Q4 2020 Trevena Inc Earnings Call
Ladies and gentlemen, and thank you for standing by and welcome to the true Vena fourth quarter and full year 2020 financial results Conference call.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Trevena fourth quarter and full year 2020 financial results conference. I'd now like to hand the conference over to your host today, Mr. Barry Shin, Senior Vice President and Chief Financial Officer. Good morning, and welcome everyone.
I'd now like to hand, the conference over to your host today, Mr. Barry Shin Senior Vice President and Chief Financial Officer.
Good morning, and welcome everyone.
With me today from true Vena, Carrie Bordeaux of President and CEO, Bob Yoder, Our Chief commercial officer, and our Chief Medical Officer, Mark them attractive.
Barry Shin: With me today from Trevena are Kerry Bourdow, our President and CEO; Bob Yoder, our Chief Commercial Officer; and our Chief Medical Officer, Mark Demitrack. We also have Dr. Greg Hammer from Stanford University Medical Center with us. Dr. Hammer was an investigator in our Phase 3 Open Label Safety Study and will be sharing his first-hand experience with Olimbic. At the end of the call, we'll open it up for questions. 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 discussed in our filings with the SEC. We undertake no obligation to update these statements beyond today.
We also have Dr. Greg Hammer from Stanford University Medical center with her.
Doctor Hammer was an investigator and our phase three open label safety study and we'll be sharing his firsthand experience with the Olympics.
At the end of the call will open it up for questions.
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.
I'll now turn the call over to Kerry.
Carrie L. Bourdow: I'll now turn the call over to Carrie. Thank you, Barry. Good morning, everyone.
Thank you Barry good morning, everyone. Thank you for joining us today for.
Carrie L. Bourdow: Thank you for joining us today. For those of you who are new to us, a little background. Trevena was built from the ground up based on Nobel Prize-winning science around GPCR selective agony. With our innovative science, we've built a pipeline that is tackling some of the most urgent diseases in CNS. Let me provide a few highlights on what we accomplished in 2020. 2020 really was an unprecedented year for Trevena.
For those of you who are new to us a little background.
Trevino was built from the ground up based on Nobel Prize, winning science around G. P T. Our selective baggage.
With our innovative science, we've built a pipeline that is tackling some of the most urgent diseases and CNS.
Let me provide a few highlights on what we accomplished in 2020 'twenty 'twenty really was an unprecedented year for trevino with Fda's approval late last year of Olympic for novel IV analgesic for acute pain, we accomplished what very few companies our size do.
Carrie L. Bourdow: With FDA's approval late last year of Olimbic, our novel IV analgesic for acute pain, we accomplished what very few companies our size do. We successfully took a drug candidate through the entire discovery, development, and commercialization process. We're in the early days of our launch, but what I can say, and Dr. Hammer will speak more to this, is that LENVIC's unique profile is compelling to physicians, especially as they evaluate LENVIC for their most challenging acute pain patients in both the inpatient hospital setting and an ambulatory surgery center.
We successfully took the drug candidates through the entire discovery development and commercialization process.
We're in the early days of our launch, but what I can say and Dr. Hamre will speak more to this is that Olympics unique profile is compelling for physicians, especially as they evaluate the lundbeck for their most challenging acute pain patients and both the inpatient hospital, setting and and ambulatory surgery centers.
Also we've now published all of the current G Olympic Gi and respiratory safety data versus IV morphine and the data is available and peer reviewed journals and this is important because of hospital formulary committees will use this data as they review and went back.
Carrie L. Bourdow: Also, we've now published all the current limbic GI and respiratory safety data versus IV morphine. The data is available in peer-reviewed journals, and this is important because hospital formulary committees will use this data as they review the Lindex.
Of course this is a unique time the launching of new product.
Carrie L. Bourdow: Of course, this is a unique time to be launching a new product. We're hearing from our customers that in some areas, they expect the impact of COVID-19 to extend into this year. We're also hearing that elective surgeries in certain regions of the country are starting to return to normal levels. And shortages for drugs like morphine continue in hospitals, which may create an opportunity for a new IV analgesic option like Lindbergh
We're hearing from our customers that in some areas. They expect the impact of the COVID-19 to extend to this year.
We're also hearing that elective surgeries and certain regions of the country are starting to return to normal levels and shortages for drugs like morphine continue and hospitals, which may create an opportunity for a new IV analgesic option like Olympic.
Carrie L. Bourdow: But you'll hear from Bob that we're being very thoughtful in our approach to staffing and commercialization activities. We've made great progress on our pipeline assets in 2020 as well, and we have a number of key catalysts on the horizon.
We'll hear from Bob that we're being very thoughtful and our approach the staffing and commercialization activities.
We've made great progress on our pipeline assets and 2020 as well and we have a number of key catalysts on the horizon.
Carrie L. Bourdow: Let me start with TRV 027, which is being studied in COVID patients by Imperial College, and they expect to complete their study in the first half of this year. They'll be reporting top-line data soon. Also on track for the first half of this year is our IND filing for TRV045; a novel S1P receptor modulator for the potential treatment of epilepsy and neuropathic chronic pain. And lastly, I'm pleased to announce that we've identified a novel oral form for TRV250, our new mechanism for acute migraine.
Let me start with T. R V O two seven which is being studied and COVID-19 patients by Imperial College and they expect the complete their study and the first half of this year.
There'll be reporting top line data soon thereafter.
Also on track for the first half of this year is our <unk> filing of TRT O for five and novel S. One for your receptor modulator for the potential treatment of epilepsy and neuropathic chronic pain.
And lastly, I'm pleased to announce that we've identified a novel oral form for Tru to 50 are new mechanism for acute migraine we.
We've already started IND, enabling work for the oral because we believe this will be very useful for migraine patients and for other CNS areas that we'd like to explore.
Carrie L. Bourdow: We've already started IND enabling work for the oral because we believe this will be very useful for migraine patients and for other CNS areas that we'd like to explore. Mark will provide additional details on all of these exciting pipeline developments later in the call. As you can see, it was an extremely productive year. We ended the year with $109.4 million in cash, which we expect will fund our operations for two years through year-end 2022.
Mark will provide additional details on all of these exciting pipeline developments later on the call.
