Strongbridge Biopharma plc
Q4 2019 Earnings Call Transcript

Published: 25 Feb 2020

[Operator:]

Ladies and gentlemen, thank you for standing by and welcome to Strongbridge Biopharma Plc Corporate Update and Fourth Quarter 2019 Earnings Conference Call. At this time all participants are in a listen only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]It is now my pleasure to introduce Lindsay Rocco of Elixir Health Public Relations.

[Lindsay Rocco:]

Thank you, Andrew, and good morning everyone. We are pleased that you could join us today for Strongbridge Biopharma's fourth quarter and full year 2019 earnings conference call. Joining me from Strongbridge this morning are John Johnson, Executive Chairman; Dr. Fred Cohen, Chief Medical Officer; Scott Wilhoit, Chief Commercial Officer; and Rob Lutz, Chief Financial Officer.Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements.Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission.Please note that during Scott's portion of the call, there will be an accompanying set of slides highlighting an initial view of the market opportunity in Cushing syndrome based upon company sponsored market research. To access and download these slides, please go to the Investor/Events/Presentations and Publications section of the Strongbridge website.These slides will also be made available online as part of the company's corporate presentation, following this call within the same section of the website.I will now turn the call over to John Johnson.

[John Johnson:]

Thanks, Lindsay. Good morning, everyone. And thank you for joining us today. For today's call, I would first like to begin by reviewing the strong 2019 performance of KEVEYIS. And would like to thank this team for their continued dedication to serving the many unmet needs of the primary periodic process community.KEVEYIS achieved revenues of $5.6 million for the fourth quarter and $21.7 million for the full year, exceeding the company's revenue guidance range of $18 million to $20 million, representing a 29% increase over the $16.8 million in total revenue in 2018.We believe that this growth can be attributed to both a steady flow of referrals from physicians that has resulted in new patient starts and improve retention rates. We are confident that we can continue this growth in 2020 and therefore today we confirmed our preliminary revenue guidance of $26 million to $27 million for this year.We also expect to realize a continued positive and growing contribution margin in 2020 from KEVEYIS. These results, coupled with actions taken in the fourth quarter to strengthen the company's overall financial position, have allowed us to extend our cash runway to the third quarter of 2021, which is at least one year beyond our anticipated timeframe for reporting top line LOGICS results.With regard to our clinical development program for RECORLEV in endogenous Cushing syndrome. Today, we announced enrollment in the Phase 3 LOGICS trial is approximately 85% complete compared to the approximately 70% complete as reported on January 9th. The company projects that all of the remaining patients require to complete enrollment are currently in the titration and maintenance phase.With this progress, over the past six weeks, we have been able to tighten our guidance to report top line data. We are now anticipating reporting the top line data from LOGICS at the end of the second quarter or during the third quarter of this year.I would like to reiterate that completing the LOGICS study and preparing a quality new drug application for RECORLEV are among our top priorities in 2020. I look forward to the continued work with this team as we plan for and execute upon a number of important milestones this year.With that, I will not turn the call over to Fred.

[Fred Cohen:]

Thank you, John. I would like to begin with a quick update on KEVEYIS development and lifecycle activities. As we have previously noted, KEVEYIS data exclusivity in the United States is currently provided through orphan drug inclusivity which expires in August of 2022.As we have previously stated, we have been working towards the possibility of obtaining intellectual property protection for KEVEYIS based upon the research that we have conducted. We are pleased to report that we are making progress towards that goal and would like to briefly describe some of our efforts.We have filed 14 patent applications in the United States, and three PCT patent applications. With all but two of these applications belonging to four primary families of patents. We filed the first of these applications with the USPTO in the fourth quarter of 2018. We are working closely with outside counsel to prosecute these patent applications.The proposed claims relate to methods of using the active ingredient in KEVEYIS in a manner consistent with the recently revised FDA labeling for the product. As we have previously stated, we have also been engaging in lifecycle development activities applicable to our KEVEYIS business.Specifically, we have developed proprietary modified release formulation prototypes of the active ingredient in KEVEYIS, and are currently testing the performance of these prototypes in a Phase 1 clinical study.Although we are optimistic about the performance of these formulations at this time for competitive reasons, we will not be disclosing details of the formulations or our thinking regarding how one or more of them might be developed further. We expect to provide further information in the second half of this year.Now, turning to RECORLEV, this morning, we provided an update on the LOGICS Phase 3 study of RECORLEV for the treatment of endogenous Cushing syndrome. We continued to advance patients through the LOGICS trial as expected and they're on track to deliver top line results at the end of the second quarter or during the third quarter of 2020.Please recall that LOGICS is a double blind, placebo controlled, randomized withdrawal study targeting approximately 46 to 54 subjects for enrollment which is comprised of four phases, a screening phase, plus three therapeutic phase.The primary endpoint comes at the end of the third phase, which is the randomized withdrawal phase. Our top line results will consist of data through the end of this space. As John mentioned earlier, we have now enrolled 85% of the patience required to complete the study.And we believe that all of the remaining patients needed to complete enrollment are currently in titrating maintenance. When all patient has been enrolled, we will provide more precise guidance for the expected timing of the announcement of top line results.As relates to an NDA submission, we continue to believe that we can submit an NDA approximately six months after top line logics results are reported. As stated previously, we believe that if our NDA is accepted for a review, we can expect a review cycle a 10 months from the date of submission, which is the standard PDUFA cycle time for a review of a new active substance via the 505 (b) (2) NDA pathway.And with that, I will now turn the call over to Scott, who will provide a commercial update. Scott?

