TherapeuticsMD, Inc.
Q3 2017 Earnings Call Transcript

Published: 6 Nov 2017

[Operator:]

Good morning, ladies and gentlemen, and thank you for joining us for the TherapeuticsMD regulatory update and third quarter 2017 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 Director of Investor Relations, David DeLucia. David, please go ahead.

[David DeLucia:]

Good morning, everyone. Thank you for joining today to discuss our TX-004HR regulatory update and third quarter 2017 financial and business results. This morning, TherapeuticsMD issued press releases announcing a regulatory update for TX-004HR and third quarter 2017 financial results. The press releases are 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; Chief Clinical Officer, Dr. Brian Bernick; and Chief Medical Officer, Dr. Sebastian Mirkin. 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 could 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 payments 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 November 6, 2017. With that, I'll turn the call over to TherapeuticsMD's CEO, Rob Finizio.

[Robert Finizio:]

Thanks, Dave. Good morning, everyone. On today's call, we'll review the following developments in our prepared remarks and then open up for questions and answers. I'll start with a regulatory update for TX-004HR. Then Dr. Bernick will provide a product review of TX-004HR and then Dr. Mirkin will provide a regulatory update for TX-004HR. And lastly, Dan will provide a review of our financial results. On November 3, 2017, the company participated in a face-to-face meeting at the FDA with the division of bone, reproductive and urologic products. I'm very happy to announce that the meeting was overwhelmingly positive and constructive. At the meeting, the division agreed to the resubmission of the NDA for TX-004HR without the need for an additional pre-approval study. The company has committed that, after approval, we will conduct a post-marketing observational study. Once the details of the post-approval protocol have been finalized, we will provide an update. But, most importantly, we believe that the financial commitment of this post-approval study will not be significant. The company believes it will be a position to resubmit the NDA within the coming weeks. We plan to let investors know when the resubmission is accepted by the FDA. Once accepted into the resubmission, the FDA will determine whether the review timeline will be two months or six months after the resubmission. The company's current expectation is for an estrogen class label, in line with our base case scenario. Through the label negotiation process, we hope to include key product attributes and differentiators. We want to thank the FDA for taking the time and effort needed in reevaluating our NDA as well as the clarity of their feedback, and concluding that it is appropriate to resubmit the NDA without the need for an additional preapproval study. I'll now turn the call over to Brian. Dr. Bernick?

[Brian Bernick:]

Thank you, Rob. And I too wish to extend my thanks to the FDA for their willingness to reconsider our application and allow us to resubmit our NDA for TX-004HR. This is an exciting time for TherapeuticsMD and should be an exciting time for both clinicians and patient. During the last 20-plus years that I've practiced gynecology, I've personally observed the multiple challenges clinicians and patients have faced prescribing and using existing FDA-approved therapies for VVA. TX-004HR was created to answer those needs and it gives me great pleasure today to announce the next steps for the resubmission of our NDA for approval to the FDA. TX-004HR is a small digitally inserted, rapidly dissolving, bioidentical estradiol vaginal soft gel. It dissolves completely without the massive discharge of the other products. It is digitally inserted without the need of an applicator into the inner, outer part of the vagina, whether the woman experiences discomfort and has a mucoadhesive that holds it in place allowing the patient to easily insert it and be ambulatory. It is estradiol vaginally, which is what clinicians are comfortable with, and it is dosed identically to the existing products of Estrace, Premarin and Vagifem, which is daily for two weeks followed by two times a week. Accordingly, there is no educational hurdle to overcome for which this represents the natural switch. The proposed unique packaging is a starter pack filed by a monthly maintenance dose pack that we believe will further enhance division and patient acceptance. A key barrier with the current therapies is the required education around both placement and dosing. Much like a Z-Pak or Medrol Dosepak, we believe that our unique blister packaging, identified by the week and day, will help simplify dosing and reduce the time it takes clinicians to educate patients. Important is the strong efficacy data for both dyspareunia and vaginal dryness, with its two-week onset of action, which is within the first prescription versus up to 12 weeks in multiple refills with the other products. And most exciting is, of course, the near absence of systemic absorption in the 4 µg and 10 µg doses. This opens up markets to other prescribers, like primary care providers and oncologists, as well as consumers that have declined therapy because of the concerns of estrogen exposure. Our 4 µg dose has the potential to be the new lowest dose available, which would be 75 times lower than Premarin cream, 25 times lower than Estrace cream, and still 2.5 times lower than Vagifem. We believe all these attributes will improve patient compliance, resulting in long-term usage. Therefore, we believe that TX-004HR, if approved, has the potential to be a best-in-class therapy and expand treatment options for the estimated 32 million women across the United States, suffering from symptoms of VVA. And now, I will turn it over to Dr. Mirkin.

