Q2 2020 Agile Therapeutics Inc Earnings Call

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Operator: All participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Matt Riley, Head of Investor Relations. Thank you, sir.

Question answer session.

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Lighter this conference is being reported and it's now my pleasure to introduce your host Mr., Matt Riley head of Investor Relations. Thank you Sir you may begin.

Matthew Riley: You may begin. Hello everyone, and welcome to today's conference call to discuss our second quarter 2020 financial results. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our outlook for the third and fourth quarters and full year 2020, management's expectations for our future and financial operational performance, our business strategy and commercialization timeline, our assessment of the combined hormonal contraceptive market, and the potential market share for TORLA, among other statements regarding our plans, prospects, and expectations. Such statements represent our judgments as of today, are not promises or guarantees, and may involve risks and uncertainties that may cause actual results to differ from the results discussed in the four of these statements.

Hello, everyone and welcome to today's conference call to discuss our second quarter 2014 financial results.

Before we start let me remind you that today's call will include forward looking statements based on current expectations, including statements concerning our outlook for the third and fourth quarters on full year 2020.

Management's expectations for our future financial operational performance, our business strategy, a commercialization timeline, our assessment of the combined hormonal contraceptive market.

And the potential market sharper twirla among others statements regarding our plans prospects some expectations.

Statements represent our judgment as of today are not promises or guarantees and they involve risks and uncertainties that may cause actual results to differ from the results discussed before these statements.

Matthew Riley: 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 today's call is not intended for promotional purposes and is not sufficient for prescribing decisions.

Please refer to our filings with the FCC, 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.

Looking statements, except as required by law.

The information on today's call is not intended for commercial purpose is not sufficient for prescribing to such a.

Joining me on todays call or out Mari agile Therapeutics, Chairman and Chief Executive Officer, and Dennis Rightly Chief Financial Officer, following our prepared remarks, well open the call your question.

Matthew Riley: Joining me on today's call are Al Altomari, Agile Therapeutics Chairman and Chief Executive Officer, and Dennis Riley, Chief Financial Officer. Following our prepared remarks, we'll open the call to your questions. Let me now turn the call over to Al. Thank you very much, Matt. Good afternoon and welcome, everyone, to our second quarter 2020 conference. The second quarter was truly remarkable in many ways as the COVID pandemic affected virtually every facet of business and society.

Let me now trying to call it out.

Thank you very much but.

Good afternoon, and welcome everyone for second quarter 2020 conference call.

The second quarter truly remarkable in many ways had to cope with pandemic affected virtually every asked every facet of business and society.

Other these unusual conditions and unique challenges I'm pleased that we continue to make significant progress on our strategic objectives have remain on track for planned fourth quarter 2020 commercial launch all twirla.

Alfred F. Altomari: Under these unusual conditions and unique challenges, I'm pleased that we continue to make significant progress on our strategic objectives and remain on track for our planned fourth quarter 2020 commercial launch of Tworalex. The dedication of our team, while working from home to ensure business continuity, has been extraordinary, and I sincerely appreciate your flexibility and commitment to Agile. We have made substantial progress on the expansion of our manufacturing process and Commercial Preparations, and that is a testament to the tireless efforts of the entire Agile team. Additionally, we've hired several key managers to our home office, as well as experienced industry veterans to our sales team, which I will provide more detail on later in the call. While we don't know how long these conditions will last and what the ultimate impact will be on our company, to date, we've been able to continue to execute our plans according to our plan in a timely manner. Now on to a review of the second quarter in greater detail, starting with manufacturing. We've completed the production of the planned manufacturing pre-validation batch of Twirl. Our next step will be to finalize the validation badge.

The dedication of our chief.

Working from home twin shore business continuity has been extraordinary.

Sincerely appreciate your flexibility a commitment to agile.

We have made substantial progress on the expansion up our manufacturing processes and commercial preparation and that is a testament to the tireless efforts over the entire agile team.

Additionally, we hired several key managers to our home office as well as experienced industry veterans for Salesforce, what do I will provide more detail on late on the call.

Well, we don't know how long these conditions will laugh and what the ultimate impacts will be our company to date.

We've been able to continue to execute our plan according to our plan pipeline.

Now, it's where we view of the second quarter in greater detail starting with manufacturing.

We've completed the production of the plan manufacturing pre validation batches world.

Our next step hoping to finalize the validation batches.

We're presently manufacturing three validation batches of Twirla.

Alfred F. Altomari: We are presently manufacturing three validation batches of Twirla that we expect will produce commercially usable product and be completed in time to support a commercial launch in the fourth quarter of 2020 as planned. Thanks to our partner, Coring International, we remain on track to achieve our manufacturing and twirl-a-supply targets. We're also on track to establishing our distribution network, having now signed wholesaler agreements with two of the three major distribution companies in the U.S. We expect to complete the agreement with the third distributor in the third quarter of 2020 and continue to discuss the distribution of Squirrella with other trade groups and wholesalers.

We expect full produce commercially usable product.

And be completed applying to support a commercial launch in the fourth quarter 2020 as planned.

Thanks to our partner Corium International we remain on track to achieve our manufacturing and Twirla supply partner.

We're on track for establishing our distribution network, having now find wholesaler agreements with two of the three major distribution companies in the U.S.

We expect to complete the agree with a third distributor in the third quarter of 2020 and continue to discuss the distribution correlate with all the trade groups and wholesalers.

Our discussion, but the major distributors have enabled us to refine our expectation about our initial stocking levels, which will be lower than we initially assumed.

Alfred F. Altomari: Our discussions with the major distributors have enabled us to refine our expectations about our initial stocking levels, which will be lower than we initially assumed. While this will affect our fourth quarter revenue guidance, we do not expect that it will have any long-term effects at this point on our overall commercial opportunity for twirling. Dennis will provide more detail about our guide. We will continue having these productive conversations in order to optimize our future manufacturing and supply chain management. Turning to an update on our sales, we are excited with the progress made during this quarter, which includes several key hires through Sineos Selling Solutions, our contract sales. We've brought on board seven seasoned sales managers, as well as Terry Herring, our new national sales manager.

Well this will affect our fourth quarter revenue guidance, we do not expect that it will have any long term effects at this point when all of our overall commercial opportunity that's world.

Dennis will provide more detail about our guidance.

We will continue happened these productive conversation in order to optimize our future manufacturing.

Quite chain management.

Turning to an update on our Salesforce, we're excited with the progress made during this quarter that includes several key hires.

Scenarios selling solutions or contract sales force, we brought on board seven either.

