Q1 2022 Trevena Inc Earnings Call

Good morning, and welcome to to the Trevino first quarter 2022 earnings conference call all.

Operator: Good morning, and welcome to the Trevena first quarter 2022 earnings conference call. All participants will be in listen-only mode.

All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero. After today's presentation there'll be an opportunity to ask questions. Please note. This event is being recorded I would now like.

Operator: Should you need assistance, please signal conference specialists by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I'd now like to turn the conference over to Barry Shin, Senior Vice President and Chief Financial Officer. Please do so.

To turn the conference over to Barry Shin Senior Vice President and Chief Financial Officer. Please go ahead.

Good morning, and welcome everyone with me today are Terry Bardot, our president and CEO , Patty Drake, our Chief commercial officer, and our Chief Medical Officer Mark demonstrate.

Barry Shin: Good morning and welcome everyone. With me today are Carrie Bourdow, our President and CEO; Patty Drake, our Chief Commercial Officer; and our Chief Medical Officer, Mark Demitrack. As a reminder, lnse inhibitors were approved by the FDA in August 2020 and indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate. The important safety information, including the box warning and the full prescribing information, are all available on Olympic.com.

As a reminder, Olympic was approved by the FDA in August 2020, and indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic after whom alternative treatments are inadequate.

The important safety information, including the box warning in the full prescribing information are all available on Olympic Dotcom.

Barry Shin: I'll remind you that Olinvik is an opioid that is a Schedule II controlled substance with a high potential for abuse similar to other opioids. We will also 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'm now turning the call over to Kerry for an overview of our first quarter of 2022 and recent business accomplishments. Kerry.

I'll remind you that the Lindbergh is an opioid that has a schedule two controlled substance with a high potential for abuse similar to other opioids.

It also will 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 first quarter of 2022 and recent business accomplishments Gary.

Thank you Barry.

Carrie Bourdow: Thank you, Barry. Good morning, everyone, and thanks for joining us. Today we'll provide an update on our refocused efforts for LENVC and updates to our pipeline assets. Let's start with LENVC. From a macro perspective, we are seeing signs that hospitals are opening back up, and things are improving, but it's taking time. Our field sales team is actively engaging burn, colorectal, and anesthesiology-related physicians. And our refocused field strategy is building momentum on the ground.

Morning, everyone and thanks for joining US today, we will provide an update on our refocused efforts for Atlantic and updates to our pipeline assets, let's start with Olympic.

From a macro perspective, we are seeing signs that hospitals are opening back up and things are improving but it's taking time our field sales team is actively engaging burn colorectal and anesthesiology related physician and our refocus field strategy is building momentum on the ground.

Carrie Bourdow: However, at the same time, I want to acknowledge that the launch has been slower than we had expected. We haven't seen the traction as quickly as we would have liked, and engaging inpatient hospital decision makers in the midst of the pandemic has certainly been difficult. I will say that the team has been able to adjust and is refocusing where needed.

However, at the same time I want to acknowledge that the launch has been slower than we had expected we haven't seen the traction as quickly as we would've liked and engaging inpatient hospital decision makers in the midst of the pandemic has certainly been difficult.

I will say that I'm proud that the team has been able to adjust and as refocusing where needed.

Carrie Bourdow: Patty will talk more about a renewed approach that she initiated mid-quarter, and in part, this included moving sales reps over from the contract sales organization to our in-house Trevena team. We do believe this is having a positive impact on helping us to have a better approach to messaging and field execution. On the clinical side, our LENDIC post-approval studies are on track, and our medical science liaisons have now been trained on the exciting new respiratory physiology data.

Patty will talk more about our renewed approach that she initiated mid quarter and in part. This included moving sales reps over from the contract sales organization to our in house Trevino team.

We do believe this is having a positive impact and helping us to have a better approach to messaging and field execution.

On the clinical side Arlinda post approval studies are on track.

Our medical Science liaisons have now been trained on the exciting new respiratory physiology data and we are adding this data to the hospital dossier for formulary Committee reviews.

Carrie Bourdow: And we are adding this data to the hospital dossier for formulary committee reviews. We also plan to present the data at the American Society of Anesthesiologists conference in the fall. And in a few months, we expect to report top-line results from the Allendic Cognitive Study versus IV Morphine, which is a very interesting area for prescribers. At the end of the year, we expect to have results from the Cleveland Clinic Outcomes Study, looking at respiratory, cognitive function, and GI tolerability, all important data we plan to discuss with the formulary committee. Patty and Mark will talk more about our plans for a limbic system later on in the call, but before I turn it over, let me make a few more comments on the pipe.

