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Edited Transcript of SBBP earnings conference call or presentation 7-Nov-19 1:30pm GMT

Q3 2019 Strongbridge Biopharma plc Earnings Call

TREVOSE Nov 17, 2019 (Thomson StreetEvents) -- Edited Transcript of Strongbridge Biopharma plc earnings conference call or presentation Thursday, November 7, 2019 at 1:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Fredric Cohen

Strongbridge Biopharma plc - Chief Medical Officer

* John H. Johnson

Strongbridge Biopharma plc - Executive Chairman

* Robert Matthew Lutz

Strongbridge Biopharma plc - CFO

* Scott L. Wilhoit

Strongbridge Biopharma plc - Chief Commercial Officer

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Conference Call Participants

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* Annabel Eva Samimy

Stifel, Nicolaus & Company, Incorporated, Research Division - MD

* 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

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Presentation

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Lindsay Rocco, [1]

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Thank you, and good morning, everyone. We are pleased that you could join us today for Strongbridge Biopharma's Third Quarter 2019 Earnings Conference Call. Joining me from Strongbridge this morning are John Johnson, Executive Chairman; Scott Wilhoit, Chief Commercial Officer; 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.

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John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [2]

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Thanks, Lindsay. Good morning, everyone, and thank you for joining us today.

For today's call, I would first like to begin by welcoming Rob Lutz to his first quarterly earnings call, following his promotion to Chief Financial Officer in September. As many of you know, Rob has been a key leader at Strongbridge for the past several years, driving our product acquisition strategy in his previous role as Chief Business Officer. We also announced this quarter the appointment of Rich Kollender, who previously served on the company's Board of Directors, to the newly created role of Chief Operating Officer.

Additionally, on Tuesday, we announced that Matthew Pauls has stepped down as President, Chief Executive Officer and Director. Both he and the Board have mutually agreed that now is the right time to transition leadership of the company. The Board is actively seeking to hire a new CEO who will be able to take the organization to the next level for patients, health care providers, employees and our investors. In the interim, I'm stepping in to help lead the organization, while the Board conducts a formal search. On behalf of the Board of Directors, I would like to thank Matt for his many contributions to the company over the years, and we wish him well in his future endeavors.

I have served as Chairman of Strongbridge since 2015, and my confidence in the company's vision and ability to deliver better results for patients living with rare diseases remains unchanged. My 3 initial priorities are first to identify a new Chief Executive Officer; second, ensure a high quality new drug application submission for RECORLEV; and third, improve the company's financial performance through cost-saving initiatives and growing KEVEYIS sales. KEVEYIS, our first commercial product, has performed well thus far in 2019, thanks to this team's dedication to serving the many unmet needs of the Primary Periodic Paralysis community. KEVEYIS achieved $5.7 million in revenue in the third quarter of 2019. Representing a 36% quarter-over-quarter increase from $4.2 million in net revenue for the third quarter of 2018. The company is on track to meet or exceed the top end of our full year KEVEYIS revenue guidance of $18 million to $20 million. Additionally, KEVEYIS reached an important milestone this quarter by turning contribution margin positive. We believe that KEVEYIS will continue to generate cash for the company moving forward, given the ability to leverage the associated operational expenses and anticipated future growth.

With regard to our clinical development program for RECORLEV in endogenous Cushing's syndrome, on Tuesday, we announced that enrollment in our Phase III LOGICS trial is approximately 2/3 complete. The company projects that based on current observations all the patients required to complete enrollment have been identified with most moving through titration and maintenance phases, and of course, the remainder in screening. With that said, we also announced a delay in reporting top line results from the end of the first quarter of 2020 to the second or third quarter of 2020. What I would like to underscore here is that we're doing everything we can to get this important product to patients. And to do so, we need to get it done right so that we submit an NDA that gives us the best chance to get this medicine to Cushing's syndrome patients. Once completed, LOGICS will provide double-blind, randomized, placebo-controlled data, making our clinical development program for RECORLEV among the most comprehensive to date in endogenous Cushing's syndrome. Later on the call, Fred will provide some detail around the reason for this delay and why the rate of enrollment and time to top line results for LOGICS has been more difficult to predict than with our prior Phase III study, SONICS.