Sales managers as well Terry hiring or new national sales leader.

Alfred F. Altomari: Terry is a recognized leader, bringing more than 30 years of pharmaceutical and healthcare experience. Over the course of his accomplished career, he has been at the forefront of launching and marketing several women's healthcare products at companies including Sibagagi, Salve, Novin, and Mr. Farmer. Turry has marketed transdermal delivery products such as Estroderm and Vival and led the launch sales team for Vival Dot. We're excited and fortunate to have Terry lead our sales. Harry has hired seven new regional sales managers. These managers have robust healthcare experience, working at well-recognized companies including Allergan, Pfizer, Novartis, Cineos Health, and Arbor Pharmaceuticals, among many others. All together, they bring an average experience of more than 25 years in sales, and more than 17 years in sales leadership.

Terry as a recognized leader, bringing more than 30 years pharmaceutical and healthcare experience.

Over the course of he's accomplished career he has been at the forefront of launching and marketing several women's health care products at companies, including.

People Doggy fall away the open at mission Pharmacal.

Terry has marketed transdermal delivery products, such as that return and by Bell and let the launch sales team for by Bell Dot.

We're excited at fortunate to have Terry lead our sales force.

How are you guys hired seven new regional sales managers. These managers have robust health care experience working up well recognized companies, including Alexander Pfizer, The BARDA Finials Hell Ann Arbor Pharmaceuticals.

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Among many others altogether if they bring.

Average experienced a more than 25 years in sales more than 17 years itself leadership, nearly 10 years and women's health care at an average of about nine drug launches.

Alfred F. Altomari: Nearly 10 years in women's health care and an average of about nine drug launches per year, which adds up to a total of 64 total product launches to date. In addition to these seven regional managers, we are in the process of hiring 73 total territory and telemarketing sales representatives.

Page, which adds up to a total 64 total product launches to date.

In addition to the seven regional managers, we were in a process of hiring 73 total territory and telemarketing sales representatives.

As mentioned last quarter were emphasize adding sales representatives with physical and virtual sabby experience and skills.

Alfred F. Altomari: As mentioned last quarter, we're emphasized adding sales representatives with digital and virtual savvy experience and skills capable of executing both remote and in-office-based sales calls given the current challenges of the pandemic. We believe that these hires fit that need and give us a solid national sales footprint. We do not currently anticipate hiring a second wave of sales representatives as previously discussed, but we will continue to consider this as a possibility in the first quarter of 2020. We initiated work to engage with third-party payers regarding coverage and reimbursement for TORLA.

People executing both from both at in office based sales calls given the current challenges of the pandemic.

We believe that these fires fit that need it gives us a solid national salesforce footprint.

We do not currently anticipate hiring a second wave of sales representatives as previously discussed, but we will continue to consider that at the possibility.

In the first quarter of 2020.

We initiated work to engage with third party payers regarding the coverage and reimbursement for Florida.

We are focused on building a value proposition that minimizes or eliminate axis barriers fill the women have access to twirla with no copays.

Alfred F. Altomari: We are focused on building a value proposition that minimizes or eliminates access barriers so that women have access to Swarovski with no co-pays. While we are also providing, we are also building a unique patch replacement program. We believe that this patch replacement program will be a high-touch, user-friendly experience for our customers. As previously announced, it is our intention only to deploy representatives in markets that are enabled or have access through the healthcare platform. Towards the end of the quarter, we announced a wholesale acquisition cost, or WAC, of $159.75 for a treatment cycle twirl-up. Each TORILA treatment cycle is packaged in a carton containing three individually pouched transdermal systems. Twirl It is used in a four-week cycle.

While we also providing well also building.

Our unique patch replacement program.

We believe that this past replacement program will be a high touch user friendly experience for our customers.

As Preleasing now and it's our intention only to deploy representatives in markets that are enabled for have access to health care plans.

Of course younger the quarter, we announced the wholesale acquisition cost or whack a $159.

Me five cents for treatment cycle Twirla.

Each treat twirla treatment cycle, it's packages, a carton containing three individual we pouch transdermal system.

Twirla his views a four week cycle.

Patient supply one patch every week for three consecutive weeks.

Alfred F. Altomari: Patients apply one patch every week for three consecutive weeks, and each patch is worn for seven days before being replaced by the next patch. No patches are worn during the fourth week.

And each patches worn for seven days before being replaced by the next batch no patches worn during the fourth week.

By comparison.

Alfred F. Altomari: By comparison, The Current Average Wax for the Top 16 Branded Combined Hormonal Contraceptives, or CHC products, is approximately $169, a unit or month of contraception. We believe that based on our current coverage and reimbursement strategy, combined with an attractive WAC price point and meeting an underserved women's contraceptive market. We have an opportunity to obtain a 5 to 8 share of the total peak, based on prescriptions of the $4.1 billion estimated addressable CHC mark.

The current average WACC for the top 16 branded combined hormonal contraceptive sports CAC products, it's approximately $169.

Our unit four month of contraceptives.

We believe that base.

Current coverage and reimbursement strategy combined with an attractive whack price point and meeting an underserved womens contraceptive market.

We have an opportunity to obtain a five to eight share of total peak.

Prescriptions of the 4.1 billion dollar estimated addressable you could see market.

From a financial standpoint, we believe we're in a solid position.

Alfred F. Altomari: From a financial standpoint, we believe we are in a solid position. As Dennis will describe shortly, our spending is in line with our expectations. And we have a robust cash balance that we think sets us up well for a commercial launch. We plan to increase spending in the coming quarters. Following the recent hiring of new sales representatives, And also as we begin to implement our marketing plans targeted at consumers. In the next few weeks, Agile will be rolling out a major, national, unbranded campaign, Set to Disrupt and Add Value to the Birth Control Conversation for Women Everywhere. The digital-first campaign is called I'm So Done, and it's aimed at inspiring women to think critically about their current birth control method and ultimately spark a social community of like-minded women and surround them with the support to enable a more educated, shared dialogue on contraceptive care with their health care provider.

As Dennis will persist well described shortly our spending is in line with our expectations and we have over but cash balance that we think that the thought well for commercial launch.

We plan to increase spending in the coming quarters.

Following the recent hiring a new sales representatives.

I'd also like we began to implement our marketing plans targeted at consumers.

In the next few weeks.

Hi, Joe will be rolling out a major national on brand the campaign.

That's a disrupt and add value to the birth control conversation for women everywhere.

The digital first campaign, it's called so Don.

