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Edited Transcript of RDUS earnings conference call or presentation 7-Aug-19 8:30pm GMT

Q2 2019 Radius Health Inc Earnings Call

Cambridge Aug 17, 2019 (Thomson StreetEvents) -- Edited Transcript of Radius Health Inc earnings conference call or presentation Wednesday, August 7, 2019 at 8:30:00pm 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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* 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

* Keith Richard Tapper

Citigroup Inc, Research Division - Research Analyst

* Kyuwon Choi

Goldman Sachs Group Inc., Research Division - Equity Analyst

* Felicia Cosman;Columbia University Medical Center

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to the Second Quarter 2019 Radius Health Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to introduce your host for today's conference, Elhan Webb, Vice President, Investor Relations. Please begin.

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

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Thank you, Norma. 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 in 3 hours following this call.

Before we begin, I would 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. Our 10-K 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.

Here is our agenda for today. Jesper will start with touching on highlights of the quarter. After Jesper's comments, Joe will provide a commercial review of TYMLOS. Charlie will then follow with a review of our latest clinical update with our cash program. Pepe will review then our financial results for the second quarter and provide details on our 2019 guidance.

Today, we are excited to have a guest speaker, Dr. Felicia Cosman. Dr. Cosman will be presenting the current treatment paradigm for the management of high-risk osteoporosis. Our management team, Dr. Cosman, accompanied by Chhaya's group will be available for Q&A at the end of the call.

I would like to now turn the call over to Jesper for an overview of our second 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. We're very pleased to report another strong commercial quarter for Radius. As we continue to increase our market share gains for TYMLOS. In the second quarter of 2019, we increased our sales for TYMLOS by 81% versus the previous year, achieving $41 million net sales, reaching an average of 35% total market share and 46% of new patient starts. We are well on our track to meet our guidance and to capture more than 50% new patient starts on anabolic therapy during the second half of 2019.

This will position TYMLOS to become the anabolic 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. With the continued strong performance of TYMLOS, we're also confident in reaching our sales guidance of 2019 and are tightening our guidance to deliver between $165 million to $170 million net sales for TYMLOS.

We're driving productivity initiatives that we will expect will enable us to exit the year with over $120 million cash balance. We are delighted to have achieved a major milestone towards our company's goal of addressing the needs of osteoporosis patients with the recent initiation of the Phase III study for the abaloparatide-patch. With the encouraging results from our patient assessment starting and the SPA agreement with the FDA, we believe that we have a clearly defined and further derisked the development and regulatory pathway for our pivotal program.

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'm excited to present our commercial update for TYMLOS sales for the second 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 continued in Q2 of 2019, growing to a 46% new-to-brand market share in the second quarter. We feel confident in our continued market share growth with TYMLOS and achieving our guidance of the NBRx anabolic market leadership during the second half of this year, which in turn, we believe, will give us total market leadership in the second half of 2020.

Based on our overall performance, we expect to deliver TYMLOS net sales in the range of $165 million to $170 million for the year. The focused efforts of the organization continue to drive these strong trends, and we expect that both the commercial and Part D books of business will provide sustainable TYMLOS growth for the rest of the year.

On the next slide, you'll see that during the month of May, patient claims data shows that TYMLOS has a 64% NBRx market share with the top 400 anabolic prescribers, which make up 30% of the anabolic market. This segment is typically a predictor of future overall market growth based on their volume potential and influence within the osteoporosis marketplace. There are similar positive NBRx growth with the Tier A segment, which represents 80% of the anabolic market.

You'll see on Slide 9 that we are also encouraged by the anabolic market growth with 4% year-over-year increase for the first half of 2019. We continue to see high growth in our targeted sources of business as we leverage our footprint to continue driving the anabolic market. Thank you all.

And I'll now turn over the call to Charlie.

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

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Thank you, Joe, and good afternoon, everybody. As we reported earlier this week, I'm delighted that we have now initiated our Phase III study for the abaloparatide-patch. The first patient has been randomized. We have multiple sites opened with additional patients in screening. In addition to initiating the Phase III study, we are also excited to have some new clinical data to share.

