Q3 2016 Earnings Call Transcript

Published: 6 Nov 2016

[Operator:]

Greetings and welcome to the Radius Health Third Quarter 2016 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the conference over to Ms. Barbara Ryan, Investor Relations for Radius Health. Thank you, Ms. Ryan. You may now begin.

[Barbara Ryan:]

Thank you. And welcome and thank you to those of you joining us on the line and the webcast this morning for a review of Radius Health’s third-quarter 2016 financial and operating results. I am 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’d like to remind you that any statements made during this call that are not historical are considered to be forward-looking 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 annual report on Form 10-K filed with the Securities and Exchange Commission as well as other reports filed with the SEC. Any forward-looking statements represent our views as of today, November 3, 2016, only. A replay of this call will be available on the Company’s website, www.radiuspharm.com. You can find the dial-in information for the replay in today’s press release as well as on the Company’s website. It’s now my great pleasure to turn the call over to Robert Ward, President and Chief Executive Officer of Radius Health.

[Robert Ward:]

Thanks, Barbara. And thank you to everyone who’s joined this conference call and audio webcast this morning. 2016 has been an exciting period for Radius Health, as we are building the base, driving progress across the portfolio while establishing our capabilities for a successful commercial launch and benefiting from our [high] performance culture. On this call, we’ll review the quarter and highlight upcoming activities. As a reminder, our primary focus is on the ongoing regulatory review of abaloparatide, both here in the U.S. and in Europe. We anticipate a CHMP opinion in Europe late this year or in 2017. And in the US, our PDUFA date is March 30, 2017. Pending positive regulatory review, we expect the first commercial sales in 2017. We are well funded to accomplish our goals, and we ended the third quarter of 2016 with $369.8 million in cash and equivalents. We are highly confident that abaloparatide has the potential to become an important medicine for the treatment of osteoporosis. To further discuss our march towards commercialization, I’d now like to introduce David Snow, Radius Health’s Chief Commercial Officer, to review our progress with abaloparatide and business developments.

[David Snow:]

Thank you, Bob. The prelaunch period is a critical time in the development of every new therapeutic. With abaloparatide, we are utilizing this period to build the right team, develop key elements of the brand, and prepare for the acceleration in our business that will occur with an approval. We’re delighted to have added exceptionally qualified, high talent individuals in the commercial group who will be leading the abaloparatide launch here in the U.S. Today, the senior leadership team and functions are in place with experienced individuals across marketing, sales, market access, and operations. During the quarter, we completed hiring senior sales leadership team and began hiring next-level sales leaders, which we will expect to complete by year-end. In Q1, we’ll bring on the full sales team and begin the training activities. We continue to advance commercial work streams across the key tasks, including, for example, health economics research and payer value proposition. Our research with payers and clinicians has shown the importance that these experts place on data showing both vertebral and non-vertebral fracture reductions when making therapy decisions for their patients. We believe that formulary placement and reimbursement will be determined in part by a therapeutic’s clinical benefit for both of these important fracture categories. This month at the American College of Rheumatology annual meeting in Washington DC, we’ll be making a presentation entitled abaloparatide subcutaneous significantly reduces vertebral and non-vertebral fractures and increases bone mineral density regardless of age, BMD t-score, or prior fracture at baseline. This past quarter, two important journals have published results from our Phase 3 ACTIVE trial. The Journal of the American Medical Association, or JAMA, publication came out in August, which was followed by the Journal of Bone Mineral Research manuscript in September, coincident with this year’s ASBMR. Now this was an exciting meeting for us and included four scientific presentations from the abaloparatide development program. A new number to treat analysis from the landmark Phase 3 ACTIVE trial shows the number of patients needed to treat to prevent one additional fracture for both abaloparatide subcu and teriparatide and should provide physicians, patients, and payers with valuable information when deciding on the most appropriate treatment options for postmenopausal women with osteoporosis. Additional analyses presented show the effect of abaloparatide subcu significantly and consistently reduced the risk of major osteoporotic fracture and any clinical fracture across the full range of postmenopausal women in the Phase 3 ACTIVE trial, irrespective of baseline risk. At the latebreaker oral session, we reported the remarkable progress we’ve made on our transdermal patch development program for abaloparatide-TD, which we believe has the potential to both expand and extend the franchise. Our business development discussions have benefited from the breadth of our progress, and we expect a partnership in place by the time of launch to maximize the abaloparatide opportunity. Bob, I’d like to now turn the call back over to you.

