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Tricida Inc (TCDA)
Q1Â 2020 Earnings Call
May 7, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, ladies and gentlemen, and welcome to the First Quarter 2020 Financial Results Conference Call. [Operator Instructions].
I would now like to turn the conference over to your host, Jackie Cossmon of Tricida. Please go ahead ma'am.
Jackie Cossmon -- Vice President of Investor Relations and Communications
Thank you, Patricia. Good afternoon and thank you for joining the Tricida first quarter 2020 financial results conference call. In today's call, Gerrit Klaerner our Founder, CEO and President, will discuss our business progress and Geoff Parker, our CFO, will then discuss our financial results for the first quarter.
Please note that in today's call, we will be making various statements that include forward-looking statements as defined under the applicable securities laws. Forward-looking statements include the potential timing for approval, our commercial launch of veverimer, anticipated activities related to our NDA filing, including the assigned PDUFA goal date and the scheduling of an Advisory Committee meeting, the potential approvability of veverimer through the Accelerated Approval Program, our hiring plans, our medical affairs commercial and managed markets activities, the conduct of our VALOR-CKD confirmatory post marketing trial, the potential impact of COVID-19, financial guidance and other 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 a copy of our press release that was 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 -- Founder, President and Chief Executive Officer
Thank you, Jackie, and thank you all for joining us on the call today. The COVID-19 pandemic has affected us all,and we are sincerely grateful to the healthcare providers and our frontline essential workers who continue to work tirelessly to serve our communities and help those in need. I also want to acknowledge our employees, who have made a remarkably smooth transition to working virtually. Working as a team, I believe, we remain as productive as ever, I'm also proud of our employees who've supported those affected by the COVID-19 pandemic in several ways, from donating masks to local hospitals to contributing generously the COVID-19 related charities, which have been matched 100% by Tricida.
Before I share the details of our commercial launch preparations, let me provide a brief update on our NDA for veverimer and our ongoing VALOR-CKD confirmatory post marketing trial. The veverimer NDA is under review by the FDA for the Accelerated Approval Program, for the PDUFA goal date of August 22, 2020 for the potential approval to market veverimer in the United States. At this time, we do not believe the COVID-19 pandemic has affected our PDUFA goal date of August 22. We continue to work cooperatively with the FDA on review matters related to our NDA. In our day 74 letter, the FDA indicated that the plan to hold an Advisory Committee meeting or outcome to discuss the application, and our late-cycle meeting with the FDA, held on May 2020. The FDA indicated it currently does not plan to hold an outcome to discuss veverimer, due in part to logistical challenges posed by COVID-19. In our late-cycle meeting with FDA, we took the opportunity to address outstanding review issues. We presented our data and rationale as to why we think veverimer satisfies the requirements for initial approval under the Accelerated Approval Program, including the magnitude and durability of the treatment effect on the surrogate markup serum bicarbonate, demonstrated in the TRCA-301 and TRCA-301E trials.
Under the initial approval, we have to ensure that U.S. patients who would be prescribed veverimer, get clinically significant benefit that outweighs the risk of treatment. Overall, while the FDA continues its review, we remain confident that our submission meets the standard for approval through the Accelerated Approval Program.
Now turning to VALOR-CKD, our confirmatory post marketing trial. In the wake of the COVID-19 pandemicm we've been carefully monitoring both the status of subjects in the trial, as well as the ongoing pace of enrollment. We have not observed any COVID-19 related discontinuations of randomized subjects in the study. And It's important to note that the study design only requires visits and investigator sites, every three months, which provides for significant scheduling flexibility. In addition, we have implemented a studywide COVID-19 contingency guidance, which is in line with corresponding FDA and EMA guidance on conduct of clinical trials during this pandemic, to ensure patient safety and well-being and to preserve the trial's integrity. This guidance allows us conduct of remote assessments of subject's safety and the delivery of study drug directly to subject comps, were allowed to ensure continuity of treatment. Regarding the pace of enrollment, a slowdown has occurred as a result of the COVID-19 pandemic. As such, we are monitoring our screening and enrollment progress and hope to bring our enrollment back to steady state, as the pandemic subsides. At this time, it appears that we will complete enrollment in the VALOR-CKD trial in the first half of 2021.
