Q4 2020 Agile Therapeutics Inc Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to the agile Therapeutics fourth quarter and full year 2020 financial results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Agile Therapeutics fourth quarter and full year 2020 financial results conference call. At this time, all participants are in a listen only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star one on your telephone. If you require any further assistance, please press star zero. I'd now like to hand the conference over to your speaker today, Matt Riley, Head of Investor Relations and Corporate Communications. Thank you.

I ask the question during the session you will need the press star one on your telephone.

You require any further assistance. Please press star zero I would now like to hand, the conference Oh Gee the speaker today, Matt Riley head of Investor Relations and corporate communications. Thank you. Please go ahead, Hello, everyone and welcome to today's conference call to discuss our fourth quarter and full year 2020 of financial results before we start let me remind you that series called on.

Matthew Riley: Hello, everyone, and welcome to today's conference call to discuss our fourth quarter and full year 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 full year 2021, management's expectations for our future financial and operational performance, our business strategy, our assessment of the combined hormonal contraceptive market, and the potential market share for Twirla, among other statements regarding our plans, prospects, and expectations.

Forward looking statements based on current expectations, including statements concerning our outlook for the full year 2021 management's expectations for our future financial and operational performance our business strategy, our assessment of the combined hormonal contraceptive market and the potential market share for Toro among other statements regarding our plans.

Prospects on expectation such statements represent our judgment 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 on the forward looking statements. Please refer to our filings of the SEC, which are available through the Investor Relations section of our website for information concerning risk factors that may affect.

Matthew Riley: 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 those discussed in the forward-looking statement. Please refer to our SEC filings, 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 company, we undertake no obligation to update forward looking statements, except as required by law. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are al Tomorrow, Agile Therapeutics, Chairman and Chief Executive Officer, and Dennis Reilly, Chief Financial Officer. Following our prepared remarks, we'll open the call to you.

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

Questions, Let me now I'll turn the call over to al.

Thank you very much Matt good afternoon from welcome everyone to our fourth quarter and full year 2020 conference call.

Alfred F. Altomari: Good afternoon, and welcome everyone to our fourth quarter and full year 2020 conference call. I'd like to start off today by highlighting the hard work and efforts of our talented team and partners resulting in the launch of our first FDA-approved product, Twirla, a once-a-week contraceptive pad. Borla was designed to fill a need in the hormonal birth control market, bringing a non-invasive, non-daily combined hormonal contraceptive, or CHC, option with a lower estrogen dose than the only other contraceptive patch available in the marketplace today.

I'd like to start off today by highlighting the hard work and efforts of our talented team and partners, resulting in the launch of our first FDA approved product for a lot of once a week contraceptive patch.

Well it was designed to fill a need in the hormonal birth control market, bringing a non invasive non daily combined hormonal contraceptive force the AC option with the lower estrogen dose then the only other contraceptive patch available on the marketplace today.

As we discussed last quarter, we were well on track to launch our product since the addressable ph D market valued at more than $4 billion and we've accomplished that objective.

Alfred F. Altomari: As we discussed last quarter, we were well on track to launch our product into the addressable CHC market valued at more than $4 billion, and we've accomplished that. All three of our validation batches of PORLA were made available for commercial use in December, leading to the achievement of our 2020 revenue target with just over $1 million in gross revenue in the fourth quarter. In addition, the sales force received their samples in late December. Thus, the traditional channel for distributing TORILA has been built.

All three of our validation batch of the poorly were made available for commercial use of December leading to the achievement of our 2020 revenue target with just over $1 million in gross revenue in the fourth quarter.

In addition, the sales force received their samples in late December.

The traditional channel for distributing squirrel that had been built our network of three major U S wholesalers as well as several regional wholesalers has been central to all of the initial stocking of poorly moving forward, we believe that our established and growing distribution network will provide the supply chain infrastructure.

Alfred F. Altomari: Our network of three major U.S. wholesalers, as well as several regional wholesalers, has been central to the initial stocking of TORILA. Moving forward, we believe that our established and growing distribution network will provide the supply chain infrastructure necessary to support the anticipated demand for TORLA. In terms of the commercialization efforts behind Swirla, our plan focuses on three primary strategies for engaging customers. First, Healthcare Professionals, or HCP.

Necessary to support the anticipated demand for 12 of them.

In terms of the commercialization efforts behind swallow our plan focuses on three primary strategies for engagement first health care professionals for HCP.

Second managed care and lastly, the consumers.

Alfred F. Altomari: Second, managed care, and lastly, the consumer. First, our efforts with ACP. Along with our partner Cineos, we're able to hit the ground running with an experienced sales force of eight regional virtual sales specialists and 65 sales professionals. This is a grand total of 73 individuals calling on the HCT audience.

First our efforts with HCP.

Along with our partner scenarios, we're able to hit the ground running with an experienced sales force of eight regional virtual sales specialists and 65 sales professionals. This is a grand total of 73 individuals calling on the HCP audience. The.

Sales force has not only been productive and the number of daily interactions with HCP from their staff, but also on generating face to face call Vin.

Alfred F. Altomari: The sales force has not only been productive in the number of daily interactions with HCTs and their staff but also in generating face-to-face calls. Since launch, we've been able to hold roughly 70% of our prescriber meetings face-to-face in a COVID-19 compliant setting. But the question on all of your minds, I'm sure, is how the law is going.

Since launch we've been able to generate roughly 70% of our prescriber meeting face to face the COVID-19 compliant setting.

But the question all of your minds I'm sure of how the launch going on.

I'd be remiss, if I did not acknowledge the challenges our team of space, both nationally and regionally, including the pandemic and kind.

Alfred F. Altomari: I'd be rude and missed if I did not acknowledge the challenges our team has faced, both nationally and regionally, including the pandemic, inclement weather, power outages, and water shortages. But taking all this into account, the short answer is that we're very happy with the momentum we are seeing and all the indicators and metrics we are monitoring to track our sales force effectiveness. Allow me to try to explain that.

On weather power outages and water shortages, but taken all of a sudden the count. The short answer is that we're very happy with the momentum we are seeing and all the indicators of metrics. We're monitoring the track our sales force effectiveness allow me to try to explain that.

Let's start with prescriptions were tier axes.

Alfred F. Altomari: Let's start with prescriptions, or TREC. In my mind, we've effectively launched our product beginning this. Since that time, we are seeing weekly compounded growth rates of approximately 30%. I do want to add a word of caution. The point I'm making is one of momentum.

My mind, we effectively launched our product beginning this year.

Since that time, we're seeing weekly compound the growth rate of approximately 30%.

I do want out of a word of caution the point I'm, making is one of the momentum we're not suggesting this is a sustainable rate for the purposes of modeling or guided we're still at very early stages of the ones with that said, we are still happy with the star.

Alfred F. Altomari: We're not suggesting this is a sustainable rate for the purposes of modeling or guidance. We're still in the very early stages of launch. With that said, we are still happy with this start.

Don't want to comment on the value of us here at <unk>.

Alfred F. Altomari: I also want to comment on the value of a TRS. Importantly, on average, each TRX has more than one unit for one cycle. The reason why is that women get more than one month's supply of chlorella when they leave the farm.

Importantly on average each tier of rack is more than one unit of one cycle.

The reason why there's women get more than one month of supply Carlo when she leaves the pharmacy.

Each to Iraq is averaging somewhere between one three to one four units or cycles received the other patient. This is in line with our internal planning.

Alfred F. Altomari: Each TRX is averaging somewhere between 1.3 to 1.4 units or cycles received by the patient. This is in line with our internal plan. Think of this as getting 40 to 45 days of Swirla at one time.

Think of this as getting 40 to 45 days of the toilet at one time.

We're monitoring other important metrics.

Alfred F. Altomari: We're monitoring other reports. Physician Prescribing as well. We are growing our base of prescribers. Since January, our week-on-week growth has been approximately 29%. The number of TRXs, e-prescribers writing, is also growing, which is another bit of news. Refills.

The physician prescribing of <unk> wallet, we are growing our base of prescribers of weak wind.

Since January of week on week growth as the.

Slide 29%.

The number of tier of axis each of prescribers, writing the bulk of growing which is another good indicator.

Refills, we're starting to see refill, which is great news.

Alfred F. Altomari: We're starting to see refills, which is great. Roughly 10% of our units dispensed so far at pharmacies are refilled, and we expect refills to accelerate as new prescriptions turn into refills. Ultimately, we are encouraged by the early results from our field representatives' efforts prior to launch and the continued upward trajectory since, as evidenced by the steady increase in TRX refunds. This indicates that providers are willing to write longer prescriptions once the patient is initially successful on the product. Everybody has discussed in the past that sampling dynamics is important for twirling.

