RVL Pharmaceuticals plc
Q4 2018 Earnings Call Transcript

Published: 28 Mar 2019

[Operator:]

Good day, ladies and gentlemen, and welcome to the Osmotica 2018 Business Update Call. At this time all participants are in a listen-only mode. [Operator Instructions] As a reminder, today's conference may be recorded. I'd now like to introduce your host for today's conference, Lisa Wilson, Investor Relations for Osmotica Pharmaceuticals. Ma'am, please go ahead.

[Lisa Wilson:]

Thank you, Liz. Welcome to Osmotica Pharmaceuticals Fourth Quarter and Full Year 2018 Business Update Call. This is Lisa Wilson, Investor Relations for Osmotica. With me on today's call are Osmotica's Chief Executive Officer, Brian Markison; Chief Operating Officer, JD Schaub; and Chief Financial Officer, Andrew Einhorn. This afternoon, the company issued a press release detailing financial results for the 3 months and full year ended December 31, 2018. This press release and a webcast of this call can be accessed through the Investors section of the Osmotica website at osmotica.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities and Litigation Reform Act. These forward-looking statements are based on information available to Osmotica's management as of today and involve risks and uncertainties, including those noted in this afternoon's press release and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Osmotica specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. A telephone replay will be available shortly after completion of this call. You'll find the dial-in information in today's press release. The archived webcast will be available for 1 year on our website, osmotica.com. For the benefit of those who may be listening to the replay or archived webcast, this call is held and recorded on March 27, 2019. Since then, Osmotica may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. And with that, I would like to turn the call over to Osmotica's CEO, Brian Markison.

[Brian Markison:]

Good afternoon, and thank you for joining our call. I'm pleased to report that in 2018, the company made meaningful traction in driving the branded portfolio and advancing the pipeline. This past year was marked by significant progress for Osmotica. We had a strong year financially. We successfully completed our IPO in the fourth quarter. We continued our transformation towards a specialty-branded business, highlighted by the launch of M-72 in early 2018, which continues to gain traction with solid growth in monthly prescriptions, and the approval and launch of Osmolex extended-release, where early trends are encouraging as well. We also continued to maintain strong and growing sales and share of the women's health care franchise, especially for Divigel, in a highly competitive category. Today, we are also reporting the completion and preliminary top line results from Study 3004, our second Phase III clinical trial of arbaclofen for the treatment of spasticity in multiple sclerosis patients. This study was a multicenter, randomized, double-blind, placebo-controlled study in which multiple sclerosis patients with documented muscular spasticity in any limb received either placebo, 40 milligrams of arbaclofen per day or 80 milligrams of arbaclofen per day. The coprimary efficacy measures assessed in this study were CGIC, Clinical Global Impression of Change, and the change from baseline in TNmAS, or the Total Numeric modified Ashworth Scale. The CGIC is a subjective, generalized global assessment of patient well-being, and the TNmAS is a more objective measure of muscular spasticity. The change from baseline through day 84 of treatment was assessed for both coprimary endpoints. Arbaclofen did not demonstrate superiority to placebo as measured by the CGIC. However, a statistically significant improvement in spasticity relative to placebo was demonstrated as measured by the TNmAS for both 40 milligram and 80-milligram doses of arbaclofen. Upon preliminary review, it appears that the CGIC failed to recognize the improvement demonstrated by the TNmAS. However, the CGIC values indicated both treatment groups improved from baseline. Preliminary results also appear to identify a dose-response relationship between the 2 strengths, with the 80 milligram dose exhibiting a stronger signal of efficacy as measured by the TNmAS scale. Though the 80-milligram per day does had a higher discontinuation rate in the study, the safety and tolerability profile was in line with previously reported results, most notably a somnolence incidence of 9.5% and 14.5% for the 40 and 80-milligram treatment arms, respectively, compared to 9.6% for the placebo treatment arm. Somnolence is one of the most frequently reported and dose-limiting adverse events associated with baclofen treatment today. Our full analysis of the data is ongoing, and we look forward to updating you once that work is complete. While the results of this study are mixed, we believe that the efficacy signal for the treatment of spasticity identified by the TNmAS endpoint is a positive result to build upon, and the profile of arbaclofen offers a meaningful benefit to patients who suffer from spasticity. Based on what we have seen thus far, we intend to continue towards submission of an NDA, although our time line may now extend past 2019. With RVL-1201, or RevitaLid, we have completed enrollment in our second Phase III pivotal efficacy trial and plan to share top line results on our previously announced schedule. Our pivotal safety study is complete, and all of the elements of the program are in line with expectations. I'd like to highlight that our second Phase III trial is identical to the first. And even though we have only blinded data for the second trial thus far, the results appear similar to the blinded data in the first trial, which translates into a high degree of confidence. Now I'd like to turn the call over to Andrew Einhorn, the company's CFO, to review our financial results. After which, JD Schaub, the company's Chief Operating Officer, will speak to some of our commercial highlights with M-72 and Osmolex. And then following JD's remarks, after some closing comments, we'll be happy to take your questions. With that, I'll turn the call over to Andy. Andrew?

