Agile Therapeutics, Inc. (OTCQB:AGRX) Q2 2020 Earnings Conference Call August 11, 2020 4:30 PM ET

Company Participants

Matthew Riley - Investor Relations
Alfred Altomari - Chairman, President & Chief Executive Officer
Dennis Reilly - Senior Vice President & Chief Financial Officer

Conference Call Participants

Daniel Busby - RBC Capital Markets
Timothy Lugo - William Blair & Company
Leland Gershell - Oppenheimer
Oren Livnat - H.C. Wainwright

Operator

Greetings and welcome to the Agile Therapeutics Second Quarter 2020 Financial Results Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mr. Matt Riley, Head of Investor Relations. Thank you, sir, you may begin.

Matthew Riley

Hello, everyone, and welcome to today's conference call to discuss our second 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 third and fourth quarters and full year 2020, management's expectations for our future and financial 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 through 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 question.

Let me now turn the call over to Al.

Alfred Altomari

Thank you very much, Matt. Good afternoon, and welcome everyone to our second quarter 2020 conference call. The second quarter was truly remarkable in many ways, as the COVID pandemic affected virtually every facet of business and society. Under these unusual conditions and unique challenges, I'm pleased that we continue to make significant progress on our strategic objectives, and remain on-track for our plans fourth quarter 2020 commercial launch of Twirla.

The dedication of our team while working-from-home to ensure business continuity has been extraordinary, and I sincerely appreciate their flexibility and commitment to Agile. We have made substantial progress on the expansion of our manufacturing processes and commercial preparations and that is a testament to the tireless efforts of the entire Agile team. Additionally, we've hired several key managers to our home office, as well as experienced industry veterans for our salesforce, which I will provide more detail on -- later in the call. While we don't know how long these conditions will last, and what the ultimate impacts will be on our company, to date, we've been able to continue to execute our plans according to our planned timelines.

Now on to our review of the second quarter in greater detail, starting with manufacturing. We've completed the production of the planned manufacturing pre-validation batch of Twirla. Our next step will be to finalize the validation batches. We are presently manufacturing three validation batches of Twirla that we expect will produce commercially usable products and be completed in time to support a commercial launch in the fourth quarter of 2020 as planned.

Thanks to our partner, Corium International, we remain on-track to achieve our manufacturing and Twirla supply targets. We're also on-track for establishing our distribution network, having now signed wholesaler agreements with two of the three major distribution companies in the U.S. We expect to complete the agreement with a third distributor in the third quarter of 2020, and continue to discuss the distribution of Twirla with other trade groups and wholesalers. Our discussions with the major distributors have enabled us to refine our expectations about our initial stocking levels which will be lower than we initially assumed. While this will affect our fourth quarter revenue guidance, we do not expect that it will have any long-term effects at this point on our overall commercial opportunity for Twirla.

Dennis will provide more detail about our guidance. We will continue to have these productive conversations in order to optimize our future manufacturing and supply chain management.

Turning to an update on our salesforce. We are excited with the progress made during this quarter that includes several key hires. Through Syneos Selling Solutions, our contract salesforce, we've brought on board seven-seasoned sales managers, as well as Terry Herring, our new National Sales Leader. Terry is a recognized leader bringing more than 30 years of pharmaceutical and healthcare experience. Over the course of his accomplished career, he has been at the forefront of launching and marketing several women's healthcare products at companies including Ciba-Geigy, Sovay, Noven, and Mission Pharmacal.

Terry has marketed transdermal delivery products, such as Estrogen and Vivelle, and lead the launch sales team for Vivelle Dot. We're excited and fortunate to have Terry lead our salesforce. Terry has hired seven new Regional Sales Managers. These managers have robust healthcare experience, working at well-recognized companies including Allergan, Pfizer, Novartis, Syneos Health and Arbor Pharmaceuticals, amongst many others. Altogether, they bring an average experience of more than 25 years in sales, more than 17 years in sales leadership, nearly 10 years in women's healthcare, and an average of about 9 drug launches each, which adds up to a total of 64 total product launches to date. In addition to the seven regional managers, we were in the process of hiring 73 total territory and telemarketing sales representatives.

