Q4 2019 Earnings Call

At this time all participants are in listen only mode. After the speaker presentation. There will be a question answer session Tactical question. During the session. You want me to press Star one on your telephone. Please be advised to today's conference is being recorded if you require any further assistance. Please press star Zero I would now went to hand the conference.

Over to your Speaker Mr. Amy Raskopf. Please go ahead man.

Thank you if it's any raskopf adelson bias scientists head of Investor Relations today, We released our financial results for the fourth quarter and full year 2019.

The press release, an accompanying slides, which you can access to the webcast are available on the Investor Relations section of Yeah look on website.

Before I begin I'd like to remind you that remarks on this call will contain forward looking statements assays on slide two.

These forward looking statements are made only as of today March 12, 2020, although the company may elect to update forward looking statements from time to time to feature we specifically disclaim any duty or obligation to do so even as new information becomes available or other events occur in the future.

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 with that I'll turn the call ever just entre Pelletier Adelson CEO.

Thank you Amy well Hello, everybody and thank you for joining us on the call.

So this morning, I'm going to open the call with just one word.

Betsy.

That's with a Pea ended H.P.H.E.W. ex <unk>.

That's the new brand name, but the FDA has conditionally approved for innovative hormone free contraceptive gel candidate formally referred to as him for.

The strong and provocative brand name incorporate several key attributes.

First the P. H alludes to succeed natural P.H. regulating mechanism of action.

Actually works by maintaining the normal bad no P. H, even when seem it is introduced thereby maintaining the natural acidic environment that's inhospitable disarm.

The double that captures the two female chromosome and it probably does not hurt but it also rhymes with sexy.

Before I move on to the quarterly update I want to know that fits conditional approval of our new brand name.

Allows us to retired the use of the name in Florida, and although we really did love and embrace that name. The F.D.A. determined that it was to close in spelling and pronunciation to Ampyra a drug for adult within that.

We were disappointed but it turned out to be a blessing in disguise because we developed and tested a number of brand name options alongside them for a and women overwhelmingly agreed that becsey was the perfect fit and increase the appeal for this innovative new product.

Moving forward, we will refer to our multi purpose that you know ph regulator, Canada at sexy for the prevention of pregnancy, and evil 100 for the prevention of Chlamydia and gonorrhea.

Now the fourth quarter 2019 capped the year, a monumental progress for Alison and it was undoubtedly the company's most exciting and most important quarter yet.

We achieved a critical milestone in November with the Resubmission ever in DJ to the FDA, which granted a six month review and aside and May twentyth that could do per day. So just a few short months away.

In December we also achieved a second major milestones positive topline results from our landmark phase Twob trial. He built 100 for the prevention of too dangerous sexually transmitted infections or Sci.

Results demonstrated the even 100 provided women relative risk reduction of 50% think when idea and 78% in gonorrhea rates compared to placebo and consistent with all previous trials you about 100 was safe and well tolerated.

These statistically significant results are particularly compelling when you consider that according to the CDC and 2018, the incidence of sexually transmitted infections in the U.S. Roes for the fifth consecutive year in a row with 1.8 million reported cases of chlamydia and nearly 600000 reported cases of gonorrhea.

Additionally, there are no approved prescription products for prevention of either of these infection. The only existing option for protection is condom, which are not female controlled and women often do not when the condom negotiation.

The FDA recently granted US an end of phase two meeting and we're looking forward to engaging with them on the phase three trial design and the clinical and regulatory path forward for either 100.

In the meantime, we are singularly focused on our rapidly approaching PDUFA date for Becsey.

We're on the cost of making history with the first significant contraceptive advanced in decades, and new non hormonal contraceptive with a favorable safety and efficacy profile and I am confident that we have established solid foundation, but highly successful launch.

Ongoing regulatory interactions with the FDA have been routine.

Manufacturing process, as well defined and underway and we're recruiting exceptional talent for our sales organization.

We're also developing a comprehensive marketing strategy that we believe will be as powerful as distinctive as our brand name.

The team is also executing on a robust publication or presentation plan.

We are slated to present this new data from in power.

