Trevena Inc (TRVN) 2015 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Trevena fourth-quarter and full-year 2015 earnings call.

(Operator Instructions)

As a reminder, this conference is being recorded. I will now turn the call over to your host, Jonathan Violin. Please go ahead.

Thank you and welcome, everyone. Thanks for joining us on this morning's call. With me today are: Maxine Gowen, our CEO; Roberto Cuca, our Chief Financial Officer; Carrie Bourdow, our Chief Commercial Officer; Mike Lark, our Chief Scientific Officer; and David Soergel, Trevena's Chief Medical Officer.

Before we begin, we wish to inform participants that we will make 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're cautioned that such 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 that we undertake no obligation to update these statements beyond today.

During today's call Max will provide a brief overview of some 2015 and recent corporate highlights. David will then provide a detailed review of our clinical programs and Terry will discuss our commercialization plans. Roberto will then review our financial results. We'll then open the call for questions.

I'll now turn the call over to Max.

Thanks, Jon. Good morning, everyone, and thank you for joining us today. 2015 was a transformative year for Trevena, with marked progress towards achieving our vision of leveraging important scientific discoveries to deliver new and differentiated therapies to patients suffering from serious medical conditions.

This was highlighted by our Phase 2b data for intravenous Oliceridine in acute pain following abdominoplasty which showed remarkable performance compared to intravenous morphine. In that study, while rapidly achieving similar levels of pain relief as morphine, Oliceridine was superior to morphine in pre-specified measures, exhibiting significantly reduced nausea, vomiting and hypoventilation events.

This is no small feat, highlighted by the recent news that the FDA has awarded breakthrough therapy designation to Oliceridine for the management of moderate to severe pain. This recognizes that our Phase 2 data suggests the potential for substantial clinical improvement over available therapies. As far as we know, this is the first and only breakthrough therapy designation for a pain program.

We've long believed that our scientific platform can identify new best-in-class and first-in-class molecules and Oliceridine continues to validate this belief. We also welcome the opportunity to work with the FDA under the auspices of our breakthrough therapy designation to finalize our Phase 3 plans at our end of Phase 2 meeting in the last week of March and look forward to sharing those plans with you when we have final written feedback from the agency.

In the meantime, we've initiated our Phase 3 program for Oliceridine with the ATHENA-1 Multi-Procedure Safety Study. We expect to initiate pivotal studies in Q2 and deliver top-line pivotal data in the first quarter of 2017 to support an NDA filing later that year.

We also made important progress across the rest of our pipeline. TRV027 for acute heart failure is nearing the completion of its 620-patient Phase 2b BLAST-AHF study and I'm excited to share that we've completed patient recruitment. We continue to expect to share top-line data in the second quarter and remind you that Allergan has an option to require worldwide rights to this program and we expect that decision in the third quarter.

TRV250, a potentially first-in-class therapy for migraine entered pre-clinical development and we anticipate filing an IND in the second half of this year. We've continued to expand our IP estate with composition and methods-of-use patents issued in the US, EU and other jurisdictions for our lead programs. And work, of course, continues in our labs to bring forward other differentiated new molecules in the coming year.

In parallel with our clinical development efforts, we've aligned our organization with our maturing pipeline, adding key personnel and expertise to the Company. One of these additions, our Chief Commercial Officer, Carrie Bourdow, will share her views of Oliceridine commercialization in the few minutes.

In addition, we significantly strengthened our balance sheet and increased our financial flexibility. Since the beginning of 2015 we have raised more than $120 million through a combination of equity and debt transactions and are funded into 2018. So we're well-positioned to advance Oliceridine through Phase 3, through an NDA filing and towards commercial launch. In short, I couldn't be more pleased with our efforts and progress in 2015.

And now I'll turn the call over to David to discuss our ongoing development efforts.

Thanks, Max, and good morning, everyone. I'd like to start with some exciting updates on TRV027, our intravenous product candidate for acute heart failure. You may remember that this molecule targets a key component of heart failure of passive physiology in a way that wasn't feasible until the discovery of biased ligands like TRV027.

