Q1 2022 Tricida Inc Earnings Call
Okay.
Good day, and thank you for standing by and welcome to the Tri Sito's first quarter 2022 financial results conference call. At this time, all participants are in a listen only mode.
After the speaker presentation, there will be a question and answer session.
Please be advised that today's conference is being recorded.
To ask a question. During this session you will need to press star one on your telephone.
If you require any further assistance please press star zero.
I would now like to hand, the conference over to your speaker today, Jackie Kaufman, Chris Cedar and please go ahead.
Thank you D D. Good afternoon, and thank you for joining the <unk> first quarter 2022 financial results and business update conference call and today's call Garrett <unk>, our founder CEO and President will provide an update on the ongoing Dallas U K D renal outcomes trial and discuss our business progress Geoff Parker our C O M C F.
Joe will discuss our financial results for the first quarter and review our financial guidance.
Please note that in today's call, we will be making various statements that include forward looking statements as defined under applicable applicable securities laws.
Are we looking statements include our anticipated activities related to our ongoing dollar CK Din renal outcomes clinical trial, including early termination of the trial anticipated endpoint event accruals and the estimated timing for receipt of top line data as well as our expectations regarding our financials runway management's assumptions expectations.
<unk> 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.
Trust me they 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 Exchange Commission.
We issued our first quarter financial results were released this afternoon, just after the close of market for copies of our press release. Please go to Www Dot Tracy the dot com and follow the link to our Investor Relations page I would also note that we have posted an updated slide presentation on the Investor Relations portion of our website that includes <unk>.
Updated information from our press release and call 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 continue to make good progress on the execution of our policy kidney renal outcomes trial as of May nine the fortunate 80 subjects randomized in the trial have an average treatment duration of approximately 25 months.
The trial is of course 233 subjects with positively adjudicated primary endpoint events.
And as you know that's end stage renal disease yesterday or greater than or equal to 40% reduction in estimate Oklahoma that penetration rate of Egfr.
As we previously reported based on our financial runway, we intend to stop the balancing of the trial early for administrative reasons in the second quarter of 2022 with continued accrual of primary endpoint events into the third quarter of 2022.
On the current event rate trend, we are updating the anticipated number of subjects was positively adjudicated primary endpoint events in the final analysis to 250 to 270.
We anticipate reporting top line results from that trial early in the fourth quarter of 2022, which would allow for approximately six months our financial runway following the announcement.
Assuming a hazard ratio of <unk> seven O.
Which corresponds to a 30% reduction in the very members placebo endpoint event, if they had 250 events in the final analysis.
<unk> 78 per cent Paula.
They're 300 events in the final analysis, the trial, because 85% switching from power to observed hazard ratio statistics, they could be successful with 250 events. If the observed hazard ratio as 0.78 Aloha.
And with 300 events, if the observed hazard ratio as 0.79 Hello.
I believe that device. He can he traveled provide interpretable data to evaluate how treatment with a very minor impact slowing of COPD progression in patients with metabolic acidosis and <unk>.
That I will turn the presentation to Jeff for an overview of our financial results for the quarter.
Thanks, Garrett our first quarter results were in line with our expectations with R&D expense of $18 $5 million and $32 $2 million for the three months ended March 31, 2022, and 2021, respectively.
Decrease in R&D expense was primarily due to decreased activities in connection with our <unk> clinical.
Clinical development program related to the manufacturing of drug substance and other clinical development costs.
G&A expense was $9 $2 million and $9 $9 million for the three months ended March 31, 2022 and.
2021 respectively.
The decrease in G&A expense was primarily due to lower legal and consulting fees.
Net loss was $29 6 million and $53 4 million and non-GAAP net loss was $22 $9 million and $38 $3 million for the three months ended March 31, 2022, and 2021, respectively.
As of March 31, 2022, cash cash equivalents and investments were $123 $7 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 topline results for valor see candy.
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 press the pound key please standby, while we compile the Q&A roster one moment.
Okay.
Our first question comes from Phil Nadeau of Cowen and company. Please proceed.
Good afternoon. Thanks for taking my questions first a financial question for you Jeff on the R&D expense it was a bit lower than we were modeling.
So it does seem like if this is your consistent R&D expense Thats, how you get to Q2 'twenty three cash runway. So are we fair to assume that R&D will be.
At similar levels kind of through at least through the end of 2022.
So Phil R&D.
For Q2, and Q3 is estimated to be similar to Q1 with an uptick in.
In Q4.
Probably up somewhere between eight and $12 million uptick in Q4, so roughly speaking that's how the year will trend out.
It's very helpful.
Second on Valor <unk>.
Just to add there.
Due to the fact that our contract with pantheon, it's somewhat lumpy.
So that's why you see that tick up in the fourth quarter in fact pay beyond ticks up then and of course, if things go as planned the valor trial will be ticking down at that time.
Got it okay.
It helps a lot with our modeling.
Second on valor.
So it looks like there were maybe 16 events that were accrued over the last two months, which is a little bit higher than.
In the past you've suggested maybe 10 to 11 events per month.
Is there any identical identifiable reasons behind that uptick or is it just the random randomness and event rates and dealing with the trial. Besides a dollar security.
So this is Gary I think you know we you know in.