We previously indicated that we were undertaking some further patient assessments to ensure that our instructions for use for the patch supported ease of use for patients, allowing accurate self-administration in the home setting. Our data shows the patient acceptability is very high, and our instructions enable highly accurate self-administration.

In addition, we have 2 new pieces of information that help us reduce clinical and registry risk in the program. First, we obtained data in our patient assessment study on changes in PINP, a biomarker that indicates bone formation. The data at 1 month looks very similar to the 1-month data we obtained for TYMLOS in the pivotal ACTIVE study. There's a correlation between PINP change and change in bone mineral density. This further increases our confidence that we can deliver noninferiority on BMD change in the WearABLe study.

Secondly, I am pleased to announce that the Phase III protocol has been agreed with FDA under a Special Protocol Assessment. As a reminder, a SpA agreement provides a concurrence with the FDA that the study can be considered adequate and well-controlled in support for marketing application.

On the next slide, the more details of the design that has been agreed under the SpA. We used the SpA process to gain agreement with FDA on key elements of the Phase III protocol, including entry criteria, dose selection, endpoints and planned analyses. We plan to enroll approximately 470 postmenopausal women with osteoporosis at high risk of fracture. Patients will be randomized to either abaloparatide-SC or the abaloparatide-patch in a 1:1 ratio. Patients will be treated for 12 months and have a follow-up visit 1 month after the completion of therapy.

The primary endpoint of this study is percent change in spine BMD at 12 months. And we have agreement with the FDA on a 2% noninferiority margin that preserves at least 77% of the historical treatment with abaloparatide-SC.

With that, I'd like to hand over to Pepe for the financial review.

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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 Q2 2019. And afterwards, I will share a perspective of profit and cash flows and financial guidance for 2019.

For the three months ended June 30, 2019, Radius reported net sales of $41 million and a net loss of $35.5 million or $0.77 per share. The dynamic on our Q2 2019 income statement is better explained on a non-GAAP basis, which is shown on the right side of the slide. These figures exclude expenses related to our share-based compensation, intangible asset amortization, noncash interest from the convertible note and other one-offs.

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 June 30, 2019 had an adjusted net loss of $25.4 million or $0.55 per share as compared to an adjusted net loss of $44.6 million or $0.98 per share for the 3 months ended June 30, 2018. On a non-GAAP basis, I wanted to highlight, first, our gross margin has slightly decreased to 91% due to the seasonality of our gross to net. We expect gross margin to slightly improve in the second half of 2019.

Second, R&D expenses grew versus Q2 2018, as we are investing on the elacestrant Phase III trial and the abaloparatide-patch study. We expect R&D expenses to continue growing in the second half of 2019. Last, SG&A continues to decrease as we continue to adjust our investment related to the launch of TYMLOS and drive productivity initiatives.

On Slide 15, you can see the drivers for the sequential growth of net sales compared to the first quarter of 2019. This is similar to the slide that I shared in the prior quarter. On the market side, sequentially, compared to Q1 2019, the anabolic market grew approximately 5%, and we experienced a bounce back in stocking trends. The market share grew from 30% average in Q1 2019 to 35% in the second quarter of 2019, which drove net sales growth by $5 million.

Finally, from a net price perspective and in line with normal payer dynamic in the U.S. business, we see a modest improvement in net price with continued impact of Medicare Part D and rate of support to patients on the commercial book of business. The slight improvement in Q2 2019 is expected to further improve in the second half of 2019, as patients pass through the high deductible period in each book of business.

On Slide 16, 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 cash and investment balance of $189 million, which is a strong balance sheet position as we continue to manage our expenses and drive TYMLOS growth. The R&D pipeline-related expenses are expected to start growing as we continue advancing our Phase III elacestrant trial and abaloparatide-patch programs. We expect in the fourth quarter of this year, that the gross profit from our growing TYMLOS revenues will fully finance SG&A, and in turn, our R&D and will start financing the pipeline.

Next, I will share guidance for 2019. Based on the anabolic market and the market share dynamic, we expect TYMLOS net sales to be in the range of $165 million to $170 million. I'm also confirming guidance 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 programs. So we are increasing our cash, cash equivalents and investment balance to over $120 million by the end of this year. It is important to reiterate the dynamic on anabolic market year-over-year growth of seasonality. The market contraction, and gross to net is expected to improve as we deliver TYMLOS growth in the second half of 2019.