At the college of Obstetrics and Gynecology meeting next month, but we learned yesterday like so many other meetings. It has been canceled due to cobot 19 concerns. So we look forward to hearing more from the organizers as they consider potential virtual options for sharing this important data.

Before I turn the call over to our Chief commercial officer rest Aaron I, just want to say that.

Yes, and I have spent our careers in women's health, we both where sales rep. We both created sales teams. We both spends a lot of kind of marketing, but most importantly rough has been responsible for an extraordinary launch of Marina. It is now well over a billion dollars and revenue.

And as we look to recruit a premier sales organization why this really matters is that the people that we want they already have jobs.

They want more than a paycheck they want to go to an organization that has a true innovation, which we can deliver on but it also batters that they are working for people that have walked their walk it creates a different level of credibility and I can assure you that when you see the kind of people that we are tracking for this organization to deliver on our launch trajectory.

We'll be nothing short of impressed so with that I would like to turn it over to Ross who in my opinion is really the only person that I would trust with the launch of Betsy. So no pressure no pressure [laughter] here CEO [laughter], thanks, Andrea no pressure so.

I got to save two though I actually feel exactly the same way I only want the most experienced sales professionals working with us on this launch and I'm confident that we are building a world class team that or sales leadership team is nearly complete we part of vice president of sale and two area sales directors, who bring a welcome.

A large pharmaceutical sales and leadership experience the table and we almost completed the hiring of our 14 regional sales managers know all these leadership people habit have extensive experience in women's health and I can personally speak to their expertise either because they are my former colleagues or because I'd talk their careers.

Expecting this opportunity to one day bring them on to the team that is going to really changed the pace of contraception in this country. So.

I also want to know that the job postings 425 sales consultants one out like that in February and you know something within two weeks, we had received more than 3000 applications.

Sales consultants recognize that this opportunity is really different.

They're they're looking to join a female forward company led by someone like yourselves or a female CEO, who has walked in their shoes and they have an opportunity to change how women feel about birth control.

But care like to this pivot real quick and turn to what our pre commercial efforts are like and I have a number really terrific highlights I want to sure.

First we intend to launch a disease awareness campaign to highlight to health care providers, the unmet need that remains for new contraceptive options that quite frankly take hormones out.

<unk>.

We're excited about both the creative execution and the potential reach of this unbranded and comprehensive print and digital campaign, which we expect to launch by the end of this month.

I can say one thing for sure it will be simultaneously bold and simple the same time.

Second we're accelerating the timeline of our direct to consumer or DTC campaign.

Traditionally contraceptive DTC marketing follow is about six months. After your HCP campaign has been watch.

That allows them to be a significant window to help HCP to understand what the new products mechanism. Bakken is the associated efficacy data in any related safety risk that might be either we intend to shorten that period the former.

We are uniquely able to do that because both the mechanism of action and the clinical story of Teksid, Oh relatively simple and because we believe women are eager to have access to these new novel more options and contraception. So it's prudent on our part to make sure we do that as quickly as we possibly can.

Now turning to patient access, which is always a question we get us our market access team is now on the ground and appropriately engaging payers and dialogue, while it's still early I mean, just tell you something that the feedback receiving from payers. Thus far confirmed that we've been saying all along which is that for a majority of women actually will be a covered benefit.

The AC and to remind you that means no co pay no out of pocket deductible.

And we're finalizing our market access strategy, including pricing and the details of our plan patient co pay card for those women, whose insurance is not cover them at launch and we look forward to sharing more about those details to be further long poured our lawn and another call.

Finally in this part I'm I'm really excited about it as a part of our launch readiness, what we've done it I ask the team to go back and take a look at what other products. It down in terms of their launch trajectory. We wanted to look at what are the most successful launches today in women's contraception, and especially looking at some of those different modalities. So we could see how they fared compared to the world.

Hi, precept, so what we Benchmarked is fourth first of all we've looked at what were the sales force sizes at launch second what was the share of voice in the contraceptive advertising the detailing effort third how long did take to get the penetration to peak sales and for what was the awareness of consumers based on DPC. Because these are the four things up.

