Q2 2021 Trevena Inc Earnings Call

August 12, 2021

[music].

Operator: Thank you for standing by, and welcome to the Trevena Incorporated second 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 will need to press star 1 on your telephone keypad. And to withdraw your question, press the hash key. If you require technical support at any time, please press star zero. I would now like to hand the conference over to your first speaker today, Barry Shin, Chief Financial Officer. Please go ahead. Good morning and welcome.

Thank you for standing by and welcome to the Divina incorporated second quarter Destocking in 'twenty, One financial results conference call.

At this time all participants are here I can only mode.

After the speaker presentation there'll be a question and answer session to ask questions. During the session you will need to press star one on your telephone keypad.

And David on your question Betsy.

Yeah, Great technical support at any time, Please press star zero.

I would now like to hand things over to your first speaker today, Barry <unk> Chief Financial Officer. Please go ahead.

Barry Shin: 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 law. These statements are subject to risks and uncertainties related to our business, including those discussed in our filings with the SEC. We undertake no obligation to update these statements beyond today. I'll now turn the call over to Carrie for an overview of her second quarter and recent business accomplishments. Carrie?

Good morning, and welcome everyone.

With me today are carried about though our president and CEO, Bob Yoder, our Chief commercial officer, and our Chief Medical Officer, Mark them attract.

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 in our filings with the SEC.

We undertake no obligation to update these statements beyond today.

I'll now turn the call over to Kerry for an overview of our second quarter and recent business accomplishments.

Carrie L. Bourdow: Thank you, Barry. Good morning, everyone. Thanks for joining us today. The second quarter marked our first full quarter since the Olympic launch. And with five months in the field, we now sit at 35 formulary approvals, more than three times the number we reported last quarter. We recognize that COVID has had an impact on sales, and formulary timelines have been delayed. But our team remains focused and adaptive, and we have a lot to be excited about, both with the LINDEC and our PIPE program. With the limbic, we're on track to reach our year-end goal of 100 formulary wins, and we're focused on that next. Because when we get in front of a customer and present the Olympic profile, there's strong interest, and physicians continue to be excited by the clinical data and the Linux value

Gary.

Thank you Barry.

Good morning, everyone. Thanks for joining us today.

Second quarter marked our first full quarter of the Olympic lives.

And with five months in the field, we now sit at 35 formulary approvals over three times the number we reported last quarter.

We recognize that Covid has had an impact on sales and formulary timelines have been delayed but our team remains focused and adaptive and we've a lot to be excited about both with the Linda again our pipeline.

Linda we're on track to reach our year end goal of 100 formulary wins and we're focused on that metric because when we get in front of a customer and present the Olympic profile, there's strong interest and physicians continue to be excited by the clinical data and the Olympics value proposition.

Carrie L. Bourdow: Importantly, we're already getting positive feedback from physicians who've had the chance to use a limbic. We've also started two new studies to build on a limbic's unique profile. The first is a clinical outcome study led by Cleveland Clinic. Remember that Cleveland Clinic came to us with an interest in expanding upon our phase three findings in three important safety areas that physicians care about. Respiratory, GI, and cognitive function. Patient enrollment is on track to start this quarter, and top line data is expected in the middle of next year. The second study is evaluating the effect of a limbic versus morphine on respiratory function in elderly and obese individuals.

Currently we're already getting positive feedback from physicians who've had the chance to youth Olympic.

We've also started two new studies to build an Olympics unique profile. The first is a quick is a clinical outcome study led by Cleveland Clinic remember that Cleveland clinic came to us with an interest in expanding upon our phase III findings in three important safety areas that physicians care about respiratory.

<unk> G I in cognitive function patient enrollment is on track to start this quarter and top line data is expected middle of next year.

The second study is evaluating the effect of Olympic versus morphine on respiratory function in elderly in obese individuals.

Carrie L. Bourdow: This study also builds upon previously published work, and patient enrollment is well underway. We expect top-line data from this study by the end of this year. And finally, we continue to advance Olympic towards approval outside the U.S. Nuo, our partner in China, recently began dosing patients in their Phase 3 trial. Once that study is complete, they expect it to have sufficient data in combination with our existing package to submit a limbic for approval.

This study also builds upon our previously published work and patient enrollment is well underway. We expect topline data from this study by the end of this year.

And finally, we continued to advance Olympic towards approval outside the U S.

<unk> our partner in China recently began dosing patients in their phase III trial once that study is complete.

I expect it to have sufficient data in combination with our existing package to submit Olympic for approval.

Carrie L. Bourdow: Beyond LENDIC, we're advancing our pipeline through partnerships with globally recognized institutions. We were pleased that the first patient was enrolled in the TRV027 Active COVID Trial, which is being led by Vanderbilt University Medical Center and funded by NIH. For TRD 045, our novel S1T receptor modulator, we're on track to file our IND for diabetic neuropathic pain this quarter. DNP is a significant market opportunity with over 5 million people affected by this painful condition and few therapeutic options available, and the National Institute on Drug Abuse, or NIDA, has resumed their study of TRV-734 for opioid use disorders.

The AGA Linda we're advancing our pipeline through partnerships with globally recognized institutions. We were pleased that the first patient was enrolled in the T. R. V. O. Two seven active Covid trial, which is being led by Vanderbilt University Medical center and funded by NIH.

T O D O four five our novel <unk> receptor modulator, we're on track to file our IND for diabetic neuropathic pain this quarter.

D N P is a significant market opportunity with over 5 million people affected by this painful condition and few therapeutic options available.

And the National Institute on drug abuse, or neither has resumed their study of <unk> 734 for opioid use disorder.

As we continue to battle the Covid pandemic, it's important that we don't forget about the other public health crises that take a toll on our communities and I'm proud that <unk> is playing a role in developing solutions for some of the largest public health issue.

Carrie L. Bourdow: As we continue to battle the COVID pandemic, it's important that we don't forget about the other public health crises that take a toll on our communities, and I'm proud that Trevena is playing a role in developing solutions for some of the largest public health issues. We have a highly skilled team with expertise in launching products both prior to COVID and now during a pandemic. We have the resources, a great product and launch strategy, interesting new data coming soon, and we're well-positioned to reach our year-end goals. So with that, let me turn the call over to Bob to talk more about the Alembic launch. Bob? Thank you, Kerry. With our first full quarter of launch complete, we continue to make progress.

To close we have a highly skilled team with expertise in launching products both prior to Covid and now during the pandemic, we have the resources a great product and launch strategy interesting new data coming soon and we are well positioned to reach our year end goals. So with that let me turn the call over to Bob to talk more about the Olympic launch.

Thank you Carrie.

With our first full quarter of launch complete we continue to make progress towards our year end goal of 100 formulary wins.

123 institutions are currently reviewing limbic at various stages and 35 accounts are added Olympic to formulary.

At the same time its no surprise that Covid has impacted our field activities.

But as the pandemic evolved so are we.

Here's where we're at.

Through the end of May Rep live engagements were holding up at around 70%.

Which really compares favorably to reported industry benchmarks.

Bob Yoder: We continue to make progress towards our year-end goal of 100 formulary wins.

Over the past six to eight weeks, we started to see that level of live engagement decline as certain regions have started shutting down again.

Bob Yoder: 123 institutions are currently reviewing LINVIC at various stages, and 35 accounts have added LINVIC to formularies. At the same time, it's no surprise that COVID has impacted our field. But as the pandemic evolves, so are we. Here's where we're at. Through the end of May, RepLive engagements were holding up at around 70%, which really compares favorably to the reported.

Additionally, formulary reviews, which historically have a seasonal slowdown during summer months have been further delayed.

But here's what we know.

When we are able to engage with the customer either live or virtually the response is consistently positive.

We continue to hear the Olympics unique profile and value proposition resonate with physicians.

For example, we're hearing great feedback about Olympics use in the ambulatory surgical setting.

<unk> pointed a rapid onset and duration of effect as the two main attributes that allow them to use Olympic in the perioperative setting all the way through patient discharge.

Bob Yoder: Reported Industry Benchmark

Bob Yoder: Over the past six to eight weeks, we've started to see that level of live engagement decline as certain regions have started shutting down.

And in the inpatient setting we're hitting their commissions are impressed with the gastrointestinal tolerability profile of Olympics.

Typically for open Gi procedures, where the use of an IV opioid is necessary, but so is minimizing adverse events such as postoperative vomiting.

Bob Yoder: have started shutting down again.

Bob Yoder: Additionally, formulary reviews, which historically have a seasonal slowdown during the summer months, have been further delayed.

We also know that health care decision makers like PMT Committee members have found a health economic model to be very beneficial in their assessment of the full value prop for Olympic.

Bob Yoder: But here's what we know. When we are able to engage with a customer, either live or virtually, the response...

Based on the early traction and positive feedback, we're expanding our outreach and access opportunities for Olympic.

So here's what we're doing there.

Bob Yoder: We continue to hear the limbic's unique profile and value proposition resonate with physicians. For example, we're hearing great feedback about the limbic system's use in the ambulatory surgical setting. Physicians point to the rapid onset and duration of effect as the two main attributes that allow them to use it in the limbic system and the perioperative setting all the way through the patient. And in the inpatient setting, we're hearing that clinicians are impressed with the gastrointestinal tolerability profile, particularly for open GI procedures where the use of an IV opioid is necessary.

First we plan to target more physicians, who are key stakeholders at large influential institutions, who can serve as the Olympic advocate during their formulary review process.

To do this we're adding five medical science liaison. So they are full MSL team can now target approximately 500 positions a top academic medical centers and other important institutions.

