Trevena, Inc. (TRVN) Q1 2021 Earnings Call Transcript

Good day, and thank you for standing by, and welcome to the Trevena First Quarter 2021 Financial Results Conference Call. [Operator Instructions]. I would now like to hand the conference over to Mr. Barry Shin, Chief Financial Officer. Please go ahead.

Thanks, operator. Good morning, and welcome, everyone. With me today are Carrie Bourdow, our President and CEO; Bob Yoder, our Chief Commercial Officer; and our Chief Medical Officer, Mark Demitrack. As a reminder, we'll be making forward-looking statements within the meaning of federal securities laws. These 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. As I'm sure you recall, OLINVYK 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. I encourage you to go to olinvyk.com. You'll find important safety information, including the box warning and the full prescribing information. I'll now turn the call over to Carrie for an overview of our first quarter and recent business accomplishments. Carrie?

Thank you, Barry. Good morning, everyone, and thanks for joining us today. For 2021, we set our sights on 2 goals: successfully launching OLINVYK; and continuing our growth in the CNS space by advancing our pipeline. I'm pleased to report that we've made significant progress on both fronts. Let me start with OLINVYK. 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 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. And as hospitals and ASPs 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 OLINVYK versus IV morphine. These data are important as they support the addition of OLINVYK on hospital formulary. And lastly, we're initiating an exciting outcome study that will be led by Cleveland Clinic. This study will build on OLINVYK's differentiated profile and has the potential to further set us apart from conventional IV opioids like morphine. On the pipeline front, we had 2 major announcements this morning. First, we announced that TRV027 has been selected by NIH and Vanderbilt University Medical Center to be included in their large multisite COVID trial. Mark will talk more about the trial. But you may also remember that just a few weeks ago, we announced that 027 will be part of another multisite trial, led by REMAP-CAP organization. So we now have 2 new studies underway for TRV027, funded by and in partnership with 2 of the largest international platform trial networks for COVID research. In total, these studies will provide TRV027 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 Trevena can be supporting this effort. For TRV045, we announced that 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's a multitude of efficacy and tolerability problems associated with current therapies. 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 OLINVYK. Bob?

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 formulary wins in 2021. Although our field team was only deployed at the end of February, we have 60 institutions reviewing OLINVYK 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 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 OLINVYK, including rapid onset effect, no active metabolites and no need for dose adjustment for renal impaired patients. 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 elective procedures over the past 12 months. As a result, many institutions are delaying their formulary reviews, sometimes by many months. 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 over time, which reflects the shifting dynamics in 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. 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 engagements. To drive additional awareness, trial and end usage, we continue to augment the personal promotion of our customer-facing team with a robust multichannel 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. 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. Our top priority is gaining formulary approvals for OLINVYK in the hospital setting. We're positioning OLINVYK 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 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. We believe the OLINVYK 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. To summarize, we had a productive first quarter. 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 OLINVYK and provide an update on our pipeline. Mark?

