Q1 2027 Beyond Air Inc Earnings Call
Speaker #1: Greetings, and welcome to the Beyond Air Financial Results for the quarter ending June 30th, 2026. At this time, participants are Nalyssa only mode. A question and answer session will follow the formal presentation.
Operator 2: Greetings, and welcome to the Beyond Air financial results for the quarter ending 30 June 2026. At this time, participants are in a listen-only mode. A question and answer session will follow the formal presentation. I would now like to turn the call over to Corey Davis, LifeSci Advisors. Please go ahead.
Operator: Greetings, and welcome to the Beyond Air financial results for the quarter ending 30 June 2026. At this time, participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. I would now like to turn the call over to Corey Davis, LifeSci Advisors. Please go ahead.
Speaker #1: And now, I would like to turn the call over to Corey Davis, LifeSci advisors. Please go ahead.
Speaker #2: 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 30th, 2026.
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 the financial results for Beyond Air's quarter ended 30 June 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 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 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.
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 the financial results for Beyond Air's quarter ended 30 June 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 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 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.
Speaker #2: 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 in 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.
Speaker #2: 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.
Corey Davis: 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 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, beyondair.net. Furthermore, the content of this call contains time-sensitive information that is accurate only as of the date of the live broadcast, 13 August 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 will turn the call over to Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.
Corey Davis: 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 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, beyondair.net. Furthermore, the content of this call contains time-sensitive information that is accurate only as of the date of the live broadcast, 13 August 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 will turn the call over to Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.
Speaker #2: 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.
Speaker #2: Furthermore, the content of this call contains time-sensitive information that is accurate only, as of the date of the live broadcast, August 13th, 2026. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.
Speaker #2: With that, I'll turn the call over to Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.
Speaker #3: 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 will keep my prepared remarks fairly brief.
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 will keep my prepared remarks fairly brief. Over the past few months, we have 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 continued 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.
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 will keep my prepared remarks fairly brief. Over the past few months, we have 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 continued 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.
Speaker #3: 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 continued to expand the commercial foundation supporting one-fifth PH.
Speaker #3: 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.
Speaker #3: As we prepare for the planned commercial launch of our second-generation one-fifth 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.
Robert Goodman: 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 30 June 2026 was $1.8 million, which is effectively flat from the March 2026 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.
Robert Goodman: 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 30 June 2026 was $1.8 million, which is effectively flat from the March 2026 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.
Speaker #3: 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 2026 quarter.
Speaker #3: 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 one-fifth PH system.
Speaker #3: 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 US GPO, becoming the third major national GPO to partner with Beyond Air.
Robert Goodman: 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 US 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 US 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.
Robert Goodman: 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 US 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 US 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.
Speaker #3: Together with our existing agreements with Premier and Vizion, these relationships provide access to a substantial portion of US hospitals and health systems and represent an important component to our commercial strategy.
Speaker #3: We also continue to expand our global distribution network through new and existing commercial partnerships, further extending One-Fifth PH's reach into international markets. Another growth center for the company will be the expansion of our international distribution.
Speaker #3: 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.
Robert Goodman: As a result of our strengthened financial position following the recent equity raise, we are 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 2 LungFit system in the US, 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 potential approval in the H2 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.
Robert Goodman: As a result of our strengthened financial position following the recent equity raise, we are 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 2 LungFit system in the US, 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 potential approval in the H2 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.
Speaker #3: We look forward to providing updates on these programs as appropriate. As it relates to the Gen 2 one-fifth system in the US, which remains under review at the FDA, we continue to believe this to be the most important near-term catalyst for the company.
Speaker #3: 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.
Speaker #3: Although the timing and outcome of the review remain subject to the FDA approval process, we continue to prepare for a potential commercial launch.
Speaker #3: We are maintaining a disciplined and focused approach to capital allocation. We continue to dedicate our resources predominantly to one-fifth 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.
Robert Goodman: 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.
Robert Goodman: 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.
