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spk04: Good afternoon, and welcome to EvoFem's Biosciences second quarter 2021 results call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to turn the call over to EvoFem's Vice President of Investor Relations, Amy Raskoff.
spk02: Thank you, and good afternoon, everyone. If you haven't done so already, I encourage you to access the second quarter of 2021 presentation and the press release we issued earlier today, both of which are at evofem.com under the Investors tab. Before we begin, I would like to remind you that remarks on this call will contain forward-looking statements, which are made only as of today, August 11, 2021. For a more detailed description of important risk factors that could cause our actual results to differ materially, please refer to our annual report on Form 10-K and our most recent file, 10-Q. With that, I'll turn the call over to Sandra Pelletier, EvoFem's CEO. Thank you, Amy, and thanks, everyone, for joining us today.
spk03: FFM delivered strong and sustainable growth in the second quarter of 2021. This includes 47% growth in Phexie prescriptions and 65% growth in units dispensed. And it also includes a 52% increase in the number of healthcare providers prescribing Phexie. We achieved this despite an ongoing and ever-changing pandemic and a time when many companies bemoaned the impact of COVID on their results, we are delivering and we are growing. The measure of a company's choices in people, strategy, and ability to execute is often best seen in times of crisis. It's much easier to perform when doctors' offices are open, when patients are not on lockdown, and when the overall tone of life is more positive. But what you're going to hear today is that we are delivering on our promise of breaking the hormone glass ceiling, regardless of obstacles. Edelman is proving the contraceptive market was ready for innovation. The birth control category has been dominated by hormones for decades, but there is a demand for a non-hormonal choice without the serious side effects that many women cannot tolerate. There are also the invisible side effects that many women feel just make them not quite like themselves. The feelings that make them worry whether something more serious is happening to their bodies because they take a hormonal medication every day that they don't even need. The demand is there as evidence by our continued growth. We look to harness that movement and accelerate our growth by launching a robust national brand awareness campaign featuring an Emmy award-winning celebrity in early September that will break conventions and will connect with women in new and meaningful ways. I'll discuss this and other ongoing initiatives after our CSO, Jay Files, reviews the financial results and Russ Behrends, our Chief Commercial Officer, discusses veximetrics and reimbursement.
spk05: Thank you, Sandra, and good afternoon, everybody. In the second quarter of 2021, net product sales increased 68% to 1.9 million, compared to 1.1 million in the first quarter. During the second quarter, we implemented cost containment measures across all departments. These included reduced spending, reduced non-salesforce headcount by 15%, eliminating certain consulting roles, and eliminating hires that were budgeted in 2021. These measures will result in aggregate savings of $9.5 million on an annualized basis. Research and development costs were $8.5 million, an increase of $1.2 million from Q1, reflecting higher enrollment in the EVIGAR trial. As a reminder, trial costs are currently paid by restricted cash from the adjuvant investment last fall. Selling and marketing costs were $27.2 million, a decrease of $3.3 million from Q1, driven by lower media and agency fees, which were offset by costs related to the FECSI sample rollout. General and administrative costs were $6.4 million, a decrease of $1.3 million from Q1, driven by lower headcount, recruiting, and outside services. As a result, total operating expenses were $43 million, a 6% decrease from Q1. As of June 30, 2021, we had 47 million in cash and cash equivalents, as well as 14.9 million in restricted cash from the adjuvant notes available for use. This totals 61.9 million for use in ongoing operations. With that, I'll turn the call over to Russ for more detail on our commercial progress. Russ?
