Agile Therapeutics Inc (AGRX) 2020 Q2 法說會逐字稿

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  • Operator

  • Greetings and welcome to the Agile Therapeutics Second Quarter 2020 Financial Results Call. (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 - Head of IR & Corporate Communications

  • 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 time line, 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 Al 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.

  • Let me now turn the call over to Al.

  • Alfred F. Altomari - Chairman, President & CEO

  • 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 planned 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 to our sales force, 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 impact will be on our company, to date, we've been able to continue to execute our plans according to our planned time line.

  • Now on to a 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 3 validation batches of Twirla that we expect will produce commercially usable product 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's supply target.

  • We're also on track for establishing our distribution network, having now signed wholesaler agreements with 2 of the 3 major distribution companies in the U.S. We expect to complete the agreement with the 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 having these productive conversations in order to optimize our future manufacturing and supply chain management.

  • Turning to an update on our sales force. We are excited with the progress made during this quarter that includes several key hires. Through Syneos Selling Solutions, our contract sales force, we've brought on board 7 seasoned sales managers as well as Terry Herring, our new national sales leader.

  • Terry is a recognized leader, bringing more than 30 years pharmaceutical and health care experience. Over the course of his accomplished career, he has been at the forefront of launching and marking several women's health care products at companies, including Ciba-Geigy, Solvay, Noven and Mission Pharmacal. Terry has marketed transdermal delivery products such as Estraderm and Vivelle, and led the launch sales team for Vivelle-Dot. We're excited and fortunate to have Terry lead our sales force.

  • Terry has hired 7 new regional sales managers. These managers have robust health care 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 health care at an average of about 9 drug launches, each, which adds up to a total of 64 total product launches to date.

  • In addition to these 7 regional managers, we are in the process of hiring 73 total territory and telemarketing sales representatives. As mentioned last quarter, we have emphasized adding sales representatives with digital and virtual savvy experience and skills, capable of executing both remote and in office-based sales calls given the current challenges of the pandemic. We believe that these hires fit that need and gives us a solid national sales force footprint. We do not currently anticipate hiring a second wave of 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 the coverage and reimbursement for Twirla. We are focused on building a value proposition that minimizes or eliminates access barriers so that women have access to Twirla with no copays 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.

  • As previously announced, it is our intention only to deploy representatives in markets that are enabled or have access through the health care plans. Towards the end of the quarter, we announced the wholesale acquisition cost, or WAC, of $159.75 for treatment cycle of Twirla. Each treat -- Twirla treatment cycle is packaged in a carton containing 3 individually pouched transdermal system.

  • Twirla is used in a 4-week cycle. Patients apply 1 patch every week for 3 consecutive weeks, and each patch is worn for 7 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 meeting an underserved women's contraceptive market, we have an opportunity to obtain a 5% to 8% share of the total peak prescriptions of the $4.1 billion estimated addressable CHC market.

  • From a financial standpoint, we believe we are 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 we -- 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 bet to disrupt and add value to the birth control conversation for women everywhere. The digital-first campaign is called "I am so Done," and 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 through business development activities.

  • Lastly, I want to remind everyone that we'll be holding a virtual Investor/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 to Dennis Reilly, our CFO, who will provide an overview of our financial results for the second quarter 2020.

  • Dennis P. Reilly - Senior VP & CFO

  • 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. The increase in 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 wholesaler stocking lifts. 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 noncash 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 plan 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.

  • Operator

  • (Operator Instructions) Our first question comes from the line of Randall Stanicky with RBC Capital Markets.

  • Daniel James Busby - Assistant VP

  • This is Dan Busby on for Randall. I've got a couple of questions. First, how far along are you in the process of manufacturing the 3 validation batches? And how quickly following the completion of that will you be in a position to launch? Do you have a particular month or period within the fourth quarter targeted for that launch? And second, can you talk a little bit more about the factors that went into your decision to cap the sales force at 73? And how much reach into the OB/GYN community does that provide you?

