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Edited Transcript of RDUS earnings conference call or presentation 8-May-19 12:00pm GMT

Q1 2019 Radius Health Inc Earnings Call

Cambridge May 16, 2019 (Thomson StreetEvents) -- Edited Transcript of Radius Health Inc earnings conference call or presentation Wednesday, May 8, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Bruce Mitlak

Radius Health, Inc. - VP of Clinical Development

* Charles Q. Morris

Radius Health, Inc. - Chief Medical Officer

* Elhan Webb

Radius Health, Inc. - Head of IR & External Communications

* Jesper Høiland

Radius Health, Inc. - President, CEO & Director

* Jose Carmona

Radius Health, Inc. - CFO, Senior VP & Treasurer

* Joseph Kelly

Radius Health, Inc. - SVP of Sales & Marketing

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Conference Call Participants

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* Alec Warren Stranahan

BofA Merrill Lynch, Research Division - Research Analyst

* Bradley Patrick Canino

SVB Leerink LLC, Research Division - Associate

* Chris Shibutani

Cowen and Company, LLC, Research Division - MD & Senior Research Analyst

* Jessica Macomber Fye

JP Morgan Chase & Co, Research Division - Analyst

* Matthew Kelsey Harrison

Morgan Stanley, Research Division - Executive Director

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Presentation

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Operator [1]

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Good morning, everyone, and welcome to Radius Health First Quarter 2019 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.

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Elhan Webb, Radius Health, Inc. - Head of IR & External Communications [2]

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Thank you, Crystal. Hello, everybody. Thanks for joining us today on our first quarter call. Our press release and the slide deck that we'll use to guide our discussion today can be found in the Investor Relations section of our website at www.radiuspharm.com. A replay of the call will also be available on our company website in 3 hours following the call.

As you can see from our safe harbor statement on Slide 2, we will include non-GAAP financial measures in today's presentation, and some of the statements will be forward-looking statements. Our 10-K and subsequent filings identify factors that would 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, May 8, 2019, only.

On Slide 3 is our agenda for today's call. I'm joined today by our CEO, Jesper Høiland, who will touch on the highlights of the quarter. After Jesper's comments, our Head of Sales and Marketing, Joe Kelly, will provide a detailed review of our commercial performance with TYMLOS. Our Chief Medical Officer, Dr. Charlie Morris, will then review the recent medical data and presentations with TYMLOS. After Charlie's comments, our CFO, Pepe Carmona, will review our financial results for the first quarter. Our management team is joined by Dr. Bruce Mitlak, who heads our clinical development for osteoporosis, 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 first quarter 2019 results.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [3]

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Thank you, Elhan. Welcome, everybody, and thank you for joining us on the call today. I'm very pleased to report another strong commercial quarter for Radius as we continue increasing our market share gains for TYMLOS. As we are celebrating the second year launch anniversary of TYMLOS, our focus today will be on TYMLOS.

In the first quarter of 2019, we doubled our sales for TYMLOS versus the previous year, achieving $29.8 million net sales, reaching an average of 30% total market share and 42% of new patient starts. Our Q1 net sales performance reflects market seasonality as expected and guided.

We exited the first quarter with 44% market share in new patient starts and expect to cross the 50% market share of new patients on anabolic therapy during the second half of 2019. This will position TYMLOS to become a market leader in 2020 to continue shaping and growing the market for the years to come and then disrupt the osteoporosis treatment with a potential introduction of our innovative abaloparatide-patch. As Joe will share in more detail, we now have the support from most osteoporosis prescribers, and they see TYMLOS as a highly differentiated anabolic treatment.

With the continued strong performance of TYMLOS, we are confident in reaching our sales guidance for 2019, and we are, therefore, narrowing our guidance to deliver between $160 million to $175 million net sales for TYMLOS. We continue to drive productivity initiatives that should enable us to exit the year with over $110 million cash balance.

