Good morning, ladies and gentlemen, thank you for joining us for the TherapeuticsMD Fourth Quarter and Full-Year 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 Therapeutics’ Director of Investor Relations, David DeLucia. David?

Good afternoon, everyone. Thank you for joining today to discuss our fourth quarter and full-year 2017 financial and business results. This afternoon, TherapeuticsMD issued a press release announcing fourth quarter and full-year 2017 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; our 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 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 20, 2018. With that, I'll turn the call over to TherapeuticsMD's CEO, Rob Finizio.

Thanks, Dave. Good afternoon, everyone. First, I’d like to thank the entire team here at our Company for all their hard work and relentless dedication over the past 12 months. Although 2017 was a challenging year for TXMD, after discussions and agreement with the FDA in November, we resubmitted our new drug application for our first product candidate TX-004HR. Our PDUFA target action date is May 29, 2018. Assuming approval, our plan is to launch TX-004HR in the third quarter of this year as early as July. In December, we submitted the new drug application for our second product candidate, TX-001HR. Based upon the results of our complete clinical program, including positive data from the pivotal Phase III REPLENISH trial, we expect our day 74 filing letter to arrive in March, and it will contain our PDUFA target action date which is currently expected to be in October, assuming acceptance of the NDA. We continue to appropriately expand our sales and commercial infrastructure to prepare for the potential launch of TX-004HR in the third quarter of this year. We have made important progress towards this goal, with our Chief Commercial Officer, Dawn Halkuff, leading the charge. In 2017, our sales team focused on our non-branded disease awareness campaign for VVA. We believe that our sales infrastructure as well as our established relationships in the OB/GYN channel will drive a successful launch of TX-004 if approved. We’ve been laser focused on launch strategy and staffing over the past few quarters and have made significant progress that I’d like to talk about. Beginning with sales, our sales management team is fully staffed and in place for the launch of TX-004HR. We now have 15 regional managers hired across the U.S. This team has either direct, women’s health experience or specific experience of…

Thanks, Rob. Both the fourth quarter and full-year 2017 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 $4.1 million in the fourth quarter of 2017, compared with approximately $4.5 million for the fourth quarter of 2016. Net revenue for the Company's prescription prenatal vitamin business was approximately $16.8 million for the full-year 2017, compared with approximately $19.4 million for the full-year 2016. R&D expenses during the fourth quarter of 2017 were approximately $11 million compared with approximately $10.3 million during the prior-year's quarter. This uptick in the fourth quarter reflects the NDA submission fees related to the submission of the NDA for TX-001HR. R&D expenses during the full-year 2017 were approximately $33.9 million, compared to approximately $53.9 million during the full-year 2016. The decreases in R&D for the full-year 2017 reflect a decline in clinical trial costs as we completed our Phase III trial. SG&A expenses for the fourth quarter of 2017 were approximately $14.2 million, compared with approximately $16.3 million for the prior year’s quarter. SG&A expenses during the full-year 2017 were approximately $57.7 million, compared to approximately $51.3 million during the full-year 2016. The increases in SG&A for the full-year 2017 are primarily due to an increase in sales, marketing, regulatory expenditure 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-004, in the third quarter of 2018. We expect these factors to increase the growth rate of our SG&A expenses throughout 2018. Turning to the bottom line, our net loss for the fourth quarter of 2017 was approximately $21.4 million or $0.10 per basic and diluted share, compared with…

