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Tricida Inc (TCDA)
Q3Â 2019 Earnings Call
Nov 14, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by and welcome to the Tricida Third Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. However, after the speakers presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder today's program may be recorded.
And now I'd like to introduce your host for today's program. Jackie Cossmon Vice President of Investor Relations and Communications. Please go ahead.
Jackie Cossmon -- Vice President of Investor Relations and Communications
Thank you, Jonathan. Good afternoon and thank you for joining the Tricida Third Quarter Financial Results Conference Call. In today's call Gerrit Klaerner our CEO President and Founder, will discuss our business progress and Geoff Parker, our CFO, will then discuss our financial results for the third quarter.
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 statements regarding our future development and commercialization plans, the conduct of our VALOR-CKD confirmatory post-marketing trial, recruitment milestones, anticipated activities related to our NDA filing, including the PDUFA goal date advisory and advisory committee topics, financial guidance and statements that are not historical facts.
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, Tricida 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. For copies of our press releases that were issued prior to this call, please go to www.tricida.com and follow the link to our Investor Relations page.
At this time, I'd like to turn the call over to Gerrit.
Gerrit Klaerner -- Chief Executive Officer and President
Thank you, Jackie, and thank you all for joining us on today's call. Let me move right into the most important news from today's press releases. We are pleased to report that our veverimer NDA has been accepted for review by the FDA under the Accelerated Approval program but no filing review issues identified. The application is under review by the division of cardiovascular and renal products for the standard review designation and the PDUFA goal date of August 22, 2020.
As a reminder, this filing acceptance under the Accelerated Approval program underscores the fact that metabolic acidosis is a serious condition and as veverimer if approved, would address an unmet medical need. Given the commercial strategy outlined at our recent Investor Day, the August 22, 2020, PDUFA date will enable a launch at the beginning of the fourth quarter of next year and provide us with a full quarter of veverimer sales in 2020. The FDA has also indicated that they are currently -- that they currently plan to hold an Advisory Committee meeting or ADCOM to discuss the application. We anticipate the ADCOM would likely occur in the first half of 2020 and we will know the topics of discussion closer to the meeting date.
Given that we are pursuing a potentially disease modifying indication in CKD utilizing the Accelerated Approval Program, we welcome this opportunity as we will be prepared to present the underlying rationale and the considerable body of evidence supporting that treatment of metabolic acidosis slows the progression of kidney disease.
Furthermore, we'll be ready to walk through all of our veverimer clinical data, including results beyond the surrogate endpoint such as improvements in how the patient feels and functions and the impact on the progression of CKD. We continue to evaluate the data from our Phase III trials in collaboration with thought leaders in the nephrology fields to understand the implications of treating metabolic acidosis for patients with CKD.
An interesting concept has emerged in the academic literature that describes CKD as a clinical model of premature aging with CKD patients experiencing many of the complications of aging. But at the younger ages than the general population. The elevated rates of aging-related disorders including cardiovascular disease, cytopenia and frailty. This is a major problem because impaired physical function leads to significant morbidity, including higher rates of falls and fractures and is also a risk fact of a death. Therefore, preserving physical function is critical in patients with CKD.
Working with Dr. Matthew Abramowitz, who is an Associate Professor of Medicine at the Albert Einstein College of Medicine, we've recently performed additional analyses of the physical function improvements we observed with veverimer our 301E long-term extension trial. We'll be submitting this work to major nephrology congress this month, so I'll just share a couple of top-line results with you today.
First, Dr. Abramowitz found that at baseline 45% of our study population was slower in performing the repeated chair stand test than the average 82 to 89-year-old, despite an average age of approximately 62 years. Second, the mean improvement of repeated chair stand test time observed in veverimer treated patients in the 301 study, 4.3 second was greater than the difference in test time between individuals in their 80s and those and their 60s. Therefore, looking at the results of the length of CKD as a model of accelerated aging, the effect of one year of treatment with veverimer on the repeated chair stand test performance appears to be equivalent to approximately a 20-year reductions in age.
Now I'd like to provide you with an update on the VALOR-CKD post-marketing trial. This is a large outcome trial that is being conducted in 33 countries at approximately 350 sites. At this point close to 95% of our targeted sites have been opened for recruitment. We anticipate randomizing 1,600 subjects in the trial and we believe that we are on track to complete enrollment of mid-2020.
