Q4 2021 Trevena Inc Earnings Call
Greetings and welcome to the fourth quarter and full year 2021 earnings conference call.
Operator: Greetings and welcome to the Trevena 24-year 2021 Ernie Scott, Currently, all participants are on the list. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference call, please call 1-866-333-4255. Please press star zero on your telephone keypad.
Currently all participants are on listen only mode.
A question and answer session will follow the formal presentation.
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Operator: As a reminder, this conference is being held, It is now my pleasure. Senior Vice President and Chief Financial Officer.
As a reminder, this conference is being recorded it.
It is now my pleasure to introduce Barry Shin Senior Vice President and Chief Financial Officer. Please go ahead.
Good morning, and welcome everyone.
Barry Shin: Good morning and welcome. With me today are Kerry Bourdow, our President and CEO, Patty Drake, our Chief Commercial Officer, and our Chief Medical Officer, Mark Demitrack. As a reminder, Olindic was approved by the FDA in August 2020 and is indicated in adults for the management of acute pain severe enough to require an IV opioid analysis, and for whom alternative treatments are an added the important safety information including the box warning and full prescribing it, are all available on olympic.com, will also be making forward-looking statements within the meaning of federal security.
With me today are Kerry Bordeaux, our president and CEO , Patty Drake, our Chief commercial officer, and our Chief Medical Officer, Mark them attractive.
As a reminder, Olympic was approved by the FDA in August 2020, and vindicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate.
The important safety information, including the box warning and full prescribing information are all available on Olympic Dot com.
We will also be making forward looking statements within the meaning of federal Securities law.
These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SEC.
We undertake no obligation to update these statements beyond today.
Okay.
Barry Shin: These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SBA. We undertake no obligation to update these statements beyond, I'll now turn the call over to Kerry for an overview of our 2021 and recent business accomplishment. Kerry.
I'll now turn the call over to Kerry <unk> for an overview of our 2021 and recent business accomplishments.
Gary.
Thank you Barry.
Carrie Bourdow: Thank you, Barry. Good morning, everyone, and thanks for joining us. 2021 was a year of progress and growth for tribute [inaudible] while we launched our novel product, during a time that our hospital customers were navigating the changing environment of the pandemic. The lessons learned from this past year of launch have enabled us to refine our commercial strategy to drive more rapid adoption of a limbic in 2022, and although we've experienced launch challenges, our confidence has grown in the potential for We've also been adding to the clinical database for a, as you may have seen in our press, Transcripts provided by Transcription Outsourcing, LLC.
Good morning, everyone and thanks for joining us today.
2021 was a year of progress and growth for trevino.
While we launched our novel product Olympic during a time that our hospital customers. We're navigating the changing environment of the pandemic. The lessons learned from this past year of launch have enabled us to refine our commercial strategy to drive more rapid adoption of Olympic and 2022.
And although we've experienced launch challenges our confidence is ground and the potential for Olin deck in our core markets.
We've also been adding to the clinical database for Olympic.
As you may have seen in our press release. This morning, we now have positive top line data in the new respiratory physiology study and complex subjects versus IV morphine.
Carrie Bourdow: And we're expecting data from two other ongoing studies later this year that may further demonstrate clinical outcomes, not only in respiratory depression, but also in nausea, vomiting, and incognitive function, all important areas that matter to health care providers and formulary decision, We continue to advance our novel pipeline as well. Two programs I'll hide.
And we're expecting data from two other ongoing studies later this year that may further demonstrate clinical outcomes not only in respiratory depression, but also in nausea, vomiting, and in cognitive function all important areas that matter to health care providers and formulary decision makers.
We continue to advance our novel pipeline as well two programs I'll highlight for.
Carrie Bourdow: For TRB045, our novel S1P receptor modulator, we began phase one clinical development to support the indication in diabetic neuropathic pain. We expect to complete phase one in the second half, for TRB 027 currently being studied in COVID. The NIH ACTIV team, led by Vanderbilt University Medical Center, has continued to add sites and enroll hospitalized, and they expect top-line data from this study mid this Importantly, the NIH team has now expanded the trial international- and we'll begin enrolling patients outside the U.S. in the coming months, while this study will certainly be important for COVID.
For TRT O four five our novel <unk> receptor modulator, we began phase one clinical development to support the indication in diabetic neuropathic pain patients.
We expect to complete phase one in the second half of this year.
For T. R V O. Two seven currently being studied in Covid patients. The NIH active team led by Vanderbilt University Medical Center has continued to add sites and enroll hospitalized patients and they expect top line data from this study mid this year.
Importantly, the NIH team has now expanded the trial internationally.
And we will begin enrolling patients outside the U S in the coming months.
While this study will certainly be important for Covid patients. We believe the study may also support the utility of <unk> seven and other disease areas, such as non COVID-19 acute lung injury or acute respiratory distress syndrome.
Carrie Bourdow: We believe the study may also support the utility of TRB027 in other disease areas, such as Non-COVID Acute Lung Injury, or acute respiratory distress Dr. Bourdow, Mark Demitrack, Jason Butler, Douglas Tsao, Unknown Attendee, Barry Shin, Trevena Inc Lastly, our partner in China, Nua, recently announced the submission of their India for, Building on this progress, we were able to unlock immediate and significant value by completing the financing we announced earlier today. We will receive up to $40 million backed by the ex-U.S. royalty and a small cap royalty on U.S. Olympics.
Lastly, our partner in China, <unk> recently announced the submission of the NDA for Olympic.
Building on this progress we were able to unlock immediate and significant value by completing the financing we announced earlier today.
We will receive up to $40 million backed by the ex U S royalty and a small capped royalty on U S Olympic sales.
Patty: This transaction strengthens our balance, provides value for an app, very clearly, not reflected in our share. [inaudible] Let me now turn the call over to Patty to talk more about our U.S. Olympic launch activities. Patty.
This transaction strengthens our balance sheet and provides value for an asset that was very clearly not reflected in our share price.
Let me now turn the call over to Patty to talk more about our U S Olympic launch activities Patty.
Thanks, Carrie and Hello to everyone joining us today.
Patty: Thanks, Carrie. And hello to everyone joining us today. There is no doubt that the year one launch experience of the limbic has come with many challenges, not least of which is navigating a novel drug launch in the middle of a global pandemic. Today, I'll walk you through the progress that we've made in our commercial strategy to accelerate the launch, and importantly, I'll share with you some early indicators that demonstrate it's working.
There is no doubt that the year one launch experience of Olympic has come with many challenges.
