Q2 2021 Agile Therapeutics Inc Earnings Call

Alfred F. Altomari: Last quarter, we started to see steady upward trends of increasing scripts, refills, and awareness of our product. And, as expected, that growth has continued through the second quarter.

Last quarter, we started to see steady upward trend of increasing scripts refills and awareness of our product and as expected that growth that continued through the second quarter.

Alfred F. Altomari: On slide four, you will see the quarterly performance since our Q4 2020 launch, and we see growth on all key performance metrics. For example, from the end of Q1 2021 to the end of Q2 2021, we saw total prescriptions, or TRXs, increase 171%. New prescriptions, or NRXs, increased 103%, and the refill rate grew 355%. While we saw significant growth in these performance metrics quarter of a quarter, there was also a consistent pattern of growth. When we break down the quarter and examine the data month over month, as you'll see on slide five, during quarter two, month over month growth of T. rexes was 35.2% in April, 26.5% in May, and 31.4% in June, while enteroxes were 20.4% in April, 10.4% in May, and 31.2% in June.

On slide 4 you.

Youll see the quarterly performance since our Q4.2020 launch.

And we see growth from all key performance metrics.

From the end of Q1.2021 to the end of Q2.2021, we saw total prescriptions or <unk> increased 171%.

New prescriptions or.

<unk> increased 103%.

And the refill rate grew 355%.

While we saw significant growth in these performance metrics quarter over quarter. There's also consistent pattern of growth.

When we break down the quarter and examined the data.

<unk> month over month as Youll see on slide 5 during quarter 2 month over month growth appear axis was 35, 2% in April 26, 5% in May and 31, 4% in June.

<unk> for 24% in April 10, 4%.

And 31, 2% in June and Refills for 76% in April 35, 9% in May and 46% in June.

Alfred F. Altomari: And refills were 70.6% in April, 35.9% in May, and 40.6% in June. One other view of the data we track is on a four-week rolling average that we discussed in our last call. And that's very consistent with our quarterly and monthly growth. We are encouraged by the fact that we're seeing consistent brand growth at the quarterly, monthly, and four-week levels. Please note that these results do not include sales in the non-retail channel, which includes clinics, institutions, and hospitals. In the second quarter, we sold an additional 2,291 units in the non-retail channel.

1 other view of the data we track is on a 4 week rolling average that we discussed on our last call and Thats very consistent.

<unk> met with our quarterly and monthly growth.

We are encouraged by the fact that we're seeing consistent brand growth at the quarterly monthly and for weak levels.

Please note that these results do not include sales and the non retail channel, which includes clinic institution.

System hospitals.

In the second quarter, we sold an additional 2291 units into the non retail channel.

Alfred F. Altomari: Because we're so focused on TRX growth, I wanted to highlight what we think is an important contributor to that growth and the health of our brand: new prescriptions and refills, both of which grew in quarter two. Every time we acquire a new patient starter, we are potentially acquiring a customer for some time to come. Each NRX has the potential to manifest itself as a repeat customer with an extended time value to the brand because NRXs can lead to refills, which can drive TRX growth.

Because we're so focused on tier ex growth.

Wanted to highlight what we think is an important contributor to that growth and the health of our brands.

<unk>.

<unk> and rebuild both of which grew in quarter 2.

Every time, we acquire a new patient start where potentially acquiring a customer for some time to come each <unk> has the potential to manifest itself as a repeat customer with an extended time value to the brands because.

For sprint for Axis can lead to refills, which can drive tier ex growth.

Alfred F. Altomari: We are confident in the health of TWLOA because we're seeing NRXs translate to refills and the potential for more patients to stay on the brand, which can, in turn, lead to more sustained growth. This leads me to a question I've heard from some of you as analysts and some investors. How does your growth compare to other combined hormonal contraceptives?

We're confident in the health of its rollout because we're seeing interactive translate for refills.

And the potential for more patients to stay on the brands, which can in turn lead to more sustained growth.

This leads me to a question I've heard.

And some of you as analysts and some investors how does your growth compare to other combined hormonal contraceptives and how should we think about these rebuilds and <unk>.

Alfred F. Altomari: And how should we think about these refills and these nanorefillable fuel cells? This is a new metric we're going to be talking about, you know, so we've never shown you before because it was still very early in the launch. I want to show you now, on slide six, a graph comparing the initial stages of the launches of Twirlip to low, low estrogen FD, a low dose prescription birth control pill and one of the biggest brands in the combined hormonal contraceptive market. This slide compares the ratios of T-Rexes to something you may not look at very often, NP-TRX, which are prescriptions for patients new to our product, TORLA, and low, low essence.

This is a new metric whether it be talked about.

Never showed you before because it was still very early in the launch I wanted to show you now on slide.

Heard from ex a graph comparing the initial stages of launches for <unk> to low low extra FTE, a low dose prescription birth control pill and 1 of the biggest brands in the combined hormonal contraceptive market.

This slide compares the ratios of <unk> to something you may not look.

I'd say, often and T <unk>.

Which are prescriptions for patients new to our product Tortola and Lo loestrin in other words, the percentages up tier axes that consists of our prescriptions for patients who have never used our product before.

Alfred F. Altomari: In other words, the percentages of T-Rexes that consist of prescriptions for patients who have never used our product before. These ratios increase when more new patients continue to fill their prescriptions. Over the first 26 weeks of launch, Lolo Astron FB developed a steady NRX volume that translated into refills, which contributed to the growth of the brand for years after launch. The total prescription to new product prescription ratio helps us understand whether we're building a base for future potential growth. And when you look at the curves on slide six, they're similar over a comparable period of time.

These ratios increase for more new.

Look at volume continue to fill their prescription.

Over the first 26 weeks of launch Lo Loestrin up being developed a steady and Rx volume that translate into refills, which contributed to the growth for the brand for years after the launch.

The total prescription for new product prescriptions ratios helped.

Pedro stand, whether we are building a base for future potential growth and when you look at the curves on slide 6 there is similar over comparable period of time.

Alfred F. Altomari: While we're still in the early stages, Twirla's steady ratio of total prescriptions to new-to-product prescriptions suggests the brand could potentially sustain long-term growth. But I want to be clear, we're not suggesting Swirlo will achieve the market share success that Lowe's and Lowexter have. And it's important to remember that the prescription volumes underlying these curves were much larger for Lolo Estrin than they were for Forla.

While we're still in the early stages Turo was steady ratio of total prescriptions to new to product prescriptions suggest the brand could potentially.

Help us all day long term growth.

I want to be clear we're not.

Not suggesting for a low vol achieved the market share success that low low last year half.

And it's important to remember that prescription volumes underlying these curves for much larger for Loma western and beyond for Formula, but we believe 1 of the key for a healthy.

Alfred F. Altomari: But we believe one of the keys to a healthy, steady, growing brand is to deliver strong total prescriptions to new-to-product prescription ratios, which is evidenced here by both of these brands. Of course, new prescriptions and substance refills are not possible without growing our prescriber base. On slide seven, you'll see prescriber growth over the course of 12 months. As of March 31st, 2021, we told you we had 855 writers

With growing brands is to deliver strong total prescriptions to noon to product prescription ratio, which is evidenced here by both of these brands.

Of course, new prescriptions and subsequent refills are not possible without growing our prescriber base for <unk>.

Slide 7 you will see.

Steady <unk> growth over the course of 12 launch as of March 31, 2021, We had told you. We had 855 writers and as we end the quarter to June 32021 that number has grown to 2087.

Alfred F. Altomari: And at the end of quarter two, June 30th, 2021, that number had grown to 2087. And that number continued to grow throughout the third quarter. Again, you'll see here that the quarter-to-quarter growth is supported at a more granular level over a month to month basis, as seen on slide eight. The growth in the number of providers writing prescriptions for TORLA has steadily contributed to a steady momentum in TRX growth. Also important to note is that the number of TRXs each prescriber is writing, or their productivity, if you will, also continues to grow.

