AcelRx Pharmaceuticals' (ACRX) CEO Howie Rosen on Q2 2016 Results - Earnings Call Transcript

| About: AcelRx Pharmaceuticals, (ACRX)

AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX)

Q2 2016 Earnings Conference Call

July 28, 2016, 04:30 PM ET

Executives

Tim Morris - Chief Financial Officer, Head of Business Development

Jane Wright-Mitchell - Chief Legal Officer

Howie Rosen - Chief Executive Officer

Pam Palmer - Chief Medical Officer and Co-Founder

Gina Ford - Vice President, Commercial Strategy

Analysts

David Amsellem - Piper Jaffray

Boris Peaker - Cowen

Ed Arce - H.C. Wainwright & Company

Michael Higgins - ROTH Capital Partners

Hugo Ong - Jefferies

Operator

Good afternoon and welcome to the AcelRx Second Quarter 2016 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded.

I’d now like to turn the conference call over to Mr. Tim Morris. Please go ahead.

Tim Morris

Thank you, operator. Good afternoon, everyone, and welcome to today’s call. On this call, I’m joined by Howie Rosen, our Chief Executive Officer; Pamela Palmer, Co-Founder and Chief Medical Officer; Gina Ford, our Vice President, Commercial Strategy; and Jane Wright-Mitchell, our Chief Legal Officer.

During the call today, we will make forward-looking statements, and Jane will now remind you of our Safe Harbor language.

Jane Wright-Mitchell

Thank you, Tim. During the call today, we will make forward-looking statements, including but not limited to statements relating to financial results and trends, the process and timing of anticipated future development of AcelRx’s product candidates ARX-04, sufentanil sublingual tablet, 30 micrograms, and Zalviso, sufentanil sublingual tablet system, including the ARX-04 clinical trial results, ability to fund the ARX-04 development from the contract with the Department of Defense, anticipated submission of the new drug application or NDA for ARX-04 to the U.S. Food and Drug Administration, or FDA; AcelRx’s pathway forward towards gaining approval of Zalviso in the U.S.; the anticipated timing, design and results of the IAP312 clinical trial for Zalviso; anticipated resubmission of the Zalviso NDA to the FDA including the scope of the resubmission and the timing of the resubmission, and FDA review time; the status of the Collaboration and License Agreement with Grunenthal, a company organized under the laws of Germany, or Grunenthal, or any other future potential collaborations, including potential milestones and royalty payments under the Grunenthal agreement; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for ARX-04 and Zalviso.

These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' ability to complete Phase 3 clinical development of ARX-04 and support ARX-04 development under the contract with the Department of Defense; AcelRx's ability to successfully execute the pathway towards a resubmission of the Zalviso NDA to the FDA, including the initiation and completion of the IAP312 clinical study for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates, including ARX-04 in the United States and Europe, and Zalviso in the United States; AcelRx's ability to receive any milestones or royalty payments under Grunenthal agreement and the timing thereof; ability to manufacture and supply sufficient quantities of Zalviso to Grunenthal on a timely basis; the commercial success of Grunenthal's launch of Zalviso in the European Union, or EU; the uncertain clinical development process, including adverse events; the risk that planned clinical trials may not begin on time, have an effective clinical design, enroll a sufficient number of patients, or be initiated or completed on schedule, if at all; the success, cost and timing of all development activities and clinical trials, including the Phase 3 ARX-04 SAP302 and SAP303 trials, and the additional clinical trial for Zalviso, IAP312; the fact that the FDA may dispute or interpret differently clinical results obtained to date from the Phase 3 SAP301 study of ARX-04; the market potential for AcelRx's product candidates; the accuracy of AcelRx's estimates regarding expenses, capital requirements and the need for financing, and other risks detailed in the Risk Factors and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-Q filed with the SEC on May 2, 2016. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or changes in its expectations.

I’ll now turn the call over to Howie, our Chief Executive Officer.

Howie Rosen

Thank you, Jane. On today’s call, we will provide business highlight and accomplishments since our last call, including an update on ARX-04 and Zalviso in a review of the second quarter financial results.

