Q1 2021 Trevena Inc Earnings Call
Okay.
Operator: Good day, and thank you for standing by, and welcome to the Trevina First Quarter 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 and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star Zero. I would now like to hand the conference over to Mr. Barry Shin, Chief Financial Officer. Please go ahead.
Good day, and thank you for attending by and welcome to the Trevino first quarter 2021 financial results Conference call. At this time, all participants are in a listen only mode.
After the speaker presentation, there will be a question and answer session.
I'll ask a question during the session you will need to press star one on your telephone.
These be advised that today's conference is being recorded.
You require any further assistance. Please press star zero I would now like to hand, the conference over to Mr. Barry Shin Chief Financial Officer. Please go ahead.
Barry Shin: Good morning and welcome everyone. With me today are Carrie Bordeaux, our president and CEO; Bob Yoder, our chief commercial officer; and her chief medical officer, Mark Demetrak. As a reminder, we'll be making forward-looking statements within the meaning of federal securities law. These statements are subject to risks and uncertainties related to our business, including those covered by our filings with the SEC. We undertake no obligation to update these statements beyond today. As I'm sure you recall, Olympic is indicated in adults for the management of acute pain severe enough to require an IV opiate analgesic and for whom alternative treatments are inadequate.
Thanks, operator.
Good morning, and welcome everyone.
With me today are Carrie Bordeaux, our president and CEO, Bob Yoder, our Chief commercial officer on our Chief Medical Officer, Mark them attract.
As a reminder, we'll be making forward looking statements within the meaning of federal Securities law.
The statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SEC. We undertake no obligation to update these statements beyond today.
And I'm sure you recall Olympic is indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate.
Barry Shin: I encourage you to go to olyndic.com. You'll find important safety information, including the box warning and the full prescribing information. I'll now turn the call over to Kerry for an overview of our first quarter and recent business accomplishments. Carey?
I encourage you to go to Olympic Dotcom.
You will find important safety information, including the box warning on the full prescribing information.
I'll now turn the call over to Kerry for an overview of our first quarter and recent business accomplishments.
Gary.
Carrie L. Bourdow: Thank you, Barry. Good morning, everyone, and thanks for joining us today. For 2021, we set our sights on two goals, successfully launching a Lindick and continuing our growth in the CNF space by advancing our pipeline. I'm pleased to report that we've made significant progress on both fronts. Let me start with a lens. First, we deployed our field team at the end of February. And like most of us, because of COVID, this team was initially in the field via Zoom and conference call. But with just one month of customer engagement, we're encouraged with the early progress. Bob will provide the details, but let me say that we've already had a formulary win.
Thank you Barry good morning, everyone and thanks for joining us today.
For 2020, one we set our sights on two goals.
That's fully launching Olympic and continuing our gross in the CNS space by advancing our pipeline.
I'm pleased to report that we've made significant progress on both fronts let.
Let me start with the Olympics.
First we deployed our field team at the end of February and like most of US because of COVID-19. This team was initially in the field via Zoom and conference calls.
But with just one month of customer engagement, we're encouraged with the early progress.
Bob will provide the details, but let me say that we've already had formulary wins.
Carrie L. Bourdow: And as hospitals and ASCs start to reopen, the team is shifting to live customer interactions. So there is more progress to come. Second, we presented our health economic models at a top pharmacy meeting last and highlighted the substantial cost savings for hospitals using Ivy Alindic versus IV more. These data are important as they support the addition of a limbic system to the hospital formula. And lastly, we're initiating an exciting outcome study that will be led by Cleveland Clinic. This study will build on a Lindex differentiated profile and has the potential to further set us apart from conventional IV opioids like morphine. On the pipeline front, we had two major announcements this morning.
And as hospitals in E. S sees start to reopen the team is shifting to live customer interactions so more progress to come.
Second we presented our health economic models at a top pharmacy meeting last month.
And highlighted the substantial cost savings for hospitals, using IV Olympic versus IV morphine.
These data are important as they support. The addition of Olin back on hospital formularies.
And lastly, we're initiating an exciting outcome study that will be led by Cleveland clinic.
This study will build on <unk> differentiated profile and has the potential to further set us apart from conventional IV opioids like morphine.
On the pipeline front, we had two major announcements. This morning, first we announced that T. R. V. O. Two seven has been selected by NIH and Vanderbilt University Medical center to be included in their large multi site COVID-19 trial.
Carrie L. Bourdow: First, we announced that TRV-O27 has been selected by NIH and Vanderbilt University Medical Center to be included in their large multi-site COVID trial. Mark will talk more about the trial, but you may also remember that just a few weeks ago, we announced that O27 would be part of another multi-site trial, led by remap cap organ. So we now have two new studies underway for TRVO27, funded by and in partnership with two of the largest international platform trial networks for COVID research.
Mark will talk more about the trial, but you may also remember that just a few weeks ago, we announced that OTI seven will be part of another multi site trial led by remap cap organization.
So we now have two new studies underway for T. R V O two seven funded by and in partnership with <unk>.
With two of the largest international platform trial networks for COVID-19 research.
Carrie L. Bourdow: In total, these studies will provide TRV-O27 data for up to 600 patients. As the lingering and long-term effects of the pandemic continue, it's important that the work to develop new treatment options also continues. And it's a great privilege that Tervina can be supporting this effort. For TRV-045, we announced that the IND filing remains on track and that we've chosen diabetic neuropathic pain as the lead indication. This is a large market where we believe 045's unique non-opioid mechanism will be a significant advantage because there are a multitude of efficacy and tolerability problems associated with current therapies.
In total these studies will provide T. R V O two seven data in up to 600 patients.
As the lingering and long term effects of the pandemic continue it's important that the work to develop new treatment options also continues.
And it's a great privilege that are tricky and it can be supporting this effort.
For TRP O four five we announced that our IND filing remains on track and that we've chosen diabetic neuropathic pain as the lead indication. This is a large market, where we believe 045 unique non opioid mechanism will be a significant advantage because theres a multitude of efficacy.
And tolerability problems associated with current therapies.
Carrie L. Bourdow: In addition to neuropathic pain, we're continuing our epilepsy-focused collaboration with NIH, and we'll provide updates as the data becomes available. Now, let me turn the call over to Bob to talk more about the early progress with Lennox. Bob?
In addition to neuropathic pain, we're continuing our epilepsy focused collaboration with NIH and we'll provide updates as the data becomes available.
Now, let me turn the call over to Bob to talk more about the early progress with a lender Bob.
Bob Yoder: Thank you, Carrie. It's great to be here this morning to provide an update on a busy and productive first quarter. Let me highlight a few key aspects of our launch. We are on our way to our overall goal of 100 Formula 1 wins in 2021.
Thank you Carrie it's great to be here. This morning to provide an update on a busy and productive first quarter.
Let me highlight a few key aspects of our launch.
We are on our way toward overall goal of 100 formulary wins in 2021.
Bob Yoder: Although our field team was only deployed at the end of February, we have 60 institutions reviewing the Olympic at various stages, and we already have 10 formulary wins. At this early phase of launch, formulary wins are the most important metric for us since they give us the best insight into initial customer interest. I am pleased with this level of early engagement, which I believe is indicative of the compelling product profile for a limbic inhibitor, including a rapid onset effect, no active metabolites, and no need for dose adjustment for renal impaired patients.
