Q1 2020 Earnings Call
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Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Trevena Inc. First Quarter Earnings 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. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star 0. I would now like to hand the conference over to your speaker today, Mr. Bob Yoder.
On your telephone please be advised to today's conference is being recorded.
If you require any further assistance please press star zero.
I'd now like to handle conference over to your speaker today, Mr., Bob Yoder Chief business Officer. Thank you. Please go ahead Sir.
Good morning, and welcome everyone. Thank you for joining us on this morning's call.
Bob Yoder: Good morning and welcome everyone. Thank you for joining us on this morning's call. With me today are Kerry Bourdow, our President and CEO, Mark Demitrack, our Chief Medical Officer, and Barry Shin, our Chief Financial Officer. Before we begin, we wish to inform participants that we will be making forward-looking statements on this call, which are made pursuant to the Safe Harbor Provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that forward-looking statements involve risks and uncertainties, including risks detailed from time to time in the company's periodic reports, followed by the securities exchange, and we undertake no obligation to update these statements beyond today. On today's call, Kerry will give some opening remarks on our progress with Oliceride, and I'll provide an overview of our commercial launch strategy. Mark will then provide some additional details on our ongoing pipeline activities, and Barry will review our financial results, followed by some time for questions. I'll now turn the call over to Carrie.
With me today or carry Bordeaux, our president and CEO.
Work Democrat or Chief Medical Officer, Bearish in our Chief Financial Officer.
For the good.
With the poor participant that we'll be making forward looking statements on this call, which are made pursuant to the safe Harbor provision of the private Securities Litigation Reform Act of 1995.
Youre cautioned that forward looking statements involve risks and uncertainties, including with detailed from time to find the company periodic reports filed with the Securities Exchange Commission.
We undertake no obligation to update you statements beyond today.
Were they call Kerry will give some opening remarks on our progress all Saturday and I'll provide an overview our commercial launch strategy.
Work that provides additional details on our ongoing pipeline activity. It very well review our financial results followed by the time for questions.
I'll now turn the call over to carry.
Thank you Bob.
Carrie L. Bourdow: Thank you, Bob. Good morning, everyone.
Morning, everyone. Thank you for joining us today I hope that a you and your families are staying safe during the some precedent in challenging times.
Carrie L. Bourdow: Thank you for joining us today. I hope that you and your families are staying safe during these unprecedented and challenging times. I'd like to open the call this morning by extending my many thanks to the healthcare professionals, our employees, and our business partners who help us move forward in our commitment to patients. Like a lot of you, we're watching the COVID situation closely. And while our priority, of course, is the health and safety of our employees and our communities, I'm also very grateful that we've been able to remain resilient and focused on business continuity.
I'd like to open the call. This morning by extending my many thanks to the health care professionals, our employees and our business partners to help us move forward in our commitment to patients.
Like a lot of you were watching the cobot situation closely and while our priority of course is on the health and safety of our employees and our communities I'm also very grateful that we've been able to remain resilient and focused on business continuity.
And to that end, let me provide a few highlights on our lead asset idealists everything as you. All know we have a PDUFA date for all the 13 of August 7th and it's clear to US that the agency is active in the review of our Resubmission I'm very pleased with a with ft A's engagement and we expect ft. A's review of our application to continue on track.
Carrie L. Bourdow: And to that end, let me provide a few highlights on our lead asset, IV oloceridine. As you all know, we have a PDUFA date for oloceridine on August 7th. And it's clear to us that the agency is active in the review of our resubmission. I'm very pleased with FDA's engagement. And we expect FDA's review of our application to continue on track. We're looking forward to receiving their decision in August. At the same time, we're working to ensure that, after approval and DEA scheduling, we can make oloceridine available to hospitals and health care providers in the fourth quarter of this year. Our commercial manufacturing facilities, which are located in the U.S., are manufacturing the drug product, as we see here. We are also actively investigating collaborations and strategic partnerships to support the U.S. commercial launch of Oliceridine, and our current ex-U.S. partners are making progress on their regulatory timelines. Our top priority is getting oloceridine to acute pain patients, and we're exploring all options to help us maximize shareholder value as we do this. So now, I will turn the call over to Bob, who will go into more detail on our U.S. commercial strategy.
Back we're looking forward to receiving their decision in August.