[Robert Ward:]

Thank you, David. We’ve continued to advance across our pipeline as our oncology team delivers new clinical data for RAD1901 in advanced breast cancer. This quarter, we have observed multiple confirmed clinical process on the RAD1901 program. The San Antonio Breast Cancer Symposium will be an important event for us this year, with three abstracts accepted for poster presentations on December 8, where we will provide an important update on our substantial progress with this program. As you know, we completed enrollment of the expansion cohort of our ongoing Phase 1 study with 20 metastatic breast cancer patients at the 400-milligram dose and the first cohort in the European Phase 1 FES-PET trial. Because of the overall progress with the RAD1901 program, we have now amended the FES-PET protocol to enroll additional patients at 400 milligrams to gather additional data. We view this as a positive change that will support our ability to accelerate the timeline for RAD1901 development. As previously disclosed, we have seen multiple confirmed clinical responses across the program in heavily pretreated patients with metastatic breast cancer who have progressed on previous rounds of therapy, including multiple hormonal agents. RAD1901 continues to be well tolerated and no dose-limiting toxicities have been observed in the program to date. We’re hosting a live panel presentation and webcast, at the San Antonio Breast Cancer symposium on December 8 for investors, highlighting two key opinion leaders in the field of breast cancer

[Nick Harvey:]

Thank you, Bob. For the three months ended September 30, 2016, we reported a net loss of 46.2 million or $1.07 per share as compared to a net loss of 28.3 million or $0.68 per share for the three months ended September 30, 2015. The increase in net loss from the 2015 period to the 2016 period included an increase in non-cash stock-based compensation expense, and was primarily attributable to the growth of the organization to continue our pipeline development and to prepare for potential sales by subcu. We have experienced substantial pricing headcount, which currently stands at 212 as of November 1. As Radius continues to advance towards the potential first commercial sales of abaloparatide subcu, we expect to continue to make further investments in launch preparations. Our cash, cash equivalents, and marketable securities balance as of September 30, 2016, was 369.8 million. We believe that our cash, 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 business development activity is sufficient to fund our development plans, U.S. commercial scale-up, and other operational activities into 2018. I will now turn the call back over to Bob.

[Robert Ward:]

Thank you, Nick. Before we open up the lines for your questions, I’d like to summarize our upcoming milestones. Our NDA and MAA are under active review in the US and Europe. We have a PDUFA date of March 30, 2017, in the US and we expect to receive a CHMP scientific opinion in late 2016 or 2017. We believe that abaloparatide is the greatest value, unpartnered, late-stage asset in the biopharm industry and we are continuing our productive business development activities. At San Antonio Breast Cancer Symposium on December 8, we will report the results of the ongoing Phase 1 expansion cohort for the 005 study and the FES-PET study in metastatic breast cancer. And we’ll host an investor panel presentation and webcast with two leading key opinion leaders in the field. On December 1, at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Meeting, we will be presenting new nonclinical data on the RAD140 program. We are on track for an IND submission for RAD140 in 2016 to enable our first-in-human studies in 2017. These two programs represent a significant presence for Radius Health in the search for new treatment options for patients with breast cancer. We’ll also be making presentations and hosting one-on-one meetings at four investor conferences over the upcoming weeks. The Credit Suisse conference at the Phoenician in Scottsdale, Arizona, on November 7. The NASDAQ 31st annual investor program in London on November 29. And on December 14, the BMO healthcare conference in New York and the Bank of America Merrill Lynch Midwest healthcare conference in Chicago. Thank you very much for your attention. We’d now like to open up the call for your questions.

[Operator:]

Thank you. We will now be conducting a question-and -answer session. [Operator Instructions]. Our first quarter is from Jessica Fye of JPMorgan. Please go ahead.

[Jessica Fye:]

Hey guys. Good morning. Thanks for taking my questions. A couple on 1901. First, how many patients will go into the FES-PET study of 400 now, given that you’ve kind of expanded that cohort? You’ve also talked about the post-palbo setting potentially representing an accelerated path to market for 1901. Can you elaborate a little bit on kind of what you’re basing that on? And lastly, on abaloparatide, I just want to clarify the comments in the press release about collaboration prior to commercialization. Is that still only X-US or could that potentially include the US as well? Thank you.

[Robert Ward:]

Thank you, Jess. Happy to address those three questions. Now here with me today is Dinesh Purandare, who is the Global Head of Oncology. And I’ll ask Dinesh to comment on some of these areas around RAD1901. But first, I did want to just thank our West Coast investors who have been able to join us this morning. I know this is quite early for the West Coast. I just wanted to let everyone know our next call will occur at the end of the day so that it’s more convenient for investors from the West Coast. Then we will alternate between morning calls and afternoon calls. I just want to let everyone know that that is for the convenience of our investing population and doesn’t represent anything other than trying to accommodate more people in participating. So Dinesh, as you think about the FES-PET study and now the amendment to the protocol, could you share with us what is our expectation for enrollment there?