In the first quarter of this year, we also made further progress with our clinical development preparations to start our Phase III study for abaloparatide-patch. We have reached our targeted scale-up of production and completed all required analytical method validations. We're on track to manufacture our clinical supplies for our Phase III study this quarter and expect to initiate our trial in August.

I will now turn the call over to Joe for a review of our commercial performance on TYMLOS.

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Joseph Kelly, Radius Health, Inc. - SVP of Sales & Marketing [4]

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Thank you, Jesper, and hello, everyone. I am excited to present our commercial update for TYMLOS sales for the first quarter of 2019.

Please turn to Slide 7. Since the launch of TYMLOS 2 years ago, we've seen a solid overall market share growth pattern, which is now continuing into 2019 by TYMLOS achieving a 42% new-to-brand market share in the first quarter with continued growth capturing a 44% NBRx market share during the month of April. This positive picture informs our expectation of achieving NBRx anabolic market leadership during the second half of this year, which in turn we believe will give us total market share leadership in 2020.

Because of our TYMLOS NBRx performance and overall positive trends, we are also narrowing our net sales guidance. We now expect to deliver TYMLOS sales in the range of $160 million to $175 million. The focused efforts of the organization continues to drive these strong trends, and we expect that both the commercial and Part D books of business will provide sustainable growth for the rest of the year.

Next slide. We are also encouraged by how the anabolic market continues to grow in 2019 with a 6% quarter-over-quarter increase. This is in line with our guidance of mid-single-digit growth within the anabolic space. As a reminder, prior to the launch of TYMLOS in 2017, the anabolic segment had been in decline for 5 years and recent expansion of the market shows that our efforts have clearly played a significant role in the growth of anabolic use.

On Slide 9, our Q1 market research with 159 health care professionals showed a statistically differentiated profile for TYMLOS versus teriparatide. The 3 main areas of difference that were called out by this group of HCPs of what we commonly hear from our customers in the field are that: One, TYMLOS has early action with bone building activity and has effect on BMD and fracture risk reduction. Two, we have an advantage with being the only anabolic that the patient does not have to refrigerate once in use. And finally, our patients and providers welcome our shorter duration of therapy with TYMLOS at 18 months versus 24 months for teriparatide. This encouraging data reinforces that TYMLOS is highly differentiated and positions us well against any potential teriparatide biosimilar or generics.

Next slide. Also, according to our most recent market research data in Q1 of this year, we have now surpassed teriparatide with 58% of Tier A health care providers stating their intent to prescribe TYMLOS versus 47% for the competitor. This is a leading indicator providing positive evidence for solid TYMLOS growth this year.

On Slide 11, we see NRx market share growth with activated TYMLOS prescribers from their core of initiation and each quarter after. We continue to show our ability to activate new TYMLOS prescribers and then accelerate their market share, where within 5 to 6 quarters, market leadership is accomplished. These trends show the confidence that health care providers have in TYMLOS due to its clinical profile, our advantage with no refrigeration once in use and our organization's dedication to women with postmenopausal osteoporosis.

On the next slide. And now we're moving into market access, our start to 2019 has been strong. We see continued new prescription volume growth in both the commercial and Medicare Part D books of business, especially with recent Part D formulary additions at CVS SilverScript and WellCare. Finally, the mission of TYMLOS to become the leader within the anabolic space continues to be the commercial team's #1 priority.

So thank you all. And I'll now hand the call over to Dr. Charlie Morris, our Chief Medical Officer.

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Charles Q. Morris, Radius Health, Inc. - Chief Medical Officer [5]

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Thanks, Joe, and good morning, everyone. What I'd like to do this morning is update you on recent publications that shows the acceptance of TYMLOS strong efficacy by osteoporosis experts and recent presentations that demonstrate our efforts to further contribute to the understanding of patients who should be considered for anabolic therapy with TYMLOS.