Not least of which is navigating a novel drug launch in the middle of a global pandemic.
Today I'll walk you through the progress that we've made in our commercial strategy to accelerate the launch.
And importantly, I'll share with you some early indicators that demonstrate its working.
Patty: There are three key actions that support the foundation of our strategy to drive even greater adoption for limbic. We are focusing on poor patient [inaudible] We are evolving our customer facing team, and we're broadening our Market Acts. Let me provide more detail on each.
There are three key actions that support the foundation of our strategy to drive even greater adoption for Olympic.
We are focusing on core patients.
We are evolving our customer facing team.
And we're broadening our market access let me provide more detail on each of these.
Patty: First, in terms of focusing on core patients, We are fortunate to have a very broad indication statement. And based on growing data set of real world evidence and our expanding clinical data profile, our research suggests that a limbic is a particularly compelling option for difficult to treat patients, like the elderly, obese, and renally impaired. We believe this is mainly due to a Linux core attribute, of Rapid Onset of Action.
First in terms of focusing on core patient.
We are fortunate to have a very broad indication statement.
And based on growing data set of real world evidence in our expanding clinical data profile. Our research suggests that Olympic is a particularly compelling option for difficult to treat patients like the elderly obese and renal impaired.
We believe this is mainly due to Olympics core attributes.
Rapid onset of action.
Patty: No act as metabolites, thus a predictable analgesic with no dose scat- and a well-characterized, safety and tolerability process. This is a very large cohort of patients in the United States. So we have made strategic choices in where to focus. This includes the critical care health care providers who focus on burn, colorectal, and open heart surgery.
No active metabolites that are predictable analgesic with no dose stacking.
A well characterized safety and tolerability profile.
This is a very large cohort of patients in the United States.
So we have made strategic choices and where to focus.
This includes the critical care health care providers, who focus on burn colorectal and open heart surgeries.
Patty: The ability to segment out this population of physicians and patients who are most likely to value the profile of a limbic, can greatly help our sales team in their commercial execution. We've already received feedback in the burn unit setting of the success that they've had since they switched to a Linzic due to a lack of tolerability with us. The next action that we've taken is that we have involved the customer facing team. Shifting our strategy beyond a purely contract failed ordinance.
The ability to segment out this population of physicians and patients who are most likely to value the profile of Olympic can greatly help our sales team in their commercial execution.
We've already received feedback in the burn unit shedding of the success that they've had since they switched to Olympic due to a lack of tolerability with other agents.
The next action that we've taken is that we haven't bought the customer facing team shifting our strategy beyond a purely contract sales organization.
We have achieved the logistical and speed to market benefits all the contract sales force.
Patty: We have achieved the logistical and speed-to-market benefits of a contract sale, and are now ready to further strengthen our execution by advancing a Trevena key account management team. We have two outstanding sales leaders with experience in pain management and burn to lead this. We also have experienced hospital key account managers with existing relationships in the market. We are confident this 40 person strong team will increase our productivity and momentum for ultimate success with Olympia. Unknown Attendee Fine.
And are now ready to further strengthen our execution by advancing a truth vena key account management team.
We have two outstanding sales leader with experience in pain management and burn to lead this team.
We also have experienced hospital key account managers with existing relationships in the market.
We are confident this 40 person strong team will increase our productivity and momentum for ultimate success with Olympic.
Finally, we broadened our market access.
Patty: We've broadened our market. Now that we have meaningful awareness and interest from physicians, It's time to drive a limbic utilization from the top down as well. Our Vice President of Market Access has expertise in this area, and we're currently in discussions with some of the largest group purchasing organizations.
Now that we have meaningful awareness and interest from physicians, it's time to drive Olympic utilization from the top down as well.
Our vice President of market access has expertise in this area and we're currently in discussions with some of the largest group purchasing organization.
Patty: These organizations have both the ability and interest, to implement OLYMVC into their membership healthcare system, in order to improve patient and it's our excellent, healthy, economic data that demonstrates substantial overall cost savings for hospitals when they use the list, that is the catalyst for these conversations. Contract negotiations are ongoing and we look forward to partnering with these organizations. Last year was certainly difficult for our hospital customers.
These organizations have both the ability and interest to implement Olympic into their membership health care systems in order to improve patient outcomes.
And it's our excellent health economic data that demonstrates substantial overall cost savings for hospitals when they use the Olympics that is the catalyst for these conversations.
Contract negotiations are ongoing and we look forward to partnering with these organizations soon.
Last year was certainly difficult for our hospital customers.
Mark Demitrack: But even with delays in formulary meetings due to COVID, we still saw a limbic added to 48 formularies and our field and medical teams met with over 700 target accounts, presenting Olympics in-depth clinical and overall value proposition, and importantly, Dr. Bourdow, Mark Demitrack, Jason Butler, Douglas Tsao, Unknown Attendee, Barry Shin, Trevena Inc, We're beginning to see an emergence of non-formulary clinical use evaluation as well as requests for over 200 in-service educational trainings over the past year. This is an important signal to us.
But even with delays in formulary meetings due to Covid, we still saw Olympic added 48, formulary and our field medical team met with over 700 target accounts presenting Olympics in depth clinical and overall value proposition.
And importantly, we're beginning to see an emergence of non formulary clinical use evaluation as well as request for over 200 in service educational training over the past year.
This is an important signal to us.
Mark Demitrack: These activities are historically held after formulary acceptance, but in the slowdown or absence of formulary reviews, we're being asked to proceed with non-formulary utilization and in-service education, demonstrating an interest and need for a limbic in the hospital. We are also at various stages of formulary review and over 150 institutions or, We're confident the execution of these three acts, of Focusing on Core Patients, evolving the customer facing organization, and broadening our market access by a new talented team of dedicated individuals will continue to build the momentum for.
These activities are historically held aster formulary acceptance.
But in the slow down or absence of formulary reviews, we're being asked to proceed with non formulary utilization and in service education, demonstrating an interest and need for Olympic in the hospital setting.
We are also at various stages of formulary review and over 150 institutions or accounts.
We are confident the execution of these three actions are focusing on core patients evolving the customer facing organization.
And broadening our market access by a new talented team of dedicated individuals will continue to build the momentum for Lindsay.
Mark Demitrack: This strategy is well aligned with our changing environment, and we're excited about the early indicators of success from our, will continue to update you as the year progresses. Let me turn the call over to Mark for an update on our clinical program. Thank you, Patty.
This strategy is well aligned with our changing environment and were excited about the early indicators of success from our customers.
