Microbot Medical Inc (MBOT) 2013 Q4 法說會逐字稿

Good day, ladies and gentlemen, and thank you for standing by. And welcome to the fourth-quarter 2013 StemCells Incorporated earnings conference call. (Operator Instructions) As a reminder, today's conference may be recorded.

It's now my pleasure to turn the floor over to Chief Financial Officer Greg Schiffman. Sir, the floor is yours.

Thank you. Welcome, everybody, and thank you for joining us today. With me today are Martin McGlynn, our President and Chief Executive Officer; Dr. Stephen Huhn, our Vice President of CNS clinical research.

Before we proceed, I would like to remind everyone that during today's call we will be making some forward-looking statements which reflect our current views and are based upon certain assumptions that may or may not ultimately prove valid. We assume no obligation to update these forward-looking statements anytime in the future, and our actual results may differ materially from anything projected during today's call due to risks and uncertainties to which we are subject. These risks and uncertainties are described in our public filings with the Securities and Exchange Commission and at the end of our earnings release, which you are encouraged to consult.

Now with that, I will turn the call over to Martin.

Well thanks, Greg, and thanks to everybody for joining us today. So I want to start off by reviewing our accomplishments over the last year, after which Dr. Stephen Huhn will provide an overview of our clinical plans for 2014. Greg will then review our financial results, and I will close with some final thoughts. Following these prepared remarks, we will then open up the call for Q&A.

So when I look back over 2013 and the start of 2014, I am proud of the continued progress we have made towards our goal of bringing a truly disruptive therapeutic to the clinic for a broad array of diseases and conditions affecting the CNS. StemCells has been the industry leader in neural stem cell research and development starting with our innovative discovery of a purified, expandable population of human neural stem cells in the year 2000.

We have established a strong base of intellectual property surrounding human neural stem cells. And in 2013, we further strengthened our patent portfolio with the outright acquisition of previously licensed patents from NeuroSpheres' holdings in addition to the acquisition of a number of patents from NsGene, which complements our portfolio.

The patent portfolio from NeuroSpheres, which was based upon the groundbreaking research by Sam Weiss and Brent Reynolds at the University of Calgary, has repeatedly been recognized as the seminal intellectual property pertaining to purified populations of human neural stem cells. So today, we have the broadest and deepest IP portfolio and the deepest IP portfolio of any company in the neural stem cell space.

So turning now to 2013 milestones, we have achieved many. So let me just start by discussing our work in spinal cord injury. We expanded the Phase I/II study in thoracic spinal cord injury from Switzerland into Canada and then into the United States and have transplanted 11 of the 12 patients planned for this study. We anticipate enrolling the last patient this month, consistent with our prior guidance.

We have already reported 12 months data on the first three patients who have completed this study. There were no safety issues associated with the cells, the procedure, or the immunosuppression regimen. Multi-segmental gains observed in sensory function in two of the three patients at six months endured to end of the study period of 12 months for those patients. Unexpectedly, between the six- to 12-month measurement time frames, one of the patients improved from a complete injury classified as ASIA A to an incomplete injury classified as ASIA B.

In late 2013, we received FDA authorization of an IND for spinal cord injury, which not only allows us to enroll patients into the ongoing Phase I/II study but creates the vehicle through which we will file the protocol to conduct the planned Phase II controlled efficacy study later this year. That protocol will include enrollment of patients with cervical spinal cord injury, which represents approximately 60% of all traumatic spinal cord injury with an estimated prevalence in the United States of approximately 1.3 million people.

We are very excited about the planned Phase II study, and Stephen will give you more details on our clinical plans later in the call. If authorized, this study will be the first time that stem cells have ever been clinically tested in cervical spinal cord injury. Once again, demonstrating StemCells' leadership in the field.

So I'd like to turn now to our program in dry age-related macular degeneration. We released new pre-clinical findings demonstrating that huCNS-SCs not only preserve photoreceptors in numbers; but when examined closely, the photoreceptors and other cells in the retina have retained normal critical characteristics.

In addition, the study confirmed that the neural stem cell [phagocytosis], the cellular debris that has been continuously shed by the photoreceptor outer segments -- and this is a function that is typically attributed to retinal pigmented epithelial cells.

These are potentially very important pre-clinical observations, as they may provide additional insight on how the cells preserve visual acuity in disorders of retinal degeneration.

