Beyond Air (XAIR) 2027 財年第一季法說會：FDA 催化劑，2026 年展望 800 萬美元

Beyond Air (NASDAQ: XAIR) 公布截至 2026 年 6 月 30 日的財年第一季營收穩定，且毛利率有所改善。管理層重點關注尚待 FDA 審查的第二代 LungFit PH 系統、商業管道的成長以及融資能力的擴大。

重點摘要

• 2027 財年第一季營收為 180 萬美元，與去年同期及 2026 年 3 月季度的營收持平。
• 毛利率從一年前的 9% 提升至 13%，連續第三個季度實現毛利正成長。
• 歸屬於普通股股東的淨虧損從 770 萬美元擴大至 790 萬美元。每股虧損為 11.00 美元，一年前為 30.67 美元。
• 管理層重申 2026 日曆年營收指引為 800 萬美元，2027 日曆年指引為 1,600 萬至 1,800 萬美元。
• 第二代 LungFit PH 仍處於 FDA 審查階段。根據目前流程進展，管理層預計可能在 2026 年下半年做出決定，時間點更有可能落在第四季。
• Beyond Air 表示，其商業管道在過去五到六個月內翻倍，同時其國際合作夥伴關係現已涵蓋 40 多個國家。

核心財務數據

業務與營運表現

Beyond Air 繼續為其第二代 LungFit PH 系統在美國的潛在商業上市做準備。該公司於 2025 年 6 月向 FDA 提交了 PMA 補充申請，並表示工程與試產正在與合約製造商順利推進。

管理層表示，FDA 已收到絕大部分所需文件，並正在幾項預期審查前審閱相關材料。最終的試產產品也正在完成中，以納入審查流程。

透過與美國第三大集團採購組織簽署全國性採購合約，商業通路進一步擴大。結合現有與 Premier 和 Vizient 的合約，這些安排涵蓋了美國相當大一部分的醫院與醫療系統。

該公司還擁有覆蓋 40 多個國家的分銷合作夥伴關係。管理層表示，在獲得相關監管批准的前提下，強化後的資產負債表應能提升其支援國際合作夥伴的能力。

Beyond Air 近期獲得高達 3,000 萬美元的融資。其中包括 1,000 萬美元的初期毛收益，以及來自可能行使的長短期認購權證的高達 2,000 萬美元。資金將用於支援試產與商業化設備製造、日常營運及國際拓展。

管理層指引

管理層重申 2026 日曆年營收指引為 800 萬美元，較 2025 日曆年增加約 15%。該預測不包含第二代 LungFit PH 系統的營收。

該公司在 2026 日曆年上半年創造了約 370 萬美元的營收，預計下半年約為 430 萬美元，以實現全年目標。管理層指出，近期的商業進展、龐大的商業管道、國際採購和積極的招投標是支撐因素。

2027 日曆年營收指引維持在 1,600 萬至 1,800 萬美元。取中位數計算，這代表將較 2026 年目標成長超過 110%。與 2026 年展望不同的是，2027 年的預測包含潛在第二代 LungFit PH 上市的營收，因此取決於 FDA 的批准。

風險與關注領域

• 第二代 LungFit PH 審查的時間點與結果仍取決於 FDA 流程。管理層拒絕提供明確的批准日期。
• 該公司仍處於現金消耗狀態，且額外的 2,000 萬美元融資取決於認購權證的行使。
• 醫院簽約涉及較長的銷售週期，這可能會影響擴大後的商業管道轉化為營收的時間點。
• 國際拓展仍須取得相關監管單位的批准。
• 2027 年營收展望假定在獲得 FDA 批准後，第二代 LungFit PH 系統將進行潛在的商業化上市。