Data suggests that TRV027 works at the angiotensin II type 1 receptor to simultaneously alleviate renal and vascular dysfunction while directly enhancing cardiac function. Because of this unique and compelling pharmacologic profile, TRV027 could be an important new option for patients with acute heart failure.

I'm happy to report that we've completed recruitment of our 620-patient Phase 2b study BLAST-AHF. We are on track to share top-line data with you in the second quarter of this year following 30-day follow-up data collection and database lock. In parallel, we'll deliver the data to Allergan.

Acute heart failure is a complex disorder and BLAST is measuring numerous important clinical end-points using a novel analytical approach. So let's take a few minutes to discuss how these data will inform future development of TRV027. As with any Phase 2 study, the aim of BLAST-AHF is to enable design of appropriately powered and de-risked Phase 3 studies.

Beyond that, need in AHF is extremely high. There have been few, if any, advances in the care of patients with AHF and the clinical outcomes, therefore, remain terrible, with significant and growing economic impact as the population ages. Because of this high level of unmet need, there's a potential to utilize novel end-points in pivotal trials, as the FDA has highlighted on several occasions in recent years.

In BLAST we're evaluating the effects of TRV027 compared to placebo on five important clinical end-points: Dyspnea, or shortness of breath; worsening heart failure; length of hospital stay; re-hospitalization for heart failure through day 30; and mortality through day 30. All of these end-points are important to patients and practitioners and any one of them, or a combination of any of them, could be the end-point in Phase 3 pivotal trials.

In BLAST-AHF we used a composite of these measures as the primary end-points, an average Z-score as we published last year in our trial design manuscript. The intent of this approach is to reward concordant positive trends such that no single component need be statistically significant for the primary end-point to be statistically significant.

So what do we do with this data at the end of the trial? Each clinical measure will be evaluated based on its observed event rate, effect size and variability. Positive data in any of these analyses could allow design of a Phase 3 end-point with appropriate power and probability of success, either as a composite end-point or as a stand-alone primary end-point pending regulatory feedback.

We also be pre-specified certain analyses that might identify populations that can respond best to TRV027 treatment. We'll segment patients by ejection fraction, systolic blood pressure, plasma renin activity and glomerular filtration rate.

Any of these sub-group analyses could suggest a more efficient Phase 3 development plan and could allow better targeting of TRV027 to appropriate patients, a precision medicine approach that cardiologists told us they would value. So as you've heard, this trial will yield a great deal of information and we look forward to sharing the results with you in the second quarter.

I also want to express my gratitude to the members of the BLAST-AHF steering committee, co-chaired by Drs. Mike Felker and Peter Pang, and to the members of our DSMB, chaired by Dr. Barry Greenberg. All of these AHF experts dedicated a significant amount of time and energy to conceive of and execute this complex trial. And thank you also to the dozens of sites and hundreds of patients who participated in BLAST and who committed themselves to help develop what we expect to be a significant advance in the treatment of acute heart failure.

Now I'd like to spend some time discussing the progress of our Phase 3 Oliceridine program. Oliceridine is a novel analgesic with a unique mechanism of action. Instead of non-selectively activating the mu receptor like conventional opioids, Oliceridine stimulates the receptor in a way that produces greater efficacy while simultaneously mitigating adverse effects. Oliceridine is therefore the first in a new class of analgesics, a mu receptor, G-protein pathway selective modulator, or mu GPS.

From the inception of this program we've been committed to bring forward a clinically-differentiated therapy and have gone head-to-head with morphine at every stage of discovery and development. We believe that this commitment and the compelling nature of the Phase 2 data were crucial to the FDA's favorable review in granting of our breakthrough therapy application. In essence, the granting of breakthrough indicates that the agency views Oliceridine as having the potential to provide a substantial clinical benefit over currently available therapies for the management of acute moderate to severe pain.

