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spk03: ladies and gentlemen thanks for standing by and welcome to the agile therapeutics fourth quarter and full year 2020 financial results conference call at this time all participants in the listen-only mode after the speaker's presentation there will be a question and answer session to ask a question during the session you need to press star 1 on your telephone if you require any further assistance please press star 0. I'd now like to hand the conference over to your speaker today, Matt Riley, Head of Investor Relations and Corporate Communications. Thank you. Please go ahead.
spk08: Hello, everyone, and welcome to today's conference call to discuss our fourth quarter and full year 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 full year 2021, management's expectations for our future financial and operational performance, our business strategy, 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 of 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 update for 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 Tamari, Agile Therapeutics Chairman and Chief Executive Officer, and Dennis Riley, Chief Financial Officer. Following our prepared remarks, we'll open the call to your questions. Let me now turn the call over to Al.
spk07: Thank you very much, Matt. Good afternoon and welcome everyone to our fourth quarter and full year 2020 conference call. I'd like to start off today by highlighting the hard work and efforts of our talented team and partners resulting in the launch of our first FDA approved product, Twirla, a once a week contraceptive patch. Twirla was designed to fill a need in the hormonal birth control market. bringing a non-invasive, non-daily combined hormonal contraceptive or CHC option with a lower estrogen dose than the only other contraceptive patch available in the marketplace today. As we discussed last quarter, we were well on track to launch our product into the addressable CHC market valued at more than $4 billion, and we've accomplished that objective. All three of our validation batches of Twirla were made available for commercial use in December, leading to the achievement of our 2020 revenue target with just over $1 million in gross revenue in the fourth quarter. In addition, the sales force received their samples in late December. The traditional channel for distributing Twirla has been built. Our network of three major U.S. wholesalers as well as several regional wholesalers, have been central toward the initial stocking of Twirla. Moving forward, we believe that our established and growing distribution network will provide the supply chain infrastructure necessary to support the anticipated demand for Twirla. In terms of the commercialization efforts behind Twirla, our plan focuses on three primary strategies for engagement. First, healthcare professionals, or HCPs. Second, managed care. And lastly, the consumers. First, our efforts with HCP. Along with our partner, Cineos, we're able to hit the ground running with an experienced sales force of eight regional virtual sales specialists and 65 sales professionals. This is a grand total of 73 individuals calling on the HCP audience. The sales force has not only been productive in the number of daily interactions with HCP and their staff, but also in generating face-to-face calls. Since launch, we've been able to generate roughly 70% of our prescriber meetings face-to-face in a COVID-19 compliant setting. But the question all in your minds, I'm sure, is how's launch going? I'd be ruined and missed if I did not acknowledge the challenges our team has faced, both nationally and regionally, including the pandemic, inclement weather, power outages, and water shortages. But taking all this into account, The short answer is that we're very happy with the momentum we are seeing and all the indicators and metrics we are monitoring to track our Salesforce effectiveness. Allow me to try to explain that. Let's start with prescriptions or tier Xs. In my mind, we effectively launched our product beginning this year. Since that time, we are seeing weekly compounded growth rates of approximately 30%. I do want to add a word of caution. The point I'm making is one of momentum. We're not suggesting this is a sustainable rate for the purpose of modeling or guidance. We're still in the very early stages of launch. With that said, we are still happy with this start. I also want to comment on the value of a TRS. Importantly, on average, each TRS is more than one unit for one cycle. The reason why is women get more than one month's supply of Corolla when she leaves the pharmacy. Each TRX is averaging somewhere between 1.3 to 1.4 units or cycles received by the patient. This is in line with our internal planning. Think of this as getting 40 to 45 days of TWRLA at one time. We're monitoring other important metrics. Physician prescribing a TWRLA. We are growing our base of prescribers weekly. Since January, our week-on-week rate is approximately 29%. The number of TRSs each prescriber is writing is also growing, which is another good indicator. Refills. We're starting to see refills, which is great news. Roughly 10% of our units dispensed so far at pharmacy are refilled, and we expect refills to accelerate as new prescriptions turn into repeat fills. Ultimately, we are encouraged by the early results from our field representative efforts prior to launch and the continued upward trajectory since, as evidenced by the steady increase in TRX refills. This indicates that providers are willing to write longer prescriptions once the patient is initially successful on the product. As we've discussed in the past, the sampling dynamic is important for swirlers. We're continuing to offer full-month sample supplies for patients to ensure individuals who are interested in Twirla have an opportunity to use it after consulting with their HCP. We believe it's important for the patient to ensure Twirla is the right product for her prior to getting their prescription and moving forward with