TherapeuticsMD Inc (TXMD) 2016 Q4 法說會逐字稿

Good day, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD fourth quarter and year end 2016 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 Director of Investor Relations, David DeLucia. David, you may begin.

Good morning, everyone. Thank you for joining today to discuss our fourth quarter and full year 2016 financial and business results. This morning, TherapeuticsMD issued a press release announcing fourth quarter and full year 2016 financial results. The press release is available on the company's website, therapeuticsmd.com, in the Investors & Media section.

On today's call from TherapeuticsMD are Chief Executive Officer, Robert Finizio; Chief Financial Officer, Daniel Cartwright; and Chief Medical Officer, Dr. Sebastian Mirkin. Also joining us for Q&A is Chief Product Officer, Julia Amadio. I would also like to point out that Dr. Brian Bernick, Chief Clinical Officer, is attending our national sales meeting and will therefore not be on today's call.

I would like to remind everyone that certain statements made during this conference call may be 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 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 on February 23rd, 2017.

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

Thanks, Dave. Good morning, everyone. 2016 was an exciting year for TherapeuticsMD. Our two late-stage product candidates, TX-004HR and TX-001HR, continue to approach commercialization and are backed by two clinically rigorous development programs and positive Phase 3 data.

I'd like to start by listing a few of our major accomplishments during the past year. In July, we filed our new drug application for our first product candidate, TX-004HR, based upon the results of our complete clinical program, including positive data from the pivotal Phase 3 Rejoice Trial. Upon acceptance of the NDA in September, we received a PDUFA target action date of May 7, 2017. Assuming approval, we plan to launch TX-004HR in the fourth quarter of 2017.

More recently, we reported positive top line data from the pivotal Phase 3 Replenish Trial for our second product candidate, TX-001HR, our bio-identical combination of estradiol and progesterone for moderate-to-severe vasomotor symptoms due to menopause. We believe TX-001HR has the potential to become the first and only FDA approved bio-identical combination of estradiol and progesterone, and also a very valuable treatment option in the large growing and underserved market for bio-identical hormone therapy.

The data supporting the market opportunity for TX-001HR continues to grow, which includes over 6 million annual FDA approved prescriptions as well as close to 18 million annual compounded prescriptions. Our relationship with potential distribution partners in the compounding pharmacy community that are also strengthening through our BIO-IGNITE program. We'll provide a detailed update on BIO-IGNITE later in the call.

Finally, we continued to appropriately expand our sales and commercial infrastructure to prepare for the potential launch of TX-004HR. We've made important progress towards this goal including hiring of Dawn Halkuff from Pfizer as our Chief Commercial Officer. Our sales team has done an outstanding job building our prenatal vitamin business into the number one prenatal products by volume in the branded commercial payer in cash-based space in 2016, and also the number of three prenatal by product volume if you include government payers. We believe we have the sale infrastructure in place as well as the established relationships in the OB/GYN channel to drive a successful launch of TX-004HR if approved.

On today's call we'll review these developments in our prepared remarks and then open up for Q&A. Dan will start with a review of our financial results, then Sebastian will provide a clinical update, and I'll review our recently announced BIO-IGNITE program and the progress that we've made thus far.

We also want to remind everyone that we are hosting an Investor Day next Wednesday on March 1st, in New York City to review both the opportunities in detail, including our launch plans for the first time for TX-004. We look forward to seeing you there.

Now let me turn the call over to Dan.

Thanks, Rob. Both the fourth quarter and full year 2016 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 $4.5 million for the fourth quarter of 2016 compared with approximately $5.6 million for the fourth quarter of 2015. Net revenues from the company's prescription prenatal vitamin business was approximately $19.4 million for the full year 2016 compared with approximately $20.1 million for the full year 2015.

Total operating expenses for the fourth quarter and full year 2016 increased compared with the fourth quarter and full year 2015. This reflects our continued investment in advancing our late-stage product candidates.

