Q3 2020 Trevena Inc Earnings Call
[music].
Greetings and welcome to the Trugreen a conference call to provide update on commercial loss activities.
Operator: Greetings. Welcome to the Trevena conference call to provide an update on commercial launch activities for Olympic. At this time, all participants are in a listening only mode.
Vic.
This time all participants are in a listen only mode. A question and answer session will follow the formal presentation for anyone should require operator just to start the conference. Please press star zero on your telephone keypad.
Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Chief Financial Officer, Barry Shin. You may begin. Good morning, and welcome everyone.
Please note. This conference is being recorded I will now turn the conference over to your host Chief Financial Officer, Mary You May begin.
Good morning, and welcome everyone with me today are Perry Bordeaux, our president and CEO, Bob Yoder, Our Chief commercial officer, and our Chief Medical Officer, and Mark them attract.
Barry Shin: With me today are Kerry Bourdow, our President and CEO; Bob Yoder, our Chief Commercial Officer; and our Chief Medical Officer, Mark Demitrack. As a reminder, we'll be making forward-looking statements within the meaning of federal securities law. These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SEC. We undertake no obligation to update these statements beyond today.
As a reminder, we'll be making forward looking statements within the meaning of federal Securities law.
These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the FCC.
We undertake no obligation to update these statements be onto that.
During today's call Chairman will open with introductory remarks, and Bob will provide an update on our ongoing launch activities for Lindbergh, which is approved in adults for the management of acute pain severe enough to require Nike opioid analgesic for whom alternative treatments are inadequate.
Barry Shin: During today's call, Carriel will open with introductory remarks, and Bob will provide an update on our ongoing launch activities for Olinvik, which is approved in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate. I encourage you to visit Olympic.com, where you can find important safety information, including the box warning and the full prescribing information. I'll now turn the call over to Carol. Thanks, Barry. Good morning, everyone.
I encourage you to visit Olympic Dot com.
Or you can find important safety information, including a box warning and a full prescribing information.
I'll now turn the call over to Ken.
Thanks, Barry Good morning, everyone. Thank you for joining us today.
Carrie L. Bourdow: Thank you for joining us today. As we announced on Friday, we are very pleased that DEA scheduling for Olinvik is now complete. And as a Schedule II product, Olinvik can directly replace drugs like ivymorphine in the hospital setting. Let me reiterate our confidence in the Lindex distinct and compelling profile, a fast two to five minute onset of action and a morphine-like epithelium.
As we announced on Friday, we are very pleased that D.A. scheduling for Olympic is now complete and as a schedule to product Linda can directly replace drugs like Ivy morphine in the hospital setting.
Let me reiterate our confidence in the lindero distinct and compelling profile a fast two to five minute onset of action morphine like efficacy no active metabolites and the dosage adjustment in renally impaired patients a large patient population with significant medical complications.
Carrie L. Bourdow: No active metabolites and no dosage adjustment in renally impaired patients, a large patient population with significant medical complications. And a limbic system has a safety and tolerability profile demonstrated in a wide range of surgeries and challenging patients, including obese and elderly patients. We're excited that we can now make a limbic system available to physicians in hospitals and ambulatory surgery centers across the country, and we know that they've been waiting to begin using a limbic system to manage their patients in acute pain. As I said on previous calls, we began manufacturing the drug product prior to approval so that we could respond quickly to our customers after approval and DEA scheduling. We are now well positioned to have a commercial supply of Olimbic available this month.
And Olympic has its safety and Tolerability profile demonstrated in a wide range of surgeries and challenging patients, including obese and elderly patients.
We're excited that we can now make Olympic available to physicians and hospitals and ambulatory surgery centers across the country and we know that they've been waiting to begin using Olympic to manage their patients in acute pain.
As I've said on previous calls we began manufacturing drug product prior to approval. So that we could respond quickly to our customers. After approval in de scheduling. We are now well positioned to have commercial supply of Olympic available. This month.
And as you'll hear from Bob. There's also a lot of important work already underway to support the rollout of our customer facing teams in the first quarter of next year.
Carrie L. Bourdow: And, as you'll hear from Bob, there's also a lot of important work already underway to support the rollout of our customer-facing teams in the first quarter of next year. We've also continued to make exciting progress with our COVID asset, TRV 027, and our ongoing collaboration with Imperial College. Unfortunately, we've all seen the rise of COVID cases in the UK, and it was important for us to work really closely with Imperial College so that they could begin dosing patients in the 027 study as soon as possible. Remember that due to the unique mechanism of 027, Imperial College, along with the British Heart Foundation, is investigating the potential for O27 to reduce abnormal blood clots and lung damage, two of the most severe complications associated with COVI
We've also continued to make exciting progress with our cobot asset to your video to seven and our ongoing collaboration with Imperial College.
Unfortunately, we've all seen the rise of Koby cases in the UK and it was important for us to work really closely with Imperial College, so that they could begin dosing patients in the other two seven study as soon as possible.
Remember that due to the unique mechanism of up to seven Imperial College, along with the British Heart Foundation is investigating the potential for OTI seven to reduce abnormal blood clots and lung damage too with the most severe complications associated with kobin.
We are proud to be working with such leading institutions and we continue to expect topline data from this study in the first quarter next year.