Often determine what's your launch trajectory looks like and based on our comparative analysis of these metrics. We believed that we plan for our span and for our emphasis coupled together with the appeal of the natural female controlled contraceptive with a very favorable side effect profile will put Becky.

Right inline with the success of those other launches now I'd like to turn it back over to our chief commercial or financial Officer, Jay file to discuss the 2019 financial Jay you discussed the motor to be no.

No doubt you can't do that ROE [laughter] gotta be the CFO I'll stick to the numbers. Okay for the year ended December 31st 20, Nike total operating expenses decreased 32% to 52.79 Baird.

Research and development costs decreased 49% to 22.2 million during 2019 of that decreased 21.2 million was due to completion of the clinical phases of Mpower and prevention.

General and administrative costs decreased 11% to 30.5 million during 2019.

Noncash stock based compensation decreased by 7.2 million and professional services and personnel costs were 3.8 million lower due to the absence of onetime costs associated with our merger that occurred in January 2018.

These were offset by a 3.4 million increase in pre commercialization advertising VR fees and sales support related costs. Additionally, payroll related expenses and consulting services increased by 2.3 million at 1.4 million respectively. During 2090.

Total other expense was 27.3 million for the year ended December 31st 20 liking primarily due to non cash charges recognized in the first half of the year.

As a result net loss attributable to common stockholders improved to 80 million or net loss of $1.99 per share for the year ended December 31st 20, Nike compared with a net loss of 125.8 million four or five or a net loss of 5.74 per share for the partner. We closed 20 young team with 23.8 million in under.

Stricter cash and equivalents and short term investments based on our current plans. We believe that we have sufficient funding through the anticipated approval effects. The as a first hormone free on demand when we control contraceptive in may.

And weaker and we are currently evaluating near term financing opportunities to further extend that runway.

And with that I'll turn it back stronger.

Thank you Jay.

You May know March is women to three months and I've been reflecting on the many significant milestones that have advanced the lives of women. We are a new player in that realm, but the opportunity that we have to address the unmet sexual and reproductive needs of women is real and its significant there are more than 17 million women who.

Don't want to get pregnant don't want hormones in their birth control and who are set up with their current option what they do want its protection control an option that doesn't require hormones and an option that speaks to their needs women want more.

That's the for the prevention of pregnancy represents a significant opportunity our market research tells us that their 17 million women out there waiting for a new hormone free option and if we were to reach just 885000 about 17 million win them and they still their prescriptions seven times a year, that's a billion dollar market opportunity.

Looking even further in the future we have a significant opportunity to help prevent the transmission of chlamydia and gonorrhea too dangerous S.T.I.s that affects approximately 2 million people every year. We're excited about the potential here and we look forward to working with the FDA to determine our best path forward.

It's going to be a transformative year for half of them and for women and we're thrilled to happy with US on this journey, so with that I would like to open up the call for questions and turn it back to the operator.

Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound.

Please standby, while the compiled acuity roster.

First question will come from Louise Chen with Cantor. Please go ahead.

Hi, Thanks for taking my questions here I had two for you. So Russ you had mentioned Marina on the call do you think sexy launch trajectory could equal that of marine or why or why not.

And then second question I had for use congratulations on the conditional approval of the name perfect. C is this a good read through to the FTC approval. That's expected at your upcoming PDUFA date or not thank you.

So great well. Thank you for that question and usually when the question like that ask everyone around the table smiles, because they say well Russians are going to get to talk about Moran. They think that that [laughter] something that [laughter], yes, but to answer the question. So one of the key things I think is that having.

Then there and done that through that whole process I was able to see first of all what were some of the issues that you would have around bringing an education awareness to the.

Hey, HCP is making sure that women are of a aware of current options. So when I look at the whole Marina family, where we really think were most like is gonna be like the Skyla Kivalina launch, which happened years later, but once the whole category had been established and when they were able to go out and to do what you know was a pretty effective method in terms of getting.

People to be aware of.

And such so I do anticipate as I've, often said at the time when writing a came to the market. It. There was this real need in women's health because there had been these messina elements around a long acting and I feel like we're in the same space today, where we've got so many women that we didn't say on this call, but 17 million women approximately it are doing nothing and that wont you.