And that number has continued to growth throughout.

For quarter.

Again, you will see here that the quarter on quarter growth is supported at a more granular level over a month to month as seen on slide 8.

The growth in the number of providers, writing prescriptions for <unk> has steadily contributed to steady momentum and Trs growth.

Third also important to note is that the number of tier act with each prescriber is writing for their productivity. If you will also continues to grow.

Alfred F. Altomari: Based on the early performance growth we're seeing with Twirla and how that compares to the growth trajectory of another brand we consider to be a successful category, we're pleased with the progress and the health of Twirla. But the question we continue to challenge ourselves is, how do we accelerate and sustain that growth?

Based on these early performance growth, we're seeing with <unk> and how that compares to the growth trajectory of another brand we considered to be ex success in the category.

Please with the progress and the health hubs for us.

But the question we continue to challenge ourselves, how do we accelerate and sustain that growth.

Alfred F. Altomari: And the answer is focusing on two major efforts, market access, and our marketing effort to pursue this goal. So I'm going to start with market access. We are seeking to increase access to TORLA through a variety of efforts, including a focus on expanding access to and reimbursement coverage for TORLA across commercial and government health insurance plans. In the second quarter of 2021, we expanded our Medicaid coverage. Patrola is now available to Medicaid patients in approximately 75% of the state, either through traditional Medicaid or managed Medicaid.

And the answer is focusing on 2 major efforts market access and our marketing efforts to pursue this goal.

So I'm going to start with market access.

We are seeking to increase access to <unk> for a variety of efforts, including a focus on expanding access and reimbursement coverage for <unk>.

Commercial and government health insurance plan.

In the second quarter 2021, we expanded our Medicaid coverage.

Now available to Medicaid patients and approximately 75 percentage of the state.

They're through traditional Medicaid and managed Medicaid.

Alfred F. Altomari: With these new additions, we have coverage of approximately 50% of the total Medicaid, Transdermal, or T-Rex market with no restrictions. Overall, we have access to approximately 55% of commercial and government CHC claims. We're encouraged by this trend, and we view this as another source of ongoing market growth for Tworla. We remain committed to expanding access to Tworla for all appropriate women interested in using our product. In addition to managed care and Medicaid access, we are now exploring access through additional state and university clinics, Planned Parenthood, and other non-retail sites in an effort to make Torla available to women everywhere. For example, we saw significant growth in the non-retail volume in state clinics in quarter two. Now on to Mark.

With these new additions, we have coverage of approximately 50% of the total Medicaid transdermal or <unk> market with no restrictions.

Overall, we have access to approximately 55% of commercial and government CHP clean.

We are encouraged by this trend and we view this as another source of ongoing market growth for <unk>, we remain committed to expanding access for <unk> for all appropriate women.

Interested in using our product.

In addition to managed care and Medicaid access we are now exploring access through additional state and University clinic.

Planned Parenthood and other non retail site in an effort to make <unk> available to women everywhere.

For example, we saw a signal.

Significant growth in the non retail volume and state clinic in quarter 2.

Now on to marketing.

Alfred F. Altomari: We believe the performance metrics we reviewed at the top of the call reflect what we consider to be a very smart approach to DTC marketing spend. As I said last quarter, we've made a large incremental branded consumer marketing spend quarter over quarter, starting in quarter two, while maintaining our disciplined approach and making the right investment at the right time to encourage strategic growth. As health care provider awareness increased leading up to and throughout the second quarter, we made what we believe to be an appropriate and necessary increase in branded DTC digital marketing investments in late May and early June.

We believe the performance metrics, we reviewed at the top of the call reflect what we consider to be a very smart approach to DTC marketing spend.

As I said last quarter, we have made.

A large incremental branded consumer marketing spend quarter over quarter, starting in quarter, 2 while maintaining our disciplined approach and making the right investments at the right time to encourage strategic growth.

As health care provider awareness increase leading up to and throughout the second quarter.

We made what we believe to be appropriate and necessary increase in branded DTC digital marketing investments in late May and early June.

Alfred F. Altomari: So your takeaway here is that we're very encouraged by the growth we're seeing based on a very disciplined DTC spend. So we expect TRX, NRX, and refills all to continue to grow as more and more women in our target audience gain exposure to Twirla advertising. Last quarter, we mentioned we're expanding Thoreau's brand digital efforts to a targeted audience by advertising on dating apps such as Tinder and OkCupid

So your takeaway here is that we're very encouraged by the growth we're seeing based on a very disciplined DTC spend so.

<unk> back to.

<unk> interact and refills all to continue to grow as more and more women in our target audience gain exposure towards advertising.

Last quarter, we mentioned, we are expanding froze brand digital efforts to a targeted audience by advertising on a dating app such as tinder.

Okay, Cupid and now we can report that relationship in less than a month has exceeded our expectations.

Alfred F. Altomari: And now we can report that the relationship, in less than a month, has exceeded our expectations. Moving forward, we'll expand our presence on the dating app, advertising on Spotify, and engaging influencer partnerships, all designed to drive awareness and ultimately trial of Tomorrow. In addition to the digital meeting campaign, we have identified and are pursuing new opportunities that drive consumer awareness and potentially lead to future growth. At our next Earnings Call, we look forward to sharing with you progress on partnering with additional channels like telemedicine, as well as potentially Planned Parenthood and Student Health Centers.

Moving forward, we will expand our presence from a dating app advertising on Spotify and engaging influencer partnerships, all designed to drive awareness and ultimately trial for <unk>.

And in addition to the digital media campaign, we have identified and are pursuing new opportunities to drive consumer awareness and potentially lead to future growth at.

And our next earning calls we look forward to sharing with you progress on partnering with additional channels like telemedicine as well as potentially planned here.

Parenthood and student health centers.

Alfred F. Altomari: Again, we believe all these efforts contribute to awareness, which we expect to contribute to more new starts and, in turn, lead to higher refills and ultimately stronger TRX performance. We believe all these components are a sign of a healthy brand and longevity for potential future growth. Before I turn the call over to Dennis, I want to reiterate that we remain steadfast in our belief that at peak, TORLA can capture up to 5% to 8% of the $4.1 billion combined promotional contraceptive marketplace. Thank you. And I'll turn it over to Dennis to talk about our finances. Thanks, Al. And thanks to everyone for joining us.

Again, we believe all these efforts contribute to awareness, which we expect to contribute to more new starts and in turn lead to higher rebuild and ultimately stronger <unk> performance.

We believe all of these components are a sign of a healthy brand.

And longevity for potential future growth.

Before I turn the call over to Dennis I want to reiterate that we remain steadfast in our belief that at peak for looking capture up to 5% to 8% for the $4.1 billion.

Combined hormonal contraceptive marketplace.

Thank you and I'll turn it over to.

Dennis will talk about our financials.

Thanks, Hal and thanks to everyone for joining us.

Dennis: As Al commented, we're really excited about the growth potential of our business. And I want to give you more clarity on the second quarter from a financial perspective, including a bit more detail on how Trola's performance has been trending year-to-date and some general parameters on how to think about our results for the full year. If you are following along in the deck, I'll be taking you through what is included on slide 11. Wholesalers completed their work down of the inventory level from the initial stocking level last December.

Now commented, we're really excited about the growth potential of our business and.

And I want to give you more clarity around second quarter from a financial perspective, including a bit more detail.

And how.

For all this performance has been trending year to date.

And some general parameters on how to think about our results for the full year.

If you are following along in the deck I'll be taking you through what is included on slide 11.

Wholesalers.

We did the work down of inventory levels from the initial stocking level last December.

Dennis: And as a result, we realized $1.2 million in net product sales revenue for the second quarter of 2021. The Rate of Inventory Depletion also came broadly in line with our expectations. And we anticipate that going forward, our product sales revenue will more closely track increasing script demand, and that wholesale or restocking should then more closely reflect retail sales. This aligns with our initial full-year expectations for Trolla, which were based on the assumption that sales growth would increase in 2021.