As mentioned last quarter, we're emphasized adding sales representatives with digital and virtual savvy experience and skills capable of executing both remote and in-office days sales calls, given the current challenges of the pandemic. We believe that these hires fit that needs and gives us a solid national salesforce footprint. We do not currently anticipate hiring a second wave sales representatives as previously discussed, but we will continue to consider this as a possibility.

In the first quarter of 2020, we initiated work to engage with third-party payers regarding coverage and reimbursement for Twirla. We're focused on building a value proposition that minimizes or eliminates access barriers so that women have access to Twirla with no co-pay. While we're also providing we are also building a unique patch replacement program. We believe that this patch replacement program will be a high touch, user-friendly experience for our customers. At pre-release and now it is our intention only to deploy representatives in markets that are enabled or have access through the health care plan.

Towards the end of the quarter, we announced the wholesale acquisition cost or WAC of $159.75 for treatment cycle Twirla. Each Twirla treatment cycle is packed in a carton containing three individually patch transdermal systems. Twirla is used in a four-week cycle. Patients apply one patch every week for three consecutive weeks, and each patch is worn for seven days before being replaced by the next patch. No patch is worn during the fourth week. By comparison, the current average WAC for the top 16 branded combined hormonal contraceptives or CHC products is approximately $169 a unit or month of contraceptives.

We believe that based on our current coverage and reimbursement strategy, combined with an attractive WAC price point, and needing an underserved women's contraceptive market, we have an opportunity to obtain a five to eight share of the total peak prescriptions of the $4.1 billion estimated addressable CHC market. From a financial standpoint, we believe we're in a solid position, as Dennis will describe shortly, our spending is in line with our expectations and we have a robust cash balance that we think sets us up well for our commercial launch.

We plan to increase spending in the coming quarters following the recent hiring of new sales representatives and also as we begin to implement our marketing plans targeted at consumers. In the next few weeks, Agile will be rolling out a major national unbranded campaign that's a disrupt and add value to the birth control conversation for women everywhere. The digital-first campaign is called I'm so done. It's aimed at inspiring women to think critically about their current birth control method, and ultimately spark a social community of like-minded women, and surround them with the support to enable a more educated, shared dialogue on contraceptive care with their health care provider.

To help bring this effort to life, we're taking a 360-degree approach, pulling in partners across emerging tech and social media, and so much more. We're excited to bring this resource to the marketplace and we'll share more details as we near its launch. In terms of our longer-term goals, we continue to explore the advancement of our existing pipeline, and its possible expansion for business development activities. Lastly, I want to remind everyone that we'll be holding a virtual investors/analyst day on September 21. We have timed this event to occur right before our planned launch of Twirla. At that time, we'll be able to provide a more detailed overview of our commercialization plan.

I'd now like to turn over the call Dennis Reilly, our CFO, who will provide an overview of our financial results for the second quarter 2020.

Dennis Reilly

Thank you, Al and thank you to everyone listening today. First, I will review our second quarter 2020 financial results. Then I will cover our financial guidance before opening up the call to Q&A. For the second quarter of 2020, Our R&D expenses were approximately $3.7 million, compared to $1.8 million in the same quarter a year ago. This increase in R&D expenses was primarily attributable to our preparations for commercial manufacturing of Twirla by Corium, our contract manufacturer, and reflects costs to complete manufacturing development work, process improvements, and pre-validation work.

G&A expenses totaled $6.4 million in the second quarter of 2020 compared to $1.8 million in the same period a year ago. The increase in G&A expenses was primarily due to an increase in commercial development expenses relating to the resumption of our pre-commercialization activities, such as brand building, advocacy, market research and consulting. G&A expenses also increased due to activities related to building out our commercial organization and included an increase in headcount, professional fees, and stock compensation expense. We anticipate that our G&A expenses 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, payroll and operating costs, and other costs related to the commercial launch of Twirla.

Net loss in the second quarter of 2020 was $10.8 million or $0.12 per share, compared to a net loss of $3.5 million or $0.08 per share in the second quarter of 2019. We ended June 30, 2020, with cash, cash equivalents and marketable securities of $87.2 million compared to $34.5 million of cash and cash equivalents as of December 31, 2019. Increasing our liquidity reflects our successful first quarter 2020 debt and equity financing, total combined proceeds of $68.4 million.

