Agile Therapeutics, Inc. (AGRX) on Q4 2022 Results - Earnings Call Transcript
Operator: Good afternoon and welcome to the Agile Therapeutics Fourth Quarter and Full Year 2022 Financial Results Conference Call. Please note, todayâs event is being recorded. I would now like to turn the conference over to Matt Riley, Head of Investor Relations.
Matt Riley: Hello, everyone and welcome to todayâs conference call to discuss our fourth quarter and full year 2022 financial results and corporate update. Before we start, let me remind you that todayâs 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 first half and full year of 2023; managementâs 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 partnership with Afaxys and its ability to promote growth; our product supply agreement with Nurx and its ability to make Twirla broadly in hub locations; our digital advertising campaign and its ability to promote growth; and our assessment of the combined hormonal contraceptive market generally, among other statements concerning 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. Further, during the course of todayâs 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. 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 todayâs call is not intended for promotional purposes and is not sufficient for prescribing decisions. Joining on todayâs call is Al Altomari, Agile Therapeuticsâ Chairman and Chief Executive Officer. Following our prepared remarks, weâll open the call to your questions. I will now turn the call over to Al.
Al Altomari: Great. Thank you, Matt. Thank you, all, for joining us on our call this afternoon. 2022 was a turning point for Agile as we continue to advance revenue growth for Twirla and transform and streamline our operating model to reduce expenses, which we believe sets Agile up for a strong year of continued revenue growth in 2023. We think the third quarter of 2022 was a breakout quarter for Agile and Twirla because we saw meaningful growth in net revenue, total demand and Twirla factory sales. Following the third quarter, many of you have been asking an important question: How do we know that the performance is sustainable and not just an anomaly? Today, I believe we can answer that question with our fourth quarter 2022 performance, which we saw continued double-digit quarter-over-quarter revenue growth combined with disciplined spending and provides insight into why we are encouraged by what weâre seeing so far in 2023. Earlier today, we issued a press release with our detailed fourth quarter and full year 2022 results. I want to walk you through a few of those results now. Net revenue for the fourth quarter was $4 million, which represented a 33% increase from the $3 million we reported in the third quarter of 2022. The 33% increase comes after we reported a 43% quarter-over-quarter from the second quarter to the third quarter of 2022. We think this is notable because we finished the second half of 2022 with momentum that contributed to full year 2022 net revenue of $10.9 million, a 165% increase over 2021 net revenue of $4.1 million. Our fourth quarter net revenue reflects improvements in the following key areas. Twirla demand for the fourth quarter, as reported by Symphony, was 37,452 total cycles, a 25% increase from the third quarter of 2022. Full year 2022 total Twirla demand was 105,667 total cycles, a 213% increase from 2021. Twirla factory sales for the fourth quarter of 2022, as reported by our wholesalers, were 43,230 total cycles, a 30% increase from the third quarter of 2022. For the full year 2022, Twirla factory sales were 114,546. This total exceeded the 113,600 total cycles which we previously guided for the year and represents a 235% increase from full year 2021. As a reminder, the difference between the demand and the factory sales cycle is that not all the prescription demand in the non-retail channel is reported into third parties like Symphony or IQVIA. The demand numbers we received from our wholesalers do include the sales to non-retail channel. And therefore, we believe that the factory sales more closely represent the total demand for Twirla across all our channels. Net revenue, demand and factory sales are all key components of our overall growth plan. So growth in these areas is only meaningful if we can simultaneously manage our operating expenses. As you can see from our results, we were disciplined in managing our spending in the fourth quarter and total year of 2022. Non-GAAP operating expenses for the fourth quarter 2022 were $9.2 million, which is identical to the $9.2 million reported for the third quarter of 2022. Full year 2022 non-GAAP operating expenses were $45.5 million, a 29% decrease from the $64.4 million reported for the full year of 2021. Before I move on to the outlook for 2023, I want to take a moment to put 2022âs year-over-year performance into perspective. From the end of the fourth quarter 2021 to the end of the fourth quarter 2022, factory sales increased 205% while OpEx decreased from $18.2 million to $9.2 million. So in the past year, we were able to grow our sales over 200% while decreasing our spending by 49%. We plan to maintain spending discipline and therefore, expect to see our total operating expenses for 2023 to be lower than 2022. Our outlook for all these measures is primarily attributable to the reengineering of our business plan as a commercial company that