Tricida, Inc.

Tricida reported Q2 2022 R&D expense of $16.9 million versus $19.8 million a year ago, and G&A expense of $9.8 million versus $9.6 million a year ago. Net loss was $28.5 million versus $33.6 million, and non-GAAP net loss was $21.3 million versus $24.6 million. As of June 30, 2022, cash, cash equivalents and investments were $98.7 million. On VALOR-CKD, the company said 1,480 subjects were randomized, 281 positively adjudicated primary endpoint events had accrued, and it now expects 285 to 295 events in final analysis, up from 250 to 270 previously. Top-line results are planned for October 2022, and management said current resources should fund planned operations into early Q2 2023, about 6 months after the expected top-line announcement.

Gerrit Klaerner framed the quarter around execution on VALOR-CKD and said the trial is proceeding in an orderly fashion across almost 200 sites in over 30 countries. He said event accrual has remained consistent and is now higher than previously modeled, which management views as supportive of an interpretable final readout. His tone was confident but careful, with repeated emphasis on the primary endpoint, the October data timing, and avoiding overreliance on serum bicarbonate modeling.

Geoff Parker said Q2 results were in line with expectations, with R&D expense down to $16.9 million from $19.8 million largely because clinical development costs fell after the May administrative stop of VALOR-CKD. G&A was $9.8 million versus $9.6 million, mainly due to higher stock-based compensation expense. He reported net loss of $28.5 million, non-GAAP net loss of $21.3 million, and cash, cash equivalents and investments of $98.7 million at June 30, 2022. He said existing resources should fund operations into early Q2 2023, roughly 6 months after the anticipated October readout.

Analysts focused on why primary endpoint accrual is running ahead of prior expectations, what hazard ratio assumptions still underpin the trial, and whether the October release will include secondary endpoints. Management said the faster accrual is still within the expected range and attributed it to continued, consistent event collection as patients finish the study. On hazard ratio assumptions, Gerrit Klaerner said the company looks at multiple evidence buckets and believes the accumulated event count gives it confidence the observed hazard ratio can come in below 0.78 or 0.79. He also said the top-line release will disclose the primary endpoint and, as much as possible, secondary endpoints and safety data, but the primary endpoint is the key regulatory focus.