ビヨンド・エア（XAIR）2027年度第1四半期決算説明会：FDAカタリスト、2026年見通し800万ドル

ビヨンド・エア（NASDAQ: XAIR）は、2026年6月30日を末日とする第1四半期（会計年度）の決算を発表し、安定した売上高と粗利益率の改善を記録しました。経営陣は、第2世代「LungFit PH」システムに関する米食品医薬品局（FDA）の審査待ちの状況、商用パイプラインの拡大、および資金調達能力の強化に焦点を当てました。

主要ハイライト

• 2027年度第1四半期の売上高は180万ドルとなり、前年同期および2026年3月期から横ばいとなりました。
• 粗利益率は前年同期の9%から13%に上昇し、3四半期連続で黒字（売上総利益の発生）を達成しました。
• 普通株主に帰属する純損失は、前年同期の770万ドルから790万ドルに拡大しました。1株当たり損失は前年同期の30.67ドルに対し、11.00ドルとなりました。
• 経営陣は、2026年暦年の売上高見通しを800万ドル、2027年暦年の見通しを1,600万ドル〜1,800万ドルとするガイダンスを再確認しました。
• 第2世代「LungFit PH」は現在もFDAの審査下にあります。経営陣は引き続き2026年後半に決定が下される可能性があると見込んでおり、現在の進捗段階を踏まえると、時期は第4四半期になる可能性が高いとしています。
• ビヨンド・エアは、過去5〜6か月間で商用パイプラインが倍増したほか、国際的なパートナーシップは現在40か国以上に及んでいると発表しました。

主要財務データ

事業および業績ハイライト

ビヨンド・エアは、第2世代「LungFit PH」システムの米国での商業化ローンチに向けた準備を継続しました。同社は2025年6月にFDAにPMA（医療機器承認申請）の補足申請を提出しており、受託製造業者とのエンジニアリングおよびパイロット製造が進展していると述べました。

経営陣によると、FDAは必要な文書の実質的にすべてを受領しており、予定されている複数の監査に先立って資料を審査しています。また、監査プロセスに含めるための最終パイロット製造も完了しつつあります。

全米第3の規模を持つ主要共同購買組織（GPO）との全国購入契約を通じ、商業アクセスが拡大しました。PremierおよびVizientとの既存の契約と合わせることで、これらの取り決めにより米国の病院およびヘルスケアシステムの相当部分へのアクセスが提供されます。

同社はまた、40か国以上を網羅する販売パートナーシップを有しています。経営陣は、貸借対照表（バランスシート）が強化されたことで、関連する規制当局の承認を条件として、国際パートナーを支援する能力が向上するはずであると述べました。

ビヨンド・エアは最近、最大3,000万ドルの資金調達を確保しました。これには、初回の総収入1,000万ドルと、短期および長期ワラントの権利行使により調達可能な最大2,000万ドルが含まれます。調達資金は、パイロット機および商用機器の製造、継続的な事業運営、国際展開を支援することを目的としています。

業績予想（ガイダンス）

経営陣は、2026年暦年の売上高ガイダンスを2025年暦年比で約15%増となる800万ドルと再確認しました。この予想には、第2世代「LungFit PH」システムからの売上高は含まれていません。

同社は2026年暦年の前半に約370万ドルを計上しており、通期目標を達成するために後半に約430万ドルを見込んでいます。経営陣は支持要因として、最近の新規顧客獲得、パイプラインの拡大、海外からの購入、アクティブな入札案件を挙げています。

2027年暦年の売上高ガイダンスは1,600万ドル〜1,800万ドルを維持しています。中間値では、これは2026年目標から110%以上の成長を意味します。2026年の見通しとは異なり、2027年の予測には第2世代「LungFit PH」のローンチによる潜在的な売上高が含まれているため、FDAの承認に依存します。

リスクと今後の注目点

• 第2世代「LungFit PH」の審査時期と結果は、引き続きFDAのプロセス次第です。経営陣は正確な承認日程の提示を控えました。
• 同社は引き続きキャッシュバーン（資金消費）の状態にあり、追加の2,000万ドルの資金調達はワラントの権利行使にかかっています。
• 病院との契約締結には長い営業サイクルが伴うため、拡大したパイプラインから売上高への変換時期に影響を与える可能性があります。
• 国際展開は引き続き、関連する規制当局の承認に左右されます。
• 2027年の売上高見通しは、FDA承認後の第2世代「LungFit PH」システムの商業ローンチの可能性を前提としています。

アナリスト質疑応答のハイライト

経営陣は、調達資金が主に事業運営費、近々の第2世代（Gen II）パイロット製造、および潜在的なFDA承認後の大規模な機器製造に充てられると説明しました。資金の一部は、ローンチ準備期間中の同社の現金需要の支援にも充てられます。

商業活動に関して、経営陣は契約の締結が明らかに増加していると報告し、過去5〜6か月でパイプラインが倍増したと述べました。最近の契約獲得や海外からの購入は、2026年暦年後半の売上高に寄与すると予想されています。

FDAの審査について、経営陣はプロセスが監査段階に入ったと述べました。文書の提出はほぼ完了しており、当局との対話も迅速に行われており、最終パイロット製造の完了後に複数の監査が予定されています。経営陣は現在のスケジュールを踏まえると第4四半期の決定がより可能性が高いと認めつつも、2026年後半とする予想を維持しました。

決算説明会（トランスクリプト）全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.