分析師問答集錦

管理層表示，融資將主要用於營運資金、近期第二代產品的試產，以及潛在 FDA 批准後的更大規模設備生產。部分資金也將用於支援上市準備期間公司的現金需求。

在商業活動方面，管理層指出簽約量有明顯回升，並表示商業管道在過去五到六個月內翻倍。近期的合約進展與國際採購預計將對 2026 日曆年下半年的營收做出貢獻。

關於 FDA 的審查，管理層表示流程已進入稽核階段。文件提交已基本完成，與該機構的溝通十分順暢，預計在完成最終試產後將進行多項稽核。管理層維持 2026 年下半年的預期，同時承認考慮到當前時程，第四季做出決定的可能性更大。

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管理層陳述

Operator

Greetings, and welcome to the Beyond Air Financial Results for the quarter ending June 30, 2026. [Operator Instructions] And now I would like to turn the call over to Corey Davis, LifeSci Advisors. Please go ahead.

Corey Davis

Thank you, Operator. Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release announcing the operational highlights and financial results for Beyond Air's quarter ended June 30, 2026. A copy of this press release can be found on our website, beyondair.net, under the News and Events section.

Before we begin, I'd 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 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 SEC, including, without limitation, the company's most recent Form 10-K and Form 10-Q, which identify 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, beyondair.net.

Furthermore, the content of this call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 13, 2026. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

With that, I'll turn the call over to Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.

Robert Goodman

Thanks, Corey, and good morning, everyone. With me today is Dan Moorhead, our Chief Financial Officer. As we just had our last quarterly call a few weeks ago, I'll keep my prepared remarks fairly brief. Over the past few months, we've been focused on positioning Beyond Air for its next phase of growth. We strengthened our balance sheet through an up to $30 million financing, regained compliance with Nasdaq's listing requirements, and continue to expand the commercial foundation supporting LungFit PH. Collectively, these actions have strengthened the company's financial position, increased our commercial reach, and enhanced our ability to execute on what we believe is a significant opportunity ahead of us.

As we prepare for the planned commercial launch of our second-generation LungFit PH system, pending FDA approval, our priorities are focused on continuing to expand market access, deepen relationships with hospitals and health systems, grow our commercial pipeline, and execute with financial discipline. We believe these efforts will position Beyond Air to drive broader adoption of the LungFit PH while creating a stronger platform for long-term growth. Turning to the financial results, revenue for the quarter ended June 30, 2026, was $1.8 million, which is effectively flat from the March '26 quarter. While revenue remained relatively consistent, we made meaningful progress advancing the commercial and operational initiatives that we believe will support stronger growth as we move through the remainder of the year and prepare for the planned launch of our second-generation LungFit PH system.

We continue to execute against several initiatives designed to expand market access and increase commercial adoption. During the quarter, we entered into a national group purchasing agreement with a leading U.S. GPO, becoming the third major national GPO to partner with Beyond Air. Together with our existing agreements with Premier and Vizient, these relationships provide access to a substantial portion of U.S. hospitals and health systems and represent an important component to our commercial strategy. We also continue to expand our global distribution network through new and existing commercial partnerships, further extending LungFit PH's reach into the international markets.

Another growth center for the company will be the expansion of our international distribution. We have a number of partnerships already in place that cover more than 40 countries. As a result of our strengthened financial position following the recent equity raise, we're in a better position to support our partners' efforts to bring LungFit PH to market in many of these areas. We look forward to providing updates on these programs as appropriate. As it relates to the Gen II LungFit system in the U.S., which remains under review at the FDA, we continue to believe this to be the most important near-term catalyst for the company.

We submitted our PMA supplement to the FDA in June of 2025, and based off of our interactions with the FDA to date, we continue to believe we are on track for a potential approval in the second half of this calendar year, although the timing and outcome of the review remain subject to the FDA approval process. Accordingly, we continue to prepare for a potential commercial launch. We are maintaining a disciplined and focused approach to capital allocation. We continue to dedicate our resources predominantly to LungFit PH.