Speaker #3: I think it is worth noting that we're not including any revenue from the second-generation one-fifth for 2026. We also reaffirm our previously issued 2027 revenue guidance of $16 to $18 million representing more than 110% growth at the midpoint compared with our 2026 guidance.
Robert Goodman: I think it is worth noting that we are not including any revenue from the second-generation LungFit for 2026. We also reaffirm our previously issued 2027 revenue guidance of $16 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 will turn the call over to Dan for a review of our financial results. Dan?
Robert Goodman: I think it is worth noting that we are not including any revenue from the second-generation LungFit for 2026. We also reaffirm our previously issued 2027 revenue guidance of $16 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 will turn the call over to Dan for a review of our financial results. Dan?
Speaker #3: The guidance for 2027 does include revenue from the potential commercial launch for the second-generation one-fifth PH system, subject to FDA approval. Looking forward, Beyond Air is approaching an important inflection point.
Speaker #3: With continued international expansion and planned commercial launch of our second-generation one-fifth systems pending approval, we have established a stronger foundation to accelerate commercial execution and drive meaningful revenue over the coming years.
Speaker #3: With that, I'll turn the call over to Dan for review of our financial results. Dan?
Speaker #4: Thanks, Bob. And good morning, everyone. I'll walk through our financial results for the quarter ended June 30th, 2026. Revenue for the quarters ended June 30th, 2026, and 2025 was $1.8 million.
Dan Moorhead: Thanks, Bob, and good morning, everyone. I will walk through our financial results for the quarter ended 30 June 2026. Revenue for the quarters ended 30 June 2026 and 2025 was $1.8 million. Gross margin for the quarter ended 30 June 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 30 June 2026 were $2 million, compared with $3.1 million for the same period last year. Selling, general and administrative expenses for the quarter ended 30 June 2026 were $4.9 million, compared with $4.7 million for the same period last year. Other expense for the quarter ended 30 June 2026 was $1.5 million, compared with $500,000 for the same period last year.
Dan Moorhead: Thanks, Bob, and good morning, everyone. I will walk through our financial results for the quarter ended 30 June 2026. Revenue for the quarters ended 30 June 2026 and 2025 was $1.8 million. Gross margin for the quarter ended 30 June 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 30 June 2026 were $2 million, compared with $3.1 million for the same period last year. Selling, general and administrative expenses for the quarter ended 30 June 2026 were $4.9 million, compared with $4.7 million for the same period last year. Other expense for the quarter ended 30 June 2026 was $1.5 million, compared with $500,000 for the same period last year.
Speaker #4: Gross margin for the quarter ended June 30, 2026, was 13%, compared with a gross margin of 9% for the same period last year. This marks our third consecutive quarter of positive gross profit.
Speaker #4: Research and development expenses for the quarters ended June 30th, 2026, were $2 million compared with $3.1 million for the same period last year. Selling general and administrative expenses for the quarter ended June 30th, 2026, were $4.9 million, compared with $4.7 million for the same period last year.
Speaker #4: Other expense for the quarter ended June 30th, 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 30th, 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.
Dan Moorhead: Net loss attributable to common stockholders of Beyond Air for the quarter ended 30 June 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 30 June 2026, we reported 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.
Dan Moorhead: Net loss attributable to common stockholders of Beyond Air for the quarter ended 30 June 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 30 June 2026, we reported 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.
Speaker #4: As of June 30th, 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.
Speaker #4: 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.
Speaker #4: This financing provides us with the financial flexibility to execute the planned commercial launch of our second-generation one-fifth PH in the U.S., pending FDA approval, as well as the international commercial expansion, subject to applicable regulatory approvals.
Dan Moorhead: This financing provides us with the financial flexibility to execute the planned commercial launch of our second-generation LungFit PH in the US, pending FDA approval, as well as the international commercial expansion, subject to applicable regulatory approvals. On our last quarterly call, we announced a change in our fiscal year-end from 31 March to 31 December. While we are referring to calendar year goals, you may notice our SEC filings will still be on our 31 March fiscal year-end. We will move to calendar year reporting with the SEC subsequent to our 31 December 2026 filing. With that, we will now open the call for questions.