Turning to our financial guidance. Based on the discussion with wholesale distributors, we have refined our current expectations on initial stocking. We are revising our fourth quarter 2020 revenue guidance accordingly. Net revenue in the fourth quarter of 2020, reflecting the initial launch of Twirla is now expected to be $1 million to $2 million. As Al told you, this reflects wholesale or stocking lips. We continue to expect our operating expenses for the full year 2020 to be in the range of $52 million to $56 million, which we previously provided with G&A expenses accounting for about 70% of this spending as we build out our commercial infrastructure. It's important to note that this expense guidance includes $2.5 million to $3 million of non-cash stock compensation expense.

Based on our current business plan, and the ability to launch Twirla, we believe that our current cash, cash equivalents and marketable securities as of June 30, 2020, will be sufficient to meet our projected operating requirements through the end of 2021. If the COVID-19 pandemic or other factors impact our current business plans or our ability to generate revenue from the launch of Twirla, we believe we have the ability to revise our commercial plans, including curtailing sales and marketing spending to allow us to continue to fund our operations.

With that, we're happy to take your questions. Operator, you may now open up the line for Q&A.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Randall Stanicky with RBC Capital Markets. Please proceed with your question.

Daniel Busby

Hi, this is Daniel Busby on for Randall. I got a couple of questions. First, how far along are you in the process of manufacturing the three validation batches and how quickly following the completion of that will you'd be in a position to launch? Give a particular month or period within the fourth quarter targeted for that launch. Second, can you talk a little bit more about the factors that went into your decision to cap the salesforce at 73? And how much reach into the OBGYN community does that provide you? Thank you.

Alfred Altomari

Hi, Dan. It's Al. So the batches are being made in sequence. So we make one, move on to the second one and the third one. It's an intricate program that we laid out as part of our submission with the FDA. So it's part of what we call our validation protocols. So there's not a lot of ways to run in parallel because that's the way we design and we have to demonstrate ourselves that each batch is up for high quality that we set forth in our NDA. So that's really why we expect that the finalization of these batches are being done right now. So we began manufacturing them so we're in as one gets done, we put it through QA, and then the next one, and then the next one, and then we write up our Validation Reports and then we're ready to go. So we're still guiding into the fourth quarter but that gives us because the other things ends in our minds and we have to be mindful that some our manufacturers in Grand Rapids, Michigan.

So as you've seen with local flares, not when everything's been great. So we want to keep that guidance right now because we just have to always be mindful of it's not our plan. So we have to be mindful of these employees coming in and so forth. So that's why we have a footnote now. You should feel comforted. I think that we continue to make investments in our salesforce. Now this advertising campaign that I managed, so we feel good right now that we're on a good path. So mark my word [ph], COVID cooperates and continues to sound schedule, we'll get out there.

Your second question about the 73; we've talked about this back and forth, and we think that's the right number. The reason why we say that is I think this is one where I would say goes into good column with COVID. Because we just are working smarter. We're going to focus in markets as I described, that are activated with managed care. We're going to focus on calling on group practices where we can get a lot of efficiencies on our call plan and then the fact that we're doing it on Zoom or telemarketing gives us additional reach. So we're going to reach it, I don't have the funnel desktops in front of us. We're as efficient as I've ever been at this point. So we'll give you that data set at the analyst day and we'll go through our desktops with you, but I'm really pleased with the reach and that's why I don't think you need a second wave at this point; this really gives us a lot of punch.

The bottom line is, I think we're working tremendously smart and translate efficiently. So I love this idea that we're doing, focus on good practices, and using the telemarketing tools that we have.

Daniel Busby

Great, thank you.

Operator

Thank you. Our next question comes from the line of Timothy Lugo with William Blair. Please proceed with your question.

Timothy Lugo

Thanks for taking my question and congratulations on the build-out. What are your thoughts around setting up a reimbursement hub? When you talked about not needing a second wave, what are the triggers you'll be looking for to determine whether that second wave of hires or not?