We also plan to present the data at the American Society of Anesthesiologists conference in the fall.

And in a few months, we expect to report topline results from the Olympic cognitive study versus IV morphine, which is a very interesting area for prescribers.

At the end of the year, we expect to have results from the Cleveland Clinic outcomes study looking at respiratory cognitive function and Gi Tolerability all important data we plan to discuss with formulary committees.

Patti and Mark will talk more about our plans for Olympic later on the call, but before I turn it over let me make a few more comments on the pipeline.

Carrie Bourdow: First, like many of you, we were disappointed that the Data Safety Monitoring Board recently stopped the TRB 027 arm of the ACTIV-4 trial. Just a reminder, the NIH came to us to study TRB 027 in hospitalized COVID patients, and this study was completely funded by NIA. We are looking forward to seeing the complete analyses, and we'll certainly update you as we learn more. For TRV045, our novel S1P receptor modulator, we expect to complete the Phase 1 study by year end.

First like many of you we were disappointed that the data safety monitoring board recently stopped the TRT O. Two seven arm for the active four trial just just a reminder, the NIH came to us to study T. R. V O two seven in hospitalized COVID-19 patients and this study was completely funded by NIH.

We are looking forward to seeing the complete analyses and we'll certainly update you as we learn more.

On T. R V O four five our novel <unk> receptor modulator, we expect to complete phase one study by by year end. We're initially looking at T. R V O four or five as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy.

Carrie Bourdow: We're initially looking at TRV045 as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. This is a large opportunity. Over 25% of diabetic patients have neuropathic pain, and the NIH is studying TRV045 in preclinical models for epilepsy.

This is a large opportunity over 25% of diabetic diabetic patients have neuropathic pain.

And the NIH is studying T. R V O four five in preclinical models for epilepsy.

Patty: We should also have that data in the second half of this year. So we could potentially have two shots on goal to pursue with CRV 045. Lastly, I'm pleased to announce that we received the first non-dilutive $15 million tranche from our financing we reported earlier in the quarter. There is a potential for another $25 million in funding from this deal, including a milestone payment upon the first commercial sale of Olimbic in China. So I know there's a lot to cover, but we'll leave time for questions. But let me turn the call over to Patty to talk more about the Olympic launch. Patty?

Should have that data also in the second half of this year.

So we could potentially have two shots on goal to pursue with the RVO for five.

Lastly, I'm pleased to announce that we received the first non dilutive $15 million tranche from our financing, where we reported earlier in the quarter.

There's a potential for another $25 million in funding from this deal, including a milestone payment upon first commercial sale of Olympic and China.

So I know, there's a lot to cover we'll leave time for questions, but let me turn the call over to Patty to talk more about the Olympic launch Patty.

Patty: Thanks Carrie, and hello everyone. Let me update you on the continued progress that we've made on the commercial strategy that was launched mid-first quarter for Lenvex. I'd like to start off by sharing that we are in the midst of contract negotiations with large hospital group purchasing organizations that represent over 5,000 member hospitals. These contracts will allow for a broadening of access to LINVIC through a top-down approach, which is the first of our three strategic pillars, and we're making headway.

Thanks, Carrie and Hello, everyone. Let me update you on our continued progress that we've made in the commercial strategy that was launched mid first quarter for Olympic.

Patty: Having a contract in place will allow the member hospitals to have access to LINVIC for the key account managers to pull through sales, and we look forward to updating you as these contracts progress. Our second pillar, focusing on core patients, led to 2,500 calls in the first quarter, over half of which were concentrated in the critical care settings of burn, colorectal, and anesthesiology. Despite very difficult access in the first half of the quarter, over 90% of these interactions were conducted in impactful face-to-face forums when access did improve in the latter part of the quarter. We continue to be invited to conduct in-service programs where we educate the entire healthcare team on the use of a limbic system in appropriate patients. In fact, we held 98 in-service programs in the first quarter.

I'd like to start off by sharing that we are in the midst of contract negotiations with large hospital group purchasing organizations that represent over 5000 member hospitals.

These contracts will allow for a broadening of access to Olympic through a top down approach, which is the first of our three strategic pillars.

We're making headway.

Having a contract in place will allow the member hospitals to have access to Linzess for the key account managers to pull through sales.

And we look forward to updating you as these contracts progressed.

Our second pillar focusing on core patient.

It has led to 2500 calls in the first quarter.

Over half of which were concentrated in the critical care settings burn colorectal and anesthesiology.

