Q4 2015 Earnings Call Transcript

Published: 26 Feb 2016

[Operator:]

Greetings, and welcome to the Radius Health Fourth-Quarter 2015 Earnings Conference Call. [Operator Instructions] As reminder, this conference is being recorded. It is now my pleasure to introduce your host, Barbara Ryan, Investor Relations. Thank you. You may begin.

[Barbara Ryan:]

Thank you, Christine. Welcome and thank you to those of you joining on the call and webcast this morning for a review of Radius Health's fourth-quarter and full-year 2015 financial and operating results. With me this morning to discuss the results and update you on our progress are Robert Ward, President and Chief Executive Officer; Lorie Fitzpatrick, Chief Medical Officer; David Snow, Chief Commercial Officer; Dinesh Purandare, Head of Oncology; Gary Hattersley, Chief Scientific Officer; and Nick Harvey, 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 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 annual report, on form 10-Q filed with the SEC and other reports filed with the SEC. Any forward-looking statements represent our views as of today, February 25, 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 website. I will now turn the call over to Robert Ward, President and Chief Executive Officer of Radius Health.

[Robert Ward:]

Thank you, Barbara, and thank you to everyone who has joined us on our conference call and audio webcast this morning. Radius Health has never been in a stronger position than we are today. We've accomplished a number of important milestones in 2015, and we have an exciting 2016 ahead of us. We ended 2015 with $473 million in cash and equivalents and are well-funded to continue to develop our portfolio and launch abaloparatide with a partner. Our lead program is based on a abaloparatide, a chemically synthesize novel 34 amino acid peptide that selectively binds to the PTH1 receptor to stimulate a bone-building, or anabolic, response. Most importantly, in 2015, we completed our Phase 3 clinical development plan for abaloparatide sub-Q and submitted our marketing authorization application, or MAA, for abaloparatide with the European Medicines Agency last November, and it is now under active review. We believe the robust clinical results from the ACTIVE an ACTIVExtend Phase 3 trial have established a favorable profile for abaloparatide, providing evidence of a significant reduction in osteoporotic fractures with an acceptable safety profile. We are on track to submit our new drug application, or NDA, to the US Food and Drug Administration by the end of this quarter. We’re highly confident that the investigational drug abaloparatide has the potential to become an important medicine for the treatment of osteoporosis. The clinical significance of these data and the approvability of this investigational drug will, of course, be made by the European Medicines Agency as they review the MAA, and the Food and Drug Administration as they review the NDA here in the U.S. Now, I'd like to introduce our Chief Medical Officer, Lorie Fitzpatrick.

[Lorie Fitzpatrick:]

Thank you, Bob. In 2015, after the positive presentation of our Phase 3 ACTIVE an ACTIVExtend results in oral sessions at the ASBMR, the enthusiasm for abaloparatide as a potential treatment to millions of patients with osteoporosis has been building. In 2015, we presented at the ASBMR and the Endocrine Society scientific meetings that the 18-month data for abaloparatide showed a significant reduction of 86% in new vertebral fractures, a 43% reduction in non-vertebral fractures, a 43% reduction in clinical fractures, and a reduction in major osteoporotic fractures of 70%, all of these numbers significant comparisons to the placebo group. The ACTIVE trial included an open-label arm were patients were treated with the anabolic agent teriparatide, currently marketed in the U.S. by Eli Lilly as Forteo. At 18 months, compared to Forteo, abaloparatide demonstrated significant increases in BMD at the total hip and femoral neck, and there was a 55% reduction in major osteoporotic fractures. The ACTIVExtend trial transitioned the abaloparatide to the placebo groups to the oral bisphosphonate alendronate, and these results represent the 25-month data. [As a reminder], when first introduced by Merck, alendronate was marketed under the brand name Fosamax. The group transitioning from abaloparatide showed no additional vertebral fractures during the six-month period of ACTIVExtend, and there is a 52% reduction in non-vertebral fractures, a 45% reduction in clinical fractures as compared to the alendronate group who transition from placebo. On April 1, immediately following the planned submission of our NDA, Dr. Felicia Cosman of Columbia University will be presenting additional compelling data from our Phase 3 ACTIVE trial at the Endocrine Society in Boston, showing that abaloparatide increases the BMD and reduces the risk of vertebral and non-vertebral fracture consistently, irrespective of baseline patient characteristics. We expect that the Endocrine Society will be an exciting meeting for Radius, and we will be hosting an event with key opinion leaders with invitations to go out shortly. In addition, we have three oral presentations at the upcoming WCO-IOF-ESCEO in Spain in April. Two of the oral presentations will review the data from ACTIVE and ACTIVExtend, our Phase 3 trial and its extension. The third presentation will evaluate the risk for fracture at baseline in the ACTIVE trial using the FRAX algorithm. We are particularly excited about the future as pending favorable regulatory review abaloparatide will be the first new drug to launch for the treatment of osteoporosis in over six years.