We'll continue to update you as the year progresses, let me turn the call over to Mark for an update on our clinical program.
Thank you Patty.
Mark Demitrack: I'd like to begin by highlighting our progress on several of our Olympic clinical studies that build on our strong legacy of peer-reviewed scientific literature. First, this morning, I'm pleased to report positive top-line results from the Respiratory Physiology Study, led by Dr. Albert DeHaan at Leiden University Medical Center. Dr. DeHaan's team used well-validated methodologies to compare a limbic and IV morphine's effect on respiratory function and pain threshold. Using two different doses of either oloceridine or morphine, administered in a crossover design. Dr. DeHaan's group demonstrated that at equal levels of pain relief, a limbic showed statistically significant lower levels of respiratory depression versus IV morphine. These data are important for several reasons.
I'd like to begin by highlighting our progress on several of our Olympic clinical studies that build on our strong legacy of peer reviewed scientific literature.
Mark Demitrack: First, it is clear that respiratory depression is the most serious adverse event related to opioid use. So, reducing this potentially fatal event even modestly is a significant aspect of the mental-invict's potential profile. Second, these results replicated the findings of our previous study conducted in young, healthy volunteers. And finally, this study extends those observations in a population of elderly and overweight people, the very subset of people who are known to be at higher risk of respiratory depression with the use of opioid medications in the post-operative setting.
First this morning I'm pleased to report positive top line results from the respiratory physiology study.
Mark Demitrack: Overall, we believe these data provide additional evidence supporting a potentially more favorable impact on respiratory function with a limbic compared to IV morphine. As with all opioids, serious life threatening or fatal respiratory depression may occur in patients treated with a limbic.
Led by Dr. Albert to Hahn at Leiden University Medical Center.
Mark Demitrack: Dr. DeHaan's team will continue to analyze this study, and we look forward to working with him to see these results reported to the wider scientific community and submitted for publication in the near future. Another study already underway is aimed at comparing the potential effects of Olympic and IV morphine on a broader array of cognitive outcomes, including motor performance, attention, reaction time, memory, and higher order executive function. This study is being conducted in partnership with the Netherlands-based Center for Human Drug Research, and we expect initial data from this study to be reported by the middle of this year.
Dr. Hans team used well validated methodologies to compare Olympic and IV morphine is effect on respiratory function and pain thresholds.
Mark Demitrack: The second major Olympic study currently in progress, is the outcomes study led by Cleveland Clinic's Outcomes Research Department. This study, also known as the Volition Trial, builds on our earlier data and is evaluating the LINVICS profile on three important clinical outcomes in the postoperative setting, namely, respiratory depression, Nazi Informatine, and Cognitive Function.
Using two different doses of either <unk> or morphine administered in a crossover design.
Hans group demonstrated that at equal levels of pain Relief Olympics showed statistically significant lower levels of respiratory depression versus IV morphine.
These data are important for several reasons.
First it is clear that respiratory depression is the most serious adverse event related to opioid use so reducing this potentially fatal event, even modestly is a significant aspect of Olympics potential profile.
Second these results replicated the findings of our previous study conducted in young healthy volunteers.
And finally this study extends those observations in a population of elderly and overweight people. The very subset of people who are known to be at higher risk of respiratory depression with the use of opioid medications in the postoperative setting.
Overall, we believe these data provide additional evidence supporting a potentially more favorable impact on respiratory function with Olympic compared to IV morphine.
As with all opioids serious life, threatening or fatal respiratory depression may occur in patients treated with Olympic.
Doctor to Hans team will continue to analyze this study and we look forward to working with him to see these results reported to the wider scientific community and submitted for publication in the near future.
Another study already underway is aimed at comparing the potential effects of Olympic and IV morphine on a broad array of cognitive outcomes, including motor performance attention reaction time memory and higher order executive function.
This study is being conducted in partnership with the Netherlands based center for human drug research.
And we expect initial data from this study to be reported by the middle of this year.
The second major Olympic study currently in progress.
Is the outcomes study led by Cleveland Clinic's outcomes Research Department.
This study also known as the volition trial.
<unk> builds on our earlier data and is evaluating the Olympics profile on three important clinical outcomes in the post operative setting, namely respiratory depression.
And vomiting.
And cognitive function.
Mark Demitrack: This project has begun enrolling patients and we continue to expect top line data from this study in the second half of 2022. I'd now like to turn to our pipeline, which saw several exciting developments in 2021, and we'll have some important catalysts coming up in this year. In the ongoing study of TRV027 in COVID patients, we expect top-line data in the second half of this year from the NIH-funded ACTIV trial led by Vanderbilt University Medical Center in the U.S. Enrollment in that study has been proceeding well, with patient recruitment open at 46 participating hospitals in the US.
This project has begun enrolling patients and we continue to expect top line data from this study in the second half of 2022.
I'd now like to turn to our pipeline.
Which saw several exciting developments in 2021, and we'll have some important catalysts coming up this year.
In the ongoing study of T. R V O two seven in Covid patients, we expect topline data in the second half of this year from the NIH funded active trial led by Vanderbilt University Medical Center in the U S.
Enrolment in that study has been proceeding well with patient recruitment open at 46 participating hospitals in the U S.
Recently, the active study has also begun plans to expand enrollment to international sites in the coming months.
Mark Demitrack: Recently, the active study has also begun plans to expand enrollment to international sites in the coming months, as a result of the significant accomplishments for the active study team over this past year, and in part due to the need to support their expansion to global study locations. We have elected to discontinue our participation with the International Remap CAHPS Study.
As a result of these significant accomplishments of the active study team over this past year.
And in part due to the need to support their expansion to global study locations.
We have elected to discontinue our participation with the international Remap cap study.
Mark Demitrack: This will allow us to focus our allocated resources for this opportunity in the most efficient manner possible. If results from the ongoing active study are positive. These data will help to provide insights to inform our understanding of whether TRV-027 may have even broader applications, well beyond COVID-19 infection alone to treat other forms of acute lung injury or acute respiratory distress. Finally! At the start of this year, we initiated enrollment in our Phase 1 Development Program for TRV-045. Our selective S1P modulator being studied for the treatment of diabetic neuropathic pain.
This will allow us to focus our allocated resources for this opportunity.
Most efficient manner possible.
Yeah.
If results from the ongoing active study are positive.
These data will help to provide insights to inform our understanding of whether T. R. V. O. Two seven may have even broader applications well beyond COVID-19 infection alone.
To treat other forms of acute lung injury or acute respiratory distress.