Let me now turn to our significant presence at the American Society of Nephrology Kidney Week meeting. The meeting provided a great venue to reach a large audience with our metabolic acidosis disease awareness campaigns. Attendance of interest at the exhibitor booth were significant and nephrologists were highly engaged. Over 1,000 nephrologists and healthcare providers visited our booth. They interacted with our Medical Science Liaisons, downloaded the Neph+ app and viewed video presentations by experts discussing the pathophysiology and clinical consequences of metabolic acidosis and the importance of assessing physical functioning in patients with CKD.
Our scientific presentations were very well received. We presented our veverimer long-term extension data that was published in The Lancet, as well as data on the mechanism of action of veverimer. Also, for the first time, we included a Medical Affairs section in our booth, which provided a forum to answer questions about the veverimer clinical trials.
The attendance for significant but unsolicited requests coming not only from the presentation of our long-term extension data at the meeting but also driven by unaffiliated third-party presentations of veverimer data suggesting it as a promising new therapy for the potential treatment of metabolic acidosis. The serious consequences of metabolic acidosis were quantified in three new studies sponsored by Tricida that were also present at the meeting.
In these studies, a cohort of over 51,000 patients with non-dialysis dependent CKD stages 3 to 5 was analyzed longitudinally. In the first study metabolic acidosis was shown to be independent predictor of adverse renal outcomes, as well as of higher healthcare costs. In fact, each 1 mEq increase in serum bicarbonate was associated with a 13% decrease in the two-year composite endpoint of death, dialysis, kidney transplant or greater than or equal to 40% eGFR decline and a 7% decrease in monthly healthcare costs.
The second study, showed that metabolic acidosis is associated with an increased risk of major adverse cardiovascular outcomes. With each 1 mEq increase in serum, biocarbonate is associated with a 2.4% decrease in new-onset heart failure, a 2.1% decrease in stroke and the 3.6% decrease in myocardial infarction.
And in the third study, metabolic acidosis was shown to be an independent predictor of adverse bone and muscle outcomes. Each 1 mEq increase in serum bicarbonate was associated with a 5% decrease in bone fractures and falls risk and a 12% decrease in failure to thrive over a two-year period.
One of the striking an important result of these three different analyses is that there is a linear relationship for all adverse outcomes across the range of serum bicarbonate levels from 12 to 29 milligrams per liter. In each instance it has incremental benefit from each 1mEq increase serum bicarbonate across the entire serum bicarbonate range.
On the disease awareness front Dr. Tangri presented as recent work describing longitudinal analyses using a database of over 35 million de-identified patients. And these analyses diagnosis and treatment rates for metabolic acidosis were assessed in a cohort of over 86,000 patients with unequivocal laboratory evidence of stage 3 to 5 chronic kidney disease and metabolic acidosis.
Surprisingly, a diagnostic code for metabolic acidosis was present in only 21% of this population. The overall frequency of an alkali therapy used in the large quarter patients with the laboratory confirmed metabolic acidosis was only 15%. Dr. Tangri's work underscores a significant under-diagnosis and under-treatment of metabolic acidosis.
The presentation of new data at the recent ASN meeting is the foundation for the success of veverimer commercial launch. They show the true impact of metabolic acidosis on a wide range of adverse clinical outcomes. We also now have the veverimer disease-modifying data published in The Lancet in June and the recent BiCARB study results that show commonly used doses of oral sodium bicarb appeared to be not efficacious and not cost-effective. And we have identified under-treatment of metabolic acidosis to be the key barrier to account for our commercial launch. Given all these factors, we believe we can mobilize nephrologists to adopt an urgency to treat attitude for the patients with CKD and metabolic acidosis.
In our commercial launch, we'll be targeting a concentrated market of 5,000 nephrologists that we believe treat the vast majority of the 600,000 patients with CKD and MA. Based on our market survey, nephrology product analogs and peer input on potential coverage decisions, we believe that we'll achieve a peak market penetration of approximately 150,000 of these 600,000 patients resulting and US peak revenue of over $2 billion per year. We are truly excited about the veverimer opportunity.
With that, I'll turn the call over to Geoff.
Geoffrey Parker -- Chief Financial Officer
Thank you. Gerrit and thank you all for joining the call today. I will now provide a brief overview of our financials. Additional detail on our third quarter financial results can be found in our press release issued earlier today and in our 10-Q, which will be filed with the SEC. We are pleased to report that we remain in a strong financial position.
As of September 30, 2019 Tricida had cash, cash equivalents and investments of $363.6 million. In the third quarter, our research and development expenses were $32 million. General and administrative expense was $13.1 million. Our net loss for the third quarter was $44.1 million or $0.89 per share, including non-cash stock-based compensation expense of $8.7 million. As we look forward to the completion of 2019, our quarterly research and development expense will likely be in the range of $35 million to $40 million in the fourth quarter, given the timing of veverimer drug substance production and an increase in our clinical trial expenses related to VALOR-CKD.
