Myomo Inc

F:0M61

Earnings Call Analysis

Myomo Expects Significant Growth in 2024

Myomo achieved a milestone as CMS finalized MyoPro's pricing effective April 1, with reimbursements set at $65,871.74 and $33,480.90 for its main models, exceeding previous proposals. The backlog grew 40% year-over-year to a record 230 patients, driving a record 183 authorizations and orders in Q4, up 87%. Full year revenue reached $19.2 million, a 24% increase, while operating expenses saw a minimal rise of 2%. The gross margin improved to 68.5% in 2023 from 65.9% in 2022. Cash and investments were $8.9 million at year-end, with cash sufficient for the next year after a January 2024 offering. Projections for 2024 include a revenue range of $28 million to $30 million, marking up to 56% growth, and achieving operational cash flow breakeven by Q4.

Introduction to Myomo's Operations and CMS Pricing Announcement

The call, led by executives of Myomo, a medical robotics company, centers around the announcement of finalized pricing for the MyoPro product line by Centers for Medicare and Medicaid Services (CMS), effective April 2023. The announced prices for two primary MyoPro models, with the Model G billed at $65,872 and Model W at $33,481, are slightly above prior proposals, signalling a strong reimbursement rate from Medicare Part B. The company highlighted the significance of the CMS ruling, marking a transformational point that promises enhanced access for patients with arm paralysis and has spurred a rapid increase in patient pipeline and backlog, suggesting growth potential for Myomo in the Medicare space.

Review of Fiscal Performance

Financially, Myomo achieved a substantial rise in revenue, recording over $19 million for 2023, which represents a 20% year-over-year growth in product revenues. This increase is attributed to a combination of a higher average selling price (ASP) and a boost in the volume of units sold, particularly through direct billing channels and internationally, with ASP experiencing an 11% rise from the previous year. Meanwhile, operating expenses for Q4 of 2023 increased by 14% due to augmented research and productivity investment, offset by a decline in advertising spend.

Financials and Guidance for 2024

Myomo's gross margin rested at 65.3% for Q4 2023, with an increase in ASP being a primary driver. For the upcoming fiscal year, the company has guided towards aggressive revenue growth, targeting $28 to $30 million, which would be a 46% to 56% improvement over 2023. This estimate is bolstered by the company's expanded Medicare Part B accessibility. However, they also anticipate initial gross margin pressure as they ramp up service delivery to Medicare patients, with general recovery expected in the latter half of 2024. Notably, the cash position at the year-end was robust, pro forma with subsequent funding at $14.3 million, considered sufficient for at least the next 12 months.

Investing in Growth and Innovation

Myomo is planning to enhance its workforce by 50 to 60 new hires to support the surge in market opportunity, specifically targeting an expansion in clinical, reimbursement, and manufacturing capacities. Furthermore, Myomo is focusing on raising R&D spending and product support, acknowledging the likelihood of new competition following CMS’s pricing publication. Strengthening their patent portfolio and maintaining their leadership status is also on the business agenda. This proactive approach in building capacity and shoring up innovation is key as Myomo anticipates ramped demand from the Medicare Part B segment.

Earnings Call Transcript 2023-Q4

[Operator]

Good day, and welcome to the Myomo Fourth Quarter 2023 Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Kim Golodetz. Please go ahead.

[Kim Golodetz]

Thank you, operator, and good afternoon, everyone. This is Kim Golodetz with LHA. Welcome to the Myomo Fourth Quarter 2023 Conference Call. Earlier this afternoon, Myomo issued a news release announcing financial results for the 3 months and year ended December 31, 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 [phone] and speak with Carolyn Curran. With me on today's call from Myomo are Paul Gudonis, 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 certain risks and uncertainties and other factors 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-K for the year ended December 31, 2023, and subsequent filings. Actual 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 the date of this call. It is now my pleasure to turn the call over to Myomo's CEO, Paul Gudonis. Paul, please go ahead.

