Q1 2020 Earnings Call Transcript

Published: 9 May 2020

[Operator:]

Good afternoon everyone and welcome to Radius Health Q1 Earnings Webcast. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, this conference call is being recorded.I would now like to turn the call over to Elhan Webb, Vice President, Investor Relations at Radius Health. Elhan, please go ahead.

[Elhan Webb:]

Thank you. Hello everybody. Thanks for joining us today.Our press release and presentation that we'll use to guide our discussion today can be found in the Investors Section on our website. A replay of the call will also be available on our company website three hours following this call. Before we begin, I'd like to remind you with our Safe Harbor slide that we'll have some forward-looking statements and include non-GAAP financial measures in our presentation today. You can find the reconciliation of GAAP to non-GAAP at the end of this presentation. Our 10-Q and subsequent filings identify factors that could cause our actual results to differ materially from those indicated by these forward-looking statements. Any forward-looking statements represent our views as of today only.Here is our agenda for today's call. Jesper will start with the Q1 highlights, Jon and Sal will provide a commercial update followed by Charles reviewing our clinical programs. Lastly, Pepe will present our first quarter financial results and 2020 guidance.I'd like to now turn the call over to Jesper.

[Jesper Hoeiland:]

Thank you. Elha. Welcome everybody and thank you for joining us on the call today.In this challenging and unprecedented time, our first quarter performance reflects strong demand for TYMLOS, our continued clinical execution and the dedication of our employees. With the onset of the pandemic, we at Radius took the key measures to protect the health and safety of our employees, while also ensuring that our medicines continue to reach the patients we serve. We were caught with our manufacturing suppliers and succeeded to assure undisrupted supply of TYMLOS.Majority of our clinical sites are open and we are making every efforts to ensure that patients currently enrolled in our clinical trials are able to receive their medication and continue their treatment. While the pandemic has led to a slowdown in enrollment and conditions are fluid, we continued to advance recruitment in our three Phase 3 studies assuring enrollment levels returned to near-normal levels in the second half of the year, we are on the track to complete recruitment this year with expected data readout in the second half of next year as we guided. The fundamentals of our commercial business remained strong and our market share with TYMLOS continued to increase.In the first quarter of 2020, we achieved $48 million net sales for TYMLOS with a 61% growth year over year. However, since the start of the pandemic, there has been a decline in patients visits to physicians' offices, which led us to slightly revise down our 2020 TYMLOS revenue guidance. On a longer-term basis, we remain confident in our outlook for strong growth once the restrictions ease and the conditions return to a normalized patterns.For me personally, it has been a tremendous privilege to serve as the CEO of Radius. I very much enjoyed interacting with all of you and will greatly miss these interactions. I remain enthusiastic about Radius' prospects and look forward to working with Kelly to make this transition as seamless and effective as possible.I will now turn the call over to Joe and Sal for commercial update.

[Kelly Martin:]

Thank you, Jesper, and good afternoon, everyone.On Slide 7, you can see since the launch of TYMLOS, we have significantly increased market share within the anabolic space from an NBRx and TRx standpoint. As we continue to grow by adding new patients to TYMLOS, we are confident that this will translate to an overall anabolic market leadership position during the second half of this year, which will be an important milestone for our first commercialized product. Also as leaders in the anabolic space, we want to continue adding new to TYMLOS prescribers as we shape the market and then look to disrupt the treatment of osteoporosis with a potential introduction of our innovative abaloparatide-patch.On the next slide, I want to update you on the actions we have taken in view of COVID-19 highlighting the fact that we quickly established process seasoned systems to distribute TYMLOS samples, [indiscernible] and educational resources back in mid-March. Also, since the beginning of the pandemic, the entire field sales force has been able to support and promote to their customers virtually, based on a rapid implementation of our platform for virtual engagements, while still being sensitive to the challenges our customers and patients are facing during this time.In this current environment, we are seeing a decline in patient office visits, leading to a delay in the initiation of treatment for new patients and there are concerns related to out-of-pocket costs as unemployment rates rise. However, we do expect new patient volumes to increase again as states begin to reopen and use of our online TYMLOS savings card can help reduce out-of-pocket cost for patients. Also the benefit of TYMLOS being in at home administered product and all patients having the ability for TYMLOS to be delivered to their homes, gives us confidence that patients can safely receive and administer our product in this current environment, unlike in office administered products for the treatment of osteoporosis.Finally, because of the work that's been done by our tech ops team, we have successfully ensured uninterrupted TYMLOS inventory and supply for patients through at least December of this year.Thank you all and I will now hand it over to Sal talk about market access.