At the same time, we're working to ensure that after approval and D.A. scheduling we can make all the 13 available to hospitals and health care providers in the fourth quarter of this year.
Our commercial manufacturing facilities, which are located in the U.S., our manufacturing drug product as we speak.
We're also actively investigating collaborations and strategic partnerships to support the U.S. commercial launch of wireless everything in our current X U.S. partners are making progress on their regulatory timelines.
Our top priority is getting over 30 into acute pain patients and we're exploring all options to help us maximize shareholder value as we do this.
So now let me turn the call over to Bob who go into more detail on our U.S. commercial strategy Bob.
Thank you very well this is certainly an exciting time for us as we continue preparations for the commercial launch of austerity either by ourselves with a partner.
Bob Yoder: Thank you, Kerry. Well, this is certainly an exciting time for us as we continue preparations for the commercial launch of Olasterity, either by ourselves or with a partner. As you'll hear me lay out, our strategy is built around focus and efficiency, targeting the right patient population, position specialties, and accounts in order to facilitate initial updates. The market opportunity is large, with approximately 45 million patients each year who receive drugs like ibuprofen for acute pain. Additionally, the overall size of the market in terms of units sold has remained relatively stable over the last 18 months. Suggesting that potent analgesics such as ibuprofen are still needed in the hospital setting. Unknown Attendee, Barry Shin, Trevena Inc., When compared to IV morphine
As you'll hear me layout, our strategy is built around focused and efficiency.
Operator: Transcribed by https://otter.ai
Targeting the right patient population physician specialties and account in order to facilitate initial uptake.
The market opportunity is large with approximately 45 million patients each year, who received drugs like I'd be morphine for acute pain.
Additionally, the overall size of the market in terms of you sold has remained relatively stable over the last 18 months.
Adjusting that potent analgesics, such as I'd be morphine are still needed in the hospital setting.
Product profile will certainly when compared [noise].
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We could excuse me when compared to I'd be Murphy.
[laughter].
[laughter].
Its differentiated in a number of key area.
Bob Yoder: is differentiated in a number of key areas. Unlike morphine, whole serine has a fast onset of two to five minutes and no known active metabolites.
Unlike morphine all serving as a fast onset of two to five minutes no known active metabolite.
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Unknown Attendee: Unknown Attendee.
HM we may have be having technical difficulties sounds like a.
Unknown Attendee: We may be having technical difficulties, it sounds like. Oh, I'm sorry about that. That's okay.
Hi, Bob.
That's okay, Bobby <unk>, South Carolina allergies kicking in go [laughter], though not exactly.
Unknown Attendee: Unknown Attendee That's okay, Bob. South Carolina allergies are kickin' in. Go ahead.
Unknown Attendee: Unknown Attendee Yeah, but no known active metabolites. Unknown AttendeeExcuse me, and no dosage adjustment needed in elderly or renally impaired patients. All this fairing offers a compelling set of attributes that address the unmet need that still remains in both the inpatient and outpatient setting. We know that roughly 20% of the overall hospital patient population is considered high risk for adverse effects, including patients with certain comorbidities, obese patients, those with renal impairment, and the elderly. We refer to this subset as our core population.
Yeah, no dose adjustment needed an elderly renally impaired page.
Oh asserting offers a compelling set of attributes that address unmet need that's you'll need to both inpatient and outpatient setting.
We know that roughly 20% or the overall hospital patient population or considered high risk for adverse effects, including patients were certain co morbidities obese patients those would renal impairment and the elderly.
We refer to the success our core patients.
Conditions continue to face particular challenges effectively and safely treating these patients.
Bob Yoder: Physicians continue to face particular challenges in effectively and safely treating these patients, and those challenges have unfortunately been highlighted by the ongoing pandemic. In Acena, our open-world real-world safety study published last year, we studied many of these high-risk patients across a range of surgical studies. In fact, 30% of patients were over the age of 65, and 50% were clinically obese.
And those challenges have unfortunately been highlighted by the ongoing and then it.
It was via our open <unk> real World Safety study published last year. We studied many of these high with patients across a range of surgical setting.
In fact.
30% of patients were over the age of 65, and 50% were clinically obese.
You may recall during our last earnings call. The March Dr., Tim Beard, colorectal surgeons practicing in Oregon described patient types very similar to those we studied.
