Q4 2019 Earnings Call
This time, all participants are in listen only mode.
Operator: All participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Bob Yoder, Chief Business Officer. Please go ahead.
A brief question and answer session will follow the formal presentation should anyone require operators restaurants. During the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Bob Yoder Chief Business Officer. Please go ahead.
Thank you and welcome everyone. Thank you for joining us on this morning's call with me today or carry Bordeaux, our president and CEO.
Bob Yoder: Thank you and welcome everyone. Thank you for joining us on this morning's call. With me today are Carrie Bourdow, our President and CEO, Mark Demitrack, our Chief Medical Officer, Barry Shin, our Chief Financial Officer, and Dr. Timothy Beard, Chair of the Department of Surgery at Summit Medical Group in Bend, Oregon. 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 Security Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties, including risks detailed from time to time in the company's periodic reports filed with the Securities Exchange Commission, and we undertake no obligation to update these statements beyond today.
Our Chief Medical Officer, Bearish in our Chief Financial Officer.
Opportunity Beard chair of the department of surgery at Summit Medical Group Bend, Oregon.
Before we begin question for participants that you'll be making forward looking statements on this call, which are made pursuant to the safe Harbor provision on the private Securities Litigation Reform Act 1995.
Youre cautioned that such forward looking statements involve risks and uncertainties, including risks detailed from time to time in the company's periodic reports filed with the Securities Exchange Commission.
Undertake no obligation to update these statements beyond today.
During today's call Kerry will review, our 2019 and recent corporate achievements and way our plan for 20 Twond.
Carrie L. Bourdow: During today's call, Carrie will review our 2019 and recent corporate achievements and lay out our plan for 2020, and Mark will provide an overview of the data from our IV olaceratine program that was recently resubmitted to FDA. Dr. Beer has also joined us this morning to provide his perspective on the current role of IV opioid analgesics in his clinical practice. Barry will then review our financial results, followed by some time for questions. I'll now turn the call over to Carrie. Thanks, Bob. Good morning, everyone.
I will provide an overview of the data from Ivy austerity program that was recently resubmitted yes.
Dr. Pepper is also joining us this morning provide his perspective on the current well I'd be opioid analgesics and its clinical practice.
Great My review, our financial results, followed by some time for questions.
I'll now turn the call over to carry.
Thanks, Bob.
Good morning, everyone. Thank you for joining us this morning [noise].
At the start up 2019, you'll remember that I laid out a plan to resubmit Oh, what they're waiting for approval into advanced the pipeline. What's your what's you're getting here. This morning on this call is that we've delivered on the plan and you'll hear that was successful resubmission of voluntary well now turn our attention to preparing for it.
Back to the approval in August of this year.
And on the pipeline right what you'll hear is that we did he development milestones. We now have to proof of concept studies underway one for acute migraine and another for opioid use disorder, and we're studying t. RV Oh poor five nobilis won't be modulator in epilepsy inept edible.
Carrie L. Bourdow: Thank you for joining us this morning. At the start of 2019, you will remember that I laid out a plan to resubmit Oletheridine for approval and advance the pipeline. What you're going to hear this morning on this call is that we've delivered on the plan, and you'll hear that with the successful resubmission of Oletheridine, we'll now turn our attention to preparing for expected approval in August of this year. And on the pipeline front, what you'll hear is that we've hit key development milestones. We now have two proof-of-concept studies underway, one for acute migraine and another for opioid use disorder. And we're studying TRV045—a novel S1D modulator—in epilepsy and a variety of other CNS conditions. Importantly, we completed all of this work while we managed our expenses very carefully. I have to say I am extremely proud of this team and what we accomplished in 2019.
To get better CNS condition importantly, we completed all of this work while we managed our expenses very carefully and I have to say I am extremely proud of this team and what was accomplished in 2019.
Let me give you a just a few more detailed on the highlights the high points from from my perspective from here as you saw last week after gay except that our resubmission of the oldest dirty and be a and it's great. They they told us that it with a complete response to they're actually letter they that produced the date of August.
Evan.
And we're looking forward to working with them as they as they review our application.
In the past you've heard me talk about the market opportunity for all the therapy. It large over 45 million patients each year and U.S. hospitals recede drugs like I'd be morphine for acute pain and about 9 million if that was station alright, greater risk of developing adverse event.
Good old are seeing right.
And without risk patients and an increase in the number of severe acute pain, certainly and we believe that that risk patient population alone represent a total addressable market of $1 billion to $1.5 billion.
That's a that's impressive but at the end of the day, it's important that we focus on why we developed a novel analgesic cycle with Dirty and the reason is to improve patient fly later on this call. We've invited Dr. 10 beer to talk with you about filling his high risk patients and the challenges that he faces in managing.
Carrie L. Bourdow: Let me give you just a few more details on the highlights, the high points from my perspective, from the year. As you saw last week, FDA accepted our resubmission of Viola-13 NDA, and that's great. They told us that it was a complete response to their action letter. They set a PDUFA date of August 7th, and we're looking forward to working with them as they review our application. In the past, you've heard me talk about the market opportunity for ulcerative colitis. It's large.
Post operative pain.
Beyond all 13, we made significant progress on the pipeline late last year, we initiated an acute migraine proof of concept study for TRP to 50 migraines also another large market approximately 650 million migraines are treated annually in the U.S. and they're still in need for.
Novel treatment option.
Do you want me to 50 is a novel new mechanism. That's one of the Delta receptor and the Delta receptor is located in the brain throughout the brain and the in the Delta receptors regulate mood anxiety and pain, including migraine pain, we're evaluating the ability of TRP to 50 to reduce the occurrence of headache.
And also to reduce potentially reduce symptomatic anxiety about half of all migraine patients experience anxiety. There are no approved treatment options that can treat both migraine, adding sites. So obviously that's would be a large market opportunity for us for T. RBC Betsy, it's a really X.
Carrie L. Bourdow: Over 45 million patients each year in U.S. hospitals receive drugs like ibuprofen for acute pain, and about 9 million of those patients are at greater risk of developing adverse events. Hospitals are seeing a rise in these at-risk patients and an increase in the number of severe acute pain surgeries. And we believe this at-risk patient population alone represents a total addressable market of $1 to $1.5 billion. That's impressive.
