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spk06: Good morning and welcome to the Trevena first quarter 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I'd now like to turn the conference over to Barry Shin, Senior Vice President and Chief Financial Officer. Please go ahead.
spk04: Good morning and welcome, everyone. With me today are Carrie Bordeaux, our President and CEO, Patty Drake, our Chief Commercial Officer, and our Chief Medical Officer, Mark Demitrak. As a reminder, Olenvic was approved by the FDA in August 2020 and indicated 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 the full prescribing information, are all available on olenvic.com. I'll remind you that Olenvic is an opioid that is a Schedule II controlled substance with a high potential for abuse similar to other opioids. We'll 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. I'm now turning the call over to Kerry for an overview of our first quarter of 2022 and recent business accomplishments. Kerry?
spk00: Thank you, Barry. Good morning, everyone, and thanks for joining us. Today, we'll provide an update on our refocused efforts for LNVIC and updates to our pipeline assets. Let's start with the LNVIC. From a macro perspective, we are seeing signs that hospitals are opening back up and things are improving, but it's taking time. Our field sales team is actively engaging burn, colorectal, and anesthesiology-related physicians and our refocused field strategy is building momentum on the ground. However, at the same time, I want to acknowledge that the launch has been slower than we had expected. We haven't seen the traction as quickly as we would have liked, and engaging inpatient hospital decision makers in the midst of the pandemic has certainly been difficult. I will say that I'm proud that the team has been able to adjust and is refocusing where needed. Patty will talk more about our renewed approach that she initiated mid-quarter And in part, this included moving sales reps over from the contract sales organization to our in-house Trevena team. We do believe this is having a positive impact and helping us to have a better approach to messaging and field execution. On the clinical side, our LENVIC post-approval studies are on track. Our medical science liaisons have now been trained on the exciting new respiratory physiology data. And we are adding this data to the hospital dossier for formulary committee reviews. We also plan to present the data at the American Society of Anesthesiologists conference in the fall. And in a few months, we expect to report top line results from the Olindic Cognitive Study versus IV morphine, which is a very interesting area for prescribers. At the end of the year, we expect to have results from the Cleveland Clinic Outcome Study looking at respiratory, cognitive function, and GI tolerability, all important data we plan to discuss with formulary committees. Patty and Mark will talk more about our plans for OLYMVIC later on the call, but before I turn it over, let me make a few more comments on the pipeline. First, like many of you, we were disappointed that the Data Safety Monitoring Board recently stopped the TRV-027 arm for the ACTIV-4 trial. Just a reminder, the NIH came to us to study TRV-027 in hospitalized COVID patients, and this study was completely funded by NIH. We are looking forward to seeing the complete analyses, and we'll certainly update you as we learn more. On TRV-045, our novel S1P receptor modulator, we expect to complete Phase I study by year-end. We're initially looking at TRV045 as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. This is a large opportunity. Over 25% of diabetic patients have neuropathic pain. And the NIH is studying TRV045 in preclinical models for epilepsy. We should have that data also in the second half of this year. so we could potentially have two shots on goal to pursue with CRV 045. Lastly, I'm pleased to announce that we received the first non-dilutive $15 million tranche from our financing we reported earlier in the quarter. There's a potential for another $25 million in funding from this deal, including a milestone payment upon first commercial sale of Alembic in China. So I know there's a lot to cover. We'll leave time for questions. But let me turn the call over to Patty to talk more about the Alimbic launch. Patty?
spk01: Thanks, Carrie. And hello, everyone. Let me update you on the continued progress that we've made in the commercial strategy that was launched mid-first quarter for Alimbic. I'd like to start off by sharing that we are in the midst of contract negotiations with large hospital group purchasing organizations. that represent over 5,000 member hospitals. These contracts will allow for a broadening of access to a LINVIC through a top-down approach, which is the first of our three strategic pillars. And we're making headway. Having a contract in place will allow the member hospitals to have access to a LINVIC for the key account managers to pull through sales. And we look forward to updating you as these contracts progress. Our second pillar, focusing on core patients, has led to 2,500 calls in the first quarter, over half of which were concentrated in the critical care settings of burn, colorectal, and anesthesiology. Despite the very difficult access in the first half of the quarter, over 90% of these interactions were conducted in impactful face-to-face forums when access did improve in the latter part of the quarter. We continue to be invited to conduct in-service programs where we educate the entire healthcare team on the use of a limbic in appropriate patients. In fact, we've held 98 in-service programs in the first quarter. I'd like to add that awareness for Alimbic has increased because of our presence at national congresses like the Anesthesiology ASRA Congress, where our Alimbic data was selected as the President's Choice Presentation. We attribute the strong execution we are seeing to our Trevena-led customer-facing team, which is the third and final element of our strategy. As I've spoken about in the past, What this team is hearing from our customers in these interactions support our belief that Olenvic is a particularly compelling option for the difficult to treat patients like the elderly, obese, and really impaired. We believe customers appreciate Olenvic's rapid onset of action, lack of active metabolites, which enables a predictable analgesic with no dose stacking, and a well-characterized safety and tolerability profile. And with that, I'll turn LaCarle over to Mark. Mark?
