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spk02: Good afternoon, and welcome to the raw medical conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. Please note, this event is being recorded. I would now like to turn the conference over to Jody Kane. Please go ahead.
spk01: This is Jody Kane with LHA. Thank you for participating in today's call. Joining me from Raw Medical are Will McGuire, Chief Executive Officer, and Andrew Jackson, Chief Financial Officer. Earlier today, Raw Medical issued a news release announcing financial results for the 2021 fourth quarter and full year. If you've not received this news release or if you'd like to be added to the company's email distribution list, please contact LHA at 310-691-7100 and speak with Daniel Shurtalk. You can also sign up for email alerts and access the news releases in the investor relations section of the raw medical website at ir.rawmed.com. During this call or in response to listener questions, management will be making a number of forward linking statements within the meaning of the Private Securities Litigation Reform Act of 1995. to the extent that statements made by management are not descriptions of historical facts regarding raw medical. They are forward-looking statements reflecting the beliefs and expectations of management as of March 23, 2022, including financial, regulatory, product development, and clinical trial expectations. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors that are, in some cases, beyond the company's control and could materially affect actual results. In particular, there is significant uncertainty about the duration and contemplated impacts of the COVID-19 pandemic and the military actions launched by Russian forces in Ukraine on the business and results of operations, including our supply chains. This means that results could change at any time, and the impact of COVID-19 and or the military action in Ukraine on raw medicals operations, financial results, and outlook is the best estimate based on the information for today's discussion. For details about these risks, please see the company's SEC filings, including raw medicals annual report on Form 10-K for the year ended December 31, 2021. which will be filed with the SEC shortly, and any other period filings done by the company, including quarterly reports on Form 10Q. Raw Medical expressly disclaims any intent or obligation to update forward-looking statements except as required by law. Today's conference call remarks will include both GAAP and non-GAAP financial results. Raw Medical believes the non-GAAP financial results provide investors with useful supplemental information about the financial performance of the business, enable the comparison of financial results between periods for certain items that may vary independently of business performance, and allow for greater transparency with respect to key metrics used by management and operating the business. Non-GAAP financial measures are presented solely for information and comparative purposes and should not be regarded as a replacement for corresponding GAAP measures. Reconciliation between GAAP and non-GAAP financial measures can be found at the end of the financial results news release that was issued earlier today. With that, I'd like to turn the call over to Will McGuire. Will?
spk05: Thanks, Jody. Good afternoon, everyone, and thank you for joining us. Today, I am pleased to outline key objectives for 2022 and highlight the significant progress we've made on our engineering programs and the clinical study for an atherectomy label. This progress was made during an especially challenging period as the pandemic continues to impact our industry's ability to conduct clinical studies and persistent supply chain challenges are affecting engineering project schedules. Starting with our engineering initiatives, last month our team met a key milestone by filing a 510 application with the FDA for our next generation Dabra catheter with a braided overjacket design and a six-month shelf life. Internally, we refer to this catheter as the Dabra 2.0. We believe the Dabra 2.0's more robust design improves deliverability and kink resistance for the physician when navigating tortuous anatomy. The design overhaul was technically demanding and required building and testing hundreds of catheters during the engineering verification and validation testing phase. We look forward to receiving feedback from the FDA on our 510 application later this year, and I want to thank the team at Raw Medical for driving this project to this point while facing the aforementioned supply chain challenges. Although the DABRA 2.0 510 filing represents a major engineering and regulatory milestone, our flagship commercial catheter will be a guidewire compatible version of the DABRA 2.0, which we refer to as the DABRA-RX. The DABRA-RX will incorporate many of the DABRA 2.0's design improvements intended to create a more robust catheter, along with the added feature of guidewire compatibility. We believe that we have made great progress toward a design freeze for the Dabra Rx following our preclinical study conducted in the fourth quarter of last year with interventionalists evaluating its use, handling, and overall performance. We anticipate finalizing the design for the Dabra Rx and completing engineering verification and validation testing later this year. We are also planning to submit a 510 application to the FDA seeking regulatory clearance at the end of the year. And lastly, under engineering accomplishments, I want to update you on two additional initiatives. First, we continue to make