Awfully, 10% of our units the spend so far at pharmacy are being filled and we expect refills accelerate as new prescriptions turning the each film.

Ultimately we are encouraged by the early results from our field representatives efforts prior to launch and the continued upward trajectory.

As evidenced by the steady increase in Trs refills.

This indicate that providers are willing to write longer prescriptions. Once the patient is the initially successful on the product.

I think the Scott in the past the sampling dynamic is importance of Korlym.

We're continuing to offer full month sample of bi for patients to ensure individuals' where interest in thriller type of opportunities to use it kept for consulting with the HCP.

Alfred F. Altomari: We're continuing to offer full-month sample supplies for patients to ensure individuals who are interested in TORLA have an opportunity to use it after consulting with their HCP. We believe it's important for the patient to ensure that squirrel is the right product for her prior to getting their prescription and moving forward with becoming a long-term squirrel user. However, initially, it does slow down the patient flow to pharmacy in the early days of launch.

We believe it's important the patient and shorts oral is the right product from her prior to getting the prescription of moving forward with the coming of long terms of all user.

Initially it does slow down the patient flow to pharmacy in the early days of launch, but we think of samples of isn't investing that introduces a C T and their patients to Paula with the potential to stimulate the future growth.

Alfred F. Altomari: But we think of samples as an investment that introduces HCTs and their patients to a new treatment with the potential to stimulate future growth. Moving forward, we'll continue to use the insights from our data-driven approach to ACP outreach to refine our targeting to the highest volume practice. While we do not expect to share all these metrics going forward on a quarterly basis, we do believe they are good indicators of the initial commercialization of soil. Now Owns Managed Care

Moving forward, we'll continue to use the insight from our data driven approach.

The outreach to refine our targeting sort of highest volume practices.

While we do not expect the share all of these metrics going forward on a quarterly basis. We do believe they are good indicators of the initial commercialization of boiler.

Now on the managed care.

We also continue to make meaningful progress on both coverage and reimbursement per swirling in a challenging managed care environment. We estimate our engagements with third party payers have resulted in swirl of having achieved approximately 40% to 45% formulary coverage since long.

Alfred F. Altomari: We also continue to make meaningful progress on both coverage and reimbursement for TORILA in a challenging managed care environment. We estimate that our engagements with third-party payers have resulted in Twirla having achieved approximately 40 to 45 percent formulary coverage since launch. Notably, this is inclusive of one of the three PBMs, or Pharmacy Benefit Managers, as well as several smaller. We continue to work towards our goal of increasing formula access with as many zero copays as possible over the course of this year.

Notable this is inclusive of one of the three pbms or pharmacy benefit managers as well as several smaller plan.

We continue to work towards our goal of increasing formulary access with as much zero co pay of possible over the course of this year.

We also expect the squirrel of will be now available to patients and one of the largest closed managed care system based on a recently negotiated GPO or group purchasing organization of the agreement. This opens another important channel for accessing twirler and represent another element.

Alfred F. Altomari: We also expect that TORLA will now be available to patients in one of the largest closed managed care systems based on a recently negotiated GPO, or Group Purchasing Organization, agreement. This opens another important channel for accessing TORLA and represents another element of our early momentum for TORLA. Please note these arrangements do not report data through Symphony or IQVY.

Of our early momentum for Korlym. Please note. These arrangements do not report data through symphony or IQ beer.

Finally, agile of currently in discussions with the specialty pharmacy and telemedicine partners in order to expand the channel that provide access the koala.

Alfred F. Altomari: Finally, Agile is currently in discussions with specialty pharmacy and telemedicine partners in order to expand the channels that provide access to SWARM. As we have said all along, we want to follow the patient on her journey and ensure that SWARM is available for her along the way. We recognize the benefits afforded by both channels and believe that bringing differentiated values to our business and patients that they'll serve. For specialty pharmacy, we prioritize buying a partner that would make squirrel easy for providers to prescribe and convenient for patients to receive. Today, we're happy to announce our partnership with Sterling Specialty Farms.

We have said all along we want to fall of the patient on her journey and ensure we're always available somewhere along the way.

We recognize the benefits afforded by both channel and believe that bringing differentiated value to our business and patients that the serve.

For the specialty pharmacy, we prioritize buying of partner that would make twirl easing for providers, the prescribed and convenient for patients to receive boiler.

Good day, we're happy to announce on our partnership with Sterling specialty pharmacy Sterling hasn't established organization with patient first philosophy that matches our ethos.

Alfred F. Altomari: Sterling has an established organization with a patient-first philosophy that matches our ethos. They also have a proven track record of providing a streamlined and personal approach, which we believe will play a critical role in accelerating the COROA update for Telemedicine Perspective. Because of the ease and convenience this channel offers patients, we are committed to selecting partners that best align with our strategic needs. We will continue to explore this area and hope to share more information about it in the near future about our efforts and developments in telemedicine.

They also have a proven track record of providing streamlined and personal approach, which we believe will play a critical role in accelerating the core of our uptake.

For telemedicine perspective.

Because of the ease and convenience the channel offers patients we're committing to selecting partners that pass the line with our strategic need will continue to explore this area and hope the share more information about this on the near future about our efforts in developments in telemedicine.

Now on the consumer engagement.

Alfred F. Altomari: Now on to consumer engagement. As a company, we're focused on and committed to providing providers that fill the unmet needs of today's women. As part of this, we believe it's important to break the stigma around conversations about birth control and ensure women are able to educate themselves on the variety of contraceptive options available and make informed decisions that best align with their own personal contraceptive needs. Since our I'm So Done, I'm Branded campaign was launched in September of last year, roughly 700,000 women have engaged with our website content via displayed and paid social efforts, which has empowered them to join in the birth control conversation.

The company, we're focused on and committed to providing providers.

Phil the unmet need of today's women of part of this we believe it's important to break the stigma around conversations about birth control and ensure women are able to educate themselves on the variety of contraceptive options available and make informed decision the best aligned with their own personal concept the need.

Since our arm so Don Unbranded campaign was launched in September of last year, roughly 700000 women have engaged on our web site content via displayed and paid social efforts, which is to empower them to join in the birth control conversations.

We're happy to note agile of breaking the contraceptive category mol by being the first on branded birth control of awareness campaign to activate on tick tock the.

Alfred F. Altomari: We're happy to note Agile is breaking the contraceptive category mold by being the first unbranded birth control awareness campaign to activate on TikTok, the most downloaded app in 2020. We're proud of these efforts and will continue to explore developing partnerships with popular lifestyle influencers and credible content providers to further advance the I'm So Dumb campaign. We believe these educational efforts are an important component and a driver of continued awareness to support the ongoing growth of Squirrel Loaf amongst our target market.

The downloaded app in 2000 and pointing on.

I'm proud of these efforts and we will continue to explore developing partnerships.

With popular lifestyle influencers incredible content providers.

To further advance the Amsterdam campaign, we believe these educational efforts are important component and a driver of the continued awareness to support the ongoing growth of the orla amongst our target market.

Learnings from the unbranded campaign translate well into the development and launch of the agile <unk> branded campaign for Korlym.

Alfred F. Altomari: Learnings from the unbranded campaign translate well into the development and launch of Agile's branded campaign for Twirlift, a direct-to-consumer, or DTC, site and social media channels, which were both launched in December. We're excited to share that in less than one month, we had approximately 300,000 engaged from our paid social media channels and expect additional and impactful DTC activations in the future. Our social media efforts are designed to drive traffic from the unbranded Anson Dunn or Torla social media pages and profiles to the respective unbranded and branded websites. We are not focused solely on building followers or accumulating likes on Instagram or Facebook.

Direct to consumer of DTC site, and social media channels, which have both been launched in December we're excited to share that in less than one month, we had approximately 300000 engagements from our paid social media channel and expect additional and impactful DTC activations in the future.

Our social media efforts are designed to drive traffic from the unbranded thompsons on or it's for all the social media pages of the profile sort of respective unbranded and branded website. We are not focused solely on building followers of accumulating like bone Instagram or Facebook, we wanted the real meaningful engage.

Alfred F. Altomari: We want to see real, meaningful engagement with the content and information on the I'm So Done and Swirlo websites, and we're seeing just that. While we are committed to becoming a market leader in women's health, we are also focused on our pipeline and the ability to help solve other unmet needs in the women's healthcare space. We believe this goal can be fueled by organic growth.