spk07: Thank you, Patty. I'd like to begin by highlighting the progress we've made in our Olenvic clinical studies. I'm especially excited by the fact that we have begun approaching important data milestones and are now able to share some of the key findings from the investments that we have made in these clinical studies. During our year-end call a few weeks ago, I reported the first of these clinical study milestones with a review of the positive top-line results from the respiratory physiology study led by Dr. Albert DeHaan at Leiden University Medical Center. We were pleased with the results of this work, which compared olivic and IV morphine in a head-to-head manner on respiratory function outcomes. The study was conducted in a group of elderly, overweight subjects. specifically because we know that older age and increased weight are two of the most important risk factors for the development of respiratory depression when opioids are used in practice. We believe the methods used by Dr. Dahan are a precise way to ask the question, do these two drugs potentially differ in how they may affect the brain's physiologic regulation of respiratory function in human beings? The answer from that study is that yes, they support our belief that they differ. And results of the study showed a statistically significant difference in respiratory function outcomes. We believe this study was important because it replicated an earlier study examining the same outcome in younger subjects. While studies like Dr. DeHaan's investigation are not practical to conduct in the post-operative setting, the data are nonetheless consistent with the observations that we have reported in the clinical setting in our patient studies, and thereby strengthen the evidence characterizing the respiratory profile of the limbic. In these studies, we have seen consistently favorable outcomes on indices of respiratory function, such as decreases in oxygen saturation or reductions in respiratory rate, as compared to IV morphine. Despite these findings, it is important to remember that as with all opioids, serious life-threatening or fatal respiratory depression may occur in patients treated with Olindic, as indicated in the boxed warning. The clinical outcomes seen in our patient-based studies were also the precise risk inputs used in our published health economic model, demonstrating that the magnitude of these clinical differences is also economically meaningful. In short, We are encouraged by the replication of this respiratory physiology data and look forward to working with Dr. DeHaan's team in reporting this new information in the scientific literature in the coming months. We believe that this data will also be a useful addition to the dossier of technical information used by our medical team to respond to questions from formulary committee members, and we look forward to making progress in those discussions. The next upcoming milestone from our clinical investigations is the top-line data readout of our cognitive function study. I mentioned previously that this study is designed to compare the potential changes in cognitive function in subjects treated with olivic and IV morphine in a head-to-head study design on a broad array of cognitive performance outcomes, including motor coordination, 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. Finally, the Volition trial, which is the clinical outcomes study led by Cleveland Clinic's Outcomes Research Department, is our second Olympic study currently in progress. The trial builds on our published clinical data and is evaluating a Linvix profile on three important clinical outcomes in the postoperative setting, namely respiratory depression, nausea and vomiting, and cognitive function. This project is actively enrolling patients, and we expect top-line data in the second half of 2022. We also have continued to make advances in our early pipelines. in particular with TRV-045, our non-opioid selective S1P receptor modulator, which we are developing for the potential treatment of diabetic neuropathic pain. We're on track to complete our Phase I development program for TRV-045 by the end of this year. Importantly, we have continued to make progress with 045 through our collaboration with the NIH's Epilepsy Therapy Screening Program, which has been examining TRV045 in a number of animal models for refractory epilepsy. We expect the NIH to complete this initial phase of work later this summer, and based on the outcomes, we will determine whether further investigation of TRV045 for certain epilepsy subtypes should be pursued. We're very excited by the opportunities that we see within our S1P program and in TRV045 in particular. We believe that TRV045 presents a potentially unique entrant to this pharmacologic class, based on the observed non-clinical study findings of reduced circulating levels of peripheral lymphocytes, and also animal data suggesting a potentially favorable clinical safety profile. As you can see, our clinical research team has been very active, and those efforts are now beginning to bear fruit. We look forward to reporting on the upcoming work in the near future. Let me now turn the call over to Barry to discuss our financials before we open it up for Q&A. Barry?
