Good morning, and welcome to the Agile Therapeutics second quarter of 2023 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. Hello, everyone, welcome to today's conference call to discuss our second quarter 2023 financial results and corporate update. Before we start, let me remind you that today's call will include forward-looking statements based on our current expectations, including statements concerning our financial outlook and financing prospects for the future. Our outlook for the second half of 2023, management's expectations for our future financial and operational performance, including our expectations regarding the market growth of Twirla and our operating expenses. Our business strategy, our partnerships with Afaxys and Syneos, and their ability to promote growth. Our relationship with Nurx and its ability to make Twirla broadly available to patients, and our assessment of the combined hormonal contraceptive market, among other statements regarding our plans, prospects, and expectations. Such statements represent our judgments as of today, are not promises or guarantees, and may involve risks and uncertainties that may cause actual results to differ from the results discussed in forward-looking statements. Further, during today's call, we will refer to certain non-GAAP financial measures. A reconciliation of GAAP to non-GAAP measures is included in our press release issued today, which can be found on the investor relations section of our website. For more information concerning risk factors that may affect the company, please refer to our filings with the SEC, which are available through the investor relations section of our website. 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 on today's call is Al Altomari, Agile Therapeutics Chairperson and Chief Executive Officer, and Amy Welsh, Chief Commercial Officer. Following our prepared remarks, we'll open the call to questions from our covering analysts. I will now turn the call over to Al. Thanks, Matt. Thank you for everyone joining us this morning. I'm personally very excited to share our quarterly results with you. That is in part of the reason why this is our first quarter we're holding our call in the pre-market. We think the 44% growth in our net revenue to $5.5 million for the second quarter, combined with our double-digit growth and demand, made this a significant quarter for both Agile and Twirla. We believe this affirms our confidence in our business plan, our progress towards the goal of generating positive cash flow and achieving 2023 net revenue in the range of $25 million-$30 million. I'm going to kick things off by reviewing the performance metrics from the second quarter of 2023 that have us all excited. Amy will then discuss why we are confident in our belief we can sustain momentum into future quarters. Twirla demand for the second quarter was 55,687 total cycles, a 24% increase from the first quarter, 2023, and another single quarter record. Retail demand, as reported by Symphony, was 35,682 total cycles in the second quarter of 2023, a 17% increase from the first quarter, 2023. The retail channel is our most profitable channel, the retail demand accounted for 64% of the second quarter, 2023 demand. Non-retail demand for the second quarter of 2023 was 20,005 total cycles, an increase of 38% from the first quarter, 2023. Our non-retail demand is comprised of data from Symphony as well as our wholesalers. Second quarter 2023 net revenue was $5.5 million, which represents a 44% increase from the $3.8 million reported for the first quarter in 2023, and a 159% increase from the $2.1 million reported for the comparable period in 2022. Factory sales for the second quarter 2023, as reported by our wholesalers, were 61,770 total cycles, compared to the 43,446 total cycles reported for the first quarter 2023, a 42% increase. As discussed last quarter, on a year-to-date basis, we think channel inventory has now normalized. We expect to see both net revenue and factory sales continue to grow in the second half of 2023, driven by our growth and demand and the execution of our business plan that Amy will describe. Gross margin a long with the growth in our net sales and demand, we continue to make progress in generating gross profit. In the second quarter of 2023, we generated a gross profit of approximately $3.2 million, or a margin of 58%, compared to the $1.8 million, or gross margin of 47% in the first quarter of 2023. We think gross margin is becoming a meaningful part of our progress. We believe we will continue to see improvement in the second half of 2023. Operating expenses, or OpEx, for the second quarter 2023 were $8.3 million, a 2% decrease from the $8.5 million reported in the first quarter of 2023. Before Amy takes over, I'd like to comment on a few other of our financial results, which we believe also demonstrate continued progress of our business. Cost of goods