Although our field team was only deployed at the end of February we have 60 institutions reviewing the Olympic at various stages and we already have 10 formulary wins.
At this early phase of launch formulary wins are the most important metric for us because it gives us the best insight into initial customer interest.
I am pleased with this level of early engagement, which I believe is indicative of the compelling product profile for Olympic including rapid onset of effect no active metabolites and no need for dose adjustment for renal impaired patients.
Bob Yoder: Launching amid an ongoing pandemic has certainly been interesting. We're continuing to learn from our customers how COVID is affecting their business. And what we've heard is while operations are slowly returning to pre-pandemic levels of activity, many hospitals are still dealing with the longer-term impact. Now that more surgeries are coming back online, hospitals are focused on prioritizing their backlogs and seeing patients who had not pursued their elected procedures over the past 12 months. As a result, many institutions are delaying their form until our review, sometimes by many months.
Launching amid an ongoing pandemic has certainly been interesting.
We're continuing to learn from our customers how COVID-19 is affecting their business and what we've heard is while operations are slowly returning to pre pandemic levels of activity. Many hospitals are still dealing with the longer term impact.
Now a bit more surgeries are coming back online hospitals are focused on prioritizing their backlogs and seeing patients who had not pursued their elective procedures over the past 12 months.
As a result, many institutions are delaying their formulary reviews, sometimes by many months.
Bob Yoder: With that being said, we're pleased with the early traction we've been getting, and the rising number of surgeries certainly represents a great opportunity for us as we gain additional proof of progress. Within the personal promotion channel, we're seeing the engagements of our field team evolve over time, which reflects the shifting dynamics and customer access due to COVID. Shortly after our full field deployment at the end of February, we were conducting most of our field calls virtually. However, we're now up to approximately 70% of our customer calls being conducted live.
With that being said, we're pleased with the early traction we've been getting and the rising number of surgeries certainly represents a great opportunity for us as we gain additional formulary approvals.
Within the personal promotion channel, we're seeing the engagements of our field team evolve overtime, which reflects the shifting dynamics and customer access due to COVID-19.
Shortly after our full field deployment at the end of February we were conducting most of our field calls virtually.
However, we're now up to approximately 70% of our customer calls being conducted live.
Bob Yoder: Even though we trained and resourced our field teams to be effective in a virtual environment, it is encouraging to see the return to face-to-face engagement. To drive additional awareness, trial, and usage, we continue to augment the personal promotion of our customer-facing team with a robust multi-channel digital engagement strategy. Our digital campaign, which includes banner ads, targeted outreach, and a presence across Medscape and other HCP-centered channels, had a reach of 98% across a target audience of 17,900 HCPs.
Even though we trained and resource our field teams to be affected in a virtual environment. It is encouraging to see the return to face to face engagements.
To drive additional awareness trial and usage, we can do to augment the personal promotion of our customer facing team with a robust multi channel digital engagement strategy.
Our digital campaign, which includes banner ads targeted outreach and our presence across Netscape and other HCP center channels.
On a reach of 98% across a target audience of 17900 Hcp's.
Bob Yoder: We're really encouraged to see that key measures of engagement are at levels of 30 to 50% higher than typical industry benchmarks. Clearly, that digital channel remains an important channel for us, and one that we continue to monitor and optimize as we track engagement. Now, I'll speak a little bit about our overall strategy for Lunt.
We've really been encouraged to see that key measures of engagement are at levels of 30% to 50% higher than typical industry benchmarks.
Clearly that digital channel remains an important channel for us and one that we continue to monitor and optimize as we track engagement.
Let me speak a little bit to our overall strategy for launch.
Bob Yoder: Our top priority is gaining formulary approvals for Olympics in the hospital setting. We're positioning it for those challenging patients who are at risk for adverse events like respiratory depression or vomiting. That is, the elderly, renally impaired patients, or patients with comorbid conditions. You've heard me say that these are the patients that stay longer in the hospital, which increases their risk for adverse events, which can then lead to an increase in overall cost to the hospital system.
Our top priority is gaining formulary approvals per Linda in the hospital setting.
We're positioning Olympic for those challenging patients who are at risk for adverse events like respiratory depression or vomiting.
That is the elderly renal impaired patients or patients with co morbid conditions.
You've heard me say that these are the patients that stayed longer in the hospital, which increases their risk for adverse events, which can then lead to an increase in overall cost to the hospital system.
Bob Yoder: We believe the Olympic value proposition is strongest for these patients, and they represent a growing portion of the hospital population. Additionally, it is that focus on the challenging patient that is driving some of the early interest in adoption in the hospital setting. So to summarize, we've had a productive first quarter.
We believe the Olympic value proposition is strongest for these patients and they represent a growing portion of the hospital population.
Additionally, it is that focus on the challenging patient that is driving some of the early interest and adoption in the hospital setting.
So to summarize we've had a productive first quarter our field teams were fully deployed late in the quarter and.
Mark A. Demitrack: Our field teams were fully deployed late in the quarter, and we're building upon our early momentum to generate formulary wins and leverage the robust early engagement we've seen from our customers. Let me now turn the call over to Mark to discuss our post-approval plan for Lindvig and provide an update on our pipeline. Thank you, Bob.
And we're building upon our early momentum to generate formulary wins and leveraged the robust early engagement, we've seen from our customers.
Let me now turn the call over to Mark to discuss our post approval plan for Olympics and provide an update on our pipeline.
Mark.
Thank you Bob.
Mark A. Demitrack: Over the past few months, we've received feedback from clinicians regarding what additional clinical data for Lindvik they would find interesting and relevant to their practice. It's been encouraging to hear such a positive level of engagement from the medical community this early on in the launch. And I'm pleased to present the details for our first post-approval study designed with this interest in mind. This will be a real-world experience cohort study initiated as a collaboration with the Cleveland Clinic. The study is being led by Dr. Dan Sessler and his colleagues in the Clinical Outcomes Research Program at the clinic. The goal of this study is to expand on the observations from our previous work.
Over the past few months, we've received feedback from clinicians regarding what additional clinical data for Olympic They would find interesting and relevant to their practice, it's been encouraging to hear such a positive level of engagement from the medical community. This early on in the launch and I'm pleased to present the details for our first.
Post approval study designed with this interest in mind.
This will be a real world experience cohort study initiated as a collaboration with the Cleveland clinic.
The study is being led by Dr. Dan Sessler and his colleagues in the clinical outcomes research program at the clinic.
The goal of this study is to expand on the observations from our previous work.
Mark A. Demitrack: Further characterizing measures of respiratory and gastrointestinal safety and tolerability. Dr. Sessler's team has pioneered the development of sophisticated continuous respiratory monitoring, increasingly used in routine clinical practice, and we plan to incorporate these approaches in the study. Gastrointestinal safety will be evaluated using multiple outcomes, including assessment of the complete responder, and namely a post-operative course with no vomiting, and no need for rescue anti-emetic.
Further characterizing measures of respiratory and gastro intestinal safety and Tolerability.
Dr. <unk> team has pioneered the development of sophisticated continuous respiratory monitoring methods increasingly used in routine clinical practice.
And we plan to incorporate these approaches in the study.
Gastrointestinal tolerability will be evaluated using multiple outcomes, including assessment of the complete responder endpoint.
Namely a postoperative course with no vomiting, and no need for rescue anti aromatics.