As hormones that we think are a really ready for something like this so I do believe that the timing is exactly right for a product like this just as it was two decades ago and ran a given the market.

And then with the second question you Wanna.

We yet so to answer the question about the read through on that conditional approval effects. The well, we hope and anticipated this will be one of many upcoming approval.

Actually is a separate you know decision point from the actual approval of Oh.

Hi, Thank you.

Thank you. Our next question will come from Ron Selvarasa issue with H.C. Wainwright. Please go ahead.

Hi, Thanks, very much for taking my questions have a few I was wondering if maybe you could start with the sales force composition and give us some details around that it would be helpful for us to at least qualitatively no. You know what you would anticipate to be the overall approach.

File in terms of their prior history, what kind of products. They previously been involved with promoting you know what kind of performance track records, they have and items of that nature that would be helpful. Thank you.

Sure. Let me start there for you on Al just real briefly give you the structure, which is now we have two areas Ethan the west and there'll be seven managers in each one of those areas enter an equal number of representatives equaled 125 to cover that we weren't really closely with hyqvia around the design of the Salesforce. So we know that we're gonna.

Be able to cover and what they classify as their key highest prescribers, 93% of all the well be lands and 89% of all the Allied health care professionals that are considered to be the top prescribers in this category and those that are not inside that that those percentages will cover what nonpersonal promotion to do that.

We're still excited about this opportunity at this time not just because of the fact that the environment is ready for it but as most of you who maybe have followed women's health care over the last several years, there's been a fair amount of disruption. So a lot of the people who we have known in the past from other organizations. We've worked with have either been displaced or are there.

In an environment today, where it's not really ideal form the company's there with may have announced recently that theyre going to disband the women's health care. So we're been able to.

Achieve really I think a very very experienced group of managers and leadership and we anticipate the same thing is going to be true simply based on a number of people who reached out to us on link then as we know that has now become one of the places where an appointment seemed to happen frequently and the number of people who reads out already with experience in this case.

Degree has been.

Simply overwhelming and we're really excited about putting together this world class sales force.

Would it be reasonable to assume that.

Many if not most of the sales people that you hire.

Our gonna be coming in with performance track Records, where you're not they were like the number one number two and the top decile pilot lease sort of performing salespeople.

Respective organizations at least at some point over the course recent careers.

Yeah, Yeah, that's exactly what we've been seeing in fact, we've kind of almost got this thing words, it's hard to keep track of Who's got the most awards and so yeah, we might have to actually put up a little bit of a score work scorecard for people. When they actually arrived is to see who actually has but yes. That's exactly what's been taking place so far and as I mentioned earlier you know this excitement is really.

It's something that Weve never seen before where it's not it's not just an opportunity to start with a a startup company like ours, that's doing something innovative but this whole notion that they're making a big difference in something that is missing right. Now for women has been one of the reasons why people have expressed that they want to common cheap the same kind of results here that they've done.

Other places.

Okay, and then with respect to the other indications that may potentially be pursued here I was just wondering if you could clarify has the end of phase two meeting in the S.T.I. prevention indication already happened or hasn't just been scheduled and if it's just been schedule.

Can you give us a sense of when it might actually occur and then also just provide some perspectives on when you anticipate the next stage in clinical development to kick off for that indication. If you anticipate that happening before the end of this year. Thank you.

Yes, so we have.

Been granted to date for our indices to meeting and it will happen in May and so we are we have prepared a briefing document for that were on track for that need to happen. We do anticipate that we will have our first patient in for the phase three study before the end of this year.

Okay Fantastic and then just one other quick one.

Given the recent announcement regarding PDL decision to liquidate I was just wondering whether you anticipate this having any potential disruptive impact either from the perspective, if the stock price or from the vantage point of you know a future capital raising and a you know what might potentially be done too.

Mitigate that yes, if any.

Well you want to certain Oh, yeah. So I don't know if you listen into Pcls call yesterday. So we do know that like you mentioned, they're looking to monetize assets by the end of year.

