Radius Recycling Inc (RDUS) 2018 Q2 法說會逐字稿

Good morning, everyone. And welcome to Radius Health Second Quarter 2018 financial results and Business Update. (Operator Instructions) As a reminder, this conference call is being recorded. I would now like to turn the conference over to Elhan Webb, Head of Investor Relations at Radius Health. Elhan, please go ahead.

Thank you, Brian. Good morning, and thank you all for joining us on the conference call and webcast for Radius Health Second Quarter 2018 Financial Results and Business Update.

Before we begin, I'd like to remind you that statements made during this call that are not historical facts are considered to the forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the Risk Factors section in our quarterly report on Form 10-Q and other reports filed with the SEC. Any forward-looking statements represent our views as of today, August 7, 2018 only.

During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding our operating performance. These non-GAAP financial measures are not to be relied upon as a substitute of -- for our financial information, presented in accordance with GAAP and are unlikely to be comparable to non-GAAP information provided by other companies.

Please refer to the slide at the end of today's presentation, which contains the reconciliations between our non-GAAP and GAAP financial measures. A replay of this call will be available on our company website at www.radiuspharm.com, and you can find the dial-in information for the conference call replay in today's press release as well as on our website.

On today's call, we will provide you with a review of Radius Health second quarter 2018 financials, an update on our pipeline and our upcoming milestones. Joining me on the call now are Jesper Høiland, our President and CEO; and Pepe Carmona, our Chief Financial Officer. Other senior management members, Gary Hattersley, our Chief Scientific Officer; Joe Kelly, SVP Sales and Marketing; and Amanda Mott, SVP Market Access will also be available for Q&A at the end of the call. I'd like to now turn the call over to Jesper, for an overview of our second quarter 2018 results. Jesper?

Thank you, Elhan. Welcome everybody, and thank you for joining us on the call today.

Slide 5. I'm very pleased with the progress that we have made and the long-term goals that we have set for Radius, becoming the market leader in the osteoporosis anabolic space with TYMLOS.

Potentially, expanding this market significantly with the launch of a convenient patch version and expanding commercially into oncology by successfully developing and maximizing the value of our pipeline assets, elacestrant and RAD140. We are very committed to strengthen and drive forward our organization to realize the large potential that lays ahead of Radius and to improve patients' outcomes and maximizing value for our shareholders.

Starting with TYMLOS. We continue to make substantial progress in expanding our market share in the U.S. anabolic osteoporosis market.

In the second quarter, TYMLOS increased its average market share in the U.S. anabolic osteoporosis market to 19% from an average of 13% in first quarter.

Our sales reached $22.6 million, representing a 56% increase over the first quarter 2018 sales. We also saw the continuation of the U.S. anabolic markets expansion with a 9% growth in volume in the second quarter over the second quarter last year.

We have made pivotal hirings to achieve our goals or strengthening our organization and supporting advancement of our new clinical pipeline to commercial readiness.

We have recently announced the appointment of Chhaya Shah, as our Senior Vice President of technical operations. Chhaya brings to Radius more than 25 years of industry experience in supply chain, quality assurance and manufacturing from various large pharma companies, including Shire, Wyeth and Abbott Labs.

Chhaya's appointment will be critical in the expanding of our technical operations infrastructure, as we advance abaloparatide patch and elacestrant into Phase III development and prepare for commercialization.

I'm very happy to share with you that we have hired a Chief Medical Officer with tremendous expertise in oncology and breast cancer. He will join us on September 4.

We plan to continue strengthening our oncology organization going forward and are committed to becoming a key player in this area.

Moving to our clinical pipeline. We have initiated a histomorphometry study for TYMLOS, which is designed to help us understand and differentiate early effects of TYMLOS on bone formation and structure. We are well on our track to start our Phase III elacestrant study in the second half of this year.