In our press release issued earlier today, we reaffirmed our previously issued revenue guidance of $8 million for calendar 2026, representing approximately 15% growth over calendar year 2025. I think it is worth noting that we're not including any revenue from the second-generation LungFit for 2026. We also reaffirm our previously issued 2027 revenue guidance of $16 million to $18 million, representing more than 110% growth at the midpoint compared with our 2026 guidance. The guidance for 2027 does include revenue from the potential commercial launch for the second-generation LungFit PH system, subject to FDA approval. Looking forward, Beyond Air is approaching an important inflection point.

With continued international expansion and planned commercial launch of our second-generation LungFit systems pending approval, we have established a stronger foundation to accelerate commercial execution and drive meaningful revenue over the coming years.

With that, I'll turn the call over to Dan for a review of our financial results. Dan?

Daniel Moorhead

Thanks, Bob, and good morning, everyone. I'll walk through our financial results for the quarter ended June 30, 2026. Revenue for the quarters ended June 30, 2026, and 2025, was $1.8 million. Gross margin for the quarter ended June 30, 2026, was 13%, compared with gross margin of 9% for the same period last year. This marks our third consecutive quarter of positive gross profit. Research and development expenses for the quarters ended June 30, 2026, were $2 million, compared to $3.1 million for the same period last year. Selling, general, and administrative expenses for the quarter ended June 30, 2026, were $4.9 million, compared with $4.7 million for the same period last year. Other expense for the quarter ended June 30, 2026, was $1.5, million compared with $500,000 for the same period last year.

Net loss attributable to common stockholders of Beyond Air for the quarter ended June 30, 2026, was $7.9 million, or a loss of $11 per basic and diluted share, compared with a net loss of $7.7 million, or $30.67 per share, for the same period last year. As of June 30, 2026, we reported cash, cash equivalents, restricted cash, and marketable securities of $15.2 million. Please note, this cash total does not include our recent financing. As Bob previously mentioned, we recently announced a financing for up to $30 million, which provided $10 million in upfront gross proceeds and the potential for up to an additional $20 million upon the exercise of short- and long-term warrants. This financing provides us with the financial flexibility to execute the planned commercial launch of our second-generation LungFit PH in the U.S., pending FDA approval, as well as the international commercial expansion, subject to applicable regulatory approvals.

On our last quarterly call, we announced the change in our fiscal year-end from March 31 to December 31. While we are referring to calendar year goals, you may notice our SEC filing will still be on our March 31 fiscal year-end. We will move to calendar year reporting with the SEC subsequent to our December 31, 2026, filing.

With that, we will now open the call for questions.

Operator

With that, we will now open the call for questions. [Operator Instructions] Our first question comes from Michael King with Rodman & Renshaw. Please proceed with your question.

分析師問答

Jillian Weiss

This is Jillian Weiss on the line for Michael King from Rodman & Renshaw. So you mentioned the financing will support the Gen II LungFit PH launch and commercial rollout. Can you give us a little more detail on what the capital will actually be used for and where you expect to see the biggest investment over the next several quarters?

Daniel Moorhead

Sure, I can take that. It really is a lot for operations. So what we have going right now is we have the pilots, which are being built on the Gen II device, in the near term, and then upon FDA clearance, we'd be building a lot more devices and gaining commercial steam for 2027 and beyond. So it's really an operations function, but a lot of it is on the device. And then we are obviously in a cash burn position right now, so it will absorb some of that burn during that period as well.

Jillian Weiss

And are things starting to pick up on the contracting side, and do you think hospitals may be more willing to spend remaining budgets heading into year-end?

Robert Goodman

Yes, we've noticed a lot of pickup with contracting. Actually, our commercial functions really picked up a lot of that pace with a number of different new opportunities in front of us. Pipelines actually doubled over the last five or six months. So as you know, long sales cycle there, yet a lot of really -- a lot of this has picked up. So, yes.

Jillian Weiss

Okay, great. Thanks for taking my questions, and congrats on the quarter.

Operator

Thank you. Our next question comes from Yale Jen with Laidlaw & Company. Please proceed with your question.

Yale Jen

My first question is, any update in terms of the supplement PMA applications? What I meant is that, any interaction with the FDA and any other related stuff? Then I have a follow-up.

