NASDAQ:AGRX Agile Therapeutics Q3 2021 Earnings Report Profile Agile Therapeutics EPS ResultsActual EPS-$7.20Consensus EPS -$7.60Beat/MissBeat by +$0.40One Year Ago EPS-$7.20Agile Therapeutics Revenue ResultsActual Revenue$1.29 millionExpected Revenue$1.49 millionBeat/MissMissed by -$200.00 thousandYoY Revenue GrowthN/AAgile Therapeutics Announcement DetailsQuarterQ3 2021Date11/2/2021TimeAfter Market ClosesConference Call DateMonday, November 1, 2021Conference Call Time8:00PM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Company ProfileSlide DeckFull Screen Slide DeckPowered by Agile Therapeutics Q3 2021 Earnings Call TranscriptProvided by QuartrNovember 1, 2021 ShareLink copied to clipboard.Key Takeaways Twirla achieved double-digit growth in Q3 2021 with cycle dispenses up 61%, total prescriptions (TRx) up 47%, new Rx up 25%, and refills up 86%, demonstrating strong patient retention and brand health. Agile expanded access and awareness through a telehealth partnership with Pandia Health, preferred Medi-Cal formulary placement, branded podcast launches on Spotify, BuzzFeed social content, and an influencer campaign featuring US Soccer star Carly Lloyd. Management highlighted ACA coverage challenges as insurers have denied contraceptive claims despite legal mandates, prompting letters from Congress and women’s rights groups urging enforcement to ensure patient access. Financially, Q3 net product revenue was $1.3 million (slightly below guidance due to an 8-day inventory reduction), operating expenses were $14.4 million, net loss was $16.8 million, and cash stood at $14.7 million, with a subsequent $21.1 million capital raise; additional funding remains necessary to achieve profitability. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAgile Therapeutics Q3 202100:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:02Good afternoon, and welcome to the Agile Therapeutics third quarter 2021 financial results conference call. Please note today's event is being recorded. I would now like to turn the conference over to Matt Riley, Head of Investor Relations. Matt RileyHead of Investor Relations at Agile Therapeutics00:00:19Hello, everyone, and welcome to today's conference call to discuss our third quarter 2021 financial results and corporate update. 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 Twirla, among others, 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. Matt RileyHead of Investor Relations at Agile Therapeutics00:01:14We 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 a prescribing decision. 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. I will now turn the call over to Al. Al AltomariChairman and CEO at Agile Therapeutics00:01:41Thank 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 Twirla. From the end of quarter two, 2021, to the end of quarter three, 2021, we saw the following. Total cycles dispensed grew 61%. Total prescriptions for TRx grew 47%. New prescriptions for NRx grew 25%. 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 brand 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. Al AltomariChairman and CEO at Agile Therapeutics00:02:46First, let me discuss what we believe are the key takeaways on these performance metrics. First, 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 who are on Twirla like Twirla and are staying on the product. In turn, this gives us the confidence in 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 Twirla 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. Al AltomariChairman and CEO at Agile Therapeutics00:03:39The 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 Twirla 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. 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 million-$1.6 million. We came in slightly under our guidance as wholesalers reduced their channel inventory by approximately eight days. Al AltomariChairman and CEO at Agile Therapeutics00:04:40The 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 reflect this 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 ramp, 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, and 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. Al AltomariChairman and CEO at Agile Therapeutics00:05:32Pandia offers an additional point of access for Twirla in this 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 Pandia at the very end of the third quarter, we expect to start seeing its contribution to our TRx access as we progress through the fourth quarter of 2021 and into 2022. Second, Medi-Cal. Al AltomariChairman and CEO at Agile Therapeutics00:06:27As we previously announced, the California Medicaid program placed Twirla on the preferred drug formulary list effective October 1, 2021. This secured a preferred position for Twirla on the formulary for Medi-Cal and its related programs, which provide health care to approximately 15 million beneficiaries. This is significant for Twirla because Medi-Cal is the largest Medicaid program in the U.S., and we believe roughly 1/3 of the existing contraceptive patch market comes from Medicaid. This just went into effect at the beginning of the fourth quarter of 2021, and we expect to start seeing its 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. Al AltomariChairman and CEO at Agile Therapeutics00:07:29We recently activated branded influencer program to increase awareness of Twirla as birth control options and encourage women in our target markets to engage in open conversations about the product. We are focused on leveraging influencers via Instagram and ensuring this program focuses on Twirla through client 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 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 envisioned, not just likes and impressions, but also in the comments and conversations. We are pleased with the first wave of influencers and the posts. We continue to focus here to reach our target market. Al AltomariChairman and CEO at Agile Therapeutics00:08:32We previously discussed our plans for DTC advertising and are pleased to announce that Twirla is the first prescription birth control brand to launch branded