focuses on leveraging external partnerships while keeping our internal infrastructure lean and efficient. We are confident in our ability to execute on our business plan, and we believe that our lean commercial platform can continue to produce strong results in 2023. To that end, in January of 2023, we reported that we expect 2023 net revenue to be in the range of $25 million to $30 million, which would represent a year-over-year growth of 129% to 175%. We recognize this goal may sound ambitious, so let me explain why we think itâs attainable. Our initial review of January 2023 demand saw a single-month record high for Twirla demand and a single-month record high for retail cycle demand, which is important because the retail side of our business is our most profitable. As we continue through the first quarter of 2023, we expect to see factory sales reflect wholesaler work down of inventory levels, which rose slightly at the end of 2022, but are encouraged by these initial trends. From what we can tell in 2023 thus far, February demand numbers appear to be on par with January and February factory sales appear to be slightly higher than that of January. The preliminary reports for the first 2 months of 2023 give us confidence that we can continue to grow Twirla and meet our 2023 goal of achieving net revenue of $25 million to $30 million and our greater financial goal of generating positive cash flow. Our commercial plan is designed to create growth by focusing on the 5 states that have the highest level of reimbursement potential for Twirla and are estimated to allow us to reach 45% of U.S. women between the ages of 18 and 24. We believe thereâs still a lot of room for growth in this segment of the contraceptive market by going deeper into these 5 states. We believe our lean commercial platform can continue to deliver the growth needed to meet our goals and, in part, because of our continued focus on collaborations with our telemedicine providers, which we hope to accelerate in the second half of 2023; and our relationship with Afaxys, which allows us to grow the non-retail channel through the Planned Parenthood centers and public health center clinics. Iâd like to take a moment to comment on a few of our other financial results, which we believe also demonstrate a year of progress in 2022. Cost of goods sold, or COGS, which consists of direct and indirect costs related to manufacturing Twirla solely were $1.7 million for the fourth quarter and $6.8 million for the full year of 2022 compared to $5.7 million and $10.7 million for the same periods of time in 2021. We closed out the fourth quarter and the full year of 2022 with a net loss of $3.9 million or $0.10 per share and $25.4 million or $1.18 per share, respectively, compared to a net loss of $19.5 million or $6.63 per share and $71.1 million or $29.28 per share for the comparable periods in 2021. These reflect the reclassification of certain warrants, which were issued in conjunction with the financing in 2021 and 2022. The reclassification of these warrants as liabilities resulted in $3.8 million in other income for 2021 and $25.5 million in other income for 2022. Moving forward, we expect to see fluctuations in our net income or loss depending on the valuation of these warrants, which will need to perform on a quarterly basis and are expected to result in non-cash accounting adjustments. We do not expect these adjustments to have any effect on the companyâs previously reported revenue, operating expenses, cash flows or cash. After deducting the other income attributed to the valuation of these warrants and the one-time only non-cash charge associated with the transfer of our equipment to Corium in the third quarter of 2022, non-GAAP loss was approximately $39.8 million for the year ending December 31, 2022, or $1.84 per share. We believe excluding these items represents a more useful comparison of the results from our operations in the periods weâre discussing. We ended 2022 with $5.2 million of cash on hand, in addition to the $75 million at-the-market, or ATM, arrangement. We will continue to evaluate all available options to finance the company and continue to explore opportunities that can potentially accelerate our time line to generating positive cash flow, including exploring business development opportunities. Before we open to Q&A, I want to emphasize that the entire organization remains focused on achieving our goals of growing Twirla, attaining the 2023 net revenue target of $25 million to $30 million and ultimately, generating cash flow positive. We remain confident we can accomplish these goals by: first, focusing on the five states that have the highest level of reimbursement potential for Twirla and are estimated to allow us to reach 45% of U.S. women between the ages of 18 and 24; second, continuing to cultivate the non-retail channel through every reach of the Afaxys customer network, which includes Planned Parenthoods and student health centers; third, increasing our footprint in telemedicine through our collaboration with Nurx, which has provided contraceptive options to more than 1 million patients. Our vision and ambition is that Nurx can accelerate the retail channel growth similar to the way Afaxys help us accelerate the non-retail channel growth. Now weâd like to give an opportunity for our covering analysts to ask any questions. Operator, you can now open the line for Q&A.