[Andrew Einhorn:]

Thank you, Brian. Total revenues in the fourth quarter of 2018 were $65.1 million compared to $74.8 million in the fourth quarter of 2017. This decrease reflects lower net pricing on sales of methylphenidate hydrochloride extended-release tablets, partially offset by higher sales of venlafaxine extended-release tablets and Divigel. The decrease also reflects the resolution of disputed gross sales deductions taken by a wholesale customer which favorably impacted sales during the fourth quarter of 2017. SG&A expenses increased to $23 million in the fourth quarter of 2018 compared to $15.7 million in the fourth quarter of 2017. This increase was primarily due to an expansion of our field force during 2018, expenses associated with the launch of Osmolex ER and costs associated with the company's IPO. R&D expenses decreased to $16.3 million in the fourth quarter of 2018 compared to $24.5 million in the fourth quarter of 2017. In late 2017, we acquired the assets of RevitaLid, Inc. for $16.4 million, which was accounted for as an R&D expense. Excluding the acquisition of RevitaLid, R&D expenses increased $8.2 million during the fourth quarter of 2018 compared to the prior year period. This reflects higher clinical trial costs for arbaclofen ER and RVL-1201, together with additional headcount. Additionally, during the fourth quarter of 2018, we recognized intangible asset impairment charges of $98 million compared to no charges in the fourth quarter of 2017. Other nonoperating expenses decreased to $5.6 million in the fourth quarter of 2018 compared to $14.3 million in the fourth quarter of 2017. The decrease resulted from lower interest expense due to a refinancing transaction that was completed in December of 2017 and a prepayment of $50 million of debt during the fourth quarter of 2018. Net loss for the fourth quarter of 2018 was $105.8 million compared to net income of $1.2 million in the fourth quarter of 2017. Adjusted EBITDA for the fourth quarter of 2018 was $14.3 million compared to adjusted EBITDA of $26.5 million in the fourth quarter of 2017. For a reconciliation of adjusted EBITDA to net income or loss, please see the tables at the end of our press release. Full year 2018 financial results are as follows. Total revenues in 2018 increased to $263.7 million compared to $245.7 million in 2017. Net product sales increased to $261.4 million in 2018 compared to $237.7 million in 2017, primarily due to methylphenidate hydrochloride ER, which was approved and launched in the third quarter of 2017, and M-72, which was launched in the second quarter of 2018, offset by lower product sales from venlafaxine ER tablets in 2018. Selling, general and administrative expenses increased to $74.2 million in 2018 compared to $57 million in 2017. This increase reflects additional sales force and marketing expenses related to the launches of M-72 and Osmolex ER and costs incurred for the company's IPO. Research and development expenses increased to $48.8 million in 2018 compared to $42.7 million in 2017. Excluding the acquisition of RevitaLid, Inc., research and development expenses increased $22.5 million in 2018 largely due to the clinical trial costs of arbaclofen and RVL-1201. For 2018 and 2017, intangible asset impairment charges were $104.2 million and $73 million, respectively, reflecting the write-downs of goodwill, in-process research and development assets and other developed technology assets. Other nonoperating expenses decreased to $20.1 million in 2018 compared to $33.6 million in 2017 due to the prepayment of debt in the fourth quarter of 2018 and lower borrowing costs associated with debt refinancing, which was completed at the end of 2017. Net loss in 2018 was $109.4 million compared to net loss of $41.1 million in 2017. Adjusted EBITDA in 2018 was $95.1 million compared to adjusted EBITDA of $99.1 million in 2017. For a reconciliation of adjusted EBITDA to net loss, please see the tables at the end of our press release. As of December 31, 2018, Osmotica had cash and cash equivalents of $70.8 million and $268.6 million in debt, net of deferred financing costs. The company also had $50 million of unused borrowing capacity available under its revolving credit facility. Now I would like to turn the call over to JD, who will walk us through our recent product launches.

