Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Isoray's Fiscal 3Q 2022 Earnings Call. At this time, all participants will are in a listen-only mode. After management's prepared remarks, there will be a question-and-answer session. I would now like to turn the call over to the host, Mark Levin. Please go ahead..

Thank you, operator. Good afternoon, and thank you for joining us today for the Isoray's fiscal third quarter 2022 earnings call for the quarter ended March 31, 2022. 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 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 10, 2022.

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 2022 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 2022 earnings conference call for the quarter ended March 31, 2022. Following my prepared remarks, our Chief Financial Officer, Jonathan Hunt will provide a more detailed review of our fiscal third quarter financial results.

I am pleased to share with you the continued progress we experienced in our fiscal third quarter. Total revenue for the fiscal third quarter increased 12% versus the year ago quarter to a record $2.91 million. Trends accelerated throughout the quarter, culminating with both record revenue and procedure volumes for the month of March.

I'm encouraged by the steadily increasing sales we have been realizing. The path of the rebound, primarily in our prostate business, has not been as fast as we would have expected.

However, the trends in our core prostate business give me incremental confidence that more and more men who have delayed treatment over the past two years are now seeking treatment at an increasing rate.

Complementing the ongoing steady rebound in our core prostate business in the March quarter was the continuing growth of our brachytherapy treatments for other cancers. Non-prostate revenue and procedures reached records in the March quarter.

The growth was driven by increasing consideration and adoption of our proprietary isotope, primarily for the treatment of brain, head and neck and lung cancers. We continue to see strong opportunities to bring Cesium's therapeutic benefits to more patients battling critical cancers such as these.

Our sense is that the continued adoption of Cesium-131 in the treatment of other cancers is going to be fueled by two key components. Certainly, our continued efforts to build awareness of the efficacy of using Cesium-131 to address these difficult to treat cancers will continue to play a meaningful role.

At the same time, a key driver has been the expansion of compelling data from clinical studies. One such study, which we have been keeping you updated about, is the ongoing Phase 1/2 trial led by researchers at the University of Cincinnati.

You no doubt remember this significant study focuses on the combination of PD-1 inhibition and Cesium-131 brachytherapy in patients with recurrent head and neck cancer. The Phase 1 portion that evaluates the safety of the treatment combination is now complete.

The investigators will be following these patients closely and we hope to move on to the larger Phase 2 part of the trial to start looking at treatment effect later this year. At that time, we anticipate that the study will move to a multi-institutional trial.

We're happy to see the interest in using Cesium-131 for the treatment of recurrent head and neck cancers with the additions of other prestigious institutions. Given the high recurrence rate in head and neck cancers, the deterioration in quality of life for many patients who have to undergo subsequent surgery and radiation is oftentimes substantial.

As was demonstrated in prior prospective studies, Cesium-131's targeted approach offers a potential effective radiation treatment regimen, but with fewer side effects, such as radiation-related damage to adjacent healthy tissues and less collateral damage to adjacent critical structures in the head and neck.

We're excited about the potential that the combination of Cesium-131 brachytherapy with Merck's PD-1 inhibitor KEYTRUDA may demonstrate in the study in terms of safety and possible disease control.

We are confident in the promise it holds and the important contribution it makes in continuing to build awareness of Cesium-131 amongst key professional constituencies. We will continue to keep you updated as the study progresses.

Another interesting data series was presented last week at the American Association of Neurological Surgeons scientific meeting in Philadelphia. The abstract demonstrated compelling clinical outcomes for recurrent glioblastoma patients treated with GammaTile Therapy powered by Cesium-131.

Similar to the head and neck studies, the unique targeted radiation of Cesium-131 seeds embedded in the GammaTile implants suggests not only the effectiveness of the treatment option, but the enhanced quality of life aspects relative to other radiation regimens, such as external beam radiation therapy.

We believe additional studies of the benefits of Cesium-131 for the treatment of certain cancers, such as these, will be additional drivers for growth in our non-prostate business. Clinical trials and studies will remain a core part of our growth strategy and we will continue to invest in these key areas of R&D.

We are also continuing with our strategic efforts focused on leveraging opportunities to further brand awareness and to build our leadership position within our key markets and constituencies. This week, we will be attending the American Urological Association, or AUA, annual meeting. The AUA meeting is considered the foremost meeting in urology.