Let me start with our recent accomplishments. This has been a productive quarter for the ARX-04 team. As you recall, we initiated two phase 3 studies last quarter, an extension to SAP302 in emergency room patients and a new study SAP303 in post-operative patients. Both of these trials have had their last patient visit and data are currently being analyzed.

We’re planning to present top line results from the emergency room study at the upcoming Military Health System Research Symposium or MHSRS on August 15 during the plenary session of the conference. Results from the other study in post-operative patients are expected to be announced before the end of the third quarter. We’ve also begun preparation of the regulatory filings and expect to submit the NDA for ARX-04 by the end of the year.

Regarding Zalviso in the U.S., if you recall from last quarter conference call that we decided to switch to the commercial manufacture of the Zalviso systems and also incorporate software and hardware improvements based on our experience in Europe. We're finishing testing the updated Zalviso systems to be used in the Phase 3 IAP312.

We're coordinating with the manufacturing vendors for final study supplies and have moved forward through pairing the clinical sites with the goal of being ready to initiate IAP312 by the end of September. Once final supply have been received and successfully tested, we anticipate being ready to begin study. Once we start and see how enrollment is progressing, we will be able to provide an estimate of the timing to study completion and NDA resubmission.

In Europe, Grunenthal continues to make progress and has introduced Zalviso in Germany, France, the UK, Italy and Belgium. Zalviso has been used by several 100 patients in dozens of hospitals. Patients, nurses and doctors have provided positive qualitative feedback on their initial experience. Grunenthal plans to launch Zalviso in the Netherlands, Ireland and Portugal by the end of the year.

Finally, in June, AcelRx was added to the broad market Russell 3000 and Russell 2000 indexes. Membership in the Russell 3000 index, as many of you know, will lead to automatic inclusion of AcelRx stock in certain growth and style indexes.

Let me turn the call over Pam now for an update on ARX-04.

Pam Palmer

Thanks, Howie. Last quarter we announced positive results for ARX-04 from the first phase of emergency room study SAP302 in which 40 adults who presented to the ER with moderate-to-severe acute pain from trauma or injury received a single dose of ARX-04. The extension phase of SAP302, which enrolled an additional 36 patients, who received up to 4 doses of ARX-04 not more than hourly as needed has now concluded.

ARX-04 efficacy will be assessed as in the first cohort based on the primary endpoint of time-weighted summed pain intensity difference to baseline over the first hour or SPID1. We are currently analyzing these results and plan to present this data at the upcoming Military Health System Research Symposium or MHSRS on August 15 during the plenary session of the conference.

For those of you who are unfamiliar with the MHSRS meeting, it is the Department of Defense's premier scientific meeting and is the only military or civilian meeting that focuses specifically on the unique medical needs of our armed services. We thought this was an appropriate venue since the Department of Defense funded the development of ARX-04. ARX-04 as a sublingual formulation avoids the time, effort, discomfort, and infection risk of initiating an intravenous line.

Moving on to SAP303, which we initiated last quarter, this multi-center open-label Phase 3 study completed enrollment of 140 patients, who are 40 years or older on schedule. In this study, patients who are reported moderate-to-severe acute pain following a surgical procedure were admitted received up to 12 doses of ARX-04 hourly as needed. The primary efficacy endpoint is the summed pain intensity difference over the 12-hour study period or SPID12. We are analyzing these results and expect to present them by the end of the third quarter.

We have a full fleet of abstracts and presentations at medical meetings in the U.S. and Europe during the second half of the year that will feature ARX-04 results. These include the World Congress of Mountain & Wilderness Medicine, August 2; The Military Health System Research Symposium, which I just mentioned on August 16; the International Society for Burn Injuries; the European Society of Regional Anaesthesia; the Emergency Nursing Association and plastic surgery meetings all in September; the EMS World Expo; European Society for Emergency Medicine; the American College of Emergency Physicians; the International Commission for Alpine Rescue and the National Conference of Corrections in October.

