TherapeuticsMD Inc (TXMD) 2018 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and thank you for joining us for the TherapeuticsMD's Third Quarter 2018 Financial Results Conference Call. Following prepared remarks from the company, we will open the call for questions.

I would now like to turn the call over to TherapeuticsMD's Vice President of Investor Relations, Nichol Ochsner. Nichol?

Good afternoon, everyone. Thank you for joining today to discuss the third quarter 2018 financial results and business update.

This afternoon, TherapeuticsMD issued a press release announcing our third quarter financial results. The press release is available on the company's website, therapeuticsmd.com, in the Investors & Media section.

On today's call are Chief Executive Officer, Robert Finizio; Chief Financial Officer, Daniel Cartwright; Co-Founder and Director, Dr. Brian Bernick; Chief Commercial Officer, Dawn Halkuff; and Chief Medical Officer, Dr. Sebastian Mirkin.

I would like to remind everyone that certain statements made during this conference call may contain forward-looking statements. Such statements are based upon current expectations, and there can be no assurances that the results contemplated in these statements will be realized. Actual results may differ materially from those statements due to a number of factors and risks, some of which are identified in our press release, our annual, quarterly and other reports filed with the SEC. These forward-looking statements are based on information available to TherapeuticsMD today, and the company assumes no obligation to update statements as circumstances change.

An audio recording and webcast replay for today's conference call will also be available online in the Investors & Media section of the company's website. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded November 7, 2018.

With that, I'll turn the call over to TherapeuticsMD's CEO, Rob Finizio.

Thank you, Nichol.

In 2018, we delivered 3 new drug approvals, a significant achievement for any sized pharmaceutical company. Our first approval was for IMVEXXY, our bio-identical vaginal estrogen product that contains the lowest approved dose currently on the market for the treatment of moderate to severe dyspareunia, a symptom of vulvovaginal atrophy due to menopause.

The second product approval was for ANNOVERA, the first long-acting prescription birth control that is patient-controlled, procedure-free and reversible, providing 1 year of protection from pregnancy.

And most recently, the approval of BIJUVA, the first and only FDA-approved hormone therapy of bio-identical estradiol in combination with bio-identical progesterone for the treatment of moderate to severe vasomotor symptoms, commonly known as hot flashes due to menopause.

Since launching IMVEXXY in August, we're seeing strong momentum and a fast ramp to paid prescriptions. We've taken a financially disciplined approach to promotion, focusing our efforts on market access as well as health care provider offices to drive awareness, adoption and adherence to maximize the value of every patient.

Based on data acquired through our copay assistance programs, total IMVEXXY prescriptions through October were approximately 28,200 paid units dispensed to approximately 12,800 patients. I'm very happy to say, in September, we had approximately 8,400 paid scripts; in October, we had approximately 13,300 paid scripts, which reflects an increase of 58% month-over-month growth. From a compliance standpoint, that translates to 2.2 fills per patient. The average for the previous 2 dyspareunia product launches during the first year was 1.7 fills per patient. In our first 4 months of launch, this early data suggests that we are already exceeding patient compliance with 2.2 fills per patient. These results parallel Vagifem's initial launch in 2000. You can see that we aligned with Vagifem's first 4 months in unit sales on the slide being displayed currently.

Moving forward, our goal is to parallel Vagifem, both unit volume and scale, even though it was launched before 2000, when the WHI was not out yet. They also had a much more agreeable payer environment. As you can see on this slide, Vagifem's scale was significant, and we are looking to achieve a similar launch in the coming months and years with a product that is even more differentiated and more innovative.

I'd like to turn the call over to Dan, our Chief Financial Officer, to provide a financial update.

Thanks, Rob.

Third quarter 2018 financial results are included in the press release issued today. Let me summarize a few key points. Net revenue from the company's prescription prenatal vitamin business was approximately $3.3 million for the third quarter of 2018 compared with approximately $4.4 million for the third quarter of 2017. This decrease was mainly attributable to a lower number of units sold and higher utilization of coupons in 2018 for our prenatal products.

