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spk01: Good afternoon, and welcome to the Agile Therapeutics Second Quarter 2022 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.
spk02: Hello, everyone, and welcome to today's conference call to discuss our second quarter 2022 financial results and corporate updates. 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 and financing prospects for the future. Our outlook for the second half of 2022, management's expectations for our future financial and operational performance, including our expectations regarding the market growth of Twrla. Our business strategy, our partnership with Afaxis and its ability to promote growth, our product supply agreement with Nurex and its ability to educate patients about Toella, our connected TV campaign and its ability to promote growth, and our assessment of the combined hormonal contraceptive market in general, 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 four different statements. Please refer to our filings in 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, Agile Therapeutics Chairman and Chief Executive Officer, and Amy Welsh, Vice President of Marketing. Following our prepared remarks, we'll open the call to your questions. And now I'll turn the call over to Al.
spk03: Thank you, Matt. And thank you all for joining us on our call this afternoon. We had a busy and productive quarter. And on this call, I'll review the key areas of the second quarter 2022 financial performance, our current cash position, and then provide a commercial update on scoreline. I'll then hand over the call to Amy Welsh, who leads our commercial efforts preview the upcoming launch of a new initiative with a leader in female telehealth, Nurex, a 30 Madison reproductive health brand. We believe the execution of our plan in the first half of 2022 has set us up well for the remainder of 2022, and I want to start off by discussing three accomplishments. We continue to grow twirl of demand and revenue. we have significantly reduced our operating expenses or OPEX. We have raised additional capital that we believe is sufficient to fund our operations through the end of 2022. First, let me touch on the twirl of demand and the company's OPEX. We are proud that today we report our second consecutive quarter of growth of twirl of demand or cycles and at the same time reducing our OPEX. Total cycles for the second quarter were 21,083, which fell within our updated guided range of 21,000 to 21,500. Growth in the second quarter cycles represents a 27% increase from the first quarter of 2022 and help us realize net product sales revenue of 2.1 million which is also within our guided range. OPEX for the second quarter of 2022 was $11.3 million, which is below the updated guidance range of $11.5 to $12.5 million. The reduction in OPEX was primarily attributable to the optimization of the Trolla Salesforce to better focus on the most productive territories with high volume and favorable third party reimbursement, as well as reducing expenses across all other areas of our business. These improvements in OPEX have resulted in a $12.2 million net loss for the second quarter of 2022. In the second half of 2022, we expect quarterly OPEX to be generally in line with the second quarter of 2022. Current and prospective investors have expressed a desire to see the company effectively manage expenses while continuing to grow the 12 demand. By demonstrating consistent progress in both of these areas, we believe investors are beginning to see what we see, which is a company with a path to reaching our goal of becoming cash flow positive. We believe we advance our goal of financing our operations, by raising proceeds through our at-the-market or ATM offering in the second quarter of 2022 and via the public offering in July of 2022. The $12.2 million in net proceeds from our ATM financing activities have allowed us to end the second quarter of 2022 with approximately $13 million in net cash. When combined with the $22.2 million in net proceeds from the July public offering, we believe we can fund our operations through the end of 2022. As previously announced, we have reduced our outstanding debt with Perceptive Advisors to $3 million by using the proceeds from the ATM. We paid $5 million to Perceptive during the second quarter, And in July of 2022, we made an additional prepayment of $7 million in exchange for a waiver of certain financial covenants at the end of 2022 and the release of our manufacturing equipment to help us restructure our commercialization agreement with Corian. We appreciate the many years of support from Perceptive, but believe the meaningful reduction in our debt improves our balance sheet and gives the company flexibility in future capital raises as well in business development and partnership opportunities. Securing this capital was a testimony to the management team and the business plans we have in place. So we believe we're now positioned to move forward in the second half of 2022, and we believe the right question to ask is now, how