improved tolerance with BID dosing relative to QD dosing.

    Improved tolerability was also observed for the typical TKI related adverse events, with a clinically meaningful reduction in Grade 3 or higher adverse events for the 8mg BID dose relative to 16mg QD. In addition, there were fewer dose interruptions and dose reductions for the BID arms relative to the same QD dose. Cohort 5 is now enrolling exclusively in the 8mg BID arm and data collection is ongoing.

    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 Spectrum's business and its future, including the significance of the preliminary dosing data for poziotinib, including the ability to achieve an improved therapeutic effect and a lowered adverse event rate with BID dosing; the demonstration of improved anti-tumor activity; the reduction in dose interruptions and dose reductions; poziotinib's potential to significantly advance the treatment of NSCLC patients with EGFR or HER2 exon 20 insertion mutations; the timing and results of the company's planned NDA submission; the overall progression of the poziotinib development program; 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 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 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 "SEC"). 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, 2020, and in subsequent reports on Forms 10-K, 10-Q and 8-K and other filings made with the SEC by Spectrum.

    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.

    © 2021 Spectrum Pharmaceuticals, Inc. All Rights Reserved

    View Full Article Hide Full Article
  4. Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations. The company will also present a poster on the evaluation of same-day dosing of ROLONTIS® (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

    Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2…

    Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations. The company will also present a poster on the evaluation of same-day dosing of ROLONTIS® (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

    Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations

    Speaker: Xiuning Le, M.D., Ph.D.

    Session: PO.CT02 - Phase 2 Clinical Trials

    Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET

    Presentation Number: CT169

    Title: Same-day administration of Eflapegrastim with chemotherapy enhances neutropenic recovery in neutropenic rats and in early-stage breast cancer patients

    Speaker: John A. Barrett

    Session: PO.CT01 - Phase 1 Clinical Trials

    Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET

    Presentation Number: CT116

    The poster presentations will be available for viewing by registered participants during the conference via the AACR website on April 10, 2021.

    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.® 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.

    © 2021 Spectrum Pharmaceuticals, Inc. All Rights Reserved

    View Full Article Hide Full Article
  5. Poziotinib receives Fast Track Designation from FDA

    Preliminary safety and efficacy data for poziotinib twice daily dosing (BID) demonstrates improved anti-tumor activity and reduced toxicity relative to once daily dosing

    FDA has scheduled the pre-approval inspection at the ROLONTIS® (eflapegrastim) manufacturing facility for May 2021

    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 and full year ended December 31, 2020.

    "The Fast Track designation for poziotinib is a significant achievement towards an expedited review…

    Poziotinib receives Fast Track Designation from FDA

    Preliminary safety and efficacy data for poziotinib twice daily dosing (BID) demonstrates improved anti-tumor activity and reduced toxicity relative to once daily dosing

    FDA has scheduled the pre-approval inspection at the ROLONTIS® (eflapegrastim) manufacturing facility for May 2021

    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 and full year ended December 31, 2020.

    "The Fast Track designation for poziotinib is a significant achievement towards an expedited review," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "In addition, we are delighted that the FDA has scheduled the pre-approval inspection at the ROLONTIS manufacturing facility for May 2021. The company has made tremendous progress advancing our development programs and conducting our clinical trials, despite the challenges of the global pandemic. I am proud of our employees who demonstrated resiliency and creativity during these unprecedented times."

    Pipeline Updates

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

    • Poziotinib received Fast Track designation from the FDA for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 insertion mutations. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions and fill unmet medical needs.
    • Spectrum is preparing a new drug application (NDA) for poziotinib in the treatment of patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations after a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020. Submission of the NDA based on the positive results of Cohort 2 from the ZENITH20 clinical trial is planned for later this year.
    • Preliminary safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial demonstrated improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also demonstrated improved anti-tumor activity with 8mg BID dosing. These results were presented at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 in early March. Spectrum will be presenting further data on BID dosing at the upcoming AACR Annual Meeting 2021.