Thank you, Bob. Over the past few months, we've received feedback from clinicians regarding one additional clinical data for OLINVYK 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 experienced 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, further characterizing measures of respiratory and gastrointestinal safety and tolerability. Dr. Sessler's 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 antiemetics. Most importantly, the study will also incorporate validated cognitive function outcome assessments. Cognitive function is a particular interest to us because of the clinical feedback received from the investigators in our Phase III ATHENA trial, who reported that they saw 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 OLINVYK, further helping to characterize its safety and tolerability profile, and will provide relevant and meaningful data that clinicians have asked for. We continue to expand the evidence base for OLINVYK, 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 2 posters, one of which received a gold ribbon, an honor awarded to only 20% of submitted abstracts at that meeting. This work was developed in collaboration with Dr. Kit Simpson, 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 III clinical development program, and use well substantiated cost inputs from government and scientific published data to estimate the cost to offset that accrues when OLINVYK is incorporated into clinical postoperative care. As an example, the economic model shows that when OLINVYK is used in high-risk, elderly and obese patients, this results in cost savings of approximately $364,000 for every 1,000 patients treated compared to the use of a conventional IV opioid. We believe these data highlight the significant cost savings that are estimated to occur in a hospital system and support the addition of OLINVYK to hospital formularies. I'd now like to turn to a discussion of our pipeline, starting with TRV027. As you saw from our announcement this morning, I'm pleased to report that the scientific communities' interest in this compound continues to grow, as demonstrated by the fact that TRV027 has recently advanced into 2 large multisite platform trials, significantly expanding the patient populations being studied. The most recent trial we announced today is known as ACTIV-4d, which is part of the effort, previously known as Operation Warp Speed, and is being led by Vanderbilt University Medical Center. The ACTIV platform trials network is funded by the NIH and as 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 ACTIV-4d, TRV027 will be administered as a monotherapy in up to 300 patients, and the trial will include a placebo control. We announced last month that TRV027 will also be included in a trial led by the International Study Consortium known as REMAP-CAP. 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 TRV027 in the initial proof-of-concept study being conducted by Imperial College London, REMAP-CAP approached us with an interest to expand 027 into a larger multisite Phase II/III trial. The proof-of-concept study recently underwent an interim analysis by Imperial College's Data Monitoring and Safety Committee, and they determined that there were no safety concerns associated with 027. REMAP-CAP's trial will be conducted in multiple sites across the U.K., including continuing at Imperial College itself as one of the participating sites. Combined, these 2 international platform trials will provide us with a detailed clinical profile of TRV027'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 TRV045, our novel S1P 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 as our initial lead indication for this asset. This is a highly burdensome condition, and currently available treatment options fall short, both in terms of efficacy and tolerability. The innovative and unique mechanism of TRV045, 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 TRV045's potential in epilepsy, and our collaboration with NIH's epilepsy therapy screening program continues to generate data that will inform our future developments of TRV045. Let me now turn the call over to Barry to discuss our first quarter financial results. Barry?

Thanks, Mark. We deployed our customer-facing team at the end of February and reported $209,000 in net sales for OLINVYK in Q1. 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 OLINVYK. Our operating expense was $10.2 million for the quarter and we expect this to increase in 2021 as we commercialize OLINVYK and advance our pipeline assets. As of March 31, we had cash and equivalents of $97.7 million, which we continue to expect will fund our operations through the fourth quarter of 2022. We'll now open the call for questions, after which Carrie will provide some closing remarks. Operator?

[Operator Instructions]. Your first question will from Jason Butler from JMP Securities.

Can you guys hear me?

Yes, we can hear you. Operator, we actually can't hear you. But Jason, we can hear you.

So first question, just on the formulary process. Obviously, not surprise and 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 the -- 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?

Yes. Thanks, Jason. I'll start, and then I'll ask Bob to add on. So a couple of things. As you said, it's always interesting, right? It's a bit of a grind to 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, 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. Formulary reviews are being delayed as the backlog of patients come into hospitals physicians, 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 economy is working really hard for us. And 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 had that data out there. It's now published. It's part of the dossier that we provide to hire. So that's working really well. We've had two hospitals that before we were out chose not to put OLINVYK 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. I've been doing this a long time. This is how hospital formularies work. I will say COVID 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 used. Bob, any other color that you want to provide?

Thanks, Carrie. Thanks, Jason, for the question, so. Not a lot. I mean, I just -- Jason, I when you describe it, you're absolutely right. It really is just grinding through. And I'm really proud of what the team is 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 the live engagements, I think we'll certainly be very helpful for us. But they're doing a great job of grinding through. And as you sort of intimated, if you've seen one formulary review process, you've seen one formulary review process. So there are definitely variances across institutions in terms of the speed, which we're working through and how they're impacted. But I'm really happy with the interest receiving customers to engage with us in that process.

Great. And then second question for me just on the outcomes trial. Can you maybe speak to how you think about are there data from this trial you think 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 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?

Yes. Great question. So 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's no approved endpoint from the FDA on how to measure respiratory depression. So they're very interested in additional ways to measure respiratory. It's a huge 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.

Yes. 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 the progressive free outcome. 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, 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 unmissed with earlier methods of assessment. So we're really excited about the opportunity to apply this more contemporary methodology to assess the respiratory outcomes. And I think it's going to give us a lot clear ability to estimate and characterize the respiratory profile associated with the OLINVYK.

Okay, great. Great to see the progress on the OLINVYK launch and also the addition of 027 into the NIH study. Congrats.

Our next question will come from Brandon Folkes with Cantor Fitzgerald.

