TherapeuticsMD's (TXMD) CEO Robert Finizio on Q2 2016 Results - Earnings Call Transcript

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TherapeuticsMD (NYSEMKT:TXMD) Q2 2016 Earnings Conference Call August 4, 2016 4:30 PM ET


Ami Knoefler - Investor Relations, Spark Biocomm LLC

David Delucia - Director of Investor Relations

Robert Finizio - CEO

Daniel Cartwright - CFO and VP, Finance

Brian Bernick - Chief Clinical Officer

Julia Amadio - Chief Product Officer


Jami Rubin - Goldman Sachs

Bill Tanner - Guggenheim Securities

Nathan Cali - Noble Financial

Annabel Samimy - Stifel


Good day, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD Second Quarter 2016 Results Conference Call. Following prepared 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?

Ami Knoefler

Good afternoon, everyone. Thank you for joining today to discuss our second quarter 2016 financial and business results. Following the market close, TherapeuticsMD issued a press release announcing second quarter results. The press release is available on the company’s website, in the Investors and Media section.

On today's call from TherapeuticsMD are Chief Executive Officer, Robert Finizio; Chief Financial Officer, Daniel Cartwright; Chief Clinical Officer, Dr. Brian Bernick, Chief Product Officer, Julia Amadio and Director of Investor Relations, David Delucia.

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 identified in our press release and our annual, quarterly and other reports filed with the SEC. These forward-looking statements are based upon 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 and 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 August 04, 2016.

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

Robert Finizio

Thanks Ami. Good afternoon, everyone. Second quarter of 2016 was transformative for TherapeuticsMD. The company is successfully executing on all front and we're making significant progress advancing our two late stage clinical assets.

I'll briefly describe some of our accomplishments during the quarter and then give an outline for this afternoon's call, but before I start, I would like to officially introduce Dr. Brian Bernick. He is our Co-Founder and Chief Clinical Officer. I would like to welcome him to our call today. Brian is a key member of our management team and due to Sebastian Mirkin travelling internationally, this is the perfect opportunity for Brian to provide our clinical update today.

On July 7, we submitted our new drug application for Yuvvexy, the conditionally approved trade name for TX-004HR, reflecting a major achievement for our company. The NDA is based upon the robust results of our clinical program, including our positive pivotal Phase III Rejoice Trial.

Yuvvexy has many differentiating features that if approved enable it to potentially become a best-in-class treatment for postmenopausal women suffering from moderate to severe dyspareunia, associated with vulvovaginal atrophy or referred to VVA.

Now on to our next product TX-001. We current remain on track to deliver results in the fourth quarter of 2016. This is for our Phase 3 Replenish Trial, which is evaluating our bio-identical combination of estradiol and progesterone for moderate-to-severe vasomotor symptoms due to menopause.

We believe that TX-001 has the potential to become the first and only FDA approved bio-identical combination hormone therapy for women and a valuable treatment option in the very large, underserved and growing market for bio-identical hormone therapy.

In addition, last month the FDA published two new draft guidance documents regarding compounded drug products that are essentially copies of approved drug products. I'll review these guidance documents as well as current market dynamics for TX-001 in more detail later in the call.

As we look towards potential launch of both products, our prescription prenatal vitamin business continues to provide an important footprint for commercialization. We'll continue to appropriately expand our sales infrastructure in the second half of '16 and prepare for the potential launch of Yuvvexy in 2017. On today's call, 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, the Brian will summarize the recent NDA filing for Yuvvexy and provide an update on the Replenish Trial. Next Julia will summarize the findings of pre-commercialization market research to support the potential launch of Yuvvexy and preview some exciting publications this fall. Then I'll review the market dynamics and recent regulatory updates related to our combination TX-001 products candidates.

And now let me return --- now let turn the call over to Dan.

Daniel Cartwright

Thanks Rob. Our financial results for the quarter ended June 30, 2016 are included in the press release issued today. Let me highlight a few key points about our second quarter results.

