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Edited Transcript of SBBP earnings conference call or presentation 6-May-20 12:30pm GMT

·24 min read

Q1 2020 Strongbridge Biopharma plc Earnings Call TREVOSE May 15, 2020 (Thomson StreetEvents) -- Edited Transcript of Strongbridge Biopharma plc earnings conference call or presentation Wednesday, May 6, 2020 at 12:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Fredric Cohen Strongbridge Biopharma plc - Chief Medical Officer * John H. Johnson Strongbridge Biopharma plc - Executive Chairman * Robert Matthew Lutz Strongbridge Biopharma plc - CFO ================================================================================ Conference Call Participants ================================================================================ * Jiale Song Jefferies LLC, Research Division - Equity Associate * Jonathan Patrick Wolleben JMP Securities LLC, Research Division - Associate * Justin Alexander Kim Oppenheimer & Co. Inc., Research Division - Associate * Lindsay Rocco;Elixir Health Public Relations;Co-Founder and Managing Partner ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good day, ladies and gentlemen. And welcome to Strongbridge Biopharma's First Quarter 2020 Earnings Conference Call. (Operator Instructions) As a reminder, today's conference call is being recorded. Now, I would like to turn the conference over to your host, Lindsay Rocco of Elixir Health Public Relations. -------------------------------------------------------------------------------- Lindsay Rocco;Elixir Health Public Relations;Co-Founder and Managing Partner, [2] -------------------------------------------------------------------------------- Thank you. And good morning, everyone. We are pleased that you could join us for Strongbridge Biopharma's first quarter 2020 earnings conference call. Joining me from Strongbridge, this morning, are John Johnson, Executive Chairman; Dr. Fred Cohen, Chief Medical 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. I will now turn the call over to John Johnson. -------------------------------------------------------------------------------- John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [3] -------------------------------------------------------------------------------- Thanks, Lindsay. Good morning, everyone. And thank you for joining today. To begin, I would like to extend our organization's gratitude to the healthcare professionals and first responders, who are bravely serving on the front lines, at such an unprecedented and challenging time. Our collective thoughts are also with the individuals and their loved ones who have been directly impacted by the COVID-19 global pandemic. This pandemic has also posed many challenges in ensuring the continuum of care for many people living with chronic conditions including rare disease. Our team has been working tirelessly, over the last several weeks, to ensure minimal disruptions for the patient and physician communities that we serve. Importantly, we are pleased to have an unaffected supply chain of our medicines, and we do not anticipate any shortages due to the global pandemic. The team's dedicated efforts; guided by the impressive leadership of Fred Cohen, our Chief Medical Officer; most notably extends the supporting our Phase III LOGICS study, which has continued to progress on track despite having sites in highly affected areas. This is in large part due to the ingenuity and commitment of the many stakeholders involved. Today, we were delighted to announce that 41 of 42 targeted study participants have completed the randomized withdrawal phase of the Phase III LOGICS study. There is 1 additional patient currently in a randomized withdrawal phase and 1 other patient scheduled to be randomized imminently. Enrollment will close on or before May 14th. We are incredibly pleased to reach this important milestone in our clinical development program for RECORLEV; a therapeutic candidate, which, if approved, we believe has the potential to play an important role in the treatment of endogenous Cushing's syndrome, given that the unmet medical needs remain very high for this rare endocrine disorder. The company continues to anticipate reporting top line results from LOGICS during the third quarter of 2020 barring any unanticipated impact due to the COVID-19. Shortly, Fred will speak to the key actions we have undertaken to maintain this timeline. Turning to KEVEYIS. We had an excellent start to this year. For the first quarter, the company achieved revenue of $6.7 million, a 54% increase compared to the $4.3 million during the first quarter of 2019. The strong revenue results can be attributed to a steady flow of new patient starts until the impact of COVID-19 started, and to improved patient retention and adherence rates, which continued into the pandemic. In fact, the number of patients taking KEVEYIS was at an all-time high at the end of March, and the strong performance for KEVEYIS' revenues continued for April during which we achieved the highest month of revenue in KEVEYIS' history. It is worth noting that the revenue performance of KEVEYIS through April 2020 does not appear to be due patients refilling prescriptions early or to increase in patients days of supply of KEVEYIS due to concerns of -- regarding COVID-19. But rather due to the [appointments] and improved patient retention and adherence rates. However, during the past 6 to 8 weeks, since the stay at home orders were implemented