As you can tell it wasn't the extremely productive year, we ended the year with $109 $4 million and cash, which we expect will fund our operations for two years through year end 2022.
I'm proud of all of that we accomplished last year, especially in light of the challenges. The COVID-19 presented to our industry and our communities and I'd like to thank our employees and our business partners for their amazing focus and resilience on delivering medicines that make a difference for patients.
Carrie L. Bourdow: I'm proud of all that we accomplished last year, especially in light of the challenges that COVID-19 presented to our industry and our communities, and I'd like to thank our employees and our business partners for their amazing focus and resilience on delivering medicines that make a difference for patients. Now, let me turn the call over to Bob to talk more about the Olympic launch. Bob. Thank you, Terry.
Now, let me turn the call over to Bob to talk more about the Olympic launch Bob.
Thank you Carrie it is great to be here. This morning to give you an update to the progress we've made with the commercial launch of of Linzess.
Bob Yoder: It is great to be here this morning to give you an update on the progress we've made with the commercial launch of Elinda. Ever since FDA approval and DEA scheduling, the team has been hard at work to build out our launch capabilities and prepare for the field launch this quarter. I am thrilled that we recently crossed the final milestone with our 40-person customer-facing team fully deployed as of late February.
Ever since FDA approval, and DEA scheduling and the team has been hard at work to build out of launch capabilities and prepare for the field launch this quarter.
I am thrilled that we've recently crossed the final milestone with our 40 person customer facing team fully deployed as of late February.
All of our new team members have prior experience and the hospital and ASC setting and many also have experienced and the acute pain space. So they are able to leverage prior relationships to facilitate early access with HCP.
Bob Yoder: All of our new team members have prior experience in the hospital and ASC setting, and many also have experience in the acute pain space. So they are able to leverage prior relationships to facilitate early access with HCPs.
Even though they pan out in the field less of the months. Our team has reported that hcp's are interested in hearing more about of Lindsay the first new chemical entity and the IV opioid space in decades and.
Bob Yoder: Even though they've been out in the field less than a month, our team is reporting that HCPs are interested in hearing more about Olinvik, the first new chemical entity in the IV opioid space in decades, and they are open to having more detailed discussions. We're deploying the customer-facing team across 550 Target hospitals and about 500 Target ASCs. We have a group of medical science liaisons in the field who are a critical aspect of our health economic strategy.
We are open to having more detailed discussions.
We're deploying the customer facing team across 550 target hospitals and about 500 target ASC.
We have a group of medical science liaisons and the field, who are a critical asset and our health economic strategy.
The call we developed to help the economic model. That's included in our comprehensive product dossier.
Bob Yoder: Recall that we developed a health economic model that's included in our comprehensive product dossier, which quantifies the overall value that Olympic can deliver to the healthcare system. Prior to the launch of our field team, we had already received positive feedback on that model in discussions with formulary stakeholders. In hiring our MSLs, we focus on bringing individuals with a strong health economics background, and they'll play a critical role in translating our model into an economic value proposition for Linvick. On the commercial side, we have a mix of regional sales managers and key account managers.
Which quantifies the overall value of the Olympic can deliver to the healthcare system.
Prior to the launch of our field team, we had already received positive feedback on that model and discussions with formulary stakeholders.
And hiring of our Msl's, we focused on bringing individuals with a strong health economics background and.
And they'll play a critical role and translating our model into an economic value proposition for Olympic.
On the commercial side, we have a mix of regional sales managers and key account managers.
Bob Yoder: This group brings an average of over 20 years of experience in pharma, along with extensive sales leadership and launch experience. They're leading our team of sales reps, all of whom bring deep experience in the acute care hospital and ambulatory surgery center setting. We are really pleased to have this level of expertise and talent supporting our launch of Olympic and the introduction of Trevena to our customers. As we think through the unique challenges of launching a new product during COVID-19, our goal is to put the right resource in the right place at the right time. We are utilizing local and state-level data on hospital protocols and elective surgery trends, as well as real-time data from our partner, Cineos Health, In addition, we also deployed a separate cohort of telesales reps who will be focused on orthopedic surgeons in both hospitals and ambulatory surgery centers.
This group brings an average of over 20 years of experience and farnell.
And with extensive sales leadership and launch experience.
They are leading our team of sales reps, all of whom bring deep experience and the acute care hospital and ambulatory surgery center setting.
We are really pleased to have this level of expertise and talent supporting our launch of Olympic and and the introduction of <unk> to our customers.
As we think through the unique challenges of launching of new products. During COVID-19, our goal is to put the right resource in the right place at the right time.
The utilizing local and state level data on hospital protocols and elective surgery trends as.
As well as real time data from our partner <unk> health to help inform our deployment strategy across a range of resources.
In addition, we also deploy the separate cohort of telesales reps, who will be focused on orthopedic surgeons and both hospital and ambulatory surgery centers.
We believe this additional promotional channel is an efficient way to drive awareness and adoption of Olympic and a key customer group.
Bob Yoder: We believe this additional promotional channel is an efficient way to drive awareness and adoption of the limbic system in a key customer group. These Telesales reps were previously engaged in the post-surgical pain space with orthopedic surgeons and are very familiar with the outpatient setting of care. As a reminder, our initial core focus covers approximately 9 million complex patients, a significant market totaling an estimated $1.5 billion addressable market opportunity. Our strategy continues to be focused on replacing conventional IV opioids with a limbic system in the right patients and surgeries, not on expanding the overall market. We've set a year-end target of 100 Formulary wins.
These telesales reps were previously engaged in the post surgical pain space with orthopedic surgeons and are very familiar with the outpatient setting of care.
As a reminder, our initial core focus covers approximately 9 billion complex patients a significant market totaling an estimated 1.5 billion dollar addressable market opportunity.
Our strategy continues to be focused on replacing conventional IV opioids with the Lindsay and the right patients and surgeries not on expanding the overall market.
We've set of yearend target of 100, formulary wins and as with any launch and the hospital space. These early months will be focused on laying a strong foundation on which to build momentum.
Bob Yoder: And as with any launch in the hospital space, these early months will be focused on laying a strong foundation on which to build momentum, things like developing customer relationships, initiating formulary discussions, and facilitating customer education. We believe that employing a thoughtful and disciplined approach will pay off in the long run for us. And with this strong field team in place, we're in a great position to begin executing on our sales plan.