Before I turn the call over to Scott for a brief commercial update, I would like to discuss our recent agreement in principle that we have reached with Novo Nordisk. This agreement pertains to the transaction we entered into with Novo Nordisk in December 2018 for the use and funding of Strongbridge's 23% field team to promote MACRILEN in the U.S. for up to 3 years. Today, we announced that we have reached an agreement in principle to terminate this agreement effective December 1, 2019. Novo Nordisk will pay Strongbridge $6 million in connection with such termination. Given that we are no longer supporting Novo Nordisk endocrine business, we have decided to eliminate approximately 23 Strongbridge field-based positions responsible for the MACRILEN sales efforts effective December 1, 2019. While eliminating positions is unfortunate and never an easy decision, this is a necessary step for the company at this time in order to reduce costs and further extend our cash runway. We greatly appreciate the commitment and the efforts of our MACRILEN field team. These actions are in no way a reflection of their dedication and hard work.

With that, I will turn the call over to Scott.

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Scott L. Wilhoit, Strongbridge Biopharma plc - Chief Commercial Officer [3]

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Thank you, John. Good morning, everyone, and thanks for joining us. As John mentioned, we are pleased with KEVEYIS' performance in the third quarter and thus far in 2019. As discussed on our last earnings call, we believe that a few key refinements to the overall commercial model that were implemented early this year have contributed to a steady flow of referrals from physicians that resulted in new patient starts and improved retention rates across our entire active base of patients. These ongoing refinements positively impacted this quarter's performance. I would like to spend a few minutes highlighting an important example of our commitment to serving patients, caregivers and health care providers who are part of -- who are part of or served Primary Periodic Paralysis or PPP community that extends beyond the provision of KEVEYIS. Strongbridge is proud to have been the leading sponsor of the 2019 Periodic Paralysis Association Conference, which took place October 25 to the 27 in Orlando, Florida. Every year, this event brings together many PPP stakeholders, including patients, their caregivers and physicians and is aimed at facilitating awareness, education and comradery among this tight-knit community. This year, for the first time, Strongbridge hosted an event with approximately 60 attendees, predominantly patients focused on the power of and importance of advocacy, education and support. The program featured 4 Strongbridge patient ambassadors to pick their caregivers who shared their journeys, living with and managing PPP. Additionally, Dr. Carlayne Jackson; and Dr. Jeffrey Rosenfeld, neurologists who currently treat PPP patients, were featured keynote speakers. We are delighted to be working closely with the Periodic Paralysis Association and look forward to further collaborating with them as we continue to support this underserved population with KEVEYIS.

Before I turn the call over to Fred who will provide key updates around the clinical program for RECORLEV, I want to reiterate and emphasize that the overall commercial model and infrastructure that Strongbridge has built can be successfully leveraged across multiple rare disease franchises and markets. I do so because it has high relevance to the commercial potential for RECORLEV. We have established relationships with key Cushing's advocacy groups and a fully operational care connection patient services team that is well positioned to handle multiple products. We remain enthusiastic regarding the commercial potential for RECORLEV. Based on our initial market assessment, we know that Cushing's syndrome market is validated with -- by a significant unmet need, physician and patient demand is high for new and innovative products in this area and the product profile for RECORLEV resonates well with the endocrinologist community. Finally, RECORLEV will have the benefit of an established pathway for pricing and reimbursement within the brand new Cushing's syndrome therapeutic area.

With that, I will now turn the call over to Fred.

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Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [4]

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Thank you, Scott. This morning, we provided an update on the LOGICS Phase III study of RECORLEV for the treatment of endogenous Cushing's syndrome. As a reminder, LOGICS is a double-blind, placebo-controlled, randomized withdrawal study targeting approximately 46 to 54 subjects for enrollment that is intended to assess the efficacy and safety of RECORLEV. The primary endpoint is the proportion of subjects with a loss of therapeutic response to RECORLEV upon withdrawing to placebo compared with the proportion of subjects with a loss of therapeutic response upon continuing treatment with RECORLEV. As designed, we have conservatively powered this study. Reflecting this, we project that a minimum 35% difference in the loss of response proportions between the active and placebo groups, will lead to a statistically significant inference.