Net revenue from the company's prescription prenatal vitamin business was approximately $4.4 million for the second quarter of 2016 compared with approximately $4.8 million for the second quarter of 2015. This change was primarily due to a decrease in the average net sales price of our products partially offset by an increase in the number of units sold. We do not expect this market impact to continue during the second half of this year.

Total operating expenses for the second quarter of 2016 decreased, compared with the second quarter of 2015. R&D expenses during the second quarter of 2016 were approximately $13.8 million compared to approximately $24.2 million during the prior year's quarter. This reflects a significant decline in clinical costs, partially offset by an increase in scale-up and manufacturing activities to support future commercialization of our pipeline.

SG&A expenses for the second quarter of 2016 were approximately $10.6 million compared with approximately $6.9 million for prior year’s quarter. This is primarily due to an increase in human resources, sales and marketing activities to support future commercialization.

As Rob mentioned earlier we anticipate the rate of our commercialization expenses to increase in the second half of the year. This is due to the expansion of our women's health sales force and our investment in pre-commercialization activities to support the potential launch of Yuvvexy in 2017.

Turning to the bottom line, our net loss for the second quarter of 2016 was approximately $21.1 million or $0.11 per basic and diluted share compared with approximately $27.2 million or $0.16 per basic and diluted share for the second quarter of 2015.

Finally, we finished the second quarter with approximately $166.5 million in cash compared with approximately $64.7 million at December 31, 2015. As a reminder, our cash balance at the end of the first quarter of 2016 was $182.1 million, which equates to a cash utilization of approximately $15.6 million in the second quarter.

We believe our strong financial position will allow us to advance our pipeline and support both Yuvvexy and TX-001 thereby enabling us to achieve our goal of becoming a leader in women's health.

Brian will now provide a clinical update.

Brian Bernick

Thank you, Dan, and thank you everyone on the call. It brings me great pleasure to speak with you today. As Rob noted, I am the Co-Founder and Chief Clinical Officer of TherapeuticsMD.

For those of you who are not familiar with me, I am a gynaecologist with 25 years of medical experience and obvious concentration in women's healthcare space. It is in this capacity that I have observed the unmet needs of clinicians and our patients and created product to answer these needs.

A prime example is Yuvvexy, our investigational applicator free vaginal softgel capsule, containing solubilized bio-identical 17β-estradiol, a hormone commonly used to treat a condition known as VVA.

The reason I wanted to create Yuvvexy was that I recognized that both clinicians and patients were frustrated by the negative physical attributes of these existing products to prove to treat VVA including their inelegance, messiness, inconvenience, efficacy and long onset of action.

Following our clinical progress these past few years. I am excited about our overwhelmingly positive Phase 3 REJOICE trial, which showed statistically significant and clinically meaningful benefit with Yuvvexy for the three doses across all four pre-specified co-primary endpoints for the treatment of moderate-to-severe dyspareunia, a symptom of VVA due to menopause.

I am also excited that the collective clinical findings for Yuvvexy and the clinical development program showed that it provided and onset of action as early as two weeks that had negligible systemic absorption comparable to Placebo and it lacked the messiness and inconvenience of other products, which often cause patients to discontinue or defer therapy.

Our NDA for Yuvvexy was officially submitted on July 7 and we expect the 10-month review process for FDA guidelines. Our NDA is anchored on the robust results of our full clinical program designed in accordance with current FDA guidelines.

This 505(b)(2) submission includes all three doses of Yuvvexy 4 microgram, 10 microgram and 25 microgram, that evaluated in the Rejoice Trial. We have also proposed new modified labeling for Yuvvexy including remove of the black-box warning and we look forward to the FDA’s feedback.

We believe that if approved, Yuvvexy has the ability to be a best-in-class therapy and expand treatment options for the estimated 32 million women across the U.S. suffering from symptoms of EVA. We look forward to working with the FDA throughout the entire review process and are extremely excited about the commercial prospects for Yuvvexy.

