Q3 2015 Earnings Call Transcript

Published: 7 Nov 2015

[Operator:]

Good day, everyone, and welcome to the Radius Health Third Quarter 2015 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Barbara Ryan, Investor Relations. Please go ahead.

[Barbara Ryan:]

Thank you, Kim. Welcome and thank you to those of you joining us on the line and the webcast this morning for a review of Radius Health third quarter 2015 financial and operating results. I'm Barbara Ryan, Radius Health's Investor Relations Officer. And with me this morning to discuss the results and update you on our progress are Robert Ward, President and Chief Executive Officer; David Snow, our Chief Commercial Officer and Nick Harvey, our Chief Financial Officer. Before we begin, I would like to remind you that any statements made during this call that are not historical are considered to be 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 most recent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission and our other reports filed with the SEC. Any forward-looking statements represent our views as of today November 5, 2015 only. A replay of this call will be available on the company's Web site www.radiuspharm.com following this call. You can find the dial-in information for the replay in today's press release as well as on the company's Web site. I would now like to turn the call over to Robert Ward, President and Chief Executive Officer of Radius Health.

[Bob Ward:]

Thank you, Barbara, and thank you to everyone who has joined us on our conference call and audio webcast this morning. As we review the company's recent performance, I'd like to highlight the importance to Radius of this year's meeting of the American Society of Bone and Mineral Research or ASBMR, which is the major annual North American bone meeting. We were pleased to have two oral and two poster presentations at the meeting, including the oral plenary presentation of our Phase 3 ACTIVExtend clinical trial by Dr. Felicia Cosman of Columbia University. Overall, the reception to the abaloparatide oral presentations and posters was overwhelmingly positive. It's been over five years since the last approval of a major new injectable osteoporosis treatment in the U.S. As a result interest in this category over the past few years has been low. Today we believe this is rapidly changing. Osteoporosis is now on the cusp of a renaissance with a series of potentially important new drugs set to launch in this large under served marketplace over the next several years. For example, while we're preparing our regulatory submission for abaloparatide, Merck is bringing forward their Phase 3 program and Amgen also has a Phase 3 program in osteoporosis. We believe we're entering a golden age for innovation in osteoporosis and this year's ASBMR meeting was a wonderful opportunity to educate key opinion leaders and prescribers in the category about the results of our Phase 3 program for abaloparatide-subcu. We're on track to submit an MAA in the European Union and an NDA in the U.S. for abaloparatide-subcu by the end of this year and pending favorable regulatory review, we're preparing for commercial launch in 2016. As a reminder in our Phase 3 ACTIVE trial abaloparatide demonstrated an 86% reduction in new vertebral fractures, a 43% reduction in non-vertebral fractures and a 17% reduction in major osteoporotic fractures. All of these were statistically significant comparisons to placebo and abaloparatide performance in the trial is very encouraging. Having successfully completed a Phase 3 trial with over 2,400 patients a big task for a small biotech company. We're now focused on building our commercial infrastructure in the U.S. and identifying the right partner to help us commercialize abaloparatide globally. We recently announced that David Snow has joined us as Chief Commercial Officer after 15 years at AstraZeneca where he delivered outstanding growth in the marketplace for their global brands. Dave is now leading our preparations for launch and I'd like to ask you David to share with us your perspectives on the market.

[Dave Snow:]