podcast 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 Carli 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 kick-starts later this year and throughout 2022, you can expect to see Carli 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. Al AltomariChairman and CEO at Agile Therapeutics00:09:35This 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 increased 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 impacts on our overall business. First, the appointment of Josephine Torrente 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. Al AltomariChairman and CEO at Agile Therapeutics00:10:26Second, the Patient Protection and 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 co-insurance, co-payments, or deductibles. Despite the ACA protection and the government's guidance on implementation, women around the country are not getting the contraceptives they need or are prescribed or are 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 regulation 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 Twirla, that has been approved by the FDA since the ACA's passage. Al AltomariChairman and CEO at Agile Therapeutics00:11:31Kimberly Whaley 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 over the call to Dennis to provide you more clarity about the third quarter from a finance perspective. Dennis, take it over. Dennis ReillyCFO at Agile Therapeutics00:12:14Thank 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-$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. Dennis ReillyCFO at Agile Therapeutics00:13:14This 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. 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 million-$18 million, with increases reflecting commercial spending on product sample batches and branded marketing. Dennis ReillyCFO at Agile Therapeutics00:14:18We close out the third quarter of 2021 with a net loss of $16.8 million or $0.18 per share, compared to net loss of $15.5 million or $0.18 a share for the comparable period in 2020. As of September 30, 2021, we had cash and cash equivalents of $14.7 million compared to $31.1 million of cash and cash equivalents at the end of the second quarter, 2021. Most recently, we raised an additional $21.1 million of net proceeds in a public offering. 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. Dennis ReillyCFO at Agile Therapeutics00:15:26We 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. Operator, you can now open up for questions. Operator00:16:13Thank 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. 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 Leland Gershell from Oppenheimer. Please proceed with your question. Leland GershellManaging Director and Senior Biotechnology Analyst at Oppenheimer00:16:42Good afternoon. Thank you very much for taking my question. Congratulations on the progress. Very encouraging to see particularly the 86% rate of refills. A couple of questions from me. Wanted to ask first in terms of the inventory of wholesalers, Dennis, you'd mentioned that 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. Leland GershellManaging Director and Senior Biotechnology Analyst at Oppenheimer00:17:08Also wanted to ask with respect to the recent initiatives by the NWLC and Congress, those letters with respect to the ACA coverage. I wanted to note one, if you can provide us with any even if just qualitative feedback on to what extent Twirla may have had challenges getting covered because of non-compliance on the part of payers under the ACA guidelines and also on any outlook on when we may see action being taken following those letters. Thanks very much. Al AltomariChairman and CEO at Agile Therapeutics00:17:44Thanks, Leland. Dennis, you wanna take the first one, and I'll take the ACA? Dennis ReillyCFO at Agile Therapeutics00:17:48Yeah, I mean, we anticipate we're there on the wholesalers. You know, we don't have control over them in any sense, but we do believe they're running pretty lean now. We expect 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. I would say they're in sync going forward. Al AltomariChairman and CEO at Agile Therapeutics00:18:24Yeah, Leland, I think my only other comment, thank you for your questions. You know, my only comment is, you know, like we thought they were at steady state. It took us down another eight days, which, you know, a bit surprised us, but it wasn't Twirla only. It was really, they're just contracting. I mean, you know, we've seen it across all the books of business. We think we're at 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 Twirla? Al AltomariChairman and CEO at Agile Therapeutics00:19:04Just to kind of lay this out for the listeners, there are two parts to the ACA when we talk about compliance. You know, I think everybody knows now that there are 18 forms of contraceptive. There is this famous chart that, you know, they cite, and the plans are required to carry one of every product, including a patch. That is part A, Leland. I think part B is the one that we think, and it is not as well discussed and, you know. If a doctor wants a woman to be on Twirla, there is a form that you will see on our website, twirla.com, called a letter of medical necessity. By law, you know, it is not a prior auth. By law, if a doctor says, "I want this woman on Twirla," you know, the plan cannot say no. Al AltomariChairman and CEO at Agile Therapeutics00:19:51The 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, it's just not us. The insurance companies are basically saying, and their PBMs are saying, "No, we're just gonna deny it," and doctors go away. That's why we set up Sterling Pharmacy and people like that say, "No, that's not how it works." It just creates, you know, a bit of a, kind of a headwind with the doctor's mind that, you know, that this drug is hard to get across the goal line. It's improving a lot, but it, you know, certainly held us back. Al AltomariChairman and CEO at Agile Therapeutics00:20:30The interesting part, if any of you have read these documentations, which I would encourage you, this is not just in the commercial plans. Unfortunately, it's in Medicaid, and 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. You know, like I said, we really applaud all three organizations for stepping up, you know. 