Despite the very difficult access in the first half of the quarter over 90% of these interactions were conducted and impactful face to face forums when access did improve in the latter part of the quarter.

We continued to be invited to conduct in service programs, where we educate the entire health care team on the use of alembic in appropriate patients.

In fact, we've held 98 in service programs in the first quarter.

I'd like to add that awareness for Linda has increased because of our presence at national Congresses like the anesthesiology asthma Congress.

Patty: I'd like to add that awareness for a limbic system has increased because of our presence at national congresses like the Anesthesiology ASRA Congress, where our Olinfic data was selected as the President's Choice presentation. We attribute the strong execution we are seeing to our Trevena-led customer-facing, which is the third and final element of our strategy. As I've spoken about in the past, what this team is hearing from our customers in these interactions supports our belief that a lymphatic is a particularly compelling option for difficult-to-treat patients like the elderly, obese, and renally impaired. We believe customers appreciate Olenvic's rapid onset of action. The lack of active metabolites enables a predictable analgesic with no dose stacking and a well-characterized safety and tolerability profile.

Where our Olympic data was selected as the President's choice presentation.

We attribute the strong execution, we are seeing to our trevino led customer facing team.

Which is the third and final element of our strategy.

As I've spoken about in the past what this team is hearing from our customers in these interactions support our belief that Olympic is a particularly compelling option for the difficult to treat patients like the elderly obese and renal impaired.

We believe customers appreciate Olympics rapid onset of action.

Lack of active metabolites, which enables a predictable analgesic with no dose stacking.

And a well characterized safety and tolerability profile.

Mark Demitrack: And with that, I'll turn Carl over to Mark. Thank you, Patty. I'd like to begin by highlighting the progress we've made in our Olympic clinical studies. I'm especially excited by the fact that we have begun approaching important data milestones and are now able to share some of the key findings from the investments that we have made in these clinical studies. During our year-end call a few weeks ago, I reported the first of these clinical study milestones with a review of the positive top-line results from the respiratory physiology study led by Dr. Albert DeHaan at Leiden University Medical Center.

And with that I'll turn the call over to Mark Mark.

Thank you Patty.

I'd like to begin by highlighting the progress we've made in our Olympic clinical studies.

I am, especially excited by the fact that we have begun approaching important data milestones and are now able to share some of the key findings from the investments that we've made in these clinical studies.

During our year end call a few weeks ago I reported the first of these clinical study milestones with a review of the positive topline results from the respiratory physiology study led by Dr. Albert to heart at Leiden University Medical Center.

Mark Demitrack: We were pleased with the results of this work, which compared limbic and IV morphine in a head-to-head manner on respiratory function outcomes. The study was conducted in a group of elderly, overweight subjects. Specifically, because we know that older age and increased weight are two of the most important risk factors for the development of respiratory depression when opioids are used in practice. We believe the methods used by Dr. Dahan are a precise way to ask the question. Do these two drugs potentially differ in how they may affect the brain's physiologic regulation of respiratory function in human beings?

We were pleased with the results of this work, which compare to Olympic and IV morphine in a head to head manner on respiratory function outcomes.

The study was conducted in a group of elderly overweight subjects.

Specifically, because we know that older age and increased weight are two of the most important risk factors for the development of respiratory depression, when opioids are used in practice.

We believe the methods used by Dr. Hahn are a precise way to ask the question.

Do these two drugs potentially differ and how they may affect the brain's physiologic regulation of respiratory function in human beings.

The answer from that study is that yes, they support our belief that they differ and results of this study showed a statistically significant difference in respiratory function outcomes.

Mark Demitrack: The answer from that study is that yes, they support our belief that they differ, and the results of the study showed a statistically significant difference in respiratory function outcomes. We believe this study was important because it replicated an earlier study examining the same outcome in younger subjects, while studies like Dr. DeHaan's investigation are not practical to conduct in the post-operative setting.

We believe this study was important because it replicated in earlier study examining the same outcome in younger subjects.

While studies like Dr. Hans investigation are not practical to conduct in the postoperative setting.

Mark Demitrack: The data are nonetheless consistent with the observations that we have reported in the clinical setting in our patient study and thereby strengthen the evidence characterizing the respiratory profile of the lymph. In these studies, we have seen consistently favorable outcomes on indices of respiratory function, such as decreases in oxygen saturation or reductions in respiratory rate, as compared to IV morphine. Despite these findings, it is important to remember that, as with all opioids, serious, life-threatening, or fatal respiratory depression may occur in patients treated with Lindic, as indicated in the boxed warning.