[Sebastian Mirkin:]

Thanks, Brian. I will now provide a regulatory update for our TX-004HR clinical probe. We are excited with our progress and I would like to commend our clinical and regulatory team for all their hard work. In August, we had a very successful pre-NDA meeting with the FDA. And we are on track to have our NDA filed in December of this year. In October 2017, we presented five oral abstracts that included numerous primary and secondary endpoints from our REPLENISH trial for TX-001HR at the North American Menopausal Society Annual Meeting. With regard to efficacy, we presented a robust data analysis of the treatment effects of TX-001HR, which show a statistical significance and clinically meaningful improvement in both Clinical Global Impression scores and in total and vasomotor Menopause-Specific Quality of Life Questionnaire score. We also presented secondary endpoint data that shows statistical significant improvement in sleep parameters and quality of life. In addition, we presented data on the safety of TX-001HR, which showed, based on prescribing information and clinical data, lower uterine bleeding rates and higher amenorrhea rate than existing FDA-approved synthetic hormone replacement therapy. This is also in contrast to the high incidence of unexpected bleeding that occurs with compounded hormone replacement therapy. The REPLENISH trial established, for the first time, that distinct doses of estradiol in combination with progesterone demonstrated both endometrial protection as well as statistically and clinically meaningful reductions in the frequency and severity of hot flashes. Both estradiol 1 mg/progesterone 100 mg and estradiol 0.5 mg/progesterone 100 mg demonstrated statistically significant and clinically meaningful results across the four core primary efficacy endpoints. In addition, endometrial safety was established in the one-year study, with an incidence rate of endometrial hyperplasia of zero percent across all doses. I would now like to turn the call over to Dan to review our third quarter financial results.

[Dan Cartwright:]

Thanks, Sebastian. Third quarter 2017 financial results are included in the press release issued today. Let me summarize a few key points. Net revenue for the company's prescription prenatal vitamin business was approximately $4.4 million in the third quarter of 2017 compared with approximately $5.5 million for the third quarter of 2016. Total operating expenses for the third quarter of 2017 decreased compared with the third quarter of 2016. These changes primarily reflect a decline in clinical trial cost as we completed our Phase III trials. R&D expenses during the third quarter of 2017 were approximately $6.4 million compared to approximately $14.7 million during the prior-year's quarter. This change is a direct result of the completion of the REPLENISH trial for TX-004HR. SG&A expenses for the third quarter 2017 were approximately $12.1 million compared with approximately $14.7 million for the prior year's quarter. This is primarily due to a decrease in sales and marketing expenditures. Turning to the bottom line. Our net loss for the third quarter of 2017 was approximately $14.7 million or $0.07 per basic and diluted share compared with approximately $25 million or $0.13 per basic and diluted share for the third quarter of 2016. We finished the third quarter of 2017 with approximately $148.3 million in cash compared with approximately $131.5 million at December 31, 2016. Cash burn was approximately $16.8 million in the third quarter. In December, we raised approximately $68.6 million in an equity offering representing the first phase of the company's financial plans. We are currently in late-stage discussions for $150 million in debt financing to secure our medium-term capital needs to support the launches of both of our late-stage product candidates. We believe our strong balance sheet and financial position allow us to continue to advance both of our late-stage product candidates towards commercialization and provide the company with sufficient access to capital to support the launches of both of our products. Rob?

[Robert Finizio:]

Thanks, Dan. I want to thank all of our employees and shareholders for supporting us during a very challenging past few quarters. Now that that's behind us, today is a major inflection point. And looking ahead, in the next few weeks, we will resubmit TX-004HR for approval. We've confirmed for December of this year TX-004HR is on time for submission to the FDA. And looking forward to potential launch, we have financed and have over $148 million on hand and we're in the very late stages of a straight debt financing process for an additional $150 million. But, most importantly, we have the talent, we have the infrastructure, we have the cash all in place for two clear potential best-in-class therapies once approved. Now, I would like to open up the line for questions. Thank you.

