IsoRay Inc. (ISR) Q4 2020 Earnings Call Transcript

IsoRay Inc  (NYSEAMERICAN : ISR) Q4 2020 earnings call dated Sep. 17, 2020

Corporate Participants:

Mark Levin — Investor Relations

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

Jonathan Hunt — Chief Financial Officer

Analysts:

Ed Woo — Ascendiant Capital — Analyst

Swayampakula Ramakanth — H.C. Wainwright & Co., — Analyst

Presentation:

Operator

Good day, ladies and gentlemen, and welcome to your IsoRay Fourth Quarter 2020 Earnings Conference Call. [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.

Mark Levin — Investor Relations

Thank you, operator. Good afternoon, and thank you for joining us today for the IsoRay fiscal fourth quarter and fiscal 2020 full year earnings call for the quarter and year-ended June 30, 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 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, September 17, 2020. 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 2020 full-year 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.

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

Thank you, Mark. Good afternoon, and thank you for joining us today for IsoRay’s fiscal fourth quarter and full year 2020 earnings conference call for the quarter ended June 30, 2020. Following my comments, our Chief Financial Officer, Jonathan Hunt, will provide a more detailed review of fiscal fourth quarter and full year 2020 financial results.

I am very pleased to announce record full year fiscal 2020 financial results, as well as fiscal fourth quarter 2020 financial results, which illustrates improving trends in the wake of the start of the COVID-19 pandemic. Revenue for the fourth quarter increased 18% over the year-ago quarter to $2.28 million. Prostate brachytherapy revenue increased 11% versus the fiscal fourth quarter of 2019. Procedure volumes and sales improved sequentially and substantially throughout the fiscal fourth quarter, after beginning the quarter with April sales down 20% versus the prior year period.

For the first quarter of fiscal year 2021, which ends September 30, we expect revenue to be between $2.3 million and $2.5 million and gross margin between 48% and 53%. For the full year fiscal 2020, total revenue growth accelerated to 32% compared to 23% growth we experienced in the prior full-year fiscal 2019. Gross profit increased 68% with gross margin expanding by over 11 percentage points to a record 52.9%. When combined with a modest 4% increase in total operating expenses, our net loss declined by 33%. Continued improvement in each of these key metrics remains a paramount focus of mine and serves as evidence that our strategy is to grow the Company and expand the usage of our proprietary Cesium-131 isotope are working.