Thank, Dan. I will now provide regulatory update for our TX-004 and TX-001 clinical programs, as well as our scientific presence in key medical meetings throughout 2018. We are excited with our progress and I would like to thank our clinical and regulatory teams for all their hard work. After a productive meeting with the FDA on November 3, we resubmitted the NDA for TX-004, which includes the 4 and 10 microgram dose on November 29. In December, the FDA accepted the NDA and acknowledged that the resubmission is a complete class II response to a Complete Response Letter received on May 5, 2017. The PDUFA target action date for TX-004 is May 29, 2018. Turing now to TX-001, we closed the year with a major accomplishment. On December 28, 2017, we successfully submitted NDA for TX-001 and expect to learn our PDUFA date in March of this year. In October 2017, we presented five oral abstracts that discuss numerous primary and secondary endpoints from our REPLENISH trial for TX-001 and the North American Menopausal Society meeting. With regard to efficacy, we presented a robust data analysis of the treatment effects of TX-001, which show a statistical significance and clinically meaningful improvement in hot flashes as indicated by the Clinical Global Impression tool that measures satisfaction with therapies. We also presented secondary endpoints that show significant improvement in sleep parameters, with very low incidence of somnolence and improvement in quality of life. In addition, we presented data on the safety of TX-001, the including rights of vaginal bleeding and amenorrhea. Although not head-to-head comparison on based historical data, TX-001 may have lower rates of vaginal bleeding and higher rates of amenorrhea rates than existing the FDA approved synthetic hormone replacement therapies. This is also in contrast to high incidence of unexpected bleeding that is reported to occur with compounded hormone therapy. We have a very busy year ahead of us in 2018 with numerous presentations of the upcoming medical meetings. We will present two abstracts at the International Society of Gynecological Endocrinology, six abstracts at the Endocrine Society meeting, two abstracts at ACOG and seven abstracts at the World Congress of Menopause. TherapeuticsMD continues to push forward as a leader in women health and our commitment is large and growing therapeutic category remains strong. Now, I want to turn the call back to Rob.

Thanks Sebastian. Looking ahead, I would like to review the catalyst for 2018. First, we expect to receive our day 74 filing letter and the potential acceptance of our NDA for TX-001 next month in March. Second, we're working to close a 200 million term-loan financing deal before they approval of TX-004 in May. Our goal is to get the best terms possible for the Company and our shareholders as we believe this will provide the Company with non-dilutive financings to support the launch of our late-stage product candidate. Our next catalyst, number three is our PDUFA data for TX-004 of May 29 and if approved becomes a new lowest effective dose that’s an elegant and convenient product for the treatment of moderate-to-severe dyspareunia due to VVA. After that our fourth catalysts were planning to host a Commercialization/Analyst Day post approval of TX-004 currently slotted for June. Our fifth catalysts this year is a launch of TX-004HR in the third quarter of 2018. Our sixth, assuming acceptance of the NDA for TX-001, we expect our PDUFA target action date in October of 2018 and if approved the launch of TX-001 in the first quarter of 2019. As you can see 2018 is a year of critical execution. By this time next year, TXMD has a potential to have full of our late stage products approved and launched, delivering on our promise to bring next-generation, innovative, bio-identical, and lower-dose estrogen products to large, underserved, and growing market of postmenopausal women. We’ll now open the call for Q&A with the operator.

Thank you. [Operator Instructions] And the first question will come from the line of Annabel Samimy with Stifel. Your line is now open.

Hi. Thanks for taking my questions, and I guess congratulations. I guess we’re in a waiting period now. So I have – one, I want to know if you could give us a little bit more color around this retail relationship that you would have with some mail order pharmacies and the largest pharmacy chains. How is it that you’re going to be avoiding, stocking or any co-pay issues that people typically face on launch? And then I want to ask you about a couple broader trends in women's health first. We've seen a lot of development in the non-hormonal space, just wondering what your thoughts are around that. Is the market and the physician population moving towards more non-hormonal options? Or is there still growth in hormones? Are there still something that's readily accepted? And then the second trend, I guess, is the emphasis of women’s health at some of the larger pharmaceutical companies has been in women's health this entire time. Maybe you can talk about some of those trends and how they might affect you? And then, I've got a final housekeeping question. I'll just save that until after this question. Thanks.

