Agile Therapeutics, Inc.

ladies and gentlemen thanks for standing by and welcome to the agile therapeutics fourth quarter and full year 2020 financial results conference call at this time all participants in the listen-only mode after the speaker's presentation there will be a question and answer session to ask a question during the session you need to press star 1 on your telephone if you require any further assistance please press star 0. I'd now like to hand the conference over to your speaker today, Matt Riley, Head of Investor Relations and Corporate Communications. Thank you. Please go ahead.

Hello, everyone, and welcome to today's conference call to discuss our fourth quarter and full year 2020 financial results. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our outlook for the full year 2021, 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 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 of 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 update for looking statements except as required by law. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are Al Tamari, Agile Therapeutics Chairman and Chief Executive Officer, and Dennis Riley, Chief Financial Officer. Following our prepared remarks, we'll open the call to your questions. Let me now turn the call over to Al.

Thank you very much, Matt. Good afternoon and welcome everyone to our fourth quarter and full year 2020 conference call. I'd like to start off today by highlighting the hard work and efforts of our talented team and partners resulting in the launch of our first FDA approved product, Twirla, a once a week contraceptive patch. Twirla was designed to fill a need in the hormonal birth control market. bringing a non-invasive, non-daily combined hormonal contraceptive or CHC option with a lower estrogen dose than the only other contraceptive patch available in the marketplace today. As we discussed last quarter, we were well on track to launch our product into the addressable CHC market valued at more than $4 billion, and we've accomplished that objective. All three of our validation batches of Twirla were made available for commercial use in December, leading to the achievement of our 2020 revenue target with just over $1 million in gross revenue in the fourth quarter. In addition, the sales force received their samples in late December. The traditional channel for distributing Twirla has been built. Our network of three major U.S. wholesalers as well as several regional wholesalers, have been central toward the initial stocking of Twirla. Moving forward, we believe that our established and growing distribution network will provide the supply chain infrastructure necessary to support the anticipated demand for Twirla. In terms of the commercialization efforts behind Twirla, our plan focuses on three primary strategies for engagement. First, healthcare professionals, or HCPs. Second, managed care. And lastly, the consumers. First, our efforts with HCP. Along with our partner, Cineos, we're able to hit the ground running with an experienced sales force of eight regional virtual sales specialists and 65 sales professionals. This is a grand total of 73 individuals calling on the HCP audience. The sales force has not only been productive in the number of daily interactions with HCP and their staff, but also in generating face-to-face calls. Since launch, we've been able to generate roughly 70% of our prescriber meetings face-to-face in a COVID-19 compliant setting. But the question all in your minds, I'm sure, is how's launch going? I'd be ruined and missed if I did not acknowledge the challenges our team has faced, both nationally and regionally, including the pandemic, inclement weather, power outages, and water shortages. But taking all this into account, The short answer is that we're very happy with the momentum we are seeing and all the indicators and metrics we are monitoring to track our Salesforce effectiveness. Allow me to try to explain that. Let's start with prescriptions or tier Xs. In my mind, we effectively launched our product beginning this year. Since that time, we are seeing weekly compounded growth rates of approximately 30%. I do want to add a word of caution. The point I'm making is one of momentum. We're not suggesting this is a sustainable rate for the purpose of modeling or guidance. We're still in the very early stages of launch. With that said, we are still happy with this start. I also want to comment on the value of a TRS. Importantly, on average, each TRS is more than one unit for one cycle. The reason why is women get more than one month's supply of Corolla when she leaves the pharmacy. Each TRX is averaging somewhere between 1.3 to 1.4 units or cycles received by the patient. This is in line with our internal planning. Think of this as getting 40 to 45 days of TWRLA at one time. We're monitoring other important metrics. Physician prescribing a TWRLA. We are growing our base of prescribers weekly. Since January, our week-on-week rate is approximately 29%. The number of TRSs each prescriber is writing is also growing, which is another good indicator. Refills. We're starting to see refills, which is great news. Roughly 10% of our units dispensed so far at pharmacy are refilled, and we expect refills to accelerate as new prescriptions turn into repeat fills. Ultimately, we are encouraged by the early results from our field representative efforts prior to launch and the continued upward trajectory since, as evidenced by the steady increase in TRX refills. This indicates that providers are willing to write longer prescriptions once the patient is initially successful on the product. As we've discussed in the past, the sampling dynamic is important for swirlers. We're continuing to offer full-month sample supplies for patients to ensure individuals who are interested in Twirla have an opportunity to use it after consulting with their HCP. We believe it's important for the patient to ensure Twirla is the right product for her prior to getting their prescription and moving forward with