And it's aimed at inspiring women to think critically about their card birth control method and ultimately spark a social community of Likeminded women and surround them with the support to enable a more educated shared dialogue on contraceptive care with their health care provider.

To help bring this effort to like we're taking a 360 degree approach cooling in partners across emerging tech and social media and so much more.

Alfred F. Altomari: To help bring this effort to life, we're taking a 360-degree approach, pulling in partners across emerging tech and social media, and so much more. We're excited to bring this resource to the marketplace, and we'll share more details as we near its launch. In terms of our longer-term goals, we continue to explore the advancement of our existing pipeline and its possible expansion through business development activities. I want to remind everyone that we'll be holding a virtual Investors Flash Analyst Day on September 21st.

We're excited to bring this resource in the marketplace and we'll we'll share more details as we near its launch.

In terms of our longer term goals, we continue to explore the advancement arbor, our existing pipeline and its possible expansion for business development activities.

Lastly.

I want to remind everyone that won't be holding a virtual ambassador slashed analyst day on September 21st we have time. This event two car right before our planned launches orla at that time, well be able to provide a more detailed overview of our commercialization plan.

Matthew Riley: We have timed this event to occur right before our planned launch of Toralex. At that time, we'll be able to provide a more detailed overview of our commercialization plan. I'd now like to turn the call over to Dennis Riley, our CFO, who'll provide an overview of our financial results for the second quarter of 2020. Thank you, Al, and thank you to everyone listening today.

I'd now like the turnover to call status, while the our CFO will provide an overview of our financial results for the second quarter 2020 [laughter].

Thank you out in fact, you to everyone listening today.

First I will review, our second quarter 2020 financial results.

Matthew Riley: First, I will review our second quarter 2020 financial results. Then I will cover our financial guidance before opening up the call to Q&A. For the second quarter of 2020, our R&D expenses were approximately $3.7 million, compared to $1.8 million in the same quarter a year ago. This increase in R&D expenses was primarily attributable to our preparations for commercial manufacturing of Torla by Corium, our contract manufacturer, and reflect costs to complete manufacturing development work, process improvements, and pre-validation. GNA expenses totaled $6.4 million in the second quarter of 2020, compared to $1.8 million in the same period a year ago. The increase in G&A expenses was primarily due to an increase in commercial development expenses relating to the resumption of our pre-commercialization activities, such as brand building, advocacy, market research, and consulting. G&A expenses also increased due to activities related to building out our commercial organization and included an increase in headcount, professional fees, and stock compensation expenses.

Then I will cover our financial guidance before opening up the call to QNX.

But the second quarter of 2020, our R&D expenses were approximately 3.7 million.

Compared to 1.8 million in the same quarter a year ago.

This increase in R&D expenses was primarily attributable to our preparations for commercial manufacturing hub twirla by corium our contract manufacturer.

And reflects cost to complete manufacturing development work process improvements and pre validation work.

<unk> expenses totaled 6.4 million in the second quarter up 20 Twond.

Compared to 1.8 million in the same period a year ago.

The increase in Gionee expenses was primarily due to an increase in commercial development expenses relating to the resumption of our pre commercial that is Asian activities, such as brand building advocacy market research and consulting.

<unk> expenses also increased due to activities related to building out our commercial organization and included an increase in headcount professional fees.

And stock compensation expense.

We anticipate that our gionee expenses will increase in the future with the commercialization twirla as we continue to grow our business.

Matthew Riley: We anticipate that our G&A expenses will increase in the future with the commercialization of Twirla as we continue to grow our business. These expenses will likely include increased selling and marketing costs, payroll, and operating costs, and other costs related to the commercial launch of Twirla. The net loss in the second quarter of 2020 was $10.8 million, or $0.12 per share, compared to a net loss of $3.5 million, or $0.08 per share, in the second quarter of 2019.

These expenses will likely include increased selling and marketing cost payroll and operating costs and other costs related to the commercial launch of twirl.

Net loss in the second quarter of 2020 was 10.8 million or 12 cents per share.

Compared to a net loss of 3.5 billion or eight cents per share in the second quarter of 2019.

We ended June Thirtyth, twentytwenty with cash cash equivalents and marketable securities.

Matthew Riley: We ended June 30, 2020, with cash, cash equivalents, and marketable securities of $87.2 million, compared to $34.5 million of cash and cash equivalents as of December 31, 2019. The increase in our liquidity reflects our successful first quarter 2020 debt and equity financing, totaling combined proceeds of $68.4 million. Turning to our financial guidance, based on our discussion with wholesale distributors, we have refined our current expectations for initial stocking. We are revising our fourth quarter 2020 revenue guidance accordingly. Net revenue in the fourth quarter of 2020, reflecting the initial launch of Twirla, is now expected to be between $1 million and $2 million.

$87.2 million compared to $34.5 million of cash and cash equivalents as of December 31st 2019.

The increase in our liquidity reflects our successful first quarter 2020 debt and equity financing total combined proceeds of 68.4 million.

Turning to our financial guidance based on the discussion with wholesale distributors, we have refined our current expectations on initial stocking we're revising our fourth quarter 2020, Revvy no guidance accordingly.

Net revenue in the fourth quarter of 2020.

Reflecting the initial launch of Twirla is now expected to be 1 million to $2 million.

Matthew Riley: As Al told you, this reflects wholesaler stocking. We continue to expect our operating expenses for the full year 2020 to be in the range of $52 to $56 million, which we previously provided, with G&A expenses accounting for about 70% of this spending as we build out our commercial infrastructure. It's important to note that this expense guidance includes $2.5 million to $3 million of non-cash stock compensation expense.

Has out told you this reflects wholesaler stocking levels.

We continue to expect our operating expenses for the full year 2020 to be in the range of 52 to 56 million, which we previously provided with GE in a expenses accounting for about 70% of this spending as we build out our commercial infrastructure.

It's important to note that this expense guidance includes 2.5 billion to 3 million of noncash stock compensation expense.

Based on our current business plan and the ability to launch Twirla, we believed that our current cash cash equivalents and marketable securities as of June Thirtyth Twentytwenty will be sufficient to meet our projected operating requirements through the end of 2021.

Operator: Based on our current business plan and the ability to launch Twirla, we believe that our current cash, cash equivalents, and marketable securities as of June 30, 2020 will be sufficient to meet our projected operating requirements through the end of 2021. If the COVID-19 pandemic or other factors impact our current business plan or our ability to generate revenue from the launch of Twirla, we believe we have the ability to revise our commercial plans, including curtailing sales and marketing spending to allow us to continue to fund our operations. With that said, we're happy to take your questions. Operator, you may now open up the line for Q&A. Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Yes, the cobot 19 pandemic or other factors impact our current business plan or our ability to generate revenue from the launch of Twirla. We believe we have the ability to revise our commercial plans, including curtailing sales and marketing spending to allow.