Alfred Altomari

The reimbursement helps him -- It's interesting. It's a very good question. We are considering doing something like that because but I don't think it's going to be the hub the way some other companies have done. In our category Tim, it tends to be a little bit black and white. If we're successful at getting the drug on formulary, then patients need no co-pays. You're in really good shape, right? I think overwhelmingly, patients are going to have access to the drug, we believe. Now we only have to zero copay. So we don't really have what we think is a lot of barriers so these patients can access to drugs. It's access to the drug and what price. So if there's any issues a doctor has litters plans that aren't on the formulary then quite frankly, the doctor can prep process medical systems and medical authorizations and the fact that prior office to get the drugs to get there. So under the Affordable Care Act, it's a doctor's right -- I'm sorry, it's a medical exception. I should be clear. The medical exception, not a prior authorization. So under the Affordable Care Act, they are going get the drug. So we would expect that if doctors have any trouble in a region, it's interesting anecdotally since we published our WAC. It's funny, a lot of little number plans that already have Twirla up and running in their plans is zero copays. So we're seeing plans already taken this off and we haven't even gotten in front of these folks. We're also pretty good start organically and then obviously, we're in negotiations with the big guys. So often would feel pretty good so far. Then with markers, -- I think the second question you asked about -- I'm going to be a little greedy on the 73. If we're playing a hot hand and the drug does as well as I think it would, we probably should expand probably deeper than that files are potentially in the primary care and pick up some other but I can't see us doing that in the near term. But I do always reserve the right if I'm playing a hot hand I'd probably stab myself. I think the expenses of Salesforce not on a defensive issue, it's more offensive, that we're hot and we're doing as well as I think we could early. I think we could then we could potentially go deeper into the best files or a little bit broader into some of the other non-OBGYN.

Timothy Lugo

All right, thanks for the question.

Operator

Thank you. Our next question comes in the line of Leland Gershell with Oppenheimer and Company. Please proceed with your question.

Leland Gershell

Hi, Al and Dennis. Thanks for taking my question. Actually teeing off from Tim's question I may have missed part of it but want to ask about the use of copay cards and any impact to gross to net that we should think about as you head into the early parts of the Twirla launch and then I've got a quick follow up. Thanks.

Alfred Altomari

Good question. Our strategy is pretty simple. We want to get access to women so they get the drug and they have no formulary barriers. So we're pretty bullish there. And the real question is at what price or what copay. So we think we will do pretty well with the zero copays, but it's a major plan. We don't get it out of the chutes and then it takes us time with virtual copay card. In my mind the copay cards are kind of the last line of defense. We'd like to think that this isn't necessary in this category if we do our jobs well. So if we do use copay cards, which will be in the bag, but that'll be more of a bridging strategy to get to a contract with managed care. So we think the primary objective is to get on the contract, get a zero copay, and then if the plan doesn't give zero copays or has any restriction, we think the next line of the offense would be the medical section. Doctors that pay that, they want this drug, they can get it. Then the redline if you will. I think they'll probably play a role, but I can't see them as widely used as you see in some of the other categories you follow. But this is got to be borne out when we set up on lines of contracts. Let me be clear, Leland. I'd hate to use them broadly. How is that? This is my other strategy.

Leland Gershell

That's very helpful. Then maybe actually, one more question, and then I'm got a follow up on this topic is, with the existing Xulane patch, have you run into any conversations with payers where there's been a -- because the product has been on the market on formulary for a long period of time. It's kind of a step-through or preferred and then Twirla becomes sort of a process that is less preferred than that one or is it in much more of an even playing field given the WAC, Twirla is regarded as being a reimbursable therapy broadly?

Alfred Altomari

We've not encountered a step therapy in our discussion. Most of our discussions have been going quite well. Our position is that we're not trying to. We're not walking in and selling with plans don't cover somebody, including the other patch. Quite candidly, we're okay to carry both patches, as long as we give a chance to compete for doctor's prescription. We don't make it add to certain Leland, if that makes sense. We think the WAC we've selected was thoughtfully done, that we think we have a good value proposition at that price with our clinical differentiation we've shown so conversations have gone quite well and that's the worst-case ends up being we're both on formulary and we'll take it to the docs and they take to consumers or to the patients. So that's really been our strategy. So we're not saying check them off, put us on. We don't approach things like that. We said, look, we believe in this product that much that we believe that we can get a doctor to write the scripts, and we get patients on our drug and we win. So we're not setting it up even as a win-loss if you will.