Yeah that and work boxing topline results on this study in the second half of this year.
Another proof of concept study we started late last year was in collaboration with the National Institute on drug abuse or group called night.
And this study is sports CRB 734 for opioid use disorder now that you're looking at the potential at 734, as a safer and better tolerated treatment option for patients suffering from a direction. We're really pleased to be working with night out to help fight the opioid crisis and I'll keep you updated as the study.
Carrie L. Bourdow: But at the end of the day, it's important that we focus on why we developed a novel analgesic like Oletheridine, and the reason is to improve patients' lives. Later on in this call, we've invited Dr. Tim Beard to talk with you about some of his high-risk patients and the challenges that he faces in managing post-operative acute pain. Beyond Oletheridine, we made significant progress on the pipeline. Late last year, we initiated an acute migraine proof of concept study for TRV250. Migraines are also another large market. Approximately 650 million migraines are treated annually in the U.S., and there's still a need for novel treatment options. TRV-250 is a novel new mechanism, and this one targets the delta receptor. The delta receptor is located in the brain, throughout the brain, and delta receptors regulate mood, anxiety, and pain, including migraine pain.
Progressive.
And then lastly, as you saw this morning, we announced that Werent, we've initiated another collaboration with the NIH to investigate the potential of TRP Oh for five as a treatment for epilepsy, Oh, four or five another another new mechanism represents a novel approach to treating neurological disorders and if the next.
Generation S. One p. receptor modulator that activate the receptor target without any idea a immuno suppression that you get you got with with other EF 14 modulators.
And I hate has already initiated the first round it out phase for epilepsy, and we believe the outset holds promise not only for epilepsy, but for a variety of cnf syndication.
With all of our assets, including over 30 were actively investigating collaborations and strategic partnership remember we already have two X U.S. partnerships for over 30, and these collaborations are going really well, we're expecting to receive a 3 million dollar milestone payment upon FDA approval level a theme.
Already.
As we continue to make progress on all 13, and the pipeline, we're going to continue to look for ways to Dan all of our assets and to maximize shareholder value with that let me now I'll turn the call over to Mark.
Thank you carry.
I'm also very pleased that we've successfully resubmitted R&D for I'd be all asserting [noise].
This milestone represents more than a year of work by members of our clinical Nonclinical manufacturing and regulatory teams and I'm extremely grateful for the opportunity to work with such a dedicated group of individuals.
I believe the outcome of that work is compelling and further strengthens our evidence in support of all the shared gain as a potential new treatment option for patients with moderate to severe acute pain.
Carrie L. Bourdow: We're evaluating the ability of TRV-250 to reduce the occurrence of headaches and also to potentially reduce symptomatic anxiety. About half of all migraine patients experience anxiety. There are no approved treatment options that can treat both migraines and anxiety.
The promise of all this everything that's a distinctive addition to a clinicians armamentarium of I'd be analgesics is built on its novel mechanism of action and you need pharmacokinetic profile.
Oh, sorry team is a new chemical entity first in this space in decades.
It was designed to optimize G protein coupled receptor pharmacology.
Carrie L. Bourdow: So, obviously, this would be a large market opportunity for us for TRV-250. It's a really exciting asset, and we're expecting top-line results from this study in the second half of this year. Another proof of concept study we started late last year was in collaboration with the National Institute on Drug Abuse, or a group called NIDA. And this study is for TRV-734 for opioid use disorder. NIDA is looking at the potential of 734 as a safer and better tolerated treatment option for patients suffering from addiction. We're really pleased to be working with NIDA to help fight the opioid crisis, and I'll keep you updated as this study progresses. And then lastly, as you saw this morning, we announced that we've initiated another collaboration with the NIH to investigate the potential of TRV-045 as a treatment for epilepsy. TRV-045, another new mechanism, represents a novel approach to treating neurological disorders.
Preferentially engaging the G protein signaling pathway responsible for analgesics.
With reduced recruitment abate in Reston, which is largely involved and development of adverse effects.
Oh surgeon has a rapid onset of action perceptible pain relief as early as two to five minutes. After the first does and lasting approximately three hours.
Providing a highly differentiated analgesic profile for connections.
Oh, sorry, being also has no evidence of active metabolite, which can complicate does saying and resulted in the emergence of delayed adverse events.
Finally, our recently published studies in special populations have shown that no dosage adjustment is necessary in patients with underlying renal impairment or in the elderly.
These attributes distinguish all the ceridian from currently available I'd be analgesics like morphing.
As a reminder, we've amassed a comprehensive clinical dataset parental charity across multiple efficacy and safety studies involving over 1800 individuals.
On past calls we've spoken about the respiratory safety data, but today I'd like to highlight the Gi Tolerability data collected during our pivotal phase three studies.
Using a complete Gee I response outcome measure.
This is a common endpoint used in drug development peremptorily metrics and defines a complete responder as a patient who reaches the end of the study period without vomiting.
And without receiving a rescue anti emetic.
The results of this analysis for almost everything are extremely compelling.
Carrie L. Bourdow: And it's a next-generation S1P receptor modulator that activates the receptor target without any of the immunosuppression that you get with other S1P modulators. NIH has already initiated the first round of assays for epilepsy, and we believe this asset holds promise, not only for epilepsy, but for a variety of CNS indications. With all of our assets, including Oletherity, we're actively investigating collaborations and strategic partnerships. Remember, we already have two ex-U.S. partnerships for Oletherity, and these collaborations are going really well. We're expecting to receive a $3 million milestone payment upon FDA approval of Oletherity. As we continue to make progress on Oatless Heritage and the pipeline, we're going to continue to look for ways to advance all of our assets and maximize shareholder value. With that, let me now turn the call over to Mark. Thank you, Kerry.
In the phase three hard tissue study patients on all asserting were three times more likely to complete the study without vomiting, and without needing a rescue anti emetic compared to patients on morphine.
We saw similar pattern in the phase three soft tissue study.
Importantly, these results held true when we control for differences and level of pain relief for cheap.