We continue to fund our operations.

With that we're happy to take your questions. Operator, you may now open up the line for QNX.

Thank you we will now be conducting a question and answer session.

Like that's the question please.

And your telephone.

Hey, confirmations on one dictate your line is and the question can you make that starts to me like some of your questions on the Q4 participant.

Operator: You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for your question. Our first question comes from the line of Randall Sinicki with RBC Capital Markets. Please proceed with your question. Hi, this is Dan Busby on behalf of Randall.

And then maybe necessary.

I think 31 moment. Please state your question.

First question comes on the line of Randall Stanicky with RBC capital markets. Please proceed with your question.

Hi, This is Tim buzby on Forendo.

Got a couple questions first how far along are you in the process of manufacturing to three validation batches and how quickly following the completion of that where you'd be in a position to launch and get a particular month or period within the fourth quarter targeted for that lunch.

Dan Busby: I've got a couple questions. First, how far along are you in the process of manufacturing the three validation batches? And how quickly following the completion of that will you be in a position to launch?

Alfred F. Altomari: Do you have a particular month or period within the fourth quarter targeted for that launch? And second, can you talk a little bit more about the factors that went into your decision to cap the sales force at 73 and how much reach into the OB-GYN community does that provide you? Thank you. Yeah, Dan. It's Al.

And second can you talk a little bit more about the factors that went into your decision to cap. The sales force at 73, and how much reach into the Ob GE Wang community does that provide you. Thank you.

Yes, Hi, Dan.

Alfred F. Altomari: Um, so the badges, you know, are being made in. So we make one, you know, move on to the second one, and the third one. It's an intricate program that we've laid out as part of our submission with the FDA. So it's part of what we call our validation protocol. So there's not a lot of ways to run in parallel because that's the way we design them. And, you know, we have to demonstrate ourselves that each batch is up to our high standards that we set forth in our NDA. So that's really why we expect, you know, that the finalization of these batches is being done right now. So we've begun manufacturing them, you know. We're in. As one gets done, we put it through QA, and then the next one, and then the next one, and then we write up our validation reports, and then we're ready to go.

I just you know are being made in sequence. So we make one you know we want to the second one in the third one it's it's an intricate you know program that we laid out as part of our submission, but yeah. Yeah. So it's part of what we call our validation protocols. So I'm just not a lot of ways to run in parallel because that's the by design.

Then.

You know the we have to demonstrate ourselves that he's back you know.

It's up to our high qualities that we set forth in RMB <unk>. So that's really why we expect that the finalization of these batches are being done right. Now so we begun manufacturing them you know where it's somewhere in that one gets done we put it for Q I and then the next one into the next one and then we write up our validates reports.

And we're ready to go so we're still guiding into the fourth quarter, you know, but that gives us because the other thing dampen our minds and no. We have to be mindful that song you know our car manufacturers and then brand <unk>, Michigan, So you've seen with the local flares.

Alfred F. Altomari: So we're still guiding into the fourth quarter, you know, but that gives us, because the other thing that's in our minds, and, you know, we have to be mindful that, you know, our manufacturers in Grand Rapids, Michigan, so as you've seen with the local flares, not for one, everything's been great, but we want to keep that guidance right now, because we just have to, it's all we have to But we're not, it's not our plan, so we have to be mindful of these employees coming in and so forth. So that's why we have a footnote.

Well, what everything's been great, but we want to keep that guidance right now because we just hop it's always be mindful of.

It's not our plan so we be mindful of these employees coming in and so forth. So that's why we have a footnote now you should show pump or did I think that you know we continue to make investments in our sales force and now this this advertising campaigns I'm not it. So we feel good right now that we're on a good path. So.

Alfred F. Altomari: Now, you should feel comforted, I think, that we continue to make investments in our sales force and, you know, this advertising campaign that I manage. So we feel good right now that we're on a good path. So, knock on wood, and, you know, COVID cooperates and continues to, you know, stay on schedule; we'll get it out there. Your second question about the 73, yeah, we talked about this back and forth, and we think that's the right number.

Local what did you know cooperates and will continue so you know sound schedule, we'll we'll get out there. Your second question about the 73, yeah. We we talked about this back and forth and we think that's the right number.

Alfred F. Altomari: You know, the reason why we say that is I think this is one where I would say goes in a good column with COVID because, you know, we just are working smarter. You know, we're going to focus on markets, as I described that are activated with managed care, we're going to focus on calling on group practices, where we can get a lot of efficiencies on our call plan. And then the fact that we're doing it now. Now on, you know, zoom or telemarketing gives us an additional read. So we're going to reach, I don't have the final dev files in front of us, but we're as efficient as I've ever been at this point, so we'll give you that data at the analyst's base, and we'll go through our dev files with you. But I'm really pleased with the reach, that's why I don't think we need a second wave at this point in time of reps This really gives us a lot of punch.

The reason why we say that is I think this is one where I would say goes into good column with Covance because.

Yeah. We just are working smarter you know we're going to focus in markets as I described that or activated with managed care, we're going to focus on calling on group practices, where we can get a lot of efficiencies on our call plan and then the fact that we're doing it I'm not one he does zoom or Telemark and gives us additional reach.

So we're going to reach the I don't have the funneled, that's awesome probably somewhere.

Additionally, as I've ever been at this point. So we'll give you that data at the analyst days and won't go for I guess I'll stick with you, but I'm really pleased with the reach that's why I don't think we need a second wave at this point of reps.

This really gives a lot of punch.

Alfred F. Altomari: The bottom line is I think we're working tremendously smart and tremendously efficient, so I love this idea that we're doing focusing on group practices and using the telemarketing tools that we have. Great, thank you. You're welcome.

The bottom line does I think we're working tremendously smarten tremendously efficient so I I love. This idea that we're doing focus on group practices and Houston to tell the telemarketing tools that we have.

Great. Thank you.

You're welcome thank you.

Operator: Thank you. Thank you. Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question. Thanks for taking my question. Congratulations on the build out. Hopefully, you can hear me. I can hear you, Tim.

Our next question comes from the line, Tim Lugo with William Blair. Please proceed with your question.

Oh, Thanks for taking my question then.

Congratulations on the Oh, the build out.

So.

Are you.