[Robert Ward:]

Thank you, Lorie. Certainly it’s an exciting development. I'd now like to turn the call over to David Snow, our Chief Commercial Officer, who is leading our preparations for launch, deeply involved in our partner conversations, and Dave, we would like you now to share your perspectives on the market.

[David Snow:]

Thanks, Bob. Radius is ramping up a broad range of abaloparatide sub-Q U.S. launch preparations, including establishing the overall brand profile through a comprehensive market research plan, developing our health outcomes materials and payer value proposition, evolving the abaloparatide sub-Q go-to-market sales approach, completing the global trade [indiscernible] and trade name development work, and finalizing our advocacy and medical education plans. Additionally, we continue to add experienced and capable Commercial Team members across our Sales, Payer, and Marketing Teams. We’re also building the requisite commercial infrastructure to enable a seamless and positive customer experience through our third-party logistics partner and hub/specialty pharmacy network. Importantly, we've engagement many healthcare practitioners and providers in varied market research projects and continue to receive positive and consistent feedback on the abaloparatide Sub-Q [indiscernible] profile. They recognize and are comfortable with abaloparatide sub-Q as a daily at-home therapy that's similar to Forteo, and clearly, there is a separate market segment of injectable osteoporosis therapies that will be administered only in doctor's office, like Prolia today. We anticipate a first launch in Europe as early as the end of 2016 in coordination with our commercial partner. And finally, we are enthusiastically advancing our U.S. launch preparations as the NDA submission goes in at the end of March. Thank you, Bob.

[Robert Ward:]

Thank you David. Dr. Hattersley, would you mind sharing with us now the progress with the abaloparatide short wear time transdermal patch?

[Gary Hattersley:]

Absolutely. Thank you, Bob. In December, we initiated our human replicative study for the optimized abaloparatide transdermal patch with the goal of determining the potential for bioequivalence with a subcutaneous injection formulation. Recall, the transdermal patch is approximately the size of a dime, and in our previously completed Phase 2 study, patients were asked to wear their patch only five minutes once a day. The goal of this transdermal program is to select an optimized transdermal patch capable of achieving a [indiscernible] equivalent to a subcutaneous injection. In the fourth quarter, we reported results from the preclinical transdermal optimization studies in monkeys, in which we identified several approaches to achieving this optimized patch profile. The human clinical replicative study is currently ongoing, and in this study, a number of different variables are being evaluated, which we believe will provide a path for selection of the optimized patch. Initial preliminary data from this ongoing study are very encouraging, and we believe the data demonstrate the ability to modify the pharmacokinetic profile of this patch. We look forward to providing further update midyear on the progress of these transdermal optimization studies.

[Robert Ward:]

Thank you, Gary. During 2015, we also made significant progress with RAD1901, which we believe is uniquely suited to potentially become the backbone oral agent for mono or combination therapy for hormone-driven or hormone-resistant advanced breast cancer. We reported in the fourth quarter of 2015, our progress with the Phase 1 dose escalation study for RAD1901 at the San Antonio breast cancer symposium, and in a moment, I'll ask Dinesh to provide a complete overview. In December, we also initiated a second oncology Phase 1 FES-PET trial for RAD1901 [indiscernible] and also in December, we initiated a low dose RAD1901 Phase 2b trial for vasomotor symptoms, which we believe is a disease state was significant unmet medical need. Dinesh?