With our clinical development of ARX-04 concluding, many of us are taking a moment to reflect on the journey that got us here. ARX-04 was an idea born a decade ago and funded by the Department of Defense for specific military need. Clinical and market research have expanded our understanding of the potential of ARX-04 to also include the treatment of acute moderate-to-severe pain in emergency medicine and for inpatient and outpatient surgeries.

We're approaching an important regulatory milestones the filing of an NDA for ARX-04 by the end of 2016. And I would like to take a moment to thank our employees whose dedication and hard work have brought us to this point. Our hard work is not done of course as we are beginning to make a number of commercial plans for ARX-04. To discuss these in more detail, I’d like to turn the call over to Gina Ford, our Vice President, Commercial Strategy. Gina?

Gina Ford

Thanks, Pam. As Pam mentioned in anticipation of submitting the NDA for ARX-04 for the treatment of moderate-to-severe acute pain, we are ramping up our commercial preparation. Over the next several months we will initiate and complete several activities aimed at helping us understand the market opportunity for ARX-04. These activities include: validating the U.S. ARX-04 market forecast, initiating market access activity, understanding the landscape and buying process in the emergency department, surveying ER nurses and ER doctors, selecting our agency of record, and selecting a trade name and finalizing packaging and designs, just to name a few.

Regarding the ARX-04 market forecast, I'd like to take a moment to review our process and expectations with you. We've analyzed the National Emergency Department’s sample, the National Survey of Ambulatory Surgery and the National Inpatient Sample and have determined the approximate number of adult emergency room visits, the number of adult patients having undergone short stay inpatient and outpatient surgical procedures, the number of non-surgical in-hospital acute pain patients and the number of patients undergoing painful procedures. An estimated 66 million of these individuals have moderate-to-severe acute pain annually, 48 million of whom appear in the emergency room. At peak sales, assuming a 2016 price of $20 per unit, taking into account standard price increases, we would expect this market to be approximately $1.3 billion.

We’ve recently presented a study on the cost of administering IV opioid in the emergency department. Based on an analysis of over 7 million patients, who received IV opioids and 614 U.S. emergency departments, it was found that doses ranged from $143 for morphine to $145 for fentanyl. We wouldn’t set the price until closer to launch; we have plenty of room to step aside.

Europe is also a significant market and one that we believe as a respective to innovative treatment options for acute pain. We have recently completed extensive market research in Europe and have determined that there are an estimated 51 million patients in emergency medicine with moderate-to-severe acute pain and 16 million with moderate-to-severe acute pain falling inpatient and outpatient surgery each year.

We believe ARX-04 could achieve a €15 price per unit. This is based on our analysis of the published price benchmarks of Penthrox methoxyflurane, which is indicated for trauma pain and [indiscernible] fentanyl products, which are indicated for breakthrough cancer pain. We are also conducting a micro-costing literature review to determine the total cost administering IV opioids per patient in EU emergency department. Based on the information, we believe the peak sales in the emergency medicine and post operative market segments across Europe to be approximately €700 million.

Unlike the United States, although analgesia for the under treatment of pain is a well-known phenomenon across European emergency rooms. We believe the number of potential patients that can be treated for moderate-to-severe acute pain will actually grow with the introduction of new products in the ER. The support our European strategy, we're actively seeking commercial partners and alternatives to commercialize ARX-04 in Europe and are moving forward on our own planning and preparation for filing MAA in the EU.

On a personal note, I want to add how exciting it is to be leading AcelRx’s commercial efforts at this stage in the company's evolution. I believe that ARX-04 has the potential to make an important impact on the treatment of moderate-to-severe acute pain for emergency medicine in the military and civilian settings. With the NDA planned by the end of the year, we will continue to make commercial preparations and share our progress in more detail later this year.

Pam, I will return the call to you.