[James Schaub:]

Thanks, Andy. 2018 marked continued progress in the evolution of our branded business, highlighted by the launch of M-72 and Osmolex ER as well as significant growth from our women's health care portfolio, led by Divigel. Additionally, we made a number of strategic investments in support of our growing portfolio of promoted brands across key areas such as patient access, field sales and marketing. We have a lot to be excited about as we turn our attention to 2019 and remain focused on solid execution and delivering growth across the promoted brand portfolio. I will now walk through some more specific updates regarding our recent launches for M-72, our unique strength of extended-release methylphenidate for patients aged 13 to 65 with ADHD and Osmolex ER, our once daily extended-release amantadine for adult patients with Parkinson's disease and drug-induced extrapyramidal reactions. I'll begin with Osmolex ER, our most recent specialty brand launch, which we initiated field sales promotion of in January. Before we get into some of the early launch highlights, I would like to briefly reorient folks around the product opportunity and strategy. We expect Osmolex ER to be a meaningful option for a broad spectrum of adult patients diagnosed with Parkinson's disease and drug-induced extrapyramidal reactions, which are involuntary movements caused by certain medications. Moreover, we have priced Osmolex ER at $450 a month, a price point we feel represents the value proposition of the product and creates a straightforward path to ensuring robust coverage, patient access and affordability. Quickly recapping the launch readiness initiatives during the fourth quarter of 2018, we completed the onboarding and initial training of a specialty neuropsych field sales team to launch Osmolex ER. We also completed and went live with Access Osmolex, our first comprehensive patient services center to support access and affordability, and in parallel, began shipping product to our pharmacy channel partners in anticipation of our full launch in January 2019. Lastly, product availability also contributed to increased payer engagement across commercial and Medicare Part D plans. Now turning to a more recent launch update. We are encouraged by the early trends, customer feedback and progress with our payer discussions for Osmolex ER. While it is still very early days, the following data points reflect progress through the end of February, where the approximately first 6 weeks of promotion. As a reminder, currently, the channel strategy for Osmolex ER does not afford regular visibility of prescription trends, but we anticipate beginning to provide additional color around actual TRx trends as we report quarterly earnings throughout 2019 and beyond. Through February of this year, we have seen solid early adoption with approximately 62 unique prescribers enrolling 145 patients via Access Osmolex, and importantly, we are seeing this adoption across the spectrum of physician specialties, including neurology, movement disorder specialists and psychiatry as supported by our broad label indication. The key product benefits have been well received by our target audience, with increased dosing flexibility, the broad indication and price being some of the features viewed most favorably early on. Our patient support services through Access Osmolex, spanning benefits investigation, verification, reimbursement support, patient assistance program and ancillary product support, have further enhanced the acceptance and receptivity from physicians and patients thus far. We are also encouraged by the enthusiasm around our Osmolex ER sample configuration, which offers physicians the ability to initiate therapy for appropriate patients on the spot while providing the added optionality for titration as 2 of 3 dosage strengths are sampled at present and a bridge to formal coverage decisions and patient receiving their regular monthly prescription. On the payer front, we are seeing good overall coverage early through formulary exception and buyer authorization while we continue our contract and discussions with commercial and Medicare Part D plans. Looking forward, we would anticipate these plans and providers to complete formulary reviews throughout 2019. More specifically, we expect expanding commercial coverage of Osmolex ER periodically over the months to come, with Medicare Part D coverage occurring predominantly in January 2020, although several plans could make decisions to add Osmolex ER as early as July of this year. We will remain disciplined in our approach and contracting strategy and believe Osmolex ER provides a meaningful option for the appropriate patient populations. Turning now to our once-daily 72-milligram tablet of extended-release methylphenidate, or M-72, for the treatment of ADHD in adult patients aged 13 to 65. M-72 was launched in April 2018 and is promoted through our broader neuroscience sales team. We are the only provider to date of a 72-milligram single-dose strength tablet and continue to view this market as a large commercial opportunity. In 2018, we experienced solid growth, resulting in over 3,000 unique prescribers and over 9800 total prescriptions at year-end. Strong payer coverage and expanding pharmacy stocking further supported that growth as approximately 60% of commercial insured patients had initial out-of-pocket co-pays of $20 or less prior to any co-pay assistance and over 2,000 pharmacies dispensed an M-72 prescription. This foundation has positioned the product well as we move into 2019. Of note, despite the reset of deductibles and prior authorization requirements associated with the new benefit plan year, we are seeing solid monthly growth through the first two months of 2019 and expect these trends to continue throughout the remainder of the year. Now I would like to turn the call back to Brian for closing remarks.

