Profound Medical Corp.

Welcome to the Profound Medical third quarter 2021 financial results conference call. My name is Hilda and I will be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press star and then one using your touchstone phone. Please note that this conference is being recorded. I will now turn the call over to Mr. Stephen Kilmer, Investor Relations. You may begin.

Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws in the United States and Canada. All forward-looking statements are based on profound current beliefs, assumptions, and expectations, and relate to, among other things, expectations regarding the efficacy of the company's treatment technologies, results of future clinical trials, the ability to obtain coding and or reimbursement from third-party payers, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance, and future commitments. Such statements involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements. which speak only as of the date of this conference call. Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. For the benefit of those who are new to the Profound story, I would like to also take a moment to summarize our business. Profound develops and markets customizable, incision-free therapies for the ablation of diseased tissue. We are currently commercializing TulsaPro, a technology that combines real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control. The technology is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities. TELSA Pro is CE-marked, Health Canada-approved, and 510K cleared by the FDA. We are also commercializing SonoLeaf, an innovative therapeutic platform that is CE-marked for the treatment of uterine fibroids and palliative pain treatment of bone mastectomies. Sonolive is also being approved by the National Medical Products Administration for the non-invasive treatment of uterine fibroids and has obtained FDA approval under a humanitarian device exemption for the treatment of osteoid osteoma. While we do not expect this FDA HDE approval to have a material impact on revenues in the near term, it is a significant milestone for our company, and we are making preparations for its U.S. commercial launch later in 2021. On the call today representing the company are Dr. Arun Manawat, Profound's Chief Executive Officer, and Aaron Davidson, the company's Senior Vice President of Corporate Development. With that said, I'll now turn the call over to Aaron.

Good afternoon, everyone, and welcome to our third quarter 2021 conference call. On behalf of the management team and everyone at Profound, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Arun in a moment for an update on our commercial activities. However, before I do, I'd like to provide a brief update on our third quarter 2021 financial results. As a reminder, we have changed our presentation currency from the Canadian to the US dollar. To streamline things, all of the numbers we will refer to have been rounded so they are approximate. For the three-month period ended September 30th, 2021, The company recorded revenue of $2.5 million, up 13% from $2.2 million in the third quarter of 2020. Total operating expenses in the 2021 third quarter, which consists of R&D, GMA, and selling and distribution expenses, were $8.6 million, an increase of 30% compared with approximately $6.6 million in the third quarter of 2020. Breaking that down further, expenditures for R&D increased 14% on a year-over-year basis to $4 million. This was primarily driven by increased costs associated with new and existing clinical trials, increased spending on MRI utilization, consultants to assist with clinical trial initiatives, travel restrictions being lifted, additional lab rentals in Germany, options awarded to employees, and additional headcount. G&A expenses increased by 35% to $2.5 million due to options awarded to employees, increased insurance costs, and an overall increase to general expenses as offices continue to reopen from COVID-19 restrictions. Finally, selling and distribution expenses increased by 72% to approximately $2 million. Overall, the company recorded a third quarter 2021 net loss of $6 million, or 29 cents per common share, compared with a net loss of $6.1 million, or 33 cents per common share for the same three-month period in 2020. As at September 30th, 2021, Profound had cash of $72.2 million US. With that, I'll now turn the call over to Arun.