Good day, ladies and gentlemen, and welcome to your IsoRay Fourth Quarter and Fiscal Yearend 2021 Financial Results Call. All lines have been placed on a listen-only mode and the floor will be opened for your questions and comments following the presentation. [Operator instructions]. At this time, it is my pleasure to turn the floor over to Mark Levin with IsoRay Investor Relations. Sir, the floor is yours.

Thank you, operator. Good afternoon and thank you for joining us today for the IsoRay fiscal fourth quarter 2021 and fiscal year 2021 full year earnings call for the quarter and fiscal year ended June 30, 2021. Before we get started, I will take a few minutes to read the forward-looking statement. Certain statements in this conference call constitute forward-looking statements within the meaning of the Private Security 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 assumption made by and 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, September 21, 2021. 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 fourth quarter and fiscal year 2021 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 Woods.

Thank you, Mark. Good afternoon and thank you for joining us today for IsoRay's fiscal fourth quarter and full year 2021 earnings conference call for the period ended June 30, 2021. Following my comments, our Chief Financial Officer, Jonathan Hunt will provide a more detailed review of the fiscal fourth quarter and full year 2021 financial results. I am very pleased to share with you the continued progress we achieved in both the fiscal fourth quarter and the full year 2021. Revenue for the fourth quarter increased 19% over the year ago quarter to $2.71 million. This represented the best quarterly revenue total since the onset of the pandemic. Although our core prostate brachytherapy revenue grew modestly in the fourth quarter and declined 6% for the full fiscal year 2021, the significant growth in our non-prostate business led to record revenue for the full year into June 30. IsoRay's sales for the treatment of these hard to treat cancers increased 92% and 68% for the fourth quarter and full year respectively. The majority of this was the results of increased adoption of Cesium-131 in the treatment of brain cancer, including sales of GammaTile therapy. We continue to believe that IsoRay's opportunity in the treatment area of brain cancers is significant. At the same time, we see continued growth opportunities in addressing additional cancer, such as head and neck and lung. While these cancer treatment areas are in earlier stages of development for us than brain cancer, we believe that we will continue to see growing opportunities for expansion. It is clear that IsoRay's business is more diversified than it has ever been with more than a quarter of the fourth quarter revenue derived from non-prostate cancer treatments. Let me be equally clear that we continue to believe the core prostate…

Thank you, Lori. I am going to discuss some of the financial information that was contained in our press release for the fiscal fourth quarter and fiscal year ended June 30, 2021, that we were released a short while ago. We anticipate that our Form 10-K will be filed with the SEC on or around September 24. Revenue for the fourth quarter ended June 30, 2021, grew 19% to $2.71 million versus $2.28 million for the same period last year. Fourth quarter revenue was comprised of 74% for prostate brachytherapy with the balance or 26% of revenue attributed to other brachytherapy, primarily sales to treat brain, which included revenue from GammaTile and GT medical technologies. As Lori mentioned, fourth quarter non-prostate revenue increased 92% to a record $704,000. Gross profit as a percentage of revenues for the fourth quarter and of June 30, 2021 increased to 49.7% compared to 47% for the quarter ended June 30, 2020. The gross margin increase was primarily driven by higher sales, which were partially offset by higher non-isotope material costs and increased payroll and benefits expense due to greater headcount. Fourth quarter gross profit dollars of $1.35 million increased 26% when compared to the same period last year. Total operating expenses, consisting of research and development, sales and marketing and general and administrative, increased 8% to $2.44 million in the quarter versus $2.26 million in the fiscal fourth quarter 2020. R&D expense increased 45% versus the comparable prior year quarter to $468,000. The year-over-year increase in research and development expenses was primarily the result of increased payroll and benefits expense due to greater headcount and higher market research expenses versus the fourth quarter of fiscal 2020. Sales and marketing expenses were $659,000 in the fiscal fourth quarter of 2021, a decrease of 4% versus…

[Operator instructions] And our first question today is coming from Frank Takkinen at Lake Street Capital Markets. Your line is live. You may begin.

Hey, thanks for taking my questions. Wanted to start with the progress in non-prostate brachytherapy. Heard all your commentary there, it sounds like things are really going well, but was hoping you could just take us a little bit deeper into why you're seeing so much success in this product line and then longer term, if you see the non-prostate line of the business starting or potentially eclipsing the prostate side of the business?

Hi, good morning, Frank. Thank you for your questions. So, at this point in time, we believe that there's a couple different factors that affected the surgical part of our business. One would be certainly when you compare it to the prostate side of the business, the prostate side of the business has been much more affected by the pandemic and the access to hospitals, excuse me. And so when you compare the two, our surgical applications, which are typically on harder to treat cancers, more aggressive later stage cancers, have not had the same problem. So that's one aspect of this. The second aspect would be that we have been seeing a lot of increase in our brain cancer treatments, which we're very excited about. We are also seeing some increase and I spoke briefly about a clinical trial we're looking at engaging in for lung cancers. The company in the past has been involved in lung cancers, but at that point in time, really the only delivery device for that was surgical application. And now we're looking into other applications in ways to do it in a less invasive manner. And we have a physician and several other physicians looking at this right now. And we're excited about that, because we're seeing physicians beginning to use that application as well.