Finally.
At the start of this year, we initiated enrollment in our phase one development program for T. R V O four five.
Our selective S. One P modulator.
Being studied for the treatment of diabetic neuropathic pain.
We believe T. R V O four fives unique profile differentiates it from currently available treatments in this pharmacologic class in both its subtype selectivity.
Mark Demitrack: We believe TRV045's unique profile differentiates it from currently available treatments in this pharmacologic class, in both. It's subtype selectivity, and because of the absence of effects to reduce circulating levels of peripheral lymphocytes, and animal data suggesting a potentially improved safety profile. The enrollment of our First View Study Cohorts is going well, and we expect to have the Phase 1 study program completed in the second half of this year. Let me now turn the call over to Barry to discuss our financials before we open it up for Q&A. Barry?
And because of the absence of effects to reduce circulating levels of peripheral lymphocytes.
And animal data, suggesting a potentially improved safety profile.
The enrollment of our first few study court cohorts is going well.
We expect to have the phase one study program completed in the second half of this year.
Let me now turn the call over to Barry to discuss our financials before we open it up for Q&A Barry.
Thanks Mark.
Barry Shin: Thanks Mark. While we continue to see a limbic usage at hospitals near, With adjustments, we reported effectively no net sales in the fourth quarter and $498,000 for the year. Our net loss was $14 million for the quarter compared to $11.9 million for the same period last year.
While we continue to see Olympic usage at hospitals near fees with adjustments, we reported effectively no net sales in the fourth quarter and $498000 for the year.
Our net loss was $14 million for the quarter compared to $11 $9 million for the same period last year.
Barry Shin: For the full year 2021, our net loss was $51.6 million compared to $29.4 million for 2020. These changes were mainly due to costs associated with our Olympic, We finished the year with $66.9 million in cash and In addition, today we announced a $40 million finance, based mainly on our ex-U.S. royalty, will receive $15 million of that up front, and the remainder on first commercial sale of a Lindic in China and other future milestones, all with limited, Repayment is highly flexible and based on a royalty from Dois, as well as a small capped royalty on U.S. net sales.
For the full year 2021, net loss was $51 6 million compared to $29 $4 million for 2020.
These changes were mainly due to costs associated with our Olympic lunch.
We finished the year with $66 $9 billion in cash and equivalents.
In addition, today, we announced a $40 million financing based mainly on the ex U S royalties.
We will receive $15 million of that upfront and the remainder on first commercial sale of Olympic in China, and other future milestones all with limited dilution.
Repayment is highly flexible and based on a royalty from the wall as well as a small capped royalty on U S net sale.
We're very happy to welcome <unk> Health Care Fund, an affiliate of CBC group as an investor intravenous.
Barry Shin: We're very happy to welcome Arborage Helper We're very happy to welcome Arborage Helperage Helperage Helperage Helperage Helperage Helperage Helperage, affiliate of CBC Group as an investor in Trevena. Our bridge has a deep understanding of global health care markets, and we're pleased that we're able to recognize the potential of Olympic in China, will now open the call for questions, after which Kerry will provide some closing remarks. Operator. Thank you. To ask a question, you will need the person. Telephone, draw your question, press the pound.
Our bridge has a deep understanding of global health care market and we're pleased that we're able to recognize the potential of Olympic and China.
Well now open the call for questions after which Carey will provide some closing remarks.
Operator.
Thank you to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.
Operator: Please stand by while we compile the Q&A roster. Our first question is from Brandon Folk, and Gerald. Hi, thanks for taking my questions and congratulations on the announcement this morning. Maybe just firstly, excluding adjustments, what was the Olympic sales in the quarter?
Please standby, while we compile the Q&A roster.
Our first question is from Brandon Folkes with Cantor Fitzgerald. Your line is open.
Hi, Thanks for taking my questions and congratulations on the announcement this morning.
Carrie Bourdow: And then secondly, you know, you do seem to be generating some pretty good data, but we're not seeing that revenue pull through. What do you think decision makers are missing here? And then maybe lastly, can you just help us frame the review timeline of Olindic in China? Thank you. Great. Thank you, Brandon.
Maybe just firstly, excluding adjustments what was the Olympic sales in the quarter.
And then secondly, you do seem to be generating some pretty good data hub.
Not seeing that revenue pull through what do you think decision makers all missing here.
And then maybe lastly can you just help us frame the review timeline of an indicative in China. Thank you.
Great. Thank you, Brian and I appreciate it.
Carrie Bourdow: I appreciate it. So let me let me start actually with the review timeline and the data and I'll turn it over to Mark and then I'll ask Barry to close on the on the revenue question on the adjustments. So. Our partner in China, they've not announced the actual timing, but if you look at a standard review time for a product like Olinvik in China, we're anticipating that it will be somewhere in the second half of 2023.
So let me let me start actually with the review timeline and the data and I'll turn it over to Mark and then I'll ask Barry to close on the on the revenue question on the adjustments.
So.
Our partner in China, and what they've not announced the actual timing, but if you look at a standard review time or for a product like Olympic in China.
We're anticipating that it would be somewhere in the second half of 2023 and Mark can provide some of the triggers it's not quite like in the U S where you're meeting with the FDA frequently that's that's not how it's done over there. So that's what we're anticipating right now and then as far as the new data that we're generating for Olympic.
Carrie Bourdow: And Mark can provide some of the triggers. It's not quite like in the US where you're meeting with the FDA frequently. That's not how it's done over there.
Carrie Bourdow: So that's what we're anticipating right now. And then as far as the new data that we're generating for Olinvik, we have already spoken with formulary decision makers, and we think this new data is going to be very well-received. We've announced the respiratory physiology data this morning. We're already starting to train our medical science liaisons The data will be part of the hospital dossier. We'll go back to formulary review meetings With that data as part of the dossier and then of course we'll be putting it out at publications and scientific, Mark, anything you want to add around that?
We have already spoken with formulary decision makers and we think this new data is going to be very well received.
Announced the respiratory physiology data. This morning, we're already starting to train our medical science liaison the data will be part of the hospital dossier will go back to formulary review meetings.
With that data as part of the dossier and then of course, we'll be we'll be putting it out at publications and scientific meetings, Mark anything you want to add around that.
Carrie Bourdow: Or the comment I made around why? Yeah, sure. Just to build on the general timing of review in China, upon initial filing, different from the U.S., there is a period of 10 months of initial first-round review, and then a company typically receives a series of questions at that point.
The comment I made around one timing.