[Dinesh Purandare:]

Sure, Bob. Thank you. So the FES-PET study, as you know, we have initiated the cohort at, we have enrolled a few patients, right, at 400 milligrams. And as you know, this is an important study for us that will be posted -- the amendment for which and the details of which will be posted on clinicaltrials.com very soon. Right now, we are going through the amendment. And just to let you know, that 400 milligrams should be enrolling at least another five patients and looking at some other doses as well, particularly at 200 milligrams. Because when we look at the healthy volunteer study that we have published previously, I just want to remind everyone that the target engagement was seen at multiple doses, including 200 and up to 500. So that’s what we are trying to explore.

[Robert Ward:]

Terrific. Thank you, Dinesh. I think your next question, Jess, was really about the question that we said we’re going to go talk to the Agency about potential Phase 2 trial design. And how would we identify the appropriate patient population for that sort of trial. Well, I think in our conversations before, we’ve talked about a number of different patient populations for which the Agency may view it as a patient population with sufficient unmet medical need that it would be appropriate for a trial. So when we set up a meeting with the Agency, we will share our thinking of different patient populations who we think may be suitable for an appropriate Phase 2 trial. And the Agency will share with us their perspectives as well. The reason why we want to be so thoughtful in the trial design is, as you know, in oncology, if in Phase 2 there is a sufficient advance in clinical benefit, there’s a potential for accelerated approval. So in order to execute on a trial, that has that opportunity, we really need to talk with the Agency and make sure that we and they are looking at the population in the same way. Now in the press release, I do realize that we often when we talk about business development, if we use the word partnership, people ask, does that mean something different than collaboration. And if we use the word business development, people ask, does that mean something different than collaboration or partnership. We’ve guided that when abaloparatide by time of launch, we believe it has the potential to be a global therapeutic. But Radius itself is not intending to build global infrastructure in order to maximize the potential of abaloparatide around the world. So by time of launch, we have intended and have guided that we would have a partnership in place that would enable abaloparatide, to be maximized in terms of a global opportunity.

[Operator:]

Thank you. The next question is from Ying Huang of Bank of America Merrill Lynch. Please go ahead.

[Ying Huang:]

Thanks for taking my questions as well. First off, Bob, I want to ask you about the comments in the press release that multiple confirmed responses have been observed in this Phase 1b trial for RAD1901. I’m just wondering if all the responses so far have been observed in the 400-milligram cohort or also in lower doses as well. And then secondly, can you provide any comments around the GI tox you have been observing from the trial as well? Lastly, I want to ask about the CMC readiness for launch of abaloparatide now that the PDUFA date is quickly approaching. Also, if you guys have had already preliminary discussions with payers about access and reimbursement. Thank you.

[Robert Ward:]

We’ll take those questions in order. You know, when you think about recent criteria that are used for looking at clinical responses, the first question is that baseline. The patient’s tumor has to be of sufficient size to be deemed a measurable tumor, such that a 30% reduction in that measurable tumor represents a partial response. With a complete response, of course, meaning that the tumor has lost again from the image. So when this occurs, when you think about how trials are run. A patient comes in for a visit where they are assessed and the tumor is measured. If at that point there’s an observation of tumor shrinkage, at the next visit, so these same observations occur, then it becomes a confirmed response. So as we’ve shared previously, full details on the trial will be disclosed at San Antonio in December. The Phase 1 expansion cohort, those 20 patients were at 400 milligram. And also in the FES-PET trial, those patients were enrolled at 400 milligrams as well. And we do anticipate an update on what is the pretreatment history on those patients and what’s been the clinical progress to date. I think on the second question, I just wanted to clarify that when you think about dose-limiting toxicity, this is the question of did a toxicity occur that meant you could not dose higher. We have not observed any dose-limiting toxicities in the trial. So remember, first we did a dose escalation from 200 to 1,000 milligrams in healthy volunteer. Then we went to the advanced breast cancer patient population and dose escalated between 200 milligrams to 600 milligrams, and then decided that 400 milligrams was the right profile for the expansion cohort and also was the right dose for starting the FES-PET trial. At 600 milligram, we did notice that there were patients for whom there was some GI upset or other related tolerability questions that have arose, whether it was reflux or vomiting or nausea. Now remember, in those studies that were conducted, we were using drug in capsule. We have other formulation activities currently ongoing at the Company and we believe that these are addressable. Dinesh, when you think about this question of the overall tolerability profile of 1901 and being able to identify the appropriate dose, are we comfortable that the profile as we know it today supports continued work at this dose level?

