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Edited Transcript of TRVN earnings conference call or presentation 7-Nov-17 1:00pm GMT

Thomson Reuters StreetEvents

Q3 2017 Trevena Inc Earnings Call

Kng Of Prussa Nov 7, 2017 (Thomson StreetEvents) -- Edited Transcript of Trevena Inc earnings conference call or presentation Tuesday, November 7, 2017 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Carrie L. Bourdow

Trevena, Inc. - Chief Commercial Officer and SVP

* Jonathan Violin

Trevena, Inc. - VP of Corporate Strategy & IR

* Maxine Gowen

Trevena, Inc. - CEO, President and Executive Director

* Roberto E. Cuca

Trevena, Inc. - CFO, SVP and Treasurer

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Conference Call Participants

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* Alan Carr

* Antonio Eduardo Arce

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Biren N. Amin

Jefferies LLC, Research Division - MD and Senior Equity Research Analyst

* Michael John Higgins

Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst

* Ryan Abbe

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Presentation

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Operator [1]

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Good morning, ladies and gentlemen, and welcome to the Travena Third Quarter 2017 Earnings Conference Call.

(Operator Instructions)

As a reminder, this conference call is being recorded.

Now I'd like to turn the call over to Jonathan Violin, Vice President of Corporate Strategy and Investor Relations. Sir, you may begin.

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Jonathan Violin, Trevena, Inc. - VP of Corporate Strategy & IR [2]

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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 Commercial Officer; 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 Provisions 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 we undertake no obligation to update these statements beyond today.

During today's call, Max will provide a brief overview of our third quarter and recent corporate highlights. Carrie will discuss how the work we've done will support a successful commercial launch of OLINVO. Roberto will then review our financial results. We'll then open the call for questions. Now I'll turn the call over to Max.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [3]

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Thanks, Jon. Good morning, everyone, and thanks for joining us today. The last quarter has seen rapid progress on a number of fronts, culminating in the recent submission of our OLINVO NDA. We've also made some decisions to support Travena's long-term growth and create meaningful value. I realize this has been a difficult year for shareholders, but we continue to see value in OLINVO and our other assets, and I'd like to share some of our recent advances.

We believe our current cash position should last into the fourth quarter of 2018 and are in active discussions for multiple partnering transactions, both in the U.S. and in ex-U. S. territories. In the meantime, we continue advancing OLINVO towards FDA approval and building the value proposition for OLINVO with our prelaunch activities, because we believe it will be a valuable new option for patients and physicians.

I'd like to spend a few minutes reviewing our recent progress in building upon our positive Phase 3 APOLLO data announced earlier this year. First, we've now successfully completed ATHENA, our Phase 3 open-label safety study. This study modeled real-world use in a wide range of procedures, including the priority procedures in at-risk patients that will be targeted at launch. We reported data from the first 418 patients at our July Analyst Day, and I'm happy to share today that we've now collected data from all 768 OLINVO-treated patients, and we've seen very encouraging results in this study.

We enrolled highly relevant patients, the at-risk segment of hospital patients who are most in need of a new analgesic option. For example, 32% were at least 65 years old. More than half were obese, with BMIs greater than 30, both of which are risk factors for opioid-induced respiratory depression.

In addition, the key surgical specialties that will be targeted at launch were well represented, including orthopedic, colorectal, general and cosmetic surgeries. Importantly, multimodal analgesia, including OLINVO, was common, with high preference of local anesthetics and nonopioid analgesics, including NSAIDs and acetaminophen. So we now have a solid foundation of experience in the patients and procedures to inform the OLINVO launch.

Second, we got valuable dosing information. Nearly half the patients received OLINVO via PCA where the other half by as-needed bolus dosing, which was given in the PACU, or recovery room, to successfully titrate patients to comfort and then dose to maintain pain relief. Maintenance dosing interval averaged 3.25 hours, indicating a very useful dosing interval for maintenance therapy. Importantly, the OLINVO AE profile was similar for PCA and bolus dosing, supporting the use of either dosing paradigm as hospitals and physicians see fit.

We saw solid evidence of effectiveness. There were less than 5% discontinuations for lack of efficacy and 2% discontinuations for adverse events. Within the context of patients undergoing major procedures and consenting to an investigational product for their pain management we think this is a very good result.

