Good day, ladies and gentlemen, and welcome to your IsoRay Inc. Third Quarter 2020 Earnings Conference Call. All lines have been placed in a listen-only mode and the floor will be open for your questions and comments following the presentation. At this time, it is my pleasure to turn the floor over to your host, Mr. Mark Levin of Investor Relations. Please go ahead sir.

Thank you, operator. Good afternoon and thank you for joining us today for the IsoRay fiscal third quarter 2020 earnings call for the third quarter ended March 31st, 2020. Before we get started, I will take a few minutes to read the forward-looking statements. Certain statements in this conference call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. When used in this conference call, words such as will, believe, expect, anticipate, encourage, and similar expressions, as they relate to the company or its management as well as the assumptions made by information currently available to the company's management, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and beliefs about future events as of today May 12th, 2020. As with any projection or forecast, they are inherently susceptible to uncertainty and changes in circumstances and the company undertakes no obligation to and expressly disclaims any obligation to update or alter its forward-looking statements whether resulting from such changes, new information, subsequent events, or otherwise. Additional information concerning forward-looking statements is contained under the headings of Safe Harbor statement and risk factors listed from time-to-time in the company's filings with the Securities and Exchange Commission. We will begin today's call with Lori Woods, IsoRay's Chief Executive Officer; and then Jonathan Hunt, IsoRay’s Chief Financial Officer, who will discuss the fiscal third quarter 2020 financial results. Following their prepared remarks, we will take questions from our analysts and institutional investors. I will now turn the call over to Lori.

Thank you, Mark. Good afternoon and thank you for joining us today for IsoRay's fiscal third quarter 2020 earnings conference call for the quarter ended March 31st, 2020. Following my comments, our Chief Financial Officer, Jonathan Hunt will provide a more detailed review of the fiscal third quarter financial results. I am very pleased to share with you the considerable progress, we continue to experience at IsoRay and the accelerated growth we realized in the quarter ended March 31st. Record revenue for the third quarter increased 50% versus the year ago quarter. This quarter comprised the top three single highest revenue months in the company's history. We continued to see substantial operational improvements in this quarter as gross margin expanded to a record 59.2%. Combine that with moderate operating expense growth, and we significantly decreased our operating loss, which was half of what it was in the fiscal third quarter of 2019. A central factor in driving strong momentum that is manifested in our financial results is our growing leadership role within the brachytherapy industry. We continue to expand our role as a trusted, valuable partner, enabling more practitioners to better treat their patients. This is evidenced again this quarter by yet another increase in new customers. As of the trailing 12 months ending March 31st, our net new physician customer count increased 33% versus the previous 12-month period. We continue to gain traction by highlighting the unique benefits of Cesium Blu and our supporting delivery devices. In addition, our best-in-class customer service and support and our expanding digital presence should allow us to continue to grow our leadership position. As we ended the quarter in March, the world saw a significant shift from the unfortunate implications of the COVID-19 global health pandemic. I am proud to report that from…

Thank you, Lori. I am going to discuss some of the financial information that was contained in our press release for the fiscal third quarter ended March 31st 2020 that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or around May 14th. Revenue for the third quarter ended March 31st, 2020 grew 50% to $2.9 million versus $1.9 million for the same period last year. The third quarter revenue was comprised of 84% for prostate brachytherapy, which grew 42% versus the fiscal third quarter of 2018. With the balance or 60% of revenue attributed to other brachytherapy, primarily sales to treat brain, which included normal revenue and GammaTile related sales to GT Medical Technologies. Gross profit as a percentage of revenues for the third quarter ended March 31st, 2020 increased to a record 59.2% compared to 45.7% for the quarter ended March 31st, 2019. The gross margin increase was primarily driven by higher sales and lower isotope unit costs when compared to the prior year comparable period. Third quarter gross profit dollars of $1.7 million increased 94% when compared to the same period last year. Total operating expenses consisting of research and development, sales and marketing, and general and administrative increased 10% from the prior year comparable period to $2.3 million from third quarter 2020 revenue growth 50%. Total R&D expense decreased slightly to $294,000 compared to $299,000 in the comparable prior year quarter. Going forward, we continue to expect proprietary R&D expense to increase back to or above levels in prior recent quarters or to roughly $300,000 to $400,000 per quarter as we are continuing to have discussions with institutions looking at the expanded use of Cesium-131. Sales and marketing expenses increased 25% versus the comparable prior year…

Thank you. [Operator Instructions] We'll go first to Jason Kolbert at Dawson James.