Operator: Thank you. Our first question will come from the line of Oren Livnat from H.C. Wainwright. Your line is open.
Oren Livnat: Thanks for taking my questions. Can you hear me?
Al Altomari: Yes, Oren.
Oren Livnat: Okay. Great. So I was hoping, first, to just talk about this $25 million to $30 million guidance that youâve reiterated. I mean that would be a pretty remarkable growth year-over-year. And Iâm hoping we can dig a little bit into, I guess, the contributors to that and visibility on that. First, I guess, can you characterize what contribution you expect, I guess, year-over-year from the retail and non-retail channels to that number? I mean, currently, I think volume-wise, retail â or non-retail is already at or above 40%. Do you expect like a major change in the mix for 2023?
Al Altomari: Yes. So Oren, this is Al. Besides Matt and I in the room, Amy Welsh, our Chief Commercial Officer; and Jason Butch, our Chief Accounting Officer, are joining me. So Iâll turn it over to Amy, but at a high level, we expect all boats to rise. I mean we expect significant contributions both from the retail, which, as I mentioned in the script, we had an all-time high in January. So retail seems to be performing well. Thatâs our most profitable book and non-retail, but maybe you can go in a little bit more detail.
Amy Welsh: Yes, thank you for the question, Oren. I donât â I expect the growth to be the same as you saw in Q4. From a non-retail perspective, that growth came from one large account and a couple of handful of moderate to smaller accounts. We look at 2023 and we see here we will have one large account each quarter. So we should be able to see that type of growth. And what weâre learning from the growth of a large account or the addition of a large account is when they come on board, thatâs where Al used to always say it looks a little lumpy. Theyâll maybe buy a lot in the beginning, and then theyâll normalize and then theyâll buy consistently. So I think that, that mix should look the same. Retail is where our bread and butter is. So weâre ensuring that we have a field thatâs optimized and growing and augmented by partners like Nurx. But I think that weâre going to stay consistent to the type of mix youâre seeing in the same type of growth rate.
Al Altomari: Yes. So Oren, to answer your question, I mean, like mathematically, the fourth quarter, we did $4 million. So on a run rate basis, weâre $16 million plus business. So we â if you apply the same growth, as Amy was saying, that weâve seen particularly in the fourth quarter and then if we could stay on that curve, youâd start seeing the numbers weâve seen. So there is no reason to believe we canât keep growing this business the way weâve been. At the same time, we will keep our hand on the rudder of the OpEx, and thatâs the 1-2 combination that gets us across the goal line and starts generating cash.
Amy Welsh: Does that answer your question, Oren?
Oren Livnat: Well, sure. Iâm going to keep digging in there until you tell me to stop. So you kind of anticipated my next question, which is this non-retail channel growth. So itâs pretty amazing how big an impact one large, I guess in California, Planned Parenthood network win can add to the total volume picture here. And you mentioned expecting one large account win each quarter. What sort of visibility do you have on that? Are you already through the process with, I guess, the P&T equivalent there and highly confident in these new wins? Do you know we have a good grasp on what kind of volume each one of those can produce? And I have more...
Al Altomari: Yes, so Iâm going to give you kind of a 30,000 view, and then Amy will â can take you through. Itâs really interesting, Oren. I think you, more than anybody, would appreciate that Governor Gavin Newsom, as you probably saw with one of the big chain accounts, kicked them off the medical formulary to defend women in the state. So in his press statement, he said that the California economy, on a GDP basis, would be the fourth largest economy in the world, which just â I know thatâs astounding. And so it talks about the five-state strategy weâre on. When we look at our five states, they represent â we talk about 45% of the market. Thatâs 41% of the GDP in this country. So Iâll turn it over to Amy on the visibility. So California is a good state for us, Oren. So Iâll let Amy tell you our visibility.