Let me now give you a commercial update on TYMLOS and an overview of the U.S. anabolic market. Please turn to Slide 6. The data on this slide shows growth by quarterly volume changes in the anabolic class. Over the last 4 quarters, we continued to see year-over-year quarterly volume growth since the launch of TYMLOS in May of last year.

As you can see in the second quarter, in 2018, the anabolic class grew by 9%, driven by TYMLOS growth. Based on this continued trend, we raised our previous expectations for 5% to 7% volume growth in the U.S. anabolic market to 7% to 9% volume growth in 2018.

We are confident that our focus, efforts, across the commercial team in promoting TYMLOS will continue to demonstrate its value and expect continued growth of the U.S. anabolic marketplace.

Slide 7. This slide shows our market share performance in the second quarter building upon the strong performance we demonstrated in Q1. TYMLOS TRx market share in the second quarter showed an increase from 13% to 19% over the prior quarter, driving net sales of $22.6 million, as we progress towards meeting our 2018 guidance of an annual average of 19% to 21% TRx market share.

Moving to Slide #8. In the second quarter of 2018, TYMLOS access increased to 265 million lives covered, representing 95% coverage in commercial in Medicaid in August, and 44% coverage in Medicare Part D. TYMLOS source of business is predominantly commercial. The U.S. commercial segment continues to grow in importance in the anabolic class.

Radius is in an active engagement in the 2019 review cycles for both commercial and Medical Part D.

In the recently released July updates, from Express Scripts, CVS Health and Optum, they confirmed the parity commercial coverage for the 2 drugs in the anabolic class.

With the foundation of our broad national coverage now, clearly established with its prescribers, TYMLOS volume has grown across both the commercial as well as the Medicare Part D segments, for the appropriate high-risk osteoporotic Part D patients. We see physicians are prescribing TYMLOS and Medicare Part D plans are permitting the use of TYMLOS, irrespective of former formulary status, demonstrating the strength of TYMLOS clinically, safety and tolerability profile.

The next slide provides some additional details on the status of our pipeline. We continue to keep our focus on both life cycle management for TYMLOS, and our 2 clinical stage oncology programs, elacestrant and RAD140, with the Phase III elacestrant study expected to start in the second half of 2018.

With our strategic partner, 3M, our efforts remain on manufacturing scale-up activities, CMC preparations and manufacturing of clinical supplies to support initiation of our abaloparatide patch pivotal Phase III study in mid-2019. I would now like to pass over the call to our CFO, Pepe Carmona. Pepe?

Thank you, Jesper. I will briefly walk through the income statement and uses of cash in Q2 2018. And afterwards, as Jesper mentioned, I will provide some updated metrics of expectations we have for 2018.

Slide 11. For the 3 months ended June 30, 2018, Radius reported net sales of $22.6 million and a loss of $68.9 million or $1.52 per share, as compared to a net loss of $68.4 million or $1.58 per share for the 3 months ended June 30, 2017. The $22.6 million sales figure represents 3 months of shipments discounted by gross to net adjustments.

As previously discussed, our revenue recognition policy is in line with U.S. GAAP. On the right side of the slide, we present the figures on a non-U. S. GAAP basis, which excludes share-based compensation, intangible asset amortization, noncash interest from our convertible notes and one-off items, including the restructuring charges and Ipsen arbitration-related payments. You can see the reconciliation between our GAAP and non-GAAP financial measures in the appendix. Radius on a non-U. S. GAAP basis, for the period June 30, 2018, reported a net loss of $45.1 million or $0.99 per share, as compared to a net loss of $56.9 million or $1.31 per share for the 3 months ended June 30, 2017.

Similar to previous quarters, I want to highlight: one, our gross margin is at 93%, which includes 5% of royalties; second, the increase in R&D expenses versus Q2 2017 is mostly driven by our TYMLOS male study and anabolic patch activities as well as expenses related to the elacestrant Phase III trial in advance of initiation of the clinical progress. Last, SG&A is fairly flat versus last year, as we have kept the organization size and expenses relatively stable. We have executed a reallocation of commercial resources to improve our marketing mix and ensure we continue to accelerate TYMLOS growth.