Our MSL team is comprised of Pharm DS with deep experience in health economic data and modeling.

They've got the right credentials and experience to communicate Olympics compelling clinical profile and health economic data.

Second.

We're expanding our list of target accounts to approximately 700 hospitals, representing approximately 60% of the IV opioid market.

These new accounts represent a significant growth opportunity for Olympic.

Bob Yoder: IV opioid is necessary, but so is minimizing adverse events such as post-operative vomiting. We also know that healthcare decision makers like P&T committee members have found the health

In closing.

Over this past quarter, we tripled our formulary wins and continued to grow the number of accounts that are moving through the PMT review process.

When we get in front of our customers.

They tell us they like the Olympics differentiated profile and value proposition.

And we're hearing positive things from customers, who are using Linda.

Bob Yoder: Members have found the health economic model to be very beneficial in their assessment of the full value prop for Linda. Based on the early traction and positive feedback, we're expanding our outreach and access opportunities for Olympians. So here's what we're doing there. First, we plan to target more physicians who are key stakeholders at large, influential institutions who can serve as a limbic advocate.

We're hiring additional MSL expand our outreach to health care professionals and extending our field coverage to include additional high volume accounts.

We started this launch at the height of the pandemic and we know how to do this in a virtual environment.

While we all certainly hope that an expanded shutdown is not coming again, we're taking steps to be as effective as possible. If we return to that environment.

I am firmly convinced in the long term valuable Lindsay and the positive change it brings to the management of severe acute pain.

Bob Yoder: as well as Olympic Advocates during the formulary review process.

Let me now turn the call over to Mark to provide a quick overview of where we are with our pipeline.

Bob Yoder: To do this, we're adding five medical science liaisons so that our full MSL team can now target approximately 500 physicians at top academic medical centers and other important institutions. Our MSL team is comprised of pharmacists with deep experience in health economic data and modeling. They've got the right credentials and experience to communicate a compelling clinical profile and health economic data. Second, we're expanding our list of target accounts to approximately 700 hospitals, representing approximately 60% of the IV opioid market. These new accounts represent a significant growth opportunity for Olympia.

<unk>.

Thank you Bob.

As you've heard we've implemented many important initiatives to support the launch of Olympic.

Among which are the two post approval clinical studies.

One in collaboration with Cleveland Clinic, and the other conducted at Leiden University Medical Center.

We also recently announced publication of our 28 peer reviewed manuscript.

Which continues to strengthen the already substantial Olympic evidence space of scientific literature available to our customers.

In addition to our progress with the Olympics with.

We've continued to advance our pipeline assets towards key milestones.

With T. R V O two seven the two Covid 19 platform trials evaluating our compound continue to move forward.

We were pleased to announce that the nationwide active trials supported by NIH and led by Vanderbilt University Medical Center recently began dosing patients.

In addition startup activities for the remap cap trial based in the U K are ongoing.

We also are eagerly awaiting the interim data from an Imperial College, London proof of concept study.

Bob Yoder: In closing, over this past quarter, we tripled our formulary wins and continued to grow the number of accounts.

That study completed enrollment in the second quarter and the research team at Imperial College expects to report their topline outcomes by year end.

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc., when we get in front of our customers, they tell us they like the limbics differentiated profile and value proposition.

Recall that prior to transitioning into the remap cap and active trials. This study underwent an interim analysis by the study's data monitoring and safety Committee.

Their review found no safety concerns associated with <unk>, seven and acknowledged that the studies progress supported advancing <unk> two seven to larger trials with efficacy endpoints.

Unknown Attendee: and we're hearing positive things from customers who are using them.

We look forward to seeing what the data from all of these studies tells us about <unk> <unk> impact on severe organ damage mortality and recovery among covid 19 patients.

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc. We're hiring additional MSLs to expand our outreach to healthcare professionals and extending our field coverage to include additional high-volume accounts. We started this launch at the height of the pandemic, and we know how to do this in a virtual environment.

With <unk> 734, neither is currently screening patients for their opioid use disorder proof of concept study.

And finally this quarter, we are on track to file our IND for <unk> five hour <unk> receptor modulator.

In diabetic neuropathic pain.

And we've begun planning for the Phase one development program for this novel compound.

Over the next few months I look forward to updating you as we continue to make progress across our pipeline.

Unknown Attendee: While we all certainly hope that an expanded shutdown is not coming again,

Let me now turn the call over to Barry to discuss our second quarter financial results.

Unknown Attendee: We're taking steps to be as effective as possible.

Barry.

Thanks Mark.

Unknown Attendee: Unknown Attendee. If we return to that environment, I am firmly convinced in the long-term...

We reported 35 formulary wins, a day and $178000 in Q2 net sales for Olympic and part due to longer timelines in this pandemic environment.

Unknown Attendee: and the long-term value of a limbic system and the positive change it brings to the management of severe acute pain. Let me now turn the call over to

We continue to believe these formulary wins are the best leading indicator in a hospital launch.

Our net loss for the quarter was $14 million compared to $6.2 million for the same period last year.

Mark A. Demitrack: Let me now turn the call over to Mark to provide a quick overview of where we are with our pipeline. Mark

This change is mainly due to expenses associated with the first full quarter of the Olympic launch.

Mark A. Demitrack: And third, we've implemented many important initiatives to support the launch of Olympics, among which are the two post-approval clinical studies, one in collaboration with Cleveland Clinic and the other conducted at Leiden University Medical Center. We also recently announced the publication of our 28th peer-reviewed manuscript, which continues to strengthen the already substantial Olympic evidence base of scientific literature available to our customers. In addition to our progress with Olympic, we've continued to advance our pipeline assets towards key milestones.

Our operating expense was $14.2 million for the quarter and we expect this to increase moderately in the second half as we continue to commercialize the Lindsay and advance our pipeline assets.

We finished the quarter with $91 million in cash and equivalents, which we continue to believe will fund our operations through the fourth quarter of 2022.

Well now open the call for questions after which Carey will provide some closing remarks.

Operator.

Thank you so much.

We will now begin the question and answer session. As a reminder, if you wish to ask a question. Please press star one on your telephone keypad.

First question from Matt.

Brandon Folkes from Cantor Fitzgerald Your line is open.

Hi, Thanks for taking my question.

Mark A. Demitrack: With TRV027, the two COVID-19 platform trials evaluating our compound continue to move forward. We are pleased to announce that the nationwide active trial supported by NIH and led by Vanderbilt University Medical Center recently began dosing patients. In addition,

Let me firstly.

And then just can.

Can you just elaborate in terms of where you're seeing the product getting used and maybe some reorders at this stage.

And then.

The decision to expand the targets at this stage of the launch.

Can you just talk about if there's any change in thinking about converting the initial targets. There is this just sort of covid.

Covid all the key things up.

Mark A. Demitrack: Startup activities for the RemapCAP trial based in the UK are ongoing, and we are also eagerly awaiting the interim data from Imperial College London's proof-of-concept study. That study completed enrollment in the second quarter, and the research team at Imperial College expects to report their top-line outcomes by year end. Recall that prior to transitioning into the remap cap and active trials. This study underwent an interim analysis by the study's Data Monitoring and Safety Committee.

Fluid and so just any color on that decision to expand the targets at this stage with us.

Continuing to drive those initial targets.

And then lastly, just yet.

Are you putting in a lot of work to produce a lot of very good data over the next 12 months on the Olympics.

Any accounts asking to wait.

And see those results ahead of adding to the formulary. Thank you.

Thanks Brandon.

So I'll start and then I'll I'll turn it over to Bob for additional color on the accounts.

So where we're getting us where we had I think described the fact that we would get a initially used in community.

Mark A. Demitrack: Their review found no safety concerns associated with 027 and acknowledged that the study's progress supported advancing O27 to larger trials with efficacy endpoints. We look forward to seeing what the data from all these studies tells us about TRV027's impact on severe organ damage, mortality, and recovery among COVID-19 patients. With TRV734, NIDA is currently screening patients for their opioid use disorder proof of concept study. And finally, this quarter, we're on track to file our IND for TRV045—our S1P receptor modulator—in diabetic neuropathic pain. And we've begun planning for the phase one development program for this novel compound.

Hospitals, because they tend to have fewer processes and that's actually what we're seeing early on we had some large academic medical centers come into the mix, which is great and we're still seeing that we've had.

Couple of integrated health systems come into.

For formulary win so I think that's really interesting. We're also saying ambulatory surgery centers, because again they tend to have fewer processes.

So where we're getting the use and the reorder is in some cases, it's with those ambulatory surgery centers. Although there are a couple of the institutions that large cancer institution I mentioned on our last quarter call I'm.

They've also had an opportunity to use it and reorder. So I think that's that's really good news that back to the continental Europe, making on the call that when physicians, who use it they like it they like what they see there theyre seeing the fast onset and they're continuing to use it.

Barry Shin: Over the next few months, I look forward to updating you as we continue to make progress across our pipeline. Let me now turn the call over to Barry to discuss our second quarter financial results.

Bob you want to talk a little bit about Brennan I think what you're describing are the 700 hospital targets that we're expanding correct.

Correct, Yes, that's what yeah, Yeah, Bob you want to talk a little bit about that.

Sure Yeah, Hi, Brandon so the thinking there is that we've kind of learned that our team has the capacity to go a little deeper and you might recall our initial targets were a combination of high volume accounts, who had demonstrated a sort of a prior history of early adoption and so we're still focused on those you should maybe think about this more.