becoming a long-term Twirla user. Initially, it does slow down the patient flow to pharmacy in the early days of launch, but we think of samples as an investment that introduces HCPs and their patients at Twrla with the potential to stimulate future growth. Moving forward, we'll continue to use the insights from our data-driven approach to HCP outreach to refine our targeting to the highest volume practices. While we do not expect to share all these metrics going forward on a quarterly basis, we do believe they are good indicators of the initial commercialization of Twrla. Now on to managed care. We also continue to make meaningful progress on both coverage and reimbursement for Twirla in a challenging managed care environment. We estimate our engagements with third-party payers have resulted in Twirla having achieved approximately 40 to 45% formulary coverage since launch. Notable, this is inclusive of one of the three PBMs, or pharmacy benefit managers, as well as several smaller plans. We continue to work towards our goal of increasing formulary access with as much zero copay as possible over the course of this year. We also expect that TWRLA will be now available to patients in one of the largest closed managed care systems based on a recently negotiated GPO or group purchasing organization agreement. This opens another important channel for accessing TWRLA and represents another element of our early momentum for TWRLA. Please note these arrangements do not report data through Symphony or IQVIA. Finally, Agile is currently in discussions with specialty pharmacy and telemedicine partners in order to expand the channels that provide access to SWARLA. We have said all along we want to follow the patient on her journey and ensure SWARLA is available for her along the way. We recognize the benefits afforded by both channels and believe that bringing differentiated values to our business and patients that they'll serve. For specialty pharmacy, we prioritize finding a partner that would make Twirla easy for providers to prescribe and convenient for patients to receive Twirla. Today, we're happy to announce our partnership with Sterling Specialty Pharmacy. Sterling has an established organization with patient-first philosophy that matches our ethos. They also have a proven tracker of providing streamlined and personal approach, which we believe will play a critical role in accelerating the core of our uptake. From a telemedicine perspective, because of the ease and convenience that the channel offers patients, we're committed to selecting partners that best align with our strategic needs. We'll continue to explore this area and hope to share more information about this in the near future about our efforts and developments in telemedicine. Now on the consumer engagement. As a company, we're focused on and committed to providing providers that fill the unmet needs of today's women. As part of this, we believe it's important to break the stigma around conversations about birth control and ensure women are able to educate themselves on the variety of contraceptive options available and make informed decisions that best align with their own personal contraceptive needs. Since our I'm So Done Unbranded campaign was launched in September of last year, roughly 700,000 women have engaged on our website content via displayed and paid social efforts, which has empowered them to join in the birth control conversations. We're happy to note Agile is breaking the contraceptive category mold by being the first unbranded birth control awareness campaign to activate on TikTok, the most downloaded app in 2020. I'm proud of these efforts and will continue to explore developing partnerships with popular lifestyle influencers and credible content providers to further advance the I'm So Dumb campaign. We believe these educational efforts are an important component and a driver of the continued awareness to support the ongoing growth of Swarov amongst our target market. Learnings from the unbranded campaign translate well into the development and launch of Agile's branded campaign for Swarov, a direct-to-consumer or DPC site and social media channels, which have both been launched in December. We're excited to share that in less than one month, we had approximately 300,000 engagements from our paid social media channels and expect additional and impactful DTC activations in the future. Our social media efforts are designed to drive traffic from the unbranded, unsubscribed, or twirl-less social media pages and profiles to the respective unbranded and branded websites. We are not focused solely on building followers or accumulating likes on Instagram or Facebook. We want to see real, meaningful engagement with the content and information on the I'm So Done and Twirla website, and we're seeing just that. While we're committed to becoming a market leader in women's health, we are also focused on our pipeline and the ability to help solve other unmet needs in the women's healthcare space. We believe this goal can be fueled by organic growth, stemming from Twirla strengthening its presence in the marketplace. Our organic growth will be supplemented by our funding efforts, which I'm pleased to announce have recently increased. While Dennis will soon go into more detail on this, we've expanded our loan facility with perceptive advisors who are now making available to Agile an additional $10 million on our loan facility upon the achievement of certain sales milestones. This in addition to perceptive advisors' $35 million loan facility from 2020, and reflects their continued confidence in our business and provides agile additional financial flexibility and options. In summary, we executed our fourth quarter 2020 plan with the launch of TWRLA and look forward to continue to educate and expand the prescriber and consumer basis on a differentiated benefit of TWRLA as we seek to continue growing market share. I'll now turn it over to Dennis Riley, our CFO, to provide a number of your financial results and a financing update. Dennis?