Got it. That makes sense. And then I wanted to switch gears to the capital allocation strategy. Appreciate all the color there again, but maybe just help us boil down where you are seeing the most rich ROI opportunity and/or differently asked, where are you guys putting the most resource to really grow the business and where do you see the most attractive opportunities?

So we continue to focus on our port core prostate market. We have a lot of opportunity there and currently we are doing several things from a marketing perspective to reengage in that setting since the pandemic has made access to hospitals and physicians more difficult. So we have reached out to figure out how to do online training, I guess, or virtual training I would call it, with proxy [ph]. This is very exciting to us because we had great success training physicians and residents prior to the pandemic. And we want to get back online with that and being able to work with proxy [ph] and set that up and maybe augment it by some in person training as well, gives us the opportunity to really expand that and get that back online and we're very excited about the potential there to get people trained, get them aware of Cesium, combining that with really helping people understand what our long-term data that came out in the late fall, just before the pandemic hit, getting them to understand that as well, that that is out there. These are things on the marketing side that we're looking at. We're looking at engaging in larger -- also in larger groups as that promote prostate cancer and we'll probably get back to you with more information on that coming up, but we've got several different fronts that we're looking at to engage in marketing. And from a sales perspective, we have a new sales manager who is working with our sales team and looking at our territories and we are open-minded to adding more sales people to our sales force. We want to make sure that when we do that, it makes sense where we're putting them and that they have the opportunity to really grow territories as we expand.

Okay. That's helpful. Sorry, go ahead.

I didn't get to the second part of your question, which was, what other -- what areas are we looking at? So prostate is certainly one of them. We talked about lung just a minute ago and our surgical applications. We're going to continue to work on those as we have been, but we're also looking at, and we made mention of this, many other opportunities, those opportunities, we really are running through some criteria on right now and as you know, due diligence can take some time. But we are hoping that in the next few months, we will have some things to say to you all about all of that. And again, it's something that would be accrued to what we're doing now, either from a delivery device perspective or from a surgical application perspective or other types of potential synergies with our core business, which is radioisotopes.

Perfect. That's helpful. And then just last one from me, circling back to Jonathan's last comments about gross margin, understanding the headwind of 5% to 10% in fiscal first half puts me at around 40% to 45% gross margins for the first half. Is this an investment in advance of being able to potentially expand margins beyond what the historical business was and call it low 50s% and then as a follow up, what's the margin profile of prostate versus non-prostate revenues.

Yeah. This opportunity that we have here, I focus more on the supply chain and being able to expand our supply chain, diversify our supply chain between the two different reactors. They're actually, reactor we've used before, that we haven't used in some time. We haven't had the need for it. But we're bringing that back online. That's where it's going to cause some of that variability as we enter into this first half of the year just trying to get the targets in the reactor, in the right spot to get the optimal I'm out of Cesium out once we pull that out of the reactor. And so just kind of looking forward to that, I think we've talked about in the past, in terms of our gross margin. We do believe we can continue to grow that that is somewhat going be based on volume. And as those volumes increase, it allows us to be more efficient and the use of our isotope going forward as well as obviously leveraging some of those fixed costs that we have in terms of the facility and things like that. And in terms of a margin breakout between prostate and non-profit state, we really have not provided that in the past. And I would say that they're overall somewhat comparable in terms of -- the surgical is really still using the same seed as what we're using in the prostate application.

Got it. Okay. Thanks for taking my questions.

Thank you.

Thank you. Our next question today is coming from Tim Chiang at Northland Capital. You may begin.

Hi. Thanks. Lori, when you talk about business development, are you prioritizing potentially accreative transactions to the top and bottom line? Is that sort of the main focus? Could you just describe, what sort of transactions we should expect in the next six to nine months?

Hi Tim. Absolutely. We are looking at and reviewing potential partnerships, acquisitions, many different types of relationships. We're looking at all of them at this point in time. And we absolutely would like them to be accretive. That being said, we're also looking at some others that would potentially disrupt bigger markets and might take a little longer to get to markets. So as you're aware, we're sitting on a lot of cash and that gives us opportunities and so we're not going to certainly not look at other things that position us well for the future that might be a little longer term, but we're also very much looking to the short term and taking a close eye on the things that are available in our wheelhouse out there and how they might integrate into our current opera.

