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Beyond Air, Inc. Q3 FY2022 Earnings Call

Beyond Air, Inc. (XAIR)

Earnings Call FY2022 Q3 Call date: 2022-02-14 Concluded

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Operator

Greetings and welcome to the Beyond Air Third Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-session will follow the formal presentation. Please note, this conference is being recorded.

Maria Yonkoski Head of Investor Relations

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today after market close, we issued a press release announcing the third fiscal quarter of 2022 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website. Before we begin, I would like to remind everyone that we will be making comments and various remarks about future expectations, plans and prospects, which constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Securities and Exchange Commission, including without limitation, the company's Form 10-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me on today's call are Steve Lisi, our Chairman and Chief Executive Officer; Duncan Fatkin, our Chief Commercial Officer; and Douglas Larson, our new Chief Financial Officer. With that, I will turn the call over to Steve Lisi, our CEO.

Thanks, Maria, and good afternoon to everyone joining us on today's call. As always, I would like to start by thanking the Beyond Air team as they continue to embody the mission of our organization and move us forward towards regulatory approvals and R&D pipeline progression and expansion. We continue to believe in the potential of LungFit PH to revolutionize the treatment of persistent pulmonary hypertension of the newborn or PPHN, in the United States and cardiac surgeries around the world. Today, our commercial team continues to prepare for a U.S. commercial launch of LungFit PH in anticipation of a regulatory decision in the first half of this calendar year. I will have our Chief Commercial Officer, Duncan Fatkin, discuss this preparation in much greater detail shortly. Beyond Air continues to work collaboratively with the FDA to bring our device to the market as quickly as possible. I won't be able to comment further on our ongoing interactions with the FDA. Except to assure everyone that the dialogue is productive, and we have provided the agency with all information and support we believe they need to grant approval for LungFit PH. Additionally, we remain on track to receive CE Mark in Europe in the first half of this calendar year. We expect to secure an international commercial partnership for LungFit for ex U.S. Markets following CE Mark, and we will provide more information on our global strategy at a later time. Turning now to recent operational highlights. In December of last year, we expanded our leadership team and welcomed Dr. Andrew Colin as our new Chief Medical Officer. Dr. Colin has been an invaluable contributor to our Scientific Advisory Board since 2013, and his advice has been instrumental to the progress of our ongoing clinical programs to date. He has been tasked with leading our late-stage development efforts of both LungFit Pro and LungFit GO systems, given his medical background as a board-certified pediatric pulmonologist with more than 4 decades of clinical experience in respiratory physiology, cystic fibrosis, and lung infections. With regards to scientific updates and our presence at upcoming medical conferences, I am happy to report that we have been accepted to present new data from our pipeline programs at 3 leading scientific conferences, all within the next four months. I will start off our pipeline commentary with our LungFit GO NTM, Lung infection pilot study. As you may recall, in December 2020, we began screening for refractory NTM patients for this pilot trial in Australia. In October, we released interim data where a total of 8 refractory NTM patients have been titrated up to the maximum dose of 250 parts per million nitric oxide in the hospital over several days and then sent home to self-administer therapy. There were no dose reductions, no steady discontinuations, and no treatment-related serious adverse events reported. Our team was very encouraged by this initial safety profile. We have now been accepted to present additional results from this pilot study at the American Thoracic Society International Conference being held from May 13 to May 18 in San Francisco. Beyond the safety profile, this study aims to evaluate efficacy parameters, such as quality of life, physical function and bacterial load among other metrics. Remember, this is a pilot study designed as a single-arm 12-week at-home trial aiming to enroll up to 20 cystic fibrosis or non-CF bronchiectasis patients with a refractory NTM lung infection at our Mycobacterium abscessus complex. It is important to note that NTM is a disease area of focus for the FDA. In fact, 50% of patients will die in less than 5 years from the initial diagnosis of Mycobacterium abscessus lung infection. As such, the success of this trial could signal that LungFit GO has the potential to be a game changer for this patient population and start to open up the enormous potential of the home market for our system. We have always had an interest in investing in other indications with our LungFit GO system and have announced our intention of beginning a pilot study to treat severe COPD exacerbations due to lung infections over the next 12 to 24 months. Moving on to our viral lung infection program, which uses the LungFit Pro system at a 150 parts per million nitric oxide to treat community-acquired viral pneumonia in adults and bronchiolitis in children under 2 years of age. As many of you may recall, we presented interim data from our adult cohort of hospitalized pneumonia patients last May at the American Thoracic Society international conference. At the time of the cutoff period for these data, we analyzed a total of 19 patients on an intend to treat basis. None of the patients in the NO treatment arm and 10 in the control arm, all of which were COVID-19 patients. These data show that 150 parts per million NO administered by LungFit Pro was deemed to be safe and well tolerated with no treatment-related or possibly related adverse events or serious adverse events. Additionally, 22% of subjects in the NO treated group required oxygen support beyond their hospital stay compared to 40% of control subjects. With respect to the duration of oxygen support, NO treated patients averaged 2 days less than control. A 26 hour reduction in mean duration of hospital stay between the NO treatment group and control was observed when adjusting for extreme outliers. Since presenting these data, we have kept the study active with trial sites open for enrollment. I'm happy to report that we have been accepted to present new data at the 32nd European Congress of Clinical Microbiology and Infectious Disease being held April 23 through 26 in Lisbon. Our team is excited to have the opportunity to share these additional data with the scientific and medical communities. Finally, I would like to provide updates on our private affiliate Beyond Cancer. Late last year, we successfully raised $30 million in a private placement of common shares to spin out our oncology program, developing ultra-high concentration nitric oxide or UNO therapy for the treatment of solid tumors. We believe UNO therapy may not only partially ablate or shrink the primary tumor, but also can arm the immune system to recognize and attack tumor cells if they metastasize to other regions in the body. Our preclinical data show that treating a tumor with UNO therapy will cause local cell death, exposing the immune system to tumor antigens, thereby creating a memory immune response. For patients, this could mean preventing recurrence or metastases. Under the leadership of CEO, Dr. Selena Chaisson, Beyond Cancer has established a 6-member board with the recruitment of Mr. David Dvorak, previously the CEO of Zimmer Biomet, and Dr. Gregory Berk, a clinically trained physician who is currently serving as a Chief Medical Officer and Interim CEO of GT Biopharma, a clinical-stage immune oncology company. Additionally, Beyond Cancer will present 2 datasets at the American Association for Cancer Research Annual Meeting, which is being held from April 8 through 13 in Orleans. Recall, we previously presented in vitro and in vivo preclinical data for ultra-high concentration gases, nitric oxide at several conferences in 2020, which suggested that direct administration of UNO therapy to solid tumors triggers a systemic antitumor immune response, which could serve as the basis for effective immunotherapy. These new preclinical data being presented in April will continue to build upon this growing body of evidence and we are excited to support the progress as a partner of Beyond Cancer. I will now turn the call over to Duncan Fatkin, the Chief Commercial Officer of Beyond Air to provide additional details on the U.S. commercial launch for LungFit PH.