spk06: Thanks, Jay. In the second quarter of 2021, Pepsi prescriptions increased 47%, and units dispensed to patients increased 65% from the prior quarter. June was our strongest month yet, with over 5,000 prescriptions and nearly 6,000 dispensed Pepsi units. Prescriptions and units dispensed trends for July are on track to meet or exceed June levels, and that is despite the heavily traveled 4th of July holidays. We also saw a 52% increase in our prescriber base from Q1 to Q2. More than 4,700 HCPs prescribed VEXI in the second quarter. From launch through July 16th, more than 7,700 HCPs have prescribed VEXI, and this number continues to grow week over week. Our strong growth was driven by a highly engaging VPC campaign, increasing access by our professional sales team, Growing awareness of PEXI among healthcare providers and women seeking contraception that is right for today. We are already seeing the benefits of the PEXI samples that we rolled out in Q2. Our team has successfully introduced sampling to our HCP audience and they have been received exceptionally well. The main benefit of a three-pack sample is that it eliminates the need to give out a retail unit for a woman to try PEXI. We recently conducted some market research to understand who's using Vexxy and where are they coming from. We learned that 49% of women coming to Vexxy were not on a method of contraception in the past year. This aligns with our expectation among this audience. As expected, we are growing the non-hormonal market. Another interesting finding is that 29% of women coming to Vexxy are switching from oral contraception, and an additional 7% are switching from hormonal rings and patches. In aggregate, more than a third of our Vexxi users have switched from hormonal contraception for Vexxi, opting for a non-hormonal contraceptive gel. This data indicates we are converting a significant number of VEXI users from the hormonal contraception segment, representing about 18 million women using hormonal contraception, which together with the women currently not using a prescription contraception, suggests that VEXI may have one of the largest target potentials of any brand in the contraception category. Another important finding of our market research is that the age of the demographic of women most likely to use VEXI is early 20s to under 35. That is, as you would say, our sweet spot, exactly what we expected and who we are already aligned with in our DTC campaign. To quickly touch on reimbursement, while we continue to work towards having VEXI placed on the ACA list of contraceptive options, Over 65% of prescriptions are currently covered for a vaccine. The prior authorization process for the remaining 35% of commercially insured women is the most straightforward, easy to complete prior authorization form that I've seen in 30 years of working in female contraception. And our approval rate on PAs exceeds the benchmarks for the category in a significant way. And finally, 100% of Medicaid recipients have access to Phexxi through the National Drug Rebate Agreement. Additionally, Medi-Cal in the state of California added Phexxi to a preferred drug position in July, providing Phexxi unrestricted access to the 2 million women eligible for contraception through Medi-Cal. With that, I'll turn it back to Sandra.
spk03: Thank you, Russ. Already, we are taking meaningful market share from hormones, and we're growing the non-hormonal market. With 47% prescription growth in Q2, we're excited to keep that momentum going and continue to increase our market share. In early September, the FECSI movement is getting kicked into high gear when we launch our new, fully integrated 360-degree marketing campaign for FECSI. The campaign was born out of the idea that women deserve to be completely in control of their bodies, of their decisions, and especially their birth control. The campaign empowers women by creating a world where they make the rules. There's no judgment, there's no settling, just an understanding that when it comes to something as important as pregnancy prevention, Phexy is a brand that listens, understands, and lets women call the shots. It's hormone-free control on their terms. I was on the set last week with our creative team and our celebrity ambassador, and I look forward to hearing your reaction to this campaign. Another key initiative is our ACA strategy. We continue to work with lobbyists, politicians, and women's advocacy groups with the goal of gaining a new category for VEXI as a vaginal pH modulator on the FDA's contraceptive category chart. We feel very strongly that our ACA efforts are going in the right direction, and recent positive progress increases our confidence that we will succeed. The Health Appropriations Committee, which funds the Office of Women's Health, included in a funding memo that they expect the Office of Women's Health to take action on the contraceptive categories chart. Additionally, the Federal Health Resources and Services Administration is currently reviewing its guidance regarding contraceptive coverage for insurers and expects to complete its review late this year. We believe that that review will culminate in a positive update to the current guidance and will ensure new and unique methods, such as FEXI, will be required to be covered by insurers in the U.S. under the ACA. Gaining this new category will provide increased access to FEXI for women across the U.S. You already heard from Russ how incredibly simple FEXI prior authorization forms are. Well, they will no longer be needed. The majority of insurers will offer FEXI to their members at no cost to women. Now turning to R&D. I'm pleased to report that enrollment in EVOGARD remains on track to complete enrollment by the end of this year. This is our pivotal phase three trial of EBO 100 for the prevention of chlamydia and gonorrhea. We continue to expect to report top line results in the first half of 2022, and assuming positive results, we will file an SNDA for these potential new indications by the end of next year with a six month review. Our work dovetails on the CDC's newly released STI National Strategic Plan that includes among its goals to support the development and uptake of STI multi-purpose prevention technologies like PECSI. Our market research estimates that prevention of chlamydia and gonorrhea is a $2.1 billion market opportunity in the U.S. alone, above and beyond the $2.4 billion U.S. opportunity in contraception that we are currently addressing. And in STI prevention, there are no FDA-approved prescription preventative measures. Right now, the choices are condoms or abstinence. And based on the continuing rise in reported STI rates, clearly that is not enough. These are just a few of the many near-term catalysts for EVOFEM that we believe will support our ongoing growth and our ability to deliver long-term value for shareholders. In the life cycle of any new successful brand, there are critical levers that must be activated. We are building our inflection point by educating healthcare providers, raising awareness among women, and driving women into offices, resulting in them getting prescriptions that are rapidly growing month over month. Bottom line, we continue to grow during COVID. This is because we have the right product, the right team, and the right message. Look, at best, when women get put on hormonal birth control, it is really a crapshoot. Maybe you won't have hormonal side effects, but maybe you will. The moodiness, the sense of just not feeling like yourself, literally crying all month long and not knowing why are just some of the things that we hear every day when we get feedback from women. Women want to feel like themselves again and stop having hormones determine how they feel. This is why sexy delivers on this Sunday. So with that, operator, please open the call for Q&A.