R&D expenses during the fourth quarter of 2016 were approximately $10.3 million compared to approximately $13.2 million during the prior year's quarter. R&D expenses during the full year 2016 were approximately $53.9 million compared to approximately $72 million during the full year 2015. These changes reflect a decline in clinical trial cost as we completed our Phase 3 trials.

SG&A expenses for the fourth quarter of 2016 were approximately $16.3 million compared with approximately $8.6 million for the prior year's quarter. SG&A expenses during the full year 2016 were approximately $53.1 million compared to approximately $28.7 million during the full year 2015. This is primarily due to an increase in sales, marketing, regulatory expenditures, and personnel costs to support future commercialization.

We are continuing to expand our women's health sales force and invest in pre-commercialization activities to support the potential launch of TX-004HR in the fourth quarter of 2017. We expect these factors to increase the growth rate of our SG&A expenses throughout 2017.

Turning to the bottom line, our net loss for the fourth quarter of 2016 was approximately $22.8 million or $0.12 per basic and diluted share, compared with approximately $17.5 million or $0.10 per basic and diluted share for the fourth quarter of 2015. Our full year net loss for 2016 was approximately $89.9 million or $0.46 per basic and diluted share, compared with approximately $85.1 million or $0.49 per basic and diluted share for the full year 2015.

Finally, we finished 2016 with approximately $131.5 million in cash, compared with approximately $64.7 million at December 31st, 2015. As a reminder, our cash balance at the end of the third quarter of 2016 was $147.5 million, which equates to a cash utilization of approximately $16 million in the fourth quarter. We believe our strong financial position will allow us to continue to advance both of our late-stage product candidates towards commercialization.

Let me turn the call over to Sebastian for our clinical and development update.

Thanks, Dan. I would like to acknowledge our clinical and regulatory team for their commitments and hard work during 2016 to successfully complete the TX-001 Replenish Trial as well as numerous TX-004 related regulatory activities including the submission and acceptance of our NDA.

In December, we reported positive top line results from our Replenish Trial for TX-001. Both estradiol 1 milligram/progesterone 100 milligrams and estradiol 0.5 milligram/progesterone 100 milligrams demonstrated statistical significance and clinically meaningful results across the four co-primary efficacy endpoints. In addition, endometrial safety was established with an incident rate of endometrial hyperplasia of 0% across all doses.

I would like to emphasize the significance of these results. The Replenish Trial established for the first time the distinct doses of estradiol in combination with progesterone demonstrated both endometrial protection as well as statistically and clear meaningful reduction in hot flashes. We are excited to move forward with our TX-001HR clinical program and plan to have our NDA filed in the third quarter of this year. Should TX-001HR be approved, it will be the first and only FDA-approved bio-identical combination of estradiol and progesterone.

Now, I would like to turn the call back to Rob, who will comment on the progress of our BIO-IGNITE program.

Thanks, Sebastian. All right, so earlier this year, we announced the initiation of BIO-IGNITE. BIO-IGNITE is an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000 to 3,500 compounding pharmacies in the U.S., and qualify their interests in distributing our hormone product candidates if approved.

Because compounded products are not reimbursed or FDA approved, the prescriptions are not tracked through the traditional drug databases such as IMS or Symphony Health. However, the compounding pharmacies that dispense these products have the prescription data that we believe will further reinforce the size of the market.

BIO-IGNITE is our plan to go right to the source at the pharmacy level to articulate to our investors three important details: number one, reinforce the size of this market through actual prescription data from the pharmacies; number two, articulate the number of compounded E+P prescriptions that are directly substitutable by our two potential doses of TX-001HR if approved; and then number three, to find the potential revenue opportunity for TX-001HR through signed distribution agreements, leveraging traditional pharmaceutical wholesale distribution channels.

Now, let's walk through an example of the progression of a pharmacy or pharmacy network through our BIO-IGNITE program. Step one, it begins with identifying a pharmacy that has expressed interest in dispensing our product candidates if approved. Number two, is having this pharmacy sign a non-binding letter of intent under which they share their current total compounded E+P prescriptions, which equates to TX-001HR volume as well as additional data points. And then number three is entering into a signed distribution agreement with this pharmacy to dispense our products in lieu of compounding if approved. These are the typical steps for pharmacy or pharmacy network in the BIO-IGNITE program which enables us to appropriately allocate the resources needed for a successful launch of TX-001 if approved.