Now I'd like to discuss the significant work that we've done to understand the impact of the COVID-19 pandemic and our potential launch of veverimer. I'll start by saying that we are a data-driven organization, and that certainly applies to our approach to our launch activities. We have evaluated multiple third-party surveys, conducted our own surveys, spoken to numerous contacts of biotechnology companies, who are launching products in this environment and carefully consider the scope and timing of our plans to launch veverimer.
First, it is clear that the COVID-19 pandemic has strained the healthcare system and in particular, it has changed the way physicians and patients are currently able to interact. The use of telemedicine to supplement office visits and additional personal protective equipment are elements of the patient doctor expense that are likely here to stay. But our research also indicates that many of the most significant disruptions will be temporary, and there is strong interest from physicians and payors for new therapies that provide health benefits to patients, and address large unmet medical needs. And our research indicates, this is particularly true in the nephrology community. As an example, at the end of April, we surveyed 50 nephrologists from around the country that typically see about 100 patients per week. They reported that the pandemic has negatively affected the activity in the practices, with an estimated 50% reduction in weekly patient visits to the offices in April, relative to a typical week earlier this year. However, the survey results also show that over 65% of these nephrologists are receptive to learning more about new products, even in the current environment, with an increased to 94% when the pandemic subsides. More specifically, when shown the veverimer target product profile, 80% of nephrologists said they would consider prescribing or definitely would prescribe veverimer via telemedicine, and 95% indicated they would consider prescribing or definitely would prescribe veverimer in the office.
We are encouraged that veverimer target product profile elicits this type of enthusiasm from nephrologists, even in virtual or in person setting. With this information in hand, allowing with a multitude of other data points, I would like to share with you today our ongoing successful prelaunch activities, and while we continue to be excited for the launch of veverimer, is approved to treat metabolic acidosis and thereby slow the progression of chronic kidney disease.
Let me start with our extensive medical affairs campaign. We launched our team of 10 medical science liaisons after the NKF Spring Clinical Meeting in March, a response of seven presentations, and poster session and the CME Symposium on interventions from metabolic acidosis and slowing CKD progression. All of these presentations and events were held virtually and well attended, giving us increased confidence, as we head into the second half of 2020, that both in person and virtual activities around disease education and veverimer can be effective. Our MSLs are engaging with the NGF meeting participants and have already virtually reached out to about 750 nephrologists. The reception and interest has been exceptional, and that's not a surprise, given the important findings from our recent nephrologists surveys, indicated that nearly 70% of nephrologists find publications or journal articles to be one of the best sources of medical information.
You'll recall, that we supported 14 posters and publications in 2019 and early 2020. These publications [Indecipherable] MSLs with many important scientific publications to facilitate appropriate scientific exchange with nephrologists about a wide range of topics related to metabolic acidosis. These include a recent special article in JASN, on the mechanism of metabolic acidosis induced kidney injury and CKD, as well as a systematic review and meta analysis of the effects of treatment of metabolic acidosis, in CJ. Presentations at major nephrology congresses have presented new data on the significant clinical consequences of metabolic acidosis to bone, muscle and kidney health, and of course if a question rises about veverimer, our MSLs would be able to discuss the veverimer 301 and 301E trial results that were published in back to back issues of The Lancet.
Another key area of focus for our medical sales team, which was the subject of presentations at both ASN, Kidney Week and NKF Spring meetings has been the current unmet treatment of metabolic acidosis. Based on multiple analysis, only 3% to 15% of patients with metabolic acidosis and CKD are currently taking an over-the-counter or alkali supplement in an attempt to manage their metabolic acidosis. This dramatic unmet treatment is likely due to the simple fact that the current over-the-counter option of sodium bicarbonate present significant challenges.
