Greetings, welcome to the Isoray's Second Quarter Fiscal Year 2021 Call for the quarter ending December 31, 2020. 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.

At this time, I'll turn the conference over to Mark Levin, with Isoray's Investor Relations. Please go ahead, Mr. Levin..

Thank you, Operator. Good afternoon, and thank you for joining us today for Isoray's fiscal second quarter 2021 earnings call for the quarter ended December 31, 2020. 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 February 9, 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 second 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 second quarter 2021 earnings conference call for the quarter ended December 31, 2020. Following my prepared remarks, our Chief Financial Officer, Jonathan Hunt will provide a more detailed review of fiscal second quarter financial results.

Although our overall business continued to be impacted by the COVID-19 pandemic, I'm pleased that we once again have achieved year-over-year growth in our fiscal second quarter of 2021. Total revenue increased 7% versus the fiscal second quarter of 2020.

Similar to the trends we've been experiencing since the onset of the pandemic early last year, our core prostate revenue declined modestly versus the year ago quarter, while our non-prostate revenue increased significantly year-over-year, driven again by treatments for brain cancer, including the sales of Cesium-131 powered GammaTile Therapy, non-prostate revenue increased 92% year-over-year.

The ongoing near-term challenges resulting from the pandemic, we continue to be very optimistic about the long-term growth opportunities for Cesium-131. As we have discussed previously, we believe that many men have been delaying annual checkups, screenings, and the treatment for prostate cancer over the last several months.

This unique situation is likely leading to a growing backlog of patients needing to be treated eventually. This is evident in the American Cancer Society's 2021 Cancer Facts and Figures report that was released in January. The widely respected annual publication estimates that nearly 250,000 new prostate cases will be diagnosed in 2021.

This represents a staggering 30% increase over 2020. The report notes that this trend is expected to continue with further increases in new prostate cases in 2022 as well.

While, we have yet to see a significant rebound in our prostate cancer business, the growing number of men with prostate cancer gives us continued confidence in the abundant opportunities for growth in our core business.

Leveraging the unique therapeutic benefits of our proprietary Cesium-131 isotope, IsoRay has continued to advance our leadership in this field with continued enhancements of our prostate product offerings. We believe that this will drive further adoption and market share gains.

Most recently, this can be seen with the FDA 510(k) clearance we received for the use of C4 Imaging's Sirius MRI markers with Cesium-131C. We believe this partnership with C4 Imaging will further expand our market opportunity within prostate brachytherapy.

This partnership gives doctors who prefer to use MRI as their imaging component, the flexibility to do so with our C's incorporated with the C4 marker technology. We will be selling C4's MRI marker technology in conjunction with Cesium-131 to those customers who prefer to use this type of imaging.

We are just now beginning a limited market release on the combination and expect it will be available for full market release later this calendar year. As I mentioned earlier, we are excited about the growth of our non-prostate brachytherapy business that continues to become an increasingly important part of our operations.

Through the first half of fiscal year 2021, 20% of total company revenue has been derived from the sales to treat cancers other than prostate using Cesium-131. Currently, the growth in these surgical applications for hard-to-treat cancers is predominantly being driven by the treatments for brain cancer, including sales of GammaTile Therapy.

GT Medical Technologies began enrolling patients in the GammaTile registry trial late last calendar year. You may recall that the objectives of this multicenter observational study were twofold.

It is designed to evaluate real world clinical outcomes in addition to patient reported outcomes that measure the effectiveness and safety of GammaTile, powered by our proprietary Cesium-131C.

We look forward to updates on the study from GT Medical Technologies as compelling results of this trial and other clinical studies for GammaTile could accelerate adoption of this unique treatment for patients battling brain cancers.

Given the highly critical nature of brain tumors and typical fast growth, the study should begin to reveal results in a relatively short period versus similar studies for other types of slower growing cancers, such as prostate.

GammaTile is a key example of IsoRay's R&D and business development efforts that aim to expand the application of our unique isotopes to a variety of hard-to-treat cancers. For these surgical applications, we are continually exploring innovative delivery technologies that highlight the effectiveness of Cesium-131.

Whether these innovations are internally developed at IsoRay, achieved through partnerships with other innovative companies or acquired expanding the breadth of delivery technologies will be central to the growth of Cesium-131 in a variety of surgical applications.

