Agile Therapeutics, Inc.
Q3 2020 Earnings Call Transcript

Published: 12 Nov 2020

[Operator:]

Good afternoon and welcome to the Agile Therapeutics Third Quarter 2020 Financial Results Conference Call. Please note today's event is being recorded. At this time all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. I would now like to turn the conference over to Matt Riley, Head of Investor Relations.

[Matthew Riley:]

Hello, everyone and welcome to today's conference call to discuss our third quarter 2020 financial results. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our outlook for the fourth quarter and full year 2020, management's expectations for our future financial and operational performance, our business strategy and commercialization timeline, our assessment of the combined hormonal contraceptive market and the potential market share for Twirla. Among other statements regarding our plans, prospects and expectations. Such statements represent our judgments as of today are not promises or guarantees and may involve risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Please refer to our filings with the SEC, which are available to the investor relations section of our website for information concerning risk factors that may affect the company. We undertake no obligation to update forward-looking statements except as required by law. The information on Today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are Alfred Altomari, Agile Therapeutics Chairman and Chief Executive Officer and Dennis Reilly, Chief Financial Officer. Following our prepared remarks, we'll open the call to your questions.

[Alfred Altomari:]

Good afternoon, and welcome everyone for our third quarter 2020 conference call. We're pleased to report that we remain on track to launch Twirla, our first FDA approved product, which is a once a week hormonal contraceptive patch. During the third quarter of 2020, we delivered on several key stated objectives. According to our plan timeline, that brings us closer to this exciting moment in Agile's history. We trained and deployed our Salesforce, executed on our manufacturing plan and progressed on our managed care opportunities, all by controlling our spending prudently. We've said all along that the launch of Twirla would happen in the fourth quarter of 2020. And today, we're excited to report that we remain on track. Thanks to the hard work and dedication of our talented leadership team and partners. We expect to launch Twirla by the end of this year. We look forward to this important milestone and to providing women with a new contraceptive choice that fits their lifestyles. For a whole team achieving this launch of Twirla while working from home since March will be a remarkable accomplishment that cannot be understated. Now on to an overview of the third quarter in greater detail, starting with manufacturing. After completing production of the pre-validation batch of Twirla, we initiated and remain on track to finalize the three validation batches that we expect will produce product to support our commercial launch. All three of these badges are expected to be released for commercial use by the end of this year. We are pleased with the progress we've made on the manufacturing front and appreciate the continued support of our partner Corium. As announced at our investors' day in September, we continue to build our distribution network by contracting with a third of the three major U.S. wholesalers as well as a number of the regional wholesalers. We believe we're installing a supply chain infrastructure that can efficiently support the commercialization of Twirla. Turning to an update on our management team and our Salesforce. We expanded the depth of our leadership team with the appointment of Dr. Paul Korner as our Chief Medical Officer. Dr. Korner is a Board Certified OBGYN with 20 years of experience in the biotech and pharmaceutical space, including significant experience with women's healthcare. We are excited to bring his wealth of knowledge and experience to the team in supporting the commercial launch of Twirla. Dr. Korner will also support our efforts in evaluating our existing pipeline, prioritizing our product candidates, while considering the development costs and the patent life and help us explore possible expansion through business development activities.

[Dennis Reilly:]

Thank you, Al, and thank you to everyone listening today. Before I summarize our third quarter 2020 financial results, I'd like to echo Al's earlier comments about the great work our team has done as we get closer and bringing Twirla to the market. Now on to the results for the quarter. For the third quarter of 2020, our R&D expenses were approximately $3.7 million compared to $2.4 million in the same quarter a year ago. The increase in R&D was primarily attributable to the cost to conduct validation work for the commercial manufacturing of Twirla by Corium, our contract manufacturer. As a reminder, all pre-validation and validation batch costs were expensed through R&D. G&A expenses totaled $11 million in the third quarter of 2020 compared to $2.1 million in the same period a year ago. This increase in G&A was due to primarily pre-commercialization activities for Twirla, such as brand building, advocacy and market research. G&A expenses also increased due to activities related to building out our commercial organization, which included an increase in headcount professional fees, and stock compensation expense. We anticipate that our G&A will increase in the future with the commercialization of Twirla as we continue to grow our business. These expenses will likely include increased selling and marketing costs, including payroll and operating costs related to the commercial launch of Twirla, legal and accounting services and other costs as expected as we grow the business. Net loss in the third quarter of 2020 was $15.5 million or $0.18 per share, compared to $4.4 million or $0.08 per share in the third quarter of 2019. We ended September 30, 2020, with cash, cash equivalents and marketable securities of $71.9 million, compared to $34.5 million of cash and cash equivalents as of December 31, 2019.