Barry Shin: Thanks, Mark. We reported 35 formulary wins today and $178,000 in Q2 net sales for a, in part due to longer timelines in this pandemic environment. We continue to believe these formulary wins are the best leading indicator in a hospital. Our net loss for the quarter was $14 million, compared to $6.2 million for the same period last year. This change is mainly due to expenses associated with the first full quarter of the Olympic launch.

Just kind of dipping down to the next lease tier of high priority targets. These are still high volume targets.

If you think about it roughly 200 hospitals do close to 80% of the overall IV opioid market. So we're still in that upper tier of opportunity, but we've just learned that our team has the capacity to begin to go out to these other hospitals and try to move them to the top of the funnel so to speak in terms of the PMT review process, while they're still moving the other ones.

Barry Shin: Our operating expense was $14.2 million for the quarter, and we expect this to increase moderately in the second half as we continue to commercialize Olenvic and advance our pipeline assets. We finished the quarter with $91 million in cash and equivalents, which we continue to believe will fund our operations through the fourth quarter of 2022. We'll now open the call for questions, after which Kari will provide some closing remarks.

Through this up 122 people, while they are still working those as well.

Yeah. The other thing I'll add is that well of course, what we're seeing in the pandemic is that folks are working virtual again, right and so that that efficiency that happens when people are able to have conference calls in the morning with physicians on the East Coast and then you know in the afternoon.

But with folks in other parts of the country, we're going to try to leverage that when we initially launched we said, let's pick the top 500 accounts, that's about 40% 45% of the IV opioid volume.

Operator: We will now begin the question and answer session. As a reminder, if you wish to ask a question, please press star 1 on your telephone. First question from Brandon Folkes from Canter Fitzgerald. Your line is open.

We're looking for triggers we were looking for for when is the right time for us to delve a little bit deeper and we think we have an opportunity to go as Bob said, maybe not to the full 1200.

Brandon Richard Folkes: Hi, thanks for taking my questions. Maybe firstly...

With the same footprint of reps because of the virtual engagements go a little bit deeper on the.

Unknown Attendee: Unknown Attendee on a limbic just, Can you just elaborate in terms of where you've seen the product getting used and maybe some reorders at this stage? and then a decision to expand the targets at the stage of the launch. Can you talk about if there's any change in thinking about converting the initial targets there? Is this just sort of... Co-host, you know, obviously things are very fluid.

Another question you asked was around the data were not having formulary committees talk about asking for the additional data set the plan all along was to launch with this core foundational fat and then continue to build on as we were describing right. There respiratory the Gi I think cognitive function is going to be a really interesting area for us.

Mark will provide a little bit of the color that we're getting from the physicians that are using the drug.

And there they are describing that.

Carrie L. Bourdow: So just any color on that decision to expand the target at this stage versus, you know, continuing to drive home those initial targets. And then lastly, just, you know, you're putting in a lot of work to produce a lot of very good data over the next 12 months under Lindvik. Any accounts asking to wait and see those results ahead of adding them to the formulary? Thank you. Thanks, Brandon. I'll start, and then I'll turn it over to Bob for additional color on the account.

That potential improvement in cognitive function that we've heard about in our open label safety study so.

It's really our plan to continue to build on the data set but it's not getting in the way of existing formulary discussions that we're having.

Alright, Thank you very much.

Thank you. So much next question from Jason Butler from Jbs JMP Securities. Your line is open thanks.

Thanks for taking the questions.

First one just in terms of the formulary approvals or reviews.

Could you speak to what the rate approve.

Approvals on the first or subsequent review cycles. It is in line with what you'd expected.

And then I have a couple of follow ups on the pipeline.

Great.

Carrie L. Bourdow: So where we're getting used, where we had, I think, described the fact that we would get initial use in community hospitals, because they tend to have fewer processes. And that's actually what we're seeing. Early on, we had some large academic medical centers come into the mix, which is great. And we're still seeing that we've had A couple of integrated health systems come into, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, So, where we're getting the use and the reorder is, in some cases, it's with those ambulatory surgery centers, although there are a couple of the institutions, the large cancer institution that I mentioned on our last quarter call, they've also had an opportunity to use it and reorder.

So.

I will say that.

You know I've been launching drugs for a long time, no one no one's really being able to look at our historical benchmarks and and and see some of the expectations given the pandemic things are taking longer both in terms of the having the meetings and then the the reorder rates or the order rates after the meeting.

But Bob I'll, let you talk a little bit more about the rate of approval I think our team has done pretty well, we're winning more than where they were not.

Which is which is good yeah.

Yeah, absolutely hi, Jason So we definitely are winning the majority and I guess the other color I'd give you is the.

A couple of the initial denials a few of those happened in advance of our team being deployed out there and able to run.

Run the P&C committee through the full dataset that Mark team has put together so.

And as you sort of alluded to it I mean these are we call. These initial denials I mean, it's not it's not a denial that they never go back to so in those couple of initial denials, we've gone back and we're re engaging with the with the advocates and so forth in trying to take another swing at it as well and so the team will continue to push even on those accounts, where we saw initial denial.

Carrie L. Bourdow: So, I think that's really good news. Back to the comments we were making on the call, that when physicians use it, they like it, they like what they see, they're seeing the fast onset, and they're continuing to use it. Bob, you want to talk a little bit about Brandon, I think what you're describing are the 700 hospital targets that we're expanding, correct?

Great.

Then on the respiratory study that will get data from later this year can you speak to the endpoints there.

And just what data, we'll see in the top line release and then four.

045.

Any more details you can give us on the phase one plans.

Bob Yoder: Bob, do you want to talk a little bit about that?

And how you know how and when we would get proof of concept results. So in addition to the <unk>.

Bob Yoder: Sure, yeah, hi Brandon. So the thinking there is that what we've kind of learned that our...

Sending dose work you do in healthy volunteers, how quickly could you start to include GMP patients into the development program. Thanks.

Bob Yoder: Our team has the capacity to go a little deeper, and you might recall our initial targets were a combination of high-volume accounts who had demonstrated sort of a prior history of early adoption. So, um,

Yeah, Great Mark Mark you when it's not sure. So Olympic Yeah go ahead, yeah, Jason So the respiratory physiology study as you May remember this is built on a collaboration that we've had with Dr. Han.

Bob Yoder: We're still focused on those. You should maybe think about this more as just kind of dipping down into the net.

Leiden University and he has.

Innovated a technique that is called.

<unk> clinical utility function analysis, which is a way of looking in a combined outcome at analgesic effect the benefit of a drug.

Unknown Attendee: [inaudible]

Unknown Attendee: The other thing I'll add is that, well, of course, what we're seeing in the pandemic is that folks are

Unknown Attendee: Of course, what we're seeing in the pandemic is that folks are working virtual again, right? And so that efficiency that happens when people are able to have conference calls in the morning with physicians on the East Coast and then, you know, in the afternoon, with folks in other parts of the country, we're going to try to leverage that. When we initially launched, we said, let's pick the top 500 accounts, that's about 40-45% of the IV opioid volume. We were looking for triggers.

And.

Then respiratory compromise.

The risk associated with the drug. So you basically have a graph that is looking at the probability of analgesia versus the profitability of respiratory depression over the concentration range of the drug. So it's a very innovative way of looking and graphic risk benefit and when we looked at that in our.

Initial data with Dr. Hans Health, we saw striking diff.

Difference between Olympic and morphine across their effective plasma concentration branches with Olympic having a much higher probability of producing analgesic benefit compared to respiratory depression analgesia as measured in the laboratory setting by <unk>.

Several different experimental pain models cold paint test than electrical paint stimulation respiratory function as measured in a rigorous way by looking at.

Unknown Attendee: We were looking for, you know, when the right time for us to delve a little bit deeper. And we think we have an opportunity to go, as Bob said, maybe not to the full 1200, but with the same footprint of reps because of the virtual engagements, go a little bit deeper. The other question you asked was around data. We're not having formula committees talk about asking for the additional data set.

Entitled Cotwo respiratory rate in response to greater inhalation of <unk>. So these are very very tightly controlled laboratory conditions that allow us to interrogate the respiratory physiology apparatus.

In the brain. So that's what we're doing in this study. This study in particular is building on the earlier work by examining and older overweight.

So it allows us to see what we expect to be an even more exaggerated difference between Olympics profile compared to morphine in the study.

Carrie L. Bourdow: The plan all along was to launch with this core foundational set and then continue to build on, as we were describing, right, the respiratory, and the GI. I think cognitive function is going to be a really interesting area for us. Mark will provide a little bit of the color that we're getting from the physicians that are using the drug, and they're describing that potential improvement in cognitive function that we've heard about in our open-label safety study. So it's really our plan to continue to build on the data set, but it's not getting in the way of existing formulary discussions that we're having.

As I said that data will be on track to report out.

By the end of this year.

Montreal and talking about it for five and your plans there.

Sure. So you asked about <unk> five where obviously we're on track to file the IND this quarter as I as I said, we've already begun.

Preparations to begin the.

The initial phase one work shortly after that and as you said that initial work first dosing will obviously occur in healthy volunteer population. We are already in the planning phase of moving quickly into patient base model. So more to come on the details of those designs in the coming in the coming months.

Okay, great. Thanks for taking my questions.

Great.

Comment I wanted to make on the respiratory physiology study is that when a doctor to handle the published that data and doctor behind presented it at conferences.

Jason Nicholas Butler: Thank you so much. Next question from Jason Butler from JMP Securities. Your line is open.