Bob Yoder: You may recall during our last earnings call in March, Dr. Tim Beard, a colorectal surgeon practicing in Oregon, described patient types very similar to those we studied who he felt might benefit from a drug such as Olifanterin. Our launch strategy is focus and target. Core patients I described earlier will be our initial focus as those patients currently present the greatest difficulty in pain management. We also plan to concentrate initially on a subset of physician specialties, anesthesiologist, colorectal, orthopedic, and cardiothoracic surgery. These specialties have a high volume of procedures in which multimodal pain management protocols frequently require drugs such as IV morphine. They are also treating a high number of our core or high-risk patients. Finally, we plan to focus on a subset of hospitals and outpatient surgery centers that have demonstrated early adoption of other Bradenton agents in the past.
Who he felt might benefit from the drugs such as old finnerty.
Our launch strategy is focused and target.
The Corporation I described earlier will be our initial focus those patients currently for the greatest difficulty in 10 minutes.
We also plan to concentrate initially on a subset of physician specialties.
See I would you.
Colorectal orthopedic and cardio thoracic surgeons.
He specialties have a high volume of procedures in which multi modal pain management.
Protocols, we could we acquired drugs such as I'd be morphine.
[laughter], there's also treating a high number of our core or high risk patients.
Finally, we play to focus on a subset of hospitals and outpatient surgery centers that have demonstrated early adoption of other bridget agents in the past.
Of course, we're closely monitoring the impact of the current endemic and how that could change our thinking about our commercialization strategy.
Bob Yoder: Of course, we're closely monitoring the impact of the current pandemic and how that could change our thinking about our commercialization strategy. But we continue to hear about high-risk patients. The challenges these patients present in effective pain management and the growing pent-up demand created by pauses in procedures considered to be elective surgeries and exacerbated by the current shortage of drugs like ibuprofen. In closing, we're taking an approach to commercialization that is all about, The Right Group of Patients Treated by a Targeted Subset of Physician Specialties and within a group of hospitals and surgery centers where we believe the potential for Let me now turn the call over to Mark to provide some additional details on our pipeline.
But we continue to hear about high risk patients.
The challenges these patients present and accepted pain management.
And the growing pent up demand treated by pauses in procedures considered to be elective surgeries and exacerbated by the courage sort of deposits like I'd be more free.
In closing, we're taking that approach to commercialization that all about focus.
Group of patients treated by a targeted subset of physician specialties.
But then a group of hospitals in surgery Center, where we believe the potential for almost there is significant.
Let me now turn the call over to Mark provide some additional details on our pipeline activities.
Thank you Bob.
Mark A. Demitrack: Thank you, Bob. Let me start with some additional comments that we all have.
Let me start with some additional comments and also do.
I'm pleased to report that we've continued to add to the body of peer reviewed literature, which is important elements supporting the launch strategy that Bob just outlined.
Mark A. Demitrack: I'm pleased to report that we've continued to add to the body of peer-reviewed literature, which is an important element supporting the launch strategy that Bob just outlined. We recently announced the publication of a comprehensive review of the non-clinical and clinical data for older Saturdays. In addition, I'd like to highlight the online publication of a poster in association with this year's ASRA meeting. The poster is titled, Low Incidence of Opioid-Induced Respiratory Depression in High-Risk, Elderly, and Obese Patients. This report summarizes the findings of a post-hoc analysis of data from the APHEMAS study. We compared the incidence of clinical indices of respiratory depression across two patient subpopulations in that study, those considered high-risk and those considered low-risk. High-risk patients were those individuals who were over 65 years old and had a BMI greater than 30.
We recently announced the publication of a comprehensive review of the Nonclinical and clinical data for older Saturday.
In addition, I'd like to highlight the online publication of a poster in association with this year's asked from either.
The poster is probably the right incidents.
Well opioid induced respiratory depression.
Risk overly obese patients.
Just report summarizes the findings of a post hoc analysis of data from the Athena study.
It could there be incidents of clinical indices respiratory depression across two patient sub populations in that study.
That was considered high risk.
And those considered low risk.
I was patients with those individuals who are over 65 years old.
And how to be a much greater than 30 as Bob mentioned earlier these patients where a large proposed kind of the study population.