But a different way all surging does just that provided pain relief comparable to morphine had strikingly lower Gi side effects.
In addition, the improvements in GI Tolerability were not due to differences in pre existing risk for nausea, vomiting, among the treatment groups.
We believe this data reinforces the overall Gi tolerability data for almost 30.
I'd now like to introduce Dr., Jim be or it was a practicing general surgeon and as a chair of the department of surgery and medical director of research at Summit Medical Group and Bend, Oregon.
Tim also serves as an affiliate professor of surgery at Oregon Health Sciences University.
We've asked him to join US this morning to provide his perspective on the current clinical challenges he patients in his hospital and outpatient practice.
And his thoughts on the old Ceridian data.
Tim.
Thank you Mark for the introduction.
Please to join the Trina 10. This morning to provide my perspective on the current role of Ivy opioid analgesics and my clinical practice and the share my thoughts on the body of data that the company has a math on their investigational product all Saturday.
Mark A. Demitrack: I'm also very pleased that we've successfully resubmitted our NDA for Iveola seridine. This milestone represents more than a year of work by members of our clinical, non-clinical, manufacturing, and regulatory teams, and I'm extremely grateful for the opportunity to work with such a dedicated group of individuals. I believe the outcome of that work is compelling and further strengthens our evidence in support of oloceridine as a potential new treatment option for patients with moderate to severe acute pain. The promise of oloceridine as a distinctive addition to a clinician's arsenal of IV analgesics is built on its novel mechanism of action and unique pharmacokinetic profile. Oloceridine is a new chemical entity, the first in this space in decades, and was designed to optimize G-protein coupled receptor pharmacology by preferentially engaging the G-protein signaling pathway responsible for analgesia with reduced recruitment of beta-arrestin, which is largely involved in the development of adverse effects. Oloceridine has a rapid onset of action, with perceptible pain relief as early as 2 to 5 minutes after the first dose and lasting approximately 3 hours, providing a highly differentiated analgesic profile for clinicians.
I'm speaking on my own accord and not in my position as a general surgeon at the summit Medical group I am a paid consultant with trevino.
Hi practices, a general surgeon and a large multi specialty group and slipped my time between a community hospital and they physician owned busy outpatient surgery Center.
I perform approximately 750 cases, a year with a third of those being done as in patients.
I spent a considerable amount of time reviewing the published data for this compound and they have a sister intravenous R&D group in data analysis I participated as an author on some of the key publications.
Believed this experience is provided me some insights into what can be expected from all the fared in central use in practice.
Well the role of Ivy opioids in the post operative pain management has undergone evolution over the years. These medications remained the pillar and standard of care for acute pain management.
My practice drugs, such as Ivy morphine lauded and fentanyl remain an integral part of all post operative pain management strategies. The main reason for this is that only these medications can provide the definitive pain relief required and certain highly painful post operative circumstances.
I can't perform surgeries in my clinical practice without them.
[noise] quarterly manage pain can have many undesirable consequences, including a lack of mobility or appetite and disrupted sleep patterns on the flipside drugs like IP morphine also have side effects, including respiratory depression, bilious, nausea and vomiting.
Sure left with a few options, but to describe opioids when they required and then to supplement their use with several additional medications in order to try to minimize or counteract these side effects.
Because of this I frequently find it necessary to prescribe as many as five to seven different additional drugs in the postoperative setting.
This unavoidable polypharmacy poses the additional challenges to patients recovery, including an increased risk of drug drug interactions the poor rate of adherence to these additional medications.
In my opinion.
Venus investigational product old asserting offers the first truly novel advance towards a solution to this problem.
I have been impressed with quality an amount of data intravenous gathered and published in peer reviewed journals.
The two pivotal phase three studies provide initial clinical data in bunyan activity and abdominal plastic surgeries and these results showed great pain relief with a potentially differentiated and approved side effect profile.
Mark A. Demitrack: Oloceridine also has no evidence of active metabolites, which can complicate dosing and result in the emergence of delayed adverse events. Finally, our recently published studies in special populations have shown that no dosage adjustment is necessary in patients with underlying renal impairment or in the elderly. These attributes distinguish oloceridine from currently available IV analgesics like morphine. As a reminder, we've amassed a comprehensive clinical data set for oloceridine across multiple efficacy and safety studies involving over 1,800 individuals. On past calls, we've spoken about respiratory safety data, but today I'd like to highlight the GI tolerability data collected during our Pivotal Phase III studies using a complete GI response outcome measure. This is a common endpoint used in drug development for anti-emetics and defines a complete responder as a patient who reaches the end of the study period without vomiting and without receiving a rescue anti-emetic. The results of this analysis for Oluseridine are extremely compelling.
We expect with conventional opioids.
The results from the phase three or real World Open label Safety study extended these findings of particular interest to me was the diverse patient population of the study many of them with multiple comorbidities, including older age obesity and diabetes.
These types of high risk patients represent ones I operate in my practice all the time.
These complicating risk factors can pose significant challenges to a patient's post operative course.
A recent patient I treat it does come to mind. This is a 52 year old woman, who needed surgery for near obstructing tumor and you're just still transfers colon.
That's the same time came to surgery with the history of quality control diabetes.
And to be am I have 53.
Challenge here was not the surgical procedure itself, but the risk that emerged in or post op recovery, given our high risk health history.
For example.
Surgical 1% of a huge infection risk so any occurrence of nausea, vomiting, or retching could disrupt the integrity of reward and lead to an infection.
This is just one example of the type of patient, who I could potentially benefit from the profile that old severity and appears to offer.
In his remarks, Mark noted the complete yard responder analysis and the clinical trials over.
Overall these data suggest that when the magnitude of analgesic benefit is held constant across treatment groups patients treated with old asserting are more likely to achieve a complete your response compared to patients treated with morphine.
Mark A. Demitrack: In the Phase III heart tissue study, patients on oloceridine were three times more likely to complete the study without vomiting and without needing a rescue anti-emetic compared to patients on morphine. We saw a similar pattern in the Phase III soft tissue study. Importantly, these results held true when we controlled for differences in the level of pain relief achieved. Put another way, all the serodine doses that provided pain relief comparable to morphine had strikingly lower GI side effects. In addition, the improvements in GI tolerability were not due to differences in pre-existing risk for nausea or vomiting among the treatment group.