[Dinesh Purandare:]

Yes, sure, Bob. Based on what we see, and as Bob said, we see upper GI effects. And again, if you look in the history of SERMs incurred, most of these molecules by the nature of their action do cause some of those nausea, et cetera, kind of effects. I think what’s important to note that our delivery rates are very limited. Also, things that normally happen when you give a third more, clotting, for instance, et cetera. If it is, we don’t see much of that either. So as far as we know today based on the profile we have, the product looks well tolerated and we’ll be discussing more of that information at San Antonio.

[Robert Ward:]

The reason why we’re thinking that San Antonio this year is so important is our understanding as abstracts have been submitted as well on some of the competing programs. And so when you think about this question of where is the appropriate treatment use for oral SERDs. One other question is how is it administered? Clearly, an oral once-a-day product would be an improvement over SERDs that may currently require intramuscular injection. The next question becomes in different settings, what is the acceptable tolerability profile? When we talk about combination studies with CDK 4/6, one of the questions is this an agent that would add to what is observed as existing tolerability or toxicity with other molecules. To date, the profile as we understand it today suggests that 1901 would be an ideal agent for considering a wide range of different combination studies. The second thing to think about is there’s a number of different markets where there’s advanced breast cancer, early-stage breast cancer, adjuvant use. In each of these settings, tolerability means something different. So if we look at agents that are used in the adjuvant setting today, many times patients discontinue and often cite hot flashes or other tolerability issues as the reason why they wanted to discontinue. So when you think about adjuvant therapy, tolerability becomes a very important issue. When you think about the advanced metastatic breast cancer setting where patients are facing progressive disease, one of the major emphasis is really on clinical benefit and the ability for physicians to be able to help the patient to control their disease state. So we believe that, for San Antonio, it will provide not just an insight on what the efficacy profile looks like in the emerging pipeline, but also terrific insights on the comparable tolerability or safety profile as well. Now, I believe your third question was as we think about commercialization for abaloparatide, one of the things that is so important is to ensure that when you have an approval that you are able to provide the product in a reproducible way. So that if physicians or patients want to use the product, it’s available to them. That was why when we put our supply chain together, we worked with Lonza, with Vetter, with well established global supply chain members who have participated in numerous pharmaceutical products that have been developed over time. And I’m very pleased that the group has been working on both supply chain and CMC has a great depth of experience. And I think we have a high degree of confidence, that pending positive approval that we are well positioned for a timely launch and to be able to successfully supply the market. Now your last question about the question of can you engage with payers. Remember in the U.S. today, prior to approval, discussions about an unapproved drug are not part of what is the allowable discussion. So any payer discussions prior to approval have to be on a blinded basis. So if you think of a payer today are they familiar with Forteo. Yes, they are familiar with Forteo. It’s been on the market for over a decade. Are they familiar with what other osteoporotic drugs? Yes, they are, because it’s been over six years since a new drug was approved in the U.S. for the treatment of osteoporosis. For abaloparatide, like everyone else, they have access to the peer-reviewed journals, whether it’s the Journal of the American Medical Association or the Journal of Bone and Mineral Research. But for our communication, we do not communicate with payers on the profile until after the drug is approved. And that’s just a unique element of how the market here in the U.S. is regulated. Now when we do talk to payers, they do share with us what are the things on their minds. Pricing, is definitely a hot topic in the country here today. When we think about osteoporosis, access to appropriate treatment, it’s currently a significant issue. Fortunately, Lorie Fitzpatrick is here. Lorie is our Chief Medical Officer. Lori, could you just remind us when we think of the two million patients a year in the U.S. that have osteoporotic fractures, what is the current landscape in terms of access and reimbursement for those patients?

[Lorie Fitzpatrick:]

Thank you, Bob. There’s really a very interesting presentation at the ASBMR this year that highlighted the fact that actually, hip fracture rates are now stable and not decreasing any longer. As you know, there are products on the market and hip fracture rates are actually decreasing in the U.S. looking at Medicare databases. What’s happened is that DEXA reimbursement went down. People stopped getting diagnosed. People stopped being treated, and as a result, there’s a healthcare crises where hip fracture rates no longer are falling. That means that we really need to get out there and be sure that we understand what patients need to be treated and that they are treated appropriately by having new drugs on the market that can actually build new bone, I think will be well positioned to be able to help these patients who are having fractures now.

