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Agile Therapeutics (NASDAQ:AGRX)
Q4 2020 Earnings Call
Mar 01, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


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. [Operator instructions] I'd now like to hand the conference over to your speaker today, Matt Riley, head of investor relations and corporate communications. Thank you. Please go ahead.

Matt Riley -- Head of Investor Relations and Corporate Communications

Hello, everyone, and welcome to today's conference call to discuss 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. 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 in the forward-looking statements. Please refer to our filings with the SEC which are available through the Investor Relations section of our website for information concerning risk factors that may affect the company.

We undertake no obligation to update forward-looking statements, except as required by law. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are Al Altomari, Agile Therapeutics chairman and chief executive officer; and Dennis Reilly, chief financial officer. Following our prepared remarks, we'll open the call to your questions.

Let me now turn the call over to Al.

Al Altomari -- Chairman and Chief Executive Officer

Thank you very much, Matt. 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 patch. Twirla was designed to fill a need in the hormonal birth control market, bringing a noninvasive, non-daily combined hormonal contraceptive or CHC option with a lower estrogen dose than the only other contraceptive patch available in the marketplace today.

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

Our network of three major U.S. wholesalers, as well as several regional wholesalers, have been central toward the initial stocking of Twirla. Moving forward, we believe that our established and growing distribution network will provide the supply chain infrastructure necessary to support the anticipated demand for Twirla. In terms of the commercialization efforts behind Twirla, our planned focus is on three primary strategies for engagement.

First, healthcare professionals or HCPs; second, managed care; and lastly, to consumers. First, our efforts with HCPs. Along with our partner, Syneos, 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.

This sales force has not only been productive in a number of daily interactions with HCPs and their staff but also in generating face-to-face calls. Since launch, we've been able to generate roughly 70% of our prescriber meetings face-to-face in a COVID-19 compliance setting. But the question in all of your minds, I'm sure, is how's the launch going. I'd be remiss 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.

So taking all this into account, the short answer is that we were very happy with the momentum we are seeing and all the indicators of metrics we are monitoring to track our sales force effectiveness. Allow me to try to explain that. Let's start with prescriptions or TRxs. In my mind, we effectively launched our product beginning this year.

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. We're not suggesting this is a sustainable rate for the purpose of modeling or guidance.

We're still in the very early stages of launch. With that said, we are still happy with this start. I also want to comment on the value of a TRx. Importantly, on average, each TRx has more than one unit or one cycle.

The reason why is women get more than one month of supply of Twirla when she leaves the pharmacy. Each TRx is averaging somewhere between 1.3 to 1.4 units or cycles received by their patients. This is in line with our internal planning. Think of this as getting 40 to 45 days of Twirla at one time.

We're monitoring other important metrics. Physicians are prescribing Twirla. We are growing our base and prescribers weekly. Since January, our week-on-week growth is approximately 29%.

The number of TRxs each prescriber is writing is also growing, which was another good indicator. Refills. We're starting to see refills, which is great news. Roughly 10% of the units spent so far at pharmacies are refills, and we expect refills to accelerate as new prescriptions turn into repeat fill.

Ultimately, we are encouraged by the early results from our field representative efforts prior to launch and the continued upward trajectory since, as evidenced by the steady increase in TRx refills. This indicates that providers are willing to write longer prescriptions once the patient is initially successful on the product. Now, to discuss the path. The sampling dynamic is important for Twirla.

We're continuing to offer full month sample supply for patients to ensure individuals who are interested in Twirla have an opportunity to use it after consulting with their HCP. We believe it's important for the patient to ensure that Twirla is the right product for her prior to getting their prescription and moving forward to becoming a long-term Twirla user. Initially, it does slow down the patient flow to the pharmacy in the early days of launch. But we think of samples of an investment that introduces HCPs and their patients to Twirla with the potential to stimulate future growth.

Moving forward, we'll continue to use the insights from our data-driven approach, ACT outreach to refine our targeting to the highest volume practices. 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 Twirla. Now, on to managed care. We also continue to make meaningful progress on both coverage and reimbursement for Twirla in a challenging managed care environment.