Mark A. Demitrack: Most important, The study will also incorporate validated cognitive function outcome Cognitive function is a particular interest to us because of the clinical feedback we received from the investigators in our Phase 3 Athena trial who reported that they saw clinically notable improvement, in the speed of cognitive recovery in their patients' post-operative We believe this study will be an important addition to the body of evidence we have assembled for a, Further helping to characterize its safety and tolerability profile, and will provide relevant and meaningful data that clinicians have asked, We continue to expand the evidence base for Olinvik, and I'm pleased to note that we recently reported the details of our health economic models at the annual meeting of the Academy of Managed Care Pharmacy. We presented two posts, one of which received a gold ribbon, an honor awarded to only 20% of submitted abstracts at that meeting.
Most importantly, the study will also incorporate validated cognizant function outcome assessments.
Cognitive function is of particular interest to us because of the clinical feedback we received from the investigators in our phase III Athena trial, who reported that they saw a clinically notable improvements in the speed of cognitive recovery in their patients postoperatively.
We believe this study will be an important addition to the body of evidence we have assembled for Olympic.
Further helping to characterize its safety and Tolerability profile.
And we'll provide relevant and meaningful data that clinicians have asked for.
We continue.
To expand the evidence base for Olympic and I'm pleased to note that we recently reported the details of our health economic models at the annual meeting of the Academy of managed care pharmacy.
We presented two posters.
One of which received a gold ribbon and on are awarded to only 20% of submitted abstracts at that meeting.
Mark A. Demitrack: This work was developed in collaboration with Dr. Kit Simpson is an expert health economist at the Medical University of South Carolina. The models are significant because they are built directly upon the evidence from our Phase 3 clinical development programs and use well-substantiated cost inputs from government and scientific published data to estimate the cost offset that accrues when a lymphatic is incorporated into clinical postoperative care. As an example, the economic model shows that when lindic is used in high-risk, elderly, and obese patients, it results in cost savings of approximately $364,000 for every 1,000 patients treated compared to the use of a conventional IV.
This work was developed in collaboration with Dr. Kipps Simpson.
And ex parte health economists at the medical University of South Carolina.
The models are significant because they were built directly upon the evidence from our phase III clinical development program.
And used well substantiated cost inputs from government and scientific published data to estimate the cost offset that accrues when Olympic is incorporated into clinical postoperative care.
As an example, the economic model shows that when Olympic is used in high risk elderly in obese patients.
This results in cost savings of approximately $364000 for every 1000 patients treated.
Paired to the use of a conventional IV opioids.
Mark A. Demitrack: We believe these data highlight the significant cost savings that are estimated to occur in a hospital system and support the addition of Lindvik to the hospital formula. I'd now like to turn to a discussion of our pipeline. Starting with PRV-027. As you saw from our announcement this morning, I'm pleased to report that the scientific community's interest in this compound continues to grow, as demonstrated by the fact that TRV-027 has recently advanced into two large multi-site platform trials, significantly expanding the patient populations being studied.
We believe these day to highlight the significant cost savings that are estimated to occur in a hospital system and support. The addition of Olympic.
Hospital formularies.
I'd now like to turn to a discussion of our pipeline.
Starting with <unk> <unk> seven.
As you saw from our announcement. This morning, I am pleased to report that the scientific community's interest in this compound continues to grow.
As demonstrated by the fact that P. R V O. Two seven has recently advanced into two large multi sided platform trials.
Significantly expanding the patient population being studied.
Mark A. Demitrack: The most recent trial we announced today, is known as Active 4D, which is part of the effort previously known as Operation Warp Speed, and is being led by Vanderbilt University Medical The active platform trials network is funded by the NIH and is their premier clinical trial initiative intended to expedite the development of COVID-19 treatment, Vanderbilt has established themselves as a leading institution in COVID-19 research here in the U.S, and we're glad to be partnering with them to address the critical need for COVID-19 symptomatic treatment As part of Active 4D, TRV-O27 will be administered as a monotherapy in up to 300 patients, and the trial will include a placebo control. We announced last month that TRV-027 will also be included in a trial led by the International Study Consortium known as Remap Cap.
The most recent trial, we announced today.
Known as active for D.
Which is part of the effort previously known as operation Warped speed and is being led by Vanderbilt University Medical Center.
The active platform trials network is funded by the NIH and is their premier clinical trial initiative intended to expedite the development of COVID-19 treatments.
Vanderbilt has established themselves as a leading institution in COVID-19 research here in the U S and we're glad to be partnering with them to address the critical need for COVID-19 symptomatic treatments.
As part of active for D. C. R V O two seven will be administered as a monotherapy in up to 300 patients.
And the trial will include a placebo control.
We announced last month that T. R. V O. Two seven will also be included in a trial led by the International study consortium known as remap cap.
Mark A. Demitrack: This long-standing international platform trial focused on treatments for lung injury has become one of the global leaders in COVID-19 research. After observing TRV-027 in the initial proof-of-concept study being conducted by Imperial College London, Remap Cap approached us with an interest to expand O27 into a larger multi-site phase two and three trial. The proof of concept study recently underwent an interim analysis by Imperial College's data monitoring and safety department, and they determined that there were no safety concerns associated with O27. The Remap Caps trial will be conducted in multiple sites across the UK, including continuing at Imperial College itself as one of the participating sites.
This longstanding international platform trial focused on treatments for lung injury has become one of the global leaders in COVID-19 research.
After observing T. R V O two seven in the initial proof of concept study being conducted by Imperial College London.
Remap cap approached us with an interest to expand out to seven into a larger multi site phase two three trial.
The proof of concept study recently underwent an interim analysis by Imperial College, as David monitoring and safety Committee.
And they determined that there were no safety concerns associated with debt of two seven.
Remap caps trial will be conducted in multiple sites across the U K.
Including continuing at Imperial College itself as one of the participating sites.
Mark A. Demitrack: Combined, these two international platform trials will provide us with a detailed clinical profile of TRV-O27's effect on mortality and organ failure in hospitalized patients with COVID-19. Finally, we've continued to make progress on our IND application for TRV 045, our novel S1P receptor module, and expect to file the I&D sometime this quarter. Based on the data we've generated in-house as part of our IND enabling activity, we chose to pursue diabetic neuropathic pain as our initial lead indication for the SAS. This is a highly burdensome condition, and currently available treatment options fall short, both in terms of efficacy and tolerability.
Combined these two international platform trials will provide us with a detailed clinical profile of T. R. V O two sevens effect on mortality and organ failure in hospitalized patients with COVID-19.
Finally, we've continued to make progress on our IND application for <unk> <unk> five.
Our novel <unk> receptor modulator.
And expect to file the IND sometime this quarter.
Based on the data we've generated in house as part of our IND, enabling activities.
We've chosen to pursue diabetic neuropathic pain.
Our initial lead indications for this asset.
This is a highly burdensome condition.
And currently available treatment options fall short both in terms of efficacy and Tolerability.
Mark A. Demitrack: The innovative and unique mechanism of PRV 045, compared to other approaches to this disorder, holds significant potential as a new treatment option with improvements in both efficacy and tolerability. I'd like to note that we continue to remain highly interested in TRV-045's potential benefits, and our collaboration with NIH's Epilepsy Therapy Screening Program continues to generate data that will inform our future developments of PRV 045. Let me now turn the call over to Barry to discuss our first quarter financial results. Barry?
The innovative and unique mechanism of <unk> four five.
Compared to other approaches to this disorder.