spk04: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. And our first question comes from Ram Salivaraju with HC Wainwright. Your line is open.
spk09: Hi. Thanks very much for taking my questions. So in the context of what you are seeing from a script trend perspective as well as underlying market dynamics, can you maybe comment a little bit on what some of the factors are that are driving women to switch from one type of contraceptive or another to FEXI? And if you can also give us a sense of what you are seeing emerging in terms of trends among women who are currently not using active contraceptive methods?
spk03: Yes, yes. Thank you for the question, mom. Well, just to start, I will say to you that what we have all been experiencing is when we open up the Pandora's box to say, let's talk about hormonal birth control, women respond quickly and say, oh my goodness, don't even get me started. Even men will say, don't even get me started. But Rex, do you want to more critically put a fine point on that?
spk06: Sure. One of the things that we found in market research, but it's also been discovered in other research, is that 70% or greater of the women who are currently using a hormonal method indicate that they have some concerns about their exposure to hormones. They indicate that when they want to become pregnant, they're afraid that that might hinder their ability to, or there's some concern about what the long-term implications of decades of hormone use has on their health. So we think that that is really probably the major driver that is taking these women. Once they've seen our DTC campaign or their healthcare professional has shared with them that there is now a new option that's available that goes beyond hormones. That is what really drives that segment. So, in a way, it's not surprising to see that we've got nearly a third of, or more than a third of our users switching from that method. But it is a pleasant thing to see because it validates all the things that we knew were true. When we started looking at some of the trends among the non-users, Again, we indicate we have about 49% of them, or roughly half that are coming from that. A couple things that I saw in that trend is that they did respond by going to their doctor's offices, as we had seen previously on market research, that 80% of those were still seeing their physician at least once or twice in a year. So it really dovetails in, as we said, that These women are saying, I only quit because there was nothing available for me, but now there is. And the women who are on hormonal methods are saying, I've been waiting for something to come. I wasn't willing to take a chance on nothing. But now that it's here, we're seeing large numbers come from that category as well.
spk09: That's very helpful. Also, I was wondering if you could comment on how you expect sales and marketing spend to evolve over the course of the second half of 2021. And specifically, when we talk about lower media and agency fees, can you discuss what you have found to be most effective in terms of media dollar allocation spend and what you have elected not to continue pursuing because it wasn't having the appropriate impact?
spk06: Well, thankfully for us, one of the things I can say is that working together with our partners that analyze all this and looked at it, we found ourselves that we pretty well have been very effective at our spend and we put it all in the right place. We did get some eyebrows lifted, I think, initially when we started going to TV because people had said, well, isn't TV sort of a thing of the past? we understood that during COVID times that women were returning to because they were at home and it wasn't just on their phone anymore, but it was actually in these capable cases. So we found that that perfect mix of being not only on air, but also on those platforms like Hulu and YouTube TV and places like that where you also can just stream it onto your device has been great. And then Mixing that in together with the search that we've done, and the amazing thing, Ron, is we're getting just an incredible amount of what we would refer to as unpaid search. In other words, it's organic. They're finding it themselves. And then when we kind of synergistically put that together with the way it is being discussed in social media among those women who have influence among others, we found that our spend is just about ideally placed, and there hasn't really had to be a whole lot of shifts or adjustment in that. So we would anticipate that going forward it would be in a very similar space as we've had it in the first part since the launch of our TTC campaign. And the same thing I think you asked on the sales side would be true. We had been pretty active at making sure our sales team was in the right places and that they were being, you know, utilized to the maximum. We've made a few switches in the sense that when we found that there was some great coverage in one part of the country where there was, you know, no access issues, we've switched those positions, but we've maintained the same spend and the same number of people that are on the, you know, out in the field calling upon healthcare providers.