[Operator:]

Thank you. [Operator Instructions] And our first question comes from Annabel Samimy with Stifel. Your line is open.

[Annabel Samimy:]

Hi, guys. Congratulations. Thanks for taking my call. Anyway, I want to know what the requirements are for you to specifically refile the NDA? Are you – and what's going to be the determining factor between the two-month review and the six-month review? Is there a change in the label? Is something specific that you're changing around the NDA filing? And then, I did notice that you're still talking about a dose range. Are you still contemplating the 4 µg to the 25 µg dose range or something more narrow? And then, I've got a follow-up. Thanks.

[Robert Finizio:]

Annabel, I'll try to hit all those. This is Rob. And if I miss any, let me know. So, as you can imagine, our team here, the regulatory, the clinical, the entire team, because we've literally been sequestered since the FDA meeting, is learning about this resubmission as we speak here today. So, we see it going in clearly in the next couple of weeks. The current thought is, all that is left is the label negotiation, which is a class I. And that's typically, what defines a class I, no new information. If there is any new information that would have to go in, it would be a class II. And you're only told that once the NDA is accepted by the FDA. So, we'll announce clearly what it is. I think you've seen the times it's taken the CRLs that were resubmitted this calendar year. You've seen how long. It hasn't taken very long for approval. But, listen, we will communicate clearly and exactly what the FDA says when they say it. So, your question on dosage, we are going to cement, as we said, the 4 and 10. We see the 25 as not as relevant given the clinical performance of the 10, as well as the non-systemic nature compared to placebo that the data suggests for the 4 and 10. We just think those are key, key selling attributes in the performance of the 10 with this kind of SYMBODA technology inside is all we think we'll need. We do have the 25 there if we ever do need it, but we don't think we do. Does that answer your questions?

[Annabel Samimy:]

Yeah, it does. And if I can just ask a follow-up, we saw a lot of action by the FDA on Friday with updating of the black box warning to a lot of different products, not just estrogen, progesterone, but we saw Vagifem, we saw [indiscernible], we saw a number of different products across all hormone therapies. Can you give us a sense of what drove that action specifically and is that – we notice it's also not on every single estrogen product. So, do you have any sense of what was going on there?

[Brian Bernick:]

Thanks, Brian. This is Brian. So, first of all, our understanding is the labeling update is only for systemic non-vaginal estrogen products. So, as it relates to TX-004HR, our estrogen and progesterone systemic product, this is all the information. It does not affect the benefit risk profile of estradiol. The data was from a meta-analysis performed in 2015 on non-vaginal systemic hormone therapy products. And the risks of ovarian cancer were already included in the existing product labeling. And we believe that this additional language that includes data from this meta-analysis to label is inconsequential. Now, as it relates to TX-004HR, our vaginal estrogen product, look, we believe this is a positive. If the FDA is willing to look at a meta-analysis data to update product labeling, then there is a great opportunity through the newly published WHI observational study on vaginal estrogen products to amend some of the warnings on these existing vaginal estrogen products. And, remember, the WHI observational stat on vaginal estrogen showed no difference in the risk of stroke, breast cancer, colorectal cancer, endometrial cancer, pulmonary embolism and DVT versus non-users, as well the risk of coronary heart disease, fracture and all-cause mortality, we're lowering estrogen vaginal usage versus non-users. So, look, if they're willing to do that, we think that that will amend the labeling for the vaginal estrogen product and we look forward to it. Thank you.

[Annabel Samimy:]

Great, thank you.

[Operator:]

Thank you. Our next question comes from Jay Olson with Oppenheimer. Your line is open.

[Jay Olson:]

Hey, guys. Congrats on the progress. And thanks for taking my question. Rob, you alluded to some differentiating features in the label as you expect estrogen class label. Can you maybe elaborate on what some of the points of differentiation are that could appear in the TX-004HR label?