Significant potential as a new treatment option with improvements in both efficacy and tolerability.
I'd like to note that we continue to remain highly interested in T. R V <unk> five's potential in epilepsy and.
And our collaboration with NIH is epilepsy therapy screening program continues to generate data that will inform our future development of <unk> 45.
Let me now turn the call over to Barry to discuss our first quarter financial results Barry.
Barry Shin: Thanks, Mark. We deployed a customer-facing team at the end of February and reported $209,000 in net sales for Lindvick in Q1. Our net loss for the quarter was $9.8 million compared to $5.7 million for the same period last year. This increased net loss was mainly due to expenses associated with the launch of a new product. Our operating expense was $10.2 million for the quarter, and we expect it to increase in 2021 as we commercialize LINVIC and advance our pipeline assets.
Thanks Mark.
We deployed our customer facing team at the end of February and reported $209000 in net sales per Linda Q1 on.
Our net loss for the quarter was $9 $8 million compared to $5 $7 million for the same period last year.
This increase in net loss was mainly due to expenses associated with the launch of Olympics.
Our operating expense was $10 $2 million per the quarter and we expect this to increase from 2021, as we commercialize Olympic and advance our pipeline assets.
Barry Shin: As of March 3rd, we had cash and equivalence of $97.7 million, which we continue to expect will fund our operations through the fourth quarter of 2020. We'll now open the call for questions, after which Kerry will provide some closing remarks. Operator.
As of March 31, we had cash and equivalents of $97 $7 million, which we.
To expect will fund operations through the fourth quarter of 2022.
Well now open the call for questions after which Carey will provide some closing remarks.
Operator.
At this time.
Question.
Operator: I'd like to remind you to ask the question. The question will come from Jason Burk.
Good question Jason.
Okay.
Thanks for taking the question can you guys hear me.
Jason Nicholas Butler: Thanks for taking the time to ask a question. Can you guys hear me?
Yes, we can hear you operator, we cant hear you, but Jason we can hear you.
Carrie L. Bourdow: Yes, we can hear you. Operator, we actually can't hear you, but Jason, we can hear you. Thanks, Carrie.
Okay. So first question just on the formulary process, obviously not surprising there's still delays in getting meetings scheduled but can you give us any color on how successful you are being in the meetings that do take place you mentioned the 10 approvals.
Carrie L. Bourdow: So first question, just on the formulary process: obviously, there's still delays in getting meetings scheduled. But can you give us any color on how successful you're being in the meetings that do take place? You mentioned the 10 approvals. Any number you can give us in terms of where you're not getting first cycle approvals? and any color into the reasons why anything unexpected there, or is it just a process of grinding through and demonstrating the value of the asset? Yeah, thanks, Jason. I'll start, and then I'll ask Bob to add on.
Any any number you can give us in terms of the where youre not getting first cycle approvals and any color into the reasons why anything unexpected there or is it just a process of of grinding through income.
And demonstrating the value of the asset.
Yeah. Thanks, Jason I'll start and then I'll, then I'll ask Bob to add on.
Carrie L. Bourdow: So a couple things, as you said, it's always interesting, right? It's a bit of a grind to get the drug on formula. But I will say, not only do we have the 10 wins, but as Bob mentioned, we've got 60 that are in various stages, which is really impressive, given that we just put the field sales organization out at the end of February, and for the most part, they were trying to engage with customers in a virtual way, right? So we're starting to see hospitals reopen. We're starting to see people engage.
So a couple of things as you said, it's a it's always interesting right. It's a bit of a grind to get the get the drug on formulary, but I will say not only do we have the 10 wins, but as Bob mentioned, we've got 60 that are in various stages, which is really impressive given that we just put the field sales organization out at the end of February and for the most part day wear.
We're trying to engage with customers in a virtual way right. So we're starting to see hospitals reopen we're starting to see people engage formulary reviews are being delayed as the as the <unk>.
Carrie L. Bourdow: Formulary reviews are being delayed as the backlog of patients comes into hospitals. Physicians and pharmacists are having to treat those patients and are not necessarily having the formulary meetings. But what I'll tell you is that the health economic data is working really hard. You know, Jason, you've covered a lot of hospital launches. A lot of companies have to wait a year or so before they get their health economic data out there. We've already had that data out there. It's now published.
On the patients come into hospitals.
<unk> pharmacists are having to treat those patients and are not necessarily having the formulary meetings, but I. What I'll tell you is that the health economic data is working really hard for us.
No Jason you've covered a lot of hospital launches.
Lot of companies have wait a year or so before they get their health economic data out there we've had that data out there now published.
Carrie L. Bourdow: It's part of the dossier that we provide to hospital formulary, so that's working really well. We've had two hospitals that, before we were out, chose not to put a limbic on formulary. The team, our medical science liaisons, and our field sales organization have gone back to some of the key opinion leaders who want to get the drug on formulary, and we're actively working through that. So there's not really anything surprising. You know, I've been doing this a long time.
It's part of the dossier that we provide to hospital formulary. He said that that's working really well we've had two hospitals that.
Before we were out chose not to put them back on formulary the team our medical science liaisons in our field sales organization have gone back to some of the key opinion leaders, who wanted to get the drug on formulary and we're actively working through that so there's not really anything surprising you know I've been doing this a long time this is <unk>.
Carrie L. Bourdow: This is how hospital formularies work. I will say COVID's made it a little bit more interesting for us, but it's incredibly impressive that the team just continues to look for ways to engage customers and get the drug views. Bob, any other color that you want to provide?
Hospital Formularies work I will say COVID-19 has made it a little bit more interesting for us, but it's incredibly impressive that the team just continues to look for ways to engage customers and get the drug abuse.
Any other color that you want to provide.
Bob Yoder: Thanks, Carrie. Thanks, Jason, for the question, too. Not a lot.
Thanks, Carrie Thanks, Jason for the question.
Bob Yoder: I mean, I just, Jason, I responded to when you described it. You're absolutely right. It really is just grinding through, and I'm really proud of what the teams were able to do in this tough situation where they started out virtually. It's hard enough to get formulary reviews moving along through that pipeline live, let alone to try to do that virtually. And so moving to live engagements, I think, will certainly be very helpful for us. But they're doing a great job of grinding it through.
Not a lot.
Based on I'm smiling when you described that Youre absolutely right. It really is just grinding through and I'm really proud of what the team's been able to do in this tough situation, where they started out virtually it's hard enough to get formulary reviews, moving along through that pipeline alive, let alone to try to do that virtually so moving from a live engagements I think will will certainly be very helpful.
For us, but there are doing a great job on grinding through and as you sort of intimated if you've seen one formulary review process, you've seen one formulary review process. So theyre definitely variances across institutions in terms of the speed what youre working through on how they're impacted but I'm really happy with the interest received from customers to engage with us in that process.
Bob Yoder: And as you sort of intimated, if you've seen one form of review process, you've seen one formula review process. So there are definitely variances across institutions in terms of the speed at which you're working through and how they're impacted. But I'm really happy with the interest from customers to engage with us in that process. Great.
Great.
Mark A. Demitrack: And then, second question for me, just on the outcomes trial, can you maybe speak to how you think about data from this trial that could be incorporated into the product label, ultimately, or is it more a focus on publication? And then, just with respect to the respiratory tools that you're talking about, obviously one of the challenges of generating data on respiratory outcomes is patient numbers. So can you maybe speak to how, with fewer patients, you can get really valuable data with the tools that are being used?