First, as BiCARB said, that sodium bicarbonate delivers excess sodium to the patient, and for patients with CKD, a reduced sodium diet is recommended to avoid exasperating common comorbidities, such as hypertension, heart failure and edema. Second and supported by peer-reviewed publications, excess sodium load has been shown to reduce the efficacy of ACEs and ARBs, hypertensive medications which are a cornerstone for the treatment regimen for CKD patients due to the ability to slow CKD progression. And third, in the recently published BiCARB study out of the U.K., sodium bicarbonate was not demonstrated to be safe or efficacious, which is considered a typically prescribed daily dose at 1.5 to 3 grams per day. As you may recall, the BiCARB study is one of the only large multi-center double-blind placebo controlled randomized trial that investigated the use of typical dose of sodium bicarb to treat metabolic acidosis, in a broad patient population over a two-year period.
In summarizing this unsuccessful study, we also concluded that our results suggest that at least for patients aged 60 and over with CKD categories 4 and 5, 1.5 to 3 grams per day of oil bicarb did not produce any health benefits and may be associated with net harms. This is an important milestone in the history of treating metabolic acidosis, as it provides clear evidence that in a well-controlled study, detailing doses of sodium bicarb are not proven to be safe, efficacious or cost effective. It is also interesting to note that the authors of the BiCARB paper reference to veverimer, as a potential new therapy for metabolic acidosis. In particular they noted that the veverimer's novel mechanism of action of binding and removing asset, could avoid the sodium related liabilities of neutralizing acids with sodium bicarbonate. They also highlighted, the veverimer clinical trial results and its ability to successfully increase sodium bicarbonate and to improve physical function related quality of life, using both patient reports and objective measures. We were pleased to see this recognition of veverimer from these external investigators.
In addition, we are supporting CMA programs that enable HCPs to obtain professional educational credits by completing courses on metabolic acidosis and the serious complications. At the NKF virtual meeting, we supported our first symposium, titled Evidence Based Interventions for MA, Slowing CKD Progression. More than 325 people participated in the livestream event and more will be able to see the program, once it is posted on the end NKF website. We supported two additional accredited programs in March, that have already garnered more than 2,300 participants. Given the success of the CMA events, we will be supporting additional courses later this year with the goal of reaching over 4,000 HCPs for the accredited education programs by the end of 2020.
And now turning to our disease awareness campaign. The key thrust in our disease awareness effort has been to emphasize the urgency to treat metabolic acidosis. Over the past year, we've made significant progress in emphasizing the understanding of and urgency to treat metabolic acidosis. As we've discussed at length for you in the past, we have an overwhelming understanding among nephrologists, that metabolic acidosis is linked to the progression of CKD, as well as worsening bone and muscle health. The current lack of urgency to treat is attributed primarily to the simple fact that physicians have not had a proven safe and efficacious FDA approved treatment to prescribe to their CKD patients with chronic metabolic acidosis. Clearly, we believe that veverimer has the potential to address this significant unmet medical need.
To deliver our disease awareness message, we have utilized multiple digital communication channels. We've generated approximately 3 million user impressions through three distinct Internet platforms; paid Internet search, display media and targeted emails. This has resulted in a 96% increase in visits to our metabolicacidosisinsights.com website from Q4 2019 to Q1 2020, and puts us well on our way to our goal of approximately 10 million user impressions. By the time of our veverimer launch and we are already seeing positive results in the nephrology community from these disease awareness efforts. A proprietary survey of 15 nephrologists that we just completed in April, showed that 82% of nephrologists surveyed, believed metabolic acidosis is associated and increased risk of CKD progression and mortality. 76 believe it is independent modifiable risk factor for CKD progression and 76% believe also it negatively impacts how patients feel and function. These are encouraging levels of agreement that emphasize understanding of the urgent need to treat MA.