Next slide. We continue to allocate resources to drive TYMLOS growth and advance our osteoporosis and oncology pipeline.

Our cash, cash equivalent, restricted cash, marketable securities and investment balance, as of June 30, 2018, was approximately $319 million. In the second quarter, we reduced our cash balance by $48 million, including an aggregate of $12 million in one-off expenses for the Ipsen arbitration payment, restructuring charges related to the shutdown of our New Jersey site and rightsizing the sales force to increase investments in other marketing vehicles that we expect to further accelerate growth.

Most of the uses of cash was for TYMLOS commercialization and R&D external expenses related to the pipeline.

We have increased cash inflows from TYMLOS revenues and income from stock options exercise in the period.

Slide 13. Previously, we guided on our expectations on U.S. anabolic osteoporosis market growth and TYMLOS U.S. anabolic market shares for 2018. We have seen positive progress in both metrics. In terms of the U.S. anabolic market, we continue to see strong market growth momentum, which you can see in Q2 2018, the market accelerated to a growth of 9% versus prior year. This is very encouraging to us after seeing this market declining prior to the TYMLOS launch at the rate of 7% in the prior 5 years.

We now expect the U.S. anabolic market to grow in volume in the range of 7% to 9% in 2018, based on the growth we have seen of new patients getting into anabolic therapies and the larger number of physicians prescribing anabolics.

From a TRx perspective, our U.S. anabolic market share grew from 13% in Q1 to 19% in Q2. This is a significant growth, which we expect will continue as we go into the second half of 2018. For now, we are maintaining our guidance in the 2018 U.S. anabolic osteoporosis market share average for TYMLOS to be between 19% and 21%. I look forward to your questions at the end of the call. With that, I will pass the call back to Jesper, for the closing remarks.

Thanks. As we approach the end of our presentation, I would like to remind you of our most important goals and upcoming milestones. In the second quarter, our Phase III ACTIVExtend results were published in the Journal of Clinical Endocrinology and Metabolism. Data from the ACTIVExtend showed the significant reduction in the incidents of fractures seen from the treatment with TYMLOS for 18 months in the active Phase III study.

And it was maintained in patients who received the follow-up alendronate therapy for 2 years. We've submitted a labeling supplement to the FDA in a connection with these results in December of 2017. We were disappointed to recently receive a negative opinion following our appeal to the CHMP on our European MAA for abaloparatide subcutaneously.

We remain committed to make abaloparatide subcutaneously available outside of the U.S., via our collaboration with Teijin Limited in Japan and through partnership agreements in other markets.

During our Osteoporosis Investor Day event on June 8, in New York, we had presentations by KOLs and provided additional details on our abaloparatide patch program, which reflect our confidence in our clinical development pathway and Phase III study.

The webcast from our investor event remains available on our web page. We are focused on achieving our remaining goals in 2018 and remain excited about TYMLOS' growth trajectory and future potential in the U.S. anabolic market. I'd like to thank you all for your support to Radius Health, and would like to ask the moderator to now open the call for questions.

(Operator Instructions) And our first question will come from the line of Salveen Richter with Goldman Sachs.

It's Maryana Breitman for Salveen. And I have a quick question. Could you talk a little bit more about Medicare Part D, what is the progress for the review cycle? And are you going to get anything additional off cycle in 2018? How do you basically -- what is the strategy for that patient segment?

I will leave this to Amanda Mott, our SVP of Market Access.

Yes, we're, right now, in the middle of the active negotiations with the Part D plans. As you know, the formal announcements come out in October. We don't comment on ongoing negotiations. But we are seeing uptake with some plans through '18 as well as also growing share even in the plans where we don't have the formal formulary coverage. So we're very optimistic for the additional adds that will come in Part D.

Got it. And just a quick question on the patch progress, where do you guys stand? What is the time line for that?