[Brian Markison:]

Thanks, JD. And before we head to Q&A, I would like to state that we are proud of the numerous accomplishments made across the entire organization in 2018 and encouraged by the progress thus far in 2019. As evidenced by the launch of Osmolex ER in January, a successful FDA inspection of our Marietta facility this past January and the timely progress of our late-stage pipeline, Osmotica is well positioned to support its ongoing transformation from a revenue base derived from our nonpromoted and generic products to a diversified branded business. Our balance sheet and cash flow also positions us to continue exploring a broad list of external business development opportunities, further augmenting the robust organic platform we have built. Thank you for your time this afternoon, and we look forward to continuing to update the market on our progress in the near future. And with that, I'd like to turn the call over to the operator for any questions.

[Operator:]

[Operator Instructions] Our first question comes from the line of David Steinberg with Jefferies. Your line is now open.

[David Steinberg:]

Thanks very much. I had two questions. First, could you give us a little more color on your potential path forward with the arbaclofen extended-release tablets? It obviously did not demonstrate superiority as measured by the CGIC scale, but on the other hand, there's statistical - statistically significant improvement in spasticity as measured by the Ashworth score. I was just curious, do you think you have a pathway to move forward with a filing or -- given the totality of the data? Or do you think you're going to have to rerun another study or 2? And then my second question revolves around the generic Concerta market. So there've been a couple of recent launches. I guess Patriot launched in February, and ANA [ph] launched generic Concerta recently. Looks like both you and Teva have actually held on to share and actually increased market share recently at the expense of Amneal and Mylan. But given the new entrants, could you fill us in on your thoughts on current market dynamics and impact of these new entrants on pricing? Thanks.

[Brian Markison:]

Okay. Thanks, David. What we'll do is we'll start with the answer to your methylphenidate question first because I believe it's a shorter answer, and then I'll come back and field the arbaclofen question. So, JD, do you want to talk about methyl?

[James Schaub:]

Yeah. Good afternoon, David. Thanks for the question. So with methylphenidate, I think you alluded to the volume component in terms of our business and being able to maintain share as we've seen an influx of new approvals and suppliers over the last several months, in particular. And I think much of that is attributed to strong customer relationships, but also some of the transitions that have occurred with the BX-rated product. I think we've seen volumes on the BX side of the methylphenidate extended-release market early on in this year begin to transition more, and I think we've also seen some of the branded business slowly start to creep back. With that, the increased competition has put some pressure on pricing, and I think that's something that, like any generic market, we've been forced to move with, but it had not affected our volume and status as a market-leading supplier.

[Brian Markison:]

Okay. So on to the arbaclofen question, and I'd like to point out that with me is also on the call, Dr. Tina deVries, our Head of R&D, and Dr. Jacobs, our Head of Clinical Development and Medical Affairs. And obviously, there, we deepened the analysis of the trial with the data that's coming in. So I want to highlight, number one, that it's preliminary. But the path forward for arbaclofen, we feel very strongly about because, as you mentioned, the Ashworth signal was pretty clear, almost striking in this particular trial. The dose-response relationship between the 40 and 80 was also quite evident. The tolerability picture of the molecule appears very favorable with somnolence, urinary symptoms, dizziness. The classic CNS-mediated side effects that affect baclofen therapy today seem to be quite favorable with this molecule, which has been our thesis from the very beginning. The other thing that I want to point out is on the Clinical Global Impression of Change, the CGIC, while we weren't superior to placebo, we certainly saw an improvement from baseline, and I think that's quite important as well. The product has an extended-release format out of the Osmodex platform. We have numerous anecdotes of patients sleeping through the night where they couldn't before even after being exposed to prior baclofen therapy. And the other part of this that's quite interesting is we have the single largest database of trials in spasticity with this program, and we believe it's rich in the data that it's going to afford us to move forward. So what I can say for sure is that we will and - we won't be required to run another clinical trial, but we feel like we have a very strong pathway ahead, and we feel the Ashworth signal was unmistakable. And David, if you'd like to comment a little bit on that, I think I've covered it, but...

