Asensus Surgical - Q1 2024

Executive Summary

• Q1 2024 revenue was $1.123M, up modestly year over year from $0.976M but down sharply from Q4’s $5.431M due to the absence of system sales; GAAP net loss was $22.5M (-$0.08 EPS) and adjusted net loss improved to $18.0M (-$0.07).
• Cash and short-term investments were $8.0M at March 31; management guided runway into Q3 2024, with an additional $10M contingent tranche supporting operations into Q4 if a definitive agreement with KARL STORZ is signed.
• The company entered a non-binding acquisition proposal and exclusivity arrangement with KARL STORZ at $0.35 per share and received up to $20M of secured bridge financing; $7M of the initial tranche was drawn, materially impacting near-term liquidity and stock narrative catalysts.
• 2024 operational milestones were reaffirmed: 8–10 Senhance program initiations, 15–20% procedure growth, LUNA design freeze in Q3, and verification/validation in Q4 (a timeline already adjusted in March); nearly 900 procedures in Q1 indicate utilization resilience amid strategic review.

What Went Well and What Went Wrong

What Went Well

• Continued utilization momentum: “nearly 900 procedures” in Q1, with pediatric traction and a new Senhance lease at Sendai Tokushukai Hospital in Japan; CEO: “steady growth in the adoption of our digital surgery solutions”.
• Liquidity bridge and strategic optionality: KARL STORZ bridge financing and exclusivity provide operating runway and a potential exit at $0.35 per share; CFO: “available cash will now sustain operations into Q3 2024”.
• Non-GAAP improvement: adjusted net loss narrowed to $18.0M vs $22.0M in Q1 2023, reflecting non-cash revaluation items; CFO reiterated usefulness of non-GAAP to assess core operations.

What Went Wrong

• Sequential revenue compression to $1.123M vs $5.431M in Q4, driven by lumpy system sales (Q4 had $3.6M system revenue; Q1 consisted of lease, instruments/accessories, services).
• Elevated operating expenses ($22.7M vs $20.4M prior year) and gross loss (-$1.933M), sustaining high burn despite cost actions initiated in 2H23.
• Balance sheet erosion and prior going-concern risk disclosure (March): year-end cash/short-term investments of $21.1M fell to $8.0M by March 31; Q4 press release flagged a going-concern paragraph in the 10-K audit opinion, underscoring financing dependency.

Transcript

Operator (participant)

Good afternoon, ladies and gentlemen, and welcome to the Asensus Surgical first quarter financial and operating results call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, May 14, 2024. I would now like to turn the conference over to Mark Klausner from Westwicke Partners. Please go ahead.

Mark Klausner (Head of Investor Relations)

Good afternoon, everyone, and thank you for joining us for the Asensus Surgical first quarter business and financial update conference call. On the call with me today are Anthony Fernando, President and Chief Executive Officer, and Shameze Rampertab, Chief Financial Officer. Before we begin, I would like to caution listeners that certain information discussed by management during this conference call, including any guidance provided, are forward-looking statements provided under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business, including any geopolitical factors beyond our control and the uncertainty of whether a definitive merger agreement can be successfully negotiated with KARL STORZ, and if executed, will be approved by our stockholders.

The company undertakes no obligation to update the information provided on this call. For a discussion of risks and uncertainties associated with the Asensus Surgical business, I encourage you to review the company's filings with the Securities and Exchange Commission, including the 2023 Form 10-K filed in March 2024 and the Form 10-Q expected to be filed later today, and any other filings we make with the SEC. During this call, we will also present certain non-GAAP financial information related to adjusted net loss attributable to common stockholders and the adjusted net loss per share attributable to common stockholders. Management believes that these non-GAAP financial measures, taken in conjunction with U.S. GAAP financial measures, provide useful information for both management and investors by excluding certain non-cash and other expenses that are not indicative of the company's core operating results.

Management uses non-GAAP financial measures to compare our performance relative to forecast and strategic plans, to benchmark our performance externally against competitors, and for certain compensation decisions. Reconciliations from U.S. GAAP to non-GAAP results are presented in the tables accompanying our earnings release, which can be found in the Investor Relations section of our website. With that, it's my pleasure to turn the call over to Asensus Surgical's President and Chief Executive Officer, Anthony Fernando.

Anthony Fernando (President and CEO)

Thanks, Mark, and thank you all for joining with us today. To start, I'll give a summary of our recent performance and notable accomplishments in the first quarter of 2024. Then Shameze will dive into our financial results. Following that, I'll discuss what lies ahead of us in 2024, and finally, we'll open the floor for any questions you may have. First, I'd like to provide an update on a recent development for the company. In early April, we entered into a non-binding letter of intent with KARL STORZ regarding a potential acquisition of Asensus. Under the proposed terms, KARL STORZ would acquire 100% of our outstanding common stock for $0.35 per share in cash.