Jason Nicholas Butler: Thanks for taking the questions. First one, just in terms of formulary approvals or reviews,

People found it as Mark said really interesting. It's the models are accepted and by formulary committees and the question was well what does it look like in Europe challenging patients right. So again, it's another way that we can.

Jason Nicholas Butler: In terms of formulary approvals or reviews, can you speak to the rates?

Unknown Attendee: is in line with what you'd expect. And then I have a couple of follow-ups in the pipeline.

Expand the data set in connection to the launch strategy. So I think that's going to be a really great.

Unknown Attendee: Unknown Attendee: Great. So

Carrie L. Bourdow: I will say that. Thank you.

Set of information for us at the at the end of this year.

Carrie L. Bourdow: You know, I've been launching drugs for a long time. No one's really being able to look at our historical benchmarks and see, you know, some of the expectations given the pandemic. Things are taking longer, both in terms of having the meetings and then the reorder rates or the order rates after the meetings. But Bob, I'll let you talk a little bit more about the rate of approval. I think, you know, our team's done pretty well. We're winning more than we're not, which is good news.

Operator next question.

Thank you. So much next question from Douglas Tsao from H C. Wainwright Your line is open.

Good morning, and thanks for taking my question, just maybe starting point I'm just curious in terms of and I ask this knowing that it's very early days, but in terms of the hospitals that are not using Olympic I'm. Just curious in terms of what you know how they're doing so a de stocking it on the shelf are they all.

Doing it ahead of cases that they think it would be most appropriate.

Bob Yoder: Yeah, absolutely. Hi Jason. So we definitely are winning the majority. And I guess the other color I'd give you is a couple of the initial denials; a few of those happened in advance of our team being deployed out there and able to, you know, run the P&T committee through the full data set that Mark provided.

And also do you have a sense of which patients that's being used in most is there a particular sort of high risk patient you know be it age obesity that they're gravitating to more more towards right now.

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee Great. And then on the

Yeah, Great question, and I'll say, let me start with just the stocking in them and turn it over to Mark has been talking with a lot of these physicians that are using it.

Unknown Attendee: Great. And then on the respiratory study that we'll get data from later this year, can you speak to the endpoints there and just what data we'll see in the top-line release? And then for 045, any more details you can give us on the Phase 1 plans and how and when we would get proof of concept results? So in addition to the, you know, the ascending dose work you do in Healthy Volunteers, how quickly could you start to include DNP patients in the development program? Thanks.

It depends right if they if they have been using it and they know they're going to use it in a certain patient population or a certain surgery, particularly in the ambulatory surgery centers. They're ordering ahead, if if it's someone that's brand new and they're there they're beginning right. There we've gotten on formulary and they want to order them.

And then it's then it's not that it's not ordered ahead, but I think it's really interesting we have some ambulatory surgery center physicians that are using it in younger patients than what we originally positioned it and in the inpatient setting. It's a it's more of that challenging patient, but let me let me not feel marks vendor because he's got some really good I think case case.

Mark A. Demitrack: Yeah, great. Mark, you want to talk about both Olympic games? Yeah, go ahead. Yeah, Jason.

Mark A. Demitrack: So the respiratory physiology study, as you may remember, this is built on a collaboration that we've had with Dr. Dahan at Leiden University. And he has innovated a technique that's called clinical utility function analysis, which is a way of looking in a combined outcome at analgesic effect, the benefit of a drug, and then respiratory compromise, the risk associated with the drug. So you basically have a graph that's looking at the probability of analgesia versus the probability of respiratory depression over the concentration range of the drug. So it's a very innovative way of looking at and graphing risk-benefit.

To describe.

Yes, good morning.

So.

What we're hearing let me talk first sort of expand on what Bob commented on on the ASC side, one of the things that the early on was recognized by clinicians is the profile of our Lindbergh lends itself as an analgesic to use throughout the case from beginning to pose.

Procedure with the intent of more rapidly.

Moving the patient through the ASC setting and that and we've heard that that's working.

Collections have been quite satisfied with the Olympics performance and that way within the inpatient setting I'll give you. An example, one of the.

The messages that we hear quite consistently is that this is a very attractive.

Option in the setting of the complex patient.

Mark A. Demitrack: And when we looked at that in our initial data with Dr. Dahan's help, we saw a striking difference between Olinvik and Morphine across their effective plasma concentration ranges, with Olinvik having a much higher probability of producing analgesic benefit compared to respiratory depression. Analgesia is measured in the laboratory setting by several different experimental pain models, such as cold pain tests and electrical pain stimulation. Respiratory function is measured in a rigorous way by looking at end-tidal CO2 and respiratory rate in response to graded inhalation of CO2.

What they what they tell us is that the respiratory profile.

Recently in sufficient patient and the patient at higher risk of post operative nausea, and vomiting are ideal candidates for the use of Olympic and this is in the setting in many instances we've heard cases of open abdominal procedures, where which are very complicated painful procedures, where these risk factors.

Combined to make the case clinically quite challenging.

Another very very interesting aspect when we hear about the inpatient settings and this comes up.

Quite a bit is what we heard in the Athena study Carrie touched on this earlier and that is that the.

Mark A. Demitrack: So these are very, very tightly controlled laboratory conditions that allow us to interrogate the respiratory physiology apparatus in the brain. So that's what we're doing in this study. This study, in particular, is building on the earlier work by examining an older, overweight age group. So it allows us to see what we expect to be an even more exaggerated difference between Olinvik's profile compared to Morphine in this study. That, as I said, that data will be on track to be reported out by the end of this year.

The use of Olympic and it makes me that much more excited about the idea of digging into this further in the outcome study that we had planned.

Okay great.

I can ask.

Other follow up just in terms of formulary approvals that you are getting are they fairly broad based right now or are there being restrictions placed on them.

Carrier would you like me to take that.

Oh, I'm, sorry, I was on mute.

Happy for you to take it but I had already answered it.

Sure go ahead.

Yeah, even in that.

So we're not we're not actually seeing patient restrictions, where if we are seeing in some cases restrictions where.

Mark A. Demitrack: Mark, do you want to talk about 045 and your plans there? Sure, so he asked me about 045.

If the physician a colorectal surgeon is the one that Mark described is asking for it if it's restricted for their use but beyond that we're not seeing a lot of the restrictions to certain patient types.

Mark A. Demitrack: Obviously, we're on track to file the IND this quarter, as I said, and we've already begun preparations to begin the initial Phase I work shortly after that. And as he said, that initial work, first dosing, will obviously occur in a healthy volunteer population. We're already in the planning phase of moving quickly into patient-based models. So more to come on the details of those designs in the coming months.

Okay, great. Thank you so much.

Yeah.

Great.

Okay. Thank you so much.

There are no further questions at this time Cary. Please go ahead.

Well. Thank you all thank you for your questions as you can hear we're pleased by the progress that we continue to make on the Olympic launch both in terms of increasing our formulary wins and advancing our post approval plan. The fact that we've more than tripled the number of approvals since first quarter, especially given that the unique.

Unknown Attendee: Great. The other comment I wanted to make on the respiratory physiology study is that when

Unknown Attendee: and Mark. So the goal of the physiology study is that when Dr. Dahan and I published that data, and Dr. Dahan presented it at conferences, people found it, as Mark said, really interesting. The models are accepted by formula committees. And the question was, well, what does it look like in your challenging patients, right? So again, it's another way that we can expand the data set in connection to the launch strategies. I think that's going to be a really great set of information for us at the end of this year.

<unk> that we've all had to navigate that such a suggests to us that formulary committees recognized Olympics value.

There's a lot to look forward to data from the first to Linda post approval study expected by the end of this year continued progress on the launch our IND filing for <unk> <unk> this quarter.

T. R V O two seven top line data from the Imperial College and updates on patient enrolment from the two Covid studies. So as you can hear there's a lot going on we look forward to updating you on all of these fronts. As we continue to remain focused on providing innovative medicines for patients and health care professionals and thank you again for joining us that concludes.

Douglas Dylan Tsao: Thank you so much. Next question from Douglas Tsao from HC Wainwright. Your line is open.

Douglas Dylan Tsao: Good morning, and thanks for taking the questions. Just maybe a starting point, I'm just curious in terms of, and I say this knowing that it's very early days, but in terms of the hospitals that are now using Alembic, I'm just curious in terms of what you know, how they're doing so, are they stocking it on the shelf? Are they ordering it ahead of cases that they think it would be most appropriate for?

Today's call.

That does conclude our conference for today. Thank you for participating you may all disconnect.

[music].

Unknown Attendee: And also, do you have a sense of which patients it's being used in most? Is there a particular sort of high-risk patient, you know, be it age, obesity, that they're gravitating towards more, right? Yeah, great question. And I'll say, let me start with just the stocking, then I'm going to turn it over to Mark, who's been talking with a lot of these physicians that are using it. It depends, right?

Unknown Attendee: If they've been using it, and they know they're going to use it in a certain patient population or certain surgery, particularly in ambulatory surgery centers, they're ordering it ahead. But if it's someone that's brand new and they're beginning, right, we've got it on formulary, and they want to order, then it's not ordered ahead. But I think it's really interesting.

Unknown Attendee: We have some ambulatory surgery center physicians that are using it in younger patients than we originally positioned it for. And in the inpatient setting, it's more of that challenging patient. But let me not feel Mark's thunder, because he's got some really good, I think, cases to describe. Yeah, Doug, good morning.

