Greetings, welcome to the IsoRay Inc.'s Q3 Fiscal Year 2021 Call. At this time, all participants will be in a listen-only mode. And the question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded. I'll now like to turn the conference over to Mark Levin, of Investor Relations. .

Thank you, Operator. Good afternoon, and thank you for joining us today for IsoRay's fiscal third quarter 2021 earnings call for the quarter ended March 31, 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 Securities Litigation Reform Act of 1995 as amended.

When used in this conference call words such as will, believe, expect, anticipate, encourage, and other similar expressions as they relate to the company or its management, as well as assumptions 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 May 13, 2021.

As with any projection or forecast, they are inherently susceptible to uncertainty and changes in circumstance 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 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 third quarter 2021 earnings conference call for the quarter ended March 31, 2021. Following my prepared remarks, our Chief Financial Officer, Jonathan Hunt will provide a more detailed review of fiscal second quarter financial results.

I am pleased to share with you the progress we've experienced in our fiscal third quarter. As we look with increasing confidence to the future opportunities for growth at IsoRay. Fiscal third quarter revenue only decreased 10% from the record quarter a year ago, but increased 10% sequentially to $2.6 million.

This was the best quarter revenue total since the onset of the pandemic. Although our prostate revenue declined from the record quarter a year ago, I haven't been encouraged by the 7% sequential growth we experienced in our core business, as well as our growing strength in adoptions for the treatment of other hard to treat cancers.

The sequential uptick in prostate brachytherapy revenue in our fiscal third quarter reinforces our belief that there is a significant backlog of patients who will be seeking treatment as a result of the many men who have delayed annual check-ups, screenings and prostate cancer treatments during the pandemic.

We expect continued gradual growth in our core prostate business as these patients come through the screening and treatment process at an increasing rate, we are also experiencing greater access to hospitals and physicians. Then we have had at any other time, since COVID started last year.

At the same time, we believe the mini strategic initiatives we have added over the past couple of years should drive continued share gains in prostate as the expected post pandemic market rebounds.

Initiatives, including product introductions, such as Blu Build, our partnership with C4 imaging and our active support of physician training programs are expected to serve as we'll in that regard. Our non-prostate brachytherapy business, which encompasses surgical applications for other cancers like brain, head, neck and lung continued to grow.

And we're increasingly a more meaningful part of our total revenue. Again in fiscal third quarter, non-prostate revenue increased 20% versus the prior year, quarter and 22% sequentially to a record of $567,000.

Once again, the majority of non prostate revenue was from brain cancer treatments through the completed capital raised during the quarter and the subsequent strengthening of our balance sheet. We have greatly enhanced isomerase abilities to capitalize on significant growth opportunities.

We believe that IsoRay enhanced capital position will allow us to make important strategic moves over time. First expect us to continue to focus on investing in our core prostate market with additional investment, particularly in sales and marketing. The goal here is to foster increasing brand awareness and product adoptions.

It will also allow us to capitalize on the steps we have taken to build IsoRay's leadership position over the past few years, reflecting on this focus on our sales and marketing team. It's the recent addition of Donna Ford as vice-president of sales and marketing.

We believe Donna's has extensive background in establishing and leading successful sales organizations within our industry. Uniquely positions, her to read our sales and marketing efforts.

You may remember in our recent announcement that her experience spans both biotechnology and medical device companies, all this with an emphasis on radioactive isotopes and monoclonal antibody technologies. Donna has had a pivotal role in launching numerous complex multi-disciplinary products, including three radioactive isotopes for cancer. Further.

We feel confident that Donna's is valuable experience in combination therapy with oncologic agents, including immunotherapy will be particularly beneficial to IsoRay strategic vision for growing new markets.

Donna joins us at a pivotal time to take advantage of our expectations that projected prostate brachytherapy marker growth will be fueled by some key developments we have shared with you. With the implementation of the previously discussed future reimbursement changes or [ph] ROA PM. Along with the anticipated increased prostate cancer diagnosis.