In 2019, 3 network meta-analyses have already been published looking at the efficacy of pharmacological therapies for the treatment of postmenopausal women with osteoporosis, including treatment with TYMLOS. All 3 publications supported the efficacy of TYMLOS.

The figures on this slide shows summary data from the largest meta-analysis presented as a part of the recently published ENDO Clinical Practice Guidelines involving almost 200,000 patients from more than 100 studies. The positive effect of TYMLOS on vertebral and non-vertebral fracture is clear. And while the number of events for hip fracture was too small for definitive conclusions, the trend clearly favors TYMLOS. Different studies include different patients, and the risk of fracture will vary from study to study, but the treatment effect of TYMLOS is striking when presented alongside other agents in this in way. As well as this acceptance of our efficacy data, we're also pleased to report within the 2 years since the launch of TYMLOS, during which time more than 20,000 patients have received TYMLOS treatment, our safety profile remains consistent with our prescribing information with no new safety signal, giving us confidence that the safety and efficacy data we saw in our Phase III studies is reflective of what we are seeing in real-world usage.

On the next slide, we see a summary of work we have conducted to understand the impact of TYMLOS on outcomes of patients with postmenopausal osteoporosis, who also have Type 2 diabetes. As the incidence of both diseases increases with age, it is to be expected that they will frequently coexist. Osteoporosis is likely to be underdiagnosed in Type 2 patients, however, as conventional bone mineral density measures do not detect the changes in bone microarchitecture that are associated with diabetes. In addition, the fracture risk of diabetic patients is approximately double that of nondiabetics for any given t-score, likely because of the microarchitectural changes and other factors such as a greater propensity to falls as a result of neuropathy and their visual changes.

Last year, we presented retrospective data from the ACTIVE study suggesting that TYMLOS improved the trabecular bone score, a measure of microarchitectural integrity, relative to placebo in patients with Type 2 diabetes. More recently, this post-hoc analysis of 125 patients in the ACTIVExtend trial, who were known to have Type 2 diabetes and received either 18 months of abaloparatide or placebo followed by 25 months of alendronate, was presented at the American Association of Clinical Endocrinologists annual conference in Los Angeles. Patients treated with TYMLOS showed significant improvement in bone mineral density relative to placebo, and the risk of fracture trended in favor of TYMLOS. Overall, these data support the need to diligently look at fracture risk in postmenopausal women with Type 2 diabetes and suggest that TYMLOS is an option for those who are identified as being at high risk.

I will now turn the call over to Pepe for a review of our financial performance.

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [6]

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Thanks, Charlie. I will walk through the income statement for Q1 2019, and afterwards, I will share our perspective of what we -- sales dynamics, trends and choices we have made on our uses of resources and discuss our financial guidance for 2019. For the 3 months ended March 31, 2019, Radius reported net sales of $29.8 million and a net loss of $42.8 million or $0.94 per share.

For us to better explain the dynamics on our Q1 2019 income statement, you can see on the right side of the slide the figures on a non-GAAP basis, which exclude expenses related to share-based compensation, intangible asset amortization, depreciation and noncash interest from the convertible bond. You can see the reconciliation between our GAAP and non-GAAP measures in the appendix.

Radius, on a non-GAAP basis for the 3 months ended March 31, 2019, had an adjusted net loss of $31.8 million or $0.70 per share as compared to an adjusted net loss of $50.1 million or $1.11 per share for the 3 months ended March 31, 2018. On a non-GAAP basis, I want to highlight that first, our gross margin has slightly decreased to 90%, and we expect it to bounce back in the second half of 2019. Second, R&D expenses slightly grew versus Q1 2018 as we started to invest in the elacestrant Phase III trial and the preparation of the abalo-patch Phase III study. Last, SG&A continues to decrease as we continue to adjust our investment related to the launch of TYMLOS and drive productivity initiatives.

