Concert Pharmaceuticals, Inc.
Q4 2019 Earnings Call Transcript

Published: 27 Feb 2020

[Operator:]

Good morning, ladies and gentlemen. And welcome to the call to discuss Concert Pharmaceuticals Fourth Quarter 2019 Financial Results. At this time all participants are in a listen only mode. Later we will conduct a question-and-answer session and instruction will flow at that time. [Operator Instructions]I would now like to turn the conference over to your host Ms. Justine Koenigsberg, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.

[Justine Koenigsberg:]

Thank you, Stephanie. Good morning and welcome to Concert Pharmaceuticals’ fourth quarter 2019 investor update.Joining me this morning with prepared remarks are Roger Tung, our President and CEO; Jim Cassella, our Chief Development Officer; and Marc Becker, our CFO. We will also be joined by Nancy Stuart, our Chief Operating Officer for the Q&A portion of the call.As a reminder, today’s discussion will include forward-looking statements about our future expectations, plans and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risk factors can be found in our most recent 10-Q filed with the SEC. Any forward-looking statements speak only as of today’s date, and we assume no obligation to update any forward-looking statements made on today’s call.With that, I would now like to turn the call over to Roger.

[Roger Tung:]

Thank you, Justine and good morning. As we enter 2020 Concert's achieved key milestones relating to each of our proprietary pipeline compounds that set the stage for this to be an important year for us. We have two distinct wholly owned product candidates that we're advancing towards late stage clinical testing.First is CTP-543 for alopecia areata. We're preparing to move into Phase 3 testing later this year, and second is CTP-692 for schizophrenia, which is now being studied in its initial trial with potential to begin pivotal testing in 2021.First, let me highlight our most advanced candidate CTP-543. We're conducting a dynamic clinical program from the treatment of moderate-to-severe alopecia areata that's poised to move ahead this year into pivotal evaluation. This past fall, we reported results from our Phase 2 dose ranging trial. The results were striking providing what we believe to be the most robust data generated to say in any control trial for the treatment of alopecia areata. Based on these findings, and those reported state by other companies CTP-543 has the potential to be the best-in-class treatment for this life altering autoimmune disease.Turning to the underlying intellectual property for CTP-543, earlier this year, we were granted a new patent relating to CTP-543 that provides protection for pharmaceutical compositions consisting of specific dose strengths and methods of treating alopecia areata with CTP-543. The issuance of this patent is significant because it covers the clinical doses that produced the robust results observed in our Phase 2 trial for Alopecia Areata and early doses that we expect to carry forward into our Phase 3 program.The patent is Orange Book eligible on approval of CTP-543. It's expected to provide protection for 5.3-inch 2037. We're continuing to pursue multiple avenues to secure additional patent protection for 543. And the issuance of these new patents is an important development within our broader IP strategy.As a separate matter recently the Federal Circuit Court of Appeals granted our motion to vacate and remand Pizzettes decision relating to our 149 patents. As a result, the IPR proceeding which is separate and independent from the new patents issued earlier this year will be reheard by a new panel of judges of Pizzettes. We remain highly committed to the continued advancement of CTP-543 as a potential treatment for alopecia areata and our development timelines for 543 we remain on track.Next, let me turn to the second property candidate in our pipeline CTP-692, which were initially developing as an adjunct treatment for schizophrenia, one of the most debilitating, devastating and costly mental disorders.Schizophrenia is highly prevalent and believed to affect nearly 1% of the worldwide population. We believe that CTP-692 represents a new mechanistic approach in treatment of schizophrenia, and one that may enable effective treatment of a broader range of disease symptoms and do existing psychotic medications.We designed CTP-692 to leverage and expand on academic studies indicating that D-serine can benefit patients with schizophrenia by helping to remediate NMDA hyper function, which is believed widely to be an important cause of veteran schizophrenia.Our preclinical data demonstrate that CTP-692 is differentiated from D-serine by its dramatically improved renal safety profile. Furthermore, no evidence of renal apartment was served in our Phase 1 trials.Patients with schizophrenia are reported to have low levels of D-serine and plasma and cerebral spinal fluid. Therefore, bolstering endogenous levels of D-serine with CTP-692 on top of their standard antipsychotic medication could offer patients a new treatment option that's fundamentally different from correct antipsychotic medicines.As a reminder, existing medicines focus on controlling dopaminergic transmission know typically poorly effective in treating so called negative symptoms and cognitive impairment, which are major reasons for poor patient outcomes.This program advanced rapidly from preclinical evaluation through Phase 1 and in December we initiated our Phase 2 trial evaluating CTP-692 as an adjunctive treatment in patients with schizophrenia.The enthusiasm among the treatment community for clinical trial has been very strong. We're on track to report top-line results by year-end. In summary, these positive developments in the ongoing execution of our business as well as in our overall strategy of designing, developing, protecting and eventually selling novel compounds with the groundbreaking potential and important diseases of latch the exciting point we've reached today with potential Phase 3 trials for two proprietary clinical programs in the near-term horizon.Let me conclude my remarks by emphasizing our optimism for 2020, which we see is a year of significant milestones for our company. As we make progress towards these inflection points, I look forward to keeping you updated.I'd like to pause here and ask Jim to discuss our clinical progress. And then Marc will review our 2019 financial results before we open the call to questions.