Slide 18 shows the drivers for revenues as we guide the second half of 2019 of $94 million to $99 million compared to the net sales of $71 million in the first half of 2019. The anabolic market is expected to grow between 6% to 8% in the second half of 2019, which is similar to last year's dynamic and should drive growth of $5 million to $6 million versus first half of 2019.

We expect to continue driving TYMLOS TRx market share growth from a 33% average in the first half of 2019 to a range of 37% to 38% average in the second half of 2019. As we have explained before, it takes about 4 quarters to translate from NBRx to TRx share performance. The NBRx in the first half and second half of 2018 were 33% and 37%, respectively, which is in line to the first half 2019 performance and the guidance for the second half of 2019. This increase in market share should drive $10 million to $12 million net sales growth in the second half compared to the first half of 2019.

Finally, we expect the net price of TYMLOS, net of all revenue reductions, to increase by 10% to 12% as we cross the balance ORR in Medicare Part D and the patient support for high deductibles in the commercial book of business. This should drive growth of $8 million to $10 million in net sales in 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 the closing remarks.

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

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Thank you, Pepe. Since the beginning of this year, we successfully executed on multiple areas achieving our commercial and clinical development goals. With the continued strong commercial performance of TYMLOS, we are confident in reaching anabolic market leadership in new patients in the second half of this year and delivering our full financial guidance, realizing $165 million to $170 million revenues for TYMLOS and advancing our innovative patch program to this pivotal stage. As we have promised, it was a significant milestone for us.

We are excited to have clearly defined and further derisked the development pathway for this program with the SpA agreement from the FDA and the recent encouraging results from our patient assessment study. We expect to complete recruitment for our abaloparatide-patch Phase III study by the end of this year and continue towards our goal of bringing a potentially transformative treatment option of osteoporosis to the market.

Slide '21. On this slide, you can see our expected milestones for the rest of this year. At this point of time, I am pleased to introduce Dr. Cosman who has more than 25 years of experience in research and treatment of osteoporosis therapies. Dr. Cosman will provide us with insights on osteoporosis treatment and the importance of anabolic therapy to address the unmet needs of osteoporosis patients. In addition to Dr. Cosman, we also have our SVP of Technical Operations, Chhaya Shah and our VP of Clinical Development, Dr. Bruce Mitlak, joining us for the Q&A today.

I would like to pass over to Dr. Cosman.

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Felicia Cosman;Columbia University Medical Center, [8]

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Thank you very much, Jesper. It's a pleasure to be here speaking to you today.

So as you are all aware, osteoporosis is a disease, where weakened bone is susceptible to fracturing with minimal trauma. And osteoporosis-related fractures have consequences: mortality, morbidity, impaired quality of life and progressive frailty and loss of independence. And these fractures are common. About half of all women aged 50 and older will experience an osteoporosis-related fracture. A lifetime risk of a hip fracture is 15% and fractures are costly. Each year, about 2 million fractures, 432,000 hospital admissions and almost 200,000 nursing home admissions are attributable to the underlying disease of osteoporosis.

But we have a bunch of challenges facing us today. We know that the majority of patients at highest risk for fractures are not being treated with anything. Below 20% of patients with new fractures are treated for their osteoporosis. There are a lot of reasons for this. Many patients have osteoporosis T-scores -- BMD T-scores that are slightly above the osteoporosis touch point, which confuses a lot of patients and physicians. Many vertebral fractures are never actually identified on x-ray. There is a tremendous inconsistency in the medical specialty guidelines where the role of anabolic therapy is consistently under-recognized. And many patients and physicians misunderstand the balance between benefits and risks of all of our medications. And they don't take into account the risks of not treating the underlying disease. And as a result, the compliance and persistence with osteoporosis therapies is really poor.

We know that prior fracture is the most important risk factor for future fractures, but this risk is not linear over time. And actually a recent fracture suggests a very high imminent or near-term risk. And I'd like to call this an osteoporosis emergency. It suggests the need to treat these patients urgently to prevent more disabling fractures. As you can see in this graph, this follows 377,500-plus women who had a first fracture followed for up to 5 years and the risk of yet another fracture, the absolute risk, was 10% in the very next year and 20% in the next 2 years. So these patients are at the highest risk that we have.