Yes, we're continuing to make some really good progress with the patch. I think we described at our last call that the key area of focus is preparation of clinical trial supplies with the initiation of that study. Good progress, and we remain on track for initiation mid-2019.

And our next question will come from the line of Jessica Fye with JP Morgan.

Just following up on the last one. I'm curious, if you can elaborate on what proportion of, say, 2Q TYMLOS scripts were covered by commercial insurance versus Medicare versus other?

So we're pretty -- Jessica, it's Amanda. We're pretty consistent with the anabolic class, you see about 50% in commercial, 50% in the Part D. We over-index a little bit on the commercial side, maybe sometimes it's within weeks, it could be 53% and 47%, but it's consistent with the class.

Also it should be noted -- Sorry, Jessica. Also it should noticed that even if we are not covered by -- in the Part D plan, very often, we manage to get it accepted as a part of -- when a doctor make a request for it.

Okay, got it. And I mean -- I don't know if maybe this one is for you, Jesper, or someone else who wants to chime in, but I guess, just bigger picture when we look at your company with some very interesting pipeline options, but data, that's likely not going to come in 2019, and couple that with some likelihood of the generic FORTEO entry at some point in 2019, the investors have to kind of look through to get to those pipeline catalysts. Can you just talk a little bit about your expectations for TYMLOS growth, as we move through that period and get closer to those pipeline catalysts?

Yes, Jessica. Basically, we're anticipating to continue growing going forward, as we've said, our aim is to become market leader in the anabolic market. And in a way, we envision things to happen, it's going to be pivotal point, it's going to be a Q3 next year in 2019. And we anticipate that the [AB] rating will go vis-à-vis to paratide and not by abaloparatide of a TYMLOS, and we continue to grow our business going forward. Also on the basis of the price point that we have picked, we think that the potential competition coming into the market being generic, being Teva, being Phoenix, being Apotex, we think that we have picked the price point that will make us still attractive for the plans to continue to give access to TYMLOS.

And our next question will come from the line of Geoffrey Porges with Leerink.

This is Brad Canino, on for Geoff. This is the first quarter, where we saw a noticeable slowdown in the growth of new patient share for TYMLOS. And it seems to be flattening around an average of looks like 34% through July. Can you tell us what you're seeing in the market that is causing this? And should we have expectations for renewed new patient share growth in the second half of the year?

Yes. This is Joe Kelly, Sales and Marketing. And our focus year-to-date has been more on the heavy prescribers within the anabolic space, and we've done a really good job. If you isolate the top 200 HCPs in that area, we have activated about 87% of them with TYMLOS. So yes, the focus in the second half is to activate more Tier A prescribers, and we can do that many different ways: first, we'll utilize and leverage those top TYMLOS prescribers to influence others within the marketplace across the U.S.; and we've also made additional investments in peer-to-peer speaker programs, where these are our promotional events for TYMLOS. And right now, we are averaging about 1,500 attendees a month for these programs. So we would expect to add on more prescribers, but also there's a depth play. So for those that are activated, we'll expect them to have TYMLOS be their anabolic of choice moving forward. And we're also investing in the Clinical Educator Programme. So we'll cover about 80% of the Tier A marketplace, where these educators actually help initiate new patients with pen trainings. And they also communicate with the patients through 18 months of therapy to be sure that they pick up the refills and they stay on therapy for the full 18 to 24 months. So we're confident that we'll continue to grow TYMLOS market share across the board, and as Jesper started, become the anabolic leaders in the near future.

Great. And then maybe for Gary, can you update us on the progress of the Part D dose expansion cohort from the elacestrant Phase I trial? How is this cohort progressing? And can we see data this year? And how do you plan to use that data to guide your development strategy?