Now, I'd like to provide our first quarterly update on BIO-IGNITE. We have officially signed a distribution agreement with Premier Value Pharmacy Compounding Network or PVPCN. This agreement is to dispense our products if approved. This network is one of the country's largest and most esteemed compounding pharmacy networks. It represents over 300 pharmacies and approximately 1.5 million annual prescriptions of compounded estradiol and progesterone that are directly substitutable to TX-001HR. We've also entered into non-binding letters of intent with an additional 362 pharmacies who will share their total compounded E+P prescription data representing approximately another 500,000 annual prescriptions of compounded E+P that are directly substitutable to TX-001HR.

In total, we've been in contact with over 20% of the high volume compounding pharmacies since we launched BIO-IGNITE just two months ago. We've identified 2 million annual prescriptions of compounded bio-identical E+P that are directly substitutable to TX-001HR and have entered into a distribution agreement addressing 1.5 million of these scripts. This puts us well on our way to potentially converting the 12 million to 18 million annual prescriptions of E+P in a compounding segment.

We believe that our success with BIO-IGNITE in such a short time frame speaks volumes to the value of our late-stage pipeline and reflects the changing dynamics of the compounding pharmacy industry related to hormones. This includes almost complete loss of reimbursement for compounded hormones, and a sharp increase in regulatory cost and oversight in a compounding business, which is only expected to grow over time.

In conclusion, we recognize that women and physicians continue to choose unapproved compounded bio-identical hormones that are cash pay instead of FDA-approved synthetic hormones that are covered by insurance. Our company was founded on the goal to give women what they are already demanding for the management of the menopausal symptoms in an FDA-approved format. It gives me great pleasure to see our product candidate one step closer to meeting these demands.

2017 is shaping up already to be a pivotal year for TherapeuticsMD. We have two late-stage product candidates in large markets representing significant near-term opportunities, revenue opportunities. Both product candidates have positive tailwinds, including demographic and regulatory factors, and we have assembled a top team in the women's health space to transition our company to a commercialization and capitalize on these growth opportunities. We look forward to the FDA's PDUFA target action date for TX-004HR on May 7 and the submission of our NDA for TX-001HR in the third quarter reflecting significant milestones for the company.

Before we open up to Q&A, I'd like to remind everyone about our 2017 Investor Day next Wednesday March 1st, in New York City. At the event, for the first time, we'll feature our go-to-market strategy for the launch of TX-004HR from the broader commercial team. We also will provide additional insights into the clinical, regulatory, and commercial aspects of both of our late-stage product candidates. We've assembled a very strong group of KOLs and outside experts to review these topics with you. Presenters will include a former FDA regulatory director of the Division of Bone, Reproductive, and Urologic products, who has previously reviewed and approved multiple VVA and VMS drugs similar to TX-004HR and TX-001HR.

We will have top GYNs or OB/GYNs, endocrinologists, and sexologists who prescribe current therapies to treat both VVA and VMS. Key opinion leaders from the compounding pharmacy community, including IACP executives and one of the principals of the Premier Pharmacy Value and Compounding Network, to answer questions about the current state of compounding and our signed distribution agreement. These experts will also reflect on our BIO-IGNITE program and what represents for the future of the compounding industry.

We appreciate your interest in TherapeuticsMD and your participation on our journey to transform the women's health space. We'll now open up the call for questions.

(Operator Instructions) Our first question comes from Jami Rubin from Goldman Sachs. Your line is now open.

Thank you very much. Just a couple of questions. Rob, first for you, the BIO-IGNITE partnership sounds really interesting. Does this in anyway obviate the need for a domestic partner? And you've never really talked about pursuing a partner outside the U.S. If you could address that. And secondly, just I was wondering if you've been communicating with the FDA on Yuvvexy about the label. And if you want to maybe take the opportunity right now to set expectations for what kind of label we can expect, i.e., modified black box, no black box, sort of how should we think about it? Thanks very much.