Dan Moorhead: This financing provides us with the financial flexibility to execute the planned commercial launch of our second-generation LungFit PH in the US, pending FDA approval, as well as the international commercial expansion, subject to applicable regulatory approvals. On our last quarterly call, we announced a change in our fiscal year-end from 31 March to 31 December. While we are referring to calendar year goals, you may notice our SEC filings will still be on our 31 March fiscal year-end. We will move to calendar year reporting with the SEC subsequent to our 31 December 2026 filing. With that, we will now open the call for questions.
Speaker #4: 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 filings will still be on our March 31 fiscal year-end.
Speaker #4: We will move to calendar year reporting with the SEC subsequent to our December 31st, 2026 filing. With that, we will now open the call for questions.
Speaker #1: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad.
Operator 2: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for questions. Our first question comes from Michael King with Rodman & Renshaw. Please proceed with your question.
Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for questions. Our first question comes from Michael King with Rodman & Renshaw. Please proceed with your question.
Speaker #1: A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.
Speaker #1: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions.
Speaker #1: Our first question comes from Michael King with Rodman & Rentra. Please proceed with your question.
Speaker #5: Hi, everyone. This is Jillian Weiss on the line for Michael King from Rodman & Rentra. So you mentioned the financing will support the Gen 2 one-fifth PH launch and commercial build-out.
Jillian Weiss: Hi, everyone. This is Jillian Weiss on the line for Michael King from Rodman & Renshaw. You mentioned the financing will support the Gen 2 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?
Jillian Weiss: Hi, everyone. This is Jillian Weiss on the line for Michael King from Rodman & Renshaw. You mentioned the financing will support the Gen 2 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?
Speaker #5: 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?
Speaker #3: 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 2 device.
Robert Goodman: Sure. I can take that. It really is a lot for operations. What we have going right now is we have the pilots, which are being built on the Gen 2 device, in the near term, and then upon FDA clearance, we would be building a lot more devices and gaining commercial steam for 2027 and beyond. It is really an operations function, but a lot of it is on the device. Then we are obviously in a cash burn position right now, so it will absorb some of that burn during that period as well.
Dan Moorhead: Sure. I can take that. It really is a lot for operations. What we have going right now is we have the pilots, which are being built on the Gen 2 device, in the near term, and then upon FDA clearance, we would be building a lot more devices and gaining commercial steam for 2027 and beyond. It is really an operations function, but a lot of it is on the device. Then we are obviously in a cash burn position right now, so it will absorb some of that burn during that period as well.
Speaker #3: 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 it's a lot of it is on the device.
Speaker #3: And then we are obviously in a cash burn position right now, so it'll absorb some of that burn during that period as well.
Speaker #5: Okay, great. 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?
Jillian Weiss: Okay, great. Are things starting to pick up on the contracting side? Do you think hospitals may be more willing to spend remaining budgets heading into year-end?
Jillian Weiss: Okay, great. Are things starting to pick up on the contracting side? Do you think hospitals may be more willing to spend remaining budgets heading into year-end?
Speaker #3: Yeah, yeah. We've noticed a lot of pickup with contracting. Actually, our commercial functions have really picked up a lot of that pace with a number of different new opportunities in front of us.
Robert Goodman: Yeah. 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. Pipeline's actually doubled over the last five or six months. As you know, long sales cycle here, yet-
Robert Goodman: Yeah. 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. Pipeline's actually doubled over the last five or six months. As you know, long sales cycle here, yet- a lot of this has picked up. So yeah.
Speaker #3: Pipelines actually doubled over the last five or six months. So as you know, long sales cycle here, yet a lot of really a lot of this has picked up.
Robert Goodman: a lot of this has picked up. So yeah.
Speaker #3: So yeah.