The data are nonetheless, consistent with the observations that we have reported in the clinical setting and our patient studies.

And thereby strengthen the evidenced characterizing the respiratory profile of Olympic.

In these studies, we have seen consistently favorable outcomes on indices of respiratory function such as decreases in oxygen saturation or reductions in respiratory rate as compared to IV morphine.

Despite these findings it is important to remember that as with all opioids serious life threatening or fatal respiratory depression may occur in patients treated with Olympic as indicated in the boxed warning.

The clinical outcomes seen in our patient base studies, where also the precise risk and puts us in our published health economic model.

Mark Demitrack: The clinical outcomes seen in our patient-based studies were also the precise risk inputs used in our published health economic model, demonstrating that the magnitude of these clinical differences is also economically meaningful. In short, we are encouraged by the replication of this respiratory physiology data and look forward to working with Dr. DeHaan's team in reporting this new information in the scientific literature in the coming months. We believe that this data will also be a useful addition to the dossier of technical information used by our medical team to respond to questions from formulary committee members, and we look forward to making progress in those discussions.

Demonstrating that the magnitude of these clinical differences is also economically meaningful.

In short we are encouraged by the replication of this respiratory physiology data and look forward to working with Doctor to Hans team and reporting this new information in the scientific literature in the coming months.

We believe that this data will also be a useful addition to the dossier of technical information used by our medical team to respond to questions from Formulary Committee members and we look forward to making progress in those discussions.

The next upcoming milestone from our clinical investigations is the topline data readout of our cognitive function study.

Mark Demitrack: The next upcoming milestone from our clinical investigations is the top-line data readout from our cognitive function study. As mentioned previously, this study is designed to compare the potential changes in cognitive function in subjects treated with a limbic and IV morphine in a head-to-head study design on a broad array of cognitive performance outcomes including motor coordination, attention, reaction time, memory, and higher order executive function.

I've mentioned previously that this study is designed to compare the potential changes in cognitive function in subjects treated with Olympic and IV morphine in a head to head study design.

On a broad array of cognitive performance outcomes, including motor coordination attention reaction time memory and higher order executive function.

Mark Demitrack: This study is being conducted in partnership with the Netherlands-based Center for Human Drug Research, and we expect initial data from this study to be reported by the middle of this year. Finally, the Volition Trial, which is a clinical outcome study led by Cleveland Clinic's Outcomes Research Department, is our second Olympic study currently in progress. The trial builds on our published clinical data and is evaluating LINVX profile on three important clinical outcomes in the postoperative setting, namely respiratory depression, nausea, and vomiting, and Cognitive Function.

This study is being conducted in partnership with the Netherlands based center for human drug research.

And we expect initial data from this study to be reported by the middle of this year.

Finally, the volition trial, which is the clinical outcome study led by Cleveland Clinic's outcomes Research Department.

Is our second Olympics study currently in progress.

The trial builds on our published clinical data and is evaluating the Olympics profile on three important clinical outcomes in the postoperative setting, namely respiratory depression.

Nausea and vomiting.

And cognitive function.

Mark Demitrack: This project is actively enrolling patients, and we expect top-line data in the second half of 2022. We have also continued to make advances in our early pipeline, in particular with TRV045; our non-opioid selective S1P receptor modulator, which we are developing for the potential treatment of diabetic neuropathic pain. We're on track to complete our Phase I development program for TRV-045 by the end of this year. Importantly, we have continued to make progress with O45 through our collaboration with the NIH's Epilepsy Therapy Screening Program, which has been examining TRV045 in a number of animal models for refractory epilepsy.

This project is actively enrolling patients and we expect topline data in the second half of 2022.

We also have continued to make advances in our early pipeline.

In particular with tier V O four five hour non opioid selective <unk> receptor modulator.

Which we are developing for the potential treatment of diabetic neuropathic pain.

We're on track to complete our phase one development program for T. R. V O 45 by the end of this year.

Importantly, we have continued to make progress with O four five through our collaboration with the NIH is epilepsy therapy screening program.

Which has been examining T O V O four five in a number of animal models for refractory epilepsy.

We expect the NIH to complete this initial phase of work later this summer.

Mark Demitrack: We expect the NIH to complete this initial phase of work later this summer, and based on the outcomes, we will determine whether further investigation of TRV045 for certain epilepsy subtypes should be pursued. We're very excited by the opportunities that we see within our S1P program and in TRV 045 in particular. We believe that TRV045 presents a potentially unique entrant to this pharmacologic class, based on the observed non-clinical study findings of reduced circulating levels of peripheral lymphocytes, and also animal data suggesting a potentially favorable clinical safety profile.

