TherapeuticsMD Inc (TXMD) 2015 Q4 法說會逐字稿

Good day, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD Fourth Quarter and Full Year 2015 Results Conference Call. Following remarks from the company, we will be opening the call for questions.

I would now like to turn the call over to Ami Knoefler from Spark Biocomm, representing Investor Relations for the Company. Ami?

^ Good afternoon, everyone. Thank you for joining today to discuss our 2015 financial and business results. Following the market close, TherapeuticsMD issued a press release announcing fourth quarter and full year 2015 financial results. Our press release is available on the company's website, ThepeuticsMD.com, in the Investors & Media section.

On today's call from TherapeuticsMD are Chief Executive Officer, Robert Finizio; Chief Financial Officer, Daniel Cartwright; Chief Medical Officer, Dr. Sebastian Mirkin; and Chief Product Officer, Julia Amadio.

Before turning the call over to the Company, I would like to remind everyone that certain statements made during this conference call may be forward-looking statements. Such forward-looking statements are based upon current expectations, and there can be no assurance that the results contemplated in these statements will be realized. Actual results may differ materially from such statements due to a number of factors and risks, some of which are outlined and 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 25, 2016.

And with that, I'll turn the call over to TherapeuticsMD's CEO, Rob Finizio.

Thanks, Ami, and good afternoon, everyone. 2015 was a breakthrough year for TherapeuticsMD. We achieved key milestones to advance our pipeline and further our mission to become a leading women's health company. Let's recap 2015.

First, we have great data. We reported extraordinarily successful results from the Phase 3 Rejoice Trial for our first product candidate, TX-004 or applicator-free vaginal estradiol softgel for the treatment of moderate to severe treatment of dyspareunia, a symptom of VVA. Sebastian and Julia will give you updates on the validated co-primary endpoint data and the commercial planning for TX-004 a little bit later on our call.

Next, we completed enrolment in the Replenish Trial, our second Phase 3 trial, one of the biggest ongoing trials in the women's health space, which we believe is powered to fulfill regulatory requirements for treatment of vasomotor symptoms in the U.S., Canada, and Europe. Sebastian will also provide an update on how the Replenish Trial is progressing.

In 2015, we also saw continued growth in our prescription prenatal vitamin business for which full year 2015 revenue increased 34% over 2014. We believe the successful operation provides an in place sales infrastructure that we plan to grow to support for the launch of TX-004.

At this juncture, I am also extremely pleased that our cash position is very healthy. Dan will give you some perspective on how we are going to, how we are viewing our specific cost for a launch of TX-004, but we are comfortable with the financial resources we have in place to execute our plan.

Finally, I'll remind you that women's health remains an area where few companies are focusing their R&D and commercialization efforts. Our company is exclusively focused on developing novel new therapies to improve women's lives. We believe that TherapeuticsMD has the products, the pipeline, and the resources to do it successfully.

Now, Dan will provide the financial update.

Thanks, Rob. With a strong cash position and the recent reduction in our R&D expenses, we believe we are well positioned financially to execute on our goals and to support the launch of our two late-stage candidates. Whilst fourth quarter and full year results are included in the press release issued today, on this call, I will make general observation about our R&D expenses and specifically our clinical trial cost.

R&D costs during the fourth quarter of 2015 were $13.3 million, a reduction from $14.2 million during their last fourth quarter. Additionally, this is the second consecutive quarter we have seen R&D costs fall. This is a result of the Rejoice Trial being completed and the Replenish Trial having the majority of the patients accept the trial. We have seen and expect to continue to see our clinical trial cost decline.

As we have discussed on the last couple of calls, we are ramping up our commercialization investment in anticipation of launching these drug candidates. The majority of the costs associated with commercialization will be categorized as R&D expenses until our product candidates are on the door step of approval.

With $67.4 million in cash at year-end, combined with the net proceeds of approximately $135 million from our recent financing our cash position is very solid. With these resources, we believe we are on track to support the launch of both of our Phase 3 products and to build upon our existing sales infrastructure which targets OB/GYN and women's health specialist.

To provide some background on the anticipating build of our sales infrastructure, we currently have approximately 35 sales representatives focused on the OB/GYN market. If TX-004 is approved, we currently expect to bring the rep count to approximately 150 at launch. For the combo launch if approved, we currently plan to add approximately a 100 more reps to bring our total sales force to around 250. We anticipate the annual cost per sales rep will be around $200,000 per year at the point of launch.

