Q1 2023 Trevena Inc Earnings Call
Hello, and welcome to the Trevino, Inc. First quarter 'twenty to 'twenty three earnings call.
All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star keep followed by zero.
After todays presentation, there will be an opportunity to ask questions Trust me. A question you May Press Star then one on your Touchtone phone.
To withdraw your question. Please press Star then two please note today's event is being recorded I would now like to turn conference over to Bearish and Chief Financial Officer. Please go ahead Sir.
Thanks, Steve.
Good morning, and welcome everyone.
With me today are Kerry Bordeaux, our president and CEO , Patty Drake, our Chief commercial officer, and our Chief Medical Officer, Mark down the track.
As a reminder, Olympic was approved by the FDA in August 2020, and contains all the Saturday and opioids, which are scheduled to control something with a high potential for abuse similar to other opioids. It's indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate.
All opioid serious life threatening a fatal respiratory depression may occur in patients treated with the Olympics as indicated in the box warning.
The important safety information, including the box warning and co prescribing information are all available on the Olympic Dot com.
We'll also be making forward looking statements under federal Securities law.
Statements are subject to risks and uncertainties relating to our business.
Those covered in our filings with the SEC.
We undertake no obligation to update these statements beyond today.
I'll now turn the call over to Karen Karen.
Overview of our first quarter and recent business accomplishments.
Gary.
Thank you Barry.
Everyone and thank you for joining we are excited about the opportunities and significant upcoming milestones for trevino. This year, let's start with the recent news last week. We were pleased to announce that <unk> received approval for a Linda can China and they expect first commercial sale in the third.
Of this year.
As a result praveen. It is due to receive a 3 million dollar milestone payment and we're eligible to receive an additional $15 million. Upon first commercial sale of Alembic in connection with the <unk> financing agreement.
In the U S. We continue to build upon the extensive dataset Berlin back we.
We announced the initial topline data from the real World outcome study that we conducted with Cleveland clinic, and we're on track to report, new respiratory and healthy utilization data and cost analyses from this study this year.
Although we acknowledge we're not where we need to be as it relates to U S Olympic sales.
You'll hear from Patty additional information to support our belief that the recent strategic shift to focus on ambulatory surgery centers, what is the right one.
Turning to T. R V 045, our novel <unk> receptor modulator, we're very happy with the progress as we now have two proof of concept clinical studies underway to support the continued development for potential use of T. R V 045 in epilepsy and chronic pain.
Two large market opportunities.
Enrollment is going well and we're expecting top line data in the third quarter of this year.
We're also assessing T. R V 045, and other potential indications such as orphan seizure disorders.
Given its unique profile and strong interest from potential partners T. R. V 045, maybe an exciting near term value driver for trevino.
As you can hear the upcoming quarter will be a busy one for us.
Now I'll turn the call over to Patti and Marc to provide more details on Olympic and TRT 045 Patty.
Thank you Carrie and good morning, everybody.
Day I'll provide you with the first quarter update on our sell through performance and the accomplishment of our efficient and effective customer facing team.
We continue to see growing use of alembic by our ASC and hospital end users, although the base remains small.
We've also seen initial direct sales flowing through our new specialty distributors that we've reported signing agreements with last quarter.
We now have been approved on 188 formularies and the majority of our orders in <unk> were from repeat accounts again, demonstrating that once physicians to try the product they continue to use it in their practice.
Our average order size also increased in the first quarter versus 2022.
We saw that increase occur in both new as well as repeat orders.
The vast majority of our sales are in the bolus dosing vials and we see a 60 40 split the business between our one milligram and two milligram vial, which is indicative of our recent focus on the ASC setting.
As mentioned previously our efficient focus on the ASC setting is due to several things.
The growing demand among patients seeking outpatient care.
A S. He's conducting more complex procedures, where linda can be a value to the patient.
We have good access to surgeons and anesthesiologists, who can parlay there a S T experience into the hospital setting.
And finally, we're also able to leverage our <unk> contract and CMS pass through status with this customer base, which is well received.
With that I'd like to turn the call over to Mark to discuss the customer feedback our medical colleagues are hearing about the volition and Artemis real world outcomes data.
Mark.
Thank you Patty.
We previously announced initial top line results from the volition and Artemis studies.
<unk> in collaboration with investigators at the Cleveland Clinic, and I'd Wake Forest Baptist Health.
These data have already been incorporated into our medical information materials and product dossier.
Growing health care providers to review the new data on the incidence of delirium.
Astro intestinal tolerability outcomes.
The length of stay data that I reviewed in last quarter's call.
While still very early.
The customers who have reviewed this information find it meaningful real world evidence that adds to our already published results.
Based on the feedback, particularly meaningful to health care providers and hospital administrators is are finding that in the Artemis study.