in most states, we have been experiencing a reduction in new patient starts, which we believe can be attributed to the limitation in our fields of -- team's ability to meet in person with prescribers, a reduction in patient visits with doctors, and patient reluctance to try new medicines. The company's field based team is currently working from their homes and employing virtual tactics to interact with the medical community. We do not believe this interim solution for interactions with our customers will be as effective as in-person contact for generating new patient starts. And we cannot predict, with certainty, when field based activity and in-person patient, doctor interactions will resume. This may ultimately affect our sales in the future. Due to the uncertainty surrounding the duration and potential business impact of COVID-19; today, we announced that we are adjusting KEVEYIS' revenue guidance from $26 million to $27 million to $22 million to $26 million. We believe the strong sales performance through April highlights the resiliency of our business, even during the most difficult operational conditions. This resiliency, combined with outstanding expense reductions, will allow us to sustain our cash runway and our ability to fund operations through the third quarter of 2021. Rob will review details related to company's financial position later on in the call. Before I turn the call over to Fred, I would like to thank the Strongbridge team for their continued work during these challenging times as we plan for and execute upon a number of important milestones this year. And with that, I will now turn the call over to Fred. -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [4] -------------------------------------------------------------------------------- Thank you, John. Before turning to the specifics related to the progress of our RECORLEV clinical development program. I would like to thank all the stakeholders who have been integral in our ability to keep the Phase III LOGICS and OPTICS studies going, despite the growing pandemic. Our employees, the study participants, and research staff, our contract research organizations, and our vendor partners have been working together during this global health crisis to mitigate the impact to our research and development efforts. While many other organizations have had to delay or stop their clinical programs altogether, we have been fortunate that innovative measures have allowed us to continue to make progress in the LOGICS trial. Specifically, in partnership with our clinical trial sites, measures such as home health visits, special transportation arrangements, telemedicine, direct to patient drug supply, delivery, and regulatory authority sanctions, protocol and monitoring flexibility are proving to be instrumental in helping investigators and study participants safely complete the required visits for the study. As John mentioned, we are excited to be closing enrollment in the Phase III LOGICS study on or before May 14. Please recall that LOGICS is a double-blind, placebo controlled, randomized withdrawal study comprised of 4 phases, screening, titration maintenance, randomized withdrawal, and restoration. The primary endpoint comes at the end of the randomized withdrawal phase. Our top line results will consist of data through the end of this phase. As of today, the LOGICS study has 41 of 42 study participants who have completed the primary endpoint. There is 1 additional patient currently in the randomized withdrawal phase progressing towards completion. And 1 other patient scheduled to be randomized imminently. In the event that the final patient awaiting randomization is not able to be randomized on or before May 14, due to logistical or other issues, enrollment will close by that date. Recall that the LOGICS protocol allows for a range in the targeted participants sample size for enrollment. This range is dependent on the observed rate of discontinuations in randomized withdrawal, which determines the number of primary endpoint completers. The protocol targets approximately 42 primary endpoint completers, providing approximately 99% power to detect a loss of therapeutic response rate of 17% in the levoketoconazole arm and 78% in the placebo arm versus the null hypothesis. Dropout rates in the randomized withdrawal phase have been much lower than originally expected. Therefore, while we have been targeting approximately 46 to up to 54 subjects for enrollment to achieve at least 42 completers, as of today, we have enrolled 43 subjects and already have 41 completers. As I mentioned earlier, we have 1 patient in the titration maintenance phase, who we anticipate randomizing imminently. As such, while we close enrollment on before May 14, we expect to have as many as 44 subjects enrolled, and up to 43 completers, if neither of the patients discontinue prior to reaching their primary endpoint visit. Barring any unanticipated impact due to the COVID-19 pandemic, the company continues to anticipate reporting top line results in the LOGICS study during the third quarter of 2020. As it relates to an NDA submission, we continue to believe that we can submit an NDA approximately 6 months after receiving top line LOGICS results and reporting them. As stated previously, we believe that if our NDA is accepted for review, we can expect a review cycle of 10 months from the date of submission, which is the standard PDUFA cycle time for review of a new active