Thank you, Bob, good morning everyone. It's important to note that over 2 million individual suffer osteoporotic fracture each year and today only a third of these are diagnosed and treated. In fact we estimate that currently bone building therapies are used by less than 1% of eligible patients. So our focus is how to address the broader market and how to improve the diagnosis and treatment rates for osteoporosis. We looked at the size of the sales forces deployed around both Prolia and Forteo and based on third-party published research we estimate that they're -- that those are in the range of around 300 sales reps or less. From a biotech perspective, this is typical of a specialty product market with a very concentrated number of high prescribers who are familiar with using injectable drugs to treat osteoporosis. We believe that one of the key elements of success will be the scientific message and how we engage with the key opinion leaders, to that end last month's ASBMR meeting was a very important meeting for Radius. The reception from the community was encouraging with a high level of interest in the new abaloparatide data. The field is beginning to think differently about how they treat osteoporosis given the potential for new therapies that have rapid onset of benefit. The second piece needed for a successful commercialization is the infrastructure and especially category like this typically reimbursement of patient support services are required to ensure the patients have access and are trained on how to use injectable treatments. With the advent of new agents we anticipate that physicians will begin to focus more on treating to target, improving skeletal health and ensuring longer fracture free intervals. We think these are all very favorable trends for abaloparatide-subcu if included. Typically, when new innovative therapies are introduced into the market, we see an increase in the rates of diagnosis and treatment. Over the next five years, we expect a significant expansion of around 10,000 U.S. based physicians who routinely prescribe injectable osteoporosis therapies. For example, in the U.S. alone, there are 55,000 additional physicians today may treat osteoporosis, but don't routinely prescribe injectable osteoporosis treatments. For those physicians, we believe that the transdermal patch development program represents an easy use option that may significantly expand our interest in bone building therapies. We believe that these trends may support expansion in other markets around the globe as well as we have previously disclosed we are currently engaged in constructive discussions to establish abaloparatide partnership. An ideal partner would have previous osteoporosis experience as well as demonstrated capabilities in launching significant specialty brands. I'd now like to turn this back -- the call back over to Bob.

[Bob Ward:]

Thanks David. I'd now like to take a brief moment to update you on activities across the portfolio. We look forward to discussing the portfolio with you in detail at our upcoming Investor Day on November 17 in New York City. In the quarter, we completed primate model studies to identify and optimize transdermal patch with the potential to deliver a bioequivalent PK profiled subcutaneous to abaloparatide. As we speak today, we're manufacturing patches and plan to start to human replicative study by the end of this year. The replicative study will enable us to fine tune the patch using human clinical data prior to performing a formal bioequivalent study. Bioequivalent is a well-established path for introducing line expansion. The FDA guidance requires have a PK profile that's between 80% and 125% of the approved drug. We'll use the data from the human replicative study to design the bioequivalent study that we expect to start next year. Accordingly, we'll submit the transdermal patch for regulatory review following the approval of abaloparatide-subcu. Turning now to RAD1901, our selective estrogen receptor degrader, which at high doses we're studying in metastatic breast cancer. In the quarter, we reported the safety and tolerability data from our healthy volunteer maximum tolerated dose study. The data shows that RAD1901 was well-tolerated across the 200 to 1,000 milligram dose range that was studied. We also reported that RAD1901 showed synergy when combined with Pfizer cdk46 inhibitor Ibrance or with Novartis' mTOR inhibitor Afinitor. The preclinical animal model shows that the RAD1901 combinations reduce the growth rates and the size of patient drive tumors to a greater extent that any single agent studies alone. This Saturday, November 7 at the AACR-NCIEORTC meeting here in Boston will be making an oral presentation of additional single agent preclinical data for RAD1901. We believe these data are supportive of a potential use of RAD1901 in tumors that no longer respond to currently available endocrine therapies. We're also very excited about our ongoing Phase 1 dose escalation study in metastatic breast cancer patients. And we're pleased to have three RAD1901 abstract accepted for presentations at the San Antonio breast cancer symposium in December. These data are currently embargoed until that conference begins. Remember the Phase 1 dose escalation study in metastatic breast cancer patients is studying the same dose range 200 milligram once daily to 1,000 milligram once daily. There are three important areas that we'll be evaluating during this trial tolerability, stable disease and signs of tumor regression. When a patient initiates on a dose level, the patient will be continually administered RAD1901 as long as the drug is well-tolerated and the patient shows stable disease. We'll be providing a full update on the Phase 1 trial of the San Antonio breast cancer symposium later this year. Now, remember the purpose of the Phase 1 study is to help us pick a dose that we believe has the best potential for the right risk benefit profile in the symposium metastatic breast cancer patient population. The dose will then be taken forward in development through the expansion cohort that will be added to the trial. We plan to commence our expansion cohort next year, the expansion cohorts will allow us to study how RAD1901 works as a monotherapy, works in combination with other agent or in patients with tumors resistant to other endocrine therapies. We recently formed a very prominent oncology advisory board which includes amongst other Dr. George Sledge from Stanford University and Dr. Carlos Arteaga from Vanderbilt and they have been advising us on how to develop these expansion cohort trial designs. So once we've identified the dose to move forward, we'll be prepared to start the expansion cohort as soon as possible. Based on the emerging preclinical data we believe that once daily oral RAD1901 has the potential to become an important option for overcoming endocrine resistance and a profile that's well suited for use in combination therapy. As we continue RAD1901 development, we're also exploring potential clinical collaborations which maintain the greatest degree of flexibility for our shareholders as we think about how to maximize value. There are additional activities currently ongoing with RAD1901. We're on track to commence both the European Phase 1 study in metastatic breast cancer patients and also the vasomotor Phase 2B study by the end of this year. Now I'd like to turn the call over to you Nick, our Chief Financial Officer to provide us an update of our third quarter results and on our balance sheet.