[Dinesh Purandare:]

Thank you, Bob. As Bob already briefly mentioned, we are pleased to inform you that we continue to make very good progress on our Phase 1 dose finding study in ER positive advanced breast cancer patients, where we are currently enrolling 600-milligram cohort and evaluating tolerability stable disease and tumor regression. We expect to complete the trial and identify a go-forward dose by the middle of this year. We anticipate reporting these results at a major scientific meeting later this year. To date, no DLTs have been observed, and we are on track to initiate our expansion cohort study in ER positive advanced breast cancer patients in second half of 2016. This signal-seeking study will look at RAD1901 as both a single agent and in combination with other agents across a variety of different patient cohorts. In January, we announced our global clinical agreement with Novartis, and we are looking forward to our collaboration on their promising molecules, such as CDK4/6 and PI3K inhibitors in the breast cancer space. Further, we are excited to announce that our RAD1901 abstract has been accepted for an oral presentation at an upcoming meeting called Impact to be held in Brussels from May 12 to 14, where we plan to provide a comprehensive overview on RAD1901, including preclinical and clinical data. In addition, RAD1901 was also accepted as an abstract at an upcoming ACR meeting to be held in New Orleans from 16th to 20th of April. Turning now to vasomotor symptoms, or VMS, VMS remains a market with significant unmet medical need. Approximately 30 million women in the U.S. alone suffer from VMS, and only half or less are on some form of treatment, mostly hormonal. We believe that RAD1901 may potentially offer an effective and safe non-estrogen treatment approach for these patients. As you may recall, Radius initiated a major clinical study in December 2015. This study looks at 5-milligram, 10-milligram, and 20-milligram doses versus placebo in 300 patients, and we are targeting to complete enrollment in 2016. What is exciting about this program is that our ongoing Phase 2b study will serve as a key efficacy study, and any formula on Phase 3 studies will mostly focus on long-term safety as required by the agency. We are also pleased to inform you that RAD1901 abstract on VMS was accepted at the Endo Society meeting to be held in Boston from 1st to 4th of April this year. Now, as we look ahead, the vasomotor commercial call pattern would have a very complementary footprint to the primary care focus for abaloparatide transdermal patch, which would allow for synergies on medical and commercial fronts. I would like to now turn over the call back to Bob.

[Robert Ward:]

Thank you, Dinesh. I'd like to ask Nick Harvey, our Chief Financial Officer, to discuss our fourth-quarter and full-year 2015 results and also provide an update on our balance sheet.

[Nick Harvey:]

Thank you, Bob. For the three months ended December 31, 2015, we reported a net loss of $33.2 million, or $0.77 per share, as compared to a net loss of $18 million, or $0.55 per share, for the three months ended December 31, 2014. For the 12 months ended December 31, 2015, we reported a net loss of $101.5 million, or $2.56 per share, as compared to a net loss of $62.5 million, or $4.04 per share, for the 12 months ended December 31, 2014. The increase in net loss for the 2014 period to 2015 period included an increase of $7.7 million of non-cash stock-based compensation expense, and was primarily attributable to the [indiscernible] to support our MAA and planned NDA submissions and to prepare for the potential commercial launch of abaloparatide sub-Q. We've experienced a substantial growth our headcount, currently at a proximally 100, and we expanded development opportunities of RAD1901. As Radius continues to advance towards the first commercial sale of abaloparatide sub-Q, we expect to continue to expand our investment and launch preparations. Our cash, cash equivalents, and marketable securities balance as of December 31, 2015 was $473.3 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 partnership activities 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 line for your questions, I would like to summarize our upcoming milestones for the remainder of year. 2016 will be a very exciting year for Radius as we look forward to continuing to execute on a number of substantial milestones and prepare for the transition to be a fully-integrated biopharmaceutical company. We’re on track to submit our NDA in the U.S. by the end of the first quarter, and our MAA is already under active review in Europe. The acceptance of the MAA in December of 2015 started the 210-day active clock to CHMP opinion in Europe. We expect to receive a CHMP opinion in 2016. We are actively engaged in partnering negotiations and expect to enter into a collaboration by the time of our first commercial launch. At the same, time we’re busy building our internal marketing organization and our launch costs are already funded on our balance sheet. By midyear, we look forward to reporting to on the results of our human replicative study for the optimized transdermal patch with the goal of demonstrating bioequivalence to abaloparatide sub-Q. We expect to complete our Phase 1 part A dose escalation study for RAD1901 in metastatic breast cancer by midyear, and plan to report those results at a scientific meeting later this year. We plan to begin the Phase 1 part B expansion cohorts in the second half of this year as well, including our clinical collaboration with Novartis. Immediately following our planned NDA submission at the end of this quarter, we'll have two presentations at the Endocrine Society here in Boston on April 1. Later in April, we have three additional presentations on abaloparatide at the World Congress of Osteoporosis in Spain. For RAD1901 and breast cancer, we'll be making presentations at the AACR annual meeting April 16 through the 20th in New Orleans, and in May, also a presentation on RAD1901 at Impact in Brussels. During the year, we'll also be making a series of presentations at investor conferences in Boston on March 8 at the Cowen Health Care Conference; in May, Deutsche Bank Healthcare Conference; and also, the Bank of America Merrill Lynch conference. Thank you very much, and Christine, we'd now like to open up the call for questions. Thank you.