Sure. So just to answer sort of -- the last part, at this point, we have all of the mature data that we need from the 2 Phase I studies we've conducted for elacestrant to enable us to design and begin to execute the pivotal Phase III study for elacestrant. So we have all of data we have in -- we need in-hand at this point. We have enrolled 10 patients in our Part D cohort. A number of those remain on treatments at this time. At this point, we don't -- we haven't made any firm plans of when we're going to provide any further updates on the Phase I program, but again, just to reiterate, we have all the data that we need in-hand at this point to initiate the Phase III study, as guided in the second half of this year.

And our next question will come from the line of Matthew Harrison with Morgan Stanley.

I guess 2 for me. So on elacestrant, can you just comment on what additional activities you need to complete before you can start that program? Is it -- clinical stride is the issue? Or are you still activating sites and trying to get through [ROVs] and things like that? So maybe if you could just comment on what's going there? And then second question is just related to guidance for the year. Obviously, market is growing faster. And so you're gaining some traction from that. Maybe just help us think, you're already in your guidance range for market share this quarter. Are you expecting growth to slow dramatically for the next 2 quarters in terms of your ability to continue to take share?

Yes, I'll take the first part of that. So the initiation of this Phase III elacestrant study is a key area of focus for us. It's really the highest priority at this point, and we're fully committed to moving that ahead as quickly as possible. With the data we shared, we remain extremely confident in the program. I do want to note that there are no outstanding clinical safety or other regulatory concerns. At this point, the focus really is around routine operational activities that are required before initiation of the Phase III. No meaningful barriers for initiation of this study. Again, really key area of focus for us. We're making really good progress, and we do remain on track for initiation in the second half of this year.

This is Pepe speaking, Matthew. So year-to-date, the average market share right now is sitting in 16%. And we have guided for the average market share to be in between 19% and 21%. You are correct, we already are within the range, as we speak. And that's how we expected to be. And obviously, by year-end, we should be higher -- where we are right now. We continue to be very optimistic that this will continue to grow. And that's how the average will get within the range. And hopefully, we'll beat that.

And Matthew, this is just Jesper speaking. I just would like to add that I'm very pleased that we have found our Chief Medical Officer, who will join us on the 4th of September. That really has been very diligently processed, that we've worked on, and we've found the person that we really want to -- for that job for -- to support us also with elacestrant going forward. A person with oncology and breast cancer background.

And your next question will come from Ying Huang with Bank of America.

This is [Alec Stranahan], on for Ying Huang. I have 2. My first relates to elacestrant and third-line breast cancer. Could you provide some detail on that Phase III design in terms of the inclusion of the active control, what kind of powering we should expect based on the 300-patient enrollment size and the study endpoints? And secondly, could you provide any guidance as to the 2019 formulary for TYMLOS? I know you have a formula exclusive with Express Scripts, so any additional color there would be great.

Yes. So I would give a high-level -- a higher-level outline of the elacestrant Phase III study. So as you described, that's third-line patient population enrolling approximately 300 patients. It's a randomized comparative study with elacestrant versus investigative choice of hormonal monotherapy, with the primary endpoint being assessment of PFS. Beyond that, we haven't provided any further details on that study such as powering. We would typically provide more information around the details of that study closer to initiation -- study initiation.

And Amanda, if you will comment on the market access?

Yes. [Alec], the -- during the Q3 call, we'll be able to give the full update on the 2019 formulary coverage. Right now, we are still in process on those contract negotiations, but it's very positive. We see the uptick relative to the -- what we do from a payer value proposition, both in the cost of treating a fracture as well as the overall responsible pricing has been very much embraced by the payers, particularly in this environment, where you see so much pressure both from the legislators and regulators relative to high-cost pricing, really showing a way forward in terms of how we approach the markets.

And our next question will come from the line of Robyn Karnauskas with Citi.

I have a just follow-up question regarding like your discussion about how you're going to approach the second half to get more prescribers on board? How does marketing to those less heavy prescribers differ from the top 200? And how do you -- so you mentioned that they're attending like these events but how do you really translate that? What would -- gives you confidence you can translate that into real prescribing?