sold, or COGS, which represents direct and indirect costs related to the manufacture of Twirla sold, was $2.3 million, or 42% for the second quarter of 2023, compared to $2 million, or 53%, for the first quarter of 2023. We ended the second quarter of 2023 with cash on hand of $2.8 million. In addition to our at-the-market, or ATM arrangement, we'll continue to evaluate all available options to finance the company. Our GAAP net loss for the second quarter of 2023 was $3.8 million, or $20.15 per share for the second quarter of 2023, compared to a GAAP net loss of $5.4 million, or $50.91, for the first quarter of 2023, and a GAAP net loss of $5.2 million, or $57.29 per share for a comparable period in 2022, respectively. Non-GAAP loss was $5.5 million, or $30.10 a share for the second quarter of 2023, compared to a non-GAAP loss of $7.1 million, or $7.76 per share for the first quarter of 2023, and $12.2 million, or $135.46 per share for the comparable period in 2022. The non-GAAP results reflect the exclusion of fair market remeasurement of warrant liabilities, which resulted in an other income of $1.7 million in the second quarter of 2023, $1.7 million in the first quarter of 2023, and $7.1 million in the second quarter of 2022. We set a single quarter record highs in demand, net revenue, factory sales, all while reporting another quarterly decrease in operating expenses. We are beyond pleased with the second quarter results, the job is not done. We continue to ask ourselves how we can accelerate our growth. I will now hand over the call to Amy to answer that question by explaining the business model, which we have built and is designed to deliver future growth across the board. Thanks, Al, and hello, everyone. Our whole organization is energized by our results in the second quarter of 2023. I would like to take a few minutes to explain why we are excited and answer the question: Can we reach our 2023 net revenue guidance of $25 million-$30 million by sustaining our current momentum, driving increased growth in future quarters, and holding our operating expenses at current levels? We think the answer to this question is yes, because of the structure of our commercial business model and the continued receptivity towards Twirla, which is now approaching 15,000 cumulative prescribers since launch. We are pursuing a business plan that is built on a commercial platform that we believe is scalable without adding a lot of fixed costs. Let me explain further. First, our business plan focuses on driving Twirla in the five states that are estimated to reach over 45% of the U.S. women ages 18 years to 24 years and have strong reimbursement profiles. This targeted geographical strategy maximizes our sales force spend in the areas we believe have the greatest opportunity and potential for growth. Second, our commercial platform is based on collaborations with Syneos and Afaxys that have been structured to minimize fixed costs and allow us to scale up or down as needed, as well as align our key partners' interests with ours so that our partner succeeds when Agile and Twirla succeed. We have pursued this by converting what we would typically be considered fixed cost for a company like Agile into variable costs. For example, through our partnership with Afaxys, 2Q 2023 non-retail demand grew 38% from our 1Q 2023. Rather than allocating the time, resources, and dollars to build and maintain our own non-retail sales force, we partnered with Afaxys to drive non-retail growth because we identified them as experts in that area. Afaxys' compensation is a combination of a fixed fee along with performance-based incentives, which helps us keep quarterly operating expenses at a stable rate without sacrificing growth potential. We have taken the same approach with Syneos, which provides our retail sales force. We believe we can now build out this commercial platform and drive additional Twirla growth by expanding our distribution channels, which we expect will increase access to Twirla without incurring additional significant operating costs. This is why we remain confident that we can achieve net revenue in the range of $25 million-$30 million, while holding our operating expenses relatively steady. I would like to take a few more minutes to provide some additional details on our plan to build out our distribution channels. In the first quarter of 2023, you saw us announce new relationships designed to further expand our commercial reach and drive Twirla growth. In the retail channel, we focused on collaborations to grow Twirla through telemedicine platforms, which we will expect to contribute to second half 2023 net revenue and retail channel growth. Advancing Twirla's availability through Nurx, Twentyeight Health, and Pandia are all part of our strategy to sustain future growth in the retail channel. We also focused on growing the non-retail channel. Twirla's availability through our relationship with FPA Women's Health and MMCAP are planned to augment Afaxys's efforts and contribute to further second half 2023 non-retail growth. Their expected contributions are a large part of why we are confident in sustained growth across the board in the second half of 2023. Strong, focused, external relationships are an integral part of our business plan, and we expect to continue to explore collaborations that can positively impact our business, allow us to expand without incurring significant costs, and promote a growing, sustainable, fiscally responsible business. We'd now like to give our covering analysts the opportunity to ask questions. Operator, you may now open the line for Q&A. Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Yeah, operator, while we're doing that, I want to introduce somebody else in the room. We also are joined in the room by Scott Coiante, our incoming new CFO. I think most of you know that Scott, you know, was a big part of the company when we took the company public, we're thrilled to have him back. I just want to let everyone know he's also in the room, and he'll be transitioning to the job in the next one week or so. All right, thank you. All right, our first question comes from the line of Oren Livnat from H.C. Wainwright. Your line is now open. Thanks. I have a bunch of questions. Congrats on a nice upside this quarter and reiterating that guidance. I guess first, you just mentioned Scott's on the call. Welcome back, Scott. I'm curious, what you found compelling about this opportunity to return to Agile, then I'll ask about some fundamentals. Thanks, Oren. Good to connect with you. Look, as you know, I was part of some really good productive years here at, at Agile, and look, it's a great team. There's a great group of people here. The opportunity presented itself for me to come back, and I'm happy to be here and continue to, you know, build on that progress that the company's been doing. Obviously, it's a pivotal time. Sorry, I just heard some feedback on the end. Can you hear me? What? Yeah, you're good. You're good, Oren. Go ahead. Okay, good. Well, let's, let's talk about Twirla. I think we're five weeks into Q3, and I know you don't give quarter-by-quarter guidance, but since you reiterated, you know, the top-line guidance, can you just talk about what sort of trends you're seeing, I guess, quarter to date, sequentially, in growth? I mean, I think we've seen over 20% total cycle demand a couple of quarters in a row, and I'm just wondering, can that trend continue, or do you expect, you know, some lumpiness as we get into summer? Oren, you're, you're stealing our thunder from my closing comments. That's okay. Now we'll answer them. There's nothing we're seeing in July that doesn't get us any, you know, any concern. In fact, we're ecstatic with July. The momentum we've seen in the second quarter continues to, to accelerate into the third quarter so far, you know, as you said, about five weeks into it. I mean, we're, we're thrilled. That's exactly right. Fingers crossed, the rest of the quarter could goes like this, Oren. we're not surprised. I mean, we would expect that. The model that Amy built has walked us through. we would expect to continue to see momentum, and that's why we reaffirmed guidance, and that's why we're, we're bullish on the year. All right. One of the big things you talked about in the past is how this success in the non-retail channel, particularly, you know, Planned Parenthood, spills over into the retail channel, which is obviously the most profitable, as you've highlighted. You've seen, you know, nice sequential demand as well, near 20% in the retail as well, I think. You know, are you seeing that spill over, or is this just traditional boots on the ground driving retail demand or the new telemedicine channels? I'll turn it over to Amy, the expert, Oren. She'll have a better answer. That's okay. Hi, Oren. Thank you for the question. Yes, we are. We saw that spill over as early as third quarter last year, Every time that we add another account on, we do some analytics in that state. We're confident when we see, you know, a few months after looking into it, that we see the spillover continue. It's the model that we had talked about a few times, Oren, where these physicians that are in Planned Parenthood more than likely also have a private or in a group practice. The confidence that they start to gain on Twirla within the Planned Parenthood structure, they're bringing over. Yes, we continue to see the spillover. Again, when we get a new account, you know, again, we're confident that the non-retail growth will go into the retail growth. All right. I guess one of the new things you announced this quarter was the non-340B, non-retail accounts, like FPA, and I think there was another one in there that I might have missed the name of. You said that's an important contributor for second half. Big