Trevena Inc (TRVN) 2020 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Trevena, Inc. First Quarter Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I would now like to hand the conference over to your speaker today, Mr. Bob Yoder, Chief Business Officer. Thank you. Please go ahead, sir.

Good morning, and welcome, everyone. Thank you for joining us on this morning's call. With me today are Carrie Bourdow, our President and CEO; Mark Demitrack, our Chief Medical Officer; and Barry Shin, our Chief Financial Officer.

Before we begin, we wish to inform participants that we will be making forward-looking statements on this call which are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that forward-looking statements involve risks and uncertainties, including risks detailed from time to time in the company's periodic reports filed with the Securities and Exchange Commission, and we undertake no obligation to update these statements beyond today.

During today's call, Carrie will give some opening remarks on our progress with oliceridine, and I'll provide an overview of our commercial launch strategy. Mark will then provide some additional details on our ongoing pipeline activities and Barry will review our financial results followed by some time for questions.

I'll now turn the call over to Carrie.

Thank you, Bob. Good morning, everyone. Thank you for joining us today. I hope that you and your families are staying safe during these unprecedented and challenging times.

I'd like to open the call this morning by extending my many thanks to the health care professionals, our employees and our business partners who help us move forward in our commitment to patients. Like a lot of you, we're watching the COVID situation closely. And while our priority, of course, is on the health and safety of our employees and our communities, I'm also very grateful that we've been able to remain resilient and focused on business continuity. And to that end, let me provide a few highlights on our lead asset IV oliceridine. As you all know, we have a PDUFA date for oliceridine of August 7. And it's clear to us that the agency is active in the review of our resubmission. I'm very pleased with FDA's engagement. And we expect FDA's review of our application to continue on track. We're looking forward to receiving their decision in August.

At the same time, we're working to ensure that after approval and DEA scheduling, we can make oliceridine available to hospitals and health care providers in the fourth quarter of this year. Our commercial manufacturing facilities, which are located in the U.S. are manufacturing drug product as we speak. We are also actively investigating collaborations and strategic partnerships to support the U.S. commercial launch of oliceridine. And our current ex U.S. partners are making progress on their regulatory time lines. Our top priority is getting oliceridine to acute pain patients, and we're exploring all options to help us maximize shareholder value as we do this.

So now let me turn the call over to Bob, who'll go into more detail on our U.S. commercial strategy. Bob?

Thank you, Carrie. So this is certainly an exciting time for us as we continue preparations for the commercial launch of oliceridine, either by ourselves or with a partner. As you'll hear me lay out, our strategy is built around focus and efficiency, targeting the right patient population, physician specialties and accounts in order to facilitate initial uptake. The market opportunity is large, with approximately 45 million patients each year who receive drugs like IV morphine for acute pain. Additionally, the overall size of the market in terms of units sold has remained relatively stable over the last 18 months, suggesting that potent analgesics such as IV morphine are still needed in the hospital setting. The product profile of oliceridine when compared to IV morphine is differentiated in a number of key areas. Unlike morphine, oliceridine has a fast onset of 2 to 5 minutes, no known active metabolites.

We may be having technical difficulties, it sounds like, Bob -- that's okay. Bob, South Carolina allergies kicking in, go ahead.

Yes. No known active metabolites and no dosage adjustment needed in elderly or renally impaired patients. Oliceridine offers a compelling set of attributes that address the unmet need that still remains in both the inpatient and outpatient settings. We know that roughly 20% of the overall hospital patient population are considered high-risk for adverse effects, including patients with certain comorbidities, obese patients, those with renal impairment and the elderly. We refer to this subset as our core patients. Physicians continue to face particular challenges in effectively and safely treating these patients, and those challenges have unfortunately been highlighted by the ongoing pandemic. In ATHENA, our open-label real-world safety study published last year, we studied many of these high-risk patients across a range of surgical settings.