spk09: Great. Very helpful. I also wanted to ask specifically about the prescriber base and how that is evolving. And if we look at the number of prescribers who have written a script for FEXI, can you see a group within that group, a subgroup, as it were, of kind of repeat prescribers? Is that a developing trend that you can actually tease out at this point, or is it really too early to tell who are likely to be kind of high-volume repeat prescribers of PEC-C at this juncture?
spk06: Well, what I will say is that we do continue to see that prescriber base grow pretty substantially month over month, quarter over quarter. And one of the reasons I think we're getting there is as we went out and had our sales people calling on offices that were still open, that weren't shut down, that wanted to find out more information in a variety of different ways, whether it was through the different programs that were offered for them to come outside of their office or inside their office or virtually. That set the base up really well for when the DTC drove these women in that they were ready to prescribe and give them the Phexxi as they had asked. Now, we started looking at how that breaks down. We're not completely ready to go down to the scientific part of this and say this is absolutely what's happening. But we do find that if you look at the top prescribers, they do tend to be more often women than men, and they tend to be maybe only in practice up to a 10-year period of time versus those who have been in practice for 25 years. Probably those who are, again, closer to their time as a resident and are finding that the women who come to them are also of the younger set versus those who are moving into more of a gynecology practice.
spk09: Great, very helpful. Just one other question. Do you have any updates at this juncture regarding the ACA ad situation?
spk03: Well, we actually, so where we are now is that we have been given some positive updates that everyone has agreed that, in fact, the contraceptive chart should be updated and will be updated. The challenge is the timing. And so the indication that's been given to us is that it will likely happen by the end of the year. However, we're not just going to sit back and cross our fingers. We actually have a very deliberate push where I'm actually going to be on Capitol Hill next month. I have a series of meetings with a variety of different advocates and politicians. And we also have a social media push talking about the fact that Our product in particular, as a vaginal pH modulator, addresses a population of women who cannot use a hormone, clinically contraindicated, and yet they are being denied access. So we have had very positive correspondence, but we have made a very serious push. And so I would say that we have agreement that we should have our own category, but the issue is timing. And so I am hoping that my trip... is really going to activate a much more precise decision point. But I would tell you if we were going to be vetting, we would say end of the year or first quarter, but we're going to try to push that to be sooner if possible.
spk09: Thank you very much.
spk04: Yeah, thanks for the questions. Thank you. Our next question comes from Annabelle Samemi with Stifel. Your line is open.
spk01: Hi, all. Thanks for taking my questions and good progress. I notice, you know, since you've implemented the sampling to, you know, I guess a three-unit sample instead of a full box, you also have 65% covered lives over 55% last quarter. So can you give us a sense of how that's potentially helped your net price, and what can we think about going forward as far as improvements?
spk06: I think one of the things Annabelle has done for our net price is because we have started seeing a greater number of those that are going through, as you said, we're starting to see that progress happen, that it by its nature has started to do that because we're not having to cover such a large amount in terms of the copay card situation. It's a part of our ACA strategy where we really believe that if we will continue to drive women who are interested in a non-hormonal method. We continue to make sure that the PA process is an easy one. We're helping the offices in the sense of we're using Cover My Meds and we're making sure that our sales people on the street understand how to activate this without it requiring a lot of time or effort on the part of the office's staff. As Sandra mentioned, it typically is just a couple of quick check boxes and we've got a good number of those that are going through that way. So that's been part of that. The sample has allowed us to then make sure that if there is a PA process going on, that for the next 24 hours or so, if that's how long it takes, that they have something in their possession to begin the process of using FEXI. And it also, as you referred to, it eliminates the need to make that first one free with a copay card in order to give them an opportunity to use the product and get some pride with it. So those are all really positive things for us, and we think that's having some real impact upon our growth today.
spk01: Okay. Any chance that you can quantify that? I think it was about $85 a that last quarter. Could you give us something for this quarter?
spk05: Yeah, this is Jay. Just to expand on that, as Russ mentioned, the focus really is on script growth through the remainder of the year leading up to ACA. And so we're not spending as much time managing the gross to net down to a specific number at this point. We're pretty happy with some of the implementations of items that we met that Russ commented on. So we won't be giving out any further guidance on that, at least through the end of the year.