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

    • The FDA's pre-approval inspection of the ROLONTIS manufacturing facility has been scheduled for May 2021. In October 2020, the FDA deferred its action on the Biologics License Application (BLA) for ROLONTIS due to an inability to inspect the drug substance manufacturing facility, citing travel restrictions related to the COVID-19 pandemic.

    IGN002, interferon/CD20 monoclonal antibody fusion protein

    • Anti-CD20-IFNα, an antibody-interferon fusion molecule directed against CD20 has two sites open for enrollment in a Phase 1 study for treating relapsed or refractory non-Hodgkin's lymphoma patients, including diffuse large B-cell lymphoma.

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

    GAAP Results

    Spectrum recorded net loss of $49.9 million, or $0.36 per basic and diluted share, in the three-month period ended December 31, 2020, compared to net loss of $40.2 million, or $0.36 per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $47.2 million in the quarter, as compared to $23.3 million in the same period in 2019. Selling, general and administrative expenses were $15.7 million in the quarter, compared to $15.1 million in the same period in 2019.

    Non-GAAP Results

    Spectrum recorded non-GAAP net loss of $28.9 million, or $0.20 per basic and diluted share, in the three-month period ended December 31, 2020, compared to non-GAAP net loss of $33.4 million, or $0.30 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $17.1 million, as compared to $22.4 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $12.3 million, as compared to $11.6 million in the same period in 2019.

    Twelve-Month Period Ended December 31, 2020 (All numbers are from Continuing Operations)

    GAAP Results

    Spectrum recorded net loss of $171.3 million, or $1.38 per basic and diluted share, in the twelve-month period ended December 31, 2020, compared to net loss of $135.4 million, or $1.22 per basic and diluted share, in the comparable period in 2019. Total research and development expenses were $109.4 million for the year, as compared to $79.3 million in the same period in 2019. Selling, general and administrative expenses were $60.4 million for the year, compared to $61.4 million in the same period in 2019.

    Non-GAAP Results

    Spectrum recorded non-GAAP net loss of $120.9 million, or $0.97 per basic and diluted share, in the twelve-month period ended December 31, 2020, compared to non-GAAP net loss of $111.9 million, or $1.01 per basic and diluted share, in the comparable period in 2019. Non-GAAP research and development expenses were $75.6 million, as compared to $72.0 million in the same period of 2019. Non-GAAP selling, general and administrative expenses were $47.2 million, as compared to $45.5 million in the same period in 2019.

    Cash Position and Guidance

    Spectrum reported cash, cash equivalents, and marketable securities of approximately $180.0 million as of December 31, 2020, compared to $224 million at December 31, 2019.

    Conference Call

    Tuesday, March 30, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic:

    (877) 837-3910, Conference ID# 3577235

    International:

    (973) 796-5077, Conference ID# 3577235

    This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals' website: http://investor.sppirx.com/events-and-presentations on March 30, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

    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) and 4 (HER2) are 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 likelihood and timing of the FDA approval of poziotinib, given its Fast Track designation and the significance of such designation, the timing of an NDA submission for poziotinib based on the positive results of Cohort 2 from the ZENITH20 clinical trial, whether the final safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial will continue to demonstrate similar results to the preliminary data, the content of the company's presentation at the AACR Annual Meeting 2021, the company's ability to advance development of its late-stage pipeline assets, the ability of such assets to meet currently unaddressed medical needs, the future potential of Spectrum's existing drug pipeline, the progression of the poziotinib, ROLONTIS and Anti-CD20-IFNα 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 preclinical and clinical data, the possibility that Spectrum's new and existing drug candidates, including 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, the possibility that the FDA postpones its pre-approval inspection of the ROLONTIS manufacturing facility past May 2021 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, 2020, 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.