Although we have made progress towards completing LOGICS we now project that we will report top line results for the study in the second or third quarter of 2020, a delay from our most recent projection of top line results by the end of the first quarter of 2020. I would like to take a few moments to provide some context around the reasons for the delay and explain why the projection for the time it will take to receive top line results spans 2 quarters. We naturally based our earlier projections for LOGICS enrollment largely on the completed SONICS study as our prior Phase III study had nearly identical entry criteria as LOGICS and employed many of the same investigator sites in the United States and Europe. Furthermore, we learned much from the SONICS experience that was anticipated to positively impact LOGICS enrollment, such as how to provide optimal concierge-level patient support services and investigator site support to remove barriers to enrollment. However, as we have learned more about LOGICS with time, particularly over the past 9 months or so, we have come to appreciate how fundamental differences between SONICS and LOGICS in terms of design and procedural intensity have translated into differences in the willingness of potential participants to sign on to and remain in LOGICS. To be specific, we now believe that the use of a placebo comparison in LOGICS, which did not exist in SONICS, is a prospect that some otherwise willing participants cannot bear even though immediate open-label rescue therapy is available should symptoms of Cushing's syndrome recur. As for the intensity of LOGICS, there are twice as many visits and procedures in LOGICS as in SONICS per unit of time. And this also appears to be taking a toll on enrollment speed. Taken together, these factors have caused us to revisit our time to complete enrollment.

I did want to comment on the fairly large window of time that we are allowing for reporting the top line results that spans the second and third quarters of next year. The design of LOGICS provides for variability in the time it takes the subjects complete each phase. LOGICS is comprised of 4 phases, screening plus 3 therapeutic phases. Let me walk you through those. Screening procedures are designed to determine eligibility for the trial. On average, it takes about 4 to 6 weeks to complete screening. The first therapeutic phase is an open-label titration and maintenance phase. During this phase, patients receive increasing doses of RECORLEV as needed to achieve normalization of mean urinary free cortisol or UFC and must maintain a stable dose for a minimum of 4 weeks before progressing to the next phase. The minimum time that each patient must spend in this phase is 14 weeks, and we allow for up to approximately 19 weeks for completion routinely, with additional time allowed on an exceptional basis. So there is a range extending to over 5 weeks between the shortest and longest durations in the titration maintenance phase.

Participants are then enrolled at their therapeutic dose into the randomized withdrawal phase, the study phase in which the primary endpoint is determined. In the randomized withdrawal phase, patients are randomly assigned to receive blinded study drug, which is either active drug at their established therapeutic dose or an equivalent number of matching placebo tablets. Biochemical markers, including UFC, and patient symptoms are assessed approximately every 10 days during this phase to determine if the patient is continuing to respond well to therapy or cortisol control is being lost. Patients who have documented loss of cortisol control can be rescued immediately with open-label RECORLEV and be moved directly into the final study phase, known as restoration. The need for early rescue is by protocol definition considered to be study completion for purposes of assessing the primary endpoint with the outcome assessed as a loss of response. So an early rescue can occur at or about 2 weeks into this phase. In contrast, patients who maintain their response to therapy and who do not require rescue therapy, complete all the visits and randomized withdrawal, which occurs no sooner than 8 weeks and up to approximately 9.5 weeks following the date of randomization. Therefore, whether or not a patient requires early rescue therapy determines the duration of time that a patient will require to complete the randomized withdrawal phase and represents cycle time variability of about 7 weeks or about 2 months.

Taken together, the protocol specified variability and the time required to complete both the titration maintenance and randomized withdrawal phases is approximately 12 weeks or about 3 months, accounting for the range in timing to the receipt of top line results that we are reporting today. We should be able to provide a more precise estimate of the timing of top line results once the last participant has completed the titration maintenance phase and has been randomized next year. As it relates to NDA submission, we believe we can submit an NDA approximately 6 months after the top line LOGICS results are reported. As stated previously, we believe that if our NDA is accepted for review, we can expect a review cycle time 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.

