TherapeuticsMD, Inc.
Q3 2018 Earnings Call Transcript

Published: 8 Nov 2018

[Operator:]

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?

[Nichol Ochsner:]

Good afternoon, everyone. Thank you for joining today to discuss the third quarter 2018 financial results and business update. This morning, TherapeuticsMD issued a press release announcing our third quarter financial results. The press release is available on the company's Web site, therapeuticsmd.com, in the Investors & Media section. On today's call our Chief Executive Officer, Robert Finizio; Chief Financial Officer, Daniel Cartwright; Co-Founder and Director, Dr. Brian Bernick; and 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 forward-looking statements are based upon current expectations, and there can be no assurance that the results contemplated in these statements will be realized. Actual results may differ materially from such statements due to a number of factors and risks, some of which are identified in our press release and our annual, quarterly and other reports filed with 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 Web site. 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.

[Robert Finizio:]

Thank you, Nicole. In 2018, we delivered three new drug approvals, a significant achievement for any size 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 which is for ANNOVERA, the first long-acting prescription birth control that is patient controlled procedure free and reversible, providing one 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 all classes to menopause. Since launching IMVEXXY in August, we are seeing strong momentum in a fast ramp and pay prescription. We've taken a financially disciplined approach to promotion, focusing our efforts on market access as well as healthcare provider offices, to drive awareness, adoption, adherence to maximize the value of every patient. Based on data acquired through our co-pay assistance program, 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 13,3000 pid scripts, which reflects an increase of 58% month over month growth. From a compliance standpoint, that translates to 2.2 fills per the patient. The average for the previous two dyspareunia product launches during the first year was 1.7 fills per patient. In our first four months of launch, this early data suggests that we are already exceeding patient compliance. With 2.2 fills for patient, these results parallel Vagifem's initial launch in 2000. You can see that we allied with Vagifem's first four months in unit sales and the slide being displayed currently. Moving forward, our goal is to parallel Vagifem that both unit volume and scale, even though it was launched before 2,000 when the WHI was not out yet. We also -- they also had a much more agreeable payer environment. As you can see on this slide Vagifem scale were significant and we're looking to achieve a similar launch in the coming months and years with a product that is even more differentiated and more innovative. I would like to turn the call over to Dan, our Chief Financial Officer to provide financial update.

[Daniel Cartwright:]

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 lack sales price of approximately $230. The large discrepancy between WAC and net revenue is mostly due to patients receiving co-pay assistance from the company. Co-pay assistance helps patients with their -- win 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 co-pay assistance will be reduced to an amount near zero. As insurance companies start covering IMVEXXY, we expect our net revenue to increase proportionately through the insurance coverage. As such, in line with our expectations, net revenue for IMVEXXY was only $.2 million for the quarter, which is significantly -- which was significantly impacted by our co-pay assistance program driven by our maximum out-of-pocket cost to the patient of $35 per prescription. We expect this period of maximum co-pay 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 paid 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 the prior year's quarter. This is primarily due to higher sales, marketing and personnel costs 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 a licensed ANNOVERA, our one-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 drive down an additional $75 million as part of the second tranche of our term loan with midcap. Let me turn the call over to Don, our Chief Commercial Officer to provide an update. Don?

[Dawn Halkuff:]

Thank you, Dan. On the commercial front, we have made significant progress. As Rob mentioned, we're 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 today 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 a number of health care practitioners that are writing today over 4,200 prescribers have written a prescription for IMVEXXY. We see this number of 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 drive sustainable growth. Now let's move onto patient. 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 build an average of 2.2x which is impressive given we are only into the fourth month of launch. As a reminder, the current annual bills per year for vaginal creams is 1.5 and vaginal tablets or Vagifem at 3.5 pills per year. As with total prescriptions, we are tracking with and expect to exceed Vagifem on pills, establishing patient adoption and adherence to therapy resulting in refill is what will drive expansion and total prescription 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've established, a focused and motivated sales organization delivering differentiated messages being pulled through with co-pay adherence program. 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 two key areas

[Dr. Brian Bernick:]