We launched IMVEXXY, our FDA-approved product, for moderate to severe dyspareunia due to menopause during the quarter. For the quarter, approximately 14,900 units of IMVEXXY were dispensed by pharmacies and paid for by patients with an average WAC sales price of approximately $230. The large discrepancy between WAC and net revenue is mostly due to patients receiving copay assistance from the company. Copay assistance helps patients when their insurance does not cover the full purchase of our drug. When the patient's insurance company starts to pay for the prescription, the company's contribution to the copay assistance will be reduced to an amount near 0. As insurance companies start covering IMVEXXY, we expect our net revenue to increase proportionally to the insurance coverage. As such, in line with our expectations, net revenue for IMVEXXY was only $0.2 million for the quarter, which is significantly -- which was significantly impacted by our copay assistance program driven by our maximum out-of-pocket cost to the patient of $35 per prescription. We expect this period of maximum copay assistance to be relatively short-term phenomena.

Now that we have delivered the scripts and we see good growing demand for the product, we are turning our attention to ensuring that insurance companies pay for IMVEXXY. Our goal for the remainder of 2018 is to complete the contracting process with the remaining large payers in the commercial space. Once completed, we believe our IMVEXXY scripts will translate into higher revenue as insurance companies begin to pay for IMVEXXY through the adjudication process, reducing the amount that TXMD has to pay. We expect you will begin to see this change in our net revenue in Q1 of 2019.

Total operating expenses for the third quarter of 2018 increased compared to the third quarter of 2017. These changes primarily reflect an increase in commercialization expenses for the launch of IMVEXXY during the quarter.

SG&A expenses for the third quarter of 2018 were approximately $30.4 million compared with approximately $12.1 million for the prior year's quarter. This is primarily due to higher sales, marketing and personnel cost to support the launch and commercialization of IMVEXXY for the third quarter.

R&D expenses during the third quarter of 2018 were approximately $6.7 million compared to approximately $6.4 million during the prior year's quarter.

Turning to the bottom line. Our net loss for the third quarter of 2018 was approximately $35.6 million or $0.16 per basic and diluted share compared with approximately $14.7 million or $0.07 per basic and diluted share for the third quarter of 2017.

Our cash position remains strong. We finished the third quarter of 2018 with approximately $190 million in cash compared with approximately $154.4 million at June 30, 2018.

We raised a net amount of $89.9 million in an equity offering in August 2018, of which $20 million of the net proceeds were paid to the Population Council to license ANNOVERA, our 1-year contraceptive vaginal system.

For the third quarter of 2018, our cash utilization for operations was $34.1 million. As of September 30, 2018, we had approximately $75 million in debt from our nondilutive term loan financing with MidCap Financial with an overall effective rate of approximately 10.9% as of September 30, 2018.

Following our planned launch of BIJUVA before the end of May 2019, we have the option to draw down an additional $75 million as part of the second tranche of our term loan with MidCap.

Let me turn the call over to Dawn, our Chief Commercial Officer, to provide an update. Dawn?

Thank you, Dan.

On the commercial front, we have made significant progress. As Rob mentioned, we are extremely pleased with the momentum of the IMVEXXY launch, which is exceeding other recent non-estrogen dyspareunia launches.

As important as knowing what we have delivered to date and that IMVEXXY is tracking with the Vagifem launch is showing that our growth is sustainable. Let me share some important metrics.

The first is the number of health care practitioners that are writing. To date, over 4,200 prescribers have written a prescription for IMVEXXY. We see this number go up every week. In addition, the differentiated product and the patient support programs are driving positive perception and future intent to prescribe. This is exactly what you want to see at this stage. Early adoption and enthusiasm, positive perception of the brand and the intent to increase prescribing. That drives sustainable growth.

Now let's move on to patients. Last week, over 2,000 new patients received an IMVEXXY prescription. Total patients that have received a prescription are approximately 12,800. Each patient has filled an average of 2.2x, which is impressive given we are only into the fourth month of launch. As a reminder, the current annual fills per year for vaginal creams is 1.5 and vaginal tablets or Vagifem at 3.5 fills per year.

As with total prescriptions, we are tracking with and expect to exceed Vagifem on fills. Establishing patient adoption and adherence to therapy resulting in refills is what will drive expansion in total prescriptions and our net revenue, once our payer coverage has been fully established.

A major focus of our commercial model is to ensure that once we capture patients, that we keep them for the appropriate length of therapy. That will expand the market for IMVEXXY. That is exactly what we are doing.