From the standpoint of clinical development, we're in a very strong position heading into our Phase 3 pivotal program. We've already completed two highly successful Phase 2 studies and from our extensive Phase 1 and 2 experience, we know a great deal about Oliceridine's characteristics: its pharmacokinetics; its efficacy; dose response; onset; and of course, its safety and tolerability.

Not only do we know a lot about Oliceridine, we also know a lot about how Oliceridine compares to conventional morphine since we included morphine in both of our Phase 2 trials. We've analyzed all of these data to inform the Phase 3 pivotal trial program that we proposed to the FDA and will discuss with them later this month. We continue to plan for comparisons of efficacy, safety and tolerability of Oliceridine to placebo and to morphine in pre-specified analyses.

Once the end of Phase 2 meeting occurs and any post-meeting follow-up is complete, we'll share additional details of our plans. In addition, we'll be presenting several abstracts at the upcoming American Society of Regional Anesthesia and Pain Medicine conference in April and the American Pain Society meeting in May. I'll now pass the call to Carrie Bourdow, our Chief Commercial Officer, to discuss our commercialization plans for Oliceridine.

Thank you, David. As Max and David described, 2015 was a very busy year for Trevena. In addition to our ongoing clinical work for Oliceridine, we've been refining our commercialization strategy in anticipation of regulatory approval and launch.

Last year we conducted market research with over 200 physicians, pharmacists, nurses and hospital decision-makers. We heard about some of their frustrations and concerns because today healthcare providers often feel as if they have to make a trade-off between effective pain management and patient safety and tolerability. And while conventional opioids like IV morphine or hydromorphone are still the most efficacious drugs we have to manage patients in pain, there's a tremendous unmet need to provide better pain relief with fewer adverse effects.

We also learned from market research that the opioid adverse effects that patients most want to avoid are nausea and vomiting, but physicians also worry about respiratory depression. Everyone is potentially at risk for respiratory depression but physicians describe the patients they worry the most about, patients with underlying respiratory problems like COPD, obese patients, the elderly patients.

We estimate that this group is at least 40% of patient population. In essence it's that group of complex patients that represent a growing proportion of hospitalized patients undergoing surgical or medical procedures. And if these patients experience respiratory issues or prolonged nausea and vomiting, they tend to have longer hospital stays that add to their risk for complications.

So because of the unmet need and the potential benefits of Oliceridine, physicians responded very positively to our Phase 2 data, highlighting Oliceridine's powerful efficacy and faster onset versus morphine and the significant decreases in nausea, vomiting and hypoventilation events. If our Phase 3 results are similar to Phase 2, we believe that upon approval Oliceridine has the potential to capture a meaningful share of the 50 million US patients who annually receive an IV opioid for pain management.

Lastly, as we all know in today's cost-focused hospital environment, the uptake of new products may depend on more than just the clinical attributes. We are working now to develop our market access and health economic strategy to support the value proposition of Oliceridine.

In our market research pharmacists and other hospital decision-makers recognize that Oliceridine's clinical benefits may provide a strong platform for demonstrating cost savings. For example, faster onset of pain relief with fewer tolerability or safety issues could allow for more rapid patient transitions through expensive hospitals settings like the post-anesthesia care unit or the ICU. Or patients may require fewer resources or drugs to manage adverse effects like nausea, vomiting, hypoventilation.

We believe that the potential benefits of Oliceridine will create a compelling value proposition for hospital decision-makers who are focused on better pain management, patient safety and overall hospital system cost savings. I look forward to providing you with additional details as our commercialization and market access plans continue to progress.

Now I'll turn it over to Roberto for a review of our fourth-quarter financials.

Thanks, Carrie. We disclosed key financial measures earlier today in our press release and will file full financial statements in our Form 10-K. For now I'll summarize the headline numbers.

For the fourth quarter we reported a net loss attributable to common stockholders of $15.5 million or $0.30 per share, compared to $13.3 million or $0.45 per share for the fourth quarter of 2014. For the year ended December 31, 2015, we incurred a net loss attributable to common stockholders of $50.5 million or $1.15 per share, compared to $49.7 million or $2.02 per share for full-year 2014.