We estimate our engagements with third-party payers have resulted in Twirla having achieved approximately 40% to 45% formulary coverage since launch. Notable, this is inclusive of one of the three PBMs or pharmacy benefit managers, as well as several smaller plans. We continue to work toward our goal of increasing formulary access with as much zero co-pay as possible over the course of this year. We also expect that Twirla will be now 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 Twirla and represents another element of our early momentum for Twirla. Please note, these arrangements do not report data through Symphony or IQVIA. Finally, Agile is currently in discussions with specialty pharmacy and telemedicine partners in order to expand the channels that provide access to Twirla. We have said all along we want to follow the patient on her journey and ensure Twirla's available for her along the way.

We recognize the benefits supported by both channels and believe that bringing differentiated value to our business and patients that they both serve. For specialty pharmacy, we prioritized buying a partner that would make Twirla easy for providers to prescribe and convenient for patients to receive Twirla. Today, we're happy to announce our partnership with Sterling Specialty Pharmacy. Sterling has an established organization with patient-first philosophy that matches our ethos.

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 this channel offers patients, we're committed to selecting partners that best align with our strategic needs. We'll continue to explore this area and hope to share more information about this in the near future, about our efforts and developments in telemedicine. Now, on to consumer engagement.

As a company, we're focused on and committed to providing providers that fulfill the unmet need of today's women. As part of this, we believe it's important to break the sigma 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 unbranded campaign was launched in September of last year, roughly 700,000 women have engaged on our website content via displayed and paid social efforts, which is to empower them to join into birth control conversations. We're happy to note that we're breaking the contraceptive category mold by being the first unbranded birth control awareness campaign to activate on Tiktok, the most downloaded app in 2020.

I'm proud of these efforts and we'll continue to explore developing partnerships with popular lifestyle influencers and credible content providers to further advance the I'm So Done campaign. We believe these educational efforts are an important component and a driver of the continued awareness to support the ongoing growth of Twirla among our target market. Learnings for the unbranded campaign translate well into the development and launch of Agile's branded campaign for Twirla, a direct-to-consumer or 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 300,000 engagements from our pay 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 I'm So Done or Twirla social media paging and profile to the respective unbranded and branded websites. We are not focused solely on building followers or accumulating likes on Instagram or Facebook. We want to see real, meaningful engagement with the content and information on the I'm So Done and Twirla 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 stemming from Twirla strengthening its presence in the marketplace. Our organic growth will be supplemented by our funding efforts, which I'm pleased to announce have 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 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.

In summary, we executed on our fourth-quarter 2020 plan with the launch of Twirla and look forward to continue to educate and expand the prescriber and consumer bases on the differentiated benefits of Twirla as we seek to continue growing market share. I'll now turn the call over to Dennis Reilly, our CFO, who will provide an overview of our financial results and the financing update. Dennis?

Dennis Reilly -- Chief Financial Officer

Thank you, Al, and thank you to everyone for joining us today. I share Al's excitement in 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 pandemic, we remain focused and continued to execute on our commitments which culminated in the December launch of Twirla. 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. This reflected the initial stocking of Twirla by wholesalers. 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.

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 attributed to the validation work we did for commercial manufacturing of Twirla by Corium, 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 $1 million a year ago, while full-year expenses were $23.3 million, versus $1.1 million in 2019.

The notable year-over-year increased results from costs associated with our pre-commercialization activities for Twirla, 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 $7.9 million in 2019. This increase in G&A reflected activities related to building out the support infrastructure, including higher personnel costs, professional fees, and the related stock compensation expense.

We ended last year with cash, cash equivalents, and 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 Twirla with sufficient cash on hand to meet our projected operating requirements through 2021. 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 Advisors.

In February 2020, 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 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 of '22. Again, it's contingent on us reaching a predetermined revenue target. So in total, we received in $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 finances.

Importantly, this capital enables increased financial flexibility and optionality for the Agile business. We're focused on remaining disciplined and nimble in our approach and are committed to making the right investment at the right time to ensure strategic growth and maximize shareholder value. Our team is excited for 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 stakeholders.

