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spk01: Good afternoon and welcome to the Agile Therapeutics 3rd Quarter 2021 Financial Results Conference Call. Please note that this event is being recorded. I would now like to turn the conference over to Matt Riley, Head of Investor Relations.
spk04: Hello everyone and welcome to today's conference call to discuss our 3rd Quarter 2021 Financial Results and Corporate Updates. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our financial outlook for the future, management's expectations for our future financial and operational performance, our business strategy, and our assessment of the combined hormonal contraceptive market and the potential market share for Twrla, among other things, regarding our plans, prospects, and expectations. Such statements represent our judgments 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 for 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 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. I will now turn the call over to Al.
spk05: Thank you very much, Matt, and thank you all for joining us this afternoon. In our third quarter, 2021, we once again saw growth in all key performance areas for Tuareg Life. From the end of Q2 2021 to the end of Q3 2021, we saw the following. Total cycles dispensed grew 61%. Total prescriptions, or TRXs, grew 47%. New prescriptions, or NREXs, grew 25%. And refills grew 86%. We're encouraged by the double-digit growth in our prescription demand but we are not content. Our goal is to accelerate the growth of Twirla Brands and reduce our time to profitability. We believe we have the awareness and access programs in place to execute on our plans and intend to make meaningful investments in marketing to help increase demand. I'll delve into these initiatives later on this call. First, let me discuss what we believe are the key takeaways on these performance metrics. Refill growth at 86% is a great sign. Our head of marketing, Amy Welsh, always reminds us that we believe this is a sign of a healthy brand because it tells us women are on Twirla, like Twirla, and are staying on the product. In turn, this gives us the confidence and the longevity of the brand because new patient starts are translating to repeat customers. Second, we want to increase the rate of new prescription growth. When we consider the rate at which toilet prescriptions are being refilled, we believe more new patient starts can lead to more refills and greater overall brand growth. Part of the new prescription equation is also the prescriber count. The prescriber count grew 63% in the quarter to 3,394 total prescribers, and we continue to consistently pick up approximately 100 new prescribers each week. Third, during quarter three, we said twirl of cycles or retail units were expected to grow between 50 and 56% higher than the retail units sold in quarter two, 2021. We saw retail units actually grow at 61% this quarter. And again, we are pleased to see this growth, but are not content. We want more. I'd like also to address the guidance provided during quarter three. During the third quarter, we said we expected quarter three 2021 net sales to be in the range of 1.4 to 1.6 million. We came in slightly under our guidance as wholesalers reduced their channel inventory by approximately eight days. The double-digit growth in prescription demand leads us to believe we have the underlying demand to support the business long-term, and we expect to see the wholesale activity reflected in the near future. Dennis will provide some additional commentary on revenues and inventory reserves for the quarter when I hand over the call to him. We need to accelerate prescription growth, which accelerates the revenue grant, and that is our singular focus. We're executing on initiatives that we believe can help accomplish this goal. For this call, I'd like to discuss three of these initiatives, telehealth, Medi-Cal, and DTC in our influencer program. First, telehealth. In the third quarter of 2021, we announced a partnership with Pandia Health, a telehealth service provider, which is now active. Pandia offers an additional point of access for Twirly in a fast-growing channel and represents the first telehealth alliance for our company and our product. We're excited to enter telehealth as its use in the contraceptive care has grown over the past several years, and has come into the spotlight during the COVID-19 pandemic. We always believed telehealth was a priority channel for our target consumer prior to the pandemic, and we believe it's even more so now. To that end, we continue to explore additional telehealth partnerships to maximize our footprint in this channel. Because Twirla became available on payday at the very end of the third quarter, we expect to start seeing its contribution to our tier Xs as we progress through the fourth quarter of 2021 and into 2022. Second, Medi-Cal. As we previously announced, the California Medicaid program placed Twirla on the preferred drug formulary list effective October 1st, 2021. This secured a preferred position for Twirla on the formulary for Medi-Cal and its related programs which provides healthcare to approximately 15 million beneficiaries. This is significant for Swirla because Medi-Cal is the largest