[Paul Gudonis, executive]

Thanks, Kim. Well, good afternoon, everyone, and thank you for joining us. Since we announced some very positive developments with CMS last week, I'll start today's call by discussing the new MyoPro pricing for patients covered by Medicare Part B, then will review our operational results for the fourth quarter and calendar year 2023. Last week, the Centers for Medicare and Medicaid Services, or CMS, finalized the pricing for the MyoPro product line, which will let effect for deliveries as of April 1 of this year. We issued a press release on March 1 with details of the pricing and a link to the CMS document describing the rationale. The MyoPro Model G, which is coded as L8702, is to be reimbursed with a lump sum payment of $65,872(sic) [ $65871.74 ] and the MyoPro Model W, which is coded as L8701, is to be reimbursed as a lump sum payment of $33,481(sic) [ $33,480.90 ]. The Model G, which includes the elbow, wrist, and grasp function represents more than 90% of our unit volume for sales directly to patients and to orthotics and prosthetics clinics. These amounts are slightly higher than what CMS proposed back in November as they added the Medicare inflation factor for the current year into calculations. These amounts are the average fee to be paid by Medicare for MyoPro and CMS will publish a more detailed fee schedule that describes the pricing for various state locations based on local cost factors.

It's been a long journey to reach this point where we can serve patients with arm paralysis who are covered by Medicare Part B health insurance, and we're delighted that we've arrived. Achieving this milestone is a transformational mole for patients and the company and opens up a new world for these stroke survivors and others who have been told will never be able to use their arm or hand again for the rest of your life. We testified at the CMS public hearing in June 2022 that the MyoPro should be correctly classified in the brace category and not as a durable medical equipment rental item like a wheelchair. And after a rule-making procedure, CMS agreed with us and announced in 2023 that the MyoPro, as a custom fabricated brace for long-term use in the home, should be included in the expanded definition of the brace category.

A year ago, we met with the DME MAC Medical Directors and shared our research about the valuable outcomes that were achieved by Medicare H beneficiaries, and we were encouraged to deliver MyoPros to this population and then submit claims. To date, we've had over 20 claims paid by Medicare, some is in rental. The rest is lump sum from deliveries after January 1, where the patient's physician has ordered the device; and where medical necessity for the MyoPro has been established. This was the first time that Medicare paid for MyoPro braces for seniors with standard Part B coverage. And while some of these payments from several regional MACs is significantly less than the new fee, we expect to be paid the correct amount for new deliveries after April 1.

Then in November 2023, CMS published its proposed pricing for the MyoPro billing codes as part of it's semiannual HCPCS public meeting, and last week's publication of the finalized Cs is the culmination of this process so we can confidently go forward to meet the medical needs of Part B patient population. We commend CMS in making these readily available to seniors with Part B coverage; as it's also a major step towards the goal of health equity. So during the fourth quarter, we could tell Part B patient candidates that they were eligible for MyoPro if they were medically qualified and had a doctor's order with supporting medical documentation to warrant a MyoPro arm brace. We began shifting our clinical resources to evaluate and engage with these candidates and have approximately 150 Medicare Part B patients in our patient pipeline as of December 31, 2023. Overall, we grew our pipeline to more than 1,000 patients by the end of the year in our backlog, which includes Medicare Part B patients awaiting delivery of their device. [Indiscernible] 230 units, which is up 40% from the end of 2022. And with the Medicare Part B patients now eligible for MyoPro, we had a record 183 authorizations and orders in the fourth quarter, up 87% from the same period a year ago. And Dave Henry, our CFO, will go over the financial details in a few minutes.

When we entered 2023, we didn't know if and when Medicare reclassified the MyoPro as a powered arm brace. We didn't know if the medical directors would approve coverage for Part B beneficiaries, and we didn't know how much they would reimburse for the devices. So at that time, we decided to focus on reliable payers such as certain Medicare Advantage plans and reduce our cash burn during the year while waiting for these decisions. We took down our headcount by 12% early in the year and reduced our advertising expenses by nearly $1 million, and yet we still grew our product revenues by 20% year-over-year. We added license revenue from our China joint venture, and we cut our cash use in operations by nearly 40%, down to $6.2 million for the year from over $10 million in the year before. We delivered over 400 MyoPros to patients in the U.S., Germany and several international markets last year, and we became more efficient with our marketing, reducing the cost per pipeline add while operating with fewer staff members. Overall, we achieved more than $19 million in revenue in 2023, our 11th consecutive year of revenue growth. I'll now turn it over to Dave for a detailed financial review of the quarter and our 2024 outlook, and I'll come back to outline our operational plans for the rest of this year.