Now let’s review the Phase 3 Replenish Trial evaluating TX-001HR our combination of solubilized bioidentical 17β-Estradiol and solubilized bioidentical progesterone for the treatment of moderate-to-severe vasomotor symptoms, due to menopause.

Should this drug be approved, we believe it would be the first and only FDA-approved bioidentical combination of Estradiol and progesterone, a wealth of medical literature including E3N, [KIT], Million Women Study, Elite and a host of others support the proposition that natural or bioidentical estradiol and progesterone are safer than the synthetic forms.

In fact there are an estimated 30 million annual prescriptions for bioidentical combination estrogen and progesterone that are filled through compounding pharmacies as there is no FDA approved and available bioidentical combination product. We believe that this represents a market opportunity of at least $5 billion.

As a practicing clinician with 25 years of medical experience, I have witnessed this paradigm shift first hand. Before the women’s health initiative results were released in 2002, hormone therapy for vasomotor symptoms, due to menopause was one of the highest prescribed set of drugs across any indication in the United States.

We believe that the market opportunity for these drugs has only grown bigger, as the population of post menopausal women has grown over 30% since 2002 and these women continue to seek therapy to elevate their symptoms.

Yet, since the WHI, there has been a massive change in the distribution of these therapies, from non-bioidentical FDA approved hormones to compounded bioidentical hormones as women demand these bioidentical hormone products.

We believe that this multi-billion dollar market is ripe for conversion to an FDA approved product that accomplishes two important feats. One, meets the demands of women for bioidentical hormones and two, satisfies the FDA's requirement for safe, effective and clinically validated products. TX-001HR was created to meet these demands.

The Replenish Trial is a randomized, double blind Placebo controlled multi-center trial that was designed to study four active arms of TX-001HR totaling 1,750 subjects across the United States and power to show statistical efficacy on hot flashes and Endometrial Protection.

We are evaluating four different doses of TX-001HR in order to demonstrate for the first time the doses of bioidentical hormone therapy that are safe and effective.

These include one milligram of Estradiol in combination with 100 milligrams of progesterone, 0.5 milligrams of Estradiol in combination with the 100 milligrams of progesterone, 0.5 milligrams of Estradiol in combination with 50 milligrams of progesterone and 0.25 milligrams of Estradiol in combination with 50 milligrams of progesterone.

Importantly, the highest doses are already well established and approved separately in other products to treat hot flashes, the primary end point as well as the standard of care to prevent endometrial hyperplasia, the other primary end point. The lowest dose was only included at the FDA's recommendation to study an ineffective dose.

Furthermore we believe that if approved, having three distinct doses allows clinicians to tailor the dose to their patient's needs as they have been a custom to with compounded therapies. Approximately, 1,642 subjects have exited the Replenish Trial and the last patient last visit is scheduled for October. With this timeline we are currently on track to release top-line results in the fourth quarter of 2016.

In conclusion, we believe that TX-001HR if approved will become the first and only FDA approved bioidentical combination hormone therapy and a valuable option to treat moderate-to-severe vasomotor symptoms to menopause. We believe that numerous economic and regulatory tailwinds should support this innovative product and we are optimistic about the opportunity that it presents for TherapeuticsMD.

Now I will turn the call over to Julia.

Julia Amadio

Thank you, Brian. Following the NDA submission for YUVVEXY, we're very focused on pre-commercialization activities including support of educational programs about VVA. We are conducting numerous market research studies including patient and physician segmentation research to better understand prescribing challenges, gap and patterns for VVA.

On the patient side, we have also been carefully studying the patient journey in the overall menopausal process in order to gain further insight on women’s motivations, needs and specific barriers to VVA treatment.

You'll recall that only 7% of the $32 million women with VVA are effectively treated with prescription therapy. There are many reasons for lack of treatment and we believe we will have a tremendous opportunity to expand the understanding, awareness and consideration of treatment options for this chronic condition.

We further believe that if approved, YUVVEXY will offer a new alternative with its unique physical characteristics, safety and efficacy profile including low systemic exposure and high patient satisfaction.