Mark Demitrack: So it's not interactive in an ongoing way as it is in the U.S. The company then has an opportunity to respond to those questions. There's a shorter second-round review that typically is on the order of six months. And then the scheduling of the controlled substance generally occurs concurrent with the review, again, slightly different from here in the U.S. So all told, again, although our partner has not announced their specific timing anticipation, judging from what we know of the regulatory process, as Kerry was saying, in the latter half of next year would be a reasonable projection. Thank you. And Barry, you want to talk a little bit about the adjustments? your comment that it made. Sounds good.
Yeah sure just to build on the the general timing of review in China.
Han initial filing different from the U S. There is a period of 10 months.
The initial first round review and then accompany typically receives a series of questions at that point, so it's not interactive.
In an ongoing way as it is in the U S. The company then has an opportunity to respond to those questions. There is a shorter second round review that typically is on the order of six months.
And then the scheduling of the controlled substance generally occurs concurrent.
The review again slightly different from here in the U S. So all told again, although our partner has not announced their specific timing anticipation judging from what we know of the regulatory process as Kerry was saying in the latter half of next year.
Or would be a reasonable projection.
Great. Thank you and Barry you wanted to talk a little bit about the adjustments in your comment that you made.
Barry Shin: Thanks, Brandon. We don't disclose gross sales figures, but I can say that the adjustments were very small and related to accruals versus actual, I think that we've all witnessed the Omicron headwinds. Trevelin in the fourth quarter that continued on into the first quarter of year, but we think that they are abating as we close out the first quarter. Did that answer your questions, Brandon? did.
Sounds good thanks Brendan.
We don't disclose gross sales figures, but I can say that the adjustments were very small and related to accruals versus actual discount I think that we've all witnessed the omicron headwinds.
In the fourth quarter that continued on into the first quarter here, but we think that they are abating.
As we close out the first quarter did.
Did that answer your questions Brandon.
Unknown Attendee: Thank you very much, everyone. Thank you. Our next question comes from Jim Butler with JMP Securities. You're on it.
Okay. Thank you very much everyone.
Thank you.
Our next question comes from Jim Butler with JMP Securities. Your line is open.
Operator: Hi, thanks for taking the questions. Just just one, I guess another one on the the commercial dynamics. Can you maybe speak to, and I get it's going to depend based on the institution, but in institutions where you've been with the products being used for at least a couple of quarters, are you seeing, you know, positive trends? Are you seeing, you know, more, more use of the drug, more users of the drug in institutions where where it can be used? Yes, Jason.
Hi, Thanks for taking the questions just one I guess another one on the commercial dynamics can you maybe speak to and I get it it's going to depend based on the institution, but in institutions, where you've been where the products are being used for at least a couple of quarters are you seeing you know positive trends are you seeing in them.
More and more use of the drug more users of the drug in an institution, where where it can be used.
Yes, Jason Hi.
Carrie Bourdow: Hi. So I'll start and then I'll ask Patty to talk a lot about it because she's been out in the field and talking with customers. We are.
So I'll start and then I'll ask Patty to talk a lot about it because he's been out in the field and talking with customers, who we are and that's one of the things that we're looking for it's why you've heard Patti talking about how she's she's excited about the opportunities.
Carrie Bourdow: And that's one of the things that we're looking for. It's why you heard Patty talking about how she's, she's excited about the opportunity. Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Unknown Attendee, Barry Shin, and so we're seeing positive trends in that area. Patty, any color that you want to provide from the conversations you're having with customers?
In institutions that sort of jumped on early on right right around the launch we're seeing expanded use sort of starts in one physician specialty colorectal for instance, and then and then expands into other physician groups and I think that's a really good sign.
In term, we look at a couple of things as you were describing we look at new customers, but we also look at reorder rates and so we're seeing.
Positive trends in that in that area, putting any color that you want to provide from the conversations you are having with customers.
Yeah, Thanks, Kerry I think.
Patty: Yeah, thanks, Carrie. I think what I find very interesting is that the different specialty types really have an appreciation for different attributes. Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, But in, for example, an ASC setting, they really are giving us feedback that they feel they're getting more PACU efficiencies, and they're sharing their experience, then, with other health care providers, either in the institution, or by specialty type. And so, it's been very, very well received by our early adopters.
What I find very interesting is that the.
The different specialty types really have an appreciation for a different attribute.
In the product obviously in the burn space. These patients pass severe pain and they appreciate so much the efficacy of the product as well as the rapid onset and no renal adjustment.
But in for example in ASC setting they really are giving us feedback that they feel that they are getting more PACU efficiencies and they're sharing their experience than with other health care providers either in the institution are or buying specialty type and so.
It's been very very well received by our early adopters absolutely.
Mark Demitrack: Okay, great. And then just a couple on the respiratory physiology study. Can you just remind us how you defined and measured respiratory depression in this study? And then, I get that you're not disclosing any more data here, but any color on, you know, what kind of magnitude of benefit you would view as meaningful or what a physician would want to see? And then just lastly, can you just speak to how, you know, respiratory depression in this study compares to how you're measuring respiratory depression in the outcome study? Thanks.
Okay, Great and then just a couple on the respiratory physiology study can you just remind us how you defined and measured respiratory depression in this study and then.
I get that Youre, not disclosing any more data here, but any color on what kind of magnitude of benefit you would view as a meaningful or what a physician would want to see and then just lastly can you can you just speak to how.
Spiritual depression in this study compares to how you're measuring a respiratory depression in the outcome study. Thanks.
Mark Demitrack: Yeah, great. Great questions, Mark. I'll let you kick off.
Yeah, great great questions, Mark I'll, let you kick off.
Mark Demitrack: Sure. So, Jason, experimentally in this study, we induce respiratory depression by having the subject breathe a concentrated gas of CO2. So it's done at an isohypercapnic manner. So we adjust the gas to gradually increase the CO2 levels. Now the impact of that is that is a direct way of essentially manipulating the control of the respiratory centers in the brain. As you do that in a human being and as CO2 levels rise in the blood, respiratory rate will go up or ventilatory rate. We measure that as a minute ventilation at a particular measured amount of CO2.
Sure so.
Jason experimentally in this study.
Induce respiratory depression.
By having the subject breathed a concentrated gas of C. O. Two so its done at an eisai with hyper kapnick manner. So we adjust the gas to gradually increase the the C. O. Two levels now the impact of that is that is a direct way.
Wei of essentially manipulating the control of the respiratory centers in the brain as you do that in a human being in a C O two levels rise in the blood.
