Q2 2020 Tricida Inc Earnings Call
I see that second quarter financial results conference call at this time, a participant lines on listen only mode. After the speaker presentation. There will be a question and answer session to ask a question. During the session you need to press star one on your telephone.
If you acquire any further assistance. Please press star zero I when I like to have the conference call over to Jackie Cosmos Senior Vice President Investor Relations and communications for trace Theater. Please go ahead ma'am.
Thank you Dr. Good afternoon. Thank you for joining the Tracy does second quarter Twentytwenty financial results Conference call today's call, Gary Claire, our founder CEO and President will discuss our business calibre and Jeff Parker. Our CFO will then discuss financial results for the first quarter for the second quarter.
Please note that in today's call, we will be making very statements that include forward looking statement as defined under applicable securities laws.
Forward looking statements include anticipated activities related to R&D filings, including the assigned to difficulties and anticipated communication from the FDA regarding the status of our application, including the potential receipt of a complete response letter the potential Approvability also there through the.
Accelerated approval program, our commercial and medical Affairs education activities, the conduct of Arbella Schicchi confirmatory post marketing trial, including the timing of the interim analysis and anticipated completion. This study financial guidance and other statements that are not historical facts.
Managements assumptions and 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 results.
Future results performance or achievements discussion or implied by such forward looking statements.
I see that 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 is described in our filings with the Securities and Exchange Commission.
For a copy of our press release that was issued prior to this call. Please go to www Dot Tracy just dot com and follow the linked quarter Investor Relations page at this time I'll turn the call over to Gary.
Thank you for joining us today on our second quarter financial results call.
In today's call will cover four topics.
A recap of where we can that be a communication.
Second an overview of unchanged fundamentals and the data supporting the safety.
I see a potential.
Uh huh.
Third the summary of feedback from an apartment community on the unmet medical need that kind of like us.
And the desire or whatever.
And finally, an overview of apart.
Ongoing biosecurity trial.
I'll begin with a quick review of European notification, we received recently and all expected next steps.
With these doesn't drive working so do you have you identified deficiencies during his review at the very when did that discussion of labeling and post marketing requirements commitments at this time.
Yes, you stated that the notification of Nok looks like the final decision on information under review.
I did not provide any further information clarity around the nature of the issues and the lines a letter or any guidance on timing on when they would provide additional information regarding.
Hi.
Early assume that when do you have to does provide additional correspondents regarding the identified today deficiencies it will likely come on or before putting a goal date of August facing.
And why do you have no additional information so since his wife working its way 20 notification. We believe we are likely to receive clarification on their issues in the form of a complete response letter with Euro and I'm like we did we will receive approval to market the very much in the United States on all the new logo on it.
Sure and continue to be surprised and disappointed by this certification from the idea.
We'll be prepared to address the abuse outstanding issues and plan to probably the class.
Heating Richard ran it typically dissolved in the meeting with you in 30 days or Chris and submission of our briefing materials.
He's worked closely with the FDIC during the very much for them to gain approval could accelerate a little color.
Our goal is to continue this cloud isn't going.
Any issues that the a few raises in the future.
Well, we will work to 80% decided by the FDA is important to note that because you need to believe that the fundamental offer their remote itself.
So it actually many are for the hardest believes that the verma continues to have an attractive compelling and positive benefit risk profile.
As a reminder, ahead some of the described not to land the publication.
So there ever showed a statistically significant increases in my comment Misperceive aborted btwob and as we 52.
He was here for your Wonder why do you Trust.
No over there and I was well tolerated only 2.6 within of subjects on November discontinued inventory versus 9.8% of subjects emphysema and.
And it showed an adverse event profile similar to placebo.
When it make extension trial.
Census data was published we've observed notice is that going for them.
And then not observed polymer drug candidate, whose mechanism Americans limited to the geometry.
Leaves a visible fraud favorable compared to systemic drug simplify uptick that's true and something that metabolism to be excluded from human body.
Well the fundamentals of the German talking to create a need for nephew group. There we therapy for these patients when do you view it provides us with feedback.
Confirming our India will be focus and trying to resolve them as quickly as possible.
We remain committed to addressing in there.
The significant unmet medical need for patients with chronic metabolic acidosis and chronic kidney disease.
If you put option to treat the approximately 3 million patients when I made the button snow that seek an evolution as much.
As a reminder, approximately 24000 people initiate dogs this or was the kidney transplant every year.
Actually I thought was in depth, but at the end stage renal disease every year, which is more than per year that breast prostate cancer.
I mean, I'll turn it to some important that this isn't feedback that we've collected from that probably 40 specialty account managers were deployed into the regions across the United States enjoy so.
To summarize extensive.
Interest from an evolving to me about the minute walk as long as remain football.
And just the first couple weeks being deployed especially on Madison, that's the only 6000 virtual and person against women discuss mineable I got to doses disease awareness with the father and this stuff.
Significant response to engage her especially from it doesn't hearing about minimize overdoses is impressive.
Back up with that Todd.
Strong acknowledgment that minimizes the doses.
