TherapeuticsMD Inc (TXMD) 2017 Q4 法說會逐字稿

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 '17 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've 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 the 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 is either direct women's health experience or specific experience of launching new drugs, which we believe represents the right mix of top talent for our therapeutic category. This sales management team is in the process of hiring 150 total reps when complete. We've also been very focused on our retail strength and partnerships given the headwinds facing the pharmaceutical industry today as of late.

TXMD has established relationships with the national mail order as well as with a large -- one of the largest retail pharmacy chains in America. We've taken the necessary steps to try to avoid stocking and copay assistance issues that typically plague launches. We believe these relationships will help us ensure that TX-004 is both available and affordable for all postmenopausal women in the U.S., whether through the mail or on the shelves of retail pharmacies nationwide.

In addition, a dedicated compounded pharmacy relationship team is now in place, with the goal of establishing effective relationships and growing our current BIO-IGNITE program. We believe this is a critical and unrecognized vertical that contains significant opportunity for both TX-004 and TX-001HR. This channel is unique to TXMD, and we believe our differentiated approach represents a significant opportunity for our company.

By utilizing a multi-threaded retail approach, we believe that we can further ensure the successful launches of our products, if approved. This underutilized network of compounding retail pharmacies has been underappreciated by the pharmaceutical industry, and we are excited to further build our relationships with them.

Lastly, we've had a significant progress on the payer side these past few quarters. We continue to have a strong dialogue with multiple major payers in preparation for the launch of TX-004HR. The feedback that we are getting is that they are -- that there are no major barriers to covering a new, lower-dose, branded estrogen product, assuming competitive or parity pricing. These discussions were held after the recent introduction of ESTRACE and Vagifem generics to the market. As a reminder, if approved, TX-004 would have a 25x lowered estrogen dose than ESTRACE and its generics and a 2.5x lowered estrogen dose than Vagifem and its generics.

On the call today, we'll review these developments in our prepared remarks and then open it up for Q&A. Dan will start with a review of our financial results, then Dr. Sebastian Mirkin will provide a regulatory update for both clinical programs. Dan?

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 from 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 $110 million -- excuse me, 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 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 approximately $22.8 million or $0.12 per basic and diluted share for the fourth quarter of 2016. Our full year net loss for 2017 was approximately $76.9 million or $0.37 per basic and diluted share compared with approximately $89.9 million or $0.46 per basic and diluted share for the full year 2016.

Finally, let me finish -- finally, we finished 2017 with approximately $127.1 million in cash compared with approximately $131.5 million at December 31, 2016. As a reminder, our cash balance at the end of the third quarter of 2017 was approximately $148.3 million, which equates to a cash utilization of approximately $21.2 million in the fourth quarter.

In September, we raised approximately $68.6 million in an equity offering, representing the first phase of the company's financing plans to support commercialization of our 2 late-stage product candidates.

We are currently in discussions for the second phase of the company's financing plans, $200 million in term loan debt financing. We intend to structure a deal that enables the company to draw tranches of debt upon approval of our late-stage product candidates. We are working to finalize the best deal for our company and our shareholders before the PDUFA date of TX-004 in May. We believe we are in a strong position to do so. Confirmation of this deal will secure non-dilutive financing to support the launches of both of our late-stage product candidates.

We believe our strong balance sheet and financial position allows us to continue to advance both of our late-stage product candidates towards commercialization and that the company has sufficient access to capital to support the launches of both of our products.

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

Thanks, Dan. I will now provide regulatory update for our TX-004 and TX-001 clinical programs as well as our scientific presence in key clinical meetings throughout 2018. We're 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 2 response to the Complete Response Letter received on May 5, 2017. The PDUFA target action date for TX-004 is May 29, 2018.

Turning now to TX-001. We closed the year with a major accomplishment. On December 28, 2017, we successfully submitted the NDA for TX-001 and expect to learn our PDUFA date in March of this year. In October 2017, we presented 5 oral abstracts that discuss numerous primary and secondary endpoints for our REPLENISH trial for TX-001 in the North American Menopause Society meeting.

With regards to efficacy, we presented a robust data analysis of the treatment effect of TX-001, which showed statistically significant and clinically meaningful improvement in hot flashes, as indicated by the Clinical Global Impression tool that measures satisfaction with therapy. We also presented secondary endpoints that show significant improvement in sleep parameters, with very low incidence of somnolence, and improvements in quality of life. In addition, we presented data on the safety of TX-001, including rates of vaginal bleeding and amenorrhea. Although not head-to-head comparison and based on historical data, TX-001 may have lower rates of vaginal bleeding and higher rates of amenorrhea than existing 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 presentation at upcoming medical meetings. We will present 2 abstracts at the International Society of Gynecological Endocrinology, 6 abstracts at the Endocrine Society Meeting, 2 abstracts at ACOG and 7 abstracts at the World Congress of Menopause.

