HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today financial results for the three-month period ended June 30, 2017.
“During the second quarter we made significant progress in our highest priority clinical programs and achieved solid performance across our commercial business,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “We completed enrollment in ROLONTIS’s ADVANCE registrational Phase 3 study ahead of schedule and enrollment in a second international study RECOVER is well under way in Europe and U.S. We are also very excited about the prospects of poziotinib in cancer patients with exon 20 insertion mutations and expect interim results from the Phase 2 lung cancer study before the end of the year. We are driven to bring our novel drugs to patients with unmet medical needs and look forward to multiple near-term development catalysts that could shape the Company’s future.”
Pipeline Update:
- 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 has completed enrollment in the ADVANCE study with 405 patients randomized and expects to report topline data in Q1 2018. To strengthen the regulatory package in the Europe and U.S., the Company is currently enrolling the 218-patient international RECOVER study. The Company continues to expect to file the BLA next year.
- Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: An investigator sponsored trial is currently enrolling at the University of Texas MD Anderson Cancer Center in non-small cell lung cancer patients with exon 20 insertion mutations in EGFR or HER2. The study is expected to yield interim results before year end. Following discussions with the FDA, the Company is initiating an additional multicenter study in a similar patient population. Spectrum is also conducting a Phase 2 breast cancer study in the third-line setting in the U.S., based on promising Phase 1 study efficacy data in breast cancer patients who had failed multiple HER2-directed therapies. The Company is in discussions with the FDA about a combination trial of poziotinib and standard of care therapy in HER2+ breast cancer patients in the second-line setting.
- QAPZOLA™, a potent tumor-activated drug for bladder cancer is being investigated for low and intermediate risk non-muscle invasive bladder cancer: The Company has an SPA from the FDA for a new Phase 3 study incorporating learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous program, this new Phase 3 study will include fewer evaluable patients (n=425 versus 1,557 patients), use a higher dosage of QAPZOLA (8 mg versus 4 mg), and will evaluate time-to-recurrence as the primary endpoint. Approximately 50 sites have been selected thus far for enrolling patients in the Phase 3 study and patients are currently being screened.
Three-Month Period Ended June 30, 2017 (All numbers are approximate)
GAAP Results
Total product sales were $31.2 million in the second quarter of 2017. Product sales in the second quarter included: FUSILEV® (levoleucovorin) net sales of $2.1 million, FOLOTYN® (pralatrexate injection) net sales of $11.2 million, ZEVALIN® (ibritumomab tiuxetan) net sales of $2.3 million, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) net sales of $2.2 million, BELEODAQ® (belinostat) for injection net sales of $3.4 million, and EVOMELA® (melphalan) for injection net sales of $10.1 million.
Spectrum recorded a net loss of $20.5 million, or $0.26 per basic and diluted share in the three-month period ended June 30, 2017, compared to a net loss of $24.3 million, or $0.35 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $15.1 million in the quarter, as compared to $14.3 million in the same period in 2016. Selling, general and administrative expenses were $17.1 million in the quarter, compared to $27.6 million in the same period in 2016.
Our June 30, 2017 cash and equivalents balance is $138.6 million. In July 2017, we sold and issued 3.2 million shares of our common stock for net proceeds of $23.7 million under our ATM. These shares and proceeds are not included in our June 30, 2017 financial statements. We have now fully utilized the ATM facility.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $8.6 million, or $0.11 per basic and diluted share in the three-month period ended June 30, 2017, compared to non-GAAP net loss of $3.7 million, or $0.05 per basic share and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $14.6 million, as compared to $12.9 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $14.5 million, as compared to $16.1 million in the same period in 2016.