Leland Gershell

Understood. Okay. Then as we think about running the opportunity, women tell, you'll have a sales infrastructure up and running with the field for us and other strategies in place. Just wondered if you can share your thoughts on what may be out there in addition to Twirla that we could see coming into the portfolio, not necessarily in terms of specific types of products, but maybe just in terms of general categories? Would it be assigned to contraception perhaps in other areas of female health? How should we think about that?

Alfred Altomari

That's really good question. We couldn't accommodate this type of -- we know now is the time we -- but first, I think our first [indiscernible] is to activate our own pipelines; it's been too long sitting dormant. So we think we have a couple of clever -- really important products, if you will, on our hands. So I think our first spend should probably guide to activating our pipelines. So hopefully, you'll hear more about that as we progress through the year. Then you're right; we have an inefficient call point with a single product, right. I mean, like -- we've been asked this time-in, time-out about why build and why not partner. We always think through the possibilities for this company. But we've made the decision based on the environment we're in, as we think -- that we think is best thing for our shareholders to build and start here.

So, I would love to grab another product that doesn't have to be in contraception. I'd like -- I think strategically the company needs to be more efficient with it's call point and let's build a pipeline and build a pipeline that addresses growth problems in the future. So, I think more to come on us on this part. I think for the first time we're going to be inquisitive, that's what we're trying to say. We haven't been that inquisitive. We feel like we had our hands full with Twirla and we felt a little bit capital should go in Twirla. But we're starting to feel good about ourselves; so we'd like to address that but also the pipeline.

So, if you hear anything, send it our way. Send it our way, we're going to look now, and we're going to listen.

Leland Gershell

Excellent. And then, in the meantime, we look forward to the Twirla launch. Thanks for taking my question.

Alfred Altomari

My pleasure, thanks.

Operator

Thank you. Our next question comes from the line of Oren Livnat with H.C. Wainwright. Please proceed with your question.

Oren Livnat

Hey, folks, I've been cutting in and out here so I hope I'm not repeating anybody. I did get the sense that a lot of people are asking about managed care and I'm going to do the same on you could tell me if you want to follow up afterwards if you don't want to be repetitive, but I noticed your WAC is about 30% higher than where's Xulane is. While I think nobody would debate that you have a differentiated profile from Xulane. I'm just curious, in your conversations with payers, since it sounds clear that you want to minimize prior often and any friction at launch and that you will give up what you need to give up on economics to get there for the most part within reason. Are you needing to match them on net price, which is probably a hefty gross net from where your WAC is? Then I have a follow up.

Alfred Altomari

Normally, if the guys do quick math. I don't believe it's 30%. I think it's more like 22% or 23%. So what we've heard is that the quote differentiation on products, when we talk to customers is to demand that if you will that delta. We don't think that's an overreach by the way. We think that what we bring to the party both clinically and also, quite frankly, with passive placement programs, that's why we keep featuring that. Because if you're a managed care organization, and a patient leaves his ruling, you paid for it. On our plan, we're going to pay for that. So we think that value add is a really important part of it. But so your sentences correctly, you're writing 131. The delta, we believe is earnable from a man's perspective, but we've not done a lot of pushback on the delta. So we don't think it's a -- that whole idea of let's do a big leap of WAC and let's roll it back is not a strategy that we subscribe to. That doesn't mean we won't be willing in certain circumstances to discount but we don't see a massive rollback. What we've heard before we got the product through and now is that we can command this type of premium. It's not a -- we don't think it's an overreach.

Oren Livnat

Okay, great. Appreciate it and regards to that fourth quarter guidance is that decreased from $46 million to $1.2 million? Is that really just a reflection of the new normal in the world of lean wholesaler stocking or is there any read through to early pull-through demand assumed with the launch maybe because of COVID or other factors?