[Operator:]

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from the line of John Newman with Canaccord. Please proceed with your question.

[John Newman:]

Hi, guys. Good morning, and congrats on all the process over the past year. So, I just had a question as to what is left in order to complete the NDA filing for abaloparatide at the end of the first quarter. Thanks.

[Robert Ward:]

Yeah, thank you, John. As you know, when we submitted our MAA in December of last year, that included our six-month stability date, and the NDA on submission at the end of this quarter will include the 12 month of stability data. Many of the information presented in the MAA is still included in the NDA, but it's formatted differently as the applications are not identical. So we're now in the process of finalizing each segment of the module, specializing four of the requirements for the U.S. here, and we'll have that submitted at the end of this quarter. Thank you, John.

[John Newman:]

Yeah, thank you.

[Operator:]

Our next question comes from the line of Jessica Fye with JPMorgan. Please proceed with your question.

[Jessica Fye:]

Hey, good morning. Thanks for taking my questions. I have a couple here if that's all right.

[Robert Ward:]

Terrific.

[Jessica Fye:]

I guess, first, on 1901, can you elaborate on whether the Impact presentation will include new clinical data or more of an overview of the clinical data we've seen? Obviously, not asking for the actual data, just whether there will be anything new there relative to San Antonio. Second question is about the TD patch. I believe in the prepared remarks, you noted that the initial patch data was pretty encouraging and it made you confident in your ability replicate the PK of sub-Q. Just to make sure I understand, was that initial patch data the preclinical data that we saw last fall, or is that initial patch data that you are gathering right now in humans? And can you elaborate a little more specifically on what you are encouraged by there? Thank you.

[Robert Ward:]

Yeah, thank you, Jessica. Great to hear from you this morning. For 1901, Dinesh, with Impact, I believe the presentation includes both preclinical and clinical data.

[Dinesh Purandare:]

Right. That's right. And the presentation will be given by Dr. Bardia from MGH. As you know, he has been involved in a variety of serve [ph] programs, including RAD1901.

[Robert Ward:]

And will Dr. Bardia be the overviewing the currently ongoing Phase 1 trial, or will he be commenting basically on the information that was presented at San Antonio?

[Dinesh Purandare:]

He'll be commenting on the information. He'll provide a complete overview of the preclinical package that we have so far and some ongoing activities that we have on the clinical front. So this will be our first opportunity in Europe to present the data in this very important conference where one of the key program focus is on endocrine therapies and endocrine resistance, particularly as we see new molecules coming in the market, like Ibrance, and the success of those indicate that endocrine backbone for these molecules would be extremely important as we move forward. Remember, Ibrance is one of the molecules. In addition, of course, we have Novartis and Lilly developing their molecules in the same space.

[Robert Ward:]

So, Dinesh, as we think about evolution of treatment, CDK4/6 inhibitor is given, you would expect that it would be most commonly used in…

[Dinesh Purandare:]

In combination.