We ended 2015 in a strong financial position with cash, cash equivalents and investments on the balance sheet of $172.6 million which we expect to fund our operations into 2018 and provide for the advancement of Oliceridine through Phase 3, into an NDA filing and towards commercial launch.

We can now open the call for questions, after which Max will give some closing remarks. Operator?

(Operator Instructions)

Jon Eckard, Barclays.

Thank you very much for taking the question.

The first one -- there was a message in the prepared remarks that I missed on the breakthrough therapy designation for oliceridine. Did the FDA offer a suggestion about what aspect of the drug's profile drove the decision behind the breakthrough therapy designation?

Hello, Jon.

The approval letter does not actually describe the agency's rationale. Obviously, the designation itself supports our view that the comparison of oliceridine to morphine shows a strong differentiation. We will be meeting with them in a few weeks here before the end of the month, and obviously at that meeting we expect to hear more from them about the specifics behind the breakthrough designation, and obviously how we might optimize our Phase III plans in order to show that benefit.

Great. Because I'm guessing, since the Phase II didn't have a stat-sig benefit on pain but it did have stat-sig benefits on nausea, vomiting, and respiratory depression, it's fairly safe to assume that either the latter two or a combination of the both was driving the decision. Is that a fair assessment?

We will definitely hear more at the end of the month. I'll let David comment, though, on the data that the FDA had in hand in order to make the decision

Hello, Jon.

The application package included the bunionectomy data. You remember from that study we showed dramatic levels of pain relief with oliceridine compared to a standard dose of morphine, both in terms of its rapidity of onset [and] the overall effect. And we also included the abdominoplasty data. So at this point, our belief is that the sum total of the Phase II data that really supports the breakthrough. But, as Max said, we will hear more.

Then could you remind me -- if it's disclosed, that is -- the time that Allergan has to make a decision once they've received the data? Is it like a 30-, 45-day window? Or have you not disclosed it?

It's not been disclosed. What we have always guided to is, they have a few weeks.

Okay. I'm just guessing, because the guidance is that they will -- you're expecting a decision from them by the third quarter. I'm just trying to back into the potential timing of when we could see top-line data ourselves. It sounds like probably at least mid-2Q at the earliest. Sounds like it would be fair, based on what you are saying.

All right, thank you very much. (laughter)

Biren Amin, Jefferies.

Hey, guys, thanks for taking my questions.

I think you've announced that your meeting with FDA later this month for end of Phase II on oliceridine. Could we still expect the Phase III efficacy portion to start in Q2? And what are you doing in the meantime as far as clinical site selection for the Phase III efficacy component?

We are still hoping to start the pivotal studies in the second quarter. Obviously, that depends on the FDA finding our proposed plan acceptable. We've put a great deal of thought and analysis into the plan, so we're optimistic that, that's the case. In the meantime, we are doing everything we can to prepare for that start. As you know, there's an awful lot that goes on before you actually recruit a patient. Everything that we can do without actually knowing the precise details of the study, ultimately, we are doing now.

Okay. On BLAST-AHF, David, you mentioned you're looking at a composite of clinical endpoints. Are there one or several endpoints that you're going to focus on when you analyze the data?

Yes. Like I said in the prepared remarks, we are capturing a lot of information on the clinical journey of the patient through the hospital, then after the hospital. All of the measures that we are making in that trial could represent a stand-alone primary endpoint or contribute to a hierarchical composite for our Phase III study. It really depends on where we see the most compelling data. That could be the shorter-term endpoints or it could even be the longer-term endpoints. It's a little difficult to answer that without having the data in hand right now.

Given the serelaxin ongoing Phase III using mortality as a primary endpoint, would you need to see a trend on that endpoint in the Phase II?

No, I don't think so. Recall that the serelaxin trial is about 7,000 patients. It's a totally different scope of work. What we're looking for is things that matter to patients when they're actually admitted to the hospital. So when they feel terrible and they're in the emergency room, we need to make these patients feel better, and then not harm them in the long run. So you need to make sure that you're not adversely affecting their long-term endpoints.