In the clinic, we transplanted the first cohort of patients with a dry AMD consisting of four low-dose patients, each receiving 200,000 cells; and four high-dose patients each receiving 1 million cells. The patients in the next cohort will have better visual acuity than those in the first cohort, and all will receive the higher dose of 1 million cells.

We now have four sites actively recruiting patients and will shortly add a fifth, which should enable us to complete enrollment in this 16-patient trial later this year, consistent with prior guidance. It is estimated that about 10 million people in the United States either have AMD or have substantial risk for receiving the diagnosis.

Turning now to the third clinical program in our portfolio, Pelizaeus-Merzbacher disease, or PMD -- a rare, fatal myelination disorder of the central nervous system.

In 2012, we published the results of a very successful four-patient Phase I trial conducted at UCSF. All four patients are now more than three years out from the transplant, and we plan to release the three-year clinical data from all patients in Q2 of this year. The data will include both clinical and MRI outcomes that were obtained as part of the four-year long-term observational study collected on all for patients.

One of the many challenges associated with rare diseases is the lack of natural history studies that document clinical features of the disease and its rate of progression. It is therefore very challenging to design controlled clinical trials which ideally should be informed by meaningful clinical endpoints for the patients in order to meet criteria needed for marketing approval.

Since completion of the Phase I study, we invested considerable effort soliciting the advice of scientists and clinicians around the world with expertise into clinical and radiological aspects of white-matter disorders. We then met with the FDA this past December to share what we had learned and to solicit their input on a registration pathway for PMD. We had a very productive meeting, and we now have a reasonable understanding of what the FDA would like to see in future trial design.

The challenge we now have is to determine how and when we might be able to conduct a third proof-of-concept trial in addition to the spinal cord injury and dry AMD trials that are already on the drawing board.

So to conclude the update on our translational efforts, I would like to add that last year we began the pre-clinical activities associated with a filing of an IND for Alzheimer's disease. These activities are being funded in part by the California Institute of Regenerative Medicine through a $19.3 million forgivable loan. We've committed to CIRM that we will file an IND within four years, but assuming that we don't hit a scientific or regulatory roadblock, we are working to file one year earlier; that is, in 2016.

Finally a few words about cell supply for our clinical trials. I'm sure you would all agree that a reliable supply of cells manufactured importance with CGMP guidelines is extremely important. Heretofore, we have relied on a third party's infrastructure for the manufacture of our clinical supplies. But we made the decision in 2013 to design, build, and commission our own state-of-the-art CGMP manufacturing facility. I'm pleased to report that we are now fully self-sufficient in that regard and have already shipped cells processed in our new facility to clinical sites.

And last but by no means least, we have expanded our clinical operations and development teams with very talented and experienced people, and we are adding additional expertise in manufacturing to (inaudible), [ClinOps], and process engineering, thereby greatly enhancing our ability to execute on the larger clinical trials we're planning to initiate later this year.

As proud as I am of the successes of 2013, I'm even more excited by the plans we have lined up for this year. We plan to complete enrollment in two ongoing Phase I/II trials, one in spinal cord injury and the other in dry age-related macular degeneration, which will be followed by the initiation of controlled Phase II clinical trials in each indication which will focus on proof of concept and measurements of efficacy.

So with that, let me now turn the call over to Stephen Huhn, who will provide additional information about these two translational programs and our ongoing clinical activities. Stephen?

Thank you, Martin. As we've indicated, we expect to complete enrollment in our current Phase I/II trial in thoracic spinal cord injury this month. We have previously reported 12-month results in the first three patients in the study with further enrollment and subsequent follow-up now available.

The principal investigator from Zurich, Dr. Kurt, will be presenting an interim update based on the minimum of six-month data for the first six subjects at the upcoming American Spinal Injury Association conference this May. We plan to provide another interim update for all 12 patients later this year and will release spinal data on the study next year.

The experience to date in the ongoing Phase I/II study in thoracic spinal cord injury supports further clinical development, and we are therefore planning to initiate a Phase II randomized, controlled study in spinal cord injury mid-year, which should complete enrollment in 2015. The Phase II protocol will then include cervical spinal cord injury and will be specifically designed to measure evidence of direct efficacy in order to establish proof of concept for this approach. The study will entail definitive and well-recognized clinical endpoints and will be powered to achieve a statistically significant outcome. As Martin indicated, the Phase II study will be the first test of stem cells for injury involving the cervical spinal cord.