So now let's look forward. What is going to continue the launch momentum?

A part of that is continuing the winning formula that we have established, a focused and motivated sales organization, delivering differentiated messages, being pulled through with copay and adherence programs. The initial launch focus in office to drive HCP awareness and adoption, along with the focus on adherence programs to increase the value of each patient, was purposeful to lay the groundwork for expansion.

Additional momentum will come from 2 key areas: first, the expansion of our sales force in the first quarter to support the BIJUVA launch, which will also expand our reach for IMVEXXY; second, we will launch our consumer marketing efforts for IMVEXXY in the beginning of 2019.

Finally, let's talk about what we believe is going to drive net revenue in early 2019: fully established payer coverage. We are near the end of the expected 6-month commercial payer block. Once this block lifts, you will see the step change in our net revenue, which as Rob mentioned, we anticipate occurring in early 2019.

Before I turn the call over to Brian, I want to briefly discuss BIJUVA and ANNOVERA. As mentioned in our last call, we plan to launch BIJUVA in the second quarter of 2019. We will follow the same approach as IMVEXXY by spending the time to get to know our customers in Q1 that helps us position BIJUVA correctly so that we are poised for the same fast ramp as IMVEXXY. We expect the same 6 months payer block for BIJUVA while negotiating with commercial payers. And very importantly, after contracts are signed, there can be up to a 90-day delay for plans to add BIJUVA to formulary and adjudicate at the pharmacy.

Following the launch of IMVEXXY and BIJUVA, we plan to launch ANNOVERA in the fourth quarter of 2019. As the first approved contraceptive product in the vaginal system class, the Affordable Care Act should mandate no out-of-pocket cost for patients.

To wrap it up, this market is responding as we expected, and initial prescriptions of IMVEXXY are delivering on the plan we laid out last year. With IMVEXXY, we spent the time to understand our customers. We presented them with a differentiated product that met prescribers and patient needs. We supported our initial plans with a WAC that was at parity with the existing products in the category to ensure we could deliver on open access, and we paired it out of the gate with a patient support program that would deliver on driving adoption and adherence so that we have the opportunity to grow the overall prescriptions in the category. The model is working. The potential is clear now, and we will follow the same model with BIJUVA.

As a reminder, I've delivered in this market before at Pfizer with the Premarin franchise, with products that were old with less-than-ideal experiences for the patient or the provider, and I am thrilled to be running the TherapeuticsMD franchise that can re-energize these markets with products that deliver progress.

I will now turn the call over to Dr. Bernick to discuss the clinical aspects of BIJUVA and ANNOVERA.

Thank you, Dawn.

The significance of our 3 approvals clearly positions TherapeuticsMD as a leader in women's health. As you have heard, in just a few short months, IMVEXXY's successful launch has been built on the simple message of an elegant soft gel vaginal insert that doesn't require an applicator, a mess-free administration, unlike the messy creams. And with only 2 times a week maintenance dosing that can be dosed any time of day and with the clear message of affordable pricing, IMVEXXY easily resonates with both health care providers and women.

With respect to BIJUVA and ANNOVERA, there has been years of pent-up demand for both of these products.

Starting with BIJUVA, as we have said repeatedly, women and their health care providers are demanding bio-identical hormone therapy to the tune of an estimated $15 million to $20 million annual prescriptions of both compounded bio-identical hormones and a separate estradiol and progesterone hormones filled annually in the United States that are not FDA approved to be used together to treat menopause-related vasomotor symptoms. Likewise, for compounding pharmacies, BIJUVA should significantly improve the net margin per script with third-party reimbursements and lower their legal and regulatory costs and risks. With this demand, we are well positioned with the only FDA-approved bio-identical combination product to meet the needs of women, their health care providers and pharmacists.

One of the most exciting features of BIJUVA is how the solubilization of estradiol and progesterone has led to significant improvements in the number of secondary endpoints that are normally -- are only associated with transdermal estradiol products and oral progesterone products. Excitingly, BIJUVA demonstrates the desired favorable lipid, coagulation and metabolic profiles as well as improvements in both the quality of life measures and improved sleep parameters that are typically only seen with a transdermal estrogen and an oral progesterone.

