Analyst Conference Summary

Reata Pharmaceuticals

conference date: November 8, 2021 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2021 (Q3, third quarter)

Forward-looking statements

Overview: Continues to prepare for bardoxolone for FA FDA filing in Q1 2022, while PDUFA for Alport Syndrome is February 25, 2022.

Basic data (GAAP):

Revenue was $7.4 million, up sequentially from $2.2 million and up from $1.4 million in the year-earlier quarter.

Net income was negative $72 million, down sequentially from negative $73 million, and down from negative $66 million year-earlier.

Diluted EPS was negative $1.97, up sequentially from negative $2.00, and down from negative $1.94 year-earlier.


Cash good through mid 2024.

Conference Highlights:

Warren Huff, CEO said "The FDA scheduled an Advisory Committee meeting for our NDA on December the eighth, and we have been actively preparing." Preparing for launches.

An FDA Advisory Committee meeting for Bardoxolone for Alport Syndrome CKD is set for December 8, 2021. In October 2021 made submission to EU.

In April 2021 the FDA accepted the NDA for bardoxolone for Alport Syndrome, setting a PDUFA date of February 25, 2022. The Phase 3 CARDINAL trial of bardoxolone methyl for CKD (chronic kidney disease) caused by Alport Syndrome reported positive topline 2-year data in Q4 2020. The study showed that improved kidney function continued in the third year of treatment, and the largest treatment effect was observed in pediatric patients. Reata is actively preparing commercial teams for bardoxolone. An Advisory Committee hearing is anticipated. A milestone pament was earned from Kyowa Kirin from the NDA submission in Japan for CKD caused by Alport syndrome. The EU application is planned for Q4 2021.

Bardoxolone Also is under review in Japan in partnership with Kyowa Kirin.

For omaveloxolone for Friedreich's Ataxia the plan is to submit the NDA in Q1 2022.

Reata is planning to amend the FALCON protocol to increase the target enrollment from 550 patients to a total of 700 patients and expects to complete enrollment in mid 2022. This is for Bardoxolone in Autosomal Dominant Polycystic Kidney Disease (ADPKD). As of Feb. 2021 over 220 patients had been enrolled. Each patient is followed for 2 years.

The Phase 2 BARCONA IST study of bardoxolone in patients with COVID-19 is enrolling. It is a randomized, double-blind trial that will enroll approximately 40 patients with a primary endpoint of safety and treatment duration of up to 29 days in hospitalized patients.

The MERLIN Phase 2 study of bardoxolone in CKD with risk for rapid progression began in February 2021 with data expected before the end of 2021.

Completed a Phase 1 study of RTA 901 for Diabetic Peripheral Neuropathic Pain (DPNP) with positive results in Q1 2021. Plans both an additional Phase 1 study in Q2 2021 and a Phase 2 study in Q4 2021.

Cash ended at $713 million, down sequentially from $756 million. No debt.

Non-GAAP numbers: net income negative $46 million, sequentially from negative $na million and down from negative $44 million year-earlier. Diluted EPS negative $1.27 sequentially from negative $na and down from negative $1.31 year-earlier.

Operating expense of $65 million consisted of $39 million for R&D, $26 million for general and administrative, and depreciation of $0 million. Other expense net $14 million. Income tax benefit $0 million.

Q&A summary:

Any additional questions from the FDA on Alport? We won't comment further on day to day discussions with the FDA. We dislosed their questions last quarter. Biggest questions for Ad Com will be known after we get the FDA briefing document: 4 issues, no safety concerns. We will be prepared to address their questions. GFR change over time is the key item.

We would expect the FDA briefing document a couple of weeks before the meeting, it will be disclosed to the public 48 hours before the meeting.

Though there is a decline in effectiveness over time after treatment ends, it remains above baseline, whereas untreated patients continue decline.

Merlin trial updates? Results delayed until Q1 2021.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.

Copyright 2021 William P. Meyers