Talphera Inc (TLPH) 2016 Q4 法說會逐字稿

Good afternoon and welcome to the AcelRx fourth quarter fiscal year 2016 financial results conference call. All participants will be in listen-only mode. (Operator Instructions). Please note, this event is being recorded. I would now like to turn the conference over to Tim Morris, Chief Financial Officer. Please go ahead.

Thank you, Austin, and good afternoon everyone, and welcome to today's call. I'm joined by Howie Rosen, our Chief Executive Officer; Pamela Palmer, our Cofounder and Chief Medical Officer; Gina Ford, our Vice President of Commercial Strategy; and Jane Wright-Mitchell, our Chief Legal Officer. During this call we will make forward-looking statements, and Jane will remind you of our Safe Harbor language.

Thank you, Tim. During the call today we will make forward-looking statements, including but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidate DSUVIA, sufentanil sublingual tablet 30 microgram, known as ARX-04 out of the United States; and ZALVISO, sufentanil sublingual tablet system, including US Food and Drug Administration, or FDA, review of the new drug application, or NDA, for DSUVIA; the potential approval of the DSUVIA NDA by the FDA; the DSUVIA and ARX-04 clinical trial results; AcelRx's path forward towards gaining approval for ZALVISO in the United States, including successful completion of the IAP312 clinical study for ZALVISO; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for DSUVIA, ARX-04 and ZALVISO; anticipated resubmission of the ZALVISO new drug application, or NDA, to the FDA, including the scope of the resubmission and the timing of the resubmission, and FDA review time; and the status of the collaboration and license agreement with Grunenthal or any other future potential collaborations, including potential milestones and royalty payments under the Grunenthal agreement.

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 the AcelRx Pharmaceuticals, DSUVIA and ARX-04 development programs, including the FDA review of the DSUVIA NDA, and the possibility that the FDA may dispute or interpret differently clinical results obtained from the DSUVIA Phase III studies. Excuse me, the ZALVISO development program, including successful completion of IAP312, and the resubmission of the ZALVISO NDA to the FDA; any delays or ability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe, and ZALVISO in the United States; the uncertain clinical development process; the success, cost and timing of all development activities; and clinical trials, including the clinical trials for ZALVISO, IAP312; AcelRx's ability to receive any milestone or royalty payments under the Grunenthal agreement and the timing thereof; ability to manufacture and supply sufficient quantities of ZALVISO to Grunenthal on a timely basis; the uncertain clinical trial -- excuse me, the uncertain clinical development process, including adverse events; 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 US Securities and Exchange Commission filings and reports, including its quarterly report on Form 10-Q filed with the SEC on November 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 over to Howie, our Chief Executive Officer.

Thanks, Jane. While this announcement [is going to] place in the fourth quarter, it's obviously going to be a topic of interest, so please allow me to take a moment to discuss our appointment of a new Chief Executive Officer. You probably saw the recent press release announcing Vince Angotti, who has agreed to join AcelRx as CEO starting on Monday, March 6. We are very fortunate to have attracted someone with Vince's many years of successful commercial and management experience to lead the Company as we prepare for the potential approval and launch of DSUVIA in the US. As many of you know, I stepped into the role of CEO for AcelRx in 2015 when the need arose. This transition to an externally recruited CEO is a key milestones in AcelRx becoming a commercial organization. I've served on the Board of Directors since 2008. I'm looking forward to helping Vince and the AcelRx team in my continued role on the Board.

Now, let's turn back to the fourth quarter achievements. The most important milestone we achieved in the fourth quarter was the submission of a new drug application, or NDA, with the US Food and Drug Administration for DSUVIA, our 30 microgram sublingual sufentanil tablet for the treatment of adult patients experiencing moderate to severe acute pain in a medically supervised setting. Recently this application was accepted for filing, and a PDUFA date of October 12, 2017 was assigned. We continue to be excited about the potential for DSUVIA because of its simple, single-dose applicator design that is administered to the patient by a healthcare professional. We are also grateful to our partners in the Department of Defense for bringing this unmet need to our attention and for their financial support.

