Global Blood (GBT) Q4 Earnings Miss, Voxelotor Gets FDA Nod

Global Blood Therapeutics, Inc. (NASDAQ:GBT) incurred a loss of $1.73 per share in fourth-quarter 2019, which was wider than a loss of 93 cents in the year-ago quarter and the Zacks Consensus Estimate of a loss of $1.22. The loss excludes a gain on lease modification of $8.3 million.

The company’s sales of $2.1 million, driven by initial sales of Oxbryta, beat the Zacks Consensus Estimate of $1 million. The company did not generate product sales in the fourth quarter of 2018.

Research and development expenses in the fourth quarter were $65 million, up 76.6% year over year. The increase can be mainly attributable to higher employee-related and elevated costs associated with the company’s sickle cell disease (SCD) program for Oxbryta, increased expenses related to preclinical research and manufacturing activities for inclacumab, and a $20 million upfront payment incurred in December 2019 related to its Syros collaboration agreement.

Selling, general and administrative expenses were $44.6 million, up 191.5% year over year. The increase was due to higher employee-related costs including non-cash stock compensation expense, and increased professional and consulting services associated with the build-out of the company's commercial operations and launch of Oxbryta.

Shares of the company have gained 22.8% year to date against the industry’s 8.5% decline.

2019 Results

Loss came in at $4.71 per share wider than the loss of $3.41 in 2018.

The company’s sales were $2.1 million. The company did not report any revenues in 2018.

Pipeline Update

In November 2020, it received FDA approval of Oxbryta for the treatment of SCD in adults, and children 12 years of age and older. The accelerated approval came three months before the action date of Feb 26, 2020. Oxbryta is the first treatment that specifically targets the root cause of SCD. Oxbryta was available to patients and physicians through GBT’s specialty pharmacy partner network within days after approval.

It initiated the HOPE-KIDS 2 study, a post-approval confirmatory study using transcranial Doppler flow velocity to assess the ability of Oxbryta to decrease the risk of stroke in children 2 to 15 years of age.

The company also initiated a dose-optimization study designed to explore the potential safety and tolerability of Oxbryta at doses higher than 1500 mg.

It 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 in patients with SCD.

Zacks Rank and Stocks to Consider

Global Blood currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector include Agenus Inc. (NASDAQ:AGEN) , Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Aduro Biotech Inc. (NASDAQ:ADRO) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Agenus’ loss per share estimates for 2020 have narrowed from $1.37 to $1.25 in the past 60 days. The company delivered a four-quarter positive earnings surprise of 23.79%, on average.

Regeneron’s earnings per share estimates have moved up from $26.76 to $28.31 for 2020 and from $28.61 to $28.93 for 2021 in the past 90 days. The company delivered an average positive earnings surprise of 1.44% in the trailing four quarters.

Aduro’s loss per share estimates for 2020 have narrowed from 86 cents to 77 cents in the past 60 days.

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