Carrie L. Bourdow: We are proud to be working with such leading institutions, and we continue to expect top-line data from this study in the first quarter of next year. Before I turn the call over to Bob, let me quickly summarize our finances. Over the past few months, we completed a number of activities to strengthen our balance sheet, including a successful $57.5 million public offering with the full exercise of the underwriters' over allotment option and receipt of a $3 million milestone payment from NUOM, our partner in China. As a result, I'm pleased to announce that we ended the third quarter with $112.7 million in cash, which we expect to fund our operations for more than two years through Let me now turn the call over to Bob. Thanks, Kerry.
Before I turn the call over to Bob Let me quickly summarize our financials over the past few months, we compute we completed a number of activities to strengthen our balance sheet, including a successful $57.5 million public offering with the full exercise of the underwriters' overallotment on.
Option.
And receipt of a 3 million dollar milestone payment from our partner in China.
And as a result, I'm pleased to announce that we ended the third quarter with $112.7 million in cash, which we expect to fund our operations for more than two years through year end 2022.
Let me now turn the call over to Bob.
Thanks Kerry I.
I'm really excited to be here. This morning to provide an update on the progress we've made as a commercial organization.
Bob Yoder: I'm really excited to be here this morning to provide an update on the progress we've made as a commercial organization. With DEA scheduling for Olinvik now complete, we're able to begin making it available to our community in preparation for this milestone. We've already completed key activities on the supply chain side to ensure we can move product through the trade channel seamlessly once a customer places an order. I am pleased to announce that we have contracts in place with the three largest wholesalers who cover the vast majority of the acute care business.
Yes scheduling for Olympic now complete we're able to begin making it available to our customers.
In preparation for this milestone we've already completed key activities on the supply chain side to ensure we can move product through the trade channel seamlessly once a customer places an order.
I am pleased to announce that we have contracts in place with the three largest wholesalers who covered the vast majority of the acute care business.
We're working with each wholesaler to ensure product is made available in their respective distribution centers to allow for fishing ordering and delivery to hospitals inventories surgery centers.
Bob Yoder: We're working with each wholesaler to ensure the product is made available in their respective distribution centers to allow for efficient ordering and delivery to hospitals and ambulatory surgery centers. You'll recall that, leading up to approval, we had already conducted a great deal of market research with formulary stakeholders on the Olympic clinical data, including preliminary pricing. With an approved label, the feedback we've received from key physicians and formulary decision makers has been positive. There is clear excitement over Olympic's 2-5 minute fast onset of action, lack of active metabolites, and no need for dosage adjustments in patients with renal impairment.
You'll recall that we didn't want to approval, we had already conducted a great deal of market research with formulary stakeholders on the Olympic clinical data.
Including preliminary pricing research.
Within approved label the feedback we've received from key positions in formulary decision makers has been positive.
It's clear excitement over Olympics, two to five minutes fast onset of action lack of active metabolites and no need for dosage adjustments in patients with renal impairment.
We also appreciate the fact that we are making Olympic available in three vial configurations that cover PC games as well as bolus dosing options.
Bob Yoder: They also appreciate the fact that we are making Olimbic available in three vial configurations that cover PCA as well as bolus dosing options. With this feedback in hand, we've finalized the wholesale acquisition cost or WAC price per vial. Let me start with PCA. For the 30 milliliter vial, the WAC price is $110.
With this feedback in hand, we finalized the wholesale acquisition cost for work price per vial.
Let me start with the P eight dose.
30, milliliter, while the whack price is $110.
Well the single dose files, which will be used multiple times per day. The workplace is $17.50 for the one ml vial and $25.75 for the true ml vial.
Bob Yoder: For the single-dose vials, which will be used multiple times per day, the WAC price is $17.50 for the 1-ml vial and $25.75 for the 2-ml vial. Given the diversity of settings of care where a limbic could be used and the fact that dosing to comfort is highly variable across patients and procedures, we think it's also helpful to frame this in terms of an approximate price range of $100 per day. An important consideration in the value proposition for a limbic system therapy is the potential cost offset we believe it will demonstrate in the hospital or ambulatory surgery center setting. When evaluating a new drug, hospitals are focused on two objectives. Improving patient outcomes and decreasing costs. Adverse events associated with conventional IV opioids, like morphine, are substantial and place a heavy burden on hospitals.
Given the diversity of settings of care were Olympic could be used and the fact that dosing for copper is highly variable the cross patients and procedures.
We think it's also helpful to frame this in terms of an approximate price range.
A $100 per day.
An important consideration in the value proposition for Olympic there's the potential cost offset we believe it will demonstrate in the hospital or inventories surgery Center said.
When evaluating a new drug hospitals are focused on two objectives the.
Improving patient outcomes and decreasing cost.
Adverse events associated with conventional IB opioids like morphine are substantial and placed a heavy burden on hospitals.
We have developed a robust health economic model to demonstrate the overall value that Olympic can bring to the overall health care system.
Bob Yoder: We have developed a robust health economic model to demonstrate the overall value that a limbic system can bring to the overall health care system. The model was developed in collaboration with an expert at the Medical University of South Carolina. And we've already received positive feedback in discussions with formulary stakeholders. Now, I'd like to move on to our ongoing customer engagement activities. As you might imagine, we're closely monitoring the impact of COVID-19 on our ability to conduct traditional face-to-face meetings with our potential customers and our key opinion leaders. What is encouraging is that we're continuing to see strong engagement from physicians across digital platforms. As I mentioned on our call in August, we'll be kicking off a multi-channel educational campaign to ensure we're providing a surround sound engagement, including a channel mix across page search, digital, print, and email. In addition to a full portfolio of print and digital materials, we will be implementing a KOL Speaker Bureau with virtual capabilities.