We conducted a major disease-related survey called the women’s empower study, which will be presented for the first time at NAMS the North American Menopause Society Conference in early October in Orlando.

The women’s empower study assess the awareness of VVA in over 18,000 post-menopausal women as well as their attitudes and behaviors associated with the treatment of the identified symptoms. The results showed 81% of women were unaware that VVA which is natural part of aging is in actual medical condition and did not know that it can be treated.

Further they have difficulty communicating with their physicians about VVA symptoms. Results of the women’s empower study will be addressed in two different presentations at the NAMS conference. Our goal is to educate clinicians and the menopause community about VVA and Dyspareunia and to encourage a more open dialogue with women and their providers about the symptoms and associated pain.

Turning to YUVVEXY specifically, we are pleased that additional analysis of the Rejoice trial have been accepted for presentation at two prominent medical conferences including representations at the International Menopause Society Meeting or IMS and a total of six presentations at NAMS.

These include additional data detailing the PK profile and low systemic absorption of YUVVEXY which are features that we continue to believe were highly differentiate our product if approved. In fact women’s empower study showed 59% of women rated the risk of systemic exposure a negative attribute of prescription treatments.

We look to continue enhancing the scientific exchange of our YUVVEXY data at medical conferences and through manuscript publication. We also continued to support the efforts of medical societies to make the information about low dose, local treatments more balanced for patient.

Finally we are actively supporting programs for women’s education awareness and understanding of the chronic issues of VVA and dyspareunia and potential consequences of not getting treated.

Now let me turn the call back to Rob.

Robert Finizio

Thanks Julia. Now back to TX-001. As Brian described earlier, we believe there are two major goals that we can accomplish with this product. One meet the demands of women for bio-identical hormones and two, satisfy the FDA's requirement for safe, effective and clinically validated products.

We believe TX-001 if approved, will become the first and only FDA approved bio-identical combination hormone therapy and a valuable option to treat moderate-to-severe vasomotor symptoms due to menopause.

We believe that there is a unique confluence of factors that could pave the way for successful launch of this product and there are a few major reasons why we feel this trajectory is achievable.

First the market is very large, under-served and growing with increasing demand from women for bio-identical hormone therapies. This has led to compounded bio-identical hormones to expand their overall market share. The market demand is further supported by a wealth of medical evidence in favor of bio-identical hormones.

Second, there is a continued effort by both the FDA and numerous medical societies including the American College of OBGYNs, the North American Menopause Society, the AMA and the Endocrinology Society to educate the public about the risks associated with unapproved compound bioidentical hormones. In addition these medical societies publicly advocate against the use of these products.

Third, the economics of compounded pharmacies have deteriorated through decreased reimbursement as well as increased regulatory costs and risks associated with preparation of compounded bio-identical hormones. We continue to take the collaborative approach to working with compounded pharmacies and the International Association of Compounding Pharmacists or IACP.

We see them as an invaluable partner in establishing TX-001 as a future standard of care in this category. We believe that compounded pharmacies will continue to play an important role and that if approved, TX-001will not only save these pharmacies unnecessary capital expenditures, but also help improve their overall economics and net revenue realized per script, as our product transitions the market from a cash paying market to a fully reimbursed market.

Finally, we believe that the regulatory landscape continues to evolve in our favor. On July 7, the FDA issued two draft guidance documents describing how the agency would implement provisions of the Drug Quality and Security Act that restrict compounding of human drug products that are essentially copies of commercially available or FDA approved drug products.

The draft guidance documents apply to pharmacies, physicians, federal facilities and outsourcing facilities. We believe this suggests that the FDA has a strong commitment to enforce the provisions of the Drug Quality and Security Act related to compounded products.

TherapeuticsMD is positioned in the right place at the right time. We have the opportunity through both retail and independent distribution pathways to establish TX-001combination product if approved as the standard of care and treatment for moderate to severe vasomotor symptoms in postmenopausal women.