Dennis Reilly

Oren, Dennis here. That is truly discussions with the wholesaler where we learned they don't put anything out into the channel into the like retail pharmacy, and they run very lean. That was really a learning as we met with the wholesalers. That's really where we're at. We just got to the new reality and we revised accordingly. If you remember on the last call, we did say that our previous guidance was wholesale or stocking also so all we've done is revise wholesaler stocking levels, which are very lean.

Alfred Altomari

I think, Oren you said well. The new worlds -- in the old world, we would give them discounts, if you will, to carry inventory in our behalf. We give them dating. In the new world, they just don't want it. They just don't want it. They're saying like we'd rather be lean and stuff differently back to your grocer that. This is where it works for our advantage because we get a chance that they get a restocking order. We're going to get it at our full price if you will, we don't want to get in the field. So they don't want it, the customer doesn't want it. We're willing to go leaner. We'll have part of the inventory in our manufacturing site. We'll have the inventory Oren so we can get it sold within 24 hours. So we will monitor inventories. They said look, we'd rather put a refill order in. This is in no way as Dennis mentioned indicative of what we believe the demand will be. This is just pure stalking. It wasn't in the first guidance in this one. So we expect when the script start walking, we'll get refills and refill orders and we'll roll and they'll come at a better price.

Oren Livnat

Right. I always did think that sounded high, given what wholesalers do these days, but I am curious. You're explicitly guiding to purely channel fill revenue in fourth quarter. Should I assume then that we're not expecting material prescription volume, even in 4Q that might translate to recognized revenue or are you just being really conservative? Or is perhaps initial sampling going to just eat into that first month or two to the extent that it's not even worth thinking about prescription volume?

Alfred Altomari

Can I say yes, yes, and yes. [Indiscernible] If we come out and say, hey, we're early in the fourth quarter, we might feel differently in guiding because back to our guidance about the fourth quarter until we land or we're in the fourth quarter. We don't want to get the cart ahead of the horse, if you will, on guidance. Secondly, your other point is uberly critical. We still intend to sample this product. I mean, at minimum, she's going to get one month thrown off. So, as we talked before with you and other folks on the street, and -- one of the likely she's going to go out with a couple of months on-off. So, we just -- I don't expect appreciable scripts in the fourth quarter because the way we're sampling, I'd like to be pleasantly surprised myself. So I just want to manage your expectations in line with mine. So I find out when we're doing it, how much samples we're putting out there; and particularly, in this new world I want to be more cautious. And yes, I'm being conservative. How's that? I hit all your buckets; yes, yes, yes.

Oren Livnat

I don't think you missed any. Thanks. Appreciate it.

Operator

Thank you. We have reached the end of our question-and-answer session. I'd like to turn the call back over to Mr. Altomari for any closing remarks.

Alfred Altomari

Thank you very much operator, I really appreciate it. As you've heard, the second quarter was certainly an unprecedented quarter filled with all kinds of challenges for ourselves and overall business environment. I don't think any of us had really seen it coming. Nevertheless, I think you've heard from us, we've successfully made progress on our all initiatives and remain on-track with launches products well in the fourth quarter. Our team has just been remarkable, both at Agile, and both at our partners, Corium and now, Syneos Health. We just have been able to -- just continue to stay on-track with our objectives which have been primarily focused on manufacturing and building out our salesforce, and the managed care as you've heard.

So as we look ahead in the third quarter, our goals are really clear. We're going to continue to ramp up manufacturing as I mentioned, and executing on these validation batches, and we expect to have them completed in the fourth quarter. And in parallel, we're seeking to get coverage and reimbursement to Twirla where a woman gets access to our product first of all, and as many women as possible at zero copay. We're confident as you've heard from myself and Dennis that we're well-positioned, both on our financial side, but also strategically. We're just knocking down our milestones, and we believe we're marching to a fourth quarter launch.

As a reminder, we'd love to tell you more about what we're doing on September 21 when we have our Analyst Day and our Investor Day; so we look forward to seeing you there, and we'll give you more granularity and more details that you've requested on this call. But I'd like to thank everybody for your following and your interest in our company. This is an exciting time, we've been through a lot with this company; so I'm just proud of where we are and I'm looking forward to practicing my craft [ph] as a commercial person, and getting this product in the marketplace.

So, thank you and be safe, and be well to you and all your families. Thank you.

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. And have a wonderful day.