Speaker #5: Okay, great. Thanks for taking my questions, and congrats on the quarter.
Jillian Weiss: Okay, great. Thanks for taking my questions, and congrats on the quarter.
Jillian Weiss: Okay, great. Thanks for taking my questions, and congrats on the quarter.
Speaker #3: Thank you.
Robert Goodman: Thank you.
Robert Goodman: Thank you.
Speaker #4: Thanks.
Dan Moorhead: Thanks.
Dan Moorhead: Thanks.
Speaker #1: Our next question comes from Yael Jen with Lead Law & Co. Please proceed with your question.
Operator 2: Our next question comes from Yale Jen with Laidlaw & Co. Please proceed with your question.
Operator: Our next question comes from Yale Jen with Laidlaw & Co. Please proceed with your question.
Speaker #6: Good morning, and thanks for taking the questions. My first question is: are there any updates in terms of the supplement PMA applications? What I mean is, has there been any interaction with the FDA or any other related matters? Then I have a follow-up.
Yale Jen: Good morning, and thanks for taking the questions. My first question is any update in terms of the supplement PMA applications? What I meant is any interaction with the FDA and any other related stuff? Then I have a follow-up.
Yale Jen: Good morning, and thanks for taking the questions. My first question is any update in terms of the supplement PMA applications? What I meant is any interaction with the FDA and any other related stuff? Then I have a follow-up.
Speaker #3: Yeah, let me take that one, Dan. So, yeah, we've had a lot of activity and a lot of progress with the PMA supplement. We've begun to submit paperwork to the FDA.
Robert Goodman: Yeah, let me take that one, Dan. We have had a lot of activity and a lot of progress with the PMA supplement. We have begun to submit paperwork to the FDA. They are already reviewing the paperwork. As Dan touched on, we are doing a couple of things with our contract manufacturer of finishing up our engineering build and our pilot builds of all the different products that will be validated by the FDA. That is all part of this slew of paperwork that goes to them, and it all kind of lands on the performance qualification. It will be a desk audit that the FDA will eventually be doing with us. All the different paperwork that is needed to go to them is getting to them on time. We are getting really good communication back and forth.
Robert Goodman: Yeah, let me take that one, Dan. We have had a lot of activity and a lot of progress with the PMA supplement. We have begun to submit paperwork to the FDA. They are already reviewing the paperwork. As Dan touched on, we are doing a couple of things with our contract manufacturer of finishing up our engineering build and our pilot builds of all the different products that will be validated by the FDA. That is all part of this slew of paperwork that goes to them, and it all kind of lands on the performance qualification. It will be a desk audit that the FDA will eventually be doing with us. All the different paperwork that is needed to go to them is getting to them on time. We are getting really good communication back and forth.
Speaker #3: 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 we'll be validated by the FDA.
Speaker #3: 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.
Speaker #3: 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.
Robert Goodman: I think I mentioned on the last call, 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 are really quick. And we are really positive on the way the process has been going.
Robert Goodman: I think I mentioned on the last call, 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 are really quick. And we are really positive on the way the process has been going.
Speaker #3: 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, when it would typically take weeks, but they're really quick.
Speaker #3: And yeah, we're really positive on the way the process has been going.
Speaker #6: So at this point, would that still be things to be submitted, or basically everything is pretty much done except waiting for their decisions?
Yale Jen: At this point, would that still be things to be submitted, or basically everything is pretty much done except waiting for their decisions?
Yale Jen: At this point, would that still be things to be submitted, or basically everything is pretty much done except waiting for their decisions?
Speaker #3: No, it's less about the decision piece and more about setting up. So, the next phase that we're in—and we're in this now—is the audit phase, as they're reviewing the paperwork.
Robert Goodman: No, it is less of the decision piece and more of setting up. The next phase that we are in, and we are in this now, is that it is the audit phase. As they are reviewing the paperwork, they will decide when the audits take place. There are a few different audits, and we are already ready for a couple of those. Once our final pilot builds are done, which are happening now, we are 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 no, we are where we should be, and they have received pretty much everything they need to receive. There is always a little back and forth, but not a back and forth that is setting us back.