Within our core prostate business, we continue to see growth that demonstrates that we are not only taking market share, but we are leading the growth of the prostate brachytherapy market overall, as evidenced by our full year 2020 net physician customer growth of 35%. Despite the challenges we faced, as a result of the COVID-19 pandemic, I am very proud of the continued progress Continued progress we have made for the full fiscal year, and I remain enthusiastic about the future growth prospects for IsoRay and Cesium-131 or Cesium Blu, as it’s known commercially. In the initial months of the pandemic, our sales force remained productive, using that time to identify and create a database of all the opportunities inherent in new and existing brachytherapy programs. Based on these regional opportunities, we added another dedicated account manager, readjusted our territories and added an additional territory to support our sales teams providing better service to existing customers, and the timely opportunity to introduce themselves to new centers and those interested in setting up a new program. As a way to continue to get our message out to prospective customers, we developed program to educate urologists on the advantages of modern brachytherapy. This program is an opportunity for us to re-engage with urologists and to communicate the recent technological advances and the recent publication of the exciting clinical outcomes of our novel isotope Cesium-131. Moving forward, we expect a key part of the continued growth in our prostate business in fiscal 2021 will come from broader availability of our proprietary intra-operative disposable delivery system, Blu Build. You may remember that our Blu Build parts manufacturer temporarily converted their production capacity to making critical PPE in support of the battle against the COVID-19 pandemic. I am pleased to report that our parts manufacturer has restored ample production capacity for Blu Build and we anticipate that our innovative disposable delivery system will gain more traction in fiscal 2021, as it will be available to a greater number of customers. In addition to creating unique delivery devices such as Blu Build to further grow our prostate business, we believe that the recent mounting long-term data showing the efficacy of our proprietary isotope will continue to drive greater adoption of Cesium-131. Hopefully, you saw our June press release, on the second key 10-year data observational study from the University of Pittsburgh School of Medicine, that further demonstrates the effectiveness of Cesium-131 in the treatment of prostate cancer. In fact, we are particularly taken by the express thoughts of the authors who commenting together said, and I quote”the shorter duration of urinary morbidity along with the lack of differences in long-term adverse effects support our preference for this isotope” The authors concluded the study demonstrated that in their words prostate brachytherapy treated with Cesium-131 achieves excellent long-term biochemical control. This observational study from the University of Pittsburgh School of Medicine combined with the Chicago Prostate Cancer Center Dtudy published in September of 2019 represents comprehensive long-term data that demonstrates Cesium-131’s success in treating low and intermediate localized prostate cancer. The studies underscore that Cesium-131’s short half life and high energy allow to aggressively attack the cancer, while reducing the potential for side effects patients may otherwise experience from prolonged radiation exposure. We believe that the growing list of long-term data should continue to help highlight the differentiating and unique qualities of Cesium-131 versus other isotopes in the treatment of prostate cancer. Beyond our success in prostate, we are continuing our efforts to build on our progress in bringing the therapeutic benefits of Cesium-131, as a treatment options for cancers throughout the body. We are very excited about the Phase I B study, we shared with you in our recent press release. As you may remember, the study will evaluate the safety and efficacy of the immunotherapy drug KEYTRUDA and Cesium-131, following surgical resection. As a treatment option for recurrent head and neck cancers. Through a research grant agreement between IsoRay and the University of Cincinnati Physicians Company, the trial, will explore potential synergies that may eventually present new and effective treatment options for difficult to treat cancers of the head and neck. We will be following the progress of the study very carefully. You may remember that a previous multi-institutional study provided evidence that the use of Cesium-131 was surgical resection is well tolerated in the treatment of recurrent head and neck cancers. What the study and our efforts to expand the use of Cesium-131 for the treatment of hard to treat cancers demonstrates is that we remain committed to continuing to be a force of leadership in the field of brachytherapy and making a difference for patients and the doctors who treat them. In fiscal year 2020, IsoRay’s continue to see an increase in the treatment of patients with brain cancer. Through orders of Cesium-131 to power GammaTile and for other non-GammaTile cancer applications, we continue to believe the brain cancer remains an area of considerable potential growth. Since our partners at GT Medical Technologies launched into full market release from the beginning of 2020, the Company now has GammaTile available in 26 hospitals across the United States. In addition, GT Medical Technologies recently announced that the University of Texas, MD Anderson Cancer Center will begin enrollment of a multi-center, randomized Phase III clinical trial of GammaTile therapy. This study will compare outcomes of 180 patients with newly diagnosed, large brain tumors who received the standard of care treatment, resection surgery and stereotactic radiosurgery to those treated with resection surgery with GammaTile Therapy placement at the time of the resection surgery. We will continue to monitor GT Medical Technologies progress, as we remain optimistic about the prospects of what GammaTile powered by Cesium-131 can do for brain cancer patients. I will now turn the call over to Jonathan to review the results of our fiscal fourth quarter and full year.

Jonathan Hunt — Chief Financial Officer

Thank you, Lori. I’m 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, 2020, that was released a short while ago. We anticipate that our Form 10-K will be filed with the SEC on or around September 21st.

Revenue for the fourth quarter ended June 30, 2020 grew 18% to $2.28 million versus $1.92 million for the same period last year. Fourth quarter revenue was comprised of 84% for prostate brachytherapy with the balance or 16% of revenue attributed to other brachytherapy, primarily sold to treat brain which included revenue from GammaTile and GT Medical Technologies.

Gross profit as a percentage of revenues for the fourth quarter ended June 30, 2020 increased to 47% compared to 45.7% for the quarter ended June 30, 2019. The gross margin increase was primarily driven by higher sales, which were partially offset by higher isotope unit costs, resulting from increased transit costs due to the COVID-19 pandemic impacts on international commercial flight capacity, as well as increased payroll and benefits expense due to an increased headcount.

Fourth quarter gross profit dollars of $1.07 million increased 22% when compared to the same period last year. Total operating expenses consisting of research and development, sales and marketing and general and administrative increased 12% to $2.26 million in the quarter versus $2.02 million in the fiscal fourth quarter 2019.

Total R&D expense decreased 6% versus the comparable prior-year quarter to $322,000. The year-over-year decrease in total research and development expenses was primarily the result of reduced expenses related to the development of the Blu Build delivery system during fiscal year 2019, which were partially offset by increased incentive compensation related to the increase in revenue and Company financial performance. Going forward, we continue to expect R&D expense to be roughly $300,000 to $400,000 per quarter, as we are continuing to have discussions with institutions looking at the expanded use of Cesium-131.