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

Questions & Answers:


Operator

[Operator instructions] Our first question comes from Randall Stanicky with RBC Capital Markets. Your line is open.

Dan Busby -- RBC Capital Markets -- Analyst

Hi. This is Dan Busby on for Randall. First question. Now that you've been on the market for a few months.

I just wondered where you're seeing the greatest uptake thus far among women. Are they switching from the pill, which is from Xulane? Is it from contraceptive naive women?

Al Altomari -- Chairman and Chief Executive Officer

You're breaking up. I'm sorry, you're breaking out. Could you just --

Dan Busby -- RBC Capital Markets -- Analyst

Oh, sorry. Yeah. Is this better?

Al Altomari -- Chairman and Chief Executive Officer

Awesome. Yeah. Thank you.

Dan Busby -- RBC Capital Markets -- Analyst

OK. 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 pill, Xulane? Contraceptive naive women? And second, from a physician prescribing perspective, what's the biggest pushback done thus far?

Al Altomari -- Chairman and Chief Executive Officer

Sure. Well, the first one doesn't really -- thanks for the question, sorry. The first one doesn't really surprise us very much. 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 had said. That's where we'd expected 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 one.

So that's not a surprise to us, but again, early days, and we'll keep you updated on all that. Pushback, I think the biggest thing we face is, again, what we'd expected in our market research, a little bit of out of sight, out of mind. A lot of physicians, and the OB/GYNs in particular, had not really used the patch mainstream for a number of years. So it's kind of getting it from the back quarter of their mind into the front of their mind, that now our patch, Twirla, can be a frontline method.

So I don't want to say ambivalence, but it's a little bit of out of sight, out of mind. So we're excited to bring this patch out and kind of bring them back into mainstream. But I think that's initially the first challenges to our reps. And both 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 there.

Dan Busby -- RBC Capital Markets -- Analyst

Yeah, that's helpful. And if I could ask one follow-up. Last week, we saw a second generic ortho ever approval. I'm just 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?

Al Altomari -- Chairman and Chief Executive Officer

No. I think your note that you sent out -- here Randall sent out, I think, summarized the company's feelings, too. It's really our issues or our challenges with the patch or opportunities are still the same. The new approval is another form of ortho ever.

It's got the same label as Xulane does. I should note -- and I think we pointed this out to the Street a few times. And after our approval, their label also reflects the BMI contraindication over 30. So we're all on an equal playing field.

And I think that's been 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 in their labels, so both products now are going to be the elevated estrogen level. So I think the competitive challenge is still the same for us. We need to differentiate our product both with our physicians, with women, and also in managed care.

And we feel like we have a great story. 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 patches. But we'll keep an eye on it, and we'll keep you posted, but that's our initial read. It's another form of Evra, same labels, no differentiation label, and we still have a very competitive difference that 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.

Dan Busby -- RBC Capital Markets -- Analyst

Got it. Thanks a lot.

Al Altomari -- Chairman and Chief Executive Officer

My pleasure. Thank you.

Operator

Our next question comes from Oren Livnat with H.C. Wainwright. Your line is open.

Oren Livnat -- H.C. Wainwright -- Analyst

Hey, guys, I apologize I didn't sit there at the very beginning of the call, but I assume you could help me out. A couple. So can you just help us understand what you're seeing? I know it's really early, but you mentioned sampling, and you mentioned leading indicators. I'm just wondering, what can you tell us with regards to that demand that we don't see yet that you do see? How about dispensed 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 offs where necessary or help them work through those medical waivers for ACAs? Is there anything you can help us with on that front? I have a follow-up.

Thanks.

Al Altomari -- Chairman and Chief Executive Officer

All right, sir. No problem, Oren. No. I think every indicator we're looking at, both hard indicators, and I'll call them softer indicators look good to us.

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 accrue every week, who are new doctors that are writing. Are the productivity of doctors going up? Is it a one-and-done prescription? 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 the volume of refills because any one patient could theoretically be 13 units a year to what it's been talked. So all of 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. So doctors converting to scripts, 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 refills, which is a good sign.

So we like that. And then the softer indicators that you were mentioning, we know they're quantifiable. The number of calls we're getting at the medical affairs. You mentioned the hubs.