[Robert Ward:]

Thank you, Lorie. I know that one of the questions has been was the declining use of bisphosphonates related to concerns over safety? So fortunately, Bruce Mitlak is here with us as well. And Bruce, as you think about the landscape in osteoporosis, as Lorie mentioned, I believe the reimbursement for DEXA was just reapproved. The National Osteoporosis Foundation and the International Osteoporosis Foundation made a major role to ensure that DEXA reimbursement has been continued. But in osteoporosis, many patients are concerned about these rare side effects not always observed with every class of drugs. What’s your view on this, the safety profile required to be acceptable?

[Unidentified Company Representative:]

Bob, thank you. And first, I’m very happy and excited to be part of joining the team here and I am very excited about the potential of abaloparatide. And as Lorie had just highlighted, I think that the current landscape really is such that new treatments and new options for people with osteoporosis are really needed by patients with osteoporosis and their physicians. As you’ve highlighted, the use of bisphosphonates has declined over the past few years. And it has declined because of the concerns about very uncommon but curious side effects that can occur. I think that the concerns around those really do highlight the need for other therapies to be available and for therapies perhaps with a unique mechanism of action to be available so that patients and physicians have options when they are considering how best to manage their osteoporosis and their risk of fracture.

[Robert Ward:]

So Bruce, in the bisphosphonates trial, I believe in the FIT trial, the FDA had a major discussion around osteonecrosis of the jaw. So when we think of it as a rare event, how rare is it? Because sometimes for patients, the concern is greatly larger than the actual incidence rate.

[Unidentified Company Representative:]

I think that’s right. I think when you think about this from the perspective of patients, numbers don’t really matter. If they are the person that’s affected, it’s serious for them. I think the types of problems that you’re talking about more often than not come up when bisphosphonates are used to treat cancers, but have been observed in patients who receive treatments for osteoporosis. And when they do, they are really serious and have a substantial impact on patients and their families. I think the numbers are debated, actually, that the frequency. And I think that the recent report in the New England Journal of Medicine written in part by Dennis Black tried to put them into context with respect to what the actual risk is versus the benefit of these treatments.

[Robert Ward:]

So Ying, when we think about what do payers express to us as their interest, their interests are ensuring that they have an efficacy profile that they understand and see as relevant to the patient population. And we have to remember, in osteoporosis today, it’s an area where there’s a high degree of sensitivity on the safety side as well. So there’s a great deal of interest of what is the safety profile for emerging therapeutics.

[Unidentified Company Representative:]

If I could just make one follow-up comment about the CMS decision, that they have released the coding and expected payments for DEXA in the coming year. I think that’s very, very important outcome for the field of osteoporosis and for patients. As you may know, the reimbursement for DEXA has been declining, which has been a negative with respect to physicians being able to think about osteoporosis, to do the test, and to manage patients. And the direction that was -- where things were going for 2017 and beyond was actually a further reduction in the reimbursement for DEXA. And I think that based on the consideration of the coding now, it appears that reimbursement for DEXA in a hospital setting is going to increase going into 2017, which is very good news for physicians who want to manage patients with osteoporosis. And ensure the diagnosis is made and ensure that people are identified for treatment.

[Robert Ward:]

And the success really of that increase in reimbursement is really due to the non-profits who represent patients who participate in the dialogue, and also the physician speaking for it of why diagnosis was important. So Ying, thank you very much for your question.

[Operator:]

Thank you. The next question is from Mara Goldstein from Cantor Fitzgerald. Please go ahead.

[Mara Goldstein:]

Thanks very much for taking the questions. I just had a couple, and the first two relate to abaloparatide. And with respect to the buildout of the commercial organization for abaloparatide-SC, is there a particular commercial group that you are benchmarking for these efforts, whether it be Forteo or denosumab. And I’m hoping that you could provide some color around that. And just to push you a little bit more on the discussion of partner for commercialization for Europe, when you mean at the time of launch, is that in all countries simultaneously or in selected territories? Because as we know, oftentimes the products in Europe are rolled out in a more fragmented basis than we see in the U.S.

[Robert Ward:]

Yes. So Mara, we said by time of launch, because as we begin commercialization, we anticipate having that partnership in place. With regards to the commercial group and benchmarking, we are aware of the change in the landscape. So if we said, well, when Forteo launched, what was the landscape? Remember that was over a decade ago. The market has changed dramatically since then. If we think about well, how long ago did Prolia launch? Well, it was six years ago. When we look at the market data that are available today, for Prolia, we see that Amgen is continuing to invest behind the brand. We see a rapid growth in terms of top-line sales, an increase in numbers of physicians prescribing. And so that suggests that it’s a market in which awareness is a very key element for driving uptake. David, today, we have more information about where patients are with a fracture than ever before. And I know we’ve talked about ensuring at launch that, we adjust our commitment to areas where the opportunity would be as opposed to what historically might have been more of a blanketed approach. David, could you talk about how our commercial group thinks about the market? And how do we make sure we focus our effort in the area that we think we’ll be the most productive?