[Operator:]

Our first question comes from Randall Stanicky with RBC Capital Markets. Please proceed with your question.

[RandallStanicky:]

Great, thanks. Al, a couple of questions for you. First, how do you think about launching with another new recent launch in the marketplace? Is there anything that you've seen or heard thus far from that launch that gives you any learnings that you can apply to your launch? So that's the first question. Then secondly, as you continue to look at the marketplace, continue to do market research, where do you think that Twirla is going to pull from? I think we can all look at Zoo lane and look at that as an obvious opportunity. When you think about the other share grab or share opportunity, which areas are you thinking is going to be most likely in the early part of the launch? Thanks.

[AlfredAltomari:]

Thanks, Randall. I just want to let the listeners know Dr. Korner is also with us if there's any questions. Randall, your two questions number one, the launch dynamics of another contraceptive in where are we going to get share from. Let me take the first one. We have good intelligence now, Randall. We have reps in the field. We have 73 people in the field. We have eyes and ears out there. I think first and foremost that I think doctors are pretty excited about now OBGYN to be for the first time in a number of years have new contraceptive options being presented to them. There's been really three or four of them in the last couple of years and can hopefully including ourselves. So I think there's heightened excitement, I would say, by the prescribers. I think that's helpful to us. They're excited that there's new options. There's excitement that companies are really stepping forward and doing research for them. So we think it's net positive for the category.

[RandallStanicky:]

Al, can ask a follow-up. As you look at the launch, the point you made it's correct. We haven't seen very many women's health launches in the last several years and we're in a pandemic right now so as you look at your 65 reps, and you look at your commercial plan, are you expecting to get greater provider touches, given the detailing aspect of this than you would normally get from kind of in-person, non-COVID environment?

[AlfredAltomari:]

Yes, that's already planned out, Randall. We have 65 office space reps, that's our footprint, that are trained to pivot either from a face to face call or telemarketing. And the eight other reps we've mentioned, they're really specialists that are, in effect, tele-detail reps. Our telemarketing reps, work for our individual sales managers. So what we're finding is that on a tele-detail, we can cover a lot of space pretty quickly. So meaning that they could be really productive. So when you sprinkle in our telemarketing or tele-detail capabilities along with our face-to-face, pretty remarkable. You're right. If there is a shining lining in this on a per capita rep basis, we can be more productive. Since we're targeting group practices, Randall, we're even more productive. So a rep going in either on a face-to-face, a launch, or a tele-detail can tag a lot of basis versus chasing individual doctors on the map. So our strategy of chasing through practices with our enhanced tele-detail capability and the willingness of doctors to let us in their office. We're well over 80% now remarkably more productive on a rep basis, Randall than I would expect even non-COVID times. So we're also a great start. I'm really proud of the sales group. They're hitting the floor running and doctors want to see us and we're very productive. I hope knock on wood that it keeps up but I'm really pleased with the traction we're getting out of the gates. You're right, that is the shining lining. On a rep basis, we're getting more mileage out of a rep than we traditionally would if they were just chasing doctors around the landscape.

[RandallStanicky:]

That's great. Thanks, Al.

[AlfredAltomari:]

You're welcome.

[Operator:]

Thank you. Our next question comes from Tim Lugo with William Blair. Please proceed with your question.

[AlfredAltomari:]

You're on mute, Tim.

[Operator:]

Apologies are our next question is actually from Oren Livnat with HC. Wainwright. Please proceed with your questions.

[OrenLivnat:]

Hey, can you hear me?

[AlfredAltomari:]

Yes. Hey, Oren.

[OrenLivnat:]

Good, I've muting myself all day. Didn't mess up this time. So a couple of questions. I guess just a follow up on COVID-related matters. It sounds like you guys are getting pretty good face-to-face but what do you think about any impact, especially as we're surging again here on new patient visits, or any patient visits for that matter? Do you think that -- if you had to moderate your internal expectations with regards to therapies getting switched in this environment or maybe people putting off starting a little bit longer than they would have otherwise?