Medicaid program in the U.S., and we believe roughly one-third of the existing contraceptive patch market comes from Medicaid. Again, this just went into effect at the beginning of the fourth quarter of 2021, and we expect to start seeing this contribution to our business as we progress through quarter four of 2021 and into 2022. Third, DTC and our influencer program. We believe that our DTC advertising program can perhaps have the biggest impact on NRX growth. We recently activated branded influencer program to increase awareness of Twirla as birth control options and encourage women in our target market to engage in open conversation about the product. We are focused on leveraging influencers via Instagram and ensuring this program focuses on TWRLA through clinic storytelling, which further is supported by our paid social amplification to reach even a broader audience. Our influencers include individuals of varying tiers from micro to macro, which we believe will allow us to optimize the unique benefits each level of influencer offers. We rolled out our first wave of activity in early October and are seeing the type of engagement we envision, not just likes and impressions, but also in the comments and conversation. We are pleased with the first wave of influencers and posts. We continue to focus here to reach our target market. We previously discussed our plans for DT advertising and are pleased to announce that Twirla is the first prescription birth control brand to launch branded podcasts on Spotify. Twirla is also the first birth control brand to run branded content across BuzzFeed, leveraging their social handles across Facebook, Instagram, and Snapchat. Finally, and importantly, we are partnering with U.S. soccer star Carly Lloyd as our corporate spokesperson. As corporate spokesperson, we believe she will help amplify the message of our commitment to women's health. As the partnership really kickstarts later this year and throughout 2022, you can expect to see Carly Lloyd promoting Agile and its mission on Instagram and Facebook, where she has a combined 2 million followers. These are important initiatives, which we believe build our business. At the top of the call, I reported we saw growth on all our key brand performance metrics. This is without the contributions of any of the programs I just mentioned. As we continue to implement these programs, we believe they will contribute significantly to increase product awareness, uptake, and growth acceleration as we finish 2021 and enter 2022. I also want to review two other announcements from the third quarter that we anticipate having positive impact on our overall business. First, the appointment of Josephine Terente to our Board of Directors. Josephine is a highly experienced regulatory expert who we believe can contribute to our growth of our company through her strategic insights on the FDA regulatory process and her experience evaluating business development opportunities. We believe this will be useful as we evaluate our own pipeline and explore other ways to expand our business. Second, the Patient Protection Affordable Care Act, or ACA, established an important standard for coverage of contraceptives. Nearly all the commercial and Medicaid coverages are required to cover the full range of female-controlled contraceptives without cost-sharing, such as coinsurance, copayments, or deductibles. Despite the APA protection and the government's guidance on implementation, women around the country are not getting the contraceptive they need or are prescribed or entitled to at no cost. Recently, health committee leaders the National Women's Law Center, and the Family Planning Council all urged the Biden administration to clarify and enforce the regulations to ensure consumers access to a full range of FDA-approved contraceptives. We believe this issue has been an impediment to prescribing and the uptake of all new, innovative contraceptive products, including Swirly, that has been approved by the FDA since the ACA's passage. Kimberly Whalen leads our policy and advocacy and market access for Agile and is closely following this development for us. We hope to see the Biden administration address this important issue and ensure all women have access to contraception that has been decided as medically appropriate between the patient and their provider. We believe that we've been able to grow despite this access barrier, and we applaud the congressional chairs for urging enforcement. I'll now turn it over to call to Dennis to provide you more clarity about the third quarter from a financial perspective. Dennis, take it over. Dennis Dixon Thank you, Al. My goal here is to highlight key financial areas related to our financial performance and our cash position, then move over to Q&A so we can answer your questions. In the third quarter of 2021, we realized net product revenue of $1.3 million on sales. As Al stated, this came in slightly under our guidance as our wholesalers reduced their channel inventory by approximately eight days, the equivalent of $115,000 to $160,000 in net sales. In addition, we made some increases on our gross to net revenue allowances. Our cost of product revenue for Q3 2021 was $2.7 million and included a $1.4 million inventory obsolescence charge.