Mark A. Demitrack: So what we're hearing, let me talk first, sort of expand on what Bob commented on on the ASC side. One of the things that early on was recognized by clinicians is that the profile of a limbic system lends itself as an analgesic to use throughout the case, from beginning to post-procedure, with the intent of more rapidly moving the patient through the [inaudible] messages that we hear quite consistently is that this is a very attractive option in the setting of the complex patient.

Mark A. Demitrack: And what they tell us is that the respiratory profile, the readily insufficient patient, and the patient at higher risk of post-operative nausea and vomiting are ideal candidates for the use of LinVec. And this is in the setting of, in many instances, we've heard cases of open abdominal procedures, which are very complicated, painful procedures where these risk factors combine to make the case clinically quite challenging. Another very, very interesting aspect when we hear about inpatient settings, and this comes up quite a bit, is what we heard in the Athena study.

[music].

Mark A. Demitrack: Carrie touched on this earlier, and that is that reorientation, the ability for the patient to participate in their own recovery, their level of alertness, and the lack of sedation are one of the most distinguishing characteristics that a clinician notices in the use of a LinVec. And it makes me that much more excited about the idea of digging into this further in the outcome study that we had planned.

Unknown Attendee: Okay, great. And if I can ask, you know, another follow-up question just in terms.

Unknown Attendee: Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host.

Unknown Attendee: that you are getting, are they fairly broad-based right now, or are there being restrictions placed on them? Thank you.

Unknown Attendee: Oh, I'm sorry. I was on mute.

Unknown Attendee: I'm happy for you to take it, but I had already answered it. Sure, go ahead.

Unknown Attendee: Yeah, even in the... So we're not actually seeing patient restrictions. We are seeing, in some cases, restrictions where if the physician, a colorectal surgeon, the one that Mark described, is asking for it, it's restricted for their use. But beyond that, we're not seeing a lot of restrictions on certain patient types. Okay, great. Thank you so much.

Unknown Attendee: Okay, thank you so much. There are no further questions at this time. Carrie, please go ahead.

Carrie L. Bourdow: Well, thank you all. Thank you for your questions.

Carrie L. Bourdow: As you can hear, we're pleased by the progress that we've continued to make on the Olympic launch, both in terms of increasing our formulary wins and advancing our post-approval plan. The fact that we've more than tripled the number of approvals since the first quarter, especially given the unique environment that we've all had to navigate, suggests to us that formulary committees recognize Olympic value. And there's a lot to look forward to, with data from the first Olympic post-approval study expected by the end of this year, continued progress on the launch, our IND filing for TRB 045 this quarter, TRB 027 top-line data from Imperial College, and updates on patient enrollment from the two COVID studies.

Carrie L. Bourdow: So, as you can hear, there's a lot going on. We look forward to updating you on all of these fronts as we continue to remain focused on providing innovative medicines for patients and healthcare professionals. And thank you again for joining us. That concludes today's call.

Operator: That does conclude our conference for today. Thank you for participating. You may all disconnect.

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Barry Shin: Thank you for standing by, and welcome to the Trevena Incorporated 2nd 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 will need to press star 1 on your telephone keypad. And to re-enter your question, press the hash key. If you require technical support at any time, please press star zero. I would now like to hand the conference over to your first speaker today, Barry Shin, Chief Financial Officer. Please go ahead. Good morning.

Barry Shin: 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 law. These statements are subject to risks and uncertainties related to our business, including those discussed in our filings with the SEC. We undertake no obligation to update these statements beyond today. I'll now turn the call over to Carrie for an overview of our second quarter and recent business accomplishments. Carrie?

Carrie L. Bourdow: Thank you, Barry. Good morning, everyone. Thanks for joining us today. The second quarter marked our first full quarter of the Olympic launch, and with five months in the field, we now sit at 35 formulary approvals, over three times the number we reported last quarter. We recognize that COVID has had an impact on sales, and formulary timelines have been delayed, but our team remains focused and adaptive.

Carrie L. Bourdow: And we have a lot to be excited about, both with Lendvic and Piper, which is a limbic. We're on track to reach our year-end goal of 100 formulary wins, and we're focused on that next because when we get in front of a customer and present the Olympic profile, they're strong, and physicians continue to be excited by the clinical data and the LINDX value proposition. Importantly, we're already getting positive feedback from physicians who've had the chance to use Lynda.

[music].

Carrie L. Bourdow: We've also started two new studies to build on a limbic's unique profile. The first is a clinical outcome study led by Cleveland Clinic. Remember that Cleveland Clinic came to us with an interest in expanding upon our phase three findings in three important safety areas that physicians care about: respiratory, GI, and cognitive function. Patient enrollment is on track to start this quarter, and top-line data is expected in the middle of next year. The second study is evaluating the effect of a limbic versus morphine on respiratory function in elderly and obese individuals.

Carrie L. Bourdow: This study also builds upon previously published work, and patient enrollment is well underway. We expect top-line data from this study by the end of this year. And finally, we continue to advance Olympic towards approval outside of the U.S. Nuo, our partner in China, recently began dosing patients in their Phase 3 trial. Once that study is complete, they expect it to have sufficient data in combination with our existing package to submit a LIMBIC for approval.

Carrie L. Bourdow: Beyond LENDIC, we're advancing our pipeline through partnerships with globally recognized institutions. We were pleased that the first patient was enrolled in the TRV027 Active COVID Trial, which is being led by Vanderbilt University Medical Center and funded by NIH. For TRD 045, our novel S1P receptor modulator, we're on track to file our IND for diabetic neuropathic pain this quarter. DNT is a significant market opportunity with over 5 million people affected by this painful condition and few therapeutic options available, and the National Institute on Drug Abuse, or NIDA, has resumed their study of TRV734 for opioid use disorder.

Carrie L. Bourdow: As we continue to battle the COVID pandemic, it's important that we don't forget about the other public health crises that take a toll on our communities, and I'm proud that Trevena is playing a role in developing solutions for some of the largest public health issues. To close, we have a highly skilled team with expertise in launching products both prior to COVID and now during a pandemic. We have the resources, a great product and launch strategy, interesting new data coming soon, and we're well-positioned to reach our year-end goals. So with that, let me turn the call over to Bob to talk more about the Olympic launch. Bob?

[music].

Bob Yoder: Thank you, Kerry. With our first full quarter of launch complete, we continue to make progress towards our year-end goal of 100 formulary wins. 123 institutions are currently reviewing LINVIC at various stages, and 35 accounts have added LINVIC to their formulary. At the same time, it's no surprise that COVID has impacted our field activity. But as the pandemic evolves, so are we. Here's where we are. Through the end of May, RepLive engagements were holding up at around 70%, which really compares favorably to reported industry benchmarks.

Thank you for standing by and welcome to day there'll be not incorporated second quarter do you does he want to watch one financial results conference call.

At this time all participants are in there I can only mode.

After the speaker presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone keypad antibody to all your questions Firstly husky.

Bob Yoder: Over the past six to eight weeks, we've started to see that level of live engagement decline as certain regions have started shutting down again. Additionally, formulary reviews, which historically have a seasonal slowdown during summer months, have been further delayed.

Yeah, great. Thank you that's a board at any time, Please press star zero.

I would now like to hand things over to your first speaker today, Barry <unk> Chief Financial Officer. Please go ahead.

Bob Yoder: But here's what we know. When we are able to engage with a customer either live or virtually, the response is consistently positive. We continue to hear that the limbic's unique profile and value proposition resonate with physicians.

Good morning, and welcome everyone.

With me today are carried about though our president and CEO, Bob Yoder, our Chief commercial officer, and our Chief Medical Officer, Mark them attract.

Bob Yoder: For example, we're hearing great feedback about a limbic system's use in the ambulatory surgical setting, positions point to the rapid onset and duration of effect as the two.

We undertake no obligation to update these statements beyond today.

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc., And in the inpatient setting, we're hearing that clinicians are impressed with the gastrointestinal tolerability profile of a, particularly for open GI procedures where the use of an IV opioid is necessary, but so is minimizing adverse events such as postoperative vomiting.

I'll now turn the call over to Kerry <unk> for an overview of our second quarter and recent business accomplishments.

Gary.

Thank you Barry.

Good morning, everyone. Thanks for joining us today.

Second quarter marked our first full quarter of the Olympic launch.

And with five months left field, we now sit at 35 formulary approvals over three times the number we reported last quarter.

We recognize that Covid has had an impact on sales and formulary timelines have been delayed but our team remains focused and adaptive and we've a lot to be excited about both with a Linda again our pipeline.

Unknown Attendee: We also know that healthcare decision-makers like P&T committee members have found the health economic model to be very...

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc. Based on the early traction and positive feedback, we're expanding our outreach and access opportunities for Olympians. So here's what we're doing there.

Bob Yoder: First, we plan to target more physicians who are key stakeholders at large, influential institutions who can serve as Olympic advocates during the formulary review process. To do this, we're adding five medical science liaisons so that our full MSL team can now target approximately 500 physicians at top academic medical centers and other important institutions. Our MSL team is comprised of PharmDs with deep experience in health, economic data, and modeling. They've got the right credentials and experience to communicate a compelling clinical profile and health economic data. Second, we're expanding our list of target accounts to approximately 700 hospitals, representing approximately 60% of the IV opioid market. These new accounts represent a significant growth opportunity for Olympia.

Currently we're already getting positive feedback from physicians who've had the chance to youth Olympic.

Laurie G I in cognitive function patient enrollment is on track to start this quarter and top lined out as expected middle of next year.

The second study is evaluating the effect of Olympic versus morphine on respiratory function in elderly in obese individuals.

This study also builds upon our previously published work and patient enrollment is well underway. We expect top line data from this study by the end of this year.