We also recently conducted two virtual advisory boards, with practicing nephrologists from around the United States in March and April, and we are exceptionally pleased and encouraged by the focus and interest that our advisory board and nephrolgoists exhibited in these sessions. Together, these two advisory boards include 24 prominent nephrologists in over a four-hour session they provided feedback on both, our disease awareness materials and that veverimer is a potential treatment for metabolic acidosis. We have come away from these interactions with even greater confidence and the significant potential value that veverimer may deliver for CKD patients with metabolic acidosis. Also, we received great interest from over 40 nephrologists, who are key opinion leaders in various geographic regions of the U.S. to serve as speakers in our peer-to-peer programs that will be planned throughout the rest of this year.
In addition to our disease education efforts, we also have made significant progress educating payers, on the health and economic implications of untreated metabolic acidosis, and have obtained good feedback on coverage for a potential first and only treatment for metabolic acidosis. Our team has now met with over 85 unique payers, who collectively represent over 290 million insured lives. It is up from the 51 payer meetings that we reported in our last call, and we are well on our way to our goal of engaging with at least 100 peers, prior to our anticipated approval. Also in March, we hosted a Managed Market Advisory Board meeting, spending a full day with 10 payers, that represent approximately 100 million lives. Our advisory board participants represented all major categories of insurers, including commercial, Medical, Medicare Advantage and Managed Medicaid plans.
The individual payer meetings have been very productive and mirror many of the opinions from the ad board participants, but our focus today is on the highlights of the ad board meeting. This meeting allowed for an in-depth discussion of the serious complications of metabolic acidosis, a discussion of current over-the-counter interventions, a review of our veverimer data and a close look at health outcomes and economic cost data that was generated from analysis of an Optum database of over 50,000 de-identified patient records. Because there are currently no FDA approved therapies for chronic metabolic acidosis, in general, the payer community is not familiar with its health and cost impacts. Therefore the Advisory Board Participants are keenly interested to learn more about the impact of metabolic acidosis on bone loss, muscle wasting, CKD progression, and increased mortality, and they were particularly appreciative that we were able to provide the real data that showed that over a two-year period, a patient with CKD and metabolic acidosis has a 1.5 times higher likelihood to progress one or more CKD stages, a 3.6 times higher likelihood of starting dialysis, and a three times higher likelihood of death, compared to a patient with CKD without metabolic acidosis. They also appreciate the simple and impressive analysis at each one milliequivalent increase in standby covenant, led to a 7% decrease in all-cause monthly healthcare costs. And finally, they were very interested to see the 40,000 per year lower overall healthcare expenses for CKD patients with sodium bicarbonate in a normal range, versus CKD patients with MA,
We also received key insights from the ad board participants on various utilization management techniques, such as prior authorizations to confirm a diagnosis of metabolic acidosis that payers may implement in the coverage decision making progress. We are assuming the prior authorizations will be required in many instances, primarily related to confirmation of sodium bicarbonate level into attestation of sodium since this comorbidities or prior use of sodium bicarbonate. On that front, we will work to ensure that healthcare providers and the office staff are able to manage prior authorization requests, in a way that mirrors existing practice. This will be accomplished with our open access distribution, which will allow nephrologists to use the preferred pharmacy of choice, via retail specialty. Additionally, they can submit prior authorization, through an electronic prior authorization system, or through the use of our patient assistant hub. Our team of field reimbursement managers will also be available to educate healthcare providers on the prior authorization requirements.
And finally, as we prepare to launch veverimer in the second half of the year, we are bearing in mind the new reality of a possible virtual launch and the potential resurgence of COVID-19 in the fall. Thankfully, we're not the first launch in this environment, and we can watch closely the success and challenges of other biotech companies that are launching products now. Based on our assessment of the impact of COVID-19 on the traditional model of physician detailing. We plan to implement our initial launch activities, the 40 specialty account managers to come on-board in key territories in the coming weeks. This field force, will allow us to reach 70% to 80% of the 5,000 highest prescribing nephrologists in the United States. We will supplement these efforts by implementing an extensive digital campaign to expand the reach of our promotional efforts. The team will be directed in support of our world-class commercial leadership team, which already includes 10 regional business directors. As they gain an understanding of the effectiveness of our field force and our digital campaign during the initial stage of the commercial launch, we plan to evaluate and adjust commercial launch as appropriate, including the ultimate size of our field sales force, which previously anticipated the deployment of 80 to 85 specialty account managers.