We know that the patients who have this high near-term risk need treatment urgently that reduces the risk of fracture quickly and provides a sustained effect after transition to long-term therapy. This includes these recent fracture patients as well as multiple fracture patients, even if they weren't so recent. And it also includes a group of patients who have very low bone mass, particularly if they have concomitant clinical risk factors. And the optimal way to treat these patients is to begin with an anabolic therapy and then transition to an antiresorptive therapy to maximize their BMD gain and to improve most substantially their bone strength for the long term.

Antiresorptive agents, which is a standard of care, do not repair structural damage and don't repair bone density deficits enough. And as a result, they may not work consistently or rapidly enough across the skeleton. You do see vertebral fracture risk reductions with these agents within a year on the order of 60% to 70%, but nonvertebral fracture risk reduction are at best 20% to 25% in magnitude and not seen before 3 years of treatment.

In contrast with abaloparatide, as I'll review for you, you see fracture risk reductions and substantial bone density building very quickly within 18 months. As you recall, the ACTIVE trial randomized osteoporosis affected women, 2,450-plus women, to placebo or abaloparatide or the positive comparator teriparatide for '18 months of therapy and then the placebo and abaloparatide groups transitioned to alendronate, a standard antiresorptive drug for the ensuing 2 years in the extension study.

One of the first signs of efficacy for abaloparatide is the increase in serum PINP, a marker of bone formation that you see doubled already within a period of 1 month and stayed above the baseline level for the entire 18 months of this study. The bone degradation or bone resorption marker, C-telopeptide, increased only about 20% and the increase was delayed within the peak at 3 months and then a quick return back to baseline levels.

Associated with these biochemical marker changes, you see that spine bone density goes up substantially very quickly, within 18 months, about 10% increases seen, and then after transition to alendronate therapy, as a continued increase over the entire 2-year period.

Associated with these bone density changes, there was a very rapid production in new vertebral fracture occurrence and actually a near eradication of vertebral fractures is seen in patients treated with abaloparatide. As you can see only 4 patients had vertebral fractures compared to 30 in the placebo group and 86% risk reduction with abaloparatide. And this was seen also, a risk reduction of similar magnitude in the extension period, even though the middle set of bars here, this is where all the subjects are on alendronate therapy. But the group that originally received abaloparatide has an 87% risk reduction for new vertebral fractures during this 2-year period compared to patients who were originally treated with placebo, which is very convincing evidence of the sustained effect of bone strengthening with abaloparatide during the initial 18 months of therapy.

We see a similar effect when we look at nonvertebral fracture. Here the abaloparatide group in purple shows the very early separation from the placebo group, and at the 18-month time frame, a 43% risk reduction is seen for nonvertebral fractures. That's about twice the magnitude of fracture risk reduction for nonvertebral fractures that we see with even the best antiresorptive therapies in about half the time.

We see that this effect, again, nonvertebral fractures is sustained over the extension period with an absolute and relevant risk reduction, which are similar at the end of the 3.5-year ACTIVE and ACTIVE extension study, as they were seen at the beginning of the ACTIVE study.

So in summary, we know that patients who have recent fractures have a very high risk of having another fracture in the next 2 years. About 1 in 5 will have another fracture. This is our urgent unmet need. Abaloparatide provides rapid and significant fracture risk reduction across the entire skeleton, spine and nonvertebral fractures. The reductions in risks are maintained after transition to alendronate and there are associated substantial increases in bone density, both at the spine and hip demonstrated when abaloparatide is used first in a sequential therapy regimen.

To optimally manage the osteoporosis treatment of 2 million patients with fractures every year, however, requires not only specialists, but also primary care providers and other health care providers as well. Transdermal abaloparatide has the potential to broaden both patient and provider acceptance with this potent therapy and has the potential to significantly reduce the burden of disease and complications from osteoporosis. Thank you very much.

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Elhan Webb, Radius Health, Inc. - Head of IR & External Communications [9]

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Thank you, Dr. Cosman. Norma, we'd like to please now open the call for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Jessica Fye of JPMorgan.