The FDA has indicated to us that it plans to hold an advisory committee meeting to review the DSUVIA application. While the date of this meeting is yet to be determined, we are expecting to meet in a joint session with both the anesthetic and analgesic drug products advisory committee and a drug safety and risk management advisory committee during the summer. We also anticipate instituting a REMS program to support the appropriate use of DSUVIA and to enhance proper administration. While we started initial preparations for the advisory committee meeting, Gina and her commercial team continue to receive positive feedback from the market as they prepare for commercialization in the US should DSUVIA be approved. For Europe, we are on schedule to submit a marketing authorization application, or MAA, under the centralized procedure during the first half of this year.

We refined our expectations for DSUVIA's market potential in the US as well as in Europe where the product is still called ARX-04, and we estimate peak revenues to be $1.1 billion and EUR700 million, respectively. We are seeing high interest from the medical community here about DSUVIA clinical results here and abroad. I'll turn the call over to Pam now, who can give you an overview of what's been presented recently and what to look for in the coming months. Pam?

Thanks, Howie. Our efforts in the fourth quarter included presentations of results from the DSUVIA clinical program at the International Society for Burn Injuries, the Annual Meeting of the American Society of Plastic Surgeons, EMS World Expo, the European Congress on Emergency Medicine, the National Conference on Correctional Healthcare, and the Obesity Society Annual Meeting. In addition, we made the first presentation of complete results from the DSUVIA Phase III SAP303 study at the Annual Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine.

SAP303, you will recall, was conducted in 140 patients aged 40 years or older who had undergone short stay inpatient or outpatient surgery. These results show that the patients administered DSUVIA experienced a 49% reduction in mean pain intensity from baseline during the first two hours, and maintained that reduction for the duration of the 12 hour study period. The most frequently reported adverse events in the study population were nausea in 27% of participants and headache in 6%.

Another recent presentation we made at the ISPOR European Congress in Vienna is worth a mention as well. That presentation outlined a European micro-costing analysis of the direct and indirect costs associated with the administration of intravenous opioids. Direct cost of hydromorphone, morphine and other opioids are easy to find and tend to be relatively low. But materials and indirect costs, such as IV set up equipment and nurse time to start an IV and to dose and monitor the patient, had not been clearly established.

Based on this analysis, we determined that an initial dose of an IV opioid can cost approximately EUR18 to EUR28 in emergency departments across the EU5. This finding was an important part of our market analysis and helped Gina and her team understand where the needs are in the market place. Our earlier analysis of the cost of IVO fluid administration in US emergency departments was presented at the US ISPOR meeting last year and is currently in press in the Journal of Health Economics and Outcomes Research. That analysis demonstrated a cost of over $140 for an IV set up and single-dose opioid administration in the emergency room.

Looking forward, we will continue to presents our clinical data at medical conferences throughout the year, and two upcoming presentations are going to occur this month at the American Academy of Pain Medicine in Orlando, and at the International Symposium on Intensive Care and Emergency Medicine in Brussels. I will now turn the call over to Gina to talk more about commercial preparations.

Thanks, Pam. And you're absolutely right, conducting that pharmacoeconomic analysis was really eye-opening. Since then we've learned a tremendous amount from KOLs about the impact that a product like DSUVIA might have in the emergency department. Not only is an initial dose of IV opioid surprisingly costly in both the US and Europe, as Pam mentioned, but it requires a patient be assigned to a bed where they can be monitored. Even the largest ERs have a limited number of beds, which they would prefer to reserve for critically ill patients.

Unfortunately, if a patient in moderate to severe acute pain from a fracture, dislocation or other trauma comes in, they will need to be assigned one of those beds in order to receive an IV opioid. So there's the increased cost -- increased indirect cost associated with IV opioids, as well as increased utilization of hospital resources, like beds, that could be used to treat more critically ill patients if their moderate to severe acute pain patients could be treated elsewhere. As it turns out, there may be alternatives. The same patient who came into the ER in moderate to severe acute pain from a fracture, instead of being assigned a bed, could be assigned to a chair where they could receive DSUVIA.