Speaker 3

Thanks, Steve, and good afternoon to our investors. As I highlighted last year, the commercial organization is ready to launch LungFit PH domestically as soon as we receive FDA approval. Our strategy has not changed. As we aim to focus on a limited release for the first 6 to 9 months post-launch and target a select number of hospitals that have level 3 or level 4 NICUs and staff experienced with inhaled nitric oxide. We continuously refine our marketing plan and work to optimize our customer service model as we draw closer to a decision date from the FDA. Our launch team is securely in place and consists of highly experienced individuals with decades of nitric oxide experience who will work closely with our target hospitals to ensure that we provide the best possible logistics support, customer service and product performance. As I’ve said before, since many of our target hospitals are currently in multi-year contracts with cylinder-based nitric oxide suppliers, we will be targeting hospitals with fewer than 12 months left on their existing contracts and we anticipate it will take approximately 4 years to have an opportunity to convert every hospital that uses nitric oxide in the United States. As a reminder, here are the main areas of immediate focus for the commercial team. First, building and developing the team. Our pre-approval launch team is ready to be deployed immediately following approval. We continue to build on the nitric oxide experience that our team has brought to Beyond Air through our intensive internal training program. As I’ve previously mentioned, we have numerous respiratory therapies on staff and experienced leaders to run our sales and marketing efforts. Our launch team is also preparing for the execution of our ex-U.S. partnership plans following CE Mark anticipated in the first half of 2022. Second, we are refining our logistics plan to ensure that the first phase of Beyond Air customers have an optimized customer experience. We are especially excited to launch our customer service and support program upon approval with a focus on flexibility and transparency with all of our customer stakeholders. Last, we are confident that customers will see significant value compared to cylinder-based systems as LungFit PH would be the first and only FDA-approved system that generates nitric oxide from room air. We look forward to sharing the logistical patient workflow and healthcare economic benefits with you in more detail upon approval. These messages will also be highlighted on the LungFit PH website, lungfitph.com, which will be made publicly available on day 1 of our launch. We are planning to attend all the major respiratory conferences throughout 2022 and look forward to engaging with potential customers when appropriate. We will continue to maintain a highly visible presence at these conferences to showcase LungFit PH and the benefits of our innovative system. Our vision is to harness the power of nitric oxide to unlock access in power healthcare providers and transform more lives in more ways. LungFit PH is a groundbreaking all-in-one nitric oxide generator, monitoring, and delivery system, and we're extremely excited to share our story with potential customers in the U.S. and beyond.