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. 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. Al AltomariChairman and CEO at Agile Therapeutics00:21:13We need to clarify this again. You know, again, it's been clarified before, and we'd encourage there, if necessary, to be enforcement. You know, something's gotta 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. When does it get fixed, Leland? That's the question Mr. Reilly asks me all the time. We just don't know. There was a short turnaround time on the Congressional letter that was probably too short. We are aware of some conversations that are going on at the highest levels. But we expect action, you know. Al AltomariChairman and CEO at Agile Therapeutics00:21:53Now the action, what it'll mean most likely, hopefully they'll reclarify all this for the industry and, if necessary, take enforcement action. You know, we still think we have our better days ahead of us on this. It just makes writing our drug a lot easier. 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 not make everybody available for no copay? Because that really was the intent of the act. That's the home run, you know. 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. Al AltomariChairman and CEO at Agile Therapeutics00:22:35You know, I 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 of, Leland. It's a nice day. Leland GershellManaging Director and Senior Biotechnology Analyst at Oppenheimer00:22:55Terrific. Thanks so much, Al and Dennis. That's about the queue. Al AltomariChairman and CEO at Agile Therapeutics00:22:58Thanks. Thanks, Leland. Operator00:23:00Thank you. The next question comes from the line of Oren Livnat from H.C. Wainwright. Please proceed with your question. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:23:09Thanks. I have a few, if you'll indulge me. Just quickly on the ACA mandate situation, how relevant is it that there is a Xulane 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 Xulane and Zafemy or however you pronounce it are out there? I have a couple follow-ups. Al AltomariChairman and CEO at Agile Therapeutics00:23:45Yeah, Oren, great question. Yeah. There's kind of like part A and part B. You know, the best we can see, you know, people are supposed to make, let's be specific about a patch, either us or Xulane or Zafemy, available on the plans. The best we can see, it appears they've done that. That's the part A. I think from a compliance perspective and, you know, in following the ACA, Oren, 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, Xulane is on formulary, in the $0 copay. We could be on formulary on a non-$0 copay. We could be. Let's say, you know, $40, $50 copay. You know, we're not getting the $0 or the preferred. Al AltomariChairman and CEO at Agile Therapeutics00:24:31In that case, we can deploy our, you know, that's easy for us to handle. We can deploy some couponing and things, you know, and handle that. Let's say we're locked out, so we're off 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 to 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. Al AltomariChairman and CEO at Agile Therapeutics00:25:04It's you know, that's just again, you know, doctor goes to the trouble, fills this out for a woman, she gets denied again, and they more than likely just wanna go back to Xulane. You know, that's the battles we're fighting, you know. 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. I do believe that if nothing else, if these letters of medical necessity just go through the system as intended, that they should go through in you know, in a very short amount of time and then the patient, by the time she gets to the pharmacy, should have that drug, and then she should be freed up. That's the way in the simplest form it works. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:25:48Okay. If I just follow up on that. You did mention in the quarter the net sales were up. I assume that means sequentially over Q2. 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 reflects some actual contracting, you know, some economics that you've worked out to get coverage on the payer side? 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? Al AltomariChairman and CEO at Agile Therapeutics00:26:43Yeah, I'll do the second part, and then, Dennis, I'll comment, and you can correct me if I'm wrong on the gross net. 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 a script. Transmit the script to Sterling." Sterling are experts at processing those claims. You know, we are seeing a lot more of our business run through Sterling. So you know, that we just basically tell the doc, say, "Hey, doc, like, just send it to us. We'll adjudicate it. We'll do the insurance claims if legal and we'll do this letter of medical necessity if we need to." Then the patient gets the choice. Al AltomariChairman and CEO at Agile Therapeutics00:27:18Let's say everything goes through swimmingly, and we get the patient across the goal line. What happens, Oren? We could say to the patient or the doc, saying, "We can ship the drug to her house, or we could ship it to her local CVS." It's a conciergerie service in effect that makes the doctor's life easier. Our best reps are the ones that just say, "Hey, doc, why work with this? Just give them us." Now, if we know we're on a plan, like in a 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, in Connecticut Medicaid, it goes through. In Medi-Cal, it's gonna go through. Al AltomariChairman and CEO at Agile Therapeutics00:27:55You don't even need to do these gymnastics. If we could point to big plans, Oren, it's a lot easier just to do it that way. I'll comment on the gross to net, and then Dennis could, you know, correct me if I'm over my skis. You know, 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. We're seeing Medicaid becoming more a part. That's a little bite of the apple. I think the other one is copay cards generally. You know, the more we're dealing with copays, copay utilization has crept up. I think there's a lot of little, Dennis. Are they the two headlines that I should remember? Dennis ReillyCFO at Agile Therapeutics00:28:33Yeah, those are it, and the copay being the one that kinda came up. Well, both came up a bit, but copay even a little bit more this quarter. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:28:45Can you tell us what the gross to nets are, sort of all in? Dennis ReillyCFO at Agile Therapeutics00:28:50You know, we're still in like, the low thirties on discounts including the 12% from the wholesalers. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:29:02Okay. Well, thanks. Got to get back to Al AltomariChairman and CEO at Agile Therapeutics00:29:06Thanks, Oren. Operator00:29:10Thank 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 Lugo from William Blair. Please proceed with your question. Analyst at William Blair00:29:29Hi, team. This is John on for Tim. Thanks so much for taking our questions. Just two from us. First one is to say congrats on your new marketing efforts. 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? 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 a mix. Are those still the trends that you're seeing, or is there any indication that mix is changing? Thanks. Al AltomariChairman and CEO at Agile Therapeutics00:30:04Yeah. No. Thank you for the questions. I mean, no, the mix, you know, based on the last time I looked at the data, hasn't changed. 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 drug before, maybe had a baby and come reentered, but she looks like a new patient to us, and about 25% come from a pill. That is our major source of volume. You know, dating apps, you know, just in general, the marketing campaigns, we're encouraged by what we're seeing. I mean, when we just started heavy on our spends, you know, in the second quarter, I think we mentioned, was pretty light spending in DTC on a relative basis. Al AltomariChairman and CEO at Agile Therapeutics00:30:45Third quarter is the first time we went at it, you know, for the most part, full bore, you know, at the levels we thought we should. We saw our, first of all, our website light up, which is very encouraging. You know, we're seeing like a tenfold increase in our hits to our twirla.com. Equally as important or more important, you know, 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. I'd love to get my sales to because I do think it works in harmony in a perfect world. Al AltomariChairman and CEO at Agile Therapeutics00:31:21You know, we're starting to see a fair number of business coming from pure white space that we have not been in front of before, which is, to me, an indicator that it's working. It works better if we have a rep there. The dating app specifically, you know, every metric that we've seen or we would have expected, because basically we're buying media. We're saying we're buying eyeballs, right? In that case, we're buying through the dating apps. We're off the charts in the execution. 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. Al AltomariChairman and CEO at Agile Therapeutics00:32:02You 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. That's top of the list of where 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. 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 it full bore, so we've decided to leave it out there a little bit longer and see what's happening and keep it fresh. Analyst at William Blair00:32:41All right. Thanks again for the update and congrats on the progress. Al AltomariChairman and CEO at Agile Therapeutics00:32:44Oh, thank you. Operator00:32:49Thank 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. Al to you. Al AltomariChairman and CEO at Agile Therapeutics00:33:26Yeah. Operator00:33:27Please go ahead. Al AltomariChairman and CEO at Agile Therapeutics00:33:27First of all, thank you, operator. Thanks to Matt and Dennis also for your help on the call. 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, you know, large multi-billion-dollar market. We discussed tonight some of the challenges we faced, but we pushed through, and particularly with some of the larger challenges that faced our company and our brand. I'm ecstatic with the brand's performance and the potential of this brand. You know, you know, we have the cash to support our business and that we anticipate that as sales grow, our optics on revenue, you know, become more and more clearer. Al AltomariChairman and CEO at Agile Therapeutics00:34:09You 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. You know, we believe that these initiatives have been effective, that helped expand Twirla's access, in particular 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. I'm pleased with the progress. You should expect more progress from us, and we'll keep you updated on future calls. Thank you, everybody, for joining the call tonight and keeping track of us and keeping updated on what's starting out to be a real exciting story. Thank you all, and everybody have a good night. Operator00:35:04This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesAl AltomariChairman and CEODennis ReillyCFOMatt RileyHead of Investor RelationsAnalystsLeland GershellManaging Director and Senior Biotechnology Analyst at OppenheimerOren LivnatManaging Director and Senior Healthcare Analyst at H.C. WainwrightAnalyst at William BlairPowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Agile Therapeutics Earnings HeadlinesAgile Therapeutics, Inc.: Agile Therapeutics Inc. Announces Completion of Acquisition by Insud Pharma, S.L.August 27, 2024 | finanznachrichten.deAgile Therapeutics Inc. Announces Completion of Acquisition by Insud Pharma, S.L.August 26, 2024 | globenewswire.comI was right about SpaceXJeff Brown predicted Bitcoin before it climbed as high as 52,400%, Tesla before 2,150%, and Nvidia before 32,000%. Now he says SpaceX is shaping up to be the biggest IPO of the decade - and three key milestones just confirmed it. In the past 21 days: SpaceX crossed 10,000 active satellites, Elon filed confidential IPO paperwork with the SEC, and another rocket