[David Henry, executive]

Thank you, Paul, and good afternoon to everyone. Let me start my remarks with a review of our fourth quarter financial results. Total revenue for the fourth quarter of 2023 was $4.8 million. This consists entirely of product revenue, which was up 18% over the prior year quarter. This growth was driven by a higher number of revenue units, which were up 6% over the 2022 fourth quarter and a higher average selling price or ASP. Revenue for the fourth quarter includes payments received on 7 Medicare Part B rental plan. Of the 107 rental units -- revenue units in the fourth quarter, approximately 32% resulted in fill, which is our term for authorizations received and orders converted to revenue in the same quarter. 65% of our revenue in the fourth quarter came from the direct billing channel compared with 73% in the same quarter a year ago. A record 23% of fourth quarter revenue came from international locations, primarily Germany. Of our direct billing revenues, 68% was from patients with payers where were able to recognize revenue delivery compared with 44% in the year ago quarter. ASP was approximately $44,500, up 11% on the prior year.

In the fourth quarter of 2023, we undertook efforts to fill the pipeline and backlog with Medicare Part B patients, particularly because effective on January 1, 2024, Medicare part B patients can be built on a lump sum basis. Reported backlog now represents insurance authorizations and orders received but not yet converted to revenue. And in the case of Medicare patients, those patients for whom we've collected medical records and de-qualify for delivery based on our inclusion criteria. Our backlog at the end of fourth quarter 2023 was a record 230 patients, which was up 40% from our backlog at the end of the fourth quarter of 2022. Fourth quarter backlog includes 44 Medicare Part B patients that have either been qualified for delivery with appropriate medical documentation, have received a MyoPro and claims have been filed that payments have not yet been received, or those have received the MyoPro and we're waiting and we're receiving continuing rental payments. These additional Part B patients added to the backlog contributed to a record 183 authorizations, orders and other additions to the backlog in the fourth quarter, which was up 87% over the prior year quarter.

As of today, approximately 40 claims have been filed with the DME MAC's and 21 have been paid, either in the form of continuing rental payments from claims filed before December 31, 2023, or lump sum payments for claims filed after January 1, 2024. Payments have been made by all 4 billing regions, remaining unpaid claims are under review by the DME MAC. Our patient pipeline increased to 1,042 candidates as of year-end 2023, up 18% from year-end 2022. 381 patients were added to our pipeline during the fourth quarter, an increase of 17% over the prior year. These pipeline additions included approximately 150 Medicare Part B patients. With our patient evaluation capacity in the fourth quarter, consistent with prior quarters, we prioritized adding Medicare Part B patients to the pipeline. We prioritize these patients because they can get converted to revenue faster than patients with Medicare Advantage and other commercial insurance plans because there is no preauthorization required to deliver a Medicare Part B beneficiary.

Gross margin for the fourth quarter of 2023 was 65.3% compared to 65% from the prior year quarter. The increase was driven primarily by a higher ASP, offset by some cost increases. Operating expenses for the fourth quarter of 2023 were $5.5 million, an increase of 14% compared with the fourth quarter of 2022. This increase was driven primarily by higher upside development spending to accelerate completion of certain sustaining engineering projects and higher incentive compensation accruals, offset by a 17% decline in advertising expense. Our cost per pipeline add was $2,246 which is down 16% compared with the prior year quarter. The operating loss for the fourth quarter of 2023 was $2.4 million compared with an operating loss of $2.2 million for the fourth quarter of 2022. Net loss for the fourth quarter of 2023 was $2.5 million, or $0.07 per share. This compares to the net loss of $2.2 million, or $0.29 per share, for the fourth quarter of 2022. Note that the $8.2 million prefunded warrants outstanding from our January and August 2023 offerings are considered common stock equivalents under GAAP and are included in our weighted average shares outstanding. Approximately 479,000 prefunded warrants were exercised during the fourth quarter.

Adjusted EBITDA for the fourth quarter of 2023 was a negative $2.1 million compared with a negative $1.9 million for the fourth quarter of 2022. To summarize our full year results, revenue for 2023 was $19.2 million, up 24% compared with 2022, while 2023 product revenue of $17.5 million was up 20%. Gross margin for 2023 was 68.5% compared with 65.9% for 2022. Gross margin on product sales for 2023 was 65.3% compared to 63.6% for 2022. Operating expenses for 2023 were $21.4 million, an increase of 2% compared with 2022. Operating loss for 2023 was $8.2 million compared with an operating loss of $10.7 million for 2022. Net loss for 2023 was $8.1 million, or $0.28 per share, compared to a net loss of $10.7 million, or $1.52 per share, for 2022. Adjusted EBITDA was a negative $7 million for 2023 compared with a negative $9.3 million for 2022.