Amy Welsh: Yes. I think your question was where are we with the process. And I think the last couple of times, weâve explained that the Afaxys sales process took a little bit longer. Yes, we, from a clinical perspective, so that itâs clear to the next handful of large accounts that provides meaningful option for their patients, so weâre past the clinical phase with all of those larger accounts. And what weâre doing is weâre trying to work with them from a financial perspective of when it makes sense to partner with Twirla and bring them on. So itâs sort of the last phase from most of those larger accounts, which is why my guesstimate we will see that happening sort of like quarterly â quarter-over-quarter throughout the year.
Al Altomari: So we won the battle clinically, Oren. So now it tends to be when is the right system, when they buy and the purchasing people who work with us. So we have optics to all of this. So we have the wins, so we expect to see volume now.
Oren Livnat: So there are additional large accounts. This is also in California theoretically?
Amy Welsh: Yes, believe it or not, yes, most of these large accounts are right there on the West Coast, specific to the State of California.
Al Altomari: What makes California peculiar, Oren, is just a little bit of a â a lot of times, a Planned Parenthood can be a single clinic like weâve talked before or in a buying group. In California, some of the affiliates tend to be in one buying group. So they â so one purchasing person or one P&T represents a number of individual affiliates. So in a lot of ways, Amy has one-stop shopping. So I think they just aggregate their volume, and look, they use that as a negotiating tool. So California seems to be, I donât know, Amy, the most organized, for lack of better words. I mean I think...
Amy Welsh: Yes, thatâs a really good way of putting it. Yes.
Al Altomari: And when we win, we win big, Oren.
Oren Livnat: Right. And so obviously, as we see volume accelerate, itâs been pretty remarkable how it can ramp in that non-retail channel already in the last quarter or two. As we see that to continue to grow, before we get carried away with how that might translate to revenue, on our end before you report, I guess an important factor is that economic side. I mean I know itâs less profitable, of course, than retail. But do you feel pretty confident that, I guess, the gross to net â or the net pricing per cycle going forward will be consistent with what youâve managed to achieve so far in the Planned Parenthood or other non-retail?
Amy Welsh: Yes. Yes, contractually, we donât expect any changes there from our pricing, 340B pricing. That should be locked, so you shouldnât see any surprises. And one thing that, when you were asking a question, Oren, that made me think about that I wanted to share is weâre also seeing a positive effect on the retail through these gains in California. I think that Al, on a couple of these calls, had explained that these physicians who work in a Planned Parenthood very often work in the community as well. So weâre starting to see a very positive effect on the non-retail account wins in California coming over into the retail side, too. So â but yes, to answer your question, no, weâre going to be consistent on the pricing.
Al Altomari: Iâll give a big picture answer. But Oren, maybe Jason can comment if I get it wrong. The mix in our third and fourth quarter hasnât changed much. So the barge almost rose. So our average yield per cycle is pretty consistent, right, quarter-over-quarter?
Jason Butch: Yes, thatâs exactly right. So like Al mentioned, Q3, Q4 is consistent. And from a forecasting perspective looking into â23, Iâm seeing a point or 2 maybe increase in the discounting across the board. So the mix does remain relatively consistent in and throughout â23.
Al Altomari: So our gross to net is maybe â I think itâs stabilizing. I donât know, for lack of better words, Jason anticipates it going up a little. But I think â as I said, weâve had the big shift in the third quarter. Fourth quarter was about the same. Weâre saying going forward, it looks pretty steady. Now if Amy is widely successful in retail, which we hope, that might change it for the good. And if the mix changes more into the other side, we will take a little bit of a haircut. But all volume is good to us. We like volume.
Oren Livnat: Yes. So, speaking of retail, thatâs growing pretty nicely. I mean I have IQVIA, and thatâs in the 50%, 60% year-over-year growth. I think Symphony is even better. How much effect of Nurx are we already seeing in the current volume, or is that really almost all upside in terms of inflection or trajectory in 2023?
Amy Welsh: Yes. Itâs going to be â we have not seen much at all. What we have been doing with our partner Nurx over the last quarter has been really just making sure that all of our tools will work with them, I think from our co-pay card to websites and co-promotion and just getting everyone up to speed to make sure that when they are ready to go full bore and completely convert to Twirla, that they are set up systematically and the patients will be able to get it seamlessly. I think you are going to see impact of Nurx in the back half of the year, hopefully as early as Q2, but confidently in Q3.