Sure. Jami, so, BIO-IGNITE was put in place so the company can gauge its resources needed for launch and articulated to the Street. So a lot of this data has been checked and tracked through IMS.

For modeling purposes, I'd like to put the whole opportunity kind of in perspective, right? So we have 1.5 million annual prescriptions, a substitutable E+P for TX-001HR. We're assuming we're going to price in parity and have a WAC price between $230 and $250 a month assuming conservative rebates and discounts at 30% per script so you can throw the whole kitchen sink in there to build your models. And then one other thing that's absolutely key that we do not see a lot of recognition for on the Street is remind everybody that on top of that 1.5 million prescriptions through the compounders of BIO-IGNITE, there are another 3.5 million separate estradiol and progesterone prescriptions annually, which is right in IMS data and referred to on our slides taken into this opportunity. This market is the most easily addressable and low-hanging fruit by TX-001HR, which equates the total of 5 million prescriptions. This is all low-hanging fruit, and you can even articulate the ages of these women taking this progesterone and estradiol in separate pills in our slide deck. So, I'd like everybody just a step back and look. We've been doing this for about 60 days, and we have 5 million addressable scripts already. It's really impressive.

And your second question relates to the label. I obviously can't get into any FDA dialogue. It's against company and corporate policy. The one thing that we do want to reinforce is that our Investor Day I think is the appropriate place to have an open Q&A dialogue around this and any other regulatory questions anyone has. We've always talked about our internal planning surrounding the label. Our best case scenario is class labeling. We know that we have a differentiated physical, clinical, and PK characteristics to capture significant share and drive a very successful launch.

Our upside scenario was a highly differentiated label. That's about as far as I can go on this call, but we love to discuss it further with you at our Investor Day with people, by the way, much more authorized and much more credible to speak to it than I am.

Anything else, Jami?

No. That's it. Thanks very much.

And your next question comes from Louise Chen from Guggenheim. Your line is now open.

Hi. Thanks for taking my questions. So, a few questions here. So, first, on the Yuvvexy approval, just curious if you will sell this product through compounders and if there's any benefit of doing that ahead of the 001 launch. And then secondly, we've received pushback that there's a lot of topical products at the compounding pharmacy. And would that be a challenge for you to switch that over to your formulation? And then lastly just here on the compounding opportunity, can you point an examples of other drugs that have been taken up by compounders which could set a precedence for 001?

Louise, it's Rob. So, starting at the top, actually kind of putting some of these together, so I think a great precedent for what we've seen previously for compounding products would be very easily looking at something like AndroGel or testosterone. So, before Testim or Axiron or AndroGel was approved, no one knew for a fact that hypogonadism was treated by testosterone. Although compounding pharmacies at this time is going to back pre-2008, 2009, at this time compounding pharmacies had a 100% of the testosterone market, a 100% of it. They were reimbursed for it, which does not exist today, for this testosterone, as well as there was no Drug Quality and Security Act making any knock-off in essential copy. And a lot of this was injectable, oral, and transdermal. And as you can imagine, these are all very different routes of administration.

Well, as you know, combined -- before the generics came out, the combined testosterone market used to be $1.6 billion and $2 billion, and this was launched without support of compounders. This was launched when compounders lost money by selling it. But what they'll tell you versus compounding their own drugs, which does not exist for us, that compounding economic environment will improve with essentially E+P.

But what they'll tell you and what I really -- this is a great topic to bring up on our Investor Day because we have number of the thought leaders there -- is that when this was approved, when Testim was approved and AndroGel approved, it basically authenticated what these compounders and doctors of integrative medicine, and primary care docs have been saying for years and years and years. That it does work. It is safe. It is effective. And then now that there's an FDA-approved drug, the compounding market grew for both the compounders and FDA-approved to massive, massive amounts.

I'd like to clearly say that we believe there are a lot more prescriptions of E+P than T alone for women and men, and that we believe we will give credibility and we will open this space up to all the integrative medicine doctors and compounding pharmacies that have been saying this stuff works. It can be proven, safe and effective. And the economic environment, and the physician environment, and the patient environment will all be improved.