This process would save the patient from an intensive IV with increased hospital throughput, decreased indirect costs, and still allow the physician to treat and monitor their patients' pain so they can address the underlying trauma. Given the size of the ER market -- an estimated 51 million adult Americans go to the ER for moderate to severe acute pain each year -- we decided to make this our additional launch target for DSUVIA. Once approved by the FDA, we will initiate our launch in a limited number of key institutions. We'll use the feedback during that initial launch to hone our strategy for a national rollout that we would expect to start in the first half of 2018.

When you factor in the markets outside of the ER -- ambulatory, short stay and inpatient surgeries, certain other hospital procedures, and certain painful procedures performed in offices -- we expect the peak sales in the US to be approximately $1.1 billion. As a reminder, we use an assumption of $45 to estimate the US market potential. However, that is not our expected price. We plan to do more analysis on the final price as we get closer to market launch.

Since our last call, we've continued our commercial preparation, including completing DSUVIA brand identity, including finalization of the logo and packaging; hosting a face-to-face meeting of our product steering committee to review the ER positioning and to explore opportunities in other parts of the hospital and non-hospital surgical settings; analyzing the results of a market access study in the EU to define the standard of care in the emergency room in postoperative pain. In the first quarter of 2017 we will continue our commercial planning and our main activities will include value proposition research, message testing, holding an advisory board with the emergency department medical directors and identifying target hospitals.

Tim, I'll turn the call to you to discuss our financial results.

Thank you, Gina. Earlier today we reported results for the fourth quarter and year ended December 31, 2016. You are encouraged to review that press release for specific details. In summary, for the fourth quarter 2016, net loss was $9.7 million or $0.21 basic and diluted net loss per share as compared to net income of $10.5 million or $0.24 basic and diluted net income per share for the fourth quarter of 2015. The decrease in net loss in the fourth quarter 2016 as compared to the fourth quarter of 2015 was primarily due to an increase in revenue, partially offset by increased operating costs and expenses.

For the full year ended December 31, 2016, we reported a net loss of $43.2 million or $0.95 basic and diluted net loss per share as compared to $24.4 million or $0.55 basic net loss per share and $0.60 diluted net loss per share for the same period in 2015. For specific details on these results, please refer to the press release and the Form 10-K. As of December 31, 2016, AcelRx had cash, cash equivalents and investments of $80.3 million. This compares to $113.5 million at the end of 2015. The decrease was primarily attributable to cash used in operating activities.

As we discussed in last quarter's call, we amended the terms of the debts payable to Hercules Growth Technology, extending the interest only period through to April 1, 2017. As a result of the FDA's acceptance of the DSUVIA NDA announced earlier, today we were able to refinance the loan in its entirety into a new, 36-month term note with an initial six-month interest only period through October 2017. The scheduled maturity date is now March 2020. In addition, under certain conditions, we may be able to extend the repayment period up to 48 months, extend the interest-only period for a total of 18 months, as well as borrow an additional $10 million under the line. In the short term, the refinancing will give us the added flexibility to fund the commercial preparation for DSUVIA.

On the investor relations front, we've already had a busy quarter, having presented at the BIO CEO Investor Conference February 14, the Source Capital Disruptive Growth in Healthcare Conference February 15, Small Cap Nation Family Office & Life Science Symposium on February 21, and the RBC Capital Markets Global Healthcare Conference on February 22. I am currently scheduled to present at the Cowen Healthcare Conference on March 8, the ROTH Annual Conference on March 12, the inaugural Trout CEO Investor West Coast Conference on March 23. And I will make a return trip to the small-cap event sponsored by Invest Securities April 18 in Europe.

We will now look for -- I look forward to seeing you in person at one or more of these events. I will now turn the call back over to Howie for a few closing comments.

Thanks, Tim, and thank you to everyone for dialing in for our fourth-quarter and year-end conference call. As you've heard, it's been an excellent quarter. We filed an NDA for DSUVIA and have a PDUFA date of October 12. We also feel we have a good understanding of the market and are busily preparing for launch. We have plans underway to file an MAA in Europe, and are considering our commercialization options in that region. In regards to ZALVISO, we are still enrolling patients in the IAP312 study, and based on anticipated completion of the study around midyear, we plan to resubmit that NDA by year-end.