As we emerge from the pandemic, we see positives for IsoRay market position beyond our core prostate market. We are pleased to see a growing use of Cesium-131 for the treatment of brain cancers.

As we continue to look at the treatment of other cancers, we expect to increase investments in growing surgical applications where we believe there's similar promise.

We are evaluating delivery technologies as well as further clinical studies to support the future growth of Cesium-131 treatments in these other cancers as we have shared with you before much like brain cancer patients and the doctors who treat them often run out of solutions to address aggressive cancers like lung and head neck.

We will also be increasing investments in research and development, particularly in the development of more clinical trials, which are essential. Given the weight of the data such trials yield. This is important not only for Cesium-131 as a standalone radiation therapy, but increasingly in combination with immuno-oncology targeted therapies.

As we have discussed, we had two immuno oncology studies, which are just getting underway. Those include the recurrent head and neck cancer trial with KEYTRUDA. The other is the metastatic melanoma trial with pivotal future investments.

In similar combination therapies for the treatment of other cancers will be critical to our position in the evolution of a leading edge cancer treatment options. The final area of investment focus we envisioned at this time will be for incremental opportunities to potentially broaden our portfolio of targeted radiation treatment therapies.

This may come in the form of new delivery devices and technologies that could compliment Cesium-131, or potentially looking at other radio isotopes whose qualities may be valuable and best suited for treating various other cancers. We are evaluating such strategic products which could come via acquisitions partnerships or internal development.

It was with these growth opportunities and the execution of our strategic plans in mind that we hired Lisa Lauer, whom we recently announced as Vice-President of Business Development, Lisa's accomplishments, speak to her proven track record in commercial execution, market access, reimbursement, and strategic portfolio development and management.

We also believe Lisa's direct responsibility over broad and scopic device portfolio that was focused on the diagnosis and treatment of malignant and benign lung disease lends itself well to a key area of focus in expanding market adoption for Cesium-131.

In addition, her previous experience at ice rate and the development and implementation of cesium, one 31 seeds for prostate cancer is yet another value add. As we also remain focused on expanding our market share in our core prostate business.

Leveraging these strengths will be instrumental in the evaluation and development of go-to market strategies to position IsoRay for the evolving cancer treatment marketplace. As you can see these remain exciting times IsoRay despite the pandemic, we are more optimistic than ever before about our future path and the success of our efforts.

We remain focused on executing our strategic plans for continued growth. We believe our efforts will have long lasting benefits to cancer patients and the doctors who treat them. Now I will turn the call over to Jonathan to review the results of our fiscal third quarter in more detail..

Thank you, Lori. I'm going to discuss some of the financial information that was contained on our press release for the fiscal third quarter ended March 31st, 2021 that we released a short while ago. We anticipate that our form 10 Q will be filed with the SEC on or around May 17th.

Revenue for the third quarter and in March 31st, 2021 decreased 10% to $2.6 million versus the record $2.88 million for the same period last year.

As Lori mentioned earlier, total revenue increased 10% sequentially from the fiscal second quarter ended December 31st, 2020 prostate brachytherapy revenue declined 16% versus the third quarter of fiscal 2020 that's procedure volumes continued to be impacted by COVID-19.

Third quarter revenue was comprised of 78% for prostate brachytherapy with the balance or 22% of revenue attributed to other brachytherapy. Other brachytherapy revenue increased 20% versus the third quarter of fiscal 2020.

The majority of other revenue in the quarter was comprised of cells to treat brain and one cancers gross profit as a percentage of revenues for the third quarter ended March 31st, 2021 was 52.4% compared to 59.2% for the quarter ended March 31st, 2020.

Driven by the year-over-year revenue decline, third quarter gross profit dollars of $1.36 million decreased 20% when compared to the same period last year, total operating expenses, consisting of research and development, sales and marketing in general and administrative total $2.13 million representing a 6% decrease versus the third quarter of 2020.