picture, how big a channel is that, you know, as an opportunity? How many more accounts are there like that? Remind us, where do they fall, sort of on the profitability spectrum of your multiple channels? I'll do profitability, then may I'll just give you kind of an overview, then Amy can talk you through FPA specifically. Profitability, if we look at kind of our profitability yield, commercial, commercial cycles are still clearly our best. Next in the, the pecking order would be FPA. You know, then we would put our, our Medicaid business, and then the Afaxys business, that's a GPO business. Kinda that's our cascade. FPA is closer to commercial, which is a really great thing for us. That and I, Oren, I mentioned this to our team. I said, "You know, when you look at California, California is, you know, bigger than the, bigger than the country of Germany from a GDP perspective." We landed not only the biggest private account in California, they claimed FPA claims to be the biggest in the country. so I don't know, Amy, why don't you take it from there? Yep. I think I'll take the part on, you know, how much potential is there with that one and the other non-340B accounts. FPA is a phenomenally phenomenal account led by a great group of OBGYNs. We just started the partnership, so we're in no way at a steady state. You know, we're just beginning to normalize now, so there's lots of growth with that single account. Strategically, other non-340B accounts, other sort of hybrid-like accounts that sit in between the commercials for the cost structure and a Planned Parenthood 340B, if you will, cost structure, that's part of our new back half of the year strategy. Some more to come on that, but we were very lucky to start with an account like FPA. It's meaningful nationwide and, and meaningful financially for us. Maybe explain how MMCAP fits into that strategy, maybe just the importance of MMCAP. MMCAP serves as a GPO for Afaxys and enables that, their sales folks to sell within deeper into colleges and universities and some government health services that the Afaxys may or may not have accounts with. MMCAP, we signed on, and it is basically, again, a volume opener. Like I was saying, earlier in the call, we're looking for partnerships that can help us have access for Twirla. MMCAP serves for us in those two channels, again, that is colleges and universities nationwide, as well as government health and human services statewide. Okay. I guess since we're talking about profitability and, you know, mix, can you talk about the sort of overall value per cycle trends, I guess from last quarter to this quarter and then going forward? You know, obviously, both channels or all channels are growing, so it's hard for us to really to guess what direction this is going. Can you give us a big picture, how we should think about that? Yeah. I'll take a shot then, you know, let Amy comment. Just when you look at the second quarter versus the first quarter, our mix, you know, of retail was stronger in the second quarter, so that's a good thing. If you do like calculating the yield per script or yield per cycle, what did we yield per cycle? It went up in the second quarter, that was primarily due to a more, I call it a favorable mix. You know, a quarter that's more balanced on retail and non-retail. Then, you know, just to put a footnote on FPA, like, one of the things we're realizing is that when we say non-retail, that's got some shades of gray in there too now, because there's a lot of differences in pricing on there. One of the things we're considering, important, you know, Scott, when he came here, called it a hybrid. That's what we think of as FPA, because it's kind of somewhere in the middle. The mix is better, the pricing is stronger, which is great. Then, as you saw in our comments with gross profit, we've outgrown some of the, you know, fixed allocations in COGS, so the margin's improving. W e have a better yield per script, Oren. We would expect to see that continue if we can continue to deliver on the, the retail mix. Then we would expect our COGS to continue to improve as we just become more variable, if you will, in COGS. You know, we've outgrown those things. It's nice, as I commented in my talk, to see we're throwing off a margin now. You know, that's starting to, you know, you know, get, you know, pretty, pretty significant. That's why we continue to see us zooming in on, you know, throwing off cash from this business, you know, so that's a nice thing. As our revenue grows, our costs become more efficient, and then we are a continued partnering model that Amy built. You know, hopefully that, you know, the OpEx stays, stays rough relative to the zip code we're in, then that's why we can close the gap. That's why we feel good with the top line and also our ability to, you know, start generating cash off this business. You anticipated my next question. Every, metric is looking