Congratulations on both sides of the business, seems going well. Maybe just some color on those 10 accounts that have put OLINVYK on formulary. I guess, firstly, sort of any color in terms of how many of those accounts placed orders during the quarter, going to, of course, in 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 OLINVYK, I guess, in those 10 wins that maybe you didn't expect? I did get your comment on sort of 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 upfront, if that's okay. Just on the pipeline. Yes. just a few -- sorry. How do we think about -- obviously, some of these have outside funding, you're launching OLINVYK. 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 looks for funding? Just what can you say from that perspective at this stage?

Thanks, Brandon. I'm taking notes. So you'll -- the team at the -- yes, I wrote them out as well. Hopefully, I'll get everything, and then I'll turn it over to Bob and Mark. Okay? So let's start with OLINVYK 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. So enough, I know we've messaged that our approach was community, community teaching. And we are getting some of those institutions, but we've had a fair number of, what I would 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 which was sort of interesting. So that's the good news and a surprise, right? And we've also, though, had those community teaching and one, I think, 1 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. 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 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 formulary review has been restricted to anesthesia and colorectal surgeons. And that's also very typical in hospital launches, right? That the pharmacy is looking for an easy way to get the use, but not let the use expand so quickly that they can't monitor it. We'll see moving forward, if it ends up being more of a protocol driven for certain patient types. I think the challenging patient positioning is really helping us get the drug in front of pharmacy and get it looked at that way. And then whoever the physician champion is it's sort of being restricted in that space. Bob, any other comments you want to make around the 60 institutions that are in various reviews, or anything I missed on the OLINVYK questioning?

Yes. Sure. What I would say is for the 60 that are reviewed, they kind of run the gamut. I mean, it really is a broad spectrum. And two things there. One, it confirms our targeting approach, which, as you may recall, was those institutions doing the large number of painful procedures and therefore, a high use of IV opioid, but had also had a history of reviewing some branded products earlier post-launch than maybe the other institutions. So it's confirmed some of that. But there are some other surprises like Carrie characterized as well. Some of the larger academic medical centers are also lumped into that group that we're in process with. So it's encouraging.

And then your question around the pipeline and how we think about the pipeline. We're -- one of the things we mentioned with TRV027 is that both of these large trials and the smaller proof-of-concept study, those are all fully funded by external partners, by NIH, by REMAP-CAP, we're just supplying drugs. With 045, we're taking the focus of -- in the chronic neuropathic pain space, right, the diabetic neuropathic pain, and we're letting NIH continue their work around epilepsy. We'll 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 funding partners to help us move the pipeline along, why we focus on launching OLINVYK. And 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 other companies. And there's really not much more I can say as far as that goes right now.

Great. And I think it's a very solid launch for the hospitals, so congratulations on that.

Your next question will come from Dana Flanders with Guggenheim.

Great. 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 you be -- will there be a control arm that you'll be paring OLINVYK to? And just on the decision to move forward with this, was that something you were hearing from physicians or formularies or maybe both? And then my second question on TRV045. Can you just kind of refresh us and explain maybe 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 I next year?

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, Cleveland Clinic, and he can talk about 045 as well. So how we got interested in Cleveland Clinic? First off, as Mark has mentioned, they have this really interesting way to look at respiratory depression. One of their physicians was involved in our Phase III open-label safety study, actually, a few of their physicians were. So they knew OLINVYK. They know the work that we've done previously in looking at respiratory depression. They had actually also seen some of the work that's been, and 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 OLINVYK. So they came to us, right, with -- 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 you'd like to provide.

Sure. So Dana, you asked a little bit about the control, how to interpret the data. The good 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 the approach that we expect to take with it. Yes, also about the interest from this. And I would say that a considerable amount of the interest in driving this really came from the clinicians and the scientific community, in large part, based on the insights and observations that we've seen and the preliminary work that was accomplished in our Phase III program. So the great data that emerged from the ATHENA study is incredibly exciting to the clinicians that we've spoken with. And they appreciate it. 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 clinicians. So that's really a big driver of our thinking about what we actually can choose to include in the studies that we're implementing in a post-approval setting. The other question 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. One is that it's 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 from what we really need in a clinical setting. The other aspect of choosing a chronic pain indication is sort of a beachhead starting point is also based on the clarity that we have about endpoints, study designs and a regulatory road map forward. And in the setting of chronic pain targets, diabetic neuropathic pain, not only is it important clinically in a highly prevalent 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. But as we've reported in the literature, we've looked at a variety of different of chronic pain targets in our animal models to date. The timing, we haven't commented specifically on that beyond where we are in terms of filing the IND, but we'll be certainly providing updates on that as we move forward.

