Trevena, Inc. (TRVN) Q4 2017 Earnings Call Transcript

Jonathan Violin - SVP, Scientific Affairs and IR Officer Maxine Gowen - CEO Carrie Bourdow - COO David Geoghegan - SVP, Operations Roberto Cuca - CFO

Jason Butler - JMP Securities Alan Carr - Needham & Company Ed Arce - H.C. Wainwright & Company Biren Amin - Jefferies Michael Higgins - Ladenburg Thalmann

Good day, ladies and gentlemen, and welcome to the Trevena Fourth Quarter 2017 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call may be recorded. I would now like to turn the conference over to Jonathan Violin, Senior Vice President of Scientific Affairs and Investor Relations Officer. You may begin.

Thank you. And welcome everyone. Thanks for joining us on this morning’s call. With me today are Maxine Gowen, our CEO; Carrie Bourdow, our Chief Operating Officer; David Geoghegan, SVP of Operations and Roberto Cuca, our Chief Financial 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 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 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 our 2017 and recent corporate highlights. Carrie will discuss how the work we’ve done will support the successful commercial launch of OLINVO. Dave will provide an update on OLINVO manufacturing and supply chain, and Roberto will then review our financial results. Following this, we will open the call for questions. I will now turn the call over to Max.

Thanks, Jon. Good morning, everyone, and thank you for joining us today. As you likely know, 2017 was a very important year for Trevena. We successfully completed our Phase 3 program and submitted an NDA for OLINVO, our intravenous product candidate for the management of moderate to severe acute pain. Our NDA was accepted for review by the FDA in early January and we’ll have an advisory committee later this year followed by the PDUFA date for potential FDA approval on November 2nd of this year. Assuming approval, we expect drug enforcement agency scheduling within 90 days of November 2nd, so OLINVO could launch as early as the first quarter of 2019. The next 12 months are going to be critical for Trevena. So, I’ll spend a few minutes discussing our priorities for this year and how we think our efforts will translate into benefits for patients and hospitals and the successful future for Trevena. I’ll then turn the call over to Carrie, who, as you may have seen, has been promoted to Chief Operating Officer. Many of you know Carrie who joined us in 2015 with a wealth of experience with hospital products that positions her perfectly for this broader role. She will share an update on launch preparations including medical affairs and commercial planning. Following that, we’ll hear from David Geoghegan, who has recently been promoted to Senior Vice President of Operations. Dave joined us in 2015, bringing deep experience in manufacturing, supply chain, quality and compliance. His leadership of these activities has put the company on very strong footing. So, I’m delighted to have him in this broader role. Up to this point, we haven’t spoken much about our manufacturing and supply chain which of course is critical, and Dave will provide you with a brief update. Before we get into details of our activity, so I’d like to step back for a moment to share our view of why OLINVO will be an important product. I’ll start with the biggest topic, the analgesics, the opioid crisis. Without a doubt this is an urgent problem in the U.S. but that term doesn’t acknowledge the full scope of our challenge. We don’t just have a crisis in the overuse and misuse of painkillers, we have a crisis in pain management of which addiction is the most visible symptom. We do a poor job of providing the right treatments to the right patients and have failed to find the right balance in the use of opioid analgesics, which remain essential for many patients. The unmet needs in pain management are evident when we consider chronic pain in our communities where opioids have clearly been over prescribed, but also an acute pain in the hospital where opioids are and will remain necessary, despite their drawbacks. These unmet needs manifest in several ways. First, in adequately managed acute pain, delays recovery and increases healthcare costs. It can also lead to a transition to chronic pain state, which often has disastrous personal and economic consequences. Secondly, prescribing patterns do not always match patient needs with the medication they receive, for example, when patients are sent home with far more opioid than they will need. Likewise titrating patient’s analgesia in the hospital often under-treats pain or exposes them to unnecessary levels of opioid side effects. Third, all of the current main stays [ph] of pain management are medications that are decades of centuries old, none of which can be used without risk of adverse effect. There are few new mechanisms of pain relief that are being investigated and fewer yet that have proven efficacious in clinical trials. To solve the opioid epidemics, the medical community will have to make improvements on each of these fronts. We think OLINVO is an innovate solution that could contribute to providing safe, effective management of acute pain and thereby play a role in the broad effort to improve patient care and public health because millions of hospital patients will continue to require an IV opioid to get through their hospital stay. These patients often also receive non-opioid medications, but they still require the rapid, powerful and systemic analgesia of opioids. In fact, when we cleared [ph] the Premier database, the data on over 500,000 patients undergoing select, highly painful procedures in 2015 and 2016, we found that even with widespread use of multimodal analgesia including non-opioids, these patients on average needed more than 25 milligrams a day or morphine or morphine equivalent. These patients are often very sick. They’re in-patients undergoing the most serious surgeries and are often at elevated risk of opioid related adverse events. And yet hospitals not treat these patients with IV opioids, because they need them to manage their severe pain to allow recovery and discharge to home. We believe OLINVO may offer a unique profile to a specific target population, patients who need IV opioid because nothing else is sufficient but are at risk from opioid-related adverse events. So, we’re very much looking forward to our advisory committee meeting later this year and to our PDUFA date in November. These will be our top priorities for the year. But in addition to OLINVO, we are also advancing TRV250 for the treatment of acute migraine. As you may recall, we disclosed interim results in November, which shows dose proportional exposure after subcutaneous administration and adequate oral bioavailability after a single oral dose. Since we have completed the preplanned dose escalation without observing dose limiting adverse events, we extended the study to explore higher doses. And we’ve now completed dosing having dose subjects up to 30 milligrams subcutaneously. While the data are not yet final, our preliminary assessment supports continued development. As we await final data, we are evaluating path forward to proof-of-concept, possibly including an avert migraine model we’ve been piloting in a separate study. And we look forward to sharing final data from the first inhuman study for this exciting program in the coming months. We’re also continuing to advance our preclinical non-narcotic S1P modulators for chronic pains, both receptors [ph] and neuropathic. To remind you, this may be a new mechanism of action of pain aiming at the other end of the pain spectrum from OLINVO chronic pain where the need for non-addictive therapies is highest. Minimal investment is required to determine if we can identify a clinical candidate and then we’ll determine if we should partner this exciting program or identify funding to progress it to IND ourselves. Regarding the non-R&D activities of the Company, we are laying the ground work for a successful and capital efficient commercial launch of OLINVO, either by us or by a partner, and seeking to extend our cash runway beyond the second quarter of 2019, through ex-US partnering and/or financing to ensure the Company can support OLINVO’s launch. And on the topic of the launch, I’ll now turn the call over to Carrie.