spk01: All right. So I guess moving on, I did notice also that you have a lot more coming from the contraceptive oral contraceptive market the hormonal market than you originally anticipated i think you only had about one to two percent penetration of that market has this changed you're thinking about how much you can penetrate this oral contraception market and the potential um you know you know upside opportunity there yeah absolutely annabelle and one of the things
spk06: that we did early on because we wanted to make sure that we were appropriately placing ourselves into an expectation that matched. We did severely cut back the anticipation of the number we would get in that category from what our market research told us because we really kind of thought our sweet spot was going to be there. If you looked at the commercial that we brought out in February, one of the things that we hit on was what we called Pilpia, and she's the woman who again represented that. And we had made a decision as we started watching for the first few months of launch became aware that there was, as we'd always said and Sandra said, if you mention non-hormonal among a group of women in a social setting or even in a business environment, you'll have them go, whoa, whoa, tell me more. And what we started seeing was that was sort of the response was, whoa, whoa, tell me more. So we started telling them more. And so that started down that road. Now, the numbers that we came up with, to your point, were pleasantly surprising from the sense that we expected that. So we will continue to be exactly where we already set our course out to be, which is to make sure those women who are using hormonal methods of contraception understand that they don't have to if that's not the right choice for them. And we kind of think that that's probably going to continue to maintain or even grow the number that we present today, which is more than a third of our users are switching. That makes this a much more attractive category to begin because as often is seen when you have an established category and people ask how many of those users are you going to move from that method to your method, it's a little easier to calculate because they're counted already among script data. And so we're going to be able to feel pretty confident that we know we're getting a good portion of ours that are already using scripts to move over from one to another. And then as we supplement that with those who have said, finally, I can come back into using something and give me the security and the peace of mind of knowing that I too now have an option for me.
spk01: Okay, got it. And one last question, if I may. I noticed that you've got an SNDA application. that you're planning for Evo 100 at the end of the year? It is an SMDA, I guess. So does that mean that you should solidify your strategy of how you're going to go forward with this product? Is Evo 100 going to be an extension of sexy at this point? And what are the, you know, benefits, disadvantages of doing it that way?
spk03: Yeah, so we, so yes, so it will be an SNDA. And again, the full enrollment will be complete at the end of this year. Our top line data will be in June of next year. And so when we really looked at it, We actually didn't find a huge advantage or disadvantage, NDA versus SNDA, because frankly, when you look at adding on the chlamydia and gonorrhea indications, we were still gonna have an opportunity to just grow a bigger piece of the market share. So when you look at the fact that there's still nothing indicated for these preventative indications, and that they are the two most diagnosed and most prescribed STIs, the market opportunity is very clear. And unlike being in the contraceptive category, right, even though as a non-hormonal on-demand product, we see ourselves as having this unbelievable innovation, yet there are still other products. Although we're converting in the hormone category to your last question, which, you know, we were going to target the 23 million women, and now we see we have a much bigger market opportunity, when you look at adding on these STI indications, it is a low-hanging fruit of epic proportions because there is nothing else. And so we're very excited that we're gonna have a six-month review. We're excited in all the research that we really anticipate our results to be comparable to our Phase IIb. And so, yes, the short answer is that we feel good about the SNDA. We think we're gonna be able to grow that additional share. And Russ, do you want to talk about the strategy for that positioning?
spk06: Yeah, well, the key thing is really among the payers, one of the nice things about having this as an SMDA is we do end up having what, if I can use a sports analogy on, you have two shots on goal, in that we have our first one with PECSI around ACA, and then when we bring that next one in, again, the ACA also outlines that in respect to preventative care for such a transmitted infection that it should be a covered benefit. So we see this as, if you will, sort of two shots on goal, two reasons for payers to really have to make sure that they can cover this because A woman who is sexually active needs to be protected from STI no matter who she is, and if she's using it for protection of STI, it will also give her the protection of pregnancy. So we really think that this gives us, if you will, that I can use that terminology, the two shots on goal, whereas other products really just are really limited to that one NDA that they have. This will be a really tremendous advantage for us.
spk01: Great. Thank you.
spk04: Thank you. Our next question comes from David M. Sellin with Piper Sandler. Your line is open.