And the need for that the April safe and efficacious therapy to treat the serious condition.
Our recent ABT one with key opinion leaders have also highlight the urgent need to slow CKD progression food or even a bit of August.
There's no to six advisory boards, so do about 72 of audience.
So a strong agreement among these is harder if approved the there could be a significant benefit to patients.
[laughter] CKD anemia.
With regard to a medical affairs activities more than 5000 participants, including this fall just another health care providers have attended continuing medical education courses on topics related to minimize acidosis at least one.
Awesome and the second quarter minimal I got the doses that dotcom website, which isn't it to be only educational side Garner 14005 visit.
This feedback and activity levels among the funding to meet again clearly indicates that offer significant interest and all the treatment of metabolic wasn't doses is linked to improve physical function not just in the context of bone and myself, but related to kidney disease progression in fact, because I've forgotten Mike.
Yes, the initiation of so there should be based primarily on signs and symptoms.
Oh, well being of the pace and not just so I'm not telling us such as in June.
Subjective and objective measures such as the first thing is.
Oh patient features and functions.
Well then in the Das initiation decision.
I'll now turn to an update on most modern drive Odyssey duty begun to anybody that we are on track to complete enrollment in this trial in the first half of 2021.
Ultimately the dollar CKD trial design to answer the question, Ken There must most ticketing for western sewage treatment mineable I got the doses.
The primary efficacy endpoint of an answer the question is a composite endpoint of we know the initiation of Dawson transportation or 40% or greater reduction in Egypt, or otherwise known as easily.
It's important also note that the Kt cure of physical function, serving as the repeat it shows Dan has a secondary endpoint in the trial as a reminder, we observed statistically significant and clinically meaningful movement for the subjects over there, but this is subject to placebo indicated to us as a function so that into the future that that's in our tier one.
The study.
As we tracked in line that number.
I'm in front of entering this trial.
We've said this is a good indication so have you pick the right patient population for its confirmatory outcome trial, we will continue to track of Andrew and the drawn up did you buy you then on the timeline for both on an interim analysis.
And anticipate completion of the by seeking the study.
Ill now turn the call it adjusts to discuss our financials.
Thank you Gary. Thank you all for joining us today on the call I will now provide a brief overview of our financials additional details regarding our second quarter results can be found in our press release issued earlier today.
Our financial position remains strong as of June Thirtyth, 2020, cash cash equivalents and investments.
Were $436.9 million.
In the second quarter, our R&D expenses were $28.8 million GNS expense was $28.4 million, our net loss for the second quarter was $58.2 million or $1.16 cents per share.
Adjusting for certain non cash expenses, such as stock based compensation.
Our non-GAAP net loss for the second quarter was $48.9 million.
In the second quarter, we issued $200 million aggregate principal amount of 3.5% convertible senior notes due 2027.
The convertible senior notes are senior unsecured obligations of the company and interest is payable on May 15, and November 15th of each year beginning on November 15 2020.
The convertible senior notes are convertible into cash shares of common stock were a combination of cash and shares of common stock at the company's election.
At an initial conversion rate of approximately 30 shares per $1000 principal amount, which is equivalent to an initial conversion price.
<unk> $33.23 per share.
Finally, we won't be evaluating our operating plan and cash runway once we receive additional clarity from the FDA, which as Garrett indicated is expected to be on or before our PDUFA goal date of August 22nd.
With that we will take your questions operator.
Sector. Thank you.
Thank you and your mind if that's the question you I suppose star one on your telephone.
I would draw your question press the pound King.
Please stand by that we've compiled the K roster.
And our first question on topline a phone they do I'm, telling you something maybe again.
Good afternoon. Thanks for taking my questions [laughter] I appreciate you don't have any more.
Information from the Afghan their projections, but could you remind does have the process for you went through to get the FDA to sign off on a the design of the pivotal study and then in particular, the serum bicarbonate primary endpoint.
I'm, sorry, discriminate between you and your FDA <unk> in the designer or are you both on the same page.
And thanks for question, we obviously worked closely with you.
On the accelerated approval process.
And I think it was really a two step process a first really to qualify we had to reach agreement, which we did.
We are treating a serious disease.
That doesn't unmet medical needs and that we have surrogate that's likely going to translate to clinical benefit.
The second step was a quantitative understanding.
In terms of how the surrogate really impact the outcome of interest in this case.
A question on the kidney disease.
And we also reached agreement on that and based on on that be design. So the studies for one through unease and also the ongoing basi Gideon confirmatory post approval study.
Got it Okay. That's helpful. And then second I. Appreciate this maybe it'd be premature, but if we were to assume data from our CKD would be necessary.
Is there anywhere that you could accelerate the completion of enrollment in that trial and or the time. It takes to get to the interim analysis give levers that you could pull to make make either those prostitutes come more quickly.
Yeah, I want to speculate in times of the the timing on the interim analysis.
I think that's something that's well no.
No more and better towards the end of the year, but.
As you as you know us we we aren't doing everything we can to recruit the trial.
Even against the backdrop of a other pandemic.