Mark A. Demitrack: As Bob mentioned earlier, these patients were a large proportion of the study population, those younger than 65 with a BMI less than 30. The results were very interesting to us. The incidence of respiratory depression was similar in both groups, despite the high-risk group being defined by two characteristics known to raise the risk of respiratory complications during treatment with conventional medications like IV morphine.
Lowest patients were defined does the opposite.
It was younger than 65 with a B.M.I. lesson 30.
The results were very interesting to us.
The incidence of respiratory depression was similar in both groups. Despite the high risk group being defined by two characteristics known to raise the rest of respiratory complications.
During treatment ventral medications like I'd be morphine.
These are consistent with feedback we receive from investigators during the Athena study on their assessment of all the serbians distinctive clinical profile.
Mark A. Demitrack: These data are consistent with feedback we received from investigators during the Athena study on their assessment of oloceridine's distinctive clinical profile. These data will serve as an important point of departure for our thinking about future research. Beyond Faraday, we continue to make good progress with our pipeline. For example, POV 045, our novel S1P receptor modulator.
These data will serve as an important part of his departure for our thinking about future research.
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Beyond that what Saturday, we continue to make good progress with our pipeline.
For TV or four or five our novel S. One p. receptor modulator.
Our collaboration with NIH is ongoing and productive.
Mark A. Demitrack: Our collaboration with NIH is ongoing and productive. They've initiated the first round of non-clinical studies in their epilepsy screening program, and we look forward to reporting on that work in the future. We announced this morning that NIH plans to begin evaluating TRV045 within another screening program, this one designed to study novel, non-addictive treatments for pain. This program is based on the Long-Standing Epilepsy Screening Program, which is viewed as a highly successful partnership model and also features a rigorous evaluation process for entry. The program includes assays and models of acute, inflammatory, and neuropathic pain, all of which are funded by NIH. The fact that TRV045 has received such interest from NIH, I believe, speaks to its exciting promise as a novel approach to treating a variety of CNS disorders.
We have initiated the first round of Nonclinical studies in their epilepsy screening program.
And we look forward to reporting on that work in the future.
Most of two announced this morning, but NIH grants to begin evaluating TRP O four or five within another screening program. This was designed to study novel non addictive treatments for pain.
This program is based on the long standing epilepsy screening program, which is viewed as a highly successful partnership model.
And also features a rigorous evaluation process for entry.
The program includes assays in models of acute inflammatory and neuropathic pain.
All of which were funded by NIH.
The fact that CRV O four or five has received such interest from NIH I believe speaks to its exciting promise as a novel approach to treating a variety of CNS disorders.
I look forward to working closely with NIH to further explore the therapeutic potential Sasha.
Mark A. Demitrack: I look forward to working closely with NIH to further explore the therapeutic potential of this asset. In parallel with these activities, we continue to make progress on our own IND enabling work with this compound. And I'm very pleased to announce that we're now planning on filing an IND application for TRV 045 in the first half of 2021. I'd now like to turn it over to Barry for a review of our 2.1 financials. Barry? Thanks, Mark.
In parallel with these activities, we continue to make progress on our own I envy, enabling work with this compound.
And I'm very pleased to announce that we're now planning on filing and I and the application for TRP O four or five in the first half of 2021.
I'd now like to turn it over to battery.
For a review of our Q1 financials sorry.
Thanks Mark.
We issued a press release and filed a form 10-Q with a full financial result.
Barry Shin: We issued a press release and filed a Form 10-Q with our full financial results. For now, I'll summarize the headline numbers. For the first quarter of 2020, we had a net loss of $5.7 million, or six cents per share, compared to $5.2 million, or $0.06 per share, for the first quarter of 2019. This increase in net loss is mainly due to higher R&D expenses associated with the TRV-250 acute migraine precoconcept study and activities to support the NDA resubmission for old authorities.
Now I'll summarize the headline numbers.
For the first quarter of 2020, you had a net loss of $5.7 million or six cents per share.
Compared to $5.2 million or six cents per share for the first quarter of 2019.
This increase in net loss is mainly due to higher R&D expenses associated with a t. RV too picky acute migraine proof of concept study and activities to support you Andy we submission for old authority.
As of March 31st 2020, we had cash and cash equivalent of $20.1 billion, which reflects the full repayment of our term loan on March thing.