Your next question will come from Jeff Jones with Oppenheimer.

Can you hear me?

Yes, Jeff.

Congratulations on a lot of progress this quarter. Obviously, lots of questions already asked. So I guess 3 for you guys. I know it's early to talk about revenue, but can you make any comment in terms of the revenue being distribution versus direct to hospital. Number two, in terms of the health economic analysis and how that being accepted to use a port 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 saying, in the area of morphine and side effects? And number three, any update on ex-U.S. partnering efforts for OLINVYK and the progress on your partners in China and Korea?

Yes. Great. Thank you, Jeff. I'll talk about the first two, and then I'll ask Mark to talk a little bit more about the ex-U.S. partnering. So on the revenue side, as we said, yes, it's still early, right? The bulk is stocking is to the wholesalers. We are getting some pull-through, but we're 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 they want to be able to input their own data. So we designed as a health economic model so that they can use some of our standard inputs, but then provide their own. And really look at what does it look like in their own institution. That's something that I learned from my previous launch days. The other thing that we did is that we worked with a fairly well-known health economist, as Mark mentioned, from South Carolina. And so, she's respected, she's published. And as you said, so it's not a Trevena model, right? It's been validated by an external health economist. And so, those are the other two reasons why -- the other reason why I think the formulary committees actually are using the data. Now if it's a smaller hospital, they may not have as many pharmacists on staff to be able to look through the model. And so they appreciate a lot of the materials and publications that we provided to support the health economic work. So more to come. I think on that. And then, let's see, you asked about ex-U.S. partnering. So Mark, I'll have you talk a little bit about Nhwa and Pharmbio. And we have no updates on additional ex-U.S. partnering. It is an area of interest for us, but right now with our partners in China and South Korea, mark, do you want to talk a little bit about some of their progress?

Yes. Just briefly, Jeff. The -- both partners continue to progress in their regulatory discussions. We had reported last year that in China, they were successful in getting their initial IND approved. And so they're making headway in 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 approvals.

Your final question will come from Douglas Tsao with H.C. Wainwright.

Can you hear me? I've been having a few technical problems this morning?

Yes. No, we can hear you.

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 noncardiac. Just curious are you enriching for types of procedures just to ensure a balance? Also, I'm just curious, in the same veins, are you sort of ensuring sort of enriching for sort of different dosing levels across the different arms of the study?

Yes, Mark?

There's no specific enrichment strategy per se in terms of enrollment. It actually takes a broad look at the large universe of patients that were 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 inclusive of the study. So that that's the approach that's being taken in. I think it gives us the most generalizability of the results in that regard. And then, we're utilizing the approved labeled dosing 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 of the study.

Okay. And just in terms of the process for formulary approvals, just -- and I might have missed it because I had some technical problems this morning. But just in terms of the balance across ASCs versus sort of hospitals.

Yes. Right. Of the 10 wins, the majority are hospitals versus ASCs. Of the 60 or so that are in various stages of review, and Bob mentioned this earlier. So it's really 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, you got to get your champion to go forward and support it on formulary 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 for the most part, on the ASC side, it moves a little bit more quickly.

Yes. I mean, so are you starting to see, in that context, spread since then you don't have a technical formulary certainly in the early going. Are you starting to see direct orders from centers that -- where there might be a champion of the product?

It's really early, but yes, we are starting to see some pull-through on the ASC side. So yes, where physicians want to use it pretty quickly, that's happening in the ASC setting. So -- and you remember that we targeted specifically both inpatient and ambulatory surgery centers for exactly this reason, 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 area of interest for us.

There are no further questions at this time. I'll turn the call back over to Carrie Bourdow for any closing remarks.

Thank you. Thank you for your questions. As you've heard today, we're encouraged by the early progress and growing interest in OLINVYK. 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 certainly recognize that COVID has had an impact on customer access. But as you've heard, we have a very focused launch approach. And we think that this will pay off for us as OLINVYK 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 TRV027 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 full pipeline. So thank you for joining us today, and that concludes today's call.

Thank you for your participation. This does conclude today's conference. You may now disconnect.