better, Oren. Everything is kicking in nicely. You actually anticipated my next question, which is just, can you just remind us sort of how your fixed cost base on the COGS side, you know, the magnitude of that, such that, you know, regardless of your weighted, and even if you had a flat net value per cycle, you know, how fast your gross margin can grow just with sales as they increase? You know, what's your quarterly underlying fixed, I guess, Corium commitment versus your variable costs? Yeah. Just to layer onto that, sorry, just to interrupt, but Afaxys, as you mentioned, you know, performance-based incentives, I'm just wondering, as that non-retail channel grows, does that, you know, do they get a bigger piece of the gross to net? Yeah. Let's do COGS first. You know, as Amy mentioned, i f you look at one of the most impressive things, I think, on our P&L, is if you look at our OpEx spending six months ago, the first six months of last year versus the first six months this year, it's, I think it's eye-opening how much OpEx we've taken off the board, right? That's the model Amy described. Also, Oren, we've been able to reduce our fixed costs internally that we were allocating in the COGS. What we're allocating in, in the COGS is people costs here that help run the business. Look, we've been able to reduce that too. The effort to reduce OpEx hit not only the SG&A lines, but it also hit COGS. The good news is there's not much allocations going forward, going in the COGS anymore. There's a, a little bit, but for the most part, it's gonna be variable. That's why we're signaling that that's gonna continue to improve. The reductions in, you know, the incentives Amy describes in our relationships with people like Afaxys, you know, are offsets of sales, so they run through the net sales line. You know, that's where you'll see that. You know, those, the cheaper ones are, you know, the, the GPO business on the Afaxys relationship, there's, that's becoming less of a big portion of our mix as Amy brings on people like Athena and grows the retail. That's what I'm referring to as mix. That's all, all those incentives are running through the reduction of sales. Even with those, we've been able to increase our yield per cycle, if that makes sense. The model is becoming efficient, Oren. I'll leave you with it's just becoming efficient. You know, it's just everything we're doing now is gets, you know, even more efficient as we can, as this model really takes shape. You know, our, our partners, as Amy mentioned, are incentivized to grow our business or they don't get paid. It's just that simple, for the most part, for the most part. Their incentives are aligned with ours. In the meantime, we can keep our fixed costs in general across the whole, you know, leaner. You keep segueing to my next question like you're looking at my page here. Speaking of the incentives of your partners to do a good job, how are the telemedicine channels working out so far? I mean, there are Nurx and others. I think Nurx has been on board for a while in terms of partnership, but I think maybe last quarter you talked about sort of it just being turned on or being fully trained up and ready to go. How are they doing in terms of, I guess you could call it promoting the product? Maybe not per se, but when women go into the Nurx channel, how are they doing with regards to, you know, offering Twirla as an option for appropriate patients? Are they hitting the targets that they or you had set in the arrangement? Yeah, I'll jump in, Oren, thank you. All of our telemedicine partners, we're lucky to have. They're great partners. Nurx, you're right, we signed them at the end of last year, and they officially now offer through their distribution channels our patch as their only patch that they send out, and that started in May. They're growing month-over-month-over-month. It was a bit of a slow start because of some of the structural changes that were happening on their end, but they have now a solid team. I'm pleased when I look at their growth week-over-week. Again, we're very lucky to have them as a partner. We just signed on Twentyeight Health, so early days there, but again, we always see growth. I think the best thing about our telemedicine partners is it's a channel that is meaningful to the women, our age group, 18 to 24-year-olds, so it's always gonna be available for them. Branded products, Twirla has kind of broken the ceiling a bit and been one of the first branded products offered on these channels. The negative about that is, you know, we help them set up a process. The positive about that is we stand there alone, but it does take a while sometimes. We see growth, and I'm more than confident in the back half of the year, we're gonna make up any type of slowness because of some of the training and the process changes that happened in the first part of the year. That the upside, a lot of the upside in