substance via the 505(b)(2) NDA pathway, barring any unanticipated FDA modifications due to the COVID-19 pandemic. In closing, I would like to thank the meeting organizers at the Society for Endocrinology, the American Association of Clinical Endocrinologists, and the European Congress of Endocrinology for their commitments to finding virtual solutions to enable important scientific exchanges absent their annual congresses. Strongbridge has had 3 submissions accepted at these upcoming meetings. First, a LOGICS study design and methodology poster will be published in the April-May supplemental issue of the Journal of the Endocrine Society in lieu of an in-person endo annual meeting. Second, results from the extended evaluation phase of the Phase III SONICS study, delivered as an oral presentation by Dr. Maria Fleseriu will be recorded and published on AACE's learning management system in May. And finally, an additional presentation of the extended evaluation phase results from SONICS was accepted by the ECE for publication in Endocrine Abstracts 2020, and for virtual presentation at a to-be determined date later in the year. And with that, I will turn the call over to Rob Lutz, our CFO, who will review financial highlights from the first quarter before we open the call up to questions. Rob? -------------------------------------------------------------------------------- Robert Matthew Lutz, Strongbridge Biopharma plc - CFO [5] -------------------------------------------------------------------------------- Thank you, Fred. Our press release contained details of our financial results from the first quarter of 2010. Rather than read through all of these details, my comments today will provide some context on our cash spend and runway. Despite the reduction in guidance for KEVEYIS revenue, the company continues to expect that it can fund operations through the third quarter of 2021 for at least 1 year following the anticipated receipt of LOGICS top line results. The reduction in force we implemented during Q4 of 2019 combined with current and future spending discipline enable us to maintain financial flexibility to meet our runway goal. Strongbridge had approximately $63 million in cash, cash equivalents and marketable securities and no debt outstanding as of March 31, 2020. Our cash burn in Q1 2020 of [$15] million was higher than the $2 million burn we had in Q4 2019. The increase was primarily due to cash outflows in Q1 2020 for severance payments and growth in working capital. Also, in Q4 of 2019, we benefited from the $6 million cash settlement with Novo Nordisk, which reduced our burn. As we've indicated, cash burn can be uneven. Going forward, we expect cash burn per quarter to be slightly higher than the average of our last 2 quarters initially and to generally moderate throughout 2020 and 2021 as we complete the LOGICS trial. And operator, with that, we are ready for questions. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) And our first question comes from the line of Justin Kim with Oppenheimer. -------------------------------------------------------------------------------- Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [2] -------------------------------------------------------------------------------- Just a few from me, on the update for KEVEYIS guidance due to COVID-19, could you share any thoughts on seasonality or color around that guidance? Do you expect those uncertainties and impact to be more strongly felt in 2Q rather than other periods? -------------------------------------------------------------------------------- John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [3] -------------------------------------------------------------------------------- Thanks for the question. First off, let me say we were really pleased with the exceptional performance of the team in the first quarter and in particular the 54% year-over-year growth. Our adherence rates have been really strong; our discontinue rates, very, very strong. And we feel really good about our business overall. What is important to remember about KEVEYIS, is that a lot of those patients are treated locally. Most patients in fact -- and there is not a center of excellence that they tend to go to. And so it requires reach out to a lot more physicians to familiarize them as each patient begins to get enrolled. And so, for us -- we've seen a drop in the new patient starts due to the face-to-face interactions. So, it's not so much seasonality. In fact, we would be having probably a different kind of discussion around guidance, but for COVID-19. We've taken a conservative view here. We're not sure when the field team will be back in. The rollout, we would expect, would be geographic, based on state and local regulations, along with when physicians in a given region might be open to see reps. So the good news is, our core business is strong, our patient adherence and discontinue rates are very, very strong; the best we've ever seen. And so, for us, we're fortunate to have that, there will be positive contribution margin from KEVEYIS this year. So, we will be making money on just those aspects that we invest in as it relates to KEVEYIS. Even with our adjusted guidance, we expect year-over-year growth. It is very hard for us to predict how the new patient starts may come in, which is why you have a wider range. And why we chose to be a little bit more conservative at this point, and then lower our