This is an important endpoint and I feel relevant to me when considering the management of patient I just discussed decreasing the risk of vomiting by two or three fold might make the difference for this patient of having a relatively straight forward post operative course.
Versus the rest that I would see.
I would be seen her back in the operating room to repair won't be hisense.
I also see the potential advantage that old certain could provide in the outpatient setting.
My ambulatory surgery center performs about 1300 cases per month.
One of our limiting factors in this setting is availability of recovery bet.
[laughter] patients are delayed and the recovery it prevents us from starting more cases.
By far the most common reason for prolonged recovery time, our pain nausea and vomiting.
As a result recovery room nurses are hesitant to give too much opioid medications as that makes patients sleepy and they do not breed as well and the other hand, if they give too little patients with too much pain, which itself may contribute to increase rates of nausea and vomiting.
Well the 13th Pharmacokinetic profile offers several attributes that could provide a bad just in this setting its care for example, its rapid onset of analgesic effect makes it very easy for physicians to use their also appears to be no need to adjust the dose for renal insufficiency, which again makes it easier positions.
Mark A. Demitrack: We believe this data reinforces the overall GI tolerability data for Olin-Sahardine. I'd now like to introduce Dr. Tim Beard, who is a practicing general surgeon and is the chair of the Department of Surgery and Medical Director of Research at Summit Medical Group in Bend, Oregon. Tim also serves as an affiliate professor of surgery at Oregon Health Sciences University. We've asked Tim to join us this morning to provide his perspective on the current clinical challenges he faces in his hospital and outpatient practice and his thoughts on the Oloceridine data. Tim?
This is expressed an important to my practice has all been fall just in our town or in our group, thus I see a lot of renally impaired patients.
Well, it's hurting also appears to have no active metabolite, which makes pain management in the short term setting like an ambulatory surgery center more straightforward.
All these factors could contribute to a decrease in like the stay in our recovery through an increase patient satisfaction.
To sum up I'm excited by the oldest 30 data that I've seen and I believe that all asserting has the potential to help address some of the post operative challenges that physicians and their patients still face.
Thank you again through the invitation to speak and I'll, Let me pass the call back to Mark.
Thanks, Tim pretty remarks, we greatly appreciate hearing your perspective on the challenges you face in your practice and what improvements you really hope to see in the current treatment landscape that would benefit both you and your patience.
Unknown Attendee: Thank you, Mark, for the introduction. I'm pleased to join the Trevena team this morning to provide my perspective on the current role of IV opioid analgesics in my clinical practice and to share my thoughts on the body of data that the company has amassed on their investigational product, Oloceridine. I'm speaking on my own accord and not in my position as a general surgeon at the Summit Medical Group. However, I am a paid consultant with Trevena.
Tim will be available to answer questions during the Q and a later on this call.
Now I'd like to turn the call over to Barry for a review of our full year financials.
Thanks Mark.
We issued a press release and filed a form 10-K with a full financial results for.
Now I'll summarize the headline numbers.
For the fourth quarter of 2019, you had a net loss of $6.4 million or seven cents per share compared to $8.0 million or 10 cents per share for the fourth quarter of 2018.
Unknown Attendee: I practice as a general surgeon in a large multi-specialty group and split my time between a community hospital and a physician-owned busy outpatient surgery center. I perform approximately 750 cases a year, with a third of those being done as inpatient surgeries. I have spent a considerable amount of time reviewing the published data for this compound, and I have assisted Trevena's R&D group in data analysis and participated as an author in some of the key publications.
For the full year 2019, we had a net loss of $24.9 million or 27 cents per share compared to $30.8 million.42 per share for 2018.
This decrease in net losses, mainly due to a head count reduction in 2018, and a decrease in R&D expenses related to your beat to 50.
At year end 2019, we had cash cash equivalents and marketable securities $35.8 million.
If additional clarity following completion of a healthy volunteer study.
Very happy to update our guidance and report that we expect this amount will fund our operations and capital expenditures into the first quarter of 2021.
Unknown Attendee: I believe this experience has provided me with some insights into what can be expected from all of serotine's potential use in practice. While the role of IV opioids in post-operative pain management has undergone an evolution over the years, these medications remain the pillar and standard of care for acute pain management. In my practice, drugs such as IV morphine, Dilaudid, and fentanyl remain an integral part of all post-operative pain management strategies. The main reason for this is that only these medications can provide the definitive pain relief required in certain highly painful post-operative circumstances. I can't perform surgeries in my clinical practice without them. Poorly managed pain can have many undesirable consequences, including a lack of mobility, poor appetite, and disrupted sleep. On the flip side, drugs like ipmorphine also have side effects, including respiratory depression, ileus, nausea, and vomiting. Physicians are left with a few options but to prescribe opioids when they're required and then to supplement their use with several additional medications in order to try to minimize or counteract these side effects.
This includes pre commercial preparation and post approval activities to ensure all the Saturday and will be available for distribution either by us or what the commercial partner in the fourth quarter of 2020.
It also includes completion of a proof of concept study for TRP to 50, an acute migraine and I indeed, enabling work for T. RV orphan.
Well now open the call for questions after which carry will provide some closing remarks.
Budget.
Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation John will indicate your line isn't a question can you May press star too if you would like to remove your question from the Q.
Those using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
One moment, please baldy poll for questions.
The first question is from Jason Butler of JMP Securities. Please go ahead.
Hi, Thanks for taking my questions I had two for Dr. beard.
You talked about the types of patient that you make might use the drug in can you talk about how you think about procedures, but you're doing and which procedures maybe warrant using the drug more than others and Ben can you just give us all any thoughts you have on cost considerations of using.
A new drugs like all the 13 and how those cost considerations comparing contrast in different institutions.
For example, the community hospital, you work and versus the outpatient.
Clinic. Thanks.