can we continue to responsibly manage expenses and continue to meaningfully grow the toilet business? And we think the answer to this question is to continue to execute the initiatives that drive volume in both the non-retail and the retail channels, while also seeking and mobilizing new strategic initiatives that can augment our business. I'll now provide an update on the FACTSIS and our DTC marketing efforts. I'll then turn over the call to Amy, who has been leading the charge on all of our commercial efforts to talk to you about the upcoming launch of our collaboration with Norex. One of the most important questions we received is the EFACSIS relationship making impact for Agile and Twrla in the non-retail channel. While the EFACSIS partnership required a significant lead time to train and deploy, we believe we're starting to see that translate into volume. In the first quarter of 2022, 485 non-retail cycles of twirl over dispense. In the second quarter of 2022, that number increased by 189% with dispensing of 1,404 non-retail cycles of twirling. We believe there's even more upside in this channel based on the reach of the AFAXIS customer network. With the recent Supreme Court ruling, we are proud to make cork twirl available to non-retail channels. Amy, who you'll be hearing from shortly, galvanized our partnership with AFACSIS in January of 2022, ahead of the Supreme Court decision. And we continue to believe it is important to support the Planned Parenthood organization. Through their group purchasing organization, AFACSIS primarily provides services to the non-retail channel. Additionally, a co-promotion program for Terrola with AFACSIS Pharma has the potential to access over 25,000 accounts, including Planned Parenthood and college and university health centers. Therefore, we believe we can realize even more meaningful volume in the non-retail channel, and with the faxes, we expect to continue to make inroads in Planned Parenthood and other non-retail customers. Related to college and university health centers, we are approaching the back-to-school season. which has historically been an active time of year in contraception. For that reason, we'll be focusing on targeted promotion of our Twirla direct-to-consumer campaign on connected TV, also known as CTV. As we previously stated, we're deploying this commercial with a highly targeted, efficient focus on women in the target demographic of 18 to 24 in states that have large markets for contraceptives and potentially strong reimbursement for Twirla. Our initial run of the commercial launched in April of 2022 and garnered positive results as we helped raise awareness, trial, and adoption of Twirla. Our data continue to show us that many women who try Twirla stay on Twirla and become retweet users. By deploying our CTV commercial at this time, When women in our target audience are having birth control conversations with the prescribers, we expect to add more long-term repeat use of the formula. Again, we think the right questions to be asking are factors and CTV programming working and having an impact on our business. We believe the answer is yes. In the first week of July, 2022, we surpassed 33,000 739 total prescriptions dispensed for twirlers. To put that in perspective, that's more than we did all calendar year 2021. And we believe the partnership with FACTS along with our targeted DTC efforts helped drive this growth. We have always said we will explore the right partnerships and initiatives at the right time to help grow our business. We continuously look for opportunities to grow our business, and I'll turn over the call to Amy, who is excited to discuss an upcoming initiative with Nurex, which we believe can contribute to the retail growth by driving our DTC and CTV efforts. Over to you, Amy.
spk00: Thank you, Al. And hello to all of you joining us today. We are excited to share that we recently signed a product supply agreement with Nurex. 30 Madison's reproductive health brand, which will make Tarolla an available option for their patients in the upcoming months. So why is this important for Agile and Tarolla? Nurex is a leader in female-focused digital healthcare amongst our target audience and offers patients access to its telehealth platform and expert medical providers that have prescribed contraception to more than 1 million patients. We believe the advantage of collaborating with RITNERx is the sophistication of their operations. Patients who are looking for contraceptive options will be able to learn about and potentially access TROLLA. By combining TROLLA with RITNERx's broad reach, we believe this initiative will help further engage patients and increase awareness and access for TROLLA. Once the initiative is officially launched, we will make an announcement. But I want to emphasize that we are excited about the potential impact this can have on twirlers awareness, adoption, and ultimately cycle suspense. Stay tuned for more. We'd now like to give our covering analysts the opportunity to ask questions. Operator, you may now open the call for Q&A.