[Scott Wilhoit:]

Thank you, Fred. Good morning, everyone, and thanks for joining us. As mentioned earlier, this portion of the call contains an accompanying set of slides to help illustrate our initial view of the market opportunity in Cushing syndrome based upon company sponsored research.To access and download these slides, please go to the Investor/Events, Presentation and Publications section of the Strongbridge website. Before we begin, and as a reminder, RECORLEV is currently being investigated for the potential treatment for endogenous Cushing syndrome.RECORLEV has not been approved by the FDA, as safe and effective. Turning to slide three. We recently conducted an in depth market assessment, which included landscape assessment on both qualitative and quantitative research with more than 160 endocrinologists.In addition, we conducted qualitative research with 10 major payers comprised of both regional and national plans. As you can see the healthcare provider qualitative research phase included 13 leading and community endocrinologist who treated an average range of 12 to 62 Cushing syndrome patients in the last six months.In the quantitative phase research phase 153, respondents treated an average of 25 to 68 endogenous Cushing syndrome patients without malignant causes in the last six months. The primary purpose of this assessment was to evaluate perceptions of current and future products for treating Cushing syndrome patients.On the following slides, we will discuss our key findings related to the market landscape, unmet needs, the potential RECORLEV opportunity and payer access. Our research here on slide four shows that the diagnosed prevalence in Cushing syndrome in the US is in the range of approximately 25,000 patients.Surgery is typically the first line treatment. However, our research indicated that approximately 8000 of these patients are pharmacologically treated. Importantly, of those 8000 patients, endocrinologists reported that approximately 40% or about 3200 patients remain uncontrolled on current treatments.As illustrated on slide five, the current product market shares as reported in our research for both approved and unapproved products shown here illustrate that none of the current treatment options have a dominant share of the market. And more than 80% of the prescription treated patients are using products that are unapproved for Cushing syndrome.Ketoconazole remains the market leader with 27% market share of patients treated. As a reminder [indiscernible] has guided to a 2020 revenue range of $355 million to $375 million for quarter, which is one of the only approved branded Cushing syndrome therapies.We also ask endocrinologists to indicate their interested in new treatment options. As you can see here in slide six, more than 80% reported moderate to high interest level in new therapies for Cushing syndrome.Endocrinologist satisfaction levels with current treatment options also underscore the need for potential new treatment options, particularly without approved products. Only 37% of ketoconazole experienced treaters are highly satisfied; 36% of metyrapone experienced treaters are highly satisfied; and only 29% of cabergoline experienced treaters are highly satisfied.In general endocrinologists indicate a higher satisfaction level with approved products. Furthermore, endocrinologists reported a considerable number of patients who were uncontrolled, which may further illustrate the need for new treatment options.Here on slide seven, we show the results pertaining to endocrinologist perceptions for the quarter. After reviewing the clinical profile for RECORLEV, which was based upon results from our recently published Phase III SONICS clinical trial 86% of endocrinologists treating more than 40 patients in the last six months, indicated they were likely to prescribe RECORLEV and 81% believer RECORLEV fulfills an unmet need.Turning to slide eight. If RECORLEV gets approved, we believe that endocrinologist may recognize the potential advantages prescribing RECORLEV on label with supporting clinical data, directions for using Cushing syndrome, and comprehensive provider of patient support.As a reminder in the U.S. ketoconazole was an only indicated as a last line antifungal, and it's not well studied prospectively in Cushing syndrome. Further, the FDA label indicates weekly liver monitoring and warns that use of ketoconazole and Cushing syndrome has not been approved.Turning to pricing and reimbursement. As you can see here on slide nine, the current annual wholesale acquisition cost for FDA approved Cushing syndrome therapeutics ranges from