[David Snow:]

Sure, Bob. Thanks. And Mara, as I shared previously, I think we’ve taken a pretty unique view of the overall market. While we certainly take a look at where promotion and prescription level data is going, I think we’ve worked really hard to try and integrate data across market level, diagnostic, claims, and epidemiology and integrating that into a decision tool that will help us with that launch. But also is informing on our deployment strategy. And so I think we’ve mentioned that, we don’t believe that a one-size-fits-all is really the best way to approach the launch. I think we’ve got a really good structure where we believe fractures are occurring where we can actually do -- have the most impact. And so we are expecting that that will ultimately be a force multiplier in helping us to really drive our share of voice and improve overall impact in the marketplace.

[Mara Goldstein:]

Thank you. And if I could just ask one question on 1901 and San Antonio breast cancer symposium. At that point, with the data dissemination, will there be a discussion around the durability of responses? Will you have enough longevity of data to be able to provide that?

[Robert Ward:]

Of course, at the San Antonio presentation, for the patients in the trial, the individual patient duration data will be observable and discussed at that time. I think, Dinesh, maybe you could just talk a little bit more about how Doctor Sledge and Dr. Kaklamani, because of their experience, really can help answer some of the questions that we often hear, which is how do we put this data in the context of the field? How do we assess its importance and meaningfulness in terms of clinical progression?

[Dinesh Purandare:]

Yes, I think what they have indicated to us in our interactions with them, we all are excited about what we see today. And that’s because of a couple of things. Number one is that there is a huge unmet need, despite the fact that we have many hormonal agents out there. There’s a huge unmet need as the treatment paradigm changes, particularly in combination with agents like the CDK inhibitors and palumistrand and AIs, there’s going to be additional need for patients who have to be managed on other treatments. So that’s number one. Number two is let’s remember that although we have drugs that work very well, safety issues and the way they are administered do become challenging. These folks come with a huge amount of experience. Dr. George Sledge, he’s been the past president of ASCO. As you probably know, renowned leader in the breast cancer field. He was instrumental in the development of the taxanes and the hormonal therapy agents as well. So he’s been helping us. And Dr. Kaklamani, who is a key player in the San Antonio area, also part of the San Antonio breast cancer meeting overall, is one of our primary investigators, and she will be there. She in fact is one of the authors of our poster of the 005 study. So they would be happy to share their experiences on the program and discuss what these futures, what these therapies could bring us in terms of patient benefits in the future.

[Operator:]

Thank you the next question is from Chris Shibutani of Cowen and Company. Please go ahead.

[Chris Shibutani:]

Thank you. Good morning. Two questions. On RAD1901, I believe an effort is to do studies looking at combination. When you do studies in combination with CDK 4/6, are you confident that you’ll be doing 400 milligrams? Or do you expect to do dose-ranging studies in combinations? And secondly, with the TD patch, we had the top-line results at ASBMR. Are you planning on providing full or more detailed results at any point in the future, either at a scientific meeting or to investors? Thank you.

[Robert Ward:]

Thank you, Chris. When you think of TD patch, at ASBMR, we had an oral latebreaker that provided detail on the results from the pilot PK study. And then on investor day, Dr. Hattersley, I believe you shared some additional information from the Certara group. Could you just remind us why is it that we work with the group at Certara? And when they do modeling, what Certara? And when they do modeling, what is the purpose of it and how can we understand what the data show?

[Dr. Gary Hattersley:]

Absolutely. The pharmacokinetic modeling that was performed by Certara that we presented at the investor day recently really provide some, really important information to understanding of what this data means. And it has enabled us to get good insights into how close the transdermal patch profile is to our target subcutaneous injection profile. So the results from this study are really important. They allow us, they inform the design of the pivotal bioequivalent study and really provide a very strong foundation for advancing the patch technology. We expect in the future to provide further information, further updates on the patch program as we continue to make more progress.

[Robert Ward:]

Thank you, Gary. Chris, we really try to commit to make sure that for investors who are following progress of the Company, that whether it’s at scientific meetings or on earning calls like this, that we make it possible for folks to be aware of our progress and can see where the Company is headed. Now what we had talked about with the transdermal patch is now the next step is to complete all of the key CMC requirements that go with bringing a product closer to conducting what would potentially be the pivotal study. So at the time of the pivotal study, some of the CMC requirements relate to having established a commercial manufacturing site. And Greg Williams, who is our Chief Development Officer, is here with us today. And Greg, could you just remind us when we think about the requirements for TD, are these standard requirements for all drugs? Is it specific for the TD program? And could you help us understand what those next steps would look like?