In fact, 30% of patients were over the age of 65 and 50% were clinically obese. You may recall during our last earnings call in March, Dr. Tim Beard, a colorectal surgeon practicing in Oregon, described patient types very similar to those we study who he felt might benefit from a drug such as oliceridine. Our launch strategy is focused and targeted. The core patients I described earlier will be our initial focus as those patients currently present the greatest difficulty in pain management. We also plan to concentrate initially on a subset of physician specialties; anesthesiologist, colorectal, orthopedic and cardiothoracic surgeons. These specialties have a high volume of procedures in which multimodal pain management protocols frequently require drugs such as IV morphine. These specialties are also treating a high number of our core or high-risk patients. Finally, we plan to focus on a subset of hospitals and outpatient surgery centers that have demonstrated early adoption of other brands and agents in the past.

Of course, we're closely monitoring the impact of the current pandemic and how that could change our thinking about our commercialization strategy. But we continue to hear about high-risk patients, the challenges these patients present in effective pain management and the growing pent-up demand created by pauses and procedures considered to be elective surgeries and exacerbated by the current shortage of drugs like IV morphine.

In closing, we're taking an approach to commercialization that is all about focus, the right group of patients treated by a targeted subset of physician specialties and within a group of hospitals and surgery centers where we believe the potential for oliceridine is significant.

Let me now turn the call over to Mark to provide some additional details on our pipeline activities.

Thank you, Bob. Let me start with some additional comments on oliceridine. I'm pleased to report that we've continued to add to the body of peer-reviewed literature, which is an important element supporting the launch strategy that Bob just outlined. We recently announced the publication of a comprehensive review of the nonclinical and clinical data for oliceridine. In addition, I'd like to highlight the online publication of a poster in association with this year's ASRA Meeting. The poster is titled low incidence of opioid-induced respiratory depression in high-risk elderly obese patients.

This report summarizes the findings of a post hoc analysis of data from the ATHENA study. We compared the incidence of clinical indices of respiratory depression across 2 patient subpopulations in that study. Those considered high risk, and those considered low risk. High-risk patients were those individuals who were over 65 years old, and had a BMI greater than 30. As Bob mentioned earlier, these patients were a large proportion of the study population. Low-risk patients were defined as the opposite, those younger than 65 with a BMI less than 30. The results were very interesting to us. The incidence of respiratory depression was similar in both groups despite the high-risk group being defined by 2 characteristics known to raise the risk of respiratory complications during treatment with conventional medications like IV morphine. These data are consistent with the feedback we received from investigators during the ATHENA study on their assessment of oliceridine's distinctive clinical profile.

These data will serve as an important point of departure for our thinking about future research. Beyond oliceridine, we continue to make good progress with our pipeline. For TRV045, our novel S1P receptor modulator, our collaboration with NIH is ongoing and productive. They've initiated the first round of nonclinical studies in their epilepsy screening program, and we look forward to reporting on that work in the future. I'm also pleased to announce this morning that NIH plans to begin evaluating TRV045 within another screening program. This one designed to study novel, nonaddictive treatments for pain. This program is based on the long-standing epilepsy screening program, which is viewed as a highly successful partnership model and also features a rigorous evaluation process for entry. The program includes assays in models of acute, inflammatory and neuropathic pain, all of which are funded by NIH. The fact that TRV045 has received such interest from NIH, I believe, speaks to its exciting promise as a novel approach to treating a variety of CNS disorders.

I look forward to working closely with NIH to further explore the therapeutic potential of this asset. In parallel with these activities, we continue to make progress on our own IND-enabling work with this compound. And I'm very pleased to announce that we're now planning on filing an IND application for TRV045 in the first half of 2021.

I'd now like to turn it over to Barry for a review of our Q1 financials. Barry?

Thanks, Mark. We issued a press release and filed our Form 10-Q with our full financial results.

For now, I'll summarize the headline numbers.