[Jim Cassella:]

Thanks, Roger. As Roger just described, we are well positioned to execute on the clinical development of both of our lead drug candidate CTP-543 for alopecia areata and CTP-692 for schizophrenia.We are highly focused on the need for an effective treatment for alopecia areata with a favorable safety profile, and we are continuing to advance CTP-543 to meet this product profile and bring it to the patient as quickly as possible.We are on track to meet with the FDA this quarter in the Phase 2 meeting. Pending the outcome of this meeting, we expect to start Phase 3 program in the second half of 2020. Putting this program into perspective, the CTP-543 results are significant for three reasons.First, we believe the data we generated in our dose ranging Phase 2 trials set a new benchmark for clinical efficacy and the treatment of alopecia areata. Among the JAK inhibitors being developed for the oral treatment of alopecia areata, CTP-543 now appears to have provided the most robust efficacy results reported to-date in any controlled trial.Second, we have identified two doses of CTP-543 with promising efficacy and tolerability profiles, both of which we believe are suitable for assessment and future trials. We also see some advantages of the 12 milligrams twice daily dose group compared to the 8-milligrams twice daily dose group, including faster onset and greater magnitude of effect.Our intent is to further test and ultimately seek approval of both the 8-milligrams BID and 12-milligrams BID doses, so that patient and clinicians will have dosing options in real world use.Third, results in our 8-milligram twice daily arm of our open label dose regimen trial were consistent with the previously reported 8-milligrams twice daily results from our Phase 2 dose ranging trials, CTP-543. We accomplished what we set out to learn with this study and based on the results, we intend to utilize twice daily dosing of CTP-543 in our clinical development program going forward.Additionally, we are delighted that our abstract was accepted for a late-breaking presentation at AAD next month. Our presentation will expand on the previously reported results from the primary efficacy endpoints of the Phase 2 trial by reporting other endpoints that quantify hair regrowth of patients in the study. This is a great opportunity to further elevate the program within the medical dermatology community.Turning now to CTP-692, our team has moved very swiftly to progress this program. In December, we initiated our Phase 2 trial with CTP-692 in patients with schizophrenia. As a reminder, we are developing 692 as an injunctive treatment for schizophrenia. Patients enrolled in a Phase 2 trial will be stable on their existing antipsychotic medication. We intend to randomize approximately 300 patients in the U.S. we're evaluating 1, 2 and 4 grams of CTP-692 once daily compared to placebo over 12-week treatment period.Our rationale for assessing CTP-692 is to offer an entirely new mechanism of action that treat schizophrenia, and to potentially more broadly addresses the symptoms not optimally treated with standard dopaminergic and surgeadrenergi antipsychotic medications. We believe that CTP-692 has the potential to improve on a primary symptom domain in schizophrenia, including positive and negative symptoms and cognitive function, when added to existing antipsychotic treatments.In the Phase 2 trial, the primary outcome measure will employ the positive and negative syndrome scale, otherwise known as PANSS and the primary endpoint will assess the change in total PANSS score at week 12 compared to baseline.The PANSS is a commonly used rating scale to evaluate symptoms in individuals with schizophrenia. The PANSS contains 30 items rated on a scale of one to seven. Items are divided into three symptom domains that includes positive symptoms, negative symptoms, and general psychopathology.Scores can be derived for each symptom domain and a total score can be calculated. We will also have some secondary endpoints, including the clinical global impression scale, as well as the personal and social performance scale.For the PANSS, we will also analyse the subscales for assessment of changes specific to positive and negative symptoms, as well as items related to cognitive function. We're hopeful that by amplifying or extending the effects of the current antipsychotic agents with CTP-692, we can move -- we can more comprehensively treat schizophrenia and provide greater benefit to these patients. Top-line data from the Phase 2 study are expected by year and 2020.It will be a productive and exciting year on a clinical front, and we look forward to providing updates on both CTP-543 and CTP-692 as 2020 progresses.Let me pause here and turn the discussion to Marc to review the 2019 financial results.