Robyn, this is Joe Kelly, again. So absolutely, as I mentioned, around the peer-to-peer speaker programs that's really a big investment for us during the second half. And we've been calling on these other Tier A segment providers now for over a year. And it's really about them identifying these patients that are appropriate for TYMLOS therapy, and it's them getting comfortable with the clinical data and them activating them on the product itself. And as Amanda had mentioned, our commercial coverage across the board is very good. Part D is solid also. And even though, where we don't have formulary status, the business is going through with prior auths, which is very encouraging. And it tells us that the clinical part of the story is really resonating with these HCPs and the payers. And you'd mentioned that top 200 and the number that we've activated, 87%, they have a lot of influence within these marketplaces. So we're leveraging those folks to help others within those markets to understand the benefit of TYMLOS and anabolic therapy as a whole. And when we look at anabolic growth at 9% for the second quarter, all of that is driven by TYMLOS. So we're really starting to change the landscape right now as far as getting these providers to understand the benefits of building bone first with TYMLOS and then maintaining, as ACTIVExtend states, with a bisphosphonate post-TYMLOS therapy. So we're encouraged by what we see coming already during the second half, only 1 month in, in July, where NRx share has already increased pretty dramatically versus quarter 2. Stay tuned.

And as a follow-up, like, are you comfortable with SG&A? Or like do you think you'll -- these programs cost more money, you'll have to focus on them more, do you need more people, and how are you thinking about your sales force and the spend on marketing these new prescribers?

Yes. This is Pepe Carmona speaking. So what we see is that we have adjusted our marketing mix to improve the return on the investment. And so we reallocate the money from sales to marketing and these type of programs. We don't see -- or we don't expect any increase in SG&A as a result of this. It's just that we [source] allocation change to improve our marketing mix.

And our next question will come from the line of Chris Shibutani with Cowen.

Many of the questions have been asked, but if I could ask on TYMLOS. Now that we're probably past 1 year in terms of the drug being available, can you talk about how the patient retention or continuation, sustained use of the drug is going as far as -- in particular, in context relative to maybe historically with FORTEO, if you have any broader market data. How are you able to maintain patients to stay on the drug during their 2-year course, now that we're halfway through 1 year?

Chris, good question. Right now, we don't have firm data, we haven't been on the market long enough to look at adherence data, by the end of the year, we should have that. But in the meantime, as I mentioned already, we did expand our Clinical Educator Programme, where those touch points with the patient will go through 18 months. Again, encouraging them to get their refills and, of course, to stay on therapy for the entire time. So we'll probably get back to you year-end to have more concrete evidence around adherence for TYMLOS. You'd mentioned the competitor, I won't come at that, but I'm sure they can give you information around their data.

To follow up on a comment that was made earlier about the pricing environment, certainly, we've just come through earnings and all the large pharma companies have kind of subsequently fallen in line with commentary that Ian Read at Pfizer provided. Your particular market with TYMLOS versus FORTEO has some unique dimensions in terms of FORTEO having historically very dramatic price increases over the last year and you guys very specifically and tactically took a notable price discount for your entry point. But what should we think about, since you're at a considerable discount to your competitor, what your view on your pricing strategy for TYMLOS, specifically, could be going forward in the coming year or 2?

Chris, basically, what we have said is we're going to take a responsible price approach to the marketplace. We have done that since we launched in May of last year. We have taken a 5.9% price increase in February as you know. And we anticipate to be responsible also going forward. You saw competition at that point of time taking a 9.9% increase. We will take a price increase going forward when it makes sense and when also, basically, the market is accepting it in a positive way. And so responsible pricing is the password from our side.

And then lastly, the CHMP decision, what about the health side of Europe and outside of the U.S., can you update us on where you are from a regulatory and strategic thinking standpoint for TYMLOS OUS outside of Europe as well?