And maybe one follow up, you mentioned the training programs that you had in place in the past, right. But then COVID happened. And I know that you want to continue to emphasize the training of new physicians for your brachytherapy treatment. How do you think you can roll that out starting in 2022? Is there a potential that you can do it virtually?

Yeah, absolutely. That's what [indiscernible] is. It's a virtual training platform and it's really exciting because it allows us a couple different things. One is you can have a doctor who's anywhere in the country, watch a live procedure with a doctor doing it, who can be talking to that doctor at the same time and walking him through it. So the potential there is really great. They have multiple cameras in the operating rooms, multiple ways of doing this. The other thing that's a nice benefit as well, is that afterwards we keep a library of those procedures. So if a doctor watched a live procedure, but then wants to go back before he does his first procedure and just make sure he understands and remembers, exactly what he saw, he has access to a library. And that library we think is going to be, very beneficial as well. So, and eventually we see this being a platform that we could use worldwide. Right now we're going to start in the US and we're going to be working on getting our positions back in the training mode and doing what we were doing before the pandemic and we think this is a very effective tool for it.

And just one last question, Lori, do you have the capability to sell Cesium outside the US or if you consider looking for a partner?

We certainly do have the capability of doing it. And over the years, IsoRay has had many partners. Well, not many, but we've had several partners. And we were actually in the process of looking at that just prior to COVID happening. And then COVID kind of shut everywhere down that we were talking to. And until we can get to the point where those countries are back online, I think we are keeping our focus in the US market, but it's not to say that we wouldn't go out beyond the US market, once things get a little easier and business gets back to normal and the potential -- the potential distributors we were talking to get back online.

Okay. Great. All thanks, Lori.

Thank you so much, Tim.

Thank you. Our next question today is coming from Mike Ott at Oppenheimer. Your line is live. You may begin.

Good morning and thanks for taking my questions. Curious, Lori and Jonathan, how much do you think sales targeting more of the ASC and physician's office settings lift your core prostate revenues over the next few quarters?

Hey, good morning, Mike. I can't give exact guidance on that at this point, but I do want to give you some color, which is we've been working with several of our physicians on this over the last couple of months and we see the opportunity. There is a real important one, both for our revenues, certainly and for patient access. Patient access continues to be an issue and it's one that the doctors are very concerned about, but it's understandable. We're still dealing with unfortunate variants and other things. And so hospitals don't have the capacity they've had. So going out and helping our physicians identify ambulatory surgery centers in their community has been one of the ways that we're trying to help drive patient access to this procedure and get them to not see this as an elective surgery. I don't think any of us feel like prostate cancer or any other cancer is an elective surgery, but unfortunately that has happened many times in many settings. So we're going to continue to work on this. We, see positive movement by getting our physicians out into ambulatory surgery settings. And so we're going to continue to do that. And I think going forward that will be a bigger piece of where some of our prostate revenue comes from.

No, that's a smart strategy, definitely during COVID. And with the prostate revenues and the quarter down, roughly 1% sequentially by our math, would you say you have any patient backlog of pent-up demand remaining, especially as you say, some patients unfortunately viewing prostate, as a bit of an elective surgery,

We absolutely do. When we looked at the American Cancer Society's statistics last year, and there are 30% increase for 2021, I think that assumption was made on the fact that we would get past the pandemic and as we are all aware of, we aren't quite past it yet. And so I feel like and looking at those numbers and then extrapolating what we have seen in the problems with access into hospitals that the backlog continues to grow. I don't have exact numbers for you on that, but certainly patients are afraid to go in and doctors are telling us that they're not -- still not seeing the numbers of patients they would expect coming through the system, although it has, and you can tell from our growth has been easing up. So we're going to keep watching this and see what happens, but right now I think we continue to be affected by COVID.

Understandable. And then if I could quickly get maybe two quick updates on first C4 MRI market that was cleared earlier this year, and also any updates on your Blue Bill motor out of the field. Thanks.

Yeah, absolutely. So on C4 imaging, we have been working through our processes and procedures so that we can have a successful limited market release. We're anticipating that we're going see the first orders happening here in the next several months. So that is coming along nicely. We're, excited about that. We're also working with CMS on the reimbursement front of that, and we're hoping to be able to hear some news one way or the other on that as well. So that has been progressing nicely. And in terms of Blue Build, I think Blue Build because it's a delivery device for the prostate market suffers a little bit from the general prostate issues we've been facing, but we continue to sell to our physicians and have identified other physicians who are interested in using it. It's a matter of access to these physicians to show them the device to train them on the device and those kinds of things. And that's where we're wanting to tie in prosimi [ph] to help us get some movement on there because access is very difficult right now.

Okay. That was very helpful. Thanks so much, Lori.

Thank you.

Thank you. [Operator instructions] At this time, we have no further questions in the queue, Ms. Wood.

Thank you so much, everyone for joining us for the second time for our earnings call. We appreciate your time. Have a great day.

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