In summary, we began our transition to a commercial company in 2016 and look forward to Vince Angotti joining us as CEO next week to accelerate this transition in 2017. On that positive note, let's open the call up to questions. Operator?

(Operator Instructions). Randall Stanicky, RBC Capital Markets.

Great. Thanks, guys. Just on pricing to begin with, I know you're using $45 as a placeholder, and this question is probably for Gina. But what are the considerations that go into where that ultimately ends up? And how do you think about the difference in pricing in the US relative to Europe? And then I've got a couple of follow-ups as well.

Good question. We completed this very broad forecast on sublingual sufentanil back last fall, and part of that process was interviewing pharmacy directors, and really asking them where they expected the product to be priced. In addition, where they would seek to maybe limit use of the product in their hospital. And that limitation sensitivity around pricing was around $50. So that's why we had some comfort in putting in our model, based on our study of the epidemiology of moderate to severe acute pain, physician preference, dosing in certain segments, we felt very confident including $45 in that model.

Okay, so it sounds like $45 is pretty close to where it's ultimately going to end up based on the work you've done so far. And then the follow-up to that, how do you think about that relative to Europe? Because obviously you have a peak sales number for Europe. You've not submitted the filing yet, but it sounds like you're close in the first half, and there's a partnering decision, I assume, that factors into that thinking as well in terms of pricing. Is that right?

That's right. And I don't have any idea where our ultimate pricing will end up as we launch this product. We have some continued analysis to do and very specific research on pricing in the US. Regarding Europe, we've also done some extensive work there as well, looking at the epidemiology, preference share, what potential analogues might be to ARX-04 in Europe. We've looked at both the transmucosal fentanyl products as well as a product that's recently been launched in the UK called PENTHROX that has a price in the GBP17, GBP18 range. So that's why we feel confident in that marketplace, in that geography, talking about a $15 -- euro -- again, put into our model to look at the peak potential for ARX-04 in those territories.

Okay, that's helpful. Howie, can I ask you a big picture question? With Vince coming on board and the strategic direction of AcelRx largely set, how much strategic variability could there be? And what I mean by that is it sounds like you've got a strategic or a commercial plan in place for DSUVIA. Could there be some change in thinking about how you go to market or change in thinking about how you think about ZALVISO?

Good question. And as I mentioned, and as you are probably aware, Vince's career comes from the commercial side before he got into general management. And so, Gina and her team are looking forward to Vince's input on more of the details. So as we mentioned, we feel like we have a good understanding of the market and where the products fit, but we still have a lot of work in terms of tactics and exactly how you enter the hospitals and what other opportunities there may be outside the hospital as well. So I definitely would expect some fine-tuning. And especially as we work from the broader strategy to the tactics, but wouldn't necessarily expect big changes in the overall direction of wanting to commercialize these products ourselves in the US.

That's great. Thanks, guys.

Boris Peaker, Cowen.

Great, thanks for taking my question. Initially I just want to focus on the broader picture, and with all the discussion about reducing opioid use in general in the medical community, are there any initiatives that are being incorporated into emergency room practice to also reduce opioid use?

Pam, do you want to address that?

Sure. The sensitivity around emergency room use of opioids really isn't that outpatient prescription that's handed to the patient. Appropriate use in the emergency room when a patient is in there for just a few hours of opioids or any analgesic that's necessary to set a fracture or deal with severe low back strain or what have you, has never really been challenged. It's the idea of these folks coming in with low back strain and then walking out with 60 Percocet or OxyContin that's really the bigger problem. But our product is purely for use while they are in the hospital.

Got you, okay. And so my other question is on -- you said you want to do a small trial launch of DSUVIA initially. What are the criteria that you're using in selecting these initial target hospitals?

We are going through the process right now of really identifying, from our ER strategy, really looking at where there's overutilization of resource, patients being delayed their treatment for an IV opioid while waiting on a bed. So we know -- or feel strongly that there's some hospitals that match that that we would really want to target first. And so we are going through the analysis right now to really look at, as Howie mentioned, how we go from the overall strategy to identifying those hospitals that can really benefit from ARX-04 to begin with, help us learn, get some initial traction and then we would plan to grow from there.