Sure. Annabel, it’s Rob. Thanks. So as far as the retail piece goes, one of the biggest headwinds in the industry is the retail channel and one of the biggest challenges for most launches is the difficulty getting their product out and stocked regardless of the medium it’s going through. So we'll give a lot more color on our – what we call Analyst/Launch Day post approval. But we've been able to successfully – given the lack of innovation in estrogen products and this growing population and the value this population has for retailers, we've been able to be very successful in multiple fronts in getting people to have an interest in what we're doing and carrying it forward. So that’s about all I can go into right now, but we plan on Analyst Day, to really lay out a number of our specific strategies here and give a lot more color. As far as the women's health and I'll turn over to Brian for the non-hormonal questions or Dr. Bernick, I should say. Look, as far as women’s health, the emphasis by companies. I would tell you in the postmenopausal space, there's definitely the emphasis and there is a wonderful round of clapping here on the commercial side, given the lack of competition. So we would hate to go into a market where you have the big guys spending lots of money to compete with you that will not be the case when we launch TX-004 and TX-001, assuming they’re both approved. The other thing is we actually do see a lot of women's health focus is just not in the postmenopausal space, specifically with hormones. If you look at the uterine fibroids, the endometriosis, and a number of other areas, there's a number of – a lot of research, bone health and things like that going on, it’s just not in the space, which we love. So if we’re successful, I think we can be successful in multiple fronts here and I hope that answers your question. I'll turn it over to Brian on the non-hormonal approach.

Sure. Quite simply I would tell you that ultimately, what patients and healthcare providers are comfortable with is estrogen and that represents 95% of the market. And it's the standard of care per the medical society, and it's what physicians have had experience with for the last 40 some years. There's been other products recently, paroxetine, Osphena, that you can see haven't fared well looking for these alternatives. Likewise, we understand that there's over 3 million women using compounded bio-identical hormones. They’re specifically going out and looking for these products when they're not even FDA approved. So that's how we view the market, and I hope that answers your question.

Annabel, just to add to that, Dr. Mirkin here, when he was at Pfizer, they spent $1 billion-plus developing DUAVEE. As we know, these treat hot flashes and protect the endometrium. I think that total of $17 million worth last year. It’s been out for about two years. Noven got paroxetine approved to treat hot flashes. That has not been very successful, and there’s other approaches Osphena, for VVA. Low-dose estrogen therapy is the front-line treatment for every single women’s health medical society and most payers that we – in fact all payers that we’ve ever seen as well as some federal guidelines there as well. So women on top of that when there's not an approved product are choosing the cash pay compounded not proven safe, not proven effective solutions over FDA approved reimbursed synthetic solutions. So what we're going to do is try to meet the demands of medical societies, meet the demands of women and give them what they're buying today and what they want today just an FDA approved reimbursed format that should lower costs for all constituents and give them something proven safe and effective for the first time.

Great. That was helpful. And if I can ask you just a quick housekeeping on SG&A, obviously you're going into launch now, but can you give us sort of a sense of how we should – the amount of SG&A or how we should expect a ramp up in SG&A for the year?

A lot of them are variables. I’d love to give you some color there. I think as we are closer to commercial day, we would be able to give you a lot more there and see what our labels like and that’s one of the main reasons. But as you know we have 15 hired managers in place, the sales training, and the sales operations. We have I believe over 50 people on the rep side in place today and we are going to 150. So it’s not too hard to do the math. The question is on the advertising side and the promotion side, the marketing budget so to speak based on the label. And if I were to give you any numbers, I’d just be guessing today until we know what the labels like, but we look forward to give you some color and future on that. What I am trying to say is there is a lot of the personal infrastructure is in place today.

Okay. Excellent. Thank you.

Thank you.

Thank you. And the next question will come from the line of Esther Rajavelu with Deutsche Bank. Your line is now open.

Hi. Thank you for taking the questions. I have a couple for Dan and then one for Rob. Can you Dan please update us on your NOL balance for as of the end of last year? And then secondly, can you tell a little bit about why the financing commitment is delayed to mid-year now from what we had anticipated it to be closer to 1Q 2018? Is there are any consideration that are preventing you from finalizing the terms right now and holding out? And then I’ll follow-up with my question for Rob.

Yes. So this is Dan. And so our NOL it will be updated in the K, when it comes out, it’s about $350 million approximately. As far as the financing, I mean we are in no hurry to put this financing in place prior to launch. This financing will be in place from the launch of both of our products, so to expand the funds to get in place before approval and final launch I think would be doing a disservice to our shareholders. That’s why we are looking at a time down the road late first quarter; early second quarter I guess would be a better way to define that. But there is just no hurry to do it.