On the next slide, I explain the dynamic of our sales compared to the Q4 2018. Sequentially, as shared in our guidance, we see seasonality impact on market and net price, or gross to net, and positive growth coming from market share gains. On the market side, we experienced a market growth of 6% compared to prior year, which is in line with the guidance of mid-single-digit growth year-over-year. Looking at the market sequentially, compared to Q4 of 2018, the market contracted 8%, which is roughly in line with the dynamic of prior years, as you can see in the appendix. It is normal in the market that there is a higher patient abandonment rate early in the year due to higher out-of-pocket cost for patients. The contraction in the market is compounded by normal adjustment of patient and of wholesalers, which impact our ex factory sales.

From a market share perspective, we can see continued growth of TYMLOS TRx as we consider the sequential market share contraction. On TYMLOS market share growth, we see a healthy demand of TYMLOS from patients.

Finally, from a net price perspective and in line with normal payer dynamic in the U.S. business, we see the impact from increased Medicare Part D manufacturer's share of payment during the coverage gap and the support from Radius to commercial patients' out-of-pocket cost.

As patients cross towards Medicare Part D coverage stage and cover the initial commercial out-of-pocket expenses, we expect to improve the net price and start leveraging the price increase that took place in January 1, 2019.

On Slide 19, we show the continued decrease of cash burn as TYMLOS continues to grow and we drive productivity in SG&A. We ended the quarter with a cash and investment balance of $205 million, which is a strong balance sheet position as we continue to manage our expenses and drive TYMLOS growth.

In the next slide, we show the sequential net sales of TYMLOS and the decrease of SG&A and R&D fixed cost. We expect to continue driving productivity throughout 2019 to manage expenses along this line. The R&D pipeline-related expenses are expected to start growing as we continue advancing the EMERALD study for elacestrant and initiate the abalo-patch Phase III trial. We expect by Q4 2019 that the gross profit from our growing TYMLOS revenues will fully finance SG&A and internal R&D expenses and start financing the pipeline.

Finally, I will share guidance for 2019 for which I highlight the changes in green. Based on the accelerated growth of share among new patients on therapy or NBRx and as we have shared before, we're increasing the lower end of our TYMLOS U.S. net sales guidance. We expect to deliver TYMLOS U.S. net sales in the range of $160 million to $175 million.

We are also guiding that we will cross the 50% market share of new patients in the second half of 2019, which positions TYMLOS towards anabolic market leadership in 2020. From a balance sheet perspective, we have been able to also accelerate productivity gains, so we are increasing our guidance for our cash, cash equivalent and investment balance to be over $110 million at the end of this year.

It is important to reiterate the dynamic on anabolic market year-over-year growth and seasonality. The market contraction and gross to net is expected to improve as we go along the year, especially as we get to the second half of 2019. I look forward to your questions at the end of the call.

With that, I will pass the call back to Jesper for closing remarks.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [7]

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Thank you, Pepe. We're approaching the end of our presentation. And I would like to remind you with this slide about our most important goals and upcoming milestones in 2019.

As we have discussed during the presentation, we have narrowed our financial guidance and expect to deliver a full year net sales of TYMLOS between $160 million to $175 million and achieve a year-end cash balance over $110 million in 2019. We're excited to move forward our abaloparatide-patch clinical program and expect to initiate our Phase III trial in August this year.

For elacestrant, our goal is to make progress in our recruitment for our Phase III monotherapy study and sign a global codevelopment, co-commercialization partnership agreement. We will be providing you an update in due time.