launched 25 more satellites. Two-thirds of every satellite in orbit now belongs to one company. The public filing could drop any day. | Brownstone Research (Ad)Agile Leadership for Pharma and Biopharma Professionals in a Hybrid World: 2-Day Training Course (Online) November 18-19, 2024 - Become Competent and Familiar in a Range of Well-Recognised Leadership TechniquesAugust 7, 2024 | globenewswire.comSTOCKHOLDER INVESTIGATION: The M&A Class Action Firm Investigates Merger of Agile Therapeutics, Inc. - AGRXJuly 3, 2024 | prnewswire.comAGRX Stock Alert: Halper Sadeh LLC Is Investigating Whether the Sale of Agile Therapeutics, Inc. Is Fair to ShareholdersJune 26, 2024 | businesswire.comSee More Agile Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Agile Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Agile Therapeutics and other key companies, straight to your email. Email Address About Agile TherapeuticsAgile Therapeutics (NASDAQ:AGRX), a women's healthcare company, engages in the research, development, and commercialization of prescription contraceptive products for women in the United States. It offers Twirla, a once-weekly prescription combination hormonal contraceptive patch. The company is also developing a pipeline of Twirla line extensions and other products, including AG200-15 Extended Regimen (ER), a regimen that allows a woman to have four episodes of withdrawal bleeding per year; AG200-15 smaller patch (SmP), which is a regimen designed to provide shorter and lighter withdrawal bleeds, and enhance contraceptive efficacy; AG200-15 ER SmP, a regimen to allow a woman to extend the length of her contraceptive cycle, as well as have shorter and lighter withdrawal bleeding episodes per year; and P-Patch, a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen. Agile Therapeutics, Inc. was incorporated in 1997 and is headquartered in Princeton, New Jersey.View Agile Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Palantir Drops After a Blowout Q1—What Investors Should KnowShopify’s Valuation Crisis Creates Opportunity in 2026onsemi Stock Dips After Earnings: Why the Dip Is BuyableTSLA: 3 Reasons the Stock Could Hit $400 in MayNebius Breaks Out to All-Time Highs—Here's What's Driving It.3 Reasons Analysts Love DexComMonolithic Power Systems: AI Stock Beat, Raised and Upgraded Post-Earnings Upcoming Earnings AppLovin (5/6/2026)ARM (5/6/2026)DoorDash (5/6/2026)Fortinet (5/6/2026)Marriott International (5/6/2026)Warner Bros. 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PresentationSkip to Participants Operator00:00:02Good afternoon, and welcome to the Agile Therapeutics third quarter 2021 financial results conference call. Please note today's event is being recorded. I would now like to turn the conference over to Matt Riley, Head of Investor Relations. Matt RileyHead of Investor Relations at Agile Therapeutics00:00:19Hello, everyone, and welcome to today's conference call to discuss our third quarter 2021 financial results and corporate update. 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 Twirla, among others, 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. Matt RileyHead of Investor Relations at Agile Therapeutics00:01:14We 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 a prescribing decision. 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. I will now turn the call over to Al. Al AltomariChairman and CEO at Agile Therapeutics00:01:41Thank 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 Twirla. From the end of quarter two, 2021, to the end of quarter three, 2021, we saw the following. Total cycles dispensed grew 61%. Total prescriptions for TRx grew 47%. New prescriptions for NRx grew 25%. 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 brand 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. Al AltomariChairman and CEO at Agile Therapeutics00:02:46First, let me discuss what we believe are the key takeaways on these performance metrics. First, 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 who are on Twirla like Twirla and are staying on the product. In turn, this gives us the confidence in 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 Twirla 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. Al AltomariChairman and CEO at Agile Therapeutics00:03:39The 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 Twirla 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. 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 million-$1.6 million. We came in slightly under our guidance as wholesalers reduced their channel inventory by approximately eight days. Al AltomariChairman and CEO at Agile Therapeutics00:04:40The 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 reflect this 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 ramp, 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, and 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. Al AltomariChairman and CEO at Agile Therapeutics00:05:32Pandia offers an additional point of access for Twirla in this 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 Pandia at the very end of the third quarter, we expect to start seeing its contribution to our TRx access as we progress through the fourth quarter of 2021 and into 2022. Second, Medi-Cal. Al AltomariChairman and CEO at Agile Therapeutics00:06:27As we previously announced, the California Medicaid program placed Twirla on the preferred drug formulary list effective October 1, 2021. This secured a preferred position for Twirla on the formulary for Medi-Cal and its related programs, which provide health care to approximately 15 million beneficiaries. This is significant for Twirla because Medi-Cal is the largest Medicaid program in the U.S., and we believe roughly 1/3 of the existing contraceptive patch market comes from Medicaid. This just went into effect at the beginning of the fourth quarter of 2021, and we expect to start seeing its 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. Al AltomariChairman and CEO at Agile Therapeutics00:07:29We recently activated branded influencer program to increase awareness of Twirla as birth control options and encourage