[AlfredAltomari:]

No, thanks, Oren. No, we haven't seen any data yet. I think we're fortunate versus so many other specialists. Our customers running an obstetric practice also. So that moves on. They're given access to the patients and so forth. From what we could see in the category, the number of prescriptions in the category hasn't fluctuated very much. It's a little off, but not like we've seen in pediatrics and so many other areas that you follow. So not one or now, not yet. We don't expect it, by the way. But we look at regions that are really impacted by COVID and you say has that bad the prescribing and I'm very impacted regions gone down? The answer's no. And we think a part of that is because they're actively getting more engaged with telemedicine. And the scripts are flowing through telemedicine, we think so. I think the physicians are being quite resourceful. So with the obstetrics in their offices being open, having to give access, even the worst state they revert to telemedicine. It hasn't dampened the category or their prescribing behavior. We monitor that pretty closely. So now we don't see it. So we're relatively optimistic that the pie is intact if you will. Maybe a few percentage points down but on the margin is not very impacted just yet. Hopefully, not at all. Hopefully, we're obviously to worse.

[OrenLivnat:]

All right. Since I'm nervous, Nellie, can you just put our minds at ease with regards to this manufacturing validation? Is everything on schedule? I noticed you tweaked down the fourth-quarter revenue guidance again, and I know that was or is all stocking. I'm wondering, has there been any change in the expected timing of the launch? And can you put our minds at ease that everything is within spec as far as you know, on the manufacturing side?

[AlfredAltomari:]

Oren, thanks for always worrying about me, I appreciate. No, we're certainly on track. I think if you think back to where we started on this journey in February with 9 or 10 employees, our plan was mothballed, no money functionally in the company. And you say, okay, we have to reactivate a plant, build staff at both our company and Corium. This is our timeline. That's why we always had it out there. Now, truth be known. I would have loved to move forward but we weren't able to do that. It just was time and not money-related. Trust me, if I could move it with money, we would have done that but this is the timeline that we put out as a team and it's just never moved. So now in the revenue guidance is no really directly related to the time of year we're coming out and then the wholesale just don't want to carry much inventory of brands, any brands out of the chute. You have to earn that inventory. So we think that's an achievable number and it's just based on the dialogue we've had. Look, the next step for us to give you more confidence on Salesforce. I've got them call on doctors from spending a lot of time and money against the consumers. We've built an internal organization, we're probably approaching 30 people in the home office now. We are full confidence in bringing this product forward but a fair balanced, I always try to be with you, like we just couldn't move forward now on despite our best efforts. Now with that said, this is the timeline our team told us so we'll get there, full confidence we'll get there.

[OrenLivnat:]

When is the last spec check, so things could start going out the door?

[AlfredAltomari:]

Right now, the batches are made. So let's just kind of put this behind. The batches are made, they're sitting there. So what functionally needs to be done at this point is all the analytics have to be done on these batches. It's not a typical, like in a typical production or a pass-fail, because the batches pass and they fail, ship them out the door. But in this proof is validation phase, we're working on the protocol that we designed with the FDA, where we actually go in and do a lot of statistical testing and things like that. So we're in the analytics part of it now. So that's what we're doing now as we speak. Then we have to believe it or not write up a report for our files, it's a self-adaptation, we don't want to file with the FDA. So we have to put it on file and satisfy that we've done everything we could. So in the football terms, we're in the red zone. I'm the big running back that's trying to reach into the goal line at this point but I'm not quite there yet because it's just a series of activities. Now, with that said, in the next near term, we'll start talking to wholesalers. And we'll just start trying to firm up orders. So we're just going to keep progressing along. So we're in that phase and that's why we mentioned we're also talking to managed care. So the other thing that I'm thrilled with, I'm happy with is well over 40% of this country's going to get our product for zero copay and growing. That's just extraordinary. We put our necks on the line so we also feel good about that orange. So I think our managed care discussions are going great. I think I own the best Salesforce I've ever privilege of working around. And the doctors are excited on I got product comments. So I hope that relieves some of your anxiety.

[OrenLivnat:]

If that's possible, you did. Thank you.

[Operator:]

Our next question comes from Timothy Lugo with William Blair. Please proceed with your question.

[TimothyLugo:]

Thanks for the questions. I'm still a little anxious. I apologize but could you talk about the validation analytics phase a bit more for final lots of product. Does any of this require in-person site inspections or in-person interaction with the agency, which may be impacted by travel policies around COVID at the agency?