spk04: Thanks, Mark. In the first quarter, we reported no net sales and $20,000 in license revenue in connection with material we provided to FarmBio, our partner for Olindic in South Korea. Our net loss for the quarter was $16.4 million, or 10 cents per share, compared to $9.8 million, or six cents per share, for the same period last year. These changes were mainly due to costs associated with our LINDEC launch and product pipeline. We finished the first quarter with $48.7 million in cash and equivalents, which we believe will fund our operations and CapEx into 2023. I note this Q1 cash balance does not include the $15 million tranche from our ex-US royalty-based financing with Arbridge, which we received in April. We expect to receive an additional $15 million tranche on first commercial sale of Olympic in China and $10 million on a commercial or financing milestone. Related to this, I'd note that we have an upcoming annual meeting with a key proposal to increase the authorized shares. This proposal is vital for shareholders' long-term value and would provide flexibility to execute on business development opportunities, achieve the $10 million non-dilutive tranche from our arbitrage transaction, and Advance Olindvik and our product pipeline. We'll now open the call for questions, after which Kerry will provide some closing remarks. Operator?
spk06: Thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Brandon folks from Cantor Fitzgerald. Please go ahead.
spk02: Hi, thanks for taking my questions and thank you for the color today on the call. Um, can you just help me think about sort of, you know, why account aren't ordering a limbic? Um, my understanding is there were accounts who use the product initially. Uh, it looks like they no longer using it. So I guess, is that just driven by formularies? Uh, are they removing a product or formulary or is it actual user experience in practice? And then maybe similarly on those 2,500 calls you called out, why do we not see sales being pulled through there? And then lastly, I guess just a little bit different, can you help us think about the Olympic opportunity in China? Thank you.
spk00: Great. Thanks, Brandon. Appreciate it. So let me – this is Carrie. Let me start just to clarify that we are seeing orders from physicians and reorders from hospitals that came on board. And, you know, I think that is in part why we are still optimistic, right? And when we continue to get a LNVIC in front of physicians, decision makers, we're hearing that the profile is resonating. Let me ask Patty to talk a little bit about the 2,500 calls and some of the in-service programs. And then I think your third question was around the opportunity in China. Yeah.
spk01: Yeah, so... So the 2,500 calls have led to sales, as Carrie mentioned. We have had pull-through sales, we've had reorders, and we've had new orders all in the first quarter. In fact, this quarter was very, very strong by comparison to the fourth quarter, yes, on a small number, but nonetheless, it's quite encouraging. On the in-service programs, keep in mind that we have to be invited in to do those programs. So those 98... in-service educational programs are for the purposes of having the entire staff understand the features, benefits, and limitations of a LNVIC and how to identify appropriate patients for the product. So all of those activities are by invitation only.
spk00: And then I think the third question was around the opportunity in China.
spk04: And, Brendan, as I'm sure you saw, we announced the Arbridge financing program. based in large part on the Chinese royalties. Our partner, Noir, filed the NDA in January, and while we're not providing guidance, generally 16 to 18 months is how long it takes for approval in China. On the Chinese approval and first commercial sale, we'd expect a $15 million tranche from the Arbridge financing, as well as a $10 million tranche on a commercial or financing milestone, potentially in the interim, so $25 million in non-dilutive financing based on those royalties. I'd also note that while the financing was based on the Chinese royalties, we are also eligible to receive the milestones, including a $3 million milestone from Noir on Chinese approval. So a lot to look forward to from our Chinese partnership over the next year or so.
spk02: Great. Thanks very much, and thanks for taking my questions.
spk06: The next question comes from Jason Butler from JMP Securities. Please go ahead.
spk05: Hi, thanks for taking the question. I guess a follow-up there on the demand trends you're seeing. Is the situation continuing to improve, you know, into the second quarter, i.e. seeing the, you know, orders and reorders continue to grow?