Respiratory rate will go up or ventilatory Ray we measure that as a minute ventilation at a particular.
Measured amount of C. O. Two then we administer drug in this case two different doses of <unk> two different doses of IV morphine and a crossover manner on separate occasions, and we measure the impact of the drug to inhibit or or reduce that that ventilatory drive and.
Mark Demitrack: Then we administer drug, in this case, two different doses of Olinvik, two different doses of IV morphine in a crossover manner on separate occasions. And we measure the impact of the drug to inhibit or reduce that ventilatory drive. And so what we see in this study is that there's a statistically significant difference over time in the influence of morphine relative to Olinvik. Olinvik has a much reduced level of impact at equivalent levels of analgesia because we established the analgesia by also testing pain threshold responses in the subject. So we can match not only effect site concentration in the plasma of the circulating drug, but also the clinical consequence of analgesic effect.
So what we see in this study is that Theres just statistically significant difference over time in the AR.
In the influence of morphine relative to Olympic Olympic has a a much reduced level.
A level of impact at equivalent levels of analgesia, because we've established the analgesia by also testing pain threshold responses in the subjects. So we can match not only affect site concentration in the plasma of the circulating drug but also the clinical consequence of analgesic effect. So it's really.
Mark Demitrack: So it's really the most direct way of measuring the impact of a drug on the regulatory centers for respiration in the brain. Now what we look for in a clinical setting, in a patient setting obviously you can't do that kind of process. You can't take somebody in the aftermath of surgery and have them artificially inhale CO2 to induce an increased respiration.
The most direct way of measuring the impact of a drug on the regulatory centers for respiration in the in the brain.
Now what we look for in a clinical setting and in a patient setting obviously you can't do that kind of process you can't take somebody in the aftermath of the surgery and have them artificially inhale C O two to induce.
Increased respiration, what we look for are more downstream indicators of respiratory compromise things like.
Mark Demitrack: What we look for are more downstream indicators of respiratory compromise, things like SpO2 levels or end tidal CO2 levels or respiratory rate. And those are the very indices that we're looking at then in the clinical studies. We did that in our early generation of studies and showed meaningful clinically and economically meaningful gains relative to the contemporaneous morphine that was used. And it's those same kind of indicators that are being measured in a more granular way in the outcome study that we're doing with Cleveland Clinic.
S. P O two levels or and title C O two levels or respiratory rate and those are the very indices that we're looking at then in the clinical studies, we did that.
In our early generation of studies and showed meaningful clinically and economically meaningful gains.
Relative to the contemporary nears morpheme that was used and it's those same kind of indicators that are being measured in a more.
Granular way in the outcome study that we're doing with with Cleveland clinic.
Yeah, Let me just add Jason I think another question that you're asking is.
Mark Demitrack: And let me just add, Jason, I think another question that you're asking. So... So what, right? So as Mark said, when you talk to anesthesiologists, they'll tell you that this methodology, this what we call the VRH model, is one of the purest ways to measure respiratory depression.
So <unk>.
So what right.
So as Mark said when you talk to anesthesiologists they'll tell you that this methodology. This what we call. The DRA. Each model is is one of the purest ways to measure respiratory depression.
Carrie Bourdow: And then the second thing that I think is really important for us from a commercial perspective, from a medical affairs perspective, is that this was done in obese and elderly subjects. So what's considered higher risk subjects. And we're seeing that same magnitude that we've seen in our other studies, a limbic versus IV morphine. So it's another indicator that what we've been seeing in normal subjects or in healthy patient populations, we're seeing now in this elderly obese population. So I think it's gonna be really insightful for our medical science team when they're out talking about this data. Okay, great. Thank you. Appreciate the color.
And then the second thing that I think is really important for us from that from a commercial perspective from a medical affairs perspective is that this was done in in obese and elderly subjects. So what what's considered higher risk subjects and we're seeing that same magnitude that we've seen in our other studies Olympic versus <unk>.
The morphine so it's another indicator that what we've been seeing in normal subjects or and healthy patient populations.
We're seeing now in this this elderly obese population. So I think it's going to be really insightful for a for a medical science team when they're when they're out talking about this data.
Okay, great. Thank you appreciate the color.
Yeah. Thank you.
Our next question comes from Douglas Tsao with H C. Wainwright Your line is open.
Mark Demitrack: Yeah, thank you. Our next question comes from Douglas Tsao, Hi, good morning. Thanks for taking the questions. Just, I know, I think you've indicated in the press release that you finished the year with 48 accounts or 48 formulary wins. And obviously, you know, COVID sort of disrupted the progress that you were making and where you wanted to be at the end of the year.
Hi, good morning, Thanks for taking the questions just I know.
Thank you indicate in the press release that you you finished the year with 48 accounts are 48 formulary wins.
And obviously COVID-19 sort of disrupted the progress that you were making and where you wanted to be at the end of the year.
Operator: You know, things have seemed to be sort of reopening, knock on wood that the A2 doesn't cause another significant wave, but sort of how far out or, you know, maybe some perspective on where you... Transcripts provided by Transcription Outsourcing, LLC. Yeah, thanks, Doug. It's a it's a great question. And so let me one of the things that I think Patty talked about is that, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Unknown Attendee, Barry Shin, Trevena Inc, Formulary meetings are still getting delayed. They're starting to get back on track.
Yeah.
Yeah things that seem to be sort of reopening knock on wood, the ph, who doesn't cause another significant way, but sort of how far out are you know maybe some perspective on where you are when you think you might hit that targeted 100 accounts.
Just sort of given some of the realities that we're facing today. Thank you.
Yeah, Yeah. Thanks, Doug it's a great question.
Let me one of the things that I think Patty talked about is that.
The dynamic has changed.
Some extended hospitals, what we used to see is that reps would go in and they present the data to a formulary committee or a medical science liaisons would they'd have formulary committees would get together they would have the meeting and they'd have standard meetings throughout the year with Covid as you said things were so disrupted.
Their staffing shortages headspace issues frankly, despite all the all the things that were going on for for our physicians and nurses sort of trying to think about patient outcomes and so what we're seeing now is.
Formulary meetings are still getting delay there, they're starting to get back on track, but what's happening is that.
Carrie Bourdow: But what's happening is that physicians are still interested in using Olimbic. And so they're approaching their formulary committee with what we're seeing is sort of non-formulary use in selected areas. So colorectal surgeons are saying, hey, let us use it in our patient population.