[Nick Harvey:]

Thank you, Bob. For the three months ended September 30, 2015, we reported a net loss of $28.3 million or $0.68 per share as compared to a net loss of $17.4 million or $0.59 per share for the three months ended September 30, 2014. The increase in net loss from the 2014 period to 2015 period is primarily attributable to the growth of the organization as we prepare our MAA and NDA submission and plan for the potential promotional launch of abaloparatide-subcu. We've experienced a substantial growth in our headcount and we expanded the development activities for RAD1901. As Radius continues to advance towards their first commercial sales, we expect to continue to expand on this month in launch preparation. Our cash, cash equivalents and marketable securities balance as of September 30, 2015 was $500.8 million, we believe that our cash and cash equivalents and marketable securities balance. Prior to the consideration of revenue from the potential future sales of any of our investigational products or proceeds from partnership activity is sufficient to fund our development plans, U.S. commercial scale up and other operational activities into 2018. I would now turn the call back over to Bob.

[Bob Ward:]

Thank you, Nick. Before we open the lines for questions, I'd like to summarize our upcoming milestones for the remainder of the year. Having both completed and reported the positive top line results for the Phase 3 ACTIVE trial in the six months ACTIVExtend, we are on track to submit an MAA in the EU and NDA in the U.S. for the investigational drug of abaloparatide-subcu by the end of this year. We plan to commence the clinical evaluation of the optimized abaloparatide transdermal patch by year-end as well. For RAD1901, we will present the results of the preclinical studies of a single agent at AACR this Saturday, November 7 in Boston and we're pleased to have had three abstracts accepted for the San Antonio breast cancer symposium in December, where we will update you on our ongoing Phase 1 trial in metastatic breast cancer. We're also on track to initiate the additional RAD1901 metastatic breast cancer Phase 1 clinical trial in the EU and the Phase 2b trial for low dose RAD1901 in vasomotor conference. We're excited to be hosting our first Investor Day in New York City on November 17 and we'll be making a presentation of the Goldman Sachs, SMID Cap Conference in New York on November 19. We want to thank you for your continued interest in Radius. And Kim, we'd now like to open up the call for questions from our audience. Thank you.

[Operator:]

[Operator Instructions] Our first question is from Jessica Fye from JPMorgan.

[Jessica Fye:]

My questions, I guess a few on 1901, first can you remind us what the target enrollment is for the first stage of your Phase 1 study in patients and how close you are to completing enrollment there? Then also you talked about starting the expansion cohorts next year 2016, its pretty wide timeframe, can you refine whether you're expecting that to be near the beginning of the year that you start those cohorts or closer to the end of the year? And then also tell us about your timing of your investor meeting you highlighted that the data coming out that San Antonio is embargoed so I guess why not host the meeting after that so you can talk about the data?