spk01: Thank you. If you'd like to ask a question, please press star then one on your telephone keypad. The first question is from Oren Libnett with HC Wainwright. Your line is open.
spk04: Thanks for taking the questions. I have a few. Obviously, a lot has been made in recent months about the momentum coming out of Washington towards hopefully enforcing this ACA contraceptive mandate that the you know, has been getting flouted by the insurance companies. And so I'm just curious, what extent, if any, have you seen any changes on the ground as a result of at least headlines? And is there anything you could do proactively on this front now that this, I guess, threat is out there from Washington to actually enforce it? Are you you know submitting and collecting data and submitting you know reports or complaints to the administration are you able to leverage this language command of washington in ongoing probably around now negotiations for next year uh just help me understand what the real effects potentially are of this uh new messaging and i have a couple follow-ups great hi or it's al no great question
spk03: So, a lot's happening in D.C. You know, as I think you remember, I think the most important thing that's happened is that we got our message to the right audience. The Monday after the announcement of Roe v. Wade, the Commissioner of Health and Human Services, Becerra, Secretary Becerra, you know, put out in the press that there was 13 insurance companies, including the PBMs, that were brought to the white house to talk about you know the enforcement of the a specific ata specifically and he's the right person this issue is on kind of um his doorstep if you will along with the two other secretaries that also regulate this secretary of treasury and labor So we weren't at the meeting, but we understand it was a very hard-hitting meeting about, you know, if necessary, to go on enforcement. Following that meeting, there was an issue of additional guidance, so the guidance in this area. And for the first time, Oren, we saw in that guidance the word enforcement. It was prominent. So I think we're at that crossroads. Related to this, I go back to the presidential order that was signed by President Biden, where Becerra was over his shoulder, that actually empowered health and human services to have on the presidential order more, if you will, teeth in this. So we're at a good point, Oren. You know, this is the first time that the guidelines included rhetoric about enforcement. I believe they're at that point. So, you know, we're starting to see things, as I think we pointed out before, we're starting to see some of the smaller downstream plans and some of the smaller PPMs comply more fully with the ACA. So we're seeing some improvement there. So your next question is what more can we do proactively? I'm so proud of our group and the industry. This is not an agile issue as we talked before. This is an industry issue. We work collaboratively with our peers, both big and small, and form the coalition that really does try to educate our regulators what we see on the ground. So to answer your question, sure, we provide information and we support because we are on the ground. We know what's happening. So we work very collaboratively, and I should say, like, we look forward to today to work more collaboratively with the insurance companies. We really want to make Twirla and all our products available, you know, as broad of audiences as we possibly can. And so we're doing that through Apexis. We're doing that through now, you know, the relationships we have on telemarketing that Amy will talk more about, as you talk about. So, Warren, I mean, I wish I could answer your question more fully if there's any more we could do. I think we've done great work. The ball is really in the court now for the insurance companies to come to full compliance. And I certainly do believe if that doesn't happen, there needs to be enforcement. And we're just at that point. But I'm optimistic that with all the attention D.C. has got on this that we'll see better compliance. We're seeing it, but I'd like to see more faster. So I don't know what to answer. Okay.
spk04: I'll dig into that more with you offline. But let me follow up with a different one on F-Axis. Obviously, a really impressive quarter-over-quarter growth in that non-retail channel. And I'm just curious, are you starting to see patterns of orders, large orders, repeat orders, such that you can start to start theoretically projecting even that channel going forward, how big it could be? Or at this point, is it still too early and really one-offs? at this point. And I guess along those lines, do you have any visibility, whether it's claims data or some other sources of data that allows you to connect the dots between orders, you know, from like a Planned Parenthood, from a faxist to actual dispensing of prescriptions? Do you know if they're just stocking up because it's available, especially in, you know, the wake of Roe, or are they actually dispensing those prescriptions through those channels?