And then second question from me just on the outcomes trial can you maybe speak to how you think about where are their data from this trial, you think could be incorporated into the product label ultimately or is it more of a focus on publication and then just with respect to the respiratory tools that you're talking about.
Obviously, one of the challenges of generating data on where spiritually outcomes as the patient numbers.
So can you maybe speak to how with fewer patients you can get really valuable data with the tools that are being used.
Mark A. Demitrack: Yeah, great, great question. So we we don't We're not necessarily planning for the data to be in the label. It certainly depends, right, what the data looks like, particularly around respiratory depression, because there's no approved endpoint from the FDA on how to measure respiratory depression. So they're very interested in additional ways to measure respiratory depression. It's a huge issue with conventional IV opioids. Let me ask Mark to talk a little bit more about the trial, and respiratory in particular is a really interesting way in which they're measuring in the Cleveland Clinic trial.
Great Great question. So we we don't.
We're not planning necessarily for the data to be in the label. It certainly depends right what the data looks like particularly around respiratory depression, because there is no.
Approved endpoint from from the FDA on how to measure respiratory depression, so theyre very interested in additional ways to measure respiratory it's a huge issue with the conventional IV opioids.
Let me ask Mark to talk a little bit more about the trial and respiratory in particular is a really interesting way in which they're measuring it in in the Cleveland clinic trial.
Mark A. Demitrack: Yeah, Jason, let me comment that since the initial studies that we did with the methodology that was used in the Apollo and the Athena studies to look at aggressive tree outcomes, the thing that's been most interesting to us is the work that, in particular, the Cleveland Clinic group has pioneered in terms of blinded, continuous respiratory monitoring. You may remember one of the more recent publications, the Prodigy Trial, was an example of this. Approach.
Yeah, Jason Let me, let me comment that since the.
The initial studies that we did with the methodology that was used in the Apollo and the Athena study is to look aggressive career outcomes. The thing that's been most interesting to US is the work that particular, the Cleveland Clinic group has pioneered.
In terms of blinded continuous respiratory monitoring you may remember one of the more recent publications. The prodigy trial was an example of this approach.
And what this enables an investigator to do is to actually capture a much more comprehensive continuous readout of the respiratory status of a patient is something that really was not methodologically feasible and some of the earlier generation of work that amount of information the additional.
Mark A. Demitrack: And what this enables an investigator to do is to actually capture a much more comprehensive continuous readout of the respiratory status of a patient, something that really was not methodologically feasible in some of the earlier generation of work. That amount of information, the additional data, provides a much more exquisite level of precision in estimating respiratory depression and seeing events that oftentimes go unnoticed with earlier methods of assessment. So we're really excited about the opportunity to apply this more contemporary methodology to assessment of respiratory outcomes.
Data provides a much more exquisite level of precision in estimating respiratory depression and seeing events said oftentimes go on mist with earlier methods of assessment. So we're really excited about the opportunity to apply this more contemporary methodology.
Two assessment.
<unk> outcomes and I think it's going to give us a lot.
Mark A. Demitrack: And I think it's going to give us a lot clearer ability to estimate and characterize the respiratory profile associated with the lends. Okay, that's great. Thanks for taking questions, and great to see the progress on the Olympic launch and also the addition of 027 to the NIH study. Congratulations. Thanks.
Clear ability to estimate and characterized the respiratory profile associated with the Olympics.
Okay. That's great. Thanks for taking the questions on <unk>.
Great to see the progress on the Olympics on churn and also the addition of 027 entity NIH study Congrats Inc. Thank you Jason we appreciate it thank you.
Carrie L. Bourdow: Thank you, Jason. We appreciate it. Thank you.
Operator: Your next question will come from Brennan, who is with Cancer Fitzgerald.
Your next question will come from Brandon Folkes with Cantor Fitzgerald.
Brandon Richard Folkes: Hi, thanks for taking my questions and congratulations on both sides of the business. It seems to be going well.
Hi, Thanks for taking my questions and congratulations on both sides of the business seems to be going well.
Maybe just some color on those 10 accounts net.
Brandon Richard Folkes: Maybe just some color on those 10 accounts that have put Lindvik on formulary. I guess firstly, sort of any color in terms of how many of those accounts placed orders during the quarter, you know, granted, of course, on the full quarter, any color on the types of centers in those 10 wins, and likewise, maybe types of centers in the 60 under review. And then any restrictions placed on Olivik, I guess, in those 10 wins that maybe you didn't expect.
I've put a linda on formulary.
I guess, firstly sort of any color in terms of how many.
Those accounts placed orders during the quarter granted gross on a full quarter.
Any color on the types of centers and those 10 wins and likewise, maybe perhaps the centers.
In the 60 under review and then any restrictions placed on our limbic against in those 10 wins that maybe you didn't.
Brandon Richard Folkes: I did hear your comment on sort of, you know, they do seem to be focused on using it in the patient population that you expected. So that's great. And then lastly, maybe I'll ask my questions up front, that's okay, just on the pipeline. There are a few, sorry.
I expect I did hear your comments on sort of yeah. They do seem to be focused on using it and the patient population and that you expected. So that's great.
And then lastly, maybe I'll ask him a question upfront if that's okay just on the pipeline.
It's a few sorry.
Brandon Richard Folkes: You know, how do we think about, obviously, some of these have outside funding; you're launching Olinvik. You know, some of these are very early stage, but very large market opportunities. How do you think about sort of funding the pipeline at this stage, sort of where you want to fund it to look for a partner or look for funding? Just what can you say from that perspective at this stage?
How do we think about obviously some of these have outside funding you launching Olin Vic.
Some of these are very early stage, but very large market opportunity. How do you think about sort of funding the pipeline at this stage to the way you want it to.
Look for a partner looks like.
And just what can you say from that perspective at this stage. Thank you.
Brandon Richard Folkes: Thanks, Brandon. I'm taking note. So you'll, the team will come down in case we do it.
Thanks Brandon.
<unk> taken note.
Carrie L. Bourdow: That's okay, yeah, so I wrote them down as well. Hopefully, I'll get everything and then I'll turn it over to Bob and Mark. Okay, so let's start with Lindvik and the types of formularies, the types of centers, and I'll provide a little bit of information. Then, as I said, I'll turn it over to Bob.
The team will go out to them ready.
In case, we need it.
Well hopefully all day.
And then I'll turn it over to Bob and Mark Okay. So, let's start with the Olympic and net debt.
Types of formularies the types of centers.
I'll provide a little bit of information and as I said I'll turn it over to Bob So intra.
Carrie L. Bourdow: So interestingly enough, I know we've messaged that our approach is community, community teaching, and we are getting some of those institutions, but we've had a fair number of what I'll call large academic medical centers. And from my previous experiences, those are really some of the toughest institutions to get. We had one really large cancer institution that actually approached us, which was sort of interesting. So that's the good news and a surprise, right?
Interestingly enough I know, we've message that our approach with community community teaching.
And we are getting some of those institutions, but we've had a fair number of what I'll call large academic medical centers and that my previous experiences those are really some of the toughest institutions to get.
We had one really large cancer institution that actually approached us.
Sort of interesting so that that's the good news and a surprise right.