These features suggest that this product should obviate the need for using separate products or compounded products.

I want to address a few things that have been brought up with respect to the BIJUVA approval and label.

The first is with respect to the post marketing commitments to further develop and validate our in-vitro dissolution method. This is only for showing manufacturing consistency between batches of how the drug is released from the capsule in an in-vitro setting for quality control assessments. There is no threshold requirement, and this is almost complete, and we expect to submit the final report next month, ahead of schedule, to enable our launch as planned.

The next thing I would like to address is the one dose approved by the FDA. Given the safety and efficacy demonstrated for the 1 milligram estradiol, 1 milligram progesterone, there was no reason for an additional dose. As the only approved bio-identical combination of estradiol and progesterone, this is the lowest-approved dose. Moreover, this is a bio-identical story, not a dose story, as it is the only approved bio-identical combination dose to satisfy the demand of this enormous market of up to 20 million annual prescriptions of unapproved bio-identical estrogen and progesterone used together. And our research shows that the 1 milligram dose is the dose health care providers, compounding pharmacies and women prefer. We believe that we can get the majority of the market that represents over a $1 billion opportunity.

I would also like to address the BIJUVA label, where the FDA has changed the label approach and included new statements.

With respect to the language of a clinically meaningful reduction of 14 hot flashes per week occurring at week 5, it is important to understand that this is consistent with the data from other products on the market today. Further, we prespecified and used the same methodology of clinically meaningfulness that was established -- that established the approval of the other products used to treat vasomotor symptoms, and it was achieved at week 4 and sustained through week 12. This, however, is not going to affect the prescribing or the use of the product.

In short, BIJUVA is a highly differentiated product in a large market that will help meet the needs of women, their prescribers and pharmacies.

Now let me move on to ANNOVERA, which I feel has been significantly underappreciated and underestimated.

As you know, on August 10, the FDA approved ANNOVERA as a new chemical entity and is the first and only patient-controlled, procedure-free, 1-year contraceptive vaginal system.

As an OB/GYN and women's health provider, I must provide the feedback from my colleagues about the importance of ANNOVERA, in that it will allow women access to long-term reversible contraception without concerns of a procedure, and it will be acceptable for nulliparous women and those women who are not in monogamous relationships, who are often counseled against the use of current long-term IUDs that are inserted into a woman's uterus due to the potential increased risk for pelvic inflammatory disease and potentially infertility. Other positive feedback is that ANNOVERA offers lower doses of contraceptive hormones, and with its controlled release delivery via the vaginal route, it avoids daily fluctuations in hormone levels. And with this new progestin segesterone acetate, it lacks androgenic, estrogenic or glucocorticoid effects and provides excellent cycle control. In fact, there is great interest from the medical community to study this product as first-line therapy for both endometriosis and fibroids instead of birth control pills given the 1-year controlled-release delivery system.

I cannot emphasize what overwhelming feedback and support we have had from women, health care providers and institutions like the U.S. Military, all who are anxiously awaiting ANNOVERA that will allow women to be in control of both their fertility and menstruation while protecting against unintended pregnancy for 1 year.

The approvals of all 3 of these highly differentiated products has earned TherapeuticsMD the reputation of being the new leader in women's health.

And with that, I will turn the call back over to Rob, who will provide some concluding remarks.

Thanks, Brian. As you can see, IMVEXXY is growing as planned, and we expect the growth to continue as we strive to mirror Vagifem's launch. However, we believe there will be an even greater incentive to prescribe, fill and use BIJUVA as it uniquely offers patients, providers and pharmacies strong clinical, economic advantages and lowers regulatory risk for pharmacies and providers. Economics are a major driver in health care today, and BIJUVA makes economic sense for all constituents.

Finally, ANNOVERA, our annual contraceptive ring, is a highly differentiated product that has the potential for no patient copay and could save insurance companies 20% to 30% when compared to NuvaRing, assuming we price approximately $1,400. Clinically, ANNOVERA changes the entire dynamic for the long-term birth control market. At approximately a $1,400 price point, ANNOVERA can create a significant amount of free cash flow for TXMD and will be our cleanup hitter when launched behind BIJUVA and IMVEXXY.

