Aurora Spine Corporation

Hey, and welcome to the Aurora Spine Report's fourth quarter and fiscal year 2022 financial results conference call. All participants will be in a listen-only mode. If you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Adam Lowensteiner with us and partners. Please go ahead.

Thank you, Betsy. Welcome, everyone, and thank you all for joining us today to review the financial results for Aurora Spine for the fourth quarter and fiscal year ended December 31, 2022. With us on the call representing the company today are Trent Northcutt, President and CEO of Aurora Spine, and Chad Klaus, CFO of Aurora Spine. Before we begin, I would like to remind everyone that statements made during the course of this call may be considered forelooking statements within the meaning of Section 27A of the Securities Act of 1933 as amended and Section 21E of the Securities Act of 1934. These statements reflect current expectations concerning future events and results. Words such as expect, intend, believe, may, will, should, could, anticipate, and similar expressions are words that are used to identify forelooking statements, but their absence does not mean forelooking. a statement is not forward-looking. These statements are not guarantees of future performance and are subject to risks and uncertainties and other important factors that could cause actual performance or achievements to be materially different from those projected. A full discussion of these risks, uncertainties, and factors, you are encouraged to read Aurora Spine's documents on file with CDAR, including those set forth in periodic reports filed under the forward-looking statements and risk factors section. Aurora Spine does not intend to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise. On this call, management may refer to EBITDAQ, adjusted EBITDAQ, adjusted net income, adjusted EPS, which are not measures of financial performance under generally accepted accounting principles or GAAP. Management believes that these non-GAAP figures, in addition to other GAAP measures, provide meaningful supplemental information regarding the company's operational performance. Investors should recognize that these non-GAAP figures might not be comparable to similarly titled measures of other companies. These measures should be considered in addition to and not as a substitute for or superior to any measure of performance prepared in accordance with GAAP. A reconciliation of non-GAAP measures to the most directly comparable GAAP measures in accordance with SEC Regulation G can be found on the company's earnings release. With that, I'd like to now turn the call over to Mr. Trent Northcutt, President and Chief Executive Officer of Aurora Spine. Trent, please proceed.