Got it. Thanks. And then for Rob, with regards to the FDA’s compounding policy priorities plan announced about a month ago, are there any early market indications on the impact on compounders or prescribing physician feedback that you can share with us?

Yes. Esther, great question. So we are kind of step out there, but we are team compounder here. We’re obviously always in respect and support the FDA, but we see an opportunity for compounding pharmacies to replace or genericize compounded drug with our branded drug where hopefully the pharmacy will not be in an cash pay environment anymore. The women will pay less out of pocket. The pharmacy will get the WAC discount that’s offered with the drug and hopefully make money in this space again. And the doctor will be approving or writing something that’s proven, safe and effective where women has less out of pocket cost. So very similar to when a generic comes out and genericizes a branded drug. We plan with our branded drugs to genericize in essence to compounded we’re applicable, and it applies and if – certain compounded pharmacies don't want to do that. We're okay with that. The market is so big, and it's not for everybody. And as far as the FDA enforcement goes, I don't know that much on there because we've been so busy trying to just develop this compounding network as a great retail outlet for both of our drugs, but I think if we're successful, we see a lot of other pharmaceutical companies do given the headwinds with the retail channels in place today. And Esther, just to close on Dan’s point, just to be crystal clear on the debt side, he is absolutely right. We don't – we can't use the money and so we’re approved and I would set the street’s expectation if our goal which is to have this $200 million term that no equity hopefully, non-dilutive at all in place before approval. And we have to get the best terms of our shareholders and the fact that we can wait makes it much, much better. And the only reason we can wait is we did the non-dilutive financing back in September.

Got it. Thank you.

The non-dilutive I should say, yes. Thank you.

Thank you. And the next question will come from the line of Ken Cacciatore with Cowen & Company. Your line is now open.

Hey, guys. Just quick question on the TX-004 launch, is the expectation with the generics now in the market that there won't be any prior authorization, you can do kind of good work upfront and work the co-pay and the managed care, so that the clinicians would be free to kind of prescribe it at will? And then my second question on TX-001, obviously it's going to be a bit of a different launch than we're used to. So can you contractual life for us kind of expectations and understand it's a 2019, but it's something where you've been interacting so much and so frequently with a lot of these compounders with your program? Is it something that could be more rapid and is it going to require much more infrastructure than you currently have when you kind of implement that plan when TX-001 launches? Thank you.

Thank you. I am Rob here. So as far as the co-pay with generics go, we since – low-dose estrogen therapy for every payer we talk to and for every medical society is the frontline therapy. I think if you're going to see step that's come in you are going to see it for things like Osphena or Intrarosa. I know that's been put in place already with one payer, but there's a lot of payers only one of them. I don't see it being a headwind at this point at all for where we are, as long as well priced competitively/at parity and we come in at a premium, I think you're going to see that. And that we have a dialogue with a number of the largest payers and that just seems to be where they are for a lot of saturation period and historic. So that's great for us and that could change. We don't expect it to change. But we will see, right. As far as the combination goes, so yes, we're going to add another plan is to add another 100 sales reps. But the BioIgnite team will already been in place for the launch of TX-004 that works directly with this compounding channel, that’s headed up by [indiscernible] here at TXMD that falls under the distribution channel folks that you guys probably know. So with that being said, that's the only add on infrastructure. As far as the ramp goes, look, if we do it successfully, I think it can be a pretty quick ramp. I expect it to be a faster ramp than TX-004. And again we will have a very clear outline from a commercial standpoint of what we think and where we're going and how exactly we're going to do this. Post approval for TX-001 as well is a current plan. I will probably put some of that in. Our TX-004/launch Analyst Day in June. And then run that out post approval of TX-001, going into Q1 of next year. So I guess what I'm trying to say, it's a little early give you all the clarity there on this call, but we do, we will provide to the Street and we do expect the faster ramp in TX-004.

