Q3 2021 Tricida Inc Earnings Call
And welcome to the choice to the third quarter of 2021 financial results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question answer session to ask a question. During this session you will need to press star one on your telephone please be advised that today's conference is being weak.
Gee, if we acquire any further assistance please press star zero.
I'd like to turn the call over to our speaker today, Jackie Cosman of choice either you may begin.
Good afternoon, and thank you for joining the <unk> third quarter 2021 financial results and business update conference call and today's call Garrick learner, our founder CEO and President will provide an update on the ongoing valor.
Come to trial and discuss our business progress Geoff Parker, our C. O O N CFO will discuss our financial results for the third 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 securities laws forward. Looking statements include our anticipated activities related to our ongoing dollar secretly renal outcomes clinical trial, including early termination of the trial and our expectations regarding our financial runway management's assumptions and X.
Spectation 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.
Tracy they can give no assurance that these statements will prove to be correct and we do not intend and under.
Takes 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 third quarter financial results press release. This afternoon, just after the close of the market for copies of our press release. Please go to Www Dot Tracey just dot com and follow the link to our Investor Relations page at this time I'll turn the call over to Gary. Thank you Jackie and thank you all for joining us today I'd.
I'd like to first Toronto announcement today regarding our plans for future administrative staff on valor.
We have spoken previously about the potential need to stop the trial early based on insufficient financial resources.
So on the press release, we believe that there is a substantial likelihood.
Not have adequate resources or be able to obtain such resources on reasonable terms and a necessary timeframe to continue about I think I need to reach the current target of 511 subjects is positively adjudicated primary endpoint events, which we anticipate would not be reached until 2024.
As such we have considered various options to terminate.
Early trials he never requested and was granted a type a meeting with the FDA to discuss.
The purchase of stopping the trial early based on financial resources, and the procedures, but study close out we.
We believe that we must be clear and helpful feedback and the FDA is preliminary comment which allowed us to cancel the actual Taipei meeting.
Among the alternatives to the FDA indicated that stopping but I was thinking you for administrative reasons pursuant to the existing protocol is likely to provide the most complete and interpretable data reduce the risk of missing data required for key efficacy analysis and maintain the integrity of the trial.
The exact timing of the administrative staff will be determined by our financial runway, we anticipate that administrative stuff would occur in the first half of 2022.
Our goal is to have approximately six months, our financial runway upon receipt of the biotech any data also based on feedback from the FDA, we will halt enrollment of additional patients in the trial in order to focus resources on maximizing of the duration of follow up and subjects currently enrolled in the trial.
I would like to emphasize that the.
Timing for stopping the trial has not yet been determined we are evaluating our financial runway and trying to have additional information on when to stop the trial as we move into the new year.
We believe that even with an early termination we can address the most important that the kidney trial objectives.
<unk> made good progress to date and the accumulation of primary endpoint events and intend to continue our focus on successful execution of the trial.
Remind us I think it is a renal outcomes trial designed to show that treating metabolic acidosis.
Their American slow take any progression.
Pardon me I apologize the cost and time to first occurrence of confirmed D. D 40 of it behind us.
We know that he is already integrated with a 40% reduction in Egfr.
We made very good progress in the trial to date, we have randomized over forecast 70 subject, but an average treatment duration of approximately 19 months.
<unk> hundred 59 subjects with positivity adjudicated primary endpoint events.
It puts us on track, though of Enphase protections and we still anticipate that we will reach to one.
50 subjects with primary endpoint events by approximately mid 2022.
However, we anticipate that administrative stop would occur in the first half of 2022, accordingly, and not likely to conduct the protocol specified time 50, then interim analysis.
We remain excited about the prospects of all of us at kidney.
Given the results comparable that's right in our own studies, even with a fewer number of primary endpoint events than originally contemplated we believe that they have a chance to reach our main trial objectives.
First and foremost our goal is to show as long a progression of chronic kidney disease. That's out there now 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 third quarter results were in line with our expectations with R&D expense of $26 6 million and $43 million for the three months ended September 32021, and 2020, respectively.
The decrease was primarily due to decreased activities in connection with our <unk> clinical development program related to manufacturing process optimization and the manufacturing of drug substance.
G&A was $9 1 million and $29 3 million for the three months ended September 32021, and 2020, respectively.
The decrease was primarily due to decreased administrative activities in connection with our <unk> clinical development program, including pre commercialization medical affairs and personnel costs.
Net loss was $39 $7 million and $77 7 million and non-GAAP net loss was $30 7 million and.
And $64 3 million for the three months ended September 32021, and 2020, respectively.
As of September 32021, cash cash equivalents and investments totaled $146 $8 million.
We have a $200 million three 5% convertible senior note outstanding with a maturity date of 2027.
At September 32021, we had approximately 50 million shares outstanding.
We believe our current financial resources will fund our planned operations through 2022, we will however continue to evaluate our financial runway over the next several months as we consider the timing for the administrative stop of Valor <unk> in the first half of 2022.
As Garrett has indicated we plan to make a decision on the timeframe for stopping the trial as we move into the new year.