[AlfredAltomari:]

Let me try to talk you off the ledge. Now your second? No, Tim. So with the way it functionally happens is that we submit a protocol to the FDA say, Hey, this is how we're going to validate our final specs, and our manufacturing process. So it's a lot of statistics and a lot of testing. That's where we are right now. Now, there's nothing that needs to be submitted. This is self-adaptation. If everything goes well, which is it appears that it has, and will we put in the files, that's it, we're done. It doesn't go anywhere. So the batches just came with line recently, and we're doing all the testing and writing up the reports. That's right now, where we are. So we're as closest close can be. In a normal situation, Tim, we wouldn't need to do any of this. We would say that the batch passed our specs, yes, no, it's black, white, if it does, you ship it. So these badges are peculiar because they're really technically developed in batch. So that's why Dennis is expensing them to R&D, they really are. And then, if we pass everything, which we expect to do, we ship it out the back door, and we use it in manufacturing, we flip it into a commercial batch. But now that's it. Nothing and it's not subject to any kind of inspection. All your files are theoretically subject to inspection at any time by the FDA. But we don't have to show it to anybody, nothing, it just stays on file, both in the company and Corium and it's always subject to a question by the FDA. But they don't have to come in and check it. It's all self-reporting validation, Tim; because most people to be truthful with ourselves, most people take this off the scoreboard even before they submit their NDAs. They just get this done. Obviously, we didn't have the financial resources to do that. That's why you're hearing more about validation than you typically would. This would never even hit your ears generally in our industry. So we just started late and it's become the gating items so that's why we're spending so much time talking about it.

[TimothyLugo:]

That's fine. I understand I guess. Can you talk maybe a bit on the marketing side now? I know Dewayne made some contracting games before you're even in the market and that led to some of that growth. We saw some of them over the past few years. Can you talk maybe are you able to break into those kind of relationships and how are you going to approach contracting in 2021?

[AlfredAltomari:]

We don't believe Tim, that they have per se contracts that we're aware of. We haven't been up against them. What they have is a monopoly and because of the Affordable Care Act, they really get on the formulary for no reason. They just get the place, there's 18 forms of contraception, they're in a monopoly, they get it. So to the best of our knowledge, there's not as lean contracts we're up against. With that said, they over often on Milan appears to put some promotional noise against that they had a smaller sales force at one point detailing the product. So they kind of pick up some volume there. We think they pick up some business now and then and paranoid accounts. So there's some contracting kind of at the planned parenthood level, but not in the PBM level or the commercial plans the way you think of them. So we think that's really kind of a residual of the ever patch days, and a little bit of selective promotion, but it's not a contracting. So to answer your question, that's not an issue. I think that's why we were in the formulary position we are already. We hope by time we ship product and have reps the rest of this year, we hope we hit closer to the 50%. Half the country is going to be in not only enabled. That doesn't mean the other half won't have access to our drugs. There may be a copay. So the 50%, 40%, we quoted as zero gooseneck, we've got it. We're inching our way up to the closer to 50%. Then with the other 50%, we think we can activate through copays. Then we have a copay card to help if we need to. But we continue to be in negotiations with the other PBMs to hopefully improve that. So hopefully, as we go in the next year, you'll figure it that's getting close to that 85% we have next on the line for.

[TimothyLugo:]

Okay, that's good to hear. And maybe Lastly, can you talk about some of the quantitative metrics around engagement on to the campaign to the unbranded campaign, which you launched?

[AlfredAltomari:]

Yes, there's a couple of different pieces that I think the big soundbite Tim is we only probably have a 50% deployed. While we deployed it, there's still a lot more to come so we turn on the lights. It has different elements. So you see us on like LinkedIn or Facebook, and that's a piece of the puzzle. But really the action, we want to bring them into our website. That's where we think the action is. So we're getting a lot of volume. I don't have the numbers in front of me but what we really want is like you anybody can tag a base on a website, but we want to see him go deeper, right? You want to go deep past the homepage and into the analytics, right that they're actually doing. We're well ahead of our metrics. I believe I said in the script, over 80% of the touches are doing stuff. So and are really engaged at a level. So that's exciting. We haven't turned on the whistles and bells yet. We'll will turn on more spending as we get closer and drive more traffic there but what we like is that we're well ahead of any metrics we expect at this point with the level of engagement which tells us that they're finding our site relevant. So hopefully more to come. But that's the metric I'm looking at, Tim. I could care less how many hits I get. I want to know how much if they're doing something so I look a layer deeper in the onion and saying are women engaged. It appears, yes. The two metrics that excite me so far, three the 40% copay, right zero copay. The 80% plus face to face details and 80% engagement in the consumer, everything we're doing we're hitting our major metrics and exceeding them. We haven't activated the field -- haven't activated the product yet. So I think we've done a great job priming the pump on our three elements, managed care, HCP and consumer saw. I just can't wait to let it loose now. Like I'm just -- I'm a wild man, Tim, what can I tell you? I just can't wait.