[Robert Finizio:]

I could. I think we've been kind of saying all along the physical attributes of this product that make it, in essence, a non-event is a very private, intimate and process for a woman. And if you look at Brian's comments, he went through a majority of those, the fact that it's mucoadhesive, it stays in place, it dissolves quickly. We think, in the label, the PKs are absolutely critical, showing a negative erring [ph] to the curve versus placebo, given all the other products are pretty systemic. There's a whole bunch of them. I would ask people to refer to our slides on that. But, Jay, to your point, the label is what's left in the process here. And once we start that, I just want to make clear, we won't discuss the label negotiation process until it's final with the FDA and then share a label with everybody. But as you know, this is a very – the estrogen class for vaginal estrogens has not had any innovation in the existing therapies. Per their label, have a long onset of action. They're very messy. It's a time-consuming process for doctors to prescribe and to show how to administer. And I think the way Dr. Bernick has come up with something easy, elegant, intuitive and packaged correctly to eliminate that, and then giving the new, lower effective doses will be the – if approved, the lowest effective dose on the market. That is the only one that would treat the vagina, and compared to placebo, not get into the blood. Those are the attributes. We believe that's a complete game changer from every sense of the word. So, I hope that answers your question. It's hard because there are so many. And that's why I would ask people to refer to our slides.

[Jay Olson:]

Okay, great. That's helpful. And then, can you describe, what is the best case scenario in terms of the soonest that you could launch and what sort of preparation work has been done?

[Robert Finizio:]

Yeah, absolutely. So, for the amount of infrastructure we've still been able to develop and for the finance department and commercialization teams to keep the burn down to where it is, given all these unforeseen processes, it's just – hats off to them. So, who wants a question, I just want to give compliments to the team because it's been hard the last couple of quarters, and that's behind us now. So, we have been able to get the sales force – we have about 80 people in the sales team. We want to launch with 120 to 150 reps for TX-004. And that will pick up immediately here. In addition to that, the key infrastructure, with like the PVPCN partnership or network for both 01 and 04, as well as the payer work, has been very, very impressive by the teams. Joe Auci and the team has done just a great job over there. And then, additionally, we will need four to six months to get formulary coverage after approval and we find that absolutely mandatory before launch. One of the worst ways to burn a launch is if a doctor prescribes it, women go to get it at the pharmacy and it's not covered by insurance and it's very expensive. So, we see inclusion with the payers, which we see this as an unmanaged class taking four to six months to get inclusion or covered, in essence, it is time line post-approval. So, expect that once we announce approval.

[Jay Olson:]

Okay, great. Thank you very much. And congrats again.

[Robert Finizio:]

Thank you. It's a great day today.

[Operator:]

Thank you. And our next question comes from Ken Cacciatore with Cowen and Company. Your line is open.

[Ken Cacciatore:]

Thanks, guys. Congrats on this very good news. Rob, you just answered a lot – a bit about – I was going to ask you about the market for 004, but still will ask just one question about that before 001. And that is, there are some generics now in the market, maybe more coming. Do you see that as an opportunity, i.e. share of voices leaving? There is also Intrarosa from a brand perspective. So, if you can just talk a little bit about the nuance and maybe how that impacts managed care, what you touched upon just a second ago? And then, on 001, maybe an update on what's been going on there. A lot of the pre-commercialization, you touched on it very briefly, but maybe an update on what's going on with the compounders and what you're learning in that market, so we can set some expectations there as well. Thanks.

[Robert Finizio:]

Thanks, Ken. So, as you know, there's 2.3 million women of the 30 million women suffering from this disease on therapy. And there's multiple barriers for entry for reasons that women don't stay on it – stay on therapy. The compliance rate is 1.5 to 3 prescriptions depending on the product. So, as you can imagine, there are significant challenges with existing products. Generics entering the market, if that could take the obstacle of financial barriers out of place to get more people to try the drugs, and the physical or the critical nature or the time it takes for doctors to prescribe these legacy products, we think it's a perfect steppingstone for our product. Remember, this is not my generic oral pill versus your generic oral pill. This is a physical intimate experience that a woman has to use for the rest of her life. So, this becomes a part of her on a daily basis that needs to be a non-event. It needs to be something fast, easy, elegant, won't require the use of all types of things to compensate for the messiness of the existing drugs. So, anything that expands the market, whether that's Intrarosa, generic entry, we do not see that affecting the payer status in the class. We see the price point as being prohibitive to have step edits, and that still is currently – we work with inVentiv on this quarterly, very closely. We see that barrier not coming up in this class at all. If that changes, we will certainly update the Street. And we think it's just positioning very, very well for expansion and for folks to graduate from generic drugs that will have the same physical issues that the products – that a branded will have right into our product, if that's where they start. So, all in all, it's a very large market, it's very healthy and we hope to increase compliance and we hope to expand the user base and whatever means get us there. Whether that's other branded products or generics, we're happy to do it.