Now, before I turn the call over to Geoff, I would we emphasize the significant scope of our commercial planning activities, as we prepare for our August 22 PDUFA date. We recognize that launching a product in normal times of challenging, but launching a new drug in the face, of what we hope will be a subsiding pandemic, will require even greater attention to every launch detail. We continue to believe that veverimer will be one of the most important therapies in the nephrology specialty area.
Geoffrey Parker -- Executive Vice President, Chief Financial Officer
Thank you, Gerrit, and thank you all for joining us today on the call. I will now provide a brief overview of our financials. Additional detail regarding our first quarter results can be found in our press release issued earlier today.
Our financial position remains strong. As of March 31, 2020, Tricida had cash and investments of $304 million. In the first quarter, our R&D expenses were $49.4 million, G&A expense was $23.5 million. Our net loss for the first quarter was $74.1 million or $1.49 per share. Adjusting for certain non-cash expenses such as stock-based compensation, our non-GAAP net loss for the first quarter was $63.8 million.
We reiterate our cash expenditure guidance for 2020 of $250 million to $260 million. We expect higher R&D expense in the first half of 2020, versus the second half, given the timing of certain expenses related to drug substance delivery and plant optimization at Patheon our CMO supplier. And with respect to G&A, given the anticipated buildup of our commercial efforts, we anticipate higher G&A in the second half of the year compared to the first half of 2020.
Based on our current operating plan, we expect that our cash and investments and our anticipated borrowing capacity under our Hercules debt facility, will enable us to fund our anticipated operating expenses and capital expenditure requirements into the second half of 2021. This forecast of our cash runway does not include any potential revenue and the related cash inflows from the commercialization of veverimer, if approved, which could extend our cash runway to profitability, if we achieve our internal commercial forecast.
With that, I'll open the call to questions. Operator?
Questions and Answers:
Operator
[Operator Instructions]. We have a question from Laura Christianson from Cowen. Please go ahead.
Laura Christianson -- Cowen -- Analyst
Hi, thanks for taking my question. I just wanted to better understand what outstanding topics still need to be addressed with the FDA, in order for veverimer to be approved and what the chance is that the PDUFA date would end up being pushed out as a result?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
Hello. This is Gerrit. So, I think we obviously don't speculate this part in the review process about where FDA is with their review. I think we've had a very constructive and collaborative late cycle interaction. As you know we are among the first to utilize the accelerated approval process. And and as such we are really looking at the magnitude and also durability of effect and also the clinical benefit that the U.S. patients get under the initial approval, while the outcome trials are still ongoing. So that's really the broad stroke things we would expect the FDA to look at, at this point in the review.
Laura Christianson -- Cowen -- Analyst
OK. Have they given you a sense of what exactly in the data they want to look at more closely? And is it your understanding that they're going to be doing that without an AdCom, but still still bringing together some experts to examine the data more closely?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
Again, we won't speculate. I think we -- I think they communicated to us that they don't anticipate having an AdCom right now, and as we've said before, its mostly due to COVID-19, but we don't know of any other activities or outside experts.
Laura Christianson -- Cowen -- Analyst
Got it. OK, that's helpful. And then I know you mentioned its mostly COVID-19 related, but do you know what other factors beyond that led to the FDA's decision to cancel the AdCom?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
No, we don't and we were happy to have an AdCom, and we were very well prepared actually and ready to go, to really go through, what we believe is really a a very favorable risk benefit profile, with a very clean safety profile and compelling efficacy data. So we were locked and loaded and and now we understand that this is not happening really in the timeframe to maintain our August 22 PDUFA date.