So right now, we have -- so as we have said before, we were waiting for a response from the CHMP to activate partnerships outside the U.S. And now knowing what that looked like, we have received several inbounds from other regions to partner on TYMLOS based on the U.S. dossier. So right now, we are in active discussions about that.

Any particular geographies that you're preferring to target that we should be monitoring?

We will do it on a region by region basis. So it will not be a -- probably one partnership. And that we will look for the largest ones and then going down in priority for the smaller ones

(Operator Instructions) And our next question will come from the line of Asthika Goonewardene with Bloomberg Intelligence.

I want to dig in a little bit about the prescriber dynamics that are driving that 7% to 9% growth in anabolic market. Where are these volumes are coming from? Maybe if you can comment, especially specialists, community GPs, or maybe a little bit of color as to are these docs looking to prescribe anabolics upfront versus the more traditional use? And I'm just trying to see if there's some sort of any paradigm shifts underwritten here? And then related now that you have a couple of more quarters of market experience with a better formulary positioning, can you comment about how prescribers are viewing the point of clinical differentiation between TYMLOS versus FORTEO or they're just largely prescribing based on formulary coverage?

Asthika, as far as moving forward and what we're seeing today, as I mentioned, we've focused on the top anabolic prescribers, which we've done a very good job with to date. But now, again, it's time to leverage those folks in various ways to influence other parts of the marketplace. But I would say, in a general sense, that most of the business today is coming from the specialists. So the rheumatologists, the endocrinologists, others, that we consider experts in the osteoporosis marketplace. And then I would say, moving forward, again, we look to expand out into the primary care market, where there is a lot of osteoporosis, but not enough anabolic use and that's where we see additional growth coming during the second half. Your second question?

Clinical differentiation.

Yes, so clinical differentiation, yes, anecdotally, we're hearing some very positive things. And as you may remember, during the first quarter, we introduced ACTIVE comparator, which does compare TYMLOS to placebo, where we saw some really nice differences from a non-vertebral standpoint. And we look to continue to differentiate abaloparatide in the marketplace, not just within the anabolic space, but also across the osteoporosis market, so that we continue to expand the entire segment moving forward.

Yes, so Asthika, it's Amanda. With respect to whether it's the coverage driving it or the clinical profile, there's sort of this tipping point that once you hit a certain level of access, which is north of the 80%, access no longer is the only driver that's really making that decision. It is now back to Joe's point, the clinical profile. And you start to see the uptake regardless of formulary positioning. In the physicians' mind, it's covered, once they have the appropriate patient, they follow a prior-auth process, they will write it. And what we're seeing is the early effects of TYMLOS, because you do have the clinical impact as early as the 1 month, but that's really part of the driving force that you're starting to see as why the differentiation between the products. So going back to even the adherence question, because you get efficacy so soon with TYMLOS, it starts to -- you start to see the prescribing in that differentiated place.

And this is Jesper speaking. I've just been out in the field, and basically if we take home messages in respect to how TYMLOS works: first and foremost, the Kaplan-Meier curve really help us from the point of view of fast onset, building bone, only 18 months; second point in that context is, of course, stable at room temperature when first used, is really a big benefit to TYMLOS, because you don't inject anything cold into your skin, it's much more comfortable. This is the anecdotal feedback that I get. And then, of course, last, but not least, the price point really appeals, in particular to the Part D patients, where rebates and coupons are not as common -- or cannot be done, so to speak.

And I'm showing no further questions in the queue at this time. So now it is my pleasure to hand the conference back over to Mr. Jesper Høiland, President and Chief Executive Officer, for some closing comments or remarks. Sir?

Thank you, Brian. And thanks to everyone, listening in, really appreciate your interest in Radius Health. We're very happy going forward, set -- growing the business to $22.6 million, 56% up. Hiring our new CMO and number of good things happening from Radius Health point of view, and we're very pleased to that, so stay tuned and thanks for your interest.

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude our program, and we may all disconnect. Everybody, have a wonderful day.