Thanks, Duncan, and good afternoon to our investors. Before I jump into the financials for the past quarter, I'd like to address a couple of housekeeping items. First of all, it's important to note that our balance sheet, P&L, and cash flows now include Beyond Cancer, our private oncology affiliate. Due to our majority ownership position, their financial statements are fully consolidated with those of Beyond Air. The P&L and equity sections in our 10-Q break out the amounts attributable to the noncontrolling interest that owns 20% of the common stock in Beyond Cancer. Second, we had a large number of warrants exercised for common stock in fiscal Q3. Especially our warrants issued in January of 2017 which expired in January of 2022. We issued just over 748,000 shares of common stock upon exercise of warrants in Q3 and brought in almost $1.4 million from those transactions. The balance of the warrants from January of 2017 were exercised in January of 2022, bringing in almost $4.6 million of additional cash, which we call out in our note on subsequent events in our 10-Q. With that, I will now turn to a brief review of our financial results for our third fiscal quarter of 2022, which ended on December 31, 2021. Revenue for the fiscal quarter ended December 31, 2021 was $0 as compared to $0.1 million for the fiscal quarter ended December 31, 2020, all of which was licensing revenue. Research and development expenses for the fiscal quarter ended December 31, 2021 were $2.5 million compared to $3.4 million for the fiscal quarter ended December 31, 2020. General and administrative expenses for the fiscal quarter ended December 31, 2021 were $4.9 million compared to $2.5 million for the fiscal quarter ended December 31, 2020. Other income and expense for the fiscal quarter ended December 31, 2021 was a loss of $0.5 million. For the fiscal quarter ended December 31, 2021, the company had a net loss of $8 million, of which $7.7 million or $0.29 per share was attributable to the shareholders of Beyond Air Inc. compared to a net loss of $5.8 million or $0.33 per share for the fiscal quarter ended December 31, 2020. For the fiscal quarter ended December 31, 2021, the company used $6.3 million of cash for operating activities. As of December 31, 2021, the company had cash and cash equivalents of $83.5 million, of which $54.5 million is in Beyond Air and $29 million is in Beyond Cancer. And keep in mind, this does not include the additional $4.6 million we brought in in January that I mentioned earlier. We believe that our cash on hand is sufficient to fund operations well beyond the next 12 months, including through the commercial launch phase of LungFit PH in the U.S.

Thanks, Doug. Operator, we are ready for Q&A now.

Operator

Thank you. And at this time, we'll be conducting a question-and-answer session. And our first question comes from the line of Gregory Fraser with Truist. Please proceed with your question.

Speaker 5

Thanks folks. On LungFit PH, I appreciate the color on your interactions with the agency. It sounds like there's nothing outstanding from your end. Is there anything specific that you're aware of that could be giving approval at this plan or do you just have to wait to see what the agency comes back with next?

Yeah. Greg, I wish I could give you something more specific, but we're just waiting to see what they come back with at this point.

Speaker 5

Got it. Okay. How far will the transport system be to the broader lung strategy when you expand to more hospitals? And can you speak to the timing of approval for a transport system?

I'll speak to the timing and I'll let Duncan tell you how important it is. The time will be, I would say, within the first 2 years after we launch the product, so maybe sometime in the 15 to 18 month time period or so to speak after we get the approval is probably when you'll see the transport unit.