The model was developed in collaboration with an expert at the medical University of South Carolina.
And we've already received positive feedback in discussions with formulary stakeholders.
I'd like to move on to our ongoing customer engagement activities.
As you might imagine we're closely monitoring the impact of Tobin 19 on our ability to conduct traditional face to face meetings with our potential customers and our key opinion leaders.
What is encouraging is that we're continuing to see strong engagement from positions across digital platforms.
As I mentioned on our call in August we'll be kicking off a multi channel educational campaign to ensure we're providing a surround sound engagement, including a channel mix across paid search digital print and email.
In addition to a full portfolio of print and digital materials, we will be implementing it came well Speaker Bureau with virtual capabilities.
The build out of our customer facing team is progressing well.
Bob Yoder: The build-out of our customer-facing team is progressing well. We have partnered with Cineos Health, an industry-leading contract sales organization with strong experience in the hospital space. And they'll be providing support for sales, market access, and medical service liaison hiring, as well as bringing critical sales and sales ops support to our team. We chose Stenehouse for several reasons.
We have partnered with Citi Your health and industry, leading contract sales organization with strong experience in the hospital stays.
Adobe, providing support for sales market access and medical science liaison hiring as well as bringing critical sales and sales ops support to our team.
We chose studios for several reasons, they're able to recruit train and deploy a field team very quickly, which will enable us to cover all of our targeted areas at launch.
Bob Yoder: They are able to recruit, train, and deploy a field team very quickly, which will enable us to cover all of our target areas at once. And they also provide us with the flexibility to evolve our staffing needs very efficiently as our business grows. I am pleased to say that the recruiting process for all customer-facing roles is underway, and we've been very pleased with the caliber of candidates we are seeing. As I previously discussed, with our targeted and focused launch, we've identified a subset of approximately 550 hospitals as early adopter institutions, meaning hospitals that conduct a higher percentage of the painful procedures where IV opioids play a critical role and who have historically adopted branded products a little more quickly than some of their peers.
Yeah. They also provide us with flexibility to evolve our staffing needs very efficiently as our business grows.
I am pleased to say that the recruiting process for all customer facing roles is underway and we've been very pleased with the caliber of candidates we are seeing.
As I previously discussed with our targeted and focused launch we've identified a subset of approximately 550 hospitals as early adopter institutions, meaning hospitals that conduct a higher percentage of the painful procedures, where IB opioids played a critical role and he had to say.
Sure, we adopted branded products, a little more quickly than some of their peers.
In addition, we're targeting around 500 ambulatory surgery centers that are either formally affiliated with our target hospitals or located nearby.
Bob Yoder: In addition, we're targeting around 500 ambulatory surgery centers that are either formally affiliated with our target hospitals or located nearby. These ASCs represent a great opportunity for early use by KOLs, as those settings traditionally have a process for adopting new products that's faster than a hospital formulary review. In many cases, clinicians will get experience with a limbic system in the outpatient setting and then bring that experience into the hospital's formulary discussion and review. Because of our targeted approach, we will be able to cover these accounts very efficiently with a footprint of approximately 40 customer-facing roles split across medical science liaisons, regional account managers, and representatives. Clearly, it's an exciting and very busy time for Trevena.
Yes, I guess you could represent a great opportunity for early use by cable wells as those settings traditionally have a process for adopting new products that's faster than it has.
Little Formulary review.
In many cases coalitions will get experience with Olympic in the outpatient setting and then bring that experience into the hospital formulary discussion and review.
Because of our targeted approach, we will be able to cover these accounts very efficiently with a footprint of approximately 40 customer facing roles split across medical science liaison regional account managers and representatives.
Clearly, it's an exciting and very busy time for two bina I'm thrilled that weve crossed this final regulatory milestones and getting Olympic approved and schedule and I very much look forward to making Olympic available to the physicians who have been waiting for this differentiated new treatment option.
Bob Yoder: I'm thrilled that we've crossed this final regulatory milestone in getting a limbic system approved and scheduled, and I very much look forward to making a limbic system available to physicians who have been waiting for this differentiated new treatment option. I'd like to close with a reminder that our objective is to facilitate the use of Olympic in the appropriate patients in place of conventional IV opioids like morphine and hydromorphine, and it is not one of an expansion of the use of IV opioids. As we continue to move forward, we remain focused on execution and taking the necessary steps to stand up our customer-facing infrastructure and teams quickly and efficiently. With that, we'll now open the call for questions. After which, Terry will provide some closing remarks. Operator.
I'd like to close with a reminder, that our objective is to facilitate the use of a little bit in the appropriate patients in place of conventional IB opioids like morphine and Hydromorphone and it is not one of expansion of the use of IB opioids.
As we continue to move forward, we remain focused on execution and taking the necessary steps to stand up our customer facing infrastructure and teams quickly and efficiently.
With that well now open the call for questions after which Terry will provide some closing remarks operator.
And at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You maybe first starting to if you like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before Christmas dark.
Operator: And at this time, we will 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 queue. You may press star 2 if you would like to remove your question from the queue.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star 2. One moment, please, while we poll for questions. And our first question is from Brandon Folkes from Canada Fitzgerald. Please proceed with your question. Hi, thanks for taking my questions and congratulations on the scheduling and imminent launch. And one question we have a lot of discussions with investors about is, just given the challenges that hospitals and ASCs have had around COVID, how do you think, Unknown Attendee? What's your view on the willingness of these centers to maybe change standard operating procedures, just given that you're going to be launching a new product? There have been two schools of thought here.