approximately 165,000 to 755,000 depending upon the product and corresponding dose.SIGNIFOR and SIGNIFOR LARs annual wholesale acquisition cost is approximately $165,000. KORLYMs annual wholesale acquisition cost ranges approximately $189,000 to $755,000. We believe that those products provide relevant potential analogs for RECORLEV if approved.As you can see here on slide 10, payers cover current branded Cushing syndrome products on a non-preferred formulary tier, as is typical for treating products treating rare disease. Additionally, as expected, all payers have prior authorizations to ensure medical necessity and appropriate use.Some payers require step-edits to other non-approved products, but not the majority. As I mentioned earlier, we conducted interviews with 10 national and regional payers where we tested both RECORLEV profile and price range.As illustrated here on slide 11, payer responded to express an initial willingness and average of six out of nine rating, to provide coverage for RECORLEV. They expect to use existing utilization management criteria to ensure appropriate patients, only appropriate patients have access to RECORLEV.As expected in some cases more highly restricted payers may require step-edit. Turning to slide 12. As a reminder, when we showed more than 150 endocrinologists to clinical profiles for all of the potential next generation products, including RECORLEV in a future state of Cushing syndrome market, they expect to dose next generation products to capture the majority of the market share.If approved RECORLEV, as part of that next generation may offer endocrinologists a useful new treatment option. As you can see here on slide 13, we plan to fully leverage our existing infrastructure in rare disease experience.Over last several years, we have built a commercial and medical affairs team that has a proven track record of success. In the near term, we aim to maximize our relationships with key opinion leaders and continue to foster relationships with leading patient advocacy groups.In addition, we intend to fully utilize our core capabilities such as marketing analytics as well as customer facing functions such as sales, patient services and medical liaisons to support our go to market strategy.Turning to slide 14, which is the final slide for this portion of the call. In terms of our initial targeting approach, we're currently planning to utilize approximately 25 to 45 customer facing field positions at launch. We believe this will provide us with the required resources to reach the approximately 1500 to 2000 community and neuroendocrine specialists and approximately 125 to 150 pituitary centers and KOLs across the U.S.In summary, we are truly energized about the potential opportunity for RECORLEV in Cushing syndrome. This research underscores the significant unmet needs as we believe RECORLEV may address. And we are eager to advance this product to market so we can hopefully make meaningful improvement in the lives of patients with Cushing syndrome.With that, I'll turn the call over to Rob Lutz our CFO, who will review our financial highlights for the fourth quarter and full year before we open up the call to questions.

[Rob Lutz:]

Thank you, Scott. Our press release contains details of our financial results for the fourth quarter and full year of 2019. Rather than read through all of those details, my comments today will provide some context on our cash spend and runway.As we disclosed previously, we ended 2019 with $78 million in cash, cash equivalents and marketable securities. And based on our projections for KEVEYIS and for operating expenditures, we expect our cash to last at least through Q3 2021, which is at least one year past our expected announcement of top line data for LOGICS.Our cash burn in Q4 of 2019 was $2 million in part because of a $6 million onetime benefit from the payment through Novo Nordisk. We expect cash burn to fluctuate due to variability in operating expenses and working capital.Additionally, we expect average cash burn to be higher in the early quarters of 2020 and trend down starting in later 2020 because we expect KEVEYIS will continue to grow. And because R&D expenses will diminish as LOGICS comes to an end.Until we achieve positive cash flow, we will regularly evaluate when and how to raise additional capital to fund our business. With a revenue producing asset and a late stage asset, both with upcoming milestones we believe there are multiple ways we can raise capital to fuel the growth for our business with the goal of increasing shareholder value.And operator, with that, we're ready for questions.