women in our target markets to engage in open conversations about the product. We are focused on leveraging influencers via Instagram and ensuring this program focuses on Twirla through client 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 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 envisioned, not just likes and impressions, but also in the comments and conversations. We are pleased with the first wave of influencers and the posts. We continue to focus here to reach our target market. Al AltomariChairman and CEO at Agile Therapeutics00:08:32We previously discussed our plans for DTC advertising and are pleased to announce that Twirla is the first prescription birth control brand to launch branded podcast 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 Carli 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 kick-starts later this year and throughout 2022, you can expect to see Carli 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. Al AltomariChairman and CEO at Agile Therapeutics00:09:35This 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 increased 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 impacts on our overall business. First, the appointment of Josephine Torrente 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. Al AltomariChairman and CEO at Agile Therapeutics00:10:26Second, the Patient Protection and 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 co-insurance, co-payments, or deductibles. Despite the ACA protection and the government's guidance on implementation, women around the country are not getting the contraceptives they need or are prescribed or are 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 regulation 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 Twirla, that has been approved by the FDA since the ACA's passage. Al AltomariChairman and CEO at Agile Therapeutics00:11:31Kimberly Whaley 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 over the call to Dennis to provide you more clarity about the third quarter from a finance perspective. Dennis, take it over. Dennis ReillyCFO at Agile Therapeutics00:12:14Thank 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-$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. Dennis ReillyCFO at Agile Therapeutics00:13:14This 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. 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 million-$18 million, with increases reflecting commercial spending on product sample batches and branded marketing. Dennis ReillyCFO at Agile Therapeutics00:14:18We close out the third quarter of 2021 with a net loss of $16.8 million or $0.18 per share, compared to net loss of $15.5 million or $0.18 a share for the comparable period in 2020. As of September 30, 2021, we had cash and cash equivalents of $14.7 million compared to $31.1 million of cash and cash equivalents at the end of the second quarter, 2021. Most recently, we raised an additional $21.1 million of net proceeds in a public offering. 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. Dennis ReillyCFO at Agile Therapeutics00:15:26We 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. Operator, you can now open up for questions. Operator00:16:13Thank 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. 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 Leland Gershell from Oppenheimer. Please proceed with your question. Leland GershellManaging Director and Senior Biotechnology Analyst at Oppenheimer00:16:42Good afternoon. Thank you very much for taking my question. Congratulations on the progress. Very encouraging to see particularly the 86% rate of refills. A couple of questions from me. Wanted to ask first in terms of the inventory of wholesalers, Dennis, you'd mentioned that 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. Leland GershellManaging Director and Senior Biotechnology Analyst at Oppenheimer00:17:08Also wanted to ask with respect to the recent initiatives by the NWLC and Congress, those letters with respect to the ACA coverage. I wanted to note one, if you can provide us with any even if just qualitative feedback on to what extent Twirla may have had challenges getting covered because of non-compliance on the part of payers under the ACA guidelines and also on any outlook on when we may see action being taken following those letters. Thanks very much. Al AltomariChairman and CEO at Agile Therapeutics00:17:44Thanks, Leland. Dennis, you wanna take the first one, and I'll take the ACA? Dennis ReillyCFO at Agile Therapeutics00:17:48Yeah, I mean, we anticipate we're there on the wholesalers. You know, we don't have control over them in any sense, but we do believe they're running pretty lean now. We expect 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. I would say they're in sync going forward. Al AltomariChairman and CEO at Agile Therapeutics00:18:24Yeah, Leland, I think my only other comment, thank you for your questions. You know, my only comment is, you know, like we thought they were at steady state. It took us down another eight days, which, you know, a bit surprised us, but it wasn't Twirla only. It was really, they're just contracting. I mean, you know, we've seen it across all the books of business. We think we're at 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 Twirla? Al AltomariChairman and CEO at Agile Therapeutics00:19:04Just to kind of lay this out for the listeners, there are two parts to the ACA when we talk about compliance. You know, I think everybody knows now that there are 18 forms of contraceptive. There is this famous chart that, you know, they cite, and the plans are required to carry one of every product, including a patch. That is part A, Leland. I think part B is the one that we think, and it is not as well discussed and, you know. If a doctor wants a woman to be on Twirla, there is a form that you will see on our website, twirla.com, called a letter of medical necessity. By law, you know, it is not a prior auth. By law, if a doctor says, "I want this woman on Twirla," you know, the plan cannot say no. Al AltomariChairman and CEO at Agile Therapeutics00:19:51The 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, it's just not us. The insurance companies are basically saying, and their PBMs are saying, "No, we're just gonna deny it," and doctors go away. That's why we set up Sterling Pharmacy and people like that say, "No, that's not how it works." It just creates, you know, a bit of a, kind of a headwind with the doctor's mind that, you know, that this drug is hard to get across the goal line. It's improving a lot, but it, you know, certainly held us back. Al AltomariChairman and CEO at Agile Therapeutics00:20:30The interesting part, if any of you have read these documentations, which I would encourage you, this is not just in the commercial plans. Unfortunately, it's in Medicaid, and 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. You know, like I said, we really applaud all three organizations for stepping up, you know. 