So, I know it's a long way to answer your question, but I love to discuss this in a lot more detail at Investor Day. Last is the route of administration. So we are directly tracking that. We believe that the doctor's viability, the doctor's validity of giving something proven, safe, and effective, as well as the patient having something that is proven, safe, and effective, now covered by insurance, pharmacy-improving economic environment, as well as meeting every medical societies' demands for patients, doctors, and the FDA is a great environment for our E+P product, and we do not see topical as a direct obstacle for converting this market at all. And we're signing these agreements, and these compounders would love to talk to you about it and why.

And just on Yuvvexy, are you going to include that in any of your agreements? Is that on the table as well?

Absolutely. And we see these physicians, we see these pharmacies as key partners with both products. We only talk about E+P and high volume because it's not tracked by IMS, and it's a little bit more complicated. And as sales -- if approved and with what we're expecting, assuming that, that happens, we are going to offer our Yuvvexy product to this network for sure.

Okay, thank you.

And our next question is from Annabel Samimy from Stifel. Your line is now open.

Hi, guys. Thanks for taking my question. You did a great job outlining how you're going to approach the compounding market. Are you approaching the retail market in just a regular fashion? And with regard to Yuvvexy, I know that the compounding market is not as large. Do you view that as kind of a pilot program for, I guess, the testing to see to how the compounding market converts to an approved bio-identical?

And then separately, I was hoping maybe you can detail, I guess, the evolving competitive landscape. For estrogen, you have [Asernus] that's been approved, you have DHEA that's been approved, Intrarosa. Intrarosa didn't have a black box label. Neither of them are pure estrogen. So, one, does that change the competitive landscape for you? And, two, does the fact that Intrarosa not have a black box, can you correlate that to what might happen with your label? Thanks.

Absolutely. So, it's a lot there.

Yes, sorry.

So -- which one would you like me to start with?

Well, let's just start with the competitiveness landscape and we'll go backwards.

Absolutely. So, Intrarosa has got a fantastic label. I mean it's really, really good. But I want to remember. I want to remind people things. Women suffering from symptoms of VVA have got barriers to being intimate. They have barriers to feeling hygienic. They have barriers to in overall wellness, pain, urination, things like that; itching and dryness. When you introduce a product like a cream that's used every single day or something like Intrarosa that's used every single day and then you go into the maintenance phase and it's continued to be use every single day, you're getting rid of the symptoms here and that's great. But these large amounts of things that are used daily create new barriers that obviously impede intimacy, make a woman feel non-hygienic, and these are physical characteristics that when used every day, we believe, are going to be obstacles that for the first time, if approved, our physical characteristics should completely remove.

Our physical characteristics are elegant, fast dissolving, less than 2% to 3% of discharge, and basically dosed whenever they want and working quickly. So there's really nothing there other than a very comfortable feeling. So, that's one of the big drawbacks we see with Intrarosa even though it has a fantastic label.

The other thing is given such a great label, if that attracts more women into the space, because there's 30 million untreated women, just like an authorized generic could attract more women into the space, it's a perfect steppingstone to our product because the issues that will be created from these products are the issues with the generics that will be the same as the branded products out today is a perfect steppingstone to what we believe if approved will be a fantastic product offering, physical benefits that are not with the current dosing out there today.

Is the efficacy competitive with (multiple speakers) --

Well, it has to be used daily. And if it's not used daily and it's used a few times a week like the older estrogen drugs, it loses efficacy. And there's a number of white papers out there on this that I'm referring to. So it is not in my opinion, my personal opinion, competitive in that way due that a woman has to use a large ovule with an applicator every single day. (Multiple speakers) And the onset of action if you look at the label is six to 12 weeks.

Okay. And how about the fact that it's not a pure estrogen?

Well, remember, the fact that it's not an estrogen, it's an analog to an estrogen. So it's put in, in the vagina and it's metabolized into estrogen, and in fact, if you look at the PK levels at day seven in their label and I know these are different women but you compare to our four or 10 micrograms, their levels are higher. They also have a level of testosterone. So it's certainly an interesting approach.