And based on the outcomes, we will determine whether further investigation of TRP, Oh, four or five for certain epilepsy subtypes should be pursued.

We're very excited by the opportunities that we see within our S. One P program and in T. R V O four five in particular.

We believe that <unk> 045 presents a potentially unique entrant to this pharmacologic class base.

Based on the observed non clinical study findings of reduce circulating levels of peripheral lymphocytes and also animal data, suggesting a potentially favorable clinical safety profile.

As you can see our clinical research team has been very active and those efforts are now beginning to bear fruit.

Barry Shin: As you can see, our clinical research team has been very active, and those efforts are now beginning to bear fruit. We look forward to reporting on the upcoming work in the near future. Now, I will now turn the call over to Barry to discuss our financials before we open it up for Q&A.

We look forward to reporting on the upcoming work in the near future. Let me now turn the call over to Barry to discuss our financials before we open it up for Q&A Barry Thanks, Mark.

Barry Shin: Thanks, Mark. In the first quarter, we reported no net sales and $20,000 in license revenue in connection with material we provided to FarmBio, our partner for Olympic in South Korea. Our net loss for the quarter was $16.4 million, or $0.10 per share, compared to $9.8 million, or $0.06 per share, for the same period last year.

In the first quarter, we reported no net sales and $20000 in license revenue in connection with material. We've provided to farm buyout, our partner for Olympic and South Korea.

Our net loss for the quarter was $16 $4 million or <unk> 10 cents per share compared to $9 $8 million or <unk> <unk> per share for the same period last year.

Barry Shin: These changes were mainly due to costs associated with our Lindig launch and product pipeline. We finished the first quarter with $48.7 million in cash and equivalents, which we believe will fund our operations and CapEx into 2023. I note this Q1 cash balance does not include the $15 million tranche from our ex-U.S. royalty-based financing with Arbridge, which we received in April.

These changes were mainly due to costs associated with our Linda launch and product pipeline.

We finished the first quarter was $48 $7 million in cash and equivalents, which we believe will fund our operations and capex into 2023.

I'd note that Q1 cash balance does not include the $15 million tranche from our ex U S royalty based financing with our bridge, which we received in April .

Operator: We expect to receive an additional $15 million tranche on the first commercial sale of Olympic in China and $10 million on a commercial or financing milestone. Related to this, I'd note that we have an upcoming annual meeting with a key proposal to increase the authorized shares. This proposal is vital for shareholders' long-term value and would provide flexibility to execute on business development opportunities, achieve the $10 million non-dilutive tranche from an Arbridge transaction, and Advance Olympic and our product pipeline. We'll now open the call for questions, after which Kerry will provide some closing remarks. Operator.

We expect to receive an additional $15 million tranche on first commercial sale of Olympic and China, and $10 million on the commercial or financing milestone.

Related to this I'd note that we have an upcoming annual meeting with a key proposal to increase the authorized shares.

This proposal is vital for shareholders long term value and would provide flexibility to execute on business development opportunities achieve the $10 million non dilutive tranche from arbitrage transaction.

And eventual then Vic and our product pipeline.

We'll now open the call for questions after which Carey will provide some closing remarks.

Operator.

Operator: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

Thank you we will now begin the question and answer session.

To ask a question you May Press Star then one on your Touchtone phone.

If youre using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.

Operator: To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our office. Our first question comes from Brandon Foulkes from Cantor Fitzgerald. Please go ahead.

At this time, we will pause momentarily to assemble our roster.

Our first question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.

Hi, Thanks for taking my questions and thank you for all the color today on the call.

Brandon Foulkes: Hi, thanks for taking my questions. And thank you for the color today on the call. Can you just help me think about sort of, you know, why accounts aren't ordering Olinvik?

Can you just help me think about sort of why accounts on ordering and then Vic.

My understanding is they were accounts who use the product initially.

It looks like a no longer using it. So I guess is that just driven by formularies Oh. They were moving a product performed very well is it actual user experience and practice and then maybe similarly on the 2500 coals.

No doubt.

Yeah.

Why do we not see sales being pulled through today and then lastly, I guess just a little bit different can you help us think about the Olympic opportunity in China. Thank you.

Great. Thanks, Brandon I appreciate it so let me this is Gary let me start just to clarify that we are seeing orders from physicians and and Reorders from hospitals that came on board.