TherapeuticsMD continues to push forward as the leader in women's health, and our commitment to this large and growing therapeutic category remains strong.

Now I want to turn the call back to Rob.

Thanks, Sebastian. Looking ahead, I'd like to review the catalysts 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 the 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 financing to support the launch of our late-stage product candidates. Our next catalyst, number three, is our PDUFA date 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 catalyst, we're planning to host a Commercialization/Analyst Day post approval of 04 currently slotted for June. Our fifth catalyst this year is the 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 the potential to have both of our late-stage products approved and launched, delivering on our promise to bring next-generation, innovative, bio-identical and lower-dose estrogen products in a large, underserved and growing market of postmenopausal women.

We'll now open the call for Q&A with the operator.

(Operator Instructions) And the first question will come from the line of Annabel Samimy with Stifel.

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 have with some mail order pharmacies and the largest pharmacy chains. How is it that you're going to be avoiding stocking or any copay 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 nonhormonal space. Just wondering what your thoughts are around that. Is the market and the physician population moving towards more nonhormonal options? Or is there still growth in hormones? Are there still something that are -- 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.

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 the 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 nonhormonal 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 guy spending lots of money to compete with you. That will not be the case when we launch 04 and 01, assuming they're both approved. The other thing is we actually do see a lot of women's health focused just not in the postmenopausal space, specifically with hormones. If you look at the uterine fibroid, the endometriosis and a number of other areas, there's a number -- 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 nonhormonal approach.

Sure. Quite simply, I would tell you that ultimately, what patients and health care providers are comfortable with is estrogen, and that represents 95% of the market. And it's the standard of care for 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 that are 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 endometrium. I think that's a total of $17 million worth last year. It's been out for about 2 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 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 demand in medical societies, meet the demands of women and give them what they're buying today and what they want today just in an FDA-approved, reimbursed format that should lower cost for all constituents and give them something proven safe and effective for the first time.

Great. Yes, that was helpful. And if I can ask you just a quick housekeeping. On SG&A, obviously, you're going into the 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 the 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 get closer to Commercial Day, we'll be able to give you a lot more there and see what our label is like. That's one of the main regions. But as you know, we have 15 hired managers in place, the sales training, the sales operations. We have, I believe, over 50 people on the rep side in place today, and we're 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 label is like. But we look forward to giving you some color in the future on that. But a lot -- what I'm trying to say is a lot of the personnel infrastructure's in place today.

And the next question will come from the line of Esther Rajavelu with Deutsche Bank.

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 talk a little bit about why the financing commitment is delayed to midyear now from what we had anticipated it to be, closer to 1Q '18? Is there any considerations 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're in no hurry to put this financing in place prior to launch. This financing will be in place for the launch of both of our products. So to expend the funds, to get it in place before approval and final launch, I think, would be doing a disservice to our shareholders. That's why we're 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's just no hurry to do it.

Got it. 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, it's a great question. So we hear all kinds of stuff out there, but we are a 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 a cash pay environment anymore. The woman 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, or a woman has less out-of-pocket cost. So it's very similar to when a generic comes out and genericizes a branded drug. We plan our branded drug to genericize, in essence, the compounded market where applicable. And when it applies -- and 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, you'll 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's absolutely right. We don't -- we can't use the money until we're approved. And I would set the Street's expectation of our goal, which is to have this $200 million term debt, no equity, hopefully non-dilutive at all in place before approval. And we have to get the best terms for our shareholders. And the fact that we can wait makes it much, much better. And the reason we can wait is we did a non-dilutive financing back in September -- non-dilutive, I should say, yes.

The next question will come from the line of Ken Cacciatore with Cowen and Company.

Just a quick question on the 04 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 copay and the managed care so that clinicians would be free to kind of prescribe it at will? And then my second question, on 01, obviously, it's going to be a bit of a different launch than we're used to. So can you contextualize for us kind of expectations? And I understand it's in '19, but is this something where you've been interacting so much and so frequently with a lot of these compounders with your program? Is this 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 01 launches?