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

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A couple on the updated guidance. Curious what you think about Teva's comments on generic Forteo this morning and whether your guidance reflects that product launch in the back half of the year or when it reflects that product launching.

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

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Thanks for the question. As we have stated before, we have considered several assumptions and expectations to provide the guidance. But the generic teriparatide is one that we have included, but we don't see that to be material to our guidance and our growth as we move forward. So it's not something that is really impacting our expectations for the balance of the year.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [4]

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Okay. Got it. And maybe just sticking with the guidance update, what's your current thinking for the 2019 anabolic market growth with what looks like a little slowing more recently? It seems like the second half market growth assumption might translate to something more like 4% full year growth, is that fair?

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [5]

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Yes. Roughly, you're right there. It's -- so we see -- as you see last year, the second half of the year grew against the first half by 8%, which is roughly what I'm guiding right now, and that would translate into roughly those numbers that you're quoting.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [6]

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Okay. And then last one just on gross to net. It seems like the gross to net you're projecting for the back half of 2019 might be a little steeper than what you realized in the back half of 2018. Is that fair?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [7]

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Yes, that's correct. So remember that there's a change in Medicare Part D coverage gap that went from 50% to 70%. And we have also added formulary access in several programs, including CVS SilverScript for Medicare Part D. So that obviously increases the gross to net.

Now what we have seen over the first 6 months of the year is that our growth has been significantly higher in Medicare Part D, so beyond our expectations, which is changing the mix of business. And normally, Medicare Part D is slightly more costly, if you were to call it, from a gross to net perspective. That's what we have been experiencing.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [8]

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And Jessica, just on the access side, you will recall that last year, we had 44% in the Part D segment that has for this year increased to 67%. That's, of course, a part of what Pepe is explaining.

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Operator [9]

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And our next question comes from Paul Choi of Goldman Sachs.

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Kyuwon Choi, Goldman Sachs Group Inc., Research Division - Equity Analyst [10]

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Maybe just pivoting to the patch program and if you could maybe expand a little bit on the initial PINP results that you disclosed. Can you maybe comment on, are you seeing in terms of additional follow-up, the durability of the increase sustaining? Is it plateauing? Or are you seeing that the trends continue to increase as the exposure type is expanded?

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Bruce Mitlak, Radius Health, Inc. - VP of Clinical Development [11]

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This is Bruce Mitlak. Thank you for your question. Maybe to be sure that I understand what you're asking, what we have presented now are results from a study where we treated patients for 29 days. That 29 days corresponds to the period of time where we see a peak in the PINP response when patients are treated. In that study, we did not continue to follow patients. But we found -- our conclusion, as we looked at this, was because we saw a peak response that was very similar between patients who had patches applied compared to patients who had subcutaneous injection, we were projecting -- we basically concluded that, that showed that the expected level of efficacy was being produced by the patch. And that increased our confidence that when we treated patients for the full years’ time that we would see the efficacy that is needed to bridge to the subcu product. Does that answer your question?

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Kyuwon Choi, Goldman Sachs Group Inc., Research Division - Equity Analyst [12]

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Yes, in part. I appreciate that you didn't -- you haven't disclosed any -- or you didn't follow the patients for a longer period. I'm just curious if there's any additional studies that you plan to do just to make sure that the durability of effect, I guess, is sustained?

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

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No, I think what we are starting is our Phase III trial. And I think what we have shown in the short study is that patients can follow the instructions, apply the patch correctly and get the exposure we expected. And that we see the pharmacodynamic response for the month and that we're transitioning into our Phase III trial.

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Kyuwon Choi, Goldman Sachs Group Inc., Research Division - Equity Analyst [14]

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And then one on the cash burn and cash position for Pepe. I guess, just as you think about the spend for the back half of this year, should we think about your net cash burn picking up, I guess, because you're -- it looks like your net cash spend per quarter continues to trend down on an overall basis. But with the Phase III programs expanding here, can you maybe just walk us through how we should think about the cash position for the next couple of quarters?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [15]

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Yes. So we finished the second quarter with $189 million. We are guiding that we will, by the end of this year, we will end up with over $220 million -- sorry, $120 million. So that's the -- there you can calculate the cash burn for the second half. The dynamic there is that we expect TYMLOS to continue to grow, which provide more cash from -- generation of cash. And then SG&A has been decreasing, as I showed in the slide, and we will continue to drive productivity initiatives that makes sense. And then on the opposite side, our ambitions are growing as we continue to recruit patients in both elacestrant and the Abalo-patch trials. By the end of this year, so in the fourth quarter, I expect TYMLOS to pay for all the SG&A of the company or they can fix the infrastructure of R&D and start paying for partially for the pipeline. That's how we're going to exit.