[Bob Ward:]

Thanks for your question, Jess. Yes. We're all very excited about the progress in the Phase 1 trial and we'll provide a full update on enrollment at San Antonio and also provide a better refinement on the starting of the expansion cohort. The reason why we're working on the design of the expansion cohorts today is to make sure that the programs are in place so when we have the dose to carry forward we're ready to execute. Remember some of the cohorts designs that we're looking at are combinations with other agents. So one element of that would be potential collaboration with other parties who are running the combination trials ourselves is certainly on the plate. In terms of the timing for Investor Day, it's always difficult to find exactly the right time. But we wanted this year to have a chance for investors to talk with us about the very important progress that we were making with our Phase III program for abaloparatide, review the full scope of the applications for RAD1901 and also introduce a little bit better understanding around RAD140, the preclinical compound in our portfolio that next year we'll be initiating clinical activities around. On Investor Day, the management team will be present both to share with investors what work they've been undertaking but to give people a chance to meet the people and directly ask questions to them as well. So the 17, we picked is being before Thanksgiving, before the end of the year rush and usually the first quarter of next year gets off to a pretty heavy start as well. So we picked it as a time to give people a portfolio update and then we look forward to next year having our second annual Investor Day and we'll probably end up being in the same quarter and just trying to pick a day that seems one that's useful within the calendar -- nothing else goes behind scheduling realistically.

[Jessica Fye:]

Okay, got it. And can I just ask a follow-up on abaloparatide related to commercialization, I think you previously suggested some sales forces in the space were more in the range of like 150 reps, something you're talking about up to 300 now, not disagreeing that 300 could be the right number, but I guess what changed in your thinking there?

[Bob Ward:]

Well, Jess, we've guided previously that we anticipated launching with about 150 sales reps. And at that time what we shared with as well was that based on third party research, our understanding was Forteo had 150 reps carrying Forteo in the first position 150 in the second position, 150 in the third position. So of course the second position call generally account as a half call and the third position call generally accounts as a quarter of a call. So when you roll that up that's ballpark-ish around 300. But with David coming into the company just a short while ago, we wanted to make sure that David had a freehand to look at the market and draw his own conclusion of what's the best way to maximize the opportunities around abaloparatide. So David could you share from your perspective as you think about the market?

[Dave Snow:]

What will it take for us to successful like from a commercial infrastructure perspective, again focusing now on the U.S.

[Bob Ward:]

Hi, Jess, I think what's important to say is a lot of this work is undergoing. So final, a final structure on that is yet to be determined, but if you look at the marketplace I think we're excited based on the things that I mentioned earlier about the potential degree. And I would say that it's not just around Forteo exclusively we think that there is a lot more opportunities. And as I mentioned with the number of physicians that we have there are certainly a meaningful cohort about 10,000 physicians but there is also group that's beyond that. And I think we want to be very careful to make sure that we're looking for the best overall profile and not just focusing on Forteo exclusive physicians. I would also say that beyond the sales force we're deploying our MSL team today and so as we build up that group I think they will help us in terms of sharing with key opinion leaders, being able to really hear from them about what are the great opportunities we would have from a clinical standpoint subsequent to our launch of the product. We're definitely are using physician prescriber data to help us determine what is the best way to put the product out there and what I'll also mention around the fractures that are going on 2 million fractures. I think that's an important component of this, how to think about where new fractures are occurring and what is the best way for us to structure our sales force to be able to take advantage of the information that's out there on these new osteoporotic patients and the importance that they have in terms of risk reduction and extending a fracture free interval. So on November 17, Dave will be giving a more in-depth review of how we analyze the market, what we see as the current trends and how the commercial opportunity will be shaped by the activities that we undertake.

[Jessica Fye:]

Got it. Thanks guys.

[Bob Ward:]

Thank you.

[Operator:]

And moving on, we have a question from Eun Yang from Bank of America/Merrill Lynch.

[Eun Yang:]

Hi, good morning guys. Thanks for taking my question. The first one is related to the estimation for MAA and NDA to FDA, can you remind us where you are in terms of CMC and in terms of manufacturing of clinical supply and also the commercial supply. And then secondly, you just came back from ASBMR, I'm curious what kind of feedback you heard from doctors regarding positioning a drug like abaloparatide to for example potential competition like Romosozumab from Amgen. And then lastly, may be you can remind us what we should expect in terms of the response rate or rate of stable disease from the Phase 1 trial for RAD1901 in the context of previous trial data that was shown by Roche's SERD and also by faslodex? Thank you.