Unknown Attendee: Because of this, I frequently find it necessary to prescribe as many as five to seven different additional drugs in the post-operative setting. This unavoidable polypharmacy poses additional challenges to patients' recovery, including an increased risk of drug-drug interactions and a poor rate of adherence to these additional medications. In my opinion.
Great. Thanks, Thanks, Jason I actually think those are three questions, but okay, well, where thatll be all right [laughter]. So Tim I don't know if you get her here on the first questions around the types of procedures. In addition to the patient that you mentioned and then secondly, talking a little bit more about cost contracting between the hospital in your ambulatory surgery Center business.
Sure.
Well the procedures I kinda split them up into in two different and same with the cost. So if you look at our inpatient procedures. I think we're also didn't we rebalanced our procedures that caused more pain, so any sort of laparotomy, making big.
Incision.
Any sort of thoracotomy, where you're going into the chest with again big incisions, we're trying our best to manage those with multi modal analgesics, but opioids play a key role. So I would say any any again procedure that causes a lot of paying so maybe not as much minimally invasive although I still see a rolling minimally invasive.
Unknown Attendee: Trevena's investigational product, Oliceridine, offers the first truly novel advance towards a solution to this problem. I have been impressed with the quality and amount of data Trevena has gathered and published in peer-reviewed journals. The two pivotal Phase III studies provide the initial clinical data for bunionectomy and abdominoplasty surgery, and these results showed great pain relief with a potentially differentiated and improved side effect profile from what we expect with conventional opioids. The results from the Phase III, or real-world, open-label safety study extended these findings. A particular interest to me was the diverse patient population of this study, many of them with multiple comorbidities, including older age, obesity, and diabetes. These types of high-risk patients represent ones I see in my practice all the time.
Surgeons as laparoscopic robotically.
I guess I would be for the inpatient and outpatient.
What I'm excited for is the fact that this drug with what appears to be lower side effects that we'd be able to get people pain free and out of the recovery room faster. So any patient I do in an outpatient surgery Center I think there would be at a goal for this this drug.
Because again, we are we're limited in space by a recovery room, and if we get back up in the recovery room or everything kind of slows down.
So I do the majority of my patient cases in an outpatient surgery center to be honest with you not just.
That's the trend nationally as more and more stuff being done Oh patients in a big part of that is controlling costs. So all I was the almost all patients we do as all patients who we are a good candidates for this drug no costs or are interesting in the hospital. It would get absorbed in what's called the DRG and the hospital.
It looks it costs somewhat but not super strict because it seems to me that like in our high school that DRG payments.
Unknown Attendee: These complicating risk factors can pose significant challenges to a patient's postoperative course. A recent patient I treated does come to mind. This is a 52-year-old woman who needed surgery for a near-obstructing tumor in her distal transverse colon and, at the same time, came to surgery with a history of poorly controlled diabetes and a BMI of 53. The challenge here was not the surgical procedure itself but the risks that emerged in her post-op recovery, given her high-risk health history. For example,
I feel fairly large and they don't micromanages very much on if we're using drugs that are a little bit more expensive than than others.
Sometimes a little bit we will get pushed back that's mostly on antibiotics and that's mostly so we're not you know.
Change in the fourth antibiotics in our in our area.
The in the outpatient surgery Center, you know the margins on the cases are much smaller and so costs are looked up more so it would be I don't have any idea of what what this drugs going to commodity cost wise.
But that that would be looked at a little more as far as do we see a benefit from that but again I think most supposed to the surgery center look at the bigger picture. So if the drug does cause a little more but people are happier getting out of the surgery center faster ever more efficient than the overall efficiency I think would far outweigh the cost the drug.
Unknown Attendee: Her surgical wound presented a huge infection risk, so any occurrence of nausea, vomiting, or retching could disrupt the integrity of her wound and lead to an infection. This is just one example of the type of patient who could potentially benefit from the profile that Oloceridine appears to offer. In his remarks, Mark noted the complete GI responder analysis in the clinical trial. Overall, these data suggest that when the magnitude of analgesic benefit is held constant across treatment groups, patients treated with oloceridine are more likely to achieve a complete GI response compared to patients treated with more.
Example of that was one Ivy town. All came out you know that that's a lot more expensive than oral tylenol, but yet we use it quite a bit because we see a benefit with that with that drug or even all the cost is more so I hope that answers your question.
That's great. Thank you very much and thanks for taking questions.
Thank you thanks.
The next question is from its from Douglas Tsao of H.C. Wainwright. Please go ahead.
Hi, Good morning, I guess my first question is productive year in terms of you think about your overall patient population, both inpatient and outpatient door you could address them separately you know what percentage of them do you think fall into this high risk category and would be candidates for use.
You know once it is eventually hopefully approved.
Unknown Attendee: This is an important end point, and it feels relevant to me when considering the management of the patient I just discussed. Decreasing the risk of vomiting by two or threefold might make the difference for this patient of having a relatively straightforward postoperative course versus the risk that I would see; I would be seeing her back in the operating room to repair a wounded history. I also see the potential advantage that the old sardine could provide in the outpatient setting.
Great. Thanks, Okay. That's great question.
Dr appeared that it did you hear the question there per se I Gotta <unk> yeah.
Yeah. So [laughter] that percent goes up daily it seems I don't know the and that patient Ike and that was a real patient example that I gave.
And I don't.
You know she was five one 325 pounds. So that was an extremely difficult case and extremely difficult post operative recovery. So I would think in our hospital. Its this when this drug it's approved in August we'd probably be able to get it to the PMT pretty fast would be my guess and it will.
You probably start using a high risk patients for people with a pulmonary issues people that are at risk for nausea, and vomiting. For example, I do a lot of laparoscopic forgot surgeries, which are cognizant publications are Paris off the journey repairs, most weaker heartburn and reflux and if those patients rats. Your vomit you can totally disrupt the wrap that you.
Unknown Attendee: My ambulatory surgery center performs about 1,300 cases per month. One of our limiting factors in this setting is the availability of recovery room beds. If patients are delayed in their recovery, it prevents us from starting more cases. By far, the most common reasons for prolonged recovery time are pain, nausea, and vomiting.
