Good day ladies and gentlemen and welcome to the IsoRay Second Quarter 2019 Call. All lines have been placed on a listen-only mode and the floor will be open for your questions and comments following the presentation. [Operator Instructions]. At this time, it is my pleasure to turn the floor over to your host, Mark Levin. .

Thank you, Operator. Good afternoon and thank you for joining us today for the IsoRay fiscal second quarter 2019 earnings call for the quarter ended December 31, 2018. 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 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.

Forward-looking statements are based on management’s current expectations and beliefs about future events.

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 heading of safe harbor statement for risk factors listed from time-to-time in the company's filings with the Securities and Exchange Commission. Statements made on today's call are as of today, February 12, 2019.

We will begin today's call with Lori Woods, IsoRay's Chief Executive Officer. And then Jonathan Hunt, IsoRay's Chief Financial Officer will discuss the fiscal second quarter 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. When I rejoined IsoRay six months ago, I made a commitment to progress. As part of the plan for the future I have been concentrating on key factors including increasing revenue, and listed shareholder value and an unwavering focus on expanding market opportunity and growth.

I believe this quarter makes an important statement. We are excited to report our seventh consecutive quarter of double-digit revenue growth ending this quarter up 24% from the year ago period.

Our core prostate brachytherapy revenue increased 29% year-over-year and included contribution from our Blu Build delivery system, which we launched in a limited capacity during the quarter. The company's record sales this quarter underscore what we have been able to accomplish and creating and sustaining momentum for our core prostate business.

Just as importantly, it offers a view of what we believe will contribute to our opportunities for expanded market adoption. It becomes clear with each quarter's results, with the benefits of Cesium-131 are getting heightened awareness and with it increased interest and acceptance among a growing number of clinicians across the country.

Clearly, the numbers this quarter are a testament to that increased awareness, interest and acceptance. Recently we distributed a press release about Blu Build and its adoption by Dr.

David Marshall at the prestigious Hollings Cancer Center where the first patient and subsequently an additional 15 patients have been treated using our innovative delivery system for Cesium-131. Dr.

Marshall's response to the use of Blu Build s for his patients has been very positive as demonstrated by the subsequent orders since treating the first patient. If you haven't had the opportunity to do so I invite you to go to our website at isoray.com and read the press release as well as view some of the related media coverage.

I'm also pleased to report that another radiation oncologist is now using Blu Build. Dr. William Tomlinson is practicing at AnMed Health in Anderson, South Carolina which provides health care for the residents of eight counties in upstate South Carolina and Northeast Georgia.

For those of you unfamiliar with AnMed Health it is a strong institution that has been serving healthcare needs in the area for 100 years. Our new partnership is just underway, with two surgical cases having been completed. We look forward to seeing this relationship progress in the months ahead.

In preparation for our formal launch of Blu Build we have assumed a very dynamic posture relative to building awareness and sales.

You may remember on our last call, I reported that we have been getting positive feedback from an increasing number of physicians, hospital and cancer centers regarding plans for adoption, we've also been supportive of institutions seeking license amendments. So they're able to use Cesium-131.

We are continuing our efforts in that regard as we work on all the pieces to support a proper product launch. As we previously stated, Blu Build allows us to address the customization segment of the prostate brachytherapy market with a disposable product.

We estimate that the addressable market for the prostate cases that require some degree of customization embodied by Blu Build represent approximately a quarter of $100 million total prostate brachytherapy market in the United States.

It is an important step forward to be able to address the prostate brachytherapy market in its entirety and we expect to continue to aggressively pursue this expanded market opportunity. On the partnership front, we have continued our supports for the efforts of GT Medical Technologies as they move forward with plans for GammaTile Therapy.

A key development for GammaTile Therapy was the recent article published in the Journal of Neurosurgery the official Journal for the American Association of Neurological Surgeons. The article is the first published on the use of Cesium-131 seed brachytherapy for the treatment of recurrent brain tumors known as meningiomas.