Things like developing customer relationships, and initiating formulary discussions and facilitating customer education.
We believe that employing a thoughtful and disciplined approach will pay off and the long run for us and with the strong field team in place, where and a great position to begin executing on our sales plan.
As Carrie mentioned, we're very encouraged by the inbound interest we have already received from potential customers and we're starting to see some exciting movement from our early leads.
Bob Yoder: As Kerry mentioned, we're very encouraged by the inbound interest we've already received from potential customers, and we're starting to see some exciting movement from our early lead. We're in the process of scheduling our first series of speaker programs, and those will begin rolling out in the next few weeks.
We're in the process of scheduling of our first series of speaker programs and those will begin rolling out and the next few weeks.
We believe the opportunity for HCP to hear from their colleagues about the differentiating features and appropriate patients for Olympics will be an important driver of expanded awareness and the initial trial.
Bob Yoder: We believe the opportunity for HCPs to hear from their colleagues about the differentiating features and appropriate patients for LINVIC will be an important driver of expanded awareness and initial trial. Many of our initial speakers have experience with a limbic system via their participation in the Phase 3 Open Label Safety Study. With our reps in the field for less than a month, I am pleased to report that we're in active formulary review discussions with a broad range of institutions and already have some early ones.
Many of our initial speakers have experience with Olympic via their participation in the phase III open label safety study.
With our reps and the field less and a month I am pleased to report that we're in active formulary review discussions with the broad range of institution and already have some early wins.
On that note I'd like to introduce Dr. Greg Hammers of perioperative physician anesthesiologist and Intensivists at Stanford.
Bob Yoder: On that note, I'd like to introduce Dr. Greg Hammers, a perioperative physician, anesthesiologist, and intensivist at Stanford. Dr. Hammer has clinical experience with a limbic system stimulator and recently submitted it to his institution's formulary committee for review. We have asked Dr. Hammer to join us this morning to provide his clinical perspective on where he sees a limbic system fit into his practice and his experience with the formulary review process at Stanford. Before we begin, I'd like to remind everyone that a limbic system is indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are not adequate. And I would encourage you to visit limbic.com for important safety information, including the boxed warning and the full prescribing information. With that, I'll turn the call over to Dr. Hammer. Dr. Hammer?
Dr. Hans Hammer has clinical experience with Olympic and recently submitted it to as institutions Formulary Committee for review.
We have asked Dr. Hammer to join US. This morning to provide his clinical perspective of where he sees the olympics fitting into his practice and his experience with the formulary review process of Sanford.
Before he begins I'd like to remind everyone that Olympic is indicated in adults for the management of acute pain severe enough to require and IV opioid analgesic and.
And for whom alternative treatments are not adequate and I would encourage you to visit of Olympic Dot com for important safety information.
And the box warning and the full prescribing information.
With that the call I'll turn the call over to Doctor him after him.
Thanks, Bob is the <unk>.
To speak with you all of this morning at this early hour out here on the West Coast.
Dr. Greg Hammer: Thanks, Bob. It's a pleasure to speak with you all this morning at this early hour out here on the West Coast. I'm happy to be given the opportunity to present a few insights from my perspective as a perioperative physician with respect to Olimbic and its role in my practice as an anesthesiologist and intensivist at Stanford. I manage patients of all ages having cardiothoracic procedures in our heart center. By way of disclosure, I'm a paid consultant with Trevena. However, the views that I'll be expressing today are my own. I'm not speaking on behalf of Stanford University.
I'm happy to be given the opportunity to present, a few insights from my perspective, as the perioperative position with respect the Olympics and its role in my practices and anesthesiologists and Intensivists the Stanford.
And managed patients of all ages, having cardiac and thoracic procedures and our heart Center.
By way of disclosures I'm, a paid consultant with Davita the.
Used and I'll be expressing today or my own I'm not speaking on behalf of Stanford.
I have read all of the phase one through phase III studies and use the Olympic and adults have and cardio thoracic procedures intravenous phase III open label safety study.
And I feel very familiar with the drug and well qualified to discuss its use and the perioperative setting.
Dr. Greg Hammer: I have read all of the Phase I through Phase III studies in youth and adults having cardiothoracic procedures in Trevena's Phase III open-label safety studies, feel very familiar with the drug, and am well qualified to discuss its use in the perioperative setting. There has been very little innovation in IV opioid pharmacology in the last few decades. Despite the fact that opioids remain an essential component of perioperative management. Until now, all opioids have worked in the same way, by binding to a receptor and turning on a switch. Unfortunately, that switch activates pain control pathways but also a number of unpleasant and serious side effects. These include respiratory depression and GI complications, including nausea and vomiting. Olympic is truly novel.
There has been very little innovation, and IV opioid pharmacology and in the last few decades. Despite the fact that opioids remain in the central component of Perioperative management.
Until now all opioids have worked and the same way by binding to receptors and turning on the switch.
Unfortunately that switch activate the pain control pathways, but also a number of unpleasant and serious side effects.
And as include respiratory depression, and Gi complications, including nausea and vomiting.
Olympic is truly novel it is chemically distinct from conventional IV opioids and does not activate these pathways equally.
What I find really exciting is that while Olympic is as effective and analgesic drug as morphine and other opioids and it is differentiating features that are important as I manage my clinically challenging patients.
Let me touch on a few of the challenges we face when managing postoperative pain.
First respiratory depression is the most read at opioid related adverse effects.
Dr. Greg Hammer: It is chemically distinct from conventional IV opioids and does not activate these pathways equally. What I find really exciting is that while olimbic is as effective an analgesic drug as morphine and other opioids, it has differentiating features that are important as I manage my clinically challenging patients. Let me touch on a few of the challenges we face when managing post-operative care. First, respiratory depression is the most dreaded opioid-related adverse effect. I was very reassured to see that Trevena looked at this in their clinical program. Respiratory depression is very difficult to study in clinical trials. There are no good ways to measure it.
I was very reassuring to see the Tribune and looked at this and their clinical program.
Respiratory depression is very difficult the study and clinical trial.
There are no good way to measure it.
So we use substitute measures like oxygen saturation and respiratory rate and.
Unfortunately, these are rather for surrogate.