retail will be due to telemedicine. All right, bigger picture. Washington activities have been interesting. We've seen, you know, maybe the third executive order to come out of this administration related to women's health and specifically coverage or lack of coverage of contraceptives. You know, Al, you're down there a bunch, I think. What's going on there in terms of, you know, words versus potential enforcement actions that they've been hinting at for a while? Do you expect anything to change, especially heading into an election cycle where women's health care is such an important part of this narrative? The answer is yes. I mean, you know, I don't think it was a surprise to us, the symbolism of that executive order being on the Roe v. Wade anniversary. I mean, the Biden administration clearly is signaling that women's health, in the broadest sense, is important to them. The Roe v. Wade or the abortion discussion on boards is a very complicated discussion. They see contraception, we believe they see contraception as an important win for women, you know. That executive order, as you saw, you know, including us, but it also including things like TRICARE, which is the military, you know, Medicaid. It was just, I had a five-point plan. Contraception needed a lot of work. You know, we, based on my discussions, you know, we believe that the right thing to do is to clarify once and for all that products like us that were approved, that don't have generic equivalents, need to get access to this country. We believe that that's coming. I can't tell you when. I don't know when. I shouldn't say I would tell you if I thought I, I had a handle on it because it's a different pace in Washington than I have. What I think we've tried to communicate here is that that is an upside to our investors. I mean, what we've created is a sustainable growing model that's growing in every channel that Amy's put a stake in. You know, we still believe that's upside to us. You know, we believe it's coming. We don't think, Oren, personally, I don't believe enforcement is the answer, because while there's three PBMs that control, you know, vast majority of lives in this country, it's up to every plan under them to administer this thing. It's unyielding. You know, you could say it's PBMs, and that's true, you know, but the implementation of the Affordable Care Act has really been the downstream plan. We think enforcement's a bit chasing of the tail. We think, you know, to get regulations out, clearly stating what I just said, I think is the ultimate answer. Then we would expect there's going to be a lot of oversight from the administration and also that the agencies that, that monitor this. I think that the enforcement will be, will be on the back end of those new regs, if you will. I think it's coming, Oren, I have a high degree of confidence. I don't want to guide to something I don't have control over, but I think it's coming. In the meantime, you should know we're just blowing out the third quarter, and that'll put more wind in our sails. All right. Well, I think that's it for me. I appreciate your patience with all the questions. Go ahead. All right, at the, as of the moment, I do not see any other questions. At this point, I would like to turn the conference back to Al Altomari for closing remarks. Great. Thank you. Oren, thank you for the thoughtful questions. You look like you preempted a couple of the callers, so this is great. You know, I guess my final thought is that in a statement, I would say the proof is in our progress. You know, we are not saying this is going to happen, we're saying this is happening. You know, for the first six months, you know, of this year versus the first six months of 2022, you saw in our data that net revenue is up 140%. OpEx, on the other hand, is down nearly 38%. As Oren asked me, you know, based on what I've seen of the third quarter so far, Amy and I feel great, you know, about that the momentum is still continuing. You know, we, we say that time in and time out, but come in and have record quarters and every metric, you know, that's important to us. The momentum that we're seeing isn't in any one channel, it's in all the channels. Retail continues to grow, non-retail continues to grow. As Amy mentioned in the question Oren had asked her about, you know, telemedicine, the momentum there has grown. We're just layering on in all our channels, continued growth, you know, because we're on a quest to once and for all, first of all, hit our guidance we've given you for the year. Hopefully, you see why we're confident in that based on this quarter's results. The ultimate prize is this vibrational cash off this business. Thank you for your attention. Thank you for following our story, and we appreciate your, you know, you staying close to us. Thank you, everybody. This concludes today's conference call. Thank you for participating. You may now disconnect.