Analyst Conference Summary

Reata Pharmaceuticals

conference date: August 9, 2021 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2021 (Q2, second 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 $2.2 million, up sequentially from $0.9 million and down from $3.1 million in the year-earlier quarter.

Net income was negative $72.7 million, down sequentially from negative $na million, and down from negative $67.6 million year-earlier.

Diluted EPS was negative $2.00, down sequentially from negative $1.86, and up from negative $2.03 year-earlier. (on higher share count)


Believes cash is sufficient to fund operations through mid 2024.

Conference Highlights:

Warren Huff, CEO said Friedreich's ataxia study of omaveloxolone met endpoints, and FDA suggested in May that Reata submit an NDA and estimate the submission date, hopefully Q1 2022. Restarted commercial preparations for omaveloxolone in Q2 2021.

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.

The back-and-forth over the bardoxolone data with the FDA was covered in great detail during the call. Reata believes they satisified the FDA on all issues raised so far. The FDA acknowledged the primary analysis was carried out as pre-specified.

A pre-NDA meeting is planned with the FDA for Q3 2021 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 300 patients to a total of 550 patients and expects to complete enrollment by the end of 2021. 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.

An investigator initiated trial of Bardoxolone for kidney-related effects of Covid-19 began in Q1 2021.

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.

A Phase 2 study PHOENIX of bardoxolone methyl for CKD from four rare causes produced clinically and statistically significant results in Q1 2019. Reata also plans to pursue IgAN, T1D CKD, and FSGS as commercial indications for bardoxolone

CATALYST Phase 3 topline data for bardoxolone for CTD-PAH (connective tissue disease associated pulmonary arterial hypertension) was expected in the first half of 2020. However, for safety the trial was stopped during the pandemic (as of May 11, 2020). Primary endpoint is 6-minute walk distance. Enrollment was completed in 2019.

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 $756 million, down sequentially from $778 million. No debt.

Non-GAAP numbers: net income negative $ million, up sequentially from negative $42 million and down from negative $ million year-earlier. Diluted EPS negative $ up sequentially from negative $1.16 and down from negative $ year-earlier.

Operating expense of $62 million consisted of $40 million for R&D, $22 million for general and administrative, and depreciation of $0 million. Other expense net $13 million. Income tax benefit $0.7 million.

Q&A summary:

Do you still have analysis work to do for the FDA, or have you covered the four issues raised? We will be preparing additional analyses to support our position, but we do not anticipate having to produce any clinical data to support the application.

The Pre-NDA meeting is mainly to discuss the standards for the mechanics of the submission.

Is there a risk of the FDA requiring additional trials? We believe the data we provided is sufficient for pre-market, we will see if there will be a need for post-approval trial data.

CMC issues? We were told we would be receiving comments on manufacturing, but we have not seen them yet.

Sensitivity analysis is what the FDA used to test your data, so it is expected.

We are unclear if the FDA completed their full review of the clinical data. We have had mutliple discussions about the 28 day off treatment wash out period, and agreement on that.

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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