Q4 2021 Tricida Inc Earnings Call

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Good day and thank you for standing by welcome to proceed as fourth quarter 2021 financial results conference call.

At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded.

For you acquire any further assistance please press star zero.

I'd now like to hand, the conference over to Jackie Kaufman with Christina Please begin.

Thank you Donna and good afternoon, and thank you for joining the <unk> fourth quarter 2021 financial results and business update conference call and today's call GERD cleaner, our founder CEO and President will provide an update on our ongoing valor she could do renal outcomes trial and discuss our business progress.

Geoff Parker, our C O O and CFO will discuss our financial results for the fourth quarter and review our financial guidance.

Please note that in today's call, we will be making forward looking statements. Various statements that include forward looking statements as defined under applicable securities laws forward. Looking statements include our anticipated activities related to our ongoing valor TKD renal outcomes clinical trial, including early termination of the trial and the estimated timing for receipt of.

Top line data and our expectations regarding our financial runway management's assumptions expectations and opinions reflected in these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from any future results performance or achievements discussed in or implied by such forward looking statements.

It can give no assurance that these statements will prove to be correct and we do not intend and undertake no duty to update. These statements. We also urge you to read the risks and uncertainties associated with our business that are described in our filings with the Securities and Exchange Commission, we issued our fourth quarter and year end financial results press release. This afternoon, just after the close of market.

Copies of our press release, please go to Www Dot Tracy the dot com and follow the link to our Investor Relations page at this time I'd like to turn the call over to Gary.

Thank you Jackie and thank you all for joining US today, we're making good progress on the execution of volatility against the backdrop of a pandemic and a war you have managed to remain on track with our projections. So pardon me endpoint events in the valor <unk> trial.

Enrollment was completed at the end of 2021 with 14080 subjects randomized.

March 28.

And then my subjects had an average treatment duration of approximately 24 months.

The trial is a code 217 subjects, but positively adjudicated primary endpoint events defined as Reno to end stage renal disease or greater than or equal to 40% reduction in estimated gold that penetration rate.

As we previously reported based on our financial runway, we intend to stop device to get the trial early for administrative reasons in the second quarter of 2022.

Continue to cool primary endpoint events into the third quarter.

Anticipate reporting top line results from the policy can he trial early in the fourth quarter of 2022.

Which would allow for approximately six months of financial runway following.

Right.

We continue to believe that the valor trial will provide interpretable data to evaluate how treatment with irma impacts slow enough ticket he progression in patients with metabolic acidosis and ticketing.

All calculations show approximately 80% power, assuming a hazard ratio of <unk> seven O and given the results from prior literature, we believe that even with a fewer number of primary endpoint events.

Literally contemplated if you have a chance to reach our main trial objectives.

With that I'll turn the presentation to Jeff for an overview of our financial results for the quarter.

Thanks, Garrett and thank you all for joining US today, our fourth quarter results were in line with our expectations with R&D expense of $36 $8 million and $27 $3 million.

For the three months ended December 31, 2021, and 2020, respectively.

The increase in R&D expense was primarily due to increased activities in connection with our <unk> development program related to manufacturing process optimization and the manufacturing of drug substance.

G&A expense was $9 $1 million and $21 $8 million for the three months ended December 31, 2021, and 2020, respectively.

The decrease in G&A expense was primarily due to restructuring costs incurred in 2020 and to decrease administrative activities, including reduced pre commercialization and medical affair activities in 2021.

Net loss was $50 million and $54 $8 million and non-GAAP net loss was $41 $1 million and $37 $4 million for the three months ended December 31, 2021, and 2020, respectively.

As of December 31, 2021, cash cash equivalents and investments were $156 million.

We believe our current financial resources will fund our planned operations into early in the second quarter of 2023, which is anticipated to be approximately six months from the announcement of top line results for valor CK D well.

With that I will turn the call over to the operator for questions operator.

Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key.

Please standby, while we compile the Q&A roster.

Our first question comes from Sergey <unk> from Needham <unk> Company. Your line is open.

Okay.

Yeah.

Sir Your line is now open.

Okay.

Yes.

Why don't you so our next question.

Our next question comes from Jessica Fye. Your line is now open.

Yeah.

Hey, there good afternoon, and thanks for taking my question.

Can you just recap the number of events you expect to have when you conduct the administrative staff and when you expect that to occur.

Yeah.