spk07: Hey, thanks. So I just have a few. So first, can you talk about or just remind us what the gross net would be in this scenario where you do get your own contraceptive category per the ACA mandate, and then to the extent that you don't get it, what would the gross net look like steady state? I don't know if you can comment on that. And then secondly, and I apologize if I missed this, what portion of covered lives as of now are covered at zero copay? And then lastly, in terms of the expansion and test DI prevention, can you talk about the expansion of direct-to-consumer testing and spend surrounding that, if not in a quantifiable sense, at least qualitatively, what that would look like with that on board. Thanks.
spk03: Yeah. So, Jay, do you want to start with first, Chris, Annette, and then we can speak about this, okay?
spk05: I think Russ can move it in with the second part of the question.
spk03: Okay, brilliant.
spk06: Yeah, so on our growth, again, we don't want to be so specific that we get held to something when we know that we've got to do that later on. But when you start looking at other brands that have been covered under ACA, you end up with a 78% net in the end, and it can even climb up into the 90 just depending on all the other factors that you have to take into that. When Sandra talks about the fact that once ACA comes in, those people who are on the copay card maybe right now are a heavy weight, if you will. They're costing us a lot. They immediately go from where you don't make a whole lot off of each person to jump right up into that 70% range and then continue to climb as you refine your cost of goods and so on. So we think that, again, that strategy makes a lot of sense. and we would expect us to jump into that range on that. And having had other products in the past and looking at those, that's a pretty consistent number just depending on where your cost of goods might lie. And then when we start looking at the portion of lives that are currently covered at zero, it's running in around the 8% to 10% range that come in at zero. And so, again, that – We see that as a big bonus just for the simple fact that here's the number of payers that have already recognized we should be one of those covered benefits. But even among those who require us to be either in a non-preferred position but still on the covered benefits, We're not seeing co-pays in those respects that are exceeding typically maybe $75 or so, and then we make sure that that buy-down allows the woman to get it at a rate that does not affect her out-of-pocket. And then the result is our gross and So we do have strategies in place to come and approach that should ACA not be put into place, which we would assure we have our best contracts available. Just as a reminder, we've talked about this before, we have chosen not to contract with PBMs and give them outrageous requests from their rebate side of that. As we grow business, we get into being in a much better position to negotiate that. So we'll be in a position at some point, should we not get ACA, to get a much more favorable rebate than they wanted to give us when we had no business at all. And then we'll work ourselves around that to make sure that we're in the right positions. Those are things we've got already in the books in the sense of saying we've got a strategy. If it doesn't come through, we won't be stuck flat-footed, but we really do believe, as Sandra said, that we're on path to get the ACA, and all this will turn into a really nice growth event.
spk03: And before Russ touches on the DTC question, David, I just want to put one more final point on this, is that just for the people who are listening that might not have done the review on ACA and what the situation is. Look, in 2010, Affordable Care Act established this contraceptive chart with 18 categories. And any product that came to market fell into those 18 categories. But what happened is that the chart did not move forward with evolution, with change. So new products have been introduced to market, but they haven't been put on the list. The difference for Phexxi is that we aren't one of those new products that already has a generic. Many of the new products that came to market had generic rings, had generic patches. Phexxi really is the innovation that we state because it is the only vaginal pH modulator, the only product with no hormones that is used on demand. And the reason our confidence level is high is that the vulnerable population, 800,000 cancer patients just this year alone, diabetic patients, patients with a high BMI, smokers, all the patients that are clinically contraindicated for hormones, they are left wanting because the majority of them will not use the only other product, which is a copper IUD, which has its own very serious side effect issues. The push is that this vulnerable population is being denied. It's just not only is it not right, but the fact that this is an FDA approved asset that was approved in May of last year, and there's still a population that literally has been told, well, too bad for you. So the door we're pushing on isn't just inside. We've been given direct feedback from the agency and the office to say, we agree. These women deserve an option. You have clearly brought that only option to the table. And so that's why we feel really confident that this is going to happen. I do appreciate that we have contingency plans. But I just wanted to point out for everybody that our confidence isn't just because, oh, we like Bexie. It's because there's a subset of women that should not be denied ethically from the only product that they can use if they're trying to manage their fertility. So then the DTC question. David, could you just state it again one more time? You want to know, I'm sorry, the investment?
spk07: Yeah, sure. Sure. What I'm just asking is, you know, the extent to which you're going to expand DTC with STI prevention in the label, and I don't know if you can talk about it quantitatively, but just even just qualitatively, what's the extent to which you're going to expand your DTC efforts to the extent you have STI prevention in the label?
