iRadimed Corporation

Welcome to the Iradimed Corporation 3rd Quarter 2020 Financial Results Conference Call. Currently, all participants are in listening mode. At the end of the call, we will conduct a question and answer session. As a reminder, this call is being recorded today, October 30, 2020, and contains time-sensitive information that is accurate only as of today. Earlier, Eradimed released financial results for the third quarter 2020. A copy of this press release announcing the company's earnings is available under the heading News on their website at eradimed.com. A copy of the press release was also furnished to the Securities and Exchange Commission on Form 8K and can be found at SEC.gov. This call is being broadcast live over the internet on the company's website at iradimed.com. And the replay of the call will be available on the website for the next 90 days. The agenda for today's call will be as follows. Roger Susi, President and Chief Executive Officer of IRADIMED, will present opening comments, then Mary Beth Smith Vice President of Sales will discuss the current environment and recent trends in customer orders. And finally, Chris Scott, Eradimed's Chief Financial Officer will summarize the company's financial results before opening the call up to questions. Some of the information to be furnished in today's session will constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are those focused on future performance, results, plans, and events and may include the company's expected future results. Iradimed reminds you that the future results may differ materially From these forward-looking statements, due to a number of risk factors, for a description of the relevant risk and uncertainties that may affect the company's business, please see the risk factor section of the company's most recent reports filed with the Securities and Exchange Commission, which, again, may be obtained for free from the SEC's website at SEC.gov. I would now like to turn the call over to Roger Susi, President and Chief Executive Officer of Eradimed Corporation. Mr. Susi.

Thank you and good morning. As the COVID pandemic continues to challenge traditional norms, our teams are fully focused on maintaining consistency in servicing and selling to our customers. While constant ups and downs created by the pandemic have obscured our business visibility, I'm very pleased to report third quarter revenue of $7.7 million. Though this is near 23% decrease from our third quarter last year, we feel that our efforts during this difficult time are paying off. For the third quarter 2020, we also reported earnings of $0.09 per share on a GAAP basis and non-GAAP earnings of $0.11 per share. Given the environment, I believe it is also important to note that sequentially Q3 revenue is 13% higher than in Q2. While Marybreath Smith will speak about the overall sales environment in a moment, we view this sequential increase positively and expect growth in the fourth quarter as well. As I've already alluded to, uncertainty around the COVID issues continue to swirl and impact us daily. The rise in positive tests around the world, including in the US, has caused governments to take a number of actions, from reinstating travel restrictions to the partial closing of businesses. As a result, hospitals in many parts of the world are preparing for yet another wave we see being discussed in the daily news cycles, all of which continues to make reliable projections of future performance impossible. To reiterate a point made last quarter, The virus continues setting the pace, and Enratamed is not alone in experiencing uncertainty. To offset this challenging environment, we continue to find innovative ways to engage our customers and drive the benefits of our products. We believe these efforts are helping us currently and will further pay off in the form of accelerated revenue growth once we are in a post-COVID setting, certainly. As an update on our regulatory activities, Last quarter, we reported that we would soon be filing a 510K application for our next generation MRI IV pump with the FDA. That was accomplished just days after that Ernie's call. We expect clearance to take yet another 12 or 14 months, however, the usual cycle. At this time, we see no major issues impeding its release and are preparing for its production. Regarding our development of new products, we continue to make progress on our FMD device. And currently in the final stages of development, our commercialization plans remain unchanged as we will expect to have a small number of operational units available before the end of the year. However, the launch and actual sales of this device we expect may be significantly slowed due to the current environment. Now I'd like to turn it over to Mary Beth to provide more color around what we are seeing in the field and recent transient customer orders.

Thank you, Roger, and good morning to everyone. As Roger just said, our ability to sell during the third quarter was negatively impacted by COVID. We started the quarter with limited access to hospitals, and as the quarter progressed, we were able to gain access to radiology and MRI suites on a case-by-case basis. However, access to the critical care areas of the hospital remain inaccessible. To offset these limitations on access, we continued with our strategy of engaging customers through virtual meetings and demonstration of our products. We have made significant strides in our ability to sell in this manner, as have our customers, who are also learning to procure in new ways. Our success with this strategy can be seen in the customer orders when comparing two COVID impacted quarters Q3 2020, customer orders grew 27% over Q2 2020. Additionally, Q3 2020 orders were down 6% over Q3 last year. Given the current environment, we believe a 6% decline in customer orders when compared to a pre-COVID period is a very strong showing. To provide a little bit more granularity, orders for the MR IV pumps for third quarter 2020 declined 36% from Q3 last year. However, Q3 2020 IV pumps grew 22% over the second this year. Additionally, customer orders for MR patient monitoring during Q3 2020 grew 26% over Q3 of last year and monitors grew 42% over Q2 of this year. Orders for IV sets are trending positively with Q3 2020 orders growing 23% over last year and 12% over Q2. We view these sequential increases positively, an indication that a thawing process is underway and that we and our customers are adjusting to a new selling process. As we look into Q4, we expect some of the level of growth over Q3, but I reiterate Roger's earlier comments. The pandemic continues to set our pace of business and our visibility remains largely abstracted. With the increase in COVID cases around the globe in recent decisions by various authorities to restate restrictions on travel on business, we will remain flexible and proactive in adapting to these continuing changes. Now, I'll turn over to Chris to summarize the financial results.