[Operator:]

Thank you. [Operator Instructions] And our first question comes from the line of Chris Howerton with Jefferies.

[Chris Howerton:]

Hi, good morning. Thanks so much for taking the questions. I guess, just real quick, maybe this one for Fred. I missed the -- you described the four patent families that you're using or considering for lifecycle management for KEVEYIS. I think I just missed the concepts there before?

[Fred Cohen:]

Thanks, Chris. We actually are not going to go into any details around the families themselves. I always said it, today's call is that the patent applications are on the active ingredient in KEVEYIS and that they are consistent with the current product labeling for the drug. So, further details to come later.

[Chris Howerton:]

Okay. Okay. Well, thanks for that. I guess, moving forward to the market research that Scott kind of went over. Just a couple of things that I'd be interested in is that -- on Slide 6, when you asked endocrinologists why they're dissatisfied or whether or not they're satisfied, I guess with current treatments. What were the drivers of dissatisfaction with current treatments primarily?

[Scott Wilhoit:]

Yes, Chris, this is Scott. Good question. I think, we had them long list several, but I think the ones that rose to the top were just a need for consistent and predictable cortisol control was one. Improve safety and tolerability, I think it's the balance of the risk benefit of that.And then I think while it was a good start, I think what rose to the top were improvements and CV related end points were meaningful to them. So I think if they were looking for products that we bring those 3 things among others to the market.

[Chris Howerton:]

Got it. Okay. And then I guess switching to the payer perspective. And I think this is frankly been a question of a lot of investors in terms of what's going to happen in the face of RECORLEV approval with off label ketoconazole.So when you talk about step-edit is a possibility for certain more conservative payers. What do you think that step-edit will be? Will it be for off label ketoconazole or other approved therapies for Cushing syndrome?

[Scott Wilhoit:]

Another good question Chris. I think that the first point I'd make is that in the work that we did, we clearly got a sense, both you saw the secondary research as well as the primary research with RECORLEV.We got the sense when they were shown the profile that they had a positive inclination to cover RECORLEV, number one. I think in terms of you mentioned, more restrictive plans, and there's always sets of restrictive plans.I think for those players, I think what you could see, it is the PA criteria that you see on the bottom of that slide that you're referencing, as well as some step through lower cost options. And one of those could be ketoconazole.The good news, I guess, in that regard is in earlier slides that we presented, there is a fairly large set of patients who are on ketoconazole. And we mentioned also that there's an uncontrolled population. We'll have to do more work around the percentage of uncontrolled within keto.But we believe there's opportunity there from that perspective.

[John Johnson:]

Chris, it's John. I do think the payers are going to find themselves in a pretty difficult position, when you have a label for keto that once against the use in Cushing's and in particular and calls out Cushing's in the label.So, as we look at it, we'll be working with payers, this is not a huge category there's not a lot of patients here. And we expect that, as physicians work with the payers to help them understand the potential risks of keto and the body of scientific evidence that's been developed.For RECORLEV that we're not going to have issues in terms of patients getting access, it may require our physicians to do a little bit more work. But certainly we think that there’ll be plenty of data for them to reference as they work with the payers to get the patients access.

[Chris Howerton:]

Sure. Okay. And then maybe just one quick one operationally, obviously, we're all waiting for the LOGICS readout and that'll be a very important event for your company and expected to move to pass or RECORLEV approval.But, in anticipation of positive results, what else has to be done in order to get the NDA submitted, anything from a CMC or other kind of perspective that we should be aware of?

[John Johnson:]

So, what we said is that, we're on track with our NDA preparation. We've been preparing for the submission for a while now. The LOGICS data are expected to be the rate limiter in terms of assembly of the package. And if we learn anything else contrary to that in the future, we'll let you know. But right now that's where we stand.

[Chris Howerton:]

Excellent. Okay. Well, thanks so much for taking the questions and I'll hop back in the queue.

[Operator:]

Thank you. And our next question comes from the line of Annabel Samimy with Stifel.

[Unidentified Analyst:]

Hi, that this is Avatar Jones [ph] on for Annabel. You guys presented some pretty compelling market research. And on slide six specifically, you mentioned that only 37% of your prescribers were highly satisfied with ketoconazole.Can you give a little more granularity on how many of those prescribers were actually just moderately satisfied, too highly satisfied? And a second question as you prepare for the potential launch of RECORLEV, do you anticipate any targeting of high volume prescribers and just what is the logistics around your approach to launch and engaging physician? Thanks.