And and events happen at the rate that they do so there's nothing we can influence, but but obviously we are encouraged by I think sort of what we're seeing both in terms on the recruitment and intensity of Android and I think we'll be able to communicate the timing of an interim.
Yeah Yeah.
Perfect. Thanks for taking my questions. Thanks.
Yeah.
Our next question will come fly now Alan Carr from Needham you may begin.
Oh, Thanks for taking my questions I'm looking at the sequence events in terms of bringing on the sales force and it was only.
Well take a few days before I notice for me.
Yes, I guess.
Maybe you can go through how you plan to leverage this group is.
No if there is a meaningful delay.
But beyond that they do today to approval.
[noise] [noise] on I Didnt fully.
I personally I assume that jobs you know.
In terms of the activity of the strategic I imagine you know processing to this really big value and verifying in the field.
The things that I think we have been able to collect from saw the Ah onez and surveys and everything else and that's that's a worthwhile activities that really outside.
Planned for launch.
Once we receive any more definitive feedback from FDA well have to see what a delay is.
And what.
I'll give an odd makes sense.
Obviously to continue that but but right now I'm actually really brought up the whole so team I think one but they're able to do.
Not just in terms of virtual meetings, but in terms of face to face meetings with and that's all it is in the office and getting really high quality information on their awareness of the disease.
I think that that is incredibly valuable will continue to do that and I'm excited about it.
[noise] you would also I think it was on the last quarterly call where are you all had.
Proposed to change to your your sales force strategy you cut back a number of.
Oh people and more of a virtual focused I know, it's somewhat premature to have an assessment of how that's going casino drug hasn't launched yet but you have.
Hey, maybe a preliminary assessment of.
Yes of how that's going to strategy is going virtual rather than.
It was reduced to reduce force in any thoughts on that at this point.
Yeah, I think a first of all I think there were quite happy that we we have the 40 Cedric con matters on board and not 80.
Given the potential for a few delays and then I think from an activity perspective, we we were surprised to see how many office visits they're able to do costs also a virtual into action and with a really good reach so we believe.
But that this is really a meaningful.
Hi.
Before you know at them at a minimum for the prelaunch activities and ultimately shouldn't the drug can it get approved you know we couldn't be could actually launch for that but you're right. It's a bit earlier and we've got to see they do have noticed that really some of the additional comac nine.
In a pressure on recently as is the changing landscape in times of the ratio of office.
And and virtual and we got to keep an eye on that.
[noise], thanks for taking my questions.
Oh.
Thank you once again that start once the questions. My next question why no Craig C., one lives that Goldman Sachs.
Maybe again.
Yes. Thanks.
During the call the taking my questions.
Maybe I'd like to just revisit kind of your expectations around timelines.
For.
The possibility that you may get a complete response letter and just want to confirm that your expectation is that.
In terms of the playbook.
My understanding as you have like 10 days to respond or or request a meeting with FDA and then I think on the earlier in your prepared comments you said it so.
We should be able to hope to get a meeting with FDA within the next 30 days I just wanted to confirm but its 30 days and not 60 days and again I don't know Sta, working all that well, but just wanted to.
Confirmed that that you're thinking about within 30 days and then just beyond that.
Yes.
When are you thinking that you might be able to come back to.
Update the market on on next steps and then I've got a follow on to that.
Rick I think you're on a thing that's correct the.
I think the most likely response, we expect as.
Complete response letter.
We.
Bob.
No as quickly as possible and send them a type a meeting that class and the briefing book.
To address.
And he was unchanged as noted in such a potential letter and it is not 60 days, it's a type a meeting so 30 days.
You know our expectation would be.
To read the letter and then basically form an opinion on all the slower than strategy and timing, though I think any options.
Oh, knowing you know any up to the potential deficiencies oh issues, it's very difficult to get.
In terms of timing and what it means the threshold you know obviously two to disclose.
[noise] [noise], Okay. Thanks, and then my follow up question and.
I was reading to the press release I was struck by the language.
But you are preparing for all eventuality is to switch to swiftly resolve any potential issues. So I guess.
Is there any additional color you can provide on.
Specifically, what what you're referring to when you're preparing for all eventuality or is it simply more of just a philosophical mindset that triggers you just have to wait and see and then you know you will activate accordingly.
No I mean, I mean, you know us we are prone to over preparing and over thinking and you know we are basically trying to get.
All information and and topics in order so we can.
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Basically respond to any issues that they would would bring up so we're not waiting you know vitameal box.
You know, we arm and Reactively, so thinking through you know what potential scenarios are and how we could quickly respond we feel a real sense of urgency.
Two.
Got a work collaboratively with FDA to overcome any of those potential deficiencies that they might might put into potential.
Okay. Thank you very much for a.
For that clarification and good luck.
Right.
Thank you.
Once again that star one for questions.
One moment for questions.
And I'm not showing any further questions on my end.
Great well, we'd like to thank you all for joining us today as always if you have additional questions. Please don't hesitate to m- email us at IR at Tracy Dotcom, Thank you and goodbye.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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