Turning now to our cash position. Cash, cash equivalents and short-term investments, as of December 31, 2023, were $8.9 million. Cash used in operating activities was $2.4 million for the fourth quarter of 2023, unchanged from the fourth quarter of 2022. For the full year, cash used in operations was $6.2 million compared with $10.2 million in 2022. We completed a registered direct offering in January 2024, generating net proceeds to Myomo of approximately $5.4 million. Pro forma for the offering, our cash balance entering 2024 was $14.3 million, which we believe is sufficient to fund our operations for at least the next 12 months.

I'll close my comments with a review of our financial guidance. As Paul mentioned, on February 29, 2024, CMS published the final fees for our two billing codes, L8701 and L8702. We're grateful that we now have clarity on reimbursement effective April 1. While our backlog is up 87% year-over-year, a good portion of that growth is from Medicare Part B patients. In the near term, Medicare patient revenues will be reported at the time of payment until sufficient collection history is established. As a result, we estimate first quarter 2024 revenues will be in the range of $4.1 million to $4.3 million, an increase of between 19% and 25% compared with the year-ago quarter, with growth accelerating through the remainder of 2024. We expect some gross margin pressure in the first half of 2024 as we ramp deliveries to Medicare patients, reporting cost of goods sold at that time while reporting revenue at payments until we build sufficient collection history to enable reporting revenue and delivery. Gross margin expansion should resume year-over-year during the second half of 2024. We're generally on track with our plans to hire at least 50 to 60 new employees by the end of the second quarter of 2024, primarily to increase our clinical, reimbursement, and manufacturing capacity. Assuming we can increase capacity as planned and assuming there's no unexpected supply chain disruptions, we believe we can achieve full year 2024 revenue of between $28 million to $30 million, an increase of 46% to 56% compared to full year 2023.

This implies more than $10 million of quarterly revenue by the fourth quarter of 2024. And at that revenue level, we believe it is achievable to be operating cash flow breakeven on a quarterly basis by the fourth quarter of 2024. Cash used for operations is expected to be higher in the first half of 2024 as we increase the cost structure in advance of meaningful Medicare property revenues and lower in the second half of the year. With that financial overview, I'll return the call back to Paul.

[Paul Gudonis, executive]

Thanks, Dave. While we start this year in the strongest position in the company's history, our investment in the high-quality clinical research resulted in Medicare coverage of our powered arm braces and this milestone has a number of benefits. We believe our addressable market has doubled since we can now serve the 50% of seniors who are covered by standard Part B Medicare. We could not provide a MyoPro to these prospects in the past and so we placed them in our database in anticipation of CMS reimbursement. Now we can meet their medical needs if there are appropriate candidates. We can now add these scans to our patient population without increasing the marketing budget. These individuals, their families and their clinicians are already contacting us, so our cost per pipeline add should come down over time. The other 50% of seniors in the U.S. were covered by Medicare Advantage plans would have an easier time maintaining approval from their health insurance plans since these payers are required to cover what Medicare Part B covers, including several large payers that have resisted covering the device in the past. Some of the Medicare Advantage plans have publicly stated that they are seeing increased medical costs post-COVID as patients seek treatments they may have postponed, and we've seen a short-term impact on authorizations received in the last few months from these payers and what may be an attempt to manage utilization. However, with the published fee in place, we intend to start evaluating patients with any Medicare Advantage plan and submitting claims in 2024, since all Medicare Advantage plans are now required to cover the MyoPro so long as the medical necessity can be established and the patient otherwise meets our inclusion criteria.

It also means for younger individuals with arm paralysis who are enrolled in commercial plans such as Blue Cross/Blue Shield, Aetna, Cigna, UnitedHealthcare, we expect to see these plans follow Medicare's guidelines over time and improve coverage of the MyoPro for their beneficiaries as well. And finally, because of this Medicare Part B coverage now in place, we are seeing new interest among orthotics and prosthetics clinics around the country and supplying the MyoPro their patients. With a much clearer reimbursement path, this O&P channel could develop into a significant source of product sales in the future. So we intend to increase our emphasis on this channel in 2024. In fact, several of our senior leadership team are meeting with O&P executives and owners at this week's annual Academy O&P conference in Chicago to begin discussing how they could become a MyoPro center of excellence.