In addition, and if a patient begins to manifest decrease or obstructed breathing, we cannot simply watch and see how bad it gets in orders of documents.
We're compelled to intervene so we lose the ability to evaluate the severity.
It makes it hard for us to accurately assess how frequently significant respiratory depression really occurred.
Fortunately, we do have an ingenious way of measuring respiratory depression, and healthy subjects, which drew Gina did and one of their clinical studies. This is called the ventilatory response.
Dr. Greg Hammer: So we use substitute measures like oxygen saturation and respiratory rate. Unfortunately, these are rather poor surrogates. In addition, if a patient begins to manifest decreased or obstructed breathing, we cannot simply watch and see how bad it gets in order to document it; we are compelled to intervene, so we lose the ability to evaluate its severity. This makes it hard for us to accurately assess how frequently significant respiratory depression really occurs. Fortunately, we do have an ingenious way of measuring respiratory depression in healthy subjects, which Trevena did in one of their clinical studies. This is called the ventilatory response. When a person breathes in a mixture of air and CO2 or carbon dioxide,
C O two tests.
When a person breed the mixture of air and C O two of carbon dioxide.
They breathe more deeply and frequently to get rid of the C O two.
This is an important homeostatic response by the brain and body.
Divina use this method to generate meaningful data to comparable index respiratory profiles of that of morphine.
And this published data will be an important consideration for formulary Committee is reviewing the Olympics.
I was also really impressed by the nausea, and vomiting adverse event profile with the Olympics and the phase III trial.
The only thing worse, the nausea, and vomiting, as nausea, and vomiting, and abreast surgical incision most.
Most patients would rather have pain, the nausea and vomiting.
Based on my own experience of the surgical patient I am in that camp.
Dr. Greg Hammer: They breathe more deeply and frequently to get rid of the CO2. This is an important homeostatic response by the brain and body. Trevena used this method to generate meaningful data to compare a limbic respiratory profile to that of morphine, and this published data will be an important consideration for formulary committees reviewing Olympic drugs. I was also really impressed by the nausea and vomiting adverse event profile with Olympic in the phase 3 trial. The only thing worse than nausea and vomiting is nausea and vomiting and a fresh surgical incision.
<unk> cross for my shoulder surgery, taking place right. After this call.
Olympic has the rapid onset no active metabolites and does not have to be dose adjusted and people with kidney disease.
These are all really desirable pharmacologic properties of any drug, especially opioids.
We're in the midst of getting Olympic added to the formulary at Stanford the process and pretty simple.
And the physician makes the request of the formulary Committee and the pharmacy in turn make the presentation of the subsequent meeting the.
And the initial target population might be the elderly and obese patients.
Dr. Greg Hammer: Most patients would rather have pain than nausea and vomiting. Based on my own experience as a surgical patient, I am in that camp, fingers crossed for my shoulder surgery taking place right after this call. Olympic has a rapid onset and no active metabolites.
The recent publication on the Phase III Open label Safety study confirmed that the at risk groups did not have of higher incidence of respiratory or Gi side effects compared to the young healthy patients who were on the Olympics.
This is big.
And since even one serious respiratory events and increased hospital stays and hospital cost.
Dr. Greg Hammer: These are all really desirable pharmacologic properties of any drug, especially opioids. We're in the midst of getting Olympic added to the formulary, and the process is pretty simple. Unknown Attendee, Barry Shin, Trevena Inc. Transcripts provided by Transcription Outsourcing, LLC. Transcription Outsourcing, LLC. Unknown Attendee, Barry Shin, Trevena Inc. Since a recent publication on the Phase 3 Open Label Safety Study confirmed that these at-risk groups did not have a higher incidence of respiratory or GI side effects compared to young, healthy patients who were on a limbic.
Even the cost of Gi related side effects can be great since nausea, and vomiting may well resolved and prolonged hospitalization and significant patient dissatisfaction.
No opioids is without risk.
Fortunately doctors and pharmacists are well versed and managing those risks.
When the formulary Committee makes the decision they look at all of the published data and look for ways to improve patient outcomes and save money for.
Praveen and has done a great job assembling a strong foundation of published data that will help formulary committee evaluate cost offsets along with considering the clinical benefit of the new drug.
To close I'm very excited to be able to use the limbic the.
Dr. Greg Hammer: This is big, since even one serious respiratory event can increase hospital stays and hospital costs. Even the cost of GI-related side effects can be great, since nausea and vomiting may well result in prolonged hospitalization and significant patient dissatisfaction.
The first new IV opioid and some time for managing acute pain.
The used it and patients and have seen how they benefited from it and.
And I look forward to having it available as part of my bracket.
Thanks for your attention I'm happy to turn the mic over to Kerry.
Thank you Greg we really appreciate your insights.
Dr. Greg Hammer: No opioid is without risk, but fortunately, doctors and pharmacists are well versed in managing them. When the formulary committee makes its decision, they look at all the published data and look for ways to improve patient outcomes and save money. Trevena has done a great job assembling a strong foundation of published data that will help formulary committees evaluate cost offsets along with considering the clinical benefit of the new drug. And to close, I'm very excited to be able to use a LENVIC.
Hal Limbic may help you treat your patients and some of the considerations for the year Formulary Committee.
Let's now move to talk more about our pipeline and I will turn the call over to Mark to review some of the key activities Mark.
Thank you Carrie.
With our innovative science and dedicated team we built the pipeline that is targeting some of the most urgent diseases and CNS.
And in 'twenty, one is certainly shaping up to be and exciting year.
I'd like to start with our newest asset <unk>.
Our V O two seven which is being studied and COVID-19 patients.
Dr. Greg Hammer: Unknown Attendee, Barry Shin, Trevena Inc. I've used it in patients and have seen how they benefit from it, and I look forward to having it available as part of my practice. Thanks for your attention. I'm happy to turn the mic over to Kerry.
Shortly after the start of the pandemic of publication out of Duke University highlighted the therapeutic potential of TRP, Oh, two sevens selective mechanism of action to restore lung function, while block and the pathway that causes multi organ damage and abnormal blood clotting and COVID-19 patients.
Carrie L. Bourdow: Thank you, Greg. We really appreciate your insights, how LENVIC may help you treat your patients, and some of the considerations for your formulary committee. Let's now move to talk more about our pipeline, and I'll turn the call over to Mark to review some of the key activities. Mark?