In summary, our company continues to execute on all of our goals and we're excited about the second half of the year. We have multiple catalysts over the next six months including progress on our Yuvvexy new drug application into the FDA and the announcement of our PDUFA date as well as the top line results from our Phase 3 Replenish Trial in the fourth quarter.

We'll now open up the call for Q&A. Operator?

Question-and-Answer Session


Thank you. [Operator Instructions] And our first question is from the line of Jami Rubin with Goldman Sachs. Please go ahead Jamie.

Jami Rubin

Thank you, appreciate the questions. First on YUVVEXY, if FDA agrees that you don't need a black-box warning, how does that change your expectations for revenues? How meaningful a change would this be?

Also on the topic of compounding pharmacies related to TX-001 have you had any direct conversations with compounding pharmacies in terms of developing partnership with these parties?

I think really there's a huge opportunity, but it’s very fragmented industry, and I would imagine partnering with all these pharmacies would be very challenging, but it also seems to be a very big part of your marketing strategy. So if you can address how you're targeting that, how we should think about that, that would be appreciated? Thanks.

Robert Finizio

Great, Jami, this is Rob Finizio, thanks. So I’ll take the compounding question first. So it's very straightforward, so compounding non-sterile compounding pharmacies or normal retail pharmacies that compounds to supplement their FDA approved sales. They're typically mom and pop type on the corner pharmacies to very small networks of groups of pharmacies.

So we're doing a lot on that side. I actually spoke at the ICPs Board Meeting two months ago. I spoke to Compounders on Capitol Hill. So the new model given the oversight and regulation with DQSA makes it very hard for these guys to operate like they used to. So a lot of external pressures number one.

Number two, as far as the economic go here, this used to be a reimbursed class just a few years ago for the most part most if not all reimbursement has been cut for this class and has become a cash pay environment where margins are extremely restrained down to a couple dollars or even losing money on the first couple of scripts.

So we see these few thousand pharmacies as normal retail distribution. They will be able to acquire the product. They'll have access to the product. And they have a 100% of these scripts in place today. If you like to see a quick uptake where they are making economically more their conforming with regulation the cutting the overhead required and they're selling an FDA approved product, we will deliver that to them.

And we think given the economics and the oversight and the changes it is going to be something that they look forward to. And we are very, very bullish and positive on that strategy.

As far as that fragmented market, we don't really see it that way. We see it as these are normal retail pharmacies. They're not just compounders that people will think 92% I believe somewhere around that number is coming from these non-sterile normal retail pharmacies, and they can access just like FDA approved drugs from any three PL or distributor.

And I think it's a pretty straightforward lines up with our sales force size and from a legislative body above them we are very well aligned. And I think you'll see more companies do this as well.

Jami Rubin

Can I just follow-up on that. Just given some of the regulatory turbulence you described. Are there any incidences of compounding pharmacies closing down or struggling any industry data points would be helpful.

Robert Finizio

Actually there's a number of them. You can go to, and then type in 43 with compounding pharmacies, they actually leave the list out there. There is an incredible amount of enforcement going on and the FDA takes this very, very seriously and it's not like one or two, there is lots and lots and lots. Just take a look at their website.

Jami Rubin

Okay. And then just on YUVVEXY and the black-box program potential removal of black-box warning?

Robert Finizio

Yes, so obviously we can't discuss any correspondents at this point with the FDA directly. As you know The North American Menopause Society and others have signed a Citizen's Petition. We obviously would respect the FDA that they will need the room to make the decision they think is most important.

We would love in our base case scenario. We actually think with our physical attributes, we can go out and absolutely game change against these antiquated products -- legacy products in the VVA market that were approved in the 70s, 80s and 90s are okay scenario is a highly differentiated label. I think our data is very strong and can support either situation.

And I do know that the FDA had an open workshop and has a strong dialogue with the medical societies to hopefully, we're saying hopefully update these labels as a class. But as again, I don't have any direct correspondence with the FDA that I can share at this point.

Jami Rubin

Thank you.

Robert Finizio

Thank you.


And our next question is from the line of Bill Tanner with Guggenheim Securities. Please go ahead.