Thank you, Max. Today, I will focus on two areas of our prelaunch strategy, our hospital account profiling and our medical affairs activities. In the past, we described the types of patients we think were the best fit for early use of OLINVO. Patients who require IV opioids that are at risk for opioid-related adverse events, either because of demographics, co-morbidities or the procedures they undergo. We’ve also now done quite a bit of work on the types of hospitals we think will drive early utilization of OLINVO. Of the 5,800 hospitals in the United States, 1,200 account for 70% of the IV opioid volume, so the business is relatively concentrated. We analyzed past launches of branded acute care hospital drugs and found that approximately 600 hospitals are what we call early adopters of these branded agents. We expect to launch first by targeting these early adaptor hospitals for faster uptake, learning from initial market indicators and then expanding investment in growing our field force and MSL. Not only is this the most capital efficient approach, but it’s also how I’ve launched hospital products in the past, and similar to how other successful hospital focused companies have launched. Another important area of focus for us is scientific exchange and medical affairs. We believe that it’s important to establish scientific relationships early in the prelaunch phase and understand how unmet clinical needs are evolving. Our medical affairs team has been in the field since late last year, learning directly from thought leaders and formulary decision makers about the unmet needs with current IV analgesics and how a new option like OLINVO might fit into clinical practice. We have also continued to publish our OLINVO data and have focused on scientific communications at key medical meetings where we have been discussing several important themes in acute pain management. One major theme is cost and economic impact of opioid-related adverse events. Last year, we presented analyses from the Premier claims database at several medical and payer focused meetings. This analysis is one of the first to highlight the increased prevalence and costs of postoperative nausea and vomiting and respiratory depression in at risk patients. We also have continued to publish data highlighting OLINVO’s unique profile. In the Journal of Clinical Pharmacology, we published data supporting OLINVO’s fast onset and lack of active metabolites, important for patients with renal compromise in whom opioid active metabolites can accumulate, leading to increased and prolonged adverse events. Renal compromise patients make up 13% of the U.S. patient population, and OLINVO may be a valuable new option for these patients and others who are at higher risk from opioid-related AEs. And lastly, we continue to highlight our multiple studies versus IV morphine. The efficacy and safety of OLINVO versus IV morphine from the Phase 2 soft tissue study was published in the Journal Pain of Research and the head-to-head Phase 3 results were highlighted at the American Society of Anesthesiology annual meeting in October. We are in the process of publishing the full study results from Phase 3. These head-to-head comparisons suggest that OLINVO has the potential to deliver pain relief comparable to IV morphine though with the potential for less nausea, vomiting and respiratory depression. As a reminder, we have now completed five head-to-head studies versus IV morphine. I don’t know any other product in this therapeutic area with such an extensive amount of comparative data. These papers and presentations are the foundation for our medical affairs activities and speak to the wealth of information that will be available to pharmacy decision makers and clinicians when they decide to evaluate how OLINVO might benefit their patients. This coming year, we will also begin to present data from ATHENA, the open label safety study designed to model real world use of OLINVO. We have an additional benefit compared to other recent launches in this space. As a new chemical entity with a novel mechanism of action, OLINVO’s development program included this large safety database. Over 200 clinicians participated in the ATHENA study, and they will use this experience at launch to educate their colleagues. To date, a feedback we’ve heard from the ATHENA trial has been encouraging. OLINVO was used in the emergency room, the PACU or recovery room, in ambulatory surgery centers and on the inpatient hospital floor. Investigators were able to successfully treat their patients with OLINVO with very low rates of discontinuations. So, in addition to our peer reviewed publications, we’ll have real world experience to help inform hospitals as they consider providing OLINVO for their patients. We believe that OLINVO is well-positioned for a successful launch with key factors that drive uptake, a focus on at risk patient types and early adopter hospitals where we can achieve rapid uptake, key opinion leader interest in OLINVO supported by the publications for our head-to-head studies versus IV morphine and the activities of our medical affairs team, and lastly strong real world evidence and potential adequacy from ATHENA investigators. With that, I’d like to turn the call over to Dave to provide an update on our manufacturing and supply chain activities.