[Scott Wilhoit:]

Yeah, good question. Let me start with the last one first. If you see on the last slide, slide 14 that we cover. This is preliminary kind of our initial view of how we would go about targeting and then potentially deploying resources against the targets.But you see, we'll use an approach of looking at a diagnostic claims data as well as prescriptions claim data. We know that there are about a 8000 endocrinologist in the U.S. likely around 1500 to 2000 neuroendocrine specialist and 100 to 150 pituitary centers.So, we think about deploying against those. We think that the range that we have in the 25 to 45 range that our customer facing physicians should cover those that range of targets. And that really comes down to about 100 to 125 targets per territory in that range.Now we'll have to do additional work as we get closer to launch to kind of refine and fine tune that. But that's kind of our initial working view of the target audiences, how we would approach it, and the potential size of the team that are customer facing.

[John Johnson:]

Yeah, and I would just add that, Scott and the team have also done some behavioral and attitudinal segmentation. For competitive reasons, we're not going to be sharing that. But that will continue to evolve as we see the data from LOGICS.And that will determine, how we put calls, how frequently we hit some of these folks. Scott's described their reach, but our frequency and some of our actual approaches with promotion will be based upon those factors. But I just want to make sure that, everyone's aware that we've undertaken that work, but we're not going to share that work.

[Unidentified Analyst:]

And the first question regarding the physicians levels of satisfaction to ketoconazole should be moderate levels of satisfaction?

[Scott Wilhoit:]

Yes. You know what I'm going to have to look at the broader slide deck. We didn't share that in this call. And we have, I don't have that data at my fingertips, but I can follow up.

[Unidentified Analyst:]

If I just ask one more. Do you have any insight on how physicians -- willing the physicians are to complete prior authorizations in step edit in this space with the concerns around the fair push back [ph]?

[Scott Wilhoit:]

Yeah. I think in general terms, I think prior authorizations in rare disease and in this category with two analog products are fairly common. It doesn't mean that physicians like it, I think it's just, it's a common thing that has to take place.And I think that, especially higher volume offices are probably very used to doing these types of prior authorizations. So, as we get closer to launch, we'll learn more. And as we launch and support physicians, under our care connection program we will provide the appropriate education for physicians to educate them on the requirements payers may have.

[Unidentified Analyst:]

Thank you.

[Operator:]

Thank you. And our next question comes from the line of Hartaj Singh with Oppenheimer.

[Hartaj Singh:]

Great, thank you for my questions. I just have a couple of follow-up questions from earlier ones. Just specifically do you think if the uncontrolled patients that you think will be more likely to sort of be candidates for RECORLEV assuming positive LOGICS and a launch?And then what do you think it'd be the patients, or you know, where there's low satisfaction with existing drugs at ketoconazole and the other one that you saw in your slides or a mix of both. Just any color there would really help? And I just got a couple of follow-up points.

[Scott Wilhoit:]

Yes. Good question. I think frankly, it's probably a little bit of both. We've got -- as John mentioned, we've got some more work. We have done some initial work on kind of the behavioral segments, in particular with ketoconazole which we're not going to share now.But I think it's both, I think those that are uncontrolled. We believe and heard through the research that that may indicate a number of potential switching that goes on in the category anyway. So that could be an opportunity, irrespective of the reason that they're uncontrolled.And I think from a behavioral perspective, there may be opportunities to target certain physicians that that utilize or don't utilize certain products.

[Hartaj Singh:]

Great. Thank you. And then do you think you will have fairly robust pharmaco-economic database, post logics? I assume that in this area where there's a lot of generics, there appears and probably require a lot of pharmaco-economic modeling. And then would you also consider consulting with ICER, prior to launching the drug?

[Scott Wilhoit:]

It's a very good question. I think, at this point is probably a little too early for us to make a call on that. Clearly we'll be discussing with payers in due course, the burden of the illness and how we view with RECORLEV as a potential treatment option. But TBD on how we would engage, ICER if we would engage or not, and any pharmaco-economic data associated with the product in particular.