Okay. And -- go ahead.

The one thing I would say, just coming back to the daily dosing, Bayer invested, we believe, a few hundred million dollars into the company, 200 million or 300 million from what we can see on some of the financial websites, and they completely walked away from the product; completely just walked away. As you know, Bayer is number two healthcare, women's healthcare company in the U.S. and number one worldwide. It's got to tell you something about the dosing, and the size and amount of the ovule.

Okay, great. And now maybe you can talk about the compounding market for Yuvvexy you're using as a pilot program for the E+P market?

Absolutely. So, we believe Yuvvexy will build trust between us and our partners. We believe there's a nice opportunity there for us and our partners. And we believe the product profile is so vastly superior to anything that the compounders could make, it will be very successful. We really do. And then on the retail side, I just want to be clear that our products will be available from any retail pharmacy. And even with the compounders, we're going through traditional distribution methods that are widely characterized and understood, kind of the spoken hub model with wholesalers and distributors.

So, our products are everywhere for the patient to get. These compounding pharmacies that are women's health specialists offer a service to the physicians, to the women that you cannot get a large retail pharmacies like CVS or Walgreens, and are typically just a different type of customer, and we want to support both.

Great. Thank you.

And our next question comes from Jay Olson from Oppenheimer. Your line is now open.

Good morning, guys. Thanks for taking my questions. I had a couple on Yuvvexy and then maybe a follow-up on TX-001HR. I noticed in your press release, in your prepared remarks, you didn't use the proposed brand name Yuvvexy. Is that a sign that you might be working on a different brand name? And then, also, just a follow-up on Intrarosa, AMAG had indicated that they were planning to develop Intrarosa for the treatment of FSD. Is that an indication that might be on the table for Yuvvexy?

Jay, it's Rob, thanks for joining. I'm going to take Yuvvexy name, and then I'm going to turn over to Sebastian for the FSD because it's really out of my area. So, I don't know how many folks in the phone have seen the Yuvafem. That's the authorized generic for Vagifem. It's got a really similar name to Yuvvexy. I mean that's got to tell you something about who is worried about someone coming into the market, right? They don't even line up with the Vagifem name, they're lining up with Yuvafem.

So, we continue to evaluate alternate brand names and are considering other names given that fact. And we believe these names could potentially be stronger. And we'll give an official name upon approval. Sebastian?

Yes. So, it would be very interesting to see what Endoceutics will do with Intrarosa in terms of FSD. Certainly, if a claim, if they have systemic levels, it will be hard to hit the CNS. I mean really interesting to see what they are going to propose.

For us, we do have a very robust lifecycle management for Yuvvexy for TX-004. We're really looking forward to sort of working on that. We're going to announce this shortly.

Okay, great. And then if I could just to follow-up on TX-001HR. Congrats on the early progress with the BIO-IGNITE program and getting the 1.5 million script volume of compounded E+P. What is your target for total E+P compounded script volume prior to launch of TX-001HR?

So we're just going to give quarterly updates until we launch is the current goal. I would like to say that I want to articulate to the Street -- so -- actually, let me step back one step -- point, Jay. There's a lot of folks out there that take a little bit of question to the size of the market. So, one thing I want to say is not only we're working through BIO-IGNITE to articulate to the Street the resources needed the size of opportunity, but we're also in discussions with IMS on this because it's a new market that they are considering and looking at. So that's one piece of it.

Number two, the overall opportunity, there's 3.5 million separate estradiol and progesterone FDA-approved tablets tracked in IMS. If you look at our Investor Day that we even state the women's ages. Remember, to prescribe two separate pills is low-hanging fruit for us to have a single combined pill because women don't want two co-pays, doctors do not want the liability if a woman does not take the progesterone. We all know that leads to, hyperplasia or endometrial cancer. And the two separate co-pays is just showing the opportunity here at 3.5 million scripts.