One moment, please while we poll for questions.
And our first question is from Brandon Folkes from Cantor Fitzgerald. Please proceed with your question.
Hi, Thanks for taking my questions and congratulations on the Sugarland and imminent launch.
One question, we have a lot of discussion with investors on is just given the challenges that hospitals and I see that had around quite a bit how do you think.
Well, what's your view on the willingness of these centers to maybe change standard operating procedures, just given that you're gonna be launching a new product you know there's been two schools of thought share one being that SAP, because they're trying to minimize any changes to standard operating procedures drink hybrid the second obviously being that yes, it's very much disruption it's right.
Brandon Richard Folkes: One being that centers are trying to minimize any changes to standard operating procedures during COVID. The second, obviously, being that there's so much disruption, it's ripe to introduce something new there. So I'd love to just get your thinking and how we should then parlay that into a launch ramp for Linvik.
To introduce something new there so I'd love to just get your thinking and how we should then parlay that into launch ramp well then Vic and then just staying on the Covance theme and all the 550 quick adopted the hospitals and the 508, you see and you talked about the AMC is adopting cui.
Carrie L. Bourdow: And then just staying on the COVID theme, of the 550 quick adopters in the hospitals and the 500 ASCs, you talked about the ASCs adopting quicker and then bringing those into the hospitals. How should we think about the hospitals versus the ASCs in terms of revenue pull through for Linvik when we're modeling? Thank you very much. Thanks, Brandon.
Okay, and then bring it back into the hospital, how should we think about the hospitals bases that you see in terms of revenue pull through for Lindbergh when we bought it. Thank you very much.
Thanks, Brendan I appreciate the question.
Carrie L. Bourdow: I appreciate the question. So, let me talk just a little bit about the introduction of a new agent and then I'll turn it over to Bob so he can talk a little bit more about how he's thinking about the launch in terms of COVID. So, you know, one of the things that we say about Olimbic, and one of the things that we worked really hard to do, is to make this as easy as possible for physicians. They don't really have to do anything new. They, in fact, we have the Olimbic morphine conversion right on the label. And by that, I mean that if they're used to using morphine at 5 milligrams, about 1 milligram of Olimbic is equal to 5 milligrams of morphine. So, and we've made the vial so that there's no refrigeration, no reconstitution. They'll be housed in the same PIXUS unit as morphine. The pharmacist will be doing the same sort of things, so there's not anything different. They're not having to use or go outside of sort of their treatment continuum. That's the first piece.
So let me talk just a little bit about the the introduction of a new agent and then I'll turn it over to Bob can talk a little bit more about how you're thinking about the the launch in terms of Cowen.
You know one of the things that we say about Olympic is that one of the things that we've worked really hard to do is to make this as easy as possible for physicians. They don't really have to do anything new or they are in fact, we have the Olympic.
Morphine conversion right in the label and by that I mean that if they're used to using morphine five milligrams or about one milligram of Olympic is equal to five milligrams of marketing.
So and we've made the vial so that Theres no refrigeration no re constitution and they'll be housed in the same pyxis unit as morphine. The pharmacists will be doing the same sort of things. So there's not anything different there they're not having to you go outside of sort of their treatment continue.
That's the first piece the second piece is that a we got broad indication statement brought dosing administration were putting out the three vial to allow for flexible treatment at the patients I think that that's you know important what we heard and then lastly, you remember that with our open label safety study Athena, we have a lot of physicians who have.
Carrie L. Bourdow: The second piece is that we got a broad indication statement, and broad dosing administration. We're putting out the three vials to allow for flexible treatment of the patients. I think that's, you know, important what we heard.
Carrie L. Bourdow: And then lastly, remember that with our open-label safety study, Athena, we have a lot of physicians who have already used Olimbic in that safety trial, and they've been waiting for it, right? So they've already sort of pinpointed the types of patients where they'd like to use the drug. Certainly, we are looking at hospitals that maybe have slowed down in terms of elective surgeries. But what we're hearing is that hospitals are trying to manage their business, and they're continuing to move forward, in particular, with things like orthopedic surgeries and some colorectal surgeries. So, Bob, I'll let you talk a little bit more about some of the things you're thinking about as you think about the launch ramp. Yeah, sure. Yeah, but I would also add to that, Brandon, there's high regional variation around that as well.
I've already used a lundbeck in that and that safety trial and they've been waiting for it right. So they they've already sort of pinpointed the types of patients that that where they'd like to use the drug certainly we are we are looking at the hospitals that maybe have slowed a in terms of elective surgeries.
But what we're hearing is that hospitals are trying to manage their business and their continuing to move forward in particular with things like orthopedic surgeries and some of the colorectal surgeries. So Bob I'll, let you talk a little bit more about some of the things you're thinking about as you think about the launch.
Yeah.
Yeah sure Yeah, <unk>, but I would also add to that list as is.
Hi, regional variation around that as well so we'll be keeping a close eye on that in terms of our deployment and things like that as well and I think what I'm hearing when I speak to some kinda wells is that they've learned a lot.