<unk> with the content and information on the answer Don it's horrible on website and we're seeing just that.

While we are committed to becoming a market leader in women's health. We are also focused on our pipeline and the ability to help solve other unmet need within the women's health care space.

We believe this goal can be fueled by organic growth.

Coming from the swirl is strengthening its presence in the marketplace.

Alfred F. Altomari: Stemming from twirl, the company is strengthening its presence in the market. Organic growth will be supplemented by our funding, which I'm pleased to announce has recently increased. While Dennis will soon go into more detail on this, we've expanded our loan facility with Perceptive Advisors, who are now making available to Agile an additional $10 million on our loan facility upon the achievement of certain sales milestones. This is in addition to Perceptive Advisors' $35 million loan facility from 2020 and reflects their continued confidence in our business and provides Agile additional financial flexibility and options.

Our organic growth will be supplemented by our funding efforts, which I'm pleased to announce the recently increased.

Well Dennis will soon go into more detail on this we've expanded our loan facility with perceptive advisors, who are now making available the agile and additional $10 million on our loan facility upon the achievement of certain sales milestones.

This in addition to perceptive advisors 35 million loan facility from 2020 and reflects their continued confidence in our business and provide agile additional financial flexibility and options.

In summary, we executed on our fourth quarter 2020 plan with the launch of swollen and look forward to continue to educate and expand the prescriber and consumer basin on a differentiated benefits of <unk> as we seek to continue growing market share.

Alfred F. Altomari: In summary, we executed our fourth quarter 2020 plan with the launch of TWALA and look forward to continuing to educate and expand the prescriber and consumer bases on a differentiated benefit of TWALA as we seek to continue growing market share. I'll now turn it over to Dennis Riley, our CFO, who will provide an overview of our financial results and the financing update.

I'll now turn the call over to Dennis Reilly, our CFO will provide an overview of our financial result, and the.

Financing update then.

Thank you al and thank you to everyone for joining us today.

Matthew Riley: Thank you, Al, and thank you to everyone for joining us today. I share Al's excitement about and gratitude for our entire organization and the efforts put forth over the past quarter and the past year. While 2020 was challenging in many ways due to the pandemic, we remained focused and continued to execute on our commitments, which culminated in the December launch of Twirl. Our company stands now on solid financial footing, and we believe we are well positioned to execute on our plan following our product launch in December. We closed out the year, achieving the gross revenue target of approximately $1 million in the fourth quarter.

I share our excitement and gratitude for our entire team and the efforts put forth over the past quarter and the past year, while 2020 was challenging in many ways due to the the pandemic, we remain focused and continue to execute on our commitments which culminated in.

The December launch of 12 of them.

Our company stands now on solid financial footing, and we believe we are well positioned to execute on our plan. Following our product launch in December we closed out the year.

Keeping the growth revenue target of approximately $1 million in the fourth quarter. This reflected the initial stocking of where all of by wholesalers.

Matthew Riley: This reflected the initial stocking of Twirlibyte Wholesale. Additionally, we delivered better-than-expected results on the expense side. Our operating expenses came in under $50 million for the full year, below our guided $52 million to $54 million range.

Additionally, we delivered better than expected results on the expense side on.

Our operating expenses came in under $50 million per the full year below our guided $52 million to $54 million range for.

For the fourth quarter of 2020, our R&D expenses were approximately $3 million compared to 2.8 for the same quarter a year ago.

Matthew Riley: For the fourth quarter of 2020, our R&D expenses were approximately $3 million compared to $2.8 million for the same quarter a year ago. For the full year, R&D expenses were $13.5 million in 2020 versus $9.9 million in 2019. This year-on-year increase was primarily due to the validation work we did for commercial manufacturing of torolobicorium by our contract manufacturer, as well as clinical development and personnel-related expenses. Selling and marketing expenses were $10.7 million in the fourth quarter compared to less than a million a year ago, while full-year expenses were $23.3 million versus $1.1 million in 2019.

For the full year R&D expenses were $13 5 million in 2020 versus $9 9 million in 2019. This year on year increase was primarily attributed to the validation work we did for commercial manufacturing of pour all of by Corium our contract manufacturer.

Well its clinical development and personnel related expenses.

Selling and marketing expenses were $10 7 million in the fourth quarter compared to less than a million dollars a year ago.

The full year expenses were $23 3 million versus $1 1 million in 2019. The notable year over year increase results from cost associated with our pre commercial.

Matthew Riley: The notable year-over-year increase results from costs associated with our pre-commercialization activities for Twirla, including brand building, advocacy, market research, and consulting, as well as the cost of establishing and maintaining our contract sales. P&A expenses totaled $3.5 million in the fourth quarter, compared to $2.5 million in the same period a year ago.

Activities for 12.

Including the brand building advocacy market research and consulting as well as the cost of establishing and maintaining our contract sales force.

G&A expenses totaled $3 5 million in the fourth quarter compared to $2 5 million in the same period a year ago.

For the full year G&A expenses were $12 7 million in 2020 versus seven 9 million in 2019.

Matthew Riley: For the full year, G&A expenses were $12.7 million in 2020, versus $7.9 million in 2019. This increase in GNA reflected activities related to building out the support infrastructure, including higher personnel costs, professional fees, and related stock compensation. We ended last year with cash equivalents and marketable securities of $54.5 million, compared to $34.5 million in cash equivalents at year-end 2019. We have strategically managed our expenses and our wealth positions to support the continued rollout of TWRLA with sufficient cash on hand to meet our projected operating requirements through 2021.

This increase in G&A reflected activities related to building out the support infrastructure, including higher personnel cost professional fees and the related stock compensation expense.

We ended last year with cash cash equivalents in marketable securities of $54 5 million.

Compared to $34 5 million cash cash equivalents at year end 2019.

We have strategically managed our expenses and are well positioned to support the continued rollout of swirl up with sufficient cash on hand to meet our projected operating requirements through 2021.

With that said.

Matthew Riley: With that said, I'd like to provide a financing update which we believe reflects confidence in our ability to support and grow our business over time, as announced in our earnings release today. We expanded our loan facility with Perceptive Advice. In February 2020, we entered into a $35 million senior secured term loan credit facility with Perceptive Advisors. It was structured in three tranches.

I'd like to provide of financing update which we believe reflects confidence in our ability to support and grow our business over time.

As announced in our earnings release today.

We expanded our loan facility with perceptive advisors in February of 'twenty 'twenty.

We entered into a $35 million senior secured term loan credit facility with perceptive advisors. It was structured in three tranches last year, we drew down $20 million on the first two tranches of this funding to support our commercialization strategy.

Matthew Riley: Last year, we drew down $20 million on the first two tranches of this funding to support our commercialization strategy for Twirla. We have a third tranche of $15 million remaining through 2021, available upon the achievement of certain revenue milestones. We are now pleased to announce that Perceptive Advisors is providing an additional $10 million in funding to us, and that will be available through June 22. Again, it's contingent on us reaching a predetermined revenue target.

The 12.

We have a third tranche of $15 million remaining through 2021.

Mailable upon the achievement of certain revenue milestones.

We are now pleased to announce that perceptive advisors, providing an additional $10 million in funding to us.

And that will be available through June of 'twenty two.

Again, it is contingent on us reaching a pre determined revenue chart.

So in total we received a $20 million on this loan facility and we now have an additional $25 million available to us.

Matthew Riley: So in total, we received $20 million in this loan facility, and we now have an additional $25 million available to us, which reflects the continued support of our partner, Perceptive Advisors, a well-regarded leader in growth capital financing. Importantly, this capital enables increased financial flexibility and Optionality for the Agile Business.

This reflects the continued support of our partner perceptive advisors, a well regarded leader in growth capital financing.

Importantly, this capital on Navy enables increased financial flexibility and Optionality for the agile business.

We're focused on remaining disciplined and nimble on our approach and are committed to making the right investments at the right time to ensure strategic growth and maximize shareholder value.

Matthew Riley: We're focused on remaining disciplined and nimble in our approach and are committed to making the right investments at the right time to ensure strategic growth and maximize shareholder value. Our team is excited about what lies ahead. We have a differentiated product that addresses an unmet need, and a balance sheet and financial flexibility that will help us execute on our strategy while delivering value to our state. With that, we're happy to take your questions. Operator, you may now open up the line for Q&A. As a reminder, to ask a question, you need to press star 1 on your telephone. To withdraw your question, press the pound or hash key.

Our team is excited for what lies ahead, we have a differentiated product that addresses an unmet need.

And our balance sheet and financial flexibility that will help us execute on our strategy.

While delivering value to our stakeholders.

