Trevena, Inc. (TRVN) Q4 2014 Earnings Call Transcript
Published at 2016-03-09 17:48:02
Jonathan Violin - IR Maxine Gowen - CEO Roberto Cuca - CFO Carrie Bourdow - Chief Commercial Officer Mike Lark - Chief Scientific Officer David Soergel - Chief Medical Officer
Jon Eckard - Barclays Biren Amin - Jefferies Alan Carr - Needham & Company Heather Behanna - Wedbush Jonathan Aschoff - Brean Capital Jason Butler - JMP Securities Ritu Baral - Cowen Michael Higgins - Roth Capital Partners
Good day, ladies and gentlemen and welcome to the Trevena Fourth Quarter and Full Year 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this conference is being recorded. I would now turn the call over to host, Jonathan Violin. Please go ahead.
Thank you and welcome everyone. Thanks for joining us on this morning's call. With me today are our 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 provisions of the Private Securities Litigation Reform Act of 1995. You are 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 Carrie 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, John. 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 series 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 suggest the potential to 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 osmosis 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 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 topline data in the second quarter and remind you that Allergan has an option to acquire 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 continue 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 and one of these additions are Chief Commercial Officer, Carrie Bourdow, who’ll share her views of oliceridine commercialization in a 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 a $120 million through a combination of equity and debt transactions and are funded in to 2018. So we are 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 pathophysiology in a way that wasn’t feasible until the discovery of Biased Ligand’s like TRV027. Data suggest that TRV027 works at the angiotensin II type 1 receptor to simultaneously alleviate renal and vascular dysfunction while directly enhancing cardiac functions. 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’re on track to share topline data with you in the second quarter of this year, following a 30-day follow-up data collection and database lock. In parallel, we’ll deliver the data [tower] again. Acute heart failure is a complex disorder and BLAST is measuring numerous important clinical endpoints 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 the design of appropriately powered and de-risked phase 3 studies. The unmet need in AHF is extremely high. There have been few if any advances in the care 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 is 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 to composite of these measures as the primary end points and average Z score as we publish 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 endpoint to be statistically significant. So what we do with all 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 endpoint with appropriate power and probability of success either as a composite end point or as a standalone primary endpoint pending regulatory feedback. We also pre-specified certain analysis that may identify populations that could 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 subgroup analysis 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 probably 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 Doctors 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 out and execute this complex trial. I 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 bringing forward a clinically differentiated therapy and have gone head-to-head with morphine at every stage 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 are in a very strong position heading in to our phase 3 pivotal program. We’ve already completed two highly successful phase 2 studies and from our extensive phase one and two experience we know a great deal about oliceridine’s characteristics. It’s pharmacokinetic, its efficacy, dose response, onset and of course it’s safety and tolerability. Not only do we know 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 that phase 3 pivotal trial program that we proposed to the FDA and we’ll 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 analysis. 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 of 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 Commercial Office 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, pharmacist, nurses and hospital decision makers. We heard about them of their frustrations and concerns because today healthcare providers often feel as if they have to make trade-off between affective 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 is 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 respiratory depression. Everyone is potential at risk for respiratory depression, as 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 represents 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 a significant decreases in nausea and vomiting and hyperventilation 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 crossed 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 in health economic strategy to support the value proposition of oliceridine. In our market research, pharmacist and other hospital decision makers recognize that oliceridine’s clinical benefits may provide a strong platform for demonstrating cost savings. For example, faster onset pain relief with fewer tolerability of safety issues could allow for more rapid patient transitions through expensive hospital setting like the post anesthesia carrying it or the ICU or patients may require fewer resources or drugs to manage adverse effect like nausea, vomiting, hyperventilation. 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 financial.
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 in to 2018 and provide for the advancement of oliceridine through phase 3 in to 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] our first question comes from Jon Eckard with Barclays. Your line is open. Jon Eckard - Barclays: First one, there was a message in the prepared that I missed on the breakthrough about therapy designation for oliceridine. Did the FDA offer a suggestion about what aspect of the drugs profile drove the decision behind the breakthrough therapy presentation?