[Operator:]

Thank you. And our next question comes from Esther Rajavelu with Deutsche Bank. Your line is open.

[Esther Rajavelu:]

Hi there. Thank you for taking my question. I have two. Can you talk about the need for additional funding prior to launch? How are these funds going to be dispensed between 04, 01 and potentially additional pipeline products that you may have and the terms financing? And then, I'll follow up with another question.

[Robert Finizio:]

Sure. The, this is Rob. So, the sales force is a single sales force with multiple products in the bag. So, the infrastructure, once it scales, there won't be additional infrastructure needed. So, the way the plan is, it's about 120 to 150 reps for 04, and then those same reps in that same team will scale to about 250 for 01. And all of those folks will carry both products, as well as a prenatals in the bag. So, that is the current plan. Upon closing of the debt, we are very well-financed to do that. And I'll turn it over to Dave for the reason why we are doing the debt, as well as the details on it.

[David DeLucia:]

Yes. Thank you very much, Esther. For Rob's point, we're in late discussions today. Our current thinking is for $150 million of term loan debt that will not include any additional dilution. As you know, upon the completion of our equity raise in September, we believe we've put ourselves in a much better negotiating position and talking with lenders and that we have the opportunity to save 1% to 2% of interest cost annually on the debt. So, once that finalized, we'll let the Street know.

[Esther Rajavelu:]

Thank you. And then, on the commercial front, are you expecting to establish a co-pay program for 04 when it gets approved?

[Robert Finizio:]

Absolutely. That's a great point that I should've mentioned before to Ken's question. So, I am glad you brought that up. Our goal is to coupon card this down. So, it's the $25 range. Don't hold me to that, so that's subject to change, but that's currently the plan today. And also, for folks that are less fortunate and can't afford the medication, they have some assistance there as well.

[Esther Rajavelu:]

Thank you very much.

[Operator:]

Thank you. And our next question comes from Bill Tanner with Cantor Fitzgerald. Your line is open.

[Bill Tanner:]

Yeah. Thanks for taking the questions and congrats, team, on the news today. I had a couple of questions, Rob, as it relates to the meeting on Friday, if it was focused really on the endometrial safety or – I'm assuming that it really wasn't the appropriate venue to discuss the labeling, so just some thoughts there. And then, I have a follow-up please.

[Robert Finizio:]

So, the FDA made it very clear that the information we submitted, which we shared with you, the meta-analysis that we did of over 5,000 articles, the WHI, the first pass information, that was a sufficient response to their safety concerns and that was some of the context of the meeting and it was overwhelmingly positive. I think we've been able to build a very good, dependable or trusting relationship with this division there. As far as the other portion of it, it was our ability to do an observational study, which we're more than happy to do, because the cost is significantly less than a Phase III or Phase IV endometrial safety study – because the FDA really wants real-world use, to answer questions and provide real-world data, and we think that's an opportunity for us to improve our label. So, we are more than happy to do this observational study. I think it's best for everybody financially. And I think it gives them the data they want and we're gung-ho to do it.

[Bill Tanner:]

Rob, on that, there is still the expectation that a 12-month endometrial safety study needs to be done as well?

[Robert Finizio:]

No. So, just to be crystal clear, there is only an ask for an observational study post-approval and there is no need for a 12-month endometrial study at this time. And I think the data submitted helped address that, that need or that response. Our complete response answered their complete response, to be technical.

[Bill Tanner:]

Okay, great. That's helpful. So then, just in the observational study, can you put a little flesh on the bone there as it relates to what the ask is and what you hope to deliver?

[Robert Finizio:]

I wish I could. But as you know, our team doesn't even know of it yet. They are hearing about it for the first time here. So, it was our first meeting there. But we certainly will get information out once we have it. I think it's an important material piece of information here and we'll get it to you as soon as we can. In addition, just as a reminder, our approval timeline is completely independent of the fate of the observational protocol development for this observational study. So, as we develop this observational study with the agency, it has no correlation or coupling to the resubmission approval process of TX-004. I just want to make sure that's clear to the Street that the two are completely independent.