In closing, we have just completed approval of 3 new branded products. Each product has the potential of significant revenue. We have accomplished this with approximately $500 million in equity financing in just under 7 years. IMVEXXY is exceeding the ramp and unit expectations. As planned, in a short period of time, payer adjudication should convert IMVEXXY sales into revenue, followed by the launch of both BIJUVA and ANNOVERA.

As you can see, we are executing in line with expectations and could not be happier with the progress we have made this year.

We'll now open up the call for Q&A. Operator?

(Operator Instructions) Our first question comes from Ken Cacciatore from Cowen and Company.

A couple of questions, one kind of specific. As you work through the payer negotiations on IMVEXXY, just wondering on the gross net normalization, are we still looking at about $100? Is there anything kind of changing in those discussions? Or maybe a little bit of just feedback on how that's progressing and where normalization shakes out. And then from the sales force, it clearly looks like a great launch. These metrics look fantastic. But any learning or feedback you can give us from the sales force in terms of refinement or messaging changes you're learning? Some folks are having success. Others aren't. So maybe just a little bit of feedback from what the sales force is telling you. And then BIO-IGNITE for BIJUVA, any update on compounders? Just kind of give us a sense of at launch, where we think we may be in terms of folks that you've contracted with?

Ken, we're going to hand it to Dan, our Chief Financial Officer, for the margin questions, Dawn for the sales rep questions, and I'm going to speak about BIO-IGNITE. Okay? Go ahead, Dan.

Ken, currently, with our -- in the current market, we expect the commercial payers to be -- around 60%, we believe, is a good number. So your $100 is pretty accurate.

Net 60%?

Net 60%, yes.

Yes. Ken, we're well into the payer contracting process and -- in the commercial side and just have a couple more of the bigger ones to close up here throughout the remainder of '18. And we don't see any reason on the commercial side it will be anything lower than 60% net to the company. Okay? Dawn?

Sure. Ken, this is Dawn. In terms of the sales force refinement question, so I think the first thing to say is, just to repeat, the sales force has done a phenomenal job in getting fast ramp out there. And if you remember, what we put out there in terms of messaging was really around this concept of redefining relief, which really combines the patient experience along with the efficacy and safety data. And so I wouldn't say there is anything that they are learning that we have to completely shift the message. What we're really learning now is those that focus more on the clinical side versus those that really supercharge on the patient experience. And so it's really just adapting to what they're hearing from their customers so that they can continue getting those initial prescriptions into repeat writing, and we're seeing that.

Ken, Rob. So as far as BIO-IGNITE goes, things are going very, very well. We will give an update -- a comprehensive update on BIO-IGNITE in February, which is our Q4 conference call, because we're getting close to the BIJUVA launch. So we were not going to get a lot of detail going today, but I can assure you that you'll be pleased when you see it. And there's a number of reasons for that, and we'll definitely hit that in February on our earnings call.

Your next question comes from the line of Chris Schott from JPMorgan.

This is actually Katerina on for Chris. So I guess, my first question is, zeroing in on like the compounding opportunity for BIJUVA. How substitutable dosing-wise and administration-wise do you think your product is in terms of, like, do you think most patients right now are taking pills versus like creams, gels and like, I guess, touch upon that. And my next question is, I guess, are you expecting for BIJUVA a faster launch curve versus for IMVEXXY or a slower one?

Sure. So Katerina, this is Rob. So as far as BIO-IGNITE goes, in the route of administration, the beauty of BIJUVA, as Brian spoke about, and we'll have a slide out on this, the panels, and I'll have Sebastian speak on these panels here in a second, the orals due to the solubilization of the estradiol and progesterone are really acting like transdermals with their panel profile. Sebastian, do you want to expand on that scientifically?

Sure. So we have a large clinical trial, the REPLENISH trial, as you know. We observe a unique metabolic profile with our product, and this is comparable to what you will see on transdermal products. Such as that we believe that BIJUVA will be capturing the majority of those women using compounded therapy nowadays.

