Agile Therapeutics, Inc.

Good day and thank you for standing by and welcome to the Agile Therapeutics Q2 2021 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Matt Riley, head of investor relations. Please go ahead.

Hello, everyone, and welcome to today's conference call to discuss our second 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, our assessment of the combined hormonal contraceptive market, and the potential market share for Torella, among other statements regarding our plans, prospects, and expectations. Such statements represent our judgments as of today, are not promises or guarantees, and may involve risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Please refer to our filings with the SEC, which are available through the investor relations section of our website, for more information concerning risk factors that may affect the company. We undertake no obligation to update forward any statements except as required by law. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are Al Altamari, Agile Therapeutics Chairman and Chief Executive Officer, and Dennis Riley, Chief Financial Officer. Following our prepared remarks, we'll open the call to your questions. Let me now turn the call over to Al.

Thank you, Matt. Good afternoon, everyone, and thank you for joining us for the second quarter 2021 earnings call. I've been looking forward to this call for a long time, and I want to thank you in advance for joining us. I'm going to jump right into the theme of today's call, growth. we're both encouraged and excited by. In the past, you've heard us talk about our future plans for Twrla. Now that conversation begins and ends with the brand's growth. So we'll start today by outlining the progress we are seeing and providing some context on why we believe growth is encouraging. We will then discuss why and how we believe we can sustain and accelerate that growth. Finally, I'll have Dennis do a quick update on our financial position before opening the lines for Q&A. Let's talk about Torello's performance. We've now completed our second full quarter as a launched and commercialized brand. Last quarter, we started to see steady upward trends of increasing scripts, refills, and awareness of our product. And as expected, that growth has continued through the second quarter. On slide four, You will see the quarterly performance since our Q4 2020 launch, and we see growth on all key performance metrics. From the end of Q1 2021 to the end of Q2 2021, we saw total prescriptions, or TRXs, increase 171%. New prescriptions, or NRXs, increased 103%. And the refill rate grew 355%. While we saw significant growth in these performance metrics quarter-over-quarter, there's also consistent pattern of growth. When we break down the quarter and examine the data month-over-month, as you'll see on slide five, during quarter two, month-over-month growth of TRXs was 35.2% in April, 26.5% in May, and 31.4% in June. Enteroxys were 20.4% in April, 10.4% in May, and 31.2% in June. And refills were 70.6% in April, 35.9% in May, and 40.6% in June. One other view of the data we track is on a four-week rolling average that we discussed in our last call, and that's very consistent with our quarterly and monthly growth. We are encouraged by the fact that we're seeing consistent brand growth at the quarterly, monthly, and four-week levels. Please note that these results do not include sales in the non-retail channel, which includes clinics, institutions, hospitals. In the second quarter, we sold an additional 2,291 units into the non-retail channel. Because we're so focused on TRX growth, I wanted to highlight what we think is an important contributor to that growth and the health of our brand, new prescriptions and refills, both of which grew in quarter two. Every time we acquire a new patient start, we are potentially acquiring a customer for some time to come. Each NRX, has the potential to manifest itself as a repeat customer with an extended time value to the brand because NRXs can lead to refills, which can drive TRX growth. We are confident in the health of Turola because we're seeing NRXs translate to refills and the potential for more patients to stay on the brand, which can in turn lead to more sustained growth. This leads me to a question I've heard from some of you as analysts. and some investors. How does your growth compare to other combined hormonal contraceptives? And how should we think about these refills and these NRXs? This is a new metric we're going to be talking about. You know, so we've never showed you before because it was still very early in the launch. I want to show you now on slide six a graph comparing the initial stages of the launches of Twirla to low, low estrogen FD, a low-dose prescription birth control pill and one of the biggest brands in the combined hormonal contraceptive market. This slide compares the ratios of T-Rexes to something you may not look at very often, NP-TRX, which are prescriptions for patients new to our product, Torla, and low, low estrogen. In other words, the percentages of T-Rexes that consist of prescriptions for patients who have never used our product before. These ratios increase when more new patients continue to fill their prescriptions. Over the first 26 weeks of launch, low, low estrogen FTE developed a steady NREX volume that translated in the refills, which contributed to the growth of the brand for years after the launch. The total prescription to new product prescriptions ratios helped