[Sal Grausso:]

Thank you, Joe, and good afternoon.As part of this commercial update, we want to take the opportunity to discuss milestones achieved during Q1 2020 that further strengthen the long-term patient access profile of TYMLOS. We continue to have strong collaborations with payers regarding TYMLOS formulary coverage. TYMLOS coverage has increased to 83% of Medicare Part D enrollees in Q1, achieving critical mass, which will further strengthen healthcare provider perception and intent to prescribe. We are actively engaged with plan sponsors to extend this coverage through 2021.Furthermore, we've been signing multi-year contracts to secure our 99% commercial coverage for the foreseeable future. We also executed a transition of the TYMLOS distribution model from full line wholesalers to special distributors and direct the specialty pharmacies in Q1. The purpose of this initiative was to further improve patient care through a network of specialty pharmacies and ensure that all patients will continue to have the option to receive TYMLOS via home delivery. The streamlining of the distribution footprint is leading to sustainable cost efficiencies and sets a strong specialty distribution capability for future Radius products. This transition will have a positive impact to gross to net for the remainder of 2020 and beyond.Thank you. I will now hand the call over to Charlie for an R&D review.

[Charlie Morris:]

Thank you, Sal, and good afternoon everyone.On Slide 11, we provide a high level view of the considerations and mitigations for our clinical trials during the COVID-19 pandemic. As you know, we have three Phase 3 clinical trials ongoing and we have continued to screen and then roll patients into all three trials. At the same time, we have worked to ensure the safety patients investigate some of this stuff, as well as our own employees and those of our CROs.All of our actions have been consistent with national and state level guidance and those issued by our research hospitals, clinics and IRBs. The safety of study patients is paramount, but patients are unable or unwilling to have in-person study visits, we have supported and acceptance safety assessments made through virtual or telehealth maintenance. To enable retention of patients already randomized on our studies, investigators are using virtual study visits and home visits and we have engaged a home healthcare agency for further home visits.In addition, we are allowing patients' assessments to be conducted locally to minimize travel and then convenience. Investigational product suppliers in sufficient quantity to ensure continuity of treatment for all patients and the career service has been engaged for shipping product directly to patients and the patients' request and well allowed by regulations.Data integrity and quality are also important concerns and all of our actions outlined so far, our adherence to regulatory guidance issued by both FDA and EMA and our prioritization of key efficacy assessments will support the quality of the data, while ensuring we have appropriate data for our key efficacy analysis. While sites are able to screen and enroll patients, we continue to support those efforts to ensure continued enrollment.On Slide 12, you see the progress we have made with our trial. First, let's look at wearABLe, the Phase 3 study for abaloparatide-patch. In January through March, we were pleased with progress with our enrollment ahead of our internal projections, driven by a lower screen failure rate, the main counter at the beginning of the study and by an increase in site screening activity. As you would expect of the impact to COVID-19 was felt, screening and enrollment slowed in April and we anticipate this will remain the case in May.There are, however, signs of renewed activity insights who previously had reduced or no activity. We have pressed ahead with regulatory submissions in several European countries and we are on track to have a first initiation of ex-U.S. sites in this quarter. As a result of the ongoing and renewed activities in the U.S. and upcoming addition of EU sites, we are targeting completion of recruitment of wearable later in the third quarter with intended data readout in the second half of 2021. Our other Phase 3 of abaloparatide is our ATOM study in male osteoporosis. With the help of our plans and mitigation, we have now enrolled around 90% of our targeted 225 patients, and we continue to expect to report top-line data in the second half of 2021.Finally for abaloparatide, we recently obtained top-line data from our bone histomorphometry study. This study looked at the early effect of histomorphometry on indices of bone formation and resumption in iliac bone biopsies obtained from 19 postmenopausal women with osteoporosis after three months of therapy. I'm pleased to say that the study achieved its primary endpoint, demonstrating a significant increase in mineralizing surface in the cancellous bone envelope providing histological evidence of an early anabolic effect of abaloparatide in patients.We plan to share full data at a medical conference later this year. The EMERALD study for elacestrant in advanced breast cancer also enrolled ahead of expectations from January through to late March, but likely abaloparatide studies show a slowdown of screening and enrollment activities in April because of COVID-19 considerations. Current screening numbers suggest enrollment in May will also be impacted. However, we anticipate improved screening activity as sites in many of the seventeen countries involve begin to reopen. As a result of the slowdown, we anticipate the completion of enrollment will now be in fourth quarter that we continue to expect data readout in 2021.With that, I'd like to hand over to Pepe for the financials.