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. 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. Al AltomariChairman and CEO at Agile Therapeutics00:21:13We need to clarify this again. You know, again, it's been clarified before, and we'd encourage there, if necessary, to be enforcement. You know, something's gotta 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. When does it get fixed, Leland? That's the question Mr. Reilly asks me all the time. We just don't know. There was a short turnaround time on the Congressional letter that was probably too short. We are aware of some conversations that are going on at the highest levels. But we expect action, you know. Al AltomariChairman and CEO at Agile Therapeutics00:21:53Now the action, what it'll mean most likely, hopefully they'll reclarify all this for the industry and, if necessary, take enforcement action. You know, we still think we have our better days ahead of us on this. It just makes writing our drug a lot easier. 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 not make everybody available for no copay? Because that really was the intent of the act. That's the home run, you know. 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. Al AltomariChairman and CEO at Agile Therapeutics00:22:35You know, I 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 of, Leland. It's a nice day. Leland GershellManaging Director and Senior Biotechnology Analyst at Oppenheimer00:22:55Terrific. Thanks so much, Al and Dennis. That's about the queue. Al AltomariChairman and CEO at Agile Therapeutics00:22:58Thanks. Thanks, Leland. Operator00:23:00Thank you. The next question comes from the line of Oren Livnat from H.C. Wainwright. Please proceed with your question. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:23:09Thanks. I have a few, if you'll indulge me. Just quickly on the ACA mandate situation, how relevant is it that there is a Xulane 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 Xulane and Zafemy or however you pronounce it are out there? I have a couple follow-ups. Al AltomariChairman and CEO at Agile Therapeutics00:23:45Yeah, Oren, great question. Yeah. There's kind of like part A and part B. You know, the best we can see, you know, people are supposed to make, let's be specific about a patch, either us or Xulane or Zafemy, available on the plans. The best we can see, it appears they've done that. That's the part A. I think from a compliance perspective and, you know, in following the ACA, Oren, 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, Xulane is on formulary, in the $0 copay. We could be on formulary on a non-$0 copay. We could be. Let's say, you know, $40, $50 copay. You know, we're not getting the $0 or the preferred. Al AltomariChairman and CEO at Agile Therapeutics00:24:31In that case, we can deploy our, you know, that's easy for us to handle. We can deploy some couponing and things, you know, and handle that. Let's say we're locked out, so we're off 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 to 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. Al AltomariChairman and CEO at Agile Therapeutics00:25:04It's you know, that's just again, you know, doctor goes to the trouble, fills this out for a woman, she gets denied again, and they more than likely just wanna go back to Xulane. You know, that's the battles we're fighting, you know. 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. I do believe that if nothing else, if these letters of medical necessity just go through the system as intended, that they should go through in you know, in a very short amount of time and then the patient, by the time she gets to the pharmacy, should have that drug, and then she should be freed up. That's the way in the simplest form it works. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:25:48Okay. If I just follow up on that. You did mention in the quarter the net sales were up. I assume that means sequentially over Q2. 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 reflects some actual contracting, you know, some economics that you've worked out to get coverage on the payer side? 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? Al AltomariChairman and CEO at Agile Therapeutics00:26:43Yeah, I'll do the second part, and then, Dennis, I'll comment, and you can correct me if I'm wrong on the gross net. 