spk00: Hey, Jason, it's Carrie. Yeah, so we... I think you're hearing this from a lot of folks. We certainly saw pandemics or spillover into January, February. As Patty said, March was frankly our strongest month, still on a small base. But we are starting to see and we are continuing to see the improvements, the engagement, the activity levels improve. And we have, I think, Patty, over 40 formularies already scheduled between now and and into the third quarter. So, I think that's a really good sign that things are starting to improve. Yeah, I agree.
spk05: Great. And then, obviously, it's only been a few weeks, but with the new respiratory safety data, have you got any feedback yet from the field or formulary committee on the results?
spk07: Jason, thanks. This is Mark Demitrak. In the early going, the material is useful. It's new information additive to what was in our technical dossier, and the interaction and preliminary interactions that the MSLs are having when asked at the committees and by our KOLs in the field has been positive. So more to come on that as we begin the rollout in the coming weeks.
spk00: Yeah, let me just add, though, that there are hospitals that asked to see this data when it was coming out. We've been talking about the fact that we've been running this study. And so the MSLs have those hospitals as their first target list. So some of the feedback Mark's talking about, and as Patty said, we've been invited back in to have those conversations with some key hospitals. So I think that's encouraging as well.
spk05: Okay, great. Thanks for taking the questions.
spk00: Thanks, Jason.
spk06: The next question comes from Douglas DeSalle from HC Wainwright. Please go ahead.
spk03: Hi, good morning. Thanks for taking the questions. Maybe can you, I apologize if I missed it, but I think, you know, we've been targeting 100 formulary rings by year-end last year, and obviously, you know, COVID sort of threw a wrench into that. I'm just curious where you actually are right now in terms of actual formulary wins.
spk00: Yeah, thanks, Doug. Yeah, we are at 49 formulary wins, and our business is predominantly inpatient, right? So I know that a lot of people are counting a lot of different things. We're counting inpatient formulary, so that's the number. And then, as I mentioned, we have over 40 that are scheduled over the next couple of quarters. that are actually scheduled meetings. So I think that's a good metric for us to continue to track.
spk03: Okay. And across the wins that you do have in terms of use rates, I mean, is it that you have a handful of accounts that are ordering? I mean, because I know you are talking about some attraction. And what's happening in the accounts where, you know, the volume just isn't, what we'd like it to be.
spk01: So the patient profile continues to expand. As you know, we've really focused on burn, colorectal, and then the open heart surgery patient, the critical care patient that the anesthesiologists send. What we find is that once an institution or a healthcare provider has experience with the product, they tend to refer to another area and then it expands. So for example, a colorectal surgeon will tell us to go speak to the burn unit because there's a particular interest there. We've seen that before and we believe that that will continue as time progresses.
spk00: The one thing, Doug, I'll say that is different from other hospital launches, and I don't know if this is a change that's going to stay in place, but hospital physicians are wanting to try it first. more so than I saw in the past. It used to be the old days. You'd get the drug on formulary, you'd get it in the Epic or the Cerner systems, and then you'd go train the staff. As Patty said, with formulary committees getting delayed, we've been training more and more staff, and then physicians have been trying to use it more in small settings, right? We may have a colorectal surgeon that will use a little bit of it to get experience while we're trying to wait for it to get on formulary. So it's been a little difficult for us to track the volume from that perspective as we're getting in orders with the idea that you're going to get it on formulary. a couple of cases early on where the drug got on formulary and began to get used in a lot of different places. That's where we're seeing a lot of the reorders. Does that help give you a little bit more color?
spk03: Yes.
spk06: There are no more questions in the queue. This concludes our question and answer session. I'd like to turn the conference back over to Carrie Bordeaux for any closing remarks.
spk00: Great. Thank you all for your questions. We believe we are well positioned in 2022 to build on the Olindic commercial launch strategy. We're looking forward to the additional data readouts that we have this year for Olindic and also the pipeline. Just a quick recap of some of the key upcoming data events. Mid-year, we're expecting Olindic versus IV morphine cognitive function data. By year end, the Alembic Outcome Study from Cleveland Clinic, looking at respiratory, cognition, and GI tolerability. Also by year end, the Phase I TRV045 in diabetic neuropathic pain. And in the second half, BNIH TRV045 animal data in epilepsy. So there's a lot going on. We'll provide you with additional updates throughout the year. And thank you again for joining us today. Operator, that concludes the call.
spk06: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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