Hopefully you can hear secondaries I've got Oh, yeah, you're good okay, [laughter] bags or what are your thoughts around setting up a reimbursement hub and when you talked about not need in the second wave what are kind of but you'll be looking for took out determine whether that's got second wave of hires or not.

Tim Lugo: Go ahead. Yeah, we're good. Okay. Thanks.

Tim Lugo: What are your thoughts around setting up a reimbursement hub? And when you talked about not needing a second wave, what are the kind of triggers you'll be looking for to kind of determine whether that second wave of hires is needed or not? Yeah, um, the reimbursement helps him, you know, it's, you know, it's interesting. It's a really good question. We are considering doing something like that, but I don't think it's going to be the hub the way some other companies have done it. In our category, Tim, it tends to be a little bit black and white, right?

Yeah.

No the reimbursement Hudson no it.

It's interesting up it's a very good question.

We are considered doing something like that because but I don't think it's going to be to have to wait. Some other companies have done in our category, Tim it tends to be little bit black and white right. So if we're successful at getting drunk on formulary and patients need no copays.

Alfred F. Altomari: So if we're successful at getting the drug on formulary, then patients need no copays, you're in really good shape, right? I mean, I think, you know, the drug overwhelmingly, patients are gonna have access to the drug. We believe, you know. Now, will they have zero copays, or not? So we don't really have what we think is a lot of barriers so at least patients can access the drug. It's access to the drug at what price?

You're really good really good shape right I mean, I think you know the drought all overwhelmingly patients are gonna have access to the drug. We believe you know that will they have zero co pays or not so we don't really have well. We think is a lot of barriers. So at least patients getting access to drugs, it's actually for the drug at what price. So if there's any issues.

Alfred F. Altomari: So if there's any issues a doctor has where there are plans that aren't on formulary, then, you know, quite frankly, well, the doctor can process medical assistance and medical authorizations and, in effect, a prior authorization to get the drug to get there. So under the Affordable Care Act, if the doctor writes in, I'm sorry, it's a medical exception. I should be clear. It's a medical exception, not prior authorization.

The Doctor has waters plans that aren't on formulary. Then you know quite frankly will do not the docker can credit process Marathon medical assistance and medical authorizations in fact, the prior office they get the drug to seek out there. So on the affordable Care Act, if a doctor rights and I'm, sorry, It's a medical exception I should be clear it's a medically.

Section not a prior authorization so they they under the Affordable Care Act definitely got the drugs. So we would expect that you see you know that if dr. 70 trouble to region. Its interesting anecdotally since we published our whack, Tim it's funny like.

Alfred F. Altomari: So under the Affordable Care Act, they're going to get the drugs. So we would expect, you know, that if doctors have any trouble in a region, it's interesting anecdotally since we published our WAC, Tim, it's funny. Like a lot of plans, there are a number of plans that already have twirl up and running in their plans with zero coordination.

The water lumber plants are already have twirl up and running and their plans a zero Coke life. So we're seeing plans already picking this up and we haven't even gotten in front of these folks and some but.

Alfred F. Altomari: So we're seeing plans picking us up, and we haven't even gotten in front of these folks. But we're also a pretty good start, you know, organically, and obviously, we're in negotiations with the big guys. So I would feel pretty good so far.

We're also pretty good start you know a organically and then obviously we're in negotiations with the big guys. So uncle would feel pretty good so far.

Alfred F. Altomari: [inaudible] I can't see us doing that in the near term, but I do always reserve the right if I'm playing a hot hand. I'd probably spam myself. I think the expansive sales force is not a defensive issue; it's more offensive. If we're hot, and we're doing as well as I think we could, early on, I think we could, then we could potentially go deeper into the Bessiles or, you know, a little bit broader into some of the other non-OBGYNs. All right, thanks for the question. Thank you. Thank you.

And then.

What markers, Tim, but I'd say the second question you asked about though.

No.

Going to be a little greedy on the 73 look I mean, if we're playing a hot and dry wall I think.

We probably should expand you know probably deeper that that falls or potentially in the primary care because some other but I can't see us doing that in the near term.

But I do what we reserve the right if I'm, playing a hot hands I'd, probably expand myself for so I I think the expenses salesforce not on a defensive issue it's more offensive.

We are hot and we're doing as well as I think we could rolling them I think we couldn't we could potentially go deeper into the that files are little bit quarter and says somebody other auto but your plans.

Alright, thanks for the question.

Operator: Our next question comes from the lines of Leland Gershel with Oppenheimer and Company. Please proceed with your question. Hi Al and Dennis, thanks for taking my question. Actually, teeing off from Tim's question, I may have missed part of it, but I wanted to ask about the use of co-pay cards and any impact on growth to net that we should think about as you head into the early part of the launch. And then I've got a quick follow-up. Yeah, a good question.

Yeah. Thanks.

Thank you. Our next question comes in the life of Leland Gershell with Oppenheimer and company. Please proceed with your question.

I wouldn't that as thanks for taking my question.

Actually taking off from from Tim's question I may have missed part of it but wanted to ask about use of co pay cards and any impact to gross to net that we should think about as you head into the early at Heart City tour launch that I've got a quick follow up thanks.

Yeah, good, especially when so yeah I mean, they you know we are our strategy is pretty simple you know we want to get access to women. So they get the drug.

Alfred F. Altomari: So yeah, I mean, you know, our strategy is pretty simple. We want to get access to women so they get the drug, and they have no formulary barriers.

Then they have no formed already barriers. So we don't we're pretty bullish there. It is the real question is at what price or what copay.

Alfred F. Altomari: So we don't we're pretty bullish about that. And the real question is, at what price or what co-pay? So we think we will do pretty well with the zero co-pays. But if a major plan, you know, Leland doesn't have, we don't get it out of the chutes.

Well, we think we will do pretty well to zero co pays but it's a major plan you know a we went up and how he knows that we don't get it out of the shoots and it takes his time over virtual co pay card in my mind to co pay cards are kind of the last one of defense, we'd like the thing that we would.

Alfred F. Altomari: And it takes us time; we'll revert to a co-pay card. In my mind, the co-pay cards are kind of the last line of defense. We'd like to think, you know, that this is necessary in this category if we do our jobs well. So if we do use co-pay cards, you know, which will be in the bag, but there'll be more of a bridging strategy to get to a contract with managed care. So we think the primary objective is to get on the contract, get a zero co-pay, you know, and then if a plan doesn't give zero co-pays or has any restrictions, we think the next line of attack would be the medical exception, you know, and guiding doctors that, hey, if they want this drug, they can get it. And then the landline, you know, if you will.

This is the necessary you know in this category, we door job well so.