So in essence, you will have these published studies that will allow your MSLs to talk with this data with your compounding pharmacists or your compounding physicians. So we believe that we -- so the oral BIJUVA would be substitutable for transdermal or oral unapproved compounded products. We think there is being approved some real good qualities there as well as economic drivers, right? Women will pay with their copay card, less out-of-pocket, and pharmacies will be able to buy it at a discount off of WAC. So like a generic product comes out, it lowers patients' out-of-pocket, and the pharmacy will make more money as the genericized is branded. We plan to genericize with our one 100 dose a majority of the scripts we talked about. We're going to genericize a compounded drug with our branded drug by lowering patients out-of-pocket and having the pharmacies buy it at a discount and make more money. And then the second piece, yes, the BIJUVA market is significantly bigger than the IMVEXXY market. You have very unique drivers. Think about just efficacy and/or safety. These are unapproved drugs where doctors are -- and patients are paying cash and doctors are choosing to use unapproved drugs because no one's listened to them and delivered what they want. And that's what we have. So you have a safety argument. You have a clear efficacy argument, and you have a clear economic tailwind. And by the way, every single women's health medical society today, that's ACOG, North American, ENDO and the FDA, all recommend against compounded product or off-label product when there is an FDA-approved option and now we're finally here with one.

Your next question comes from Annabel Samimy from Stifel.

So I wanted to go back to the prior question about, I guess, the substitutability of BIJUVA for the compounded product. Now I understand the metabolic profile, and it's going to be the safest, most efficacious. Is there a perception issue with one 100 dose that it's not the lowest effective dose given that physicians have sort of been told by all the medical societies, you should start HRT at the lowest effective dose. Is there going to be a perception problem? Or do they appreciate these different panels and profiles that you have with this product? And then secondly, if you could give us some color around, I guess, you've given a little bit of metrics around covered lives up to this point. Is there anything that you can tell on where you are now? And then third, could you tell us where most of the IMVEXXY prescriptions are driven from now. Is it more retail? Is it independent? How can we, sort of, capture this market and the numbers that we're seeing?

Annabel, this is Brian. I'll take the first part of the question. So let me just start by saying this is not Prempro. These are bio-identical hormones. And in fact, this is the first combination of bio-identical hormones that have been studied in any large randomized placebo-controlled trial, the largest of its kind. And with that, it's the first approval by the FDA. And as Sebastian mentioned, the lipid, the metabolic, the cardiovascular profiles along with the quality of life and sleep, they all speak to the benefits of this first and only FDA-approved product. And that should obviate the need for any other dose, any other delivery system, and of course, here in the U.S., the oral dose is the most preferred route for compliance. So as far as substitutability, we believe that this is substitutable for the entire market as we see it today. I'll hand off to Dawn for the next part.

Annabel, so in terms of where the prescriptions are coming from for IMVEXXY, we know that IQVIA is not necessarily picking up all of our data, and really, that's because we're selling direct to pharmacy in many cases, and so they're not seeing the numbers go from wholesale or retail, which is where IQVIA picks it up. So we do see retail growing each week, but again, a lot of it is through our direct to pharmacy, and we expect working with IQVIA in the next few months for that to be more accurate over the course of time so you can see it in those numbers.

Annabel, it's -- go ahead, I'm sorry. I'll be quiet. Go ahead. Sorry about that.

No -- just with the direct to pharmacy, are these direct to independent-type pharmacies? Or are these retail pharmacies as well, chains, et cetera?

Everybody. We sell to everybody, everybody that wants it, and why endure the distribution cost if you don't need to, right? Now it is available through Cardinal and [Cord] and McKesson and everybody else. But if they want it, we'll sell it directly to them. And we do distribute to them as well. And so we'll work with IQVIA. It will update. We'll get there. And Annabel, something you've brought up with me a number of times that I was going to speak on here is BIJUVA will not typically be tracked when it goes through for the unapproved market, which is developed by compounding pharmacies. The 2 fill market, that's typically your Walgreens and CVS, it will be much more accurate. But we're working with them on that as well because they want access to that data as well. So we're cooperating with IQVIA, and I think we'll get it right. And you'll see it. It's just a matter of time. And by the way, I'm told this is very typical for a launch.

Okay. And then the last question about metrics around covered lives right now?