Bill Tanner

Thanks for taking the questions. Rob, I had one for you and then I had one for Brian. You mentioned in your prepared remarks about pre-commercialization activities, and I guess presentation they empower survey data might be something akin to that.

But I am just wondering if you could speak to what would be doable prior to the drug is approve to YUVVEXY's approval and things like disease awareness or possible, just maybe help us little bit over there.

Robert Finizio

Yes, absolutely so non-branded awareness campaigns are certainly in our crosshairs. What we plan to do is we're in the planning phases of this now, but early next year post combo data is to have an Investor Day.

In this Investor Day we will share the very clear articulation of where we are going and how we are getting there, how we are taking on the non-branded and then hopefully we are approved what we are hoping for here. Our specific product or branded marketing campaign, where we're going and how we're going to get it done.

Right now Bill, it's complicated to get into that type of detail on this kind of a call would probably leave more questions than not, but we will certainly update shareholders. I do want to state that there are lot of very, very attractive markets not just women's health out there where this can be applied.

As you know we will take women's health head on and if we do go outside of that, we would partner for that, but the data looks very, very positive and it really seems the physical attribute of the products of YUVVEXY and the data we have to support those physical attributes really address a number of the physical shortcomings of the creams and the vaginal tablets that are out there today.

We also are very bullish on our clinical attributes with the onset of action and the PKs and things of that nature that that is very, very good to address some of the shortcomings of the legacy that products out there and we look forward to lining that all up for everyone, taking it out and showing the complete plan.

Bill Tanner

Got it. Okay, that's great. And then Brian I had a question for you. You talked about with 01 the four doses and it sounds like maybe the lowest dose you would not expect to work and maybe even if it does you wouldn’t expect to file.

I think you mentioned that you file on the three doses. So I am just wondering if you can maybe speak to those three doses and how they line up against what people that are going to compounding pharmacy might get that would be helpful.

Brian Bernick

Thanks, Bill. As I noted, we are studying doses that are already well established and approved separately with other products to treat hot flashes, as well as the standard of care to treat endometrial hyperplasia. while the fourth dose was put there at the FDA's recommendation, if in fact we find it to be safe and effective then that would be wonderful. We could submit for all doses.

Again just to be clear it was submitted at their request to study an effective dose. But these doses represent by far the vast majority of doses that clinicians prescribe and we believe that these doses will all be efficacious and safe.

Bill Tanner

Okay. Yeah, that's kind of what I was trying to get it. Okay. Thanks very much.

Robert Finizio

So we've actually surveyed that question and we'll release specific data around it in the future. But to Brian's point, the currently compounded written scripts and strength of those estradiol and progesterone within those scripts our dose selection mirrors that very, very closely and we think we can address vast majority of the market if not all the market with those doses.

Bill Tanner

Got it. Thank you.

Robert Finizio

You got it.


And our next question is from the line of Karen Aswani with Noble Financial. Please go ahead.

Nathan Cali

Hey, guys. This is Nathan. Thanks for taking the question this afternoon.

Robert Finizio

You got it Nathan. Good to hear from you.

Nathan Cali

Likewise. So just a question for Dan. What is sort of the expectation on the increased cost line Q2 preparation for launch of YUVVEXY?

Daniel Cartwright

Nathan, we never tended to put forecast out there in the market, but big picture wise, we are going to prepare for launch in 2017. So we're going to start getting everything ready for that process and everything from what Rob talked earlier which was unbranded campaign all the way through putting the first doses out -- the first prescription out in the market and following that at.

So I think big picture that's what we see happening and going into 2017 and we are going to prepare that way. I can give some little bit more color around that which information that I think would be very easy for you to come up with your own numbers. We certainly see the sales force as we said somewhere between 100 and 150 reps to launch YUVVEXY specifically into the OB-GYN market GYN in this case.

Any partnering outside of that specialty we would not do ourselves. We would hook our train to a partner and have that launch it into other areas. We are currently -- our reps are about 200,000 or under is what the guidance we've given to the street.