We saw promising adverse event rates. The frequency of the typical adverse events of nausea, vomiting and constipation were lower in ATHENA than we observed in our retrospective premier hospital database analysis of patients receiving conventional opioids for procedures in our key target specialties, though, of course, the methodology in these two datasets was not identical.

In addition, the AE frequencies were generally lower in ATHENA than in our APOLLO studies, consistent with our expectations of OLINVO's advantages versus IV morphine translating to real-world experience. I'm also pleased to note that no patient in any trial has needed naloxone to reverse the effects of oliceridine.

Equally important to us was investigator feedback, since it helps us identify potential future studies of OLINVO and may indicate what evaluations hospitals might consider for their own assessments of OLINVO's performance. Based on feedback we've heard from multiple study sites, we are now planning retrospective chart reviews in orthopedic and colorectal procedures in which we are interested in understanding measures such as a sedation and return of bowel function,

We're very pleased with the ATHENA results that we've seen so far and are looking forward to sharing more data from the ATHENA trial in the coming months.

In parallel to our OLINVO NDA preparations, we've also conducted a strategic evaluation of our pipeline and resource allocation. For the last 18 months the bulk of our resources had been allocated to OLINVO, as we completed an entire Phase 3 program in just over a year.

As we execute on the OLINVO prelaunch activities and advanced TRV250 and our S1P modulators in Phase 1 and preclinical stage, we did not believe further new molecule discovery was going to drive shoulder return in the foreseeable future. The decision to halt our new molecule discovery was a difficult one, but we believe it necessary for the success of the company and value creation for our shareholders.

We've extended our cash runway and significantly reduced our operating expenses, but have retained development, regulatory and commercial expertise to advance OLINVO to FDA approval and conduct the necessary prelaunch activities. And, although we're focused on our OLINVO program, we're ready to advance TRV250 and potentially one of our S1P modulators.

And in light of this I'd like to share an update on an early pipeline, starting with TRV250, our investigational product for the treatment of acute migraine, a novel, potentially first-in-class mechanism. I'm pleased to report today that TRV250 has successfully completed the preplanned single ascending subcutaneous dose protocol in our first-time-in-human study in healthy volunteers.

In the doses studies to date, TRV250 demonstrate dose-proportional exposure after subcutaneous administration and was safe and well-tolerated at all doses tested. Because no dose-limited adverse events have been identified, we've expanded the study to establish a maximum tolerated dose to support future Phase 2 planning. In addition, we have preliminary data for a basic oral formulation administered to healthy volunteers suggesting TRV250 has adequate oral bioavailability to support further development via the oral route.

In light of the promising early results and our ability to expand the study to higher doses, this trial should now read out in the coming months, depending, of course, on many dosing cohorts we need to study. Once we complete the study we'll evaluate collaboration opportunities to fund and advance and TRV250 into Phase 2 and beyond.

Additionally, we unveiled a new program, a series of S1P modulators that show promise as non-narcotic, nonopioid analgesics for neuropathic pain, inflammatory pain, and chemotherapy-induced peripheral neuropathy. We're seeking multiple paths to move one of our molecules forward into development and look forward to updating you in the future.

And, finally, I'd like to thank Mike Lark, our Chief Scientific Officer, who's been with us since we started Trevena and who'll be departing the company in mid-December. Mike and his biology and chemistry teams very successfully helped grow the company from a platform concept through delivery and development to the cusp of commercialization. We will miss Mike as a colleague, a leader and a friend.

And now I'd like to turn the call over to Carrie to discuss why we're so optimistic about OLINVO's clinical and commercial potential.

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Carrie L. Bourdow, Trevena, Inc. - Chief Commercial Officer and SVP [4]

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Thank you, Max. I thought I'd spend a few minutes reflecting on what we've learned in our market research and launch planning in the last few months. We've spoken with over 400 pharmacists, physicians and nurses, in both the inpatient and outpatient hospital setting, since we received our Phase 3 data, and we've heard four main questions that hospitals have when they evaluate a new drug.