Total R&D expense increased 23% versus the comparable prior year, quarter to $362,000.

The increase in total research and development expenses was primarily the result of increased payroll benefits and share based compensation from greater headcount and increased protocol expenses, which were partially offset by a reduction of development expenses for the Blu Build delivery system versus the comparable prior year period.

Sales and marketing expenses decreased 28% versus the comparable prior year quarter to $581,000.

The decrease in sales and marketing expenses, which was driven primarily by declines in travel and trade show costs due to COVID-19 limitations, as well as decreased incentive compensation resulting from lower revenue growth compared to the prior year comparable period, G&A Expenses of $1.18 million represented an increase of 2% versus the fiscal third quarter 2020, the year-over-year increase was primarily the result of increased director and officer insurance expense increased payroll due to merit increases it consulting expenses and bad debt expense, but was partially offset by decreased travel costs due to COVID-19 restrictions as well as decreased employee hiring costs and legal fees.

IsoRay's net loss for the third quarter ended March 31st, 2021 was $745,000 compared to a net loss of $545,000 for the quarter ended March 31st, 2020, the net loss per basic and diluted share was $0.01 versus the net loss of $0.01 for the quarter ended March 31st, 2020.

Basic and diluted share results are based on weighted average shares outstanding of approximately 122.6 million at the fiscal third quarter 2021 versus 67.6 million for the prior year period as of March 31st, 2021.

The company had cash, cash equivalents and certificates of deposit that total $64.8 million or approximately $0.46 per share compared to $2.39 million at the end of fiscal year 2020 and of June 30th, 2020, the company has zero long-term debt shareholder's equity at the end of the fiscal third quarter 2021, total $68.1 million versus $5.7 million at the end of fiscal year 2020.

I will now turn the call over to the operator to take questions for our analysts and institutional investors..

Thank you. We will now be conducting a question and answer session. [Operator Instructions]. Our first question is from Frank Takkinen - Lake Street, capital markets, please proceed..

Hey, thanks for taking my questions. Congrats on the return to sequential growth and growth in the quarter. I wanted to start with your primary prostate brachy market. First. I was hoping that you could share some monthly procedural information with us as it trended over fiscal Q3.

And if you could maybe give us an early taste into how those procedural volumes have been trending in the early part of fiscal Q4?.

So we don't give guidance on specific numbers per say, but I would love Frank to address kind of what we're seeing in the marketplace and what's starting to happen and how excited we are about what we view as kind of coming out of the pandemic and starting to move forward.

We've had a lot of access to hospitals and the physicians that we haven't had since the pandemic started. And we hear from our physicians that they're seeing an increased number of patients coming through the system. It's not an immediate sort of thing that happens.

The patient has to work through a couple of different physicians before they get to actually a brachytherapy procedure, but they're starting to see that those those channels are filling up with patients who've gotten in, who've gotten diagnosed and are moving through. So we're, we're very excited to see that.

And we are excited to see that our numbers are starting to reflect that as well. So we feel like that gives a lot of credibility to what we're seeing..

Got it. That's helpful.

Why don't I move over to the nonprofit state or non prostate brachytherapy revenues, particularly brain as this continues to perform? Well, I was hoping you could just take a moment to kind of give us a broader overview of the brain cancer market specific to brachytherapy and how you feel you're positioned and how, how will you feel that can trend over time?.

Yeah, absolutely. So in brain brachytherapy, surprisingly, we've seen kind of the same kind of problem in some degree to some degree that we've seen with prostate. And that is I think most likely because patients haven't gotten diagnosed to begin with or aren't getting into the system.

So surprisingly we saw early on in the pandemic that those numbers were a little bit flat, but now we're seeing a return to growth in those numbers, which you're seeing definitely as we report here today. And what we're expecting is to see that number continue to grow.