[TimothyLugo:]

Good to hear, Al. Thanks for all the questions.

[Operator:]

Thank you. Our next question comes from Leland Gershell with Oppenheimer and Company. Please proceed with your question.

[LelandGershell:]

Good afternoon, Al. Thanks for taking my questions. As we head into the Twirla launch and with the rise of telemedicine channels, probably accelerated a bit by the COVID condition. Want to ask with your intel what you could tell us about what the utilization of telemedicine versus women, either seeing or perhaps calling or zooming in with their providers, as they seek out their birth control options, whether it's new patients coming online, whether it's existing patients who are just looking to kind of streamline the process and getting prescriptions that way. Wanted to know if you could share with us your understanding there and also how that may relate to your efforts with regard to the Twirla launch on that part of the market. Thanks.

[AlfredAltomari:]

Yes, thanks. I would characterize it as a really small but growing very quickly part of the OB-GYN practice. I personally believe in the studies we've done a lot has to do with reimbursement. Because right now on our COVID environments, CMS is giving some pretty liberal reimbursement to Doc's for telemedicine visits. It's worth their while including OB-GYN to engage their patients through telemedicine. There's a school of thought that the back goes back less. I think order magnitude is difference between like $29, and approximately 75-ish so that's my understanding of the reimbursement. If it boomerangs back to $25 to $30 we're going to see it go down again. So it really is a function of we believe the reimbursements at the time. With that said, it's growing quickly and somewhat regionally, Leland, so we are watching it, I believed our company has to be involved in that channel, either for now, for the future. So we're watching telemedicine. We think it's real, we think it's going to grow, we think it's a function, that growth is going to be a function of reimbursement. We think tele-prescribing is going to continue to grow. But we haven't seen it that big in contraception yet. The data is not there yet because as you know a lot of this market is refills, just repeat business. But that's a bolus that's not as impacted, because quite frankly, a doctor can just get take a phone call and handle that. So we're watching the new starts, and they don't seem to be that influenced just yet but it's early days, and I'm not 100% convinced we have great tools yet to monitor that. So it's something we're keeping an eye on. But I think the real metric for all of us is saying what's reimbursement going to be? I hate to be that crass but I think that really it is a direct relationship between reimbursement and telemedicine, both in OB-GYN, but across the country. So we'll have to see where that lands post-COVID. So is it worth the doctor's time to do it? The answer is yes now and also at $29. I don't know if that is. It's probably better to open your practice and have less patients flowing through. That's the metric we're watching just yet. So it's a small but emerging channel. I believe we should put a bet there and so we want to put the applier in that space. So we're going to probably do that down the road. We're looking at potentially alliances but we're still studying just yet. So we're not sure today one needs to do just yet. But something that's high on our radar screen that we should get on to pronto. We don't think it has a direct impact on Twirla either way, right now, but down the road, it might. That's what we see so watch reimbursement. Watch the reimbursement from CMS and then if it goes down, we'll see if the visits stay up. There's a direct correlation between that at least what we've seen in the data.

[LelandGershell:]

We'll watch that. That's helpful. Then a question maybe for Dennis in terms of the cost of goods with those three batches expensed through R&D and then you're going to have been commercial inventory just how we should think about normalization of COGS as you get into 2021. Would we see that kind of hit 2Q or mid-year? I guess it depends on the size of the batches and your sales uptick.

[Dennis Reilly:]

Yes. Get beyond the first two quarters, it will get more normalized and will be some fixed cost in there too of our staffing and some depreciation, which is in cash, but there'll be some fixed cost we'll have to overcome just by absorption over time, but I would think, on a net sales basis, we'd still be 15% to 20% longer range as a COGS of net revenue, somewhere in that range. So if it's kind of -- that just should be right in the ballpark.