[Bill Tanner:]

And the last question is, what's a typical turnaround. So, when you submit, when would you expect theoretically to get back from the FDA as to whether it's class I or class II.

[Robert Finizio:]

I believe it's a 30 day response and that is the most amount of time that's asked of. And we will, certainly – the second we get any information on that that's very material, we will turnaround an 8-K right away.

[Bill Tanner:]

Okay, all right. Thanks very much.

[Robert Finizio:]

Thank you, Bill.

[Operator:]

Thank you. And our next question comes from Matthew Andrews with Jefferies. Your line is open.

[Matthew Andrews:]

Hey, good morning. A couple on 001. Do you plan on filing the NDA for the top two doses or the top three from the REPLENISH study? And then, second, can you talk about feedback from advisors and clinicians coming out of the NAMS meeting as it relates to 001? Any commentary around what aspect of the data they found very encouraging? Thanks.

[Robert Finizio:]

So, Matt, it's Rob. And I'll turn it over to Brian and Sebastian on the NAMS part. We're planning currently on filing for the top two doses, and not the three doses. And turn it over to Brian and Sebastian on NAMS.

[Sebastian Mirkin:]

Yeah. Thank you, Matt. So, your question on NAMS, so you could see how much of an excitement it was in the meeting. We had five oral presentations and the rooms were packed. The need for bioidentical hormones is reflected by the fact that there are around 3 million women using compounded HRT. So, there's a clear demand around that. And that data is very strong at any angle that you look at that. We show a clinical meaningful effect on the reduction of hot flashes, severity and frequency, which was supported by several PRO too. So, that was remarkable. But it's the first time that estrogen and progesterone show that type of effect. In addition to that, sleep. Women slept much better taking TX-004HR in the clinical trial, without the somnolence that Prometrium induced. You are present that. So, you would appreciate how much excitement was around that. Median profile and endometrial protection, never ever, before this REPLENISH trial, a continuous, combined estradiol/progesterone show endometrial protection. And here we are, with all doses show endometrial protection, paired that with the remarkable low incidence of bleeding profile. When you compare our bioidentical hormone versus the synthetic HRT products already approved in the market, there is a remarkable delta in the reduction of irregular bleeding. All this stuff, certainly, we hope to get it in the label here and there. So, the amount of excitement at NAMS around our product was really, really high. I'm very proud to be part of the team.

[Brian Bernick:]

Yeah. Good point, Sebastian. So, comparing the label from the approved products to the data we have that our data suggest is just really, really strong. And as we file 01, we will bring the message forward in a very clear, concise way because the medical community really is excited about it. Anything else, Matt?

[Matthew Andrews:]

No, that's it. Thank you.

[Brian Bernick:]

Thank you, Matt.

[Operator:]

[Operator Instructions] And our next question comes from Thomas Smith with Morgan Stanley. Your line is open.

[Thomas Smith:]

Hey, guys. Good morning. Thanks for taking the questions. I just had a couple. Firstly, I guess I was wondering, what are the gating factors for resubmitting the application for 004? Will you be waiting for the formal minutes from the FDA meeting?

[Robert Finizio:]

No. We agreed with the division and some of the higher ups there that we don't need to, that they – I guess, Thomas, they were super supportive. So, we're going to refile. The team, as I told you, is learning about it right now. We will get together. We will compile the data. And we will get it submitted. And we think we can do it in the next few weeks. And we'll 8-K once it's accepted.

[Thomas Smith:]

Okay, got it. And, Rob, I just wanted to clarify a comment you made around the launch timing for 004. It sounds like formulary access is going to be pretty significant gating factor. And you mentioned the kind of four to six-month timeframe. Does that mean, if you received approval in Q1 or Q2, would you end up waiting, I guess, four to six months to really get that level of formulary access that you're looking or are going to end up launching the drug kind of in that Q1 or Q2 timeframe? Just trying to get a better sense of the launch timeline.