Well, congratulations. I know there's a lot of chaos going on across the United States. But you did put up great numbers. I think the best numbers I've seen since I'm following IsoRay. So that really is a great accomplishment. If I understand what you said Lori, the majority of those revenues were driven by prostate cancer. But you're beginning to have a glimmer of hope that GT Medical will come online as GammaTile and their salesforce engages. Is that right?

Yes, that's correct Jason. And thank you, we're very excited about what we did this last quarter. To your question, yes, most of it was from prostate and then we are hopeful that GammaTile will be gaining traction and moving forward now that they've done their full market release.

Okay. And I just want to make sure I understood a couple of things. You mentioned that there is going to be some interruptions in COVID, both in terms of Blu Build, the device, and just a lot of other factors, but at the end of the day, procedures that were being lined up are going to be rescheduled. So, we might see a dip in April that might come back to an increase in May or June and quarter may end up being somewhat in line with kind of prior expectations. Is that fair to say?

Well, I think it is fair to say that we've gotten a lot of feedback from our customers that indicates that those cases that were cancelled toward the end of March and maybe didn't get scheduled at the beginning of April. They all believe that those cases will be back and be scheduled. And so I can't speak to exactly how next quarter will turn out. But we're very hopeful that over the next few months, we'll get them all back and taken care.

Sure, of course. And one last question, to -- I wanted to make sure I understood the acronym ROAPM this single bundle payment, multiple cancers that levels the playing field for brachytherapy, but what this row pan stands for?

It's the radiation oncology -- Jonathan helped me out here.

Yes, but I did get it right, it is R-O-P-A-N, right?

It's R-O-P-A-M. So, it's radiation oncology--

Alternative payment method.

Got it, alternative payment method. That's right, I just wanted to get it right so that we go in print. Listen, one last question Lori, cash is starting to get tight, do you have any thoughts about how you're going to handle the -- your cash capital needs?

I'm going to turn that question over to Jonathan.

Okay.

Jason, so, we continue to believe that at our current cash levels and based on our current burn rate that we have sufficient cash to last us throughout the remainder of this calendar year. And as you probably know, we do have an ATM in place which although it's not an immediate financing, it does give us the flexibility to sell stock at the current market price in the market from time-to-time at our discretion. So, we'll continue--

Preservation of the balance sheet through an ATM. That makes sense.

Yes.

Okay. All right. Sounds good. And so, Lori, any -- thank you very much for that. I appreciate it. Lori, any particular events or catalysts that we should look at? I mean, you and I have been doing this a long time. And IsoRay is the turtle slow and steady, but really showing some nice progress, is there -- but we all love catalysts and events. Is there a catalyst or an event that I could hang my hat on?

I might have answered that question differently if we weren't in the middle of a pandemic, but I think right now really, it's important that we stay focused on our core strategy, which is growing our prostate market and getting new patients in the door, organic growth for those customers that we already have, and keep that moving forward. And as things clear out and this whole thing with COVID-19, I think we'll be able to talk to you more about relationships we're developing with the research centers and some other ongoing things. We're just -- with this popping up in the middle here the last couple months, we're just not ready to have those discussions.

Sounds very reasonable. Thank you. I guess what I was going to ask one last thing it was at what point do you start to see your ability to expand manufacturing margins or get more leverage out of the cyclotrons that are producing the seeds?

Actually, we buy our radioisotopes from facilities in Russia and they constantly work on refining how we're going to get our isotope and one of the reasons we're very pleased to partner with them is they've done a fantastic job of that and they ship us very, very pure isotope. So, it has been one of the things that has helped drive our gross margins up is the fact that we don't have to refine the isotope once we get it, we don't have to spend time and money doing that. We get very, very pure isotope from Russia. So, that's been very helpful for us.