But just question doctors are asking, they're requesting literature from us, which is great. There are doctors that were not calling now are calling for samples, which is great, which means our advertising to doctors is working. So there are some of the things. And then as you mentioned, the last, but certainly not least, the reps.

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 get their 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.

I know it's the end of a month, but effectively, we probably had one good pass, maybe two passes at offices, a lot of practices are under group practices. 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. Look, it's significantly more samples than put out than we have prescriptions for at this point.

So samples are, as I mentioned on the call, and we think of it like an investment. And so everything seems to be pointing north. The weather would cooperate, and everything would settle down a little bit around the country, that would make our job a little bit easier. But with that said, we pushed through.

Oren Livnat -- H.C. Wainwright -- Analyst

All right. Clearly, we can't build a model on 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 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 a true prescription pull-through kind of situation, right? And then I have a follow-up on managed care.

Al Altomari -- Chairman and Chief Executive Officer

Yes. I wish I can guide you when we can guide ourselves. I mean, on the kind of the return on sample investment, I could tell you, if you just think about 73 people calling on doctors and they make multiple calls per week. Just try to put your mind around six or seven weeks of sampling and the number of offices you think we've seen.

So that will give you an idea of the volume samples that are out there. But again, they haven't turned enough. We haven't just been able to establish our own model, if you will, 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 turn around and do write the product.

So that's a good thing. So we're all in 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.

And this is one of the areas that in a COVID environment, not being able to see the sample closets and watching it turn does get in our way a little bit, because when we turn over to sample jobs to 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. So on that one aspect of the launch is where our hands are a little tied behind our back.

Oren Livnat -- H.C. Wainwright -- Analyst

All right. And then just quickly on managed care. I don't think Xulane is obviously the biggest source of prescriptions, probably the tens of millions of pills like you've said in the past. But where do you stand in your 40% to 45% coverage with regards to Xulane, whether it be parity or ahead of them? I'm trying to understand for that initial wave is there any hurdles to someone prescribing, getting reimbursed for your product vis-a-vis Xulane, 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?

Al Altomari -- Chairman and Chief Executive Officer

You know, most of our -- where we're on formulary, Oren, I believe this is my memory. So I believe in most situations, we're on at parity. So in other words, a doctor more than likely can write both brands. And actually, that's something we kind of target to the plans.

We believe kind of we have to walk the talk. We believe in giving women choices and doctors choices. So for instance, Oren, on the GPO, we just were awarded. There on there with us.

So if we don't believe we can get a doctor to write our prescription, we've been -- that's a different problem, right? So we're just saying, put us on with it, gives me an even shot. So in general, that's our position. In general, that's what we see their plans. A lot of the plans don't want to talk to us, quite frankly, because it's a little early in the launch, and we just don't have enough beach at of volume, so we would expect to keep growing.

And we're just going to -- like we did with the GPO. We're going to pick off big pieces of volume that doesn't necessarily run through IQVIA or Symphony. So this is a closed system we picked up, so we're just going to keep following the women on her journey. Where she goes, we'll go and try to open those markets.

But in general, to answer your question, we're parity with them. And then as I mentioned with the earlier call, most of our volume isn't coming from -- very little of our volume is coming from a Xulane patient. They really coming from pill patients. So that's why we don't care as long as we're in there and we can generate volume with a doc, that's all we care about.

Oren Livnat -- H.C. Wainwright -- Analyst

All right. Thanks, guys.

Al Altomari -- Chairman and Chief Executive Officer

Thank you.

Operator

Our next question comes from Leland Gershell with Oppenheimer. Your line is open.

Leland Gershell -- Oppenheimer & Co. Inc. -- Analyst

Thanks for taking my question and congrats. First question, just in terms of the type of patients you're getting onto Twirla. 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 just kind of trying to get a sense of -- is there kind of a sweet spot in terms of the type of women who's coming onto Twirla that you're seeing? I know it's early days. And then I've got a follow-up.

Al Altomari -- Chairman and Chief Executive Officer

Yes, Leland. I mean, thank you for the question. Yes. 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. Yes, they tend to be women that have come off the pill so I would say the initial uptake is more in the 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, the contraceptive market.

