Reata Pharmaceuticals, Inc.
RETA
reported fourth-quarter 2021 loss of $2.35 per share, wider than the Zacks Consensus Estimate of a loss of $2.31.
However, the above loss included stock-based compensation and a non-cash interest expense. Adjusted loss for the quarter was $1.59 per share, also wider than the loss of $1.25 per share recorded in the year-ago period.
Total revenues, comprising collaboration revenues, were $0.9 million compared with $3.2 million in the year-ago quarter. Revenues were almost in line with the Zacks Consensus Estimate of $1 million.
Shares of Reata have plunged 79.4% in the past year compared with the
industry
’s decrease of 37.7%.
Image Source: Zacks Investment Research
Full-Year Results
For full-year 2021, Reata generated total revenues of $11.5 million compared with $9 million recorded in 2020.
For 2021, the company reported a loss of $8.19 per share compared with net loss of $7.35 per share in 2020. Adjusted loss came in at $5.34 per share compared with net loss of $4.70 per share in 2020.
Quarter in Detail
Adjusted research and development expenses rose 8.6% year over year to $35.5 million.
Adjusted general and administrative expenses were $21.4 million, up 74% from the year-ago period.
The company had cash and cash equivalents of $590.3 million as of Dec 31, 2021, compared with $713.2 million as of Sep 30, 2021. The company expects its cash resources to fund operations through 2024-end, which was earlier expected through mid-2024.
Pipeline Update
Reata has developed its lead pipeline candidates — bardoxolone methyl (bardoxolone) and omaveloxolone — for rare forms of chronic kidney disease (“CKD”) and neurological diseases, respectively. Reata had reacquired the development, manufacturing and commercialization rights for omaveloxolone and bardoxolone from
AbbVie
ABBV
in 2019.
The company also reacquired ex-U.S. rights to bardoxolone, omaveloxolone and its proprietary Nrf2 product platform from AbbVie during the same time. With this move, Reata is likely to record total sales following potential launches instead of royalties, if they were owned by AbbVie.
On Feb 25, the FDA issued a Complete Response Letter (“CRL”) to the new drug application (“NDA”) for bardoxolone for the treatment of patients with CKD caused by Alport syndrome. The CRL indicated that the regulatory body cannot approve the NDA in its present form.
Reata continues to work with the FDA to decide the next step forward for bardoxolone.
In December 2021, an FDA advisory committee
voted
against approval of the bardoxolone NDA, stating that clinical data provided with the NDA does not support the effectiveness of the candidate in slowing the progression of CKD.
The CRL from the FDA is expected to further delay the approval for bardoxolone in the United States.
Reata is also developing bardoxolone for treating autosomal dominant polycystic kidney disease (“ADPKD”) in a late-stage study. The company has recently filed a protocol amendment and requested a Type A meeting with the FDA to discuss the ADPKD development program.
Reata is developing its other lead pipeline candidate, omaveloxolone, as a potential treatment for Friedreich’s ataxia (“FA”).
In January 2022, the company initiated a rolling submission of an NDA seeking approval for omaveloxolone for the treatment of patients with FA. The company expects to complete the submission of the NDA by the end of first quarter of 2022.
Reata Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Reata Pharmaceuticals, Inc. price-consensus-eps-surprise-chart
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Reata Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Reata currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Dynavax Technologies Corporation
DVAX
and
Kaleido Biosciences, Inc.
KLDO
, both carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Dynavax’s earnings estimates have been revised 10.3% upward for 2022 over the past 60 days. The stock has rallied 40.3% in the past year.
Earnings of Dynavax have surpassed estimates in each of the trailing four quarters.
Kaleido Biosciences’ loss per share estimates have narrowed 11.3% for 2022 over the past 60 days.
Earnings of Kaleido Biosciences have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
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