Thank you, Dawn. The significance of our three approvals clearly positions TherapeuticsMD as the leader in women's health. As you’ve heard in just a few short months, IMVEXXY's successful launch has been built on the simple message of an elegant softgel vaginal insert that doesn't require an applicator, a mess free administration unlike the messy creams. And with only two times a week maintenance dosing, that can be dosed any time of day and with a clear message of affordable pricing, IMVEXXY easily resonates with both healthcare 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 in the 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 the separate estradiol 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 end points that are normally are only associated with transdermal estradiol products and oral progesterone products. Excitingly BIJUVA demonstrates the desired favorable lipid coagulation and metabolic profile as well as improvements in both the quality of life measures and improved sleep parameters, that are typically only seen with the transdermal estrogen and in oral progesterone. These features suggest that this product should obviate the need for using separate products or compounded products. I wanted to address a few things that have been brought up with respect to the BIJUVA approval and label. The first is with -- 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 and 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. It's 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 pharmacists 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 five, it is important to understand that this is consistent with the data from other products on the market today. Further, we pre-specified and use the same methodology of clinically meaningfulness that was established -- that established the approval of the other products used to treat vasomotor symptoms and it achieved at week four and sustain 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 one-year contraceptive vaginal system. As in OB/GYN and women's health provider, I must provide the feedback for my colleagues about the importance of ANNOVERA and that it will allow women access to long-term reversible contraception without concerns of a procedure and it will be acceptable for [indiscernible] 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 suggested on acetate it lacks antigenic estrogenic 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 one-year controlled release delivery system. I cannot empathize 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 one year. The approvals of all three of these highly differentiated products have there in 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 provide some concluding remarks.

[Robert Finizio:]

Thanks, Brian. As you can see IMVEXXY is growing its plans 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, sell and use BIJUVA as it uniquely offers patients, providers and pharmacies strong clinical, economic advantages and lowers regulatory risk for pharmacy's and providers. Economics are our major driver in healthcare 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 co-pay and could save insurance companies 20% to 30% when compared to NuvaRing, assuming we priced approximately $1,400. Clinically ANNOVERA changes the entire dynamic for the long-term birth control market. At approximately $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 three new branded products, each product has the potential of significant revenue. We’ve accomplished this with approximately $500 million in equity financing and just under seven years. IMVEXXY is exceeding the ramp in unit expectations. As planned, in a short period of time, payer adjudication should convert IMVEXXY sales into revenue followed by the launch of BIJUVA and ANNOVERA. As you can see, we're executing in line with expectations, and could not be happier with the progress we've made this year. We will now open up the call for Q&A. operator?

[Operator:]

[Operator Instructions] Our first question comes from Ken Cacciatore from Cowen & Company. Please go ahead.

[Ken Cacciatore:]

Hey, guys congratulations on all the early progress. So 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 are maybe a little bit of just feedback on how that’s progressing and were normalization shakes out. And then from the sales force clearly it 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 a BIO-IGNITE for BIJUVA, any update on compounders? Just kind of give us a sense of at launch where we think we maybe in terms of folks that you’ve contracted with? Thank you.

[Robert Finizio:]

Ken, we are 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.

[Daniel Cartwright:]

Hi, Ken. Currently we -- with our -- in the current market, we expect the commercial payers to be around 60%, we believe it's a good number. So your $100, its pretty accurate.

[Ken Cacciatore:]

Net 60%

[Daniel Cartwright:]

Net 60%, yes.

[Robert Finizio:]

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

[Dawn Halkuff:]

Sure. Hi, Ken. So this is Dawn. In terms of the sales force refining 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's 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 the customers so that they can continue getting those initial prescriptions until we keep [ph] writing and we are seeing that.

[Robert Finizio:]

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

[Ken Cacciatore:]

Great. Thanks so much.

[Robert Finizio:]

Thank you.

[Operator:]

Your next question comes from the line of Chris Schott from J.P. Morgan. Please go ahead.

[Unidentified Analyst:]

Great. Thank you. This is actually Catherina 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, jells 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? Thank you.

[Robert Finizio:]

Sure. Catherina, 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 will have a slide out on this, that the panel and I will let 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 our panel profile. Sebastian do you want to spend on that scientifically.

[Dr. Sebastian Mirkin:]

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 a capturing -- the majority of those women using compounded therapy nowadays.