spk04: This reflects our initial reserve for inventory that is not expected to be sold prior to its shelf life date. which is 12 months prior to expiry.
spk05: Our operating expenses were $14.4 million in Q3 2021 versus $14.7 million in the same period a year ago. We remain focused on maintaining our disciplined spending approach and making the right investments to encourage strategic growth and maximize shareholder value. while implementing what we believe to be impactful partnerships and agreements. We anticipate our quarterly spending for the fourth quarter 2021 to be in the range of $15 to $18 million, with increases reflecting commercial spending on product sample batches and branded markets. We close out the third quarter of 2021 with a net loss of $16.8 million, or 18 cents per share, compared to net loss of $15.5 million, or 18 cents a share for the comparable period in 2020. As of September 30th, 2021, we had cash and cash equivalents of $14.7 million, compared to $31.1 million of cash in cash equivalent at the end of the second quarter, 2021. Most recently, we raised an additional $21.1 million of net proceeds in a public offering.
spk04: We will require additional capital to achieve our goal of profitability. We anticipate that as we accelerate sales growth, our optics on revenue will become clearer and allow us to better define the path and timeline to profitability.
spk05: We continue to evaluate all options available to us to finance the company. We were thrilled to see Perceptive Advisors once again support our company in our most recent raise, as well as several other high-profile institutions. We currently have no plans to further leverage the company with debt and pull down additional funds under the perceptive facility. We'll continue to explore various business development and partnership opportunities in our quest to accelerate our path to profitability. We're happy to expound on any of these areas discussed during today's call, and operators, you can now open up for questions.
spk01: Thank you. As a reminder, to ask your question, just press star and then the number one on your telephone keypad. Again, just press star and then the number one on your telephone keypad. And to withdraw your question, just press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Leyland Gershel from Oppenheimer. Please proceed with your question.
spk04: Oh, good afternoon. Thank you very much for taking my question. Congratulations on the progress.
spk05: Very encouraging to see the 86% rate of refills. A couple of questions from me.
spk04: Wanted to ask first in terms of the inventory at wholesalers. Dennis, you mentioned the eight days scaling down. Just wondering if there's any expectations for any further shifts in inventory in the channel or if that should be stable from now on. Also wanted to ask with respect to the recent initiatives by the NWLA and Congress, those letters, with respect to the ACA coverage. I want to note, one, if you can provide us with any, even if just qualitative feedback on to what extent Torla may have had challenges getting covered because of noncompliance on the part of payers under the ACA guidelines, and also on any outlook on when we may see action being taken
spk05: um, um, following those, those letters. Thanks very much. Thanks Leland. Dennis, you want to take the first one and I'll take the ACA. Yeah. I, I mean, we, we anticipate we're there on the, uh, on the wholesalers. Um, you know, we don't have control over them in any sense, but we do believe they're running pretty lean now. And so I, I, we expect our, uh, our scripts and ultimately our cycle sales, which is a month's supply, to start to match up very closely in Q4 and going forward with actually wholesaler sales. So I would say they're in sync going forward. My only other comment, thank you for your questions. My only comment is we thought they were at status It took us down another eight days, which, you know, a bit surprised us, but it wasn't twirl only. Really, they're just contracting. I mean, you know, we've seen it across all the books of business. So we think we're in steady state, but we thought that before. But, you know, we'll continue to monitor it. But at this point, I don't know how much more lower they can go. It's almost just in time inventory at this point, Dennis, I would think. So about the Affordable Care Act, your second comment, Leland. Yeah, so how has it impacted twirlers? So just to recap. kind of