With that we're happy to take your questions.

Operator, you May now open up the line for Q&A.

As a reminder to ask the question the need to press Star one on your telephone to withdraw your question press the pound or hash key please standby, while we compile the Q&A roster.

Operator: Please stand by while we compile the Q&A roster. Our first question comes from Randall Stenecke with RBC Capital Markets. Your line is open. We're you're breaking up. I'm sorry.

Our first question comes from.

Randall <unk> with RBC capital markets. Your line is open.

Hey, guys.

Randall.

First the question now that you've been on the market for a few months.

Seeing the greatest uptake thus far of among women.

No.

The thing.

Women.

You're breaking up I'm, sorry, you're breaking up could you just kick oh, sorry from them.

Randall Stenecke: Could you just get Oh, sorry. Yeah, is this better? Awesome, yeah, thank you. Okay, perfect. Yeah, so I'll just say that again. Can you talk about where you're seeing the greatest uptake thus far among women, whether that be from the pills, Zulane, you know, contraceptive naive women? And second, from a physician prescribing perspective, what's the biggest pushback been thus far? Sure, well, the first one doesn't really apply, thanks for the question, sorry. The first one doesn't really surprise us very much.

Yes is this better zone.

Awesome, Yeah, Okay perfect. Yeah. So I'll just I'll, just say that again can you talk about where youre seeing the greatest uptake thus far of among women, whether that'd be from the pills. The lane contraceptive naive women and second from a physician prescribing per site perspective, what's the biggest pushback on thus far.

Sure well the first is the first one on.

Nothing really thanks for the question sorry.

The first one doesn't really surprise us very much subs, so far the bulk of the prescriptions. We're seeing you know Bert B. It all very early days are coming from women that were once on the pill or coming off the pill. So if you will switchers you know that have come on one method to another so and that's what our early market research et cetera.

Alfred F. Altomari: So far, the bulk of the prescriptions we're seeing, be it all very early days, are coming from women that were once on the pill or coming off the pill. So, if you will, switchers, that have come off one method to another. And that's what our early market research said, that's where we'd expect it, because that's really the insight we built the brand around, the idea of a more convenient alternative to pills. So that answers the first question.

That's where we'd expect it because that's really the insight we built of the brand around the idea of of a more convenient alternative to build so that answers. The first one so that's not a surprise to us but again early days of well, we'll keep you update on all of that.

Alfred F. Altomari: So that's not a surprise to us, but again, early days, and we'll keep you updated on that. Pushback, you know, I think the biggest thing we face is, again, what we'd expected in our market research, you know, a little bit of out of sight, out of mind. You know, a lot of physicians, in the OBGYNs in particular, had not really used the patch mainstream for a number of years. So it's kind of getting it from the back corner of their mind until the front of their mind is that now our patch, Twirl It, can be a frontline method. So I don't want to say ambivalent, but it's a little bit of "out of sight, out of mind."

Pushback I think I think the biggest thing we face of again, what we had expected in our market research you know of.

Little bit of out of sight out of mind, you know a lot of positions in the obgyn is of particular had not really use the patch mainstream for a number of years. So it's it's kind of getting it from the back quarter of their mine until the front of their mind is that now our patch twirl it can be a frontline method.

Don't Wanna say ambivalent, but it's a little bit of out of sight out of mind.

So we're excited to bring the patch out on kind of bringing back into the mainstream but I think that's initially to the.

Alfred F. Altomari: So, you know, we're excited to bring this patch out and kind of bring it back into the mainstream. But I think that's the initial first challenge for us, our reps. And both of these are what we expected. It's always nice to see that your market research actually plays out well. I hope that answers your question. Yeah, that's helpful.

The first challenges of our reps again and both of these of what we expected. It's always nice to see that your market research actually plays out well I hope that answers your question Sir.

Yeah, that's helpful and if I could ask one follow up in the last week, we saw a second generic or so ever approval. Just wondering if we should be worried about potential competitive implications for twilla, whether that be in the form of potentially greater pricing pressure in the category or even just confusing doctors now that there is the third patch on the market.

Alfred F. Altomari: And if I could ask one follow-up question. Last week, we saw the second generic ortho ever approval. I was wondering if we should be worried about potential competitive implications for Twirla, whether that be in the form of potentially greater pricing pressure in the category or even just confusing doctors now that there's a third patch on the market.

No I.

Alfred F. Altomari: No, you know, I think your note that you sent out, that Randall sent out, I think summarized the company's feelings, too. You know, it's really our issues or our challenges with the past, you know; our opportunities are still the same. The new approval is another form of orthorhaborate. It's got the same label as Zulane does.

I think your note that you sent out the Randall the spin out I think summarize the company's feelings too.

It's really our issues of our challenges with the patchwork of where our opportunities are still the same.

The new approval is another form of of whatsoever. It's got the same label.

Ruling does.

It's also I should note and I think we pointed the south of the street of coupons that after our approval of their label also reflects the BMI.

Alfred F. Altomari: You know, it's also, I should note, and I think we've pointed this out to the street a few times, but after approval, their label also reflects the BMI contraindication over 30. So we're all on an equal playing field. I think that's lost on doctors. One of the things we're talking to doctors about is that, look, I mean, the BMI is a level playing field and very prominent on their labels. So both products now are going to be the elevated estrogen level.

Communication of over 30, so we're all on an equal playing field on I think that's been lost on the doctors one of the things we're talking the dockers about.

Look I mean, the BMI is the level playing field and very prominent there labels. The both products now are going to be the the elevated estrogen levels. So.

Alfred F. Altomari: So, you know, I think the competitive challenge is still the same for us. We need to differentiate our products, both with our physicians and with women, and also to manage care. And we feel like we have a great story.

I think the competitive challenge is still the same growth we need to differentiate our product both of our positions with women and also the managed care and we feel like we are of great story.

So that's and I think the as Randall said and the vote and you said in your note.

Alfred F. Altomari: You know, so that's, and I think, as Randall said in his note, and you said in your note, it's good to see people that there's value, that the market is, indeed, there's a real market here for Pat. But we'll keep an eye on it, and we'll keep you posted, but that's our initial read. It's, you know, another form of ABRA, same label, no differentiation label, and, you know, we still have a very competitive difference that, you know, we're getting traction with doctors and managed care with, so we expect to stay on that. But if anything changes, we'll let you know. I got it.

Could the thing you know on people that there's value that the market is indeed the the.

The real market here for patches.

But we'll keep an eye on it and we'll keep you posted but that's our initial read it.

You know another form of of Abra same labels no differentiation label and we still have a very competitive difference that.

Where we're getting traction with doctors of managed care with so we expect the spec to stay on that but prevented from changes right now.

Got it thanks al.

Randall Stenecke: Thanks, Al. Oh, my pleasure. Thank you. Our next question comes from Oren Livnat with HC Ringwraith. Your line is open. Hey guys, I apologize. I missed the very beginning of the call, but I assume you can help me out. A couple.

No my pleasure. Thank you.

Our next question comes from Oren <unk> with H C. Wainwright Your line is open.

Hey, guys I apologize I missed the fair at the beginning of the call, but can you could help me out couple of so can you just help us understand what you're seeing I know, it's really early but you know you mentioned the sampling and you mentioned you know leading indicators and I'm just wondering what what can you share.

Oren Gabriel Livnat: So, can you just help us understand what you're seeing? I know it's really early, but you mentioned sampling, and you mentioned, you know, leading indicators. I'm just wondering, what can you tell us with regard to that? You know, demand that we don't see yet that you do see.

Tell us with regards to that.

You know the demand that we don't see yet that you do see.

Oren Gabriel Livnat: How about dispense samples, maybe refill requests, so to speak, from physicians' offices for more samples? Maybe reimbursement hub inquiries you're getting to help people do prior operations where necessary or help them work through those medical waivers for ACAs. Is there anything you can help us with on that front?

How 'bout dispense samples, maybe refill requests so to speak from physicians offices from more samples maybe.

Berkman hub inquiries, you're getting to help people do prior offs, where necessary or help them work through those medical wafers for HCA is there anything you can help us with on that front I have a follow up thanks.

Alfred F. Altomari: All right. Sure. No problem, Oren.

Alright, sure I'm up on one.

No I think every indicator we're looking at both hard indicators around the home software indicators.

Alfred F. Altomari: No, I think every indicator we're looking at, both hard indicators, and I'll call them softer indicators, you know, look good to us. And I think we mentioned before, one of the things we look at is the number of doctors we kind of add up every week. Who are the new doctors that are writing? Are the productivity of doctors going up? Is it a one-and-done prescription?