And as a result, we realized 1.2 million and net product sales revenue for the second quarter of 2021.

The rate of inventory.

Completion.

<unk> broadly in line with our expectations.

And we anticipate that going forward, our product sales revenue will more closely track to increasing script demand.

Had that wholesaler restocking should then more closely reflect retail sales.

Dennis: As product samples are worked through, our prescriber base expands, patient awareness of Trolla increases, refills begin to occur, and overall, we gain traction in the CHC market. Regarding our quarterly call, our cost of product revenues for Q2 were $1.1 million, which included expenses for supporting our manufacturing and distribution, as well as personnel, and a half a million dollars of non-cash depreciation expenses. We expect these fixed costs will become less significant as our sales grow with the anticipated volume.

This aligns with our initial full year expectations for 12 of which were based on the assumption that sales growth would increase in 2021 as product samples are worked through our prescriber base expands patient awareness of 12 increases.

Those begin to occur.

Overall, we gained traction in the CHP market.

Regarding our quarterly cost our cost of product revenues for Q2 were $1.1 million, which included expenses for supporting our manufacturing and distribution as well as.

Dennis: Our operating expenses were $16.7 million in Q2 versus $10 million in the same period a year ago. We expect our third quarter expenses to be similar to this, but they could be a million or two, either way. It's a function of how fast sampling and other costs come.

<unk>.

And I have a million dollars of noncash depreciation expense.

We expect these fixed costs will become less significant as our sales growth with anticipated volume.

Dennis: But these are relatively stable costs for us. As we closed out the second quarter with a net loss of $17.6 million, or $0.20 per share, compared to a loss of $10.8 million, or $0.12 per share, for the comparable period in 2020. At June 30th, 2021, we had cash, cash equivalents, and marketable securities of $31.1 million, compared to $54.5 million at year-end 2020. As a reminder, we have access to $25 million in capital through our loan facility with perceptive advice, including a tranche of $15 million in 2021 and a tranche of $10 million in the future. They'll be available both contingent on a predetermined revenue target.

Our operating expenses for $16.7 million in Q2.

Person 10 million the same period a year ago.

We expect our third quarter expenses to be similar to this but they could be $1 million or 2 either way.

Function of how fast sampling and other cost come but these are relatively stable costs for us.

First just as we closed out the second quarter with a net loss of $17.6 million or <unk> 20 per share compared to a loss of $10.8 million or 12 cents per share for the comparable period in 2020.

At June 30 of 2021, we had cash cash equivalents and marketing.

Total securities of $31.

Dennis: We'll continue to monitor our spending closely, and if needed, we have the ability to modify our sales and marketing expenses. Additionally, we have the potential to access additional capital, whose ATMs are at the market facility, which we can raise up to $50 million in gross proceeds. To date, we've sold $7 million under this through Common Stock through the ATMs. Our team continues to be excited for what lies ahead. We believe we have established and are still encouraged by the momentum for 12.

$1 million.

<unk> to $54.5 million at year end 2020.

As a reminder, we have access to a $25 million capital through our loan facility with perceptive advisors, including a tranche of 15.

Market a billion in 2021, and a tranche of 10 million in the future there'll be available both contingent on a predetermined revenue targets.

Dennis: We remain focused on maintaining our disciplined and nimble approach and making the right investments to encourage strategic growth and maximize shareholder value. With that, we are happy to take your questions. Operator, you may now open up the line for Q&A. Thank you.

We will continue to monitor our spending closely and if needed we have the ability to modify our sales and marketing spend a.

<unk>, we have the potential to access additional capital through our ATM or at the market facility, which we could raise up to $15 million in gross proceeds to date, we've sold 7 million under this through common stock through the ATM.

Operator: Thank you. At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. Again, that is star, then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A transcript. I have a first question coming from the line of Oren Livnat with H.U. Wainwright. Your line is

Our.

Our game continues to be excited for what lies ahead. We believe we have established and remain encouraged by.

For the momentum for <unk>, we remain focused on maintaining our disciplined and nimble approach and making the right investments to encourage strategic growth.

Oren Gabriel Livnat: Hi guys, thanks for the questions. I'm sure you're aware that there is a pretty big discrepancy out there in some of the third-party data services, you know, from Symfony and IQVIA. I happen to generally rely on the latter, and it looks like it was more than 2x the volume, I guess, you guys quoted and what Symfony is saying, for 2Q.

Our key and maximize shareholder value.

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

Thank you at this time I would like to remind everyone. There.

Alfred F. Altomari: So I'm just wondering if you can talk a little bit about, you know, if you have any understanding through your diligence as to what that may or may not be and where that's coming from. It seems to have maybe corrected in the last couple weeks. And then, you know, help us understand going forward if the lower Symfony volume is the right number, you know, what kind of economics we should be thinking of around those prescriptions or slightly higher dispensed prescriptions out to pharmacy you're seeing, so we can model this going forward. And I do have a follow-up. Thanks. Hi Oren. Thanks for the call.

To ask a question press Star then the number 1 on your telephone keypad again that is.

Growth and then the number 1 on your telephone keypad for boss for just a moment to compile the Q&A roster.

Hi, My first question coming from the line of Orientalism assets with H C. Wainwright. Your line is open.

Hi, guys. Thanks for the questions.

You are aware that there is a pretty big discrepancy out there and some of the third party data services for.

From Symphony.

And <unk> I happened to generally rely on a ladder and it looks like it was more than 2 ex the volume I guess you guys quoted and whats Anthony is saying for 2 Q. So I'm just wondering if.

Alfred F. Altomari: So, Symphony and IQVIA, we are Symphony prescribers. We get a little bit of the IQVIA data. They're really not off. You have to look at it, Oren, in two buckets, if you will.

I'm, just a little bit about it.

If you have any understanding.

Diligence as to what that may or may not be and and where that's coming from it seems to maybe be corrected in the last couple of weeks and then you know help us understand going forward you know its debt.

Alfred F. Altomari: There's the retail segment, you know; you just can't look at TRX, which is my point. If you look at retail, which is where the bulk of the prescriptions go through, they're not off. They're really not off. So, the way we look at our business, we think about what's going on through retail, which is the more traditional channel of pharmacies. And then in this segment, it's different. There's a pretty big all other category that we started describing.

Lower you know Symphony volume is the right number.

As you can tell what kind of economics should we be thinking of around.

Those prescriptions or does this feel slightly higher defense prescriptions at the pharmacy, you are saying so we can model this going forward and I do have a follow up thanks.

Yeah.

Hi, Ron Thanks for the call.

So symphony and <unk>, we are symphony.

Alfred F. Altomari: We got some business that ran through there and some of the mail order business and things like that. So, we think what happened on the operative orders, we think that IQVIA's algorithms that forecast or trend these other categories, you know, we're off. We're off. And, you know, we alerted them that we think they were off. And I think they did correct themselves. So, I think the way we look at the business, Oren, and the way we model, we say, let's model the traditional channels, which is retail.

So subscribers can get a little probably ought to be a data.

They're really not off with you you have to look at it as sort of 2 buckets. If you will.

For the REIT Theres the retail segment.

You just can't look at peer average.

Price points.

If you look at retail, which is where the bulk of the prescription.

Prescribed to growth, but theyre, not all theyre really not off.

The way, we look at our business, we think what's gone through retail which is the more traditional catalog for pharmacies and then unless segmented different there is a pretty big all other category that we started describing we got from some business that ran through there in some of the mail order business.

Alfred F. Altomari: It's not, they aren't off, you know, the food services. And then, if you will, we layer in the all other channel on top of that, you know, saying, okay, what else is happening in the all other category? Because the all other category, Oren, is a little bit lumpy.

So things like that so we think we think what happened on the operative word if you think about at QB as algorithms that forecast for trend leads all other categories.

Alfred F. Altomari: You know, there's, there's, you know, big purchases sometimes. There's a lot of our mail order scripts going to our partner Sterling. And the algorithm is just sort of projecting this, we think. And I really, I really emphasize the word we think because we spent a little bit of time; we were aware of it. The bulk of, for instance, the bulk of the Bloomberg term was relying on Symphony.