Speaker 3

Yeah, Greg, thanks for the question. So the transport system, it's important that there is a transport system that the hospital has access to. The good news for us is that we have made a decision to have a controlled phased launch and in that first period where in the first 6 to 9 months we go to 10 to 12 hospitals. We've previously talked about we don't anticipate there to be any resistance, so there not being a transport system available. And in fact, based on the feedback we've had from many of the customers that have approached us, they can definitely use our system without a transport system being available for a significant period of time, by which time we will have a transport solution. And we believe it will have some significant differentiation that will be welcomed by our customers.

Speaker 5

Got it. Thanks, that's very helpful. And then on LungFit Pro, will the additional data from the study that you'll be presenting, will these be the same group of patients or will you have data for additional patients including non-COVID folks?

Yes, there will be more patients for sure.

Speaker 5

Got it. Thank you, and thank you for taking the questions.

Thanks, Greg.

Operator

And our next question comes from the line of Suraj Kalia with Oppenheimer & Company. Please proceed with your question.

Speaker 6

Good afternoon, everyone. Steve, I have a couple of questions for you and one for Duncan. First, Steve, I appreciate your comments about not detailing the FDA process for PPHN. I was wondering if you could share any updates since the last conference call. Additionally, can you provide any insights regarding the ongoing bankruptcy situation and whether you are noticing any structural changes in the marketplace as you prepare for the commercial launch? Duncan, for Beyond Cancer, could you explain how we should approach Opex or Beyond Cancer in the context of Beyond Air? Thank you, gentlemen, for addressing my questions.

All right. Suraj, I'm going to give that last one to Doug on the Beyond Cancer side. That's a finance question there. So let's take them kind of in order. So while you just do me a favor, because we were a little bit shocked when you said question for Duncan and it came out as a cancer question. So just kind of recap your question so we could take them in order please. I apologize. Real quickly, don't say the whole question again. Suraj.

Operator

Hi, Suraj. Is your phone on mute?

Speaker 6

Can you hear me now? Sorry.

Now I can. Yes.

Speaker 6

Okay. Apologies. So very briefly, any new info provided on PPHN?

Yeah. The answer to that is, no new information has been provided.

Speaker 6

Okay. Any structural changes in the marketplace with the ongoing bankruptcy and are you seeing any changes as you prepare for commercial launch?

I don’t want to comment on the public details regarding their bankruptcy, but in terms of the market, I believe there hasn’t been much change in the past two years since before their bankruptcy. The competition has remained consistent, and I don’t think the bankruptcy has had a significant impact. Now that they are emerging from bankruptcy, we also don’t see much difference to be honest. Duncan, do you have anything to add?

Speaker 3

No, I think Steve captured it. It's certainly nothing that changed our strategy.

Speaker 6

And Steve, maybe for Duncan. Just the Beyond Cancer OpEx flow, or should we think about it from a housekeeping perspective? Gentlemen, thank you.

Speaker 3

So the expenses for Beyond Cancer, they'll be consolidated to Beyond Air. We own 80% so we'll consolidate all those expenses, and you'll be able to see that broken out; that's 20% that's not owned by Beyond Air will have to be broken out in our financials. And I think Doug you may want to just comment on how it's shown in the 10-Q.

So right now, we're consolidating 100% of Beyond Cancer into Beyond Air. So when we had the $30 million investment, the 20% or $6 million flows into noncontrolling interest. And then as we generate, in this case, losses through the quarter, 20% of the losses also flow into noncontrolling interest. And in future quarters, we're going to be breaking that out so that you can see the equity bridge from the $30 million original to – sorry, from the $6 million in noncontrolling interest to the ending position for the quarter.

Speaker 6

Thank you.

Operator

And our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Speaker 7

Hey, thanks for taking the question and congrats on the progress. Just wanted to focus a little bit more on the PMA process ongoing. Can you give us any sense, it seems like you're basically ready to launch any day now. Can you give us a sense in terms of what the next steps are with the FDA? Is it just waiting for approval? Are you expecting another turn and more questions from them?

So, Matt, it's an ongoing process. So we continue to work with the FDA to get to this end game of approval. So, I mean, I'm not going to say much more than that or no more than that, let's say. And as for the commercial team, they're ready to go. I mean, if the FDA were to give us a call tonight and say, you're approved on Monday, Duncan and his team will be ready to launch it on Tuesday. No problem. That's not going to happen. I'm just giving you an example.