Sales and marketing expenses were $690,000 in the fiscal fourth quarter Fiscal fourth quarter of 2020, an increase of 1% versus the comparable prior year period. The increase in sales and marketing expenses was driven by higher payroll benefits and share-based compensation, resulting from increased incentive compensation related to the full-year sales increase of 32%, but was partially offset by significant declines in travel, convention and trade show expenses due to COVID-19. G&A expenses of $1.25 million, increased 25% versus $1 million in the fiscal fourth quarter 2019. The year-over-year increase in G&A expenses was driven primarily by increased incentive compensation related to the full-year increase in revenue and Company financial performance, headcount, insurance premiums and public Company related expenses when compared to the comparable prior year period. IsoRay posted a net loss of $1.19 million for the fourth quarter ended June 30, 2020 compared to a net loss of $1.1 million in the — for the quarter ended June 30, 2019. The net loss per basic and diluted share was $0.02 versus the net loss of $0.02 for the quarter ended June 30, 2019. Basic and diluted share results are based on weighted average shares outstanding of approximately 68.1 million at fiscal year-end 2020 versus 67.4 million for the prior year period. Turning now to our full year 2020 results. Revenue for the full year ended June 30, 2020 increased 32% to a record $9.68 million compared to $7.31 million for the prior year. Prostate brachytherapy revenue represented 86% of total revenue at fiscal year-end 2020 versus 89% for the prior fiscal year. The Company’s core prostate brachytherapy revenue increased 29% versus the full year ended June 30 2019. Full year at non-prostate revenue grew 60% versus fiscal year 2019 and was driven by growth in sales to treat brain including sales of GammaTile Therapy, lung and gynecological cancers. Gross profit as a percentage of revenues for the full year ended June 30, 2020 was 52.9% versus 41.7% for the full year ended June 30, 2019. As Lori said at the beginning of the call, full year gross profit dollars of $5.12 billion increased 68% when compared to the fiscal year 2019. The gross margin was primarily driven by higher sales, as well as decreased isotope unit costs compared to fiscal year 2019. Total operating expenses of $8.6 million for the year ended June 30, 2020 increased 4% from $8.3 million in fiscal year 2019. Total R&D expenses decreased 24% to $1.13 million from $1.47 million in fiscal 2019. The decrease in total research and development expenses was primarily the result of lower overall protocol expenses combined with reduced spending related to the development of the Blu Build delivery system during fiscal year 2019. These declines were partially offset by increased incentive compensation related to the increase in revenue and company financial performance in fiscal year 2020. Sales and marketing expenses increased 11% to $2.98 million versus the prior fiscal year. The increase was largely attributed to higher payroll benefits and share-based compensation resulting from increased incentive compensation related to the sales increases and an increase in physician-led training exercises versus the prior fiscal year. These increases were partially offset by decreases in travel and convention costs due to COVID-19 in the second half of fiscal 2020. General and administrative expenses increased 10% to $4.57 million versus the prior year fiscal year. The year-over-year increase in G&A expenses was driven primarily by increased incentive compensation related to increase in revenue and Company financial performance, headcount, insurance premiums and public company related expenses when compared to fiscal year 2019. The Company’s net loss improved significantly to $3.45 million for the fiscal year ended June 30, 2020. This compares to a net loss of $5.14 million in fiscal year 2019. The net loss per basic and diluted share was $0.05 versus $0.08 in fiscal year 2019. Basic and diluted share results are based on weighted average shares outstanding of approximately 67.6 million at fiscal year-end 2020 versus 67 million for the prior year period. As of June 30, 2020, the Company had cash, cash equivalents and certificates of deposit that totaled $2.39 million compared to $5.33 million at the end of fiscal 2019 — ended June 30 2019. The Company has zero long-term debt. Shareholders’ equity at the end of fiscal 2020 totaled $5.72 million versus $7.68 million in the prior-year comparable period. During the fourth quarter and fiscal 2020, the Company sold 1,247,232 common shares through its ATM facility and realized gross proceeds from those sales of approximately $920,000. I will now turn the call over to the operator to take questions from our analysts and institutional investors.

Questions and Answers:

 

Operator

[Operator Instructions] We’ll take our first question from Ed Woo with Ascendiant Capital. Thank you, sir. Please go ahead.

Ed Woo — Ascendiant Capital — Analyst

Yeah, congratulations on the quarter and annual results. My question is — has to physicians that you’ve been interacting with making sales calls. Have they said that — things are pretty much back on track or there is still significant delays from the pandemic?