Ken, Rob here. So as far as the copay with generics go, we -- low-dose estrogen therapy, for every payer we talk to and for every medical society, is the front-line therapy. I think if you're going to see step edits coming, you're 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 we're priced competitively/at parity. If we come in at a premium, I think you're going to see that. And that -- we've had a dialogue with a number of the largest payers, and that just seems to be where they are for low-dose estrogen, period, end of story. So that's great for us. That could change. We don't expect it to change. But we'll see, right? As far as the combination goes, so yes, we're going to add another -- the plan is to add another 100 sales reps. But the BIO-IGNITE team will already be in place for the launch of 04. That works directly with this compounding channel, and that's headed up by (inaudible) 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 04. And again, we'll 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 01 as well is the current plan. I will probably put some of that in our 04 Launch/Analyst Day in June and then round that out post approval of 01 going into Q1 of next year. So I guess what I'm trying to say, it's a little early to give you all the clarity there on this call, but we do -- we will provide to the Street, and we do expect a faster ramp in 04.

And the next question will come from the line of Jay Olson with Oppenheimer & Co.

I was curious about the May 29 PDUFA for TX-004. I think some people were surprised by the class 2 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, that there's a chance they could make a decision before May 29?

We have no idea. And the second we know, we -- and the second we know anything different than what we've declared or 8-Ked, we will certainly let the street know. We just don't know of anything different. I think the class 2 is more from a procedural basis of regulatory definition than for what's relevantly new or not new. I wish I had 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 004 on private payer formularies and then Medicare Part D coverage?

Sure. So on the private side, it's 4 to 6 months for them to start picking you up. We plan on launching and doing supplementation. 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 begins to balance itself out. That's the 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 ends, so to speak, in September, so we will be potentially a year behind there, depending on how we approach it. And 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.

And the next question comes from the line of Matthew Andrews with Jefferies.

Rob, 2 for you and then 1 for Sebastian and Brian. So first of all, can you discuss when you will enter labeling discussions with the FDA on 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, Matt. So label negotiation, as we know, starts 30 days before the PDUFA date, typically, even in a resubmission situation. 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 the FDA viewed the resubmission as a complete response. Does that say anything relative to their view on the CMC portion of the application? Do 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 being viewed as a complete response? Is it a read-through to how they see CMC?

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 not be the exact phrase. But there were no approvability issues on the CMC side in the CRL, just to be clear. Does the FDA want to go and expect 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 to kind of tie together, the label negotiations and Jay's question, 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 realize, 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.

Got it. 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 finally committed to implementing the Drug Quality and Security Act that was passed in 2013. And over these years, they've developed. 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 state regulators, how they're 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 the 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 it's 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 the Congress enacted back in 2013.

And the next question comes from the line of Thomas Smith with Morgan Stanley.

Just a couple in 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 much incremental investment you think you'll need for launching 001?

Sure. Tom, it's Rob. We should have 100%, give or take a few percent if people quit -- I mean, that was a joke. But we should have approximately 100% going into PDUFA from a resource and infrastructure in place, ready to go and -- 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 01 is approved, which is certainly what the company expects, is to add 100 reps. So that 100 reps would be ready for launch or hired for launch of 01. Whether we have 100% in place at that point or not, we would certainly articulate when we get closer to it, depending on how the launch of 04 and the training 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. 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 the -- you'd originally guided to having the terms locked up in Q4, and then it kind of seemed to slip into Q1. Just wondering, I mean, are there any explicit gating factors to locking down the terms?

No, not at all. So it's -- 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 you'll be happy with if we had to, but we're going to get the best terms that we want because we have all the time until approval. So we feel pretty good there.

(Operator Instructions) And the next question will come from the line of Caroline Palomeque with NOBLE Life Science.

Basically, just a quick question on the -- you mentioned some abstracts that will be presented at upcoming scientific meetings. I was just wondering if you could elaborate sort of on the content, on the abstracts. Will there be any new analysis or anything we can expect from that side?

Sure. So we have so much activity on that front of the company. We have 2 key presentations in International Society of Gynecological Endocrinology, where we're going to present more data on the safety and the middle safety profile of 01 as well as additional data on the PK of 04. After that, we're going to go to the Endocrine Society Meeting in Chicago, Illinois. It's probably the most prestigious meeting for this field. And there's a variety of presentation for both, 01 and 04, key secondary endpoints of the REPLENISH trial as well as key comprehensive data of 04. From there, we go to ACOG, in which we also have some presence, again, similar unique data and non-published already for both product, 01 and 04. And we're going to close the year -- or 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 these key meetings. So we look forward to see you and your colleagues in one of these venues.

And at this time, I'm 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. Thanks, everybody, for joining the call. And to all our patient, loyal investors, we really appreciate the support 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.