Several institutions, we're interested in studying T. R V O two seven and the team at Imperial College, London is currently sponsoring and leading of trial and 60 hospitalized adult COVID-19 patients.
Mark A. Demitrack: Thank you, Kerry. With our innovative science and dedicated team, we built a pipeline that is targeting some of the most urgent diseases in CNS. 2021 is certainly shaping up to be an exciting year. I'd like to start with our newest asset, TRV027, which is being studied in COVID-19. Shortly after the start of the pandemic, a publication out of Duke University highlighted the therapeutic potential of TRV027's Selective Mechanism of Action to restore lung function while blocking the pathway that causes multi-organ damage and abnormal blood clotting in COVID-19 patients.
The primary endpoint is the prevention of abnormal blood clotting.
They are also evaluating overall disease outcome, including lung function.
They expect to complete the study and the first half of this year.
With our Delta receptor agonists T. R V $2 50.
We reported earlier today that we've made significant progress by identifying and novel oral formulation and we've already embarked on the necessary IND, enabling work to make this oral formulation available for human use.
We believe that this will significantly extend our patent for this compound.
We continue to believe that the Delta receptor is an important therapeutic target.
Because of its broad distribution and brain areas that are key for the regulation of pain mood and anxiety.
Mark A. Demitrack: Several institutions were interested in studying TRV027, and the team at Imperial College London is currently sponsoring and leading a trial in 60 hospitalized adult COVID patients. The primary endpoint is the prevention of abnormal blood clotting. But they're also evaluating overall disease outcome, including lung function. They expect to complete the study in the first half of this year with our Delta receptor agonist, TRV250. We reported earlier today that we've made significant progress by identifying a novel oral formulation.
With an oral formulation now in hand.
Alongside the existing subcutaneous formulation, we've been studying up to this point.
We are in an advantageous position to continue for future development efforts with this compound.
Finally, I would like to comment on our work with T. R V O for five our S. One P receptor modulator.
Let me highlight two important attributes of this compound.
First it's specific.
Perfect for the type one form of the <unk> receptor, that's prevalent and brain tissue.
And secondly to your V O for five appears to have no effect on peripheral lymphocyte trafficking.
The common side effects of current S. One P modulators on the market that can lead to Lymphopenia and immunosuppression.
Mark A. Demitrack: And we've already embarked on the necessary IND-enabling work to make this oral formulation available for human use. We believe that this will significantly expand our patent portfolio for this company. We continue to believe that the Delta receptor is an important therapeutic target because of its broad distribution in brain areas key to the regulation of pain, mood, and anxiety, with an oral formulation now in hand, alongside the existing subcutaneous formulation we've been studying up to this point.
We believe these combined attributes make tier V O for five unique among compounds in this space.
And ideally suited for exploring CNS clinical indications like chronic neuropathic pain or epilepsy.
We've been fortunate to collaborate with the NIH on this program and.
And while that work is ongoing we've made progress on our own and enabling efforts and are on track to submit our initial IMD for tier of V. O four of five in the first half of this year.
We're excited about the prospects for T. R V O four of five moving forward and for our exploration of the best <unk> Pharmacology and general.
Mark A. Demitrack: We are in an advantageous position to continue future development efforts with this compact. Finally, I would like to comment on our work with TRV045—our S1P receptor module. Let me highlight two important attributes of this compound. First, it's specific to the type 1 form of the S1P receptor that's prevalent in brain tissue. Secondly, TRV045 appears to have no effect on peripheral lymphocyte traffic, a common side effect of current S1P modulators on the market that can lead to lymphopenia and immunosuppression. We believe these combined attributes make TRV045 unique among compounds in this space and ideally suited for exploring CNS clinical indications like chronic neuropathic pain or epilepsy.
Let me now turn the call over to Barry to discuss our financial results for the year Barry.
Thanks, Mark for.
For the fourth quarter of 2020, we added a net loss of $11 $9 million.
Compared to $6 $4 million for the fourth quarter of 2019.
And this increase of net losses, mainly due to preparations for the commercial launch of Olympic.
Our operating expense was $12 $1 million in the fourth quarter of 2020, and we expect this to increase moderately in 2021, as we deploy of customer facing team and commercialize the Olympic.
We significantly strengthened our financial position last year, with and oversubscribed $57 $5 million public offering in August as well as receipt of a $3 million milestone payment from <unk> our partner in China.
As a result.
Barry Shin: We've been fortunate to collaborate with the NIH on this program, and while that work is ongoing, we've made progress on our own IND enabling efforts and are on track to submit our initial IND for TRV 045 in the first half of this year. We're excited about the prospects for TRP 045 moving forward and for our exploration of S1P pharmacology in general. I will now turn the call over to Barry to discuss our financial results for the year. Barry?
And I'm pleased to report cash and equivalents of $109 $4 million at year end 2020.
Which we expect will fund our operations through the fourth quarter of 2022.
This includes two years of Olympic commercialization and progress across our pipeline.
We'll now open the call for questions after which Carey will provide some closing remarks opt.
Operator.
Ladies and gentlemen, if you'd like to ask a question at this time. Please press the star and the number one key on your Touchtone telephone to withdraw your question press the pound key.
Barry Shin: Thanks, Mark. For the fourth quarter of 2020, we had a net loss of $11.9 million compared to $6.4 million for the fourth quarter of 2019. This increase in net loss is mainly due to preparations for the commercial launch of a lending platform.
And then that is star then one if you'd like to ask a question at this time.
Our first question comes from the line of Dana Flanders with Guggenheim.
Great. Thank you very much for for the questions and.
Congratulations on all of the progress.
Just two quick questions if I could.
Was wondering if you could give us a little more color on.
Barry Shin: Our operating expense was $12.1 million in the fourth quarter of 2020, and we expect this to increase moderately in 2021 as we deploy a customer-facing team and commercialize Olympics. We significantly strengthened our financial position last year with an over-subscribed $57.5 million public offering in August, as well as receipt of a $3 million milestone payment from NOAA, our partner in China. As a result, I'm pleased to report cash in equivalent of $109.4 million at year-end 2020, which we expect will fund our operations through the fourth quarter of 2022.
Some of the formulary.