[Bob Ward:]

Thank you, Yang. We really appreciate the question, let me just jot it down real quick to make sure I don't miss the three. So it was CMC, NDA prep, feedback from ASBMR?

[Eun Yang:]

Yep.

[Bob Ward:]

And then what is our expectations around Phase 1, right?

[Eun Yang:]

Right and also in historical context of the data generated by faslodex and the Roche SERD drug in the clinic?

[Bob Ward:]

Right. So what we think about MAA and NDA prep, so we'll be out with the continuing update as we move through the final part of the year, our progress towards submitting our first product for registration. We're on track and we're very comfortable with our position today and on Investor Day we'll be able to provide greater detail around progress on NDA, MAA. With regards to feedback from ASBMR and the question about the competitive landscape, I think one of the things we heard in conversations that was new information for us was the enthusiasm around Merck's cat-K program. Most of the investigators we talk to express the very positive view that they thought this was a very important mechanism of action because remember for that oral molecule which in many ways would be a replacement for bisphosphonate, bisphosphonates lock up the mineral matrix of bone. So that the cells that modulate bone growth cannot have a more difficult time of resorbing bone, in contrast with cat-K it affects an enzyme pathway. So those cells are poised and available to change bone over time and so there is potential for synergy that cat-K may offer with bone building therapies that would be unique new entrant into the field. So it's very strong interest in cat-K very, very favorable feedback. The second one was the whole question about guideline and treat to goal. Remember in the ACTIVE trial we showed an 86% reduction in new vertebral fractures and then in ACTIVExtend, the abaloparatide patients that went on to alendronate has zero new vertebral fractures during that six month period. So that will be a six month fracture free interval. One of the questions in the group that we're developing guidelines that will be released shortly, is how do you treat patients to goal, how do we improve overall skeletal health so patients show reduced risk of fractures and experience a period of time where they have a fracture free interval. So we think guideline development will be very important and we heard a lot of feedback around questions of how fast agent build bone, how safe are these agents, are they introducing new risks into the category or these mechanisms or action that we're familiar with. As the drugs are used both to build bone and then to maintain bone, so for example if you think of ACTIVE that's the build trial design when those went into ACTIVExtend on a alendronate that was to maintain portion of the trial. We heard a lot of discussions around build and maintain, in the maintain side, will patients have a fracture free interval such as we've demonstrated. With regard to some of the newer mechanisms action, remember Novartis has a DKK-1 a program that's a little earlier in development and then Amgen has the anti-sclerostin program that's in late stage development, both of these are new mechanism of action they represent a change of thinking how one would modulate bone. Abaloparatide and Forteo both bind to the PCH-1 receptor, this is the receptor that we use everyday to change or either increase or decrease bone skeletal health, so it's the physiologic pathway for bone regulation. The newer mechanism of actions that are being studied represent a different way of changing bone metabolism than the way in which we physiologically regulate bone. So we've heard a lot of interest that the new mechanism of actions may offer a different benefit and then I think there is an interest also on understanding what's the long-term exposure look like and what's the overall patient experience. So we'll look forward to learning more about these mechanism of actions. But the important part Yang is the conversation with vibrant, people see osteoporosis changing dramatically. The level of interest in the field has never been higher and the thought that there could be new therapeutic options coming forth had physicians very excited. I think there is a fair amount of buzz that ASBMR "Golden age of osteoporosis," so we found the overall conversation quite encouraging. For RAD1901 when we think about the Phase 1 trial, the basic question is as we dose escalate from 200 to 1000 milligram, first questions are around tolerability, do all of the patients tolerate the drug in the same way. And then, the second question comes up is there a change in the period of which you see a stable disease of that one dose is that longer than another dose and then the third question beyond that is there a dose that which we start to see signs of tumor regression. Remember in the endocrine-mediated therapy category where SERDs like faslodex have played typically physicians view these drugs as tumor static whether its the small number of what could be a partial response. Remember Phase 1 is not really the efficacy portion of the trial, Phase 1 is asking the question of what's the right dose from a risk benefit to take into a more formal evaluation of efficacy or the expansion cohort's Phase 2 and Phase 3 trial answer those, that's the question. So for us what we're looking for in Phase 1 is what's the best dose for tolerability, where patients show the best response in terms of stable disease and/or based on our preclinical data we'd have reasons to believe that 1901 is a potential to show tumor regression. So that's the gamut that we'll be looking for out of the Phase 1 trial and that San Antonio we'll be happy to share full update on what's happening with the trial as well as the other presentations will include more information around the overall profile for RAD1901.