Look good the one look good to us and I think we mentioned before one of the things. We look at is the number of doctors. We are kind of accrue every week, who are new doctors that are writing or the productivity of the doctors going the opposite of one and done prescription or are they getting more productive our doctors, writing refill RFP or pharmacies that getting the refill.

Alfred F. Altomari: Are they getting more productive? Are doctors writing refills? Are pharmacies getting the refills? Because I think ultimately this is a category that's built on, you know, the volume of refills because any one patient could theoretically be 13 units a year to us as we talk. So all those kind of hard indicators Oren that I'm looking at right now all seem to suggest, and I think TRX, to me, is the math of that, if you will; it's the outcome of that math.

Because I think ultimately this is the category that's built on you know on the.

Of refills because of any one patient could theoretically be 13 units a year of Chaucer has been clock. So all of those kind of hard indicators of where in that on I'm looking at right now on.

<unk> seen the suggesting I think <unk> to me is the math of that if you will it's the outcome of that math, so doctors converting to the Scripps multiple scripts multiple strips turning of the refill. So as I mentioned on the call that about 10% of our units that you've got the spend from pharmacy are already refills, which is a good sign so we.

Alfred F. Altomari: So doctors writing multiple scripts, multiple scripts turning into refills. So, as I mentioned on the call, that about 10% of our units that got dispensed through pharmacy are already refilled, which is a good sign. So we like that, you know, and then the software indicators that you're mentioning are quantifiable.

Like that.

The the software indicators, the you're mentioning kind of we know they're core quantity quantify will the number of calls we're getting the medical affairs. You know you mentioned the hubs, but just questions doctors are asking the they're requesting literature from us.

Alfred F. Altomari: The number of calls we're getting from medical affairs, you know, you mentioned the hubs, but just questions doctors are asking. They're requesting literature from us, which is great. Doctors that we're not calling on are calling in for samples, which is great. Which means our advertising to doctors is working. So there are some things, and then, as you mentioned, the last but certainly not least, the reps.

The great. The doctors that we're not calling on are calling in for samples, which is great which means our advertising the doctors of working.

So there are some of the things and then as you mentioned of the last but certainly not least the reps I mean are they deploying the samples and doctors in the midst of Covid and even though we're seeing doctors face to face a lot of times, we can't get the the sample closet like we used to but with that said we are deploying a lot of samples and the answer. Your question. We're just starting to see them. If you will turn its the only I know what's the.

Alfred F. Altomari: I mean, are they deploying samples and doctors in the midst of COVID? And even though we're seeing doctors face to face, a lot of times, we can't give it a sample closet like we used to. But with that said, we're deploying a lot of samples, and to answer your question, we're just starting to see them, if you will, turn. You know, it's only, I know it's the end of the month, but, you know, effectively, we've probably had one good pass, maybe two passes with offices. And a lot of practices are Oren or group practices.

End of the month, but you know from.

Effectively we probably had one good as of May be too fast Kathy with office of the a lot of practices Orner group practices. So I think it's a little too early to see if the samples of our turning because I can't tell yet, but it feels good and we are deploying a lot, but that's something we're keeping an eye on both of them is significantly more samples and put on.

Alfred F. Altomari: So I think it's a little too early to see if the samples are turning because I can't tell yet, but it feels good, and we're deploying a lot. So that's something we're keeping an eye on. And so everything seems to be pointing north. You know, if the weather would cooperate and everything would settle down a little bit around the country, that would make our jobs a little bit easier.

Out then we of prescriptions for at this point the samples are as I mentioned on the calls and we think of it like an investment.

So everything seems to be pointing north.

Oren Gabriel Livnat: But with that said, we push through. All right, now, you know, clearly, we can't, you know, build a model on, you know, good vibes yet; it's too early for that. But if you could just maybe give us any sense of the magnitude of samples that are, you know, being put out into the channel, we're trying to get a sense of, theoretically, how much demand has to get soaked up before we see, you know, a true prescription pull-through kind of situation, right?

The weather would cooperate and everything will settle down a little bit around the country that would make our job a little bit easier, but with that said we pushed through.

Alright, and I you know clearly we can.

Can you know build a model on the goodbye yet it's too early for that but if you could just maybe give us any sense of the magnitude of samples that are you know.

You can put out into the channel you know, we're trying to get a sense of theoretically how much demand has to get soaked up.

Before we see you know the true prescription pull through kind of situation ramping and then.

And then I have a follow up on managed care of things.

Oren Gabriel Livnat: And then, and then I have a follow-up on managed care. Yeah, so we, you know, I wish I could guide you when we can guide ourselves. I mean, I'll make kind of a return on the sample investment.

Yes.

Wish I can guide you on we can got ourselves I mean on the kind of the return on sample investment I can tell you. If you just think about 70 free people, calling on doctors and they make multiple calls per week.

Alfred F. Altomari: I could tell you if you just think about 73 people calling doctors, and they make multiple calls per week. You know, just try to put your mind around, you know, six or seven weeks of sampling in the number of offices you think we've seen. So that'll give you an idea of the volume of samples out there.

So I'm just trying to put your mind around six or seven weeks of sampling as you know in the number of offices. We think we've seen so that'll give you the idea of of the volume samples are out there.

Alfred F. Altomari: But again, you know, they haven't turned enough yet. We haven't been able to establish our own model, if you will, of how that's going to work. We just think, based on what we're seeing, that a lot of the doctors that we leave samples with turn around and do right by the product. So that's a good thing.

But again they haven't turned enough we haven't been able to establish our own models will now of how you know how that's going to work. We just think based on what we're seeing that a lot of the doctors that we leave samples to turnaround and do right. The product. So that's the good thing so it's a little early days, but we'll keep it on.

Alfred F. Altomari: So it's a little early days, but we'll keep an eye on it. If we can get smarter than that, we'll let you know. But it's a little tough right now.

I Wonder if we can get smarter net we'll let you know, but it's it's it's a little tougher now than the.

This is one of the the areas that the.

Alfred F. Altomari: And this is one of the areas where, in a COVID environment, not being able to see the sample closet and watching the turn starts getting in our way a little bit. Because when we turn over to sample doctors, unless they let us see the sample closets, there's no accounting. I can't follow the pull through unless we can get into the closets and see it.

The COVID-19 environment, not being able to see the sample closet and watching the current starts to get in our way of little bit because when we turnover at the samples of the doctor's unless they let of the sample closet here.

No accounting I can't follow of the pull through of unless we can get into the closets and see it.

So on that one aspect of the launch of floor of our hands are little tied behind our back.

Oren Gabriel Livnat: So on that one aspect of the launch, our hands are a little tied behind our backs. All right, and then just quickly, I manage care, you know. I don't think, you know, Zulane is obviously or, you know, the biggest source of prescriptions is probably the tens of millions of pills, like you've said in the past. But you know, where do you stand in your 40 to 45% coverage with regard to Zulane, whether it be parity or ahead of them?

Alright, and then just quickly on managed care you know them.

I don't think Xu Lane is obviously or you know the biggest source of prescriptions is probably the tens of millions of pills like you've said in the past but.

Where do you stand in your 40 to 45 per cent coverage with regards to zoo lane, whether it be parity or ahead of them and I'm trying to understand for that initial wave.

Oren Gabriel Livnat: You know, I'm trying to understand for that initial wave, is there any hurdle to someone prescribing getting reimbursed for your product, you know, vis-a-vis Zulane or a generic that's coming behind it? Or in your contracts you're negotiating going forward, does it come up at all? Is it even relevant?

Is there any hurdles of someone prescribing getting reimbursed for your product.

The zoo lane or or of generic that's coming behind it.

Or in your contracts your negotiating going forward does it come up at all of isn't even relevant.

Most of our most of our work.

Alfred F. Altomari: You know, most of our, most of our, where we're on, on formulary, we're on, you know, I believe, this is my memory, so I believe in most situations we're on parity. So, in other words, a doctor can more than likely write both brands. And actually that's something we kind of say to the plans. You know, we believe, kind of, we walk the talk; we believe in giving women choices and doctors choices.

We're on Contra on formulary will Arne I believe this is on my memory. So I believe in most situations where on the parity. So in other words, the doctor more than likely can write both brands and actually that's something we.

We kind of guidance to the plans, we believe kind of we got the walk the talk we believe in Brooklyn, giving women choices and doctors choices. So for instance, the warrant on the GPO. We just we just were awarded.

Alfred F. Altomari: So for instance, Oren, on the GPO, we just, we just were awarded. They're on there with us. So we don't believe we can get a doctor to write our prescription that, you know, we've been, you know, that's a different problem, right?