  • Alfred F. Altomari - Chairman, President & CEO

  • Yes. Dan, it's Al. So the batches are being made in sequence. So we make one. We wanted a second one and the third one. It's an intricate program that we've laid out as part of our submission with the FDA. So it's part of what we call our validation protocol. So there's not a lot of ways to run in parallel because that's the way we design it. I mean we have to demonstrate ourselves that each patch is up to our high qualities 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've begun 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 thing, Dan, is in our minds, we have to be mindful of this our manufacturers in Grand Rapids, Michigan.

  • So as you've seen with local flares -- everything has been great. But we want to keep that guidance right now because we just have to always be mindful of -- look, 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 sales force and this advertising campaign that I manage. So we feel good right now that we're on a good path. So knock on wood, COVID cooperates and continues to stay on schedule, we'll get it out there.

  • Your second question about the 73. Yes, we 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 it goes in a 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 -- I don't have the final deals in front of us. So we're as efficient as I've ever been at this point. So we'll give you that data at the Analyst Day, and we'll go through our deciles with you. But I'm really pleased with the reach. That's why I don't think we need a second wave at this point of reps. This really gives us a lot of punch.

  • The bottom line is I think we're working tremendously smart and intrinsically efficient. So I love this idea that we're doing, focused on group practices and using the telemarketing tools that we have.

  • Operator

  • Our next question comes from the line of Tim Lugo with William Blair.

  • Timothy Francis Lugo - Co-Group Head of Biopharma Equity Research

  • Congratulations on the buildout. Are you -- hopefully, you can hear me.

  • Alfred F. Altomari - Chairman, President & CEO

  • I can hear you, Tim. Go ahead. Yes, you're good.

  • Timothy Francis Lugo - Co-Group Head of Biopharma Equity Research

  • What are your thoughts around setting up a reimbursement hub? And when you talked about not needing the second wave, what are kind of the triggers you'll be looking for to kind of determine whether that second wave of hires or not?

  • Alfred F. Altomari - Chairman, President & CEO

  • Yes. The reimbursement hubs, it's interesting. It's a very good question. We are considered 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 categories, Tim, it tends to be a little bit black and white, right? So if we're successful at getting the drug on formulary, then patients need no copays, you're in really good shape, right?

  • I mean I think the -- overwhelmingly, patients are going to have access to the drug, we believe. Now will they have 0 copays or not? So we don't really have what we think is a lot of barriers, so at least patients can access the drug. It's access to the drug at what price. So if there's any issues that doctor has, where there's plans that aren't on formulary, then, quite frankly, the doctor can process medical systems -- and medical authorizations and, in effect, a prior auth to get the drug to get there.

  • So on the Affordable Care Act, if the doctor writes and -- I'm sorry, it's a medical exception. I should be clear. It's a medical exception, not a prior authorization.

  • So they -- under the Affordable Care Act, they're going to 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. Tim, it's funny. Like there are a number of plans that already have Twirla up and running in their plans at 0 copays. So we're seeing plans already picking us up, and we haven't even gotten in front of these folks in. And but -- so we're off to a pretty good start organically, and obviously, we're in negotiations with the big guys. So I feel pretty good so far.

  • And then next thing with markers, Tim -- but -- I think the second question you asked about -- I'm going to be a little greedy on the 73. Look, I mean, if we're playing a hot hand and the drug does as well as I think as it does, we probably should expand probably deeper in the deciles or potentially in the primary care and a couple 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 stay myself first.

  • So I think the expansion of sales force is not on a defensive issue. It's more offensive. If we're hot and we're doing as well as I think we could earlier than I think we could, then we could potentially go deeper into the deciles or a little bit broader into some of the other non-OB/GYNs.

  • Operator

  • Our next question comes from the line of Leland Gershell with Oppenheimer & Company.

  • Leland James Gershell - MD & Senior Analyst

  • Actually, teeing off from Tim's question, I may have missed a part of it. But I 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.