Thank you, everyone, for your time today. I would like to ask the moderator now to open the call for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Jessica Fye from JPMorgan.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [2]

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I have a question on gross to net. It looks like net price in 1Q was a little lower than we happened to have modeled. So maybe 2 questions on that actually. I know you cite the typically lower kind of just market volume in 1Q versus 4Q, but that's kind of something we can capture. So I'm curious when you talk about what sounds like a 1Q drop in channel inventories, if you could quantify that if that's the case. And then on the donut hole, can you maybe tell us what proportion of the donut hole obligation you project for the full year was recognized in 1Q? I'm trying to think about gross to net in 2Q.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [3]

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Pepe?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [4]

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Thank you, Jessica. So if you take a look at the slide where we reconcile versus Q4, $6 million is market seasonality. About 8% decline is attributed to the overall sequential market decline of the anabolic segment. So that will be about $3 million out of the $6 million, and $3 million will be related to seasonal adjustments of days of -- based on handling the trade, which is basically a couple of days. We're still within the range what we have guided before of about 2 to 3 weeks.

On the coverage gap question, from the patients that came in from the end of 2018 and 2019, I would say half of them normally get the third pen, which they want to go through the coverage gap in the first quarter and then there's a lag into the second quarter. Now throughout the year, all the new patients, if they don't have a high comorbidity with other drugs, they will go again through coverage gap. As I explained before and I guided, our overall net price of '18 to '19 is going to slightly increase. The seasonality that you see now in the first quarter is kind of normal at the beginning of the year because of the higher deductibles that we see from patients.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [5]

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Okay, got it. So net price should be up on year-over-year basis in the second half relative to the second half of 2018?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [6]

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Yes. That's correct.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [7]

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Okay. And maybe just a last one. When we think about you crossing that 50% NBRx share mark in the back half of the year, can you remind us the projected lag between when you cross that threshold and when we'll see that in the TRx share?

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Joseph Kelly, Radius Health, Inc. - SVP of Sales & Marketing [8]

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Jessica, this is Joe. And typically what you see is about a 9- to 12-month lag from NBRx share translating to total market share leadership for TYMLOS. So we don't commit to exactly when in 2020, but most likely around mid to late next year.

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Operator [9]

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Our next question comes from Ying Huang from Bank of America Merrill Lynch.

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Alec Warren Stranahan, BofA Merrill Lynch, Research Division - Research Analyst [10]

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This is Alec on for Ying. Given that the abaloparatide-patch went into the clinic in August, could you give us a sense of the steps once you get the patch ready for patients? And then what are your thoughts on the approval of EVENITY from Amgen? I'm particularly interested with regards to the patients indicated on the label and the safety and efficacy comparison in the coming months.

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [11]

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Yes, let me answer the first one, and then I will pass it to Charlie so -- or to Bruce. So right now, we have finalized all the analytical methods that are required in order to start manufacturing the clinical supply with 3M. So 3M as we speak they are getting ready to manufacture all the clinical supplies in the second quarter, as previously committed, so that together in the right timing to start the trial on August. Importantly, as we get into the execution of this trial, we have already contracted the CRO that will be helping us to execute the trial, and we're already helping them to select the right sites to have a fast enrollment.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [12]

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Bruce?

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Bruce Mitlak, Radius Health, Inc. - VP of Clinical Development [13]

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I can just -- as Pepe highlighted, we're about within 90 days of when we start the study. So I think we're working with the CRO to identify the sites. We have investigator meetings planned. We have the instructions for use lined up. And I think we are on track to beat the August start date.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [14]

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Bruce, the other one.

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Bruce Mitlak, Radius Health, Inc. - VP of Clinical Development [15]

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I'm sorry. Could you repeat the question about EVENITY?

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Alec Warren Stranahan, BofA Merrill Lynch, Research Division - Research Analyst [16]

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Sure. I was just wondering how you're seeing that comparing to TYMLOS, particularly the patients indicated on the label and also the black box safety warning and any efficacy comparison.

