Analyst Conference Summary

conference date: November 8, 2022 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2022 (Q3, third quarter)

Forward-looking statements

Overview: Looking forward to FDA decision in late February.

Basic data (GAAP):

Revenue was $0.5 million, down sequentially from $0.8 million and down from $7.4 million in the year-earlier quarter. All revenue is from collaborations.

Net income was negative $79 million, down sequentially from negative $74 million, and down from negative $72 million year-earlier.

Diluted EPS was negative $2.16, down sequentially from negative $2.02, and down from negative $1.97 year-earlier.

Guidance:

Cash good through end of 2024.

Conference Highlights:

Warren Huff, CEO said "FA is a relentless, dehabilitating muscular disorder which affects approximately 4,000 diagnosed patients in the United States. There are no approved therapies for these patients... (who typically) pass away from the disease in their mid-thirties. Omaveloxolone PDUFA date is now February 28, 2023." Reata is preparing for commercial sales, is hiring a team.

The PDUFA date for omaveloxolone for the treatment of patients with FA (Friedreich's ataxia), with priority review designation, is now February 28, 2023. This NDA is supported by the efficacy and safety data from MOXIe Part 1, Part 2, and MOXIe Extension studies. There will not be an Advisory Committee meeting. Fast Tracked. Rare Pediatric Disease designation. There is currently no approved therapy for Friedreich's Ataxia. Plans to submit an MAA to the EU in Q4 2022.

An FDA Complete Response Letter was issued for Bardoxolone for Alport Syndrome CKD (chronic kidney disease) on February 25, 2022. Problem is disease is slow and EGFR is not considered a clinical endpoint by all physians, or the Advisory Committee. Could be fixed by a large Phase 3 trial in Japan in biabetic CKD with new primary endpoints of dialysis delay. The Japanese Ayame trial follows patients for 3 years and should complete enrollment in 2022. Reata is working with the FDA on next steps. In October 2021 made submission to EU. Reata is actively preparing commercial teams for bardoxolone, including beginning discussions with payers.

During the latest meeting, the FDA indicated that post-marketing requirements and label review are ongoing. With respect to post-marketing requirements and commitments, FDA stated that if omaveloxolone is approved, they anticipate requiring a drug-drug interaction trial with CYP3A4 modulators, a thorough QT trial, and an evaluation of pregnancy outcomes.

Reata REACH program will help FA patients get therapy, including commercial copay assistance.

The Phase 3 Falcon study of bardoxolone in autosomal dominant polycycstic kidney disease (ADPKD) is enrolling. The FDA has confirmed that postive Falcon study results would support registration. The protocol was amended to a primary endpoint of eGFR change from baseline at week 108. At end of Q3 2022 605 of the planned 850 patients had been enrolled.

Preclinical work indicates omaveloxolone may be applicable to progressive suprnuclear palsy, ALS, Parkinson's, frontotemporal dementia, Huntington's, Alzheimer's, and epilepsy.

Completed a Phase 1 study of RTA 901 for Diabetic Peripheral Neuropathic Pain (DPNP) in healthy volunteers with positive PK results in Q1 2021. Currently in Phase 1 pharmacology study. Plans a Phase 2 study in Q4 2022 which will be randomized and placebo controlled.

Cash ended at $436 million, down sequentially from $481 million. No debt.

Non-GAAP numbers: net income negative $54 million, down sequentially from negative $na million and down from negative $46 million year-earlier. Diluted EPS negative $1.47 up sequentially from negative $na and down from negative $1.27 year-earlier.

Operating expense of $71 million consisted of $43 million for R&D, $27 million for general and administrative, and depreciation of $0.3 million. Other expense net $9 million. Income tax $0 million.

Q&A selective summary:

Are you still in labelling discussions with the FDA? The FDA stated that label review is underway. Our proposed label language was stale due to the major amendment, we offered to offer proposed changes, which they said they would like. We will be submitting our label proposed language very soon.

If the FDA approves the drug, they have a process for post-marketing requirements and the specific label. They did not raise any new isues for approval, but did say existing issues were under continuing review.

Pediatric trial plans? We reached an agreement for the EU for pediatric care in order to submit the application for adults to them. We would like to be able to lower the age range in any future label. The FA community is eager to have the drug available to patients under the age of 16.

We plan a post-marketing registry study to cover some of the FDA requests.

Manufacturing? We are working with a couple of contract manufacturers. We believe they will be ready for the launch.

Commercialization in Europe? We plan to launch it ourselves. We have hired our leadership team there.

Bardoxalone? Disappointed with CRL. Principle issue is novelty. Improvements in EGFR is a new approach, which raises questions about the mechansism. The Japanese study should answer those questions. It is large and each patient is on drug for 3 years, so the data could be important in engaging with regulatory agencies and the nephrology community.

It does take time, a few weeks, for payers to update their policies after an FDA approval.

The FDA did not provide a specific reason to cancel the Advisory Committee meeting, but the context is our mid-cycle meeting provided sufficient data for approval without an Ad Com.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: