Talphera Inc (TLPH) 2016 Q2 法說會逐字稿

Good afternoon, and welcome to the AcelRx second-quarter 2016 financial results conference call. All participants will be in listen-only mode. (Operator Instructions)

I would now like to turn the conference over to Mr. Tim Morris. Please go ahead.

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, our Co-Founder and Chief Medical Officer; Gina Ford, our Vice President of 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.

Thank you, Tim. During the call today we make forward-looking statements including, but not limited to, statements related to financial results and trends; the process and timing of anticipated future development of AcelRx's product candidates ARX-04, sufentanil sublingual tablets 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 United States Food and Drug Administration, or FDA, AcelRx's pathway forward towards gaining approval of Zalviso in the US; the anticipated timing, design and results of the IAP312 clinical trial for Zalviso; anticipated resubmission of the Zalviso NDA to the FDA, including 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 law of Germany, or Grunenthal or any other future potential collaborators 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 III clinical development of ARX-04 and support ARX-04's development under the contract with the Department of Defense, AcelRx's ability to successfully execute the pathway forward 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 inabilities 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 on the Grunenthal agreements, 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 develop process including adverse events, the risk of planned clinical trials may 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 III ARX-04, SAP302 and SAP303 three trials, and the additional clinical trials for Zalviso IAP312. The fact that the FDA may dispute or interpret differently clinical trial results obtained to date from the Phase III SAP301 study of ARX-04, the market potential for AcelRx's product candidates, the accuracy of AcelRx's estimates regarding expensive capital requirements and the need for financing and other risks detailed in the risk factors and elsewhere in AcelRx's United States Securities and Exchange Commission filing 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 will now turn the call back over to Howie, Chief Executive Officer.

Thank you, Jane. On today's call we will provide business highlights and accomplishments since our last call, including an update on ARX-04 and Zalviso and 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 will recall, we initiated two Phase III studies last quarter: an extension to SAP 302 in emergency room patients; and a new study, SAP303, in postoperative patients. Both of these trials have had their last patient visits, and data are currently being analyzed. We are 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 postoperative patients are expected to be announced before the end of the third quarter. We have also begun preparation of regulatory filings and expect to submit the NDA for ARX-04 by the end of the year.

Regarding Zalviso in the US, you will recall from last quarter's conference call that we decided to switch to the commercial manufacture of the Zalviso system and also incorporate software and hardware improvements based on our experience in Europe. We were finishing testing the updated Zalviso system to be used in the Phase III IAP312 study. We are coordinating with the manufacturing vendors for final study supplies and have moved forward with preparing the clinical site with the goal of being ready to initiate IAP312 by the end of September.

Once final supplies have been received and successfully tested, we anticipate being ready to begin the 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 hundred 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 conclusion of AcelRx stock in certain growth and style indexes.

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

Thanks, Howie. Last quarter, we announced positive results for ARX-04 for the first phase of emergency room study, SAP302, in which 40 adults who presented at ER with marked 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 four doses of ARX-04 not more than hourly if needed, have now concluded.

ARX-04 efficacy will be assessed as in the first cohort based on a primary endpoint of time-weighted 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 Systems 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 felt 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 III study completed enrollment of 140 patients who are 40 years older or older on schedule. In this study, patients who reported marked severe acute pain following a surgical procedure were administered up to 12 doses of ARX-04 hourly as needed. The primary efficacy endpoint is the sum to 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 slate of abstracts and presentations at medical meetings in the US and Europe during the second half of the year that will feature ARX-04 results. These include the World Congress on (sic - of ) Mountain and Wilderness Medicine, August 2; the Military Health System Research Symposium, which I just mentioned, on August 15; the International society for Burn Injuries, the European Society of Regional Anesthesia, the emergency nursing association and plastic surgery meetings, all in September; the EMS world expo. European society of emergency medicine, the American College of Emergency Physicians, the international commission, Alpine rescue and the national conference of corrections, all 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 severe pain in emergency medicine and for inpatient and outpatient surgery. We are approaching an important regulatory milestone: 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 of Commercial Strategy. Gina?

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 US ARX-04 market forecast, initiating market access activities, 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 a national emergency department 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 nonsurgical, 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 creases, we would expect this market to be approximately $1.3 billion.

We 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 in 614 US emergency departments, it was found that doses range from $143 for morphine to $145 for fentanyl. We wouldn't set the price until closer to launch; we have plenty of room to set the price.

Europe is also a significant market and one that we believe is receptive 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 following inpatient and outpatient surgery each year. We believe ARX-04 could achieve a EUR15 price per unit. This is based on our analysis of the published price benchmarks of Penthrox methoxyflurane, which is indicated for trauma pain, and [branded] fentanyl products, which are indicated for breakthrough cancer pain. We are also conducting a micro-costing literature review to retirement determine the total cost of administering IV opioids per patient in EU emergency department. Based on this information, we believe peak sales in the emergency medicine and postoperative market segments across Europe to be approximately EUR700 million.

Unlike the United States, oligoanalgesia for the undertreatment of pain is a well-known phenomenon across Europe in 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. To support a European strategy, we are actively seeking commercial partners and alternatives to commercialized 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'll return the call to you.

Thanks, Gina. Lastly, regarding Zalviso in the US, I wanted to comment on our protocol for IAP312. We aim to enroll approximately 315 adult postoperative patients, and patients will self administer 15 micrograms of sublingual sufentanil as needed for 24 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 dropped 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 are 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 will continue to learn from their experience so that we can apply their insight to an eventual Zalviso launch in the US.

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

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 of 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 from 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.

As of 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 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, as beginning in October of 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 conference and plan to present in September at the BioCentury newsmaker conference and the annual Rodman & Renshaw Global Investment Conference sponsored by HC Wainwright.

I'll now turn to call back to Howie for a few closing comments.

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 of the year. We basically completed two Phase III 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 are on track to submit the NDA for ARX-04 to the FDA this year, and we are 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 303 in preparing our regulatory filing for ARX-04. We'll keep you updated as we meet these milestones. And thank you for your continuing interest in AcelRx.

Now we'd like to open it up to calls -- or to questions; sorry.

(Operator Instructions) Randall Stanicky, RBC Capital Markets.

Great. Thanks. This is Ashley Ryu on for Randall. I just had a few. First, with Zalviso it looks like we can now expect a late September start. How does the new trial date for Zalviso affect your cash burn expectations? And also if you could just touch upon the feedback from Grunenthal around Zalviso progress now that the private launch has begun to roll out in key regions? And is the launch progressing as expected? Thank you.

Sure. Hi. This is Tim. I'll take the first one. 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 the 302 and the 303 study. So it 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 you like to comment on that?

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

Great. Thanks.

David Amsellem, Piper Jaffray.

I just wanted to drill down a bit on how you are thinking about the opportunity for [04], so a couple of questions on that front. First, do you think that you could be running into a paradigm where the opportunity is diminished just because of all of the public health concerns surrounding the use of opioids and the CDC guidelines that will come out earlier this year? So, I'm wondering how you think that the public health agencies around opioid diversion and abuses, they'd affect the opportunity for 04.

And then secondly, it's no secret that you've got cheaper opioid options in the hospital that are available -- generically available. So, I guess the question is how do you get P&T committees on board with what presumably will be a premium-priced product? Thanks.

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

The vast majority of the concern on opioids, which is a legitimate concern, is around the outpatient prescribing. As it relates to the emergency room study, the concern is around the dispensing and prescribing of opioids for the patients to go 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 in a postoperative setting still strongly recommend the use of opioids. Of course, they do caution that multidisciplinary approach should be used, but that's been consistent with guidelines over the past 10 years. And we completely agree with those guidelines as well.

So, in the medically supervised setting, certainly in acute moderate to severe situations, no one is dialing back the use of opioids or recommending dialing back the use of opioids. It's the prescribing in the outpatient setting and also for chronic use in the outpatient setting that is problematic.

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 [IF 4] recently. So I believe really based on our pharmacoeconomic story at the pharmacodynamics, pharmacokinetic profile of sublingual sufentanil for use in acute pain in emergency room will be very appealing for the pharmacist to review.

Thank you.

Boris Peaker, Cowen.

My question first on ARX-04 -- I'm just surprised why you would use a 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?

We will be extensively -- I think I listed many of them in that long 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'll be looking at efficacy. There are so many different ways to present that data and look at that data and do 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 SAP302 data. And because of all their 25 million reasons for us to present -- that's how much money to gave us to present data at their conference, and 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 chosen for one of those. So we are very honored, in fact, to present at that meeting.

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, misuse, loss, abuse or anything like that that would -- maybe we wouldn't think of as investors?

You know what? Actually, with -- because it's a C-2 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 all along. We are currently -- we'll continue 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 cognitive impairment analysis. And, as you know from our release of the first 40 patients -- that first cohort, we in fact saw no impact on cognitive functioning with sublingual sufentanil, which is very different than what has been published in the literature regarding ketamine.

Got you. Okay. My last question on 304 is what commercial investments are you making right now? When do you plan to actually start hiring maybe the head of the sales force or, specifically, sales force leaders for various geographies and making further investments commercially into the drug?

This is Howie now. I'll answer that for you. As Gina mentions during the call, we are really focused on the commercial strategy and understanding the market research. We've had some add boards and have more coming up where we can sit face-to-face with people in the various hospitals and the various specialties.

So, our plan in terms of building out the infrastructure would be next year. So, we feel like we still have plenty of time with the commission in the fourth quarter in a 10-month PDUFA review that next year is the right time to be putting the plans in place and the things in place to be building out the sales force and the other infrastructure we need.

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

Ed Arce, HC Wainwright & Co.

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 are 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 US and EU markets.

Good question, Ed. We are in the process of evaluating potential partners to do a validated forecast for us. We'll go out -- resurvey emergency room physicians, we'll survey anesthesiologists, we'll 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 pulled together later this fall.

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

Ed, hi. This is Tim. We do hope to hold another analyst day later in the fall, where we are happy to kind of share with you the results that we've learned in terms of revalidation of the forecast, in terms of some of the information that Gina is able to obtain through some of these surveys and the like. So, yes, we would be happy to kind of share more details with it with you guys once they are available.

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 new potential issues with the device.

It is used in terms of modifications that would require some additional testing?

Right. 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.

This is how it -- 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 to the software which are relatively easy to do, and then there's a part here or there where we've made changes to improve the reliability and the 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 we've taken some time before we actually start a study.

Okay. And then one last one, if I may -- just in terms of funding, could you 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, Grunenthal?

This is Tim. The DOD contract 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 PDUFA fee that we'll have to pay. So, that -- we don't expect additional funding above and beyond the contractual amount, but we do expect to be able to collect the entire amounts of the contract -- this particular portion.

And then in terms of Grunenthal, while there are some milestones and the like out there, we don't anticipate this year, at least, obtaining any of those additional development and/or sales milestones.

Okay. Great. Thanks.

Michael Higgins, ROTH Capital Partners.

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 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 under and over 40.

We're still under review. Our statistician is working to get us the top-line data on that. So, we had 40 patients in the first cohort, which was single-dose cohort. We had 36 in the multiple-dose cohort. And we're -- they're all still -- there's three sites we're looking at, folks who come in the emergency room with injury, et cetera. So that there is not a huge difference in general between the last 36 and the first 40, but we'll have all of that data sewn up just in time, in fact, for the August 15 presentation. So we're kind of cutting it down to the wire.

Understood. Okay. Thanks, ma'am. And a quick question on IAP312, if I could. Any additional instructions to the nurses and the patients before starting Zalviso, anything materially different? Or is it mostly changes in the devices that you are banking on?

We're expecting the device, obviously, to function very well. The engineers have been doing a great job just of fine-tuning that.

The one key thing for 312, remember, is that we're actively having as an endpoint looking for the dropped tablets. We never had that as an endpoint in the previous Phase III. It was just when they were noted -- it was documented. That's where I think the slight difference there is we're actively having nurses look for that. And the FDA 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. So that's really the only difference with the 312 study versus the other study.

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

Yes, the error rate is not a dropped tablet. So it's the two things. An error rate specifically relates to the device actually not dispensing, versus a dropped tablet is actually a user interface issue where the patient is just not using it correctly.

To me, it wasn't the actual -- our number was extremely low, if you remember, from how many thousands of actual tablets were dispensed that were observed. I think they just wanted to make sure that's that wasn't some sort of tip of an iceberg because, again, it was not a measured endpoint. We know our clinical sites. We were very happy to do that study for them again because we know, in fact, that it was not a problem.

Understood. Very helpful. Thanks, guys.

Hugo Ong, Jefferies.

Thanks for taking my questions, and congrats on all the progress. Just a question on ARX-04 -- on your pharmacoeconomic analysis, I noticed that you didn't include infection risk in 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?

Absolutely. Great question. What we did for Zalviso is we actually -- exactly what we're doing for ARX-04 is for abstracts with purely around the hard costs of setting up and using -- well, in the case of Zalviso, an IV opioid PCA. We then layered on later for the actual pharmcoeconomic publication the soft costs around avoiding infections, things like that. That's exactly what we're planning on here. The (inaudible) abstract was around the hard cost advantages of ARX-04, and we're planning on a publication that will come out with both hard and soft costs.

Okay. Great. And when can we expect that publication?

Well, we're in the process of working on it. So, you know, journal -- you can't project predict with journals. They may accept it and then take three or four months to actually get it. So, we usually do all of our open access, so hopefully sooner than later. But we're still working on writing that up right now.

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

Yes; absolutely.

Okay. Great. Thanks a lot, guys.

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

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

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.