[Robert Finizio:]

So, in essence you will have these published studies that will allow your MSLs to talk with this data with your compounding pharmacist or your compounding physicians. So we believe that we saw that oral [ph] BIJUVA would be substitutable for transdermal or oral unapproved compounded products. We think there's a [indiscernible] approved some real good qualities there as well as economic drivers. Women will pay with our co-pay card less out-of-pocket and pharmacies will be able to buy it in a discount off a WAC. So a lot like a generic product comes out, it lowers patients out-of-pocket and the pharmacy will make more money as a generic -- genericized branded. We plan to genericize with our 1100 dose, a majority of the scripts we talked about, we are going to genericize a compounded drug with our branded drug by lowering [ph] 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 were doctors are and patients are paying cash and doctors are choosing to use unapproved drugs, because no one listen to them and delivered what they want. And that's what we have, to 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 are finally here with one.

[Unidentified Analyst:]

Great. Thank you.

[Robert Finizio:]

Thank you.

[Operator:]

Your next question comes from Annabel Samimy from Stifel. Please go ahead.

[Annabel Samimy:]

Hi. Thanks for taking my question. Great launch metric. So I want 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 its going to be the safest mystification. Is there a perception issue with 1100 dose that it's not the lowest effective dose, given that physicians have sort of been told by all the medical society you should start HRT with at the lowest effective doses. Is there going to be a perception problem or did 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 [technical difficulty] the way you’re now? And then, third could you toss where most of the IMVEXXY prescriptions are driven from now? Is it more retail or is it independent, how could we sort of capture this market in a number that we’re seeing? Thanks.

[Dr. Brian Bernick:]

Thanks, Annabel. This is Brian. I will 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 you know as Sebastian mentioned, the lipid, the metabolic, the cardiovascular profile, 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 does, any other delivery system and of course here in the U.S the oral dose is the most preferred route for compliance. So, it's hard substitutability, we believe that this is substitutable for the entire market as we see it today. I will hand out to Dawn for the next part.

[Dawn Halkuff:]

Hi, Annabel. So in terms of where the prescriptions are coming from for IMVEXXY, we know that IQV is not necessarily picking up all of our data and really that's because that we're selling direct to pharmacy in many cases. And so they’re not seen in the numbers go from wholesale to 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 actually more accurate over the course of time. So you can see it in those numbers.

[Robert Finizio:]

You know, Annabel, this is -- go ahead, I’m sorry.

[Annabel Samimy:]

No, just on the direct to pharmacy …

[Robert Finizio:]

Sorry. I will be quiet, go ahead. Sorry about that.

[Annabel Samimy:]

No, just with the direct to pharmacy, are these direct to independent type pharmacies or are these retail pharmacies as well, chain etcetera.

[Robert Finizio:]

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

[Annabel Samimy:]

Okay. And then the last question about metrics or uncovered lives.

[Robert Finizio:]

Yes. So things are going great. We’ve got as we’ve announced 37% unrestricted, I mean, there's no step at it, no prior off coverage. We don’t see anything on the commercial side that will require a step at it, or commercial -- I’m sorry, or prior off at all in the commercial zero. We plan as we get to this end of the six months 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 six-month block. We did not have that with the prenatal market, for what I understand from other companies, it's very standard now. And it's -- we are going to have the same thing for BIJUVA. We are not sure in a [indiscernible] because of the accountable care in contraceptive market, but expected for BIJUVA as well.

[Annabel Samimy:]

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

[Robert Finizio:]

Remember, so let's just put this market in a whole, okay. So the market as a whole is 24% approximately, Part D, 75% commercial -- 74% commercial. And it's a little bit of cash pay in there. So we are targeting 60% to 65%, more than 65% or the 75%. So I want to look at us a goal of 90% commercial coverage. As our goal, just like our competitors at Pfizer Allergan would have. Although it is to get that done, in Q1 or Q2 and see the revenue pull through on that. I can't tell you we have most major payers signed or signing now as we get to the end of six-month block. It's just when are they going to start to adjudicate, right. And we are going to see that big step up in Q1 and a small one in Q4.

[Annabel Samimy:]

Okay, great. Thank you.

[Robert Finizio:]

Okay? Does that help?

[Annabel Samimy:]

Yes. A - Robert Finizio\ All right. Thanks.

[Operator:]

[Operator Instructions] Your next question comes from the line of Jay Olson from Oppenheimer. Please go ahead.