It presents positive results for a clinical trial supporting the efficacy and safety profile of GammaTile Therapy. The article suggests a contributing factor to the study's positive results relative to prior brain brachytherapy studies was the unique benefits of Cesium-131.

It points to Cesium-131's short half life and low energy profile compared to prior studies which utilize iodine C brachytherapy. GT Medical Technologies issued a press release on January 3rd, summarizing the article publication.

In support of their efforts, IsoRay engaged in social media outreach to further awareness posting on Twitter, LinkedIn, and Facebook, as well as posting a banner on our website homepage linking to their news release. Recently, GT Medical Technologies issued a press release announcing the completion of the $10 million capital raise.

As they move forward with their plans for their expected broader commercial launch of GammaTile Therapy. They tell us, they remain targeted for the launch during the summer of this year. When I rejoined IsoRay, one of the areas, where it was evident there were immediate opportunities for improvement was within operations.

It was clear that there was untapped potential to allow us to get better leverage at the gross profit line.

It is encouraging to see some of the initiatives undertaken such as the reallocation of employees and resources, investments in automations and enhancements and raw material purchases that have led to gross margin expansion over the past several quarters, reaching record gross profit this quarter and achieving a gross margin above 40% for the first time in the company's history.

These important steps forward are indicative of the progress we're seeing, but we view this is only the beginning. We see a path forward that we believe will allow us to achieve additional gross profit improvement as sales levels continue to increase.

And as we continue to focus on expanding market penetration, and our vigilance in pursuing additional operating efficiencies. Operational enhancement has also included a recognition of our need to address the overall depth of the management team in an important discipline. To that end, we hired Jonathan Hunt as CFO in December.

The position of CFO is a critical component to any Executive Management team. No organization can fulfill its envisioned destiny without proper financial management and stewardship. Factors still key to the health of any organization. Jonathan brings extensive financial and operational experience to the company. He is a proven force for change.

As can be seen in his successful track record as a versatile financial professional with demonstrated successes in executing turnaround strategies, dispensing critical guidance on forecasting and planning, supplying leadership and process improvement operations and contract management and his contributions in helping organizations achieve profitable growth.

Jonathan's extensive financial and operational experience, his familiarity with our industry and with IsoRay itself is already proving to be invaluable to our team and the future we envision. I will now turn the call over to Jonathan to review the results of our fiscal second quarter..

Thank you, Lori. I'm going to discuss some of the financial information that was contained in our press release for the fiscal second quarter and the December 31, 2018 that we released a short while ago. We anticipate that are Form 10-Q will be filed with the SEC on or around February 14.

Revenue for the second quarter ended December 31, 2018 grew 24% to a record $1.9 million versus $1.54 million for the same period last year. Second quarter revenue was comprised of 89% for prostate brachytherapy with the balance or 11% of revenue attributed to other brachytherapy that primarily is comprised of brain and lung.

Gross profit as a percentage of revenues for the second quarter ended December 31, 2018 increased to a record 40.2% compared to 34.6% for the quarter ended December 31, 2017 and 33.5% in the first quarter.

The gross margin increase was primarily driven by higher sales and continued operating efficiencies from better leverage of our facilities, personnel and isotopes. Record second quarter gross profit dollars of $765,000 increased 44% when compared to the same period last year.

Total operating expenses consisting of sales and marketing, general and administrative and research and development were $2.22 million in the quarter versus $2 million in fiscal second quarter of 2018.

Total R&D expense increased 22% versus the comparable prior year quarter to $414,000 due to increases in proprietary product development expenses primarily related to the development of the recently launched Blu Build delivery system that is now contributing revenue.

This increase in R&D expense was partially offset by the continued winding down of collaborative R&D expenses, primarily related to the development of GammaTile Therapy. Sales and marketing expenses were $702,000 in the fiscal second quarter of 2019 representing a 4% increase versus a comparable prior year period.