You know, we believe we will be very successful with BIO-IGNITE. There is no number. And my team and part of the ability for us to show you the efficacy of my team in preparing this for launch is to articulate a clear number for you and a commitment through distribution agreements and then previously through LOIs. And there's really -- I probably think that's the best way to answer it. I would expect us to be very successful. In just 60 days, we've signed a distribution agreement for 1.5 million scripts and articulated a full 2 million scripts.

So, I'm not sure if that answers your questions. It's kind of roundabout way. If it doesn't, please let me know.

Okay. That's helpful. We'll look forward to learning more next Wednesday. And then just one last question on TX-001HR, when should we -- can you remind us when we'll see the full Replenish results?

Absolutely. Sebastian?

Yes, we're going to be presenting all these at the Endocrine Society Meeting first week of April here in Orlando for you. So, all of us are welcome to attend the meeting.

Great. Thank you very much.

And our next question comes from Bill Tanner from Cantor Fitzgerald. Your line is now open.

Thanks for taking the question. Rob, I want to go back to your PVPCN example. So I think you mentioned that there are -- that they write 1.3 million prescriptions or fill 1.3 million prescription perhaps for E+P that are substitutable that you think it would be substitutable for 001. So, wondering if you have a sense of the percentage of -- or what's -- that 1.3 million, what is that as a percentage of all of the E+P prescriptions that they write whether they are substitutable or not? So just thinking about if you could use PVPCN as a proxy for the overall market, what is the TAM there? And then I had a follow-up.

Yes. There's a number of ways to look at that, Bill. So, the first way to look at it is we don't have a higher dose and we didn't try a higher dose for perimenopausal. Rich Moon will be -- who's one of the principals and a director on the company. He will be at Investor Day. By all means, he will be an open book on their numbers. What they've shared with us is we address about 80% of their scripts, and that 80% is actually 1.5 million. We can address a perimenopausal market segment. There's a couple of niches in there that we do not address. But we look forward to walking you through that or he does at our Investor Day, and we'll share all that with you.

And by the way, we want to articulate what we're being communicated with that we are directly addressable to our products within our dosage range assuming the two are approved. And we won't take in anything that's outside of the range of what we can address in our BIO-IGNITE program.

And then, maybe a follow-up for -- maybe it's better for Sebastian. This is as you think about then the E+P prescriptions that are filled for doses that would not be substitutable. Question would be what -- is there a rhyme or reason for those particular doses? And could one contemplate that over time percentage of those women might migrate over to what are the FDA approved doses that 001 could potentially provide?

Yes, Bill. That will be an alternative that they could have over time. It's certainly something that we are exploring.

And, Bill, there is about 7% to 8% of the market that's like a two 200-dose. In other perimenopausal women, their hormone levels are up and down, and you really have to override the systems. You need a real high-dose. We saw that it's such a small market niche, so we didn't do [those]. We could do a follow-up study to get that kind of market once we get some good revenues going here and just kind of own the market.

The other thing is this customized dosing is really misperceived by the Street, and I think that's done purposely by some of the people that really don't believe in the product or the company. And if you look at that, doctors don't -- for the most part, we have the script data, the actual scrip data, to back this up. Doctors don't move between 0.5 and 1 milligram of estradiol. They don't move to like 0.5 to 0.67 and have that be something we couldn't address.

What they'll do is they'll add on other treatments outside of 0.5 100 and 1 100. They'll add testosterone as customization, they'll add thyroid medicine, they'll add DHEA as medicine, they'll add estriol or estrone. And the customization is to treat other symptoms than the base hot flashes and endometrial protection, and 87%, 88% of those doses are 0.5 and 1 milligram. So the customization theory that we would need in between doses, aside from what we already have, just do not hold water with the market data we have. And we already have 20% of the market covered. It just doesn't exist. It's a real headache.

Well, I mean that's kind of the point of my question is how much of the doses that they're using, how much of that is actually biologically substantiated or how much of it is done empirically versus how much of it is done just because this is the way they've always done that there and potentially providing an opportunity for physicians to rethink how they're treating patients? By the way different -- at doses that you're using there, the women symptoms are perfectly fine or addressed?