spk06: Yes. So, David, I think what you call the perfect timing from the sense of saying when we get approved for STI, we will be at a stage when the DTC for contraception would have, by its nature, started to drop down in spend because our awareness is now high enough that we don't have to keep that same level of spend. And it will really be, if you will, sort of it transfers over then so that we don't have to increase our DTC spend in order to go out and make the STI brand or approval aware to consumers. So it will really be at the perfect timing as we're seeing our need to talk about contraception go down. it will then increase when we talk about SCI. But the other side of that coin is, and it should, and again, I'm projecting into the future, it should be less for the simple fact that we no longer have to educate the masses on, well, what is this non-hormonal vaginal pH modulator that you've got? They will be aware of that to a much higher degree, so it takes much less effort in order to say, and then not only in contraception, but also in STI, and so it'll bring those two together in a nice way. So we would anticipate that when it comes on board, our DTC spend does not actually go up below, well, We'll continue to drop down, but not at the same rate it would if there was only one indication.
spk07: Thanks. Thanks. Very helpful.
spk04: Our next question comes from Jeff Hung with Morgan Stanley. Your line is open.
spk08: Thanks for taking the questions. For the sample program that you started in May, what kind of feedback are you hearing from physicians and your sales reps on the samples translating to more scripts being filled And is there a way that you can actually tease out the additional contribution from the samples?
spk03: Yeah, I mean, I'll have Russ jump in more, but the one thing that has been very important is our consistent and ongoing training of our sales force. So you heard us say that when we talk about prior auths or medical necessity forms, our call point one is FEXI. Our call point two is prior auth. I mean, our reps are constantly trained. And my point in saying that is that the reps go in with an absolute expectation that the doctors only get a sample if it is associated with a prescription, period. This isn't let's try different flavors of ice cream in the grocery store. This is serious. And these samples... are going to be given with the expectation that prescriptions follow. Now, and I mean that. Like, you have to understand, too, that there's not a lot of companies, there's a lot of companies that told their sales force to stay home during COVID. Literally, stay home. Well, we weren't one of them, I can assure you. And so being one of the very few companies that are still in those offices, the reps are going in, and not in a, too aggressive way, but in an appropriate way to expect that the prescriptions go hand-in-hand. And it's really working. You know, we're giving them different messages on different styles and personality types, but I would tell you the effectiveness of the prescriptions going hand-in-hand with the samples has been very, very encouraging.
spk06: And I don't know if, Russ, you wanted to... The only thing I'll say is that You know, we did launch the sample program in May, so we only had about half of the quarter of which there were actually samples in the field. So it's been a little bit too early to say we think that that's resulting in a certain number of scripts being filled. What we can say, and just to add to Sandra's comments, and this is a little bit more anecdotal, but I've been out in doctors' offices talking to them and talking about how the samples fit, and I've got to tell you that Almost without exception, I'm thanked by them that they have that because at this point in time, there are really only one other contraception in their cover that has a sample to offer to women. So they've really appreciated that we came up with this for them. And quite honestly, many of them never actually physically have seen a unit outside of the the pictures, and this allowed them to start touching, feeling, and handling. So it's been a really tremendous response on that, and we would anticipate as we watch this over the next quarter that we're going to see it definitely translate into a great return on our investment.
spk03: And you know what, Jeff, the final note is that our samples, too, just so everybody knows, they aren't actually given out by the rep. So the doctors order them on the iPads, and then they get shipped. The rep gets a notice. So it's a second opportunity for the rep to go into the office to verify the samples came, is everything good. So it's just yet another opportunity for them to have an additional call with the doctor. The reps don't have to have storage facilities. They don't have to count inventory. None of that extra expense or time. It just goes right to the doctor's office.
spk08: Thanks. And then back in March, you indicated that it would take about five to seven months to get a better sense of the real refill rate. Can you talk about what you're seeing, or when do you think that you would have a better sense of the refill rate?