spk06: Thank you, Al, and thank you to everyone for joining us today. I share Al's excitement in and gratitude for our entire team and the efforts put forth over the past quarter and the past year. While 2020 was challenging in many ways due to the pandemic, we remained focused and continued to execute on our commitments, which culminated in the December launch of Twirla. Our company stands now on solid financial footing, and we believe we are well positioned to execute on our plan following our product launch in December. We closed out the year achieving the gross revenue target of approximately $1 million in the fourth quarter. This reflected the initial stocking of Torla by wholesalers. Additionally, we delivered better than expected results on the expense side. Our operating expenses came in under $50 million for the full year, below our guided $52 to $54 million range. For the fourth quarter of 2020, our R&D expenses were approximately $3 million compared to $2.8 for the same quarter a year ago. For the full year, R&D expenses were $13.5 million in 2020 versus $9.9 million in 2019. This year-on-year increase was primarily attributed to the validation work we did for commercial manufacturing of Twirla Bicarium, our contract manufacturer, as well as clinical development and personnel-related expenses. Selling and marketing expenses were $10.7 million in the fourth quarter, compared to less than $1 million a year ago, while full-year expenses were $23.3 million versus $1.1 million in 2019. The notable year-over-year increase results from costs associated with our pre-commercialization activities for Twrla, including the brand building, advocacy, market research and consulting, as well as the cost of establishing and maintaining our contract sales force. G&A expenses totaled $3.5 million in the fourth quarter compared to $2.5 million in the same period a year ago. For the full year, G&A expenses were $12.7 million in 2020 versus $7.9 million in 2019. This increase in G&A reflected activities related to building out the support infrastructure, including higher personnel costs, professional fees, and the related stock compensation expense. We ended last year with cash, cash equivalents and marketable securities of $54.5 million, compared to $34.5 million cash equivalents at year-end 2019. We have strategically managed our expenses and our wealth positions to support the continued rollout of Torolla, with sufficient cash on hand to meet our projected operating requirements through 2021. With that said, I'd like to provide a financing update, which we believe reflects confidence in our ability to support and grow our business over time. As announced in our earnings release today, we expanded our loan facility with perceptive advisors. In February 2020, we entered into a $35 million senior secured term loan credit facility with perceptive advisors. It was structured in three tranches. Last year, we drew down $20 million on the first two tranches of this funding to support our commercialization strategy for Twrller. We have a third tranche of 15 million remaining through 2021. available upon the achievement of certain revenue milestones. We are now pleased to announce that Perceptive Advisors is providing an additional $10 million in funding to us, and that will be available through June of 22. Again, it's contingent on us reaching a predetermined revenue target. So in total, we received in $20 million in this loan facility, and we now have an additional $25 million available to us, which reflects the continued support of our partner, Perceptive Advisors, a well-regarded leader in growth capital financing. Importantly, this capital enables increased financial flexibility and optionality for the agile business. We're focused on remaining disciplined and nimble in our approach and are committed to making the right investments at the right time to ensure strategic growth and maximize shareholder value. Our team is excited for what lies ahead. We have a differentiated product that addresses an unmet need and a balance sheet and financial flexibility that will help us execute on our strategies.
spk03: while delivering value to our stakeholders with that we're happy to take your question operator you may now open up the line for q a as a reminder to ask a question you need to press star 1 on your telephone to draw your question press the pound or hash key please stand by where we compile the q a roster our first question comes from Randall with RBC Capital Markets. Your line is open.
