IsoRay, Inc. Common Stock (DE)

Greetings, and welcome to ISRA Inc's Q3 Fiscal Year 2021 call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mark Levin of Investor Relations.

Thank you, operator. Good afternoon, and thank you for joining us today for the ISRA Fiscal Third Quarter 2021 Earnings Call for the quarter ended March 31st, 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 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 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, ISRA's Chief Executive Officer, and then Jonathan Hunt, ISRA'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 ISRA'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 the Fiscal Third Quarter financial results. I am pleased to share with you the progress we have experienced in our Fiscal Third Quarter As we look with increasing confidence to the future opportunities for growth at Issa Rae, 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 am 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 checkups, 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 than we have had at any other time since COVID started last year. At the same time, we believe the many 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 Blue Build, our partnership with C4 Imaging, and our active support of physician training programs are expected to serve us well in that regard. Our non-prostate brachytherapy business, which encompasses surgical applications for other cancers like brain, head and neck, and lung, continued to grow and were 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 raise during the quarter and the subsequent strengthening of our balance sheet, We have greatly enhanced ISARAY's abilities to capitalize on significant growth opportunities. We believe that ISARAY's 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 investments, 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 ISRA'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 Fort as Vice President of Sales and Marketing. We believe Donna's extensive background in establishing and leading successful sales organizations within our industry uniquely positions her to lead 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, multidisciplinary products including three radioactive isotopes for cancer. Further, we feel confident that Donna's valuable experience in combination therapy with oncologic agents, including immunotherapy, will be particularly beneficial to ISARAY's strategic vision for growing new markets. Donna joins us at a pivotal time to take advantage of our expectation that projected prostate brachytherapy market growth will be fueled by some key developments we have shared with you. With the implementation of the previously discussed Future Reimbursement Changes, or ROAPM, along with the anticipated increased prostate cancer diagnosis as we emerge from the pandemic, we see positives for ISRA's 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 is 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 and 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 have 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 Optivo. Future investments in similar combination therapies for the treatment of other cancers will be critical to our position in the evolution of leading edge cancer treatment options. The final area of investment focus we envision 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 complement cesium-131 or potentially looking at other radioisotopes 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 developments. 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 a broad endoscopic 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 Isoray in the development and implementation of cesium-131 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 ISARAY for the evolving cancer treatment marketplace. As you can see, these remain exciting times for ISARAY. 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.