NYSEAMERICAN:MYO Myomo Q2 2023 Earnings Report $2.86 -0.20 (-6.54%) Closing price 05/30/2025 04:10 PM EasternExtended Trading$2.99 +0.13 (+4.55%) As of 05/30/2025 07:16 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Myomo EPS ResultsActual EPS-$0.04Consensus EPS -$0.04Beat/MissMet ExpectationsOne Year Ago EPSN/AMyomo Revenue ResultsActual Revenue$5.96 millionExpected Revenue$5.75 millionBeat/MissBeat by +$210.00 thousandYoY Revenue GrowthN/AMyomo Announcement DetailsQuarterQ2 2023Date8/9/2023TimeN/AConference Call DateWednesday, August 9, 2023Conference Call Time4:30PM ETUpcoming EarningsMyomo's Q2 2025 earnings is scheduled for Tuesday, August 5, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Myomo Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 9, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:01Good afternoon, and welcome to the Myomo Second Quarter 2023 Earnings Conference Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Kim Golodetz. Operator00:00:36Please go ahead. Speaker 100:00:38Thank you, operator, and good afternoon, everyone. This This is Tim Golodetz with LHA. Welcome to the Myomo Second Quarter 2023 Conference Call. Earlier today, Myomo issued a news release announcing Financial results for the 3 months ended June 30, 2023. If you would like to be added to the company's e mail distribution list to receive future announcements, Please register on the company's website at myomo.com or call LHA at 212-838 3,777 and speak with Carolyn Curran. Speaker 100:01:13With me on today's call from Myomo are Paul Godonis, Chief Executive Officer and Dave Henry, Chief Financial Officer. Before we begin, I'd like to caution listeners that statements made during this conference call by management Other than historical facts are forward looking statements. The words anticipate, believe, estimate, expect, intend, Guidance, outlook, confidence, target, project and other similar expressions are typically used to identify such forward looking statements. These forward looking statements are not guarantees of future performance and may involve and are subject to risks and uncertainties and other that may affect Myomo's business, financial condition and operating results. These and additional risks, uncertainties and other factors are discussed In Myomo's filings with the Securities and Exchange Commission, including the Form 10 Q for the quarter ended June 30, 2023, and subsequent filings. Speaker 100:02:11Actual outcomes and results may differ materially from what's expressed in or implied by these forward looking statements. Except as required by law, Myomo undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after Speaker 200:02:29It is Speaker 100:02:29now my pleasure to turn the call over to Myomo's CEO, Paul Gudonis. Paul, please go ahead. Speaker 200:02:36Thanks, Kim. Good afternoon, everyone, and thanks for joining us. As we reported in our earnings press release, We had a very solid quarter with year over year growth in revenue and in all of our key operating metrics. More specifically, we continue to increase shipments of our We received the final license payment for our joint venture in China, which has enabled the launch of the business there. And most importantly, we had a significant positive development in I'll start by reviewing the operational highlights during Q2 from the front end of the pipeline through the delivery and revenue. Speaker 200:03:29Our direct to consumer marketing strategy of using TV advertising and social media to inform patients and family members about the MyoPro To restore movement in paralyzed arms is working very well. We added more than 400 medically qualified patients to the patient pipeline in the second And these candidates are all covered by insurance plans that have paid for MyoPro in the past. Earlier this year, we began focusing on payers that have a Track record of reimbursing for the MyoPro, resulting in what we believe is a higher quality pipeline than in the past, and we're building it more efficiently with the smaller staff this year. We obtained authorizations and orders for 125 devices during the quarter, which is up 23% from the year ago quarter. And with the shipments and payments we received, our product revenues were up 15% year over year. Speaker 200:04:23In addition to the strong revenue, we were paid the final installment of the China joint venture initial license fee of just over $1,700,000 Bringing our Q2 total revenue to $6,000,000 We've been working on this joint venture for several years now And with the COVID-nineteen pandemic winding down and the resumption of economic activity in China, our joint venture partners, We're now in the process of setting up manufacturing and sales operations to serve the Greater China market. With an estimated 14,000,000 people with paralyzed arms and 2,500,000 new strokes each year, China represents the world's largest market opportunity for the MyoPro. We have a joint venture project team that's assisting in preparing the manufacturing infrastructure, establishing the supply chain for components and engaging rehab hospitals for distribution of the MyoPro to patients. We sent a couple of our clinical specialists to China to We've also received a total of about $300,000 in orders for the clinical version of our product called the MobileArm Rehab Kit to be used for demos and training and for the MyoPro control system chips and software, which will be used in the initial production run by the JV. The MyoPro control system order represents the initial purchase commitment under the guaranteed minimum payment provision of the JV contract. Speaker 200:06:03And this contract provides for a total of $10,750,000 in MyoPro control unit purchases over the next 10 years. I also want to note that these components are manufactured in the U. S. And are IP states firmly with Myomo. And Then on June 30, the Centers For Medicare and Medicaid Services, known as CMS, issued a proposed rule that, if adopted, We reclassified the MyoPro as a covered benefit in the brace category with a lump sum payment. Speaker 200:06:34In addition, CMS stated its intention to This is a very significant development because it allows to serve patients in the U. S. We're covered by standard Medicare or Part B fee for service and would allow the MyoPro to be reimbursed on a lump sum basis The way all the other payers in the U. S. Currently pay for MyoPro. Speaker 200:06:58We currently provide the MyoPro to seniors with certain Medicare Advantage plans, Yes, half the seniors in the U. S. Are covered by Part B, so our addressable market is poised to increase substantially. For those of you who are new to Myomo, here's a quick summary on Medicare. In January 2019, CMS made unique product Bill and Co is referred to as HCPCS codes effective for the MyoPro. Speaker 200:07:24However, CMS classified the MyoPro As durable medical equipment or DME, which classified it as a device to pay on a monthly rental with coverage on a case by case basis. While this opened up the large Medicare Advantage patient population to us, our position has been that the MyoPro is a custom fabricated brace long term use and that it should be classified in this benefit category. Discussions with the CMS staff got delayed due to COVID, And then we were invited to make our case at the CMS public hearing in June of 2022. At that presentation, We made that presentation and we have follow-up meetings with the CMS staff and with the medical directors of the DME MACs, the Medicare Administrative Contractors. The most recent of these meetings was this past April, where we presented compelling new research about the patient outcomes and the value of the MyoPro to individuals of Medicare age. Speaker 200:08:22We are encouraged to file claims for Part B patients, so we've now fit 6 patients And submitted 6 claims for payment. These claims are under review at this time and it's unclear how the proposed rule that's now come out would affect the processing of these claims that were submitted to D and A Max before the publication of that proposed