laid this out for the listeners. There's two parts of the ACA when we talk about compliance. You know, I think everybody knows now that there's 18 forms of contraceptive. There's this famous chart that, you know, they cite. And the plans are required to carry one of every product, including a patch. So that's part A, Leland. So I think part B is the one that we think, and it's not as well discussed, you know, but if a doctor wants a woman to be on Tarla, There's a form that you'll see in our website, twirla.com, called Letter of Medical Necessity. By law, you know, it's not a prior auth. By law, if a doctor says, I want this woman on Twirla, you know, the plan cannot say no. The decision is up to the doctor. It's not a prior auth. It's not like anything else we've seen. It's a very unique aspect. We have seen a lot of denials for Twirla and a lot of the new brands. You know, so... It's just not us. So the insurance companies are basically saying, and their PBMs are saying, now we're just going to deny it, and doctors go away. So that's why we set up Sterling Drug and people like that that say, no, no, no, that's not how it works. So it just creates a bit of a kind of a headwind with the doctor's mind that this drug is hard to get across the goal line. Now it's improving a lot. But it certainly held us back. And the interesting part is, I know you've read these documentations, which I would encourage you. This is not just in the commercial plans. Unfortunately, it's in Medicaid. It's also in the government's own plans. Their own books of business and their own employees aren't getting the access they deserve. So like I said, we really, really applaud all three organizations. for stepping up, you know, and it's the voice of, you know, Congress, it's the voice of the Women's Law Center, who's been the person in the courts fighting a lot of these cases over the years about the ACA, and it's the women's group. So, you know, each one of them spoke with a pretty loud voice, as we are, you know, that this wasn't the way the law was intended. So we need to clarify this again, you know, again, it's been clarified before, and we'd encourage to, if necessary, to be enforcement, you know, something's got to change. Despite that, we're proud to grow. I mean, to put up the growth we've done, you know, as you might imagine, I'm very proud of the organization. So when's it going to get fixed, Leland? That's the question Mr. Riley asks me all the time. You know, we just don't know. There was a short turnaround time on the congressional letter that was probably too short. So we are aware of some conversations that are going on at the highest levels, you know, but we expect – action you know um now the action what it'll mean most likely um hopefully they'll re-clarify all this um for the for the industry and if necessary take enforcement action but um you know we think we still think we have our better days ahead of us on this it just makes writing our drug a lot easier um you know and ideally we'd love to be on all One of the letters actually went as far as saying all the brands should be available. Every FDA product should be available. Why are we dealing with this chart? Why don't make everybody available for no copay? Because that really was the intent of the act. So that's the home run. So if we can't get the home run, just to be able to get the prescriptions and the doctor's wishes would certainly be a win for us. Thank you for your comment about refills. I'm thrilled. It just speaks to this brand and the stickiness of this brand and, you know, women just liking this product. It just makes us feel great and just gives a beachhead of volume every week to build off Llewelyn. So it's a nice day.
spk04: Terrific.
spk05: Terrific. Thanks so much, Alan Dennis. It's about the queue. Thanks. Thanks, Llewelyn.
spk01: Thank you. The next question comes from the line of Oren Livnitz from HC Wainwright. Please proceed with your question.
spk02: Thanks. I have a few, if you'll indulge me. Just quickly on the ACA mandate situation, how relevant is there that there is a Zulane generic out there now? I mean, we know that they're not even living up to their promise, probably, of even covering one of every form under ACA. But even if they were to meet that low bar, do you think you would still have some challenges getting coverage in that regime, given Zulane and Zephemi, or however you pronounce it, are out there? And then I have a couple follow-ups.