Processes undergoing right now and.
Wondering how many are actually reviewing all and Vic if you can share of that and then I guess across some of the early wins you're seeing.
Are there any restrictions in place.
For old index.
Among the target patient population.
And that you'd expect it to use and then my second question apologies if I missed this but just on T. R V O two seven and.
The reason for the delay and data I think originally it was <unk> of this year and and now you are saying first half of 'twenty, one and I'm wondering if you have any color on that thank you.
Barry Shin: This includes two years of limited commercialization and progress across our pipeline. The call for questions will now open, after which Kerry will provide some closing remarks. Operator. Ladies and gentlemen, if you'd like to ask a question at this time, please press the star, then the number one key on your touchtone telephone. To withdraw your question, press the pound key.
Good morning, Dan and thank you for the question so.
I'll start and then if Bob and Mark on the jump in as well on the color for the formulary wins and then it's pretty early right for US we just got our field sales organization and the sell out what.
What I can say inter.
Interestingly enough is that we have not had major restrictions placed placed on the drag of one.
Operator: Again, that is star then one if you'd like to ask a question at this time. Our first question comes from the line of Dana Flanders with Guggenheim. Great. Thank you very much for the questions and congratulations on all the progress. I had just two quick questions if I could.
And of the the larger institutions that put the drug on formulary.
Was interested in it for a particular patient group, but decided not to put restrictions on it. So I thought that was really really interesting so more to come obviously as we continue with the launch processes.
Carrie L. Bourdow: First, I was wondering if you could give us a little more color on some of the formulary processes undergoing right now and wondering how many are actually reviewing OLINVIC, if you could share that. And then, I guess across some of the early wins you're seeing, are there any restrictions in place for OLINVIC among the target patient population that you'd expect to see use? And then my second question, apologies if I missed this, but just on TRV027: any reason for the delay in data?
And we will be providing additional updates.
Let's see I think you also asked about <unk> seven and the delay and the data. So this is the study as you remember that's being run by Imperial College in London, and they are partnering with the British Heart Foundation, I think youre, saying Thats a lot with with Covid studies.
It's such an interesting and disease, you know their peaks and valleys and how the <unk>.
Carrie L. Bourdow: Unfortunately, it was 1Q of this year, and now you're saying first half of 2021. I'm wondering if you have any more color on that. Thank you. Good morning, Dan. Thank you for the question. So I'll start, and then Bob and Mark want to jump in as well. On the color for the formulary wins, I mean, it's pretty early, right, for us.
Studies of recruiting and and frankly this one this one is not up to US right. This is really more of Imperial college driving driving the processes. So.
We've been really pleased with Imperial college, and all of that Theyre doing.
And they're one of the top the.
Institutions with regard to Covid debt, there's not really any additional information around the around the timing marketing thing you'd like to add I know, you're really close to the team there at Imperial College.
Carrie L. Bourdow: We just got our field sales organization, our MSLs, out. What I can say, interestingly enough, is that we have not had major restrictions placed on the drug. One of the larger institutions that put the drug on formulary was interested in it for a particular patient group but decided not to put restrictions on it.
Yes, David just to Echo what Carrie was saying.
As you know the.
The.
Cases, and the prevalence of of Covid is in somewhat of an unpredictable.
Of course, Theres been peaks and valleys.
Over over time, it's also obviously a very.
Carrie L. Bourdow: So I thought that was really, really interesting. So more to come, obviously, as we continue with the launch processes. We'll be providing additional updates.
Clinically challenging population to treat that as Carrie said.
The team at Imperial College is directing the study and so we follow the.
Carrie L. Bourdow: I think you also asked about O27 and the delay in the data. So this is a study, as you remember, that's being run by Imperial College London, and they're partnering with the British Heart Foundation. So we've been really pleased with Imperial College and all that they're doing. They're one of the top institutions with regard to COVID, but there's not really any additional information around the timing. Mark, anything you'd like to add? I know you're really close to the team there at Imperial College.
Their lead and their guidance as to the progress that they're making.
That works.
Sure.
Of anything you'd like to earnings and the formulary colors.
No I think you covered it I think yeah.
I think we're good.
Okay. Thank you.
Our next question comes from Brandon Folkes with Cantor Fitzgerald.
Hi, Thanks for taking the questions and congratulations on all of the progress.
Maybe just following on from the formulary additions question and.
Can you give any color in terms of wage of had the early wins and kind of maybe where you are.
Or have date set for reviews of these academic centers community hospitals any color there would be helpful.
Mark A. Demitrack: Yeah, Dana, just to echo what Kari was saying. As you know, the cases and the prevalence of COVID have been on somewhat of an unpredictable course. There've been peaks and valleys over time.
And then secondly, and.
And you're deploying reps into the field, how should we think about maybe the percentage of reps that are allowed sort of face to face.
Mark A. Demitrack: It's also obviously a very clinically challenging population to treat. But as Kari said, the team at Imperial College is directing this study. And so we follow their lead and their guidance as to the progress that they're making on that work. Bob, anything you'd like to add about the formulaic colors?
With the customers. Thank you.
Great. Thank you. Thank you Brandon.
So again on on on the color of the formularies.
Let's see what I can say is that we've been really pleased with the reviews at both ambulatory surgery centers and.
Bob Yoder: No, I think you covered it. Yeah. Yeah, yep. I think we're good.
Hospital institutions and you heard Dr Hammer for.
And Stanford described the process and his institution, which is a large academic medical center you can hear his interest.
Operator: Okay, thank you. Our next question comes from Brandon Folkes with Cantor Fitzgerald. Hi, thanks for taking the questions and congratulations on all the progress. Maybe just following on from the formulary additions question, can you give any color in terms of where you've had the early wins and kind of maybe where you are?
And at the.
And potentially the.
The way in which he'll go about getting Stanford on our <unk>.
Getting Olympic on the sand per formulary and I think that's pretty similar to what we've heard from other academic medical centers.
And.
You remember that we are targeting with our field sales organization more of the community community teaching organizations, because they tend to have less.
Carrie L. Bourdow: or have dates set for reviews, you know, are these academic centers, community hospitals, any color there would be helpful. And then, secondly, as you're deploying reps into the field, how should we think about maybe the percentage of reps that are allowed to have face-to-face contact with customers? Thank you. Unknown Attendee Great, thank you.