rule. So what's next? CMS is accepting public comments on this proposed rule until the end of August, and then they'll hold a public hearing on this topic as well as propose the allowable fee for While there's no specific time line for implementing the new rule or holding a public hearing, next hearing is usually in the fall And then coverage and pricing go into effect sometime after that. Although I'd love to have a definite answer for you at this time, The process of the MyoPro covered as a powered on race is closer than ever to the goal line. Speaker 200:09:16In the meantime, we're not sitting still Since many Part B patients contact us each month about a MyoPro for the paralyzed arm, we're proceeding to screen these patients for medical eligibility We're building a pipeline of Part B patients so that we can serve them after coverage and a fee are established. With that overview, I'll now turn Speaker 300:09:45Thank you, Paul, and good afternoon, everyone. Speaker 400:09:47To end the call's comments regarding coverage by CMS, if the proposed rule is adopted and the MyoPro is Reimburse by CMS on a lump sum basis, the working capital required to grow our business to a level that supports cash flow breakeven is expected to be less than if the MyoPro were reimbursed as a rental. The reason for that is because under the proposed rule, we wouldn't have to wait 13 months to be Turning now to our Q2 financial results. Total revenue for the Q2 of 2023 was $6,000,000 That includes revenue from the payment of the remaining initial license fee by our joint venture partner in China. As a result, total revenue was up 62% compared with the prior year quarter. Excluding that payment, product revenue of $4,200,000 increased 15% year over year. Speaker 400:10:44This growth was driven by a higher number of revenue units, offset by a lower average selling price or ASP. We recognized revenue on 97 units in the quarter, which was an increase of 21% over the prior year. ASP was approximately $43,700 down 5% from the prior year due to payer and channel mix. The direct billing channel represented 79% of revenue in the 2nd quarter compared with 83% in the prior year quarter. International revenue represented 12% of product revenue in the 2nd quarter. Speaker 400:11:21The remaining 9% of revenue was from the VA and domestic O and P channels. Backlog represents insurance authorizations and orders received have not yet converted to revenue. Our backlog at the end of Q2 2020 We received 125 authorizations and orders for MyoPro's during the 2nd quarter, an increase of 23% compared with the prior year quarter. Our patient pipeline increased to 9 69 candidates at the close of the 2nd quarter, up 27% from the year ago quarter. This result of which has been revised to reflect only known payers. Speaker 400:12:07408 patients were added to our pipeline during the Q2, an increase of 28% over the prior year. The year ago pipeline additions have also been revised to reflect only known payers. Gross margin for the Q2 of 23 was 71.8 percent compared to 65.3% for the prior year quarter. Excluding the impact of the license revenue, Gross margin on product revenue was 60.5%, a decrease of nearly 500 basis points compared with the prior year quarter. The decrease was due to a lower ASP and higher inventory and warranty reserves. Speaker 400:12:46Operating expenses for the Q2 of 2023 were 5 $400,000 an increase of 2% compared with the Q2 of 2022. The modest increase was driven primarily by A higher incentive compensation accrual offset by lower advertising expenses, which decreased 18% compared with the prior year quarter. We're on pace to spend roughly $1,000,000 less on advertising in 2023 versus 2022, which is part of the $2,000,000 in annual OpEx Savings we're expecting for the year. Our cost per pipeline add decreased to $2,074 which is down 57% compared with the prior year quarter. As a result of the license revenue, operating loss for the Q2 of 2023 was $1,100,000 compared with an operating loss of $2,900,000 for the Q2 of 2022. Speaker 400:13:42Net loss for the Q2 of 2023 was $1,000,000 or $0.04 per share. This compares with a net loss of $2,900,000 or 0.4 $0.02 per share for the Q2 of 2022. Note that the $6,800,000 pre funded warrants issued in our January 2020 These three offerings are considered common stock equivalents under GAAP and are included in our weighted average shares outstanding. None of the pre funded warrants have been exercised as of today. Adjusted EBITDA for the Q2 of 2023 was a negative Speaker 300:14:17$800,000 compared Speaker 400:14:17with a negative $2,500,000 for the Q2 of 2022. To summarize our year to date results, Revenue for the 1st 6 months ended June 30, 2023 was $9,400,000 up 25% compared with Same period a year ago, while year to date product revenue of $7,700,000 was up 17%. Year to date gross margin was 70.1% compared with 66.0 percent in the year ago period. Year to date gross margin on product sales for Q2 of 2023 of 63.4%. Operating expenses for the first half of twenty twenty three were $10,400,000 a decrease of 2% compared with the same period a year ago. Speaker 400:15:05Operating loss for the 1st 6 months of 2023 was $3,800,000 compared with an operating loss of $5,600,000 for the same period a year ago. Net loss for the 1st 6 months of 2023 was 3,700,000 or $0.14 per share compared with a net loss of $5,700,000 or 0.83 percent per share for the same period a year ago. Adjusted EBITDA was a negative $3,200,000 for the 6 months 1st 6 months of 2023 compared to the negative $4,900,000 in the year ago period. Turning to our cash position. Cash, cash equivalents and short term investments as of June 30, 2023 for $9,000,000 Cash used in operating activities was $300,000 for the Q2 of 2023 compared with $2,600,000 for the prior year quarter. Speaker 400:15:57The reduction was driven by the license payment and cash generated by changes in working capital, primarily due to an increase in incentive compensation liabilities. Looking ahead, while our backlog entering the 3rd Quarter is higher compared with the prior year quarter and is slightly higher sequentially, the potential ASP in the backlog was lower due to payer mix. As a result, we believe that slight year over year revenue growth is attainable, while sequential revenue growth will be challenging. Our ability to deliver product revenue in 2023 that meets our target of 20% to 30% year over year growth will depend on the number of insurance authorizations and orders we've received over the next few months. With that financial overview, I'll turn the call back to Paul. Speaker 200:16:45Thanks, Dave. Well, I hope we've conveyed our readiness to spring into action once Medicare Part B becomes a reality for us, while continuing to demonstrate excellent progress with the business in the meantime. So with that overview, we're now ready to take your questions. Operator? Operator00:17:03We will now begin the question and answer session. The first question comes from Ben Haynor of Alliance Global Partners. Please go ahead. Speaker 500:17:26Good afternoon, gentlemen. Thanks for taking the questions and congrats on the development over at CMS. First off for me, if I do the math correctly, it looks like the pipeline drops improved pretty impressively from The prior quarter, is there anything that you attribute that to? Is it just noise? Is it an improvement And the metrics from the virtual waiting room that you implemented or what would you ascribe that to? Speaker 200:17:59Well, Ben, thanks for your comments. Within our department of patient advocacy, we now have a role called patient navigator, and These individuals are working with these patients, following up with their physicians, therapists, acquiring the necessary medical documentation. I think that increased engagement with these patients is paying off by having more patients continue to go through the process to obtain their MyoPro. Speaker 500:18:29Okay. Got it. Sounds interesting. And then on the 30 Medicare Part B patients you've added to the Line, are those kind