For offense.

We alerted them.

We think there wasn't the golf and I think the correct itself, but I think the way we look at the business for it in a way.

Since model, we think let's model the traditional channel which is retail.

They arent off.

Alfred F. Altomari: So, I know a couple of you rely on IQVIA, but we did the best we could to downplay it. But, you know, you know, the sweet spot of the market in the retail segment, where the bulk of the patient goes through, the databases are very similar.

Food services and then we if you will we layer in the all other channel on top of that channel.

Okay, what else is happening the all other category because the only other category is a little bit lumpy.

True.

No big purchases sometimes.

We've seen a lot of our mail order scripts of Archrock partners Sterling and the algorithm.

Alfred F. Altomari: Yeah, okay. And then just to the basics, I guess close to that.

Projected them, we think and I really I really emphasize the word we think because we spent a little bit of time, we are aware of it the bulk of the for instance, the bulk of the Bloomberg terminals rely on Symphony. So I know a couple of really rely on our kids here, but we did the best.

Alfred F. Altomari: to the basics, I guess, gross to net. You know what your contracts are. I do want to touch on contracts again in a follow-up. You know, and I guess you can see the volume going out the door and what you're shipping to wholesalers to restock. But, you know, how do you think we should think about gross to net now and in Q2 and going forward to sort of come up with a realistic value prescription, so to speak?

Is that kind of sound profit, but.

The sweet spot of the market in the retail segment, where the bulk of the patient goes for the database for very similar.

If that makes sense yeah, Okay, and then just to the basic I guess gross to net and say you know what your contracts are I do want to touch on contracts again and a follow.

Dennis: We haven't guided it, and we're still on a bit of a moving target. We mentioned these Medicaid contracts. We're just getting them under our belts, and then going forward to project growth in that, we have to say how much of our business is going to go through Medicaid. So until we get all the basic contracts up and running, we haven't been able to guide it. So we're still trying to get our arms around it because it really does depend on the mix of patients.

And I guess, you can see the volume going out the door and what youre shipping to wholesalers to restock, but you know how do you think we should think about gross to nets now in Q2 and going forward to sort of come out with a realistic value prescript so to speak.

Sure we haven't guided it in.

Follow up so that's still in our in that warrant a bit of a moving target we mentioned Medicaid contracts.

Dennis: We know what we pay for commercial lives, and we know we pay for Medicaid lives, but until we see how much of our business runs through each channel, we're not in a really great position to do much as opposed to that. But all in all, we like the contracts.

Just getting them under our belt and then gone forward project growth and that we have to say how much of our business is going to go for Medicaid. So until we get all of the base for contracts up and running we havent been episodic price.

Alfred F. Altomari: We like the access. Our primary goal is access at a decent price, and I think we've achieved that. Okay, just to talk about access, you know, like, I have no doubt that your demand is ultimately way higher than where it is today. And, you know, in a massive market, it's clearly, you know, a sliver that's there for you. But, you know, you do talk about access, and that's crucial, right? It has to be easy to get.

So we're still trying to I'm trying.

Where's firms around it because it really does depend on the net Ah patients we know what we pay for commercialized.

For Medicaid lives, but until we see how much of our business from <unk> channel.

Really great position to do.

We want good growth from that.

But all in all we like we like the contracts, we like the access our primary.

To get all of those assets at a decent price and I think we've achieved that.

Okay, and just to talk about access you know like I have no doubt debt.

Alfred F. Altomari: So when you talk about, quote, unquote, access to 55% of commercial government life, I think I've asked this on, you know, pretty much every call I've ever done, "what does access really mean?" You know, it's one thing to not be blocked; it's another thing for it to be affordable or easy to be prescribed and fulfilled at the pharmacy. So, you know, what are you seeing?

Demand is ultimately way higher than where it is today and I know in a massive market is clearly a sliver that's there for you but.

You you do talk about access and and that's crucial right. It has to be easy to get so when you talk about quote unquote access to 55% of commercial and government lives I think I've asked you. This on pretty much every call I've ever done you know what it's access really mean.

It's 1 thing to not be blocked it's another thing for it to be affordable.

Alfred F. Altomari: And how does the ACA, you know, how's that playing out in terms of preferential access? Yeah, I mean, when we use the word access, we mean that it's easy for a doctor to write. So when we quote 55%, it means that it's in a formulary position that he can write the drug. You know, so when, in theory, under the Affordable Care Act, everybody can write the drug, and we could, we could quote 100% because, in theory, patients are supposed to be able to have access across all the commercial plans, you know, with their doctors just writing a letter of medical necessity.

D to be prescribed and fulfill filled at the pharmacy. So what are you seeing and how does the ACA.

That playing out in terms of preferential access.

Yes, I mean, when we use the word access we mean, it's easy for a doctor right. So when we quote 55% it seems as though in a formulary position.

Or easy can write for drugs.

So when you know in theory on the Affordable Care Act everybody can write the draws and make it up we could quote a 100% because in theory, if patients are supposed to be able to have access across all the commercial plans.

With their doctors, just writing a letter of medical necessity.

Alfred F. Altomari: So, you know, we try to, if you will, quote, where there's easy access, I guess, Orin, is the way we think about it to 55% of where doctors can write about it and, you know, get the drug through. But like you said, under the Affordable Care Act, these drugs should be more broadly acceptable, but it involves work by doctors, you know, so, you know, we don't want to overstate it.

But you know we tried to if you will for.

That's easy access I guess, the Orange is the way we think about it for 55% is where doctors can write in and get the.

It drives the debt the drug group.

You said under the Affordable Care Act these drugs should be more broadly acceptable, but involves pork by the doctors. So we don't want to overstate it, but we want to keep chipping away, but those other London.

Alfred F. Altomari: So we want to keep chipping away, but those other ones and, you know, we've added more, and you know, and we expect going forward, you'll hear that number get bigger. So that's, that's how we're using the word access. That's a very good question. Okay. I appreciate that. Thank you.

We're under we've added more and we expect going forward, you'll hear that number getting becker.

But that's how for how we're using the word axa for very good questions.

Okay I appreciate that thank you.

Kim Lugo: Next question, coming from the line of Kim Lugo with William Blair, your line is open. Thanks for the question and congratulations on the progress and also for providing us with all the KPI metrics. It's very helpful.

Next question from from the line of <unk> with William Blair. Your line is open.

Yes.

Thanks for the question and congratulations on the progress and also for providing all the kpis metrics that are very helpful.

Alfred F. Altomari: And I guess going into one of the non-retail channels. I believe you mentioned your prepared comments were around 2,000 in the quarter. How meaningful do you expect that channel to be kind of a quarter of a quarter throughout the remainder of the year? And is that something that could fluctuate in Q3 and Q4? Or what are your just expectations?

And I guess going into 1 of the the non retail channel I believe you mentioned in your prepared comments sales around 2000 in the quarter.

How meaningful.

Meaningful do you expect that channel to be kind of quarter over quarter throughout the.

The year end is that something that can fluctuate Q3, and Q4 or what are your expectations there.

Alfred F. Altomari: Well, Tim, first of all, thanks. And, you know, we appreciate it. We'll try to use it as transparently as possible. We like showing the metrics, the way we look at the business. So thanks.

For Tim first of all thanks.

We appreciate it we'll try to give transparency, we'd like to show in the metrics.

But we look at the business. So thank God, we appreciate that comment.

Alfred F. Altomari: We appreciate that comment. Yeah, so that channel is really an interesting one for us. So like Oren's question, if you heard his question, in some respects, they were picking up some business and straightlining it, if you will, you know, on one scenario. So that was kind of like one algorithm.

Yes, so that channel is really an interesting 1 for us for like Orange question. If you heard his question in some respects they were picking up some business in straight lining it if you will.

And wanted to scenario so that was kind of 1.1 algorithm and then on day 1 we quoted.