Thank you, Carrie. It’s a pleasure to be here today to share an update on some of the operational aspects of the OLINVO program that have become increasingly important as we prepared and submitted our NDA and now as we approach the potential approval and commercialization. We have a strong internal team overseeing analytical and [ph] pharmaceutical development, manufacturing, supply chain and quality with over 150 years of combined industry experience. This team is actively managing our third-party contract manufacturing organizations or CMOs to support our NDA and commercialization efforts. We have well-established relationships with these CMOs and have commercial supply agreements in place. OLINVO API and drug products are manufactured by Altami, [ph] the Company we’ve worked with since 2010. Under our direction, they have successfully manufactured clinical supplies of OLINVO in support of the clinical development program. At the same facilities, we have also made full scale, primary stability batches to form the basis of the stability section of the NDA. OLINVO drug product is also manufactured by Pfizer CentreOne who has been contracted as an additional drug product manufacturer. And we plan to leverage their scope and economies of scale to complement Altami. [Ph] All this preparation has been done assuming OLINVO will receive a Schedule II designation from DEA. And therefore, we have ensured that each of our partners have the appropriate DEA licensing for handling C2 compounds with their respective tests. The CMC sections of the NDA were completed in collaboration with our supply chain CMOs and are now under FDA review with the rest of the file. We’ve had constructive interactions with the FDA throughout the development program. Importantly, our quality team has developed a rigorous internal quality system and has worked closely with the quality organizations of each of our supply chain partners to ensure that OLINVO will be made with the highest quality standards. So in summary, we have experienced team that is actively managing the supply chain with well established CMOs. The team is continuing to support FDA review of the OLINVO NDA and preparations for commercialization based on robust and repeatable processes and sound quality systems. And now, I’ll turn it over to Roberto, for a review of our fourth quarter and full year financials.

