Global Blood Therapeutics, Inc. (GBT - Free Report) incurred a loss of $1.07 per share in the third quarter of 2019, which was wider than a loss of 83 cents in the year-ago quarter and the Zacks Consensus Estimate of a loss of $1.03.
The company did not record any revenues during the quarter.
Research and development (R&D) expenses in the third quarter were $39.1 million, up 18.5% year over year. The increase can be mainly attributable to higher employee-related costs and elevated costs associated with NDA submission activities.
General and administrative (G&A) expenses were $29.7 million, up 137.6% year over year. The increase was due to higher employee-related costs and elevated expenses associated with the buildout of the company’s commercial operations.
Shares of the company have gained 16.9% year to date compared with the industry’s growth of 0.2%.
The company’s lead product candidate is voxelotor (GBT440), an oral, once-daily treatment for sickle cell disease (SCD).
In September, the FDA accepted Global Blood’s new drug application (NDA) seeking accelerated approval for voxelotor in SCD. The agency granted the NDA priority review and set an action date of Feb 26, 2020. The company intends to launch the drug by the first half of 2020. If the drug is approved, it could bring millions of dollars for the company annually.
The company is on track to initiate a post-approval confirmatory study on voxelotor. The study aims to achieve the primary endpoint of transcranial Doppler flow velocity before the end of 2019.
The company has another pipeline candidate, inclacumab, a novel fully human monoclonal antibody against P-selectin, in its portfolio. The drug is being developed as a treatment for vaso-occlusive crises (“VOC”) in patients with SCD.
Global Blood has an exclusive worldwide license agreement with drug giant, Roche Holding AG (RHHBY - Free Report) , for the development and commercialization of inclacumab.
The company expects net loss to significantly increase in the fourth quarter of 2019 on higher expenses related to the continued buildout of commercial infrastructure, as it prepares for the potential commercial launch of voxelotor, the expansion of its manufacturing efforts for the same, the commencement of additional clinical studies on the drug in SCD and the advancement of its pipeline programs, including the inclacumab program.
Zacks Rank and Stocks to Consider
Global Blood currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks in the biotech sector are Alkermes Plc. (ALKS - Free Report) and AVEO Pharmaceuticals Inc. (AVEO - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80% on average.
AVEO’s estimates have gone up from a loss of 6 cents to a profit of 1 cent for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 28.34% on average.
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