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

Thanks, Dan. 2016 is on track to be another turning point for our company. As we anticipate, filing our first NDA, I am preparing to launch TX-004, the first product candidate from our pipeline. Following a very positive Phase 3 data from our Rejoice Trial, we anticipate an NDA filing for TX-004 by the end of June for all three doses, namely four, ten, and 25 micrograms.

We also are very pleased to begin presenting additional data from the Rejoice Trial to the medical community. Some of the Rejoice Trial result will be presented this week for the first time during the annual meeting of International society for the study of women's sexual health known as ISSWSH. The ISSWSH poster will be available on our website this afternoon, and we have included these data in our press release issued today. This poster includes result on a validated co-primary endpoint as well as a key secondary endpoint related to vaginal dryness.

Dyspareunia and vaginal dryness often co-exist. However, recent drugs approved for dyspareunia have not demonstrated a statistical significant difference over placebo for the end point of vaginal dryness. The result for dyspareunia and vaginal dryness in the Rejoice Trial are statistical significant different from placebo at all three doses. We believe that these data reinforce the overall strength of our clinical package to support potential approval of TX-004.

Let me now review these results so you will appreciate the robustness of the data. There has been a slight statistical improvement for the co-primary endpoint of dyspareunia for all three doses. I will start with 25-microgram dose. The 25-microgram dose demonstrated a highly statistical significance and clinically meaningful results with the p-value of less than 0.0001 across all four co-primary endpoints as well as the key secondary endpoint of vaginal dryness. You can appreciate that statistical significance has improved for the co-primary endpoints of dyspareunia.

The 10-microgram dose also demonstrated a highly statistical significant and clinically meaningful result with p-value of less than 0.0001 across all four co-primary endpoints and the secondary endpoint of vaginal dryness. Again, you can appreciate that statistical significance has improved for the severity of dyspareunia.

The 4-microgram dose demonstrated a highly statistical significant result with the p-value of less than 0.0001 for the co-primary endpoint of vaginal superficial cells, vaginal parabasal cells, and vaginal pH. For the subjective co-primary endpoint of dyspareunia, the four microgram dose also show a reduction in severity of dyspareunia that was statistical significant different on placebo at the 0.0149 level, which represents greatest statistical significant than we initially reported.

For the secondary endpoint of vaginal dryness there was a statistically significant reduction in the severity of vaginal dryness with the p-value of 0.0014. Not only the PK data for all three doses demonstrated negligible to very low systemic absorption of 17beta-estradiol supporting and confirming our earlier findings from the Phase 1 study in which TX-004 demonstrated three times lower serum estrogenic concentration or lower systemic exposure at the vaginal tablet that is currently in the market.

Let me turn now to the Phase 3 Replenish Trial that is evaluating TX-001, our combination of natural estradiol and natural progesterone for the treatment of vasomotor symptoms due to menopause. The Replenish Trial is evaluating four different doses of TX-001 in over 1,750 subjects at approximately 100 sites in the U.S. The Replenish Trial has been fully enrolled as of October 13 2015, and is powered to meet regulatory standards in terms of efficacy and safety in the U.S., Canada, and Europe.

Let me remind you that the Replenish Trial is evaluating doses of estradiol that have been proven to treat vasomotor symptoms and doses of progesterone that have been shown to effectively protect endometrium for estrogenic stimulation.

But now, I would like to give you the first clinical update for the Replenish Trial. As of this week, over 1,400 subjects have already exited the trial. And while the data remain blinded the incidence of endometrial replacement for these subjects is below 1% which is the required threshold for the primary endpoint for endometrial protection. While this could change, we are currently very optimistic about the progress of the trial because TX-001 uses the same SYMBODA technology as a basic of use in the successful Rejoice Trial. Finally, we continue to expect the top line result from the Replenish Trial late in the fourth quarter of 2016.

Now, I will let Julia to give you an update on the commercial planning.