Bob Yoder: And so we'll be keeping a close eye on that in terms of our deployment and things like that as well. And I think what I'm hearing when I speak to some KOLs is that they learned a lot early on in the COVID crisis that I think they're applying now about their processes and how to be efficient moving forward. In terms of the split between ASCs and hospitals, if you look at the number of patients, there are certainly more patients in the outpatient setting, the ambulatory surgery center setting. And in fact, hospitals are pushing more procedures out to the outpatient setting because it's a lower cost setting of care. So there are more patients in the outpatient setting. However, those patients are getting dosed less frequently and with lower dosages than in the inpatient setting.
Early on in the call. The crisis that I think are applying now about their processes and how to you won't be efficient moving forward in terms of the split between I guess he's at hospitals you look at the number of patients. There are certainly more patients in the outpatient setting the inventories surgery center setting and in fact hospitals are pushing more procedures out to.
The outpatient setting because it's a lower cost setting of care, but so so there's more patients in the outpatient setting however.
However, those patients are the dose less frequently with lower dosage is then the inpatient setting so on balance over the longer run whether be early years in the outpatient setting overtime the bigger chunk of our business will come from the inpatient setting because any individual patient is getting those longer with higher doses than you might see in the outpatient setting.
Bob Yoder: So on balance, over the longer run, while there'll be early use in the outpatient setting, over time, the bigger chunk of our business will come from the inpatient setting because any individual patient is getting dosed longer and with higher doses than you might see in the outpatient setting. Does that help? Very helpful. Thank you very much. Our next question is from... David Gaiman with Guggenheim.
Does that help.
Very helpful. Thank you very much.
Our next question is from.
David Gaming.
Moving I'm. Please proceed with your question.
Unknown Attendee: Please proceed with your request. Thank you for the questions. This is Devin on behalf of Dana Flanders at Guggenheim.
Hi, Thank you for the questions. This is Devon on poor Dana Flanders at Guggenheim Just one and then I'll have a follow up I guess with the batches that you now have available and there I know you guys have been ramping manufacturing capacity pre approval what are the gating factors for.
Unknown Attendee: Just one, and then I'll have a follow-up. I guess with the batches that you now have available, I know you guys have been ramping up manufacturing capacity without pre-approval. What are the gating factors for launch this quarter now that you have, I guess, DEA scheduling and then just one follow-up after that? So we can make the drug available. We'll be, as we said on the call, putting the drug in the channel this month so physicians can order it. We won't have our field team deployed until the first quarter of next year.
Launch a this quarter now that you have or I guess you guys got drilling and then just one follow up after that thank you.
So we can make drug available will be as we said on the call will be putting a drug in the channel. This month I'm physicians can order. It we won't have our field team deployed until first quarter of next year. So I think that's a lot of it and you know we'll.
Unknown Attendee: So I think that's a lot of it. And, you know, we'll be adding to our website. We'll be pushing out pharmacy newsletters. But as far as, Unknown Attendee, Barry Shin, Trevena Inc., Yeah, yeah, absolutely, Devin.
Be adding to our website will be pushing out you know pharmacy newsletters, but as far as.
A big sort of push I guess that that probably will take place or early first quarter, Bob I know you've been working really closely with the wholesalers and may be able to add some color.
Yeah Yeah.
Yeah, absolutely done so we have as I mentioned, we have contracts with all three of the big the big three wholesalers and we're now talking with them there are buyers and talking about the initial stocking and across two distribution centers and things like that so so we'll be ready as product becomes available to support their needs across their distribution centers.
Bob Yoder: So we have, as I mentioned, we have contracts with all three of the big wholesalers, and we're now talking with them, their buyers, and talking about initial stocking across their distribution centers and things like that. So, we'll be ready as product becomes available to support their needs across their distribution centers. Okay, great. That's very helpful. And then as far as access to formulary for I guess hospitals and ASCs, I know you guys announced that you have done some diligence and pharmacoeconomic data. Are there any plans to formally release that data, whether it be through publication or through presentation, like a press release? Just trying to get a sense if that will be publicly available. Yes, yes, absolutely. It's a really great point.
Okay, Great. That's very helpful and then as far as access onto formulary for I guess hospitals Nancy's I know you guys are now that you have done some diligence and Pharmaco economic data is there any plans to formally released that theater.
Whether it be through publication or presentation like press release, I'm, just trying to get a sense of that won't be a publicly available.
Yes, yes, absolutely it's a really great point, so we as as Bob mentioned, we're working with the health economists at a medical school, South Carolina and she's looking for to publishing this information we intend to have the data available and we will be.
Carrie L. Bourdow: So we, as Bob mentioned, are working with a health economist at the Medical School of South Carolina, and she's looking forward to publishing this information. We intend to have the data available, and we will be publishing it before our field sales organization gets out, whether it's accepted for publication, and we can, you know, make that information known. But, for now, I think we're starting to put a lot of information in our pharmacy newsletters, and as we do that, we'll begin adding it to our corporate deck so that we can talk about it publicly, but it's a great point. We absolutely intend to publish. Okay, great.
Publishing it before our field sales organization get gets out whether it's accepted for publication and we can make that information now but front.
For now I think where we're starting to put a lot of information in our pharmacy newsletters and as we do that we'll begin adding it to our corporate tax so that we can talk about publicly but its a great point, we absolutely intend to publish.
Okay, great. Thank you.
Unknown Attendee: Thank you. And our next question is from Jason Butler with J&P Securities. Please proceed with your questions. Hi, thanks for taking the questions. I had a couple on Olimbic and then a follow up on the 2.7 COVID program.
And our next question is from Jason Butler with JMP Securities. Please proceed with your question.