of like newly acquired patients or are you kind of reactivating some folks that You may have contacted you in previous periods and expressed interest in the MyoPro. Speaker 200:18:54Yes. Most of these are new prospects that contact us because with our advertising, we get a lot of calls Or the forms get filled out on our website. And we typically have hundreds of Medicare Part B patients that contact us. And in the past, We've had to put them on hold saying we'll give you an update when we have more information from CMS for coverage. But now we can tell these patients, if you're interested, let's do a telehealth screening, go to your physician, get a Written orders so that when we do get coverage by Medicare, we can start to service. Speaker 200:19:34So these patients are contacting us every month, and now We can start to build this pipeline in anticipation of being put into the correct benefit category. Speaker 400:19:47And to be clear, the patients that are in the Medicare pipeline, that's separate from the 9 Speaker 500:20:06Is that something you intend to break out in the future? Or will that kind of come together as Hopefully, this benefit category change occurs. Speaker 400:20:17Yes. Well, it will come together eventually, but for now yes, sorry. It will come together potentially, but for now, we'll keep it separate. Speaker 200:20:26Yes. That's right. Eventually Medicare Part B becomes another good payer like the other Speaker 500:20:35Okay, perfect. And then lastly for me, kind of a clarification. You mentioned the 300,000 in Orders for the MARC clinical units and maybe I missed this. Did those ship in Q2 or is that something that's going to occur Later this year or has occurred in Q3? Speaker 400:20:54That will occur during the second half of this year. Operator00:21:05The next question comes from Scott Henry of ROTH Capital. Please go ahead. Speaker 600:21:10Thank you and good afternoon. I think I'm just going to dig in a little deeper on the CMS situation to get a better understanding of exactly what it means and I guess for starters, when if you convert CMS to being a lump sum Payment versus rental over a period of time, do you expect the total amount To be significantly higher, the same, I wouldn't expect it to be less, but How should we think about that amount and when will we know and do you have a sense of what direction that amount will be? Speaker 400:21:54I wouldn't I mean, it all depends on the fee that they charge. But just speaking in general terms, there is Roughly 5% adder that the D and E MAX will apply to cap payments to account for that time value of money as compared to paying on a lump sum basis. But However, under Medicare rules, you're not allowed to bill the patient For a rental, if the patient for whatever reason isn't using it. And so there could be situations if we were a rental where Patient could have a health event or something like that and then they wouldn't use they would stop using the MyoPro and we couldn't bill for it. And in that particular case, you could be in a situation where you couldn't get your entire 13 months of rental payments. Speaker 400:22:53So I think overall, if you look at it qualitatively, I think lump sum is better financially obviously for us Then being reimbursed on a cap level basis. Speaker 600:23:06Okay. So it sounds like conceptually it's the same, but significantly better terms. Is there a way to get higher payments from this process? Or is that something over time or sometimes they go lower over time? Just trying to get Speaker 400:23:23a sense about that. Yes. Our expectation would be The fee that Medicare ultimately sets is going to be lower than our ASP now. How much lower, we have no idea. That's other than that, anything else that would be just pure speculation on that part. Speaker 600:23:43Okay. All right. That's fair. Now, What is the difference between L8701 and L8702? Speaker 200:23:53L8702. 200 bottles? Got it. L-eight thousand seven hundred and one is the MyoPro W, which is just the elbow and the wrist. L-eight thousand seven hundred and two is the elbow, wrist and the hand, the grasp unit. Speaker 200:24:10So that is reimbursed at a higher rate. Speaker 600:24:13Okay. Excellent. Now the other question I had is, obviously, you're going through the CMS path And 1 Avenue, but you're also talking to the DME MAX. Are those separate Processes or how do those two events tie together? Speaker 200:24:37Yes. Well, the linked in The DME MAC contractors, these medical directors basically worked for CMS. Our CMS staff directed us to go meet with the medical directors, which we did in April, presenting new research That is in the process of being published from our patient registry of several clinical studies showing the value of the device for Medicare age population. And the CMS takes those recommendations from the DME MAC medical directors in making their assessment of whether to cover the device or not. So it's an integral part of the process and we had a good meeting in April. Speaker 200:25:18And then in June, CMS came out with this rule that says There's value in power devices and these should be included in the brace category, which is a covered benefit category. Speaker 600:25:32Okay. So those 6 specific filed claims, can they get paid out before as rental or do they wait in the Q until all of this plays out at the end of the year. Speaker 200:25:47Yes, we're not sure. We filed those claims with Speaker 400:25:50the medical documentation. Speaker 200:25:53They might start getting paid now, perhaps as a rental. And then When CMS puts out the rule and pricing as a lump sum, they may shift at that point. I don't know until we see what happens on those, Scott. Speaker 600:26:08Okay. Yes, there's a lot of moving parts, so I'm Just trying to understand it all. And then as far as timeline, I mean it sounds like let's say they publish this At the end of 2023, when does the spigot get opened up? When can you start getting patients in this category. Speaker 200:26:32Yes. So they have no specific time line, but if they do publish the rule by the end of the year, it's Combined with the home health rule, which usually is, it could go effective by January 1, Probably at the earliest. Then the question is, when do they publish an allowable fee? Now typically what CMS does is they have these meetings twice a year, In the meeting agenda, a couple of weeks ahead of the meeting, the meeting probably takes place at the end of November, early December. Should they publish a price, we'll be able to comment on it as well as others can. Speaker 200:27:17And then they can make their decision to Publish it in the alphanumeric code set and it could go effective January 1 or it could be effective 90 days later with the next quarterly updates. Speaker 600:27:31Okay. All right. So this is something we'll continue to track. And I guess my understanding is The benefit is among seniors, it potentially doubles the market Without any additional effort from you from a selling perspective, so it brings some economies to the business model. Is Is that a fair way to think about it? Speaker 200:27:59Yes, that's a good way to look at it because again the advertising, the other lead generation activities we're doing He's already encouraging those Part B patients to contact us. So there's no additional advertising cost. There is other cost though To follow-up with these patients, talk to their physicians, gather their medical documentation because you have to have that in place to be able to fit these patients. The other side benefit to this is many other commercial plans will often follow what Medicare does. And also Medicare Advantage plans, some plans pay for the MyoPro today, others don't or require us to go through an appeals process. Speaker 200:28:44If it's covered by Part B, they will be required by law to also cover the MyoPro. So other Medicare Advantage seniors We'll have access to the MyoPro for the first time. So it's a significant increase in our addressable market. Speaker 600:28:58Okay, great. That should do it for