Limbic treated patients showed a statistically significant 1.6 day lower overall hospital length of stay compared to matched population of patients treated with other intravenous opioids.
There was no statistically significant difference in the average duration of time in the PACU and this study while these analyses do not provide definitive data regarding group differences as seen in our prospective randomized study. We believe these data bring a unique perspective to understanding how drugs may perform.
In the real World.
We hope to present this data later this year at a major anesthesiology meeting.
We also continue to make significant progress with tier V 045, our novel <unk> receptor modulator.
I've mentioned before some of the key features that we believe make O four fives profile unique.
In non clinical studies, unlike other drugs that target the <unk> receptor T. R. V 045, recycles internalized bound receptor very rapidly back to the cell surface, which results in no receptor desensitization and as a result, we saw no reduction in peripheral lymphocyte.
Site levels, which we would expect would lead to no long term immune suppression.
Yeah.
Also important is the T V 045 binds specifically to the subtype one of the five different <unk> receptor subtypes.
We believe this receptor specificity is meaningful.
<unk> one receptor is highly expressed on and regulates the function of specific cell targets in the brain.
For example, astrocytes and microglia ourselves.
These cells are believed to play a central role in the regulation of brain signaling events.
Key to the development of chronic pain.
And also play key roles in the physiology of how seizures develop and how they persist and causing epilepsy.
Finally, our non clinical safety data with tier V. 045 showed no changes in blood pressure heart rate or respiratory function, which had been reported with other drugs that target. The S. One P receptor.
This potential differentiation is now further supported by the evidence seen in our first in human Phase One study results that we reported last year.
Taken together these features of <unk> Oh, four fives design open up the possibility of exploring its use in epilepsy, and chronic pain, where reduce lymphocytes and immunosuppression would not be desirable features.
Okay.
Earlier this year, we announced that we began enrollment in two proof of concept studies for four or five.
The first study is intended to evaluate <unk> receptor mechanism of action and target engagement in the brain and in the periphery using a variety of human experimental pain models.
The second study uses transcranial magnetic stimulation.
Probe the potential effect of TRP 045 on cortical excitability in the brain.
Both of these studies are nearing completion of enrollment and we.
To report topline data in the third quarter of this year.
As a final comment.
Previously reported the evidence we've generated in our non clinical work with tier four five, particularly the findings in animal models of epilepsy through our collaboration with NIH is epilepsy therapy screening program.
Based on the encouraging findings NIH funded new evaluations of <unk> 45 in additional complex animal models, which are exploring the potential for TRP 045 to modify the development of seizures or potentially prevent them from developing in the first place.
Building upon the evidence from these studies, we've begun exploring the potential application of about four five in certain orphan epilepsy conditions.
As you can see our research team has made great progress this past year.
We're continuing to advance the real world evidence base for Olympic and we are on the cusp of some important catalysts that will help define the clinical path forward for T. R V 045 in.
In addition to exploring some further new avenues of potential application for this novel compound in our <unk>.
Non clinical studies.
I look forward to updating you in the coming months on all of these fronts.
I'll now turn the call over to Barry to review, our third quarter financials.
Sorry.
Thanks Mark.
In the first quarter, our net loss was $7 $8 million or <unk> 81 per share compared to $16 $4 million or $2 48 per share for the same period last year.
This reduced net loss was largely due to cost savings we implemented in 2022.
We remain committed to managing our expenses and cost effectively advancing our pipeline.
We finished the first quarter with $27 4 million in cash and equivalents.
Together with a $3 million milestone, one big Chinese approval and the $15 million financing tranche from arbitrage upon first commercial sale in China Xinhua next quarter.
This would extend our runway to mid 2024.
We believe were funded through many value driving milestones with several in the very near term.
Our T O V 045, we expect top line data from our proof of concept target engagement study using a variety of pain model.
We also expect topline data from our proof of concept Tms study for seizure disorders.
For Olympics, we expect to report new respiratory data for the first time, Mark 200 patient study using continuous respiratory monitoring devices as well as reporting other final data my volition and Artemis studies.
Yeah.
I want to stress that we expect all of these milestones for T. O P 045, and the Olympics and the upcoming third quarter, if not sooner.
We also continue to investigate partnering and other opportunities for Olympic enough pipeline candidates, which will drive additional resources and build shareholder value.
Yeah.
Well now open the call for questions after which Terry will provide some closing remarks.
Keith.
Yes. Thank you at this time, we will begin the question and answer session.
I ask a question you May press Star then one on your Touchtone phone.
If you are using a speaker phone please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
At this time, we'll pause pause.
Pause momentarily to assemble the roster.
And the first question comes from Doug Arthur with H C. Wainwright.
Hi, Good morning, Thanks for taking my questions. I think you said you're on formulary at a 188 hospitals I'm just curious given the focus now on a S sees is that skill as much shows you a sort of benchmark.