Pam Palmer

Thanks, Gina. Lastly, regarding Zalviso in the U.S., I wanted to comment on our protocol for IAP312. We will aim to enroll approximately 315 adult postoperative patients and patients who will self administer 15 micrograms of sublingual sufentanil as needed for 24 hours to 72 hours to manage their moderate-to-severe acute pain. The study will measure device usability including the failure to dispense medication as well as the incidence of misplaced or drop tablets. Efficacy pain measurements and safety data will also be collected.

As Grunenthal’s launch is progressing, we are receiving some valuable feedback. Grunenthal’s customers are reporting that they appreciate the noninvasive nature of Zalviso and they're experiencing good efficacy for pain control with sublingual sufentanil. The launch of course is in its early days, so while these anecdotal reports are encouraging, we will wait a few more quarters before making a formal assessment. We will continue to support Grunenthal as they continue their European launch and we will continue to learn from their experience, so that we can apply their insight to eventual Zalviso launch in the U.S.

Tim, I will return the call back to you to discuss financial results.

Tim Morris

Thank you, Pam. Earlier today we reported financial results for the second quarter ended June 30, 2016. You are encouraged to review that press release for specific details. In summary, the net loss for the second quarter of 2016 was $11.1 million or $0.24 net loss per share, as compared to $8.9 million or $0.20 net loss per share for the second quarter last year.

During the second quarter of 2016, we recognized revenue of $1.3 million under the collaboration agreement with Grunenthal and $3.2 million related to work performed under the DoD contract for ARX-04. This compares to $500,000 in revenue recognized under the collaboration agreement with Grunenthal and $1.4 million in revenue recognized related to the DoD contract for the second quarter last year. We expect to begin to recognize royalty revenue Grunenthal sales in Europe next quarter.

For the six months ended June 30, 2016, we reported net loss of $22.1 million or $0.49 net loss per share. This compares to $18.9 million or $0.43 basic net loss per share and $0.47 diluted net loss per share for the first six months of 2015.

During the six months ended June 30, 2016, we recognized revenue of $3.1 million under the collaboration agreement with Grunenthal and $4.4 million related to work performed under the DoD contract. This compares to $700,000 in revenue recognized for Grunenthal and $1.4 million in revenue under the DoD agreement for the first six months of 2015.

At June 30, 2016, we had cash, cash equivalents and investments of $98.8 million. This compares to $113.5 million at the end of December 2015. The decrease was primarily attributed to the cash used in operating activities. The net change in cash of $15 million was expected. We do anticipate quarterly burn in the second half will increase at beginning in October this year we are scheduled to begin to repay amounts under the Hercules loan at a rate of $1.6 million per month.

On the investor relations front, we presented earlier this month at the Cantor Fitzgerald. The pledge and plan to present in September at the BioCentury NewsMakers Conference and the Annual Rodman & Renshaw Global Investment Conference sponsored by H. C. Wainwright.

I will now turn the call back to Howie for a few closing comments.

Howie Rosen

It's hard to believe that the year is over half over, but when I think back we've made great progress with ARX-04 during the first two quarters for the year. We basically completed two phase 3 studies and began work on the NDA filing as well. So I'd like to thank the entire team for all the work they've been doing.

As I mentioned earlier, we're on track to submit the NDA for ARX-04 to the FDA this year and we're working towards submitting the MAA in Europe in the first half of 2017. Over the next few months, we will be presenting results from SAP302 and SAP303 and preparing our regulatory filing for ARX-04. We'll keep you updated as we meet these milestones and thank you for your continued interest in AcelRx.

Now, we would like to open it up to questions.

Question-and-Answer Session

Operator

We will now begin the question-and-answer session. [Operator Instructions] And our first question comes from Randall Stanicky of RBC Capital Markets. Please go ahead.

Unidentified Analyst

Thanks. Great, thanks. [indiscernible] here on for Randall. I just had a few. So, first with Zalviso, it looks like we can now get back to late September start, how is the new trial data for Zalviso affect the cash burn expectation? And also if you could just touch upon the feedback from Grunenthal around Zalviso progress now that the pilot launch has began to rollout in two regions? And is the launch progressing as expected?