Carrie L. Bourdow: and we've also, though, had community teaching and one, I think, one large ambulatory surgery center. The mix, as far as the 60s that are in various stages, I'll ask Bob to talk a little bit about, but let me actually answer one of your other questions. I think you asked about restrictions.
And.
We've also had those community teaching and one I think when large ambulatory surgery center the mix as far as debt. This the $60 that are in various stages I'll I'll ask Bob to talk a little bit about let me actually answer one of your other questions. I think you asked about restriction so.
Carrie L. Bourdow: So we are not seeing any restrictions that we did not expect. What we're seeing is that the restrictions, for the most part right now, and that is, As you said, it's so early; it's hard to say that this is how it's going to be moving forward. But the restrictions have been to physician groups, not necessarily the higher-risk patients, but for instance, the formula review has been restricted to anesthesia and colorectal surgeons.
We are not seeing any restrictions that we did not expect what we're seeing is that the restrictions for the most part right now on as you said, it's so early it's hard to say that this is this is how it's going to be moving forward, but the restrictions have been too busy.
Eastern groups not necessarily the higher risk patients, but for instance that the formulary review has been restricted to anesthesia in colorectal surgeon and that's also very typical in hospital launches right that the pharmacy is looking for an easy way to to get the use but not let us expand.
Carrie L. Bourdow: And that's also very typical in hospital launches, right? The pharmacy is looking for an easy way to get the product into use but not let the use expand so quickly that, you know, they can't monitor it. We'll see moving forward if it ends up being more of a protocol-driven trial for certain patient types. I think that the challenging patient positioning is really helping us get the drug in front of pharmacists and get it looked at that way.
So quickly that that debt they can't monitor it.
And we will see moving forward if it ends up being more of a protocol driven for certain patient types.
I think that the challenging patient positioning is really helping us get the drug in front of pharmacy and get it get it looked at that way and then whoever the physician champion is is it sort of being restricted in that space.
Carrie L. Bourdow: And then whoever the physician champion is, it's sort of being restricted in that space. Bob, any other comments you want to make about the 60 institutions that are in various reviews or anything I missed on the Olympic questioning?
Any other comments you want to make around the 60 institutions that are in various reviews or anything I missed on the Olympic.
Olympic questioning.
Bob Yoder: Yeah, sure. What I would say is that for the 60 veteran view, they kind of run the gamut. I mean, it really is a broad spectrum and there are two things there. One, it confirms our targeting approach, which, as you may recall, was, you know, those institutions doing a large number of painful procedures and therefore a high use of IV opioids but had also had a history of reviewing some branded products earlier post-launch than maybe there are other institutions. So it's confirmed some of that. But there are some other surprises, like Carrie characterizes. Some of the larger academic medical centers are also lumped into that group that we're in the process of working with. So it's encouraging.
Yeah sure what I would say is for the 60 day review that they kind of run the gamut I mean, it really is a broad spectrum and two things there one confirms our targeting approach, which as you may recall was those.
She is doing the large number of painful procedures and therefore, a high use of IV opioids, but had also had a history of reviewing some branded products earlier post launch than maybe other institutions. So it's confirmed some of that but there are some other surprises like Harry characterize as well some of the larger academic medical centers are also on <unk>.
Into that group that were in process with so it's encouraging.
And then your question around the pipeline and how we think about the pipeline.
One of the things we mentioned with <unk> seven is that both of these large trials and the smaller proof of concept study those are all fully funded by external partners by by NIH Remap cap, we're just supplying drought.
Carrie L. Bourdow: And then your question about the pipeline and how we think about the pipeline. One of the things we mentioned with TRV-O27 is that both of these large trials and the smaller proof-of-concept study are all fully funded by external partners, by NIH, by Remap Cap. We're just supplying drugs. With 045, we're taking the focus in the chronic neuropathic pain space, right, diabetic neuropathic pain, and we're letting NIH continue their work around epilepsy.
With O four five we're taking the focus in the chronic neuropathic pain space right. The diabetic neuropathic pain and we're letting NIH continue their work around epilepsy will.
See what that data looks like we'll build that into our plans, but we're certainly interested in partnering as well.
I think it's been really encouraging that we can use these external.
Carrie L. Bourdow: We'll see what that data looks like, and we'll build that into our plans. But we're certainly interested in partnering as well. I think it's been really encouraging that we can use these external funding partners to help us move the pipeline along while we focus on launching Alindic. And, you know, as Mark said in his comments, the fact that we've got external partners coming to us to help study the drug, and then, of course, we're interested in potentially partnering with, you know, other companies. And there's really not much more to it.
Funding partners to help us move the pipeline along while we focus on launching alembic.
And the.
As Mark said in his comments the fact that we've got external partners coming to us.
To help studied the drug and then of course, we're interested in and potentially partnering.
With with.
Other other companies and Theres really not much more I can say is as far as that goes right now.
Great. Thank you very much.
Everything well congrats on.
Congrats its a lot right to describe all that.
We're doing okay.
And I have it I think it's a very solid launch for a hospital. So congratulations on net debt. Thank.
Brandon I appreciate it.
Carrie L. Bourdow: Great, thank you very much. You know how you got everything.
Carrie L. Bourdow: Congratulations. It takes us a lot, right? To describe all that we're doing. Yeah, I appreciate it. I think it's a very solid launch for a hospital.
Carrie L. Bourdow: So congratulations on that. Thank you, Brandon. I appreciate it.
Operator: Your next question will come from Dana Flanders with Guggenheim.
Dana Flanders: Great, thank you very much. Good morning.
Dana Flanders: I've got just two questions on the pipeline. First, just on the clinical outcome study that you announced this morning, when would you expect to get data from that study? And given some of the novel endpoints, will there be a control arm that you'll be comparing Olinvik to? And just on the decision to move forward with this, was that something you were hearing from physicians or formularies, or maybe both?
How quickly can just move into phase one next year. Thank you.
Dana Flanders: And then my second question on TRV 045, can you just kind of refresh us and maybe explain what from a clinical and competitive standpoint led you to diabetic neuropathic pain as the indication that you're going to move forward with? And how quickly could this move into phase one?
Great Great Alright, So I I wrote down most of these questions. Let me start with I'll start with Cleveland Clinic, I'll Outsmart to talk more about the study Cleveland clinic and he can talk about 045 as well so how how we got interested in Cleveland <unk> first off is Mark mentioned they have this really interesting way to look at respiratory depression.
Carrie L. Bourdow: Great, great. All right, so I wrote down most of these questions. Let me start with, I'll start with Cleveland Clinic. I'll ask Mark to talk more about the study, and he can talk about 045 as well. So how did we get interested in Cleveland Clinic? First up, as Mark mentioned, they have this really interesting way to look at respiratory depression. One of their physicians was involved in our phase three open-label safety study. Actually, a few of their physicians were.
One of their physicians was involved in our our phase three open label safety study actually a few of their physicians were so they knew Olympic They know the work that we've done previously looking at respiratory Depression day. It actually also seen some of the work that's been that we've talked a little bit about anecdotal feedback that we got.
Around cognitive function, which is a really interesting area that could further help differentiate <unk>. So so they came to us right with and it's we don't at this point.
Carrie L. Bourdow: So they knew it was limbic. They knew. They knew the work that we'd done previously in looking at respiratory depression. They had actually also seen some of the work that's been, that we've talked a little bit about, the anecdotal feedback that we got around cognitive function, which is a really interesting area that could further help differentiate Alinvec. So they came to us, right? And it's, we don't, at this point, we don't have a lot of specifics around timing. We are expecting that we'll start enrollment in the third quarter, but I'll ask Mark to talk a little bit more about the novel endpoints, the study, and any other additional details he'd like to provide.