[Marc Becker:]

Thank you, Jim. As I review our 2019 financial results, please reference the financial tables filed in today's press release. Research and development expenses were $59.8 million in 2019, compared to $43.1 million in 2018, an increase of $16.7 million.The increase in research and development expenses related primarily to Phase 2 development of CTP-543, as well as Phase 1 clinical trials and manufacturing costs to support the continued development of CTP-692 into Phase 2 testing.General and administrative expenses were $20.3 million for 2019 compared to $22.9 million for the same period in 2018. The decrease is primarily attributable to decreases in legal and employee related expenses. Our net loss for 2019 was $78.2 million or $3.29 per share compared to net loss of $56 million or $2.40 per share in 2018.Finally, we ended the fourth quarter of 2019 with $106.4 million in cash, cash equivalents and investments. In January of this year, we completed a follow on offering with net proceeds of approximately $70 million.As a result, under our current operating plan, we expect our cash to fund the company into the second half of 2021. As Roger mentioned at the start of the call Concert has achieved several key milestones relating to our proprietary pipeline, it set the stage for 2020 to be an important year for us.Our two wholly owned product candidates CTP-543, for alopecia areata, and CTP-692 for schizophrenia, or advancing towards late stage clinical testing. The ongoing execution of our business makes us optimistic for 2020 which we see is a year of significant milestones for our company.This concludes our prepared remarks and we would be happy to address any questions.

[Operator:]

[Operator Instructions] Your first question comes from the line of Joon Lee from SunTrust.

[Joon Lee:]

Hi, guys. Thanks for taking my questions, and congratulations on all the progress. Regarding the 543, could you help us understand what the 659 patent is and basis for being granted competition of matter patent? And for the 149 patents, what's your strategy to prevail this time around with the new panel? And how critical is it they could prevail in light of the 659 patents already giving you competition a matter of protection? And I have follow-up. Thank you.