[Robert Ward:]

…with an endocrine therapy?

[Dinesh Purandare:]

Right. And Bob, that's why the medical community is extremely excited in molecules such as RAD1901 because these molecules will form the backbone. So when we look at a script to be written on a CDK inhibitor, whether it's Ibrance or other molecules to follow, we expect that they will be combined within endocrine therapy such as RAD1901.

[Robert Ward:]

Excellent. Thanks you. And now, Gary, with the human data being generated now in the replicative study, Jess is curious as to what elements of it are encouraging. Now, of course, we generally don't disclose confidential information of ongoing trials, but perhaps you could share with us from the primate work that was done last year and now with the human studies that are ongoing.

[Gary Hattersley:]

So you are right. We are actually very excited about the progress with this transdermal program to date. The preliminary data, just to confirm, is preliminary clinical data, which tell us that we are really on the right track towards bioequivalence. And when we do make a selection of the patch, which will be based upon evaluation of multiple different criteria as part of this planned part of this study, we'll obviously plan to provide further updates.

[Robert Ward:]

So further, a final selection of patch, Gary, will be including not just bioequivalence, but also manufacturability, cost of goods, intellectual property, [indiscernible] and a number of elements that go into evaluating a pharmaceutical for development.

[Gary Hattersley:]

Absolutely. They're all very important characteristics – components of this transdermal program.

[Robert Ward:]

Terrific. Thank you.

[Jessica Fye:]

Thanks, guys.

[Operator:]

Our next question comes from the line of Ying Huang with Bank of America Merrill Lynch. Please proceed with your question.

[Unidentified Analyst:]

Hey, it's [indiscernible] for Ying. I just have a couple of questions. How important do you think the nonvertebral differentiation is in the commercial setting? And what you expect to be included in your label now? And then on the transdermal patch, I think you just touched upon this, but will you be disclosing the human replicative study results? And then how quickly can the bioequivalent study be completed? Thanks.

[Robert Ward:]

Thank you. I think one of the most important things to think about nonvertebral fractures, these represent the most frequent fractures in osteoporosis and represent the bulk of the expense. So as payers think about alternatives of which therapy to adopt, nonvertebral fractures are front and center as the primary driver of both morbidity, mortality, and cost. But Dr. Lorie [ph] can you share with us from an epidemiology perspective as we think about nonvertebral fractures?

[Lorie Fitzpatrick:]

Yes, nonvertebral fractures are really important because they are not only 73% of the total fractures that occur, they account for 96% of the healthcare costs. So they are expensive, and you are right, they really affect patients. What’s even more fascinating is that patients who have had a hip fracture, most of them have actually had a fragility fracture earlier, which means we need to actually start treating these nonvertebral fractures early in patients' lives to prevent the hip fracture down the line. So they are very, very important to have that indication and to be sure that we have such a great results with abaloparatide compared to placebo in nonvertebral fractures.

[Robert Ward:]

We are also often asked about osteonecrosis of the jaw. Did we observe that in the abaloparatide program? Could you help remind us for osteonecrosis of the jaw and atypical femoral fractures, what is the rate in which that is observed, and what has been our clinical experience?

[Lorie Fitzpatrick:]

Yeah, so osteonecrosis of the jaw and atypical femoral fractures are typically seen with antiresorptives, such as bisphosphonate and Prolia. And the rates of incidents vary with the length of time that the patient is treated. So the longer they are treated with an antiresorptive, the higher the rates become. So although they are relatively rare, they are a definite side effect that can occur. And these vary, for example, for osteonecrosis of the jaw, can be up to 100 patients per 100,000 patient years with long-term use. And atypical femoral fractures may be anywhere from two in 100,000 with a short-term treatment to 78 per 100,000 with longer-term treatment. It's very interesting because an anabolic agent, such as Forteo, that's been on the market for 12 years, there's been no sign of either ONJ or AFF. We have not seen this with abaloparatide, nor would we expect to see it with an anabolic agent such as abaloparatide.