[Eun Yang:]

Thank you, Bob.

[Bob Ward:]

Thank you, Yang.

[Operator:]

[Operator Instructions] We'll move on to Jeff Chen from Cowen & Company.

[Jeff Chen:]

Hi, guys, thank you for taking my questions and congrats on all the progress. Bob, if I may just ask so you're planning to start a Phase 1 study in EU -- RAD1901 probably likely to discuss this at Analyst Day. But could you just help me understand how that program or that trial will help the expansion study or how that working with each other? Thanks.

[Bob Ward:]

Thanks Jeff. Happy to provide details. And yes, at the Investor Day we'll do an even more in-depth discussion. So remember in our original healthy volunteer maximum tolerated dose study we performed FES-PET, so this is where PET imaging is used to ask the question of when estradiol itself form of estrogen is used to bind to the receptor you can image how many receptors there are that are interacting with estrogen. So in the healthy volunteers that we showed after seven days of dosing both 200 milligram and 500 milligram we had full suppression of the FES-PET signal. Now these were in patients that did not have tumors. So now in the EU Phase 1 metastatic breast cancer study, these will be patients that have a wider variety of stages of metastatic breast cancer in terms of their exposure to previous agent and the FES-PET imaging allows you to image, which of the tumors are higher expressers of the estrogen receptor. And then as the patient takes RAD1901, you will be looking to determine that the dose they started on fully suppresses receptor expression of the tumor. So this is a pharmacodynamic endpoint that can allow a physician to say, if I have a patient that has ER positive tumors and I start them on an ER degrader does FES-PET suggest the dose they're on fully suppresses the receptor in the tumor. So we think this pharmacodynamic information will be very important as we go forward asking what's the best dose to continue to develop as we look at the expansion cohort. Does that makes sense?

[Jeff Chen:]

Yes. That's very helpful thanks. And looking forward to the Analyst Day.

[Bob Ward:]

Terrific, we'll see you there.

[Operator:]

[Operator Instructions] We'll take a question from Mara Goldstein from Cantor Fitzgerald. Ms. Goldstein, your line is open please go ahead.

[Mara Goldstein:]

Yes. Can you hear me?

[Bob Ward:]

Yes. We can.

[Mara Goldstein:]

Hello, great, thanks, sorry. Well, phone difficulty, again. I'm hoping that may be you can provide a little bit of color around the reimbursement for environment for osteoporosis drugs just given what we've seen in the market in the last two years with a variety of generics coming into play and how that perhaps shapes the value proposition for you?

[Bob Ward:]

That's a terrific question, Mara, because there is -- really more important than this whole question of patient access. David had mentioned a moment ago last year in the U.S. or this year in the U.S. expected 2 million individuals who have an osteoporotic fracture, two thirds of those patients are neither diagnosed nor treated only one third are diagnosed and treated. So when you see this concept of access, it's a couple of different question, what is if that enables the physicians to diagnose the disease and the second is when patients are diagnosed what's their ability to access medication. David, I know when we've talked we feel that osteoporosis is a little different than other categories for example Kaiser is a closed healthcare system they've prioritized osteoporosis care. Because in a closed healthcare system the initial fracture and preventing the second fracture is really in the same payer bucket. In other healthcare systems the fracture might be happening in a hospital with care is happening in an office place. So from -- to answer Mara's question, how will we tackle reimbursement and ensure patients have access appropriate patients have access to osteoporosis.