Developments such as these are why we remain excited about the growth opportunities ahead in both our core prostate business, as well as the continued expansion into the treatment of other cancers. We believe the use of Cesium-131 in the treatment of such cancers as brain, head and neck, gynecological and lung hold great promise.

As we look to the future of cancer treatments and how Cesium-131 and the role of target radiation will play, our vision continues to include a focus on the importance of immuno-oncology. As we have shared with you, we firmly believe that immunotherapy will increasingly be central to the treatment of cancers in the future.

Key to this, will be the further investment in R&D resources for the studies on the combination of immunotherapy utilizing Cesium-131 for the treatment of different cancers. In that regard, we look forward to updating you on the progress of two studies moving forward that we have discussed previously.

The University of Cincinnati, KEYTRUDA study, for recurrent head and neck cancers remains on track. This planned 50 patient Phase 1/2 clinical trial will be the first brachytherapy plus PD-1 inhibitor combination study.

We believe immunotherapy in tandem with resection and Cesium-131, may assist patients in the clearing of disease sites outside the surgical and radiation fields. The other study, which focuses on the treatment of metastatic melanoma, will evaluate the effect of combining Cesium-131 brachytherapy with an immune checkpoint inhibitor.

This pilot study should be enrolling their initial patients soon. We are also actively evaluating potential new studies and developing collaborations with additional institutions for similar combination therapies for the use of treating other cancers. Opportunities and growth naturally lead me to talk about our recent financing.

Last week, we had a successful secondary offering that raised gross proceeds of $51.75 million, this capital raise positions us to properly evaluate and capitalize on the growth opportunities ahead.

In closing, we believe the steps we have taken to reinvigorate the organization and build on our successes with expanded adoption and new applications for the treatment of other cancers holds great promise for a bright future.

Building awareness has opened the door to capitalize on what we see as robust growth opportunities in our core prostate market. The steps we are taking today in expanding innovative delivery technologies like GammaTile to grow the applications of Cesium-131 in difficult to treat cancers is another key part of that future.

Just as important, is our pivotal involvement in the future of immuno-oncology and a decisive role, we expect Cesium-131 to play. From my vantage point, these steps speak to what I told you when I became permanent CEO two years ago.

At that time I noted that it was a start of a period that I believed would be punctuated by growth, expansion and opportunities to better convey to all of our stakeholders, that IsoRay has just begun to hit its stride. Together, we are paving the way for new successes and seeing that vision become a reality.

Now, I will turn the call over to Jonathan, to review the results of our fiscal second quarter in more detail..

Thank you, Lori. I am going to discuss some of the financial information that was contained in our press release for the fiscal second quarter ended December 31, 2020, that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or around February, 11.

Revenue for the second quarter ended December 31, 2020 grew 7%, to $2.36 million versus $2.21 million for the same period last year. Prostate brachytherapy revenues declined 4% versus the second quarter of fiscal 2020, as procedure volumes continued to be impacted by COVID-19.

Second quarter 2021 prostate revenue and procedure volumes were in line with the first quarter of fiscal 2021. Second quarter revenue was comprised of 80% the prostate brachytherapy with the balance or 20% of revenue attributed to other brachytherapy.

As Lori mentioned earlier, other brachytherapy revenue increased 92% versus the second quarter of fiscal 2020, and was primarily driven by cells to treat brain cancer, which included revenue from GT Medical Technology.

Gross profit, as a percentage of revenues for the second quarter ended December 31, 2020, was consistent at 49.5%, compared to 50.4% for the quarter ended December 31, 2019, driven by the revenue growth, second quarter gross profit dollars of $1.17 million increased 5% when compared to the same period last year.

Total operating expenses consisting of research and development, sales and marketing, and general and administrative totaled $2.04 million, represented a modest increase versus the second quarter of 2020. Total R&D expense increased 3% versus the comparable prior year quarter to $285,000.

The increase in total research and development expenses is primarily the result of 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 7% versus the comparable prior year quarter to $619,000.

The decrease in sales and marketing expenses was primarily driven by declines in travel and tradeshow costs due to COVID-19 restrictions, as well as decreased incentive compensation resulting from lower revenue growth compared to the prior year comparative period.