Thanks Sebastian. Our primary focus for TX-001HR is to prepare and submit an NDA for filing before June 30th for our novel product candidate for dyspareunia. This is a planned 505(b)(2) submission with an anticipated 10-month review process. While the FDA will make the ultimate decision on approval, we believe our data could provide a strong set of tools for our candidate to compete in the market by capturing current share and attracting new patients to treatment. We believe the Rejoice Trial results support the unique attributes of our product candidate, and if approved, its potential position as a highly differentiated therapy that features a new lower, effective dose, which could attract new patients to therapy; negligible to low systemic absorption; a fast onset of action based on efficacy being demonstrated in Rejoice Trial at week two; strong efficacy across multiple symptoms of VVA including pain during sex and vaginal dryness; an easy to use product with no applicator or messiness; excellent tolerability with no significant difference versus placebo; and a 95% patient satisfaction rate. To be clear, we intend to file our NDA with no black-box warning in our proposed labeling.

Importantly, we believe that our PK data from the Rejoice Trial are key for market differentiation and are aligned with the FDA's meeting on November 10th to review low dose vaginal estrogen labeling. Also of note is the recent ACOG Committee Opinion No. 659, which adds to the medical community support for removal of or relabeling of the black-box warning for vaginal estrogen. Again, based on this support and our data, we currently intend to file our NDA for TX-004HR with no black-box warning in our proposed labeling. Although there is no assurance that the FDA will agree to our proposed labeling or the exclusion of the black-box warning.

Given the changes in this therapeutic category, our IP position is of growing importance. I am happy to announce that we received notification of a patent allowance from the U.S. Patent and Trademark Office for the TX-004HR product, which embodies our SYMBODA technology. This allowance touches upon the unique nature of TX-004HR including its low systemic exposure PK data. We believe that this allowance will strengthen protection for our branded candidate with patent coverage through 2033.

Looking ahead, we have submitted two late-breaking abstracts to ENDO, the Annual Endocrine Society Meeting, taking place in Boston on April 1st through 4th. We believe this is a perfect venue to present the full efficacy and PK data along with safety data from the Rejoice Trial to the medical community.

In conjunction with the anticipated online release of late-breaking abstracts by the Endocrine Society, we are planning an update on the Phase 3 Rejoice Trial data on Monday, March 7, during our presentation at the Annual Cowen Healthcare Conference. Please watch for our confirmation of the webcast and details for that event, which will take place at 4:40 that day and include an extended Q&A session with participation from leading women's health experts.

On commercial planning front, we are moving forward with important planning activities based on the Phase 3 data. We recently received conditional approval from the FDA for a brand name for TX-004HR, our candidate in development for treating pain during sex. YUVVEXY, Y-U-V-V-E-X-Y, is the new brand name and is easy to phonetically pronounce and remember. We think it holds tremendous promise for broadly marketing the product to women. We are also actively working on unique packing that we believe will further enhance physician and patient acceptance.

As you know, a key barrier with current therapies is the required education around both placement and dosing. Much like the EpiPen, 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 physicians to educate patients by serving as a patient education tool. Together with our applicator free softgel capsule technology, we believe this self-explanatory packaging should save physician time and improve patient compliance, and expand prescribing beyond the OB/GYNs to the multitude of primary care providers. Our goal is to make YUVVEXY easy to prescribe and easy to use, expanding treatment to the millions of untreated women.

Now, let me turn the call back to Rob.

Thanks, Julia. As you all know, women's health is our focus. If YUVVEXY is approved, our current plan is to launch with our own sales force covering women's health via the domestic OB/GYN market.

We believe that we have the skill set, the funding, and the experience to launch YUVVEXY into the women's health market in a cost effective manner if approved. If we decide to go into the PCP market or internationally given the attributes of our product and the size of the opportunity, we would seek a partner with more resources in a broader commercial footprint. While we are highly focused on executing the YUVVEXY program successfully, we are increasingly excited about the opportunity for our combo candidate in the Replenish Phase 3 results later this year.

As Sebastian mentioned, our blinded combo trial has over 1,400 of the 1,750 patients that have exited so far. And the incidence of hyperplasia is below the 1% required by the FDA for approval. It's a very positive sign.

Now, let me give you an update on the combination hormone therapy market. We also believe that the market opportunity for our bio-identical estradiol and progesterone also known as "combo," the product candidate continues to evolve favorably. There's approximately 3,000 non-sterile retail pharmacies that compound E plus P products, and they are very focused on supporting the needs of women going through menopause. We believe that currently they have strong relationships with the customers in a cash pay environment.