Ultimately I think the main take away from that was would dominate really reiterated was the fact that they really don't anticipate doing anything that would be harmful to have a family and I think we interpret that as it really makes sense to wait for some degree of an inflection point, which is obviously for do find that occurs later in may.

You know, we do know that they have engaged story a add to explore opportunities, but every indication that we have a at least pulling from the communications from their press release and discussion yesterday is it'll be a very methodical process and it shouldnt be anything access ever damaging to us away from what we're seeing right now and the other thing.

Just to add ROM is that I mean, the positive is that we have been very actively engaged with Trey a and with PD L. And so the parties that are interested obviously want to talk to the company and they want to do their own diligence and so we have been very collaborative and we've all these ongoing discussions so we feel.

Good about the process you know what we wish it wasn't happening at all [laughter], but we have been very engaged and included and we feel good about that so you know we don't feel.

As vulnerable as you know you might think because we're very active and the parties that are interested are serious player to we would like to have a shareholder so so far so good.

And just for clarification, so that may mean that whoever winds up taking on the eagleson stake that PDL. Currently holds could potentially also step in and performed a function that you were previously anticipating PDL would would performance that is that reasonable.

Oh, yes, <unk> that is reasonable.

Thank you.

Thank you. Our next question will come from Leland Gershell with Oppenheimer. Please go ahead.

Hey, guys. Good morning, Thanks for taking my questions sounds like the plans really coming together.

Wanted to ask a first just on the DTC a delay shortening you'd mentioned from six to four months Ross I just want to drilled on not furthers that is that something which you worked out with the agency or is that something what you presumptively feel you'd be able to getting any better follow too. Thanks.

Yeah. When there is there's actually know formalized guidelines it requires a certain amount of time, what the agency really asked people to do and our situation is to assure that the health care provider community as is fully brought up to speed and so what we've done just based on even like discussions with with people like yourself as an example.

We find that the story is not so complicated and the patient profile of who'd before is not so difficult and the fact that from a safety perspective, we had no less than 2% discontinuation in our trial based on side effects that we feel like we could we could move that up and the reason that we've picked that timing is because ending.

If you start looking from the end of November all the way through say mid January that's not an ideal time to be trying to launch a DTC campaign. Therefore, I was prudent on our part to try to launch it early in Q4, instead of waiting towards that six month Mark.

Okay. Thanks, that's helpful. And then also wanted to ask I know the producers still a little ways away, but to the extent that you've had labeling discussions if you've had them and if there any limitations that we should be aware of not only ask that because of other experience as we've had with other products from other companies in this category.

Sure respecting the fact that of course those are hormonal product. Unlike.

Thanks.

Sure so our interactions with FDA during the rainy agreed have been routine we actually would anticipate sort of as a standard routine practice that they would start lately negotiations about a month before pretty funny. So we've not had any formal discussions with the agency or around lately, but we anticipate that started.

In late April.

Okay and then my last question I guess are either <unk> or Jay kind of a commercial financial question is as you look at your budget for the initial launch and Youre going to have obviously your sales organization then D.

Line kind of social media based marketing initiatives I know, you're not giving guidance at this point, but if you could maybe comment on what the.

Proportional spend you would allocate to those would be over let's say the first 12 months lunch.

Yeah, Yeah, sure not a problem and the kind of I guess, what kind of reiterate some some general comments on that area that we've kind of given in piecemeal and maybe a little bit of an update to so.

I'm, just kind of working through the various components we do.

I anticipate that the annualized salesforce itself will be approximately 35 million and and now that DTC range on an annualized basis is it's going to fall within the 30 to 50 million range and give us some of it depends on when what rest pull the trigger but we believe that some more accurate range of one DTC will be on an annual.

Basis.

Overall Gionee would you anticipate that is going to be relatively consistent with not a lot of fluctuations should continue into the mid twentys and that.

Commencement of the phase three four Sci that Kelly had mentioned overall, we're anticipating that could run about 35 million a that obviously will be spread out across the the length of the trial, which should be greater part of year year and a half. So the majority of that cost cut falling 2021, but I guess the kind of wrap it all in.

