Radius Recycling, Inc.

today's conference is scheduled to begin shortly please continue to stand by thank you for your patience Thank you. Thank you. Good day and thank you for standing by. Welcome to the Radius Health Inc. Third Quarter 2021 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star, then 1 on your telephone keypad. Please be advised, today's conference may be recorded. If you require operator assistance during the call, please press star, then 0. I'd now like to hand the conference over to your host today, Ethan Holdaway, Head of Investor Relations. Please go ahead.

Hello, everyone, and thank you for joining us today. A press release and presentation that we will use to guide the discussion can be found in the investor relations section of our website. A replay of the call will also be available on our website three hours afterwards. Before we begin, I'd like to remind everyone of our safe harbor statement on page two. This presentation includes forward-looking statements and non-GAAP financial measures. You can find the reconciliation of GAAP to non-GAAP at the end of the presentation. Our most recently filed 10-K and subsequent filings identify factors that could cause our actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent our views as of today only. On today's call, Kelly Martin, President and CEO, will start with his opening comments. Steve Helwig, our Finance and Accounting Officer, will then provide a financial update. Chaya Shah, Senior Vice President and Clinical Program Lead, will follow with an update on Elastostron and Abalaparatide development progress, and Bob Valentine, Strategic Business Officer of Abalaparatide, will finish up by providing a commercial update. We will then open the call for questions, and I would now like to turn it over to Kelly.

Thanks, Ethan, and good morning, everybody. Thank you for spending a few minutes with us today to go through our third quarter presentation earnings and some of the results of the business. It was a very busy quarter for us. We don't necessarily run the company quarter by quarter, but the activity level is very high across all aspects of our business, and we'll share that with you this morning. I'd like to highlight a number of things which we think are particularly important from the quarter. First and foremost, Bala Paratide On the male study, we announced positive results from the pivotal trial several weeks ago, a great step forward for that molecule and an interesting opportunity in the marketplace. Secondly, for abaloparatide, we resubmitted into the European marketplace last week. We had indicated that that was our goal second half of this year, that we would resubmit into Europe, and we accomplished that. Third thing for abalaparatide is the TD pivotal readout remains on time for a Q4 readout for this year. I know lots of people are focused and interested on that, as we are as well. In the elastostrand molecule, we announced that the pivotal trial delivered positive results, so our partner, Menorini Group, and ourselves are very pleased with that. We will go through with you very specifically during this call. Steve Helwig will outline the business relationship we have with Menorini. We also outlined that fairly explicitly in our earnings announcement. And Shia Shah will go through some of the highlights at the high level of that trial. Clearly an important step forward in the space and an important step forward for Menorini and ourselves. For RAD011, the Prader-Willi syndrome pivotal trial is on time to start towards the end of this year or the very early part of next year. And importantly, we've completed our lifecycle planning with that molecule. And over the next few weeks, we will announce and roll out additional indications that we will take forward with RAD011. all of which we're very excited about and looking forward to sharing our thoughts and thinking with you in the very near term. Our near-term focus as a business and as a company are multiple things, and we highlighted a few. First and foremost, Tim Lowe's commercial. We are focused on continuing from a growth point of view, a productivity point of view, and very specifically a segment focus point of view. As we indicated in the earnings announcement, our productivity is up. Our revenue is up. We would like to expand the denominator or the baseline of that business, and that's what Danielle and Bob Valentine are working on from a business point of view. From Abala Paratide, our preparation and anticipation of introducing mail indication to Abala Paratide, it's an important piece of work. something that we have done some work on to date and will continue to emphasize over the next several months, again, in anticipation of including the male indication in the U.S. for Ebola parasite. We're also doing preparation, as we have been doing, on the transdermal system, or TD. Important to us is what the actual data will say. That data will give us some definitive information with regard to pricing, reimbursement, and the segment or segments that we believe will be most applicable for TD. Last but not least, in the Bala Paratide, we continue to expand the global footprint of this asset. As we, again, indicated in the earnings announcement, a lot of progress is being made in Canada. A lot of progress is also being made in Japan, which I and remind folks it's the largest anabolic market in the world. And we will look to expand the footprint in other countries and or geographic regions as we conclude transactions. From an Elastostrand point of view, again, our focus with Menorini Group is to prepare and accelerate, if possible, the regulatory pathway and discussions in both the U.S. and Europe, It's something that we have an integrated approach to, and it's a very big focus of ourselves and the Menorini Group with regard to this asset. RAD011, we will initiate the Prader-Willi trial, and we'll also, as I said before, share some lifecycle opportunities for this asset. When we purchased RAD011, we very specifically indicated that this was a pipeline within a molecule, and we look forward to sharing that information. with all of you in the next few weeks. The last thing I want to touch upon is something I've touched upon before, but just wanted to remind and continue to emphasize, which is our approach and philosophy in running the business at Radius and the things that are very important to us as we build a distinctive company. First and foremost, our culture. We continue to build a culture around exceptional people who are very team-oriented, and we've made great strides and progress on that over the last 18 months, and we'll continue to make more. It's kind of a never-ending goal and objective and one that we're very focused on. We're very focused on executing against plan in a very high-quality manner. In the last year or so, We completed the enrollment on three pivotal studies. We've had readouts on two of the three. We're awaiting the third. We've resubmitted this asset into Europe. We are working closely with our partner in Japan on abalaparatide. We've in-licensed a synthetic CBD asset that has very broad applicability across neuro and neurobehavioral and psychiatric indications. And last but not least, from a business P&L and cash point of view, we're very resolute on managing all of those pieces together in a high-quality way. From a perspective point of view, we manage for short-term progress, but we also do that within an intermediate term map and roadmap. There's many things over the intermediate term we would like to accomplish in but you can only accomplish those if you get things done in the short term. And so we balance both short term with an intermediate view of where we're going and how we intend to get there. Very importantly, we strive to be outstanding stewards of capital, people who provide us capital, whether it's debt, equity, cash. We want to make sure that we are managing that capital in a thoughtful manner and You know, once again, managing for the short term but balancing against intermediate term objectives. We look at the company from a portfolio basis. We try to consistently see where we can reduce risk. That risk may be execution risk. It may be partner risk. It may be competitive risk. It may be pricing risk. Balance that risk with opportunity to create more on the upside, whether that's additional indications, additional geographies, additional partnerships. So we continually look at our portfolio from a risk and return point of view, and we try to manage risk down and opportunity upside up. And last but not least, we will continue to be active in our own capital structure, not be passive participants in our capital structure, When we have opportunities to improve our capital structure, we will do that at the right time and for the right reasons. And I think that's an important aspect of this company as you look forward to now three different assets with potential for both, with success, potential revenue, milestones, and growth. And so using that capital, prospective capital in return, part of the usage of that will be to be active in our own capital structure. I think that's an important thing to emphasize. So with that, as Ethan said, joining me on this call, we have some fantastic people. I'm going to turn the call to Steve Helwig in a second. He's our principal finance officer and is doing a great job in that role. You'll hear from Shia about both Elastostrand and Ebola Paratide in her role. guiding those two assets from a development and regulatory and operational point of view. And last but certainly not least, you'll hear from Bob Valentine on some of the core topics and analysis within the commercial space. So with that, I'm going to turn it over to the very capable hands of Steve Helwig, and he'll walk you through the key aspects of our financial performance for the quarter.