spk01: Hey, guys. This is Randall. First question, how have you been on the market for a few months? Talk about where you're seeing the greatest uptakes thus far among women, which is from the pill, which is from the plane, which is from contraceptive naive women.
spk07: You're breaking up. I'm sorry. You're breaking up. Could you just... Oh, sorry. Yeah, is this better? It's fine. Awesome, yeah. Thank you.
spk02: Okay, perfect. Yeah, so I'll just say that again. Can you talk about where you're seeing the greatest uptake thus far among women, whether that be from the pills, Elaine, you know, contraceptive naive women? And second, from a physician prescribing perspective, what's the biggest pushback then thus far?
spk07: Sure. Well, the first one doesn't really – thanks for the question, sorry – The first one doesn't really surprise us very much. So far, the bulk of the prescriptions we're seeing, be it old, very early days, are coming from women that were once on the pill or coming off the pill. So if you will, switchers that have come off one method to another. And that's what our early market research had said. That's where we'd expect it because that's really the insight we built the brand around. the idea of a more convenient alternative to pills. So that answers the first one. So that's not a surprise to us. But again, early days, we'll keep you updated on that. Pushback. You know, I think the biggest thing we face is, again, what we'd expected in our market research, you know, a little bit of out of sight, out of mind. You know, a lot of physicians in the OBGYNs in particular had not really used the patch mainstream for a number of years. So it's it's kind of getting it from the back corner of their mind until the front of their mind that now our patch can be a frontline method. But I don't want to say ambivalent, but it's a little bit of out of sight, out of mind. So, you know, we're excited to bring this patch out and kind of bring it back into the mainstream. But I think that's initially the first challenge is our reps. Again, and so many of what we expect. And it's always nice to see that your market research actually plays out well. I hope that answers your question, Joe.
spk02: Yeah, that's helpful. And if I could ask one follow-up. Last week we saw a second generic ortho ever approval. Just wondering if we should be worried about potential competitive implications for Twirla, whether that be in the form of potentially greater pricing pressure in the category or even just confusing doctors now that there's a third patch on the market.
spk07: No, you know, I think your note that you sent out, that Randall sent out, I think summarized the company's feelings too. You know, it's really our issues or our challenges with the patchwork. You know, our opportunities are still the same. The new approval is another form of ortho. Ever. It's got the same label ruling does. You know, it's also I should note, and I think we pointed this out for the street a few times, but after our approval, their label also reflects the BMI contraindication over 30. So we're all on an equal playing field. I think that's been lost on doctors. One of the things we're talking to doctors about is that, look, I mean, the BMI is a level playing field and very prominent in their label. But both products now are going to be the elevated estrogen level. So, you know, I think the competitive challenge is still the same for us. We need to differentiate our product both with our physicians, with women, and also to managed care. And we feel like we have a great story. You know, so that's and I think that Randall said in his note and you said in your note, you know, it's good to see, you know, people that there's value that the market is indeed, you know, there's a real market here for patches. But we'll keep an eye on it and we'll keep it posted. But that's our initial read. It's, you know, another form of VABRA, same label, no differentiation label. And, you know, we still have a very competitive difference that, you know, we're getting traction with doctors and managed care with. So we expect to stay on that. But if anything changes, we'll let you know.
spk02: Got it. Thanks, Al.
spk07: Oh, my pleasure. Thank you.
spk03: Our next question comes from Oren with HC Ringright. Your line is open.
spk05: Hey, guys. I apologize. I missed the very beginning of the call, but I assume you can help me out. couple so can you just help us understand what you're seeing i know it's really early but you know you mentioned sampling and you mentioned you know leading indicators i'm just wondering what can you tell us with regards to that um you know, demand that we don't see yet that you do see. How about dispensed samples, maybe refill requests, so to speak, from physicians' offices for more samples, maybe reimbursement hub inquiries you're getting to help people do prior-offs where necessary or help them work through those medical waivers for ACA. Is there anything you can help us with on that front? I have a follow-up. Thanks.
