TherapeuticsMD, Inc.
Q4 2015 Earnings Call Transcript

Published: 26 Feb 2016

[Operator:]

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?

[Ami Knoefler:]

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 and 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 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 February 25, 2016. And with that, I will turn the call over to TherapeuticsMD's CEO, Rob Finizio.

[Robert 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-04, a 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 under validated co-primary endpoint data and the commercial planning for TX-04 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 facilitate 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-04. 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-04, but we are comfortable with the financial resources we have in place to execute our plan. Finally, I will remind you that women’s health remains an area where few companies are focussing their R&D and commercialization efforts. Our company is exclusively focussed 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.

[Daniel Cartwright:]

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 their 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 cost 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 OBGYN and women’s health specialist. To provide some background on the anticipated build of our sales infrastructure we currently have approximately 35 sales representatives focussed on the OBGYN 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.

[Sebastian Mirkin:]

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 probable 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, or 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 on 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 [Indiscernible] 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 getting [ph] 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 the 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 the statistical significance has improved for the severity of Dyspareunia. The 4 microgram dose demonstrated a highly statistic 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 a statistical significant refund on placebo at the 0.0149 level which represents greatest type of 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 7β-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 that [Indiscernible] that is currently in the market. Let me turn now to the Phase 3 Replenish Trial that is alleviating 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 1750 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 allotting doses of estradiol that have been proven to treat vasomotor symptoms and doses of progesterone that have been shown to effectively protect the endomysium [ph] for estrogenic stimulation. But now, I would like to give you the first clinical update for the Replenish Trial. As of this week, over 1400 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 SYMBOLA technology as a basic abuse in the successful Rejoice trial. Finally, we continue to expect the topline 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.

[Julia Amadio:]

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 result 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 labelling. Importantly, we believe that our PK data from the Rejoice trial are a key for market differentiation and are aligned with the FDA’s meeting on November 10th to review low dose vaginal estrogen labelling. Also of note is the recent ACOG committee opinion number 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 labelling. Although there is no assurance that the FDA will agree to our proposed labelling 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 trade mark 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 had submitted two late breaking abstracts to ENDO, the annual endocrine society meeting taking place in Boston on April 1 through 4. 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

[Robert Finizio:]

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 be at the domestic OBGYN 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 focussed 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, 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 favourably. There is approximately 3000 non sterile retail pharmacies that compound E+B [ph] products and they are very focused on supporting the needs of women going through menopause. We believe that currently we have strong relationships with the customers and 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 compounds and 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 products. Also, in regulatory compliance related to these products, improved their productivity and probably most of all their margins. In fact, we are 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 Intendors [ph] 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 peer [ph] loan 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 as we look forward to even better 2016 and with that I will turn it over to the operator to take questions.

[Operator:]

Thank you. [Operator Instructions] Our first question comes from the line of Bill Tanner from Guggenheim Securities. Your line is now open.

[Bill Tanner:]

Thanks for taking the questions and maybe for you Rob or Sebastian. Just on the ISSWSH presentation, I am 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.

[Sebastian Mirkin:]

Thank you Bill. The reason that we are releasing the dryness and ISSWSH is because Dyspareunia on dryness are almost always coexistent. Most of the product 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 type currency 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’ve had 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 asset will be accepted that we’ll submit it to the meeting.

[Bill Tanner:]

Got it. That’s helpful. And maybe if I can just touch 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 know 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 if unless it’s a different call point.

[Robert Finizio:]

Sure, hey Bill. So there is about 24,000 OBGYN we want to get to. So 250 reps typically are 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 out and how it’s a matter of scaling effectively, cost effectively and making sure you are not you know -- it and taking more of cost effective but rapid approach as you go. And the good thing is, as you got your infrastructures in place teams here we are in most of the major markets already and it’s basically splitting concept going forward and we think we can get it done.

[Bill Tanner:]

Okay. Great. Congrats on the progress.

[Robert Finizio:]

Thank you.