There continues to be an expensive use of bio-identical combination of hormone therapy as citied in recent publications with over 30 million prescriptions each year for a compounded bio identical estradiol and progesterone. The Drug Quality and Security Act and other forces have cut most, if not all, reimbursement for compounding drugs, and we believe this is affecting most compound in pharmacies. Assuming positive data and approval for estradiol and progesterone product candidate, we see these pharmacies as a strategic fit and partners for TherapeuticsMD. Our goal is to build a bridge that economically [in sense] non-sterile, retail pharmacies that currently compound estradiol and progesterone products to sell our product.

Also, in regulatory compliance related to these products, improve their productivity and probably most of all their margins. In fact, we're conducting market research with the compounding industry to collect important data to further articulate the needs of women adding clarity to their size, the scope and the opportunity within the current bio-identical HRT market. We expect to provide an update on those data later this year.

Before I close, I want to highlight that we have an exciting set of events currently planned for each quarter of 2016. In Q1, we have the ISSWSH presentation that Sebastian mentioned followed by a full presentation of the Rejoice Trial data on March 7 at the Cowen Conference in Boston. In Q2, we anticipate the annual Endocrine Society meeting where the Rejoice data will be presented to the medical community. In the second quarter, we also have the intended filing of our NDA for YUVVEXY.

Also in late Q2, early Q3, we'll have an additional investor event to review the strategies for both of our product candidates. Our goal will be to give you a complete overview of the commercial and clinical strategies for both product candidates. The meeting will be attended by leading experts in the VVA and menopause markets as well as experts from the compounding pharmacy community.

We anticipate in Q3 reporting our transdermal Phase 1 data for our proposed P alone in combination estradiol and progesterone cream products. And late in Q4, we anticipate top line data for the Replenish Trial for our combination candidate.

To summarize, 2015 was a breakthrough year for TherapeuticsMD. We are at a great point as we continue to execute on our mission. The good news is we look forward to even better 2016. And with that, I will turn it over to the operator to take questions.

(Operator Instructions) Our first question comes from the line of Bill Tanner from Guggenheim Securities. Your line is now open.

Thanks for taking the questions. And maybe for you Rob or Sebastian, just on the ISSWSH presentation, I'm curious as to the reason for the release on the vaginal dryness or presentation of the vaginal dryness data. I mean I understand that obviously you got another medical meeting, you'd like to have something else to present, so just curious on the selection there. And then as we think forward for the Endocrine meeting, can you give us a sense, I mean, without going, I guess, in the explicit detail what incremental data would be presented there that what do you top line recently and then what's going to be at ISSWSH? Thanks.

Thank you, Bill. The reason that we are releasing the dryness at ISSWSH is because dyspareunia and dryness are almost always coexistent. Most of the products current in the market do not improve dryness. The three doses of TX-004 show statistical difference or placebo not only for dyspareunia but for the key endpoint of dryness. We believe that this is unique and this highly differentiates other products from the other drugs currently in the market. This is relevant for this particular meeting which is a meeting for international sexuality for women health. That's the reason we pick this specific meeting to release this important information.

In term of the Endocrine Society, we're going to have a full presentation of the Rejoice Trial data. This is one of the most prestigious meeting, medical meeting going on in 2016 in North America, therefore we are going to have two set of data, a full set of clinical data including secondary points in full, primary endpoints, and safety and tolerability, and a second abstract with all our pharmacokinetic analysis. We hope, of course, that this [possibly] will be accepted that we already submitted to the meeting.

Got it. That's helpful. And maybe if I can just touch one more, Rob, on the staffing just in terms of the sales force, so 150 to support 004 and then an incremental 100 for 001. Does that speak to a difference in the calling universe or is it something that you kind of want to get 004? I guess is there some level of profitability or some expense that you want to maintain lower before 001 comes on board, just trying to understand a little bit why you would be adding on 001 unless it's a different call point?

Sure, hey, Bill. So there's about 24,000 OB/GYNs we want to get to. So 250 reps -- typically our territories as I say now have about 100 docs per rep. So it's just a number of math. As far as when you bring them on and how, it's a matter of scaling effectively, cost effectively, and making sure you are not shotgunning it in taking more of a cost effective but rapid approach as a goal. And the good thing is we got our infrastructures in place. Teams here, we're in most of the major markets already, and it's basically splitting concept going forward. And we think we can get it done.

Okay. Great. Congrats on the progress.