  • Alfred F. Altomari - Chairman, President & CEO

  • Yes. Good question, Leland. So yes, I mean, we -- 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 don't -- we're pretty bullish there. And the real question is at what price or what copay. So we think we'll do pretty well with the 0 copays. But if a major plan, Leland, doesn't have -- we don't get it out of the shoots and it takes us time, we'll revert to a copay card. In my mind, the copay cards are kind of the last line of defense. We'd like to think that we -- this isn't a necessary in this category if we do our jobs well.

  • So if we do use copay cards, which will be in the bag -- but there'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 0 copay. And then if the plan doesn't give 0 copays or it has any restrictions, we think the next line of the offense would be the medical exception and got the doctors to say, "Hey, they want this drug, they can get it," and then the landline, if you will.

  • So 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 going to be borne out when we can finalize these contracts.

  • So let me be clear, Leland. I'd hate to use them broadly. How's that? This is my other strategy.

  • Leland James Gershell - MD & Senior Analyst

  • That's very helpful. And then maybe actually one more question, and I've kind of got a follow-up on this topic is, with the existing Xulane patch, have you went into any conversations with payers where there's been a kind of -- because that 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 product that is less preferred than that one? Or has it been much more of an even playing field, and given the WAC, Twirla's required as being a reimbursable therapy broadly?

  • Alfred F. Altomari - Chairman, President & CEO

  • Yes. So we've not encountered a step therapy 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 telling the plans, "Hey, don't cover somebody, including the other patch." Quite candidly, we're okay if they carry both patches, as long as we get a chance to compete with the doctor's prescription. So we don't make it adversarial if that makes sense.

  • So we think the WAC we selected was thoughtfully done, that we think we have a good value proposition at that price with our clinical differentiation we showed. So conversations are going quite well, and that the worst-case ends up being, we're both on formulary and we'll take it to the docs and tech the consumers or to the patients and let them decide. So that's really been our strategy. So we're not saying, "Kick them off. Put us on." And 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 write the script. And we get the patient on our drug, so we win. So we're not setting it up even as a win loss, if you will.

  • Leland James Gershell - MD & Senior Analyst

  • Understood. Okay. And then as we think about sort of running the opportunity at women's health, you'll have a sales infrastructure up and running with the field force and other strategies in place. Just wondering if you could share any 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 outside of contraception, perhaps in other areas of female health? How should we think about that?

  • Alfred F. Altomari - Chairman, President & CEO

  • Yes. That's a really good question. Yes. I mean we put a comment in the script that say, "Look, is the time." We first -- I think our first thought will be is to activate our own pipeline. It's been too long sitting dormant. So we think we have a couple of clever, really important products, if you will, in kind of in our hands. So I think our first spend should probably be guided to activating our pipeline. So hopefully, you'll hear more about that as we progress through the year.

  • Then you're right, I mean, look, we have an inefficient call point with a single product, right? I mean, like, we've asked this time and time out about why build and why not partner? And look, we've always think through the possibilities for this company. But we've made the decision based on the environment we're in that we think the best thing for 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 this call point and, look, build a pipeline and build the pipeline that addresses growth well into the future. So I think more to come on us, for the start.

  • I think for the first time, we're going to be acquisitive. That's what we're trying to say. We haven't been that inquisitive. We feel like we had our hands full in Twirla, and we felt all the capital as we go against 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 willing to listen now. We're willing to listen.

  • Leland James Gershell - MD & Senior Analyst

  • Excellent. And then in the meantime, looking forward to the Twirla launch.

  • Operator

  • Our next question comes from the line of Oren Livnat with H.C. Wainwright.

  • Oren Gabriel Livnat - MD & Senior Healthcare Analyst

  • 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. You could tell me if you want to follow after if you don't want to be repetitive.

  • But I noticed your WAC is about 30% higher than where Xulane is. And well, 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 or any friction at launch and that you will, I guess, give up what you need to give up on the 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 to net from where your WAC is? And I have follow-ups.