80% to 90% to answer your question, and we don't believe there's going to be any relearning of dosing at all here. And remember, there's an endo -- with estradiol and progesterone, there's a safety component. And we know 0.5 treats vast majority of women; and if not, 1 milligram treats up to 90% of the women. And you need an established dose of progesterone to protect the endometrium. Unlike the other customization agents, they don't stimulate the endometrium so there's not such a tight dosing regimen. And there is no clinical statistical differences between 0.5 and 0.75 and 1 or 0.67 and 1, thus the prescriptions just really are out there. There is a small niche that will do that, but we see it less than 7% to 10% in a prescription data we have, which is 20% of the market.

Okay. All right, thanks.

Thank you. Good questions.

(Operator Instructions) And the next question comes from Matthew Andrews from Jefferies. Your line is now open.

Yes, thank you, good morning. Three from me, Rob. Can you talk about how long you'd expect it will take to reach out and have a dialogue with the remaining roughly 2,500 independent compounding pharmacies through BIO-IGNITE?

Two, can you talk about where you are with the sales force expansion? How many of the 100 additional reps or so that you were going to bring on for Yuvvexy? Where are you with hiring those? How many have been brought on? And when will they be finally hired?

And then lastly, three, as it relates to BIO-IGNITE, what are some of the similarities with the Makena compounding pharmacy strategy after Lumara decided to partner with the compounding pharmacies and you saw the significant ramp in revenues? You know, what can you take away from the Lumara experience that you have leveraged through BIO-IGNITE for 001? Thanks.

Thanks Matt. So, how long, well, we have some time here. And we will pursue it. I have not put -- so a lot of the goals, upper management will put time frames around this. We will continue to pursue it. Our top goal is, on the sales side and the biz dev side, is to launch Yuvvexy. Their second goal is to get the market ready for 001. And it's a crossover exercise between sales, and biz dev, and channel development. They all have three different departments here.

So that relates right into the sales force expansion. So we actually have our national sales meeting going on this week; that's why Dr. Bernick isn't here. He certainly will be here in the future ones. This company is reinventing itself from a sales on the second or third burner, in clinical development in the front burner to everyone from the CEO or chairman to the janitor here will be focused on sales.

Sales is in our DNA. We are a focused company. We've hired top talent again. And we have, I believe, between 65 and 75 reps hired of the 110 or 120 we need to get Yuvvexy out in the street. And that is our absolute top priority.

The sales folks, as you might have noticed to our prenatal numbers, are focused absolutely today at going out to their new offices or existing offices, and not just working with the OB/GYNs but crossing over to the just appeared GYN segment, understand do they treat with hormones, do they treat VVA, how do they feel about estrogen, what products do they like, so all the profiling. So, assuming approval, which is what we hope for and expect here, they will be ready to go, know what offices are going, how the office staff feels and what the doctors preferences are, and ways to align our products with those preferences.

And then the last piece is Makena. We will have the team that actually developed this compounding strategy at Lumara/AMAG led by Joe Auci, who we brought in here to do very successful things. I think the key here is when Lumara launched Makena, not only did they tell the compounding pharmacies that they couldn't have the product which 100% of the product was coming from compounders, but they actually turned around and sue them if they compounded it. The Drug Quality and Security Act was not in place, and Joe Auci came in and reversed that. He actually said, look, these guys could be our best sales folks, these, guys, these compounding pharmacies can be our best supporters, and even after all those missteps at launch, Lumara still turned around and I believe their latest numbers were between 60% and 70% of market conversion. Very impressive by them. And we look to style the same model but keep it positive upfront, guarantee them that they can have the access to the product, and make sure that it improves their economic environment and still supports the patient and doctors in the way that's the most important to them.

Okay. Thanks. See you next week.

Thank you. Look forward to everybody joining at Investor Day. And it's just been a great quarter. And we are getting ready to launch, and we look forward to everyone that would like to join Investor Day to reach out to Dave and get -- make a reservation, and we love to see you there. Thank you.

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now all disconnect. Everyone, have a great day.