First, does the drug provide a benefit over current drugs, especially for those patients that may be difficult or costly to treat? To date we've conducted five head-to-head studies versus morphine, and we believe the data show that OLINVO provides a fast onset, clean offset, the expected efficacy of an opioid, with an improved safety and tolerability over morphine. Physicians in market research told us that it's this combination of potential benefits that is unique for OLINVO and may help them better manage their patients.

When we asked physicians to select the patient types where OLINVO would be their first choice over morphine, three of their top picks were the elderly, obese and renal-impaired patients, because these patients are a higher risk for respiratory issues. Also selected were patients who have had a history of nausea or vomiting or those who are having procedures where vomiting can negatively impact the outcome. Physicians tell us that these at-risk patients represent approximately 40% to 50% of their current patient population, and we estimate that the initial OLINVO target is between 7 million to 9 million hospital inpatients.

The second question from hospitals is what will be the budget impact of the new drug, and by budget impact they're looking to understand not just the price but also potential cost offsets or cost benefits if the new drug can help them improve patient care and manage costs across the hospital system.

To address this question, we conducted market research with 200 hospital pharmacists and physicians using a blinded profile of our Phase 3 head-to-head clinical results. We learned that the decreases seen in respiratory depression and vomiting versus morphine were meaningful, and especially important for those at-risk patients that are costly for hospitals to manage.

They also told us that a price range of $60 to $100 a day reflects the significant value that OLINVO may provide to the inpatient setting. And we now know which of our targeted hospitals have case mixes associated with these at-risk patients and procedures and therefore may be early adopters of OLINVO.

The third question hospitals have relates to physician demand. Hospitals want to know that there are a group of physicians that see value in using the new drug, but we also recognize the importance of physician experience and advocacy on formulary uptake. We expect the OLINVO launch to focus on key physician specialties such as orthopedic, colorectal, cardiothoracic and cosmetic, because theses physician groups require IV opioids in a large number of at-risk patients.

In addition, many of these targeted physicians practice in both the hospital inpatient and outpatient or ambulatory surgery centers, and we know that physicians may first try a new drug in the outpatient setting, since new medications can be reimbursed with passthrough status for 2 to 3 years post launch. Physicians can then bring their experiences with the drug into the hospital to educate formulary committees.

In addition to the unmet needs I've described for at-risk patients, we see an opportunity for OLINVO in the outpatient setting, where the potential for rapid onset, clean offset and reduced AEs can aid patient throughput. And so OLINVO can be targeted to select hospital outpatients and ASEs to help drive early experience.

Finally, the results from the ATHENA trial will help us address hospitals' fourth question, how will a new drug perform in the real world? As you heard Max describe, the ATHENA trial modeled real-world use, and OLINVO was used in multiple at-risk patients and targeted procedures. Over 200 physicians, nurses and other healthcare providers across dozens of sites participated in ATHENA, and we expect to present and publish many of the subpopulation findings from ATHENA at upcoming medical meetings.

In closing, we know the hospital is a multiprong sell. The good news is that we believe we have a novel, differentiated product, and our targeted prelaunch strategy ensures that we've positioned OLINVO for a successful launch. And with a strong patent protection until at least 2032, OLINVO has a very long runway to capitalize on this significant opportunity.

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

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Roberto E. Cuca, Trevena, Inc. - CFO, SVP and Treasurer [5]

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

For the third quarter, we reported a net loss attributable to common stockholders of $16 million, or $0.27 per share, compared to $29.9 million, or $0.57 per share, for the third quarter of 2016. Research and development expenses were $10.2 million in the third quarter of 2017 compared to $25.5 million for the same period in 2016. This decrease resulted primarily from the completion of our Phase 3 program for OLINVO.

General and administrative expenses were $5.2 million in the third quarter of 2017, compared to $4.1 million for the third quarter in 2016. This increase corresponded with modest growth in the commercial organization as we prepare for potential OLINVO approval next year. We expect commercial expenses to increase as that approval nears.

Cash, cash equivalents, and marketable securities were $76.6 million as of September 30, 2017, which we expect will fund operations for at least twelve months from today. And, as Max mentioned, we are evaluating the full range of options to bolster our balance sheet and support the efficient launch of OLINVO.

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

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Questions and Answers

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Operator [1]

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Thank you. This is the operator once more.