General and administrative expense is likely to increase to be in the range of $20 million to $25 million in the fourth quarter, given the steady increase in expenses related to our commercial preparations for the anticipated launch of veverimer. These combined R&D and G&A fourth quarter expenses include an estimated $12 million to $14 million in non-cash stock-based compensation.
From a cash burn perspective, we reiterate our guidance that our use of cash in 2019 will be between $135 million and $145 million. We project that our cash on hand, together with our borrowing availability under our Hercules debt facility will be sufficient to fund the anticipated launch of veverimer in 2020, and to support our operations well into 2021.
Finally, I am pleased to report that we hosted our first Investor Day on October 15 in New York City. If you would like to listen to the event, it is available as a replay on our website. The event included a panel of medical experts, who discussed the serious consequences of metabolic acidosis and its link to CKD progression, and presentations from our Medical Affairs team and our Commercial team, who discussed our veverimer launch dynamics and preparations.
I would now like to turn the call over to the operator for any questions. Operator?
Questions and Answers:
Operator
[Operator Instructions] Our first question comes from the line of Phil Nadeau from Cowen & Company, your question, please.
Phil Nadeau -- Cowen & Company -- Analyst
Good afternoon and thanks for taking my question and congrats on the progress. First question is on your investment of the FDA Advisory Committee. Appreciating that the review is in the early days, did the FDA provide any reason for wanting an ADCOM for the filing?
Gerrit Klaerner -- Chief Executive Officer and President
Phil, no -- I mean they did not, and I think typically what they do is they communicate the specific topics shortly before potential advisory committee meeting.
Phil Nadeau -- Cowen & Company -- Analyst
Do you have any theories as to why they might want one?
Gerrit Klaerner -- Chief Executive Officer and President
Yeah. I've learned over the years not to speculate. And I think we're obviously very excited to actually present our data. I think both from the perspective of standard review and the outcome, when you look at our program we are among the first to really utilize the Accelerated Approval path with a renal indications. And when we had our pre-NDA meeting, I think we shared all the data with them that we had available, including the data beyond the surrogate. So again I'm not speculating about any potential topics for the ADCOM but this is exciting. I mean I think not many people have had pursued a major disease modifying renal indications under Subpart H.
Phil Nadeau -- Cowen & Company -- Analyst
Right. Great. Okay. That is helpful. Second question, I apologize, when you mentioned the physical function analyses that were new, I only got the very basics of the second one, the 4.3 seconds, good 4.3 seconds, could you review that again, what was that finding?
Gerrit Klaerner -- Chief Executive Officer and President
Phil, I think there's always a quest to translate the finding in that test. Right? The 4.3 second improvement from baseline into something that basically the treating physician can understand and what Dr Abramowitz has is a model that expresses these physical functioning results in terms of aging. And when you -- when he basically did a post-hoc analysis with our one-year data, he found that that effectively the improvement seen with veverimer equates to about a 20-year reduction in physical function age.
Phil Nadeau -- Cowen & Company -- Analyst
Got it. Okay. That is very clear. Thank you. Third question is on the completion of enrollment for the confirmatory study now being in mid-20, that's going to be somewhat later than we had been anticipating, is my memory incorrect there? And if not, if it is a little bit later, what has led to the delay? What has resulted in a delay?
Gerrit Klaerner -- Chief Executive Officer and President
Yeah. We -- I think we are very happy. I think this is one of the fastest recruiting outcome trials. And I think we obviously had this tied to the NDA submission. Originally, we were able, early on to remove that as a provision or as a hurdle for NDA submission. But the trial is going extremely well and I think we are excited to really follow our post-marketing or post-approval commitment.
Phil Nadeau -- Cowen & Company -- Analyst
Okay. That is helpful. And then, Geoff, last question is for you, just on the G&A for Q4, should we consider that as the baseline off of which we grow our 2020 estimates or are there any one-time charges in Q4 specifically in G&A that won't repeat in 2020?
Geoffrey Parker -- Chief Financial Officer
I do think you should begin to use that as a baseline, and we'll be -- we'll plan to talk about 2020 early in 2020. But as you begin to adjust your model, I think that's a fair baseline. Remember, G&A will begin to include S in the G&A. So it'll be SG&A.
Phil Nadeau -- Cowen & Company -- Analyst
Got it. Thanks for taking my questions and congrats again on the progress.