For the first quarter of 2020, we had a net loss of $5.7 million or $0.06 per share compared to $5.2 million or $0.06 per share for the first quarter of 2019. This increase in net loss is mainly due to higher R&D expenses associated with the TRV250 acute migraine proof-of-concept study and activities to support the NDA resubmission for oliceridine. As of March 31, 2020, we had cash and cash equivalents of $28.1 million, which reflects the full repayment of our term loan on March 2.

We continue to expect that this amount will fund our operations and capital expenditures into the first quarter of 2021.

This includes the expected approval of oliceridine in August and post-approval activities to ensure oliceridine is commercially available in the fourth quarter of 2020.

We'll now open the call for questions, after which Carrie will provide some closing remarks. Rachel?

(Operator Instructions)

Your first question comes from the line of Jason Butler.

First one on oliceridine. Can you just give us any color around manufacturing inspection? Did you have a pre-approval inspection during the first cycle NDA review? And do you expect any additional inspections to be needed by FDA before your PDUFA date?

Good morning, Jason. Thanks for the question. We did not have previously an inspection, but the -- so I mentioned the sites are in the U.S., the API and drug product sites are in the U.S., which we think is a good thing. And they have been inspected last year for other products, didn't have any issues, no 483s. So we're not anticipating that manufacturing is going to be a problem at all for us.

Okay. Great. You ran through some of the patients you're targeting, but the high-risk for adverse events and the physicians as well. As you think about the beginning of a resumption of elective procedures, where is the overlap? And how do you think about the dynamics of which procedures could ramp sooner and where we could see a prolonged postponement of procedures and ultimately, are you looking to refocus any of your launch strategy in response to these dynamics?

Yes. So I'll let Bob address this, but let me just say that we're talking with a lot of our key opinion leaders across the country. And it's not necessarily which procedures may start kicking in sooner. It's really based on geography, in some cases. Our core areas, as Bob mentioned, cardiothoracic, colorectal, orthopedic, certainly cardiothoracic, we believe will start happening sooner. And of course, like everyone, we're sort of thinking through what our launch strategy will look like. Let me just brag on Bob really quickly before I turn it over. So one of the reasons we had -- we asked Bob to join Trevena is that he has a lot of experience in nonpersonal promotion launches, launching with more of a digital focus. So I think that's going to serve us well when we sort of think through our launch strategy. But Bob, any additional comments?

Sure. Yes. Jason, thanks for the question. So the one thing I'd say about the procedures piece of it is the things I'm reading at least, say, as elective procedures that were paused or canceled are coming back online, what I've been reading is that the patient type that they're looking to prioritize are typically those higher-risk patients because oftentimes that profile just gets riskier with time. So they're trying to, in many cases, push those high-risk patients to the front of the queue as those procedures come back.

Around the strategies, obviously, we're watching very closely what the pandemic is doing to HCP engagement. In this case, I think the early trends seem to suggest that physicians are engaging remotely a little more. They're open to that more. Digital channels are getting more robust as well. So I think, overall, an effective engagement in the future and one we're going to be thinking about is likely the flexibility to dial up or dial back a wider array of channels, digital channels, nonpersonal promotion, things like that. Certainly, until we see what will happen with the traditional face-to-face access with HCPs over time. But we definitely are going to keep an eye out and think creatively about how we're going to engage with HCPs and what, I guess, will be the new normal going forward.

Great. And then just one more for me on 045. Obviously, the work being done at NIH. But can you discuss or point to any additional preclinical work that you guys need to do in-house to support the IND filing in the first half of next year?

Yes. Thanks, Jason. Mark, do you want to talk a little bit about 045?

Sure. Sure, Jason. So our burden of activity really revolves around much of the conventional components of any IND that would need to be assembled. So we have to, obviously, proceed with the necessary tox work and the manufacturing readiness that we need for the formulation that we would bring into human use. So those programs are proceeding, as I mentioned, on plan at this time.

Any other questions, operator, Rachel?

Your next question comes from the line of Douglas Tsao.