Oren Livnat: Okay. And can you just remind us, that â you are going to be the exclusive patch, right? So, are they just going to â I guess similar to Planned Parenthood that have adopted your product, are they just going to exhaust whatever, I guess, Xulane or generic supply they have and then go wholly into Twirla prescribing?
Al Altomari: Yes. We are â think of that as a formulary. We are in a preferred position on their formulary. Itâs going to be up to them how to manage the patient. Amy has been really sensitive to patients. Like if a woman is on Xulane and she is happy, she should stay. She should stay. I mean we really â thatâs really some of behind the scenes things we have been talking about. Now, we hope a new patient comes in, we get that patient. But our â we are in a preferred position, which is great. We are a good partner with them. Amy works hand-in-hand with them. But we say, look, do whatâs right for the patient. In the long run, we will benefit. So, thatâs kind of in our philosophy.
Amy Welsh: Definitely.
Al Altomari: So, itâs not going to be black and white like in some of the Planned Parenthood are in right falling off . So, thatâs a little different situation. This will be kind of â as Amy was saying, we will grow into it.
Oren Livnat: And I guess just one last one on retail long-term. Has there been any noticeable tailwind or change in payer coverage or payer compliance with coverage mandates with regards to Twirla or any other contraceptives that you have seen since the White House started to bring some real heat on to the payers?
Al Altomari: The answer is yes. I mean Amy and I review that data a lot. I mean what we see is all boats are rising. In the early days, kind of the headwinds would require doctors doing these letters of prior auth, as we talked you through, Oren, or letters of medical necessity. And they were even being stopped, which is what we thought was wrong. We are seeing them go through. So, there is less friction, if you will, on the script. The scripts have a better chance of getting filled. Another reason we like in Nurx and specialty pharm is that they can talk to patients through and say, hey, it might take us a week or two weeks to get this paperwork in. In the meantime, here is a sample. So, the answer is yes, and we see it across all brands, which is great. When â your question on formulary, no, we havenât seen much movement in formulary. So doctors, we still think, the big win for us. Imagine today, we get the formulary wins, Oren. The wins â what we are doing right now is remarkable, I believe in retail. But formularies, I think a whole different game if we can unlock the formularies.
Oren Livnat: Sure. So, if there is some improvement on the compliance with letters of medical necessity or whatever â the waiver, so to speak, for ACA, is it an opportunity for you to go back? I imagine early on some people wrote, especially when you had a broader footprint with sales, some people wrote prescriptions and were probably inappropriately rejected by payers. And I can only imagine thatâs a tough first impression for a doctor to have with any product launch. Do you have the opportunity to go back and revisit as this landscape has improved a little bit to some of these doctors and say, hey, I know you tried and failed before, but try again?
Al Altomari: Yes. I mean two things. One, itâs better than it was, but itâs still not perfect. So, we are routinely answering questions by Congress and the Senate about is it fixed yet, your question, and the answer is no. We believe we shouldnât even have to do a lot of this work. So, not all of them go through at 100%. So, itâs very plan-specific. Some plans or PBMs do better than others. So, while itâs improved, itâs not perfect. So, we are routinely being advised to answer Congress and answer the Senate on this. They still have an active eye on this. So, I think while itâs getting better, itâs not perfect. And then we do tell doctors. We do tell doctors itâs getting better. But rather than just sending the script down the street to the local CVS, give us the script. Once itâs in our hands, our hit rate is a lot higher. Amy can â I mean itâs as close as we can handle that script across the goal line. But if she goes to a CVS and they say, your card doesnât work, thatâs a big customer die for them. So, thatâs why we think specialty pharm and telemedicine are so important to us. I mean thatâs the strategy. The more volume we get there, Oren, our hit rate only can go up.