  • Alfred F. Altomari - Chairman, President & CEO

  • No, that's fine. I mean let me ask the guys to do quick math. I don't believe it's 30%. I think it's more like 22% or 23% or -- yes. So what we've heard is that the clinical differentiation on our product, when we talk to customers, can command 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 the cash replacement program. That's why we keep featuring that because if you're a managed care organization and a patient loses Xulane, you pay for it. On our plan, we're going to pay for that. So we think we have that value-add, the really important part of it. But your guidance is correct. You're right, $131. All right.

  • So yes. But that delta, we believe, is earnable from a managed care perspective. So we've not gotten a lot of pushback on that delta. So we don't think it's a -- that whole idea of, "Let's do a big, lethal WAC and let's roll it back," is not a strategy that we subscribe to. That doesn't mean we won't be willing, under certain circumstances to discount, but we don't see a massive rollback to that. So that -- what we've heard before we got the product group and now is that we can command this type of premium. It's not enough, but we don't think it's an overreach.

  • Oren Gabriel Livnat - MD & Senior Healthcare Analyst

  • Okay. Great. Appreciate it. And with regards to that fourth quarter guidance, is that decrease from 4 to 6 to 1.2, 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 P. Reilly - Senior VP & CFO

  • Oren, Dennis here. That is purely 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. And that was really a learning as we met with the wholesalers. And that's really where we're at. We've just kind of got through 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, and so all we've done is revise wholesaler stocking levels, which are very lean.

  • Alfred F. Altomari - Chairman, President & CEO

  • Yes. And I think, Oren, you said it well, it's a new world. I mean we -- in the old world, we would give them discounts, if you will, to power inventory on our behalf, and given dating. And 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 said differently, back to your gross to net. This is where it works for our advantage because we get a chance that if they get a restocking order, we're going to get it at our full price, if you will. We don't think it in these deals.

  • So they don't want -- the customer doesn't want it, we're willing to go leaner. We'll have a ton of inventory in our manufacturing site. We'll have the inventory oriented, so we can get it so much in 24 hours. So we will monitor inventory and say, "Look, we'd rather put a refill order in." So we -- this is in no way, as Dennis mentioned, indicative of what we believe the demand will be. This is just pure stocking. It wasn't the first time on this one. So we expect, when the scripts start walking, we'll get refills and refill orders, and we'll roll, then they'll come at a better price.

  • Oren Gabriel Livnat - MD & Senior Healthcare Analyst

  • Right. And I guess I always did think that sounded high given what wholesalers do these days. But I am curious, you're explicitly guiding, I guess, 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, I guess, recognized revenue? Or are you just being really conservative? Or is perhaps initial sampling going to just eat into those first month or 2 to the extent that it's not even worth thinking about prescription volume?

  • Alfred F. Altomari - Chairman, President & CEO

  • Can I say yes, yes and yes? So now if we can come out and say, "Hey, we're early in the fourth quarter. We might feel differently guiding you." But if it goes back to our guidance about the fourth quarter, until we land on where 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 overly critical. We still intend to sample this product. I mean, at minimum, she's going to get 1 month on us. So as we talked before with you and other folks on The Street -- and more than likely, she's going to go out with a couple of months on us. So we just -- I don't expect appreciable scripts in the fourth quarter and 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 that's why, 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 Gabriel Livnat - MD & Senior Healthcare Analyst

  • I don't think you missed any.

  • 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 F. Altomari - Chairman, President & CEO

  • 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 all our initiatives and remain on track to launch this product, Twirla, in the fourth quarter.

  • Our team has just been remarkable, both at Agile and both at our partners, Corium and at Syneos Health. We just have been able to just continue to stay on track of our objectives, which have been primarily focused on manufacturing and building out our sales force 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 complete in the fourth quarter. And in parallel, we're seeking to get coverage and reimbursements for Twirla, where a woman gets access to our product, first of all, and as many women as possible at a 0 copay.

  • We're confident, as you've heard from myself and Dennis, that we're well positioned both on a 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 as a commercial person, 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.