Barry Shin: As of March 31, 2020, we had cash and cash equivalents of $28.1 million, which reflects the full repayment of our term loan on March 2. We continue to expect that this amount will fund our operations and capital expenditures into the first quarter of 2021, including the expected approval of Oliceridine in August and post-approval activities to ensure Oliceridine is commercially available in the fourth quarter of 2020.
We continue to expect but this amount will fund our operations and capital expenditures into the first quarter of 2021.
This includes the expected approval of all the parity in August and post approval activities to ensure older 30 minutes commercially available in the fourth quarter 2020.
Well now open the call for questions after which carry will provide some closing remarks.
Operator: We'll now open the call for questions, after which Carrie will provide some closing remarks. Rachel? Thank you. Bye-bye. Bye-bye. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by; we'll be compiling the Q&A room. Your first question comes from the line of Jason Butler. You may begin.
Rachel.
I tell you really baked.
As a reminder to ask a question you will need to press star one on your telephone to be draw your question breast it pound or hashed.
Please standby won't be compiled acuity roster.
Your first question comes from the line of it Jason Butler you may begin.
For taking the questions.
Jason Nicholas Butler: for taking the questions. First one on oliferidine, can you just give us any color around manufacturing inspection? Did you have a pre-approval inspection during the first cycle NDA review? And do you expect any additional inspections to be needed by FDA before your PDUFA date?
First one on all the 13.
Just can you.
It was any color around manufacturing inspection did you have a pre approval inspection during the first cycle and be a review and do you expect any additional inspections that to be needed by the a before before your PDUFA date.
Good morning, Jason Thanks for that thing for the question. We did not have previously a and inspection, but the so I mentioned the sites or <unk> or in the U.S., the API and drug products I turn the U.S., which which we think is a good thing and and they haven't been inspected last year for other products didn't have it.
Carrie L. Bourdow: Morning, Jason. Thanks for the question. We did not have an inspection before, but as I mentioned, the sites are in the US, the API and drug product sites are in the US, which we think is a good thing. And, and they were inspected last year for other products and didn't have any issues, no 483. So we're not anticipating manufacturing is going to be a problem at all for us.
Any issues no for 83, so we're not anticipating manufacturing is is gonna be problem at all for us.
Okay great.
Jason Nicholas Butler: Okay, great. You ran through some of the patients you're targeting, but the high risk for adverse events and the physician positions as well. As you think about, you know, the beginning of the resumption of elective procedures, where's the overlap? And how do you think about the dynamics of which procedures could ramp up sooner and where we could see a prolonged postponement of procedures? And ultimately, are you looking to refocus any of your launch strategy in response to these dynamics? Thanks.
You ran through some of the patient.
You are targeting but not the high risk adverse events and the physician 'cause issues as well as you think about you know the beginning of a resumption of elective procedures, whereas the overlapping and how do you think that the dynamics of which procedures could ramp sooner and where we could see a prolonged postponing Uh huh.
Procedures and ultimately are you looking to refocus any of your loan strategy in response to.
These dynamics thanks.
Yeah, So I'll, let Bob Bob addresses that let me just say that we're talking with a lot of our key opinion leaders across the country and it's not necessarily which procedures may may start kicking in senior it's it's really a base based on geography in some cases.
Carrie L. Bourdow: Yeah, so I'll let Bob address this, but let me just say that we're talking with a lot of our key opinion leaders across the country, and it's not necessarily which procedures may start kicking in sooner. It's really based on geography in some cases.
You know our core areas as Bob mentioned cardio thoracic colorectal orthopedic certainly cardio thoracic. We believe we'll we'll start a you know happening sooner and of course like everyone or sort of thinking through what our launch strategy will look like let me just brag on Bob really quickly before I turn it over so one of the reasons.
Bob Yoder: You know, our core areas, as Bob mentioned, cardiothoracic, colorectal, orthopedic, certainly cardiothoracic, we believe will start happening sooner. And, of course, like everyone, we're sort of thinking through what our launch strategy will look like. Let me just brag on Bob really quickly before I turn it over. So one of the reasons we asked Bob to join Trevena is that he has a lot of experience in non-personal promotion launches, launches with more of a digital focus. I think that's going to serve us well when we sort of think through our launch strategy. But, Bob, any additional comments?
We had a we ask Bob to join Interveners that he has a lot of experience and a non personal promotion launches lunching with a more of a digital focus I think that's going to serve us well and we sort of think through our lunch strategy, but Bob any any additional comments.