Great. Thanks so much.

Thank you.

Thank you. And the next question will come from the line of Jay Olson with Oppenheimer & Company. Your line is now open.

Oh, hey guys. Thanks for taking my question. I was curious about the May 29 PDUFA for TX-004. I think some people were surprised by the Class II designation? Do you think that in light of the fact that the FDA had a lot of the data that was included in the NDA resubmission, if there's a chance they could make a decision before May 29?

We haven no idea and the second we know anything different than what we have declared or 8-Ked, we will certainly let the street know. We just don't know of anything different. I think the Class II is more from a procedural basis of regulatory definition than for what's relevantly new or not new. I wish I have more color for you. I just don't. And if anything comes early, we'll certainly let the street know as soon as we know.

Okay. And then can you just talk about how long it would take to get TX-004 on private payer formularies and then Medicare Part D coverage?

Sure. So on the private side, it's four to six months for them to start picking you up. We plan on launching and doing some supplication, so although the net margins will be lower at first, but we'll get the script volume going, and then you'll see as the coverage is picked up behind it that begin to balance itself out, that's current plan, which we’ll give a lot more detail on our June Launch/Analyst Day. And as far as the federal side, as you know, their fiscal year starts and end, so to speak, in September, so we will be a potentially a year behind there depending on how we approach it. That's something specifically for our managed care team to address with you guys in more detail, and we'll be happy to do that as we get closer to PDUFA.

Okay. Great. Thanks for taking the questions.

Yes. Thank you.

Thank you. The next question comes from the line of Matthew Andrews with Jefferies. Your line is now open.

Hey, good afternoon. Rob, two for you, and then one for Sebastian and Brian. So first of all, can you discuss when you will enter labeling discussions with FDA on TX-004? Two, the release and as you noted, FDA viewed deal for submission is complete. But what does that mean from a CMC perspective? And then Brian and Sebastian, FDA issued guidance recently on compounded drug products, to what extent do you think the updated guidance speaks to how Dr. Gottlieb and the FDA view compounded E plus P as a public safety issue and how that may speak to potential support of approval of your drug? Thanks.

Thanks, Matt. So label negotiation, as we know, starts 30 days before the PDUFA date typically, even in a resubmission situations. So I know it's not clear for a lot of people, so it’s something I'm glad you brought up, so we can clarify. So we expect, on April 29, to start label negotiation. And the CMC piece, I'm not sure any question was there. Can you ask that again?

Yes. Just curious to what extent that FDA viewed the resubmission as a complete response. Does that say anything relative to their view on the CMC portion of the application? Did they need to go in and inspect the commercial facility that will be making the gel caps, et cetera. Just what can you say relative to it being viewed as a complete response? Is there read through to how they see CMC?

Oh yes, sure. So there was only one approvability issue in the CRL, single one. It was “lack of long-term general safety” I believe. Don't hold them – that's out of memory, not reading from that, so that might be the exact phrase, but there were no approvability issues on the CMC side in the CRL, just be clear. Does the FDA want to go and inspect manufacturers, if they are? My guess is, it’s on the manufacture side of routine inspections. I don't know if it has to do with us, not aware of anything there at all. So I just don't see anything. And it’s kind of tied together, the label negotiations in Jay’s question on the PDUFA date and why. One of the things I just thought of when you brought that up, Matt, and I didn't think of it when Jay asked the question was I don't know if you guys realized, but you’ve got Lipocine's PDUFA date in May. You’ve got Esmya, Allergan’s uterine fibroid product, in May as well as us. And if you look at their April calendar, I know – ends March, I know it's fall. So that could be another reason this procedural format was followed, just due to bandwidth. There's a lot going on in this division right now. And you can look all that up. Just a little bit more color, I don't know whether it’s helpful or not, but I think it's all procedural.

Yes. Got it. Thank you. And then just the question for Brian and Sebastian on the updated guidance and how the FDA may view compounded E plus P as a public safety issue?