(Operator Instructions)

Our first question comes from Jason Butler, from JMP Securities.

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Ryan Abbe, [2]

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It's Ryan for Jason. I had a question about physician feedback and how that's evolved, given the presentations and publications on the Phase 3 data throughout 2017.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [3]

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Sure. So, it's been really interesting, because physicians, as we've been reporting out the head-to-head Phase 3 data, link it to some of the earlier studies and publications they've seen. And one of the comments that we continue to get is that it's the totality of the data that's impressive to them, because, as I mentioned on the call, in five head-to-head studies we've shown either better efficacy or better safety and tolerability. And so as we've published more and more of our information or presented at more and more scientific meetings, they're looking for those links, and when they see, for instance, oxygen saturation and respiratory events in multiple studies in multiple different ways that's confirming for them that this truly is a differentiated profile.

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Ryan Abbe, [4]

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Okay, great. That's helpful. Thanks. And then you can also discuss how the breakthrough status for OLINVO impacted the interactions with the FDA during the NDA submission process?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [5]

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Sure. So, I think each division uses the breakthrough therapy designation differently. And so we had -- we certainly had frequent interaction with the project leader and a number of interactions with different members of the review team. I can't say if that was different because we had breakthrough therapy designation, but it certainly was helpful.

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Ryan Abbe, [6]

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Okay, great. Then one last one on the S1P programs, are you targeting specific subtypes or combinations of subtypes of the receptors? Thanks.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [7]

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We are, but we haven't yet disclosed that for competitive reasons.

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Ryan Abbe, [8]

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Okay. Thank you.

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Operator [9]

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Our next question comes from Alan Carr, from Needham & Company.

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Alan Carr, [10]

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A couple of them, one around ATHENA. I wonder if you could give us a sense of when we might see more of that data, and also wondering if -- doesn't sound like it, but I'm wondering if there's anything different that you learned when going from 418 to 768 patients. The other is around regulatory. Any sense of advisory committee meeting here, and I suppose you'll learn whether or not you have a priority review at the filing date? Thanks.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [11]

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Good morning, Alan. I'll try and remember all the questions. So, we will be rolling out the data from ATHENA at scientific meetings. As you know, in the pain space they sometimes can have rather a long lead time to get into -- go through abstract review, etc. So we don't have any specific plans to tell you yet, but we will keep you informed of that. There were really no differences, no substantial differences at all between the data from the first cut and the second cut, which was obviously very encouraging. If anything, I think the data looked a little bit more favorable when they were all combined, the larger number. No concerns at all there. And then the review -- oh, yes, are we going to have -- so we would -- this is an NCE, as you well know, so we would anticipate having an advisory committee meeting. Of course, we learn that later from the FDA. I think it would be surprising if we don't. And, yes, we hear about that at the time that the NDA is accepted, we hope.

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Alan Carr, [12]

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Okay. And I guess with S1P (inaudible), how much more work do you plan to do with S1P internally?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [13]

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So I just corrected what I just said. We learn about priority review. That was the part of the question I was answering there, when we hear about the (inaudible). So, well, we would very much like to identify a clinical candidate, and that's what we're planning. That's what we're actually actively doing right now. We have a number of potential candidates, and we're just doing the final evaluation of those. How much further we can go will depend somewhat on our resources at the time. I mean, we --

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Alan Carr, [14]

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A Phase 1 is a possibility, it sounds like, if you feel like you have the resources for it.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [15]

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Exactly. Down the road. Down the road it would be, yes.

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Alan Carr, [16]

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Okay. Well, thanks very much.

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Operator [17]

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Our next question comes from Ritu Baral, from Cowen.

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Unidentified Analyst, [18]

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This is Alex on for Ritu. One question for Max. Could you expand on the comment you made about AEs being lower in ATHENA than APOLLO? Was this across all AEs? And how do you think regulators and future P&T committees will view those differences?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [19]

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So, yes, it was pretty much across the board of all of the side effects that we see. As you know, we usually report greater than 5%. And we saw quite a deal lower levels of side effects across all of those. We would imagine that the use in a real-world setting will be meaningful to both regulators and to P&T committees, as opposed to use in a highly not real world. I don't know what the word is I'm looking for, a setting as in APOLLO. I would also say that -- I would remind you that we did this very large study of a Premier database with several hundred thousand queries, and we did that really to give us a baseline of how we would expect to see conventional opioid levels of side effects in the real world in exactly the same setting that we are using for ATHENA. And comparing those levels that we saw in the Premier data with ATHENA, ATHENA levels, again, were a good deal lower than in the Premier database, in which patients were treated with conventional opioids.