Again, that doesn't surprise us. I think where we would like to see doctors use the product -- clearly, we like doctors using the product even on switching patients, if you will. But we'd like to see some more of the new patients that are naive the therapy if you will, the new Star patients because we think that's kind of an easier ask. But right out on sheet, sitting in the middle of bell curve, as you would expect.

We've seen not a lot young, not a lot older, that's sitting in that kind of experience user of pills. So that's what we're seeing out of the chute. But we'll see if that changes over. That's what our models suggested we would get.

So I'm not surprised, but we're going to keep a look at it. That's the best read 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 then it's thick and that it's coming from around the country, right? So the good news is it's not coming from one region.

It's just not one doctor, if you will, or one geo-target. 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 the doctors. So the lack of consistency on that one, Leland, makes me excited.

That's what we see so far. We're going to keep looking at, and if it changes, we'll keep you updated. But that's what we see in the early days.

Leland Gershell -- Oppenheimer & Co. Inc. -- Analyst

Thanks. And then just, actually, two 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. It's early days, again, but just looking at the gross-to-net, you're running kind of at 25% and maybe, Art, it's actually 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.

Al Altomari -- Chairman and Chief Executive Officer

So, Dennis, I'll take the first part and you can close out for Leland. So, yes. So, Leland, yes, I mean, you should expect that we're going to follow the business, right? So in the commercial channel that we see in IQVIA and Symphony, that really are the commercial books of business. And 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 women go, we're going to follow them. When it's kind of a state level, the Medicaid can be important to us, depending 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 student health centers. And so if that's where her journey takes us, we'll follow her. So I guess the answer is yes, you should expect us to keep trying to win strategic books of business that we can bring Twirla to.

So I hope that makes sense, but more to come. But we've got one in the boat, so we're going to keep trying, Leland. But we were excited to get such a big one early. Dennis, do you want to take a shot at the gross-to-net?

Dennis Reilly -- Chief Financial Officer

Yes. 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 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 could take us -- and that's where I get into the mid-30s.

It's a mixed bag. But if I was 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.

Leland Gershell -- Oppenheimer & Co. Inc. -- Analyst

Terrific. Thanks. I appreciate the additional color.

Operator

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

Unknown speaker

Hey, guys. This is Larkin on for Tim. 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 IQVIA and Symphony that give us a good sense of how prescribing is going? And secondly, I guess, you mentioned the pipeline briefly in the prepared comments. Can you sort of expand on that? What are you thinking? When should we start to see an uptake there?

Al Altomari -- Chairman and Chief Executive Officer

Sure. Yeah, that's two very good questions. So the first one, as far as samples, it's interesting. We don't point this out, but Xulane where they do sample, they give one patch out to a woman.

So one week of therapy. We give out a full box, which is a trade cycle on a factor of three -- it's a month, right? We're giving away a month at minimum. So if you think about it, we know doctors often give out more than one month. We don't want to oversample, but we not, on average, it might be closer to two.

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 on the first quarter and the early days of launch. We think we had a good month or two ahead of us of heavy sampling. We're actually happy, as I mentioned, with the trajectory of the brand with -- that's actually getting to retail because our reps are really just battling through some of the -- I mentioned some of the challenges they've been facing, but really have just been in front of the doctors a handful of times. So we know we need to be in front of them a couple more times.

So I think what we see is that there's this sampling phenomenon is going to last, I think, into at least the first quarter. That's why we've been without -- to be inexplicit, we just think the first quarter from a TRx point of view is going to 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 the March -- and then we kind of outgrow it a little bit, I think. So I think we're in it for at least a quarter, maybe in the early second quarter, but that's as best we could see because I think it's just math.

We give out at least one month, maybe two. We've seen them in January. That means if they wrote a prescription, they're not going to pharmacy up to March. So I think we've got to work past, at least that first bolus into the first 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, we're targeting group practices, but we're influencing only a couple of the doctors at a time. So there's still a lot of opportunities inside the practice. So we still have got to expand our beachhead of doctors and then obviously work for the samples.