Thank you.

Our next question comes from the line Annabel Samimy from Stifel. You line is now open.

Hi, this is Andrew Ang in for Annabel. Thanks for taking my questions. First, how should we think about the Replenish Trial and the potential outcome? You could potentially have the lowest available dose, but if it doesn't resolve the VMS as expected, could this still be viable product offering for hyperresponders similar to what you sort of envisioned for the 4-microgram, for the VagiCap? And second, how would you think about the parts outside the U.S.? Will you be seeking more development in regulatory or just commercial? Thank you.

So thanks for joining. That was funny hearing your voice when I said Annabel. So we all chuckled here. So just to understand your questions, I want to answer them directly. So, your question on the combination product, which is estradiol and progesterone, to treat vasomotor symptoms and protect endometrium due to menopause, your question there was do we think the lowest dose might work like the VVA 4-microgram did?

Or more of if it doesn't work as expected to resolve the vasomotor symptoms, could it still be a viable option for the hyperresponders?

Ah, I see. So, as you know, just to caveat since this is a legal call, the data is obviously still blinded. So I am just taking what our scientists have told us. The previous two or three approvals in this space, the lowest doses, did not separate at week four and week 12, but the higher doses did and they were approved. So you look at Activella, Enjuvia, and a few others.

So that precedent does exist. I am personally hoping that they all work, and they all separate at week four and week 12. But if we did have separation that was stat sig by week 12, there is a chance that that lowest dose would still be approved. So, it's something I'm glad you actually brought up because I'm sure we've been talking about VVA so much. A lot of people aren't aware of that.

But remember, all of our doses, our new lower effective doses in the E plus P trial on the progesterone side or the progestin side, which is clearly the bad actor from the WHI, remember that progesterone arm had a 24% increase in breast cancer and a big increase in cardiovascular disease. And the progestin came out of that as the bad actor, thus so much bio-identical sales going to the compounding market. So we're really excited about all the doses, hopefully being new or effective doses.

Great. Thank you. And on the second one, about the partnership, if you will just be seeking development regulatory or just commercial outside of the U.S.?

We are open to everything at this point. And it's early, we're just, as you can tell, getting our validated data in. So, we'll update you on that one should we have something.

Great. Thank you.

Thank you.

Thank you. Our next question comes from the line of Ken Cacciatore from Cowen. Your line is now open.

Hey, guys. Just a question as we get closer to the VVA launch. Can you just remind us the level of current competitive sales in that market? And then maybe this might be a little bit more difficult, can you talk about the 4-microgram? And you keep on alluding to the fact that it could expand the market. So could you give us maybe a preview up to what degree you think those sales could inflect change in terms of the size of the market with that product, put a little new ones around your commentary? Thank you.

Sure, Ken. This is Rob. So the current market is 1.5 billion domestically in the U.S. There's about 6 million scripts a year for the current VVA products. A vast majority, 1.4 billion of that are from three products; two of which are cream, one of which is the Vagifem tablet. So the competitive nature out there we don't really see in the 35 sales territories, OB/GYN markets that we're calling on, which is most of the major NFL cities in the country, so to speak.

My understanding, and this won't be for every market but most it will be for, Vagifem isn't really sampling any more. Premarin is not really promoting. I mean think about it, the product is approved in 1970s. There's not much to say here originally. And then Estrace does do some promotion. But as you know, it looks like Pfizer and Allergan are going to become one, so who knows how that's going to end up.

So we really, really like this market because from the low dose estrogen products, which are by far, you know, 95-plus percent of the market, it is not a competitive promotional environment, and we think if we can have not just numerically lower doses but all of our doses from a PK standpoint seem to be less airy under the curve or less systemic exposure than anything on the market today and hopefully a much stronger usability factor. And if we are lucky a superior label, we think we can really do damage in that $1.5 billion market.

Now to your point, there is 30 million, 30 million untreated women out there. And if you read the IMS study or the revival reveal studies, all which we had nothing to do with, the actual barriers to entry are what we design this product to overcome. So whether it was the inelegance or uncomfortableness, length of time to full efficacy, or the estrogenic exposure that women didn't like which causes them to only get three prescriptions a year for the cream and maybe four for the tablet, we think our data suggest for our product candidate that we might be able to have a better mouse trap there or very clearly could. So we think that that untreated market, if positioned, correctly could open up for us and we are excited to hopefully get a strong differentiated label and go in and try to take that down.