[Greg Williams:]

Right. So for all drug products, typically the study would be conducted based on product that’s manufactured at a scale 1/10 of that which would be planned for commercial manufacture. It would be typically conducted using product manufactured, at the location of the intended commercial manufacturing site. Now this is standard. This is consistent across each of the different product types’ therapeutic categories. And we are in the process of evaluating the best way to make those things happen.

[Robert Ward:]

Thank you, Greg. And then once that’s in place, that gives us the batches of patches to conduct a study that we would view as being the key pivotal study for transdermal. Now for RAD1901, remember that at this point, we are at least a year ahead of where we thought we would be. Not too long ago, we were talking about why we thought we’d be doing multiple parallel expansion cohorts. But because of the emerging data from our current expansion cohort in the FES-PET trial, we believe we have the data we’ll need to go forward and talk with the Agency about designing a Phase 2 trial. And gaining alignment with the Agency of what’s the right unmet medical need population to look at. We believe that the monotherapy for RAD1901 is more likely to be a better timeline in terms of taking the product today through the development process. And when you think about combination data, we have shared in numerous calls preclinical data, demonstrating why RAD1901 has demonstrated synergy with a number of different molecules in different classes, and why that was so encouraging for thinking of RAD1901 in the combination setting. So Lorie, when you think about monotherapy development and then when you first start combination therapy to ensure patient safety, would you start at your targeted therapeutic dose? Or are there some requirements to first establish safety when studying the combo, and then dose escalate to what might be a therapeutic range?

[Lorie Fitzpatrick:]

Thanks, Bob. When you’re working with two potent compounds, you do want to start slowly injecting and work your way up usually. And you make that decision based on what the side effect profile of each individual compound is. That makes it safer for the patient. But of course, because these are very ill patients, you do want to dose escalate very quickly into something that is efficacious, but remains safe.

[Operator:]

Thank you. The next question is from Salveen Richter of Goldman Sachs. Please go ahead.

[Unidentified Analyst:]

Hi, this is actually Kerry on for Salveen. Congrats on the progress and thanks for taking my question. Just first, on the launch with the CHMP opinion due in the coming few months, could potential discussions delay your X-US launch? And secondly, what level of efficacy data can we expect to see at RAD1901? Will we see top-line response, clinical benefit rates? Any biomarker data, pretreatment history, or subgroup analyses in addition to the safety data? Thank you.

[Robert Ward:]

First, let’s just jump to San Antonio. As I mentioned in San Antonio, the 20 patients in the 400-milligram expansion cohort and the 3 patients in the FES-PET study at 400 milligrams will be the trial focus for a response of both safety, clinical, and all relevant data related to these trials. And that’s why we’re so excited about San Antonio this year. Because when we think about San Antonio, it’s actually going to be the biggest SERD meeting of the year. Our understanding is the major clinical programs will all be putting their data on the table, so to speak. And that we anticipate that there will be a high degree of interest, not just on the clinical profile, but asking the questions about tolerability and safety. So we’re very much looking forward to San Antonio. You know, we are pleased that our plan enables us to be confident that we are on track to meet our objectives. So when we think about launch and as we’ve guided numerous times, having a partnership in place by time of launch, that we are pleased with the progress we’ve made and we are comfortable with the guidance that we’ve put forth.

[David Snow:]

Bob, this is David. This one other thing to add to that is remember that outside of the US, where econ becomes a really important component of that with single-payer systems, we’ve continued to work to make sure that we are putting together best overall econ analytics package, which will certainly serve us and our partnership very well.

[Robert Ward:]

You’re right, David. A lot of times when people think about small biotech companies, the question is what is their capability for commercialization? Now David, you came to us previously having served as president of China for AstraZeneca, which was, if I’m not mistaken, their fastest-growing market. Could you tell us more about the experience level of the people that you’ve brought into the Company? And why would we view in a partnering perspective that abaloparatide is a turnkey opportunity. Meaning that the commercialization groundwork has firm footing. Why is it that we believe a global partner working with us looks across the table and sees people that have the same depth of experience and understanding of how to commercialize products as they have? I think it would be helpful if you could share some of the brands that you’ve been involved in launching over time, since I know a number of them are household names.