Being a part of this gathering is critical because the organization provides urologists with information on the latest innovations in urologic medicine. It plays a central role in connecting industry with physicians and creating a partnership aimed at providing urologists the tools to more effectively diagnose and treat urologic diseases.

Another high profile event will see Isoray at center stage. This year's American Brachytherapy Therapy Society 2022 annual conference next month in Denver is widely anticipated in the brachytherapy community. This will be the first in-person annual meeting in almost two years and we are excited to have a central part in this year's event.

ABS annual meetings are well known for their outstanding attendance and impact on hands on educational opportunities, interactive sessions with experts and industry demonstrations of state-of-the-art equipment, software and services, widely recognized for the value it provides oncologists practicing in this field of medicine a central role of this prestigious event is meaningful.

As a sponsor, Isoray will be hosting a lunch symposia on the benefits of MRI assisted radiosurgery for the treatment of prostate cancer. The lecture is entitled Eliminate Uncertainty, Increase Precision and Reduce Toxicity MRI assisted radiosurgery, or MARS, the MD Anderson technique using Cesium-131. Dr. Steven J.

Frank, MD, Radiation Oncologist at MD Anderson Cancer Center and inventor of the C4 Sirius Marker will be presenting. As described by Dr. Frank, MRI assisted radiosurgery is the next generation of brachytherapy by utilizing MRI at every step of the quality assurance process to improve clinical outcomes.

MARS enables treatment planning to the intraprostatic dominant lesions, reduces exposure to external urethral sphincter and ensures precise radiation dose delivery. Cesium-131 is the only isotope that is FDA approved to be used in conjunction with the Sirius Marker.

We continue to work to finalize our validations and processes in anticipation of a formal launch later this year. In addition to the luncheon, Isoray has two abstracts submitted from the Cesium-131 Advisory Group, or CAG.

These abstracts are based on 12 years of experience in Cesium-131 implants from each of the CAG physicians who came together to provide recommendations on how best to implant using Cesium-131.

This knowledge and experience targets new practitioners who can benefit from their cumulative experience and be confident in how they treat their patients using Cesium-131. Before I turn the call over to Jonathan, I want to address our isotope supply chain.

Recall that we currently source our cesium isotope from two separate reactors, both of which are located in Russia. We have not experienced any disruptions or significant delays to date and continue to have a consistent supply of isotope from these reactors.

Of particular importance, Cesium-131 is a medical isotope that is not subject to any sanctions. We continue to monitor the situation closely but do not believe that there is a risk to the supply chain at this time. 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 am going to discuss some of the financial information that was contained in our press release for the fiscal third quarter ended March 31, 2022 that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or before May 13.

Revenue for the third quarter ended March 31, 2022 grew 12% to a record $2.91 million versus $2.60 million for the same period last year. Prostate brachytherapy revenue increased 8% versus the third quarter of fiscal 2021.

Third quarter revenue was comprised of 75% for prostate brachytherapy therapy with the balance or 25% of revenue attributed to other brachytherapy, driven primary the result of the 90% increase in cost of product sales when compared to the year ago quarter.

The primary drivers were increased isotope cost due to ordering additional supply and payroll and benefits expense due to merit increases. Gross margin increased 620 basis points sequentially from fiscal second quarter when we incurred higher isotope cost as a result of the additional reactor coming online to support future growth of the company.

Third quarter gross profit dollars of $1.44 million increased 5.8% when compared to the same period last year. Total operating expenses consisting of research and development, sales and marketing and general and administrative increased 32% to $2.82 million versus $2.13 million in the third quarter of 2021.

Total R&D expense increased 52% versus the comparable prior year quarter to $549,000. The increase in total research and development expenses was primarily the result of increased payroll and benefits expense due to greater headcount versus the prior year comparable period and an increase in consulting expenses related to market research.

Sales and marketing expenses increased 18% versus the comparable prior year quarter to $687,000.

The increase in sales and marketing expenses was driven primarily by increases in travel and tradeshow costs and increased payroll and benefits expense due to merit increases, new hires and increased incentive compensation versus the prior year comparable period.

G&A expenses of $1.58 million represented an increase of 34% versus the fiscal third quarter 2021.