Brandon Foulkes: My understanding is that there were accounts who used the product initially, but it looks like they are no longer using it. So I guess, is that just driven by formularies? Are they removing a product or formulary? Or is it actual user experience and practice?

And you know I I think that is in part why we are still optimistic right and when we continue to get Olympic in front of a physician's decision makers were hearing that the profile is resonating let me I'll ask Pat to talk a little bit about the 2500 calls and some of the in service programs.

Brandon Foulkes: And then maybe similarly, on those 2500 calls, you called out, you know, Unknown Speaker 33.33, "Why do we not see sales being pulled through there?" And then lastly, I guess it's just a little different. Can you help us think about the Olympic opportunity in China?

Brandon Foulkes: Thank you. Thanks, Brandon. I appreciate it.

Carrie Bourdow: So let me, this is Carrie. Let me start just to clarify that we are seeing orders from physicians and reorders from hospitals that have come on board. And I think that is in part why we are still optimistic, right? And when we continue to get a limbic in front of physicians and decision makers, we're hearing that the profile is responding. Let me ask Patty to talk a little bit about the 2,500 calls and some of the in-service programs. And then I think your third question was about opportunities in China.

And then I think you've got third question was around the opportunity in China Yeah.

Unknown Attendee: Unknown AttendeeYeah, so the 2,500 calls have led to sales. As Carrie mentioned, we have had pull-through sales, we've had reorders, and we've had new orders all in the first quarter. In fact, this quarter was very, very strong by comparison to the fourth quarter.

Yeah. So.

The 2500 calls how have led to sales as Carey mentioned, we have had.

Pull through sales, we've had reorders and we've had new orders all in the first quarter. In fact this quarter was very very strong by comparison to the fourth quarter, yes on a small number.

Unknown Attendee: Yes, it's a small number, but nonetheless, it's quite encouraging. On the in-service programs, keep in mind that we have to be invited in to do those programs. So those 98 in-service educational programs are for the purposes of having the entire staff understand the features, benefits, and limitations of LINVIC and how to identify appropriate patients for the product. So all of those activities are by invitation only. And then I think the third question was around the opportunity in China, so I don't know if you have... And Brendan, as I'm sure you saw, we announced the Arborage financing based in large part on Chinese royalties. Our partner, Nuwa, filed the NDA in January, and while we're not providing guidance, generally 16 to 18 months is how long it takes for approval in China.

But nonetheless, it's quite encouraging.

On the in service programs keep in mind that we have to be invited in to do those programs. So those 98 in service educational programs are for the purposes of having the entire staff understand the features benefits and limitations of the Lindbergh and how to identify appropriate patients for the product. So.

All of those activities are by invitation only.

And then I think the third question was around the opportunity and in China.

And Brennan as I'm sure you saw we announced the average financing.

Based in large part on the Chinese royalties, our partner noir filed the NDA in January and while we're not providing guidance generally 16 to 18 months is how long it takes for approval in China on the Chinese approval and first commercial sale.

Unknown Attendee: On the Chinese approval and first commercial sale, we expect a $15 million trunch from the Arborage financing, as well as a $10 million trunch on a commercial or financing milestone, potentially in the interim, so $25 million in non-dilutive financing based on those royalties. I'd also note that while the financing was based on Chinese royalties, we are also eligible to receive the milestones, including a $3 million milestone from Nuwa on Chinese approval. So there is a lot to look forward to from our Chinese partnership over the next year or so. Great Thanks very much.

We expect a $15 million tranche from the average financing as well as a $10 million tranche on a commercial or financing milestone you know potentially in the in terms of $25 million.

In non dilutive financing based on those those royalties I'd also note that while the financing was based on the Chinese royalties. We are also eligible to receive milestones, including a $3 million of milestones milestone from Noah on Chinese approval. So a lot to look forward to from China.

His partnership over the next year or so.

Great. Thanks, very much and thanks for taking my questions.

Yeah.

The next question comes from Jason Butler from JMP Securities. Please go ahead.

Jason Butler: And thanks for taking my question. The next question comes from Jason Butler from JMP Securities. Please go ahead. Hi, thanks for taking the question. I guess a follow-up question on the demand trends you're seeing is the situation continuing to improve, you know, into the second quarter, i.e., seeing orders and reorders continue to grow? Hey, Jason, it's Carrie.

Hi, Thanks for taking my question.

Just a follow up there on the demand trends Youre seeing is as the situation continuing to improve.

Into the second quarter I have seen the orders and Reorders continue to.

Two to grow.