I would like to highlight 2 other updates on RECORLEV. First, at the end of October, we held a routine biannual data and safety monitoring board meeting for LOGICS, and based on their assessment of the benefits and risks of therapy, the DSMB recommended that the study continue as planned. Second, in September, the SONICS pivotal Phase III study of RECORLEV, including comprehensive results through the end of the maintenance phase, were published online in The Lancet Diabetes & Endocrinology. We are currently working on additional SONICS publications that we expect to be published in 2020.

With that, I will turn the call over to Rob Lutz, our CFO, who will review financial highlights from the third quarter before we open the call to questions. Rob?

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Robert Matthew Lutz, Strongbridge Biopharma plc - CFO [5]

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Thank you, Fred. Our press release contains details of our financial results for the third quarter of 2019. Rather than read through all those details, my comments today will provide some context on our cash spend and runway. Strongbridge ended the quarter with approximately $80 million of cash and cash equivalents and no outstanding debt versus approximately $86 million and no outstanding debt at the end of Q2, a net cash use of $6 million in the quarter. As we mentioned previously, our cash spend can vary materially quarter-to-quarter. For example, in the third quarter, our net cash used was favorably impacted by payments we received on our contract with Nova Nordisk from Q2 and Q3 services rendered and by other positive working capital changes. With approximately $80 million in cash, plus the $6 million settlement with Novo Nordisk and with the anticipated KEVEYIS sales growth and product profitability, we are updating our cash runway guidance. We now forecast we can fund operations as currently planned through at least Q2 of 2021, which is beyond the projected timing for receipt of LOGICS top line results and the anticipated submission of U.S. NDA for RECORLEV. This updated guidance is 1 quarter beyond what we projected previously.

And operator, with that, we are ready for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Annabel Samimy from Stifel.

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Annabel Eva Samimy, Stifel, Nicolaus & Company, Incorporated, Research Division - MD [2]

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So just on the enrollment of LOGICS, are you using any new tools to speed up that enrollment? And is it difficult to find patients? Or is it just that they're hesitant, especially in light of the fact that they have rescue because presumably, the responses that you're seeing in the treatment phase are pretty quick? And then also, is it a matter of communication with these patients where they don't really understand the whole rescue component of it. So just wondering if you're doing anything there or changing anything there in terms of trying to enroll these patients. And then just switching to the agreement with Novo Nordisk and removal of the sales force. Is there -- was there any thought to transitioning some sales to boost KEVEYIS until RECORLEV is available, just because there's potentially an opportunity to boost the sales? Or do you not see that opportunity right size for KEVEYIS, and there will be no need for that? And where are you on life cycle management on KEVEYIS, any development there for extending the life of the drug?

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Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [3]

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Okay. Annabel, this is Fred. Your question was about tactics we've been using to enroll the study. I think what's important to keep in mind, number one, is we believe that we have now identified all the patients necessary to complete the study. So I don't know that it's worth reviewing the enrollment tactics that we use at this point given the progress that we've made to date. And so I think -- I'll leave that there. If you have a follow-up question, I'll be happy to address that. Scott, I believe that you want to address the question about RECORLEV?

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Scott L. Wilhoit, Strongbridge Biopharma plc - Chief Commercial Officer [4]

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Yes, thanks Fred. Yes, so we -- regarding that question, we did evaluate that option among many. And it's a good question. I think given the earlier comments regarding the time line for RECORLEV as well as the need to manage our cash situation, we decided to make the decision that we've announced today.

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Annabel Eva Samimy, Stifel, Nicolaus & Company, Incorporated, Research Division - MD [5]

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Okay. Can I just follow up on that? Does that mean that you don't really have much opportunity for life extension on KEVEYIS?

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Robert Matthew Lutz, Strongbridge Biopharma plc - CFO [6]

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I can answer that. This is Rob Lutz. So we are continuing to pursue life cycle opportunities, and as we've said previously, we'll have a detailed update on that in the first half of 2020.

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Operator [7]

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Your next question comes from the line of Roger Song from Jefferies.