[Roger Tung:]

Thanks very much for the question. So, I think your last point is really the most salient one, which is with the new patent issuance. That's really what we are seeing is an important aspect of our overall intellectual property strategy that an additional patent that we have filed and are in the process of filing will provide what we believe will be strong protection for CTP-543 2037 and hopefully beyond.So, with regard to what the new patents covers, it is specifically relating to pharmaceutical compositions, that is a combination of CTP-543 and pharmaceutical excipients for dosing into humans. As the dose levels, which were the ones that related with that provided the robust results that we saw in our case to study. Those are, of course the dose that we intend to take into Phase 3 and eventually have on our product label.And therefore, those product claims as well as the use of CTP-543, the treatment of hair loss and specifically alopecia areata would provide strong protection for 543. With respect to the 149 patents, we don't know at this point what opportunity will have for additional arguments around the validity of that patent. We believe that the arguments that we've made frankly should prevail as sense, but obviously if we have an opportunity for further oral argument or any additional written arguments, we will take advantage of that.

[Joon Lee:]

Great. Very helpful. And for the 692 programs for schizophrenia, it seems like, there is a lot of scientific rationale for using an MDA agonist to treat schizophrenia given that antagonists that known illicit schizophrenia like symptoms. And it looks like some of your competitors are looking at an MDA positive balustrade modulator for cognitive impairments associated with Huntington's, Parkinson's and Alzheimer's diseases to this list a few. Do you have any plans for those indications as well down the road?And also, maybe can you talk about why targeting the glycine site may be a better approach than targeting the glutamate site, given that they're both coagonist. Thank you very much.

[Roger Tung:]

Sure. So, glutamate is more specifically related according to the literature to the potential negative outcomes of excessive toxicity, whereas glycine is really a coagonist site is less associated with that and as lead specifically to be deficient in terms of exposure in patients with schizophrenia.There's a fairly extensive literature indicating that both plasma levels and through the spinal fluid levels of the series, which is believed to be the most important coagonist of glutamate FBN MDA receptor are low in patients with schizophrenia.And that's the rationale for our interest in enhancing it along with of course the initial academic studies that suggested that treatment with D-serine itself can potentially remediate the overall symptomatology of schizophrenia including both positive symptoms, as well as other symptom domains which are not well treated by current toxopsychotic agents, such as negative and cognitive domains.As you indicated, there has been -- there remains and has been now for probably three decades a strong interest in attempting to enhance glutamatergic transmission specifically through the NMDA receptor. And that has been interest that's applied not only to schizophrenia, but to other areas of cognitive dysfunction and negative symptomatology across a number of diseases.We, of course are very interested in expansion of use of CTP-692. But right now, we're very focused on trying to run a positive and statistically significant positive outcome in our schizophrenias study. And after that of course we'll work towards exciting indications.

[Joon Lee:]

Thank you.

[Roger Tung:]

Absolutely.

[Operator:]

Your Next question comes from the line of Lisa Bacon [ph] from JMP Securities.

[John Walden:]

This is John Walden on for Lisa. Just a couple quick questions for me, what are your key discussion topics at the end of Phase 2 meeting? And then kind of what are your thoughts you discussed your two doses moving forward but as far as endpoints duration number of patients. And where the gating factors from the end of Phase 2 to starting the trial?

[Jim Cassella:]

Yes, sure. So, Hi, this is Jim, thanks for the question. So, this will be -- and the Phase 2 means are pretty comprehensive meeting to talk not only about the specific Phase 3 plants but also the, the whole program aimed towards our registration.So, just -- so in focusing on the, the Phase 3, obviously there are things that we need to get alignment on with the FDA including endpoint patient characteristics duration of the trial et cetera.We think we're in a very, very good position because of the Phase 2 trial which was a definitive dose ranging trial where we've been able to identify our dose range. We identified a 4-milligram BID dose that did not work and we're not carrying forward. We identified the patient population that we're ---will be relevant for the Phase 3 program, and obviously our endpoint using salt as an assessment tool.So, I think we're going into that meeting with a very solid database and evidence to support our Phase 3 plan and that will be a good portion of the discussion. Once we get agreement with the FDA on the Phase 3 plans and also talking in the general perspective of the program will be able to then get our study sites up and ready to go do the logistics for supply chain for a much larger trial again for Phase 3 assuming that we have agreement with the FDA, we'll be talking on the order, 600 or so patients.This will be a multinational trial. We are currently working in the U.S. and Canada, but we plan on expanding into Europe. So, there are logistics to get going for that trial. So, we are confident that we will be able to get that going in the second half of this year.