progress on the laser development front with various upgrades to the DABRA system, and we anticipate completing design work for a new CPU over the next few months. Second, we continue to build upon our work that we believe will show that our laser system can be utilized to create shock waves of sufficient magnitude to fracture calcium in arteries in a procedure known as intravascular lithotripsy. Fracturing calcium in coronary or peripheral arteries can make them less rigid, thus facilitating the ease and safety of subsequent procedures. We are currently fabricating various prototype systems and intend to conduct further preclinical studies in the next few months to advance our initial bench-top and preclinical findings. We anticipate completing design concept selection and initiating a development project in the second half of this year. Although we're still in the early phases of this project, I continue to be quite excited about this application given the potential to create significant shareholder value if we are able to develop a competitive product in the emerging intravascular lithotripsy market. One final note before turning to the clinical study. We announced the granting of a US patent last month for a support catheter for use with a small flexible liquid core catheter for laser ablation of arterial plaque blockages to restore blood flow. This new patent is the 10th US patent issued to Raw Medical under an intellectual property strategy that we believe to be important for maintaining our competitive position both now and in the future. Moving to our pivotal clinical study to obtain an FDA atherotomy indication for the DABRA eczema laser system. This continues to be a top priority for all medical and we believe that securing clearance for this indication will significantly expand our addressable market beyond our existing clearance for crossing chronic total occlusions or CTOs. As I have referenced before, A third-party research group estimates the value of the combined CTO and atherectomy markets in the U.S. at approximately $900 million for 2022. We are pleased that the FDA agreed to a protocol amendment to increase trial enrollment from 100 to 125 subjects. Our primary reason for this request was subject fallout, for follow-up visits that we believe was due to the COVID-19 pandemic. We have enrolled an additional 13 subjects in this study since mid-November, bringing total enrollment to date to 98 subjects. This trial is approved for up to 10 clinical sites, and we currently have seven sites cleared for enrollment. Two of these sites have reached their quota for the maximum number of subjects, and the remaining five sites are actively screening subjects. Due to the unpredictable impact the COVID-19 pandemic has had and will continue to have on enrollment in this study, we cannot accurately estimate when enrollment will be complete. With that being said, our goal is to complete study enrollment in Q3 2022 and finish six-month follow-up in early 2023. Now, I will turn the call over to Andrew Jackson to review our financial results. Andrew?
spk06: Andrew Jackson Thank you, Will. As a reminder, we completed the divestiture of our dermatology business in August 2021 in a transaction that provided immediate cash proceeds to fund our initiatives in the large and growing vascular market. We are reporting 2021 historical operating results and related assets and liabilities of the dermatology business as discontinued operations. Unless otherwise noted, the financial results I'll discuss today relate to continuing operations. Also, please recall that in late 2020, we paused our commercial shipments of catheters and are only supplying catheters to support our atherectomy clinical study. We do, however, recognize revenue on product used in the clinical study. Net revenue for the fourth quarter of 2021 consisted of product sales of $5,000. This compares with zero net revenue for the fourth quarter of 2020. Gross loss was $0.3 million for the fourth quarter of 2021. compared with $0.4 million for the fourth quarter of 2020. SG&A expenses for the fourth quarter of 2021 were $4.2 million versus $6.4 million for the prior year period. The 2021 fourth quarter decrease of $2.2 million compared to the prior year fourth quarter includes a decrease of $1.2 million in personnel costs and a $0.6 million decrease in stock-based compensation. SG&A expenses for the fourth quarters of 2021 and 2020 included stock-based compensation expense of $0.2 million and $0.8 million, respectively. R&D expenses for the fourth quarter of 2021 were $3.7 million, compared with $3.4 million for the prior year period. The 2021 fourth quarter reflects an increase of $0.3 million in personnel and consulting expenses related to work with our next generation catheters, including increased shelf life and improved deliverability, and also progress with the athorexomy clinical study. R&D expenses for each of the fourth quarters of 2021 and 2020 included stock-based compensation expense of $0.1 million. The gap net loss from continuing operations for the fourth quarter of 2021 was $8.3 million, or $1.23 per share, on 6.7 million weighted average shares outstanding. This compares with the gap net loss from continuing operations for the prior year quarter of $10.2 million, or $3.54 per share, on 2.9 million weighted average shares outstanding. Adjusted EBITDA for the fourth quarter of 2021 was negative $7.8 million, compared with negative $8.8 million for the prior year period. A reconciliation of gap net loss to non-gap adjusted EBITDA is included in today's press release. Turning to our full-year financial