    © 2021 Spectrum Pharmaceuticals, Inc. All Rights Reserved

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (Unaudited)

     

    Three Months Ended

    December 31,

     

    Twelve Months Ended

    December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

    $

     

     

    $

     

     

    $

     

     

    $

     

    Operating costs and expenses:

     

     

     

     

     

     

     

    Selling, general and administrative

    15,703

     

     

    15,065

     

     

    60,357

     

     

    61,373

     

    Research and development

    47,185

     

     

    23,290

     

     

    109,377

     

     

    79,325

     

    Total operating costs and expenses

    62,888

     

     

    38,355

     

     

    169,734

     

     

    140,698

     

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

    (62,888)

     

     

    (38,355)

     

     

    (169,734)

     

     

    (140,698)

     

    Other income (expense):

     

     

     

     

     

     

     

    Interest income (expense), net

    125

     

     

    920

     

     

    1,342

     

     

    4,996

     

    Other (expense) income, net

    12,780

     

     

    (3,345)

     

     

    (2,940)

     

     

    (8,892)

     

    Total other (expense) income

    12,905

     

     

    (2,425)

     

     

    (1,598)

     

     

    (3,896)

     

    Loss from continuing operations before income taxes

    (49,983)

     

     

    (40,780)

     

     

    (171,332)

     

     

    (144,594)

     

    Benefit for income taxes from continuing operations

    75

     

     

    579

     

     

    60

     

     

    9,208

     

    Loss from continuing operations

    $

    (49,908)

     

     

    $

    (40,201)

     

     

    $

    (171,272)

     

     

    $

    (135,386)

     

    Income from discontinued operations, net of income taxes

    10,149

     

     

    1,150

     

     

    10,404

     

     

    22,697

     

    Net loss

    $

    (39,759)

     

     

    $

    (39,051)

     

     

    $

    (160,868)

     

     

    $

    (112,689)

     

     

     

     

     

     

     

     

     

    Basic and diluted loss per share:

     

     

     

     

     

     

     

    Loss per common share from continuing operations

    $

    (0.36)

     

     

    $

    (0.36)

     

     

    $

    (1.38)

     

     

    $

    (1.22)

     

    Income per common share from discontinued operations

    $

    0.07

     

     

    $

    0.01

     

     

    $

    0.08

     

     

    $

    0.21

     

    Net loss per common share, basic and diluted

    $

    (0.29)

     

     

    $

    (0.35)

     

     

    $

    (1.29)

     

     

    $

    (1.02)

     

     

     

     

     

     

     

     

     

    Weighted average shares outstanding, basic and diluted

    141,432,302

     

    111,355,254

     

    124,386,545

     

    110,585,768

    SPECTRUM PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

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

     

    December 31,

     

    2020

     

    2019

    ASSETS

     

     

     

    Current assets:

     

     

     

    Cash and cash equivalents

    $

    46,009

     

     

    $

    64,418

     

    Marketable securities

    134,016

     

     

    159,455

     

    Accounts receivable, net

    67

     

     

    441

     

    Other receivables

    2,394

     

     

    9,558

     

    Prepaid expenses and other current assets

    4,161

     

     

    10,148

     

    Total current assets

    186,647

     

     

    244,020

     

    Property and equipment, net

    3,577

     

     

    11,607

     

    Facility and equipment under lease

    2,247

     

     

    3,806

     

    Other assets

    4,327

     

     

    4,000

     

    Total assets

    $

    196,798

     

     

    $

    263,433

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable and other accrued liabilities

    $

    43,771

     

     

    $

    54,284

     

    Accrued payroll and benefits

    9,375

     

     

    7,686

     

    Total current liabilities

    53,146

     

     

    61,970

     

    Other long-term liabilities

    9,409

     

     

    11,070

     

    Total liabilities

    62,555

     

     

    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; 146,083,110 and 113,299,612 issued and outstanding at December 31, 2020 and 2019, respectively

    146

     

     