Tim Morris

Sure. Hi, this is Tim. I will take the first. The cash burn – we’ve assumed that in cash burn in the guidance we have previously given. Essentially that spending for the 312 study will replace some of the spending that was ongoing for that 302 and 303, so really shouldn't have much if any dramatic impact on a quarter-to-quarter basis. In terms of feedback from Zalviso in Europe, Pam would like to comment on that.

Pam Palmer

Sure. In fact the launch is going exactly as they laid it out and Grunenthal is very detailed with us in what they are planning to do and they've accomplished country by country and hospital by hospital exactly what the plan. So, they're marching forward and expanding as predicted and as laid out.

Unidentified Analyst

Great, thanks.

Operator

Our next question comes from David Amsellem of Piper Jaffray. Please go ahead.

David Amsellem

So, just wanted to drill down a bit on how you think about the opportunity for 04. So a couple of couple questions on that front. First, do you think that you could be running in a paradigm where the opportunity is diminish just because of all of the public health concern surrounding the use of opioid when the CDC guidelines started to come out earlier this year? So I'm wondering how you think that – the public health agencies around opioid divergent and abuse might affect the opportunity for 04? And then secondly, it's no secret that you've got kind of cheap royalty adoptions in the hospital that are available, generically available. So I guess the question is how do you get P&T Committees onboard with, presumably it will be a premium price product? Thanks.

Howie Rosen

Sure, David. Pam will address your first question and Gina can follow-up.

Pam Palmer

Yeah, the vast majority that concern on opioids, which is – which is a concern is around the outpatient prescribing. As it relates to the emergency room setting, the concern is around the dispensing and prescribing of opioids for the patients to go home and use at home. Currently, the most recent guidelines in fact that just came out from three different organizations in February around treating acute pain in the hospital and postoperative setting still strongly recommend the use of opioids. Of course, they do caution that a multidisciplinary approach should be used, but that's been – since it’s the guidelines over the past 10 years and we completely agree with those guidelines as well. So in the medically supervised settings certainly in acute moderate severe situations, no one is dialing back the use of opioids or recommending dialing back into opioids, it’s the prescribing in the outpatient settings and also for chronic use in the outpatient settings that is problematic.

Gina Ford

Hi, David. This is Gina. I just want to address your question regarding P&T Committees. We do have a very robust health economic story to tell. Pam has already presented that data in poster format at [indiscernible] recently. So I believe really based on our pharmacoeconomics, the pharmacodynamics, pharmacokinetic profile of sublingual sufentanilfor use in acute pain, an emergency room will be very appealing for [indiscernible] to review.

David Amsellem

Thank you.

Operator

Our next question comes from Boris Peaker of Cowen. Please go ahead.

Boris Peaker

Great. Thank you for taking my question. My question first on ARX-04, I’m just surprised why you would use the Department of Defense meeting to present the data where the ultimate goal is to really promote it to emergency room physicians? Aren't there ER related conferences where you think that that would make sense to profile this drug?

Pam Palmer

We will be extensively – I think I listed many of them in that – a list of meetings that I mentioned, but we're going to many, many emergency room meetings. The data is quite robust. We'll be looking at safety, we will be looking efficacy, there are so many different ways to present that day and look at data into subgroup analysis of that data that we will be presenting ARX-04 at many of these different meetings. Just the timing of the MHSRS came about right when we were getting top line [indiscernible] because of all their 25 million reasons for us to present. That’s how much money they gave us to present data at their conference, we really felt honored and they selected us. I think it was 17 abstracts were selected for plenary sessions out of 1,400 and we were chose for one of those. We are very honored in fact to present that meeting.

Boris Peaker

Got you. Okay. Now in terms of from the regulatory perspective staying with ARX-04, in the emergency room study, are there any unique safety endpoints or things that the FDA requested to look at maybe in terms of pill handling, miss you, loss, abuse or anything like that that would maybe we wouldn't think of as investors?