Hi, Thanks for taking the questions I had a couple on Ilim back and then a follow up on the I know two seven cobot programs. So for Olympic can you just break down a little bit more froze your assumptions that go into that at all.
Jason Nicholas Butler: So for Olimbic, can you just break down a little bit more for us your assumptions that go into that average WAC pricing of $100 a day? Just trying to get a sense of how much you know bolus use you're expecting versus PCA. And then, in terms of formulary reviews, anything you're hearing from the field about how the pandemic is impacting the ability of hospitals to conduct formulary approvals or delays, you know, around that process? Sure. So I'll start on the pricing, and I'll turn it over to Bob, who can close on the pricing and then talk a little bit more about what he's hearing. So, in terms of bolus and PCA use, the majority of the use is bolus. It's about 65, 70 percent of bolus use in hospitals across the country. Certain hospitals are slightly different, but so is the bulk of bolus. PCA dosing is about 30 percent or so.
Whack pricing of $100 a day, just trying to get a sense of how much you know bolus use you're expecting versus PCIA and then in terms of formulary reviews any anything you're hearing from the field about how the pandemic is impacting the the ability of hospital to conduct formulary.
Rubles or or or delays you know around that process.
Sure. So I'll start on the pricing and I'll turn it over to Bobby can close on the pricing and then talk a little bit more about what he's hearing so its current in terms of bullets in PC I use the it the majority of the use is bolus, it's about 65, 70% bolus use in hospitals.
Across the country certain hospitals are slightly different but so the bulk is bolus P.C.A. dosing is you know about 30% or so.
You know pain acute pain is.
Carrie L. Bourdow: You know, pain, acute pain, has a wide variety of surgeries and patient types. And so when we think about that $100 a day, we're thinking about everything from orthopedic surgery, which, as Bob mentioned, may have fewer vials but may have higher doses, all the way to colorectal surgeries, for instance, where patients are dosed with multiple vials per, per, per day and actually over the course of the treatment in the hospital setting. So in terms of that $100 a day price point, you think about orthopedic being maybe around $70 a day or so, colorectal, gynecologic, some of those longer-term surgeries may be closer to $130 or so, and that's a mix between the one MIG and the two MIG.
Has a wide variety of surgeries and patient types and so when we think about that $100. A day, we're thinking about everything from orthopedic surgery, which as Bob mentioned may have fewer vials, but may have higher doses all the way to colorectal surgeries for instance that where where patients are done.
Just with multiple vials per per per day, and actually over the course of the treatment in hospital setting.
So in terms of that $100 a day price point, you think about orthopedic being maybe around $70 a day or so colorectal gynecologic some of those longer term surgeries, maybe closer to 130 or so and that's a mix between the one megabit to mix. Some of this is based on our Athena study, which was modeled.
Carrie L. Bourdow: Some of this is based on our Athena study, which was modeled after real-world use, and a lot of it is based on market research that we've done, discussions that we've had with Athena stakeholders and how they treat acute pain patients in the hospital setting. Does that help, Jason? That gives you some sense of the wide range of surgeries that we're thinking about. Bob, anything else that you want to add to that one, and then I'll let you address the question around what you're hearing around formulary adoption during the COVID pandemic. Yeah, I don't think I have anything else to add to the pricing one. That covers it. In terms of the pandemic, Jason, it's, like I said before, it's certainly highly variable by region.
After the real world use and a lot of it is based on in market research that we've done discussions that we've had with Athena stakeholders and how they treat acute pain patients in the hospital setting.
Hi, Jason that gives you some sense of the wide range of surgeries that were thinking about.
Bob anything else that you want to add on that one and then I'll. Let you address the question around the what you're hearing around formulary adoption during the cobot pandemic.
Yeah, I don't think anything else to add to the pricing one I think that covers it in terms of the pandemic Jason It. So like I said before it's certainly highly variable by region, but I, but when I'm talking to physicians, they are saying that they're getting sort of back to business and they you know they learned a lot for the first time through with the cobot Spike.
Bob Yoder: But I'm talking to physicians, and they are saying that they're getting sort of back to business, and they, you know, they learned a lot the first time through with the COVID spikes, and they know they need to keep things running this time around. So I've heard that they're sort of getting back to business as usual in terms of formulary. That being said, the cycle still is roughly six to 12 months before you know once a product is reviewed for formulary approval and then used before that. So, but again, I think we're going to keep a close eye on it. And we're going to make sure that we allow that insight to inform our deployment and things like that. But at this point, it seems like they're sort of managing through it.
And they know they need to keep things running this time around so I've heard that there there were sort of getting back to business as usual in terms of formulary that being said the cycle still as you know roughly six to 12 months before you know once the product is reviewed for formulary approval and then use before that so.
I think we're going to keep a close eye on it and we're going to make sure that were we allowed that insight to inform our deployment and things like that but at this point it seems like.
They are sort of managing through it.
Great and then just 027, yes remind us of the patient characteristic and end point, but that you're assessing them will have data from in the first quarter.
Bob Yoder: Great. And then just on 027, can you just remind us of the patient characteristics and endpoints that you're assessing, and we'll have data from in the first quarter? Sure. Mark, do you want to talk a little bit about 027?
Sure Mark you want to talk a little bit about or to seven.
Sure Hi, Jason Thank you for the question the.
Mark A. Demitrack: Sure. Jason, thank you for the question. The patients that are enrolled in the study are patients who are hospitalized with a confirmed diagnosis of COVID. And these are adults, so they are 18 or older.