Thanks, Dave. 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 $14.7 million or $0.24 per share, compared to $36.1 million or $0.67 per share for the fourth quarter of 2016. For the full year ending December 31, 2017, we reported a net loss attributable to common stockholders of $71.9 million or $1.21 per share, compared to $103 million or $1.97 per share for the year-ending December 31, 2016. This reduction in 2017 expenses compared with 2016 was largely attributable to substantially reduced R&D expenses following the completion of the OLINVO Phase 3 program, and the cessation of early stage research in the fourth quarter of 2017. Specifically, research and development expenses were $49 million for the full year 2017, compared to $90 million in 2016. We expect this decline to continue in 2018. General and administrative expenses were $19.6 million for the full year, compared to $16.1 million in 2016. The increase was largely attributable to increased headcount and other investments in preparation for the commercialization of OLINVO. Cash, cash equivalents and marketable securities were $66 million as of December 31, 2017, which together with the interest thereon, we expect will fund operations into the second quarter of 2019. As Max mentioned that we are evaluating the full range of options to increase our resources to support the efficient commercial launch of OLINVO. We can now open the call for questions, after which Max will give some closing remarks. Operator?

Thank you. [Operator Instructions] Our first question comes from the line of Jason Butler of JMP Securities. Your line is now open.

Hi. Thanks for taking the questions. I had two. First one, Carrie, congrats on the promotion. Can you just give us anymore color that you’re having with the discussions with the early adopter hospitals that you’re targeting? And how they might introduce the drug, for example, or any planning, pilot studies et cetera?

Sure. Thank you, Jason. Yes. So, one of the things that distinguishes as early adopters, as I mentioned is that they added specifically Ofirmev, Exparel and also [indiscernible] which is another recent launch in acute care market. They’ve added them on formulary. So, what distinguishes an early adopter is that they have the physicians, in particular have a willingness to advocate for branded drugs that they believe are better and offer advantages to certain patient population. So, we’re beginning to have those conversations now. I would also tell you that the Athena investigators, the Athena sites that were enrolled in the open label safety study are part of that early adopter list because they already have experience with OLINVO and can already describe some of the advantages of OLINVO over conventional IV opioids. So, more to come on that. We’ll be rolling out additional information on both the hospitals and the physicians that make up that group.

I think to answer your question a bit more specifically though, we have had a number of requests, let’s say, maybe proposals is too strong, from ATHENA investigators who would like to study other aspects of OLINVO. So, that’s the sort of thing that we’ll be working on in the future.

Okay, great. And then, Max, just you mentioned partnering remains strategic option. Can you just talk about what the priority level there is, both US and ex-US and when if you did decide to partner would be the right time.

Of course, yes. So, we are still actively engaged in multiple discussions, but we do continue to focus on our ex-US discussions as we’ve previously said. We are open to partnering in US under the right circumstances. While those discussions are ongoing, we still continue to plan for the launch, so that we will be ready to bring OLINVO to patients once it’s approved, either with or without a partner.

Thank you. Our next question comes from [indiscernible] of Barclays. Your line is now open.

Thanks for taking the questions. I’m on for Doug Tsao. So, just previously, you’ve mentioned that patients on OLINVO have been experiencing less confusion; there have been trends to see that. Have you been able to elucidate any more data on this? And then, just on the commercial side, in terms of reimbursement, do you think you’ll be able to get a J code? Thanks.

So, we’ll let Carrie comment on J code issue in a few moment. Just to remind everyone, this observation of less sedation, less confusion that goes by I think the lot of terms when clinicians see this in their patients is something that was continuously reported to us by ATHENA investigators. We had a little bit of preclinical data suggesting potential for less sedation, but it’s not something that we really measured as an endpoint in any of our studies. So, it’s really something that reason, more organically based on what physicians are seeing when they treat their patients with OLINVO. So it’s something that we are interested in following going forward, but not something that we have a lot of prospective data on at the moment. That said, it’s something that matters for a number of reasons. One, sedation is a component of opioid-induced respiratory depression. And so, it’s something that physicians and nurses are aware of. They are thinking that it could be a sign of incipient trouble. But it’s also obviously a part of patient care, particularly for example in orthopedics when rapid transition to physical therapy is important, having someone elucidated is not helpful. So, I think both, in terms of safety and in terms of potential economic benefits related to patient throughput, this is something that we are really interested in hearing about from these ATHENA investigators.

And as it relates to the J code and as you know, we will apply for the J code after we have approval, after we launch. We are anticipating that within the outpatient area that we’ll have pass-through for at least the two to three years. And so, we’ll have the advantage of ASP plus 6% and then we’ll apply for J code and we’ll see. We do have a CMS consultant that is working with us right now, so we are starting those plans and have a lot of work already that is conducted in this area.