Laura Christianson -- Cowen -- Analyst
Got it. OK. And then my last question is just, if you anticipate any changes in the payer mix, in the patients that end up initiating on treatment with veverimer when it's launched, just given changes in insurance coverage due to unemployment?
Geoffrey Parker -- Executive Vice President, Chief Financial Officer
So Laura, it is something that we're monitoring very carefully. At this juncture, we haven't changed our mix yet, but we're going to be looking at that. Obviously we have a lot of folks who have moved from employment to unemployment, which may increase the the Medicaid portion of our of our mix. But we haven't formally updated that model yet. But we're looking at it carefully.
It's worth noting that as patients move from commercial certainly to Medicaid, those are two groups of insurance types that should have good access to the drug.
Laura Christianson -- Cowen -- Analyst
Great, thank you so much.
Operator
[Operator Instructions]. Your next question is from Graig Suvannavejh from Goldman Sachs. Your line is open.
Graig Suvannavejh -- Goldman Sachs -- Analyst
Thanks for taking my question. Congrats on continued progress toward hopefully a successful outcome with your PDUFA. I've got a couple of questions if I could; first, I just wanted -- certainly, to be one of the first drugs to go through potential accelerated approval process is exciting, and it shows kind of openness and receptivity by the FDA. I'm just trying to think about what -- in a downside scenario again, since this is not oncology. How are you thinking about the risk that there may be a situation where they're not comfortable approving a product on the merits of just one study. So its my kind of -- my first question so to speak. And then maybe the second question that I might ask you is, just a follow-up on the last question asked by the prior analyst, given the changes in unemployment versus those that are employed, do you have to start thinking about patient co-pay assistance or other programs, and in terms of how you're thinking about what that might look like, and just kind of maybe a follow-on to that is -- or related to that, is have you done any recent work around pricing and do you feel good where you are with your pricing assumptions or have there been any additional -- has there been any additional work that's been done, with respect to how you're thinking about pricing? Thank you.
Gerrit Klaerner -- Founder, President and Chief Executive Officer
On the FDA question, I think we've addressed before. I think the -- obviously we have an accelerated approval. You have to demonstrate a surrogate effect that is likely going to -- reasonably likely going to translate to clinical benefit, and then have the ability to design an outcome trial, which we've done and that outcome trial is ongoing well on its way, and that's very clear. And then on top of it obviously, while that outcome trial is going on for a few years, you also have to ensure that the patients who are getting it on and the initial approval in the U.S. patients are really getting clinical benefit. And those are the two components that -- and the two boxes we need to check and when you look at our back to back Lancet papers, when you look at the safety data, when you look at the efficacy data, both on the surrogate and beyond the surrogate in terms of the physical functioning, the quality-of-life and the objective chair test data, we are very confident that this is a very favorable risk benefit profile. So we don't see -- our read on the overall situation has really not changed and I think we remain confident that the drug will be approved on August 22 and again I think that you're right, this is not oncology that has done a lot of Accelerated Approvals, so we don't have a lot of things to point to, where this has successfully worked. I think that's a fair statement.
On the -- I think on the payer mix -- I think the -- more Medicaid patients. I think the biggest impact is maybe a different sort of gross to net.
Geoffrey Parker -- Executive Vice President, Chief Financial Officer
Yeah Graig, as you think about access to the drugs, Medicaid obviously has a 23.1% discount off WACC for their price and then they have a mid single-digit co-pay to access the drug. So as you think about the shift to Medicaid patients, access to the drug should be equal for those two patient populations. But as that mix trends toward Medicaid, that will modestly impact our gross to net, so that maybe a modest increase there. But overall, we think it shouldn't affect the penetration of the patient population.
And then with regards to pricing, again, given our patient population with commercial Medicaid and Medicare with low income subsidy, all of those patient populations are not affected directly by the cost, that's carried by the insurer. But for the Medicare patient obviously that's a consideration, but we believe that our pricing is still very well substantiated by the health economic work that we've done.