[John Walden:]

Great. And then with the upcoming baricitinib Phase 3 study. Can you just kind of discuss your thoughts on that program and your overall competitive positioning? Thanks.

[Roger Tung:]

Yeah, thanks, John. With respect to baricitinib, we don't have confirmation as of right now, about what doses are being tested. And there's in terms of actual clinical data that's been reported today, only a single patient who has had results in alopecia areata, and that was at a substantially higher dose and it's currently approved. So, at this point, I think what we can say is that we don't have a lot of information to go along with respect to baricitinib other than the current product label.As you know, baricitinib was not approved at the 4-milligram level and was approved in the U.S. at the 2-milligram level, but with a significant black box warning associated with compound.So, it remains to be seen how the dermatology division will deal with the approval of that compound and what doses are being tested and what doses are going to be put up for approval. So, at this point, it's more of a stay tuned situation.

[John Walden:]

Great, thanks guys.

[Operator:]

Your next question comes from the line of Adam Walsh with Stifel.

[Adam Walsh:]

Good morning, guys. Thanks for taking my questions. And I'll add my Congrats on the progress recently. I have a couple of questions. The first one is, can you give us any granularity on the enrollment in the 692 Phase 2 at this point. I'm looking at your guidance for timing for that data by year end 2020 and I'm just trying to get some granularity around that. Thanks.

[Jim Cassella:]

Hi, Adam, this is Jim. So yeah, so, I think, it's an ongoing trial and we really can't talk specifics here. But I think I can say that, things are going as we expected, and we are still giving the guidance for data readout by the end of the year.

[Adam Walsh:]

Okay. And then, in terms of the kind of ongoing patent litigation battle with insight, I'm just curious, are there any, can you foresee any court or PTAB decisions over the next 12 to 18 months, can you and if so, can you kind of layout the timelines for when we might be getting different hearings or decisions.

[Roger Tung:]

Hi, Adam, this is Roger. Thanks again for your questions. As you - I believe you know the vacating of the order and treatment of PTAB was done under the Arthrex ruling, which was unprecedented, let's say and at this point, I think we really don't have a lot of visibility in terms of how PTAB is going to be dealing with that pooling.So, it's entirely possible that it will be kicked back under the typical timelines of a one-year timeframe. But it's also possible that it'll be adjudicated more quickly than that. At this point, we just don't have anything to go on, because there's really no precedent for this situation.

[Adam Walsh:]

And then Roger on the new Pat, and I'm just curious, I mean, is there kind of a historically relevant anticipated response on behalf then say what should we expect now that the new patent has been issued?

[Roger Tung:]

Well, I think it's the case that of course, any patent can be challenged for any reason. We believe that we have a strong situation with that patent for a number of reasons. One of them, as I indicated on the call is that the specific dose strengths that are covered under that patent are the ones that provided a very impressive clinical results in our Phase 2 study.The protection of the compound is very specific to a particular composition of matter of CTP-543, as well as levels of deuterium enrichment in that compound, so it's very narrow and specific patents. And the patent was also issued by the office with full knowledge of existing litigation regarding the 149 patents. So, we think that overall it's a very strong position to be upheld if it is challenged.

[Adam Walsh:]

That's helpful. Roger. Thank you. And then Marc, just really quickly on the OpEx, can you speak to the kind of the how we should be thinking about the ramp in the R&D, over the next and even SG&A over the next 12 to 18 months? I know you've given kind of the overall cash guidance, but I'm just curious, kind of sequencing it out during the 2020 quarters how we should think about the spending? Thank you.