Bob Yoder: Sure, yeah. Hi Jason, thanks for the question. So one thing I'd say about the procedures piece is the things I'm reading, at least as elective procedures that were paused or canceled, are coming back online. What I've been reading is that the patient type that they're looking to prioritize are typically those higher-risk patients because, oftentimes, that profile just gets riskier with time. So they're trying to push those high-risk patients to the front of the queue as those procedures come back.
Sure Yeah, Hi, Jason Thanks for the question. So one thing I'd say about the procedures piece of it is the things I'm reading at least they as procedure as an elective procedures that were paused or cancelled or coming back online.
I've been reading is that the patient type that they're looking to prioritize our typically those high risk patients because often times that profile just gets riskier with time, so they're trying to in many cases push those high risk patients to their front of the Q as those procedures come back.
Around the strategies, obviously, we're watching very closely what what the pandemic is doing to HCP engagement.
Bob Yoder: Around the strategies, obviously, you know, we're watching very closely what the pandemic is doing to HPP engagement. In this case, I think the early trends seem to suggest that physicians are engaging remotely a little more. They're more open to that now. Digital channels are getting more robust as well. So I think overall, an effective engagement for the future, one we're going to be thinking about is likely, you know, the flexibility to dial up or dial back a wider array of channels. Digital channels, non-personal promotion, things like that. Certainly until we see what happens with traditional face-to-face access with HCPs over time. But we definitely are going to keep an eye out and think creatively about how we're going to engage with HCPs and what I guess will be the new normal going forward.
In this case I think the early trends seem to suggest that physicians are engaging remotely a little more they're open to that more digital channels are getting more robust as well.
So I think overall and effective engaged on the future one we're gonna be thinking about is likely.
The flexibility to dial up or dialed back the wider array of channels digital channels non personal promotion things like that I'm certainly until we see what so what will happen with so the traditional face to face access where they see pease overtime, but we definitely are going to keep an eye out and think creatively about how we can engage with.
CP than the in what I guess will be the new normal going forward.
Great and then just one more for me on four or five obviously your work being done in H. Ah, but can you discuss or point to any additional preclinical work that but you guys need to do in house to support the eye and be filing in the first half next year. Thanks, Yeah. Thanks, Jason Mark.
Jason Nicholas Butler: Great, and then just one more for me on 045, obviously the work being done at NIH, but can you discuss or point to any additional preclinical work that you guys need to do in-house to support the IND filing in the first half of next year?
Mark A. Demitrack: Yeah, thanks, Jason. Mark, Mark, do you want to talk a little bit about the fire?
Mark you want to talk a little bit of if I'm sure five.
Sure Jason.
Mark A. Demitrack: Sure, Jason. So, our burden of activity really revolves around much of the conventional components of any IND that would need to be assembled. So, we'd obviously have to proceed with the necessary toxicology work and the manufacturing readiness that we need for the formulation that we would bring into human use. So, those programs are proceeding, as I mentioned, on plan at this time.
So our Oh, hi burden of activity really revolves around a much of the conventional components of any idea that would need to be assembled so we'd have to proceed.
With the necessary Tox work and the manufacturing readiness and that we need for the formulation that we would bring into human use. So those programs are proceeding as I mentioned are on plan at this time.
Okay, great. Thanks for taking the questions.
Jason Nicholas Butler: Okay, great. Thanks for taking the questions. Thanks, Jason.
Operator: Thanks, Jason. Any other questions, Operator? Rachel?
Thanks, Jason.
The other questions operator Rachel.
Your next question comes from the line of Douglas Child, You May ask your question.
Douglas Dylan Tsao: Your next question comes from the line of Douglas Tsao. You may ask your question.
Morning, Doug I'm, sorry, sorry about that have you done okay.
Douglas Dylan Tsao: Morning, Doug. Oops, sorry.
Douglas Dylan Tsao: All right, sorry about that. I had you down. Good morning. Just maybe I'd touch on a little bit, you know, and obviously you've spoken about sort of some of the delays and sort of the backlog and elective procedures. Just sort of in the context of the shortages that seem to be taking place for a lot of IV pain medications, just given the demands placed on hospitals because of COVID, and does that affect your launch strategy in any way?
