On March 6, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported financial results for the three-month period and year ended December 31, 2017 (Press release, Spectrum Pharmaceuticals, MAR 6, 2018, View Source [SID1234524425]).
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"2017 was a landmark year for Spectrum driven by advancements in our pipeline," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Poziotinib has the potential to be a life-altering therapy for cancer patients with exon-20 insertion mutations. ROLONTIS gives Spectrum a near-term opportunity to compete in a blockbuster market. We expect several pipeline milestones in 2018 and we look forward to keeping you updated."
Pipeline Update:
Poziotinib, an irreversible tyrosine kinase inhibitor:
The Company has initiated a multi-center study which is currently enrolling Non-Small Cell Lung Cancer (NSCLC) patients. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations at several leading cancer centers. The study will evaluate objective response rate (ORR) as the primary endpoint, and disease control rate (DCR), duration of response (DOR), and safety as secondary endpoints.
An investigator sponsored trial is currently enrolling at the University of Texas MD Anderson Cancer Center in NSCLC patients with exon 20 insertion mutations in EGFR or HER2. The study yielded preliminary results demonstrating evidence of significant antitumor activity in NSCLC patients with EGFR exon 20 insertion mutations, with preliminary data in the first 11 patients showing an unconfirmed Objective Response Rate of 73%. Safety profile was consistent with those previously described for poziotinib and other TKIs. The Company expects additional data from this study in 2018.
An abstract on poziotinib was accepted at AACR (Free AACR Whitepaper). Primarily pre-clinical data will be available at AACR (Free AACR Whitepaper) on the anti-tumor activity of poziotinib in HER2 exon-20 insertion mutations in NSCLC.
Spectrum is also conducting a Phase 2 breast cancer study in the third-line setting in the U.S.
ROLONTIS(eflapegrastim), a novel long-acting GCSF:
A registrational Phase 3 study ADVANCE was initiated under an SPA with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. The Company announced the ADVANCE study met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms.
The Company has completely enrolled RECOVER, an international Phase 3 trial that has a similar design.
The Company expects to file the BLA in Q4 2018.
2018 Guidance
The Company expects total revenue to be between $90 to $110 million in 2018. Gross margin is expected to improve primarily as a result of enhancements to Evomela manufacturing. R&D expense is expected increase driven by additional spend on pipeline.
Three-Month Period Ended December 31, 2017 (All numbers are approximate)
GAAP Results
Total product sales were $27.9 million in the fourth quarter of 2017. Product sales in the fourth quarter included: FUSILEV (levoleucovorin) net sales of $0.9 million, FOLOTYN (pralatrexate injection) net sales of $11.0 million, ZEVALIN (ibritumomab tiuxetan) net sales of $3.9 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.2 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, and EVOMELA (melphalan) for injection net sales of $8.3 million.
Spectrum recorded net loss of $28.6 million, or $0.29 per basic and diluted share in the three-month period ended December 31, 2017, compared to net loss of $18.1 million, or $0.23 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $22.1 million in the quarter, as compared to $16.0 million in the same period in 2016. Selling, general and administrative expenses were $29.2 million in the quarter, compared to $18.9 million in the same period in 2016.
During the quarter the Company purchased $69.5 million face value of its convertible debentures for $27.3 million in cash and 5.4 million newly-issued shares of our common stock. The Company ended the quarter with cash, cash equivalents and marketable securities of $227.6 million.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $22.8 million, or $0.23 per basic and diluted share in the three-month period ended December 31, 2017, compared to non-GAAP net loss of $8.1 million, or $0.10 per basic and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $21.3 million, as compared to $15.4 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $19.1 million, as compared to $15.6 million in the same period in 2016.
Twelve-Month Period Ended December 31, 2017 (All numbers are approximate)
GAAP Results
Total product sales were $116.2 million for the twelve months ended December 31, 2017. Total product sales decreased 9.7% from $128.6 million in the same period of 2016.
Product sales in 2017 included: FUSILEV (levoleucovorin) net sales of $7.3 million, FOLOTYN (pralatrexate injection) net sales of $43.0 million, ZEVALIN (ibritumomab tiuxetan) net sales of $11.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $6.6 million, BELEODAQ (belinostat) for injection net sales of $12.4 million, and EVOMELA (melphalan) for injection net sales of $35.2 million.
Spectrum recorded net loss of $91.2 million, or $1.07 per basic and diluted share in the twelve-month period ended December 31, 2017, compared to net loss of $69.8 million, or $0.96 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $65.9 million for the year, as compared to $59.1 million in the same period in 2016. Selling, general and administrative expenses were $84.3 million for the year, compared to $88.4 million in the same period in 2016.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $52.1 million, or $0.61 per basic and diluted share in the twelve-month period ended December 31, 2017, compared to non-GAAP net loss of $16.8 million, or $0.23 per basic and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $63.4 million, as compared to $54.1 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $65.4 million, as compared to $64.1 million in the same period in 2016.