[AlfredAltomari:]

We think there's allocations that are involved, Leland also besides the direct cost from Corium. We pay a piece price in Corium as you know, but we have some internal cost that are dedicated to that. So we have some fixed costs that we're going to start restating to COGS and in fact.

[Dennis Reilly:]

Right. You're going to have a supply chain organization very small, but somebody's that basically going to manage Corium for us and will have to be allocating some of their cost over to that area. So, with very little volume early on, it's not going to be absorbed but will become insignificant over time to the COGS.

[LelandGershell:]

That's helpful, thanks very much for taking the questions and congratulations.

[AlfredAltomari:]

Thanks, Leland, appreciate it.

[Operator:]

Thank you. Our next question comes from Paul Biedlingmaier with Edward Jones. Please proceed with your question.

[PaulBiedlingmaier:]

Thank you. Just a quick question, could you possibly broach the issue with the pricing of the product in comparison to existing products there?

[AlfredAltomari:]

Paul, nice to meet you. I don't believe we have the privilege. But, yes, so just I'll frame the kind of the football field for you. The most relevant -- we compare ourselves more to the branded products, if you will. The other patch goes out the back door at $122 a month there which we call wholesale acquisition or we'll call whack. Some of the birth-control pills that are branded could be as high as $210 I just put the summary even over $200. So if you want to use that as your kind of goalpost, the median in the category is probably $165, $170 the median. We chose a price of $159.75. That's what we sell the wholesalers for. So we are closer to the low end of the medium if you will, but we're not as low as the other patch because the payers who ultimately pay for this product said, look, you have what they believe is a better product, in our case, a better patch. They'll give us some premium pricing but at the same time, we can't go up to $200 so we've chosen to put the ball closer to the pin ball that's more relevant. So when we get in front of managed care we're not starting in these big differences because one of the patent and we have a rollback that price anyhow, more than likely. So we said why are we playing that game? Let's just start a rational price slightly less than the average or the median, if you will. When we tell that to customers they're like and then the other part of our value proposition, you heard me mention a couple of times the patch replacement program because if a patch falls off, women have trouble with pills, women lose pills they lose patches. So we said, as a manufacturer looks, she can call us and we will give it to her for free. So in the other patch the payer, the managed care groups paying that. So they're not paying $122, they're paying slightly more than that if you know what I mean for the replacements. So when we say, hey look, here's our price, here's where it's at, we're eating the cost of these replacements. You're only paying for three patches. That's why I think the payers are starting off saying, "Hey, will cover this product." So I don't know, we started a more rational place, Paul. It seems to be working for us. I hope that makes some sense. If not, you just have fall for our price back from Enea , it just seems like a silly game to me.

[PaulBiedlingmaier:]

Thank you.

[AlfredAltomari:]

You're welcome. Thanks for taking the call.

[Operator:]

Thank you. There are no further questions at this time, I'd like to turn the floor back over to Al Altomari for any closing remarks.

[Alfred Altomari:]

Well, thank you, everyone. Thanks for the questions is always they're really great so, appreciate it. As you hopefully can see in the third quarter of 2020, we feel like we've delivered against the manufacturing plan, the managed care plan, the customer engagements, our financial objectives and we are on track, launching Twirla in this quarter. Leading up to this important milestone we remain committing to minimizing access barriers for women and by extending the coverage and reimbursement for Twirla. We're allocating a substantial amount of our resources to completing the validation process, not the batches the process and we will continue to use our salesforce out there to build awareness and engaging these customers are really important and robust dialog and we're really pleased with the progress we've made in confident that strategy is going to pay off for us. To get the market ready for the product seems to be the right thing to do. Looking ahead to our next call, I look forward to talking about an update on our launch activities, in all our metrics, We'll discuss with you. We hope to discuss with you the feedback we're hearing both from patients and the physicians. We believe the future for Agile is really bright and also we're excited, we look forward to talk about real data with you next quarter -- next time we talk and we look forward to becoming and continue to becoming a leader in this space. So we want to thank you for dialing in, your interest in our company and thank you for the support and we look forward to the next hopefully not too distant future you'll hear the product is shipped. So, thank you.

[Operator:]

Ladies and gentlemen, this concludes today's webcast. You may now disconnect your lines at this time. Thank you for your participation, and have a great day.