[Pepe Carmona:]

Thanks, Charles.Slide 14 shows our revenue bridge versus the same quarter of 2019. TYMLOS in Q1 delivered $48 million in net sales, which represents a growth of 61% versus prior year. This is in the upper side of the guidance range we provided for Q1, which was between $45 million to $48 million. The revenue growth was driven primarily, but our continued market share increases, which is now at 44% as previously noted by Joe.As explained in the past, our revenue is highly predicted from our new patient starts, which now spend at 53% share. So market share growth contributed with $13 million to net sales versus prior year. Importantly, you can also see that our net price improved versus prior year contributing an additional $5 million in net sales. The execution of the change in our go-to-market strategy, which was explained by Sal allowed us to maximize our price increase and provide significant efficiency in our gross to net deductions.This net price improvement enabled us to hit the higher side of the revenue guidance. We are very confident on the mid to long-term growth prospects of TYMLOS and our ability to achieve market leadership with an optimized go-to-market strategy, which should provide sustainable growth in the years to come. In the appendix, you will also be able to see a breach of revenues comparing Q1 2020 versus Q4 2019.In Slide 15. I will walk through the income statement, but whether explain the dynamics, I will focus on the right side of the slide that shows the figures on a non-GAAP basis. You can see the reconciliation between our GAAP and non-GAAP measures in the appendix. Radius on a non-GAAP basis for Q1 2020 had an adjusted net loss of $27.4 million or $0.59 per share as compared to an adjusted net loss of $31.8 million or $0.70 per share for Q1 2019. Key points on the income statements are

[Kelly Martin:]

Thank you, Pepe. I just have a few comments before we turn to questions. Focus on these things. Firstly on a personal basis, I'm thrilled to be part of this organization. I have known of Radius four years past and I'm delighted with the opportunity to join this team, work with the board and the employees on the business and moving forward. So I'm very thrilled to be here.Secondly, in my first 10 days of being associated with the company, I would give two very simple observations. First and foremost the business as well runs, if not very well run. Secondly, the team is an exceptionally good team across the board, across the various functions as I have gotten to know them, it's a very well run business by a very good group of people.The third of my comments is about Jesper. I have known Jesper in the past. I have never worked closely with him. I've had an opportunity in the last few weeks to do so. I would share with all of you three things. One is, he is an exceptionally good business executive. He has built and created here at Radius an excellent company. Secondly, I think even more importantly, he is an exceptional person, his character and integrity are beyond reproach and he and I have worked very well together. He's made an exceptionally easy for me to get acquainted to Radius.And last but not least, I think I speak for all of us that we wish him nothing of the best of success in Denmark. He has invited all of us to visit at a moment's notice, but we wish you Jesper, all the best in the world and we thank you for leaving this company in excellent shape.

[Jesper Hoeiland:]

Thank you very much, Kelly and team. Thank you very much. So with that operator, we'll now open it up for questions and the team will be delighted to answer the questions. I will say that we're doing this Q&A session virtually given the COVID situation. So we'll do our best to make sure based on specific questions at the right people answer at the right time.So, operator, if you can open it up for questions.

[Operator:]

[Operator Instructions] Our first question comes from Jessica Fye with JP Morgan. Your line is open.

[Jessica Fye:]

Hey guys, good afternoon. Thanks for taking my question. Can you hear me alright?