Speaker 7

Okay. Fair enough. And maybe just switching to some of your programs that you have in pilot stage of development. LungFit Go, can you give us a sense in terms of the ongoing pilot study in the at home setting? When do you think that study could complete? And then what the next steps are for developing in NTM and kind of map that out for us a little bit. I guess you did announce you plan to launch additional work in COPD in the next 12 to 24 months, but focusing on NTM, what are the next steps there?

We are expecting to gather data at ATS, and the study will conclude its 12-week follow-ups over the summer with the last patient. Following that, it will take several months to analyze the data and prepare a pre-submission for the FDA. We also have some laboratory work in progress. Once we receive the final samples from patients, we'll send them for further analysis, which is essential for our presentation to the FDA. We plan to wait for this data before initiating our process with them. We anticipate starting a new study around the middle or latter part of 2023, which involves identifying and engaging with clinical sites and setting them up, a process that can take 6 to 9 months. While there’s a chance it could be expedited, I want to be cautious as this is new territory for the FDA, physicians, and patients involved. We hope the data proves strong and gains quick acceptance, but until then, we will keep our timeline flexible. Regarding LungFit GO and COPD, we aim to focus on patients who primarily use the device at home. We are confident in our LungFit Pro system from the pilot study transitioning into the LungFit GO system, as it is ready for the home market. We are excited about the system's performance, ease of use, and the positive feedback from participants, including engineers, physicians, and medical staff involved remotely. This strong feedback has pushed us to pursue COPD. If we can initiate efforts this year, that would be excellent, though it might extend into 2023. It can be challenging to expedite processes in light of how new this is for everyone we’re working with.

Speaker 7

All right. Okay. Fair enough. And just to be clear, so final data from the pilot study late this year and then embark on potentially a pivotal study starting mid to the second half of next year. That makes sense.

I don’t expect that there will be any patients enrolled in 2023. It will likely be later because it takes time to get sites operational, set up, and go through the IRB process. So, I would suggest looking toward the end of 2023 at the earliest, but more realistically in the first half of 2024 for starting a study. I hope it will be quicker than that, but these processes take time. We have surprised a few people with our efforts, and we understand that not everyone is familiar with what nitric oxide is and its effects. However, it seems that people are starting to understand, given the progress we’ve made over the past few years.

Speaker 7

Okay. Good. Can you help us understand the next steps for the LungFit Pro pilot study? I believe you will have additional data in April, so what are the plans for wrapping up that study and progressing to the next phase of development?

That study is wrapping up now. I mean, in this winter we were in I guess the back half of the winter to now. So we're wrapping the study up and we're moving as fast as we can here. And the key for this is seasonal. We need to do a study that all the patients we're targeting are enrolled within the same winter season. So we're fighting against the clock here to try to get things done and work with the FDA to get this study off the ground so we can get going coming up this November. So we're working on that, stay tuned. If we can get everything done in time, we'll be doing the study this coming winter.

Speaker 7

Okay. Great. All right. Thanks for taking the questions, Steve.

Thanks, Matt.

Operator

Our next question comes from the line of Yale Jen with Laidlaw & Company. Please proceed with your question.

Speaker 8

Good afternoon, and thanks for taking the questions. I just want to follow up on what Matt had asked and maybe the last one. Which is for the LungFit Pro the study you are talking about, would that be for pediatric or for adult or you have not decided?

It would be for adults.

Speaker 8

Okay. And two quick questions here. First one is, it's a little bit more fun, which is that, have you guys give a formal name for the oncology treatment at this point?

So, we're using UNO therapy right now for ultra-high nitric oxide. So, we'll see how that goes, but we're calling it UNO therapy at the moment. So not like the card game, but we'll see what we can do with it. But that's the name now, and we'll see how that progresses as we go forward.

Speaker 8

Okay. And last question here is actually for Duncan. I’m just curious in terms for the LungFit PH, as you promote that, do you potentially will go through some of the group purchasing organization or that's purely not relevant and just go to each hospital specifically?