And processes in place or less processes as it relates to formulary committees, but we had quite a few investigators that were involved and the open label safety study and Athena like Doctor doctors Hammer.
Bob Yoder: Thank you, Brandon. So again, on the color of the formularies, let's see, what I can say is that we've been really pleased with the reviews at both ambulatory surgery centers and hospital institutions. And you heard Dr. Hammer from Stanford describe the process.
And that want to get Olympic on formulary really quickly so more to come obviously as we as we get a little bit more information, we'll certainly be providing that.
And then I think you had a question around the the reps and I'll, let Bob handle that.
Great Yeah, Thanks, and Brandon for the question so.
Carrie L. Bourdow: Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., You remember that we are targeting with our field sales organization more the community, community teaching organizations because they tend to have less, Unknown Attendee. But we had quite a few investigators that were involved in the Open Label Safety Study in Athena, like Dr. Hammer, that want to get a limbic on formulary So more to come, obviously, as we get a little bit more information, we'll certainly be providing that. And then I think you had a question about the reps, and I'll let Bob handle that. Yeah, thanks.
Good question about the percent allowed face to face. The first thing I'd say is it's highly regionally specific and it really does vary quite a bit depending on where you are and the country and what's happening there.
I will say the week.
We've trained and resource our folks to be effective and either setting so during the training process and and and the creation of resources, we put things together. So they can be effective and both the virtual engagement with customers.
And through the CRM platform and things like that and live and certainly.
The guidance is live where and when you can and then certainly virtual if you need to fall back on that platform. So on.
I think nationally if you look at some national audit data.
On the range is probably 50 50 national but I would say, that's highly variable and and localized.
Great. Thank you very much.
Bob Yoder: Thanks, Brandon, for the question. So it's a good question about the percent allowed face-to-face. The first thing I'd say is it's highly regionally specific. It really does vary quite a bit depending on where you are in the country and what's happening there.
Our next question comes from Jason Butler with JMP Securities.
Hi, Thanks for taking the questions just a couple.
The Doctor Hammer a question for you if I can appreciate your perspectives on on Olympic can you maybe give us any thoughts.
Bob Yoder: I will say that we've trained and resourced our folks to be effective in either setting. So during the training process and in the creation of resources, we put things together so they could be effective in both virtual engagement with customers through the CRM platform and things like that, and live. And certainly, the guidance is live where and when you can, and then certainly virtual if you need to fall back on that platform. So I think nationally, if you look at some national audit data, the range is probably 50-50 nationally, but I would say that's highly variable and localized.
Beyond Houston Your hospital of the types of institutions that makes sense for the company for folks on first and how they can best message the drug's value proposition.
Sure well I think of as I said initially targeting.
Targeting.
For the elderly and obese populations, which are.
Very important high risk Cup.
Couple of populations and all hospitals and essentially.
Based on the data from Phase III study that there is no incremental respiratory depression or increase and or rather a theres, no increase and nausea, and vomiting and that elderly group. So.
Operator: Great, thank you very much. Our next question comes from Jason Butler with JMP Securities. Hi, thanks for taking the questions. Just a couple. Dr. Hammer, I have a question for you, if I can, I would appreciate your perspectives on Olimbic.
I think thats those are two excellent population of the targets or wherever the patients our house I think our.
Good targets, Mike mentioned that one.
And get familiar with using the drug and those populations for example, and and other high risk population.
Dr. Greg Hammer: Can you maybe give us any thoughts beyond use in your hospital, the types of institutions that make sense for the company to focus on first, and how they can best communicate the drug's value proposition? Sure. Well, I think, as I said initially... Unknown Attendee targeting. Unknown Attendee Elderly and Obese Populations, which are, very important high-risk couple of populations in all hospitals essentially. Unknown Speaker Based on the data from phase 3 study that there's no incremental respiratory depression or increase in, or rather, there's no increase in nausea, vomiting, and that the elderly, So.
Such as those who are reasonably ex debated but need opioid analgesia.
And others at risk with respiratory diseases, and so on and that once people are familiar with using the drug dosing the drug using it as the bullets and PTA.
Debt, it's useful spreads on I saw.
And the same thing with the.
And the transition from bio pants, all of the protocols and induction drug and anesthesia.
<unk> was 50 cents for a syringe and Propofol was $8 50, but it was appropriately and successfully market as the drug that resulted in earlier awakening and more rapid readiness for recovery of discharge and so we started using it for that purpose and pretty soon and it was being used for all kinds of different indications because.
Unknown Attendee: Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Good target. My sense is that one Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Unknown Attendee, Barry Shin, Trevena Inc., Unknown And then a question on TRVR045: can you give us any high-level thoughts on the scope of the Phase 1 program, as well as the single and multiple ascending PK work?
And people got familiar with it and.
The pharmacokinetics.
Like the safety.
And so I believe the same thing is going to happen with the Olympics.
Great.
And then a question on CRB are.
Zero for five can you give us any high level thoughts on the the scope of the phase one program.
As well as the single and multiple ascending PK work are there any PD markers, you'll be evaluating and any potential to include patients and the phase one program and in addition to healthy volunteers.
Unknown Attendee: Are there any PD markers you'll be evaluating, and any potential to include patients in the Phase 1 program in addition to healthy volunteers? Thanks. Thanks, Jason, and Mark. Sure. Jason, so at this point, we've not described the details of the Phase I program, as you know. But, in addition, I think you can imagine that in addition to the standard information that we would need to collect, given the targets that are under consideration, we'd obviously look pretty carefully at several experimental models that could be used for PD endpoints.
Thanks, Jason Mark.
Sure.
Jason So at this point, we've we've not describe the details of the of the Phase One program as you know so in addition, but in addition, I think you can imagine that in addition to the.
The standard of information that we would need to collect given.
The targets that are that are under consideration.
Obviously look pretty carefully at <unk>.
Several of the experimental models that could be used for PD endpoints.
Mark A. Demitrack: And some of those may well be more appropriate in individuals with a diseased state for us to look at. So it is certainly something that's on our radar screen, but we haven't discussed details of the program at this stage. Okay, great.
And some of those may well be more appropriate.
In individuals with a disease state for us to look at so it is it is certainly something that's on our radar screen, but we havent. We havent discussed details of the program at this stage.