[Robert Ward:]

Thank you. And then for major osteoporotic fractures, that includes not just nonvertebral fractures, but other key fractures that are the driver. So when we look at the major osteoporotic fracture results from the abaloparatide trial experience, could you remind us of how those results have come out and how that relates to other anabolics?

[Lorie Fitzpatrick:]

Yeah, major osteoporotic fractures are very, very important. In fact, the FRAX algorithm that calculate risk of fracture, calculates the risk of hip fracture and also the risk of major osteoporotic fractures. Those fractures include the shoulder, the wrist, the hip, the clinical spine fractures, and those are the ones that really predict the risk of future fracture. So having an indication that would have on major osteoporotic fractures would be a lovely thing to have.

[Robert Ward:]

Terrific. So Gary, when the transdermal patch data mature and you've completed the optimization, I believe the question was will we be presenting that data, or how will we inform people about the program?

[Gary Hattersley:]

Sure. As already mentioned, that clinical study is currently ongoing. We are evaluating a series of different modifications to the patch as part of that study. So, of course, we will want to evaluate all of those changes before deciding the next steps for the program. But of course, we believe that bioequivalence will be a path for registration of the transdermal patch, and we will, of course, speak with regulators to confirm that they are in agreement with that strategy.

[Robert Ward:]

Terrific. Thank you.

[Operator:]

Our next question comes from the line of Mara Goldstein with Cantor Fitzgerald. Please proceed with your question.

[Mara Goldstein:]

Thanks very much. I appreciate it. So I guess my questions are really more about kind of go-to-market strategy at this point. And you've obviously described the opportunity to have a partner, but is the go-to-market strategy contingent upon that partner and how might it change or not change, if you will, with the revelation of the [indiscernible] data last week?

[Robert Ward:]

Well, Mara, I think, like everyone else, we were quite surprised to read the content of the press announcement, but we do not have access to data other than what was included in the press announcement. So I know there's been a lot of questions about that program, and we really suggest those be referred back to UCB and Amgen who really have the totality of the data. From our go-to-market strategy, as we've said all along, we've had very productive conversations and our desired partner is one with a successful track record of building global brands in osteoporosis, demonstrated capabilities not just in the commercial world, but also on the research world, so that in working with this partner, we can assure at that abaloparatide becomes available to patients around the world as quickly as possible following regulatory approval and commercial launch. So when we think about the plans that go forward, we've guided that we would focus our commercial efforts here in the U.S., and as David Snow had shared with you a moment ago, those efforts are currently ramping up an ongoing. We've also guided that by time of launch, we'd have a partner to enable abaloparatide to be commercialized around the world. Those conversations are quite productive and we've found a high level of enthusiasm because most of our partners have expressed their appreciation of the robust clinical data supporting abaloparatide. Partners have shared with us they were very pleased to see that anabolic or bone-building agent like Forteo was included in our fracture reduction style. Our partners have told us that BMD differentiation is important, but that they really wanted to know how our fracture reduction benefit compares. And we've been asked over and over again about vertebral fracture reduction with abaloparatide at 25 months, none vertebral fracture reduction with abaloparatide at 18 and 25 months, clinical fracture reduction for abaloparatide at 18 and 25 months, major osteoporotic fraction reduction at 18 and 25 months, and consistently partners say back to us they appreciate the data package that we are bringing forth and our quite interested in the overall profile of abaloparatide. So as we've said previously, we've had very productive conversations and we anticipate that by time of launch, we will have a partnership in play.

[Operator:]

[Operator Instructions] Our next question comes from the line of Jeff Chen with Cowen. Please proceed with your question.

[Jeff Chen:]

Hi. Good morning. Thanks for taking my questions. Just to follow up on the patch development, the transdermal patch, so if you were to see the PK/PD data that you desire in midyear and the FDA agrees to pursue bioequivalence trial, could you just elaborate on what that trial would potentially look like and the timing of it?