spk05: Yeah, Lauren, great question. Yeah, so So there's kind of like part A and part B. So, you know, the best we can see, you know, people are supposed to make, let's be specific about a patch, either us or Zulane or Zelfemini available on the plans. The best we could see, it appears they've done that. So that's the part A. So I think from a compliance perspective and, you know, and following it'll act or they seem to be in compliance there. The part B of the act is let's use a situation that we're not on formulary. Zulane's on formulary. um in the zero copay so we could be on formulary on a non-zero copay we could be a let's say um you know forty dollar fifty dollar copay you know we're not getting a zero or the preferred so in that case we can deploy our you know that's easy for us to handle we can deploy some um couponing and you know and handle that but let's say we're locked out so we're all formulary in that situation you go to our website you pull down that form the doctor fills it out and that script's supposed to walk not only the first time, Oren, but every time she goes in the fill. She's on it. She's got a, you know, in the system. That's where we're seeing, you know, a lot of the resistance, you know, to comply with that part of the Affordable Care Act. So it's, you know, that just, again, you know, doctor goes to trouble, fills this out for a woman, she gets denied again, and they more than likely just want to go back to the zoo leave. you know, that's the battles we're fighting, you know, but now with that said, contextualize COVID for what we've been through with COVID and this resistance we're getting in some of the plans and just try to put our growth in perspective on that. So I do believe that if these, if nothing else, if these letters of medical necessity are just go through the system as intended, they should go through it, you know, in a very short amount of time. And then the patient by time she gets the pharmacy should have that drug and then she should be freed up. So that's, That's the way in the simplest form it works.
spk02: Okay. And then if I just follow up on that, you did mention in the quarter the growth to nets were up. I assume that means sequentially over 2Q. Is that simply a reflection of just having to have increased? patient assistance utilization in light of the challenges you've just, you know, covered? Or is that also potentially reflecting actual contracting some, you know, some economics that you've worked out to get coverage on the payer side? And in the meantime, you know, where you don't have coverage and you don't have ACA compliance, you know, how are you making sure that doctors don't get, you know, frustrated and give up so that they can, you know, continue to keep writing it and patients keep getting it one way or another, you know, profitably or otherwise, so that, you know, down the road, you can convert all that, you know, into, you know, sustainable revenue.
spk05: Yeah, I'll do the second part, and then I'll comment, and you can correct me if I'm wrong on the gross net. So the last part of your last question, you know, the simplest way our reps do this is they just tell a doc, just give us the script. Transmit the script to Sterling. Sterling are experts at processing those claims. We are seeing a lot more of our business run through Sterling. So we just basically tell the doc, say, hey, doc, just send it to us. We'll adjudicate it. We'll do the insurance claims, and we'll do this letters of medical necessity if we need to. And then the patient gets the choice. Let's say everything goes through swimmingly, and we get the patient across the goal line. What happens, Lauren, we could say to the patient or the doc saying, we can ship the drug to our house or we could ship it to our local CVS. So it's a concierge service, in effect, that makes the doctor's life easier. So our best reps are the ones that just say, hey, doc, why work with this? Just give them to us. Now, if we know we're on a plan, like in a big, big area that we've got a lot of great coverage, we shouldn't have to do that. You know, there are major books of business that we could just say, look, and Connecticut and Medicaid, it goes through. And Medi-Cal is going to go through. You don't even need to do these gymnastics. So if we can point to big plans, Oren, it's a lot easier just to do it that way. And then I'll comment on the growth in that, and then Dennis could, you know, correct me if I'm over my skis. But, look, we're seeing more of our business running through Medicaid, as we would expect, as we've signaled. That's an important part of our business. Remember, in the first and second quarter, we didn't have much Medicaid coverage. So we're seeing Medicaid becoming more apart. So that's a little bite of the apple. And then I think the other one is copay cards generally. You know, the more we're dealing with copays, copay utilization has creeped up. But I think there's a lot of little, Dennis. But are they the two headlines that I should remember? Yeah, those are it. And the copay being the one that kind of came up, well, both came up a bit with copay even a little bit more at this quarter.
spk02: Can you tell us what the growth tenets are sort of? All in?
spk05: You know, we're still in, like, the low 30s on discounts, including the 12% from the wholesalers, you know.
spk03: Okay.
spk02: Well, thanks. Thanks, Art.
spk01: Thank you. Once again, as a reminder, to ask your question, just press star and then the number one on your telephone keypad. Again, just press star and then the number one on your telephone keypad. For the next question, we have now the line of Tim Lago from William Bear. Please proceed with your question.