And how many of these hospitals do you anticipate? I just want to get a sense of -- would it be any kind of material revenue from these hospitals that would provide a good read-through to other hospitals? Or is it going to be just too few of them to really make a conclusive estimate?

Yes, Boris, Tim here. The revenue won't be significant or even probably recordable. It's the learnings from the hospital, it's the establishment of best practices, the throughput, the data that we get from those early on. But the revenue numbers will be insignificant.

Okay, great. Thank you for taking my questions.

Michael Higgins, Roth capital partners.

Hi guys, thanks for taking the questions. If we can go across the pond for a moment, just looking ahead to the potential DSUVIA European rights. How has the feedback been so far? What kind of companies are you talking to? Are they larger or smaller? Are you favoring a one-company approach versus several? Any color you can provide there would be helpful. Thanks.

Sure. The potential market, potential partners in Europe take all forms and shapes, from multinationals to pan-European to regional. Even though we think sometimes of Europe as one nation, one country, and we will be under a central procedure, each market is slightly different. So we will look at a variety, we won't lock ourselves in. Obviously for us it's about maximizing the value and the potential of the asset.

In terms of timing for that, is that something you want to do after approval? Or would you consider that prior to approval?

Yes, it's hard to put a timeline on BD activities. We will continue to talk to folks, and if we have something we like, we will do it. If not, we'll cross that bridge when we come to it.

Mike, I'll just jump in and say one thing we did do with ARX-04 is we have put together the MAA ourselves, and we'll be prosecuting that ourselves. So in the case of ZALVISO, we felt as a company we weren't comfortable doing that, and we did wait until we had a partner. So we are being more proactive with ARX-04 so that we can keep building value, and we have the flexibility now to be able to wait for the right kind of deal, because we are moving the product ahead in the regulatory process.

Sure. And from a value standpoint, makes more sense to hold onto it, so point taken. And back here in the US, what are your thoughts and potential timing for an AdCom? With an October 12 PDUFA, you could fall into that August trap, so wondering what kind of timing you're looking for there.

We are planning sort of July-August timeframe. I'm not quite sure what you mean by the August trap. Actually if you look back the past few years, this division has had meetings in August, I know last year, I think the year before, and you could probably go back past years. So if you referring to everyone going away in August and nothing happening, they do have a history of actually having AdComs in the early part of August.

Okay. Understood. And if I can move to ZALVISO, any stocking that we saw in Q4 numbers? Any updates you can provide for us there in the country-by-country launches?

No, I wouldn't -- there obviously is a little bit of inventory, but not enough to point out. We don't have any breakdown of the country-by-country revenues. We do know that Grunenthal is now engaged in nine countries across Europe for the commercial launch of the product.

Okay, that's helpful. Should we see a few more here in the first half of the year?

Yes, they do continue to plan to roll out. They have the rights to all of Europe, which includes 40 territories. But they are being methodical and they are rolling it out across all the different countries and territories.

And they are continuing to make the transition from what they were doing in terms of their pilot rollouts to a broader commercial effort in the countries, and they are doing that this year.

And then one final one. Financially, operationally, it looks like you've got some programs that are winding down, then marketing spend will gradually increase later in the year, more so in 2018 it seems like. If, Tim, you can provide us some sense as to how the quarters may look, looking into 2017.

Sure. I think I'll just reiterate the guidance that we had given previously. The historical burn is around $10 million a quarter. I would expect that trend to continue at least through the first half, given guidance that we would expect to end Q2 at around $50 million in cash. Beyond that, assuming there's a positive decision at advisory committee, you would expect the commercial spend to increase, but I haven't given much if any guidance on that.

Very helpful. Thanks, guys.

Ed Arce, HC Wainwright.

Great, thanks for taking my questions. So first one, just focused on DSUVIA and your upcoming AdCom. Just wanted to get a little more details around some of the key aspects that you are thinking of or preparing for in particular things where you think the FDA and the panel could focus on how you're (technical difficulty) through that. And then I have a couple follow-ups.