results, net revenue for 2021 consisted of product sales of $22,000. This compares with net revenue for 2020 of $0.3 million, which primarily consisted of product sales. Our gross net loss decreased to $1.5 million in 2021 from $1.9 million in 2020. SG&A expenses for 2021 were $15.5 million, and this compares with $24.5 million in 2020. The decrease was due primarily to a reduction in legal fees and lower headcount. SG&A expenses in 2021 included stock-based compensation of $1.8 million compared with stock-based compensation for 2020 of $3.2 million. R&D expenses for 2021 were $12.3 million versus $9.0 million for 2020. The 2021 expenses included increases of $2.2 million in personnel costs and consulting expenses $0.7 million for supplies and $0.5 million in other expenses, which includes costs associated with our atherectomy clinical trial. R&D expenses for 2021 included stock-based compensation of $0.3 million compared with $0.4 million for 2020. Other income net for 2021 was $2.0 million, primarily due to the gain on the forgiveness of the PPP promissory note. The gap net loss from continuing operations for 2021 was $27.3 million or $5.39 per share on 5.1 million weighted average shares outstanding. This compares to the gap net loss from continuing operations for 2020 of $35.3 million or $20.79 per share on 1.7 million weighted average shares outstanding. Net income from discontinued operations for 2021 was $2.2 million or 43 cents per share. This compares with the net loss from discontinued operations for 2020 of 0.7 million or 43 cents per share. Net income from discontinued operations for 2021 included a gain on sale of the dermatology business of 3.5 million. We used 27.6 million in cash to fund operating activities for both continuing and discontinued operations during 2021. This compares with $28.3 million used to fund operating activities for both continuing and discontinued operations during 2020. We exited 2021 with cash and cash equivalents of $15.0 million. Subsequent to the end of the year, in February 2022, we completed a public offering resulting in net cash proceeds to Rye Medical of $10.7 million. With that, I'd like to open up the call for questions. Operator?
spk02: We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.
spk05: While we're waiting for the first question, I want to recognize the hard work by the entire raw medical team. as we've come a very long way in developing a competitive product line to address the large and growing PAD market. We've also made tremendous strides during the global pandemic in advancing our pivotal atherectomy trial with the objective of significantly expanding our addressable market. Okay, operator, we're ready for the first question.
spk02: And the first question comes from Jeffrey Cohen with Ladenburg-Thalman. Please go ahead.
spk04: Hi, Will and Andrew. How are you?
spk02: Good. How are you? Good, thanks.
spk04: Just fine. So, firstly, could you walk us through how you feel the margins might kind of work out over the next year or two as further development of the new over-the-wire product?
spk06: Well, the margins will, you know, this year it's still in the development phase and, you know, we expect to, be filing the atherectomy submission early next year. So we don't expect any significant margins as we start commercializing. We would expect those to come into fruition in the later years.
spk04: Got it. OK. And do you expect to have any locations or centers outside the US for any filings over the next two years at all? Or is that still a bit early?
spk05: I'd say it's a bit early. Probably the next couple of years our focus will remain in the U.S., Jeff. And if you look at the atherectomy market itself, the overwhelming majority of the procedures and the revenue for atherectomy is in the U.S. So there's not a huge incentive to go outside of the U.S. from a revenue generation perspective.
spk04: Okay, got it. So it sounds like you're doing some early work there on the lithotripsy side. Could you envision in a few years perhaps having a few products on offer, or could you also envision that you may have one product both capable of delivering light energy as well as shockwave energy?
spk05: Yeah, that's a good question, Jeff, because right now our – You know, the atherectomy catheter, if you put it in some sort of medium that absorbs the energy, it does produce the shockwave. So we're going through a process now of evaluating different design concepts. Some of the design concepts we're looking at would involve a catheter that's specially made for lithotripsy and only can do lithotripsy. It's not unimaginable, though, that you could have a design concept where the the catheter, the base catheter could perform atherectomy or lithotripsy. That's a bit more complex and not one that we've spent a lot of time on so far, but we'll really try to get to a point the second half of this year where we can further outline the concept that we're going to pursue and what that looks like and kind of the timeline for it. It's probably... You know, if you're starting today, you should think that we're at least a couple of years, I mean, probably three years out from having a lithotripsy product. But, yes, certainly we hope to be on the market with an atherectomy product and a lithotripsy product at some point in the future.
spk04: Okay, got it. And then lastly for us, could you talk about the current studies and the expected filing late this year on the guidewire capability Do you currently have enough generators out in the field to run those studies at the FDA in particular centers, or will you have to be producing more generators?