So I would say if I did give a number of inpatient, but I would say or what I would consider higher risk in the this drug is just tailor made for I'd go that probably a 50 or 60%. Unfortunately I don't have.
Unknown Attendee: As a result, recovery room nurses are hesitant to give too much opioid medication as that makes patients sleepy, and they do not breathe as well. On the other hand, if they give too little, patients will have too much pain, which itself may contribute to increased rates of nausea and vomiting. Douglas Bourdow, Mark Demitrack, Jason Butler, Brandon Folkes, Douglas Tsao, Patricia Drake. This is especially important in my practice, as all the nephrologists in our town are in our group. Thus, I see a lot of renally impaired patients. Ulcerative Colitis also appears to have no active metabolites, which makes pain management in a short-term setting, like an ambulatory surgery center, more straightforward.
Oh practice, where I can operate on all that then healthy patients all the time I wish, but this doesn't exist.
All the and they're getting into the outpatient though these are healthier patients by definition, we don't do anyone over an essay three in an outpatient surgery center should there healthier, but I think their benefit again, it's a little different it's not so much for the their post operative risk the drug to be used for its what appears to be lower side.
Effect profiling and patient satisfaction and ease of getting them through our system.
Okay, and then just one follow up.
Or two parts one for Dr. Beard I know you mentioned, you're often treating you know sort of taking a polypharmacy airport just curious what drugs till the third in alone would be able to a place and then just a question for carrier in terms of onto your view of what Ah, Yes, one p., what you're going into epilepsy just curious.
How it was epilepsy was the first indication selected for development. Thank you.
Right Yeah.
Unknown Attendee: All of these factors could contribute to a decreased length of stay in our recovery room and increased patient satisfaction. To sum up, I'm excited by the olesteridine data that I have seen, and I believe that olesteridine has the potential to help address some of the post-operative challenges that physicians and their patients still face. Thank you again for the invitation to speak, and now let me pass the call back to Mark.
Tim I'll, let you I'll, let you start.
And I'll, let Terry.
Sure. So we've developed a massive what are called U.S. pathways. After surgery for a lot of or surgeries, which is enhanced recovery after surgery I'm sure my with them.
And in that pathway, we do everything we can to optimize patients full stop it.
So, let's say I do a collective me on someone take out a corn for colon cancer.
We obviously do a lot of stuff pre opt for those patients, but post operatively, even though they may get tap blocks are these rectus sheath blocks. They all get Ivy opioids. So the drugs, we give to counteract IPO goods, we give a drug called El pen or Andrei which is a powerful acting mu opioid receptor antagonist.
Mark A. Demitrack: Thanks, Tim, for your remarks. We greatly appreciate hearing your perspective on the challenges you face in your practice and what improvements you really hope to see in the current treatment landscape that would benefit both you and your patients. Tim will be available to answer questions during the Q&A later on in this call. I'd now like to turn the call over to Barry for a review of our full year financials. Thanks, Mark. You should have a press release and filed a Form 10-K with a full financial result.
Which blocks the side effects that opioids have on the guts opioids class affiliates are they caused the got not to move you can't pass gas or stool. So you get that drug we give a whole bevy of anti emetic, probably at least three different anti emetic to prevent the nausea, and vomiting, including sometimes we get degradation in surgery or zachry.
On or trying to again or competition.
Any of those we can give to stop the post operative nausea vomiting. We also then our super aggressive.
Barry Shin: For now, I'll summarize the headline numbers. For the fourth quarter of 2019, we had a net loss of $6.4 million, or $0.07 per share, compared to $8.0 million, or $0.10 per share, for the fourth quarter of 2018. For the full year of 2019, we had a net loss of $24.9 million, or $0.27 per share, compared to $30.8 million, or $0.42 per share, for 2018.
With a rest respiratory care on these patients. So we get a respiratory therapy console do incentives barometers may or may not give them.
Nebulizers if they need it so I think those are the three.
The main areas that we're giving drugs to counteracted the side effects of opioids.
And it sounds like it it's difficult for you right now that just say what all the 13 may replace it you've got to get it in your hand, I think anything right bigger.
It's really thats question around what what potentially only 30 and could we play right now like we're hoping because yeah and what I tried to mentioned in my talk is when you give so many different drugs to the polypharmacy. The the compliance to that regiments is fairly low that's what we're finding out with a U.S. protocol is that we give all these different drugs.
Barry Shin: This decrease in net loss is mainly due to a headcount reduction in 2018 and a decrease in R&D expenses related to TRD250. At year-end 2019, we had cash, cash equivalents, and marketable securities of $35.8 million. With additional clarity following completion of our Healthy Volunteer Study, I'm very happy to update our guidance and report that we expect this amount will fund our operations and capital expenditures into the first quarter of 2021. This includes pre-commercial preparation and post-approval activities to ensure Oliceridine will be available for distribution either by us or with a commercial partner in the fourth quarter of 2020. It also includes completion of a proof-of-concept study for TRV250 in acute migraine and IND-enabling work for TRV045; we'll now open the call for questions, after which Carrie will provide some closing remarks.
And then people actually don't really get them schedule, because it's too much the compliance is fairly low. So yeah. We don't know I'm. It that's why I'm excited for the started to get approved to try to see how much we can eliminate because anything we can do to simplify it would be great.
Thank you. Thank you and then and then don't tend to follow up on your question right smoking. So quick reminder, now I'll turn it over to March talk specifically about epilepsy, but there are other areas that that we've studied a win CRV for fiber in the process of looking at chemo induced peripheral neuropathy as it is another area that we've looked at.
On the animal data and then epilepsy was really a marks are going out and then talking to folks that are that are involved in looking at epilepsy Ah drugs and let's see trial Smart, let me talk a little bit about yeah, Doug. So great question and then as you know.
Well, we've talked in the in the past the S&P target is really quite interesting because of its a broad representation in the CNS. So.
Really the challenge for US is more focused since there's an enormous number of targets that are potential interest and as Carey mentioned.
Most of our early work, let's focus on chemotherapy induced peripheral neuropathy and rodent model. That's one of the best studied.
Animal models for the S&P system, but because of S&P localization on a cell types in the brain, particularly greenfield cell types or astrocytes. It has demonstrably impact on various measures of membrane.
