On February 28, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period and year ended December 31, 2018 (Press release, Spectrum Pharmaceuticals, FEB 28, 2019, View Source [SID1234533836]).

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"2018 was a very productive year for Spectrum in which our two promising pipeline products significantly progressed in clinical development," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We begin 2019 with great momentum after meeting the enrollment target for the first cohort in our pivotal poziotinib study and submitting the BLA for ROLONTIS to the FDA at the end of 2018. In 2019, we are laser-focused on continuing to develop our two late-stage products, poziotinib and ROLONTIS, and looking for new opportunities that build upon these assets."

Pipeline update:

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

Enrollment in the EGFR, previously treated NSCLC cohort (cohort 1) in the ZENITH20 trial was completed; topline results are expected in Q4 2019.
Enrollment in the HER2, previously treated NSCLC cohort (cohort 2) in the ZENITH20 trial is expected to be completed in Q4 2019.
Initiation of pan-tumor and combination trials expected to be in H2 2019.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:

Spectrum submitted the BLA with the FDA in late December 2018. Due to the government shutdown, the file was officially received on January 28, 2019.
Pipeline update continued:

Spectrum has begun launch readiness activities including inventory build and commercial preparedness.
Data from the Phase 3 study (RECOVER) was presented in a poster session at the San Antonio Breast Cancer Symposium in December 2018. The RECOVER study was the second pivotal trial to meet all primary and secondary endpoints and demonstrated comparable safety and tolerability profiles to pegfilgrastim.
2019 Guidance

Assuming the previously announced divestiture transaction closes in March, we expect 2019 SG&A costs to decrease by approximately 30 percent relative to 2018. We expect 2019 R&D costs to increase nominally as reduced spending on the legacy assets is offset by the increased spending on pre-commercial supply and tech transfer activities for ROLONTIS and poziotinib. With the increase of cash from the sale of our commercial assets, we expect our cash balance to be sufficient to fund operations for at least three years.

Three-Month Period Ended December 31, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $28.0 million in the fourth quarter of 2018. Product sales in the fourth quarter included: FOLOTYN (pralatrexate injection) net sales of $12.2 million, EVOMELA (melphalan) for injection net sales of $7.5 million, BELEODAQ (belinostat) for injection net sales of $3.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $0.9 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.3 million, KHAPZORY (levoleucovorin) net sales of $0.9 million, and FUSILEV (levoleucovorin) net sales of $0.4 million.

Spectrum recorded net loss of $49.2 million, or $0.47 per basic and diluted share in the three-month period ended December 31, 2018, compared to net loss of $28.6 million, or $0.29 per basic and diluted share in the comparable period in 2017. Total research and development expenses were $34.5 million in the quarter, as compared to $22.1 million in the same period in 2017. Selling, general and administrative expenses were $23.3 million in the quarter, compared to $29.2 million in the same period in 2017.

The company ended the quarter with cash, cash equivalents and marketable securities of $204 million.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $32.1 million, or $0.30 per basic and diluted share in the three-month period ended December 31, 2018, compared to non-GAAP net loss of $22.8 million, or $0.23 per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $33.6 million, as compared to $21.3 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $19.9 million, as compared to $19.1 million in the same period in 2017.

Twelve-Month Period Ended December 31, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $104.5 million for the twelve months ended December 31, 2018. Total product sales decreased 10.1% from $116.2 million in the same period of 2017.

Product sales in 2018 included: FOLOTYN (pralatrexate injection) net sales of $48.0 million, EVOMELA (melphalan) for injection net sales of $28.3 million, BELEODAQ (belinostat) for injection net sales of $12.3 million, ZEVALIN (ibritumomab tiuxetan) net sales of $7.0 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $5.5 million, KHAPZORY (levoleucovorin) net sales of $0.9 million, and FUSILEV (levoleucovorin) net sales of $2.4 million. Spectrum recorded net loss of $120.0 million, or $1.16 per basic and diluted share in the twelve-month period ended December 31, 2018, compared to net loss of $91.2 million, or $1.07 per basic and diluted share in the comparable period in 2017. Total research and development expenses were $95.0 million for the year, as compared to $65.9 million in the same period in 2017. Selling, general and administrative expenses were $90.7 million for the year, compared to $84.3 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $86.8 million, or $0.84 per basic and diluted share in the twelve-month period ended December 31, 2018, compared to non-GAAP net loss of $52.1 million, or $0.61 per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $91.0 million, as compared to $63.4 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $76.5 million, as compared to $65.4 million in the same period in 2017.

Conference Call

Thursday, February 28, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 2797623

International: (973) 796-5077, Conference ID# 2797623

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: View Source on February 28, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.