Okay. That’s helpful. And can I ask one more follow-up question? You previously talked about hiring about 100 launch personnel for the OLINVO launch. What’s the status of that? How far long are you and if you give any additional details? Thanks.

Yes. So, a typical hospital sales force is between 60 to 100 reps, and that’s what I’ve referenced in the past. As I mentioned on the call, we are doing this analysis around our early adopters and our key accounts. So, I haven’t declared yet on what are field sales organization will look like. I want to get a little further down the path on those critical hospitals. And I also mentioned that this market in particular is a really concentrated market. So, we’ve hired part of our MSL team. They’ve been out in the field since late last year. And we’re in the process of going through and thinking about how we’ll build our own sales force organization or working with the contract sales organization.

Thank you. Our next question comes from the line of Alan Carr of Needham & Company. Your line is now open.

Hi. Thanks for taking my questions. Can you go through the DEA review process and maybe your thoughts on maybe any particular areas with OLINVO in that review? And then, also, what’s your share count end of December and now? Thanks.

Thanks, Alan. This is Jon. So, I’ll answer the DEA scheduling question and see if anyone else on the team wants to chime in, and then check [ph] out number. So DEA scheduling by statute supposed to occur within 90 days of approval. In our case, as we said in the past, OLINVO, based on the basic science, based on preclinical data and our human abuse liability study, at doses that give equivalent analgesia, we see like in -- very similar to morphine, no worse than morphine. So, given that this in the hospital, this is given only under supervision by healthcare professionals we are quite comfortable with our expectation that this will be a schedule. So, we’re not expecting any prolonged debate. We’re really asking that this to be treated in the most cautious manner available, that means will be stored right next to the vials of IV morphine and managed accordingly. So, it’s more just a process of getting the drug assessment, the drug liability assessment review by the DEA, get the scheduling done. So I’ll pause there to see if anyone else in the team has color to add.

So, our share count at the end of the year was about 67 million and our most recent share count will come out on our Form 10-K in the day or so.

If I can follow up on migraine program. Can you add little more detail around the work you’ve done with IV and oral, and with this migraine model you’re contemplating, any details around that?

Sure. So, we’ve conducted a pilot study with a CRO that specializes in this area in the UK. And we have generated data, which allow us to predict the reliability of first of all generating migraine like headaches, we’ve evaluated the migrainess of the migraine headache, to use technical term, and we’ve evaluated the efficacy of chronic of generally used migraine drugs like triptans to treat those headaches. And so, all of that allows us we hope to -- or will allow us to project whether or not that will be a reliable model for us to test the new therapy in and hopefully to be able to size the study.

And you’re looking at both, at injection and oral formulation?

So, we have studied so far multiple doses subcutaneously of 250 and a single dose orally. So, we would likely do a proof-of-concept study using subcu formulation because that would be the most efficient, most quick way to go forward.

And just to remind you, when we think about acute migraines, there are both subcu and oral products in the triptans widespread availability, oral medications, the subcu still are used to a reasonable extent. So, there is I think potential utility of both routes. At this early stage, it’s really a question of how do we most efficiently establish proof-of-concept before then figuring out what the most valuable product would be to move forward.

Thank you. Our next question comes from the line of Ed Arce of H.C. Wainwright & Company. Your line is now open.

Hi, everyone. Thanks for taking my questions. Some have already been asked and answered, but I did want to ask about the two compounds TRV250 and the SP1 modulator. You’ve discussed I think the potential to identify either funding sources or partnership with the SP1. Is that also the case with TRV250, given the continuing development work on the doses there?

So, we haven’t made a definitive decision about how to progress that forward. I think the -- ones always open to partnering discussions, but right now we are preparing to do -- the plan is in place to do a proof-of-concept study ourselves.

Okay. And then, maybe one follow-up related to an earlier question about the signals you’ve seen from the ATHENA study about less sedation and confusion, and that aspect been related to respiratory depression. Have you put together any sort of concrete plans to investigate that further, perhaps upon further funding or some other scenario? Thanks.

It’s an incredibly interesting area, and we -- it’s such a reproducible finding, as we talk to more and more investigators that it’s something that we really do think it’s worth pursuing. We actually are in the process of looking at models for evaluating sedations with experimental drugs and new drugs, so that is something that we are pursuing for the future.

Thank you. [Operator instructions] Our next question comes from the line of Biren Amin with Jefferies. Your line is now open.