Okay, great. Thanks for taking the questions.
Carrie L. Bourdow: Thanks for taking the question. And Jason, I appreciate the question. I'm going to build, actually, on the question that you asked around Olympic as well, because one of the things I think that we spend so much time talking about what our initial focus is, but let me just tell you, as you know, that we received a broad indication statement. It's the broadest indication statement that we could have received. And when you look at the open-label safety study that Dr. Hammer was involved in, you know, lindic was used in everything from medical pain, so things like sickle cell, pancreatitis, you know, broken arms in the emergency room, all the way to some of the more severe procedures that you hear us talk about, colectomies, total hip, total knees, in multiple settings, in the emergency room.
And Jason and I appreciate the question I'm and I'm going to build that actually on the question that you asked around the olin deck as well because.
One of the things I think that we spend so much time talking about what our initial focus is but but let me just tell you as you know debt. We received the broad indication statement. It's the broadest indication statement that we could have received and when you look at the open label safety study the Doctor Hammer was.
And Bob and.
And.
Olympic wishes and everything from medical pain, so things like sickle cell pancreatitis broken arms, and the emergency room and all the way to some of the more severe procedures that you hear US talk about colectomy is total have total knees and.
In multiple settings of emergency room and.
Carrie L. Bourdow: We actually had a lot of plastic surgeons that were involved in the study, so things like breast augmentation or facial surgeries. And in particular, in some of those areas, plastics, right, those are cash-paying patients. So we have patent life on a lindic out until 2032 without any extensions.
We actually had a lot of plastic surgeons that were involved and the study so things like breast augmentation or of facial search surgeries and in particular and some of those areas.
Ex right those are cash paying patients. So we of patent life on Olympic out until 2032 without without in the extensions you hear Dr. Hammers excitement of using it and academic academic medical center like Stanford, but I really I do agree with him and that really just getting started with the potential.
Operator: You hear Dr. Hammer's excitement about using it in an academic medical center like Stanford, but I really do agree with him that we're really just getting started with the potential opportunity for a lindic. So I appreciate the question. Our next question comes from a line from Douglas Tsao with H.C. Wayne. Hi, Chris Bialython for Doug Tsao. Thanks for taking my question. I actually have two.
<unk> index and I appreciate the question.
Our next question comes from the line of Douglas Tsao with H C. Wainwright.
Oh, Hi, crispy all of the song for dogs. So thanks for taking my question. So actually of two I was wondering if you could maybe tell us which surgical indications are you seeing the most and the least uptake and right now and if you've had any formulary losses, what are some of the reasons for that and how do you plan to over.
Unknown Attendee: I was wondering if you could maybe tell us which surgical indications you are seeing the most and the least uptake for right now? And if you've had any formulary losses, what are some of the reasons for that, and how do you plan to overcome these in the future? Thank you. Morning, Chris. I don't think we have much information on surgical indications.
The comedies and the future. Thank you.
Good morning, Chris on.
I don't think we have much information around the surgical indications.
Carrie L. Bourdow: You know, we have anesthesiologists that are asking to have the drug placed on formulary. Our focus is also on the surgery areas are colorectal, orthopedic, and gynecologic. So those are really the three main areas. And they use a lot of IV opioids; they use a lot of drugs with IV morphine or IV hydromorphone. We've not had any formulary losses yet.
Here, we have the anesthesiologists that are asking to have the drought and placed on formulary. Our focus is also on the on the surgery surgery areas or colorectal.
Orthopedics and gynecologic and those are really the three main areas and they use a lot of IV opioid use of lot of drugs with the.
Like IV morphine or IV hydromorphone.
We've not had formulary losses.
Carrie L. Bourdow: It's early, right? It's early days. So we'll be able to provide a little bit more color on that. And as I said earlier, as you heard Bob say, we're just getting our field pills organization out, our medical science liaisons. There were a lot of physicians that were involved in the early open-label safety study that had been waiting for the drug. So those, as you might imagine, are the first group of physicians to advocate for the drug on formulary.
Its early right. It's early day, so so we'll be able to provide a little bit more color on that and as I said earlier and as you heard Bob say, we're just getting our field sales organization out our medical science liaisons and there were a lot of physicians that were involved in the early open label safety.
Study that had been waiting for the drug and so those as you might imagine on the first group of physicians to.
To advocate for the drug on formulary. So again early days right and will provide additional color as we moved three of the launch.
Carrie L. Bourdow: So again, early days, right? We'll provide additional color as we move through the launch. All of you, thank you. Thank you. That concludes today's question and answer session. I'd like to turn the call back to Carrie Boudreau for closing remarks. Thank you. Thank you all for your questions. And as you heard from us today, we are excited to now be underway with our full commercial launch of Alembic. The feedback and interest, as we've stated, that we've received from physicians like Dr. Hammer reiterate our confidence in Alembic's differentiated clinical profile.
Awesome. Thank you.
Thank you.
That concludes today's question and answer session I'd like to turn the call back to Kerry Boudreaux for closing remarks.
Thank you. Thank you all for your questions and as you heard from US today, we are excited to now be underway and our FERC full commercial launch of all index the.
Feedback and interest.
And as we stated that we've received from physicians like Doctor Hammer.
Reiterate our confidence and Linda ex differentiated clinical profile and we obviously are committed to delivering this novel therapeutic option to patients and hospitals and ambulatory surgery centers across the country.
Carrie L. Bourdow: And we obviously are committed to delivering this novel therapeutic option to patients in hospitals and ambulatory surgery centers across the country. Additionally, as you've heard, we're prepared to take the pipeline across a number of key milestones, and we look forward to sharing additional updates with you as we achieve success on all these fronts and continue to grow as an innovative CNS company. So thank you very much for joining us today, and that concludes today's call. Ladies and gentlemen, this concludes today's program. Thank you for participating. You may now disconnect.
And additionally, as you've heard and we're prepared to take the pipeline across a number of key milestones and we look forward to sharing additional updates with you as we achieve success on on all these fronts continue to grow as an innovative CNS company. So thank you very much for joining us today and that concludes today's call.
Ladies and gentlemen. This concludes today's program. Thank you for participating you may now disconnect.
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Okay.
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Operator: [inaudible]