guidance. -------------------------------------------------------------------------------- Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [4] -------------------------------------------------------------------------------- Maybe then, on LOGICS spread. Just wondering if you had any discussion with the regulators on some of the secondary endpoint benefits observed in SONICS and how the design of LOGICS might be able to or not be able to explore those points? -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [5] -------------------------------------------------------------------------------- Yes. So, I'm not going to get into specifics of our FDA interactions. What I will say is a couple of things. Number one, if you look at some recent FDA approvals by this division. Particularly, have a look at Isturisa label, which is the latest approval in Cushing syndrome, you'll see some mention of secondary endpoints in the clinical study section. And that has been seen with some prior labels as well, so I'll leave that -- I'll leave you to interpret what that might mean. I will say that in the LOGICS study, and this will be detailed in our poster for endo. We are studying secondary endpoints that we thought could react in a timeframe consistent with the length of the randomized withdrawal phase of the LOGICS study, which is the double-blind, placebo-controlled portion; which, as you may recall, is nominally 8 weeks long. And so, you're looking for sort of fast reacting endpoints things like glucose, body weight to some extent. And so, we're looking at those secondary endpoints. And certainly, if they can hit within that 8 week time frame to show a reversal, when switching to placebo that would be a nice confirmation of those benefits that we saw in the open label SONICS study. And so, we will be reporting with the top line results on some of the endpoints as well. -------------------------------------------------------------------------------- Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [6] -------------------------------------------------------------------------------- And maybe just the last point on some of the [pair] work that's being done. Do you have any color around what constitutes sort of failure and tolerance and some of the step edits that are placed on the currently available branded products, and how that may or may not change with Isturisa's commercialization. -------------------------------------------------------------------------------- John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [7] -------------------------------------------------------------------------------- Fred, do you want to take that? -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [8] -------------------------------------------------------------------------------- Step edits, in terms of Isturisa. Well, at this point, I don't think we have enough color into what these step edits are going to look like for access to Isturisa because it hasn't been launched yet in the United States, I think. And maybe Rob can speak to this more. But in terms of what we've seen for the other commercial products in the United States, for the most part, step edits are not a major feature of accessing those commercial products. Typically, what's needed is attestation that another product has been tried and failed in some cases. And in some cases there is no such attestation needed. So, we'll have to see what Isturisa's step edits look like, once that gets established in the U.S. market. Rob, I don't know if you have any update to add on to that? -------------------------------------------------------------------------------- Robert Matthew Lutz, Strongbridge Biopharma plc - CFO [9] -------------------------------------------------------------------------------- No, no, well said Fred. I think that covers it. -------------------------------------------------------------------------------- Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [10] -------------------------------------------------------------------------------- That's really it for me, and I'll hop back in the queue, thanks. -------------------------------------------------------------------------------- Operator [11] -------------------------------------------------------------------------------- And our next question comes from the line of Roger Song with Jefferies. -------------------------------------------------------------------------------- Jiale Song, Jefferies LLC, Research Division - Equity Associate [12] -------------------------------------------------------------------------------- Congrats on the strong Q for KEVEYIS and the close enrolment -- and close to the enrolment completion for LOGICS. So maybe, just a few quick ones from me. So, first I think Fred, you mentioned since the dropout rate is lower than expected, I am just curious, do you have any color on to what might drive this lower, kind of, dropout rates like lower [AE] or et cetera? -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [13] -------------------------------------------------------------------------------- Sure. So just as a reminder, we took a pretty conservative approach, when determining the expected dropout rate and the sample size targets, to ensure that we would have enough flexibility to remove more patients if we needed to, because we definitely wanted to make sure that we had an adequate number of completers, having targeted 42 completers. So, the fact that we didn't need to enroll for any -- bring many