Physicians are still interested in using Olympic and so they're they're approaching their formulary committee with what we're seeing is sort of non formulary use in selected areas. So colorectal surgeons are saying, hey, let us use it in our patient population and that's getting approved and you know I've been in the hospital arena for a long time, it's real.
Carrie Bourdow: And that's getting approved. And you know, I've been in the hospital arena for a long time. It's really fairly different from what we had seen in the past. And then as Patty referenced, our refs are getting invited in to train physicians and nurses in these educational. So I want to see a few more months of how things are opening up before I'll provide guidance on formularies, but as you heard me talk about earlier, there'll be other things like new customers, reorder rates that we can provide guidance on in the out months. Is that helpful, Doug, to give you a sense of what's happening? Yes, that is helpful. Yeah, thank you.
Fairly different from what we had seen in the past and then as Patti referenced where our reps are getting invited in to train physicians and nurses and these these educational meetings. So I wanted to see.
A few more months of how things are opening up before I'll provide guidance on formularies, but.
As you heard me talk about earlier there'll be other things like new customers reorder rates that we can provide guidance on.
You know the out months does that helpful that gives you a sense of how that is helpful.
Yeah. Thank you and then.
Carrie Bourdow: And then, You know, for both 045 and 027, I mean, I know you're sort of weighting data, and 027, obviously, you know, if it shows a significant benefit in COVID, that would sort of be a direct path. But I'm just curious, in 027, Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Unknown Attendee, Barry Shin, What we think it will show, how quickly do you think you can be in a patient study, a phase two study?
Hum for pulp 045, the Nokia seven I mean, I know, you're sort of waiting data and two seven obviously.
If it shows a significant benefit in COVID-19 that would sort of be a direct path, but I'm just curious <unk> seven.
What is your sort of interest level in pursuing other indications and how quickly after getting data from.
The active study would you look to do that and in terms of all four five I'm just curious how quickly.
If the phase one study shows what you what we think it will show how quickly do you think you can be.
In a patient study a phase II study. Thank you.
Carrie Bourdow: Yeah, great, great question. So I'll start with 027-045 and then I'll ask Mark to provide any additional color. So on 027, we're already starting to map out market opportunities in the non-COVID related acute respiratory distress syndrome or acute lung injury. It just depends to some extent, really, what the data looks like.
Yeah, Great Great question, So I'll I'll start with Ot seven O four five and then I'll ask mark to provide any additional color. So on O. Two seven we're already starting to map out market opportunities in the non COVID-19 related acute respiratory distress syndrome or acute lung injury.
Some of it just depends on to some extent really what what the what the data looks like in some of the areas that that we've talked about some of the pulmonary areas.
Carrie Bourdow: In some of the areas that we've talked about, right, some of the pulmonary areas, anti-infective areas, it's actually more of a rare disease space, which is interesting to us, right? So, depending on what the data looks like, we potentially could move relatively quickly. And, you know, that involves a whole host of conversations that we're starting to think about internally. In terms of 045, and you've heard us talk a little bit about this, our intent would be to move into a proof-of-concept study as quickly as we could, after, again, after we see the phase one data.
Anti infective areas, it's actually more of a rare disease space, which is interesting to us right. So depending on what the data looks like we potentially could move relatively quickly.
And you know that.
That involves a whole host of conversations that we're starting to think about internally.
In terms of O four five.
And you've heard us talk a little bit about this our intent would be to move into a proof of concept study as quickly as we could after after again after we see the phase one data and.
Carrie Bourdow: And as we get a little bit closer to the end date around phase one, we'll talk a little bit more about our sense of what that proof-of-concept study might look like. But, Mark, let me turn it over to you and see if you have any additional comments you want to make. Yeah, just to sort of build on what Carrie was saying, you know, it's clear if you if you look at the literature, the renin-angiotensin system and the angiotensin 1 receptor in particular, there's ongoing data constantly emerging in the scientific literature underscoring the importance of that system in modulating the inflammatory response to acute lung injury, infectious and non-infectious acute lung injury.
As we get a little bit closer to the end date around phase one we'll talk a little bit more about our our sense of what that phase that proof of concept study might look like but Mark Let me, let me turn it over to you and see if you have any additional comments you want to make.
Yeah, just to sort of build on what Carrie was saying.
It's clear if you if you look at the literature, the renin angiotensin system and the angiotensin one receptor in particular.
There's there's ongoing data constantly emerging in the scientific literature underscoring the importance of that system in modulating the inflammatory response to acute lung injury infectious and non infectious acute lung injury. So we continue to believe that the the promise.
Mark Demitrack: So we continue to believe that the promise for that target is considerable. And there's a variety of potential options, some that are in the rare disease arena that are of interest in thinking about it. And as Carrie said, we're sort of constantly inspecting the literature. Obviously, the results from the O27 study, given that that's clearly a population that's undergone an acute infectious insult to the lung and also with a variety of illness, comorbidities should give us insight not only into its role with COVID, but broader understanding of the potential impact on other targets outside of COVID. And I just echo what Carrie's saying about O45.
Where that target is considerable and theres a variety of potential options. Some that are in the rare disease arena that are of interest in thinking about us and as Carey said, where we're sort of constantly inspecting the literature. Obviously the results from the O. Two seven study given that that's a key.
Clearly.
Population that has undergone an acute.
Infectious insult to the lung and also with a variety of illness, Comorbidities should give us insight not only into its role with COVID-19 , but broader understanding of the potential impact on other other targets outside of Covid.
Carrie Bourdow: We're pleased with the progress that we're making so far in the initial cohorts in the phase one study. And as soon as we have sufficient insight and understanding to prepare for our proof of concept study, we'll be proceeding with that. So more to come on that in the coming months. Yeah, and we expect to have the phase one program complete the by the end of this year. That's, I think it was part of your question, I think you asked.
And I'll, just echo what carries saying about <unk> five.
We're pleased with the progress that we're making so far in the initial cohorts in the phase one study and as soon as we have sufficient.
Insight and understanding to prepare for our proof of concept study will be proceeding with that so more to come on that in the <unk>.
Months.
Yeah, and we expect to have the phase one program complete by the end of this year.
I think it's part of your question I think you asked.
Unknown Attendee: Okay, great. Great. Thank you. Thank you. Our next question comes from Jeff. Oppenheimer, your line is, Thank you very much for taking the question, guys.
Okay great.
Great.
Thank you.
Thank you. Our next question comes Jeff Jones with Oppenheimer. Your line is open.
Thank you thank.