Our performance and I guess did you said that we are still pursuing additional hospital formulary. What's the number that you think you need to sort of hit critical mass. Thank you.
Hey, Todd. Thank you. Thank you for the question. So just to clarify first and then I'll turn it over to Patty that number is hospitals and also integrated our systems.
Systems that include ambulatory surgery centers that have had that put the drug on formulary. So went into when they haven't formulary meeting and there are more than just one physician deciding right. We count we count that as part a and in the larger number of Patty I'll, let you talk about the the hospital focus versus ASC, Yeah, I mean carries.
Right. The 188 is reflective of both hospital and ASC.
And as you well know this is always a process. We're getting on formulary is simply step one even though that step takes months and months. It is step one and after that we need to get the staff educated through our in service programs. After that we have to ensure that we have a smoother distribution channels and poor hospital with using one of the big three.
We're glad to be sure that they have stocked within the right <unk>.
Tribunal center and in some of the a S. C scenarios they want their own distribution not the big three we have to establish that which we talked about in the last quarter. So our base is small, but we're clearly a prep preceding N and progressing in the right direction and those trends are you know.
But what we wouldn't want to see not fast enough and against a very small base, but clearly the right direction.
Okay, great. Thanks, and then for 045 I'm just curious I think Mark you mentioned potentially pursuing rare orphan epilepsies I'm, just curious sort of how do you sort of go through and think about which ones you might potentially target. Thank you.
Sure Doug.
Thank you for the questions.
Our focus.
As you probably know is that amongst the orphan epilepsies, where we're kind of interested in are the ones that marry up nicely with the presumptive mechanism.
That we have for 045, and so we generated a reasonable amount of data to date supporting the theory that anti inflammatory action in the brain as I mentioned astrocytes in microglia being key targets of interest.
As a way we think about how the drug will work that said then we turn to the to the array of orphan epilepsies and.
There are several in there where anti inflammatory mechanisms arguably play a critical role for example, it's well known that infantile spasms.
As an example is an illness.
There inflammatory mechanisms play a critical role.
And the overall pathophysiology of perpetuating the seizures in that condition. So that's kind of how we we think about this it's not not.
Not just sort of going down the list per se, but trying to have a rational approach based on how we understand.
The drug works.
Okay.
And I guess, maybe when you step back how do you think about the commercial model.
Because it's sort of the pricing model and sort of very different when we think about sort of orphan epilepsy and rare epilepsies versus syndications that have much more prevalent are popular with patient populations.
Yeah, It's a great question, Doug and as you might imagine we're doing that work now.
So that when we have the proof of concept data next quarter. We can we can start to talk more about the path forward for T. I D 045, but it's it's a great question Thankfully we have a we have some really good folks involved in helping us assess the overall market opportunity.
Okay, great. Thank you.
So more to come right, I guess, Israeli where I'm say more to come as we roll out the data.
Right.
Okay. Thank you and the next question comes from Brandon Folkes of Cantor Fitzgerald.
Hi, Thanks for taking my questions.
Staying on slide no.
As we look to who would the topline data in the third quarter of this year. How are you thinking about what you may present to the street and how you may present, it and what I mean by that is you know how much data should we expect initially versus may perhaps keeping some of that data for presentation at scientific conferences.
General just given potential novelty all young full part thank you.
It's a good question.
Brandon.
As we've done in the past.
When we when we have new emerging data we.
We do reveal the topline results and generally speaking.
That's a that's a reasonable approach for any company and taken it typically does not.
Jeopardize our ability to presented at future meetings, so we'd be we'd be sort of going down both of those paths simultaneously disclosing what we found in a timely way.
To the public as well as our working actively to get it into presentations at meetings and ultimately into print.
For the General Scientific committee to community to review and.
And see you in detail. So I don't think that's going to present, a problem for us and we'll be as prompt and Fisher.
Efficient as we can be in presenting the data yeah, I agree I mean will present, especially because their proof of concept studies, we wanted to make sure we get the information out there. So that we can then talk about the path forward right. We have these two large opportunities Brandon you know, we as trevino, we're going down the.
The chronic pain path and then the NIH began studying T. RVO for five four for epilepsy, and and because of that we have now. These two opportunities. So I think it'll be really important for us to present the proof of concept study results for both of the studies at.
At the time, we receive them so great question, though.
Right well, that's crazy I look forward to continuing to take care.
<unk>.
Thank you and this concludes our question and answer session I would like to return the floor to carry Bordeaux for any closing comments.
Great. Thank you. Thank you for joining us this morning on the call as you heard we have several near term milestones and we're excited about the upcoming opportunities for <unk>. We look forward to providing you with additional updates and thank you that concludes this morning's call.
Thank you and as mentioned the conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.
Yeah.
Yeah.
Okay.