Patients that are enrolled in this study are patients who are hospitalized with a confirmed diagnosis of coated and these are adults age 18.
Or older.
So it really is a fairly broad net but as you know in a in the UK in particular to get into the hospital patients.
Mark A. Demitrack: So it really is a fairly broad net. But as you know, in the UK in particular, to get into the hospital, patients are generally fairly ill and acute with the illness at time of entry. The primary outcome measure that Imperial College is looking at is an intermediate marker of clotting. They're using a measure called D-Dimer, which is one of the main laboratory components that's used to monitor coagulopathy and risk for clotting.
Patients generally are fairly.
Ill and acute with the with the onset time entry the primary outcome measure the Imperial College is looking at is an intermediate marker of clotting, they're using to measure called D dimer, which is one of the.
Main laboratory components its use to monitor.
Good luck, let's see in at risk for.
For clotting, and then important secondary outcomes, our key recovery milestones either the progress of the disease the.
Mark A. Demitrack: And then important secondary outcomes are key recovery milestones, either progress of the disease. Unknown Attendee, Dr. Mark Bourdow, Mark Demitrack, Jason Bourdow, Unknown Attendee, Barry Shin, These patients are non-ventilated, Jason, but if they become ventilated while they're in the hospital, then we'll of course continue to treat them. I think one important point is, if you remember when we first started this study, the requirement was patients had to be over the age of 65, and then Imperial College actually broadened that to patients over the age of 18, and I think that speaks to, I know in the conversations we've had with them, it speaks to the fact that we're seeing, in particular, the abnormal blood clots in younger and younger patients, and so I think this will be one of the first studies that look at such a wide range in age, in terms of blood clots and lung function.
The greater morbidity or.
Hi to improvement in time to discharge also measures of pulmonary function are being assessed in the study. So it's a fairly broad looked at the clinical milestones as well as the intermediate milestone that's probably good luck.
And these these patients are non ventilated, Jason but if if they become ventilated while they're in the hospital that will of course continue to treat them I think one important point is if you remember when we first started the study. This is that it that requirement was patients had to be old age of 65, and then Imperial College.
Hi, Brian that patients over the age of 18, I think that speaks to I know in the conversations we've had with them. It speaks to the fact that we're seeing in particular, the abnormal blood clots in in younger and younger patients and so I think just will be one of the first studies that that look at such a wide range.
Age in terms of blood clots in lung function.
Carrie L. Bourdow: Great, that's really helpful. Thanks for the questions and congratulations again on the progress. Thank you, Jason. We appreciate it. And our next question is from Douglas Tsao with AC Rainwright. Please proceed with your question. Hi, good morning.
Great. That's really helpful. Thanks for the thanks for the questions and congrats again on the progress. Thanks.
Thank you Jason we appreciate it.
And our next question is from Douglas Tsao H.C. Wainwright. Please proceed with your question.
Hi, good morning, Thanks for the update just curious could you maybe walk through the process and timing for getting the various reimbursement codes you don't win and in particular getting pass pass through status and how you think that you know potentially benefits you are more informed the launch strategy.
Douglas Dylan Tsao: Thanks for the update. Just curious, can you maybe walk through the process and timing for getting the various reimbursement codes, you know, and in particular getting pass-through status and how you think that potentially benefits you or informs the launch strategy? Thank you. Good morning, Doug.
Thank you.
Sure. Good morning back. Thank you appreciate it Bob.
Carrie L. Bourdow: Thank you. I appreciate it. Bob?
Bob Yoder: Sure. Yeah. Hi Doug.
Sure Yeah, Hi, Doug Thanks for the question.
Bob Yoder: Thanks for the question. Let me start with inpatient. It's fairly straightforward for inpatient. So upon the first commercial... And by the way, this would be the process any new product launch would follow through. So nothing unique for us.
Let me start inpatient it's fairly straight forward for inpatient so upon first commercials and by the way. This is this will be the process any new product launch it would follow through so nothing unique for us.
But upon first commercial sale, we'll file the paperwork for a miscellaneous J code and when they have to sign a J code will be used in the inpatient setting the DRG, but again, it's not really a reimbursement issue because obviously the DRG is reimbursed at the procedure level.
Bob Yoder: But upon first commercial sale, we'll file the paperwork for a miscellaneous J code, and when that's assigned, that J code will be used in the inpatient setting in the DRG. But again, it's not really a reimbursement issue because, obviously, the DRG is reimbursed at the procedure level. In the outpatient setting, what will happen is we'll apply for a miscellaneous C code. That's granted, and for the first quarter or two, and it depends on the submission timing, customers will get reimbursed at 95% of AWP. And then at some point when the CMS does the review, they'll come back and either grant or not grant pass-through status. If we get pass-through status, we get a permanent C code, and for the next two to three years, that gets rolled into the reimbursement for the patients... They get reimbursed at basically ASP plus 6%. If it's not granted, a pass-through is not granted, Doug, then we default back to the J-code.
The outpatient setting what will happen to apply for a miscellaneous C code that's.
That's granted and for the first quarter or two it depends on the submission timing.
Customers will get reimbursed at 95% Okay W.P.
And then at some point when the CMS does that mean, you will come back and either grants or not grant pass through status. If we get pass through status, we get a permanent C code and for the next two to three years that gets rolled into the the reimbursement for the they get reimbursed that basically a ASP plus 6% it.
If it's not granted a pass through is not granted talk then then we'd default back to the J code and basically whatever they get reimbursed for the outpatient procedure Olympic would be would be partly have to cover that as its just taken in patients.