The approval letter does not actually describe the agency’s rationales’. But 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 3 plans in order to show that benefit. Jon Eckard - Barclays: Great, because I’m guessing since the phase 2 didn’t have a static benefit on pain, but it did static benefit on nausea and vomiting and respiratory depression. It’s fairly safe to assume that either the latter to or a combination of the both was driving the decision. Is that a fair assessment?
We’ll definitely hear more at the end of the month. I’ll let David just comment on the date that the FDA had in hand in order to make the decision.
So the application package included the bunionectomy data. So 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 (inaudible) in terms of the overall effect, and we also included the abdominalplasty data. So at this point our belief is that the sum total of the phase 2 data does really support the breakthrough, but as Max said we’ll hear more. Jon Eckard - Barclays: Could you remind me, if it’s disclosed, that is the time that Allergan has to make a decision one they’ve received the data. Is it like 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. Jon Eckard - Barclays: Okay, I’m just guessing because the guidance is that you’re expecting decision from them by the third quarter, I’m just trying to back in to the potential timing of when we could see the topline data ourselves, but it sounds like probably at least mid-2Q at the earliest sounds like its looking fair based on what you’re just saying.
Our next question comes from Biren Amin with Jefferies. Your line is open. Biren Amin - Jefferies: You’ve announced that you’re meeting with FDA later this month for end of phase 2 on oliceridine. Could we so expect the phase 3 efficacy portion to start in Q2, and what you’re doing in the meantime as far as clinical site selection for the phase 3 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 and we’ve put a great deal of thought and analysis in to 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. So as you know there’s awful lot that goes on before you actually recruit a patient. And so everything that we can do without actually knowing the precise details of the study ultimately, we are doing now. Biren Amin - Jefferies: On BLAST-AHF, I think 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?
Yeah, like I said in the prepared remarks, we are capturing a lot of information on the clinical journey of the patient through the hospital and then after the hospital, and all of the measures that we’re making in that trial, could represent a standalone primary endpoint or contribute to a hierarchical composite for our phase 3 study. So it really depends on where we see the most compelling data and so that could be the shorter term endpoints or can be the longer time endpoints. So, it’s a little difficult to answer that without having the data in hands right now. Biren Amin - Jefferies: Given the serelaxin ongoing phase 3 using mortality of the primary endpoint, would you need to see a trend on that endpoint in the phase 2?
No, I don’t think so. We recall that the serelaxin trial is about 7,000 patients. So it’s a totally different scope of work. What we’re looking for is things that matter to patients when they are actually admitted to the hospital. So when they feel terrible and they are in the emergency room, we need to make these patients feel better and then not harm them in the long run, right. So you need to make sure you’re not adversely affecting their long term end points. And 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 outcome. So that’s been the big learning over the last 5 or 10 years. So, I don’t think that we have to see a trend necessarily in very long term follow-up in these patients and their study, because I think we’ll have all the data we need from the early matters. Biren Amin - Jefferies: And then Max just on the Allergan option, given Pfizer Allergan’s going to close in the second half, are there any implication and whether at least with Allergan provide a timely response.
So, yes it does look like it’s going to all happen at the same time of course. I think we have a contractual agreement that they have a certain amount of time to make their decision and we expect whether it’s Allergan or the combined company, they will conform to the contract.
Our next question comes from Alan Carr with Needham & Company. Your line is open. Alan Carr - Needham & Company: Thanks for taking my questions, a couple of them. One of them is around oliceridine, is your expectation that you’d that both phase 3 in 2Q and what of all three trials, including the safety trial be done at the same time in the first quarter. And then the other one around 027, if Allergan or Pfizer options it, what roll would you have in development going forward and what are your expectations for when a phase 3 program would start.
I’ll let David pick up on the oliceridine question and then maybe I’ll take that along.