[Hartaj Singh:]

Great. Thank you. And last question just on KEVEYIS. I thought it was fascinating. Are you afraid you're talking about the long acting version? Do you think that -- I'm really looking forward to seeing your thoughts on second half year.Do you think that with a long acting data of KEVEYIS in an episodic disease, like periodic paralysis, you could actually potentially increase the number of patients, because I imagine short acting drugs are harder to episodic disease like periodic paralysis, just any thoughts there? And again, thank you for all the questions.

[John Johnson:]

So by way of clarification, Hartaj, we didn't say anything about long acting formulation, we said modified release. And I would also point out that in our current formulation of KEVEYIS, although it is an immediate release formulation, has a very long half-life, approximately 36 hours or so. So it's steady, state basically the patients don't go through any substantial trough cycling as you might expect with a very short acting drug.So they keep a fair amount of drug on board, even at the lower doses. And so hopefully that addresses your question. But all I can say is in terms of the modified release is that although we are optimistic, at this point, we're just not ready to disclose the details of our thinking around that. But we promise when the time is right we’ll be much more forthcoming.

[Hartaj Singh:]

Great. Thank you for all the questions.

[Operator:]

Thank you. And our next question comes from the line of Esther Hong [ph] with Janney Montgomery Scott.

[Esther Hong:]

Hi, good morning. So with Phase 3 SONICS data soon approaching, NDA submission expected later this year, maybe early next year. Can you speak about the potential nextgen competitive landscape for Cushing and specifically osilodrostat and how you think RECORLEV and osilodrostat that would both fit in the treatment of Cushing? Thanks.

[John Johnson:]

So thanks. Yeah. So just to clarify LOGICS is this study that we're waiting for the Phase 3 data.

[Esther Hong:]

I am sorry. My bad.

[John Johnson:]

Yeah, no worries. At the end of the second quarter or third quarter. In terms of next generation what the landscape Scott pointed out in his slide, some of the drugs we think are likely to be a part of that next generation, including osilodrostat, which was recently approved by the European Medicines Agency, is awaiting approval by the FDA.And then another drug in Phase 3 RECORLEV is the drug from [indiscernible], which is the so called next generation version of misoprostol. So we think we have a pretty good handle on what the current profiles are of that of those two drugs.Obviously, we're waiting for more details on both of them to emerge. Osilodrostat is the narrow one. It is an adrenal cortisol synthesis inhibitor. It acts very specifically with high potency against one of the enzymes responsible for the synthesis of cortisol, as well as aldosterone. And that enzyme is 11 beta hydroxylase.RECORLEV also blocks that enzyme. The main difference between the two drugs in terms of mechanism now is that RECORLEV blocks several different enzymes along the pathway that lead to cortisol synthesis. So in that way, you get a basically a blockage of activity along the cortisol and androgen synthesis pathways with RECORLEV that you don't get with osilodrostat.So that when feedback, not to get too technical, but when feedback disinhibition occurs, and you get ACTH from the pituitary go up, driving adrenal steroid production. When you block only one of the enzymes, all the other steroids that are under the control of ACTH can be increasing synthesis.So with the dug that's a very specific block or like osilodrostat or metyrapone you do tend to see things like a mineralocorticoid, weak mineralocorticoid production go up, that is the precursors to aldosterone, as well as androgens.Those are considered unfavorable types of effects in a cortisol blocker. You would prefer for a cortisol blocker 2 block cortisol, perhaps block androgen production in the adrenal gland, but not do anything to increase precursors or do very little. And so that's the main point is differentiation there. Osilodrostat that you can think of it as a very potent and longer acting form of metyrapone in that regard.

[Esther Hong:]

Thank you.

[Operator:]

Thank you. I'm showing no further questions at this time. I will now turn the call back over to the Executive Chairman, John Johnson for any closing remarks.

[John Johnson:]

Thank you. In summary, 2019 was an important year for Strongbridge. KEVEYIS became contribution margin positive and heads into 2020 with solid momentum. The LOGICS trial is approaching its conclusion. I would like to take a moment to thank all the patients who agreed to be part of the trial for their contribution to the Cushing's scientific body of evidence.The initial market research with physicians in this disease area were impressive. These findings combined with the interest expressed by endocrinologists in prescribing RECORLEV, if approved, provides increased confidence in a potential successful launch.Finally, I would like to thank all of our employees for their continued dedication and support on behalf of the physicians and patients we serve. Thank you for joining today's call and for your continued support.

[Operator:]

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.