So, it's a little -- I guess this position is a little bit different than what you typically see, is that usually you think of AdComs being called because there some major question or issue around the drug. And as you know with this division, they really have put in place just the practice of -- with a new opioid having an AdCom. And so, as I mentioned, it's not like there's something in particular about our product, this is oh, we need to have an AdCom. It's more just we fall into -- (technical difficulty) it's the sort of thing you would call collateral labeling if you were talking about the product label. But as typical with these products, it's a joint between the division as well as the safety panel. And so, I don't know, Pam, if you want to comment on the types of things that often come up in terms of REMS and those types of things.

Sure. Recently it's been around the abuse-deterrent nature of opioids and the outpatient use of them. And our product is so different, being in a medically supervised setting and not being an extended release product, that we are not even sure what they would utilize an AdCom for, what would be the question [posed them]. And we've not definitively, actually heard, as we stated, that if we're going to have one and what date it would be on. So we are just assuming that we are having one, and we're going forward and preparing for it as best we can, assuming it will be in the July-August timeframe.

Right. Well, I guess that's -- what I was really driving to is that, given the compound is so well known and understood and this isn't an oral that is given in the hospital, and all those other abuse issues are almost -- they don't apply. But their I think practice has been, as you mentioned with all opioids, is to have one. So I'm not really sure what they're going to fill the half day or day with in terms of questions.

We will prepare and we will eventually find out.

Okay. And in terms of your ongoing discussions with potential partners, in Europe and perhaps in other areas, one question I was wondering is in your agreement with Grunenthal, is there any sort of a legal structure in there, some sort of a right of first refusal, around the compound that would apply to DSUVIA as well? Or is that -- is there no such --

Correct, yes. There's no rights to ARX-04 in the agreement for Grunenthal, and their agreement is exclusive to EA 40 for ZALVISO.

Okay. And then just one last question, Tim. I just wanted to, if you could, go over again refinancing terms that you mentioned earlier just to get that clear.

Sure. So the debt that you will see on the balance sheet at the end of 2013, the 21-some-odd million dollars is now going -- [starting on the 2016] is now going to be reset on a 36-month amortization, beginning today, with a six-month interest-only period that will go through October of 2017. Also included in the refinancing or the new note is the ability to earn two additional six-month interest-only periods following the initial six-month period, that have to do essentially with the approval of DSUVIA in the US and the collection of an additional $40 million by the partner or new equity in the same timeframe. We also have the ability to, if we've reached those last two requirements, to get an additional year amortization. So that would push the term out an additional 12 months as well.

Okay, great. Thanks for taking the question.

Hugo Ong, Jefferies.

Thanks for taking the question. Most of mine have been asked, but let me follow up with just one question on DSUVIA. In the past you've hinted at running a head-to-head trial of DSUVIA versus IV morphine. Can you talk a little more about the design and what you hope to show with that trial?

Sure. Our plan is to start that trial at the end of this year following our PDUFA date with DSUVIA here in the US. And it's really to help support both DSUVIA here in the US as well as ARX-04 in Europe. And the idea is looking at -- for the first hour of efficacy, and that hour would start with randomization. So the idea is that you would randomize someone to receive DSUVIA; all the nurse has to do is go to the Pyxis, take out the drug and dose the patient. But if they get randomized to the IV morphine arm, they actually have to go and collect the materials, start the IV, then go to the Pyxis, get the drug -- dose of morphine, bring it to the patient, dose the patient, etc.

So we're really trying to show that when someone is walking through a door without an IV that it's actually faster for sublingual DSUVIA than having to start an IV and dose them with an IV opioid. And in fact we've already shown in our ZALVISO studies that sublingual sufentanil is more rapid than IV morphine when they are started at the same time. So when we actually have a head start with having to start the IV, we think that that SPID1, the SPID over the first 60 minutes, will in fact be pretty easy to show both noninferiority as well as probably superiority.

Okay. And when would you expect this trial to finish?

Well, we're -- we'll probably run about six months in mice with that.

Okay. And would the DOD pay for this trial?

No, this is something we would be using probably for commercialization purposes here in the US. Europe often likes to see active comparator studies, and our MAA will be in process at the time. So it's just almost belt-and-suspenders in case they want to see a little extra data possibly there.

Got it, okay. Thanks for taking the questions.

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

Thank you. We look forward to keeping you apprised of our progress and thank you again for joining us for our call today and have a good afternoon and evening.

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