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Jiale Song, Jefferies LLC, Research Division - Equity Associate [8]

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So maybe a quick follow up for the enrollment. So Fred, I understand that you say you have identified all the patient necessary for LOGICS. But just curious if you see kind of an expected dropout during the titration and the maintenance phase so that you may need to kind of refine additional patients. Or is that not the case so far?

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Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [9]

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At this time, we believe we have identified all the subjects that we will need to complete the study, and that does take into account our projections based on what we've observed in terms of attrition. I'm not going to get into specifics about any observations that we've made. But we are standing by that projection.

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Jiale Song, Jefferies LLC, Research Division - Equity Associate [10]

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Sure. And one question for the -- for John, it's the -- for the Novo field force. So I understand the initial plan is that we can leverage those sale force for detailing to endocrinologists in the field. And later, we can leverage them to launch quickly for RECORLEV. Now we kind of eliminated those kind of teams. Is that possible you still can leverage their equities or relationship established later when we launch the product?

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John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [11]

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Great question. So -- into Annabel's earlier question, we feel like we have good coverage with our sales force today with KEVEYIS. So adding more folks on to that from a financial standpoint when they make sense, and we're very conscious of our burn rate. I think it's important to keep in mind, while we had to make a very difficult decision to take those folks out, we continue to have MSLs who hold the relationships with the top thought leaders in this field. Beyond that, with KEVEYIS, what it really did for Strongbridge was it helped us build a commercial infrastructure, and that infrastructure goes across patient advocacy, reimbursement, how you handle the data, how you process sales, all the things that you need to do to be prepared. So when we go into the RECORLEV launch. We will have those relationships with our thought leaders. And importantly, we have all the pieces in place to just plug RECORLEV in. In an ideal world, would I have liked to have those people calling on endocrinologists up to the launch? Of course. But given where we're at, and we've heard very clearly from our investors that we have to manage our cash. We made this difficult decision. But while it sets us back a little bit, we think, by and large, given the experience with KEVEYIS and our MSLs will be fine.

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Jiale Song, Jefferies LLC, Research Division - Equity Associate [12]

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Sure. Maybe just one last question. Can you maybe comment on Tuesday's update, I think the stock reacted pretty negatively and yesterday pulled back a little bit? And what's your view of the driver of this stock reaction in general, if you can?

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Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [13]

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Yes, I think it's difficult for us always to project. But certainly, the delay was something that we didn't anticipate and clearly concerned folks, especially as it relates to our cash runway, which is why we took the steps that we took around cash runway to help stretch that out. Getting rid of the field force as quickly as we did, reaching settlement with Novo as quickly as we did versus litigation were all parts of the strategy to overcome some of the concerns that we heard following Tuesday's announcement. What hasn't changed, though, I think is very important, and that is that RECORLEV remains a potentially very important options for patients with Cushing's syndrome. What hasn't changed is investigators' enthusiasm for the product, and we remain very bullish on the prospects for that long term. But we want it sooner, of course, but the profile continues to look to continue to get very positive feedback on it. And we were very pleased. What kind of got lost in everything was the KEVEYIS performance, which we were pleased and have it turn contribution margin positive for us, it's -- that's 6 months ahead of what we had initially planned. And so kudos to the team. While it's just marginally positive at this point, we believe that sets us up to spend more cash in a much more significant manner next year. And so we hope as the markets digest this and understand some of the steps that we've taken here in the near term, but most importantly, keep long-term in mind that we will see the thought come back.

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Operator [14]

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Your next question comes from the line of Justin Kim from Oppenheimer & Company.

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Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [15]

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Just maybe to touch on the time lines. Our math kind of puts the whole process in about 25 to 30 weeks. So if we think about sort of those numbers, does that kind of imply that you would have to have patients entering dose titration before the end of the year for Q2 readout? And maybe even for late 1Q for a 3Q readout. Is that the right way to think about it?