Just maybe first touch on a little bit and obviously, you've spoken about sort of some of the delays and sort of the backlog in elective procedures. Just sort of the context of the shortages that seem to be taking place for a lot of IV pain medications, just given the demand placed on hospitals because of COVID and does that affect your launch strategy in any way? And then also, and I might have missed it, a lot going on in the household this morning. Just in terms of the pause for TRV250 and when you might be able to get that started again?

Yes. So I'll -- let me handle that first, and then I'll turn the question over to Bob around some of our additional commercial strategies. So on TRV250, as you mentioned, it's -- we are on pause, that study is being conducted in the U.K. and like everyone, we're sort of watching and having conversations with the clinical site in the U.K.

So as soon as they feel comfortable to get moving again. We don't -- we'll be doing that. But we don't have any additional guidance on that.

We removed the timing guidance on TRV250. But we are having active conversations with the clinical side. So it's good. Bob, you want to -- I know you talked a little bit about the commercial strategy in COVID and COVID patients, but any other additional comments you want to make, certainly with the focus around high-risk patients, and COVID. We've always been focused in high-risk patients, but there's a heightened sensitivity of what happens when those patients get sick in the hospital. So Bob, I don't know if you want to talk a little bit more about that.

Yes. I mean, Doug, I mean, I think you're right in pointing out definitely that's the -- there's many unfortunate things around the pandemic, and certainly, one of them is that physicians have realized. I've seen -- we've all seen now that these high-risk patients present a lot of challenges in clinical management.

Specifically to your question around the shortage too, I mean, I think there was some data out there publicly from (inaudible) that talked about at least within March, maybe the first part of April even that there was pretty significant shortage.

I think fill rates were hovering in the 70% range for IV opioids, driven, I think, a lot of -- use in COVID patients, incubated patients. But the other impact to that is that, that leaves less available for use in where traditionally use in postsurgical, moderate and acute pain, moderate to severe pain. So I mean, I think, I don't know beyond what I said before, Doug, in terms of change our strategy. It certainly tightens our urgency to be prepared for a really successful launch and get the product out there. So that compelling profile is in the hands of our physicians and they can use it where they -- were syndicated on where they see fit.

And maybe as a follow-up, I know it's still obviously very early days, and you're sort of limited in what you can do in terms of gauging with clinicians at this point. But just curious if you've gotten feedback from people sort of anxious to get it because, obviously, I think the COVID-19 crisis is really sort of exposed the vulnerability of the American health care system from a capacity standpoint. Have you gotten feedback that sort of greater interest in oliceridine because that's certainly one of the attributes of the product is really to sort of help improve efficiency of the system, which perhaps, I think we probably took for granted before this sort of took place.

Yes. It's a really good point. And I think we've talked before about the -- in particular, the investigators that were involved in ATHENA are interested in getting oliceridine, having oliceridine as an alternative. We're 3 months away from PDUFA date. So I think that's -- they're excited about that potential opportunity of having oliceridine here relatively soon. I do agree with you. I think, as I mentioned earlier, it's in particular, the high-risk patients, right? What we've talked about. You've heard us talk about is when these patients get sick, they stay even longer in the hospital, they put a lot of cost into the hospital system. They're some of the hardest, most difficult patients to treat. So it's been a focus of ours since the beginning to focus on those patients. That's where we think we'll get the initial use for oliceridine. Beyond that, as it relates to COVID, I think we're all sort of watching things and staying focused on getting oliceridine approved by the agency.

I am showing no further questions at this time.

I would now like to turn the conference back to Carrie Bourdow, CEO.

Great. Well, thank you all. I appreciate all of the questions this morning. And as you can hear, we are optimistic and excited about oliceridine and the PDUFA date that is quickly coming up. We're also excited about TRV045 and the NIH interest in 045 and also the progress that we've made in our IND capabilities and the ability to have an IND, hopefully, in the first half of next year.

So thank you again for the time despite all the craziness that we're all dealing with. As you hear, we are passionate about our mission in developing novel medicines for patients in need. Thank you again for joining us this morning.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.