What recent data have shown is that if you can actually improve some of these short-term measures, like more rapidly improved dyspnea, prevent worsening heart failure during hospitalization, you can actually improve some of those longer-term outcomes. That's been the big learning over the last 5 or 10 years. I don't think that we have to see a trend necessarily in very long-term follow-up in these patients in the study, because I think we'll have all the data we need from the early measures.

Okay. And then, Max, on the Allergan option -- given Pfizer-Allergan is going to close in second half, are there any implications on whether Allergan -- at least for Allergan -- so I can provide a timely response?

Yes, it does look like it's going to all happen at the same time, of course. We have a contractual agreement that they have a certain amount of time to make their decision, and we expect that, whether it's Allergan or the combined company, they will conform to the contract.

Okay, great, thanks.

Alan Carr, Needham & Company.

Thanks for taking my questions. A couple of them.

One of them around oliceridine. Is your expectation that you'd start both Phase IIIs in 2Q? Would all three trials, including the safety trial, be done the same time in first quarter? And then the other one around 027. If Allergan or Pfizer options it, what role would you have in the development going forward? And what are your expectations for when a Phase III program would start? Thanks.

Hello, Alan. I'll let David pick up on the oliceridine question and then maybe I'll take a --

Alan, how you doing?

We are starting both Phase III studies in parallel, to the extent that one can start two studies exactly at the same time. But we're doing everything to operationalize both of those trials now. As you know, we've already started the open-label safety work as of the beginning of the year. So we've started building the safety database already. Because of the higher number of expected patients in that study, that open-label safety study is expected to take pretty much -- is pretty much expected to be on the path towards the NDA.

At the end of the day, everything is expected in time for preparing an NDA file for the second half of 2017. Everything we expect to deliver in that same time frame, around the first quarter of 2017.

So all three may be done in first quarter.

Yes, done by first quarter.

That's obviously dependent on what the FDA says to us at the end of the month. All of these comments, obviously all of these remarks, are contingent on the results of that conversation.

With respect to 027's future path forward: if Allergan does choose to exercise their option and license the program, they take the program forward themselves at their own expense. They have the right to design and develop the drug as they wish. We do, obviously, have a joint committee that oversees that. Obviously, because we know right now most about the drug, we would expect to be involved in those early plans. However, it's very hard for us -- since it will be in their hands -- it's very hard for us to guide on when that's likely to happen. There's going to be a ton of data coming out of this trial. A lot of analyses will need to be done before they or we would feel comfortable designing the Phase III program. Then, as you know, it usually takes six months or so once you've decided what you want to do, to do all the work that it takes to get the trial started. So I would imagine it would be sometime in the next year, 2017, but that's really just our best guess right now.

Great; thanks very much

Sure, thanks.

Heather Behanna, Wedbush.

Hey, good morning, thanks for taking the questions.

Just a quick oliceridine question. At the pain meeting at the end of the month, you're presenting some data, and you've cut the data to look at more [temporal] measurements, [medium] time to effective utilization, things like that. I was curious if these data really reinforce the rapid onset? Or if you've gotten feedback in your conversations with KOLs, and these kinds of measurements or ways of looking at utilization are really what sets oliceridine apart?

Hello, Heather.

We're going through secondary and exploratory analyses from both of our Phase II studies, and actually the entire program, including some really interesting simulation work and so forth. This is just part of that roll-out of data from a clinical perspective. We believe that there are some very strong characteristics that favor oliceridine compared to current conventional opioids. I'll let Carrie talk about the work that she's done externally. Those characteristics are power -- how effective the drug can be -- its speed of onset, and its better safety and tolerability profile. We think that, as we roll all of these pieces of data out, that holistic picture is going to become even clearer as time progresses.

But I'll let Carrie talk about the market research and so forth.

Good morning, Heather, how are you?

As David described, I think that we've really been pleased to show the profile in market research and hear physicians comment specifically on the faster onset. That's been an important take-away that they've received from the data. And it's tied into this idea that, if they can treat patients more quickly, as I said earlier, they potentially can get them out of the PACU or even the ICU, either discharged home or onto the floor. So the idea of certainly providing faster pain relief to patients is important, but also the underlying economic message, I think, is what we continue to hear.