Oren Livnat: Okay. And just lastly, I appreciate the patience. OpEx, you mentioned it being down year-over-year. I guess can you talk about that? Is that expected to be sort of flattish or up a little bit from the current level as you sort of have these new programs rolling out and you suddenly get a lot more traction? And I guess on your guidance of $25 million to $30 million, you have an ambition of actually potentially cash flow breakeven at some point before the year-end, which would be pretty remarkable. And I am just trying to figure out, at what OpEx level do you feel like you can maintain sustainable growth, right? Like you have obviously reorganized a lot, and you have got a lot of momentum on the sales side. How much gross long-term do you think you can sustain beyond even 2023 and just reaching breakeven with this footprint? Do you think you are right-sized for substantial growth beyond 2023, or would you have to start investing more again?
Al Altomari: No, to answer your last question first, I believe we are right-sized and we can sustain growth, the growth we are on. But itâs based on one word, Amyâs ability to partner. We canât do it alone. So, I think as long as we have these great partnerships, Oren, maintain a strong presence in the field and a good leader like Amy that can really keep all â everybody working on all the oars in the water at the same time. I think we can continue to sustain this growth, right. And down the road, we would love to invest in the business again, I will be honest. But we are not there yet. But I am not going to try to pull them out either. I mean I think we have a good investment to work off of, and I am happy and I am pleased with the level. To your next question about the range, we â Jason and I think itâs in a range. So, I think before we said $9 million to $10.5 million, something like that, because it gets a little lumpy at times. When we buy samples, for instance, we had to buy the batch and expense it in that quarter. So, I think we are in kind of a range of, I will call it, $9.5 million to $10.5 million, I think was what we said before. The $9.2 million we are proud of. Thatâs done in a great day. Thatâs a lot of belt tightening. But we didnât cut corners. Amy got the investments she needed to grow this business. She wasnât complaining. She always wants more, but she is not complaining. And then with â I just want to clarify the profitability, I mean cash flow sustainability. We are not going to be sustainable this year. We are not going to throw off the year. There is not going to be â I know you know this. But we see the fourth quarter or maybe the last couple of months of the year that will break through there. So and then hopefully, we donât go back and then we go into â24 that way. So, we are shooting for the fourth quarter-ish. Thatâs where the lines cross. And if we can keep the OpEx in roughly the same zone of like $9 million to $10 million, we probably, Jason, need a $12 million net on the top line. And then we have the cost of goods sold that would â thatâs the math. So, it really is just arithmetic. So you say, what level of sales do we need to cover the OpEx? Itâs probably $12 million net. So, thatâs â and that number doesnât look scary to us.
Oren Livnat: Alright. Well, I look forward to future results, and keep up the good work. Appreciate it. Thank you.
Al Altomari: We are losing questions, Oren. I think you got everybodyâs questions. We are listing questions out of the queue, but thank you.
Operator: Thank you. I would now like to turn the conference back to Al for closing remarks.
Al Altomari: Great. Thank you very much, operator. Now, I would like to take a couple of minutes to comment on the recent special meeting we had with our shareholders. To continue to execute on our business plan and achieve our objective for 2023 and beyond, it was really important that we regain our compliance with our Nasdaq Listing and so to put us in a position to raise capital across a broader base of such sources. While we believe the notable growth in 2022, it just wasnât enough to regain our compliance with Nasdaq Listing standards in our first compliance period. We have been granted a second compliance period with Nasdaq, but we needed to obtain authorization by our shareholders to implement a reverse stock split. If and when the Board believes itâs the right time, we explored all â to let the shareholders know, we explored all the available âoptions available to us before concluding that our ability to implement a reverse stock split puts the company in potentially the best position to regain the Nasdaq Listing requirements and to appeal to a broader base of investors and to improve the perception of our common stock and overall, the investment and â with the investment community, the scrutiny by the investment community. So, we would take a minute to thank our shareholders for your understanding of this issue. It was a challenging issue for us to think through that â we really appreciate your support and your understanding and your support of this important resolution. So, we just want to say thanks. And we are just off to a great start in â23. We are proud of 2022. We are off to a great start in â23, and we are not going to sleep until we hit the commitments we have given you. We take pride in that. And the ultimate prize is to grow a sustainable business that generates strong cash. So, thank you to the shareholders, and thank you for those that are following us. We really do appreciate it. So, thank you.
Operator: This concludes todayâs conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.
