Spectrum (SPPI) Earnings And Sales Beat Estimates In Q3
Zacks Investment Research | Nov 08, 2018 08:01PM ET
Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) incurred an adjusted loss of 17 cents per share in the third quarter of 2018, narrower than the Zacks Consensus Estimate of a loss of 21 cents but wider than the year-ago quarter loss of 11 cents per share.
Quarterly revenues came in at $25.3 million, down 21.4% from the year-ago quarter. The top line, however, beat the Zacks Consensus Estimate of $24.6 million.
Spectrum Pharma’s shares have declined 32.3% so far this year compared with the industry ’s decrease of 2.7%.
Quarter in Detail
Total product sales came in at $24.6 million, down 23.8% year over year. Sales were generated by six marketed products — Fusilev ($0.6 million), Folotyn ($11.3 million), Zevalin ($1.5 million), Marqibo ($1.1 million), Beleodaq ($3.2 million) and Evomela ($6.9 million). Evomela is facing pricing pressure due to generic entry.
License fees and service revenues were $0.7 million compared with $5.2 million in the prior-year quarter.
Adjusted research & development expenses were $20.2 million, up 53% from the year-ago quarter. Adjusted selling, general and administrative spending was up 3.4% to $16.6 million.
2018 Guidance
The company tightened its revenue guidance range for 2018 to $100-$110 million from the previous guidance of $95-$115 million. The company expects to have enough liquid funds to continue its operations into 2020.
Pipeline Update
Spectrum Pharma is evaluating one of its key pipeline candidates, poziotinib, in several mid-stage studies for the treatment of lung cancer and breast cancer. In September, the company presented updated interim data from a phase II study evaluating poziotinib in heavily pre-treated non-small cell lung cancer (“NSCLC”) patients with an exon 20 mutation in EGFR or HER2.
The candidate achieved confirmed overall response rate (“ORR”) of 43%, disease control rate (”DCR”) of 90% and median progression free survival (“PFS”) of 5.5 months in patients with EGFR mutation. The confirmed ORR was 42%, DCR was 83% and median PFS was 5.1 months in patients with HER2 mutation.
The company successfully completed two phase III studies on its another pipeline candidate, Rolontis, which showed that the candidate was non-inferior to Amgen Inc.’s (NASDAQ:AMGN) Neulasta in improving duration of severe neutropenia in patients with breast cancer.
Spectrum Pharma is planning to submit a Biologics License Application (“BLA”) by the year end, following a positive pre-BLA meeting with the FDA.
In October, the FDA approved Khapzory (levoleucovorin) for three indications. The drug is approved as a rescue after high-dose methotrexate therapy in patients with osteosarcoma to reduce toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination and for treating metastatic colorectal cancer in combination with fluorouracil.
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