[David Jacobs:]

No, I think you covered it, Brian. Just to recapitulate, we have a good dose-response with the Ashworth signal for the 40 milligrams and the 80 milligrams dose. As Brian mentioned, this is the largest, most robust MS spasticity trial. And as you all know, the Ashworth Scale is the definitive assessment for spasticity in multiple sclerosis. So I think we feel pretty confident where we have a very clear signal of efficacy with arbaclofen in this patient population.

[Brian Markison:]

Okay. Let’s move to the next question.

[Operator:]

Our next question comes from line of David Maris with Wells Fargo. Your line is now open.

[David Maris:]

Good afternoon. Just a few questions. So from a business development standpoint, you mentioned there a robust pipeline. We've always thought of Osmotica as a bit of a blank sheet with good adjusted EBITDA, a not-too-extended balance sheet and good cash from operations. That should allow you to do bolt-on deals but also larger deals. Can you give us any color on what you're thinking about? Is it only bolt-on deals? Are you looking at other pipeline-type deals or other larger deals? And is that part of the business strategy? Or is it more just opportunistically you'll look at things as they come along? Thank you.

[Brian Markison:]

Yeah, thanks, David. Well, quite frankly, we are looking at a robust set of business development opportunities right now. We're certainly open to all shapes and sizes. We'd like to be, in our current footprint right now, which is mostly neuro, and then with RVL, we're excited that our women's health care team will be able to take that into the market when it gets approved. So we're looking at bolt-ons where we have capacity in our R&D shop right now as the 2 major programs wind down. We have commercial scale and capability that is quite flexible, and we're very proud of the team that's out in the field today. And so in terms of scale, we're certainly open. We don't want to use our stock right now, but if the right proposition were to come along, we would take a hard look at it.

[David Maris:]

Great. And just a follow-up on the R&D spending expectation for 2019, if we think about last year as being a big spend year because of the ongoing studies and the thought was that, that may be moderating this year, should we just consider that it will continue at a similar rate or maybe slightly higher than it was last year given that you may do additional work on arbaclofen?

[Brian Markison:]

I think even if we do additional work on arbaclofen, it will be lower this year than last year. We're not giving guidance, but it will definitely be lower.

[David Maris:]

Great. Thank you.

[Brian Markison:]

All right. Next question please.

[Operator:]

Our next question comes from the line of Randall Stanicky with RBC Capital Markets. Your line is now open.

[Dan Busby:]

Thanks. This is Dan Busby on for Randall. Couple of questions as well. For M-72 specifically, you talked about it a little bit, but what's the outlook there? And what do you expect in terms of the sales ramp for that product going forward? And to date, I think uptake has been rather slow but steady. Do you expect that trend to continue for the foreseeable future? Or do you have a reason to believe that sales could accelerate at some point in the future?

[Brian Markison:]

Yeah. Thanks, Dan. We're seeing a fairly steady ramp and growth in the molecule month to month, so we're pretty encouraged about that. I think at some point, it will even ramp a little quicker as it gets seated more deeply in the marketplace, but, JD, do you want to add some color to that?

[James Schaub:]

Yeah. So I think beyond the stable growth that we have seen over the first 11 months of launch now, we would expect some acceleration as we continue to go. And I think that's a function of where the field is in terms of targets and their ability to be in these offices and identify the appropriate patients for 72-milligram therapy. And the fact that we continue to believe in the opportunity, the volume of patients that are out there on high doses of methylphenidate daily, in particular, 72 milligrams and some other configuration of 2 by 36 or 54 and 18, that this is a product that we expect to not just continue to grow at a stable pace, but accelerate as well. Now what does that look like? By no means is that a doubling and a complete hockey stick of the trajectory curve, but I do think the ongoing learning’s and the relationships and the utilization of this product and comfort level, again, this market going back a handful of years now, there are a few patient sensitivities as you move from product to product even within the same molecule that, that will contribute to acceleration of the growth clip.