[Marc Becker:]

Yes, thanks for the question. So yes, cash will last into the second half of 2021 which we mentioned earlier, and regarding build up with expense, yes, it is natural that the expense on R&D will go up now that we're into a Phase 2 trial for 692 and planning the Phase 3 trial for 543. So, expenses will ramp up the burn rate that we're projecting for this year is approximately $90 million and it will be sequenced according to the clinical development milestones that we've laid out.

[Adam Walsh:]

Thanks very much and congrats.

[Operator:]

The next question comes from the line of Esther Hong from Janney.

[Esther Hong:]

Hi, good morning. So, as Roger mentioned, the Arthrex, the Smith & Nephew ruling is relatively new. So, can you speak of any other cases earlier in the queue to patent 149 that are being reheard under that ruling and then the outcome, and when the outcomes of those cases may occur? Thanks.

[Jim Cassella:]

Hi, Esther, thanks very much for the question. I can't claim to have a lot of expertise on case law associated with Arthrex versus Smith & Nephew. Of course, Arthrex, itself is the first case to be remanded and presumably to rehearse. We know that there are other cases, multiple other cases that have been also vacated and remanded. But I'm not going to try to get into the law of this because it's outside of any expertise that I claim to have.

[Esther Hong:]

Okay, thanks. And also, congrats on the progress with all the programs.

[Jim Cassella:]

Thanks very much.

[Operator:]

Your next question comes from the line of Difei Yang with Mizuho Security.

[Difei Yang:]

Hi. Good morning, and thanks for taking my question. Just a couple, the first one is related to CTP-543. After the end of Phase 2 meeting with the FDA, would you expect to press release the findings or the designs or maybe holding a conference call, what should we be expecting there?

[Justine Koenigsberg:]

Difei, it's Justine here. I guess, we would expect some form of communication to lay out our plan for our Phase 3 program.

[Difei Yang:]

Okay, great. Thanks. And then follow-up on the CTP-692, so historically, we have seen clinical data of the syringe showing roughly a 10-point difference versus placebo understand score, which is a scale for the assessment of negative symptoms. How should we think about that difference in terms of the negative subscale?

[Jim Cassella:]

Hi Difei, it's Jim. So, I think when -- we look at the literature, where there's been positive reports on multiple of the domains of positive and negative symptoms. I think that SANSS has been used and there's been the negative symptom factors for as well from the PANSS as well. I think what we see in this trial where there has been positive benefit is that we do see meaningful movement on both the SANSS and the PANSS negative symptoms scale as well.So, I think when we designed our trial, we tried to triangulate using all the information that we had from all those positive trials to really get a sense for where we would be in terms of the individual subscales.However, I do want to remind you that we are looking at the total symptom score, the total PANSS score. Because what that does for us, it allows us to look holistically at the patient. We know that this hearing has shown in the literature that it can move the negative symptoms, it can move the positive symptoms and improve on cognitive functions, as measured by the PANSS scale. So, we can parse those subscales out. But our focus is still on the holistic treatment of the patient by looking at the total PANSS improvement.

[Difei Yang:]

Thank you so much, Jim for the explanation. Then my final question is, how should we think about the placebo response any time we run sort of psychiatric related trials, placebo sometimes is always a concern?

[Jim Cassella:]

Absolutely. Now, it's been - placebo is CNS trials is always an issue. As you know, I've been doing this for a long time, we really spent a lot of time at the investigator meeting and in design of the trial to really keep the placebo response as low as possible. We've instituted things in the trial that will keep it low as possible. We have basically a screening qualification period where we're looking for stability of the patient on hands and making sure that they are actually complying with their antipsychotic medication.We've done things to reduce the amount of time in the clinic where we know that multiple assessments things that you don't need to do can influence placebo response. So, we're very directed at getting our PANSS assessment and in the other two secondary advocacy endpoints, the PSP and the CGI.So, I think we really built in a lot of things into the trial to really keep the placebo response under control. The other thing is that we're using very experienced sites, a lot of these sites I've worked with in the past, for my past CNS programs, you'll really spend a lot of time focused on really trying to reduce those variability that we know can lead to increased placebo response.So ,I think I can say that we're really comprehensively trying to hit the placebo by like multiple factors, by the way, we control the trial, by the way, we designed the trial and by the way, we are working with the sights.