We don't have a lot of specifics around timing, we are expecting that will start enrollment in the third quarter, but I'll ask mark to talk a little bit more about the novel endpoints. The study and any any other additional details you'd like to provide.
Sure. So Danny you asked a little bit about the the.
The control, how how to interpret the day to the the good.
Moos on that point is that because on the work that the the clinic and others have done and looking at somebody's endpoints. There really is a rich amount of historical data and understanding of what these outcomes look like in the in the face of conventional opioid treatment. So it gives us a <unk>.
Mark A. Demitrack: Sure, so Dana you asked a little bit about the control, how to interpret the data. News on that point is that because of the work that the clinic and others have done in looking at some of these endpoints, there really is a rich amount of historical data and understanding of what these outcomes look like in the face of conventional opioid treatment. So it gives us a great landscape upon which to put the outcomes from this real-world cohort in proper context. And that's generally how the approach is taken. that they expect to take with them. You also asked about the interest in this.
<unk> landscape upon which to put the outcomes from this real world cohort in proper context, and that's that's generally the approach that they expect to take with it. Yes also about the interest from this and I would say that a considerable amount of the interest in drive.
Doing this really came from the clinicians and the scientific community in large part based on the insights on observations that we've seen in the preliminary work that was accomplished in our phase three program. So the the great day that that emerged from the Athena study is incredibly exciting to the to the clinicians that we've spoken with and.
Mark A. Demitrack: And I would say that a considerable amount of the interest in driving this really came from clinicians and the scientific community, in large part based on the insights and observations that we've seen in the preliminary work that was accomplished in our Phase 3 program. So the great data that emerged from the Athenaeus study is incredibly exciting to the clinicians that we've spoken with, and they appreciate it.
<unk> they they appreciate it they recognize the significance of it and providing this additional level of granularity and uhm incremental understanding of the characterization of the outcome is is very very important for clinicians. So that's really a big driver of our thinking about.
Mark A. Demitrack: They recognize the significance of it. And providing this additional level of granularity and incremental understanding of the characterization of the outcome is very, very important for a clinician. So that's really a big driver of our thinking about, you know, what we can actually choose to include in the studies that we're implementing in the host of approval settings. The other question I asked about 045, the work that we've done. A large amount of our internal work has focused on characterizing 045 in a variety of different chronic pain models. And we've done that for several reasons.
You know what what we actually can choose to include.
In the studies that we're implementing in a post approval setting.
Mark A. Demitrack: One is that there just remains an incredible landscape of unmet medical need, although there's an array of options that clinicians and patients can choose from, particularly in the area of diabetic neuropathic pain. You know as well as I do that the outcomes that are offered, both in terms of maximal efficacy that's seen as well as tolerability, fall quite short of what we really need in a clinical setting. The other aspect of choosing a chronic pain indication as sort of a beachhead starting point is also based on the... the clarity that we have about endpoints, study designs, and a regulatory roadmap forward.
Mark A. Demitrack: And in the setting of chronic pain targets, diabetic neuropathic pain, not only is it important clinically in a highly prevalent and burdensome condition, but it probably provides us the clearest clinical and regulatory path forward. And so that's also one of the contributing factors in our thinking about choosing it. As we've reported in the literature, we've looked at a variety of chronic pain targets in our animal models to date. The timing, You know, we haven't commented specifically on that beyond where we are in terms of filing the I&D, but we'll certainly provide updates on that as we move forward.
Alright, so we've looked at a variety of different chronic.
Chronic pain targets in our animal models to to date.
The timing.
You know, we we haven't commented specifically on that be on where we are in terms of filing b B I N T, but will be will be certainly providing updates on that as we move forward.
Alright, thank you.
Operator: Your next question will come from Jeff Jones with Oppenheimer.
Your next question will come from Jeff Jones with Oppenheimer.
Jeff Jones: Good morning, guys. Can you hear me? Yes, hey Jeff. Congratulations on a lot of progress this quarter. Thank you. Obviously, lots of questions have already been asked. So, I guess three for you guys. I know it's early to talk about revenue, but can you make any comment in terms of revenue being distribution versus direct to hospitals. Number two, in terms of the health economic analysis and how that's being accepted, to use a poor term by hospital pharmacies, and how many you would say are really needing to do their own work in terms of looking at their own data sets, perhaps, say, in the area of morphine and side effects. And number three, any update on XUS partnering efforts for Elinvik and the progress with your partners in China and Korea?
Good morning, guys can you hear me.
Yeah, Hey that.
Oh, congratulations on a a lot of progress this quarter okay.
Obviously lots of questions already asked so I guess three for you guys. I know it's early to talk about revenue buttons can you make any comment in terms of.
The revenue being distribution versus direct to hospital.
Uhm number two in terms of the health economic analysis, and how that's being accepted to use the port term by hospital pharmacies and how many you would say are really needing to do their own work in turn.
I'm, so looking at their own datasets, perhaps say in the area of morphine and side effects.
And number three any update on X U S partnering efforts for Olympic and the progress on your partners in China and Korea.
Yeah, great. Thank you, Jeff I'll I'll talk about the first two and then I'll ask Mark to talk a little bit more about the ex yes, partnering so on on the revenue side as we said, yes. It's it's early right that the bulk is is stocking is is to the wholesalers. We are getting simple through but you know so early right where.
Jeff Jones: Yeah, great. Thank you, Jeff.
Carrie L. Bourdow: I'll talk about the first two, and then I'll ask Mark to talk a little bit more about the ex-US partnership. So on the revenue side, as we said, yes, it's early, right? The bulk is going to be stockpiled for the wholesalers.
Carrie L. Bourdow: We are getting some pull-through, but we're, you know, so early, right? We're not providing the distribution yet. On the health economic data, it's actually being well accepted for a couple of reasons. So to your point, one of the ways in which hospitals like to look at these models is that they want to be able to input their own data. So we designed the health economic model so that they can use some of our standard inputs but then provide their own and really, you know, look at what it looks like in their own institution.
Oh, not providing the distribution yet on the health economic data, it's it's actually being well accepted for a couple of reasons. So to your 0.1 of the ways in which hospitals like to look at these models is they they want to be able to input their own data. So we design did that help economic model. So.
The day can use some of our standard inputs, but didn't provide their own and and really you know look at what is it looked like in their own institution. That's you know something on that I learned from that my previous launch date and the other thing that we did it that we worked with a fairly well no in hell.
Carrie L. Bourdow: That's, you know, something that I learned from my previous launch days. The other thing that we did is that we worked with a fairly, well-known healthy economist, as Mark mentioned from South Carolina. And so she's respected. She's published. And as you said, so it's not a Trevina model, right?
The economist is Mark mentioned from from South Carolina, and so she's respected cheese, she's published and as you said so it's not a trivino model right. It's been validated by an external help economist instead those are those are the other two reasons why are the other reason why I think the.
Carrie L. Bourdow: And so those are the other two reasons why, or the other reason why I think the formulary committees are actually using the data. Now, if it's a smaller hospital, you know, they may not have as many pharmacists on staff to be able to look through the model.
Formulary committees actually are using the data now if it's a smaller hospital.