me. Congratulations on that progress and thank you for taking the time to walk through it. Speaker 200:29:07Thanks Scott. Operator00:29:09The next question comes from Anthony Vendetti from Maxim Group. Please go ahead. Speaker 700:29:15Thank you. So at the end of the second quarter or right at How many sales reps do you have right now? Speaker 200:29:26Well, we don't have sales reps as you might think of, Anthony, for like Like an implantable medical device. So we have a call center, about 10 people based in Texas, Following up with prospects or family members that contact us. And then we have another 10 certified process orthodists, these are clinical professionals, licensed professionals around the country, we then follow-up with the patients to conduct evaluations, to measure them, fit them when we get an authorization. So we don't have the typical Salesforce that you might think of at a bought by a Boston Scientific device type company. Speaker 700:30:09So these 10 people that are at the call centers and the 10 orthotists, Are they full time employees or 1099s or how does that work? Speaker 200:30:21They're full time employees. Speaker 400:30:23Okay. Speaker 700:30:26Were any of them added during the Q2 or is this is you're already staffed for the anticipated ramp this year? Speaker 200:30:37We added 1 new certified prosthesis in the Midwest in the Q2. And so we're staffed So right now and also we believe that we can handle with this team an incremental volume increase for the Part B patients. But eventually, as the Part B volume ramps up, we'll have to add more clinicians in the field as well as more people in our customer experience department. Speaker 700:31:06Okay. Speaker 500:31:10So Speaker 700:31:12Maybe you sort of answered this, but maybe give what's your anticipated timeline in terms of hearing back From the MAX on the timeline for in terms of Speaker 200:31:32When Speaker 700:31:34the brace will be sort of approved for reimbursement as a brace? Speaker 200:31:41Yes, so good question. So right now, the proposed rule was published at the end of June. There's a 60 day comment period, so we're going to file comments as well as others in the industry, physicians, patient groups And so on. That closes August 29. Then CMS staff, Medicare staff will review those comments And then they could issue a final rulemaking anytime after that. Speaker 200:32:09So it could happen this fall, although They may push that out, but we are hoping that they will do it this fall. And then as far as publishing the fee, As I mentioned to the earlier question, they will usually publish a proposed fee And the CICPIC's semiannual agenda and then after comments on that, that fee could go live As early as January 1, but it could be sometime in 2024. Speaker 700:32:43Okay. So if things go well, They will review it after the comment period on August 29. They will come up with a proposed fee in the fall, which could go Live 1onetwenty 4, but if not, 1onetwenty 4, then hopefully sometime in 2024. Speaker 200:33:04Yes, that's correct. Speaker 700:33:07Okay. All right, great. I will hop back in Speaker 200:33:10the queue. Thank you. Operator00:33:15The next question comes from Edward Speaker 300:33:20Congratulations on the quarter. Can you provide some comments on how your European business is doing? Is it doing as well as the U. S. Business? Speaker 300:33:28And have you guys thought about expanding outside of Germany? Speaker 200:33:34The international business is growing. As Dave reported, it's 12% of our revenues. Now we've been adding business development managers and a few clinical trainers in Germany. We have about 100 orthotics and prosthetics clinics that have signed on to distribute the MyoPro in Germany. We focused on Germany because We're making good progress on reimbursement with the payers, statutory health insurance coverage there. Speaker 200:34:06If we have to appeal a denial, we're getting good responses from the social courts in Germany That are directing the payers to pay for the MyoPro. Our advertising approach there using social media has been gaining traction We decided to focus in Germany because again it's a large market, over 80,000,000 population, good reimbursement, a lot of Need there as well. So rather than make the investment in opening up other markets, we should take 2 to 3 years to get reimbursement, get Distribution channel going, we said let's double down and bring the MyoPro to more patients in Germany. Speaker 400:34:49Yes. The other geography we're seeing benefit to is Australia. It's certainly not as large as Germany that we're having We're starting to have patients approved through the National Disability Insurance Scheme In Australia, now for the first time. So I think that has an opportunity to channel partner in Australia that we work with. And so there's the opportunity there To see more revenue out of that geography as well. Speaker 300:35:26That sounds good. Are you guys in Canada at all? Speaker 200:35:31We have a medical device license to distribute in Canada. We signed up a couple of O and P clinics there. So no orders in there yet, but I know we have a couple of patients in the O and P pipeline there. Speaker 300:35:54I would say Dave doesn't move too far from the border. You should send him over one of these days. That's all the questions I have. Thank you. Speaker 400:36:02Thanks, Ed. Operator00:36:05This concludes our question and answer session. I would like to turn the conference back over to Paul Gudonis for closing remarks. Speaker 200:36:13Well, thanks, operator. I just want to mention everyone we're available through virtual and in person investor meetings. So please contact LHA Investor Relations to set up the time and of course, we'll keep you informed of developments at CMS, our status for the Medicare Part B patients. And just before we sign off, I want to remind you that we're very excited about My Oil's future beyond the Medicare opportunity we discussed today. We've got a compelling proven advanced technology product that addresses a large market opportunity. Speaker 200:36:44As you see, we are improving our operational Efficiencies across the board with the pipeline revenue growth and managing our operating expenses. Our international sales are growing as we discussed. We by the ongoing contribution from our joint venture in China, and we continue to innovate in product design and business processes so we operate more efficiently as we scale the business. Well, thank you for your continued interest in Myomo, and have a good day, everyone. Operator00:37:12The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by Key Takeaways Myomo reported 62% total revenue growth in Q2 to $6.0 million (including a $1.7 million China JV license payment), with product revenue up 15% to $4.2 million on 97 units shipped (+21%) and 125 insurance authorizations/orders (+23%). Received the final $1.7 million license payment from its China joint venture and is now setting up manufacturing, supply chain and rehab-hospital distribution in Greater China, backed by a $10.75 million guaranteed minimum purchase of control units over the next 10 years. The CMS proposed rule would reclassify MyoPro as a covered powered brace with lump-sum Part B reimbursement and transitional pass-through, potentially expanding the addressable senior market by up to 50% and reducing working-capital needs versus rental payments. Patient pipeline grew 27% year-over-year to 969 medically qualified candidates, with cost per pipeline addition down 57% to $2,074, driven by targeted DTC marketing and focus on payers with established MyoPro reimbursement records. Myomo ended Q2 with $9.0 million in cash and short-term investments, is on track for $2 million in annual OpEx savings, and believes modest Q3 revenue growth and 20–30% full-year product revenue growth remain attainable pending new insurance authorizations. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallMyomo Q2 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Myomo Earnings HeadlinesInsider Buying: Thomas Kirk Acquires 50,000 Shares of Myomo Inc (MYO)May 14, 2025 | gurufocus.comEarnings call transcript: Myomo Q1 2025 reports strong revenue growth, stock dipsMay 9, 2025 | uk.investing.comTrump Exec Order 14179 is wealth “gift” to good Americans?Is President Trump’s Executive Order 14179… A secret way to restore wealth for good citizens? If you’ve suffered financial hardship…Our President may have solved everything.May 31, 2025 | Paradigm Press (Ad)Myomo Inc (MYO) Q1 2025 Earnings Call Highlights: Record Revenue Surge and Strategic InnovationsMay 8, 2025 | finance.yahoo.comMyomo outlines 2025 revenue target of $50M-$53M amid advancements in product and marketing strategiesMay 7, 2025 | msn.comMyomo, Inc. (MYO) Q1 2025 Earnings Call TranscriptMay 7, 2025 | seekingalpha.comSee More Myomo Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Myomo? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Myomo and other key companies, straight to your email. Email Address About MyomoMyomo (NYSEAMERICAN:MYO), a wearable medical robotics company, designs, develops, and produces myoelectric orthotics for people with neuromuscular disorders in the United States, China, Germany, and internationally. The company offers MyoPro, a myoelectric-controlled upper limb brace or orthosis product used for supporting a patient's weak or paralyzed arm to enable and improve functional activities of daily living. It also provides the MyoPro 2, including control technology, configuration software and user interface, and pop-out battery for extended use of the brace; and MyoPro2+ that comprises 3D printed orthotics capability, software enhancements, and a design for donning and doffing of the device. Its products are designed to help improve function in adults and adolescents with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury, and other neurological disorders. The company sells its products through various sales channels, including orthotics and prosthetics providers, the Veterans Administration, and its distributors. Myomo, Inc. was incorporated in 2004 and is headquartered in Boston, Massachusetts.View Myomo ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles e.l.f. 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There are 8 speakers on the call. Operator00:00:01Good afternoon, and welcome to the Myomo Second Quarter 2023 Earnings Conference Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Kim Golodetz. Operator00:00:36Please go ahead. Speaker 100:00:38Thank you, operator, and good afternoon, everyone. This This is Tim Golodetz with LHA. Welcome to the Myomo Second Quarter 2023 Conference Call. Earlier today, Myomo issued a news release announcing Financial results for the 3 months ended June 30, 2023. If you would like to be added to the company's e mail distribution list to receive future announcements, Please register on the company's website at myomo.com or call LHA at 212-838 3,777 and speak with Carolyn Curran. Speaker 100:01:13With me on today's call from Myomo are Paul Godonis, Chief Executive Officer and Dave Henry, Chief Financial Officer. Before we begin, I'd like to caution listeners that statements made during this conference call by management Other than historical facts are forward looking statements. The words anticipate, believe, estimate, expect, intend, Guidance, outlook, confidence, target, project and other similar expressions are typically used to identify such forward looking statements. These forward looking statements are not guarantees of future performance and may involve and are subject to risks and uncertainties and other that may affect Myomo's business, financial condition and operating results. These and additional risks, uncertainties and other factors are discussed In Myomo's filings with the Securities and Exchange Commission, including the Form 10 Q for the quarter ended June 30, 2023, and subsequent filings. Speaker 100:02:11Actual outcomes and results may differ materially from what's expressed in or implied by these forward looking statements. Except as required by law, Myomo undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after Speaker 200:02:29It is Speaker 100:02:29now my pleasure to turn the call over to Myomo's CEO, Paul Gudonis. Paul, please go ahead. Speaker 200:02:36Thanks, Kim. Good afternoon, everyone, and thanks for joining us. As we reported in our earnings press release, We had a very solid quarter with year over year growth in revenue and in all of our key operating metrics. More specifically, we continue to increase shipments of our We received the final license payment for our joint venture in China, which has enabled the launch of the business there. And most importantly, we had a significant positive development in I'll start by reviewing the operational highlights during Q2 from the front end of the pipeline through the delivery and revenue. Speaker 200:03:29Our direct to consumer marketing strategy of using TV advertising and social media to inform patients and family members about the MyoPro To restore movement in paralyzed arms is working very well. We added more than 400 medically qualified patients to the patient pipeline in the second And these candidates are all covered by insurance plans that have paid for MyoPro in the past. Earlier this year, we began focusing on payers that have a Track record of reimbursing for the MyoPro, resulting in what we believe is a higher quality pipeline than in the past, and we're building it more efficiently with the smaller staff this year. We obtained authorizations and orders for 125 devices during the quarter, which is up 23% from the year ago quarter. And with the shipments and payments we received, our product revenues were up 15% year over year. Speaker 200:04:23In addition to the strong revenue, we were paid the final installment of the China joint venture initial license fee of just over $1,700,000 Bringing our Q2 total revenue to $6,000,000 We've been working on this joint venture for several years now And with the COVID-nineteen pandemic winding down and the resumption of economic activity in China, our joint venture partners, We're now in the process of setting up manufacturing and sales operations to serve the Greater China market. With an estimated 14,000,000 people with paralyzed arms and 2,500,000 new strokes each year, China represents the world's largest market opportunity for the MyoPro. We have a joint venture project team that's assisting in preparing the manufacturing infrastructure, establishing the supply chain for components and engaging rehab hospitals for distribution of the MyoPro to patients. We sent a couple of our clinical specialists to China to We've also received a total of about $300,000 in orders for the clinical version of our product called the MobileArm Rehab Kit to be used for demos and training and for the MyoPro control system chips and software, which will be used in the initial production run by the JV. The MyoPro control system order represents the initial purchase commitment under the guaranteed minimum payment provision of the JV contract. Speaker 200:06:03And this contract provides for a total of $10,750,000 in MyoPro control unit purchases over the next 10 years. I also want to note that these components are manufactured in the U. S. And are IP states firmly with Myomo. And Then on June 30, the Centers For Medicare and Medicaid Services, known as CMS, issued a proposed rule that, if adopted, We reclassified the MyoPro as a covered benefit in the brace category with a lump sum payment. Speaker 200:06:34In addition, CMS stated its intention to This is a very significant development because it allows to serve patients in the U. S. We're covered by standard Medicare or Part B fee for service and would allow the MyoPro to be reimbursed on a lump sum basis The way all the other payers in the U. S. Currently pay for MyoPro. Speaker 200:06:58We currently provide the MyoPro to seniors with certain Medicare Advantage plans, Yes, half the seniors in the U. S. Are covered by Part B, so our addressable market is poised to increase substantially. For