Jessica I think obviously, the administrated stopped as determined by our cash bonds and not you know not by a particular number of events and I think give it a cash bond I think we expect to accrue approximately 240 to 150 events.

I think with 2017, but pretty close we've been I think accruing on average over the last 15 months between 10 and 11 events.

And we expect to accrue into.

Into the third quarter. So so we feel pretty good about.

Our ability to reach you know that that number of approximately 240 to 250 patients with primary endpoint events.

Great. Thank you.

Thank you.

Our next question comes from Sergey <unk> with Needham <unk> Company. Your line is now open.

Okay.

Okay.

Sergey are you there.

Yes.

Our next question comes from Phil <unk> with Cowen. Your line is now open.

Good afternoon, Thanks for taking our questions just a few from US first on the situation Eastern Europe .

When we talked last you were assuming that no more events, we're gonna be accrued from the Ukraine.

Due to the.

Unfortunate war there what is the most recent update or have those events in fact stopped accruing from Ukraine or are you actually still seeing some patients go to the clinic.

You know I think in our projections, we are not counting on any additional event.

From Ukraine, I think you know as you've said sort of you know it's a very unfortunate situation. It's a very serious situation and we I think so you know we see bravery and from the Ukrainian people across the board. We do have some patients actually showing up for study visits.

I don't think we have a crude any additional events and that's a longer process and again, we don't we don't rely.

In any event from from Ukraine that would be pure upside.

And we I think we're comfortable with the 240 to 250 to 55 number without any events coming from Ukraine.

That's very helpful and what about the neighboring countries such as Poland any disruptions due to.

Due to the refugee crisis or any other issues in those countries.

And we haven't seen any any impact and we would hope that oh.

NATO it wouldn't get involved because they may have a bigger problem and all that are at hand, but but again I think so far we've seen the disruption really.

Limit it to two Ukraine.

Perfect.

Second question is on <unk>.

The process of the administrative staff. Thank you send your prepared remarks, you can stop the study in Q2.

But continue to accrue.

Defense through Q3 with the data in Q4, so I guess, what does the stopping and how do you continue to accrue events.

So stopping the study.

I think that our at the study stop we would basically ask decides to have the patients come in for a final study visit and obviously during those visits that patients can have either confirmatory events or Additionally index events.

And I think the way we've structured it as that.

Shortly before the database lock, we would we would still allow for for those visits to happen.

And for those events to be confirmed.

To maximize really the amount of follow up that they're getting from this study and so we.

I think it's a it's pretty common practice.

Even under a normal wind down that sort of up to a month or two before database lock you you do them.

Yeah.

Basically cool events and collect data.

Perfect.

Third question is on the true hazard ratio in your prepared remarks, you mentioned, 80% power to detect a hazard ratio of <unk> seven.

Curious to get your updated thoughts if there are any on what you think the true hazard ratio.

Is based on the academic literature and your own experiences print seven approximately where do you think it's likely to fall out or is there a chance it could be even more.

Yeah, I think some of the academic studies, you know, that's where I would say single center trial, but not necessarily double blind randomized in all cases, they showed hazard ratios that were significantly smaller.

And as we've said we would not rely on that so we're quite comfortable with them.

<unk> seven mm and I think yeah, I think it could it could be lower than that.

But from a statistical perspective, yeah. That's I think an important threshold also pharma clinical significance perspective, I think this is the right threshold and so.

We are.

Still very confident that that's the bar we can reach.

Perfect domestic I'm sorry last question from US is on the FDA filing process.

Once you have the data should they be positive.

Long would it take you to particularly the funding and are there additional conversations you'd have to have with the FDA in order to be able to.

To file.

Yes, I think we are.

We continue to look at that you know and.

Obviously is a clear are and the more positive data.

The less need to delay the submission and as part of the submission obviously, there's a you know there's a pre NDA submission meeting.

It's more of a mechanical but but so I think sort of the clearer the resolve the more we're going to run towards Resubmission.

Perfect. Thanks for taking our questions.

Yes.

Thank you as a reminder to ask a question Thats Star one.

And I'm currently showing no further questions at this time I'd like to hand, the conference back over to Jacky.

Kaufman for closing comments, thank you Norma and thank you all for joining US today as always if you have additional questions don't hesitate to E mail us at IR at <unk> Dot com, Thank you and goodbye.

Ladies and gentlemen, thank you for your participation in today's conference you May now disconnect everyone have a wonderful day.

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