Speaker 3

Yes, thanks for the question, Yale. Just a reminder, we're definitely not promoting the product right now, obviously. But certainly going forward, of course, we will engage with buying groups as appropriate because we have a phased launch. The initial phase, that group of hospitals I mentioned, there's certainly not going to be any of those kind of arrangements in place, but definitely have been contacts from various groups, and a lot of the key hospitals that you would know around the country, there is a lot of interest in our technology. And we will negotiate and discuss that with them accordingly. But reinforcement that we don't expect to be competing on price; we focus very much on the benefits that we provide, both potentially, clinically, logistically and then in terms of patient workflows. So that's a long yes, but not now.

Speaker 8

Understood. And maybe just squeeze one more in terms of LungFit GO; in terms of the level of nitric oxide based on PPM, is that the same for the NTM versus COPD or they could be different? Thanks.

Thanks, Yale. For NTM, we increase to 250 parts per million for patients with COPD who have lung infections leading to severe exacerbations. It's important to note that we are treating the exacerbation, not the underlying COPD condition. We haven't finalized the upper limit for treatment yet, but it will be at least 150 parts per million. It could potentially be 200 or 250, but we are unsure at this time. I don’t believe we can exceed 250 parts per million for now, which will likely be the maximum we consider at this moment. This isn't related to the machine or our device; it's based on what we have learned so far while staying within safety limits.

Speaker 8

Okay, great. That's very helpful. Again congrats on the progress. We look forward to the launch.

Thanks, Yale.

Operator

Our next question comes from Scott Henry with ROTH Capital. Please proceed with your question.

Speaker 9

Thank you and good afternoon. Just a couple of questions; most of mine have been answered already. I guess, for Doug a couple of modeling questions. First, G&A was certainly above trend in the third quarter. Is there some one-time events in there from the Beyond Cancer transaction or perhaps maybe it should take a step up as you have that entity as well? Just trying to get a sense of how to think of G&A going forward?

Sure. Yeah. No problem. Thanks for the question. So, there were a couple of things that happened in there. Certainly, the setup of the cancer business did generate some legal fees, especially some one-time costs around that creation. You may have noticed we didn't use a bank, but that didn't keep the legal fees down, so we did have those. We also had restricted share grants in the quarter, and the way we account for that. So this is a non-cash item, obviously, but the way we account for that is, we take each tranche and spread it over the life of the tranche. And so, whenever we have grants we have a pickup through the P&L, that's fairly significant. So between those two items, that explains the biggest chunk of the increase.

Speaker 9

Okay, great. And you did mention the warrant transactions, particularly in January. I haven't seen the Q yet, but could you give us a sense of where the real-time shares are today?

Yes. So we just put up the shelf registration. So the share count is in there, I believe –

Speaker 3

Actually for stage two Q as well, it’s $29.8 million.

There you go. Yes, I think it's almost the same as what we had in the shelf.

Speaker 9

Okay. Perfect. Thank you. Final question. I think you've talked about this in the past, Steve, but as we get closer to potential launch, how would you kind of categorize the manufacturing capacity, any supply issues or you feel pretty good about that for the considerable future?

So, I think for the first 6 to 9 months of our focused launch, we're all set. I think there's nothing really that concerns us with respect to supply or manufacturing capacity for that timeframe. But as we go beyond that, we have to manage the supply chain. I don't think our capacity – our actual manufacturing capacity is fine. It's really supply chain; I mean there are still things that are difficult to source out there. I'm sure we're not the only company to say that, nor are we the only one to have the problem. I think things are getting a little bit better. And I hate to say it. I mean, I wish we had approval already, but this little bit of a push out has helped us to be able to source some of these things so that we do feel more comfortable going beyond that first 6 to 9 months. So we do feel a little bit better about that, but I don't want to say it's something that isn't in a concern; it has to be a concern given the environment in the world right now. But we're certainly comfortable to get through the first phase and to the second phase of our launch. But I don't want to be too bold and say, it's not an issue. But I'm very confident with the team and the things that they put in place to make sure that we're going to do okay in the next 2 or 3 years with supply chain. I'm actually quite impressed with the team. Glad I have them because they know more than me, so it's a good thing.

Speaker 9

Okay, great. Thank you for the color, and thank you for taking the questions.

Thanks, Scott.

Operator

And we have reached the end of the question-and-answer session. I'll now turn the call over to Steve Lisi for closing remarks.

Thanks everyone for joining today. Much appreciated, and we look forward to the next time we speak.

Operator

And this concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.