those of you who are new to Myomo, here's a quick summary on Medicare. In January 2019, CMS made unique product Bill and Co is referred to as HCPCS codes effective for the MyoPro. Speaker 200:07:24However, CMS classified the MyoPro As durable medical equipment or DME, which classified it as a device to pay on a monthly rental with coverage on a case by case basis. While this opened up the large Medicare Advantage patient population to us, our position has been that the MyoPro is a custom fabricated brace long term use and that it should be classified in this benefit category. Discussions with the CMS staff got delayed due to COVID, And then we were invited to make our case at the CMS public hearing in June of 2022. At that presentation, We made that presentation and we have follow-up meetings with the CMS staff and with the medical directors of the DME MACs, the Medicare Administrative Contractors. The most recent of these meetings was this past April, where we presented compelling new research about the patient outcomes and the value of the MyoPro to individuals of Medicare age. Speaker 200:08:22We are encouraged to file claims for Part B patients, so we've now fit 6 patients And submitted 6 claims for payment. These claims are under review at this time and it's unclear how the proposed rule that's now come out would affect the processing of these claims that were submitted to D and A Max before the publication of that proposed rule. So what's next? CMS is accepting public comments on this proposed rule until the end of August, and then they'll hold a public hearing on this topic as well as propose the allowable fee for While there's no specific time line for implementing the new rule or holding a public hearing, next hearing is usually in the fall And then coverage and pricing go into effect sometime after that. Although I'd love to have a definite answer for you at this time, The process of the MyoPro covered as a powered on race is closer than ever to the goal line. Speaker 200:09:16In the meantime, we're not sitting still Since many Part B patients contact us each month about a MyoPro for the paralyzed arm, we're proceeding to screen these patients for medical eligibility We're building a pipeline of Part B patients so that we can serve them after coverage and a fee are established. With that overview, I'll now turn Speaker 300:09:45Thank you, Paul, and good afternoon, everyone. Speaker 400:09:47To end the call's comments regarding coverage by CMS, if the proposed rule is adopted and the MyoPro is Reimburse by CMS on a lump sum basis, the working capital required to grow our business to a level that supports cash flow breakeven is expected to be less than if the MyoPro were reimbursed as a rental. The reason for that is because under the proposed rule, we wouldn't have to wait 13 months to be Turning now to our Q2 financial results. Total revenue for the Q2 of 2023 was $6,000,000 That includes revenue from the payment of the remaining initial license fee by our joint venture partner in China. As a result, total revenue was up 62% compared with the prior year quarter. Excluding that payment, product revenue of $4,200,000 increased 15% year over year. Speaker 400:10:44This growth was driven by a higher number of revenue units, offset by a lower average selling price or ASP. We recognized revenue on 97 units in the quarter, which was an increase of 21% over the prior year. ASP was approximately $43,700 down 5% from the prior year due to payer and channel mix. The direct billing channel represented 79% of revenue in the 2nd quarter compared with 83% in the prior year quarter. International revenue represented 12% of product revenue in the 2nd quarter. Speaker 400:11:21The remaining 9% of revenue was from the VA and domestic O and P channels. Backlog represents insurance authorizations and orders received have not yet converted to revenue. Our backlog at the end of Q2 2020 We received 125 authorizations and orders for MyoPro's during the 2nd quarter, an increase of 23% compared with the prior year quarter. Our patient pipeline increased to 9 69 candidates at the close of the 2nd quarter, up 27% from the year ago quarter. This result of which has been revised to reflect only known payers. Speaker 400:12:07408 patients were added to our pipeline during the Q2, an increase of 28% over the prior year. The year ago pipeline additions have also been revised to reflect only known payers. Gross margin for the Q2 of 23 was 71.8 percent compared to 65.3% for the prior year quarter. Excluding the impact of the license revenue, Gross margin on product revenue was 60.5%, a decrease of nearly 500 basis points compared with the prior year quarter. The decrease was due to a lower ASP and higher inventory and warranty reserves. Speaker 400:12:46Operating expenses for the Q2 of 2023 were 5 $400,000 an increase of 2% compared with the Q2 of 2022. The modest increase was driven primarily by A higher incentive compensation accrual offset by lower advertising expenses, which decreased 18% compared with the prior year quarter. We're on pace to spend roughly $1,000,000 less on advertising in 2023 versus 2022, which is part of the $2,000,000 in annual OpEx Savings we're expecting for the year. Our cost per pipeline add decreased to $2,074 which is down 57% compared with the prior year quarter. As a result of the license revenue, operating loss for the Q2 of 2023 was $1,100,000 compared with an operating loss of $2,900,000 for the Q2 of 2022. Speaker 400:13:42Net loss for the Q2 of 2023 was $1,000,000 or $0.04 per share. This compares with a net loss of $2,900,000 or 0.4 $0.02 per share for the Q2 of 2022. Note that the $6,800,000 pre funded warrants issued in our January 2020 These three offerings are considered common stock equivalents under GAAP and are included in our weighted average shares outstanding. None of the pre funded warrants have been exercised as of today. Adjusted EBITDA for the Q2 of 2023 was a negative Speaker 300:14:17$800,000 compared Speaker 400:14:17with a negative $2,500,000 for the Q2 of 2022. To summarize our year to date results, Revenue for the 1st 6 months ended June 30, 2023 was $9,400,000 up 25% compared with Same period a year ago, while year to date product revenue of $7,700,000 was up 17%. Year to date gross margin was 70.1% compared with 66.0 percent in the year ago period. Year to date gross margin on product sales for Q2 of 2023 of 63.4%. Operating expenses for the first half of twenty twenty three were $10,400,000 a decrease of 2% compared with the same period a year ago. Speaker 400:15:05Operating loss for the 1st 6 months of 2023 was $3,800,000 compared with an operating loss of $5,600,000 for the same period a year ago. Net loss for the 1st 6 months of 2023 was 3,700,000 or $0.14 per share compared with a net loss of $5,700,000 or 0.83 percent per share for the same period a year ago. Adjusted EBITDA was a negative $3,200,000 for the 6 months 1st 6 months of 2023 compared to the negative $4,900,000 in the year ago period. Turning to our cash position. Cash, cash equivalents and short term investments as of June 30, 2023 for $9,000,000 Cash used in operating activities was $300,000 for the Q2 of 2023 compared with $2,600,000 for the prior year quarter. Speaker 400:15:57The reduction was driven by the license payment and cash generated by changes in working capital, primarily due to an increase in incentive compensation liabilities. Looking ahead, while our backlog entering the 3rd Quarter is higher compared with the prior year quarter and is slightly higher sequentially, the potential ASP in the backlog was lower due to payer mix. As a result, we believe that slight year over year revenue growth is attainable, while sequential revenue growth will be challenging. Our ability to deliver product revenue in 2023 that meets our target of 20% to 30% year over year growth will depend on the number of insurance authorizations and orders we've received over the next few months. With that financial overview, I'll turn the call back to Paul. Speaker 200:16:45Thanks, Dave. Well, I