Robert Goodman: No, it is less of the decision piece and more of setting up. The next phase that we are in, and we are in this now, is that it is the audit phase. As they are reviewing the paperwork, they will decide when the audits take place. There are a few different audits, and we are already ready for a couple of those. Once our final pilot builds are done, which are happening now, we are 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 no, we are where we should be, and they have received pretty much everything they need to receive. There is always a little back and forth, but not a back and forth that is setting us back.
Speaker #3: They'll decide when the audits take place. And there's a few different audits. And 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.
Speaker #3: And their teams will come in and do their audits with us. But yeah, no, we're where we should be. And they've received pretty much everything they need to receive.
Speaker #3: 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?" or, "Oh yeah, that was in document A." So yeah, everything's where it should be.
Robert Goodman: It is more of a, "Hey, can you furnish us this?" And "Oh yeah, that was in document A." So everything is where it should be.
Robert Goodman: It is more of a, "Hey, can you furnish us this?" And "Oh yeah, that was in document A." So everything is where it should be.
Speaker #6: Okay. Maybe just a follow-up on that, which is that given we are already in the midst of the third quarter right now, so should we realistically expect the potential decision likely be in the fourth quarter?
Yale Jen: Okay, maybe just follow up on that, which is that, given we are already in the midst of Q3 right now, so should we realistically expect the potential decision likely be in Q4?
Yale Jen: Okay, maybe just follow up on that, which is that, given we are already in the midst of Q3 right now, so should we realistically expect the potential decision likely be in Q4?
Speaker #3: Yeah. I mean, what we're trying not to do is pinpoint an exact date. And, Yael, the only reason for that is, you know.
Robert Goodman: Yeah. What we're trying not to do is pinpoint an exact date. Only, Yale, the only reason for that is, it's not like with pharmaceuticals where you have a PDUFA date. Since it's a medical device, we have to give a range. Yes, to your point, yeah, we're now a month into Q3, so likely that would be a Q4 period. We're still in H2 and yeah, if you were to want to try to figure out, would it be in Q3 or Q4, that's up to the FDA and how they're processing everything. 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.
Robert Goodman: Yeah. What we're trying not to do is pinpoint an exact date. Only, Yale, the only reason for that is, it's not like with pharmaceuticals where you have a PDUFA date. Since it's a medical device, we have to give a range. Yes, to your point, yeah, we're now a month into Q3, so likely that would be a Q4 period. We're still in H2 and yeah, if you were to want to try to figure out, would it be in Q3 or Q4, that's up to the FDA and how they're processing everything. 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.
Speaker #3: It's not like with pharmaceuticals where you have a PDUFA date. Since it's a medical device, we have to give a range. And yes, to your point, yeah, we're now a month into Q3.
Speaker #3: So likely, that would be a Q4 period. We're still in H2. And yeah, if you were to want to try to figure out, would it be in Q3 or Q4?
Speaker #3: 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.
Speaker #3: But we're only a month and a half away from Q4.
Speaker #6: Okay. Great. Maybe a last question, which is slightly different from the earlier one, which is that given that the guidance you have 8 to 10 million revenues for the for this year, calendar 26, so a major a majority of them will come from the second half, which is starting this quarter.
Yale Jen: Okay, great. Maybe last questions, which is slightly different from the earlier one, which is that, given that the guidance you have, 8 to 10 million revenues for this year, calendar 2026. So a majority of them will come from the H2, which is starting this quarter. Just curious, what are the confidence at this point to support you feel that the H2 will have a greater revenue growth versus the H1? Thanks for taking the questions.
Yale Jen: Okay, great. Maybe last questions, which is slightly different from the earlier one, which is that, given that the guidance you have, 8 to 10 million revenues for this year, calendar 2026. So a majority of them will come from the H2, which is starting this quarter. Just curious, what are the confidence at this point to support you feel that the H2 will have a greater revenue growth versus the H1? Thanks for taking the questions.