Bob Yoder: In closing, over this past quarter, we tripled our formulary wins.

And finally, we continue to advance towards approval outside the U S.

Our partner in China recently began dosing patients in their phase III trial once that study is complete.

Unknown Attendee: Unknown Attendee, Mark Demitrack, Jason Butler, Unknown Attendee, Barry Shin, Trevena Inc. When we get in front of our customers, they tell us they like the LIMBICS differentiated profile and value proposition, and we're hearing positive things from customers who are using it. We're hiring additional MSLs to expand our outreach to healthcare professionals and extending our field coverage to include additional high-volume accounts.

I expect it to have sufficient data in combination with our existing package to submit Olympic for approval.

The on the Olympic we're advancing our pipeline through partnerships with globally recognized institutions. We were pleased that the first patient was enrolled in the T. R. V. O. Two seven active Covid trial, which is being led by Vanderbilt University Medical center and funded by NIH.

Unknown Attendee: We started this launch at the height of the pandemic, and we know how to do this in a virtual environment. While we all certainly hope that an expanded shutdown is not coming again, we're taking

C N V O four five our novel <unk> receptor modulator, we're on track to file our IND for diabetic neuropathic pain this quarter.

D N P. A significant market opportunity with over 5 million people affected by this painful condition and few therapeutic options available.

Unknown Attendee: We're taking steps to be as effective as possible if we return to that environment. I am firmly convinced in the long-term value of a limbic system and the positive change it brings to the management of severe acute pain. Let me know.

And the National Institute on drug abuse, or neither has resumed their study of <unk> 734 for opioid use disorder.

Mark A. Demitrack: Let me now turn the call over to Mark to provide a quick overview of where we are with our pipeline. Mark

Mark A. Demitrack: As you've heard, we've implemented many important initiatives to support the launch of LINVIC, among which are the two post-approval clinical studies, one in collaboration with Cleveland Clinic and the other conducted at Leiden University Medical Center. We also recently announced the publication of our 28th peer-reviewed manuscript, which continues to strengthen the already substantial Olympic evidence base of scientific literature available to our customers. In addition to our progress with Lindbeck, we've continued to advance our pipeline assets towards key milestones.

To close we have a highly skilled team with expertise in launching products both prior to Covid and now during the pandemic, we have the resources a great product and launch strategy interesting new data coming soon and we're well positioned to reach our year end goals. So with that let me turn the call over to Bob to talk more about the Olympic loss.

Yeah.

Thank you Carrie.

With our first full quarter of launch complete we continue to make progress towards our year end goal of 100 formulary wins.

123 institutions are currently reviewing limbic at various stages and 35 account that added a little bit to formulary.

At the same time its no surprise that Covid has impacted our field activities.

But as the pandemic evolved so are we.

Here's where we're at.

Through the end of May Rep live engagements were holding up at around 70%.

Mark A. Demitrack: Startup activities for the RemapCAP trial based in the UK are ongoing, and we are also eagerly awaiting the interim data from Imperial College London's proof-of-concept study. That study completed enrollment in the second quarter, and the research team at Imperial College expects to report their top-line outcomes by year end. Recall that prior to transitioning into the REMAP-CAP and ACTIV trials. This study underwent an interim analysis by the study's Data Monitoring and Safety Committee.

Which really compares favorably to reported industry benchmarks.

Over the past six to eight weeks, we have started to see that level of live engagement decline as certain regions have started shutting down again.

Additionally, formulary reviews, which historically have a seasonal slowdown during summer months have been further delayed.

But here's what we know.

When we are able to engage with the customer either live or virtually the response is consistently positive.

We continue to hear the Olympics unique profile and value proposition resonate with physicians.

Mark A. Demitrack: Their review found no safety concerns associated with 027 and acknowledged that the study's progress supported advancing O2-7 to larger trials with efficacy endpoints. We look forward to seeing what the data from all these studies tells us about TRV027's impact on severe organ damage, mortality, and recovery among COVID-19 patients. With TRV 734, NIDA is currently screening patients for their opioid Use Disorder Proof of Concept study. And finally, this quarter, we're on track to file our IND for TRV045—our S1P receptor modulus—in diabetic neuropathic pain. And we've begun planning for the phase one development program for this novel compound.

For example, we're hearing great feedback about Olympics use in the ambulatory surgical setting.

<unk> pointed a rapid onset and duration of effect as the two main attributes that allow them to use Atlantic in the perioperative setting all the way through patient discharge.

And in the inpatient setting we're hitting the conditions are impressed with the gastrointestinal tolerability profile of Olympic, particularly for open Gi procedures, where the use of an IV opioid is necessary, but so is minimizing adverse events such as postoperative vomiting.

We also know that health care decision makers like PMT Committee members have found a health economic model to be very beneficial in their assessment of the full value prop for Olympic.

Based on the early traction and positive feedback, we are expanding our outreach and access opportunities for Olympic.

So here's what we're doing there.

First we plan to target more physicians, who are key stakeholders at large influential institutions, who can serve as the Olympic advocate during their formulary review process.

To do this we're adding five medical science liaison. So they are full MSL team can now target approximately 500 positions at top academic medical centers and other important institutions.

Our MSL team is comprised of Pharm DS with deep experience in health economic data and modeling.

They've got the right credentials and experience to communicate Olympics compelling clinical profile and health economic data.

Barry Shin: Thanks, Mark. We reported 35 formulary wins today and $178,000 in Q2 net sales for a limited time, part due to longer timelines in this pandemic environment. We continue to believe these formulary wins are the best leading indicator in a hospital. Our net loss for the quarter was $14 million, compared to $6.2 million for the same period last year. This change is mainly due to expenses associated with the first full quarter of the Olympic launch.

Second we're.

We're expanding our list of target accounts to approximately 700 hospitals, representing approximately 60% of the IV opioid market.

These new accounts represent a significant growth opportunity for Olympic.

In closing over this past quarter, we tripled our formulary wins and continued to grow the number of accounts that are moving through the PMT review process.

When we get in front of our customers.

They tell us they like the Olympics differentiated profile and value proposition.

And we're hearing positive things from customers, who are using Linda.

We are hiring additional MSL expand our outreach to health care professionals and extending our field coverage to include additional high volume accounts.

Barry Shin: Our operating expense was $14.2 million for the quarter, and we expect this to increase moderately in the second half as we continue to commercialize Alembic and advance our pipeline app. We finished the quarter with $91 million in cash and equivalents, which we continue to believe 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.

We started this launch at the height of the pandemic and we know how to do this in a virtual environment.

While we all certainly hope that an expanded shutdown is not coming again, we're taking steps to be as effective as possible. If we return to that environment.

I am firmly convinced in the long term valuable Lindsay and the positive change it brings to the management of severe acute pain.

Let me now turn the call over to Mark to provide a quick overview of where we are with our pipeline.

Mark.

Thank you Bob.

As you've heard we've implemented many important initiatives to support the launch of Olympics.

Among which are the two post approval clinical studies, one in collaboration with Cleveland Clinic and the other conducted at Leiden University Medical Center.

We also recently announced publication of our 28 peer reviewed manuscript, which continues to strengthen the already substantial Olympic evidenced space of scientific literature available to our customers.

In addition to our progress with the Olympics.

Brandon Richard Folkes: Hi, thanks for taking my question. [inaudible] Unknown Speaker On a limbic level, can you just elaborate in terms of where you've seen the product getting used and maybe some reorders at this stage?

We've continued to advance our pipeline assets towards key milestones.

With TRP O two seven the <unk>.

<unk> Covid 19 platform trials evaluating our compound continue to move forward.

We were pleased to announce that the nationwide active trials supported by NIH and led by Vanderbilt University Medical Center recently began dosing patients.

In addition startup activities for the remap cap trial based in the UK are ongoing.

Unknown Attendee: and then a decision to expand the targets at the stage of the launch. Can you talk about if there's any change in thinking about converting the initial targets there? Is this just sort of...

We also are eagerly awaiting the interim data from an Imperial College, London proof of concept study.

That study completed enrollment in the second quarter and the research team at Imperial College expects to report their topline outcomes by year end.

Carrie L. Bourdow: Unknown Attendee, Barry Shin, Trevena Inc., You're putting in a lot of work to produce a lot of very good data over the next 12 months under Lindvik. Any accounts asking to wait and see those results ahead of adding to the formulary? Thank you. Thanks, Brandon. So I'll start and then I'll turn it over to Bob for additional color on the account.

Recall that prior to transitioning into the remap cap and active trials.

This study underwent an interim analysis by the study's data monitoring and safety Committee.

Their review found no safety concerns associated with up to seven and acknowledged that the studies progress supported advancing <unk> two seven to larger trials with efficacy endpoints.

We look forward to seeing what the data from all these studies tells us about <unk> <unk> impact on severe organ damage mortality and recovery among covid 19 patients.

With <unk> 734, neither is currently screening patients for their opioid use disorder proof of concept study.

And.

Linley this quarter, we're on track to file our IND for <unk> five hour <unk> receptor modulator <unk>.

Diabetic neuropathic pain.

And we've begun planning for the Phase one development program for this novel compound.

Over the next few months I look forward to updating you as we continue to make progress across our pipeline.

Let me now turn the call over to Barry to discuss our second quarter financial results.

Right.

Thanks Mark.

We reported 35 formulary Wednesday and $178000 in Q2 net sales for Olympic and part due to longer timelines in this pandemic environment.

We continue to believe these formulary wins are the best leading indicator in a hospital launch.