[Difei Yang:]

Thank you so much, Jim, and best wishes in 2020.

[Jim Cassella:]

Thank you very much.

[Operator:]

Your next question comes from the line of Robin Garner from LifeSci.

[Robin Garner:]

Good morning to the Concert team and thank you for taking my questions. My first question is regarding the newly issued patent and I'd love to hear any further detail you can provide on the excipients that are covered under those claims and how important are they for the delivery of CTP-543 of the treatment?

[Roger Tung:]

Hi, Robin, this is Roger, thanks very much the question. So, in principle, this covers any excipients, which enabled the delivery of CTP-543 in an old form for the treatment of alopecia areata, or for frankly, any other utilization of 543. What the patent is directed for is facts that we discovered that a specific amount of a specific molecule with a specific level of deuterium incorporation has remarkable in an end, previously unprecedented results in the treatment of the specific disease in the alopecia areata.And that specific set of both the NTT-543, the delivery of the NTT-408 [ph] for treatment of a disease state that provides the basis on which the patent was issued and the utilization of 543 going forward.

[Robin Garner:]

Okay, thank you very much for that. Can you also comment, this is also regarding CTP-543 on the endpoints that are used, being used by competitor programs in Phase 3 and any insights that Concert Phase 2 might show us in terms of being able to achieve those end points.

[Jim Cassella:]

Yeah, so hi, Robin, this is Jim. So, I think the commonality that we have across all the various companies that are looking at alopecia areata is that we're all using this salt scale. So, I think that's a very important fact. And I think that provides a lot of consistency. So, in our program we have trained and certified Raiders, not unlike I could believe what other companies are doing.And but then it comes down to how do you look at the salt data, and from our Phase 2 trial our dose ranging trial, as others have coming into the first trial with [Indiscernible] trial alopecia areata, we looked at a 50% change from baseline and call that a responder, not unlike what others have done.And then from there, you get a slight to the data, we have very nice dose related responses and very significant results for our 8-milligrams to 12-milligram BID doses. Like the fact that we have the SALT data allows us to go in there and slice the data up in other ways because you have your basic raw data set. So, for example, we can look at the number of people who achieve an absolute SALT score of let's say SALT 20, which means that they have 80% hair coverage.So those are the kinds of things and when we look at those kinds of data, we see this same kind of consistent, beautiful, dose related responses. So, no matter how we looked at our SALT data set, we saw very significant differences depending on how you look at the slice of the data.I think when you start looking at, for example, just clinicaltrial.gov listings, and you start seeing that companies are looking at more along the lines of the absolute SALT scores in one way or another looking at something like a 10% or 20%, hair loss, or 80%, or 90%, hair on scale.So, I think those are the kinds of things that we're thinking about that we'll be talking over with the FDA and we'll come up with that final number that we will use as our primary endpoint. But I feel very confident from the data that we have from our definitive those ranging trial that we have good data to support whatever we're going in with.

[Robin Garner:]

Thank you for that answer. And just my final question if there any further information from Otsuka Avanir on their clinical activities that they're continuing to conduct on 786?

[Jim Cassella:]

So, they have not really provided any recent updates.

[Robin Garner:]

Okay, thank you so much. And thanks for answering my questions.

[Operator:]

I'm showing no further questions at this time. I would now like to turn the conference back to this Justine.

[Justine Koenigsberg:]

Thank you. I would like to thank everyone for joining us this morning. Please note, we'll be participating at the Oppenheimer Healthcare Conference next month and the Wainwright London Conference in April and hope to see many of you there. This concludes today's call. Thank you.

[Operator:]

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. And have a wonderful day.