Hey, Jason It's karri, yeah. So we I think you're hearing this from a lot of folks we certainly saw pandemics or spillover into January or February as Patty said in March was up was frankly are our strongest months still on a small base.

Carrie Bourdow: Yeah, so we, I think you're hearing this from a lot of folks, we certainly saw pandemics or spillover into January, February, as Patty said, March was, frankly, our strongest month still on a small base. But we are starting to see, and we are continuing to see the improvements, the engagement, the activity levels improve. And we have, I think, Patty, over 40 formularies already scheduled between now and the third quarter. So I think that's a really good sign that things are starting to improve. Yeah, I agree.

But we are starting to see and we are continuing to see the improvements the engagement that the activity levels improve.

And and we have I think Patty over 40 formularies already scheduled between between now and into the third quarter. So I think that that's a really good sign that things are starting to improve.

I agree.

Carrie Bourdow: Great. And then, obviously, it's only been a few weeks, but with the new respiratory safety data, have you got any feedback yet from the field or formulary committee on the results? Jason, thanks. This is Mark Demitrack.

Great and then obviously, it's only been a few weeks, but with the new respiratory safety data have you.

Feedback from the field or formulary committee on the on the results.

Mark Demitrack: In the early going, the material is useful. It's new information additive to what was in our technical dossier. And the preliminary interactions that the MSLs are having when asked at the committees and by our KOLs in the field have been positive. So more to come on that as we begin the rollout in the coming weeks. Yeah, let me just add though that there are hospitals that asked to see this data when it was coming out, right? We've been talking about the fact that we've been running this study. And so the MSLs have those hospitals as their first target list.

Jason Thanks This is <unk>.

Mark Denman track.

In the early going the the the material is useful.

It's in new information additive to what was in our technical dossier.

And the interaction and preliminary interactions at the Msos are having when.

When asked.

The committees and by our Kols in the field has been has been positive so more to come on that as we begin the rollout in the coming weeks. Yeah. Let me just add though that there are hospitals that apt to see this data.

When it when it was coming out why we then we'd been talking about the fact that we've been running this study and so the msos have those hospitals as they are first target list. So their billings. So some of the feedback Mark is talking about them and as Patti said, we've been invited back in to have those conversations with some key hospitals. So I think that's encouraging as well.

Carrie Bourdow: So they're going, so some of the feedback Mark's talking about, and as Patty said, we've been invited back in to have those conversations with some key hospitals. So I think that's encouraging as well. Okay, great.

Jason Butler: Thanks for taking the question. Thanks, Jason. The next question comes from Douglas Tsao from H.C. Wainwright. Please go ahead. Hi, good morning.

Okay, great. Thanks for taking my questions.

Thanks, Jason.

The next question comes from Douglas Tsao from H C. Wainwright. Please go ahead.

Douglas Tsao: Thanks for taking the questions. Maybe can you, um, I apologize if I missed it, but I think, you know, we've been targeting 100 formulary rings by year end. And obviously, you know, COVID sort of threw that wrench into that.

Hi, good morning, Thanks for taking the question just maybe can you.

Well, Mike I.

I apologize if I missed it but I think we had been targeting 100 formulary range by year end last year, and obviously COVID-19 sort of through that went into that and I'm. Just curious where you actually are right now in terms of actual 4 million lives.

Unknown Attendee: I'm just curious where you actually are right now in terms of actual formulary rings. Unknown AttendeeYep, thanks, Deb. Yeah, we're at 49 formulary wins.

Yeah. Thanks, Doug Yeah, we're at 49 formulary wins.

And that's in our business is predominantly in patient right. So I know there's a lot of people are counting a lot of different things, we're counting inpatient formulary. So that that's the number and then as I mentioned, we have a 40% are scheduled for the next couple of quarters are actually scheduled meetings. So I think that's a good good metric.

For us to continue to track.

Okay and across the win that you do have.

In terms of use rates I mean is it.

You have a handful of accounts that are ordering I mean, because I know you are talking about some seeing some traction.

And what's happening in the accounts, where the volume just isn't.

What we'd like it to be.

So the patient profile.

<unk> used to expand as you know, we've really focused on burn colorectal and then the open heart surgery patient critical care patient that the anesthesiologists then what we find is that once an institution or a health care provider has experienced with the product they tend to refer to another area and then it.

Unknown Attendee: And that's, you know, our business is predominantly inpatient, right? So I know that a lot of people are counting a lot of different things. We're counting inpatient formulary. So that's, that's the number.