Yes, so things are going great. We've got, as we have announced, 37% unrestricted. That means no step edit, no prior auth coverage. We don't see anything on the commercial side that will require a step edit or commercial -- I'm sorry, or a prior auth at all in the commercial, 0. We plan, as we get to the end of this 6-month block, to finish the contracts with almost all of the major payers here in these next few months, and you're going to start to see an inflection point, a little inflection point in Q4 and a very big one in Q1. So it's just that 6-month block. We did not have that with the prenatal market. From what I understand from other companies, it's very standard now. And it's -- we're going to have the same thing for BIJUVA. We're not sure on ANNOVERA yet because of the accountable care and contraceptive market, but expect it for BIJUVA as well.

Okay. And that target of around 60% coverage. Is that -- what is the timing for that, for reaching that target again?

Well, remember, so let's just put the market in a whole, okay? So the market as a whole is 24% approximately Part D, 75% commercial or 74% commercial, and there's a little bit of cash pay in there. So we're talking 60% to 65%, more like 65%, of the 75%. So I want you to look at it as a goal of 90% commercial coverage, as our goal just like our competitors at Pfizer or Allergan would have. Our goal is to get that done in Q1 or Q2 and see the revenue pull-through on that. I can tell you we have most major payers signed or signing now as we get to the end of 6-month block. It's just when are they going to start to adjudicate, right? And we're going to see that big step-up in Q1 and a small one in Q4.

(Operator Instructions) Your next question comes from the line of Jay Olson from Oppenheimer.

I was curious about the 2.2 fills per patient in only 4 months post launch. It seems like a pretty impressive fill rate. Can you just talk about how you expect that fill rate to grow as the launch progresses over time?

Sure. Jay, it's Dawn. So yes, it is an impressive fill rate for only after 4 months. It means that the majority of our patients are getting more than 1 fill to do it in such a short period of time. So I think for us, we've always said that we're gunning for the 3 to 4, and so simply, it's really continuing the focus on adherence and making sure that the copay program is available to all patients and keeping a real focus on that. That's a major difference of some of the approaches that I've seen taken in the past, where the copay cards are really used in such a small percentage of patients, and it really does hurt the adherence programs as well as some of the block and tackle of getting out there with refill reminders, et cetera, and just following up with the patients. So all those things are really delivered throughout our marketing program and just as people are able to get to 3 and 4, remember, we're only out there for 4 months. We -- just mathematically, we expect it to grow.

Great point. And it's in line -- our goal -- or the company's goal, led by Dawn, is to really expand that compliance to grow the market initially. And as you know, she's introducing the consumer-focused marketing effort. And now that all the health care professionals know who we are in Q1, that should also offer additional growth.

Okay. That's very helpful. And then with regards to the 4,200 prescribers, can you maybe just talk qualitatively about these doctors? Are these doctors the early adopters? And how many total prescribers do you plan to reach with your promotional efforts?

Jay, it's Dawn, again. So a lot of OB/GYNs, as you would expect, the high writers in the category. But also remember the model that we put forward. We went after early on making sure that the prenatal folks, that we've been calling on for years, that we got in front of them first. They know TherapeuticsMD. And so those are a lot of those writers as well. And what we plan to do moving forward is that same model for BIJUVA. So again, lots of OB/GYNs, high writers in the category, but folks that also knew Therapeutics and knew our prenatals.

Your next question comes from the line of Dana Flanders from Goldman Sachs.

It's Michael on for Dana. Congratulations on the recent approval. Regarding IMVEXXY's 90-day lag in commercial payer reimbursement, I was just curious to know if you expect the scripts to become paid sooner. And also, when we look at your cadence compared to INTRAROSA, for example, can you tell us what is driving the strong launch?

Sure. So -- Michael, it's Rob. So the payer block is a 6-month block that all products get, that I'm aware of, unless it's in a real specialty niche market, oncology and things like that, life-threatening. But that seems to be everywhere, and there can be another 90-day lag till the payers start paying. But during that 6-month block is when the payers negotiate with you. You have to pay for tier 3 access nowadays. It's really changed since when we launched the prenatals. And we weren't aware that was going to happen with IMVEXXY, but we're trying to say now expect that for BIJUVA. So we're at the tail end of that so it's behind us. And again, we're in good shape with all the payers. As far as your next question goes, Michael, I'm going to turn it over to Dawn.

