Spectrum Pharma (SPPI) Incurs Wider-Than-Expected Q4 Loss
Zacks Investment Research | Feb 27, 2020 08:46PM ET
Spectrum Pharmaceuticals, Inc.’s (NASDAQ:SPPI) fourth-quarter 2019 adjusted loss of 30 cents per share was wider than the Zacks Consensus Estimate of a loss of 26 cents. However, adjusted loss narrowed compared to the year-ago quarter’s loss of 41 cents.
Shares of Spectrum Pharma were down 1.3% in after-market trading on Feb 27, following the earnings release. In fact, the company’s shares have decreased 77.7% in the past year compared with the industry ’s decline of 10.7%.
Quarter in Detail
The company did not record any revenues during the quarter as it sold its marketed portfolio to privately-held Acrotech Biopharma in March 2019. The Zacks Consensus Estimate for revenues was pegged at $1 million.
Adjusted research & development (R&D) expenses were $22.4 million, down 23.3% from the year-ago quarter.
Adjusted selling, general and administrative (SG&A) expense was down 171% to $11.6 million.
2019 Results
Spectrum Pharma did not record any revenues for the full year. Adjusted loss for the period was $1.01 per share, narrower than the year-ago adjusted loss of $1.20 per share.
Pipeline Update
Spectrum Pharma’s lead product, Rolontis, is under review in the United States. In December 2019, the FDA accepted the biologics license application seeking approval for Rolontis for the management of chemotherapy-induced neutropenia. A decision is expected by Oct 24, 2020. The company is actively preparing for the launch of Rolontis, following a potential approval.
The company is developing its pipeline candidate, poziotinib, as monotherapy or in combination with other drugs for the treatment of lung cancer and breast cancer.
A multi-cohort phase II study — ZENITH20 — is evaluating poziotinib in non-small cell lung cancer (“NSCLC”) patients with an exon 20 mutation in EGFR or HER2. The company completed enrollment in the two cohorts of the ZENITH20 study — previously treated NSCLC patients with EGFR or HER2 exon 20 insertion mutation — in the first half of 2019. The study is enrolling NSCLC patients in the cohorts evaluating the candidate in treatment-naive patients with EGFR or HER2 mutation, previously treated patients with atypical EGFR or HER2 mutation, and patients treated with AstraZeneca’s (NYSE:AZN) Tagrisso in first-line setting who have acquired EGFR mutations.
In December 2019, the company announced that poziotinib failed to meet pre-specified primary endpoint of objective response rate in the previously-treated EGFR NSCLC cohort. However, the company stated that it will continue to evaluate the candidate in this patient population based on positive monotherapy drug activity observed in the clinical study. It will provide an update on the overall program strategy in the first quarter of 2020.
Top-line data from the previously-treated HER2 NSCLC and first-line EGFR NSCLC cohorts are expected by mid-2020 and year-end, respectively. The company stated that favorable data from each cohort can support a regulatory application submission seeking approval for poziotinib.
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