hope we've conveyed our readiness to spring into action once Medicare Part B becomes a reality for us, while continuing to demonstrate excellent progress with the business in the meantime. So with that overview, we're now ready to take your questions. Operator? Operator00:17:03We will now begin the question and answer session. The first question comes from Ben Haynor of Alliance Global Partners. Please go ahead. Speaker 500:17:26Good afternoon, gentlemen. Thanks for taking the questions and congrats on the development over at CMS. First off for me, if I do the math correctly, it looks like the pipeline drops improved pretty impressively from The prior quarter, is there anything that you attribute that to? Is it just noise? Is it an improvement And the metrics from the virtual waiting room that you implemented or what would you ascribe that to? Speaker 200:17:59Well, Ben, thanks for your comments. Within our department of patient advocacy, we now have a role called patient navigator, and These individuals are working with these patients, following up with their physicians, therapists, acquiring the necessary medical documentation. I think that increased engagement with these patients is paying off by having more patients continue to go through the process to obtain their MyoPro. Speaker 500:18:29Okay. Got it. Sounds interesting. And then on the 30 Medicare Part B patients you've added to the Line, are those kind of like newly acquired patients or are you kind of reactivating some folks that You may have contacted you in previous periods and expressed interest in the MyoPro. Speaker 200:18:54Yes. Most of these are new prospects that contact us because with our advertising, we get a lot of calls Or the forms get filled out on our website. And we typically have hundreds of Medicare Part B patients that contact us. And in the past, We've had to put them on hold saying we'll give you an update when we have more information from CMS for coverage. But now we can tell these patients, if you're interested, let's do a telehealth screening, go to your physician, get a Written orders so that when we do get coverage by Medicare, we can start to service. Speaker 200:19:34So these patients are contacting us every month, and now We can start to build this pipeline in anticipation of being put into the correct benefit category. Speaker 400:19:47And to be clear, the patients that are in the Medicare pipeline, that's separate from the 9 Speaker 500:20:06Is that something you intend to break out in the future? Or will that kind of come together as Hopefully, this benefit category change occurs. Speaker 400:20:17Yes. Well, it will come together eventually, but for now yes, sorry. It will come together potentially, but for now, we'll keep it separate. Speaker 200:20:26Yes. That's right. Eventually Medicare Part B becomes another good payer like the other Speaker 500:20:35Okay, perfect. And then lastly for me, kind of a clarification. You mentioned the 300,000 in Orders for the MARC clinical units and maybe I missed this. Did those ship in Q2 or is that something that's going to occur Later this year or has occurred in Q3? Speaker 400:20:54That will occur during the second half of this year. Operator00:21:05The next question comes from Scott Henry of ROTH Capital. Please go ahead. Speaker 600:21:10Thank you and good afternoon. I think I'm just going to dig in a little deeper on the CMS situation to get a better understanding of exactly what it means and I guess for starters, when if you convert CMS to being a lump sum Payment versus rental over a period of time, do you expect the total amount To be significantly higher, the same, I wouldn't expect it to be less, but How should we think about that amount and when will we know and do you have a sense of what direction that amount will be? Speaker 400:21:54I wouldn't I mean, it all depends on the fee that they charge. But just speaking in general terms, there is Roughly 5% adder that the D and E MAX will apply to cap payments to account for that time value of money as compared to paying on a lump sum basis. But However, under Medicare rules, you're not allowed to bill the patient For a rental, if the patient for whatever reason isn't using it. And so there could be situations if we were a rental where Patient could have a health event or something like that and then they wouldn't use they would stop using the MyoPro and we couldn't bill for it. And in that particular case, you could be in a situation where you couldn't get your entire 13 months of rental payments. Speaker 400:22:53So I think overall, if you look at it qualitatively, I think lump sum is better financially obviously for us Then being reimbursed on a cap level basis. Speaker 600:23:06Okay. So it sounds like conceptually it's the same, but significantly better terms. Is there a way to get higher payments from this process? Or is that something over time or sometimes they go lower over time? Just trying to get Speaker 400:23:23a sense about that. Yes. Our expectation would be The fee that Medicare ultimately sets is going to be lower than our ASP now. How much lower, we have no idea. That's other than that, anything else that would be just pure speculation on that part. Speaker 600:23:43Okay. All right. That's fair. Now, What is the difference between L8701 and L8702? Speaker 200:23:53L8702. 200 bottles? Got it. L-eight thousand seven hundred and one is the MyoPro W, which is just the elbow and the wrist. L-eight thousand seven hundred and two is the elbow, wrist and the hand, the grasp unit. Speaker 200:24:10So that is reimbursed at a higher rate. Speaker 600:24:13Okay. Excellent. Now the other question I had is, obviously, you're going through the CMS path And 1 Avenue, but you're also talking to the DME MAX. Are those separate Processes or how do those two events tie together? Speaker 200:24:37Yes. Well, the linked in The DME MAC contractors, these medical directors basically worked for CMS. Our CMS staff directed us to go meet with the medical directors, which we did in April, presenting new research That is in the process of being published from our patient registry of several clinical studies showing the value of the device for Medicare age population. And the CMS takes those recommendations from the DME MAC medical directors in making their assessment of whether to cover the device or not. So it's an integral part of the process and we had a good meeting in April. Speaker 200:25:18And then in June, CMS came out with this rule that says There's value in power devices and these should be included in the brace category, which is a covered benefit category. Speaker 600:25:32Okay. So those 6 specific filed claims, can they get paid out before as rental or do they wait in the Q until all of this plays out at the end of the year. Speaker 200:25:47Yes, we're not sure. We filed those claims with Speaker 400:25:50the medical documentation. Speaker 200:25:53They might start getting paid now, perhaps as a rental. And then When CMS puts out the rule and pricing as a lump sum, they may shift at that point. I don't know until we see what happens on those, Scott. Speaker 600:26:08Okay. Yes, there's a lot of moving parts, so I'm Just trying to understand it all. And then as far as timeline, I mean it sounds like let's say they publish this At the end of 2023, when does the spigot get opened up? When can you start getting patients in this category. Speaker 200:26:32Yes. So they have no specific time line, but if they do publish the rule by the end of the year, it's Combined with the home health rule, which usually is, it could go effective by January 1, Probably at the earliest. Then the question is, when do they publish an allowable fee? Now typically what CMS does is they have these meetings twice a year, In the meeting agenda, a couple of weeks ahead of the meeting, the meeting probably takes place at the end of November, early December. Should they publish a price, we'll be able to comment on it as well as others can. Speaker 200:27:17And then they can make their decision to