more patients above the targeted completed number is very welcome news. And currently, the most important factor that led to the low dropout rate, at least lower than expected, was our decision to provide for early rescue therapy in randomized withdrawal as soon as it was considered to be needed, and confirmed to be needed by bio-chemical markers and other markers, the physical signs and symptoms of the disease returning. So, the use of that rescue therapy provided some reassurances to patients and the physician investigators who are caring for them, that it would not be necessary to leave the study, should the disease signs and symptoms recur during the treatment in the blinded, randomizing withdrawal phase. The other key factor, I think, is that all the subjects who entered into the randomized withdrawal phase had already experienced at least 14 weeks of therapy, and they all had achieved a tolerated therapeutic dose. And so now, looking back on the SONICS results, we know that once you've achieved a therapeutic dose and have been on the drug for some time, such as 3 to 4 months that the incidents of adverse events that lead to discontinuation diminishes over time. So I think, if we had wanted to be less conservative, we could have bargained for lower dropout rate, but as it was we are very pleased with what we saw. -------------------------------------------------------------------------------- Jiale Song, Jefferies LLC, Research Division - Equity Associate [14] -------------------------------------------------------------------------------- Maybe just a quick follow-on question for that. So, regarding the early use kind of rescue med, so just can you kind of remind us how you are going to kind of accommodate to the primary endpoint analysis for those kind of patients use the rescue med? -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [15] -------------------------------------------------------------------------------- Yes. So, anyone who takes a rescue medication by virtue is having met the criteria for early rescue is considered having loss response in the primary endpoint. So, they will be counted in the column of loss of response. Now, what that may mean is that we will have some patients who have active therapeutic losing response. And we did account for that in our study power. In other words, losing response even if it's maybe just a transient. And then we do expect a very high proportion of the placebo switch patients to lose response and need early rescue. -------------------------------------------------------------------------------- Jiale Song, Jefferies LLC, Research Division - Equity Associate [16] -------------------------------------------------------------------------------- Got it, yes. So, many of those patients are from the placebo arm. Okay, got it. Okay. And then the -- so for the NDA submission you guided a 6 month after the top line data and that you -- can you kind of remind us what else needs to be done besides the LOGICS data -- -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [17] -------------------------------------------------------------------------------- So, I think what we said before is that the LOGICS study is really the rate-limitimg step for an NDA submission. So, preparing the LOGICS study results in a format suitable for submission. And to some extent integrating those results with results from prior studies is going to be the really the rate-limiting step to filing a submission. -------------------------------------------------------------------------------- Jiale Song, Jefferies LLC, Research Division - Equity Associate [18] -------------------------------------------------------------------------------- And maybe just a last quick one. So, we know you have been kind of contemplating the lifecycle management strategy for KEVEYIS, so just any kind of evolving thinking along that and the way we're going to see that kind of come up? -------------------------------------------------------------------------------- John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [19] -------------------------------------------------------------------------------- Yes, so I think what we talked about, on the last call, is that we have filed 14 patent applications in the United States around KEVEYIS and as well as 3 PCT global patent applications. All but 2 of those belong to 4 primary families of patents and all of these relate to the current product labeling for KEVEYIS. So, we continue to prosecute and advance these patent applications with the respective offices. And we expect to give an update in the second half of this year on our progress there. In addition, we've continued to advance the modified release formulation of KEVEYIS that we talked about in our last call. We're not prepared today to discuss any results from that, but we're pleased with progress. -------------------------------------------------------------------------------- Operator [20] -------------------------------------------------------------------------------- (Operator Instructions). Our next question comes from the line of Liisa Bayko with JMP Securities. -------------------------------------------------------------------------------- Jonathan Patrick Wolleben, JMP Securities LLC, Research Division - Associate [21] -------------------------------------------------------------------------------- This is Jon on for Liisa. Thanks for taking the questions. Just one on kind of your market research. Are