[Operator:]

Yes. We can.

[Jessica Fye:]

Okay. Great. You talked about having TYMLOS coverage for 83% of Part D lives through 2021 and working on multi-year contracts to maintain your high level of commercial coverage. Can you elaborate on how long those contracts are on the commercial side? And what that means to you in terms of the potential future availability of Forteo generics?

[Kelly Martin:]

Sal, do you want to answer that one?

[Sal Grausso:]

Sure. Hi, Jess. Thanks for the question. Yes for the commercial contracts, so we typically have contracts in place that go to two to three years that we've been very pleased with our discussions with the payers, they definitely see the value in TYMLOS irrespective of what happens with the teriparatide molecule. So we are in good position and we feel strong and confident about our coverage going forward.

[Jessica Fye:]

Okay. Great. I just want to make sure I understand some of the kind of pushes and pulls around net price this year. Can you quantify the positive gross to net impact of moving to a specialty distribution system? What does that mean for kind of the year-over-year net price in 2020 relative to 2019, all else equal, just thinking about that change?

[Pepe Carmona:]

Yes. This is Pepe, Jessica. Thanks for the question. if you see the reconciliation of Q1 versus last year, you see a $5 million improvement just from net price improvements and that net price improvement include the net effect of the price increase that we took of 7.9% which a portion of that was the net price and the rest is basically improvements in the efficiencies that we have gained through the change in the distribution model. We see that this is something that it's going to impact this year, but it's going to be sustainable through years to come. And we are not guiding exactly how this, but definitely before we're guiding to have a net price to be flat from $19 million to $20 million, we are expecting a net price increase now.

[Jessica Fye:]

Okay. So that was actually my follow-up. So, this shift was not contemplated in the prior 2020 guidance?

[Pepe Carmona:]

That's correct.

[Jessica Fye:]

Okay. And I guess also related to the guidance. When you referenced the potential challenges in patients' ability to pay were you suggesting a potential volume hit as patients maybe assess their ability to cover co-pays or were you talking about perhaps higher gross to nets as there is a mix shift toward Medicaid?

[Pepe Carmona:]

Let me take that one. The ability to pay is more about the people that are unemployed and how they're going to continue to pay for the medication. We expect that some of those people are going to stay through COBRA or are they all going to Medicaid and that could have an impact into our gross to net. Now, we believe that the net effect of all of that is still going to see our net price increase year over year. And by the way obviously as you know one we have said in the past for all patients in the commercial space we're providing vouchers and other mechanism in order to make them pay zero dollar out of pocket. So we are [indiscernible] patients we go through the process.

[Jessica Fye:]

Great. Thank you.

[Pepe Carmona:]

Welcome.

[Operator:]

Our next question comes from Mohit Bansal with Citi. Your line is open.

[Mohit Bansal:]

Good morning. Congrats on the progress and thanks for taking our questions. My first question was really just about what you're seeing in terms of average months on drug. I know the label recommends 18 months but we've gotten feedback that doctors are pushing it out to something closer to 24. Is there any color that you could provide or feedback on average months on drug?

[Jesper Hoeiland:]

Joe, you want to ask that one

[Kelly Martin:]

Yes. Sure. Hey Mohit how are you? So yes, we haven't given any guidance as far as adherence or months on TYMLOS is concerned, but certainly it's something that we've been focusing on since launch, but we do have strategies and resources in place that can certainly help that particular metric, but nothing that we're going to share now or probably even in the future.

[Mohit Bansal:]

Okay. Great. And then my follow-up is just given the pandemic and what it's doing to your distribution channel and then looking toward the patch, is there any color you can share in terms of shelf life expectations or storage requirements? Sorry for the patch versus TYMLOS as it is now? Thanks.

[Kelly Martin:]

Yes. We don't expect many changes between them. This is the process that you need to follow with the FDA [indiscernible] start with 24 months and that we have expanded no major changes between the products.

[Mohit Bansal:]

No big differences. Okay and then just last one, in terms of business development previous comments suggests that you were waiting until the elacestrant divestiture to really make any big moves. Is that still the case and should we expect that move to be toward endocrinology? Thanks guys.