[Robert Ward:]

Thank you, Jeff, and I apologize, Mara, for not answering that. I know that you'd also asked the same question. I would encourage – the FDA has made available online guidance for bioequivalence. And if you read the guidance, what it outlines is really kind of a two-step process. One step is called a pilot PK profile, and what the pilot PK study helps to evaluate is what's the relative variability of the drugs you're talking about, how many patients are required, because it's really in many cases a mathematical calculation how many patients are required and how long that takes. Typically, in the world of biopharmaceutical research, bioequivalence studies are viewed as rapid and relatively straightforward. I think as Gary Hattersley shared, once we have our bioequivalence data, we, of course, believe bioequivalence would be the path to approval, but we [inaudible] talk with the agency about that, make sure that they are in alignment with us both here and in Europe. Transdermal patch would be a product that would follow on pending positive approval of abaloparatide sub-Q because the bioequivalence would then compare it to abaloparatide sub-Q. And Jeff, one of the things that is really important for us to think about in the transdermal patch program is not just from a regulatory perspective how bioequivalence would play out, but David Snow, I believe in your market research, you found that, for example, here in the U.S., if we look at just the prescribers of Forteo and Prolia, that 80% of those high prescribers, that's 12,000 physicians, but there's 55,000 additional physicians who routinely treat osteoporosis, but don't use injectable drug. So as you think about what the market research has told us about physicians who are looking for a needle-free or short-work-term opportunity to introduce abaloparatide, what would be ways that we might think about doing additional work so that for those physicians, they had a comfort level with the safety efficacy and usability of the program?

[David Snow:]

Thanks, Bob. Certainly, if you look at today's injectable market, there is a high degree of comfort with the existing injectable agents like Forteo where there is a lot of familiarity with that subset of mostly specialty physicians. But clearly, there is a large number of meaningful prescribers of osteoporotic oral therapies that would be interested and find transdermal therapy perhaps more attractive to their practice. And so we could see that the transdermal product is a natural progression, an incremental add-on in these patients, a real opportunity to bring anabolic therapy to a group of patients that haven't had the opportunity previously.

[Robert Ward:]

Great. And will the transdermal patch require patients to go to their doctor's office for administration, or will the transdermal patch be an at-home product?

[David Snow:]

Well, certainly, we foresee the patch itself to an at-home product, just like sub-Q will be available on daily sub-G at-home therapy.

[Robert Ward:]

Terrific.

[Jeff Chen:]

Thanks very much.

[Robert Ward:]

Thank you.

[Operator:]

Our next question is a follow-up question from John Newman with Canaccord. Please proceed with your question.

[John Newman:]

My question has already been answered actually. Thank you.

[Robert Ward:]

Okay.

[Operator:]

Thank you. Mr. Ward, it appears we have no – I'm sorry. We did get a follow-up question from Jessica Fye with JPMorgan. Please proceed with your question.

[Jessica Fye:]

Hey, guys. Thanks for taking the follow-up. I just wanted to clarify the answer on whether we will get new clinical data for 1901 at the Impact meeting. It sounds like we're probably going to get new data in the fall as [indiscernible] San Antonio. Is that the right way to interpret your response to that earlier question?

[Robert Ward:]

Jessica, I think we are expecting that Phase 1 dose escalation study will be completed in the first half of the year and that we'll report the totality of that data out at a scientific meeting in the latter half of this year. Dr. Bardia has a wide depth of experience working with both our serve program and other serve programs. So Dr. Bardia will provide an overview of the preclinical and clinical data. But no, his presentation is not focused on the final result of Phase 1 dose escalation because that trial we do expect to finish this year, but we of course want to finish and submit that to scientific conference. Is that helpful?

[Jessica Fye:]

Yes, perfect. Just trying to confirm if there would be like a couple incremental patients there or not, but it sounds like we are going to complete the study and get it done.

[Dinesh Purandare:]

That’s correct, yeah. We plan to complete this study and report the totality of the information, as Bob just outlined.

[Jessica Fye:]

Okay. Got it, thank you very much.

[Operator:]

Mr. Ward, it appears we have no further questions at this time. I would now like to turn the floor back over to you for closing comments.

[Robert Ward:]

Terrific. Thank you very much. We really appreciated having a chance to share with you today, not just the progress from 2015, but some of the very exciting milestones ahead in 2016. We think this is a transformational year for Radius, and our goal is to make an important contribution to medicine and we are very pleased with the progress we've made with our clinical programs. Thank you very much.

[Operator:]

Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.