Sure. Michael, so your question was what's driving the strong launch, the differentiated launch versus INTRAROSA? And just to remind folks, the product IMVEXXY and then as we get to BIJUVA, these are products that were designed with an understanding of what health care professionals want and what patients want. So part of why it's delivering is because the products make sense to folks. They know estrogen, and they know that this is a better patient experience. So out of the gate, we have a really good story to sell with great products. Outside of that, we have a fantastic sales force who has been really focused on the core messages, and we did -- as we spoke about before, we made sure that before we got approval and a full launch, that we were out there, understanding our customers prior, so that when we got in, we were not spending the time figuring out sales reps, figuring out the customers, figuring out all the block and tackle stuff that takes the few months of launch. We were purposeful about that, which allowed us to get out of the gate strong.

In comparison to INTRAROSA, I think INTRAROSA did something similar. They went out and very smartly or intelligently educated all the health care providers. And as you know, they just launched their direct-to-consumer and a lot of other initiatives. So I think you'll see them pull through better here. And I think it's not us or them. I think they're doing the right things. And I think we can both do well, and we can both grow this market. And they're really coming on pretty well here, and we like what they're doing.

Your next question comes from the line of Bill Tanner from Cantor.

I was on another call so I apologize if these have been gone over. Just maybe a couple for Dawn. On the 4-mic, I appreciate that it's been launched much more recently than the 10, and I'm just curious if there is any color from the field as to how that dose is actually being adopted, if it's more new patient starts or patients on the 10 are converting back. And then would be interested at what point in time do you think -- think sometimes interchange -- people interchangeably think about adherence and compliance. But I sort of think about adherence as patients getting on and staying on, and then compliance is obviously how much of it they're taking as it is prescribed. But at what point in time do you think you'll be able to get more of a feel for what the longer-term or what the actual adherence and the compliance rates might actually be?

So Bill, it's Rob. I'll hand it to Dawn as well. Thanks for calling. So as far as -- because one's an administrative thing -- as far as the 4 and 10 goes, we don't have a lot of data on the 4 yet. That's analytical. We have a lot of great qualitative data because there is a good subset. One of the advantages of IQVIA not being very active -- accurate yet on TXMD's volumes of scripts, the 4 and 10 ratios as well, strategically, we're not going to release those until IQVIA does. Just because -- think about it, if you're a generic competitor, we're off to a strong launch. They're not seeing that in IQVIA, and if you had to go after one dose over the other, if there was an imbalance, that data would help them with that. So just strategically, we're going to kind of hold that back for today, but I'm sure it will come out in Q1 -- Q4, Q1. So with that being said, I'll pass it over to Dawn on the other questions.

Sure. Bill, so in terms of the 4-microgram, as Rob said, we launched it a little later so that we don’t have many months of data on the 4-mic. So -- but qualitatively, what I'm hearing from the field is it's being extremely well received. It's nice -- new news for us as we're bringing out the initial launch over the next few months. And for some doctors and some patients, that's the appropriate dose, and so having that option for us is a good thing, and so -- but later in terms of the quantitative data. As far as adherence in terms of the number of months on, and I think you define adherence and compliance correctly, compliance being are they taking it correctly. Again, I think we need about a year of data to really see sort of where things shake out. What I'm encouraged by is these initial months showing such strong out of the gate, and it tells me that we can achieve that goal that we put out there really getting between 3 and 4 fills per patient, but about a year, a year's worth of data.

Okay. And then just on the compliance part, I mean, I guess that's also TBD, right, in terms of just kind of -- I mean, nobody is 100% compliant with any medication ever, it seems like so...

Yes. Listen, I would tell you, in this sector from the previous folks, where there was really good compliance in place, when you can grab that data, it's about 8 fills a year. People come on and come off during the year, high deductible plans influence that. So I think you could top out at about 8 if you do just a great job.

And then with the compliance, also, are they taking it correctly, right? Are they taking it twice a week? And again, we're not seeing any issues with that right now. But you're right, not everybody takes it exactly as planned. But again, as long as we're seeing the fills anywhere between sort of 25 and 35 days, we know that generally speaking, that they are taking it correctly because they're filling at the appropriate time and that's what we're watching.

I'm showing no further questions at this time. I will turn the call back over to Mr. Robert Finizio. Please go ahead.

Thank you, everyone, for joining today. We appreciate your time, and we appreciate your patience. Thank you.

Well, ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.