So based on the label, the only variable you'd have would be your advertisement, right and based on the outcome of the label that would be something that we can hopefully define in the future. But as Dan said we can't -- we just can't give guidance, we don’t know what the label is, but we do know hard and fixed costs are.

Nathan Cali

Okay, all right. Great. Thanks. That helps. And then on the hiring of those reps, do you expect it to trend up as you go into '17 obviously you are not going to start just hiring everybody out once, you sort of a gradual trend towards the time of your PDUFA date that how you see the ramp of that?

Robert Finizio

Sure. So we actually are approximately 50 reps today. So on the sales side, so once the application is received and that PDUFA date or accepted by the FDA's technical term and now PDUFA date is given, obviously we'll update The Street, we feel that’s a nice strong catalyst to move forward for us here.

At that point we will start to implement the other hiring processes. As you know these reps will be out there selling our prenatal products into the same offices, they'll be calling with the YUVVEXY product assuming approval.

So that will be a gradual process and it's very good to have the infrastructure and the relationships in place when you do launch YUVVEXY and that's exactly what we are going to do.

Nathan Cali

Excellent, thanks. And then just a follow-up question maybe for Rob as far as compounders going out of business so to speak. Do you believe that this is because a combination of the increased regulation and the reimbursement landscape or more so towards the margin compression and the reimbursement landscape?

Robert Finizio

Yes, to both of those. So we are seeing some consolidation amongst these non-sterile retail compounding pharmacies which do vast, vast majority of bio-identical compounding. So a little bit of history there. Most of the major plans Optum, CVS Caremark things like that has cut most reimbursement outside of pediatrics for compounded medications.

That with the Drug Quality and Security Act where certain things need to be documented, oversight needs to be in place and then the upcoming I believe in early 2018 the U.S. P800 safety standards related to hormones would require do ventilation system at zero gravity and it's just getting very, very technical.

Go back before the reimbursement change in Drug Quality and Security Act were in place, I think compounders were charging cash pay on average our data suggest $50 out of pocket in getting a good amount of reimbursement and the reimbursement is gone, it can't raise the price very much.

So it's just a very, very difficult situation for them to be in and we're hoping we positioned our drug and it is very well received as a solution for that, which cuts our oversight, cuts our cost to be compliant with Drug Quality and Security Act.

Definitely the new guidance from the FDA claiming this will be an essential copy if they were compounded when ours is approved, would go away and then hopefully it would improve their economic environment or at least that’s our goal.

So I think everything has come together very nicely for this drug and we are in a great position given there is about 30 million prescription of bio-identical hormones for menopause a year.


[Operator Instructions] And our next question is from Annabel Samimy with Stifel. Please go ahead.

Annabel Samimy

Hi, guys. Thanks for taking my questions. I want to follow-up on the dosing question that Bill asked. You mentioned if it was affected you would obviously go forward with the lowest dose, but you mentioned a few times in the past that some other drugs did not demonstrate and they still went for with a lower dose, is that still a possibility given that menopausal societies have essentially recommended that you offer low to second hyper responders out there.

So, I just wanted to understand what we should assume if that lowest effective dose isn’t exactly ideal?

Robert Finizio

Sure, sure, so I just want to rephrase and make sure we’re answering the right question. I think it's a good question for Brian. So, with the combination I believe we're talking about the lowest effective dose, your question is regards to that given Activella and Enjuvia and some of their lowest doses didn’t quite make it, but they were new lower effective doses were still approved, is that your question?

Annabel Samimy

Right, right, so would you, if you are did not make -- would you still move forward with given that there are potentially hyperresponders out there and that there could a population that would need that lowest dose.

Robert Finizio

Absolutely so yeah, it’s a good background question. So, there is a president with the oral estrogens and progestins for hot flashes where the lowest dose in the studies had some response, they would definitely separate it from placebo, but they didn’t necessarily hit the targets that the FDA sets forth in their draft guidance, but since their lower doses and the guidance today is to start with the lowest effective dose they're considered safer.