If I may, injury to the cervical spinal cord and neck usually results in loss of both arm and leg strength and, as we have said, accounts for almost 2/3 of spinal cord injuries. As a result of this trauma, patients with cervical injuries are much less likely to function independently and are typically unable to manage many activities of daily living.

However, cervical injury represents a patient population in whom a small gain in motor strength could result in improved upper extremity function with the associated potential to enhance all of the above. Regaining even a single level of motor function in cervical cord injury could result in measurable benefit for the patient. Therefore, the endpoints in the Phase II trial will focus on measuring direct changes in strength and function of the upper extremities. Based on our pre-clinical research and the experience in the Phase II trial in thoracic injury, we are very excited about the prospect of testing the potential of our HuCNS-SC cells for cervical spinal cord injury.

As we finalize the ultimate design of this study that will be proposed to the FDA, we've engaged a wide range of experts in spinal cord injury. Based on their feedback, we have added an open-label dose escalation cohort to the beginning of the study. We would expect to release the interim data from this first cohort, which will explore dose escalation, in mid-2015. The dose escalation arm will be followed by the larger randomized blinded and controlled cohort of this study.

The addition of the dose escalation cohort results in a slight delay to the interim readout of the controlled study cohort, which should now be expected to occur in early 2016. This interim analysis will be triggered when at least six months of data becomes available from the first half of the patients enrolled in the randomized controlled arm of the study. We will continue to expect the final Phase II data readout in late 2016, again, consistent with our previous guidance.

So I'd like to switch now to our dry age-related macular degeneration Phase I/II study, which is currently ongoing, and we anticipate completing enrollment in the second quarter of this year and plan to have the first date release from this study in the middle of the year. The data will include patients from both the low- and high-dose regimen that Martin referred to and that, in fact, comprises the first cohort of the study. Based on the ongoing safety results, we have not seen any safety issues with the cells, procedure, or in the immunosuppressant regimen.

Our experience to date on the open-label trial -- on the open-label dry age-related macular degeneration trial strongly supports a controlled Phase II study that will measure efficacy and, again, establish proof of concept. To that end, the study will be powered to achieve a statistical result based on accepted clinical endpoints in vision research, such as best corrected visual acuity and geographic atrophy. We plan to initiate this Phase II study later this year.

One of the challenges stem cells has faced since beginning clinical trials in 2006 for a range of indications involving the brain, spinal cord, and eye is the significant regulatory constrictions placed on first-in-human safety studies. The constraints included limiting the number of sites actively recruiting patients as well as controlling the rate at which we could transplant patients. We understand the importance of demonstrating safety in the early stages of clinical development not only for the cells but for all of the associated procedures and interventions.

Until last year, the clinical paradigm had been limited to a model of one site and one PI per indication, but we are very pleased now to have recently expanded the current thoracic spinal cord injury trial from not one but three countries and five clinical sites for the ongoing AMD trial.

As proof-of-concept studies, the planned Phase II efficacy trials in spinal cord injury and AMD are designed to demonstrate whether our platform technology, based on proprietary HuCNS-SC cells, can result in a meaningful clinical benefit for patients. To accomplish this, these multi-center studies will be significantly larger in scale than any of our previous open-label studies. And to support timely accrual, we plan to have at least 10 sites actively enrolling patients in each trial. We expect to complete enrollment in both studies but and 2015 and have final data readouts in 2016, assuming no unexpected delays.

So in conclusion, this is an incredibly exciting time for me and the rest of the team here at StemCells. We have been pursuing this technology for over 13 years and are now on the threshold of conducting randomized controlled studies to demonstrate proof of concept. It's worth emphasizing that both studies target areas of medicine with significant unmet need for therapeutic approaches.

I'll now turn the call over to Greg.

Thank you, Stephen. First, I want to say how excited I am to be a part of this management team. As Martin and Stephen have indicated, 2013 was a very successful year for stem cells. In 2013, we made substantial progress in our clinical development efforts as well as completing the build-out and validation of our manufacturing facility, all while keeping tight control of our cash burn and strengthening our balance sheet.

I'm going to speak mainly to the full-year results, and if there are specific questions you have about Q4, then we can cover those in the Q&A session.