spk07: All right. Sure. No problem, Warren. No, I think every indicator we're looking at, those hard indicators, and I'll call them software indicators, look good to us. I think we mentioned before one of the things we look at is the number of doctors we accrue every week. Who are new doctors that are writing? Are the productivity of doctors going up? Is it a one-and-done prescription? Are they getting more productive? Are doctors writing refills? Are pharmacies getting the refills? Because I think ultimately this is a category that's built on the volume of refills because any one patient could theoretically be 13 units a year. So all those kind of hard indicators, Oren, that I'm looking at right now all seem to suggest, and I think TRX to me is the, math of that, if you will, the outcome of that math. So doctors converting to strips, multiple strips, multiple strips turning into refills. So as I mentioned on the call, that about 10% of our units that got dispensed through pharmacy are already refilled, which is a good sign. So we like that. You know, and then the software indicators that you're mentioning, you know, they're quantifiable. The number of calls we get in the medical affairs, you know, you mentioned the hubs. It's just questions doctors are asking, and they're requesting literature from us, which is great. Doctors that we're not calling on are calling in for samples, which is great. You know, it means our advertising to doctors is working well. So there are some of the things, and then as you mentioned, the last but certainly not least, the rest. I mean, are they deploying samples and doctors in the midst of COVID? And even though we're seeing doctors face-to-face, a lot of times we can't get in a sample closet like we used to. But with that said, we're deploying a lot of samples. And to answer your question, we're just starting to see them, if you will, turn. You know, it's only, I know it's the end of the month, but, you know, effectively we've probably had one good pass, maybe two passes with all of this. And a lot of practices are on our group practices. So I think it's a little too early to see if the samples are turning, but I can't tell yet. But it feels good, and we're deploying a lot. So that's something we're keeping an eye on. But there's significantly more samples being put out than we have prescriptions for at this point. So samples are, as I mentioned on the calls, we think of it like an investment. And so everything seems to be pointing north. You know, if the weather would cooperate and everything would settle down a little bit around the country, that would make our jobs a little bit easier. But with that said, we'd push through.
spk05: All right. You know, clearly we can't, you know, build a model on, you know, good vibes yet. It's too early for that. But if you could just maybe give us any sense of the magnitude of samples that are, you know, being put out into the channel. You know, we're trying to get a sense of, theoretically, you know, how much demand has to get soaked up before we see, you know, a true prescription pull-through kind of situation, right? And then I would follow up on managed care.
spk07: Yeah, so we, you know, I wish I can guide you on we can guide ourselves. I mean, on the kind of the return on sample investment, I could tell you if you just think about 73 people calling on doctors and they make multiple calls per week, Just try to put your mind around six or seven weeks of sampling in the number of offices you think we've seen. So that'll give you an idea of the volume samples that are out there. But again, they haven't turned enough. We haven't been able to establish our own model, if you will, of how that's going to work. We just think, based on what we're seeing, that a lot of the doctors that we leave samples to turn around and do write the product. So that's a good thing. So it's a little early days. But we'll keep an eye on it. If we can get smarter than that, we'll let you know. But it's a little tough right now. And this is one of the areas that in a COVID environment, not being able to see the sample closet and watching the turns does get in our way a little bit. Because when we turn over the sample jobs to doctors, unless they let us see the sample closet, there's no accounting. I can't follow the pulse unless we can get into the closet and see it. So on that one aspect of the launch, our hands are a little tied behind our back.
spk05: All right. And then just quickly on managed care, you know, I don't think, you know, Zulane is obviously the biggest source of prescriptions. It's probably the tens of millions of pills, like you've said in the past. But, you know, where do you stand in your 40% to 45% coverage with regards to Zulane, whether it be parity or ahead of them? You know, I'm trying to understand for that initial wave, uh is there any hurdle to someone prescribing getting reimbursed for your product you know vis-a-vis uh zulane or or a generic that's coming behind it um or in your contracts you're negotiating going forward does it come up at all is it even relevant you know most of our most of our where we're on contract on formulary we're on you know i believe this is my memory so um
spk07: I believe in most situations we're all on a parity. So in other words, a doctor more than likely can write both brands. And actually that's something we kind of flagged to the plans. You know, we believe kind of we have to walk the talk. We believe in giving women choices and doctors choices. So for instance, on the GPO, we just were awarded. They're on there with us. So we don't believe we can get a doctor to write our prescription that, you know, we've been you know, that's a different problem, right? So we just say, hey, put us on with it, get some even shots. So in general, that's our position. In general, that's what we see their plans. A lot of the plans don't want to talk to us, quite frankly, because, you know, it's a little early in the launch and we just don't have enough beach out of volume. So we would expect it to keep growing. And we're just going to, like we did with the GTO, we're going to pick off big pieces of volume, you know, that doesn't necessarily run through our Cuvia, you know, or Symphony. So this is a closed system we picked up So we're just going to keep, you know, keep following the woman on her journey. Where she goes, we'll go and try to open those markets. But in general, to answer your question, we're parity with them. And then, but over time, as I mentioned with the earlier call, you know, most of our volume has been coming from, very little of our volume is coming from a Zooline prescriber, a Zooline patient. They're really coming from pill patients. So that's why we don't care as long as we're on there and we can generate volume with a doc. That's all we care about.