On their own there with them. So we don't believe we can get.

The Doctor writes a prescription that.

And you know that that.

But the different problem right. So we just say and put us on what the gives me even shots of the in general that's our position in general that's what we see their plans from.

Alfred F. Altomari: So we just say, hey, put us on with it, give us an even shot. So in general, that's our position; in general, that's what we say to the plans. A lot of the plans don't want to talk to us, quite frankly, because our, you know, it's a little early in the launch, and we just don't have enough beachhead volume. So we would expect it to keep growing and, like we did with the GPO, we're going to pick off big peaks, pieces of volume, you know, that don't necessarily run through our cuvia, you know, or symphony.

A lot of the plans don't want to talk with quite frankly, because it's a little early in the launch and we just don't have enough. The each of the volume. So we would expect it to keep growing and we're just kind of like we did with the G. P of we're going to pick off big pigs pieces of volume.

That doesn't necessarily run through our <unk> or symphony. So this is a closed system. We picked up so we're just going to keep you know keep following the woman owner journey, where she goes will go and try to open those markets. So but in general to answer your question, we're parity with them.

Alfred F. Altomari: So this is a closed system we picked up. But we're just going to keep following the woman on her journey, where she goes, and we'll go and try to open those markets. So, in general, to answer your question, we're parodies.

And then as I mentioned with the earlier call.

Oren Gabriel Livnat: And then, but over time, as I mentioned with the earlier call, you know, most of our volume isn't coming from a Zooling patient. Very little of our volume is coming from a pill patient. So that's why we don't care as long as we're on there and we can generate volume with a doctor. All right, thanks. My pleasure.

Most of our volume is coming from.

Very little more volume coming from the ruling prescriber of Luling patients, they're really coming from Phil of patients.

That's why we don't care as long as we're on there and we can generate volume with the Doc that's all we care about them.

Alright. Thanks.

My pleasure. Thank you.

Operator: Thank you. Our next question comes from Leland Gershel with Oppenheimer. Your line is open.

Our next question comes from the line crucial with Oppenheimer. Your line is open.

Leland Gershel: Hey Al, thanks for taking my question and congratulations. First question, just in terms of the type of patients you're getting on to twirl up, clearly most of them are coming from the pills, but could you maybe provide a bit more granularity? Are these patients who are, or women who are in their younger years, are they a bit older? I'm kind of trying to get a sense of, is there kind of a sweet spot in terms of the type of woman who's coming on to twirl that you're seeing?

Oh, Hey, Thanks for taking my question and congrats.

First question just in terms of the the type of patients you're getting on to our tour of the clearly most of them are coming from the the pills, but could you maybe provide a bit more granularity nor these patients who are current or women who were in the younger years.

Are they are the COVID-19 older I'm kind of.

Trying to get a sense of is.

Is there kind of the sweet spot in terms of the the type of woman who's coming on too.

The two to tour of the machine and I know, it's early days and then I've got a follow up thanks.

Alfred F. Altomari: I know it's early days, and then I've got a follow-up. Yeah, Leland, thank you for the question. Yeah, I mean, you answered the last part right. I mean, it's a little early days, but we can't help ourselves looking at the data. Yeah, they tend to be women that have come off the pill.

Yes. Thank.

Thank you for the question Yeah, I mean, it's the.

You answered the last part right I mean, its little early days, but we can't help ourselves looking at the data.

I think they tend to be women that have come off the pill. So I would say the initial uptake is more in the you know.

Alfred F. Altomari: So I would say the initial uptake is more in the, you know, early to mid 20s. So it's not younger, it's not older, it's sort of in the middle of the bell curve, if you will, for the contraceptive market. Again, that doesn't surprise us. I think where we would like to see doctors use the product.

Early to mid Twenty's. So it's it's not youngers on older stock sort of in the middle of the Bell curve. If you will of the contraceptive market again that doesn't surprise us I think where we would like to see doctors use the product we will clearly we like doctors using the product even on switching patients if you will but we'd like to see some more.

Alfred F. Altomari: Clearly, we like doctors using the product, even on switching patients, if you will. But we'd like to see some more, you know, the new patients, the naive, the therapy, if you will, the new starter patients, because we think that's kind of an easier ask. But right out of the chute, sitting in the middle bell curve, as you would expect, you know, we've seen not a lot of young, not a lot of older, that's sitting in that kind of experienced user of pills.

All of the new patients the naive to therapy, if you will.

The new start patients because we think that's kind of an easier asked.

But right out of the chute sitting in the middle of a bell curve as you would expect we've seen not of lot young not a lot of older. That's sitting in that kind of experience you know user of pills.

Alfred F. Altomari: So that's what we're seeing out of the chutes, but we will see if that changes. That's what our models suggested we would get.

So that's what we're seeing out of the chutes, but we'll save that changeover, that's what our model suggested we would get.

So I'm not surprised but we're going to keep a look at it that's the best of breed, we can get just yet on patients and the other thing that I think is exciting.

Alfred F. Altomari: So I'm not surprised, but we're going to keep a look at it. That's the best lead we can get just yet on patients. And the other thing that I think is exciting, to answer your question more fully, what I'm excited about is it's a mile wide and it's thick in that it's coming from around the country, right? So the good news is it's not coming from one region, not one doctor, if you will, or one geotarget, if you know. It's coming from multiple states, multiple doctors, which is good. So I like the fact that we're getting uptake across the country and across doctors. So in that there, the lack of consistency on that one, Leland makes me excited.

The answer your question, we're fully what I'm excited about is it's the mile widen in the stick in that it's coming from around the country right. So the good news, it's not coming from one region of there's not one doctor if you will on one geo targeted.

Coming from multiple states multiple doctors, which is good so I like the fact that we're getting uptake across the country and across the doctor So because of it.

That the or the lack of lack of consistency on that when we what makes me excited so.

So that's what we see so far we're gonna keep walking out of the changes, we'll keep you updated but that's what we see from the early days.

Leland Gershel: So that's what we see so far. We're going to keep looking at the changes. We'll keep you updated. That's what we see in the early days. Thanks.

Thanks, and then just actually two to briefly so just following up on the GPO agree.

Alfred F. Altomari: And then, just actually, to briefly, so just following up on the GPO agreement having been signed, just wondering if you're in negotiations with other such closed systems and if we should expect to see more down the line. And then a question, maybe more for Dennis, just it's early days again, but just looking at the growth to net, you're running kind of at a 25% that may be artificially, you know, affected by the early launch. Just want to know if that's something we should think about going forward or if that's going to shift a bit as the launch matures. Thanks. So, Dennis, I'll take the first part, and you can close out for Leland.

The agreement having been the sign just wondering if you're in negotiations with other such closed systems and if we should expect to see.

Mortgage on the line and then a question maybe more for Dennis just it's early days again, but just looking at the gross to net youre running kind of at the 25% then maybe artist actually.

You know affected by the early launch just want to know if that's something we should think about going forward or if that's been a shift of bit of a bunch of of choice. Thanks.

So Dennis I'll take the first part and you can close out per Leland.

So yes totally linear I mean, you should expect that we're going to fall of the business right. So in the commercial channel that we've seen on Q V. On Symphony that really are the commercial books of business and there are there are other books of business out there there's closed systems around the country. There are very big systems that we just landed this one so if that's where.

Alfred F. Altomari: So, yeah, Leland, I mean, you should expect that we're going to follow the business, right? So, in the commercial channel that we see on our QVR and Symphony, that really is the commercial books of business. And there are other commercial books of business out there. There are closed systems around the country.

Alfred F. Altomari: You know, there are very big systems like this one. So, if that's where women go, we're going to follow them. You know, when it's kind of at the state level, Medicaid can be important to us. You know, depending on the price, we're looking at some of the Medicaid volume. Down the road, I mean, we look at other places like student health centers. So if that's where her journey takes us, we'll follow her.

Women go were going to fall of them you know I wanted to kind of of state state level.

The the Medicaid, but can be important to us the.

Pending on the price and so we're looking at some of the Medicaid volume down the road I mean, we look at other places like the.

The student health centers, and so if that's where her journey takes us will follow her so I guess the answer is yes, we should expect us to keep trying to win strategic books of business that we can bring swirl of too.

Alfred F. Altomari: So I guess the answer is, yes, you should expect us to keep trying to win strategic books of business that we can bring Swirla to. So I hope that makes sense, but there is more to come. But, you know, we got one in the boat, so we're going to keep trying, Leland. But we were excited to get such a big one so early. Dennis, you want to take a shot at the gross net? Yeah, hi Hayley then.