For 2013, total revenue was down slightly year-over-year, a total of approximately $165,000. Licensing revenue was down year-over-year primarily due to a one-time fee from a license agreement with genOway, which was booked in 2012. Our SC Proven sales increased 17% in 2013 to approximately $1 million. We see opportunities for the SC Proven business and expect to see continued growth in their revenues.

Operating expenses were up year-over-year by approximately 25%, or about $5.8 million. This increase reflects increased enrollment in the ongoing Phase I/II trials and preparation to initiate the Phase II efficacy proof-of-concept studies Stephen discussed earlier.

Similarly, loss from operations increased by approximately 27%, or approximately $6.1 million, driven by the $5.8 million growth in operating expenses.

For the full year 2013, we reported approximately $2.2 million in net other income below the operating line. This is comprised of approximately $3.3 million of income associated with the change in the fair value of our warrant liability. This is a non-cash income item driven by change in the value of our stock price.

Just a reminder, under warrant liability accounting, an increase in share price leads to an increase in the warrant liability, while a decrease in share price leads to a decrease in warrant liability. Changes in warrant liability are passing the statement of operations as income or expense. In addition to the warrant liability, we have approximately $1.2 million of interest expense.

We reported a net loss of $0.61 per share in 2013, or an aggregate net loss of $26.4 million. In 2012, we reported a net loss of $0.99 per share, or $28.5 million. The net loss decrease year-over-year was primarily due to the change in the fair value of our warrant liability.

Our cash usage was approximately $28 million for 2013. This included approximately $4.7 million of capital investment. Our year-end cash and cash equivalents were up by approximately 37% to approximately $30.6 million, giving us a strong balance sheet to continue to move our clinical operations forward.

For 2014, we expect to see net cash usage, which includes capital costs, CRIN funding for Alzheimer's research, and the debt servicing costs in the range of $30 million to $34 million. The year-over-year growth is driven by increased clinical activities and costs associated with scaling the manufacturing operations to deal with substantially higher planned patient volumes in 2014 and 2015. The growth in clinical activity also includes activities associated with filing our IND in Alzheimer's disease, which is partially funded by CIRN.

For your cash models, we expect to receive CIRN proceeds of approximately $5.8 million in 2014 and approximately $4.3 million of cash usage associated with serving our outstanding loan with Silicon Valley Bank.

Let me now turn the call back to Martin for some final closing comments.

Thank you, Greg. Well, hopefully I have conveyed to you what I believe will be a transformational year for StemCells, Inc. We're completing our Phase I/II studies and embarking on much larger clinical trials with hard clinical endpoints that are focused on efficacy. This is the culmination of 13 years of painstaking methodical research.

We have continuously been pioneers in the field of human and neural stem cell science, and that leadership continues this year with our plans to be the first company to treat a cervical spinal cord injury patient with stem cells. We are the only company with a pipeline of products than encompass the entire CNS system including the brain, eye, and spine.

We will release more data on new patients this year than we have since we began our clinical programs in 2006. We plan to treat as many patients this year as we have since we began our clinical trials back in that same time frame in 2006.

Next year, we will see the patient volumes increase substantially again. Now for the investors on this call, that should translate into much better insight into the capabilities of this technology in the near term; and within the next two to 2.5 years, final results from two phase-II controlled proof-of-concept efficacy studies. And on top of this, we're looking to file an IND for Alzheimer's disease in 2016. So hopefully, you can see why I'm so excited about our prospects going forward.

In conclusion, before we start the Q&A, I want to let you know that we're not planning to announce additional details of either trials' protocol designs until we have received an FDA green light to proceed. We can say that the patients enrolled will be representative of the patients that we intend to treat. The trials will have hard clinical endpoints that will be statistically powered to demonstrate clinical benefit, and they will be blinded trials.

So with that, I would now like to open the call for questions.

Thank you, sir. (Operator Instructions) Keay Nakae, Ascendiant.

Yes, thank you. My question is as we think [for] about a spine study in cervical spine injury, can you give us a sense of what that patient population who, in your thinking, would be eligible for the study might look like and also the ability to enroll a study that has those types of patients in it? How quickly or easily or challenging doing that type of patient population study would be?