As far as the second question of the pipeline, I'm very excited about the work Dr. Korner has been doing. Paul Korner has come in. And he's kind of take 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 want to bet on them. But I think before we get in front of you, what we really want to know is that there's a buy-in with the FDA on the path forward. So phenomenal amount of work.

[Inaudible] a lot of things, so you probably know more about our pipeline in your short time here than the company has known because we spent so much of our effort on Twirla. So he's taken a fresh, very healthy look at our pipeline and done some great technical work. And Amy Welsh, our head of marketing has some great consumer insights and physician insights. And we're going to try to marry all that up with some FDA feedback and say, OK, this is the bet we want to make.

So the short answer to your question, I think it's going to be into the second half, hopefully, before we 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's inherited, and he would tell you it himself, a lot of tough choices. All of our three programs peer viable and peer exciting.

So I think if anything, prior to sizing them in the early days of a company like ours is going to be the biggest challenge. So more to come, more realistically to second half.

Unknown speaker

Thank you.

Operator

Our next question comes from Naz Rahman with Maxim Group. Your line is open.

Naz Rahman -- Maxim Group -- Analyst

Hey, guys, congrats on the launch. I just had a few questions on the 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 co-pays? Or are you guys bringing them down with the co-pay assistance cards? Or has anyone actually had to pay out the pocket so far based on what you know?

Al Altomari -- Chairman and Chief Executive Officer

Yeah. Good question. I mean, I think we're going to keep, I think, chipping away at this, Naz. I mean, we would like to -- the big bolus could happen if we can get the second and hope for 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 to kind of an upwards climb and picking up lives. There's still a lot of business out there that we can control and we're getting. Because remember, while the PBM's influence a lot of the planned decisions, we also are mindful in certain states, for instance, the state mandate supply.

So we see another PBM is under contract. We're picking up plans under it, if you know what I mean, in certain we're the point in saying, look, my state, I'm going to cover it. So that's good news. So I think you should expect kind of like incremental new release from us as it's incremental pickups if you will.

And then what we're seeing as far as coverage, I mean, we haven't seen a lot of cash out of pocket, to answer your question. So we've experienced a significant amount of the plans that already picked us up at zero co-pays. And there's some co-pays involved. We do have a co-pay program that does help.

But so far, we've not been two of our SEs with co-pays, and we're not seeing a lot of cash. Now, cash could mean they got scared off, too, because even though I haven't seen it, they could have gone to the pharmacy and say, 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 this as we get there. But a lot of zero co-pays -- the co-pays that are -- the plans are required-- a lot of them don't look that onerous for us, and we're willing to help out a little bit.

This is where sampling happens. And then on the Affordable Care Act, the last piece of the complicated puzzle is 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 to offer one oral, 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. And then once they free up that patient, they should be good for the length of her therapy.

So we're seeing all of the above. I haven't seen that much cash, but I'll take a look at after the call, make sure I'm on good ground.

Operator

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

Al Altomari -- Chairman and Chief Executive Officer

Great. Thank you, operator. I'd like to just close out just by saying that 2020, obviously, was a very important year for Agile. Despite the widespread impact of the pandemic, we're able to persevere, and we continue on our plan and importantly, accomplishing our goal of launching Twirla, 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 Syneos to develop our sales force.

Finally, despite the inherent challenges in the pandemic operating environment, we're able to address an unmet need in phase market with the launch of Twirla. I'm incredibly proud of the hard work and the 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 need.

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 Twirla and look forward to continuing this trajectory as we work toward our goal of becoming a leader in women's health. I'd like to thank everybody for joining on today's call.

I know it's a busy season for you all. 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.

Operator

[Operator signoff]

Duration: 47 minutes

Call participants:

Matt Riley -- Head of Investor Relations and Corporate Communications

Al Altomari -- Chairman and Chief Executive Officer

Dennis Reilly -- Chief Financial Officer

Dan Busby -- RBC Capital Markets -- Analyst

Oren Livnat -- H.C. Wainwright -- Analyst

Leland Gershell -- Oppenheimer & Co. Inc. -- Analyst

Unknown speaker

Naz Rahman -- Maxim Group -- Analyst

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