비욘드 에어(XAIR) 2027 회계연도 1분기 실적 발표 컨퍼런스 콜: FDA 촉매제, 2026년 800만 달러 전망

비욘드 에어(NASDAQ: XAIR)는 2026년 6월 30일로 끝난 회계연도 1분기 매출이 안정적인 수준을 유지하고 매출총이익률이 개선되었다고 발표했습니다. 경영진은 2세대 룽핏 PH(LungFit PH) 시스템에 대한 미국 식품의약국(FDA)의 심사, 상업적 파이프라인 성장, 그리고 자금 조달 능력 확대에 집중했습니다.

핵심 요약

• 2027 회계연도 1분기 매출은 180만 달러로, 전년 동기 및 2026년 3월 분기(직전 분기)와 동일했습니다.
• 매출총이익률은 전년 동기의 9%에서 13%로 상승하여 3분기 연속 매출총이익 흑자를 기록했습니다.
• 보통주 주주 귀속 순손실은 전년 동기 770만 달러에서 790만 달러로 확대되었습니다. 주당순손실은 전년 동기 30.67달러에서 11.00달러를 기록했습니다.
• 경영진은 2026년 매출 가이던스 800만 달러와 2027년 매출 가이던스 1,600만~1,800만 달러를 재확인했습니다.
• 2세대 룽핏 PH는 현재 FDA 심사 단계에 있습니다. 경영진은 현재 절차 진행 상황을 고려할 때 결정을 받을 가능성이 있는 시점을 2026년 하반기로 지속 예상하고 있으며, 4분기에 결정될 가능성이 더 높다고 보고 있습니다.
• 비욘드 에어는 지난 5~6개월 동안 상업적 파이프라인이 2배로 늘어났으며, 글로벌 파트너십 대상 국가는 현재 40개국 이상으로 확대되었다고 밝혔습니다.

주요 재무 데이터

사업 및 영업 성과

비욘드 에어는 2세대 룽핏 PH 시스템의 미국 상업 출시 가능성에 대비해 준비 작업을 지속했습니다. 회사는 2025년 6월 FDA에 PMA 보충 신청서를 제출했으며, 위탁생산업체(CMO)와 엔지니어링 및 파일럿 제조가 순조롭게 진행되고 있다고 밝혔습니다.

경영진은 FDA가 필요한 서류의 대부분을 접수했으며 예상되는 여러 실사에 앞서 제출 자료를 검토 중이라고 밝혔습니다. 실사 절차에 포함하기 위한 최종 파일럿 제품 제조도 마무리되고 있습니다.

미국 내 세 번째 대형 그룹구매조직(GPO)과의 전국 구매 계약을 통해 상업적 접근성이 확대되었습니다. 이번 계약은 프리미어(Premier) 및 비지엔트(Vizient)와의 기존 계약과 함께 미국 내 병원 및 보건 시스템의 상당 부분에 공급할 수 있는 기반을 제공합니다.

회사는 또한 40개국 이상을 아우르는 유통 파트너십을 보유하고 있습니다. 경영진은 관련 규제 당국의 승인을 전제로, 강화된 재무상태표 덕분에 해외 파트너를 지원하는 능력이 향상될 것이라고 언급했습니다.

비욘드 에어는 최근 최대 3,000만 달러 규모의 자금을 확보했습니다. 이에는 1,000만 달러의 선급 총수익과 단기 및 장기 워런티의 행사 가능성을 통한 최대 2,000만 달러가 포함되어 있습니다. 자금 조달액은 파일럿 및 상업용 기기 생산, 지속적인 운영, 해외 시장 확장에 사용할 예정입니다.

경영진 가이던스

경영진은 2025년 대비 약 15% 증가한 2026년 매출 가이던스 800만 달러를 재확인했습니다. 이 전망치에는 2세대 룽핏 PH 시스템의 매출은 제외되어 있습니다.

회사는 2026년 상반기에 약 370만 달러의 매출을 올렸으며, 연간 목표를 달성하기 위해 하반기에 약 430만 달러를 예상하고 있습니다. 경영진은 최근의 상업적 계약 성과, 파이프라인 확대, 해외 구매 요청 및 활성화된 입찰 참여를 지지 요인으로 꼽았습니다.

2027년 매출 가이던스는 1,600만~1,800만 달러를 유지했습니다. 중간값 기준으로 이는 2026년 목표치 대비 110% 이상의 성장을 나타냅니다. 2026년 전망과 달리 2027년 예측에는 2세대 룽핏 PH 출시 가능성에 따른 매출이 포함되어 있으므로 FDA 승인 여부에 달려 있습니다.

리스크 및 주목할 점

• 2세대 룽핏 PH 심사의 시기와 결과는 여전히 FDA 절차에 달려 있습니다. 경영진은 구체적인 승인 날짜 명시를 사양했습니다.
• 회사는 여전히 현금 소모 상태에 있으며, 추가 2,000만 달러의 자금 조달은 워런티 행사에 따라 결정됩니다.
• 병원과의 계약 체결은 판매 주기가 길어, 확대된 파이프라인이 매출로 전환되는 시점에 영향을 미칠 수 있습니다.
• 해외 시장 확장은 해당 규제 당국의 승인 대상입니다.
• 2027년 매출 전망은 FDA 승인 이후 2세대 룽핏 PH 시스템의 상업적 출시 가능성을 전제로 합니다.

애널리스트 Q&A 주요 내용

경영진은 조달된 자금이 주로 운영 자금, 단기 2세대 파일럿 제조, 승인 가능성 이후의 대규모 기기 생산에 사용될 것이라고 밝혔습니다. 조달금의 일부는 출시 준비 기간 동안 회사의 현금 수요를 충당하는 데에도 쓰일 예정입니다.

상업적 활동과 관련하여 경영진은 계약 체결이 명확히 증가했으며 지난 5~6개월 동안 파이프라인이 2배로 늘었다고 보고했습니다. 최근의 계약 수주와 해외 구매건은 2026년 하반기 매출에 기여할 것으로 기대됩니다.

FDA 심사와 관련하여 경영진은 절차가 실사 단계로 진입했다고 설명했습니다. 서류 제출은 대부분 완료되었고, 당국과의 소통도 원활하게 이뤄지고 있으며, 최종 파일럿 제품 제조 후 여러 실사가 진행될 예정입니다. 경영진은 현재 일정을 감안할 때 4분기에 결정될 가능성이 더 높아 보인다는 점을 인정하면서도 2026년 하반기 승인 예상을 유지했습니다.

실적 발표 설명회(Earnings Call) 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.