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Unidentified Analyst, [20]

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Got it. That's helpful. And then one for Carrie. You mentioned it briefly in the prepared remarks, but could you gives us a little more detail on your initial plans for penetrating the inpatient versus outpatient markets and how we should think about differential pricing in these situations?

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Carrie L. Bourdow, Trevena, Inc. - Chief Commercial Officer and SVP [21]

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Yes, good catch, Alex. So, we've spent the bulk of our effort thinking about the inpatient opportunity, and that's really where a lot of these at-risk patients are housed. But as we began planning for our inpatient focus, a lot of our advisors, the orthopedic surgeons, colorectal surgeons in particular, and cosmetic surgeons, interestingly enough, have told us that we really should think about the outpatient, as well, because a lot of times the physicians will get experience in the outpatient setting. The reimbursement is different. So in the hospital, as you know, it's DRG. In the hospital outpatient ambulatory surgery center it's what we call average selling price plus 6%, and that's what you hear this term pass through for the first 2 to 3 years. And that's helpful, because it gives physicians an opportunity to try to a drug in the outpatient setting without as many concerns around how it's going to impact their budget. And then, of course, cosmetic surgery is potentially cash. And so as we begin to look more and more at some of the really interesting data coming out of ATHENA and we studied, for instance, breast augmentation, and that's a very painful surgery, so some of our ATHENA investigators have told us that we really need to think about patient throughput in the outpatient setting, because there if a patient vomits or has any sort of respiratory issue or is sedated, for instance, that slows that patient discharge. And so that's very meaningful for the hospital in outpatient setting. So those just gives you some of the ideas that we're pulling together. And I plan to talk more about my outpatient strategy in the next few months. We have procedures outlined in the outpatient setting as well as our targeted customers, as well.

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Unidentified Analyst, [22]

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Got it. And any comment on differential pricing here?

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Carrie L. Bourdow, Trevena, Inc. - Chief Commercial Officer and SVP [23]

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No, not yet. But, yes, that was my comment around good catch. Good catch there, Alex. But, yes, we are exploring all opportunities.

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Unidentified Analyst, [24]

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Got it. Thank you guys.

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Operator [25]

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Our next question comes from Biren Amin, from Jefferies Group.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [26]

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Maybe, Max, I'll just start with, I guess, the panel that you were on, and given the focus on opioid addiction in D.C., do you think FDA would be receptive towards approval of a new opioid?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [27]

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Hi, Biren. Well, I think a new opioid that was an improved opioid absolutely they would be receptive to it. And of course that's what we believe that we have here. I think that specifically, in particular, though, an IV hospital-based product. All of the focus of attention right now on opioids, both prescription and non, is in the community, of course, with oral opioids, and not in the hospital, where it's, I think, very well understood that IV opioids are required to manage and treat patients effectively. So this is really not the focus at all of the concern around the opioid epidemic. And I think the reason that we're getting invited to these discussions such as the one you're referring to at the HHS is because we're seen as a novel option, a better, potentially, better option that is -- and in fact the focus of that discussion with HHS was all around new approaches to treating pain as well as addiction. And so that's why we were included.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [28]

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Got it. And then just on your partnership comments, are you looking for a particular type of deal structure in the U.S. versus ex-U. S.?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [29]

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Well, I think what I would say there is we do not plan in any way to have any infrastructure ex-U. S. at all. In terms of in the U.S. I think we are open to all structures. I mean, our goal here is to optimize shareholder value, and, depending on the conditions, as conditions change we obviously are going to retain our flexibility as to how we believe that might be best effected. So that's probably the most I can say at this point.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [30]

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And I guess the plan is that you hope to have a partner in place before the PDUFA?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [31]

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You mean before the approval?

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [32]

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Yes.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [33]

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Yes. I would hope so, yes, and potentially a number of partners in different territories.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [34]

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Great. Thank you.