Alfred F. Altomari: And then the one we quoted, you know, Tim was, I don't want to say direct, they didn't buy the product from us, they bought it from a wholesaler. It was a state clinic, you know, that just bought it directly, 2,000 units, you know, directly from one of our wholesalers, which is, Tim was an exciting guy to get that big of an order. I gotta tell you, that's about what went on the retail channel that month.

For what Tim was with them I don't want to say a direct identified a product from us they bought it from a wholesale of the state clinic.

That just bought it directly 2000 units.

<unk> found directly from 1 of our wholesalers, which other than what was an exciting day to get that big of an order I got to tell you. That's about 1 for the retail channel that Montana.

Alfred F. Altomari: So we'd like to think that channel is going to become more important, Tim, but it's early days, I think that'll be conservative, the way you think about it, so we get our legs under it. But it's exciting, though, I think what makes us excited, Tim, is that, you know, the public sector accounts, and there's a ton of them, this is just scratching the surface, this happened to be a state clinic, you know, and the interesting thing, and I have to say, we didn't have a rep in front of them, they just heard about the brand, they thought the brand was great, they put a big order in, and now we're trying to say, do you want more?

So.

We'd like to think that channel is going to become more important than but it's early days, but I think that'll be conservative for what you think about it so we get our legs under it but it's exciting.

I think what makes us excited for them is that the public sector accounts and Theres a ton of them. This is just scratched the surface.

Happened to be a day clinic.

The interesting thing and I have to say if we didn't have a rep in front of them. They just heard about the brand and they bought the brand with great. They've got a big order in and now we're trying to stay true.

Alfred F. Altomari: So in the meantime, there's a lot of Planned Parenthood, business, student health center, telemedicine, so we haven't begun, Tim. So I think for us... We want to kind of think about the business in our retail as our bread and butter, and then we're just going to have to keep you updated on this business. It's lumpy, Tim. I don't know what else to say, but in a good way, because they don't order every day sometimes, so it's almost like the way you follow hospital businesses. Sometimes they buy big boluses at once, but we're going to have to just monitor that.

More so.

So on the mix so in the meantime, there's a lot of planned Parenthood business student Health Center telemedicine. So.

We haven't begun to them so I think for.

And we want to kind of think about the business and our retailers are bread and butter and then we're just going to have to keep you updated on this business. It's lumpy Tim I don't know what else to say, but in a good way.

Yes.

They don't order every day, sometimes so.

It's almost like the way you can follow hospital business with them, sometimes they buy big bolus of that launch.

We're gonna have to just monitor debt so.

Alfred F. Altomari: So the good news is we have customers, Tim, that we don't even know about, so we're excited. We'll take this problem every day, Tim. Every day of the week, we'll take this problem.

The good news is we have customers than we'd even though about sales.

Excited [laughter], we'll take those problems every day to them for every day of the week will take 2 problem exactly we've got to learn.

You got to learn to get more import growth, but we're pretty excited.

A new channel emerging growth.

Alfred F. Altomari: It's kind of the power of a large market. I understand that in some of the other sectors as well.

For us.

It's kind of a power of a large market.

I understand that some of the other sectors as well.

Alfred F. Altomari: And I guess drilling down a little bit more on access, and maybe you talked about this with Oren's question, but we're approaching kind of a contracting season for commercial pairs when we tend to see announcements. Is this something you're actively pursuing?

No.

And I guess drilling down a little bit more on the access and maybe you can talk.

About this.

With our Orange question, but we're approaching kind of a contracting.

Season for commercial payers when we tend to see announcements is this something you're actively pursuing and should we expect kind of a 2022.

Alfred F. Altomari: And should we expect kind of a 2022, you know, just something to watch out for in the contracting season as they're approaching? Yeah, Tim, great question. The answer is it's the bid and ask season. Yeah, we're in the hot and heavy of it. Yeah, also, it has to do with some of the Medicaid business we've been winning because, in effect, we're winning early contracts for next year. So we're right in the middle of the cycle.

Just something to watch out for in the contracting season is approaching.

Yeah Timm great question. The answer is it's the bid and ask season, yes.

We're in the hot and heavy of it yeah.

It has to do with some of the Medicaid business, we've been winning because in effect for a wedding early contracts for next year. So we're right in the heat of the cycle, yes. So I think you're going to start hearing us reaffirm some of the coverage mcgyver hopefully keep adding to it. So in our strategy is to build that book of business. We've got.

Alfred F. Altomari: Yeah. So I think you're going to start hearing us, you know, reaffirm some of the coverage we have or hopefully keep adding to it. So, you know, our strategy is to build that book of business we've got, and hopefully we'll have more good news for you next quarter. And then supplement it with that whole other channel, if you will, the non-retail channel.

Hopefully we'll have more good news for you next quarter end.

And then supplemented with that all other channel if you will the non retail channel. So we're for traffic and we're flying them, but yes, we're in that range, where vendor for signing off on a lot of bad thing, though right now yes.

Alfred F. Altomari: So we're, we're strappy, Tim, we're fine. But yes, we're in it. We're in it. We're just signing off on a lot of good stuff, you know, right now. Yeah.

That sounds great. Thanks for the update.

Alfred F. Altomari: That sounds great. Thanks for the update. My pleasure, Tim. Thank you.

My pleasure. Thank you.

Our next question coming from the line of Leland <unk> with Oppenheimer. Your line is open.

Unknown Speaker: Hey, good afternoon guys. Thanks for taking my questions and thank you for the very informative update. I'm glad to see the OPEX is kept under control as you continue to grow the product. I wanted to ask a few questions. First, in terms of sampling initiatives, Alan, on the last call you mentioned that those may be easing as we get through the second quarter. Perhaps those have continued more than you'd expected based perhaps on greater physician demand or interest. I want to kind of ask what your current sampling looks like and how that may wind down as we get through the rest of the year. I also want to ask about the types of patients who are coming on Twirla.

Hey, good afternoon, guys. Thanks for taking my questions and thank you for the for the very informative.

Update and glad to see the the Opex is kept under control as you continue to grow.

The debt.

Product.

I wanted to ask a few questions first in terms of sampling initiatives I think Alan in the last call. You mentioned that those may be easing as we get through the second quarter, perhaps those have continued more than you'd expected base, perhaps on greater physician demand wanted to or interest wanted to kind of ask what your.

What are your kind of current Sam.

<unk> looks like and how that may.

Wind down.

As we as we get through the rest of the year also wanted to ask about the types of patients who are coming onto <unk>.

Alfred F. Altomari: If you could kind of give us a rough breakdown of patients who've been on the legacy patch versus those who are new to contraception or perhaps those who've been on oral and are switching, and any directional trends you may be seeing there since Twirla has been on the market. And finally, as more and more women out there are becoming aware of the product and are coming to see their doctors, and with COVID easing a bit, more and more patients are going into their doctors or asking about it.

If you could kind of give us a rough breakdown of patients who've been on the legacy patch versus those who are.

Annuity contraception, or perhaps those who have been on an oral in our switching and any any directional trends you may be seeing their assets, where there has been on the market and then finally.

As more and more women out there are becoming aware of the product and are coming to see their doctors and with COVID-19 easing a bit more and more patients are going.

Coming into 2 their doctors are asking about it.

Alfred F. Altomari: You have that, and you also have doctors who may be familiar with the old patch and may have some reservations and may not be used to the new patch. So I want to ask what that opportunity does that create for Agile to kind of provide a way for docs to be more informed about Twirla and its differentiation and perhaps to have less reservations about prescribing it. If there's a run-on sentence, I've got a run-on question, you've got four parts, let me see if I can do this. I didn't get it all.

You have that and you also have doctors, who may be familiar with the old patch and may have some reservations and may not be used to the new patch. So wanted to ask what does that what opportunity does that create for agile to kind of provide a way for docs to.

The more informed about portola and its differentiation and perhaps have less.

Reservation about prescribing it thanks.