[David Snow:]

We certainly have had a history in launching brands across the team. We’ve got experienced people here from AstraZeneca, CSL Behring, which had a number of launches recently. Amgen obviously experienced their mark. Just a range of people. Obviously, while I was in China, we launched a number of products in the respiratory and cardiovascular areas. I think what’s really important and noticeable about here is that Greg and his team are doing a great job in terms of regulatory work and assuring that we have the right profile to help us have a really successful opportunity behind us. And if you look at the overall market opportunities, while we recognize that there’s 1.5 million fractures annually in the U.S. in Europe alone, there’s 3 million fractures. So we think that there’s sizable opportunity for products that hit the right profile that have a really strong efficacy framework. Obviously with the ACTIVE study, you’re looking at comparative data potentially. There’s lots of good information here that may get an attractive opportunity. So we’ve also, because of the opportunity we’ve got here with Radius, we’ve been attracting strong talent that know how to work in terms of patient experience programs, building out the infrastructure necessarily to launch here. Lots of strong sales leaders have come to us that also understand the specialty arena. How do we integrate that data and bring on the right teams to help us be successful here. So across the board, I think we’ve been working hard to make sure that from a pre launch standpoint, we’ve been getting the right team, the right experience, the right preparations. And I think that will certainly translate on a global level when we work through this partnership discussion.

[Robert Ward:]

Perfect. Thank you, David. Now, you know, one other thing to think about with abaloparatide being a typical specialty biologic product, particularly here in the U.S. one of the important elements is also about this concept of peer-to-peer communication. Often, a group of skilled individuals who are not considered sales reps but in fact are part of medical affairs are able to talk with peer-to-peer for scientific communications. This would be the medical science liaison group. Now Lorie, as you think of the medical affairs team, I know we are delighted to announce we have a new clinician who’s joined the bone group and brings terrific experience. But for the medical science liaison group, could you tell us a little bit about that group and the type of experience those individuals have?

[Lorie Fitzpatrick:]

Yes, Bob. We’ve been so fortunate the recruitment of our MSOs. They are highly experienced in the field of osteoporosis. They are well qualified, they know the therapeutic area cold. And they know all of the key experts in the field. So they already been out there for a couple months working with these key experts to learn more about what the unmet needs are in the field. And we’re really pleased that we have -- they come from companies with big names that have products in the market already. So they really know what they’re doing.

[Robert Ward:]

Terrific. Thank you, Lorie. So when we think about launch and we think about partnering, we are pleased when we sit down at the partnership table that the party on the other side of the table looks across and sees a company that is well prepared to execute, laying the groundworks for global brand development so that it is indeed a turnkey operation, which we do think is the key to timeliness and execution. Is there another question?

[Operator:]

Yes we do have another question from line of Eun Yang of Jefferies. Please go ahead.

[Carmen Augustine:]

This is Carmen on for Eun. Thanks for taking the question. So how are you thinking about timing of the initiation of the bioequivalent study for abaloparatide-TD. And on a related note, do you think the partnership discussions that are ongoing for abaloparatide-SC could apply to abaloparatide-TD as well? Would a partner be interested in that asset as well?

[Robert Ward:]

Carmen, as we think about different partners, some partners have strong primary care capabilities. Other partners have strong specialty biologics experience. Some partners bring commercial expertise; other partners can work with you on elements as ongoing brand development in terms of clinical development or in terms of manufacturing. So when we think about different partners, each partner brings a unique set of capabilities to the table. And so the partnership that works best for Radius and another party is really kind of a customized discussion. So when you think of transdermal patch, what we’ve indicated is that we would conduct that pivotal bioequivalent study at a time when we have completed all the standard requirements for scale-up and manufacturing. So that’s work that’s ongoing now, and we’ll be back with the guidance on when the TD study will complete probably as we move into next year.

[Operator:]

Thank you. I would now like to turn the conference back over to Mr. Ward for any closing remarks.

[Robert Ward:]

Yes, so I’d like to thank everybody for joining us on the call today. We have never felt that Radius was in a stronger position than it is today. Progress across the portfolio. A dedicated group of individuals who continue to demonstrate high performance. A late-stage asset under regulatory review both here and in Europe, with positive regulatory approval on the cusp of becoming a commercial company, which will dramatically accelerate our business. With 140 moving into the clinic next year, that would give us three different clinical programs. And that goes to the depth and quality of the science here at Radius. So I wanted to thank everyone for joining us on our call today. We’ll look forward to our call next quarter. And please be aware that will be done at the end of the day East Coast to enable our West Coast investors to participate at a time that’s more friendly in their time zone. Thank you very much.

[Operator:]

Thank you. Ladies and gentlemen, this does conclude today’s teleconference. You may disconnect your lines at this time and thank you for your participation.