Our net loss for the quarter was $14 million compared to $6.2 million for the same period last year.

This change is mainly due to expenses associated with our first full quarter of the Olympic launch.

Our operating expense was $14.2 million for the quarter and we expect this to increase moderately in the second half as we continue to commercialize Olympic and advance our pipeline assets.

We finished the quarter with $91 million in cash and equivalents, which we continue to believe will fund our operations through the fourth quarter of 2022.

Well now open the call for questions after which Carey will provide some closing remarks.

Operator.

Thank you Phil Mics.

We will now begin the question and answer session. As a reminder, if you wish to ask a question. Please press star one on your telephone keypad.

Bob Yoder: Bob, you want to talk a little bit about Brandon, I think what you're describing are the 700 hospital targets that we're expanding, correct? Correct. Yeah, that's what, yeah. Yeah. Bob, you want to talk a little bit about that? Sure. Yeah. Hi, Brandon. So the thinking there is that what we've

First question from Brandon Folkes from Cantor Fitzgerald Your line is open.

Hi, Thanks for taking my question.

Let me firstly.

And then just.

Can you just elaborate in terms of where you're seeing the product getting used and maybe some reorders at this stage.

Then.

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc., And so we're still focused on those. You should maybe think about this more as just kind of dipping down into the next lowest tier of high-priority targets. These are still high-volume targets. If you think about it, roughly 1,200 hospitals handle close to 80% of the overall IV opioid market. So we're still in that upper tier of opportunity, but we've just learned that our team has the capacity to begin to go out to these other hospitals and try to move them to the top of the funnel, so to speak, in terms of the P&T review process while they're still moving the other ones through, those other 123, while they're still working on those as well.

The decision to expand the targets at this stage of the launch.

Can you just talk about if there's any change in thinking about converting the initial targets. There is this just sort of.

Covid, obviously things up.

A very fluid and so just any color on that decision to expand the target at this stage with us.

To drive home.

<unk> targets.

And then lastly, just yet you are putting in a lot of work to produce a lot of very good data over the next 12 months on the Lindbergh.

Any accounts asking to wait.

See those results ahead of adding to the formulary. Thank you.

Thanks Brandon.

So I'll start and then I'll turn it over to Bob for additional color on the account, so where we're getting used.

We had I think I described the fact that we would get a initially used in community.

Unknown Attendee: The other thing I'll add is that, well, what we're seeing in the pandemic is that folks are working virtual again, right? And so the efficiency that happens when people are able to have conference calls in the morning with physicians on the East Coast and then, you know, in the afternoon with folks in other parts of the country, we're going to try to leverage that. When we initially launched, we said, let's pick the top 500 accounts. That's about 40-45% of the IV opioid volume.

Couple of integrated health systems come into.

For formulary win so I think Thats really interesting. We're also seeing ambulatory surgery centers, because again they tend to have fewer processes.

They've also had an opportunity to use it and reorder. So I think that's that's really good news that back to the comments, we are making on the call that when physicians who use it they like it they like what they see there theyre seeing the fast onset and they're continuing to use it.

Carrie L. Bourdow: We were looking for triggers. We were looking for, you know, when the right time for us to delve a little bit deeper. And we think we have an opportunity to go, as Bob said, maybe not to the full 1200, but with the same footprint of reps because of the virtual engagements, go a little bit deeper. The other question you asked was around data. We're not having formula committees talk about asking for the additional data set.

Bob you want to talk a little bit about Brennan I think what you are describing are the 700 hospital targets that we're expanding correct.

Correct, Yes, that's what yeah, Yeah, Bob you want to talk a little bit about that.

Carrie L. Bourdow: The plan all along was to launch with this core foundational set and then continue to build on, as we were describing, right, the respiratory, and the GI. I think cognitive function is going to be a really interesting area for us. Mark will provide a little bit of the color that we're getting from the physicians that are using the drug, and they're describing that potential improvement in cognitive function that we heard about in our open-label safety study. So it's really our plan to continue to build on the data set, but it's not getting in the way of existing formulary discussions that we're having.

Prior history of early adoption and so we're still focused on those you should maybe think about this more as just kind of dipping down to the next lease tier of high priority targets. These are still high volume targets.

If you think about roughly 200 hospitals do close to 80% of the overall IV opioid market. So we're still in that upper tier of opportunity, but we've just learned that our team has the capacity to begin to go out to these other hospitals and try to move them to the top of the funnel so to speak in terms of the PMT review process, while theres still moving the other ones.

Through 123, while they are still working those as well.

Jason Nicholas Butler: Thank you so much. Next question from Jason Butler from JMP Securities. Your line is open.

But with folks in other parts of the country, we're going to try to leverage that when we initially launched we said, let's pick the top 500 accounts, that's about 40% 45% of the IV opioid volume.

Unknown Attendee: Thanks for taking the questions. First one, just in terms of formulary approvals or reviews.

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc,

We were looking for triggers we were looking for for when is the right time for us to to delve a little bit deeper and we think we have an opportunity to guidance as Bob said, maybe not to the full 1200, but with the same footprint of routes because of the virtual engagements go a little bit deeper.

Unknown Attendee: is in line with what you'd expect, and then I have a couple follow-ups in the pipeline.

Unknown Attendee: Unknown Attendee: Great. So

Carrie L. Bourdow: I will say that You know, I've been launching drugs for a long time. No one's really being able to look at our historical benchmarks and see, you know, some of the expectations given the pandemic. Things are taking longer, both in terms of having the meetings and then the reorder rates or the order rates after the meetings. But Bob, I'll let you talk a little bit more about the rate of approval. I think, you know, our team's done pretty well. We're winning more than we're not, which is good news.

Other question you asked was around the data were not having formulary committees talk about asking for the additional data set the plan all along was to launch with this core foundational fat and then continue to build on as we were describing right. There respiratory the Gi I think cognitive function is going to be a really interesting area for us.

Mark will provide a little bit of the color that we're getting from the physicians that are using the drug.

And there they are describing that.

Bob Yoder: Absolutely. Hi Jason.

Bob Yoder: So we definitely are winning the majority. And I guess the other color I'd give you is a couple of the initial denials. A few of those happened in advance of our team being deployed out there and able to, you know, run the P&T committee through the full data set that Mark's team has.

That potential improvement in cognitive function that we've heard about in our open label safety study so.

It's really our plan to continue to build on the data set but it's not getting in the way of existing formulary discussions that we're having.

Alright, Thank you very much.

Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc,

Thank you. So much next question from Jason Butler from Jbs JMP Securities. Your line is open.

Thanks for taking the questions.

Unknown Attendee: [inaudible] Unknown Attendee Great. And then on the, um, the

Yes.

First one just in terms of the formulary approvals or reviews.

Unknown Attendee: Great. And then on the respiratory study that we'll get data from later this year, can you speak to the endpoints there and just what data we'll see in the top-line release? And then for 045, any more details you can give us on the Phase 1 plans and how and when we would get proof of concept results? So obviously, in addition to the, you know, the ascending dose work you do with healthy volunteers, how quickly could you start to include DNP patients in the development program?

Could you speak to what the rate approval.

Approvals on the first or subsequent review cycles. It is in line with what you'd expected.

And then I have a couple of follow ups on the pipeline.

Great.

So.

I will say that.

You know I've been launching drugs for a long time, no one no one's really being able to look at our historical benchmarks and and see some of the expectations given the pandemic things are taking longer both in terms of the having the meetings and then the reorder rates or the order rates after the meeting.

Mark A. Demitrack: Yeah, great. Mark, you want to talk about both Olympic games? Yeah, go ahead. Yeah, Jason.

But Bob I'll, let you talk a little bit more about the rate of approval I think our team has done pretty well, we're winning more than where they were not.

Which is which is good yeah.

Yeah, absolutely hi, Jason So we definitely are winning the majority and I guess the other color I'd give you is the.

A couple of the initial denials or a few of those happened in advance of our team being deployed out there and able to run.

Run the P&C can be through the full dataset that mark team has put together so.

And as you sort of alluded to it I mean these are we call. These initial denials I mean, it's not it's not a denial that you never go back to so in those couple of initial denials, we've gone back and we're re engaging with.

Advocates and so forth in trying to take another swing at it as well and so the team will continue to push even on those accounts we saw initial denial.

Great and then on the the respiratory study that will get data from later this year can you speak to the endpoints there.

And just what data, we'll see in the top line release and then for 045.

Mark A. Demitrack: And when we looked at that in our initial data with Dr. DeHaan's help, we saw a striking difference between Olinvik and Morphine across their effective plasma concentration ranges, with Olinvik having a much higher probability of producing analgesic benefit compared to respiratory depression. Analgesia is measured in the laboratory setting by several different experimental pain models, such as cold pain tests and electrical pain stimulation. Respiratory function is measured in a rigorous way by looking at end-tidal CO2 and respiratory rate in response to graded inhalation of CO2.

Any more details you can give us on the phase one plans.

How you know how and when we would get proof of concept results. So in addition to the <unk>.

The ascending dose work you do in healthy volunteers, how quickly could you start to include DMD patients into the development program. Thanks.

Yeah, Great Mark Mark you and its not sure well so.

Olympic Yeah go ahead, yes, Jason so the respiratory physiology study as you May remember this is built on a collaboration that we've had with Dr. <unk> at.

Leiden University.

He has.

Innovated.

Technique, that's called clinical utility function analysis, which is a way of looking in a in a combined outcome analgesic effect the benefit of a drug.

And.

Then respiratory compromise.

The risk associated with the drug so you basically have a graph.