Right, but if there's a run on sentence either run on question for me.

If I could.

Right.

Yes.

Alfred F. Altomari: I'm going to go to number three, which is the users. You know, like you said, who are we seeing in the marketplace? It's really interesting.

Got it all right I'm going to go to number 3 which I think.

Are you there.

I think it was.

Who is who we.

Staying in the marketplace, it's really interesting.

Alfred F. Altomari: Number one, about 50% of all our prescriptions are new to contraception, meaning they're a new user, which is about what we thought, but it's trending on the higher side of what we thought. So the doctors are using our product, and that will be asked by our reps. We say, hey, why don't you give it a try on a new patient in the waiting room? Because we think it's a little bit less confrontational, you know, if you will. Now, I've also got the question, do we target Zulane or the other patchers, Zulane users? The answer is absolutely yes, we do.

Number 1 is about 50% of all our prescriptions are new contraception, meaning there are new user.

It's about what we thought but trending on the higher side of what we thought.

Thought so the doctors are using our product line.

From where.

And that's what the ask is by a rep. We say hey, why don't you give it a try on a new patient and you're waiting room, because we think it's a little bit less compensation. If you will.

Now I've also got the question do we target ruling or the other pads for Zululand music answered.

Absolutely, yes, we do.

Alfred F. Altomari: You know, related to that, when we go to doctors who already feel comfortable with patches, so we target their offices, but we don't, say, take them off the other patch, if you will. So it's related to the way we target doctors, and I'll get to your fourth question, and then I'll work backwards again. So 50% are new users, 25% have come off a pill, not a patch. 75% to almost 80% of Zulane have been either new to the method or new to patches. And then the remaining percentage are scattered around ring users and patch users. So that's really great.

A related that's let me go to the doctors that have already feel comfortable with patches. So we target their offices, but we don't take them off the other patch. If you will so it is related to the way, we target doctors and I'll get to your fourth question and then I'll work backwards again.

So that so 50%.

<unk>, new users, 25% have come off a pill not a patch.

75 to almost 80% Leland are.

Either new to the method or are new to that.

And then the remaining percentage they are scattered around ring users patch users. So that's that's really great but to.

Alfred F. Altomari: But to your other question about, you know, if I was saying what surprised me so far, it's slow to get a doctor to write a patch of any kind if they've never written one before. I think we've talked before, Leland, a lot of the young doctors are, you know, a little bit reticent about using patches. So our low-hanging fruit is patch users, and there are a lot of them. So, you know, the other ones we're not giving up on, you know, but we're really, in effect, it's going to take us more time. So samples, you know, was just one of your other questions. I'll let them comment here, comments about OPEX. But samples continue to be critically important.

Question about you know if I would say what surprised me so far.

The it's slow to get.

Doctor to write a patch of any kind if they've never written 1 before so a lot of I think we've talked before leaving a lot of the young doctors are little bit rather than using patches. So far.

Our low hanging fruit is on patch users and theres a lot of them. So yes.

The other ones were not giving up on.

But we're really in effect for the kind of take us more time.

So samples with your 1 of your other question and I'll, let them comp and your comments about opex, but simple continue to be critically important.

Alfred F. Altomari: You know, what we're finding in general, we're going, there's still a significant demand as COVID opens up offices, Leland. I mean, for the first time, our reps are really getting in the sample closet for the first time. And we're just saying we want them to own those closets.

What we're finding.

In general we're going there's still a significant demand as COVID-19 opened up offices Leland I mean for the first time, our reps are really getting into sample closet for the first time and we just spent we want them to own those cloud present don't be shy. So so I don't think sampling demand and kind of.

Alfred F. Altomari: We're saying, don't be shy. You know, so I don't think sampling demand is kind of, you know, in a kind of steady state yet. So we did our first loading of the channel, if you will, in a good way, loading, not bad loading, you know, getting them out deployed, you know, but still, our reps are a lot of times on Zoom calls. And it's hard to judge, you know, doctor.

Kind of a steady state yet.

So we did our first loading of the channel if you will in a good way loading non pad loading.

Getting a mouth deployed but for a rep for a lot of time zone zoom calls and it's hard to judge has seen a doctor so what we're finding from the field.

Alfred F. Altomari: So what we're finding in the field and, you know, meeting with our regional managers this week is that there's new demand for samples just in general. So I think we're still using a decent amount of them. You want to mention OPEX control? I think it's very nice of you.

Meeting with our regional managers. This week is that there is new demand for samples as just in general So I think.

We're still you've got a decent amount of them and you wanted to mention that Opex control a very nice deal. So yes.

Dennis: Yeah, I mean, we do. We've been pretty, you know, guarded. We've really tightened down on our OPEX. And going forward, as I said, we expect it to be within a million or so of what we had this quarter.

Okay.

<unk> been pretty guarded literally have tightened down on our opex.

And going forward as I said, we expect it to be within $1 million or so of what we have.

Had this quarter.

Dennis: And that's really the way we're managing. Yeah, and we appreciate you know, you know, because I mean, we try to make good bets, if you will. I mean, we bet on what we think works. And we're, you know, everything else, it's just got to be secondary at this point. I mean, we have a responsibility to our shareholders to keep our heads about them.

And that's really the way we're managing it.

Yes.

Appreciate it.

Remember because I mean, we try to make good bets. If you will I mean, we bet on what we think works spend versus everything else.

Just gotta be secondary at this point I mean, we have responsibility to our shareholders to keep our heads about them, but I think.

Alfred F. Altomari: But I think based on the performance, we're seeing the brand grow, I feel like we're making good bets. So Dennis keeps me honest, as you know, so, you know, we're putting the bets in the right place. Excellent. Terrific. Thank you very much, Al and Dennis. Did I get them all? Did I get it all, Leland? You got it all. Thank you. Alright, thanks

From the performance for sand in the brand's growth I feel like we're making good bet. So Dennis keeps me honest as you know so.

The best in the right places.

Excellent terrific. Thank you very much Melinda.

But I get them, all but I get it all.

You got them all thank you so much alright. Thanks.

Danielle Basby: We have our next question coming from the line of Danielle Basby with RBC Capital Markets. Her line is open.

Our next question coming from the line of Danielle <unk>.

RBC capital markets. Your line is open.

Danielle Basby: Hey, good afternoon, guys. I've got a couple questions.

Hey, good afternoon, guys I've got a couple of questions.

Alfred F. Altomari: First, I think I heard you reaffirm your five to 8% peak market share target earlier in the call. Can you talk a little bit more about the factors that give you that confidence in light of some of the competitive developments we've seen this year, with Van Niel launching a generic DuLane product and now Beatrice talking about introducing a low dose version of DuLane? Yeah, I mean, you know, you have to tell you, you were one of the first ones that kind of predicted it.

First I think I heard you reaffirmed your 5% to 8% peak market share target earlier in the call can you talk a little bit more about the factor.

What gives you that confidence somebody from the competitive developments we've seen this year.

Madame Noire launching a generic line product and now via <unk> talking about introducing a low dose version of the line.

Yes.

To tell you Youre you.

You were 1 of the first 1 debt kind of predicted it.

Alfred F. Altomari: And here's the bold, bold insight. Number one, since the second patch generic came out, they're having our shares grow. They've taken all the shares from Zuling, so that's good for us. And that's what you originally said in your notes. The second insight you had was really interesting. I don't know if you've looked at it. You know, right now in the middle of COVID, the CHC market's rather flat. The only growth area is in patches.

And here's the bold bold inside number 1.

The second patch generic came out there havent our shares grown they've taken all the share from zoning for.

That's good for Us and that's what you had originally said in your notes. The second insight you had was really interesting I don't know if you've looked at it right.

Right now in the middle of Covid.

We see markets, rather flat the only growth area as patches.

Alfred F. Altomari: You know, it's really interesting. We're outpacing the market. So the patch pie continues to grow, and so my confidence has to do with patches becoming more mainstream again, as we thought. So you end up being right then you had this one when you said they weren't going to clip us, and they were more likely going to clip each other. And that's what we're seeing in the marketplace. But the good news is that the second patch didn't, didn't ding us at all, and it didn't ding the category.