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 a script. Transmit the script to Sterling." Sterling are experts at processing those claims. You know, we are seeing a lot more of our business run through Sterling. So you know, that we just basically tell the doc, say, "Hey, doc, like, just send it to us. We'll adjudicate it. We'll do the insurance claims if legal and we'll do this letter of medical necessity if we need to." Then the patient gets the choice. Al AltomariChairman and CEO at Agile Therapeutics00:27:18Let's say everything goes through swimmingly, and we get the patient across the goal line. What happens, Oren? We could say to the patient or the doc, saying, "We can ship the drug to her house, or we could ship it to her local CVS." It's a conciergerie service in effect that makes the doctor's life easier. Our best reps are the ones that just say, "Hey, doc, why work with this? Just give them us." Now, if we know we're on a plan, like in a 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, in Connecticut Medicaid, it goes through. In Medi-Cal, it's gonna go through. Al AltomariChairman and CEO at Agile Therapeutics00:27:55You don't even need to do these gymnastics. If we could point to big plans, Oren, it's a lot easier just to do it that way. I'll comment on the gross to net, and then Dennis could, you know, correct me if I'm over my skis. You know, 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. We're seeing Medicaid becoming more a part. That's a little bite of the apple. I think the other one is copay cards generally. You know, the more we're dealing with copays, copay utilization has crept up. I think there's a lot of little, Dennis. Are they the two headlines that I should remember? Dennis ReillyCFO at Agile Therapeutics00:28:33Yeah, those are it, and the copay being the one that kinda came up. Well, both came up a bit, but copay even a little bit more this quarter. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:28:45Can you tell us what the gross to nets are, sort of all in? Dennis ReillyCFO at Agile Therapeutics00:28:50You know, we're still in like, the low thirties on discounts including the 12% from the wholesalers. Oren LivnatManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:29:02Okay. Well, thanks. Got to get back to Al AltomariChairman and CEO at Agile Therapeutics00:29:06Thanks, Oren. Operator00:29:10Thank 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 Lugo from William Blair. Please proceed with your question. Analyst at William Blair00:29:29Hi, team. This is John on for Tim. Thanks so much for taking our questions. Just two from us. First one is to say congrats on your new marketing efforts. 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? 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 a mix. Are those still the trends that you're seeing, or is there any indication that mix is changing? Thanks. Al AltomariChairman and CEO at Agile Therapeutics00:30:04Yeah. No. Thank you for the questions. I mean, no, the mix, you know, based on the last time I looked at the data, hasn't changed. 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 drug before, maybe had a baby and come reentered, but she looks like a new patient to us, and about 25% come from a pill. That is our major source of volume. You know, dating apps, you know, just in general, the marketing campaigns, we're encouraged by what we're seeing. I mean, when we just started heavy on our spends, you know, in the second quarter, I think we mentioned, was pretty light spending in DTC on a relative basis. Al AltomariChairman and CEO at Agile Therapeutics00:30:45Third quarter is the first time we went at it, you know, for the most part, full bore, you know, at the levels we thought we should. We saw our, first of all, our website light up, which is very encouraging. You know, we're seeing like a tenfold increase in our hits to our twirla.com. Equally as important or more important, you know, 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. I'd love to get my sales to because I do think it works in harmony in a perfect world. Al AltomariChairman and CEO at Agile Therapeutics00:31:21You know, we're starting to see a fair number of business coming from pure white space that we have not been in front of before, which is, to me, an indicator that it's working. It works better if we have a rep there. The dating app specifically, you know, every metric that we've seen or we would have expected, because basically we're buying media. We're saying we're buying eyeballs, right? In that case, we're buying through the dating apps. We're off the charts in the execution. 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. Al AltomariChairman and CEO at Agile Therapeutics00:32:02You 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. That's top of the list of where 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. 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 it full bore, so we've decided to leave it out there a little bit longer and see what's happening and keep it fresh. Analyst at William Blair00:32:41All right. Thanks again for the update and congrats on the progress. Al AltomariChairman and CEO at Agile Therapeutics00:32:44Oh, thank you. Operator00:32:49Thank 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. Al to you. Al AltomariChairman and CEO at Agile Therapeutics00:33:26Yeah. Operator00:33:27Please go ahead. Al AltomariChairman and CEO at Agile Therapeutics00:33:27First of all, thank you, operator. Thanks to Matt and Dennis also for your help on the call. 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, you know, large multi-billion-dollar market. We discussed tonight some of the challenges we faced, but we pushed through, and particularly with some of the larger challenges that faced our company and our brand. I'm ecstatic with the brand's performance and the potential of this brand. You know, you know, we have the cash to support our business and that we anticipate that as sales grow, our optics on revenue, you know, become more and more clearer. Al AltomariChairman and CEO at Agile Therapeutics00:34:09You 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. You know, we believe that these initiatives have been effective, that helped expand Twirla's access, in particular 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. I'm pleased with the progress. You should expect more progress from us, and we'll keep you updated on future calls. Thank you, everybody, for joining the call tonight and keeping track of us and keeping updated on what's starting out to be a real exciting story. Thank you all, and everybody have a good night. Operator00:35:04This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesAl AltomariChairman and CEODennis ReillyCFOMatt RileyHead of Investor RelationsAnalystsLeland GershellManaging Director and Senior Biotechnology Analyst at OppenheimerOren LivnatManaging Director and Senior Healthcare Analyst at H.C. WainwrightAnalyst at William BlairPowered by