spk06: We are seeing what we would say looks like the trend increase. up as we're looking at two things that IQVIA is turning into us and showing us. One is that those refill rates are going up, not as a rate that you would typically expect of a monthly method where you can start tracking it month over month. But we never anticipated that would be the case. But the other thing that we're seeing is that the – and we talked about this – the units that are dispensed now are starting to increase at a rate that's a little bit higher than what you would say the prescription that's going out there. indicating that a lot of physicians are now starting to say, rather than making a prescription a box of 12, they're making a prescription two boxes of 12. That in itself, again, extends the length of time that's going to happen between that original and initial script and the refill. So we're doing two things, Jeff. One is trying to get a handle on it with IQVIA to be able to track this in a way that allows us to really quantify where and how these are going out. And the second part is recognizing that what the great number of women who actually started using our product in March, as you said, and since March, You need four or five or six months to get to a feeling of where that's going to fall out respective to each person. Remember, we did our market research. We projected six to seven fills in a year. But again, that was off of a category that's brand new. So we were assuming based on what we heard from women and physicians in our market research how frequently they would use it, and we watched our utilization during the clinical trial. We think we're pretty close to that number, but we'll probably need to have, you know, again, a few months out from that time where really we started with the bolus of our users in March. All right.
spk08: Thanks. And if I can ask one last question. For the upcoming marketing campaign that you're starting next month, What would you want to see to consider the campaign success, and how quickly can you see the impact, and how long do you think it would take to translate to greater numbers of scripts and sales? Just how should we be thinking about that? Thanks.
spk03: Yeah. So the campaign that's kicking off in September, we would say conservatively, if you look at other endorsements, and other campaigns. So this is your campaign, and it really is multi-level. And so I would say that conservatively, we are saying that we expect a 25% lift on the campaign conservatively. Now, launching in September, I would tell you that by the data that we are going to get by the end of October, early November, that's when we anticipate we would see that kind of a movement. And again, that's really looking at Look, the tough part is, you know, with all the other parameters in this moment in time and, you know, the country, are things going to maintain the way they are now? And so we're thinking end of October, beginning of November, we'll see the positive push from the campaign kicking off in September.
spk06: Right. To get a more, I guess, a fine tune to that is keeping in mind the lag we have in Scripps and so on, we would expect to start seeing, you know, within the first four to six weeks, some of that take off. The one thing I will say, Jeff, is that when we did this in February, we saw, you know, a pretty quick response within a few weeks. and we had virtually 4% awareness before the campaign kicked off. As we see a triple or even four times higher awareness when we enter into this campaign, we would anticipate that the response will be fairly quick and keep moving. I'm not going to be quite as brave as Sandra, although I'm very, very bullish on the fact that If you look back at the trends you saw happen in that first few weeks post the DTC campaign in February, I think we can expect that and more as we move into this new campaign because it's just the quality of the message that will go out with a familiar voice and a higher awareness to start with.
spk03: Well, and also, too, Jeff, just to add one more thing, I do think the thing that all of us internally find very refreshing about this new thing is that It really does speak to the fact that women don't have sex every day. And if they're not feeling as good as they should and they really want a healthier choice and they want to manage their fertility, taking control of that with sexy is an opportunity for them to feel good, for them to have a good quality of life, for them to not have to worry about visible or invisible side effects that are occurring, and should they decide they want to get pregnant. Once you stop taking Phexy, it's out of your system. You can get pregnant tomorrow if you choose to. There is no flush-out period. If you are breastfeeding, you don't want to have hormones in your breast milk. If you're walking your dog or at your child's recital, do you really need contraception? No, you don't. So the great thing about the campaign is that it really speaks to the real-world practicality of what's really going on with women's lives. And I think you're also going to find the messaging, although, yes, it's a little humorous, but really the intention is to talk about meeting women where they are and really talking about the real things that women bury, the dirty little secrets about the side effects that really happen that no one talks about. And I just want to say, just because something has been done one way, it doesn't make it right. And for too long, women have been asked to suck it up and to be quiet and to be martyrs and just suffer through it. And sexy now allows them to say, I'm not going to do that anymore. And so this campaign, I think, is going to appeal to a variety of different women in a very meaningful way. And so we're excited about it, you know. And so, yeah, we really believe that women are going to leave looking at some of these messages saying, you know what, I have a better option.
spk08: Great. Thank you.
spk04: Thank you. That concludes the question and answer period. I will now turn it back. The call back to Sandra Perretier for closing remarks.
spk03: Well, thank you, everybody, for joining us today. We really appreciate it. We appreciate your ongoing support. We have a lot of leverage that we are going to continue to execute on. We look forward to sharing more with you at the September equity conferences and on our Q3 call in November. So have a great rest of your day, and thank you again for your time.
spk04: This concludes today's conference call. Thank you for participating. You may now disconnect.
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