Operator
Thank you. Our next question comes from the line of Jessica Fye from JP Morgan. Your question please.
Jessica M. Fye -- JPMorgan -- Analyst
Hey guys, good afternoon. Thanks for taking my question. With the VALOR trial expected to complete enrollment in the middle of 2020. Can you remind us when we should expect the interim and the full readout? I think in the past you were indicating that the interim could come two to three years after full enrollment and the full read out would be three to four years after full enrollment. Is that still accurate or if not, can you update those time-lines?
Gerrit Klaerner -- Chief Executive Officer and President
Yes. That's still accurate. It's an event driven trial and I think those estimates are correct.
Jessica M. Fye -- JPMorgan -- Analyst
Great. Thank you.
Operator
Thank you. Our next question comes from the line of Alan Carr from Needham, your question please.
Alan, you might have your phone on mute.
Alan Carr -- Needham & Company -- Analyst
Hi. Thanks for taking my questions. Can you talk a bit more about the commercial prep. What are the -- when do you plan to or how are you going to stage this over time in terms of MSLs and sales force and that sort of thing? Thanks.
Gerrit Klaerner -- Chief Executive Officer and President
Alan, I think if you've seen I think our presence at ASN and that was an important tempo event. I think the -- from an MSL perspective, we plan on really ramping this up early in the year to really do the disease awareness and really the NKF Spring meeting is I think the key kick-off for some of the field-based activities.
Alan Carr -- Needham & Company -- Analyst
Great. Thanks for taking my question.
Gerrit Klaerner -- Chief Executive Officer and President
Thank you.
Thank you.
Operator
Thank you. Our next question comes from the line of Greg Suvannavejh from Goldman Sachs. Your question please.
Greg Suvannavejh -- Goldman Sachs -- Analyst
Yeah. Hi, good afternoon. Thanks for taking my question and congrats on the progress. I've got two questions if I may. One with respect to the cardiovascular and renal products division, maybe from a high level, can you give us some perspective on historically speaking the division's, I don't know openness to innovation or are they a more conservative type of division? So any color from your perspective would be helpful there.
And then my second question, does have to do with kind of payback on Alan's question around commercial readiness. Do you have an idea of when you might be able to more granularly detail kind of the commercialization efforts and/or expand about something you plan to provide say at a view around 2020 financial guidance or just kind of how do you expect to communicate numbers and strategy around commercialization? Thanks.
Gerrit Klaerner -- Chief Executive Officer and President
Hi, Greg. So, on cardio-renal, I think we've really worked closely with them since the early days of the program and I think they are very aware of the need for new disease-modifying treatments, specifically in the renal portion of cardio-renal. And they have been an excellent partner in helping us do and pursue this program and under Subpart H and I think that this is something that we've been working on and meeting with them quite frequently, even this year on some of the physical functioning endpoints.
So really open for innovation, and engaged and interested, I think in enabling new disease-modifying treatment in CKD. On the commercial planning, I think we started to provide some of the details and more on a strategic level at our Investor Day. Now that we have the dates, I think Geoff, I think toward the middle of the year I think will provide more detail on.
Geoffrey Parker -- Chief Financial Officer
That's right. I would add that in addition, our guidance on sales force size continues to be -- originally, we had always talked about 80 to 100 reps in the field, we've narrowed that down closer to 85 as the appropriate number that can effectively detail the 5,000 key nephrologists who were in the market, who represent the vast majority of the scripts and the patients we are seeking. So a classic specialty sales force size and -- but we will anticipate giving more guidance in 2020 on that.
Greg Suvannavejh -- Goldman Sachs -- Analyst
Thank you very much.
Operator
Thank you. And this does conclude the question-and-answer session of today's program. I'd like to hand the program back to Jackie Cossmon for any further remarks.
Jackie Cossmon -- Vice President of Investor Relations and Communications
Thank you, Jonathan, and thank you all for joining us today on the call. If you have questions please don't hesitate to contact us. You can reach us at tricidair.com and we look forward to helping you further. Thank you and goodbye.
Operator
[Operator Closing Remarks]
Duration: 25 minutes
Call participants:
Jackie Cossmon -- Vice President of Investor Relations and Communications
Gerrit Klaerner -- Chief Executive Officer and President
Geoffrey Parker -- Chief Financial Officer
Phil Nadeau -- Cowen & Company -- Analyst
Jessica M. Fye -- JPMorgan -- Analyst
Alan Carr -- Needham & Company -- Analyst
Greg Suvannavejh -- Goldman Sachs -- Analyst