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Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [16]

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So again, just to reiterate, dose titration is a minimum of 14 weeks. We allow 5 weeks or so play on the long end there. And then the randomized withdrawal is up to 9.5 weeks. So you can do the math and then figure out when the last patient would need to come into randomization. We're allowing ourselves approximately 5 weeks or so from the date that the last patient has completed randomized withdrawal until the receipt of the top line results. And of course, we report those results as soon as we can sort it through them and make sure that we understand them.

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Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [17]

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Okay, that's excellent. And maybe just with respect to the trial size, the 46 to 54 patient range. Is that sort of driven by a function of just potential attrition that sort of where you might lose patients? In that number?

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Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [18]

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Yes, yes. So the attrition observations drive the target randomization. And basically, the way the trial is designed is that the holding -- we hold the power constant at 98%, which, of course, is very conservative and very high. And so we hold that constant. And then the number that are needed to go into the study to afford us the number of completers, right? So that's what drives the -- the completers' rate is what drives the ultimate sample size that we need. And that's why there's a range associated with that. Up to 54.

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Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [19]

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Okay. Okay, got it, got it. And then maybe just a last one on the P&L. With the recent MACRILEN update and management transition, could you give just maybe a little bit of color of how we should think about OpEx for the remainder of the year and whether you anticipate that the lumpiness -- or that there would be any lumpiness or that the reported results are somewhat reflective of a go-forward rate, excluding any Novo payments.

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Robert Matthew Lutz, Strongbridge Biopharma plc - CFO [20]

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Right. Good question. This is Rob Lutz. So I think like any company, we will have continued variability in our cash flow quarter-to-quarter. And so the focus is on reaching the spending runway out through Q2 of 2021. We'll see some ups and downs in that. And so we're not going to comment further on individual quarterly cash flow projections. I will point out that one of my priorities that I outlined earlier is to make sure that we're spending more efficiently. And we will be taking a very hard look at all of our costs. We are very conscious of that runway. And I think you can expect to hear more in the quarters ahead about our progress there and being good stewards of the investors' money.

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Operator [21]

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Your next question comes from the line of Liisa Bayko of JMP Securities.

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Jonathan Patrick Wolleben, JMP Securities LLC, Research Division - Associate [22]

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This is Jon on for Liisa. Just one on RECORLEV. And I know the plan was to have some synergy between the MACRILEN sales force and when we look at the Cushing's opportunity in RECORLEV, can you discuss kind of what that sales force might look like? I'm not sure if it was just going to be the 23 or some additional? When you talk about ramping up commercial for RECORLEV, how do you think about kind of the size of that force?

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Scott L. Wilhoit, Strongbridge Biopharma plc - Chief Commercial Officer [23]

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Yes, good question. This is Scott. Yes, so we haven't done any detailed planning around sales force sizing, but there are analogs in the market right now and our current 23 -- 23 that we had in place, would have given us a good foundation. So I think from a range perspective, somewhere in the 25% to 30% is probably a good starting point. We'll have to do more work around that as we get closer, but that's probably the best current thinking.

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Jonathan Patrick Wolleben, JMP Securities LLC, Research Division - Associate [24]

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And then with KEVEYIS, I remember you guys took a price increase around this time last year. I was wondering if you could discuss any kind of pricing strategy moving forward for KEVEYIS?

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Fredric Cohen, Strongbridge Biopharma plc - Chief Medical Officer [25]

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Yes. No, we're not going to comment on any potential future actions or our strategy.

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Operator [26]

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

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John H. Johnson, Strongbridge Biopharma plc - Executive Chairman [27]

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Thank you, and thanks again, everyone, for joining us.

In summary, what I would say is that Strongbridge has made significant strides towards its mission of serving the unmet needs of the rare disease patient population. We are pleased with the growth of KEVEYIS on a year-over-year basis. Sales of KEVEYIS are trending nicely, and the product has turned contribution margin positive. While LOGICS data are delayed, we are approaching the end of this critical trial. We believe that RECORLEV is a potential important treatment option for the patients. I want to thank the investigators and the patients in the LOGICS trial for helping us to deliver these important data. Finally, I want to thank our employees who continue to be extraordinarily dedicated to the patients we serve and our mission. Thank you for joining today's call and for your continued support.

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Operator [28]

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