You know they may not have as many pharmacists on staff to be able to look through the model and so day appreciate a lot of the materials and publications that we provided to support the healthy comic work some more to come I think I think on that and then let's see you asked about ex U S. Partnering some mark I'll I'll have you talk a little bit about <unk>.
Carrie L. Bourdow: And so they appreciate a lot of the materials and publications that we've provided to support the health economic work. Some more to come on that, I think. And then, let's see, you asked about ex-US partnering. So, Mark, I'll have you talk a little bit about NWA and Farm Bio. And we have no updates on additional ex-US partnering. It is an area of interest for us. But right now, with our partners in China and South Korea, Mark, would you like to talk a little bit about some of their progress? Yeah.
Why and farm bio and and we have no updates on additional ex you is partnering it is an area of interest for us, but right now with our partners in China, and South Korea, Mark you Wanna talk a little bit about some of their progress.
Yeah. It's just briefly just the both both partners continue to progress on their regulatory discussions we had reported last year that in China. They were successful in getting their initial I N D approved and so they're they're making headway and design of the clinical plan that they would need move.
Mark A. Demitrack: Yeah, just briefly, Jeff. Both partners continue to progress in their regulatory discussions. We reported last year that in China, they were successful in getting their initial IND approved, and so they're making headway in the design of the clinical plan that they would need moving forward. So we're pleased with the progress that both partners are making within their own countries in terms of regulatory approval. Great. Thank you very much, guys. And congrats again on a great quarter.
Forward. So we're we're pleased with the progress that that both partners are making within their own countries in terms of regulatory approvals.
Great. Thank you very much gross and congrats again on a great quarter.
Carrie L. Bourdow: Thank you. Thank you, Jeff.
<unk>. Thank you Jeff.
Your final question will come from Douglas, how with H C y night.
Operator: Your final question will come from Douglas Sal, with H.C. Wainwright.
Douglas Dylan Tsao: Good morning. Good morning. Can you hear me? I've been having a few technical problems this morning.
It's more high on good morning, good morning.
Can you hear me I've I've been having a few technical problems. This morning, Yeah. Yeah, no. We can hear ya. Okay. So just in terms of the Cleveland Clinic study I'm, just curious because you sort of characterize as sort of major surgery. That's non cardiac just curious where you've been enriching four types of procedures just to ensure a balance also I'm just.
Douglas Dylan Tsao: Yeah, no, we can hear you. Okay, so just in terms of the...
Douglas Dylan Tsao: Okay, so just in terms of the Cleveland Clinic study, I'm just curious because you sort of categorize the major surgeries that are non-cardiac. Just curious, are you enriching for types of procedures just to ensure a balance? Also, in the same veins, are you sort of ensuring, you know, sort of enriching for sort of different dosing levels across the different arms of the study? Yeah, Mark.
Curious and the same things you know, where you sort of insuring you know sort of for enriching for sort of different dosing levels across the different arms of the study.
Yeah Mark.
Mark A. Demitrack: There's no specific enrichment strategy per se in terms of enrollment. It actually takes a broad look at the large universe of patients where post-operative pain management involves the use of an IV opioid. So any eligible surgical procedure where an opioid would play a role in acute pain management would be included in the study. So that's the approach it's being taken in the sign. I think it gives us the most generalizability of the results in that regard.
Mark A. Demitrack: And then we're utilizing the approved labeled doses to model the use. So it really is establishing a context of a true reflection of real-world use of the product, which is the intent of the data collection and the outcome characterization in the study. Okay. And just, You know, in terms of the process for formula approvals, and I might have missed it because I had some technical problems this morning, but just in terms of the balance across ASCs versus, you know, sort of hospitals,
Carrie L. Bourdow: Yeah, so right, of the 10 wins, the majority are hospitals versus ASCs. Of the 60 or so that are in various stages of review, Bob mentioned this earlier, so it's really a wide range, right? Most of the formula review processes are taking place in the inpatient setting where, you know, you've got to get the drug on formulary, you've got to get your champion to go forward and support it on formulary, and then it's part of the EMR system.
60, or so that are in various stages of review.
<unk> mentioned this earlier, so it's really a.
On a wide range right most of the formulary review processes are taking place in the inpatient setting where you got to get the drug on formulary.
Champion.
To go forward and supported it on formulary and then and then it's part of the EMR system. There are some large ambulatory surgery centers that do have a formulary and that's some of the wins that we've had as well, but but for the most part on the ASC side that it moves a little bit more quickly.
So are you starting to see in that context spreads since many don't have quota technical formulary certainly in the early going are you starting to see orders from.
Carrie L. Bourdow: There are some large ambulatory surgery centers that do have a formulary, and that's some of the wins that we've had as well. But for the most part, on the ASC side, it moves a little bit more quickly.
Surgery centers that.
Where there might be a champion of the product.
Well, it's really early but but yeah, we are starting to see some some pull through on the ASC side, So yeah, where physicians want to use it pretty quickly that is happening in the ASC setting so and you remember that we targeted specifically both inpatient and ambulatory surgery centers for exactly this reason.
Carrie L. Bourdow: Yeah, I mean, so are you starting?
Unknown Attendee: It's really early, but
Unknown Attendee: Okay, great. Thank you so much.
Unknown Attendee: Great, thank you.
Operator: There are no further questions at this time. I'll turn the call back over to Carrie Burdow for any closing remarks.
Right, because we knew we could get.
Early use on in the ASC, but the inpatient opportunity longer term is really going to be the.
The area of interest for us.
Carrie L. Bourdow: Thank you. Thank you for your questions.
Okay, great. Thank you so much great. Thank you.
There are no further questions at this time I'll turn the call back over to Cary Brito for any question closing remarks. Thank you. Thank you for your for your questions as you've heard today.
Carrie L. Bourdow: As you've heard today, we're encouraged by the early progress and growing interest in Olympic. We're tracking towards our year-end goal of 100 formularies, and we're excited that the Cleveland Clinic will be generating the new data that you heard about with the potential to further set us apart from conventional IV opioles. We certainly recognize that COVID has had an impact on customer access, but as you've heard, we have a very focused launch approach.
We're encouraged by the early progress and growing interest in Olympic we're tracking towards our year end goal of 100 formularies and we're excited that the Cleveland clinic will be generating the new data that you heard about with the potential to further set us apart from conventional IV opioids we.
We certainly recognize that COVID-19 has had an impact on customer access.
As you've heard we have a very focused launch approach and we think that this will pay off for us as Olympic continues to get traction in the hospital and in the ambulatory surgery Center markets.
Carrie L. Bourdow: And we think that this will pay off for us as Lendick continues to get traction in the hospital and the ambulatory surgery center markets. We're also looking forward to the upcoming catalyst associated with our pipeline. The great news today announced around TRV-027 and its potential to help reduce the impact from COVID, and the substantial progress that we've made with our other pipeline assets highlight the exciting advancements we're making across the pool pipeline. So thank you for joining us today, and that concludes today's call.
We're also looking forward to the upcoming catalyst associated with our pipeline the great news today announced around CRV O two seven and its potential to help reduce the impact from COVID-19 and the substantial progress that we've made with other our other pipeline assets highlight the exciting advancements we're making in cross across the full pipeline. So thank you.
For joining us today and that concludes today's call.
Operator: Thank you for your participation, which does include today's conference. You may now disconnect.
Thank you for your participation. This does conclude today's conference you may now disconnect.
Okay.
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