Thanks Lori. Congratulations, everybody at IsoRay. Really appreciate it. Stay safe. Thank you.

Thank you, Jason, so much. You too.

We'll go next to Ed Woo with Ascendiant Capital

Yes, I also like to say congratulations. This is a very great quarter, especially in this environment. My question is -- congratulations also on getting the additional billing codes from Medicare. Just walk them through some of the details, does that mean that you have now have approval for hospitals to bill Medicare for these additional procedures? And what is the reimbursement rates?

So, I see -- the reason you want to have ICD 10 PCS codes is because they play a really important role in communicating claims information. And that really helps ensure the establishment of appropriate groupings. So, in the in-patient setting, it's going to be a group of codes around a specific type of treatment. While there's never been able to be a Cesium portion of that and so it's been very difficult to set payment levels in relationship to using Cesium. So, it's very key for us to get these ICD 10 PCS codes, because now that really helps ensure that we get the appropriate group rate -- groupings and levels of payments for hospitals in the in-patient setting.

So, does that mean a hospital today can now use Cesium-131 and get reimbursed for it whereas yesterday, they wouldn't be able to?

Well, many hospitals have been using Cesium-131 to-date and they just didn't have a code to tell Medicare that they were actually using it. And so as of today, they have a code that they will use when they use Cesium-131 to tell Medicare and by extension, other insurers, that they are using Cesium in this particular type of surgery and that it justifies additional payment for that procedure. And they'll gather data over time to help determine what the appropriate reimbursement rates will be. But it's a big step toward working for a strong reimbursement for Cesium in the in-patient setting where we've always just been in the out-patient setting before.

Great. So, the reimbursement rate for in-setting is still a work in process?

Exactly. And this was a key milestone to really make that move forward.

Great. Is there any timeline on when the next step would be?

So, that's something that CMS works on and each year as they set new reimbursement rates, they will take this into account. So, now it's an evolving process from year-to-year as to how they're going to set those rates. And we don't have any control over that. So, there's not a next step for us to take. We've taken the step of making sure we got these codes in place and now Medicare pulls that into their system.

Okay, but this is definitely a good positive first step -- or milestone?\

Yes.

Great. Another question I have is -- obviously, fortunately, lucky your business hasn't been effective relatively. What about outreach to physicians and getting the word out on Cesium-131, has that been slowed as well with shelter-in-place or do you still see good outreach to new positions?

That's a great question Ed. And it's been very interesting because, of course, our salesforce loves being right in front of the physicians and talking to them. So, it has been an adjustment. It's been one that we found has been working better than we thought it was going to. We have new patients that have come -- sorry, new physicians who have come on board. And we also have had some really great interaction with physicians on conference calls -- multiple physicians on conference calls, lots of things that I think we're all adjusting to, seeing each other on video camera and working day in and day out that way, we're finding that works with physicians. And the feedback we've gotten is that in many ways, they like that because it allows them to manage their time better, and they can still have good communications with us. So, it's an adjustment like I think it is for many businesses across many sectors, but so far, it's been going very well.

Great. Well, thank you for answering my questions and wish you continued luck going forward. Thank you.

Thank you so much.

We'll go next to Bill Urschel, Accord Partners.

I'd like to echo my congratulations, guys, but my questions were answered by -- in the earlier answer, so I'm good to go. Thank you.

Thank you so much Bill.

[Operator Instructions] I have no other questions holding at this time. So, I'll turn the conference back to Ms. Woods for any additional or closing comments.

Thank you, everyone, for joining us today. We're really excited about what we've been able to share with you today. And we're going to work hard to ensure that we get this very valuable treatment out to physicians and their patients and that we really help work with our policymakers in Washington D.C. to understand how important it is that cancer patients have access to treatment during this difficult time and what a great treatment brachytherapy is during this time as well. Thank you for your time today and have a great evening.

Ladies and gentlemen, that will conclude today's conference. We thank you for your participation. You may disconnect at this time and have a great day.