us understand whether we were building a base for future potential growth. And when you look at the curves on slide six, They're similar over a comparable period of time. While we're still in the early stages, Twirla's steady ratio of total prescriptions to new-to-product prescriptions suggests the brand could potentially sustain long-term growth. I want to be clear. We're not suggesting Twirla will achieve the market share success that LoloExtra has. And it's important to remember that prescription volumes underlying these curves were much larger for LoloExtra than they are for Twirla. But we believe one of the keys to a healthy, steady, growing brand is to deliver strong total prescriptions to new to product prescription ratios, which is evidenced here by both of these brands. Of course, new prescriptions and subsequent refills are not possible without growing our prescriber base. On slide seven, you'll see prescribers' growth over the course of Torello's launch. As of March 31st, 2021, we had told you we had 855 writers. And at the end of quarter two, June 30th, 2021, that number has grown to 2,087, and that number continues to grow throughout the third quarter. Again, you'll see here that the quarter-to-quarter growth is supported at a more granular level over month-to-month as seen on slide eight. The growth in the number of providers writing prescriptions for TWRLA has steadily contributed to a steady momentum in TRX growth. Also important to note is that the number of TRXs each prescriber is writing, or their productivity, if you will, also continues to grow. Based on the early performance growth we are seeing with Twirla and how that compares to the growth trajectory of another brand we consider to be a successful category, we're pleased with the progress and the health of Twirla. But the question we consider to challenge ourselves is, how do we accelerate and sustain that growth? And the answer is focusing on two major efforts, market access and our marketing efforts to pursue this goal. So, I'm going to start with market access. We are seeking to increase access to Twrla through a variety of efforts, including a focus on expanding access and reimbursement coverage for Twrla across commercial and government health insurance plans. In the second quarter of 2021, we expanded our Medicaid coverage. Torello is now available to Medicaid patients in approximately 75% of the states, either through traditional Medicaid and or managed Medicaid. With these new additions, we have coverage of approximately 50% of the total Medicaid transdermal or TRX market with no restrictions. Overall, we have access to approximately 55% of commercial and government CHC claims. We are encouraged by this trend, and we view this as another source of ongoing market growth for Twirla. We remain committed to expanding access for Twirla for all appropriate women interested in using our product. In addition to managed care and Medicaid access, we are now exploring access through additional state and university clinics, Planned Parenthood, and other non-retail sites in an effort to make Troila available to women everywhere. For example, we saw significant growth in the non-retail volume in state clinics in quarter two. Now onto marketing. We believe the performance metrics we reviewed at the top of the call reflect what we consider to be a very smart approach to DTC marketing spend. As I said last quarter, we've made a large incremental branded consumer marketing spend quarter over quarter, starting in quarter two, while maintaining our discipline approach and making the right investments at the right time to encourage strategic growth. As healthcare provider awareness increased leading up to and throughout the second quarter, We made what we believe to be appropriate and necessary increase in branded DTC digital marketing investments in late May and early June. So your takeaway here is that we're very encouraged by the growth we're seeing based on a very disciplined DTC spend. So we expect TRX, NRX, and refills all to continue to grow as more and more women in our target audience gain exposure to Twirla advertising. Last quarter, we mentioned we're expanding Fro's brand digital efforts to a targeted audience by advertising on the dating app, such as Tinder and OkCupid. And now we can report that relationship in less than a month has exceeded our expectations. Moving forward, we'll expand our presence on the dating app, advertising on Spotify, and engaging influencer partnerships, all designed to drive awareness and ultimately trial for Fro's. In addition to the digital meeting campaign, we have identified and are pursuing new opportunities to drive consumer awareness and potentially lead to future growth. At our next earning call, we look forward to sharing with you progress on partnering with additional channels like telemedicine, as well as potentially Planned Parenthood and student health centers. Again, we believe all these efforts contribute to awareness, which we expect to contribute to more new starts and in turn lead to higher refills and ultimately stronger TRX performance. We believe all these components are a sign of a healthy brand and longevity for potential future growth. Before I turn the call over to Dennis, I want to reiterate that we remain steadfast in our belief that at peak, Twirla can capture up to 5% to 8% of the $4.1 billion combined hormonal contraceptive marketplace. Thank you, and I'll turn it over to Dennis to talk about our financials.