spk03: All right. Thanks.
spk07: My pleasure. Thank you.
spk03: Our next question comes from Leland Gershaw with Oppenheimer. Your line is open.
spk09: Hey, Al. Thanks for taking my question, and congrats. First question, just in terms of the type of patients you're getting onto, clearly most of them are coming from the pills, but could you maybe provide a bit more granularity You know, are these patients who are women who are in their younger years? Are they a bit older? I'm kind of trying to get a sense of, you know, is there kind of a sweet spot in terms of the type of woman who's coming on to twirl that you're seeing? I know it's early days. And then I've got to follow up.
spk07: Yeah, Leland, I mean, thank you for the question. Yeah, I mean, you answered the last part right. I mean, it's a little early days, but we can't help ourselves looking at the data. Yeah, they tend to be women that have come off the pill. So I would say the initial uptake is more in the early to mid-20s. So it's not younger, it's not older. It's not in the middle of the bell curve, if you will, the contraceptive market. Again, that doesn't surprise us. I think where we would like to see doctors use the product, clearly we like doctors using the product even on switching patients, if you will, but we'd like to see some more, you know, the new patients, the naive, the therapy, if you will, the new start patients, because we think that's kind of an easier ask. But right out of the chute, sitting in the middle of the bell curve, as you would expect, you know, we've seen not a lot young, not a lot older, but sitting in that kind of experienced you know, user of pills. So that's what we're seeing out of the chutes. But we will see if that changes. That's what our model suggested we would get. So I'm not surprised that we're going to keep a look at it. That's the best read we can get just yet on patients. And the other thing that I think is exciting answer your question more fully. What I'm excited about is it's a mile wide and it's thick in that it's coming from around the country, right? So the good news is it's not coming from one region, not one doctor, if you will, or one geotarget. It's coming from multiple states, multiple doctors, which is good. So I like the fact that we're getting uptake across the country and across the doctors. So And the lack of consistency on that one really makes me excited. So that's what we see so far. We're going to keep looking at it. The changes will keep you updated. But that's what we see in the early days.
spk09: Thanks. And then just actually two briefly. So just following up on the GPO agreement having been signed, just wondering if you're in negotiations with other such closed systems and if we should expect to see more down the line and then a question maybe more for dennis just it's really days again but just looking at the gross to net you're running kind of a 25 percent that may be artifactually um you know affected by the early launch just want to know if that's something we should think about going forward or if that's going to shift a bit as the launch matures thanks so dennis i'll take the first one you can close out for leland um
spk07: So, yeah, you should expect that we're going to follow the business, right? So in the commercial channel that we've seen on QVR and Symphony, that really are the commercial books of business. And there are other books of business out there. There's closed systems around the country. There are very big systems that we just landed this one. So if that's where women go, we're going to follow them. You know, on kind of a state level, you know, the Medicaid can be important to us. you know, depending on the price. And so we're looking at some of the Medicaid volume. Down the road, I mean, we look at other places like student health centers. So if that's where her journey takes us, we'll follow her. So I guess the answer is yes, you should expect us to keep trying to win strategic books of business that we can bring TOROLA to. So I hope that makes sense, but more to come. But You know, we got one in the boat, so we're going to keep trying, Leland. But we were excited to get such a big one early. Dennis, you want to take a shot at the gross net?