We are starting both phase 3 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. And 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. So at the end of the day, everything is expected in time for preparing an NDA file for the second half of 2017. So everything we expect deliver in that same timeframe around the first quarter of ’17. Alan Carr - Needham & Company: So all three may be done in first quarter, is it -?
Yeah. Alan Carr - Needham & Company: Okay.
Done by the first quarter.
So that’s obviously dependent on what the FDA says to us at end of the month. All of these comments, obviously all of these remarks are contention on the results of that conversation. With respect to 027’s future fast forward. So 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, and 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 and since it will be in their hands, it’s very hard for us to guide on when that’s likely to happen. So there’s going to be ton of data coming out of this trial. A lot of analysis will need to be done before I think they or we would feel comfortable designing the phase 3 program, and 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 takes to get the trial started. So I would imagine it would be some time in the next year 2017, but that’s really just our best guess right now.
Our next question comes from Heather Behanna from Wedbush. Your line is open. Heather Behanna - Wedbush: Just a quick all asserting question, at the team meeting at the end of the month, you’re presenting some data and you sort of cut the data to look at more - some total measurements kind of medium time for (inaudible) utilization and things like that. I was just curious that used data just really reinforced the rapid onset or if you’ve gotten sort of feedback in your composition to repair these kinds of measurements or ways of looking at utilization overly and what set they’ve apart.
So we’re going through secondary and exploratory analysis from both of our phase 2 studies and actually the entire program including some really interesting simulation work and so forth. So, this is just part of that roll-out of data from our perspective or from a clinical perspective. We believe that there is some very strong characteristics that favor all oliceridine compared to conventional opioids, and I’ll let Carrie talk about the work that she’s done externally. But I know these characteristics are power and so how effective the drug can be, its speed of onset and its better safety and tolerability profile and we think that as we roll of these pieces of data out, that sort of holistic picture is going to become even clearer as time progresses. But I’ll let Carrie talk about the market research and so forth.
As David described we’ve really been pleased to show the profile and market research and here physicians come in specifically on the faster onset, that’s been an important takeaway that they’ve received from the data. And it’s really tied into this idea that if they can treat patients more quickly, as I’ve said earlier, they potentially can get them out of the [tact] or even the ICU, either discharge home or on to the floor. So the idea of certainly providing faster pain relief to patient is important, but also the underlying economic message I think is what we continue to hear.
Our next question comes from Jonathan Aschoff with Brean Capital. Your line is open. Jonathan Aschoff - Brean Capital: I was wondering, you mentioned other new molecules; can you give us any clues as to what they may be?
No. We do have some very active research going in the lab, on the platform. We specifically don’t talk about the targets, but 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, and until we usually have a candidate selected. But I will tell you, we’re doing some very interesting things. Again, we are not in a therapy area constrained environment here. We follow the science and so the things that we’re working on now and not in the areas that we are 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 a huge unmet need and a very large commercial opportunity also. Jonathan Aschoff - Brean Capital: So in terms of 130s commercialization, can you help us better understand the breakdown, the extent to which you’re talking to peers versus docs and nurses, just because as you know money is never been a matter less tomorrow than today.
Yes, slightly I appreciate that. It’s the hospital decision makers, the pharmacist and hospital and administrators that we’ve been speaking with about the potential uptick from an economic perspective from a formulae perspective. I would also say though that, as you know, frequently physicians and physiologist surgeons, they sit on the P&T formulary reviews as well. So I think altogether, I would say if I had the split we talked to about two-thirds of physicians including physicians that sit on formulary and about a third of the pharmacist and other hospital decision makers.
Our next question comes from Jason Butler with JMP Securities. Your line is open.
Hi, this is Harry on for Jason. Just had two question TRV027, so with the enrollment on BLAST-AHF, how was that, if you could give some color on how that’s coming along since the interim. Second question is on the end points going in to the phase 3 trial. It seems like many other trials have booked at symptomatic endpoints or at the more mortality or outcome oriented endpoint. Do you feel that you need both of these end points in a phase 3 trial or may be asymptomatic benefit is sufficient if of great magnitude.