With that I will turn the call over to the operator for questions operator.
Okay.
As a reminder to ask a question you will need to press star one on your telephone to read your question press the pound key.
Our first question comes from the line of.
Jessica Fye from Jpmorgan.
Hi, Good afternoon. This is Daniel for Jessica Fye. Thank you for taking my question first could you elaborate for us how stopping the trial early would reduce the risk of missing data required for efficacy analysis.
[laughter].
Yes. This is Gary.
No I think it is.
And when you when you stop the trial early there's this off not capturing all the information.
You know that was collected in the trial and to create bias. So I think what but does it just meant to say that but in the scenario of an early stop we are working on procedures and have input from FDA in regards to.
How does that.
Minimize the chance for bias.
And to maximize the probability of the data.
Such activities.
Really sort of.
Minimizing missing data.
Okay.
I don't know if there is a good way of phrasing it but it seems that.
Thank you.
Your odds of success to push that trial at least a little closer to completion.
And I'm sure it's possible that their investors feel more comfortable in investing behind those types of success. When the trial allowed to run longer is that an option in your mind raising additional capital to Brian to try a longer and if not all the way to completion.
Hi, This is Jeff I would just emphasize again that we remain comfortable with the progress of the trial and we remain comfortable that given our expectations for the performance of the trial that even with six months of cash remaining at the result of the receipt of the data we should be in good position.
So as of now we're very comfortable with our financial position and what that can lead to in getting the readout on valor Kitty.
Okay and last one Gary you mentioned.
That this will be able to address and most important objectives can you elaborate for those perhaps on what those objectives are.
Really that means that we hit the primary and secondary endpoint.
Off the trial.
Okay, great. Thank you.
Our next question comes from the line of Peter Coleman.
Hi, Thank you for taking my question and congrats on the alignment with the FDA. So my question is about the is that right.
So far still been tracking with the estimated accrual timeline based on your internal forecast.
Is it continuing to look linear even.
Yeah.
Patient recruitment get to completion.
Yeah, Thanks for that.
Knowledge mind off of really you know I think are aligning with FDA that there wasn't important.
Step for us on an important topic, you know and how to facilitate the early stop and and to really have a productive interaction.
With the FDA. So we are excited about it and I appreciate you acknowledging it.
Yes. So the events are exactly as we had forecasted and if you go to our corporate.
Patients when you look at that curve, we're right on it so that that is really really good news and <unk> and I think that could be.
We are following that that projection.
And as a note.
David we have updated the deck. So if you go to our corporate website Slide 15, you can see the 159 subjects that Garrett referenced earlier is on the chart and it's right in line with our expectations.
Thank you so much.
Yes.
Our next question comes from the line of Joseph <unk> from Needham and company.
Hi, everyone. Thanks for taking our questions.
From us.
Can you just sort of update your.
In the past you've given.
Some nice back.
Background on hazard ratios and probabilities of stopping at various.
That interim analysis.
And then given your updated guidance today on an administrative staff.
Has that changed in terms of the powering.
And sort of the probability of us.
Our success.
Based on your hazard ratios and your powering assumptions, maybe you could provide some updated guidance on that and then secondly on.
You commented that you plan to make a decision.
Stuart in terms of exactly when to stop the.
Trial early yes could you elaborate a little bit more on what factors are going into that is it does it does.
Based on cash runway or or would you.
We'd like to get to a certain.
Certain number number of patient.
That would be helpful. Thank you.
Yeah No. Good question, Ryan I think the all of the assumptions all the statistical considerations and all the education that we've done over the past month.
All of this is still valid and the pickup.
But just to be clear from a regulatory perspective and from a protocol perspective in order to get to basically you know.
Interpret all the data, even though you pre specified the certain number of events and now you are using.
Yeah.
Smaller number of events that number can only be driven by your financial sort of runway. So you can say, hey, I'm aiming for a certain number of events. So we are very careful to follow the protocol and the rules of an administrative staff. So that we can't really match.
Somebody has the interpreter will any of the data.
But again everything in our corporate presentation. That's it's still there because it's still applies but we want to be very clear that in the context of the modalities of an early stopping and is solely driven by the by the financials.
And again, we need some time because look I mean I've been doing this for 20 plus years.
I don't remember the last time, you get you know a preliminary Ah Wesson comments from some from FDA and ER and that basis. You are you basically don't meet the actual meeting. So this just happened so give us some time.
In preparation mode for the actual type a meeting.
Which which now because they still happy but with quite frankly the off on this from the preliminary but those bonds that we are we are not proceeding with them. So it gives us a chance to work through all of the other.
A financial aspect that determined not to how but when they go on to stop.
Great. Thanks for taking my question.
Yeah.
There are no further questions at this time, please continue Ms Jackie.
Thank you and thank you all for joining us today and as always if you have additional questions. Please don't hesitate to email us at IR at <unk> Dot com, Thanks, again and goodbye.
Ladies and gentlemen, this concludes today's conference call. Thank you everyone for participating you may now disconnect.
Yeah.
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