Really interesting we're outpacing the market so the patch pie.

The growth and for my confidence has to do with patches, becoming more mainstream again, which we bought.

So you end up being right. Then you had that you had this 1 when you said they weren't going.

Clifford.

More likely going to clip with each other and that's what we're seeing in the marketplace, but the good news the second Patterson.

Ingots at all and it didnt being the category for the category is growing.

Alfred F. Altomari: So the market is growing. And we're hoping the category continues to grow as we kind of unlock the potential of COVID, even though this category has been generally flat. But it's good.

And we're hoping the category continues to grow as we kind of unlock out of Covid, even though this category has been generally flat.

Alfred F. Altomari: And you know, the other part of my bullishness has to do with our accessing these other channels. You heard these long conversations about these other channels. I think that we can continue to follow a patient and say, where else is she going besides CVS? You know, telemarketing, Planned Parenthood, student health centers, and these state and county organizations.

The other part of my.

Bullishness that has to do with our accessing the debt you've heard these long conversation about these other channels I think that we can continue to follow the patient day, where else does she Columbus Cvs.

Telemarketing planned Parenthood health centers in the state and county organizations, there's a ton of business out there. So that's why we're bullish.

Alfred F. Altomari: There's a ton of business out there, so that's why we're bullish. But I feel like we're just, I love the growth we posted, you know, but we're not by any means done. So we're just, you know, you know, just still a lot of the market we haven't been in front of. So, that gives me the confidence to kind of reaffirm that patches look like people are getting back in fashion again with them.

I feel like we're just I love the growth, we posted but we're not at any means done. So we're just.

Just still a lot of the market, we havent been in front of so but that gives me the confidence to kind of reaffirm that.

Patches look like it looks like people are getting back in Vogue again with them and.

Alfred F. Altomari: And you know, it's our job to make them pick our patch. You know, and then I, you know, I can't comment on the other patch, but I saw what you saw. It appears it's only going to the clinic. It looks like it's years out. And at this point, you know, take a look at the market share of Zulane. Zulane is dropping fast.

It's our job to make them.

Patch.

And then I know I can't comment to you know the other part for me. That's all what you saw you know it appears it's only going to the clinic. It looks like a few years out and at this point do you know when you take a look at the market share of a ruling the range dropping fast I mean, the question is how much share we would have lost and when they launch that.

Alfred F. Altomari: I mean, the question is, how much share will they have left when they launch that? So I mean, their competitors took a lot of gas, you know, a lot of share away from them. And like I said, we kept growing. Good questions, though. Thanks. Got it. Thanks for the call.

For a competitor it took a lot of thought of GAAP with well you know a lot of a lot of share away from them.

And like I said, we we kept growing.

2 questions. Thank you.

Got it thanks for that color and just 1 follow up perhaps for Dennis I can.

Danielle Basby: And just one follow-up question, perhaps for Dennis, I could probably do the math on the cash runway, but you mentioned the $25 million tranche you have potentially available. Can you share anything about the achievability of those targets? Do you expect to be able to access that cash, or is it still a little bit up in the air? You know, we're until we get to 31 million right now, and we're able to tap the ATM. On Perceptive, you know, there are targets there.

Probably do the math on cash runway, but you mentioned that $25 million tranche.

Once you have potentially available can you share anything about the achieved the ability of those targets and do you expect to be able to access that cash or is it still a little bit up in the air.

Yes.

We get for $31 million right now.

We were able.

Moving to tap the ATM on perceptive.

You know.

Dennis: We haven't disclosed them. They're challenging targets for us, but, you know, they've been a great partner to us for years now. And, you know, we'll continue the dialogue, and we'll let you know. You know, it's not a slam dunk. We'll get that money from them. Uh, you know, we kind of trust the partnership and, and, uh, we'll continue with the dialogue.

For our targets there we haven't disclosed them.

They're challenging targets for us but.

It's been a great partner to us true for years now.

<unk>.

We'll continue the dialogue and we'll let.

No.

It's not it's not a slam dunk, we will get that money from them, but yet.

You know, we kind of trust the partnership and.

We will continue with dialogue.

Okay got it thanks.

Nazibur Rahman: Our next question comes from the line of Naz Rahman with Maxim Group. Your line is open.

Thanks, Dave.

Our next question coming from the line of Nat Sherman with Maxim Group. Your line is open.

Alfred F. Altomari: Hey guys, thanks for taking my question. Now that you've seen more demand sales, are you guys seeing the demand script where the patient sees $0 copay? Or do you find them mostly using the copay cards or paying for the product? I have a follow-up question. Yeah, it's a tough question.

Hey, guys. Thanks for taking my question now that you've seen more demand sales are you guys seeing the demand spread for patient see zero dollar co pay or do you find them multi using the co pay cards are paying.

Product as a follow up question.

Yes, it's a tough for us I don't have more of the top of my head, but a significant amount of our patient status for zero co pay.

Alfred F. Altomari: I don't have them all at the top of my head, but a significant amount of our patients get them for zero copay, you know, just because it's under the Affordable Care Act. And so, you know, to answer your question, it's going to be all around the board. The Medicaid patient, when we're in a strong contracting position with them, you know, some states could be $2 or $5, and it's really virtually zero.

For the portable care Act and so.

So it sort of answer your question from you all around the board the Medicaid patient when we're in a strong contract.

And for the positioning with them, sometimes it could be $2.5 and that's really virtually zero. So on those books of business. The patient is really paying virtually non nothing so that's really good for the patient and it's really good for us.

Alfred F. Altomari: So in those books of business, the patient is really paying virtually nothing. So that's really good for the chronic patient, and it's really good for us. You know, with our copay business, I mean, our copay cards, I don't believe are a runaway by any means. You know, we use them on a really situational basis. That's something Dennis keeps an eye on.

Our co pay for the business I mean, our copay card you know I don't believe are a runaway.

Lacking any means we use them on a really situational basis, that's something balance keeps an eye on that as a lot of for recycle out of cash and then pay for the patient. So we haven't over relied on our co pay card, but he's still real healthy brand without them.

Alfred F. Altomari: That's a lot of cash, and we're going to take a lot of cash in this case for the patient. So, you know, we haven't over-relied on our copay cards. I mean, this is a real healthy brand without them, you know, a knock on wood, but it's there in case we need it.

Knock on wood, but its there in case, we need it it's meant to be we don't just sort of help.

Alfred F. Altomari: It's meant to be, we don't... We don't want the co-pay card to be a bridge to a better outcome for the patient, either navigating her zero co-pay or us getting on formulary. We just can't see us running a long-term business on the back of co-pays. I think they're very needed on a situational basis, if you will, and that's the way we use them, very strategically. But we're pleased that our overall growth from that is pretty good right now. We haven't over-relied on them, knock on wood.

It sounds right, but we don't want the co pay card we want the co pay cards to be a bridge to a better a better outcome for the patient either navigating her zero co pay.

Or that's getting a lot of events are on formulary, we just.

It just can't be up running a long term business on the back of co pays I think theyre very needed assets situational basis.

For example, and that's the way we use it very strategically, but we're pleased that our overall growth from that is pretty good right. Now we have an over a line on O&M knock on wood. So so far so good.

Alfred F. Altomari: So far, so good. It's a situational bridge for patients or plans, but the bigger idea is to get on formulary. We as a company believe in getting on formulary. We just can't run a business not in a good relationship with our payers, so we just are really always at the table with them trying to either get formulary access or get better access.

Our situational bridge for patient for our plans for the bigger ideas get on formulary.

We just we as a company believe.

Loans formulary, we just don't we just can't run a business.

What.

Kind of a good relationship with our payers. So we just are really always at the table with some from it even get formulary access to get better access.

Got it and the patients that are getting charla at this.