[Dan Busby:]

Okay. That's helpful. And then just one question for Andy. For the $98 million intangible asset impairment charge last quarter, can you just tell us which products or development programs that relates to?

[Andrew Einhorn:]

Sure. The $98 million in the last quarter includes about $86 million related to a goodwill impairment charge that we took. We also discontinued development of a generic product that we were working on that we had acquired in a previous acquisition and also a product that have been partnered that came back to us. We made the election not to commercialize that product and discontinue that product.

[Dan Busby:]

Okay. Got it. Thanks.

[Brian Markison:]

Okay. Next question please.

[Operator:]

Our next question comes from the line of Emily Field with Barclays. Your line is now open.

[Emily Field:]

Hi. Thank you. Yeah, I was just - it seems that with arbaclofen, it almost looks like the study results from 3002 and 3004 are somewhat flipped, in that I believe there wasn't much separation from the curve with placebo on the Ashworth Scale in that study, whereas the CGIC, there was a clear separation. Is there any kind of intuitive reason that you understand thus far for what may have caused that difference? And then is the extended time line just needing more time to go through the secondary endpoint analysis? And also, is there anything in the safety results that would cause you not to seek approval for both of the doses? And then just on the financials, I believe David's question was with regards to R&D run rate, but I was just curious if the - if we'll just have a similar SG&A run rate that we saw in fourth quarter to continue into 2019 on a quarterly basis?

[Brian Markison:]

Well, Emily, that was a bunch of questions. Are you in the U.K.?

[Emily Field:]

Yes.

[Brian Markison:]

Oh, I'm sorry. I can't see the screen for the queue. If I knew you're on, I would try to get to you first, so I apologize.

[Emily Field:]

It's okay.

[Brian Markison:]

Okay. So SG&A would seem to be similar to the fourth quarter of 2018, give or take a little bit. So again, we're not giving guidance, but...

[Andrew Einhorn:]

We've now put in place the sales force for Osmolex. We have public company costs and other marketing programs. We don't anticipate - we anticipate that, that would probably be a very similar runway - run rate.

[Brian Markison:]

All right. And then on arbaclofen, 3002, arbaclofen met both coprimary endpoints, the CGIC and the Ashworth, and, in fact, baclofen did not meet statistical significance in that trial on the CGIC versus placebo. Here, we have a very similar - in 3004, in the new study, we have a very similar Ashworth effect, 40-milligram, 80-milligram, both showing efficacy, both meeting the prespecified hierarchy that we set out for it. And what we're seeing with CGIC is what's been commonly described as a study effect, where patients coming in to the trial, even if they're all placebo, with such a difficult disease often respond to anything, particularly the attention that's paid to them in the trial and the hope of being on something that's really going to help them. And I think, David, if you want to elaborate on that. But before you do, Emily, did I get your - all the questions on arbaclofen correct? Or did I miss a question?

[Emily Field:]

No. And then the only other question – the follow-ups that I had was just, I'm assuming the extended time line is just needing to go through the secondary endpoint analysis given that you don't believe you'll need any incremental studies. And then just that there were no signals that would cause you not to seek approval of both doses.

[Brian Markison:]

No, I think on the latter part of the question, we're going for both, we're going to go for both doses. We did have a higher dropout rate on the 80-milligram. And we did see, as you would expect, an increase in adverse events relative to the 40-milligram. But for all of the subjects on the 80-milligram that completed, again, they had a significant benefit on the Ashworth Scale, and they did improve in their own baseline on the CGIC, so we're encouraged by that. And I think on the secondary endpoints, we're awash in preliminary data, and we haven't really gotten that far yet. And the reason that we're disclosing so early upon preliminary review is because we have the K deadline, and we don't believe that the CGIC value was going to change materially. So we decided that we would let everybody know as soon as we could. So David, do you want to add a little bit to that?

[David Jacobs:]

Yeah, I just wanted to add one more point with regards to the 80-milligram dose insofar that was not studied in the 3002 study. And I think we're assured insofar that we didn't see any new - or we didn't have any new concerns with regards to the qualitative adverse events that we're seeing with the 80-milligram dose. So nothing prohibitive along those lines.

[Emily Field:]

Okay. Thank you very much.

[Operator:]

And I'm showing no further questions in queue at this time. And that will conclude today's question-and-answer session. Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone, have a great day.