Operator: Congratulations on the multiple announcements today. I think folks have done a pretty Good job of asking sort of a battery of questions, I guess one detail that around, for the financing announced this morning. Is there any detail you can provide around that definition of financing or commercial milestone for the final $10 million tranche? And also. Any detail around the Remap CAP program?
Thank you very much for taking the question guys.
Congratulations on the multiple announcements today.
I think folks have done a pretty good.
Good job of asking.
Sort of a battery of questions I guess, one detail that.
Around.
For the financing announced this morning is there any detail you can provide around that definition of financing or commercial milestone for the final $10 million tranche.
And also.
Carrie Bourdow: Had that actually started enrolling? And I'll just stop there. Unknown Attendee, Barry Shin, Trevena Inc., Douglas Tsao, Unknown Attendee, Barry Shin, Spinning into International Science is going to allow us to focus our efforts there. And the studies were sort of different.
Any detail around the remap cap programs hit that actually started enrolling.
And I'll just stop there.
Yeah, great. Thanks, Thanks, Jeff Remap cap had not started enrolling in enrolling patients for TRT O. Two seven that the over arching study has started and is ongoing but for for Ot seven they had not.
Not yet.
Begun adding patients and so sort of that coupled with honestly, it's more of the acceleration on the NIH and the NIH study and then now NIH active.
Expanding into international sites.
It's going to allow us to focus our efforts there and the studies were sort of different the NIH active study is placebo controlled.
Barry Shin: The NIH active study is placebo-controlled, is sort of more the typical study that the FDA would be looking for, so it just made sense for us to sort of partner with them in terms of supply. We're not paying for the study. We're not paying for the international expansion, but we are providing drug, and so focusing our efforts there made a lot of sense. Barry, any comments you want to make on the financing and the milestones?
Is sort of more of the typical study that the FDA would be looking for so it just made sense for us to to sort of partner.
With them in terms of supply we're not we're not paying for the study were not paying for the international expansion, but we are providing providing dragon so focusing our efforts there made a lot of sense.
Barry any comments you want to make on the financing and the milestone.
Barry Shin: Unknown Attendee Yeah, thanks, Jeff. And a lot of comments I'd like to make on the financing. I'm absolutely thrilled to be able to announce the deal. $40 million is a very meaningful amount for us. And even the 15 million upfront, when you compare that against our enterprise value, you can see that it was clearly not built into our stock price, from my perspective.
Yeah.
Thanks, Jeff and a lot of comments I would like to make on the financing I'm, absolutely thrilled to be able to announce the deal $40 million is a very meaningful amount for us and even the $15 million upfront when you compare that against our enterprise value you can see that was clearly not built into our stock price from my perspective.
Barry Shin: Unknown Attendee, Barry Shin, Trevena Inc. So, again, I think it's a, Unknown Attendee, Barry Shin, Trevena Inc, and Milestones. First commercial sale in China is pretty straightforward.
Very flexible repayment based on royalties no financial covenants.
Again I think it's.
Barry Shin: $15 million will receive news of that. And then with respect to the $10 million that will receive on commercial or financing milestones, we haven't filed the agreement yet, and we're looking at CTRs, but I can say that on the commercial fund, combination of commercial progress both with respect to accounts and net sales or on the financing front. Unknown Attendee, Barry Shin, Trevena Inc, you look to model this out. Yeah, appreciate that Barry.
Very solid addition.
To our balance sheet.
You specifically asked about the the milestones.
One of the.
The milestones first commercial sale in China, it's pretty straightforward that $15 billion would receive.
News of that and then with respect to the $10 billion that we'll receive on commercial or financing milestones.
Haven't filed the agreement yet.
Looking at <unk>, but I can say that on.
On the commercial front, it's a combination of.
Commercial progress both with respect to accounts.
Net sales.
Or on the financing front.
The combination or it can be one of either a financing transaction or a partnering transaction with enough to talk about.
So I hope that does provide a little bit of color.
As you look to model this out.
Yeah, I appreciate that Barry.
Barry Shin: And I guess the last question, just since we are effectively at the end of Q1, if there's... Any color you can provide on what you're seeing in Q1 versus the end of the year, I know you're not providing reorder rates or things of that sort, but any color into what you're seeing into Q1 versus the end of the year. Thanks, as we mentioned the headwinds that we saw in Q4 of last year continued into Q1, but we believe that they are abating as we close out Q1. So we will see the impact of that in Q1, but we expect we hope that thing is normalized as we can go into 2022.
The last question is just since we are effectively at the end of Q1.
If there's.
Any color you can provide on what youre seeing in Q1 versus the end of the year.
I know youre, not providing reorder rates or things of that sort, but any color into what youre seeing into Q1 versus the end of the year. Thanks.
Yes.
Do you want to continue yeah, yeah, as we mentioned the headwinds that we saw in Q4 of last year continued into Q1, but we believe that they are abating as we close out Q1. So.
So we will see the impact of that in Q1, but.
We expect we hope that things normalize as we go into 2022 here.
Barry Shin: And then, Jeff, as I mentioned earlier, things like formulary when, Unknown Attendee, Barry Shin, Trevena Inc, Okay, appreciate it. Thanks, guys. Thank you. Thank you, and I only show no further questions at this time. I like to call back [inaudible] Great, thank you all for your questions and, As you heard on the call, while the pandemic presented unique challenges to our Olympic U.S. launch activities, we made adjustments where needed, were well positioned in 2022 for success. And I'm excited about the new clinical data we'll have for Alinda. Unknown Attendee, Barry Shin, Trevena Inc, This concludes today's conference call. Thank you for participating. You may now disconnect. [music]
And then Jeff as I mentioned earlier things like formulary wins.
Order rates customer rates those are things that that will be providing additional information around and we expect to be reporting once you hear relatively soon that we're you know we're waiting on a few things here before we close out the quarter.
Okay. Appreciate it thanks guys.
Thank you.
Thank you no further questions at this time I'd like to turn the call back over to Cary Bordeaux for closing remarks.
Great. Thanks, Thank you all for your questions and.
As you heard on the call while the pandemic presented unique challenges to our Olympic U S launch activities, we made adjustments where needed.
Well positioned in 2022 for success and I'm excited about the new clinical data, we will have for Olympic.
Commercial strategy that Patty outlined two to accelerate our performance and the important advancements that we've made in our pipeline.
So as you can hear we have multiple catalysts coming up I look forward to providing you with additional updates throughout the year. Thank you everyone. Appreciate I appreciate the time this morning.
This concludes today's conference call. Thank you for participating you may now disconnect.
Yes.
Yes.
[music].
Yeah.
Yeah.
Yes.