Yes. Thanks for taking my questions. Maybe just on the AdCom, what topics do you expect FDA to focus on regarding the AdCom?

Hi, Biren. Well, we expect the FDA questions to focus on safety and efficacy and with benefit analysis of OLINVO. I think the actual advisory committee questions are lot more unpredictable. And so, obviously, right now we are actively in preparation for any and all questions that we can think of that the committee may ask. We’ve from the interactions we have had with the FDA, we’ve seen interactions with the FDA, now the usual back and forth in a submission, we certainly haven’t had any indication of any specific areas of focus for them.

Got it. And then, I think Carrie mentioned that there are 600 hospitals in the U.S. that are early adaptors. So, how is the Company defining early adaptors, is it first few quarters of launch, is it first few years of launch? And also, I guess, I am expecting you would have to go through formulary community review. So, how fast do you expect to go through these hospitals? Can you just -- and so can you just talk about these aspects?

Yes. So, the way that we defined early adaptor was actually within the first year. So, they had to have adopted two out of the three and had sustained view. So, Biren, I know, you’ve covered other hospital launches. Formulary is not always the end all. And so, some of these hospitals, in particular what I think what profiling is, their willingness and interest to pilot the drug. A lot of the large academic medical centers, they want their own physicians to try the drug before they’ll assess formulary. So, we are in the process now of segmenting, peering these hospitals, these 600 hospitals by some of these other aspects as well. So, I don’t have any answer on what percent would put the drug on formulary within the first three to six months, six to eight months, after 12 months. So, I’ll provide that information a little bit closer to launch.

And Carrie, do you have any color in terms of how much morphine use at the 600 early adaptors and then what are your thoughts on pricing in early adaptor sensitive side?

Yes. We do have how much morphine, IV morphine, IV hydromorphone, I don’t have the numbers off the top of my head, but it is one of the areas that we use to peer these hospitals. So, we have our own -- in addition to the IV opioid volume metrics, we are looking at whether they use IV morphine, IV hydromorphone, where they use it. And then your second question was on pricing. So, quite a few of these hospitals have value-based metrics in place; that’s one of the areas we’re interested in. And by that they are not just interested in managing their budget, they are interested in improving patient outcomes and improving throughput for instance or readmissions. So, we have all of that information as part of the color around these hospitals.

Thank you. [Operator Instructions] Our next question comes from Michael Higgins of Ladenburg Thalmann. Your line is now open.

If I could ask on TRV250, how much present the Phase 1 results, are you looking for a press release or it might just be in the conference?

Hi, Michael. Thanks. So, since this is a single ascending dose study in healthy subjects, as you heard both multiples of subcu doses, a single oral dose, the result I think will be really important for development of the program. Just to be clear, we don’t expect to have any signs of efficacy or pharmacology. So, the key thing for us is going to be knowing that the drug has the pharmacokinetics, the safety and tolerability to support further development. And as you heard, the preliminary data has been very encouraging. So, we’ll certainly share the final results when we have them depending on when that -- the actual mechanism by which we’ll communicate that will be determined, but we certainly look forward to wrapping that study up and figuring out how to move this program forward to proof of concept which could be really exciting study.

Yes. We’re sharing enthusiasm. So, look forward to seeing it. Second one on the kind of a follow-up by I suppose on the AdComs, often time these are grouped for another NDA review. Any signals from the agency to that regard, any expectations for this to be part of the two-day meeting?

We have not heard anything on the scheduling of the AdCom just yet, we are expecting that probably not until closer to the summer time.

Thank you. At this time, I’m showing no further questions. I would like to hand the call back to Max Gowen for any closing remarks.

Well, thank you everyone for your questions, great questions as always. You’ve heard that we remain very optimistic and committed to making Trevena a success. OLINVO is on track for an advisory committee meeting and potential NDA approval later this year. Our 250 and S1P programs offer tremendous future upside. I’d like to emphasize that we believe we are one of only a few remaining companies working on solutions to the pain crisis and are proud to be bringing innovative new potential pain therapies to patients. And as always, we look forward to sharing updates with you in future.

Thanks, Max. I would like to remind listeners that a replay of this call will be available on the Company’s website at www.trevena.com. On behalf of Trevena management, I’d like to thank you all for joining us. I’ll be available for any further inquiries following the conclusion of the call. With that, we’d like to end. Thank you.

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone have a great day.