The year-over-year increase was primarily due to increases in payroll and benefits expense due to annual merit increases and greater headcount, employment hiring expenses, IT consulting expenses, D&O insurance premiums, public company expenses, audit and legal expenses, severance, and travel expenses versus the prior year comparable period.

The third quarter net loss was $1.35 million versus a net loss of $745,000 during the same prior year period. The net loss per basic and diluted share was $0.01 versus the net loss of $0.01 for the prior year fiscal third quarter.

Basic and diluted share results are based on weighted average shares outstanding of approximately 142 million at fiscal third quarter 2022 versus approximately 122 million for the prior year period.

As of March 31, 2022, the company had cash, cash equivalents and certificates of deposit that totaled $58.9 million or approximately $0.41 per share compared to $63.8 million at the end of the fiscal year 2021 ended June 30, 2021. The company has zero long-term debt.

Shareholders' equity at the end of the fiscal third quarter 2022 totaled $63.2 million versus $67.4 million at the end of fiscal year 2021. I will now turn the call over to the operator to take questions from our analysts and institutional investors..

Certainly. The floor is now open for questions. [Operator Instructions]. Your first question is coming from Frank Takkinen with Lake Street Capital Markets. Please pose your question. Your line is live..

Great. Thanks for taking my questions. I wanted to start with just how are you feeling about the environment. If you could provide any month-to-month commentary, that'd be fantastic, January, February and March.

And then if you could extend that into April and May in what you're feeling out there, and if you're feeling that we're approaching a more normalized environment at this point?.

Hi, Frank. Good afternoon. If we start back in January and look at January and February, we felt that there was maybe a slight impact from some ongoing COVID-related issues. And I think what we're seeing as we progress through to April and May is what everyone else is seeing is that impact seems to be resolving somewhat.

Access to healthcare hasn't been impacted as much by some of these recent variances, some of the previous ones. So we continue to see access to hospitals and physicians stay pretty steady, which has been really nice to see..

Okay, that's helpful. And then I recall from the last call, and I know there's some commentary on this call that now is the time to accelerate our sales and marketing efforts is the comment I'm remembering.

Just curious on some of the internal investments that have been made; headcount, marketing, what should we kind of be expecting, what happened in the quarter and what do you think about accelerating revenue from some of these initiatives on a forward basis?.

So we're working on that right now. And as we've talked about in the past, we are absolutely dedicated to increasing our sales presence with sales people as well as investments into marketing, things like direct to consumer and other areas. And we're in the process of doing that right now.

It takes a little bit of time to get all the resumes through the system and get people interviewed and make the right choices there. But we're doing that on a daily basis and hope to have a lot to report next quarter..

Okay. And then just last one for me, I appreciate the commentary on the Russian reactors.

Just curious if there's any initiatives in place to diversify outside of Russia, or at this point you feel that's unnecessary and you feel like your supply is relatively predictable and not needing to extend to a new geography at this point in time?.

Well, I'd have to say that we always look at what the different options are, and we have been prior to this particular incident as well. But currently, we feel very comfortable with getting our isotope supply from Russia. We have had no hiccups in terms of supply from Russia in either Russian reactor.

And we feel pretty confident that at this point in time, we don't need to be looking to go anywhere else. We will always investigate other options like we have prior to this, but right now we're feeling very comfortable..

Great. That's good color. Appreciate taking my questions and congrats on all the progress in the quarter..

Thanks, Frank..

Your next question is coming from Mike Ott with Oppenheimer. Please pose your question. Your line is live..

Hi, Lori and Jonathan. Thanks for taking my questions tonight. Picking up on that last question, I know you said obviously the Russian supply chain is intact, no delays and your fiscal 3Q gross margin was ahead of our estimates.

But how should we think about gross margin in the next few quarters following the new reactor that came online late last year and some of the higher costs maybe around airfreight or isotopes, if you expect those to continue going forward?.

Absolutely. There is a lot of supply chain cost pressure right now. And I think everybody in any industry is experiencing that. So we're going to continue to try to grow our gross margins as we always have in the best way possible. But I think looking forward, the kinds of things that we're doing, I don't know that it would have a huge impact.

So I think if you look at where our margins are right now, although we'll continue to manage those as well as we possibly can and always have, I wouldn't expect to see a lot of change in that over the immediate timeframe..