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Bruce Mitlak, Radius Health, Inc. - VP of Clinical Development [17]

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Sure. Well, first, I think we welcome other agents in the osteoporosis space. It's an area where we really need to have a stronger voice so we could -- patients with osteoporosis are identified and treatments are available. We also acknowledge that Amgen -- or we look to Amgen having now decided that an anabolic therapy is something that is important to bring forward at this point. I think we've highlighted over time the importance of anabolic therapies versus the antiresorptive therapies that are out there. I mean as you highlight, the EVENITY label, romosozumab, has a fairly complicated benefit risk. And I think that we are really very confident in our own data, the efficacy that we demonstrated for our molecule and are confident in our ability to continue to be a valued option for prescribers and have incorporated this thinking into our projections for sales going forward. We will wait and see exactly how EVENITY is incorporated. But I think based on the way it needs to be used, that is physicians need to administer it monthly, giving 2 injections. And the patient selection, based on the risks and benefits of the label, I think suggests that it may take some time for people to be able to really use it more broadly.

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Alec Warren Stranahan, BofA Merrill Lynch, Research Division - Research Analyst [18]

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Great. And actually you answered my second question about the full year guidance and whether that incorporated EVENITY into it though.

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [19]

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Yes, that's incorporated in the full year guidance as well as the -- we expect to become the market leaders in anabolic.

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Operator [20]

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Our next question comes from Geoffrey Porges from SVB Leerink.

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Bradley Patrick Canino, SVB Leerink LLC, Research Division - Associate [21]

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This is Bradley on for Geoff. I appreciate the patch trial initiation guidance. Last year, your R&D day, you indicated data could be possible for 2020. I don't know if you still believe that, that was the case. And then two, on gross to net, you mentioned increased support for commercial patient deductibles. I want to ask if that was just for Q1 in relation to other quarters or if that's something you're signaling as an increased in patient assistance throughout the rest of 2019. And then looking ahead to 2020, do you expect your Medicare coverage to materially increase from 2019? And if so, will that change in patient mix create incremental headwind for 2020 that we should think about?

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Charles Q. Morris, Radius Health, Inc. - Chief Medical Officer [22]

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So I'll take the first part. This is Charlie. So terms of the patch, what we previously indicated, there's no change to this. And so the intention is to complete recruitment of the study by the end of this year so that the final patient would have their last treatment visit by the end of 2020, which would actually pervade into '21. So there's no change to what we previously indicated, and we continue to target that. And as Bruce has mentioned, we are -- we've now fully engaged already with the CRO and beginning the initiation process, so that once we hit August and have sites ready, we can hit the ground running.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [23]

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And Pepe, if you'll take the gross to net, and I'll take the 2020 question.

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [24]

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Okay. So from a patient assistance on deductibles, it is normal that at the beginning of the year, as patients are in the commercial space, they need to pay an initial stage of coverage. The companies, in this case Radius with TYMLOS, will support them as they pass through that stage. Later on the year, then that decreases as -- or only impacting new patients, not patients that are coming or that have been on therapy at the end of 2018. So net to net, our gross to net will improve as we go along the year. And overall, as you look at '19 versus '18, the net price is going to slightly grow.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [25]

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And this is Jesper speaking. On the 2020 question, first and foremost, we are extremely happy, of course, with the commercial access that we're having, which is superior to that of teriparatide. And also, if you're looking at it from a Part D point of view, we are very pleased with the 67% that we're having for Part D. And that means that basically, we have full access to the marketplace. So of course, we would like to see an increase for 2020 in the Part D segment, but it all boils down to cost of rebate vis-à-vis the PBM. So we are very pleased with the position that we're in right now in terms of market access, and could we see no hindering in the marketplace from our point of view.

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Operator [26]

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Our next question comes from Chris Shibutani from Cowen.

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Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [27]

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I wanted to ask about elacestrant. Can you just maybe give a sense for what you're thinking about -- you've been quite forward about describing how you're seeking a partnership on the codevelopment, co-commercialization front. Where are you progressing there? And how we should think about maybe combination agents that you're contemplating? I think CDK4/6 is one that historically has been there. But are you thinking more broadly? Any color on that progress will be helpful.