spk05: Right now our study, we're at seven sites. We're cleared to go up to ten sites. So we have sufficient laser units for the clinical study. Once we get an RX product approved, which would be going into next year, we may decide, even if it's approved before we have an athrex communication, we may decide to get some experience with it. But I think the experience that we would seek would be limited, and we would have sufficient laser units in-house to place at any sites we'd go in the near future.
spk04: Okay, and then lastly for us, Any obstacles as far as timelines for engineering and catheter production as you head into the studies, head further into the studies this year? Do you have enough inventory or enough on order with some clear line of sight?
spk05: I'd say right now our inventory is good for the foreseeable future. We will be placing some additional orders to support some of the engineering builds in the latter half of this year. At this point, we think we're in good shape there, but that has been a source of concern for us in the past and a source of concern for others in the industry with some of the supply chain issues out there. Right now, we think we're in good shape, but again, until the product is in-house, we're not completely in the clear, but You know, if you look at what we're doing now to maybe what we would have done two or three years ago, Jeff, we will be ordering things further in advance, and we may carry more inventory now to get us through any unforeseen supply issues. But so far, so good.
spk04: Okay. Perfect. That does it for us.
spk02: Thanks for taking the questions.
spk05: Great. Thank you. Thanks, Jeff.
spk02: The next question is from Vernon Bernardino with HC Wainwright. Please go ahead.
spk03: Hi, Will and Andrew. Congrats on the 510K application and the progress with enrollment in the atherectomy pivotal study. I was just wondering as far as enrollment concerns, what kind of challenges are you still seeing perhaps, if any, in enrollment for that study versus what you saw previously during the, let's say, the height of the pandemic, and what things have you seen that are perhaps, in one way to describe, have released the floodgates so that enrollment could actually accelerate?
spk05: Yeah, good question. You know, if you look at, if you just take a look at our enrollment over the past few quarters, or I'm sorry, the past few calls, you know, this call we We announced 13 additional subjects enrolled. I think the previous call was 15, and maybe the one before that was 20. We definitely were hurt over the past 90 days since early November of last year by the Omicron variant, and fewer people were willing to go and get any sort of elective procedure. I think it probably not only impacted our clinical study, but it would have impacted probably companies that you guys are covering that are doing procedures out there right now. So it was a tough environment. That seems to be getting better right now. And so we're hopeful as we go forward this year that we'll see enrollment accelerate. I don't remember the exact numbers, but if you look at our enrollment last year during the pandemic, I think January and February, probably January, February, and then maybe November, December were probably some of the lower months. But last year we did see an acceleration into April, May, and June in enrollment. I don't know that that will happen this year, but right now the pandemic seems to be subsiding, at least for the time being. And so we would be hopeful that visits to clinics pick back up and that people are more willing to – you know, sign an informed consent for a clinical study and commit to coming back for the 30-day and the six-month follow-up.
spk03: Yeah, I'm crossing my fingers as well. And if I got this correctly, regarding the 510 application, you expect the FDA feedback later this year, correct? If you have made the filing for the 510K, What is the current, let's say, dynamic you're experiencing as far as FDA feedback and what you have gleaned from interactions with the FDA? Any delays or how slowly they're actually processing these kind of applications?
spk05: Yeah, that's a good question. You know, we're... You know, they try to get you an answer, you know, kind of a final answer, if it's possible, within 90 days. I think we actually filed back in February. You know, I would say we've already had some interaction with the FDA. I don't think we can glean anything either positive or negative from that interaction other than I think it's positive that we're already getting questions and overall, more of an overall comment, you know, the FDA is is trying to be much more interactive with a lot of their submissions. So asking questions earlier on versus, you know, waiting till to the end and starting to ask questions at that point. So we've already had some questions. So we know that they're looking at the, uh, at the submission or at least part of the submission, uh, but can't really read anything into it, uh, at this point.
spk03: Great. Um, thank you for, um, answer my questions. I'm looking forward to continued progress.
spk05: Great. Thanks a lot. Thanks for your questions. Thanks, Vernon.
spk02: This concludes our question and answer session. I would like to turn the conference back over to Will McGuire for any closing remarks.
spk05: Thank you again for joining us this afternoon and for your interest in raw medical. As discussed today, we're making excellent progress against our strategy to address the large growing PAD market. with our advanced Eximer laser-based technology, putting us on a path to building shareholder value. And as always, we are committed to our mission of saving lives and limbs. Have a nice afternoon, everyone.
spk02: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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