Okay, that's helpful. Thanks, Lori. And then, great to hear on the University of Cincinnati finishing the Phase 1 portion of the trial.

And do you know yet when we might get the first readout from the Phase 2 portion that you're hoping to start later this calendar year?.

So they're going to follow those patients for a little bit. So I wouldn't expect in the next couple of quarters to be talking about that specifically, because they want to make sure that those patients are doing very well.

But assuming that that does progress like that, we would expect to see then the entry into Phase 2 somewhere toward the end of the year and patients start to accrue for that phase as well. So we're pretty excited to get to that point and to also get the information out on Phase 1..

Great. Thanks so much for taking my questions..

Thanks, Mike..

Your next question is coming from Tim Chiang with Northland. Please pose your question. Your line is live..

Hi, Lori. I think last quarter you had mentioned hospital staffing shortages as one of the headwinds to greater brachytherapy procedures.

Are you still experiencing that right now? And if so, when do you think those will abate?.

We're seeing employment pressures across the board, and that does include hospitals and ambulatory surgery centers, although we see it less than the ambulatory surgery setting than we do in the hospital setting.

And I think that continues maybe to be part of the reason that we haven't seen that kind of wave of patients coming through the system as the system doesn't have the number of employees that might wish to have to be able to handle the kinds of volumes they have in the past. And I think we are, to your point, seeing some of that still going on.

And I don't have a good crystal ball on when that will ease up. I think across the board, if you look at many industries, employment is certainly a concern. And having the right employees and the right numbers of employees will continue to be something that people watch very closely..

And maybe just one follow up. I think, Jonathan, you had said that R&D expense is up around 50% or so year-over-year.

Is that sort of a good run rate going forward?.

Yes, that should be a pretty good run rate in that category. We'll obviously keep you updated as things change. But it's been kind of in that neighborhood now for the last several quarters, and we would anticipate it staying there..

Right. And maybe one last question, Lori, for you. I know that you had been using Proximie to leverage virtual training programs.

But are you still doing that, or are you planning on doing more face-to-face type programs going forward?.

So we're pretty excited that we can get back into the face-to-face. And it's really going to be based on what is easiest for the physician. So we're going to offer both. Some of the physicians we found really want to have the opportunity to get out and meet with people face-to-face and get in training and do that together with another physician.

But a lot of them don't have the time to leave their practices. And so we're going to continue to supply both of those training opportunities to physicians and really let them decide what works best for them..

And you mentioned the AUA meeting coming up.

How many physicians do you plan to meet up with at this conference, I was just wondering?.

So the AUA meeting, it's a huge conference. And we have several of our staff there.

And the reason, because it's such a large meeting, we aren't necessarily a big presence as some of the other big urologic companies are but we're there so that we can meet with physicians that are interested in cesium and spend time with physicians that we've met with prior to that meeting in many cases where we know they're going to be there and they'd like to spend some additional time with us.

We use this meeting as an opportunity really for those one-on-one meetings that we've had with folks in the past and then getting additional information to them, as well as making sure that we have a presence there so that as physicians are on the exhibitor floor, they can come to us and ask any questions that they have..

I see. Okay, all right. Well, thanks for the color, Lori..

Thanks, Tim, so much..

[Operator Instructions]. And Tim Chiang is back in the queue with a follow-up question. Please pose your question. Your line is live..

Lori, since I have you, I might as well ask the business development question, because obviously you have significant amount of cash, right? And I've just sort of wondering, do you still -- have you guys still been looking at business development opportunities? And do you plan on doing any business development this year?.

We absolutely have been looking at business development opportunities. And I think one of the things that was kind of telling today in our call is that our expenses for market analysis is up significantly. Because we don't give specific guidance around this, what I would say is yes, we are definitely looking at that.

Yes, we have some things that we find are very interesting. And we're doing the market research to really support looking further at getting into those areas or participating with those companies on either distribution, joint venture, whatever it might be, we're definitely in that process as we speak..

Okay, super. Thanks, Lori..

Thanks so much..

There appear to be no further questions in queue at this time. I would now like to turn the floor back for closing remarks..

Thank you everybody for joining us today. We hope you have a great evening. Bye-bye..

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