Thank you, Adam. I'd like to welcome everyone to the Aurora Spine's fourth quarter and fiscal 2022 financial results conference call. Earlier today, we issued a press release detailing our financial results. Hopefully, you've had a chance to review this press release. But if not, a copy can be found on our website at www.aurora-spine.com under the investor section or other financial websites. To lay out the agenda for today's call, let me first summarize a few key events of the quarter and the year. I'll then take a bit of status to talk about each of the initiatives and products like Zip and Silo, as well as our initiatives on the Spine Division, including our DEXA product line. Chad will then give a recap to the financial resorts. We will conduct a Q&A session at the end. The key events in fourth quarter fiscal year 2022, I'm going to give you a market overview of the dynamics of the products in our clinical studies. The fiscal 22 was a great year for Aurora. We had several accomplishments. Many of them broke well within the future. At a high level, we reported record revenues with strong growth of 41% to 14.9 million. We received FDA clearance for our silo TFX, which was a tremendous event for our company and the silo franchise. By now, having a metal implant with transfixing capabilities, we also advanced our DEXA technology with the FDA clearance of the DEXA-L. We also won an award for the best new product of the year at this year's NAS event for the DEXA product. We also embarked on clinical studies with many of our products during 2022, into 2023, and it's important to have the data to share with the industry when selling our products. We received early positive results from our ZIP device, which has been building momentum as well. Looking into 2023, we believe that our proper track to continue revenue growth, while the fourth quarter was a bit slower than we anticipated, as well as the first quarter of 2023, It took time to make some of the changes to prepare the company for long term, including adding some new personnel like Matt Goldstone, Aurora's new chief business officer. Matt has hit the ground running and has quickly been able to add new positions that have already opened up some key accounts for Aurora. He is highly focused on the big picture and is energized about our unique product offering and working diligently in building out our strategic sales organization. On a macro level, we continue to see momentum gaining in the minimally invasive surgery market, especially with regards to the reimbursement coding as insurances are embracing more procedures that can be done minimally invasive manner and have a patient recoup at home for quicker timeframe. Aurora's products like the Zip and the Silo are very complimentary to doctors and their patients, and especially designed for minimally invasive procedures. I believe it is at this catalyst that while our products are able to gain traction that we've been receiving. In addition, our products offer alternative ways for doctors to treat patients with as little pain and medications as possible, especially given the opioid epidemic that has hit the United States in the recent decade. This, too, is a main tailwind for the med tech industry. While Q4 was a little bit on the quiet side, we've been very busy behind the scenes and preparing the siloed TFX for commercialization. We received FDA clearance for the TFX only a few months ago, and it was a very important catalyst for Aurora, as it is a major future growth opportunity within the SI joint market, which is still very early stage innings. Obtaining this clearance approves our IP franchise, but also demonstrates that we've created a new product that offers transfixing capabilities, which is something many doctors are desiring. We have already began an alpha launch stage for this product with initial surgeries taking place during the first quarter of 2023, and so far it has been a breakthrough product for doctors and patients. We are currently gearing up for the next phase of the product launch, and preparing additional kits to gear up for commercialization later this year. We'll definitely keep investors updated as things progress with the TFX, as we believe this will be a contributor to our growth for several years to come. The ZIP series continues to be a nice contributor to Aurora. During Q4, we were pleased to learn of the initial positive interim results from our clinical study using the ZIP. which was published in an abstract posting in the publication Pain and Therapy, the title of a perspective, observational, open-labeled, non-randomized multicenter study measuring functional outcomes in a novel interspinous interlamino fusion device. This is a low-pain, refined study. The publication discussed the results of an interim three-month analysis, which included 54 patients, of which 82% reported improvements as a result of the procedure, while 65% of the patients demonstrated clinical meaningful improvement in their pain and function. The publication also demonstrated that the use of the ZIP device was both effective and safe at a three-month follow-up. The study remains active and enrollment is continuing with more follow-up data expected in the future and more patient data is completed. The study included results gathering 11 doctors and was conducted on behalf of Aurora Spine to determine the utility of using the interspinous fusion device as a fusion therapy for the treatment of lumbar stenosis. The treatment of lumbar stenosis is a large, unmet treatment that bridges the gap between conservative measurements and invasive surgery procedures. This publication is an exciting validation of Aurora Spine's ability to provide safe and effective outcomes by utilizing the Aurora Zip product line. We look forward to additional results set to be published at a 12-month collection point and believe it will continue to trend positively for our physicians and their patients. Last but not least, moving on to DEXA, we have invested heavily during 2022 building several surgical kits for the DEXA-C, and we are in the midst of placing them to doctors as we speak. We started 2022 initially with two kits in the field and were able to ship another two early in September. To date, we have 10 kits shipped out in the field, working on shipping out the remaining 30 we have ordered. We were hoping to place these kits sooner, but did incur a minor manufacturing issue and required some easy fixes that have been rectified. We are working diligently to place these kits with doctors that will utilize the product as well as partnering with the appropriate hospitals that can accept new products. Getting the DEXA-C placed has been a bit challenging, but it's a key priority amongst our sales team. And now that we received IRB approval for a study using the DEXA-C, we are confident that we can place these kits into the field in the coming months. To summarize, I'm extremely proud of our team's performance and staying focused on building this company. We are well positioned to take advantage of the growth markets with several new proprietary products. We remain focused on penetrating these markets further this year through continuing training sessions and clinical trials. Looking to longer terms, we are well positioned for success, especially we have the new products and more clinical studies proving out our technologies and teaching of our doctors to use the Aurora products. We remain highly focused on the opportunities that are in front of us, and continue to invest our growth in each of our major platforms, the ZIP, the Silo, and the DEXA technology. I will now turn the call over to Chad Klaus, Aurora Spine CFO, who will review the financial results. Chad, please proceed.