you including Isturisa's profile when you, kind of, talked to that comparison. I guess, can you kind of give us your thoughts on RECORLEV is shaping up compared to Isturisa? -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [22] -------------------------------------------------------------------------------- Sure. Yes, we did include their profile in the market research we did. So, all of the data that Scott discussed on the last call was, in fact, included when we did the market research with physicians. And so, we're not going to get into the specifics about how we stack up, or our strategy, but to say that we're very comfortable with the fact that there will be good acceptance for RECORLEV. It certainly has a place. And I think the important thing to keep in mind is that of the 8,000 patients that are treated today by the use of these medicines by prescription, about 3,800 are not well satisfied and not well controlled. And so, there remains strong unmet need that we believe that we'll continue to see that when RECORLEV was -- if approved, hits the market. But the direct answer to your question is, yes, in all of our market research we included their profile. -------------------------------------------------------------------------------- Jonathan Patrick Wolleben, JMP Securities LLC, Research Division - Associate [23] -------------------------------------------------------------------------------- And Fred can you remind us how often patients are being measured per urinary free cortisol during the randomized withdrawal? And I heard you talk about kind of your expectations for loss response, can you just go over that one more time? -------------------------------------------------------------------------------- Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [24] -------------------------------------------------------------------------------- Yes. So, I think what I mentioned in the call script was the original powering assumptions for the study. And just to remind you what those were, that we were targeting approximately 42 primary endpoint completers, which would provide approximately 99% power to detect a loss of therapeutic response rate of 17% in the levoketoconazole arm and 78% in the placebo arm versus the null hypothesis. We are looking frequently at those UFC as well as late-night salivary cortisol. UFC is the primary determinant of the loss of response in the -- for the primary end-point. And the interval is approximately 10 days -- every 10 days during the randomized withdrawal period. -------------------------------------------------------------------------------- Jonathan Patrick Wolleben, JMP Securities LLC, Research Division - Associate [25] -------------------------------------------------------------------------------- And just one last book keeping. What was gross to net for the quarter for KEVEYIS? And then what are your expectations for the year? -------------------------------------------------------------------------------- Robert Matthew Lutz, Strongbridge Biopharma plc - CFO [26] -------------------------------------------------------------------------------- Yes, so the gross to net was in the 25% range for the quarter. And that Q1 gross to net is usually higher than the rest of the year. So, we always expected to moderate it. In Q1 we see patients starting up again with their insurance plans. So it can be at higher deductibles and co-pays and the things that affects some of our gross to nets. And so, we typically see it higher. And so, we expect it to moderate down back to our usual, which is more like low 20s, if you will. -------------------------------------------------------------------------------- Operator [27] -------------------------------------------------------------------------------- I would now like to turn the call back over to Executive Chairman John Johnson for closing remarks. -------------------------------------------------------------------------------- John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [28] -------------------------------------------------------------------------------- In closing, on behalf of the organization, I would also like to thank the biotech and pharmaceutical companies working towards developing COVID-19 vaccines and treatments, for their efforts in responding to this global health emergency. This is a unique opportunity for our industry to demonstrate the incredible value that scientific rigor and talent can create for the global health community. Through transparency, collaboration and compassion, I believe that we can mitigate the impact that this virus poses in the near term and ultimately eliminate its threat in the future. In the meantime, as the situation continues to evolve, our primary focus will remain on the health and safety of our employees and the patient and physician communities that we serve. This is a challenging time in so many ways, but I've been truly humbled by the spirit in which our nation and communities have come together to support one another. Strongbridge has committed to supporting national COVID-19 relief efforts including making a charitable contribution to the American Nurses Association COVID-19 Response Fund. We know there is a long road ahead and we will continue to help one another during this unprecedented time. Thank you again for joining today's call and for your continued support as we prepare for a number of key milestones in the coming terms and the coming months. Thank you.