[Operator:]

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

[Unidentified Analyst:]

Hi, this is Andrew [ph] in for Annabel. Thanks for taking my questions. First, how should we thing about the Replenish Trial and the consensual outcome, you could potentially have the lowest available dose, but if it doesn’t resolve the VMS as expected cause this will be viable product offering for hydro responders similar to what you sort of envision for the more for microgram for the [Indiscernible]. And second how would you think about the parts you chart outside the U.S. will you be seeking more development in regulatory or just commercial? Thank you.

[Robert Finizio:]

So thanks for joining. I was finally hearing your voice and I said Annabel. So we are all chuckled here. So just to understand your questions and 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 for 4 microgram there.

[Unidentified Analyst:]

Or more of if it doesn’t work as expected to resolve the vasomotor symptoms, because it will still be a viable option for the hyper responders?

[Robert Finizio:]

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 scientist have told us. The previous two or three approvals in this space the lowest doses did not separate every [Indiscernible] 12 but the higher doses did and they were approved. So you look at Activella [ph] in Juvia and a few others. So that precedent does exist. I am personally hoping that they all work and they are separated week formerly 12, but if we did have separation that was [Indiscernible] 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 are new low effective doses in the E+B trial on the progesterone side, or the progestin side which is clearly the bad actor from the WHI. I mean 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 a bad actor thus so much bio identical sales going to the compounding market. So we are really excited about all the doses, hopefully being new or effective doses.

[Unidentified Analyst:]

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.?

[Robert Finizio:]

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

[Unidentified Analyst:]

Great. Thank you.

[Robert Finizio:]

Thank you.

[Operator:]

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

[Ken Cacciatore:]

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 four microgram and you keep on alluding to the fact that it could expand the market. So could you give us maybe a preview upto 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.

[Robert Finizio:]

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 on 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 over the land [ph] market that we are 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 the most it will be for Vagifem isn’t really sampling any more. Premarin is not really promoting, I mean think about 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 or what we design this product to overcome. So whether it was the inelegance or un comfortableness, length of time to pour efficacy or the estrogenic exposure that women didn’t like which [Indiscernible] 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 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.

[Ken Cacciatore:]

Great. Thanks for the context.

[Robert Finizio:]

Thank you.

[Operator:]

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.

[Nathan Cali.:]

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.

[Robert Finizio:]

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 Compounded Pharmacies out there at JPMorgan with us. And we’ve gone quiet tied with that group and we 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, 0.5,100,0.550,0.2550 if you wanted to move around up and down dosages depending on where women how 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.

[Nathan Cali.:]

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 this 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 those criteria, so that compounders may not even be able to compound this product on a high volume basis?

[Robert Finizio:]

Sure so, well, as you compounders have to make a individual prescription per person, they can’t do a high volume. You know Bill Nixon [ph] is the one sitting pharmacists on that committee. 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 asking the poster child for the first time. We think high water floats all boats. We think we can increase the productivity, their compliance and of course their margin significantly. We don’t even think we need that are 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 pharmacists on that panel and they can all be sure to get you in touch with him to answer your question.

[Nathan Cali.:]

Okay. Great. Thanks.

[Robert Finizio:]

Thanks. Thanks for calling in.

[Operator:]

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

[Chris Howerton:]

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

[Sebastian Mirkin:]

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 1400 its not everybody completed the full trial.

[Chris Howerton:]

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

[Robert Finizio:]

No. Chris our submission couple of million scraps for VVI 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 compound a mix stuff up in the back. They are normal retail pharmacies but they have these services, they really care to women’s menopausal needs and they look at women holistically. They look at their thyroid. Their sexual function, their hot flashes, and we that’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+B bio identical is 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 every two and something that women don’t complaint about and are compliant with, just like the physicians. So the answer to your question, absolutely yes, we look forward to working very closely with them on a distribution basis.

[Chris Howerton:]

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

[Robert Finizio:]

Thanks, Chris.

[Operator:]

Thank you. 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.

[Robert Finizio:]

Great. Thank you everyone 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.

[Operator:]

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.