Reata Pharmaceuticals , Inc . (RETA Quick Quote – ) reported a loss of $2.35 per share for the fourth quarter of 2021, up from the Zacks Consensus Estimate of $2.31.
However, these losses include stock-based compensation and non-cash interest expense. Adjusted loss for the quarter was $1.59 per share, also up from a loss of $1.25 per share in the same quarter last year.
Total revenue, including partnership revenue, was $0.9 million compared to $3.2 million in the same period last year. Revenue was almost in line with Zacks' consensus estimate of $1.0 million.
Reata's share price has fallen 79.4% over the past year, compared to a 37.7% decline for the company.
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Full year performance
For the full year 2021, Reata's total revenue will be $11.5 million, compared to $9 million in 2020.
For 2021, the company reported a loss of $8.19 per share compared to a net loss of $7.35 per share in 2020. Adjusted loss is $5.34 per share, compared to a net loss of $4.70 per share in 2020.
Adjusted R&D expenses increased 8.6% year-over-year to $35.5 million.
Adjusted general and administrative expenses were $21.4 million, an increase of 74 percent from the same period last year.
As of December 31, 2021, the company had cash and cash equivalents of $590.3 million, compared to $713.2 million as of September 30, 2021. The company expects its cash resources to fund operations through the end of 2024, compared to the previous expectation of mid-2024.
Reata has developed its lead drug candidates – methylbardoxolone (bardoxolone) and omadaviron – for the treatment of rare chronic kidney disease ("CKD ") and neurological disorders. Reata reacquired the rights to develop, manufacture and commercialize omaveloxolone and bardoxolone from AbbVie (ABBV Quick Quote – ) in 2019.
At the same time, the company also reacquired U.S. ex-rights to bardoxolone, omaveloxolone and its proprietary Nrf2 product platform from AbbVie. Through this move, Reata may be able to record gross sales rather than royalties upon potential release if it is owned by AbbVie.
On February 25, the FDA issued a complete response letter ("CRL") to a new drug application ("NDA") for bardoxolone for the treatment of patients with CKD caused by Alport syndrome. The CRL indicates that the regulator cannot approve the NDA in its current form.
Reata continues to work with the FDA to determine the next step in the development of bardoxolone.
In December 2021, the FDA Advisory Committee opposed approval of the bardoxolone NDA, stating that the clinical data provided by the NDA did not support the effectiveness of the drug candidate in slowing the progression of CKD.
The FDA's CRL is expected to further delay the approval of bardoxolone in the United States.
Reata is also developing bardoxolone for the treatment of autosomal dominant polycystic kidney disease ("ADPKD") in a late-stage study. The company recently submitted a protocol amendment and requested a Class A meeting with the FDA to discuss plans for the development of ADPKD.
Reata is developing its other lead drug candidate, omaveloxolone, as a potential treatment for Friedreich's ataxia ("FA").
In January 2022, the company began a rolling NDA submission seeking approval for omaveloxolone for the treatment of patients with FA. The company expects to complete the NDA submission by the end of the first quarter of 2022.
Zacks Rank and Stocks to Consider
Reata currently owns the Zacks Rank #3 (Hold). Better-ranked stocks in the biotechnology space include Dynavax Technologies Corporation (DVAX Quick Quote – ) and Kaleido Biosciences, Inc. (KLDO Quick Quote – ), which currently both receiving a Zacks Rank #2 (Buy). As you can see.
Dynavax has raised its 2022 earnings forecast by 10.3% in the past 60 days. The stock has risen 40.3% over the past year.
For the past four quarters, Dynavax has exceeded earnings expectations.
Kaleido Biosciences has narrowed its 2022 loss per share estimate for the past 60 days by 11.3%.
Kaleido Biosciences has exceeded earnings estimates in three of the last four quarters and missed estimates in the other quarter.