If we do use <unk> co pay cards, which will be in the bag, but they'll be more of a bridging strategy to get to a contract with managed care. So we think the primary objective is to get under contract go to zero co pay.

And then if that's the plan doesn't get the old co pays or has any restriction we think the next flying to.

The offense would be the medical exception.

Pardon doctors that pay that they want this drug they can get it and then landline. If you know if you will so I think they'll probably probably you know I'm you know play a role, but I can't see them as widely used as you see in somebody other kind of course you follow.

Alfred F. Altomari: So I think they'll probably, probably, you know, you know, play a role, but I can't see them being as widely used as you see in some of the other categories you follow. You know, let me be clear, Levi. I'd hate to use them broadly.

Yeah, but this has got to be borne out when we set up on lipid contracts.

Gotcha I'd hate to let me, let me be clearly with I'd hate to you I'd hate to use the broadly held that [laughter] my other strategies.

Alfred F. Altomari: How's that? This is my other strategy. That's very helpful. And then maybe actually one more question and then I've got a follow-up on this topic is, you know, with the existing Zulane patch, have you went into any conversations with payers where there's been a, you know, kind of, Because that project has been on the market, on formulary, for a long period of time. [inaudible] Yeah, so we've not encountered a step therapy, you know, discussion, you know, most of our discussions have gone quite well. You know, our position is that we're not trying to, You know, we're not walking in and telling the plans, hey, don't cover somebody, including, you know, the, you know, the other patch, quite, quite candidly, we're okay to carry both patches, as long as we give a chance to compete, you know, with the doctor's prescription, you know, so we don't make it adversarial, if that makes sense, you know, so we think the WAC we selected, you know, was thoughtfully done, you know, that we think we have a good value proposition at that price with our clinical differentiation we've shown.

That's a that's very helpful and then maybe actually.

One more question.

But on this topic as you know what the existing Xueling patch if you went into any.

Conversations with payers, where there's been a.

You know kind of.

Because the participant in the market formulary for a long time its.

The step through our preferred and then twirla become sort of the.

Hey, you know probably that that is less prefer them that one or is it much more of an even playing field and.

Given the whack a twirla is regarded as being a.

Reimbursable therapy broadly.

Yeah. So we've not encountered a step therapy discussion most of our discussions of the gone quite well.

You know our position is that we're not trying to.

You know, we're not walking in and fell in the plan is hey don't copper somebody including you know the or the other pets quick math quite candidly. We're okay did carry both patterns evolve we give a chance to compete well you know what for dockers prescription. So we don't make it adversarial, even if that makes sense you know so we think.

The whack we've selected.

That was thoughtfully Don you know on that we think we have a good value proposition at that price with our clinical differentiation. We showed so conversations are going quite well and that the worst case ends up being were both on formulary.

Alfred F. Altomari: So conversations are going quite well, and if the worst case ends up being that we're both on formulary, we'll take it to the doctors and take it to consumers or to patients and let them decide. So that's really been our strategy. So we're not saying kick them off, put us on, and we don't approach things like that. We said, look, we believe in this product so much that we believe that we can get a doctor to write about it. And we get the patient on our drug, and we win. So we're not setting it up even as a win-loss, if you will.

Well take it to the docs and take the silver is our to the patients and what does the side.

So that's really been our strategy, but we're not saying take a law put up on and we don't approach things like that we said look we believe in this product that much that we believe we can get docket right. The scripts and we got a show in our drug we win so we're not setting it up even as a win loss if you will.

Understood. Okay, and then you know, it's we think about sort of running the opportunity when until.

Alfred F. Altomari: Understood. Okay. And then, you know, as we think about sort of broadening the opportunity for women's health, you'll have a sales infrastructure up and running with the field force and other strategies in place. Just wondering if you could share any thoughts on what may be out there in addition to TORILA that we could see, coming into the portfolio, not necessarily in terms of specific types of products, but maybe just in terms of general categories. Would it be, you know, outside of contraception, perhaps in other areas of female health? How should we think about that? Yeah, that's really a good question.

Sales infrastructure up and running with appeal for us and other strategies in place just wonder if you could share any thoughts on what may be out there. In addition to twirla, though because see.

Coming into the portfolio not not necessarily in terms of specific types of products, but maybe just in terms of general categories would it be outside the contraception, perhaps in other areas of female health, how should we think about that.

Yeah, that's really good Chris you haven't we couldn't comment in the suburbs Teva Now's. The time, we first I think our first of all the lenders to activate our own pipeline since she's long sitting dormant you know so we think we'd have a couple of clever you don't really important products. If you will in Kandahar art on our hands I think our first.

Alfred F. Altomari: Yeah, I mean, we put a comment in the script to say, look, you know, now's the time we first, I think our first thought we learned is to activate our own pipeline. You know, it's been sitting dormant for too long, you know, so we think we have a couple of clever, you know, really important products, if you will, in kind of our, in our, in our hands. So I think our first priority, Ben, should probably be guided to activating our pipeline, so hopefully you'll hear more about that as we progress through the year than you might. We have an inefficient call point with a single product, right? We've been asked this time and time again about why build and why not partner, and look, we always think through the possibilities for this company, but we've made the decision based on the environment we're in that it is the best thing for our shareholders to build and start here. So I would love to grab another product that doesn't have to be in contraception.

Spend should probably be guided so activating our pipeline so hope that you'll hear more about that's.

Good progress through the year.

But you're right I mean, we have an inefficient call point with a single product right I mean.

We've been asked this time and time out about why why building why not partner and you know we look we always think or the possibilities, but its company column.

We we've made the decision based on the environment when that we think I think for our shareholders the build and and start here. So I would love to grab and other products that doesn't have to be in contraception.

Like I think strategically the company needs to be more efficient with its call point and look filled the pipeline and build the pipeline that's address growth well into the future. So I think more to come went up this part I think for the first time, we're gonna be inquisitive, that's what we're trying to say.

Alfred F. Altomari: I think strategically, the company needs to be more efficient with its call points, and let's build a pipeline and build a pipeline that addresses growth well into the future. So I think more to come on us from the start. I think for the first time, we're going to be inquisitive; that's what we're trying to say. So, if you hear anything, send it our way; send it our way; we're willing to listen now. Excellent. In the meantime, we look forward to the twirl launch. Thanks for taking my question. [inaudible] Thank you. Our next question comes from the line of Oren Livnat with H.P. Wainwright.

We haven't been lateral is it do you know.