I just returned from a trip to Germany to meet with our colleagues there. We have a growing profitable business in Germany, and we should see continuing growth in international revenues as more O&P clinics become trained on how to provision the MyoPro and a larger number of the German statutory health insurers cover the device for their beneficiaries. And the China JV, in which our company has a 19.9% equity interest, could start production sales this year upon approval by their national regulatory agency. With this clarity from CMS, to serve seniors of Part B coverage, we're now ramping up our capacity to meet anticipated demand. As Dave stated, we started the year with 104 employees, and we are planning to hire 50 to 60 more to double our clinical, reimbursement, manufacturing capacity by the second half of the year. With this larger market opportunity in front of us and the new capital we've raised, we'll also be increasing our spending on research and development and product support as our volumes grow so that we continue to innovate, add to our IP portfolio and build on our market-leading position since a published fee often attracts competition into a product category. With CMS coverage now in place, we have the opportunity to make the MyoPro the standard of care for individuals suffering from long-term upper extremity impairments due to stroke, brachial plexus injury or other neurological conditions. So with that overview of 2023 and looking to our plans for 2024, we're now ready to take your questions. Operator?

[Operator]

[Operator Instructions] The first question comes...

[Paul Gudonis, executive]

Before we take the first question, I want to mention that we are available for virtual and in-person investor meetings. So please contact LHA Investor Relations at the time to meet with us. So operator, whenever you're ready, we are ready for the first question.

[Operator]

Thank you. The first question comes from Anthony Vendetti from Maxim Group.

[Anthony Vendetti, analyst]

I wanted to focus on the increase in capacity, the manufacturing capacity, to get to the $28 million to $30 million. Obviously, this is great news with the reimbursement coming in at the levels that it came in at and the backlog and pipeline growing. So Paul, I think you said you're planning to double capacity. How are you going about that? And what limiting factors or roadblocks do you see to getting that done in time to meet this guidance for 2024?

[Paul Gudonis, executive]

Well, thanks, Anthony. Well, last year, I hired a very experienced manufacturing executive named Colin Anderson. And he's been expanding our team here in our Boston facility. So we've been adding more workstations, training more manufacturing assembly folks, quality folks. We just had a meeting with [ CogMetics ], one of our suppliers, this week. And so we're getting prepared to double our output between now and the second half of the year. And then going forward, we're going to be looking at expanded facilities as well to continue to expand because, again, we've got such a large market opportunity in front us now.

[Anthony Vendetti, analyst]

And then just the ramp that is going to be in the second half, that's mostly -- that ramp is mostly to serve the Medicare Part B. I mean, obviously, you'll be serving the other commercial patients as well. But the ramp that you're talking about is going to be driven largely by Medicare Part B, correct?

[Paul Gudonis, executive]

Yes. The additional volume will be coming from these Medicare Part B patients because we've essentially doubled our addressable market, Anthony. So we'll continue to see growth in our Medicare Advantage, commercial plans. Our international team will continue to grow. And on top of that, all the Medicare Part B patients who we can now serve.

[Anthony Vendetti, analyst]

And lastly, the 50 to 60 new employees, approximately how many of those will be on the reimbursement side?

[Paul Gudonis, executive]

It's a smaller number, a few people, what we call patient navigators to work with patients, members of our clinical reimbursement team to collect medical documents. But most of the growth will be in our call center, customer experience operation, intake coordinators. More CPOs, certified process [indiscernible] in the field to evaluate and then deliver the product patients, the manufacturing inspection team and then our follow-on MyoCare coaches and clinical specialists to follow up with patients. So the majority will be folks that are in the field operations and line manufacturing operations. And if you look at 50% to 60% growth in headcount, yet we're going to be doubling capacity and revenue volume. So there's -- that's where we made some really good efficiencies because we've already built the infrastructure for the company.

[David Henry, executive]

So most of the headcount, as it's driven by increasing clinical, manufacturing and reimbursement capacity. So everything else is like the overhead and things like that is secondary. So we want to make sure that's the first priority as we're adding headcount.

[Operator]

The next question comes from Edward Woo from Ascendiant Capital.

[Edward Woo, analyst]

Congratulations on the quarter. My question is, was that correct that you said that European international revenue was 23%? Is that -- that seems like a very high amount. Do you anticipate international being that high or more going forward?

[David Henry, executive]

I think 23% was correct. That was the percentage of revenue in the fourth quarter. And as Paul just mentioned, I think we're looking at growth in international revenues continuing into 2024.

[Edward Woo, analyst]

Great. Is it mainly in the German market where you guys have had a lot of your growth previously? Or have you guys considered expanding to the rest of Europe?

[Paul Gudonis, executive]

This is primarily in Germany, Edward. We built up a really good business, developed a clinical team now. We've recruited 100 orthotics and prosthetics clinic locations. I met with some of them last week, and we're getting good reimbursement progress there in Germany. So we said, look, let's double down in Germany because it's a large market, over 80 million population so large prevalence in new strokes. So that's our best market right now, and we may look at other international market expansion later on. But we go where the reimbursement is, and the reimbursement is in Germany right now.