Alfred F. Altomari: And the patients that are getting Perla, at this point, how many cycles of Perla scripts are they getting for it? Is it still like 1.3 to 1.4x months? Or are you seeing patients get longer prescriptions? Now, you know, it's pretty steady. You know, you'll see in those graphs we provided when you get a chance to look at some of the screenshots, you'll see TRX, and if you look at the ratio, it's 1.3. Some weeks it's 1.32, but it's hovering.

And Gary how many cycles of total scripts are they getting for it. It just felt like the 1.3 to 1 point for X months are you seeing patients again longer prescriptions.

No you know its pretty steady, though you'll see in those graphs. We provided when you get a chance to look at from a screenshot.

You'll see <unk>, if you look at the ratio the 1 point for some weeks of.

This 0.32, but it's hovering we expect some plans are you know in the mail order business are allowed to get more if you will cycles at a time, so if anything it should eek up a little bit, but we're not standard.

Alfred F. Altomari: We expect some plans are, you know, in the mail order business, they're allowed to get more, if you will, cycles at a time. So if anything, you know, it should eke out a little bit, you know, but we're not seeing it. It's pretty steady right now. But I'd leave it at that. And so we talked the other way. In some of the negotiations we're in, they're going to be letting doctors write longer prescriptions. And that would be great for us, by the way; we'll take it. But for right now, it's really steady at around 1.3.

Pretty steady right now, but I'd leave it at that and say that we've talked to otherwise and some of them are in negotiation.

Bumbles, we're in they're gonna be flattened doctors write longer prescriptions that would be great for us by the way, we'll take it but for right now it's really studied for around 1.3.

For the engine.

Which as you know this I was just curious.

What that means is for those that are kind of new doors as well that means every <unk> is worth 30% more.

Chase off rather than you know so.

The value of the patient on that first script is obviously a lot more it it really ends up being a big number you could see on the curves it doesn't take much to get these curves bending upwards pretty quickly because of that and new refills in.

Alfred F. Altomari: Unknown Executive, Nazibur Rahman, Scott Coiante, Amy Welsh, Matthew Riley, Agile, Got it. And the final question is, some of the larger non-retail orders you saw in QQ, is there like the potential to sign a recurring contract with those purchasers? Or would they just have to kind of go through wholesalers?

It's a good business, we're getting we're just getting at a point, where getting a base of refill.

So I from new business coming in and we get that 1.3 multiplier and it's starting to become a real healthy little business for Ron. So we're excited to lead our job is to get new prescriptions. The more we get we get a multiplier on them.

Got it and my final question is some of their larger non retail orders you saw in <unk> is there like a potential.

So to sign a recurring contract with those purchases or would they just have to kind of go through wholesalers.

Alfred F. Altomari: No, that is a fabulous question. The answer is we'd love to sign an agreement because it's not, you know, we're at the whims of a purchasing manager that we'd like to be in a long-term, better relationship, you know, that it's not just a here and there purchase. So to answer your question, we would love to do that. That goes with Planned Parenthood, that goes with Student Health Centers, that goes with all these clinics.

No.

That is a fabulous question and answers, we'd love to find an agreement because it's not it whereas.

The wins are a purchasing manager of that line.

Now that we would we'd.

We gotta be it in the long term better relationships and I'm not it's not as though you know us.

Hearing their purchase so to answer your question, we would love to do that.

Those with planned Parenthood debt because of student health centers from bodies clinic, we just have a bias.

Alfred F. Altomari: We just have a bias, you know, to get on their contract. So, you know, we just like that. For now, it's a little bit more lumpy, you know, but just from our own planning, it's the federal organization if we can get them. And, you know, for right now, they can buy the product for wholesalers, which is great. So we could see the movement.

Debt on their contract so.

We just like that for now.

Like it's a little bit more lumpy, but just from our own planning et cetera, organizing if we can get them in.

For right now they can buy the product for the wholesalers, which is great. So we could see the movement you know theres a fair number of hospitals around the country to buy our products, but that was the most significant 1 is trying to get doctors and for treating pain.

Alfred F. Altomari: You know, there are a fair number of hospitals around the country that buy our products, but that was the most significant one. They're starting to get doctors and, you know, they're just treating patients in university settings. And so these kind of non-retail businesses are starting to get interesting enough. But we don't want to chase them.

And University center settings, and so these kind of like.

Non retail business is starting to get interesting enough, but we don't want to chase. It we want to we want to develop a strategy for opening this channel in a big way, but for right now we will take the business, we'll take the sale price book of business day, because I told him when he asked that.

Alfred F. Altomari: We want to develop a strategy for opening this channel in a big way, but for right now, we'll take the business. We'll take the sale. That was a nice book of business. As I told Tim when he asked that question, that wasn't about as much as we sold in the retail channel that month. So one order, you know, was great. It was a good day. So, yes, we would like to get on the contract with them and develop a strategic relationship.

And that was about as much as we sold in the retail channel that month, So 1 order with bank debt.

This was good was a good day.

Yes, we would like to get on the contract with them to develop a strategic relationship with them.

Alfred F. Altomari: Got it. Thanks for taking my questions. My pleasure. Thank you. Thanks for listening.

Got it thanks for taking my questions.

Pleasure, Thanks, Dave Thanks for listening.

Operator: Thank you. There are no further questions at this time. I will turn the call back over to Altomari.

That question there are no further questions at this time I will now turn the call back over for 2 all tomorrow.

Alfred F. Altomari: Well, thank you, operator. And thank you, everybody listening in. Yeah, I'd like to close today by saying that we believe we have the building blocks in place for continued growth and remain on track to achieve our near-term goal, which is establishing a presence in this multi-billion dollar hormonal contraceptive market. And I hope you can hear some of the excitement in our voices and that, you know, we believe we're just, you know, on the way on that journey. Number one, we have an approved product that's growing and all the major performance metrics in a valuable market, and we believe we've only scratched the surface.

Well, thank you operator, and thank you everybody listen I'd.

I'd like to close day by saying that we believe we have the building blocks in place for continued growth and remain on track to achieve our near term goals, which is establishing for them.

And this multibillion dollar hormonal contraceptive market and I hope you can hear some of the excitement in our voices that we believe we're just.

On the way on that journey.

Number 1 we have an approved product thats growing and all of the major performance metrics.

And a valuable marketing and we believe it's only scratch the surface.

Operator: And, you know, we're unleashing DTC advertising in a very responsible way. And, you know, we're further developing some of these channels you all asked me about, you know, but in the meantime, our bread and butter is in the retail market. And, you know, we need to continue to get doctors aware of and comfortable writing our products, and particularly those that are already comfortable writing patches. While we're happy with the growth today, we believe there's a lot more on the table.

Surface and we are on leasing you know very in a very responsible way DTC advertising and we are further developing somebody's channel that you won't we estimate about.

In the meantime, our bread and butter is in the retail market and we need to continue to get doctors aware and comfortable writing our product in particular assets that are comfortable already comfortable writing.

Patches.

While we are happy with the growth rate, we believe theres a lot more on the table. So hopefully as we talked in the future you'll hear more about houses. These programs are working and more about our growth.

Operator: So hopefully, as we talk in the future, you'll hear more about, you know, how these programs are working and more about our growth. I'd like to thank everybody for joining us on the call. Be well as always, and we look forward to providing you updates in the future on the advancement of our business in our next earnings call and hopefully seeing each other, hopefully, face to face, and not in the near future. So, thank you, everybody. Be well, and be safe.

I'd like to thank everybody for joining us from our call B wells always and we look forward to providing you updates for the future on the advancement of our business, but our net.

<unk> earnings call and hopefully each.

Each other hopefully face to face masks in near future. So, thank you, everybody and be well and be safe.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

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

[music].

Okay.

Yeah.

Q2 2021 Agile Therapeutics Inc Earnings Call

Demo

Agile Therapeutics

Earnings

Q2 2021 Agile Therapeutics Inc Earnings Call

AGRX

Monday, July 26th, 2021 at 8:30 PM

Transcript

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