[Jay Olson:]

Hey, thanks for taking the questions. I was curious about the 2.2 fills per patient in only four months plus launch. It seems like a pretty impressive field rate. Can you just talk about how you expect that to already to grow as the launch progresses over time?

[Dawn Halkuff:]

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

[Robert Finizio:]

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

[Jay Olson:]

Okay, thank you. 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?

[Dawn Halkuff:]

Hi, Jay. It's Dawn again. So a lot of OB/GYN 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 that the prenatal folks, that we’ve been calling on for years, that we gotten some of them first, they know TherapeuticsMD. And so those are a lot of those writers as well. And that we plan to do moving forward is that same model for BIJUVA. So again lots of OB/GYN high writers in the category, but folks that offer new therapeutics, then [indiscernible] prenatal.

[Jay Olson:]

Great. Thanks for taking the questions.

[Dawn Halkuff:]

Thanks, Jay.

[Robert Finizio:]

Thank you.

[Operator:]

Your next question comes line of Dana Flanders from Goldman Sachs. Please go ahead.

[Unidentified Analyst:]

Hi. It's Michael on for Dana. Thank you taking the questions and congratulations on the recent approval.

[Robert Finizio:]

Thank you.

[Unidentified Analyst:]

Regarding IMVEXXY's 90 day lag in commercial payer reimbursement, just curious to know if you expect those scripts to become [indiscernible]? And also when we look at your cadence compared to [indiscernible] for example, can you tell us what is driving the strong launch? Thanks.

[Robert Finizio:]

Sure. So, Michael, its Rob. So the payer block is a six-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 that seems to be everywhere and there can't be another 90 day lag till the payers start paying, but during that six-month block is when the payers negotiate with you. You have to pay for two or three access nowadays. It's really changed since we launched the prenatals. And we weren't aware that was going to happen with IMVEXXY. But we are trying to say now expect that for BIJUVA. So where is the tail end of that, its 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.

[Dawn Halkuff:]

Sure. Hi, Michael. So your question was what’s driving the strong launch? The differentiated launch versus [indiscernible]. And just a reminder of the product IMVEXXY and then as we get to BIJUVA, these are products that were designed with an understanding of what healthcare professionals want and what patients want. So part of why it's delivering is because the product makes 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 tell with great product. Outside of that we have a fantastic sales force who had been really focused on the core messages and we did as you -- as we spoke about before, we made sure that before we got approval of the 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 rep, figuring out the customers, figuring out old block and tackle stuff. That takes a few months of launch. We were purposeful about that with the latter get out of the gate strong.

[Robert Finizio:]

Okay. In comparison into [indiscernible] something similar. They went out in very smartly, or intelligently educated all the health care providers 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.

[Unidentified Analyst:]

Thanks.

[Operator:]

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

[Bill Tanner:]

Thanks for taking the questions. I was on another call. So I apologize if these have been gone over. Just maybe couple for Dawn. On the [indiscernible] I appreciate that it's been launched much more recently than the TAN [ph]. And I’m just curious if there's any color from the field as to how that doses are actually being adopted, if it's more new patient start to patients on the Tanner converting back. And then I would be interested at what point time in time do you think you take some times interchangeably -- people interchangeably think about adherence and compliance. But I sort of think about adherences patients getting on and staying on compliance is obviously how much of it they are taking. As it is prescribed, at what point in time do you think you'll be able to get more of a feel for what longer term or what the actual adherence in the compliance rates might actually be?

[Robert Finizio:]

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

[Dawn Halkuff:]

Sure. Hi, Bill. So in terms of the 4 microgram, as Rob said, we launched a little later, so 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. That’s why 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 [indiscernible] and I think you need to find 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 shakeout. What I’m encouraged by is these initial months showing such so -- such strong out of the gate and it tells me that we can achieve that goal that we put out there really getting between three and four fills per patient about a year with the data.

[Bill Tanner:]

Got it. 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's is a 100% compliant with any medication ever, it seems like. So …

[Robert Finizio:]

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.

[Dawn Halkuff:]

Yes and then with the compliance [indiscernible] taking it correctly. They’re 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 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 are watching.

[Bill Tanner:]

Got it. Okay. Thanks very much. Congrats on the early launch.

[Dawn Halkuff:]

Thanks, Bill.

[Robert Finizio:]

Thanks, Bill.

[Operator:]

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

[Robert Finizio:]

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

[Operator:]

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