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Operator [16]

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And our next question comes from Geoffrey Torges (sic) [Geoffrey Porges] of SCP Bank (sic) [SVB Leerink].

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Bradley Patrick Canino, SVB Leerink LLC, Research Division - Associate [17]

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This is Brad Canino on for Geoff. It doesn't seem like the patch study is large enough to really have an impact on TYMLOS sales. But since we all are watching the prescription data, do you expect the enrollment at all to interrupt the NBRx trend that you're seeing towards that 50% guidance that you've put out for year-end?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [18]

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So the guidance already capture -- obviously, we are going to have trial ongoing. But just to be clear, there's roughly 600 to 700 NBRx or new patients every week. And the study will capture less than 500, so -- as a whole so that we don't see this is a major impact to our revenues.

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Bradley Patrick Canino, SVB Leerink LLC, Research Division - Associate [19]

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Okay. That's perfect. And then just on the Medicare Part D redesigns that have been floating around Congress, could you comment on how that could impact your business here?

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [20]

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This is Jesper speaking. I think that's a little hard to predict, because we haven't seen the final print. There's a lot of discussion going back and forth. So I think we will have to say that the final impact is going to be in 2021, 2022 as far as I'm concerned and from what I've seen. So it's not something that is within our guidance as we're speaking.

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Operator [21]

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And our next question comes from Mohit Bansal with Citigroup.

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Keith Richard Tapper, Citigroup Inc, Research Division - Research Analyst [22]

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This is Keith on for Mohit. A quick one regarding TYMLOS Medicare Part D coverage versus private payer revenue growth. Should we watch for an inflection point later in the year? Or has that already happened? And then do you expect a gradual tailwind going forward?

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Joseph Kelly, Radius Health, Inc. - SVP of Sales & Marketing [23]

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This is Joe. So of course, you have more patients that are now getting through the donut hole. So yes, we would expect additional growth and some gross to net impact, as Pepe had mentioned. So certainly, we'll have some advantages during the second half versus the first half in that particular segment.

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

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This is Pepe. There's a slide on the back that shows first half to second half revenues, and that does give you an indication of the market growth in the second half that we expect to grow between 6% and 8% against the first half. Market share to pick up to about 37%, 38%, which is in line with the NBRx of the second half of last year. And then the net price against the first half to improve between 10% and 12%. Those are the 3 components that drive the revenues for the second half against the first half.

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Keith Richard Tapper, Citigroup Inc, Research Division - Research Analyst [25]

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Okay. That's helpful. And any color on when we'll hear an update on RAD140 or the partnership with elacestrant?

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Charles Q. Morris, Radius Health, Inc. - Chief Medical Officer [26]

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Keith, this is Charlie. For RAD140, you'll see there is an update on the Phase I data that has been included in the Q. We have now data from the Phase I study. We've identified our maximum tolerated dose at 100 milligrams and we have treated a number of patients. We understand the pharmacokinetics. We have seen some evidence of clinical activity. In terms of next steps, what we've said is that we're going to continue to evaluate the potential in the preclinical -- in the clinical setting to understand potential ways forward, but there isn't an immediate plan to initiate a Phase Ib study.

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Keith Richard Tapper, Citigroup Inc, Research Division - Research Analyst [27]

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Okay. That's great. Go ahead, sorry.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [28]

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Regarding partnership work, we continue to be in discussions with partners, and there should be an update before in year-end.

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Operator [29]

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(Operator Instructions) Our next question comes from Chris Shibutani of Cowen.