[Kelly Martin:]

Mohit, this Kelly. You should absolutely expect us to first focus on completion of a business development transaction and in parallel for that the company has already been looking at a number of interesting things, the majority of which are in endocrinology, but we'll be very disciplined in our approach and will focus on completing a transaction and working on completing a transaction as is currently under way.

[Operator:]

Thank you. Our next question comes from Vikram Purohit with Morgan Stanley. Your line is open.

[Vikram Purohit:]

Hi, thanks for taking my question. So, I had one on the Phase 3 wearABLe Study. So, you mentioned that you're still targeting completion of enrollment by the third quarter with data in the second half of 2021 and I was curious what kind of view regarding an economic reopening and normalization in the U.S. and EU is that timeline predicated on? So in other words, how much risk do you think there is to this timeline and eventual data in the second half of 2021 if the impacts of COVID-19 to stay for considerably longer than whatever your base case of U.S.? That's my first question.

[Kelly Martin:]

Charlie?

[Charlie Morris:]

Thank you. Vikram. I think we've sort of used the same general assumptions as Joe has talked about the commercial front. We had great momentum in the first quarter of this year. Obviously that's now slowed down, we are anticipating world reopening toward the end of this quarter and into the next quarter, and we also have the ad of the ex-U.S. sites coming on board with a lot of the recovery and having already begun in many of those countries. So the internal aspects of it is fine. We have our assumptions and those are assumptions what drive our view that this should be done in third quarter ever, but other factors COVID continuation we are going to wait and see. We had to use a plan we think it's realistic based on everything that we're hearing so that's really how we came to feeling comfortable and this can be delivered in the third quarter.

[Vikram Purohit:]

Okay. Understood, and then I had a follow-up on elacestrant. So you mentioned that you were in late stage discussions for a potential partner just to the extent you can. Could you characterize for us kind of what some of the push pull drivers of those discussions have been, but are you can say around that would be helpful?

[Charlie Morris:]

Yes. As we have commented in the past, [indiscernible] and obviously the discussions are more on the economic terms, we're not going to provide details of those discussions, but that's usually the essence of it.

[Vikram Purohit:]

Okay. Fair enough. Thank you.

[Operator:]

Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

[Unidentified Analyst:]

Hi, this is Lisa on for Paul Choi, thanks for taking our questions. I guess just to start off, can you guys characterize a bit on how sales and doctors are identifying new patients and what you've seen previously? Thank you.

[Charlie Morris:]

Joe.

[Kelly Martin:]

Yes. Thanks. So, yes, right, identifying patients for TYMLOS that the same way they would pre-pandemic and overall as mentioned during the presentation, we've seen a slight decline in NBRx volume due to the situation that we're in. And the question that we're asking is whether this is lost or just delayed business and we feel it's delayed and we do expect that to return to normal volumes for TYMLOS from a new patient standpoint during the second half of this year as states do open back up. So, we're confident staying in touch with all of our HCPs, we're providing them additional reasons to use TYMLOS for the right patient types and obviously the resources required to initiate these patients on our products.

[Unidentified Analyst:]

Great, thank you very much.

[Operator:]

Thank you. Our next question comes from Geoffrey Porges with SVB Leerink. Your line is open.

[Unidentified Analyst:]

Hi guys, this is Neil filling in for Geoff. Congrats on the quarter and the transition. Kelly, I had a question for you just on a higher level. As you begin your tenure, what do you see as the greatest opportunities for Radius and the greatest challenges and how is the tenure of what you might seek to do impacted by the current balance sheet?

[Kelly Martin:]

Thanks for the question. The insight nearest and biggest opportunity is the osteoporosis market, which is a significant be somewhat underserved and see something that we have built an excellent reputation and brand. So, a natural extension to that with the patch opportunity and that drug delivery technology is clearly a very significant opportunity that's line and site. I don't view the balance sheet as any particular challenge at all.There's lots of ways to move forward overtime but as I answered previously, our first focus is on the business development side with Elacestrant and that's our current focus. Somewhere down the road with completion of that transaction in some way shape or form, we will then assess opportunities that we have with the balance sheet that we have, but there's enormous amount of things out there that are potentially of interest to us, but we'll take a very disciplined management approach in evaluating all of those things, some of which that activity is currently going on.

