Analyst Conference Summary

conference date: February 28, 2019 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2019 (Q4, fourth quarter 2018)

Forward-looking statements

Overview: Bardoxolone Phase 3 trials completed enrollment.

Basic data (GAAP):

Revenue was $8.5 million, up sequentially from $5.2 million and down from $10.0 million in the year-earlier quarter.

Net income was negative $25.6 million, down sequentially from negative $30.8 million, and down from negative $16.7 million year-earlier.

Diluted EPS was negative $0.86, up slightly sequentially from negative $1.07, and down from negative $0.64 year-earlier.

Guidance:

Pivortal data from 2 trials will read out in the second half of 2019.

Conference Highlights:

Warren Huff, CEO of Reata, said "we completed enrollment in two pivotal studies, CARDINAL in Alport syndrome and MOXIe in Friedreich's ataxia. We also reported positive data from three cohorts of the PHOENIX trial in rare forms of chronic kidney disease (CKD), and announced plans to launch FALCON, a Phase 3 trial of bardoxolone methyl (bardoxolone) in patients with autosomal dominant polycystic kidney disease (ADPKD) during mid-2019."

Revenue is from partners and is down due to completing recognition of prior milestones. It is most pro-rated from earlier milestones.

Expects cash-based expenses to increase as development is accelerated and preparations for commercial launch are made. Also investing in commercial manufacturing capabilities.

The Phase 3 CARDINAL trial of bardoxolone methyl for CKD (chronic kidney disease) caused by Alport Syndrome is fully enrolled with topline data expected in the second half of 2019.

Partner Kyowa Hakko Kiri initiated a pivotal Phase 3 trial in diabetic CKD in Japan during 2018. The EU granted Orphan Drug status in May 2018.

A Phase 2 study (PHOENIX) of bardoxolone methyl for CKD from four rare causes produced clinically and statistically significant results in Q1 2019. Bardoxolone demonstrated a statistically significant improvement from baseline in mean eGFR of 7.8 mL/min/1.73m2 (p≤0.00001; n=103) after 12 weeks of treatment. Each individual cohort demonstrated statistically significant increases in mean eGFR representing recovery of multiple years of kidney function loss based on historical average eGFR decline. Reata announced the clinical trial design for FALCON, a Phase 3 study of bardoxolone for the treatment of patients with ADPKD and expects to dose the first patient in mid-2019. Reata also plans to pursue IgAN, T1D CKD, and FSGS as commercial indications for bardoxolone

Omaveloxolone for Friedreich's ataxia is in a Phase 2 registrational trial (MOXIe) with enrollment completed. Topline data should be available in the second half of 2019. Granted EU Orphan Drug status in July 2018.

CATALYST Phase 3 data for bardoxolone for CTD-PAH (connective tissue disease associated pulmonary arterial hypertension) is expected in the first half of 2020. Primary endpoint is 6-minute walk distance. Enrollment proceeding as planned.

Reata has been hiring professionals in preparation for the product launches.

Cash ended at $338 million, down sequentially from $375 million.

Operating expense of $33.4 million consisted of $25.3 million for R&D, $7.9 million for general and administrative, and depreciation of $0.1 million. Other expense $0.6 million.

Q&A:

Timing of trial results, expect one before the other? Clinical trials.gov is not updated in real time. Sticking to just second half for both trial readouts.

Competition from Otsuka CKD tolvaptan drug? The community is encouraged there is a first treatment for CKD. It varies by nephrologist. There are over 100,000 PKD patients. Our mechanism of action is very different. There should be significant uptake for any new therapy.

Falcon DPKD trial? Gating activity is the usual, we already have feedback from regulators, we are developing sites. On track to start dosing midyear. Very similar to Cardinal trial.

We have not seen any significant changes from a maximum dose, though we did see some indications of that in early trials. May be from specific conditions of those patients. We conducted a series of analyses so it should not be a factor in the Cardinal study.

Sales force buildout? We have been building the leadership team. We have 100% of the commercial rights for bardoxolone for CKD in the US.

Bardoxolone pricing v. tolvaptan? The Tolvaptan profile is very distinct. Our trials increase gfr on trial and then retain later. Bard looks more effective and is safer. No comment on pricing.

Omav? Phase 2 could support approval if positive, per FDA guidance. We are already prepping commercial activity for Friedreich's ataxia.

A whole series of other mitochondrial related diseases might be treatable by Omav.

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