[Dave Snow:]

Well, certainly, the peer environment in the U.S. has been changing over the last few years, but so has the overall treatment of patients with osteoporosis. We've actually seen a lot of changes in terms of bisphosphonate usage and the level of dissatisfaction with that category. So I think physicians and patients both are looking for more effective therapies because an important component of the overall outlook here from an access stand point. I would also say that if you look at this marketplace the guidelines around us I think the -- what we heard today ASBMR is that they're interested in changing the overall guidelines and looking to move products like abaloparatide or anabolics earlier in the treatment schedule and I think we really encourage that the guidelines may be changing around us which would also encourage us return the discussions with payers. And even yesterday if you look at the FDA meeting there was discussion around the labeling of osteoporotic drugs and again we think that's an encouraging side of the FDA itself is suggesting that perhaps may be that the treatment of osteoporotic drugs is not moving in the right direction and that they would encourage that newer therapies may have an opportunity. We think that the shorter treatment duration and high response rates would be favorable with payers especially if you look at the active study and the comparison we have and ACTIVE comparative that's also we think that that will be highly responsive path [indiscernible] payer. So over all, we think it's a -- we have a lot of be encouraged about with the overall profile and we look forward to more than investing this with payers in the U.S.

[Mara Goldstein:]

And is it your perception that the commercial market follows the Medicare market or the other way around in terms of reimbursement?

[Bob Ward:]

Well, that's a very important question Mara, because if you think of the age at which patients have fractures, in historical field of osteoporosis there was a lot of discussion around hip fractures because wrist fractures, it was the site that many agents were not able to demonstrate efficacy around. Now the typical hip fracture patient might be 75 to 85 years old, the typical wrist fracture patient might be in their 50s or in their early 60. So if you say for wrist fracture discussion those are patients who are likely to be working at commercial insurance and by the time you start talking about hip fracture patients those are patients that are much more likely to be a government payer. So one of the important parts of the evolution of osteoporosis is thinking more about the fracture cascade, patients have different rates of fractures at different ages. And as we talk about preventing subsequent fracture in different age groups of patient a payer mix changes considerably as well. So certainly for drugs that have focused on older patient population, it's really government payer market.

[Mara Goldstein:]

Okay. And if I can follow-up on 1901 and the commentary around FES-PET imaging, do you, I guess the question I would have there do you envision that this would be a routine diagnostic test sort of physicians treating patients and how commonly -- use it is today?

[Bob Ward:]

That's a terrific question, Mara, because one of the questions really is about the adoption of technology in oncology. So whether it's genetic profiling of tumor, so for example a lot of discussion around ESR1 view, these are tumors whether receptor changes so which drug binds to the mutated receptors of important thing to understand. Second piece of that would be using imaging technology, say if a patient has multiple tumors, are they all ER positive or some of them ER positive, are there combos I want to use. So right now on oncology we've seen an escalation in the overall cost of care. In cases where technology can help lower that cost to care we'd expect to see rapid adoption. Typically, FES-PET has done now, really the major academic centers particularly areas that have an active research program, but it's not really for a community physician, a technology that they'd have access to. So when you think of the work we're doing in the EU right now, it's very important from scientific perspective to be able to say as you pick the right dose, do you show that in the tumors you suppressed all the receptors. Once we pick that dose and we better understand the suppression level it's likely that physicians will feel comfortable using that dose without reconfirming that suppression in each patient. And as the field continues to evolve, we would expect people will use technology more widely in oncology in part as a way to make treat more effective.

[Mara Goldstein:]

Okay. I'll hop back in the queue. Thanks.

[Bob Ward:]

Thanks Mara.

[Operator:]

And that does conclude our question-and-answer session today. Mr. Ward, I'll turn the conference back to you for any additional or closing remarks.

[Bob Ward:]

What we thought was a very exciting the quarter. We appreciate your time today to share with you an update. And we look forward to seeing you in New York City on November 17 for our first Investor Day. Thank you very much.

[Operator:]

And that does conclude our conference today. Thank you all for your participation.