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Operator [35]

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Our next question comes from Ed Arce, from H.C. Wainwright & Co.

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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [36]

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I have a few. First, for Maxine, perhaps a little bit different take than the previous question. Given your multiple ongoing discussions with potential partners both in the U.S. and ex-U. S., how do you think about the relative attractiveness of the various potential scenarios, specifically across geographies and potential financial structure? That's one. The second one, for Carrie, in the list of the four questions that you outlined from clinicians, nurses and others, if you could, it'd be helpful if you could expand a bit on the third question around physician demand and advocacy and give us a little more color around what you're hearing. And then, finally, for Roberto, if you could let us know when to expect the 10-Q filing. Thank you so much.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [37]

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Good morning, Ed. So I will just take the first question, then. I think there's probably not much more that I can add at this point in terms of specificity with respect to your question. I would say, though, that we are very much aware that the market potential for at least conventional opioids is much lower in ex-U. S. countries than it is in the U.S. Pain is not treated as aggressively in countries outside the U.S. in general, and so those drugs don't have such a large market. How that will develop with what we would believe to be a better, safer opioid for the hospital obviously is yet to be seen. So I guess that's my main comment about how ex-U. S. would compare with U.S. types of partnerships. Carrie, did you want to --

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Carrie L. Bourdow, Trevena, Inc. - Chief Commercial Officer and SVP [38]

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Sure. Good morning, Ed. So, on the physician advocacy piece, there's a couple things to it. One is what sort of feedback do physicians give to formulary committees. Are they willing to go and advocate for your drug? And we've spent a fair amount of time in market research and also talking with our advisors on their willingness to advocate for OLINVO, in particular for those at-risk patients. And then after they go and advocate, how receptive are formulary committees? And I think it depends on the hospital. In large academic medical centers physicians still certainly have a voice at the table, but it's a larger committee and the process may take longer. In community or community teaching hospitals, orthopedic surgeons, for instance, still have a lot of power. And when they go and ask for a drug to be added to formulary, because they're orthopedic surgeons and they tend to actually be the ones that are making money for hospitals, the P&T usually moves forward with that. I would also say that the fact that we are positioning this for these at-risk patients is really important, because physicians feel like, the physicians we've talked to, that they're very comfortable in asking for the drug to be added to formulary and advocating it for at-risk patients. And so that also fits in with how we're building and thinking about advocacy. Our medical affairs team, I haven't talked a lot about that group, but they are out and meeting physicians at medical meetings and creating advisory boards where they're talking to physicians about their willingness and interest in advocating for OLINVO. So that's a really important part of our prelaunch activities.

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Roberto E. Cuca, Trevena, Inc. - CFO, SVP and Treasurer [39]

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And on the timing of the 10-Q filing, we expect that to be in before 9:00 this morning.

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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [40]

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Okay, great. That's really helpful. Actually, one further follow-up, if I may. If I think through, again, your multiple partnering discussions, and as you look to find avenues for further funding, I was wondering if your discussions with partners could also potentially include TRV250 with separate (inaudible) that potentially had seen sort of proof of discussions that you're having now. Thanks.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [41]

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Well, our discussions are focused on OLINVO, but of course there are parties who are more broadly interested, as well.

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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [42]

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Okay, thank you, Max. Appreciate it.

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Operator [43]

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And our last question in the queue comes from Michael Higgins, from ROTH Capital.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [44]

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Carrie, you've given us an excellent summary of the outlook, what your strategies are. If I could go a bit further, you may not be able to go this far, but one of the characteristics of a launch sometimes can be the impact of hospital (inaudible) P&Ts as well as docs that are faster to adopt versus others. So in your roughly 8-million-patient focus, how do you include the potential for faster adoption rates amongst maybe guys that have picked up Exparel or Ofirmev, how do you adjust your targeting based on those characteristics?