Robert Goodman

Yes, let me take that one, Dan. So yes, we've had a lot of activity and a lot of progress with the PMA supplement. So we've begun to submit paperwork to the FDA. They're already reviewing the paperwork, as Dan touched on. We're doing a couple of things with our contract manufacturer, finishing up our engineering build and our pilot builds of all the different products that will be validated by the FDA. So that's all part of this slew of paperwork that goes to them, and it all kind of lands on the performance qualification. It'll be a desk audit that the FDA will eventually be doing with us.

So all the different paperwork that's needed to go to them is getting to them on time. We're getting really good communication back and forth. I think I had mentioned on the last call, but this is a really good team over at the FDA. Very communicative, they get back to us within minutes or hours, sometimes days if it would typically take weeks, but they're really quick. And we're really positive on the way the process has been going.

Yale Jen

So at this point, would that still be things to be submitted, or basically everything is pretty much done except waiting for their decisions?

Robert Goodman

No, it's less of the decision piece and more of setting up. The next phase that we're in, and we're in this now, is that it's the audit phase. As they're reviewing the paperwork, they'll decide when the audits take place. There's a few different audits. We're already ready for a couple of those. And once our final pilot builds are done, which are happening now, we're doing that, then that part of the process will be dropped into their audit queue and their teams will come in and do their audits with us.

But yes, we're where we should be and they've received pretty much everything they need to receive. There's always a little back and forth, but not a back and forth that's setting us back. It's more of a, 'Hey, can you furnish us this?' 'oh, yes, that was in document A.' So, yes, everything's where it should be.

Yale Jen

Maybe just follow up on that, which is that given we are already in the midst of the third quarter right now, so should we really expect the potential decision likely be in the fourth quarter?

Robert Goodman

Yes, you know, I mean, what we're trying not to do is pinpoint an exact date. Only, Yale, the only reason for that, as you know, is it's not like with pharmaceuticals where you have a PDUFA date. Right, it's a medical device, we have to give a range. And yes, to your point, yes, we're now a month into Q3, so likely that would be a Q4 period. We're still in H2, and yes, if you want to try to figure out whether it be in Q3 or Q4, that's up to the FDA and how they're processing everything. So I guess let me step back and just say it's still going to be in H2, but we're only a month and a half away from Q4.

Yale Jen

Great. Maybe the last question, which is slightly different from the earlier one, which is that, given that the guidance you have $8 million to $10 million revenues for this year, the calendar '26, so a majority of them will come from the second half, which is starting this quarter. And just curious, what are the confidence at this point to support you feel that the second half will be -- have a greater revenue growth versus the first half?

Robert Goodman

Yes, so a couple of pieces on that, and Dan can definitely weigh in as well. But no, not $8 million to $10 million. The guidance was $8 million for this year. And so we're looking, really it's, if we could roll in about $3.7 million in H1, that means around $4.3 million in H2, and we're very confident that we'll be hitting that number. And the reason being is the pipeline that I referred to earlier. We've already started to see wins come in the quarter we're in right now, which will have some impact on the H2 numbers.

And then in addition to that, our international is starting to pick up a little bit, which is good. And that's immediate revenue recognition, as you know, because those are all being purchased. And then under our subscription model, where if you grab $1 million of business, it's not spread out over 12 months, and if we close that deal in November, you're really only getting a couple of hundred thousand dollars, you get the whole $1 million, right? So we have a lot of tenders that we have our hands firmly around.

We have already won a number of opportunities within this quarter that we know will be seeing that bump up as well. So, yes, we're reaffirming certainly the $8 million and we're also firmly standing behind our 2027 guidance. So, yes, I hope that answers that.

Yale Jen

That's very helpful. I appreciate it. And best of luck going forward. And thanks.

Operator

We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Robert Goodman for closing comments.

Robert Goodman

I just want to thank everybody for joining the call this morning and for all your support. And we look forward to continuing to provide feedback and updates, and look forward to our next call together. Have a great day.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.