Good morning, just you maybe first touch on I'm, a little bit you know and obviously you've spoken about sort of some of the delays and sort of the backlog in an elective procedures.
Just you just heard of the context of the shortages that seem to be taking place for a lot of Ivy pain medications, just given the demand.
Based on hospitals, because of Covidien and and does that affect your launch strategy in anyway, and then also and I and I might've missed it a lot going on in the household [laughter] I'm just in terms of the pause for CRV to 50 and when you my.
Carrie L. Bourdow: And then also, and I might have missed this, Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host of the Goldstein on Gelt radio show. He is a licensed financial professional both in the U.S. and Israel. Securities offered through Portfolio Resources Group, Inc., Member FINRA, SIPC, MSRB, NFA, SIFMA. Accounts held by National Financial Services, LLC. Member NYSE & SIPC, a Fidelity Investments company. His book Building Wealth in Israel is available in bookstores, on the web, or can be ordered at www.profile-financial.com.
He able to get that started again.
Yeah. So I'll, let me, let me handle that first and then I'll turn into question over to Bob around some of our additional commercial strategy. So on T. every 250 as you mentioned, it's a we are on pause that study is being conducted in the UK and you don't like everyone, we're sort of watching and having conversations with the Clint.
Carrie L. Bourdow: Yeah, so let me handle that first, and then I'll turn the question over to Bob about some of our additional commercial strategies. So on TRV-250, as you mentioned, we are on pause. That study is being conducted in the UK, and like everyone, we're sort of watching and having conversations with the clinical site in the UK. So as soon as they feel comfortable enough to get moving again, we'll be doing that. But we don't have any additional guidance on that. We removed the timing guidance on TRV-250.
Michael side in the UK. So as soon as Ah you know they feel comfortable to a two to get moving again, we don't.
Yeah, we'll be doing that but we don't have any additional guidance on that Oh, we removed the a the tightening guidance on T.V. 250, but we are having on active conversations with the clinical site. So it's good.
Carrie L. Bourdow: But we are having active conversations with the clinical site, so it's good. Bob, I know you talked a little bit about the commercial strategy for COVID and COVID patients, but you know, any other additional comments you want to make? Certainly, with the focus around high-risk patients and COVID, you know; we've always been focused on high-risk patients, but there's a heightened sensitivity to, you know, what happens when those patients get sick in the hospital. So, Bob, I don't know if you want to talk a little bit more about that.
Bobby <unk> I know you talked a little bit about the commercial strategy in Covidien 'cause it patience, but you know any other additional comments you want to make up certainly with.
The focus around high risk patients and Kobe that yeah, we've always been focused in high risk patients, but oh, there's a heightened sensitivity of Ah you know what happens when those patients get sick in in the hospital. So I don't know if you want to talk a little bit more about that.
Yeah, I mean I Doug.
Bob Yoder: Yeah, I mean, hi, Doug. I mean, I think you're right.
I mean epic you're ready to pointing out definitely that's the there's many unfortunate things around the pandemic and certainly one of them is acquisitions of grill I've seen we've all seen now that these high risk patients present, a lot of challenges and clinical management.
Bob Yoder: You're definitely pointing out that there are many unfortunate things around the pandemic, and certainly one of them is that physicians have realized, I've seen, we've all seen now that these high-risk patients present a lot of challenges in clinical management. Specifically to your question around the shortage, too, I mean, I think, you know, there was some data out there publicly from Vizians that talked about, at least within March, maybe the first part of April even, that there was a pretty significant shortage. I think still rates were hovering in the 70% range for IV opioids, driven, I think, a lot by use in, you know, COVID patients, and intubated patients. But the other impact of that is that that leaves less available for, you know, use where it's traditionally used in post-surgical moderate acute pain, moderate severe pain. So, I mean, I think, I don't know, beyond what I said before, Doug, in terms of change, our strategy is certainly Unknown Attendee, Barry Shin, Trevena Inc.
Specific to your question around the shortest too I mean, I think you know there were some data out there are public people busy into talked about.
We stood at March maybe the first part of April even that yes. There was there a pretty significant shortage I think fill rates were hovering in the 70% range for IB opioids, driven I think a lot I use.
Token patients integrated patients but.
The other impacted added that that leaves that's available for use in what is typically use and postsurgical modern acute.
Paint moderate severe pain, so I mean, but I don't know beyond what I said before Doug it's always a cheaper strategy certainly.