To one in the concise Damon for you overall, even though we're not like giving any sort of revenue guidance as of yet we still anticipate that ultimately we will be to breakeven by the end of 2022.

Terrific, Thanks very much.

Thank you. Our next question comes from Yes mean, Rahimi with Roth capital.

I see and I have three different question for you. It's a question number one it.

I know you guys have been working diligently.

Fine.

Non diluted funding opportunities, however, where how did your PDUFA date is right in may as we're dealing with.

All the challenges associated with corn, a virus and in the market condition. So can you help us to visualize obviously in order to put a.

Competitive commercial plan together you need the cash for it so given the market conditions given the also certain discussions with strategic certain things slow down a win win with a kind of dynamic that's going on so how is that handicapping you within a few months everyone starts are being affected to that question number.

To use a if you could give us a little bit color on how your.

Pricing discussions again.

After the labor negotiations what kind of work have you gotten in terms of how important is co pays for a you know for women and pricing and then third bucket is just more color on sort of.

Prevention of Gonorrhea, and Chlamydia trial, what are known stop the trial design that we can be a sure being part of it. So thank you that's or sort of three different things.

Okay, so with that but one is just start out with the non dilutive option absolutely, yes, good question and and understandably why that would come up.

Yeah, you you know us while that we don't sit around and wait for things to happen, we're pretty darn proactive. So we've been very active in really looking for opportunities are you really kind of bolster our working capital position.

Up through and including beyond produce any end of may as such I, we're not really anticipating this to be a the current market conditions to be a handicap towards currently at all because.

We have been ahead of the curve I do expect some some near term.

You know movement on that and then ultimately we still are on plan to execute everything that we have lined up for pre commercialization phase and don't anticipate any slowdown in activities at all even when they do for has been.

Hi restaurant type of course likely yeah. So as many people know when you bring our new product to market. The payers have up to six months to determine what they're going to do with it most of indicated that they will.

Have a sad covered position than 88 out of the gate, we will have a co pay card that has already been.

No determined and that co pay card will allow for women to get their first one at no co pay no deductible at all.

Just a acts like a sample because sampling today has become more challenging and then moving forward from that point as as their plan started covering it they wont wont require the co pay card, but those who do we'll still have it in place to assure that that's the case and in terms of pricing, we're actually working still right now with a Putnam who does.

A lot of this pricing work to determine what our optimal pricing would be from that perspective, and so we'll be able to give you how clearer guidance later on.

Kelly.

Yes, so with regard I think the question around the phase three trial was around a study design and any sort of ideas on what that looks like at this 0.0, we do anticipate and say design for the phase three trial will be similar to what we saw with and prevent however, it is one of the topics that we're going to be discussing with the FDA at the end of phase two meeting.

And so we'll be able to provide additional clarity you. After we've had discussions with Yankee and the in their agreement on our plan moving forward.

Yes, I mean does that answer your question.

Yeah. Thank you team for that pretty answered.

Great.

Thank you. Our next question will come from Randall Stanicky with RBC capital markets. Please go ahead.

Hi, good morning, especially on for Randall and so there seems to be an increase in interest and the woman's health space.

The bigger announced that more recently being Burke announcing spin and dot Spinco will.

We'll be looking for BD opportunities Myspace, sorry, guys. As you guys think about building out a platform here does this up chicken interest generally kind of change anything in terms of your strategic plan, whether that means that you're seeing more opportunities to partner internationally or anything else.

And is there any update on the international Sean Thanks.

Yeah. So thanks for the question. So I guess, here's what I would say that one we are absolutely thrilled because I'm sure you can imagine we know that women are the healthcare consumers, we know that women often make the decisions for themselves and their children and their spouses and their parents and so we are really excited about the uptick in interest but to be even more direct.

Short answer is yes, we actually have had.

An incredibly positive influx of collaborative calls on discussions with people who have assets that would really fit perfectly in a U.S. platform, meaning a commercialization team and you know, creating a field organization is no small task and it takes a lot of discipline and we intend to have the premier Wen.

