Spectrum Pharmaceuticals Reports Fourth Quarter 2019 and Full Year 2019 Financial Results and Pipeline Update

• BLA for ROLONTIS^® (eflapegrastim) accepted for FDA review - PDUFA date on October 24, 2020
• Data from poziotinib Cohort 1 of ZENITH20 accepted for podium presentation on March 18 at 11^th Annual Congress on Pulmonary and Respiratory Medicine in Amsterdam
• Spectrum plans to hold a conference call following the data presentation to review the data and strategy of the program

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period and year ended December 31, 2019.

“ROLONTIS is in active review by the FDA and we are preparing to launch shortly following approval,” said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. “We believe this market represents a significant commercial opportunity and our prelaunch activities are well underway. We have a podium presentation on poziotinib in a few short weeks, we have taken steps to adjust our strategy and we have multiple data catalysts in 2020. I look forward to updating you on our progress throughout the 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 has been set for October 24, 2020.
• In October 2019, Spectrum presented a poster at the ASCO Supportive Care in Oncology Symposium in San Francisco. The poster highlighted integrated efficacy data from the Phase 3 ROLONTIS clinical trials, ADVANCE and RECOVER, which studied more than 600 patients combined and met all primary and secondary endpoints.
• An abstract reporting preclinical data on eflapegrastim or pegfilgrastim using “same day dosing” as chemotherapy has been accepted for presentation at the AACR meeting April 24-29 in San Diego.

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

• The pre-specified primary endpoint in a Phase 2 clinical trial (ZENITH20) evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations was not achieved in Cohort 1.
• Data from Cohort 1 will be presented in a podium presentation at the 11^th Annual Congress on Pulmonary and Respiratory Medicine in Amsterdam on March 18^th.
• Cohort 2 of the ZENITH20 trial enrolling previously treated HER2 non-small cell lung cancer patients is fully accrued and is expected to have topline results by mid-year 2020. Cohort 3 of the ZENITH20 trial enrolling first-line EGFR NSCLC patients is expected to have topline results by year-end 2020. Either cohort has the potential to support a future NDA submission.

Three-Month Period Ended December 31, 2019 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $40.2 million, or $0.36 per basic and diluted share, in the three-month period ended December 31, 2019, compared to net loss of $53.1 million, or $0.50 per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $23.3 million in the quarter, as compared to $29.9 million in the same period in 2018. Selling, general and administrative expenses were $15.1 million in the quarter, compared to $16.6 million in the same period in 2018.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $33.4 million, or $0.30 per basic and diluted share, in the three-month period ended December 31, 2019, compared to non-GAAP net loss of $43.4 million, or $0.41 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $22.4 million, as compared to $29.2 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $11.6 million, as compared to $14.0 million in the same period in 2018.

Twelve-Month Period Ended December 31, 2019 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $135.4 million, or $1.22 per basic and diluted share, in the twelve-month period ended December 31, 2019, compared to net loss of $126.7 million, or $1.23 per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $79.3 million for the year, as compared to $75.2 million in the same period in 2018. Selling, general and administrative expenses were $61.4 million for the year, compared to $62.7 million in the same period in 2018.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $111.9 million, or $1.01 per basic and diluted share, in the twelve-month period ended December 31, 2019, compared to non-GAAP net loss of $124.3 million, or $1.20 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $72.0 million, as compared to $72.1 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $45.5 million, as compared to $53.2 million in the same period in 2018.

Cash Position and Guidance

Spectrum reported cash, cash equivalents, restricted cash, and marketable securities of approximately $224 million as of December 31, 2019, compared to $204 million at December 31, 2018. Based on current operating plans, Spectrum expects that SG&A expense will increase in the second half of this year as we scale up our commercial operations in preparation to launch ROLONTIS.

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 February 27, 2020 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 FDA approval of ROLONTIS, the size of the potential market for ROLONTIS and the timing of its commercial launch, 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 timing of the results of cohort 2 and cohort 3 in Spectrum’s ZENITH20 study and their potential to support future NDA submissions, the future potential of Spectrum’s existing drug pipeline, the progression of the poziotinib development program 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, 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.

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