Bob Yoder: And basically, whenever they get reimbursed for the outpatient procedure, you know, a limbic would be part, they'd have to cover that, as if it were just like an inpatient. So those are the two paths on which we're on. Your question around what it means in terms of pass-through, getting it or not, it's certainly advantageous to get it, but it's not a business hindrance. There are a lot of successful products in the outpatient setting that have not gotten it. OfferMeth comes to mind.
So so those are the two past which were on your question around what it means in terms of pass through getting it or not.
It's certainly advantageous to get it but it's not a business hindrance. There was a lot of successful products in the outpatient setting you have knocked out that offer me have comes to mind. So that does not receive pass through status and I still do quite well within within the outpatient setting I think what it defaults back you is I think we'll have a very compelling clinical profile.
Bob Yoder: So that button does not receive pass-through status and still did quite well within the outpatient setting. But I think what it defaults back to is I think we'll have a very compelling clinical profile in the outpatient setting that I think clinicians will find advantageous, and we'll use it and look for other ways to optimize their reimbursement within the APC code. We're certainly going to apply for a pass-through status, Doug, and so we'll update you all as we continue to get those timelines. Okay, and I mean, did that sort of thinking about the pop, you know, sort of both possibilities, sort of think affect how you price Olympic at $100 per day? That's certainly factored in, correct?
In the outpatient setting, but I think clinicians will find advantageous animal well use it and look for other ways to optimize their reimbursement within the APC code.
Yes, I mean does that imply for fast yeah, we're certainly going to apply for pass through status yet again, so we'll we'll update well update you all as you know we continue to get those timelines.
Okay, and maybe did that sort of thinking about the pop you know sort of bolt possibility. So to think back to how you price Olympic at that $100 per day.
That's certainly factor that correct.
Okay.
And thinking about the in patient outpatient business that.
Bob Yoder: And think about the inpatient and outpatient business that we talked about earlier. And then just one final question, and I don't know if you touched on this, I'm jumping between a couple calls this morning, but, you know, in terms of timing of starting to have formulary meetings, has that begun, and do you have a sense of how long it will take you to have those formulary meetings, the formulary committee? Yeah, so we have already gotten inbound interest from various groups, in part, as you mentioned And as Bob said, there are, in some cases, some ambulatory surgery centers that are looking to add it on more quickly. So, in the inpatient setting, formulary reviews are normally around 6 to 12 months, depending on the hospital. As you've heard, our targeting, we're in that community, the community teaching bulk of hospitals that tend to put drugs on formulary a little bit more quickly. We've also analyzed the early adopter hospitals.
You know that we talked about earlier yeah.
And then just one final question and I don't know if you touch on jumping a couple calls this morning, but you know in terms of timing of starting to have formulary meetings has that gone and do you have a sense of you know how long. It you sort of think about that your target universe of accounts.
Actually the Athena.
You know it's high how long before you will be able to have had those formulary meeting from their formulary committee meetings for for most of those targets.
Yeah. So we have already gotten inbound interest from from various groups in part as you mentioned because of Athena because people have been waiting for the track and as Bob said, there's there's in some cases some ambulatory surgery centers that are looking to add it on more quickly.
So in the inpatient setting it's it's normally a formulary reviews normally around six to 12 months, depending on the hospital as you heard our targeting is we're in that community community teaching a bulk of hospitals that tend to put drugs on formulary a little bit more quickly. We we also analyze the.
The early adopter hospitals, we won't have feet on the street right, we want to have our customer facing team on the street until the first quarter. So while we've gotten some inbound interest from some physicians and formulary stakeholders that know the drug I think the bulk of the formulary scheduling if you well well start to happen or early first quarter.
Carrie L. Bourdow: We won't have feet on the street, right? We won't have our customer-facing team on the street until first quarter. So, while we've gotten some inbound interest from physicians and formulary stakeholders that know the drug, I think the bulk of the formulary scheduling, if you will, will start to happen early in first quarter. Okay, great.
Okay, great. Thank you.
Thank you.
Carrie L. Bourdow: Thank you. Thank you. We have reached the end of the question and answer session, and I'll now turn the call over to CEO Kari Bourdow for closing remarks. Thank you. And thank you all for your questions. As you've heard from all of us this morning, this is truly a transformational time for Trevena. We're assembling a strong and experienced Alembic launch leadership team. And you heard me say that we're executing on our tactical plans to ensure drug product availability beginning this month. And we're moving forward with the build-out of our field team for deployment next year. In parallel, I think what you've also heard is that our pipeline remains a top priority. And we'll be supporting Imperial College as they continue to enroll COVID patients for the TRV02 study. We look forward to sharing additional updates with you as we make progress across all fronts. And I thank you again for joining us. That concludes today's call. And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
And we have reached the end of the question and answer session I'll now turn the call over to see ORKAMBI Murdo for closing remarks.
Thank you and thank you all for your questions as you've heard from all of US. This morning. This is truly a transformational time for trevino were assembling a strong and experienced a lending launched leadership team at you here that we're executing on our tactical plans to ensure.
Drug product availability beginning this month.
And we're moving forward with the build out of our field team for deployment next year in parallel I think what you've also heard is that our pipeline remains a top priority and we'll be supporting Imperial college as they continue to enroll cobot patients for the Ti Vo two study we.
We look forward to sharing additional updates with you as we make progress across all fronts and I. Thank you again for joining us that concludes today's call.
And this concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.