Great. Thanks for the context.

Thank you.

(Operator Instructions) Our next question will be coming from the line of Nathan Cali from Noble Life Science. Your line is now open.

Hey, guys, thanks for taking the question. Just a quick question, some of my other questions are answered, but for the combination, is it known what the high volume compounded dosing strengths are in that space currently? Any color on that?

Hey, Nathan, it's Rob. Thanks for dialing in. So, yes, we've got a lot of data on that. As you probably saw, we had the previous president and CEO of the International Academy of Compounding Pharmacists out there at JPMorgan with us. And we've gone, I mean, quite tight with that group and we really, really like them a lot, it's a good fit. So answer to your question, we designed our four doses. So any permutation of estradiol or progesterone that we are aware of could be obtained, right? So if you look at the way these are 1100, 0.5100, 0.550, 0.2550 if you wanted to move around up and down dosages depending on where women hot flashes are or come up with different type of permutations, if these doses are proven safe and effective and approved we will have that ability. And that was one of the design features in building this out.

Okay. Any color on this upcoming meeting about criteria for potential difficult to compound from products? Is there any color from you guys that is prospective on and is may be a bit of detailed question on especially the combo product meeting those six criteria? Is there any color from your perspective on your ability to meet that criteria? So that compounders may not even be able to compound this product on a high volume basis?

Sure. So -- well, as you know, compounders have to make individual prescription per person. They can't do a high volume. [Bill Nixon] is the one sitting pharmacist on that committee. And we can put you in touch with him to give you the detail. We believe as a company that these compounding pharmacies, having lost almost all reimbursement and working with industry and us being the poster child for the first time, we think high water floats all boats. We think we can increase their productivity, their compliance, and, of course, their margin significantly.

So, to be honest with you, we don't even think we need to marginally difficult to compound. Is it a potential that it could be put there? Maybe. But Bill can really answer your question. He knows all about it. And again he's a one sitting compounding pharmacist on that panel, and, Nathan, I'll be sure to get you in touch with him to answer your question.

Okay, great. Thanks.

Thanks. Thanks for calling in.

Sure.

Our next question comes from the line Chris Howerton from Jefferies. Your line is now open.

Hi. Hey, thanks for taking the questions. I just had two kind of quick ones. For Sebastian, for the endometrial hyperplasia information, you gave to us -- can you provide us with a average follow-up on that incidence rate?

Sorry, Chris, the clinical trial is [think of it as] one year duration, 12 months. This is a requirement by the FDA, therefore, you know, subjects are expected to finish the trial. Certainly in this 1,400, it's not everybody completed the full trial.

Okay. So basically you can't give out that information yet but it's okay. Okay and then just another real quick one. I guess this one would be for Rob. For the YUVVEXY launch, do you think there will be significant involvement of any compounding pharmacies in the commercialization efforts for that? Or are you really gearing that towards the combo product exclusively?

No. Chris, there is our estimation, a couple of million scripts for VVA flowing through the compounding pharmacies, and that's kind of off-the-radar revenue. These non-sterile retail pharmacies that fill FDA approved drugs, they sell bubblegum and they also compound or mix stuff up in the back, they are normal retail pharmacies but they have the services that really cater to women's menopausal needs. And they look at women holistically. They look at their thyroid, their sexual function, their hot flashes, and we -- it's just perfect for us. So obviously we'll launch with the retail folks as well.

But to be honest with you, we see that market for both products as a key partner. Obviously the E plus P bio-identical is a high flyer, but I'll tell you these pharmacists are key distribution allies. They love the idea of negligible to no systemic exposure, things working at week two and something that women don't complaint about and are compliant with, just like the physicians. So to answer to your question, absolutely, yes, we look forward to working very closely with them on a distribution basis.

Okay. Right. Well, that's all I got. Thanks a lot.

Thanks, Chris.

And I'm not showing any further questions at this time. I would now like to turn the call back over to Robert Finizio for any closing remarks.

Great. Thank you, everybody, for joining today. We had a fantastic 2015. It looks right now to be an even more exciting 2016. And I'm very, very happy to give everyone an update on the combination trial finally, and I look forward to catching with folks at the upcoming conferences. And if anyone has any questions, please reach out to one of us and we'll be happy to answer. Thanks.

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