Pam Palmer

You know what actually with – because of the C2 drug, every single study that we run that is exactly what we have to do. We have to reconcile down to the pill on every single one of our studies. So that's something we've done along. We are currently – we have continued to do it for these studies. We've never seen a problem with that. I will say that one of the requests for special measurements in the emergency room study was in fact by the Department of Defense. They requested cumulative impairment analysis. And as you know from our release of the first 40 patients at first cohort, we in fact found no impact on cognitive functioning with sublingual sufentanil, which is very different than what it's been published in the literature regarding ketamine.

Boris Peaker

Got you. Okay. My last question on 04 is what commercial investment are you making right now? When do you plan to actually start hiring, maybe the head of the sales force specifically sales force leaders for various geographies and making further investments commercially into the drug?

Howie Rosen

Yeah, this is Howie. I will answer it, Boris. As Gina mentioned during the call, we are really focused on the commercial strategy, understanding the markets, market research, we’ve had some AdWords [ph] and have more coming up where we can sit face to face with people in the various hospitals in the various specialties. And so our plan in terms of building out infrastructure would be next year. So we feel like we still have plenty of time with a commission in the fourth quarter timing, 10 months, PDUFA review that – next year is the right time to be putting the plans in place and the things in place to be building up the sales force and the other infrastructure we need.

Boris Peaker

Got you. Okay. Thank you very much for taking my questions.

Operator

Our next question comes from Ed Arce of H.C. Wainwright & Company. Please go ahead.

Ed Arce

Hi, guys. Thanks for taking my questions. I guess the first one is for Gina. I was wondering as you described about ramping up your commercial prep for ARX-04 and some of the survey work and other things that you're looking at. If you could give us a little more detail around the activities related to validating your market forecast specifically with the market opportunities that you quoted for the U.S. and EU markets?

Gina Ford

Good question, Ed. We are in process of evaluating potential partners to do a validated forecast for us. We will go out, resurvey emergency room physicians, we will survey anesthesiologist, we will survey surgeons, so we get a good feel for exactly what's going on in the market. We use the newest epidemiology information that we can find and we hope to have that all together out later this fall.

Ed Arce

Could we expect any further details around that later this year perhaps?

Tim Morris

Yeah, Ed, hi, this is Tim. We do hope to hold up another analyst day later in the fall, we were happy to kind of share with you the results that we've learned in terms revaluation of the forecast in terms of some of the information that you know is able to obtain through some of these surveys and the like. So, yeah, we'd be happy to kind of share more details with you guys ones they are available.

Ed Arce

Okay, great. And then switching gears to Zalviso, as you noted, you are working through a number of software and hardware improvements, I was just wondering how you go about making those corrections and improvements on the one hand while making sure that you don't at the same time create a new potential issues with the device?

Howie Rosen

Issues in terms of modification that would require additional testing?

Ed Arce

Right. I mean as you work on correcting or improving the process of dispensing the drug with the device catching any potential new problems that could come up with changes to the existing device?

Howie Rosen

Yes, it does exactly. Two things, one, to keep in mind is that the drug part hasn't changed at all and in terms of the device, the changes are not significant. Some of the changes which is the software which are relatively easy to do and then there's a part here and there where we'd make changes just to improve the reliability and usability. And basically as we have – previously we have a pretty extensive process for doing bench testing and other evaluations of the system as we go along. And that's what we’ve been doing and the reason it was taking some time before we actually started up the study.

Ed Arce

Okay. And then one last one if I may just in terms of funding. Could you expects or expect to receive any potential additional funding from the DoD between now and submission on ARX-04? And are there any potential near-term milestones from your partner in Europe something critical?

Howie Rosen

Yeah, just on that DoD contractor essentially is a fixed amount. So we do anticipate we should be able to kind of continue to bill and collect all of our activities under that including the – but if you don't, we will have to pay. So that’s – we don't expect additional funding above and beyond contractual amount, but we do expect it to be able to collect the entire amount of the contract of this particular portion. And then in terms of Grunenthal, well, there are some milestones in out there; we don't this year at least obtaining any of those additional development and/or sales milestones.

Ed Arce

Okay, great, thanks.