The last two or three months, we do see them more than we had I think just over 20 events a month before in March and then now as you said 16 in April .
I think its still a modest uptick, but but you know we've actually that's why we updated the projected.
Projected number of primary endpoint events in the final analysis. So we went from 240 to 55.
$250 to 72 to accommodate this.
You know I would say you know the robustness that we're seeing I wouldn't say uptick.
Got it Okay, and then last question again on <unk>.
In the.
So I'd say you referenced at Kohl's.
So the hazard ratio observed hazard ratio of <unk> seven to $8 79.
For statistical significance based on events between 250 and 300.
Let's talk about assuming quite 10000 stimulations, we used to calculate those numbers can you maybe go into a bit more detail as to.
How exactly you did calculate to be observed.
Hazard ratio, that's necessary for stat, Sig, especially benefit negotiating.
It's basically to look at the random variability in our stimulation, where tens or hundreds of thousands of times you run the trial and look at the results.
And then you look at the threshold that you need to be a buffer in the case of hazard ratio below in order to be statistically significant and I think what's really I think consistent with what we've said before is at $2 15.
250 events is really a bit of a part two as you can see every 50 events. There. After I give you maybe one point or one off higher sort of special deposit base right and remember with 511 events, we would've been able to have statistical significance, but I think it is appointed.
Eight three so the hazard ratio appointed three and so you're seeing this and in this very table and I think it's helpful to.
To add a 300 event call them, yeah to illustrate and sort of the potential range of scenarios.
And in those simulations or is it just really significant.
Every time that hazard ratio or is there some threshold like cut that hazard ratio, it's statistically significant.
100%.
They always give you 99.
So something like this and so Ah I can check back with US. It was all of a statistician, but those are conservative I think estimates based on these these simulations.
The vast majority of the time it would be Patrick.
Perfect. Thanks for taking my questions.
Thanks Bill.
Thank you. Our next question comes from Jessica Fye of J P. Morgan. Please proceed.
Hey, good afternoon doesn't shale for Jess and thank you for taking our questions. So.
Couple of.
From us.
Assuming positive top line results.
Any guidance you can give us regarding how you would prepare for a potential filing an IND.
Launch further down the line internally and then.
How would you thinking about.
Extending the financial rumba, assuming positive result.
Thank you.
Yeah.
So with regards to the first part of your question, where you asked me about the timing of Resubmission and <unk> date.
Yeah, and then also is there anything you're preparing or thinking about.
To prepare for the potential launch internally, yes, yes. So we are always updating and reviewing our commercial plans commercial assumption. So we're doing that.
Over the next few months as well as we did last summer. So while we don't expect to have any significant spend on commercial.
Prior to data, we arent doing background work to to update our plans for commercial.
With regards to timing overall towards a potential commercial launch presuming we have the announcements of the valor study early in Q4, we would anticipate filing a resubmitting the NDA in Q2 of 'twenty three and have a potential <unk> date in Q4 of 2023, that's a six months.
A review for our Resubmission and then.
Roughly speaking would have a launch in Q1 of 2024, so I'm presuming positive data on seats and dollar CK D. We wont put those plans into motion later this year with regards to capital and runway as I discussed earlier, we have sufficient capital based on our current plans through.
Through the first quarter of next year into the early part of Q2 of 2023.
We also have in place.
A warrants that were related to our.
Our direct equity investment at the end of last year. So we have 7 million warrants outstanding with an exercise price of 11 and those warrants would expire.
Weeks after the announcement of Valor CK D data if in fact, our stock price trades above $15 per share with a certain volume requirement, but assuming a good reaction to the valor positive data.
We would have the opportunity to bring in $77 million through the exercise of those warrants which would take us.
Into late 2023 with regards to capital and I think with regards to any further.
Additions to capital, we'll we'll address that after we receive and announced the valor CK need data.
Yeah.
Okay.
Operator.
Thank you. Our next question comes from Madhu Kumar of Goldman Sachs. Please proceed.
Hey, guys. Thanks for taking our question. This is Rob on for Madhu I was just wondering.
Is there anything that would change your expectation for the top line data like quick.
Quicker accrual of events or slower or is that.
<unk> already set in stone.
Yeah I think.
Yeah, just to remember the.
The top line data is driven by our.
Our balance sheet, and you know and really sort of what we've discussed around.
The administrative stop.
That this is really you know it.
Six months of cash left and it's not driven by targeting a certain number of events. So then the cool.
Has really nothing to do with the timing of the administrative staff and corresponding of the the timing of top line data.
Okay. Thank you and then just one other question.
What would be the cadence for data release posted top line.
Yeah.
I think a very traditional.
You know I think we will obviously.
Obviously, you look at the primary endpoint and that are you know and then as we've said you know between you know what's appropriate to to put it into the initial personal needs what's appropriate and you know I think you know if it's positive data obviously into one of the top journals.
We're not going to reinvent the playbook here.
Alright, thank you.
Thank you at this time I'd like to turn it back to Jackie Kaufman for closing remarks.
Thank you D D and thank you all for joining us today as always if you have additional questions. Please don't hesitate to email us at IR at <unk> Dot com, Thank you and goodbye.
Okay.
Thank you. This concludes today's conference call. Thank you for participating and you may now disconnect.
Yeah.
Okay.
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