Great, thanks for the color.

Jonathan Aschoff, Brean Capital.

Hello, thanks.

I was wondering, you mentioned other new molecules. Can give us any clues as to what they may be?

No. We do have some very active research going on in the lab, on the platform. We specifically don't talk about the targets that we are working on, because it takes a lot of really detailed research to figure out which targets will benefit most from a biased ligand approach. So our approach is to wait until we feel that we have a significant lead on potential competitors by making sure that we don't talk about the targets that we're working on until we usually have a candidate selected.

I will tell you we are doing some very interesting things. Again, we are not in a therapy area-constrained environment here. We follow the science, and so the things we're working on now are not in the areas that we're developing drugs in as well. I would highlight, though, TRV250, which is obviously a very interesting and exciting molecule -- this we hope will reach an IND stage later this year and will be developed initially for the treatment of acute migraine, which, as you well know, is still a huge unmet need and a very large commercial opportunity also.

Okay, so in terms of 130's commercialization, can you help us better understand the breakdown and the extent to which you're talking to payers versus docs and nurses. Because money is never going to matter less tomorrow than today.

Yes, I appreciate that.

It's the hospital decision-makers -- the pharmacists and the hospital administrators -- that we've been speaking with about the potential uptake from an economic perspective, from a formulary perspective. I would also say, though, that, as you know, frequently physicians, anesthesiologists, surgeons -- they sit on the P&T formulary reviews as well. I think that altogether I would say, if I had to split, we talk to about two-thirds of physicians, including physicians that sit on formulary; and about a third of the pharmacists and other hospital decision-makers.

Okay, all right, thanks, guys.

Jason Butler, JMP Securities.

This is Harry on for Jason.

Just had a few questions on TRV027. So with the enrollment on BLAST-AHF, if you could give some color on how that is coming along since the interim? The second question is on the endpoints going into the Phase III trial: it seems like many other trials have looked at symptomatic endpoints or a more mortality- or outcome-oriented endpoint. Do you feel that you need both of these endpoints in a Phase III trial? Or maybe a symptomatic benefit is sufficient, if of great magnitude?

Hello, Harry, it's Dave; how are you?

We indeed have finished recruiting the trial. So we're in the process now of conducting the final follow-up for the last few patients. There's a 30-day follow-up for the primary endpoint, and then we'll have data clean-up, database lock and so forth; and then expect to share data in the second quarter. We've done quite well, actually, on recruitment, I would have to say.

With respect to endpoints, the key problem for patients with acute heart failure is symptomatic worsening. The reason why they've come to the hospital is because they feel terrible. They can't breathe, they're fatigued beyond all measure. What they go into the hospital for is to seek relief of those symptoms, and that's done over a relatively short period of time. So most acute heart failure trials have focused on these shorter-term measures, like improving shortness of breath, which is what the majority of patients come to the hospital for. But newer things, newer endpoints, have been identified that can also be robust measures and could potentially be linked to improving longer-term endpoints. For example, preventing worsening heart failure in the hospital seems to portend better outcomes for patients even at 30 and 180 days.

As I said during the script, the agency is open, really, to a whole series of potential endpoints, whether it's hierarchal endpoints, capturing short-term measures; as long as there's no worsening of long-term measures, they've been open to that. But of course we would have to have a specific conversation with the agency about our plan once we digest all of our data from this trial.

Great, thanks.

And last question -- on the statistical analysis for the BLAST trial, have you guys had a chance, or will you have a chance, to look at the blinded data? And if you can make, or anticipate making, any changes on the stat plan? Or is there very little focus on trying to hit on the composite endpoint in this trial?

The trial is designed to hit the primary endpoint, that's the purpose. I think, as I described in the script, the purpose of Phase II, from a broader perspective, is not just succeeding on a primary endpoint; it's being able to look at the components, the measures, that you collect from the trial and being able to develop an endpoint or endpoints that can get you a registrable drug through Phase III. That's very much our approach. Of course we've designed the trial to succeed on the primary, but that's the key there.