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

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Congratulations on the updated progress that you have with the patch. In particular, that was very reassuring in terms of your time lines. You have made comments about some of the research that you guys have done, surveying clinicians, where you talk about a potential "tripling of the market in PMOT or Patient Months on Therapy." And you cite some pretty specific numbers, 338,000 to over 1 million. And I'm just trying to figure out how I should be thinking about slicing and dicing that number. I think there are certain assumptions that seem to go into that months on therapy, including what kind of adherence that you expect for the injection versus the patch. Can you help us a little bit understand better where those numbers are coming from and what the componentry is, because it's a tripling of PMOT, but there are some variables underneath that? It's certainly not tripling of units or patients. I would think that there are some other variables. Can you help us understand that?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [31]

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Yes. Let me just level set. This is a market research study done by one of the most well-known research company in the U.S. It was a study that was done in the last quarter of last year. It included 200 physicians that treat osteoporosis and also included discussions with several PBMs and other players in the market. The study was done independent to Radius. So it was -- we contracted it but it was done externally. What the output of the study suggests is that in the -- compared to the market of 2018 in which we have a bit over 300,000 patients on therapy, which is number of patients that are treated for a full month in a year, you see that the market is expected to triple in -- with the introduction of the patch and the development of the category as we move forward. It included several assumptions on pricing, on generic teriparatide entrants. It also had some sensitivity to romosozumab and others. So it was a pretty comprehensive modeling with several assumptions included in it. And I would say the key takeaway for us is that we will not only expect to play in a triple market with abaloparatide as a franchise with SC and the patch, we'll take a lion's share of that market. We expect around 60% market share of that market.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [32]

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And Chris, just to put the numbers into perspective, today, we anticipate that between 40,000 and 50,000 are treated. If we just -- let's take that number back to 2010, 2011, that number was around 120,000. In other words, you have seen a strong, strong decline since 2010 until the point of time when TYMLOS was introduced into the marketplace in June of 2017. And therefore, of course, from there on, you have seen a growth in the marketplace, which is, of course, what we're very, very encouraged by. And we do believe that these numbers are doable.

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Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [33]

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So then just to be clear I'm understanding the numbers you're using, when you say 60% share, that would be you expecting of the units of abaloparatide, 60% of those at some point would be from the patch and 40% would be from the injection, is that correct?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [34]

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No, sorry, for not being clear. Of the entire market, we expect 60% of that market to be abaloparatide, 40% to be the competition, which could include teriparatide generic and branded.

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Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [35]

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Got it. And within your abaloparatide, what do you foresee as being the potential split between patients on patch versus injection, particularly as you get to a more mature state, maybe 4, 5, 6, years in?

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Jose Carmona, Radius Health, Inc. - CFO, Senior VP & Treasurer [36]

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So the range is 47% for the patch and about 15% for SC. What will happen dynamically here is that SC will take market leadership, but we're guiding second half of next year to be TRx market leaders. After the introduction of the patch, there will be a market growth and cannibalization from the SC. We don't expect SC to go away. We believe that the 2 products will play well in the market and both will be used, but the patch would be the largest business there.

So just to be more explicit on the growth, the growth of this market is coming primarily from AMCPs that right now treat osteoporosis, but not with an anabolic. Most of them are general practitioners that -- but right now, you use antiresorptives. And the ease of use and ease of training a patient with the patch, it helps to penetrate that prescriber base. That's one of the biggest drivers of the growth.

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Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [37]

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It's a busy earnings call, but I had more to learn about the subcu patch, I'll ask -- I'll talk to you guys with more questions in the future, but I appreciate the incremental insights. Congrats on a solid quarter.

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Operator [38]

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At this time, I'm showing no other questions. I'd like to turn the call back over to Jesper Høiland for closing remarks.

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Jesper Høiland, Radius Health, Inc. - President, CEO & Director [39]

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Thank you, everyone, for joining us on the call today. We are really pleased with the performance that we have shown here in the second quarter. Of course, first and foremost, in the commercial area where Radius continues to grow the TYMLOS market share and also, where we have really executed on our clinical programs now coming out of the Phase III program for abaloparatide-patch.

So all in all, we feel that we are on a very good place this time of the year and really look forward to -- towards the end of the year. So thank you to all of you for listening in and joining us today.

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Operator [40]

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Ladies and gentlemen, thank you for your participation in today's conference. You may disconnect. Everyone, have a wonderful day.