Unknown Attendee: And then, as I mentioned, we have over 40 that are scheduled for the next couple of quarters that are actually scheduled meetings. So I think that's a good, good metric for us to continue to track. Okay, and across the wins that you do have, in terms of use rates, I mean, is it that you have a handful of accounts that are ordering, I mean, because I know you are talking about some things, some traction. What's happening in the accounts where the volume just isn't what you would like it to be?

Unknown Attendee: So the patient profile continues to expand. As you know, we've really focused on burn, colorectal, and then the open heart surgery patient, the critical care patient that the anesthesiologists send. What we find is that once an institution or a healthcare provider has experience with the product, they tend to refer it to another area, and then it expands. So, for example, a colorectal surgeon will tell us to speak to the burn unit because there's a particular interest there.

Span. So for example, colorectal surgeon will tell us to go speak to the burn unit because there's a particular interest there we've seen that before and we believe that that will continue as time progresses.

Unknown Attendee: We've seen that before, and we believe that that will continue as time progresses. The one thing, Doug, I'll say that is different from other hospital launches that I've seen, and I don't know if this is a change that's gonna stay in place, but hospitals and physicians are wanting to try it first. Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena, Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, There are no more questions in the queue.

One thing Doug I'll I'll say that is different from other hospital launches that I and I you know I don't know if this is a change that's going to stay in place, but hospitals physicians are wanting to try it.

First or so then I then I saw him in the past right. It used to be the old days, you can get the drug on formulary it get it in the end. They you know the epic or Cerner systems.

And.

You'd go train you go train the staff as Patty said we.

With formulary committees getting delay we've been training more and more staff and then physicians have been trying to use it in more in small settings right.

While it may have a colorectal surgeon that I'll use a little bit obviously get experience, while we're trying to wait for it to get on formulary. So it's been a little difficult for us to track the volume from that perspective as.

As you know we're getting in orders with the idea that you're going to get it on formulary.

A couple of cases early on where the drug got on formulary and began to get used in a lot of different places, that's where we're seeing a lot of their reorders does that help give you a little bit more color.

Okay.

Okay.

There are no more questions in the queue. This concludes our question and answer session.

Unknown Attendee: This concludes our question and answer session. I'd like to turn the conference back over to Kerry Bourdow for any closing remarks. Great, thank you all for your questions. We believe we are well positioned in 2022 to build on the Alembic commercial launch strategy.

Like to turn the conference back over to Cary Bourdieu for any closing remarks.

Great. Thank you all for your questions. We believe we are well positioned in 2022 to build on on the <unk> commercial launch strategy. We're looking forward to the additional data readouts that we have this year for Linda can also the pipeline just a quick recap of some of the key upcoming data events.

Carrie Bourdow: We're looking forward to the additional data readouts that we have this year for Alembic and also the pipeline. Just a quick recap of some of the key upcoming data events. Mid-year, we're expecting data on limbic versus IV morphine cognitive function. By year end, the Alembic Outcome Study from Cleveland Clinic, looking at respiratory, cognition, and GI tolerability. Also by year end, the Phase 1 TRV045 trial in diabetic neuropathic pain.

Operator: And in the second half, NIH TRV045 animal data on epilepsy. So there's a lot going on. We'll provide you with additional updates throughout the year. And thank you again for joining us today. Operator, that concludes the call.

Mid year, we're expecting Olympic versus IV morphine cognitive function data.

By year end the Olympic outcome study from Cleveland Clinic looking at respiratory cognition in Gi Tolerability also by year end the phase one T. R. B O four five in diabetic neuropathic pain and.

And in the second half DNI H T. R V O four five animal data in epilepsy. So theres a lot going on will provide you with additional updates throughout the year and thank you again for joining us today, operator that concludes the call.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect, home, Tommy Wiseau, Fatty Ahni, Marvin Brown Nat, Richard Magna, Mel Benson, Jack Jensen, Lewis Cyrus, Daniel Frazer, Alice Shigler, Tina Tisto, Roy Arrington, Andy Serum, Mark Bommack Mitchell, Nic Dabillet, Ben Sligert, Todd Harvey, Michelle Hi, giving our good, honorable address to our fellow educators, Mr. Thank you all for listening. (inaudible).

Okay.

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Hmm.

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Unknown Attendee: .. ... Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Jason Butler, Douglas Tsao, Unknown Attendee, Barry Shin, Trevena Inc Unknown Attendee, Barry Shin, Jason Butler, Douglas Tsao, Unknown Attendee, Barry Shin, Trevena Inc, www www. DoubleAid.com

Yeah.

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