[Edward Woo, analyst]

Great. Well, thank you, and congratulations.

[Operator]

[Operator Instructions] The next question comes from Ben Hayner from Alliance Global Partners.

[Benjamin Haynor, analyst]

First off, for me, you mentioned the O&P clinics becoming more excited with the Medicare reimbursement amount being announced and coverage being in place for Part B. Can you talk a little bit about how those folks look at the product and maybe a little bit more color on the sorts of people you're meeting with at the upcoming conference here, Paul, for the O&P folks?

[Paul Gudonis, executive]

Well, the O&P channel is very well positioned to provide the MyoPro to patients, what's been a barrier to adoption has been the reimbursement process, and that's why we integrate it forward with our own direct billing clinical team in the field. But O&P clinics, it's approximately 3,000 locations in cities all across the country. They see a lot of stroke patients already for what are called ankle and foot orthosis, ASOs. So patients are already coming into their clinical facilities requiring an orthosis for, for example, foot drop. And many of these patients will also have upper extremity weakness. So we think it's been very natural for these O&P clinicians to look at these patient candidates walking in and saying, look, you might be a candidate for MyoPro, let's say, a prescription from your doctor if you're a medically appropriate candidate. So that's why we think it's a good opportunity for them. They're certainly interested in growth, and this is the largest growth opportunity in the field of orthotics and prosthetics. And there are a number of meetings going on this week in Chicago at the conference with a number of companies from the largest to some of the individual clinics that have known the MyoPro. They know our team for a number of years, and now they've seen the green light that they can go out and serve these patients.

[Benjamin Haynor, analyst]

Okay. That's definitely helpful. And then on -- you mentioned the MyoPro centers of excellence or becoming a MyoPro center of excellence for these O&P clinics. What does that entail? Does that exist now? Help me out with that a little bit more?

[Paul Gudonis, executive]

Yes. We have such a program. You have to go through a certain amount of clinical training by our staff. We will assist you with the evaluation and fitting of initial patients. And once you pass that certification, then you are what we call center of excellence and then you can start to fit patients, and we may even refer patients to you depending on different geographies.

[Benjamin Haynor, analyst]

Okay. That's helpful. And then do you need to hire folks to do that trade? Is that part of the 50-60 people you're hiring?

[Paul Gudonis, executive]

Yes, it includes some O&P channel managers as well as expanding our clinical training staff to be able to train these additional channel partners.

[Benjamin Haynor, analyst]

Okay. Got it. And then just on the guidance for Q1 and the remainder of the year. I mean, is that -- is the step-up kind of a function of waiting on shipping some of these things out to Medicare patients until the reimbursement was set? So instead of shipping the last week of March moving -- and maybe shipping the first week of April. What's the right way to think about that?

[David Henry, executive]

That's the right way to think about it. If that makes sense.

[Benjamin Haynor, analyst]

Okay. Fair enough. It makes complete sense. And then -- lastly for me on the guidance. You mentioned Q4, potentially getting to cash flow breakeven. Where do you -- and you also mentioned the step-up in gross margin in the second half? Where should we be looking at exiting the year in terms of gross margin? I mean does that get into the 70's?

[David Henry, executive]

I think it's -- I do think with volume increases and probably opportunity to increase our ASP a little bit now that we have the Medicare fees in place, I think it's possible, certainly to be more than 70% in the fourth quarter.

[Benjamin Haynor, analyst]

Okay. Got it. I think that's all I had, gentlemen. Congrats on all the progress and getting the reimbursement in place.

[Operator]

[Operator Instructions] Seeing as there are no further questions, I would like to turn the call back over to Paul Gudonis for closing remarks.

[Paul Gudonis, executive]

Thanks, operator. Well, I want to thank the new investors that had faith in us and our products and participated in our capital raises over the past 15 months. We've been able to track well-regarded fundamental health care investors who see the long-term potential of this business, and we've had a number of executives and Board members increased their stock holdings as well. We're now focused on scaling the business with operational efficiencies, so we can meet this increased demand, achieve our goal of cash flow breakeven by the end of the year under the various assumptions that Dave pointed out. We're delighted to put this major reimbursement issue behind us and 2024 will be a transformational year for Myomo. We're thrilled to be in a position both to grow the company significantly and to improve the quality of life for a larger number of patients. Thanks for your continued interest in our company, and have a good day.

[Operator]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.