G&A expenses of $1.13 million represented an increase in 5% versus the fiscal second quarter 2020.

The year-over-year increase was primarily the result of increased director and officer insurance expense, increased payroll due to annual merit increases, and IT consulting expenses; that was partially offset by decreased travel costs due to COVID-19 restrictions, as well as decreased employee hiring costs and legal fees.

Isoray narrowed its net loss to $868,000 for the second quarter ended December 31, 2020, versus a net loss of $897,000 for the quarter ended December 31, 2019. A net loss for basic and diluted share was $0.01 versus from the loss of $0.01 for the quarter ended December 31, 2019.

Basic and diluted shares results are based on weighted average shares outstanding of approximately 83.0 million at fiscal second quarter 2021 versus 67.4 million for the prior year period.

As of December 31, 2020, the company had cash, cash equivalents and certificates of deposit that totals $9.59 million, compared to $2.39 million at the end of fiscal year 2020 ended June 30, 2020. The increase in cash was the result of the closing of a public stock offering in October of this fiscal second quarter. The company has zero long-term debt.

Shareholders' equity at the end of fiscal second quarter 2021 totaled $12.8 million versus $5.7 million at the end of fiscal year 2020. During January 2021, 12.6 million warrants and options were exercised for aggregate gross proceeds of approximately $7.9 million.

As Lori mentioned, the company closed a public offering of 41.4 million shares of its common stock at a price of $1.25 per share on February 8, 2021, which includes the underwriter's exercise of the option to purchase an additional 50% of the shares of common stock offered in the public offering.

Gross proceeds before underwriting discounts commission estimated offering costs were approximately $51.75 million. I will now turn the call over to the operator to take questions from our analysts and institutional investors..

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question is from the line of Mike Ott with Oppenheimer. Please proceed with your questions..

Good afternoon. Thanks for taking my questions. So the quarter was pretty in line with your September quarter.

Would you say it's still fair to characterize your revenue trajectory as a gradual improvement from COVID? Spring 2020 low points, or did you like many other med techs feel any pressure in December as COVID cases picked up?.

Hi, Mike, thanks for your question today. So we've been recovering since our low point last April, it has been slow. And I think a lot of that is due to our core business, which is prostate and the demographic of that patient, which is 60 years and older.

And, it's been a period of time when it's been difficult to get in, and a lot of people just don't want to get in. So we are encouraged that we continue to see improvement. And we're really at this point in time watching for when this wave of patients who needs to get in to get their prostate cancer diagnosed will be able to get back in the system.

And really, we've been feeling this way, I think talking to everyone about this since the COVID pandemic started.

And one of the things that really, we feel good about and really backed up what we've been saying and what we've been hearing is that the American Cancer Society just in January released their facts and figures publication, which is a really well-known publication with estimates for the coming years cancer in many areas.

And what was very interesting to us is they are estimating that there's going to be a 30% increase in prostate cancer diagnosis in this year, and maybe more next year.

So what we feel like is that these patients as the vaccine rolls out and they can become more mobile and feel better about getting into see their doctors will get diagnosed, and we will be able to help them fight their cancers..

Okay, that's very helpful. Thanks, Lori.

And then on the GT registry trial, you mentioned that I know you just started, but do you have any estimate as to when we might start to see some early results from that one?.

I'm sorry, Mike, I don't. I would think, though, that the results would come back certainly a lot quicker than our 10-year data, since prostate or since brain cancer is more aggressive. So I'm hoping that we'll see something over the next year or two definitive on that..

Okay. That makes sense. And then finally realizing that your sales force certainly had the adapter in COVID.

But can you give any additional color on Blu Build traction so far, the early launch? How is it fearing new versus existing accounts? Or higher volume users anything like that you can share, Lori?.

Yes, absolutely. So although we're not giving specific guidance on it, I'd love to give you some color on that. We had to adapt when the pandemic hit like everybody else did. And we're getting 6very adaptive to Zoom, and being able to present to new facilities about Blu Build during that period of time.

We continue to do that and we're excited about the existing customers we have and the new customers that are looking at Blu Build.

We feel like once, really things kind of even out in radiation oncology that we will see several of these customers who have shown interest really be able to, in an easier way, get their hands on and be able to start using it. Like everyone else in this sector, we're having the same issue of actually getting into the hospital physically.