Okay. First of all, the protocol in the study is targeting cervical spinal cord injury patients, which as we've mentioned, represents about 2/3 of traumatic spinal cord injuries. So the number of patients for cervical spinal cord injuries is significantly greater than the number of patients out there with thoracic spinal cord injury. Our planning would suggest that we'll be able to enroll patients that are needed for the study within about 12 months of initiation.

And secondly, as you know, with the thoracic spinal cord injury study, we were limited to one site in Switzerland where we dosed I think it was nine patients out of the 11 that have been dosed to date. Whereas going forward, we'll have at least 10, if not more, sites that will be enrolling in the cervical spinal cord injury. So more sites, greater incident to patients, and a track record in terms of knowing how to interact with this patient population and how to handle the logistics. Does that help?

Yes, it is helpful. And just as you think about sites, obviously there's centers of excellence that know how to treat these patients. Just geographically, is there any way to kind of match up where they are located versus the -- again, just thinking about the logistics and the ability to get the right patients to the right centers to enroll them into your study.

Right. So I forgot to add earlier on in answering the first part of the question that we'll be targeting to enroll patients to cervical spinal cord injury classified as As, Bs, and Cs.

With regards to patient centers, our game plan is to conduct this study in North America, so that includes the United States and Canada. The sites that we are targeting roughly approximate to centers of density of population and well distributed throughout North America so that the amount of travel time and the logistics and access to the centers is dramatically reduced and less taxing on the patients and their families.

Okay. Well, we look forward to you guys moving into that phase of the study and just want to say it's nice to see that the enrollment has finally started to move in your favor.

Stephen Dunn, LifeTech Capital.

Hey guys, thanks for taking my questions, and congratulations on a great 2013.

Thank you.

I just had some housekeeping questions because you've been really thorough and had multiple calls. Just to put a finer point on the PMD progress going forward, have you decided to definitively do a third proof of concept, or you are still debating whether to do anything at all?

At this stage, our priority and our planning and our resources are focused on getting the Phase II studies in spinal cord injury and AMD up and running. We continue to look for ways and means that we can fold in a third Phase II study, i.e. the one in PMD. But quite frankly, with limited resources, both human and financial, I think that would be a challenge for us to fold in a third program in 2014.

But having said that, the data from the first study -- and we'll be releasing more data at the three-year time point -- is very, very compelling and very encouraging. So we definitely remain interested in advancing the program. The challenge for us is prioritization and using limited resources.

Okay. Of the cervical spinal cord programs, I recall CIRN had granted you a $20 million loan that about a year ago you passed up. Do you anticipate that coming back, or are you doing this fully without the CIRN funding?

Steve, the CIRN award, again, in the form of a forgivable loan was to fund pre-clinical activity in the field, focusing more or less on cervical spinal cord injury. We've managed to advance the program beyond the pre-clinical area of investigation. As you heard, the Phase II protocol that we will be submitting to the FDA will include cervical spinal cord injuries. So the plan of the Company is to fund that Phase II proof-of-concept study from its own resources.

Okay. Alzheimer's -- I know you don't want to talk about clinical trial design, and it's very early in the game right now. Do you -- I'm going ask you anyway, do you anticipate the initial trials to be in patients with severe Alzheimer's or mild to moderate? In other words, do you feel at this stage the FDA is going to make you use the end-stage patients like they have in PMD and CL?

Well, that's an open question. Obviously -- let me tell you what our preference would be. Our preference would be to do the earlier studies in the mild to moderate patient population. What we are looking here is that memory and performance of memory. We're not looking to change the pathology of the brain -- of the Alzheimer's brain.

Earlier on, the FDA was in a very hypersensitive mode with regards to safety. And I think we've seen a slow but sure sense of -- greater sense of assurance about what we're doing -- the cells and how we go about doing our business.

So while the first trials in the brain were in rarer fatal disorders and in the worst of the worst, we're hoping that the human safety data profile and the very good profile that we have to our clinical trials will help us support the argument with the agency to allow us to go towards the less severely impacted patients as opposed to what we've seen in the past where we've had to go into the worst of the worst in each disease category. And that carried through not just into the -- on the brain but also in spinal cord injury and in the eye. In each case, that was the regulatory paradigm.

Remains to be seen how the FDA will respond to the data that we've started to generate, and we'll be further along in terms of clinical trials in human data at the time we get to file an IND. So it'll be an interesting conversation.