Looking at the probability of analgesia versus the probability of respiratory depression over the concentration range. The drug so it's a very innovative way of looking and graphic risk benefit and when we looked at that in our.

Initial data with Dr. Hans Health, we saw a striking.

Difference between Olympic and morphine across their effective plasma concentration branches with Olympic having a much higher profitability of producing analgesic benefit compared to respiratory depression analgesia as measured in the laboratory setting.

Bye.

Several different experimental pain models cold pain tests, and electrical paint stimulation respiratory function.

Measured in a rigorous way by looking at.

One is building on the earlier work by examining and older overweight age group. So it allows us to see what we expect to be an even more exaggerated difference between Olympics profile compared to morphine in the study.

Mark A. Demitrack: Mark, do you want to talk about 045 and your plans there? Sure, so you asked about 045.

That as I said that data will be on track to report out.

By the end of this year.

Mark A. Demitrack: Obviously, we're on track to file the IND this quarter, as I said, and we've already begun preparations to begin the initial Phase I work shortly after that. And as you said, that initial work, first dosing, will obviously occur in a healthy volunteer population. We're already in the planning phase of moving quickly into patient-based models. So more to come on the details of those designs in the coming months.

Mark do you mind talking about it for five and your plans there.

Sure. So you asked about <unk> five where obviously we're on track to file the IND this quarter as I as I said, we've already begun.

Preparations to begin the.

The initial phase one work shortly after that and as you said that initial work first dosing will obviously occur in a healthy volunteer population.

We're already in the planning phase of moving quickly into a patient based model so more to come on the details of those designs in the coming in the coming months.

Unknown Attendee: Great. The other comment I wanted to make on the respiratory physiology study.

Unknown Attendee: And the other comment I wanted to make on the respiratory physiology study is that when Dr. DeHaan and I published that data, and Dr. DeHaan presented it at conferences, people found it, as Mark said, really interesting. And the models are accepted by formulary committees.

Okay, great. Thanks for taking the questions.

Great Let me.

Comment I wanted to make on the respiratory physiology study is that when a doctor behind when they published that data and doctor behind presented it at conferences.

People found it as Mark said really interesting. It's models are accepted and by formulary committees and the question was well what does it look like in Europe challenging patients right. So again, it's another way that we can.

Unknown Attendee: And the question was, well, what does it look like in your challenging patients, right? So again, it's another way that we can expand the data set in connection to the launch strategy. So I think this is going to be a really great set of information for us at the end of this year.

Expand the data set in connection to the launch strategy. So I think that's going to be a really great.

Set of information for us at the at the end of this year.

Douglas Dylan Tsao: Thank you so much. Next question from Douglas Tsao from HC Wainwright. Your line is open.

Operator next question.

Thank you. So much next question from Douglas Tsao from H C. Wainwright Your line is open.

Douglas Dylan Tsao: Good morning, and thanks for taking the questions. Just maybe a starting point, I'm just curious in terms of, and I say this knowing that it's very early days, but in terms of the hospitals that are now using Alembic, I'm just curious in terms of what you know, how they're doing. So are they stocking it on the shelf? Are they ordering it ahead of cases that they think it will?

Good morning, and thanks for taking my question just maybe just shown important just curious in terms of and I say ask this knowing that it's very early days, but in terms of the hospitals that are now using alembic.

I'm just curious in terms of what you know how they're doing so a de stocking it on the shelf are they ordering yet ahead of cases that they think it would be most appropriate.

Unknown Attendee: Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host. Yeah, great question. And I'll say, let me start with just the stocking, then I'm going to turn it over to Mark, who's been talking with a lot of these physicians that are using it. It depends, right?

And also do you have a sense of which patients that's being used in most is there a particular sort of high risk patient.

Be it age obesity that they're gravitating to more more towards right now.

Yeah, Great question, and I'll say, let me start with just the stocking that I will turn it over to Mark has been talking with a lot of these physicians that are using it.

Unknown Attendee: If they've been using it, and they know they're going to use it in a certain patient population or certain surgery, particularly in ambulatory surgery centers, they're ordering it ahead. But if it's someone that's brand new, and they're beginning, right? We've got it on formulary, and they want to order, then it's not ordered ahead. But I think it's really interesting.

Brand new.

They are beginning right there, we've gotten on formulary and they want to order them.

Then then it's then it's not it's not ordered ahead, but I think it's really interesting we have some ambulatory surgery center physicians that are using it in younger patients than what we originally positioned it and in the inpatient setting. It's a it's more of that challenging patient, but let me let me not feel marks vendor because he's got some really good I think case.

<unk> to describe.

Yes, good morning.

Mark A. Demitrack: So, what we're hearing, let me talk first, sort of expand on what Bob commented on, on the ASV side. One of the things that early on was recognized by clinicians is that the profile of a limbic system lends itself as an analgesic to use throughout the case, from beginning to post-procedure, with the intent of more rapidly moving the patient through the ASC setting. And we've heard that that's working, and clinicians have been quite satisfied with the limbic system's performance in that way.

Okay.

A an analgesic to use throughout the case from beginning to post procedure with the intent of more rapidly.

Moving the patient through the ASC setting and that and we've heard that that's that's working.

Collections have been quite satisfied with the Olympics performance and that way within the inpatient setting I'll give you. An example, one of the.

Mark A. Demitrack: Within the inpatient setting, I'll give you an example. One of the messages that we hear quite consistently is that this is a very attractive option in the setting of the complex patient. And what they tell us is that the respiratory profile, the readily insufficient patient, and the patient at higher risk of postoperative nausea and vomiting are ideal candidates for the use of LinVec. And this is in the setting of, in many instances, we've heard cases of open abdominal procedures, which are very complicated, painful procedures where these risk factors combine to make the case clinically quite challenging.

<unk>.

Messages that we hear quite consistently is that this is a very attractive opt.

Option in the setting of the complex patient and what they what they tell us is that the respiratory profile.

Recently in sufficient patient and the patient at higher risk of postoperative nausea, and vomiting are ideal candidates for the use of Olympic and this is in the setting in many instances we've heard cases of open abdominal procedures, where which are very complicated painful procedures, where these risk factors.

Combined to make the case clinically quite challenging.

Mark A. Demitrack: Another very, very interesting aspect when we hear about inpatient settings, and this comes up quite a bit, is what we heard in the Athena study. Carrie touched on this earlier, and that is that reorientation, the ability for the patient to participate in their own recovery, their level of alertness, and the lack of sedation are one of the most distinguishing characteristics that a clinician notices in the use of a LinVec. And it makes me that much more excited about the idea of digging into this further in the outcome study that we had planned.

Another very very interesting aspect when we hear about the inpatient settings and this comes up.

Quite a bit is what we heard in the Athena study Carrie touched on this earlier and that is that the.

The reorientation the ability for the patient to participate in their own recoveries or level of alertness and the lack of sedation is one of the most distinguishing characteristics that a clinician notices in the use of Olympic and it makes me that much more excited about the idea of digging into this further in the.

Unknown Attendee: Okay, great. And if I can ask, you know, another question just in terms of the formulary approvals that you are getting, are they fairly broad-based right now, or are there being restrictions placed on them?

Some studies that we have planned.

Okay great.

And if I can ask.

Another follow up just in terms of formulary approvals that you are getting are they fairly broad based right now or are there being restrictions placed on them. Thank you.

Unknown Attendee: Thank you.

Unknown Attendee: Oh, I'm sorry. I was on mute.

Yeah.

Okay.

Carrier would you like me to take that.

Unknown Attendee: I'm happy for you to take it, but I had already answered it. Sure. Go ahead. Yeah, even in the...

Oh, I'm, sorry, I was on mute.

For you to take it but I had already answered it.

Sure. So go ahead Brad.

Unknown Attendee: So, we're not actually seeing patient restrictions. We are seeing, in some cases, restrictions where if the physician, a colorectal surgeon, as the one that Mark described, is asking for it, it's restricted for their use. But beyond that, we're not seeing a lot of restrictions on certain patient types. Okay, great. Thank you so much.

Yeah, even in the.

We're not we're not actually seeing patient restrictions, where if we are seeing in some cases restrictions where.

Physician a colorectal surgeon is the one that Mark described is asking for it if it's restricted for their use but beyond that we're not seeing a lot of that.

Restrictions to certain patient types.

Unknown Attendee: Okay, thank you so much. There are no further questions at this time. Carrie, please go ahead.

Okay, great. Thank you so much.

Yeah great.

Great.

Okay. Thank you so much.

There are no further question at this time Gary. Please go ahead.

Carrie L. Bourdow: Well, thank you all. Thank you for your questions.

Well. Thank you all thank you for your questions as you can hear we're pleased by the progress that we've continued to make on the Olympic launch both in terms of increasing our formulary wins and advancing our post approval plan. The fact that we've more than tripled the number of approvals since first quarter, especially given that you.

<unk> environment that we've all had to navigate that such a suggest to us that formulary committees recognized Olympics value and there is a lot to look forward to with data from the first Olympic Post approval study expected by the end of this year continued progress on the launch our IND filing for <unk> 045 this quarter.

T. R V O two seven top line data from the Imperial College and updates on patient enrollment from the two Covid study. So as you can hear there's a lot going on and we look forward to updating you on all of these fronts. As we continue to remain focused on providing innovative medicines for patients and health care professionals and thank you again for joining us that can.

Operator: That does conclude our conference for today. Thank you for participating, and you may all disconnect.

<unk> today's call.

That does conclude our conference for today. Thank you for participating you may all disconnect.

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