In health care sales organization, we already have an amazing medical science liaisons, we have our payer team that's exceptional so putting a product in our portfolio makes perfect sense and so we are having.

Very fruitful discussions with partners, who want somebody in the U.S. I've been in turn we're also looking to partners that maybe there's an opportunity where they would then look at sexy for their organization outside of the U.S.. So I will tell you that with the results of our phase Twob study on chlamydia and gonorrhea.

We purposely slowed down our discussions for X U.S. licensing because all those discussions were just around the contraceptive indication once people saw the clinically significant results. It actually escalated conversations with players that were larger would allow you know much different.

Much bigger upfront.

Payments, which would be you know very very positive. So at the end of the day I would say that we are still having ongoing discussions, but the discussions have pivoted a little bit because we're talking about both the contraceptive NDRC I indications now with partners outside of the U.S.

There's no you know soon to be forthcoming announcement as of yet, but the conversations are very very much ongoing.

I don't know if you pointed out that huh okay.

Great. Thank you so much.

Thank you. Our next question will come from Annabel Samimy with Stifel. Please go ahead.

For taking my call.

It's been answer but I can.

Sexy seems.

Interesting consumer angle to it you know it's also a simple story limited side effects in terms of your approach. The market are you taking more of consumer approach to make it you know.

Seem less prescription drug and more like a customer product that can be accessible to all patients and is that part of your angle to approach the market and then secondly, just I know you touched on the pair question and for the most part.

He has been a pretty good about mandating coverage.

Contraception.

I was curious to know how much.

On.

The classification.

The kitchen.

This drug.

Changes to it and if there any.

Changes.

In terms of coverage mandate given some of the things that are sitting at the Supreme Court. Thanks.

Great. So thanks those questions.

When we when we take a look at first of all the aspect of why is it a prescription there is to really important aspects that we think are important for to be a prescription. One is just the counseling aspect of this as we all know there's no systemic activity. So if you don't use the product or you don't use a correctly. It has zero effect. So it's important for us to make sure.

That all women understand how to use it and assured that they use it with each and every active sex so having that discussion with the healthcare professional is going to be really important.

It is as you mentioned, a very consumer sensitive category and we know that the women in this category you asked for a certain brand we'll get it so we're making it as easy as possible for women to get will have a very significant telemedicine efforts. So that women don't have to go through a lot of hoops in order to get their effect he sent to them there or.

Required from the pharmacy, so we're responding to that pretty significantly and we know from the efforts we did around and power. When we went out to do a basically what's like DTC, where we went online digitally and posted for women who would be interested in a non hormonal method that women are responding to this.

Exceptionally positive so we do anticipate that this will drive.

You know a large volumes of women to go to their health care provider to ask for the product and when we started looking at the that the next question around the FDA. One of the things are really make us different is even without it being in a different classification, everyone has recognized that our mechanism of action is really standalone.

So for most of those payers they've kind of said, even if we're not sure where this fifth we do know that is spits in as a standalone and as a standalone were not required to necessarily be into one of those 18 categories.

That other products that that maybe already have a modality isn't the same as there were forced to try to see if they couldn't fit into one of those categories. So for us we're not going to be disadvantaged in any way.

Based on what I can tell you. This is we did our market research before and we talk to payers, who represented about 70% of the commercial lives in the United States and we learned that they thought they recovered now that our market access team has actually out there are calling on those payers. What we're finding is that they're telling them face to face. The exact same things that we heard and mom.

But research so we're pretty positive that.

Not only not only is our strategy in line, but that is that we're not going to be impacted by this question of do we have to have a 19 category or not because we've been told pretty clearly that we're going to get down to on a covered under asea.

Thank you.

Thank you I'm showing no further questions in the queue. At this time I would now like to turn the call back over to Miss on Dri pellets here for any further remarks.

I just want to thank you all again I know that there are a lot of things that take your time and there's a lot of distracting things happening in the world. So we really appreciate and we're very very grateful that you took the time to be on this call. Today. We appreciate your ongoing interest and your support of women's health and we look forward to speaking with you soon and continuing to update you. So have a great rest of your day.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

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