We feel like we had our hands spoken for wireless and be thoughtful capital Chicago Twirla, but we're starting to feel good about ourselves so we'd like to dress bag, but also pipeline.

So I'll be here anything Sundar, what I'm going our way we're rolling.

Well Melissa.

Excellent and then in the meantime, we look forward to the throw launch thanks, taking my question.

My pleasure thanks.

Thank you. Our next question comes from online offering was not with H.C. Wainwright. Please proceed with your question.

Operator: Please proceed with your question. Hey, folks. I've been cutting in and out here, so I hope I'm not repeating anybody. I did get the sense that a lot of people are asking about managed care, and I'm going to do the same. And you could tell me if you want to follow up afterwards, if you don't want to be repetitive. But I noticed your WAC is about 30% higher than where Zulane is. And well, I think nobody would debate that you have a, you know, differentiated profile from Zulane.

Hey, folks I've been at cutting in and out here. So I hope I'm not repeating anybody I didn't get a sense that a lot of people are asking about managed care and I'm going to do the same on you could tell me if you bought a follow up afterwards.

Repetitive, but I noticed your whack, it's about 30% higher than where zoo Lainez, then well I think nobody would debate that you have a differentiated a profile from do lane I'm just curious in your conversations of payers since it sounds clear that you want to minimize prior off any friction.

Oren Gabriel Livnat: I'm just curious, in your conversations with payers, since it sounds clear that you want to minimize prior authorizations and any friction at launch, and that you will, I guess, give up what you need to give up on the economics to get there for the most part within reason. Are you needing to match them on net price, which is probably a hefty gross net from where your WAC is? and I have followed. I don't believe it's 30%; I think it's more like 22 or 23.

Launch in that you will I guess.

Give up what you need to give up on economics to to get there for the most part within reason.

Are you needing to match them on net price, which is probably [laughter].

I have two gross to net from where your whack S.

Follow ups.

So are you I thought I find that were not Miss the guys quick math I don't believe it started for side I think it's more like 20% to 23%.

Yeah. So what we've heard is that the clear differentiation of our product we talked to customers is to command that that if you will that Delta you know, we don't think that's an overreach by the way Yeah, we think that what we break the party.

Alfred F. Altomari: Yeah, so what we've heard is that the clinical differentiation on a product, when we talk to customers, can command that, if you will, that delta. We don't think that's an overreach, by the way. We think that what we bring to the party, both clinically and also, quite frankly, with the patch replacement program. That's why we keep featuring that. Because if you're a managed care organization and a patient loses a joint, you pay for it.

Both clinically and also quite frankly wouldn't Patrick placement program. That's why we keep featuring that because if your managed care organizations and you know a patient lives is doing you pay for it you know on our planned.

Alfred F. Altomari: On our plan, we're going to pay for that. So we think we have that value add, that's a really important part of it, but you're going to just correct me. You're right. 131.

So we think.

That value add that's a really important part of it.

Got it is correct me you're right it 131 right. So.

Yes.

Alfred F. Altomari: Yes, but that Delta we believe is earnable, you know, from a managerial perspective, but we've not gotten a lot of pushback on the Delta. So we don't think that whole idea of, "Let's do a big leap of whack, and let's roll it back" is not a strategy that we subscribe to. You know, that doesn't mean we won't be willing under certain circumstances to discount, but, so that we hear before we got the product through, and now is that we can, we can, we can command, you know, this type of premium. It's not an overreach; we don't think it's an overreach.

That Delta, we believe its irgovel no problem and surface, but we've not done a lot of push back on the adult. So we don't think it says that that whole idea of let's do a big leap all WACC and let's roll. It back is not a strategy that we subscribe to get out.

That doesn't mean, we won't be willing under circumstances.

Certain circumstances to discount, but we don't see a massive roll back to that.

That we what we've heard before we got the product group and now is that.

We could we can we can command you know this type of thing it's not enough, but we don't think it's been overreach.

Okay, great appreciate it and so with regards that fourth quarter.

Alfred F. Altomari: Okay, great. Appreciate it. And with regard to that fourth quarter... guidance. Is that decreased from four to six to 1.2?

Hi, This is that decreased from four to six to 1.2 that really just a reflection of the new normal in the world of lean wholesaler stocking or is there any read through to early pull through demand assumed.

Oren Gabriel Livnat: Is that really just a reflection of the new normal in the world of lean wholesaler stocking? Or is there any read through to early pull through demand assumed with the launch, maybe because of COVID or other factors? Hey, Oren Dennis here.

With the launch may be cut the cobot or or other factors.

Hey aren't Dennis here that you surely discussions with the wholesale or where we learned.

Matthew Riley: That was purely discussions with the wholesalers, where we learned they don't put anything out into the channel, into the like retail pharmacy, and they run very lean. And that was really a lesson as we met with the wholesalers. And that's really where we're at. We've just kind of got to the new reality, and we revised accordingly.

They don't put anything out into the channel into that like retail pharmacy, and they run very lean and that was really old, earning as we met with the wholesalers.

And that's really where we're at we just got kind of got to the new reality and we've revised accordingly, if you remember on the last call. We did say that are our previous guidance was wholesaler stocking also and so all we've done is revised wholesaler stocking levels, which are very leap.

Matthew Riley: If you remember on the last call, we did say that our previous guidance was wholesaler stocking levels also. And so all we've done is revised wholesaler stocking levels, which are very lean. Yeah, and I think, Oren, you said it well, the new world. I mean, we, in the old world, we would give them discounts, if you will, to carry inventory on our behalf, we'd give them dating. And in the new world, they just don't want it.

And I think or new set well for new new World I mean, we Neil World, We would give them discounts. If you will carry inventory on our behalf different dating and in the new world. They decided they just don't want it. They just don't want at the same like you know, we'd rather be lean and said differently back to your growth that you know this is where I work for our advantage.

Alfred F. Altomari: They just don't want it. They're saying, you know, we'd rather be lean. And said differently, back to your growth and that, you know, this is where it works for our advantage, because we get a chance that they get a restocking order, we're going to get it at our full price, if you will, we don't have to give them these deals. So they don't want, the customer doesn't want it, you know, we're willing to go leaner, we'll have So we will monitor inventory; they said, look, we'd rather put a refill order in. But this is, in no way, as Dennis mentioned, indicative of what we believe the demand will be. You know, this is just pure stocking stuff. It wasn't the first item in this one, so.

We get a chance if they get a restocking water, we're going to get into that our full price. If you will we don't think in the field. So they don't want to talk and run the want it you know where we're willing to go leaner I will hop on of inventory at our AR.