Publish it in the alphanumeric code set and it could go effective January 1 or it could be effective 90 days later with the next quarterly updates. Speaker 600:27:31Okay. All right. So this is something we'll continue to track. And I guess my understanding is The benefit is among seniors, it potentially doubles the market Without any additional effort from you from a selling perspective, so it brings some economies to the business model. Is Is that a fair way to think about it? Speaker 200:27:59Yes, that's a good way to look at it because again the advertising, the other lead generation activities we're doing He's already encouraging those Part B patients to contact us. So there's no additional advertising cost. There is other cost though To follow-up with these patients, talk to their physicians, gather their medical documentation because you have to have that in place to be able to fit these patients. The other side benefit to this is many other commercial plans will often follow what Medicare does. And also Medicare Advantage plans, some plans pay for the MyoPro today, others don't or require us to go through an appeals process. Speaker 200:28:44If it's covered by Part B, they will be required by law to also cover the MyoPro. So other Medicare Advantage seniors We'll have access to the MyoPro for the first time. So it's a significant increase in our addressable market. Speaker 600:28:58Okay, great. That should do it for me. Congratulations on that progress and thank you for taking the time to walk through it. Speaker 200:29:07Thanks Scott. Operator00:29:09The next question comes from Anthony Vendetti from Maxim Group. Please go ahead. Speaker 700:29:15Thank you. So at the end of the second quarter or right at How many sales reps do you have right now? Speaker 200:29:26Well, we don't have sales reps as you might think of, Anthony, for like Like an implantable medical device. So we have a call center, about 10 people based in Texas, Following up with prospects or family members that contact us. And then we have another 10 certified process orthodists, these are clinical professionals, licensed professionals around the country, we then follow-up with the patients to conduct evaluations, to measure them, fit them when we get an authorization. So we don't have the typical Salesforce that you might think of at a bought by a Boston Scientific device type company. Speaker 700:30:09So these 10 people that are at the call centers and the 10 orthotists, Are they full time employees or 1099s or how does that work? Speaker 200:30:21They're full time employees. Speaker 400:30:23Okay. Speaker 700:30:26Were any of them added during the Q2 or is this is you're already staffed for the anticipated ramp this year? Speaker 200:30:37We added 1 new certified prosthesis in the Midwest in the Q2. And so we're staffed So right now and also we believe that we can handle with this team an incremental volume increase for the Part B patients. But eventually, as the Part B volume ramps up, we'll have to add more clinicians in the field as well as more people in our customer experience department. Speaker 700:31:06Okay. Speaker 500:31:10So Speaker 700:31:12Maybe you sort of answered this, but maybe give what's your anticipated timeline in terms of hearing back From the MAX on the timeline for in terms of Speaker 200:31:32When Speaker 700:31:34the brace will be sort of approved for reimbursement as a brace? Speaker 200:31:41Yes, so good question. So right now, the proposed rule was published at the end of June. There's a 60 day comment period, so we're going to file comments as well as others in the industry, physicians, patient groups And so on. That closes August 29. Then CMS staff, Medicare staff will review those comments And then they could issue a final rulemaking anytime after that. Speaker 200:32:09So it could happen this fall, although They may push that out, but we are hoping that they will do it this fall. And then as far as publishing the fee, As I mentioned to the earlier question, they will usually publish a proposed fee And the CICPIC's semiannual agenda and then after comments on that, that fee could go live As early as January 1, but it could be sometime in 2024. Speaker 700:32:43Okay. So if things go well, They will review it after the comment period on August 29. They will come up with a proposed fee in the fall, which could go Live 1onetwenty 4, but if not, 1onetwenty 4, then hopefully sometime in 2024. Speaker 200:33:04Yes, that's correct. Speaker 700:33:07Okay. All right, great. I will hop back in Speaker 200:33:10the queue. Thank you. Operator00:33:15The next question comes from Edward Speaker 300:33:20Congratulations on the quarter. Can you provide some comments on how your European business is doing? Is it doing as well as the U. S. Business? Speaker 300:33:28And have you guys thought about expanding outside of Germany? Speaker 200:33:34The international business is growing. As Dave reported, it's 12% of our revenues. Now we've been adding business development managers and a few clinical trainers in Germany. We have about 100 orthotics and prosthetics clinics that have signed on to distribute the MyoPro in Germany. We focused on Germany because We're making good progress on reimbursement with the payers, statutory health insurance coverage there. Speaker 200:34:06If we have to appeal a denial, we're getting good responses from the social courts in Germany That are directing the payers to pay for the MyoPro. Our advertising approach there using social media has been gaining traction We decided to focus in Germany because again it's a large market, over 80,000,000 population, good reimbursement, a lot of Need there as well. So rather than make the investment in opening up other markets, we should take 2 to 3 years to get reimbursement, get Distribution channel going, we said let's double down and bring the MyoPro to more patients in Germany. Speaker 400:34:49Yes. The other geography we're seeing benefit to is Australia. It's certainly not as large as Germany that we're having We're starting to have patients approved through the National Disability Insurance Scheme In Australia, now for the first time. So I think that has an opportunity to channel partner in Australia that we work with. And so there's the opportunity there To see more revenue out of that geography as well. Speaker 300:35:26That sounds good. Are you guys in Canada at all? Speaker 200:35:31We have a medical device license to distribute in Canada. We signed up a couple of O and P clinics there. So no orders in there yet, but I know we have a couple of patients in the O and P pipeline there. Speaker 300:35:54I would say Dave doesn't move too far from the border. You should send him over one of these days. That's all the questions I have. Thank you. Speaker 400:36:02Thanks, Ed. Operator00:36:05This concludes our question and answer session. I would like to turn the conference back over to Paul Gudonis for closing remarks. Speaker 200:36:13Well, thanks, operator. I just want to mention everyone we're available through virtual and in person investor meetings. So please contact LHA Investor Relations to set up the time and of course, we'll keep you informed of developments at CMS, our status for the Medicare Part B patients. And just before we sign off, I want to remind you that we're very excited about My Oil's future beyond the Medicare opportunity we discussed today. We've got a compelling proven advanced technology product that addresses a large market opportunity. Speaker 200:36:44As you see, we are improving our operational Efficiencies across the board with the pipeline revenue growth and managing our operating expenses. Our international sales are growing as we discussed. We by the ongoing contribution from our joint venture in China, and we continue to innovate in product design and business processes so we operate more efficiently as we scale the business. Well, thank you for your continued interest in Myomo, and have a good day, everyone. Operator00:37:12The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by