So we're starting to see that get a little bit easier. And we're hoping that that will continue in that way..

Great. That's it to me. Thanks for the update..

Thanks, Mike..

Thank you. Our next question is from the line of Frank Takkinen with Lake Street. Please proceed with your question..

Hey, thanks for taking my question. Just a couple from me today. I wanted to start with a little bit more of a big picture idea. So there's a phenomenon of COVID backlog and incoming reimbursement change next year, as well as coming off of some positive 10-year data for Cesium-131 last year.

So I was hoping you could kind of help us better understand how you feel about brachytherapy coming back into a standard treatment option. And some, maybe anecdotal feedback you're getting from radiation oncologists about reintroducing and using brachytherapy more frequently with the different tailwinds that are coming together at the same time..

Well, I think you described it really well. We've got several really positive things that can come together here. Coming to where we get some vaccine out there and hopefully get the pandemic more under control, so patients can feel comfortable going back in.

And then the ROAPM which was moved to January 1, 2022, I think we've got several different things here that are going to be very positive for prostate brachytherapy, certainly, hopefully to the rest of our fiscal year and then certainly moving towards the end of this coming calendar year and then right into January.

I think we just have things lined up very well. And we are working very hard right now. Our sales force is very focused on making sure that we have a broad base of customers, who win as these things happen and trigger interest in brachytherapy, we can be positioned to help as many people as possible.

And I'm sorry, can you repeat your second part of that question?.

Just what you're hearing anecdotally from radiation oncologists about the adoption of brachytherapy in the field, if it's an expectation that it could come into more of a regular standard treatment option for prostate cancer patient?.

Yes, absolutely. So we are getting currently inbound calls from radiation oncology departments and institutions where maybe in the past, they had a brachytherapy program and they don't necessarily now or they never had one, wanting to find out if we can help them with setting those up again.

And one of the things we're finding is we have this discussion is they're quite aware of the change in reimbursement and how that may affect their institutions.

And what's really heartening is that because we have so much clinical data, when you combine clinical data with favorable reimbursement, you really have the opportunity to grow a sector like ours, significantly.

So we're looking forward to and we're really happy with what we're hearing from folks about the resurgence and interest in prostate brachytherapy..

Great. And then moving on to your recent 510(k) clearance with the Sirius MRI marker.

Could you just take us a little bit deeper on the significance of this milestone? And if there's any opportunity to further improve reimbursement for those radiation oncologists who elect to use these MRI markers?.

Yes, absolutely. So we look at a lot of things like this. And as we're assessing these things, there's different things that jump out to our attention. One of the things that jumped out and made us look more seriously at C4 MRI marker is that a lot of the thought leaders were beginning to look at this and use MRI imaging technology.

It's a technology that we haven't used that much in the past. It has typically been CT, an ultrasound base.

But as imaging improves and there's more options in imaging, certainly we want to make sure that our seats combine with those imaging options, so that we can make sure that the residents coming out of residency programs and out of medical school that are being taught how to use MRI have that option.

So we felt like as we look to the future, we wanted to be well positioned to be able to take care of all physicians and their imaging preferences. I think that going forward, we have some interesting opportunities here to work with C4 and really looking forward to what we can do together..

Perfect. And then last one for me, and thanks for taking all my questions. Just a housekeeping question, where does share count and cash stand after the rays as well as the warrant conversion? I know there's quite a few moving pieces. So I think it'd be useful to level set everybody on where that's standing after all of these transactions..

You got it, Frank. This is Jonathan. So after this transaction with the 51.75 million gross proceeds plus the warrant exercises that occurred during January, as well as the ending cash position we anticipate be in the neighborhood of about $60 million or so at this time.

And then in terms of the shares, there was the 83 that was outstanding at the end of December for some additional 12 or so that were issued as part of the warrants. And then the 41.4 million that were issued through the rays that was completed that closed earlier this week..

Perfect. Thanks again for taking all my questions..

Thanks, Frank..

Thank you. [Operator Instructions] Thank you. At this time, there are no additional questions, I'll turn the floor right to Lori Woods, for closing remarks..

Thank you, everyone for joining our conference today. We appreciate your time. Have a great afternoon. Bye-bye..

This concludes today's conference. Thank you for your participation. You may now disconnect your lines at this time..