Yes. My question was really driven by the fact that FDA is under pressure to have some kind of therapeutic for Alzheimer's, and there's been so little promising candidates out there. So I thought they might --

No, I think that's right. That's absolutely right, Stephen. And, again, there's a great need. There's a tsunami building up with the demographics and the potential that this disease has in terms of wreaking havoc not just on patients and their families but also in the healthcare system and the costs of managing Alzheimer's patients. So we will obviously hope to be beneficiaries of that when we do get around to agreeing the protocol with the FDA as part of the IND filing procedure.

Great. One last question and I'll jump back in queue. You stated your CGMP facility is now fully sufficient. Does that mean you require no third-party support now and that bodes well -- and everything you do, you do in-house now?

That is correct.

Great, congratulations. All right, thanks so much, guys. I'm looking forward to a great 2014 and onward.

(Operator Instructions) Pamela Bassett, Maxim Group.

Hello, it's Jason Kolbert and Dr. Bassett at Maxim. Hi, guys. How are you? I just want to touch on manufacturing a little bit. So tell me a little bit about the difference between clinical manufacturing and commercial manufacturing and where you think COGS might go long-term. And especially since you have such an expert CFO who's got so much experience in this area, so help us understand the value proposition as you look towards commercial scale.

Sure. And thank you very much for the lead-in there, Jason. When I look at the COGS, obviously it is an area where I just started having activities with the team. We clearly -- this is one that you have an awful lot of infrastructure that you do have an ability to leverage. There's a lot of activities that are important for us as we move this forward.

So clinically, you can imagine the volume's certainly far less than what we'd be looking for assuming success and we move forward commercially. And from that standpoint, the process engineering that I think Martin had talked about that we are making -- looking to make investments in, some activities with automation that will definitely yield some fairly substantial decreases and a lot of leverage in the infrastructure that we have.

I think it's early for us to give a specific estimate in terms of where we think COGS are going to end up. But that being said, this is a process that -- it is an off-the-shelf type of a product. It's one that we believe is very scalable, and we have a lot of activities underway to assure that we can scale this very cost-effectively. Martin, I don't know if you have anything else you want to add.

Yes, look, essentially the way you do business in -- with biologics is that your process has to meet the guidelines that are appropriate for your stage of clinical trial activity. So we're currently in full compliance with CGMP guidelines. And as you move forward into pivotal studies beyond the Phase II studies that we are currently talking about for this year, your process has to become more tightly controlled and need even tighter regulations as you move forward all the way through to a final BLA.

We're currently operating at what you would describe as that pilot scale level. But the process is very scalable, and it would be a little bit of a waste of exercise to talk about cost of goods from the pilot scale with single-center, small numbers, open-label studies. It's a multi-national, multi-center larger numbers of trials. So it's a scalable process, and it's an area where we management recognize that we will have to continue to invest in as we move closer and closer to regulatory approval to market our products.

Thanks, Martin. And that's a great lead-in to the next direction which is as you are now on the precipice of really substantial proof-of-concept data, at what point do you take a look at bringing a partner in, whether it's big pharma or big biotech to understand what the pivotal requirements would be as a result of kind of this early proof-of-concept data?

Well, heretofore, we have funded all of our activities with shareholder investment. And I think it's fair to expect that real partnering opportunities and real value creation will kind of come together congruently when you've got data from well-controlled studies of the kind that we're going to initiate this year. So I think the data will do the talking. I think the data will be the deciding factor in terms of the interest of potential partners.

I think it would be fair to say that, over the years, we've had conversations with potential partners -- folks we've shown an interest in what we're doing, and vice versa. So it's not like we're completely blinded and we haven't ever had any conversations with potential partners. These conversations go on, notwithstanding the fact that, quite honestly, everybody really wants to see data from well-controlled studies before they can price the risk and price the value, if you will.

Thank you, Martin. Thank you, Greg. Look forward to (multiple speakers).

(Operator Instructions) At presenters, at this time I'm currently showing no additional phone questions in the queue. I'd like to turn the program back over to Martin and Greg for any additional for closing remarks.

Thank you again, and thanks to everybody for joining us today for our quarterly call. And I look forward to updating you on our clinical progress as the year proceeds. Thank you all.

Thank you, gentlemen, and thank you, ladies and gentlemen. Again, this does conclude today's call. Thank you for your participation, and have a wonderful day. Attendees, you may log off at this time.