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Carrie L. Bourdow, Trevena, Inc. - Chief Commercial Officer and SVP [45]

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Yes, thank you, Michael. It's a great question. So we do a couple things. So we start with the account mapping. And I referenced in my talk earlier that we now know the hospitals that have -- could potentially be early adopters. And so part of that is understanding where IV opioid volume is the highest. We've now matched our appropriate DRGs based on our priority procedures to those top accounts. And, as you commented on, we now know which hospitals have adopted Exparel and Ofirmev and did that early on. And that's part of the account mapping that we do. So that, then, gets the right targets. And then, as to your comment, we're using the priority procedures and the DRG margin analysis, to help pinpoint for our representatives where they would go in first, the kinds of messages they would say, and to which physician groups. So those priority procedures, we talk about them in bulk, but we actually have them categorized by orthopedic, colorectal, cosmetic and some of the other areas of focus. And then, as I mentioned, we link that back to the DRG and the margin analysis. And I'll also say that our medical affairs team is using that same sort of account mapping to target their top KOLs.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [46]

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Very helpful. Thank you. When you take a look at the different hospital P&Ts, it would be helpful to us to have a better understanding of your expectations, if you can give us some kind of color around what duration would you expect to get half of those targeted hospitals P&Ts to get OLINVO on formulary. Is that something you're looking for in the first year, maybe into the second year?

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Carrie L. Bourdow, Trevena, Inc. - Chief Commercial Officer and SVP [47]

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Yes, I'm smiling, because people are smiling at me around the table. Yes, that's probably a little further than we're willing to go this morning, Michael, but I appreciate the question.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [48]

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Got to ask.

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Carrie L. Bourdow, Trevena, Inc. - Chief Commercial Officer and SVP [49]

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That's right. That's right.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [50]

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I will say, though, that it is actually quite helpful for us to be following other branded launches in this very specific marketplace. We can glean quite a good bit of information to help our own planning and activities.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [51]

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From that, just a follow-up, then. What have you seen from the others? Were they able to get half of the formularies to get their drug on in the first year, or does it take into the second year?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [52]

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Well, I think that we've learned what Carrie has just outlined, and we'll take full -- make full use of that.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [53]

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All right. I'm going to switch to 250 if I could. I understand you're pleased with the many absorption characteristics of the subQ and the oral. I'm just wanting to get a better sense of the oral's capabilities. Did that delta between those two formulations, did that remain consistent from the lowest dose to the highest dose, or did it at least maintain the same trajectory from lowest to highest dose?

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [54]

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Yes, good question. So, as I said, this was a preliminary evaluation of oral availability. So we actually were able to test only a single dose, which was consistent with one of the other -- with one of the subQ doses. But we don't have a full dose range of oral dosing at this point, so I can't answer your question.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [55]

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I see. So a single ascending but on the subQ, but on the oral it was one dose.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [56]

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Exactly.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [57]

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Got you. Okay. And then last question would be could you help us with any kind of a cash burn guidance here? You noted you've got 12 months from today of cash. How much of that would include spending for marketing?

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Roberto E. Cuca, Trevena, Inc. - CFO, SVP and Treasurer [58]

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So, we haven't released specific guidance on what the breakdown is between that, but the cash flow lasts us at least 12 months from today, and we do expect to be increasing our investment into all the commercialization efforts as we get nearer to the PDUFA date for OLINVO.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [59]

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Appreciate it. Thanks, guys.

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Operator [60]

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I show no further questions in the queue at this time. I would like to turn the call back over to Maxine Gowen, CEO, for any closing remarks.

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Maxine Gowen, Trevena, Inc. - CEO, President and Executive Director [61]

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So, I'd just like to thank you all for all your questions, very good questions, as always. Hopefully you've heard why we continue to believe that OLINVO will be an important and valuable product for not only patients but also shareholders. We're hard at work to make that belief a reality. And I hope you'll continue to follow us as we move OLINVO and our earlier programs forward. And, of course, as always, we look forward to sharing updates with you in the future. So thank you all for your interest and for your time today.

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Jonathan Violin, Trevena, Inc. - VP of Corporate Strategy & IR [62]

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Thanks, Max. I'd just like to remind listeners that a reply of this call will be available on our website at www.trevena.com. So, on behalf of the management team I'd like to thank you all again for joining us today, and we'll be able for any further inquiries following the conclusion of the call. And with that, operator, please end the call.

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Operator [63]

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Understood. Ladies and gentlemen, this does conclude your (inaudible) for today, and you may all disconnect. Everyone have a great day.