Agile Therapeutics, Inc.

Good afternoon and welcome to the Agile Therapeutics first 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 Investors Relations.

Hello everyone and welcome to today's conference call to discuss our first 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 Twirla, among other statements regarding our plans, prospects, and expectations. Such statements represent our judgment 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. We undertake no obligation to update forward-looking statements except as required by law. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are Al Tamari, Adult Therapeutics Chairman and Chief Executive Officer, and Dennis Riley, Chief Financial Officer. Following our prepared remarks, we'll open the call to questions. Let me now turn the call over to Al.

Thank you very much, Matt. Good afternoon and welcome everyone to our first quarter 2021 conference call. To kick off the call, I'd like to highlight what we believe are the four most significant takeaways from today's update. Number one, I want to remind everybody we began our initial commercial shipments of Twirla to the wholesalers in late December 2020. As the wholesalers work down their inventory, we anticipate product revenue will more closely reflect script demand growth at the retail level. Number two, Our Salesforce received their samples also in late December and commenced distributing samples to healthcare providers, or HCPs, in the first quarter of 2021. While samples are not reflected in the total prescriptions or the TRX data, we believe samples often lead to HCPs writing future prescriptions. Number three. We will continue to invest in growing Twrla and expect our operating expenses in the second quarter of 2021 to be higher, reflecting increased spending on brand marketing and product sampling. Number four, we are excited about the recent growth in the number of HCP writers and the resulting tier X growth. And we believe the brand is laying the foundation for revenue growth into 2021. To that end, I want to spend our time today walking through Twirla's progress to date and why we are so encouraged. I will also discuss updates on our marketing efforts to increase awareness of Twirla. Finally, we'll provide an update on our financial performance. We're using Sides this quarter to guide and supplement today's conversation, and you'll hear me refer to these as we progress through the updates. You can find this presentation on our website. Now, let's talk about Twirla's performance. First, I'd like to give an update of Twirla and our performance to date, our first full quarter of commercial launch. As I mentioned, we banned sampling in the first quarter, and we believe our sampling efforts are important to driving HCP and patient awareness with Twirla. The first several weeks of quarter one included intensive sampling, and in the weeks that followed, we've seen steady trends of increasing scripts, refills, and awareness of our product. On slide four of the deck, which outlines a four-week rolling average over the first quarter, you'll be able to see the trend quite clearly, and we're thrilled to see the growth on all these key performance metrics. We believe this is a sign of a healthy brand and have seen these trends continue into the early part of the second quarter. As we progress through 2021, As we did so in our earnings press release, we expect to update you on a quarterly basis rather than providing such granular detail as shown on slide four. But we thought this data would be useful for the purposes of providing on initial insights into the first quarter of our launch. Our growth in total prescriptions was driven by an increased number of prescribers and growing refill rates. The graph on slide five showcases our monthly RX data. As you can see, increasing the number of TRXs from January onward and the increasing refill trend as well. We expect this uptake will continue as we move into the second quarter and beyond. We're pleased with the progress to date on the growth of our prescriber base. When we last spoke, we told you that we would continue to focus on educating and expanding our prescriber base as we seek to grow our brand. I'm excited to update you on this progress of what we're seeing. During the first quarter, the number of prescribers has increased dramatically. As of March 31st, we had more than 855 writers, and the number has continued to increase into the second quarter to over 1,200 prescribers. You can see the prescriber growth on slide six. The growth in the number of prescribers writing TRXs for Twirla has continued to steadily grow and increase in the momentum at the TRX level. Importantly, the number of TRXs each prescriber is writing is also growing, and we're seeing higher refill rates. And approximately 25% of our units dispensed at pharmacies are now refills. Our sales team of 65 sales representatives and eight virtual sales specialists continue to engage with both in-person and virtual visits with prescribers. With vaccination rates continuing to increase, we anticipate having the ability to meet in-person with a growing number of practices, which we expect to enable us to make continued inroads and complement with our virtual sales efforts. I also want to comment on our efforts to expand our distribution network. On our last call, we discussed a new arrangement with Sterling Specialty Pharmacy. Today, we can report this relationship, while in its early stage, has been a very productive one. We're encouraged by the efforts to date and believe this collaboration will support our continued sales uptake of Swirla. While the agreement's only been active for one month, we see a number of patients and prescribers continuing to grow. We also recognize the increasing role of telemedicine in facilitating access when we continue to evaluate this channel as we move forward with TWRLA. Now in the managed care, we remain focused on increasing access to TWRLA through a variety of efforts, including the focus on expanding access and reimbursement coverage for TWRLA across managed care and government insurance plans. In particular, we made a lot of progress in obtaining Medicaid coverage for Twirla. Currently, Twirla is covered with no prior authorization in 20 states, and we're expecting coverage in Texas in May of 2021. The Medicaid market represents a large number of combined hormonal contraceptive, or CHC, users. Medicaid volume for oral contraception total prescriptions in 2020 was nearly 8 million. It's worth noting. that we believe roughly one-third of the business of the other patches comes from Medicaid. We're encouraged by this trend and view this as another source of ongoing market growth for Twirla. We remain committed to maximizing access for Twirla for all women interested in using our product. Now I'd like to turn to a marketing update. I want to spend some time on the work we've been doing to increase awareness of Twirla. If you've been following along with the deck, I'm now on slide seven. We focused on reaching HCPs and consumers alike through our branded and unbranded marketing efforts. Let me walk through some of our efforts this quarter. For the I'm So Done unbranded campaign, our efforts continue. Last quarter, we told you we were the first unbranded contraceptive campaign to launch on TikTok. This was very positive for us, driving increased visits on our unbranded websites. We believe this is a strong indication of the interest and underlying need for birth control education. We're also leveraging AumSumDone to drive awareness of the birth control category. And now we're focused on driving TWRLA consideration and trial amongst consumers. This leads us into our branded TWRLA efforts. We believe that a robust brand marketing effort is important to drive awareness and trial of TWRLA. Our strategy is focused on reaching women with a multi-channel creative campaign that positions Twirla as the first and only weekly contraceptive patch that delivers a low dose of estrogen and which meets women at key moments in their day to support engagement with our brands. With this in mind, we're extending our digital reach by advertising on dating apps, which include Tinder and OkCupid. Over 29 million women leverage dating apps and the user base skews to millennials and Gen Z, both of which coincide with the Twrla market segment. Moreover, we expect to begin advertising on Spotify, which has a monthly user base of approximately 22 million US women between the ages of 18 and 34. The key takeaway here is that we're strategically rolling out more and more branded consumer marketing communications and resources as we simultaneously increase HCP awareness. We expect a stronger incremental branded consumer investment to continue over the quarter and into the quarters throughout 2021, and we look forward to providing you additional updates. Before handing over the microphone to Dennis, I'd like to reiterate our commitment of building a robust women's healthcare business. We believe this is the first step of achieving this is through the growth of Twrla. I'll now turn over the call to Dennis Riley, our Chief Financial Officer, and he'll provide an overview of our financial results and our business update. Dennis?