Stability and as a result people became interested in the idea of exploring it in epilepsy models and although it's not as well studied as the she IDN work. There has been some animal work done with some of the available S. One PD ligands like I think all them out of for example.
Barry Shin: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For those using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Now you know that can go line is a non selected as one p. modulator and it also is accompanied by peripheral immuno suppressant. The S. One p. one receptor target, which is what zero four or five is directed at is a bit more selective to the CNS receptors and it also.
It was absent immunosuppression.
And our studies to date, so it allows us to build on some of the literature that exists.
For the epilepsy target in animal models with earlier total compounds and that really is kind of the thing that prompted our interest the collaboration with the DSP emerge from those discussions GTSP program is a longstanding well regarded.
Operator: One moment, please, while we pull for questions. The first question is from Jason Butler of JMP Securities. Please go ahead. Hi, thanks for taking the questions. I had two for Dr. Beard.
Preclinical screening program Thats on sponsored by N D S through the NIH, it's been in existence for about 30 years and has actually shepherded along several pretty key.
Jason Nicholas Butler: First of all, you talked about the types of patients that you might use the drug in. Can you talk about how you think about the procedures that you're doing and which procedures maybe warrant using the drug more than others? And then can you just give us any thoughts you have on cost considerations of using a new drug like doluseridine and how those cost considerations compare and contrast in different institutions? You know, for example, the community hospital you work in versus the outpatient clinic. I actually think those are three questions, but okay.
At the epileptics or to the market in there in their experience. So we're pretty gratified that in our discussions that.
We've been engaged in this program so further updates in future.
Thank you.
[noise]. This concludes the question and answer session I would now lets turn it back to carry bar Jones for closing comments.
Great. Thank you and and thank you for <unk> for your question. Thank you Dr. beard for for addressing the questions. We appreciate that let me close with some of the key points. They start today first we executed on our plan. We did what we said we're going to do we resubmitted the Andy April with very got confirmation from after.
Unknown Attendee: Well, that will be all right. So, Tim, I don't know if you can hear the first questions around the types of procedures in addition to the patients that you mentioned, and then secondly, talking a little bit more about cost, comparing the hospital and your ambulatory surgery center. Sure. Well, the procedures, I kind of split them up into two different types, and then same with the cost. So, if you look at our inpatient... The procedures I think that we're illustrating would be best are procedures that cause more pain. So any sort of laparotomy where you're making big incisions, any sort of thoracotomy where you're going into the chest with, again, big incisions. We're trying our best to manage those with multimodal analgesia, but opioids play a key role. So I would say any, again, procedure that causes a lot of pain, so maybe not as much minimally invasive, although I still see a role in minimally invasive surgery, which is laparoscopic and robotic.
Hey that the submission with complete and we also advanced the pipeline as we carefully managed our expensive I'd like to add my thanks to the team for their hard work in Connecticut.
We expect 2020 to be a transformational year for trevino with the oldest 13, India now under FDA review preparing for expected approval in August and we're also going to continue to make progress on the pipeline. So I will continue to provide update.
The year Progressive. Thank you again for joining us this morning on the call.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
[noise].
Unknown Attendee: I guess that would be for the inpatient. An outpatient, what I'm excited for is the fact that this drug, with what appears to be lower side effects, we'd be able to get people pain-free and out of the recovery room faster. So any patient I do in an outpatient surgery center, I think there would be a role for this drug. Because, again, we are limited in space by the recovery room. And if we get backed up in the recovery room, everything kind of slows down. So I do the majority of my patient cases in an outpatient surgery center, to be honest with you. That's the trend nationally, too.
Unknown Attendee: It's more and more stuff being done as outpatients, and a big part of that is controlling costs. So all, I would say almost all patients we do as outpatients would be. (inaudible) Changing the Floor of Antibiotics in our Area. In the outpatient surgery center, you know, the margins on the cases are much smaller, and so costs are looked at more.
Unknown Attendee: So it would be, I don't have any idea of what this drug is going to come out as cost-wise, but that would be looked at a little more as far as whether we see a benefit from that. But again, I think most of us at the surgery center look at the bigger picture. So if the drug does cost a little more, but people are happier getting out of the surgery center faster and are more efficient, then the overall efficiency, I think, would far outweigh the cost of the drug. An example of that is when ivy Tylenol came out. It's a lot more expensive than oral Tylenol, but we use it quite a bit because we see a benefit from that drug even though the cost is more.
Unknown Attendee: So I hope that answers your question. Yes, that's great. Thank you very much and thanks for taking the question. Thank you. The next question is from Douglas Tsao of H.C. Wainwright. Please go ahead. Hi, good morning. I guess my first question is for Dr. Beard.
Douglas Dylan Tsao: In terms of you think about your overall patient population, both inpatient and outpatient, or you could address them separately, you know, what percentage of them do you think fall into this high-risk category and would be candidates for use, you know, once it is, hopefully, approved? Great. Thanks, Deb.
[noise] [noise].
Operator: Great questions. Dr. Beard, did you hear the question about the percent of hypertension? Yeah, so that percent goes up daily, it seems.
[noise].
Unknown Attendee: I don't know. And that patient, that was a real patient example that I gave. And I don't, you know, she was 5'1", 325 pounds.
Unknown Attendee: So that was an extremely difficult case, and extremely difficult postoperative recovery. So I would think in our hospital, if this drug gets approved in August, we'd probably be able to get it to the PNT pretty fast. That would be my guess. And we'd probably start using it on higher-risk patients, so people with pulmonary issues, people that are at risk for nausea and vomiting. For example, I do a lot of laparoscopic foregut surgeries, which are called Nissen fundamentations or parastrophageal hernia repairs, mostly for heartburn and reflux. And if those patients retch or vomit, you can totally disrupt the wrap that you've done. So I would say if I had to give a number of inpatients that I would say are what I would consider higher risk and that this drug is just tailor-made for, I'd put it probably at 50 or 60 percent. Unfortunately, I don't have any...