spk03: Yeah, I'll answer maybe the last part and then, you know, a couple of your points, and I'll ask Amy to comment more fully on the customer level. Their business flows through IQV and Symphony, as we've discussed, but on a different audit called the non-retail audit or the institutional audit. Unfortunately, the organizations don't report prescriber-level data, you know, on that audit. So it's sort of like a hospital system line that we see it going in, we don't see the pull-through. what gives us great comfort that annual common on we see repeat orders that we love repeat orders that that something's walking around when we see that i i want to say also um we saw a lot happening before row so this wasn't a roe v way that that volume assault wasn't roe v way we saw that continuously so um and then but i i will say our customer got significantly distracted you know doing roe v way the plan paranoid accounts because we have to go through a formulary system situation They came off game in July. So we still see significant volume there. We've got a number of customers set up. Amy will talk about what she's saying in the repeat orders. But do you want to give a little more call, Lauren?
spk00: No, thank you. And, Oren, thank you. I know we could talk more offline. But to answer your first part of your question, yes, we do now see a pattern, right? For some of the early Planned Parenthoods, they came on board in Q1, and even at the start of Q2, we're understanding. which ones order monthly, which ones order weekly, what that looks like, and how do we project from a forecasting perspective. And now that we're looking at some moderate to even some larger accounts coming on board, we're able to properly forecast this in the back half of the year. So it's not, I think, an exact science just yet, but now that we're in the middle of the year, we're able to properly plan.
spk03: All right. It's still, you know, or even for us, I mean, it's a little lumpy. You know, we're starting to understand their patterns. Some customers buy once a week. Some customers buy once a month. So we're getting the hang of it, you know, but it's not like a pharmacy that buys every day. Pharmacies get on-demand shipping. There's a little bit of, you know, but what gets us all comfortable is we love repeat orders. We know it will. We're seeing repeat orders, so that gets us excited.
spk04: All right. I appreciate it. I'll let somebody else ask a question.
spk03: Thanks, Lauren.
spk01: A further question? I'll turn it over to Mr. .
spk03: Great. Well, thank you all. So, just a couple of closing remarks. You know, our goals with the company, as you can see, are to grow the Twirly Love Accounting brand with also a big end and, you know, get the cash flow positive. We believe we've taken important steps towards these goals in the second quarter. by once again increasing Twrla's demand and revenue significantly, at the same time reducing our OpEx footprint. For the second half of 2022, our focus is on expanding growth of Twrla, which is our rallying cry, and operating OpEx in line with what you've seen in the second quarter. You know, we do believe that our execution in the first half has set us up for success in the second half, and we'll continue to drive the initiatives Even as we bring on new initiatives, you know, they don't replace the previous ones. Our job is to keep executing all the initiatives that we've been talking about so we can continue to keep seeing the double-digit quarterly growth. You know, those initiatives that we talked about, the Apexis and the non-retail, that's our partner. Our targeted efforts with CTV and the launch of our new relationship in the telemarketing channel or teleprescribing channel with Norex. And supporting most, or as importantly, our sales force, who's on the ground generating demand for us. We'll continue to engage on and look at the external factors that Oren was just talking about that, you know, we're not totally in control of, you know, but we still think we should be at the table discussing these because they do have an impact on our growth. And we believe, you know, as I said, you know, things are turning for the better. We continue to believe that an enforcement of the federal law on the contraceptive coverage is good public policy. And these times, we also see this as a real opportunity for us. We're both engaged on this issue and very supportive of the progress that the Health and Human Services in particular has been making. Until then, we continue to focus on what we can control and delivering on what we think is achievable and a very targeted plan to build our business. So hopefully you get a sense that we have strategic initiatives in both of these channels, which can really grow our business, both in the retail side and in the non-retail side. We've signed up with some great partners. And so to me, we've got all the pieces in place to really significantly grow this business and to get to cash flow positive. So I thank you all for listening. We appreciate it. We're looking forward to seeing more of you in the upcoming months. So thank you again for listening in today.
spk01: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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