Manufacturing site will have the inventory already so we can get its own within 24 hours. So we will monitor inventories. They said look we rather put a recent water in so we.

This is in no way as Dennis mentioned indicative of what we believe it Mandel Big you know this is just pure stocking it wasn't the first guided the this one so.

We expect when the script start walk him will get refills and refill orders and we'll roll then they'll come at a better price.

Alfred F. Altomari: Right. And I guess I always did think that sounded high, given what wholesalers do these days. But I am curious. You're explicitly guiding, I guess, to purely channel fill revenue in the fourth quarter. Should I assume, then, that we're not expecting material prescription volume even in 4Q? That might translate to, I guess, recognized revenue, or are you just being really conservative? Or is perhaps initial sampling going to just eat into those first month or two to the extent that it's not even worth thinking about prescription volume?

Right and I guess I always to think that thought at high given.

Wholesalers did these days, but I am curious.

Your explicitly guiding I guess 10, she purely channel fill revenue in fourth quarter.

Should I assume then that.

We're not expecting material prescription volume even in for Q that might translate to I guess reckon recognize revenue or are you just being really conservative or perhaps initial sampling gonna just eat into those first month or to that extent that it's not even worth thinking about prescription volume.

Alfred F. Altomari: Can I say yes, yes, and yes, so that you hit everybody in the right bucket? And so, no. If we can come out and say, hey, we're early in the fourth quarter, we might feel differently about you, but it goes back to our guidance for the fourth quarter. Until we land on where in the fourth quarter, we don't wanna get the cart ahead of the horse, if you will, in guidance. Secondly, your other point is uberly critical. We still intend to sample this product. I mean, at minimum, she's gonna get one month on us.

But I'd say, yes, yes, and yes.

[laughter] buckets.

Got it it looks as if we if we come out and say Hey, we're early in the fourth quarter, we might feel differently about and you because it goes back to our guidance about the fourth quarter until we landal, where in the fourth quarter, we don't want to cut the cord ahead of the horse. If you will guidance secondly, your other point is overly critical we still intend to say.

Ample this product I mean at minimum she's going to get one month or thrown off. So you know we talked before with you when other folks the street and you know one of likely she's going to go out with a couple of months on off. So we just I don't expect appreciable scripts in the fourth quarter and because the wafer sampling all like that.

Alfred F. Altomari: So, you know, we've talked before with you and other folks in the street, and, you know, more than likely, she's gonna go out with a couple months on us. So we just, I don't expect appreciable scripts in the fourth quarter because of the way we're sampling. I'd like to be perfectly surprised myself, so I just wanna make sure your expectations align with mine. I'll find out when we do it, you know, how many samples we're putting out there, and particularly in this new world, I want to be more cautious. And yes, I'm being conservative.

Pleasantly surprised myself, so I just want a magnet.

Your expectations lined with mine so I'd point out when we're doing it you know how much samples were putting out there and and particularly in this new world I want to be more cautious and get them being conservative How's that I hit all your buckets, yes, yes, yes.

Alfred F. Altomari: How's that? I hit all your buckets. I don't think you missed any.

I don't think you Miss any thanks appreciate it sorry, thanks art.

Oren Gabriel Livnat: Thanks. I appreciate it. Thank you. We have reached the end of our question and answer session. I'd like to turn the call back over to Mr. Altomari for any closing remarks. Thank you very much, operator. I really appreciate it. As you know, the second quarter was certainly an unprecedented quarter, filled with all kinds of challenges for ourselves and, you know, the world business environment. I don't think any of us can really, really see it coming.

Okay. Thank you we have reached the end of our question and answer session I'd like to turn the call back over to Mr. also Murray for any closing remarks.

Thank you very much operator, I really appreciate it.

You've heard the second quarter was certainly an unprecedented quarter filled with all kinds of challenges for ourselves and overall business environment. I don't think any of US. Good really is really seen common never Nevertheless, I think you've heard from US we've successfully made progress when our or initiatives and remain on track for more just products and Portland fourth quarter.

Alfred F. Altomari: Nevertheless, as you know, we've successfully made progress on our initiatives and remain on track to launch this product in the fourth quarter. Our team has just been remarkable, both at Agile and both with our partners Corium and Alsthenios Health. And we just have been able to just continue to stay on track with our objectives, which have been primarily focused on manufacturing and building out our sales force and managed care, as you've heard. So as we look ahead in the third quarter, our goals are really clear. We're going to continue to ramp up manufacturing, as I mentioned, and executing on these validation batches, and we expect to have a complete fourth quarter. And in parallel, we're seeking to get coverage and reimbursements for Forlove, where a woman gets access to our product, first of all, and as many women as possible at a zero co-pay. We're, we're confident, you know, as you've heard from myself and Dennis that we're well positioned both on the financial side, but also, you know, strategically. We're just knocking down our milestones. And we believe we're marching to a long fourth quarter.

Our to our team has just been remarkable both at agile and both at our partners Coram and how serious health and we just have been able to just continue to stay on track or objectives, which had been primarily focused on manufacturing and building out our salesforce and and the managed care as you've heard so.

As we look ahead in the third quarter. Our goals are really clear, we're going to continue to ramp up manufacturing as I mentioned and executing on these validation batches and we expect to haven't completely fourth quarter and in parallel we are seeking to get coverage and reimbursement floral a woman get access to our product first of all of that many.

Women as possible what is your copay.

Work, we're confident you know as you've heard from myself and Dennis that we're well positioned both for a financial side, but also you know strategically we're just knocking down our milestones and we believe we're marching to a fourth quarter launch as a reminder, we'd love to tell you more about what we're doing and on September 21st when we have our analyst day and.

Alfred F. Altomari: As a reminder, we'd love to tell you more about what we're doing on September 21st when we have our Analyst Day and our Investor Day, so we look forward to seeing you there, and we'll give you more granularity and more details that you've requested on this call. But I'd like to thank everybody for their support and their interest in our company. It's been an exciting time. We've been through a lot with this company. I'm proud of where we are, and I'm looking forward to practicing my craft as a commercial person and getting this product in the marketplace.

Our investor days, when we look forward to senior there and we'll give you more granularity in more detail that youve requests on this call, but I'd like to thank everybody for your here following and your interest in our company.

An exciting time, we've been through a lot with this company so I'm.

Proud of where we are and I'm looking forward to.

Practicing my crafted the commercial person getting this product in the marketplace. So thank you and be safe and be well to you and all your family's thank you.

Operator: So thank you, and be safe and be well to you and all your families. Thank you. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.

Thank you that concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.

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