The FDA and I think its Activella and their lowest dose. I believe Enjuvia and there is one or two more, and actually even paroxetine only had one hot flash and not two and separated not only formerly 12, but somewhere in the middle. They were all approved and if we were in that situation, which we could be, we certainly would file for approval on that, but we just want to make it clear to the street that dose was put in there as an ineffective dose and if we had the outcome you just suggested, I think you could win on both sides.

Annabel Samimy

Okay, that’s helpful. Thanks and then want to go back to couple things that you stated, I guess there were a couple statements you made first in the survey you mentioned about I think 81% of women had little awareness of VVA as the condition and then you also mentioned that a number of large players and obviously there has a much innovation and there seems to be a need for something innovative to move away from some of these legacy products.

So, can you may be talk about this market dynamic right now if 81% of women don’t really -- are not really aware of VVA, like what is the patient demand for these drugs, new patient demand number one? And number two, if there has been that more innovation in the marketplace, is there corporate demand, from a competitive perspective to be involved with these newer types of, newer innovative drugs that you now have in your hands?

Robert Finizio

Yes, Annabel so, there is a very clear segmentation in this market, so of the 32 million women, 16 million women, 32 million in this country have moderate to severe, not slight, but moderate to severe symptoms of VVA that need treatment. 16 million of these women that’s half are not aware that this is something that could be easily and very safely treated and that it's not just part of getting older.

Lot of the interviews in the data we have suggest the women are shamed this population of women feel like there are just old and uncomfortable and it's really unfortunate because it's very easily treated and rectified especially when a time were women want to feel younger, acting younger, living longer is really where a lot of the cash pay prescription therapies like Botox and Enjuvia all those are going.

So, with that being said, the other 16 million women as you can imagine 14% of those women are the 2.3 million women that are getting treatment today. But what happens is that current products and I’m sighing like we [reveal], they take a long time the work, so you are on your second or third prescription before you start to see efficacy, they are very, very messy.

So it inter fears with the women’s life. You have to use these creams and vaginal tablets before bed. They leak out. You have to wear a pad the next day. They're very, very cumbersome, they're very uncomfortable, they're very messy and if you look at physical data from the trial, I believe we address every one of those physical or uncomfortable features that exist with the current products today.

Now in the clinical side, the time it takes to work is typically 5.7 to 12 weeks. So woman could go through an entire prescription not see any efficacy whereas our data suggests a two week onset of action as well as you use our product, you're completely ambulatory, you can go to work, you can go to the gym, you don't have to stay in bed. It will not dislodge in only 2% or 3% of the women had any vaginal discharge compared to 100%.

So we think that a lot of the reasons that half of the women that are aware of this product that have tried previous products and because there is lack of efficacy or the physical natures of it. They stopped, and they go back on and go off. We think that we can really reverse that trend. If our data plays out in the field the way we hope to, in the way it definitely suggests that we'll win the trial and we can grow that audience.

Annabel Samimy

And how about from the corporate side, and see like they were very active in terms of innovation, so is there a demand on their side to get their hands on something like that?

Robert Finizio

Well considering those complications with it and there's a lot of issues, it's a chronic progressive disease that causes more healthcare costs. We think that's a no brainer. It definitely is. There's also a quality of life that can be improved very clearly stated in some of these studies. So we're actually looking at that as we speak and we'll certainly communicate in the future with you on that.

Annabel Samimy

Got it. Thanks.


Ladies and gentlemen, this concludes our Q&A session for today. I would like to turn the call back to Robert Finizio for final remarks.

Robert Finizio

Thank you everyone for joining the call today. We had a very important quarter with key events in our pipeline and progress towards potential launch of YUVVEXY in '17. We also eagerly await the results of the Replenish Trial in the fourth quarter for our combination products.

It's a very exciting time at TherapeuticsMD and we're really glad you joined us today and look forward to speaking with you next quarter. Thank you.


Ladies and gentlemen thank you for participating in today's conference. This concludes the program. And you may all disconnect. Have a wonderful day everyone.

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