Unknown Attendee: Okay, and then just one follow-up. I know you mentioned that you often treat, you know, sort of taking a polypharmacy approach. Just curious, what drugs would olotheirodine alone be able to replace?
Unknown Attendee: And then just a question for Kari, in terms of GRV 045, the S1P, which is going into epilepsy, just curious how it was that epilepsy was the first indication selected for development. Thank you.
[noise] [noise].
Unknown Attendee: Tim, I'll let you start on all those areas. Sure, so we've developed these massive, what are called ERAS pathways after surgery for a lot of our surgeries, which is enhanced recovery after surgery, I'm sure you're familiar with. And in that pathway, we do everything we can to optimize patients' post-op. So let's say I do a colectomy on someone, take out a colon for a coin.
[music].
Unknown Attendee: We obviously do a lot of stuff pre-op for those. But post-operatively, even though they may get tap blocks or these, you know, rectus sheath blocks, they all get IV opioids. So the drugs we give to counteract IV opioids; we give a drug called alveolopan or EnterAid, which is a peripheral-acting mu-opioid receptor antagonist that blocks the side effects that opioids have on the gut. So opioids cause an ileus, where they cause the gut not to move. You can't pass gas or use the restroom.
Unknown Attendee: So we give that drug. We give a whole bevy of anti-emetics, probably at least three different anti-emetics to prevent nausea and vomiting, including sometimes they get decadron in surgery or Zocran or Krennergan or Compazine. Unknown Attendee. Do you know any of those we can give to stop the post-operative nausea and vomiting? We also are super aggressive with our respiratory care for these patients. So we get a respiratory therapy consult, do incentive spirometers, and may or may not give them. Nebulizers if they need them
Carrie L. Bourdow: So I think those are the three main areas where we're giving drugs to counteract the side effects of opioids. And it sounds like it's difficult for you right now to say what olitharity may replace. You've got to get it in your hands, I think, and use it, right?
Unknown Attendee: Douglas Tsao, Patricia Drake, Unknown Attendee, Barry Shin, Trevena Inc., And what I tried to mention in my talk is that when you give so many different drugs to polypharmacy patients, the compliance to that regimen is fairly low. That's what we're finding out with our ERAS protocol, is that we give all these different drugs and then people actually don't really get them scheduled because it's too much. The level of compliance is fairly low.
Unknown Attendee: So yeah, we don't know. That's why I'm excited for this drug to get approved, to try it, and to see how much we can eliminate because anything we can do to simplify it would be great. Thank you. And then Doug, to follow up on your question about S1P. So a quick reminder, and I'll turn it over to Mark to talk specifically about epilepsy. But there are other areas that we've studied with TRV-4-5 and are in the process of looking at chemo-induced peripheral neuropathy, another area that we've looked at in animal data.
Carrie L. Bourdow: And then epilepsy was really, Mark's going out and talking to folks that are involved in, you know, looking at epilepsy drugs and epilepsy trials. So Mark, I'll let you talk a little bit about that. Yeah, I can say it's a great question.
[music].
Mark A. Demitrack: And as we've talked in the past, the S1P target is really quite interesting because of its broad representation in the CNS. So really, the challenge for us is to focus more, since there's an enormous number of targets that are of potential interest. As you mentioned, most of our early work was focused on chemotherapy-induced peripheral neuropathy and rodent models. That's one of the best studied animal models for the S1P system. But because of S1P localization to cell types in the brain, particularly glial cell types or astrocytes, it has a demonstrable impact on various measures of membrane stability. And as a result, people have become interested in the idea of exploring it in epilepsy models. And although it's not as well studied as the CIPN work, there has been some animal work done with some of the available S1P ligands, like fingolimod, for example.
Oh.
[music].
Oh.
[music].
Mark A. Demitrack: Now, you know that fingolimod is a non-selective S1P modulator, and it also is accompanied by peripheral immunosuppression. The S1P1 receptor target, which is what 045 is directed at, is a bit more selective for the CNS receptors, and it also does not cause immunosuppression in our studies to date. So it allows us to build on some of the literature that exists for the Epilepsy Target in Animal Models with earlier tool compounds. And that really is kind of the thing that prompted our interest. The collaboration with the ETSP emerged from those discussions. The ETSP program is a longstanding, well-regarded preclinical screening program that's sponsored by NINDS through the NIH. It's been in existence for about 30 years and has actually shepherded along several pretty key anti-epileptics to the market in its experience.
Mark A. Demitrack: So we were pretty gratified in our discussions that we've engaged in this program. So, further updates in the future. Thank you. Great. This concludes the question and answer session. I would now like to turn it back to Keri Bourdow for closing comments. Great, thank you. And thank you for your questions. Thank you to Dr. Beard for addressing the questions.
Carrie L. Bourdow: We appreciate that. Let me close with some of the key points that you heard today. First, we've executed on our plan. We did what we said we were going to do. We resubmitted the NDA for Ola Therapy, got confirmation from FDA that the submission was complete, and we also advanced the pipeline as we carefully managed our expenses. I'd like to add my thanks to the team for their hard work and commitment. We expect 2020 to be a transformational year for Trevena. With the Ola Therapy NDA now under FDA review, we're preparing for expected approval in August, and we're also going to continue to make progress on the pipeline.
Carrie L. Bourdow: I will continue to provide updates as the year progresses. Thank you again for joining us this morning on the call. This concludes today's teleconference. You may disconnect your lines at this time.
Operator: Thank you for your participation, https://www.facebook.com.com or www.instagram.com https://www.instagram.com © BF-WATCH TV 2021, ?? ?? ?? [inaudible] https://www.youtube.com or the link in the description below. © BF-WATCH TV 2021, [inaudible] , , , , , , , , , [inaudible]. .. .. ... , https://www.youtube.com Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, © BF-WATCH TV 2021 and Unknown Attendee. Transcribed by Transcription Outsourcing, Inc. Transcribed by Transcription Outsourcing, Inc. [inaudible] , , , , , , , © BF-WATCH TV 2021, © The Ultimate Parody Site! [inaudible] ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Copyright © 2020, New Thinking Allowed Foundation, , , , , , ? ? ? ? [inaudible] © The Ultimate Parody Site!