Speaker #6: And just curious, what are the confidence levels at this point that support your feeling that the second half will have greater revenue growth versus the first half? Thanks for taking the questions.
Speaker #3: Yeah, so a couple of pieces on that—and Dan can definitely weigh in as well—but no, not $8 to $10 million. The guidance was $8 million for this year.
Robert Goodman: Yeah. So a couple of pieces on that, and Dan can definitely weigh in as well. But no, not an 8 to 10. The guidance was $8 million for this year.
Robert Goodman: Yeah. So a couple of pieces on that, and Dan can definitely weigh in as well. But no, not an 8 to 10. The guidance was $8 million for this year.
Speaker #3: And so.
Speaker #6: Hey, David, I'm sorry.
Yale Jen: 8 billion, I am sorry.
Yale Jen: 8 billion, I am sorry.
Robert Goodman: We are looking. Yeah. So, really, if we could roll in about 3.7 in H1, that means around 4.3 in H2. We are very confident that we will be hitting that number, and the reason being is the pipeline that I referred to earlier. We have already started to see wins come in the quarter we are in right now, which will have some impact on the H2 numbers. In addition to that, our international is starting to pick up a little bit, which is good. That is 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 is not spread out over 12 months, and if we close that deal in November, you are really only getting a couple of hundred thousand dollars. You get the whole $1 million, right?
Robert Goodman: We are looking. Yeah. So, really, if we could roll in about 3.7 in H1, that means around 4.3 in H2. We are very confident that we will be hitting that number, and the reason being is the pipeline that I referred to earlier. We have already started to see wins come in the quarter we are in right now, which will have some impact on the H2 numbers. In addition to that, our international is starting to pick up a little bit, which is good. That is 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 is not spread out over 12 months, and if we close that deal in November, you are really only getting a couple of hundred thousand dollars. You get the whole $1 million, right?
Speaker #3: We're looking yeah. Yeah. So I mean, really, it's if we could roll in about 3.7 in H1, that means around 4.3 in H2. And we're very confident that we'll be hitting that number.
Speaker #3: 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 we'll have some impact on the H2 numbers.
Speaker #3: 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.
Speaker #3: Because those are all being purchased. And then, under our subscription model, if you grab a million dollars of business, it's not spread out over 12 months.
Speaker #3: And if we close that deal in November, you're really only getting a couple of hundred thousand dollars. You get the whole million dollars, right?
Speaker #3: So, we have a lot of tenders that we have our hands firmly around. We've already won a number of opportunities within this quarter that we know will be seeing that bump up as well.
Robert Goodman: 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. Yeah. So we are reaffirming certainly the $8 million, and we are also firmly standing behind our 2027 guidance. Yeah, I hope that answers that.
Robert Goodman: 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. Yeah. So we are reaffirming certainly the $8 million, and we are also firmly standing behind our 2027 guidance. Yeah, I hope that answers that.
Speaker #3: So yeah, so we're reaffirming certainly the 8 million. And we're also firmly standing behind our 2027 guidance. So yeah, I hope that answers that.
Speaker #6: Okay. Great. That's very helpful. I appreciate it. And best of luck going forward. And thanks.
Yale Jen: Okay, great. That is very helpful. Appreciate it and best luck going forward. Thanks.
Yale Jen: Okay, great. That is very helpful. Appreciate it and best luck going forward. Thanks.
Speaker #3: Yeah. Great. Thanks, y'all.
Robert Goodman: Yeah, great. Thanks, Yao.
Robert Goodman: Yeah, great. Thanks, Yao.
Speaker #1: 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.
Operator 2: 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.
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.
Speaker #3: Yeah, I just want to thank everybody for joining the call this morning and for all your support. We look forward to continuing to provide feedback.
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.
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.
Speaker #3: And updates. And look forward to our next call together. Have a great day.
Operator 2: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