    113

     

    Additional paid-in capital

    1,021,221

     

     

    918,205

     

    Accumulated other comprehensive loss

    (1,829)

     

     

    (3,498)

     

    Accumulated deficit

    (885,295)

     

     

    (724,427)

     

    Total stockholders' equity

    134,243

     

     

    190,393

     

    Total liabilities and stockholders' equity

    $

    196,798

     

     

    $

    263,433

     

    Non-GAAP Financial Measures

    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 from continuing operations and non-GAAP net loss per share from continuing operations. 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 loss from continuing operations in its evaluation of the company's core 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

     

    CONTINUING OPERATIONS ONLY

     

     

    Three Months Ended

    December 31,

     

    Twelve Months Ended

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    (1)

    GAAP selling, general and administrative

    $

    15,703

     

     

    $

    15,065

     

     

    $

    60,357

     

     

    $

    61,373

     

     

    Non-GAAP adjustments to SG&A:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (3,354)

     

     

    (3,393)

     

     

    (13,127)

     

     

    (13,822)

     

     

    Depreciation expense

    (55)

     

     

    (96)

     

     

    (130)

     

     

    (276)

     

     

    Lease expense

    23

     

     

    (25)

     

     

    69

     

     

    (282)

     

     

    Severance expense

     

     

     

     

     

     

    (1,515)

     

     

    Non-GAAP selling, general and administrative

    $

    12,317

     

     

    $

    11,551

     

     

    $

    47,169

     

     

    $

    45,478

     

    (2)

    GAAP research and development

    $

    47,185

     

     

    $

    23,290

     

     

    $

    109,377

     

     

    $

    79,325

     

     

    Non-GAAP adjustments to R&D:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

    (1,094)

     

     

    (882)

     

     

    (4,692)

     

     

    (4,254)

     

     

    Depreciation expense

    (33)

     

     

    (36)

     

     

    (131)

     

     

    (81)

     

     

    Impairment of second source manufacturer

    (28,197)

     

     

     

     

    (28,197)

     

     

     

     

    Other R&D milestone payments

    (750)

     

     

     

     

    (750)

     

     

    (2,751)

     

     

    Severance expense

     

     

     

     

     

     

    (260)

     

     

    Non-GAAP research and development

    $

    17,111

     

     

    $

    22,372

     

     

    $

    75,607

     

     

    $

    71,979

     

    (3)

    GAAP net loss from continuing operations

    $

    (49,908)

     

     

    $

    (40,201)

     

     

    $

    (171,272)

     

     

    $

    (135,386)

     

     

    Non-GAAP adjustments to net loss from continuing operations:

     

     

     

     

     

     

     

     

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

    33,460

     

     

    4,432

     

     

    46,958

     

     

    23,241

     

     

    Adjustments to other (income) expense

    (12,379)

     

     

    2,969

     

     

    3,521

     

     

    9,418

     

     

    Adjustments to benefit for income taxes

    (75)

     

     

    (579)

     

     

    (60)

     

     

    (9,208)

     

     

    Non-GAAP net loss from continuing operations

    $

    (28,902)

     

     

    $

    (33,379)

     

     

    $

    (120,853)

     

     

    $

    (111,935)

     

    (4)

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

    $

    (0.35)

     

     

    $

    (0.36)

     

     

    $

    (1.38)

     

     

    $

    (1.22)

     

     

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

    $

    (0.20)

     

     

    $

    (0.30)

     

     

    $

    (0.97)

     

     

    $

    (1.01)

     

     

    Weighted average shares outstanding, basic and diluted

     

    141,432,302

     

    111,355,254

     

    124,386,545

     

    110,585,768

    (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 non-recurring severance expenses, other R&D milestone achievement payments, and impairment of second source manufacturer 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) and (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 from continuing operations - per basic and diluted share: 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.

    View Full Article Hide Full Article
View All Spectrum Pharmaceuticals Inc. News