spk06: Yeah. Hey, Leland. You know, it's a mixed bag, Leland. Right now, I don't think 25% is the very long-term rate. I would anticipate it's in the mid-30s. But, you know, it's a mixed bag early on. We paid some stocking fees to the wholesalers So that stuff was a little bit higher, but we don't have, um, the big managed care contracts that, you know, may over time, depending on our mix, um, you know, if we need to sign them, we will. And that could take us. And that's where I get into the mid mid thirties. Um, it's a mixed bag, but if I was doing a model, uh, I think we should, you know, when you get out, especially out in a, in a year or two, uh, I would say, uh,
spk04: the mid-30s is probably more realistic all right terrific thanks i appreciate the additional colors our next question comes from tim luther with william blair your line is open hey guys this is lachlan on for tim thanks for taking the questions um i guess first of all you know i appreciate that there's not a lot you can say about sampling and the pull through there but Do you have any sense of, you know, when we should expect to start to see some reliable numbers coming through IQVIA and Symphony that give us a good sense of, you know, how prescribing is going? And secondly, I guess, you know, you mentioned the pipeline briefly in the prepared comments. You know, can you sort of expand on that? What are you thinking, Len, should we expect to see an update there?
spk07: Sure. Yeah, that's Two very good questions. So the first one, you know, for example, say, you know, you know, unlike, you know, it's interesting, you know, we don't point this out, but Zulane, where they do sample, they give one patch out to a woman. So one week of therapy, we give out a full box, which is a trade cycle. And in fact, it's three, it's a month, right? We're giving away a month, a minimum. So, um, If you think about it, you know, we know doctors often give out more than one month. You know, we don't want to oversample, but we know, you know, on average it might be closer to two. So if you think about where we are in the launch cycle, this is why we've been, you know, a bit heavy-handed with, you know, creating expectations on the first quarter and the early days of launch. You know, we think we've got a good month or two ahead of us of heavy sampling. You know, we're actually – happy as I mentioned with the trajectory of the brand with what's actually getting to retail because our reps are really just battling through some of the, I mentioned some of the challenges they've been facing. They really are just been in front of the doctors a handful of times. So we know we need to be in front of them a couple more times. So I think what we see is that the sampling phenomena is going to last, I think, into at least the first quarter. That's why we've been, without being explicit, we just think the first quarter from a TRX you know, point of view is going to be, as we saw a little bit in January, picking up some steam in February, and we would hope the steam continues to pick up in the March. And then we kind of outgrow it a little bit, I think. So I think we're in for at least a quarter, maybe in the early second quarter. But that's the best we could see. Because I think it's just math. You know, we give out at least one month, maybe two. You know, we've seen them in January. I mean, they wrote a prescription. They're not going to pharmacy to March. You know, so I think we've got to work past at least that first bolus into the first, you know, first, you know, quarter. And then down the road, we're calling on multiple doctors in that practice. So we're seeing, you know, as we mentioned to you before, we're targeting group practices, you know, but, you know, we're influencing only a couple of doctors at a time. So there's still a lot of opportunity inside the practice. So we still have got to expand our BCHAT of doctors, you know, and then obviously work through the samples. As far as the second question in your pipeline, I'm very excited about the work Dr. Corner has been doing. Paul Corner has come in. kind of taken a clean sheet of paper you know for our pipeline um you know we've done some market research we've done some technical reviews and we're actually going to probably talk to the fda on kind of what our ideas of the various paths forward and so we would expect you know hopefully in the second half this year to be able to get some clarity on you know what we want to bet on and when we want to bet on them and but i think before we get in front of you what we really want to know is that there's a buy-in with the fda on the path forward so phenomenal amount of work. We tease Paul a lot. I tease him a lot. I said, you probably know more about our pipeline in your short time here than the company's known, you know, because we spent so much of our effort against Corolla. So he's taken a fresh, you know, very healthy look at our pipeline and done some great technical work. And, you know, Amy Walsh, our head of marketing, has done some great consumer insights and physician insights. And we're going to try to marry all that up with some FDA feedback and saying, okay, this is the bet we want to make. So to short answer your question, I think it's going to be in the second half, you know, hopefully before we can give you more clarity. But for now, you should know we're kicking the tires hard, and, you know, hopefully we're excited about our pipeline. I think Paul's inherited, and he would tell you this himself, a lot of tough choices. All of our three programs, you know, appear viable and appear exciting. So I think, if anything, prior to deciding them in the early days of a company like ours, it's going to be the biggest challenge. So more to come, more realistically the second half. You're welcome.