So I hope that makes sense, but more to come but we got one in the boats outboard and keep trying and Leland. So the but this we were excited to get set the big one early on.

I just want to take a shot the gross to net.

Yeah, Hi, Haley.

You know, it's a mixed bag Leland right now I don't think 25% is.

Is the very long term rate.

Matthew Riley: It's a mixed bag, Leland. Right now, I don't think 25% is the very long-term rate. I would anticipate it's in the mid-30s, but it's a mixed bag.

I would anticipate it's in the the mid Thirty's.

But you know it's a mixed bag of early on we paid some stocking fees to the wholesalers. So that stuff was a little bit higher but we don't have.

Matthew Riley: Early on, we paid some stocking fees to the wholesalers, so that stuff was a little bit higher, but we don't have the big managed care contracts that may, over time, depending on our mix, if we need to sign them, we will. And that's where I get into the mid-30s. It's a mixed bag, but if I were doing a model, I think you should, when you get out, especially out in a year or two, I would say mid-30s is probably more realistic.

The big managed care contracts that may over time, depending on our mix.

If we need the sign them, we will and that could take us and that's where I get into the mid mid thirties.

The mixed bag, but if I was doing the model I think we you should you know when you get out of the especially out in the in a year or two.

I would say the.

The mid Thirty's is probably more realistic.

Leland Gershel: All right, terrific. Thanks. I appreciate the additional color.

Alright, perfect. Thanks, I appreciate the additional color.

Thanks Louis.

Operator: Thank you. Our next question comes from Tim Luca with William Blair. Your line is open. Hey guys, this is Lachlan, on behalf of Tim.

Our next question comes from Tim Lugo with William Blair. Your line is open.

Hey, guys. This is lachlan on for Tim Thanks for taking the questions.

Tim Luca: Thanks for taking the questions. I guess, first of all, I appreciate that there's not a lot you can say about sampling and the pull-through there, but do you have any sense of when we should expect to start to see some reliable numbers coming through by QVIRA and SINFONI that give us a good sense of, you know, how prescribing is going? And secondly, I think, you mentioned the pipeline briefly in the prepared comments. Can you sort of expand on that?

I guess first of all I appreciate there's not a lot you can say about sampling and the the pull through that but do you have any sense of when we should expect to start to see some reliable numbers coming through <unk>.

Give us a good sense of it.

The amount prescribing is going.

And secondly, I guess.

You mentioned the pipeline briefly in the prepared comments.

Yeah.

Sort of expand on that what what are you thinking when should we start to see an update there.

Alfred F. Altomari: What are you thinking? When should we expect to see an update there? Sure. Yeah, that's two very good questions.

Yeah.

Sure Yeah. The two very good questions on so the first one.

Alfred F. Altomari: So the first one, you know, as far as samples go, it's, you know, unlike, you know, it's interesting, you know, we don't point this out, but Zulane, where they do samples, they give one patch to a woman, so one week of therapy. We give out a full box, which is a trade cycle. And, in fact, it's a month, right?

Samples.

Unlike you know its interesting you know we didn't we don't point this out, but zulay, where they do sample they'd give one patch out two of a woman. So one week of therapy, we give out of full box, which is the trade cycle on the fact that it fits the model right, we're giving away a month of minimum so.

Alfred F. Altomari: We're giving away a month, a minimum. So if you think about it, we know doctors often give out more than one month. We don't wanna oversample, but we know on average, it might be closer to two.

If you think about it we know doctors often give out more than one month, we don't on Oversample, but we know you know.

On average that might be closer to two so if you think about where we are on the launch cycle. This is why we've been a bit heavy handed with creating expectations on on the first quarter in the early days of launch.

Alfred F. Altomari: So if you think about where we are in the launch cycle, this is why we've been a bit heavy-handed with creating expectations for the first quarter and the early days of launch. Yeah, we think we have a good month or two ahead of us of heavy sampling. You know, we're actually happy, as I mentioned, with the trajectory of the brand, with what's actually getting for retail, because our reps are really just, you know, battling through some of the, I mentioned some of the challenges they've been facing. They really have just been in front of the doctors a handful of times.

Out of a good month of two ahead of us of the heavy sampling.

We're actually.

Happy as I mentioned with the trajectory of the brand with what's actually getting from retail because of our reps are really just battling through some of them I mentioned some of the of the challenges they've been facing the really are just been in front of the doctors the handful of times. So we know we need to be in front of them a couple of more times.

Alfred F. Altomari: So we know we need to be in front of them a couple more times. So I think what we see is that, you know, the sampling phenomenon is gonna last, I think, into at least the first quarter. That's why we've been, you know, without, you know, could be an explicit, we just think the first quarter from a TRX point of view is gonna be, as we saw a little bit in January, picking up some steam in February, and we would hope that steam continues to pick up in March and then we kind of outgrow it a little bit, I think. So I think we're in it for at least a Because I think it's just math.

I think I think what we see is that the the <unk>.

Sampling phenomenon going on last I think into the at least the first quarter. That's why we have been without no could be an explicit we just think the first quarter from a T Rex.

The point of view, it's going to be as we saw a little bit in January of picking up some steam in February and we would hope the themes continues the pickup in the March and then that would be kind of outgrow it a little bit I think so I think where it is for at least the quarter maybe end of the early second quarter.

But that's the best we could see day, because I think it's just it's just math.

Alfred F. Altomari: You know, we give them out for at least one month, maybe two, we saw them in January. That means even if they wrote a prescription, they're not going to the pharmacy until March, you know? So I think we've got to work past at least that first bolus into the first, you know, first, you know, a quarter. And then down the road, we're calling on multiple doctors in that practice. So we're seeing, you know, as we mentioned to you before, we're targeting group practices, you know, but, you know, we're influencing only a couple of doctors at a time.

We give out of leaf volume month, maybe two.

We've seen them in January that means the even if they wrote a prescription they're not go on the pharmacy to March.

So I think we've got to work path at least that first bolus and the the first you know first.

On a quarter and then down the road, we're calling on multiple doctors in that practice. So we're seeing.

As we mentioned to you before were targeting group practices.

But you know we're influencing on a couple of the doctors at a time, so there's still a lot of opportunity inside the practice. So we still of that expand our beachhead of doctors.

Alfred F. Altomari: So there's still a lot of opportunity inside the practice. So we still have got to expand our beachhead of doctors, you know, and then, and then obviously work through the samples. As far as the second question, your pipeline, I'm very excited about the work Dr. Korner has been doing. Paul Korner has come in, he's kind of taken a clean sheet of paper, you know, for our pipeline. We've done some market research, we've done some technical reviews, and we're actually going to probably talk to the FDA about our ideas for the various paths forward.

And then obviously worked with the samples.

As far as the second question on your pipeline I'm very excited about the work darker corners window on call corners come in.

Kind of taken a clean sheet of paper.

For our pipeline.

We've done some market research we've done some technical reviews, and we're actually going to probably talk to the FDA on kind of what our ideas of the various paths forward and so we would expect hopefully in the second half of this year to be able to give some clarity on what we want to bet on and when we one of bad on them and but I think before we get in front of you what we really want to know is that.

Alfred F. Altomari: So phenomenal amount of work; we tease Paul a lot, I tease him a lot. I said, you probably know more about our pipeline in your short time here than the company knows, you know, because we spent so much of our effort against squirrel. So he's taken a fresh, you know, very healthy look at our pipeline and done some great technical work. And, you know, Amy Welsh, our head of marketing, has done some great consumer insights and physician insights, and we're going to try to marry all that up with some FDA feedback and say, okay, this is the bet we want to make.

There's a buying with the FDA on the path forward. So the nominal amount of work with cheese, Paul I tease. The mulatto said you probably know more about our pipeline in your short time here then the company's zone, because we spent so much of our African for all of the so you've taken a fresh very healthy look at our pipeline and from some great technical work and.

Amy Welsh our head of marketing funds from grain.

Consumer insights and physician sites, we're going to try to marry all of that up with some FDA feedback and saying. Okay. This is the battle, we want to make so the short answer your question I think it's gonna be end of the second half hopefully before we got on I'm, giving you more clarity, but for now you should know.

Alfred F. Altomari: So the short answer to your question, I think it's going to be in the second half, you know, hopefully before we can give you more clarity. But for now, you should know, we're kicking the tires hard, and, hopefully, and we're excited about our pipeline. I think Paul has inherited, and he would tell you this himself, a lot of tough choices, all of our three programs, you know, peer viable and peer exciting. So I think, if anything, prior to sizing them in the early days of a company like ours, it's going to be the biggest challenge. So more to come, more than realistically, the second half.