becoming a long-term Twirla user. Initially, it does slow down the patient flow to pharmacy in the early days of launch, but we think of samples as an investment that introduces HCPs and their patients at Twrla with the potential to stimulate future growth. Moving forward, we'll continue to use the insights from our data-driven approach to HCP outreach to refine our targeting to the highest volume practices. While we do not expect to share all these metrics going forward on a quarterly basis, we do believe they are good indicators of the initial commercialization of Twrla. Now on to managed care. We also continue to make meaningful progress on both coverage and reimbursement for Twirla in a challenging managed care environment. We estimate our engagements with third-party payers have resulted in Twirla having achieved approximately 40 to 45% formulary coverage since launch. Notable, this is inclusive of one of the three PBMs, or pharmacy benefit managers, as well as several smaller plans. We continue to work towards our goal of increasing formulary access with as much zero copay as possible over the course of this year. We also expect that TWRLA will be now available to patients in one of the largest closed managed care systems based on a recently negotiated GPO or group purchasing organization agreement. This opens another important channel for accessing TWRLA and represents another element of our early momentum for TWRLA. Please note these arrangements do not report data through Symphony or IQVIA. Finally, Agile is currently in discussions with specialty pharmacy and telemedicine partners in order to expand the channels that provide access to SWARLA. We have said all along we want to follow the patient on her journey and ensure SWARLA is available for her along the way. We recognize the benefits afforded by both channels and believe that bringing differentiated values to our business and patients that they'll serve. For specialty pharmacy, we prioritize finding a partner that would make Twirla easy for providers to prescribe and convenient for patients to receive Twirla. Today, we're happy to announce our partnership with Sterling Specialty Pharmacy. Sterling has an established organization with patient-first philosophy that matches our ethos. They also have a proven tracker of providing streamlined and personal approach, which we believe will play a critical role in accelerating the core of our uptake. From a telemedicine perspective, because of the ease and convenience that the channel offers patients, we're committed to selecting partners that best align with our strategic needs. We'll continue to explore this area and hope to share more information about this in the near future about our efforts and developments in telemedicine. Now on the consumer engagement. As a company, we're focused on and committed to providing providers that fill the unmet needs of today's women. As part of this, we believe it's important to break the stigma around conversations about birth control and ensure women are able to educate themselves on the variety of contraceptive options available and make informed decisions that best align with their own personal contraceptive needs. Since our I'm So Done Unbranded campaign was launched in September of last year, roughly 700,000 women have engaged on our website content via displayed and paid social efforts, which has empowered them to join in the birth control conversations. We're happy to note Agile is breaking the contraceptive category mold by being the first unbranded birth control awareness campaign to activate on TikTok, the most downloaded app in 2020. I'm proud of these efforts and will continue to explore developing partnerships with popular lifestyle influencers and credible content providers to further advance the I'm So Dumb campaign. We believe these educational efforts are an important component and a driver of the continued awareness to support the ongoing growth of Swarov amongst our target market. Learnings from the unbranded campaign translate well into the development and launch of Agile's branded campaign for Swarov, a direct-to-consumer or DPC site and social media channels, which have both been launched in December. We're excited to share that in less than one month, we had approximately 300,000 engagements from our paid social media channels and expect additional and impactful DTC activations in the future. Our social media efforts are designed to drive traffic from the unbranded, unsubscribed, or twirl-less social media pages and profiles to the respective unbranded and branded websites. We are not focused solely on building followers or accumulating likes on Instagram or Facebook. We want to see real, meaningful engagement with the content and information on the I'm So Done and Twirla website, and we're seeing just that. While we're committed to becoming a market leader in women's health, we are also focused on our pipeline and the ability to help solve other unmet needs in the women's healthcare space. We believe this goal can be fueled by organic growth, stemming from Twirla strengthening its presence in the marketplace. Our organic growth will be supplemented by our funding efforts, which I'm pleased to announce have recently increased. While Dennis will soon go into more detail on this, we've expanded our loan facility with perceptive advisors who are now making available to Agile an additional $10 million on our loan facility upon the achievement of certain sales milestones. This in addition to perceptive advisors' $35 million loan facility from 2020, and reflects their continued confidence in our business and provides agile additional financial flexibility and options. In summary, we executed our fourth quarter 2020 plan with the launch of TWRLA and look forward to continue to educate and expand the prescriber and consumer basis on a differentiated benefit of TWRLA as we seek to continue growing market share. I'll now turn it over to Dennis Riley, our CFO, to provide a number of your financial results and a financing update. Dennis?