Yes. I think what's clear here is that the FDA is – it’s finally committed to implementing the drug quality and security act that was passed in 2013. And over these years they've developed and now in 2018, you see the states cut out their significant policy development and how they're going to handle it, how they're going to work with the state regulators, how they are going to work with the key stakeholders, so that they can advance these measures. And we recognize that it’s a significant concern, the compounding in this space, because as we've discussed the standard of care by script volume in the space of estrogen and progesterone is an unapproved drug. So we think that this is positive and I think that an opportunity to meet the needs of people who require compounding and provide safe alternatives when necessary and when not necessary make sure that everyone’s in compliance with the act of Congress enacted back in 2013.

Okay. Thank you.

Thank you. And the next question comes from line of Thomas Smith with Morgan Stanley. Your line is now open.

Hey guys. Thanks for taking the questions. Just a couple on your commercialization plans. First, how much of your sales force and infrastructure do you intend to have in place ahead of the 004 PDUFA date? And then can you just remind us of how you’re your incremental investment you think you'll need for launching 001? Thanks.

Sure. Hey Tom. It’s Rob. So we should have a 100%, give or take a few percent if people quit I mean, that’s was a joke. But we should approximately 100% going into PDUFA from a resource and infrastructure in place, ready to go and where it is then a laser focus of the company to execute and prepare for that PDUFA date. And I think we've been doing a really good job. We’ve got some really experienced professionals in place. So the incremental increase assuming one is approved which is certainly what the company expects is to add 100 reps, so that 100 reps would be ready for a launch or hired for a launch of 01. Whether we have 100% in place at that point or not, we would certainly articulate as we get closer to it depending on how the launch of 04 and the trading and the rollout is going. And it’s about the best color I can give you at this point, but other than that, we should be ready to go.

Okay. That's helpful. Thanks. And then just maybe to follow-up on an earlier question around the term-loan financing. Understanding what you're saying in terms of not being able to access the cash ahead of the action date, but I think that you had originally guided to having the terms locked up in Q4 and then it kind of seem to slip into Q1. Just wondering I mean are there any explicit gating factors to – for locking down the terms?

No, not at all. So it's pretty clear, right. We've got time on our side and we're going to get the best deal we can and we're not in a rush and I think we could pick up and get done very, very quickly a deal that we’re going to be happy with. We have to, but we're going to get the best terms that we want because we have all the time till approval. So we feel pretty good there.

Okay. Thanks guys.

Thanks.

Thank you. [Operator Instructions] And the next question will come from the line of Caroline Palomeque with NOBLE Life Science. Your line is now open.

Hi. Thanks for taking the question. Basically just a quick question on the – you mentioned some abstracts that will be presented at the upcoming scientific meetings. I was just wondering if you could elaborate sort of on the content, on the abstracts that will be any new analysis or anything we can expect from that time.

Sure. So we've got so much activity on that from the company. We have two key presentations in the International Society of Gynecological Endocrinology where we’re going to presenting more that on the safety and the middle safety profile of TX-001 as well as additional data on the PK of TX-004. After that, we're going to go to endometrial safety meeting in Chicago, Illinois. It’s probably the most prestigious meeting for this field and this variety of presentation for both, the TX-001 and TX-004, a key secondary points of the REPLENISH trial as well as a key comprehensive data of TX-004. From there, we go to ACOG, which we also have some presence, again similar unique data and non-published already and for both product TX-001 and TX-004. We're going to close the year, probably the first Q of the year in International Menopause Society Meeting, the World Congress on Menopause in Vancouver, which again we're going to be presenting important data on our REPLENISH trial as well as REJOICE. So we have tons of information coming up very interesting data. All the societies are very excited. We received tons of invitations to make our data available in this key meeting. So we look forward to see you and your colleagues in one of these venues.

Okay. That’s very helpful. Thanks.

Thank you. End of Q&A

Thank you. And at this time, I am showing no further questions. I would now like to turn the conference back over to Mr. Robert Finizio, Chief Executive Officer for closing remarks.

Thank you. Thank you everybody for joining the call and to all our patients and loyal investors, we really appreciate the support that you've given us throughout the year. And we look forward to delivering a great well executed 2018. Thank you.

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