Heightens, our urgency to.
Be prepared for a really successful launch and get the product out there. So that's compelling profile can isn't the ends of our position today from users. They worked indicated where they see fit.
And yeah, Yeah, maybe it is like it is a follow up I know, it's still obviously very early days and and you should have limited in what you can do in terms of gauging with clinicians at this point, but just curious if you've gotten feedback from people sort of anxious to get it because obviously I think.
Douglas Dylan Tsao: And, you know, maybe as a follow-up, I know it's still obviously very early days, and you're sort of limited in what you can do in terms of gauging with clinicians at this point, but just curious if you've gotten feedback from people sort of anxious to get it, because obviously, I think..., you know, COVID.
Douglas Dylan Tsao: [inaudible]
You know co bid.
The covenant team a crisis is really shouldn't exposed to vulnerability of the American health care system from a capacity standpoint, you gotten feedback that you know sort of greater interest in all the Saturday because that's certainly one of the attributes of the product is really just sort of help improve efficiency of the system, which perhaps I think Republic.
Took for granted before you know this this too.
Sure It took place.
Yeah, It's a it's a really good point I think we've talked before about the in particular, the investigators that were involved in Athena.
Carrie L. Bourdow: Yeah, it's a really good point. I think we've talked before about the, in particular, the investigators that were involved in Athena are interested in getting oloceridine, having oloceridine as an alternative. We're three months away from the PDUFA date, so I think that's, you know, they're excited about that potential opportunity of having oloceridine here relatively soon. I do agree with
Or are interested in getting almost everything having only ferreting is and it's an alternative.
Where we're three months away from PDUFA date. So at this I think that's that's you know there they're excited about the adapted the potential opportunity of having all the theme here.
Relatively soon I do agree with you I think it as I mentioned earlier, it's in particular at a high risk patients right well, we've talked about you've heard US talk about is when these patients get sick they stay even longer in the hospital. They put a lot of either cost into the hospital system. There are some of the the hardest most difficult pace.
Carrie L. Bourdow: I think, as I mentioned earlier, it's in particular high-risk patients, right? What we've talked about, and you've heard us talk about, is when these patients get sick, they stay even longer in the hospital, they put a lot of cost into the hospital system, and they're, you know, some of the hardest, most difficult patients to treat. So it's been a focus of ours since the beginning to focus on those patients. That's where we think we'll get the initial use for oloceridine. Beyond that, you know, as it relates to COVID, I think we're all sort of watching things and staying focused on getting oloceridine approved by the agency.
Concentrate so it's been a focus of ours since the beginning to focus on those stations. So that's where we think we'll get p. initial use.
Oh, asserting beyond that and you know as it relates to kind of it I think we're all sort of watching things and.
And staying focused on getting old 13 approved by the agency.
Okay.
Great Thats. It for me. Thank you. Thank you guys appreciate it.
Douglas Dylan Tsao: Great, that's it for me, thank you.
Operator: Thank you. Thank you, Doug. I appreciate it.
I'm showing no further questions at this time I would now like to turn the conference back for California C.L.
Carrie L. Bourdow: I am showing no further questions at this time. I would now like to turn the conference back to Terry Bourdow, CEO.
Great well. Thank you all I appreciate a all of the questions. This morning, and as you can hear we are optimistic and are excited about or 30, NAND, but they do for date that is that as quickly and coming up.
Carrie L. Bourdow: Great. Well, thank you all. I appreciate all of your questions this morning, and as you can hear, we are optimistic and excited about OLA-13 and the PDUFA date that is quickly coming up. We're also excited about TRV-045 and the NIH interest in 045 and also the progress that we've made in our IND capabilities and the ability to have an IND, hopefully, in the first half of next year. So thank you again for your time. Despite all the crazyness that we're all dealing with, as you hear, we are passionate about our mission, developing novel medicines for patients in need. Thank you again for joining us this morning.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: [inaudible]
We're also excited about T. RV O four or five and the NIH entrust and over a five and also the progress that we've made a in our I into your capabilities and the ability to have an I'd Ah Ah hopefully in the first half of next year. So thank you again for the time despite a.
All the craziness that while dealing with as you here, we are passionate about our mission and developing novel medicines for patients in need. Thank you again for joining us this morning.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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