spk03: Our next question comes from . Your line is open.
spk07: Hey, guys. Congrats on the launch and taking my question. I just had a few questions on the managed care. So I know you guys are currently in continuing negotiations, but when can we expect the next meaningful bolus of patients for coverage. And for the patients that are covered, are they seeing $0 copays, or are you guys bringing them down with their copay assistance cards, or has anyone actually had to pay out of pocket so far based on what you know? Yeah, good question. I mean, I think we're going to keep, I think, chipping away at this. I mean, you know, we, you know, we would like to, you know, the big bolus could happen if we can get one, you know, the second and hopefully the third PBM to turn around, you know. But I think in the meantime, we're going to keep chipping away at this. So hopefully we'll continue to kind of an upward climb and picking up lives. There's still a lot of business out there that we can control and we're getting. Because remember, you know, while the PBMs influence a lot of the planned decisions, we also are mindful in certain states, you know, for instance, the state mandates apply. So we see, you know, the PBMs on their contracts you know, we're picking up plans under this, you know what I mean, in certain states. And we're the point I'm saying, look, in my state, I'm going to cover it. So that's good news. So I think you should expect kind of like incremental moves from us, you know, or just incremental, you know, pickups, if you will. And then, you know, what we're seeing as far as coverage, I mean, you know, we haven't seen a lot of cash out of pocket, to answer your question. You know, so we've experienced a lot, a significant amount of the plans that already picked us up at zero co-pays And there's some copays involved. You know, we do have a copay program that does help. But so far, we've not been too over our seas with copays, and we're not seeing a lot of cash. Now, cash could mean they got scared off, too. Even though I haven't seen it, they could have gone to the pharmacy. I'm not paying that. So we haven't seen it, but we're keeping an eye on it, again, but we're studying all this as we get there. But, you know, a lot of zero copays and, you know, the copays that are, you know, that are The plans that are required don't, you know, a lot of them don't look that onerous to us, and we're willing to help out a little bit. This is where sampling happens. And then on the Affordable Care Act, you know, the last piece of the complicated puzzle, if we're not covered under the plan, on the Affordable Care Act, it's our knowledge or our understanding that if a doctor wants, you know, a woman to be on Toralax, he can intervene with a letter of medical necessity. So we are seeing those go through, and doctors and staff are advocating for us and their patients. And then once they free up that patient, he should be good for a length of a therapy. So we're seeing all of these, Bob. You know, I haven't seen that much cash, but I'll take a look at it after the call and make sure I'm over the ground.
spk08: Thanks for taking my question.
spk07: No, you're my pleasure. Thank you.
spk03: There are no further questions at this time. I'll turn the call back over to Al for closing remarks.
spk07: Great. Thank you, Operator. I'd like to just close out today by saying that 2020 obviously was a very important year for Agile. Despite the widespread impact of the pandemic, we were able to persevere, and we continued on our plan and, importantly, accomplishing our goal of launching SquirrelNet, which we were thrilled about. You know, with Agile receiving FDA approval and funding from Perceptive Advisors, and well from an equity financing transaction we did in 2020. We've made a number of key hires, including our chief medical officer, Dr. Paul Corner, and secured a partnership with Cineos to develop our sales force. Finally, despite the inherent challenges in a pandemic operating environment, we're able to address an unmet need in Faye's market with the launch of Twirla. I'm incredibly proud of the hard work and tireless effort of our whole team over the course of this last year. As we look ahead in 2020 and beyond, we are really optimistic and excited about the opportunities before us to help more women find a product that really meets their needs. We're confident we have that product. We have the right people, and we have the right plan in place. We continue to be excited about the early acceptance and growth of Squalane and look forward to continuing this trajectory as we work towards our goal of becoming a leader in women's health. I'd like to thank everybody for joining us on today's call. I know it's a busy season for you all. You know, we wish you well. We wish you to be safe. And we look forward to speaking to you all and hopefully on our first quarter 2021 earnings call. So with that said, I thank you and good night.
spk03: This concludes this conference call. You may now disconnect.
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