[Robert Finizio:]

Yeah. Tom, I'm glad you brought that up. I want to make sure it's really clear. So, this class as a whole, the vaginal estrogen class, as well as the oral estrogen class, it's kind of ditto for both, so they are unmanaged classes by payers. They are paid four, page five. So, there is no P&T review with the vast majority of payers. So, once you get your approval, your NDA number, so to speak, Medi-Span and First Databank, there are just natural formulary updates or FTP downloads, so to speak, between the payers and what's approved and you would be given tier three status without going through P&C review with the vast majority of payers, 95-plus-percent is the data that I have in front of me. So, we want that process to happen. That typically takes anywhere from three to six. We're saying four to six months, just to be a little bit more conservative. So, all we need to do is get it approved and we should be set. And that would be, in essence, four to six months after the approval It should be uploaded and covered by the payers and we will hit the ground hard.

[Thomas Smith:]

Okay, got it. Thanks, Rob. That's helpful. Just one other question on the 001 application, can you talk about, I guess, any gating factors that are remaining there in terms of the filing in December?

[Brian Bernick:]

Tom, this is Brian. We had a great meeting, pre-NDA meeting with the FDA at the end of August where they confirmed the completeness of our package and we're fully on track to file it in December.

[Robert Finizio:]

Tom, in essence, if we saw any material issues with filing on time, we would've brought them up here today or before once we knew. So, we just don't see any and we've had the pre-NDA meeting. So, we think we are in great shape there. In my closing remarks, we're hitting on all cylinders from financing, from clinical milestones, from infrastructure, from personnel. We are really here. We are here. And this is – although last couple of quarters have been tough, we're ready to go.

[Thomas Smith:]

Yep. Understood. Okay, thanks, guys.

[Robert Finizio:]

Thank you.

[Operator:]

Thank you. And our next question comes from Caroline Palomeque with Noble Capital Markets. Your line is open.

[Tarun Aswani:]

Aswani in for Caroline. And thank you for taking the question and congratulations on the positive news. I just have a quick question about the BioIgnite program. What updates, if any, do you have on the annual prescription directly substitutable to TX-004HR and is there any progress on the distribution agreements for those prescriptions that have already been signed?

[Robert Finizio:]

To be honest with you, I haven't been looking at that. At this point, there's really no updates. But it will be much more important and stronger role going forward, with 01 being filed and once it's accepted. We've identified over 2 million scripts in just a few months that we did focus on this. And we think this program will only grow in the future. We continue to develop our relationship with PVPCN to construct the appropriate infrastructure and logistics needed, so that the compounded pharmacy market has the ability to obtain and dispense our products, once approved or if approved, however you want to phrase that. And we see those guys as – all compounders just are absolutely critical for us. And we see them as very, very important because in the hot flash bioidentical market, they own the market and we see that we will be able to enhance their pharmacy practice with some great products and, hopefully, cover by reimbursement. Okay?

[Tarun Aswani:]

Okay, great. Thank you for the color.

[Robert Finizio:]

Thank you.

[Operator:]

Thank you. And we have a follow-up from Matthew Andrews with Jefferies. Your line is open.

[Matthew Andrews:]

Yeah. Thank you. Good morning. Rob, can you just talk about how important by BioIgnite and the relationship with PVPCN can be for 004 in terms of leveraging the compounding pharmacies and the relationships they already have with women using compounded estrogen? Thanks.

[Robert Finizio:]

Yeah, Matt. And we don't talk about that very often. The folks at PVPCN and the compounding group as a whole, kind of covered under the IACP umbrella, where we're a partner, we do see a good amount of compounded vaginal atrophy scripts. The exact numbers, we don't have, but I'll tell you there is a good amount in there. And we look forward to making our TX-004 once approved or after approval available to this network. And we see them as just a key partner. And our future pipeline products that we will develop or anything we would, say, license, we would want to fit into that channel as well too. So, we see this as a very important partnership for us for our commercialization strategy. And we're going to execute on it.

[Matthew Andrews:]

Okay, great. Thank you.

[Robert Finizio:]

Thank you.

[Operator:]

Thank you. And I'm showing no further questions at this time. I'd like to turn the call back to Mr. Robert Finizio for any closing remarks.

[Robert Finizio:]

Thank you for joining the call this morning to all of our patient and loyal investors. We really appreciate the support that you've given us throughout the year. And we look forward to a great 2018. Thank you.

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone, have a great day.