G&A expenses grew 12% to $1.1 million versus fiscal second quarter 2018. The increase in G&A expenses was predominantly the result of legal and public company expenses related to the company's annual shareholder meetings in December, as well as increased payroll costs related to greater headcount versus a year ago period.

IsoRay posted a net loss of $1.41 million for the three months ended December 31, 2018, compared to a net loss of $1.46 million for the second quarter ended December 31, 2017. The net loss per diluted share was $0.02 versus $0.03 in the prior year period.

The weighted average share counts were 67.3 million at the end of the fiscal second quarter of 2019 versus 55.1 million in the prior year period. As of December 31, 2018, the company had cash, cash equivalents and certificates of deposit that totaled $7.87 million, the company has zero long-term debt. I will now turn the call back over to Lori..

Thank you, Jonathan. We are very pleased to have you on-board. That concludes our prepared remarks. The operator will now take questions from our analysts and institutional investors..

Thank you. The floor is now open for questions. [Operator Instructions] We have a question from RK Swayampakula. Please state your question..

Couple of quick questions.

Did that, did the first half of fiscal year 2019 being under what is the strategy for the rest of the year and what should we expect in terms of growth in indications outside of prostate such as brain and lung? And what kind of strategy are you applying in that?.

Well, I think the first part of that question I'll answer first and that is we will continue to expand our launch of Blu Build. We've been doing a limited launch at this point in time, and we'll continue that for a little bit longer and then go into it more of a broad based launch on the Blu Build.

We also have GammaTile, who is getting prepared for a launch a little later this summer. So that will also be part of what we're doing.

And then I'm sorry, could you repeat the second part of your question?.

I just wondering, what's the strategy for trying to expand. You said in the prepared remarks, 89% of the revenues are coming right now from prostate and rest from the brain and lung.

What's the strategy to increase the percentage of revenues from the other two indications outside of prostate like the brain and lung?.

So I'll find prostate, we really have lung and head and neck and some of these other areas that we're looking at. Those areas are led primarily by innovative physicians, who are based at teaching hospitals, who are looking for solutions for patients that really don't have good solutions.

So you'll see that percentage of our business kind of go up and down overtime. If at some point in time, we identify like we did with GammaTile a good way to address that market. Then we will focus on how we can find a delivery device or a mechanism to help physicians bring this to a broader base of patients..

And then over the last few quarters there has been certainly been growth in terms of quarter-over-quarter growth and also year over year growth. But if you maintain that growth obviously the Blu Build expand helps a bit or maybe more.

How do you plan to leverage that because you're saying right now you're trying to do is commercialize at a limited level, but what time would you make that as a bigger focus and try to expand on that commercialization front..

I'm sorry. .

And what needs to happen, for that to become a major focal point in terms of expanding and commercialization..

I'll address that in three ways. First of all in terms of our prostate business, we are currently 5% to 7% of what we see that market our revenues are 5% to 7%. So that gives us a whole lot of area in prostate that we need to continue to work towards increasing that percentage and growing our prostate business. So there's still a lot of business there.

With Blu Build, Blu Build really gives us and I foot into 25% of the prostate brachytherapy mark that we didn't have access to. So we will, as part of our prostate business be focusing on providing different ways for physicians to do prostate brachytherapy and one of those ways will be Blu Build.

And we're really excited because that gets us into an area that we before have not had access to.

In terms of other areas and expanding we are currently focused with GammaTile Therapy and working towards its launch when GT Medical Technologies is ready prepared to do that launch we'll be right there with them and we look forward to moving forward with them in that area.

In the other areas, those continue to be things we look at it and evaluate but at this point in time, I don't have anything to discuss..

Thank you. And I'll, thank you for that taking all my questions. And I'll come back to the queue later..

And there are no further questions..

Thank you everyone for joining us today and we hope you have a good evening..

Thank you. This concludes today's conference call. We thank you for your participation. You may disconnect your lines at this time and have a great day..