Particularly the tires hard and hopefully and we're excited about our pipeline I think Paul's inherited and he would tell you. This themselves a lot of tough choices all of our three programs.

Peer viable in the peer exciting so I think of anything prior to as a priority of the size of them from the early days of a company like ours.

The biggest challenge so more to come for Lyft realistically the second half.

Thanks.

Tim Luca: Thank you. Thank you. You're welcome. Our next question comes from Naz Rahman with Maxine Group. Your line is open.

Youre welcome.

Our next question comes from NAV.

Robin with Maxim Group Your line is open.

Nazibur Rahman: Hey guys, congrats on launching and taking my question. I've just had a few questions on managed care. So I know you guys are currently in continued negotiations, but when can we expect the next meaningful bolus of patients for coverage? And for the patients that are covered, are they seeing $0 copays, or are you guys bringing them down with copay assistance cards, or has anyone else had to pay out of pocket so far based on what you know? Yeah, a good question.

Hey, guys. Congrats on the launch and taking my question instead of a few questions on.

On the managed care. So and you guys are currently in continued negotiations, but when can we expect the next meaningful bolus of patients.

For coverage and for the patients that are covered are they seeing zero dollar co pays or are you guys, bringing them down with the co pay system of cards or has anyone actually have to pay out of pocket. So far based on what you know.

Yeah. Good question I mean.

I think we're going to keep I think chipping away at the three now.

Alfred F. Altomari: I mean, I think we're going to keep chipping away at this. That's, I mean, you know, we would like the big bullets to happen if we can get one, you know, the second and, hopefully, the third PBM to turn around. But I think in the meantime, we're going to keep chipping away at this. So hopefully, we'll continue on in kind of an upward climb and picking up lives.

We.

We would like to you know the big bolus could happen if we can get one you know the.

Second of the health of the third P b on the turnaround.

But I think in the meantime were to keep chipping away at this so we're hopefully we'll we'll continue to kind of an upward climb in picking up lives. There's still a lot of business out there that we can control and we're getting because remember while the pbms influenced a lot of the the plans decisions. We also are mindful in certain states for instance, the state mandate supplies.

Alfred F. Altomari: There's still a lot of business out there that we can control and we're getting. Because remember, you know, while the PBMs influence a lot of the plans' decisions, we also are mindful in certain states, you know, for instance, state mandates apply.

So we see even though the P. P M on the contract we're picking up plans under the you know what I mean in certain states, where the plan, saying welcome I stayed on I'm going to cover it. So that's good news. So I think you should expect kind of like incremental noise from us or just incremental picks up pickups of if you will and then the now what we're seeing as far as coverage.

Alfred F. Altomari: So we see that a PBM is on a contract, you know, we're picking up plans under, if you know what I mean, in certain states. And the plan is saying, look, in my state, I'm going to cover it. So that's good news. So I think you should expect kind of like incremental noise from us, you know, or just incremental, you know, pickups, if you will.

Alfred F. Altomari: And then, you know, what we're seeing as far as coverage, I mean, you know, we haven't seen a lot of cash out of pocket, to answer your question. You know, so we experienced a lot, a significant amount of the plans that already picked us up at zero co-pays. And there are some co-pays involved. You know, we do have a co-pay program that does help. But so far, we've not been too over our skis with co-pays, and we're not seeing a lot of cash. Now, cash could mean they didn't, and they got scared off too, because even though I haven't seen it, they could have gone to the pharmacy. I'm not paying for that.

Jimmy.

We haven't seen a lot of cash out of pocket to answer your question.

So we've experienced a lot of significant amount of the plans that are already picked us up of zero co pays and Theres some co pays the involved.

We do have a copay program that does help but so far.

We've not been too over our skis with co pays and we're not seeing a lot of cash now cash could mean, they didn't they got scared off too because even though I havent seen it they could have gone on the pharmacy I'm not paying that so we haven't seen it but we're keeping an eye on for again, but we're studying all of this as we get there, but you know a lot of zero co.

Alfred F. Altomari: So we haven't seen it, but we're keeping an eye on it, again, but we're studying all this as we get there. But, you know, a lot of zero co-pays and, you know, the co-pays that are, you know, that are, the plans are required, don't, you know, a lot of them don't look that onerous to us, and we're willing to help This is where sampling happens.

Based on the co pays that are that are the plans of required on some.

On a lot of them don't look that owner of spots and we're willing to help out a little bit. This is we're sampling happens and then on the affordable Care Act the.

Alfred F. Altomari: And then under the Affordable Care Act, you know, the last piece of the complicated puzzle, if we're not covered under the plan, under the Affordable Care Act, it's our knowledge or our understanding that if a doctor wants the woman to be on TORLA, he can, he can intervene with a letter of medical necessity. So we are seeing those go through, and doctors and staff are advocating for us and their patients.

The last piece of the complicated puzzle.

If we're not covered under the plan funding of Affordable Care Act as far as our knowledge of where our understanding that if a doctor wants.

The what would the on spoiler on peak and we can intervene with a letter of medical necessity. So we are seeing those go through the doctors and staff are advocating for us and their patients and then once they free up that patients who should be good for the third or the length of therapy. So we're seeing all of the above you know I haven't seen that much.

Alfred F. Altomari: And then once they free up that patient, she should be good for the length of her therapy. So we're seeing all of the above, you know. I haven't seen that much cash, but I'll take a look at it after the call, make sure I'm over the line. Thanks for taking my question.

Cash, but I'll take a look on after the call make sure I'm on the ground.

The second question.

Nazibur Rahman: No, it's my pleasure. Thank you. There are no further questions at this time. I'll turn the call back over to Al for closing remarks. Great, thank you, operator.

And those types of.

Thank you.

There are no further questions at this time I'll turn the call back over to al for closing remarks.

Great. Thank you operator.

I'd like to just close outs day by saying that 2020. The obviously it was a very important year for agile.

Alfred F. Altomari: I'd like to just close out today by saying that 2020 obviously was a very important year for Agile. Despite the widespread impact of the pandemic, we were able to persevere, and we continued on with our plan, and importantly, accomplishing our goal of launching SquirrelS, which we were thrilled about, with Agile receiving FDA approval and funding from Perceptive Advisors, and as well from an equity financing transaction we did in 2020. We've made a number of key hires, including our Chief Medical Officer, Dr. Paul Korner, and secured a partnership with Cineos to develop our sales force. Finally, and despite the inherent challenges of the pandemic operating environment, we are able to address an unmet need in today's market with the launch of Twirla.

Spite the widespread impact of the pandemic, we were able to persevere and we continued on our plan and importantly, accomplishing our goal of launching square all of which we were thrilled about.

With agile receiving FDA approval and funding from perceptive advisors and as well from an equity financing transaction. We did in 2020, we've made a number of key hires including our Chief Medical Officer, Dr. Paul Korner, and secure the partnership with Cineaste develop our sales force.

Finally, despite the inherent challenges in the pandemic operating environment, we're able to address an unmet need in todays market with the launch of twirler I'm incredibly proud of the hard work and the tireless effort of our whole team over the course of this last year as.

Alfred F. Altomari: I'm incredibly proud of the hard work and tireless effort of our whole team over the course of this last year. As we look ahead in 2020 and beyond, we are really optimistic and excited about the opportunities before us to help more women find a product that really meets their needs. We're confident we have that product, we have the right people, and we have the right plan in place. We continue to be excited about the early acceptance and growth of 4LA and look forward to continuing this trajectory as we work towards our goal of becoming a leader in women's health. I'd like to thank everybody for joining us on today's call. I know it's a busy season for you all.

As we look ahead in 2020 and beyond the we're really optimistic and excited about the opportunities before us to help more women find the product that really meets their needs. We're confident we have that product we have the right people and we have the right plan in place.

We continue to be excited about the early acceptance and growth of swirling and look forward to continue this trajectory as we work towards our goal of becoming the leader in women's health.

I'd like to thank everybody for joining us on today's call. The note. The busy season for you all we wish you well and wish you the be safe and we look forward to speaking to you all and hopefully on our first quarter of 2021 earnings call. So without it but I. Thank you and good night.

Alfred F. Altomari: You know, we wish you well. We wish you to be safe, and we look forward to speaking to you all, and hopefully, on our first quarter 2021 earnings call. So with that said, I thank you, and good night. This concludes today's conference call. You may now disconnect. (inaudible)

This concludes today's conference call you may now disconnect.

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