Graig Suvannavejh -- Goldman Sachs -- Analyst
OK, thank you very much.
Operator
And we have another question coming from Jessica Fye from JP Morgan. Your line is open.
Daniel Wolle -- JP Morgan -- Analyst
Good afternoon, everyone, this is Daniel for Jessica Fye. Thanks for taking our question. While the COVID-19 situation is evolving, how are you planning for the possibility that social distancing measures will still be in place during the launch of veverimer?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
Yes Daniel, I think that's exactly why we are capitalizing on the fact that we don't have a sales force hired yet. And so, the approach of really getting the key territories and the key sort of sales reps on board, this will allow us over the next few months to really figure out how effective is the virtual detailing and the communication. And to us basically, when you look at it, we don't know what the ratio is and the second half of this year of in-office versus virtual, and we also don't know how effective the virtual detailing is going forward. And so really what we're doing over the next three or four months, with the 40 reps, is to really learn the -- how efficacious the virtual approach is, and hopefully by then, we also have a better read of what the mix will be of in-office versus virtual. So instead of trying to to really get an Internet survey and predict this, we are actually generating data to really be able to plan accordingly.
Daniel Wolle -- JP Morgan -- Analyst
Got it. And then at that point, when do you then plan to hire the remaining 40 to 45? Will that be dependent on the data?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
Exactly. I think it could be as early or right after PDUFA or it could be that we get our first quarter of of really promotional effort under our belt and do it in the first in the first quarter of 2021. So that remains to be seen and will really give our regional business directors the chance to do a bottoms-up approach here and to really territory by territory, look at this and see what's needed and go forward accordingly.
Daniel Wolle -- JP Morgan -- Analyst
Did you by any chance receive any color on what the topics would have been on the AdCom, when you had that late stage communications interactions with the FDA?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
No, I would have loved to find out, but we didn't -- we are ready for all topics.
Daniel Wolle -- JP Morgan -- Analyst
Which were, sorry?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
So the entire obviously is sort of. From going to all of our data on the surrogate, on measures beyond the surrogate if you think about it, we obviously had results, a 65% reduction in DD50, death, dialysis, a 50% eGFR reductions. We had results on how patients feel and function as measured by the five times repeated chair test. We had results on patient reported outcomes and improvements, that were a multiple of what's considered clinically significant minimally. So we were ready to talk about all this, and excited to do so. And then, I think we were obviously informed that we wouldn't have an outcome at this time point.
Daniel Wolle -- JP Morgan -- Analyst
Got it. Has the FDA completed conducting inspections of the manufacturing facilities in the U.S. as well as outside?
Gerrit Klaerner -- Founder, President and Chief Executive Officer
Yeah, I think we are not commenting on the exact status of inspections. But as you might -- as you can imagine, every sponsor over the pending application right now is in a holding pattern, where FDA can't obviously at the moment inspect manufacturers or clinical sites.
Daniel Wolle -- JP Morgan -- Analyst
That's all I had. Thank you very much.
Gerrit Klaerner -- Founder, President and Chief Executive Officer
Thank you.
Operator
I am showing no further questions at this time. I would now like to turn the conference back to Jackie Cossmon.
Jackie Cossmon -- Vice President of Investor Relations and Communications
Thank you, Patricia. And thank you all for joining us on today's call. If you will be virtually attending the Goldman Sachs 41st Annual Healthcare Conference, we'll look forward to connecting with you there. And as always, if you have questions, please don't hesitate to contact us at [email protected]. Thank you and goodbye.
Operator
[Operator Closing Remarks].
Duration: 37 minutes
Call participants:
Jackie Cossmon -- Vice President of Investor Relations and Communications
Gerrit Klaerner -- Founder, President and Chief Executive Officer
Geoffrey Parker -- Executive Vice President, Chief Financial Officer
Laura Christianson -- Cowen -- Analyst
Graig Suvannavejh -- Goldman Sachs -- Analyst
Daniel Wolle -- JP Morgan -- Analyst