With respect to blinded data, I'm not sure how we would make adjustments to the analysis plan based on blinded data. We wouldn't anticipate doing that work already at the end of the trial.

Ritu Baral, Cowen.

Hello, it's [Allie] on for Ritu. Thanks for taking the question.

Wondering if you have any OpEx guidance going forward as you're starting to work on these Phase IIIs?

Hi, Ritu, I'll let Roberto take that one.

We haven't provided any guidance on our R&D or SG&A spend. But that said, with the launch and expected execution of two Phase III pivotal studies and an open-label safety study over the course of this year, it wouldn't be unreasonable to expect that R&D expense at the very least would be greater than it was in similar periods last year. But the exact cadence of that still remains to be determined.

Okay. And based on your current Phase III trial assumptions, assuming nothing changes after FDA meeting, how much do you expect each trial to cost? If you have any color on that, and of what duration?

We haven't provided any guidance on the exact cost of the studies.

Got it, great. Thanks for taking the questions.

Thank you.

Michael Higgins, Roth Capital Partners.

Good morning, guys, thanks for taking the questions. I guess I'm going to follow up where we just left off.

Can you take a look at the Phase II per-patient costs and give us some sort of an assessment on the upcoming Phase IIIs? Would it be a bit higher? Sometimes in Phase II you can do a bit more work that can cost a bit more. But how do we look at the cost per patient Phase IIs to figure out how it would look for the Phase III cost?

Hello, Michael, how you doing?

Of course we've done that, but we haven't guided with respect to what the specific costs were for the Phase II trials. And there is variation, as you pointed out. In Phase II trials, per-patient costs tend to be a little bit higher than Phase III, because you're doing more exploratory measures and so forth. With some volume, the higher volume, in Phase III, typically the per-patient cost goes down. But we haven't specifically said what the per-patient cost is for any of our trials.

Okay, very helpful; thanks, guys.

(Operator Instructions)

Caroline Palomeque, Wallachbeth.

Thanks for taking my question. A lot of these questions have been asked before, I jumped on the phone a little bit late.

Any more color on pricing for oliceridine? Or any more thoughts on how that can make it competitive versus something like morphine? I don't know if it's eligible, [as] IV drugs all look like vouchers and coupons. Wondering how you're thinking about that or if you've already talked about it? Thanks.

We actually have not done formal pricing research yet. When we are out talking with pharmacists, hospital decision-makers, they frequently reference the recent branded launches of EXPAREL, OFIRMEV. That price range was around -- starting launch around $60. I think OFIRMEV is up to about $140. EXPAREL is around $300 for surgery. The other thing that they talk about is that certainly oliceridine has head-to-head data versus morphine in addition to placebo, unlike some of the other products that are launching in the marketplace. So that gives you some sense of things.

I think the second part of your question was around vouchers and coupons. We have not talked about that. I will tell you from my hospital experience, that's not too quickly done in a hospital setting. But we haven't worked through any of those kinds of things.

Thank you.

I'm showing no further questions. I will now turn the call back over to Maxine Gowen for closing remarks.

So thanks to you all for all of your questions. As you've heard, 2015 was a tremendous year for Trevena and we look forward to continuing this momentum in 2016 as we approach numerous important milestones which we have highlighted today. Of course we look forward to updating you on our programs over the course of the year. I'll also be presenting a corporate overview this morning at the Cowen annual healthcare conference, which will include some of the data that we've discussed today. So anyone interested may access the webcast on our website.

Thank you all for your interest and for your time today.

Thanks, Max.

I'd like to remind listeners that a replay of this call will be available from the Company's website at www.trevenainc.com. On behalf of the management team at Trevena, I would like to thank everyone for joining us today. I'll be available for any further inquiries. With that, Stephanie, please conclude the call.

Thank you, ladies and gentlemen, that does conclude today's conference. You may all disconnect and everyone have a great day.