spk03: Hi, Tim. This is John. I'm for Tim. Thanks so much for taking our questions. Just two from us. So first, I wanted to say congrats on the new marketing efforts. and I was wondering if you could give an update on your previously announced campaign, such as your efforts on the dating app. Do you have any updates on how those campaigns are progressing, and do you have any insight into how they've been translating into scripts? And second, on previous calls, you've noted that about half of your patients have been brand new to contraception, about a quarter switches from pills, and the remainder are mixed. Are those still the trends that you're seeing, or is there any indication that mix is changing? Thanks.
spk05: Yeah, no, thank you for the questions. I mean, um, No, the mix, you know, based on the last time I looked at the data, hasn't changed. So, directionally, what you just quoted is still there. About half our business comes from what we believe is a new start. You know, she could have been on drugs before and maybe had a baby and reentered, but she looks like a new patient to us and about 25% come from a pill. So, that is our major source of knowledge. You know, dating apps, you know, just in general, the marketing campaigns, we're encouraged by what we're seeing. I mean, our... when we just started heavying up our spends, you know, I think we mentioned in the second quarter was pretty light spending in DTC on a relative basis. Third quarter is the first time we won at it, you know, for the most part, full bore, you know, at the levels we thought we should. And we saw our, first of all, our website light up, which is very encouraging. You know, so we're seeing like a tenfold increase in our hits through our twirler.com. But equally as important or more important, we're seeing prescriptions. One of the things we look at is we look at where our prescriptions are coming from, and we're starting to see prescriptions starting to show up in parts of the country that we don't have reps in. So I'd love to give my sales – because I do think it works in harmony in a perfect world. But we're starting to see a fair number of business coming from pure, pure white space that we have not been in front of before. which is, to me, an indicator that it's working. So it works better if we have a rep there. And then the dating app specifically, you know, every metric that we've seen or we would have expected, because basically we're buying media. So we're saying we're buying eyeballs, right? So in that case, we're buying through the dating apps. We're off the charts in the execution, so we're just getting more visits, you know, more continuity on these apps. That seems to be our highest-performing, media, you know, on the dating apps, which I know is obvious, but we actually rank them. We say, it's like buying advertising. You say, I bought advertising in 10 magazines in the old days, and which one worked better? We're actually able to tell, you know, which ones are getting the most traffic and the most pull-through and the most eyeballs, and that's top of the list. I think the answer, if Amy was here, she would say she's thrilled with that idea, because it's unique. It's perfectly targeted, and it's actually, you know, outperformed all our metrics, but Still early days. I mean, we still got to see our campaign run a little bit longer. It's only been kind of a few months running at full bore. So we're excited to leave it out there a little bit longer and see what's happening and keep it fresh.
spk03: All right. Thanks again for the update and congrats on the progress.
spk05: Oh, thank you.
spk01: Thank you. Once again, as a reminder, to ask your question, just press star and then the number one on your telephone keypad. There are no further questions sent to you. I will now turn the call back to Al. First of all, thank you, operator.
spk05: Thanks to Matt and Dennis also for your help on the call. So hopefully you had a couple takeaways tonight. You know, number one, first and foremost, we need to remind ourselves we have an approved product that's growing in a very large multibillion-dollar market. We discussed tonight some of the challenges we faced, but we pushed through, and particularly today, with some of the larger challenges that faced our company and our brand, but I'm ecstatic with the brand's performance and the potential of this brand. You know, we have the cash to support our business and anticipate that as sales grow, our optics on revenue, you know, become more and more clearer. So, you know, it'll be much easier for us to define our path to profitability because that's our singular quest in the company to become profitable and sustainable companies. You know, we believe that these initiatives, you know, have been effective, that, you know, that have helped expand Twirla's access, and particularly our DTC programs that we think are aimed at accelerating our growth. We'll continue to explore and implement additional partnerships and keep you updated on those. You know, we continue to look for other opportunities to expand the brand and expand its reach. There's a lot more of the market that we still think we can get at. So, I'm pleased with the progress. You should expect more progress from us, and we'll keep you updated on future calls. But thank you, everybody, for joining the call tonight and keeping track of us and keeping updated on what's starting to be a real exciting story. So thank you all, and everybody have a good night.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect.
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