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

Hi Ed Woo. And thank you for your question today. We are communicating a lot with our physicians currently and what we’re seeing is that — certainly, the biggest impacts to date, we experienced was at the end of March and into April, and after that both our numbers as well as our physicians saw an increase back trending — back towards normal patterns. We have seen a little bit of fluctuation in that, just based on some of the public health concerns and that’s had kind of near-term effect on patient volumes from one market to another. But by and large, we’re seeing the trend heading in the right direction.

Ed Woo — Ascendiant Capital — Analyst

Great. And then my next question is, trade shows were such a big part of your marketing program. Now that, it doesn’t seem to be happening anytime soon. Have you been able to your outreach and marketing?

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

That’s a really great question. So yes, trade shows are and professional society meetings really haven’t been happening and probably won’t happen this fall, as well. What we have found to be very effective, I think like a lot of other people, is working with Zoom and Microsoft teams and other platforms to communicate directly with our customers and our sales team has done some training on that and has really found that has been in the effective way to continue and reach out and talk to our customers. It certainly isn’t the same as being with them face-to-face. But as things have eased up over the summer, our sales force back in the field. We continue to ask them to be very careful for themselves as well as follow all the rules in the institutions that they’re visiting. But we are seeing more, more opening up of that type of activity as well.

Ed Woo — Ascendiant Capital — Analyst

Great, well thank you and wish you guys, good luck.

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

Thank you, Ed.

Operator

[Operator Instructions] We’ll take our next question from RK Ramakanth. Please go ahead.

Swayampakula Ramakanth — H.C. Wainwright & Co., — Analyst

Thank you. Good evening, Lori, and congratulations on a very, very good year. Blu Build — is expected to be the driver of growth, as you just stated in your opening remarks. So, in terms of In terms of trying to maintain that. How confident are you about your manufacturers ability not to be overrun by the requirements of COVID-19. And also to maintain the inventory that you need for keeping up the sales, because it looks like the sales are growing pretty good, as well?

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

Absolutely. So our our Blu Build manufacturer is back to manufacturing medical devices and we expect no interruptions, nor concerns in terms of capacity for them to provide us with what we need. I’m super excited about Blu Build because our sales team has a lot of — it took us a little longer to get it out because of what happened with COVID and our manufacture converting to PPE manufacturing. However, there are a lot of doctors that we’re interested in it and who have stayed interested in a store sales team is very busy doing virtual presentations of Blu Build and how to use it and that’s been going very well. So we are very excited about that. In terms will be overall manufacturing of our seed, we during — COVID didn’t see any supplier issues with our isotope or any other components of our manufacturing. And have really stayed very stable in that area as well. So we’re feeling very good about all of our suppliers and manufacturers that support us.

Swayampakula Ramakanth — H.C. Wainwright & Co., — Analyst

Yeah, talking about suppliers. So, can you talk a little bit more about the quality of the supplier and assurance that — if there is an issue with your current supplier that you have a second resupply out to go to for Cesium?

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

Absolutely. So, in speaking of the isotope specifically, we — in our 15 years of working to get isotope from our partners in Russia have never — never had a problem or a missed delivery during COVID specifically, they may made every single weekly order that we put in and got it to us. We saw more issues, actually with the — giving it to us in the United States. So the actual carriers, we had to move from commercial flights to cargo flights, which were a little bit more expensive. But again, now that we’re seeing things lighten up a bit, we’re back to using commercial carriers and we’re out of cargo and so it has all worked very seamlessly. As you can imagine, we watch that very, very closely, but it has worked out very well and we’re very pleased with it.

Swayampakula Ramakanth — H.C. Wainwright & Co., — Analyst

Thanks. So the last question from me is on GammaTile. Obviously the GammaTile seems to be growing strong with making up 16% of your sales in the year. So what are the tricks that you need to continue to play to make sure that part of — that segment of the business continues to grow beyond 16% in the coming year?

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

So just a note of clarification, they are less than 10% of our overall revenue. But you’re absolutely right, they have grown a lot this year. We are very excited for them about that, and we are looking forward to their continued growth. And we were really closely with them to make sure that we understand what they’re forecasting, their business to look like. So that we have all of the components that we need to supply them that we have everything in place in our manufacturing facility to make sure that there is no hiccups because we want to continue to support them and it makes a lot of sense for us to be in a position where we can be absolutely every single order they give us at any point in time that they give it to us.

Swayampakula Ramakanth — H.C. Wainwright & Co., — Analyst

Thank you, Lori, and good luck.

Lori A. Woods — Chief Executive Officer & Member of the Board of Directors

Thank you so much, RK.

Operator

[Operator Closing Remarks]