Operator

Our next question comes from Michael Higgins of ROTH Capital Partners. Please go ahead.

Michael Higgins

Thanks. Hi, guys. Thanks for taking my questions. A question here on SAP302, it looks like you’ve got data in hand from that short study from – just over a month ago and you've got a presentation coming up in about two weeks out. Hoping to get some insight from you as to how that data looks? And specifically any information you can share by age based on those over and under 40?

Pam Palmer

Yeah, we're still under review. Our statisticians working to get us the top line data on that. So we had 40 patients in the first corporate, which was single dose cohort, we had 36 in the multiple dose cohort and we are – they are still – these three sites that we are looking at, folks who come into the emergency rooms with injury, et cetera. So there is not a huge differences in general between the last 36 and the first 40, but we will have all that data shown up just in time and fact for the August 15 presentation, so we are kind of cutting it down to the wire.

Michael Higgins

Understood. Okay, thanks, Pam. A quick question on IAP312 if I could. Any initial instructions to the nurses and the patients before starting Zalviso materially different or is it mostly changes in the device that you are backing up?

Pam Palmer

No, we are affecting the device obviously to function very well. The engineers have been doing a great job just fine tuning that. The one key thing for 312 remember is that we are actively having as an endpoint looking for the drop catalyst. We never had that as an endpoint in the previous stage 3, it was just when we were noted it was documented. That’s why I think this slight difference there is as we are actively having nurses look for that. AFD [ph] just wants to make sure that it’s not just an accidental finding that it was an overt endpoint that was measured and they just want to feel comfortable. And so, that’s really the only difference with the 312 study versus our other studies.

Michael Higgins

Do you think if you repeated the same error rate of drop tablets, the FDA would be okay with the engaged acceptance?

Pam Palmer

Yeah. I mean the error rate – error rate is not – a drop tablets was – those are two things. An error rate specifically relates to the device actually not dispensing versus a drop tablet is actually a user interface issue where the patients just not using it correctly. To me it wasn’t the – our number was extremely low if you remember from how many thousands of actual tablets were dispensed that were observed. I think they just want to make sure that that wasn’t some sort of tip of an iceberg because again it was not a measured endpoint. We know our clinical sites, we are very happy to do that study for them again since we know in fact that it was not a problem.

Michael Higgins

Understood. That’s very helpful. Thanks guys.

Operator

Our next question comes from Hugo Ong of Jefferies. Please go ahead.

Hugo Ong

Hi guys. Thanks for taking my questions and congrats on all the progress. Just a question on ARX-04. On your pharmacoeconomics analysis I noticed that you didn’t include infection risk and other complications like you did with Zalviso. Any intentions to do that kind of analysis and does it suggest maybe that the cost of IV opioids might be higher?

Pam Palmer

Absolutely, great question. So what we did for Zalviso is – we actually exactly what we are doing for ARX-04 is for abstract that’s purely around the hard cause of setting up and using in the case of Zalviso and IV opioid TCA. We then layered on later for the actual pharmacoeconomic publication the soft case around avoiding infections and things like that. That’s exactly what we are planning on here and is for abstract that was around the hard cause advantages of ARX-04 and we are planning on a publication that will come out with both hard and soft cause.

Hugo Ong

Okay, great. When can we expect that publication?

Pam Palmer

Well, we are in the process looking on it. So, I can’t predict with journals. I mean they may accept it and then take three, four months to actually get it. We usually do all of our open access. So hopefully sooner than later, but we are still working on writing that up right now.

Hugo Ong

Got it. Understood. And I believe you mentioned that a similar analysis will be done for European emergency departments and will infection risk be evaluated there as well?

Pam Palmer

Yes, absolutely.

Hugo Ong

Okay, great. Thanks a lot guys.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Mr. Howie Rosen for any closing remarks.

Howie Rosen

Thank you. We look forward to keeping everyone updated on our progress and meeting you possibly on some of our upcoming road shows and these investor conferences. I want to thank you again for joining us for our second quarter call and I hope everyone has a good afternoon.

Operator

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.

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