[Unidentified Analyst:]

Great, thank you very much.

[Operator:]

Thank you. [Operator Instructions] Our next question comes from Annabel Samimy with Stifel. Your line is open.

[Annabel Samimy:]

Hi guys, thanks for taking my question. Just had a couple, first, can you tell us if you saw during the first quarter any accelerated buying of TYMLOS we did see that with a lot of other drugs I'm just wondering if you can quantify that, if there was some?And then the second question I have has to do with, I guess your longer-term guidance of 20% CAGR. I think part of that has to do with broader market growth and it doesn't look like it was [indiscernible] flat this quarter. So, have your expectations for 20% CAGAR change and have your market growth expectations change? Thanks.

[Pepe Carmona:]

Joe, do you want to answer the first one?

[Kelly Martin:]

Yes. Sure. Hey Annabel. Yes. The volume or stockpiling like here some people calling it, it did occur in some parts of the industry, but was mainly limited to retail products and since TYMLOS is in the specialty space this dynamic did not occur for us in Q1, and these were expected to most growth trends for the quarter. So hopefully that answers your question.

[Annabel Samimy:]

Hi. Yes it does.

[Pepe Carmona:]

Annabel. So, and the second question I think referring back toward Kelly as said this is a large market that is underserved and has low penetration so the opportunity is there, it is not changing because of COVID-19 and so we're not changing our three-year guidance for the company. We will continue to assess the pandemic and any potential impact we may have in our business, but the opportunity is there. And we believe we are what we have done and it's a great job to take the market leadership in the category.

[Annabel Samimy:]

Okay. Can I just ask one more follow-up, I mean it looks like you have some decent continuity of treatment or opportunity for decent continuity of treatment with patients unlike some other physician administered drugs out there? So have you seen any uptick from physicians for opting for your treatment, because its simple mail order self-administered over other self-injected treatments or have all-new patient starts all that altogether?

[Pepe Carmona:]

Back to you Joe.

[Kelly Martin:]

Yes. I'll answer your last question and by no means have new patient starts going to zero. We're still seeing that business continue. As far as your question is the type of maybe new prescribers for adding on yes those are continuing to even in the remote environments and with the fact that TYMLOS can be administered at home and deliver to their home by [indiscernible] or via mail order from a Word [ph] CBN that is certainly something that's been attractive to the HCPs that we're talking to, and for the patients of course.

[Pepe Carmona:]

So just let me see if I complement there. So there is a [indiscernible] administered in the office, but those problems are having [indiscernible] talent. So it's an opportunity for us that we're taking advantage. Yes.

[Annabel Samimy:]

Okay. Great. Thank you.A - Pepe CarmonaYes.

[Operator:]

Thank you. Our next question comes from Eun Yang with Jefferies. Your line is open.

[Eun Yang:]

Thank you. For TYMLOS you have an agreement with the Teijin in Japan. So are you expecting some work to revenue at some point?

[Pepe Carmona:]

Good question and good to hear you. In the deal offer with Teijin we are not allowed to comment on the progress. So we are expecting them to make an announcement and we will keep you a price of that. And now, as you know, they have been running since 2017 of Phase 3 bridging study.

[Eun Yang:]

Right. Okay. And then TYMLOS competition [indiscernible] expired in 2016 and you have [indiscernible] extension, is that into 2021 and do you expect generic challenge around the time?

[Pepe Carmona:]

Well, we believe we have a very strong patent on methods and we expect that the patent for the SC get us to 2031 and then the patent for the patch give us to 2036. So we are in a very comfortable position. Thank you for the question.

[Operator:]

Thank you. And I'm showing no further questions at this time, I'd like to turn the call back over to Kelly Martin for closing remarks.

[Kelly Martin:]

We want to thank everybody for participating in our call. We want to wish Jesper all the luck in the world and he has kindly agreed to remain an advisor to both myself and the Board in the company and we will certainly take advantage of this good gesture. And we look forward to continuing to provide updates as the business progresses. So everybody stays safe and we will keep you all posted on our progress.Thank you very much.

[Operator:]

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