There've been a lot of initiative started with GT medical that we reported previously about clinical trials and those kinds of things where they are going to be having centers that are enrolling patients. I think we're starting to see some of that.

I think we're also starting to see the, both they and us have been able to get back in front of neurosurgeons and radiation oncologists again, where we haven't for the last few quarters had that same flexibility and being able to talk to these physicians and help them understand the benefits of cesium one 30, one for brain, and all of that is really coming back.

And you're seeing that in the numbers and we expect that to grow into continue because we have both, as we reported before and GT medical technologies has expanded their approval for treatment, and now they can treat any metastatic cancer in the brain. And so that allows a broader group of patients to be selected for this particular procedure.

So we see this, this area continuing to grow and we expect to see some upticks in the upcoming quarters on this. Definitely..

Perfect. And then just last one for me, I was hoping you could remind us of some timelines around potential milestones associated with your studies underway in that head and neck area with KEYTRUDA, as well as in melanoma area with Optivo..

Absolutely. So milestones would really be reflective of patients starting to accrue for the trials. And then you look at going out and unlike our prostates data, where we had to go at 10 years, we are expecting this to be a lot faster, a cruel.

So getting out a year, 18 months, 24 months, we would expect that these centers would be wanting to talk about what's happening with the data sets and the patients involved in these clinical..

Perfect. Thanks for taking my questions. .

Thank you. Our next question is from Mike Ott with Oppenheimer. Please proceed..

Good afternoon. Thanks for taking my questions and congrats on a nice quarter. Lori and Jonathan, I'm doing though, which is obviously unique to you guys. You mentioned that, you know, hospital access is improving.

Have you seen any new customers evaluate or start using do builder? Are they all still fairly preoccupied with COVID?.

You know, they tend to be fairly preoccupied with COVID and what we've noticed during this period of time is that a lot of the physicians are staying with the types of procedures that they're familiar with so if you, if you categorize them as in the evaluation process, we have several and an increasing number of people in that in terms of actually having them using the product.

I think COVID has slowed us down certainly in this area. And I think we'll start seeing as we come out of COVID and they start seeing more patients filling up coming into their offices and getting scheduled brachytherapy, we'll start seeing them then move from that evaluation process into using the product..

That's great to hear. Okay. And then shifting gears on the C4 MRI marker that was cleared back in January. I wonder if you could just update us on, you know, any traction with KLS and also your own internal validation work. Are you still targeting? I believe it was fiscal 2022 for the full launch of that T4. Okay..

Yes. So we're, we are definitely still targeting that timeline. We have been proceeding with our internal evaluations. I think we're very close to being finished. We have engaged with KOL and MD Anderson in particular to do some evaluation for us, make sure that we're ready for our full market launch we're.

So I would, I would say that all the things that we had put in place that we needed to accomplish and the milestones for this are moving along just fine. And on our we're on our timeline on that, to be able to release this product a little later this year..

And finally, you know, back in March, she signed a new purchasing agreement with JFC isotope that despite COVID tapering off in the U S anyway, we seem to be reading more about supply chain disruptions.

Just curious how your supply chain is doing these days?.

You know, that's a great question. Our supply chain has been very solid for us throughout this entire epidemic. And that really speaks to how well that the, the group over in Russia has managed what's happening in their particular facilities.

We have not had any issues at all, any I think I've spoken to this before our biggest issue was with airlines and that was easy to overcome by switching to different plans that we already had in place.

So from a, a on the ground perspective in Russia and getting our isotope, we're not expecting any issues there nor are we expecting any issues on getting the isotope here to us in the U S and that has been backed up by this last year of not having any issues at all..

Excellent. That does it for me. Thanks. Sorry..

Thanks so much, Mike..

Thank you. Any more questions? Okay. If there are no more questions and this will end the question and answer session, and I would like to turn the call back to Lori Woods for closing remarks..

Thank you everyone for joining us this afternoon. We appreciate your time and attention. Have a great day..