It’s Dave. So 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. So there’s a 30 day follow-up for the primary endpoint and then we’ll have data clean out, database lock and so forth and expect to share data in the second quarter. So we’ve done quite well actually on recruitment I 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, right. You can’t breathe; they are fatigued beyond all measure. And what they go in to the hospital for is to seek relief of those symptoms, right. And that’s done over a relatively short period of time. So most acute heart failure trials are 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 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 pretend better outcomes for patients even at 30 and 180 days. So 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.
Last question, on the statistical analysis for the BLAST trial, how you guys had a chance or will you have a chance to look at the blinded data and if you can anticipate making any changes on this [side] plan or is there a 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 focus. But I think as I described in the script, the purpose of phase 2 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 in the trial and being able to develop an endpoint or endpoints that can get you a register for drug through phase 3. So that’s very much our approach, but 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 the adjustments to the analysis plan based on blinded data, but we wouldn’t anticipate doing that, we’re probably at the end of the trial.
Our next question comes from Ritu Baral with Cowen. Your line is open. Ritu Baral - Cowen: Just wondering if you have any OpEx guidance due in part as you’re starting to work on these phase 3?
Hi Ritu, and I’ll 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 3 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 period last year, but the exact cadence of that still remains to be the determined. Ritu Baral - Cowen: Okay, and just based on your current phase 3 trial assumptions assuming nothing changes after the FDA meeting, how much kind of do you expect each trial to cost, if you have any color on that and for what duration?
We haven’t provided any guidance on the exact cost of the studies.
Our next question comes from Michael Higgins with Roth Capital Partners. Your line is open. Michael Higgins - Roth Capital Partners: A follow-up where we just left off; but can you take a look at the phase 2 per patient cost and give us some sort of an assessment on the upcoming phase 3s would be a bit higher, sometimes in phase 2s you can do a bit more work, they can cost a bit more. So how do we look at the cost per patient in phase 2 to figure out how it would look for the phase 3 cost?
Of course we’ve done that, but we haven’t guided with respect to what the specific costs were for the phase 2 trials. And there is variation as you pointed out. So in phase 2 trials per patient cost tend to be a little bit higher than phase 3, because you’re doing more exploratory measures and so forth. And with the some volume per patient, hard volume in phase 3 typically the per patient cost goes down. But we haven’t specifically said on what the per patient cost is for any of our trials.
[Operator Instructions] our next question comes from the line of Carolyn [Polemeque] with (inaudible). Your line is open.
I don’t know if [anyone’s] asked before. I just jumped on the call a little bit late, but just (inaudible) on pricing for all the fair deals or any more thoughts on how that can relate with your competitive versus something like morphine. I don’t know if it’s eligible for IV drug (inaudible) and coupons. Just wondering how you’re thinking about that or if you’ve already talked about it?
We actually have not done formal pricing research yet, but when we are out talking to a pharmacist, hospital, decision makers, they frequently reference the recent branded launches of Exparel or Ofirmev. So that price range was around, starting launch around $60, I think Ofirmev is up to about 140 now. Exparel’s around $300 for [surgery] and the only thing that they talk about is that certainly oliceridine has head-to-head data versus morphine in addition to placebo unlike some of the products that are launched in the market place. 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 specifically done in a hospital setting. But we haven’t worked through any of those kinds of things.
And showing no further questions, I will now turn the conference over to Maxine Gowen for closing remarks.
So thank you all for all of your questions, and 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’ve highlighted today. And of course we look forward to updating you on our programs over the course of the year. I’ll also be presenting at 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 my access the webcast on our website. So 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 Sarah, can you please conclude the call?
Thank you ladies and gentlemen. That does conclude today’s conference. You may all disconnect. Everyone have a great day.