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [28]

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Yes, Chris. Thanks for asking. The process started at the beginning of the year of full outreach to several players in the market, and conversations are ongoing right now. We have several players in the data room and working with us. It's a process that, as we have explained before, normally take about 3 quarters to materialize. It can slip a quarter or so, but we are very confident that this year, we're targeting to finalize a deal.

What type of structure do we want there? It is a codevelopment. So we will develop the asset in combination. And it's a co-commercialization agreement, so we want to have a footprint in the U.S. in partnership with another player. And then outside the U.S., we would basically monetize the asset through royalties and milestones.

So what type of combination trials we will be targeting? Obviously, our CDK4/6 is probably the lion's share of what we see combination trials to go for. But there may be others that make sense that we're not ready probably to disclose at this point. Do you have any comments to that, Charlie?

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Charles Q. Morris, Radius Health, Inc. - Chief Medical Officer [29]

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Yes. I mean obviously the CDK has always been the priority. It's a significant player in first and second line with palbociclib, in particular, really growing in that space, but the other 2 in there as well. But I think it's very likely, I think, that we're going to see our palbociclib -- PI3 kinase inhibitor coming into play as well. So I think that will certainly be of interest. And m-TOR inhibitors are still there, but perhaps with lower interest. They're largely being relegated to late line therapy. But I certainly think the PI3 kinase and CDKs are going to be top of mind as we discuss with a partner in due course.

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Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [30]

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And quickly on RAD140. Last quarter you gave us a sense that you're expecting to complete enrollment of the Phase I and would provide additional program updates to the first half of this year. I apologize if you mentioned something during this call, but any updates there? And should we expect anything on either elacestrant or RAD140 at ASCO?

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [31]

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We have some information just around the elacestrant EMERALD study at ASCO. There won't be data for RAD140, but we anticipate being ready to provide an update on the next quarter's call.

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Operator [32]

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(Operator Instructions) And our next question comes from Matthew Harrison from Morgan Stanley.

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Matthew Kelsey Harrison, Morgan Stanley, Research Division - Executive Director [33]

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We were just wondering how management's preparing for the expiration of Forteo patent. And what the current expectations are for the launch of those kinds of generics?

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Joseph Kelly, Radius Health, Inc. - SVP of Sales & Marketing [34]

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This is Joe. And as you've heard during the presentation, we feel confident. One, would be the clinical differentiation that we have with TYMLOS versus the teriparatide molecule. That shows up within trials. It's starting to show up now from feedback we're getting from surveys and actual interactions with customers, KOLs that are out in the field.

From a differentiating standpoint, the refrigeration, the storage aspect of TYMLOS being once in use, it doesn't require that; where teriparatide, the molecule does. And also, our price, we're very confident with where we are right now versus the branded teriparatide. So regardless of whether a biosim or a generic may come in, we feel comfortable with where we are across those areas. And potentially, by the time one of these biosims or generics hits the market, we feel confident that our position of strength as far as market leadership from an NBRx and maybe TRx standpoint will allow us to continue to grow TYMLOS in that more, I guess, competitive environment that may be in our future.

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Operator [35]

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And I am showing no further questions from our phone lines. And now I would like to turn the conference back over to Jesper Høiland for any closing remarks.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [36]

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Thank you very much. Thank you, everyone, for listening in. I just want to highlight 3 points.

First and foremost, we're making good progress and are well into the year. We continue to gain market share, and we are leaning towards crossing the fine line of market leadership with we have set ourselves as a very important goal for us for driving the business forward.

On the 3 points that I think is a take-home message from the Q1 result is we lifted guidance for sales for the year, $160 million to $175 million for TYMLOS sales. We will initiate the patch in the month of August. We're also saying it's a very, very important milestone for us and a catalyst for us going forward. And then last but not least, we're also making progress on the partnership. So all in all, we feel we have had a good start to the year, and we continue to progress throughout the year.

So thank you, everyone, for your support, and look forward to discuss with you in more details in the coming days.

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Operator [37]

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Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program.

You may all disconnect. Everyone have a wonderful day.