As a reminder, KARL STORZ is a global leader in the medical technology industry, offering state-of-the-art endoscopes, medical instruments, and devices for minimally invasive procedures across various surgical specialties.

KARL STORZ is an independent, family-owned company with a strong global presence and is committed to visionary design, precision craftsmanship, and clinical effectiveness. We believe that this potential acquisition by KARL STORZ provides an attractive opportunity to deliver unmatched clinical value coupled with state-of-the-art robotics and digital solutions to the operating room. KARL STORZ's global presence and scale, resources, and commercial capabilities could enable broader adoption of our combined digital surgery solutions and maximize the potential of LUNA and the ISU. As previously disclosed, we have granted KARL STORZ a 10-week exclusivity period to conduct due diligence and negotiate a definitive merger agreement. This exclusivity period started on March 28, 2024, and is ongoing.

During the exclusivity period, KARL STORZ is providing us with up to $10 million in financing through a fully secured promissory note to support our operations, and if a definitive merger agreement is successfully negotiated and executed, an additional $10 million will be available to us as we pursue all necessary approvals. Since announcing the potential transaction on April 3rd, we have been working closely with KARL STORZ to facilitate their due diligence process. As of today, we have drawn the first $7 million of the $10 million tranche of the note, which has provided liquidity for operations.

To evaluate the potential terms of the transaction and make a recommendation to stockholders, our board has formed a transaction committee. While there is no assurance a transaction will be completed, we believe exploring this opportunity with KARL STORZ is in the best interest of the company and our stockholders.

If we are able to finalize the definitive merger agreement with KARL STORZ, we will move expeditiously to secure stockholder approval for the proposed acquisition. Further updates will be provided as appropriate. Despite the ongoing diligence activities, we remain focused on our business and, in particular, the continued growth of the Senhance system and ongoing development of the LUNA system and ISU. In the first quarter, the Senhance system was used in nearly 900 procedures worldwide. By continually capturing data from these surgeries, our machine learning capabilities improve, allowing us to provide increasingly valuable clinical insights to surgeons through the Intelligent Surgical Unit in the future. With specialized 3 mm and 5 mm instruments, the Senhance surgical system is uniquely designed for the delicate nature of pediatric procedures.

As more pediatric surgeons recognize Asensus' unique system design, which not only preserves minimally invasive surgery but also advances laparoscopy and robotics with digital surgery solutions, we expect the number of pediatric procedures performed using Senhance and the ISU to continue to grow. Moving to new program initiations. In April, we announced that Sendai Tokushukai Hospital in Japan entered into an agreement to lease and utilize one of our Senhance surgical systems. This represents the second institution within one of Japan's largest private hospital systems to adopt our technology. I view this as further validation of the growing trust in our Senhance system in the Japanese market. In summary, the first quarter saw steady growth in the adoption of our digital surgery solutions and continued progress in enhancing the capabilities of the Senhance platform.

We are excited about the potential opportunity to join forces with KARL STORZ to accelerate our mission of digitizing the surgical environment. While we work towards a potential transaction, our team remains focused on executing against our key initiatives, including driving further adoption through new program initiations, increasing procedure volumes, expanding our clinical registry, and advancing our LUNA platform development. We believe we are well positioned for continued momentum in 2024. With that, I would like to turn the call over to Shameze for a financial update.

Shameze Rampertab (CFO)

Thanks, Anthony. Turning to the first quarter, where the three months ended March 31, 2024, the company reported revenue of $1.1 million as compared to revenue of $1 million in the three months ended March 31, 2023. Revenue in the first quarter of 2024 included $0.5 million in lease revenue, $0.3 million in instruments and accessories, and $0.3 million in services. For the three months ended March 31, 2024, total operating expenses were $22.7 million as compared to $20.4 million in the three months ended March 31, 2023. For the three months ended March 31, 2024, net loss attributable to common stockholders was $22.5 million or $0.08 per share as compared to a net loss attributable to common stockholders of $22.2 million or $0.09 per share in the three months ended March 31, 2023.

For the three months ended March 31, 2024, the adjusted net loss attributable to common stockholders was $18 million or $0.07 per share as compared to an adjusted net loss of $22 million or $0.09 per share in the three months ended March 31, 2023. Adjusted net loss is GAAP net loss adjusted for the following items: amortization of intangible assets, change in fair value of contingent consideration, and change in fair value of warrant liabilities, all of which are non-cash charges. Adjusted net loss attributable to common stockholders is a non-GAAP financial measure. Reconciliation from GAAP to non-GAAP measures can be found in our earnings release. Turning to the balance sheet, the company had cash, cash equivalents, and short-term investments, excluding restricted cash, of approximately $8 million as of March 31, 2024.

Based on the recent financing received from KARL STORZ and our current operating plan, we project that available cash will now sustain operations into Q3 2024. If we sign the definitive agreement with KARL STORZ, the additional $10 million that we would be eligible to receive would support operations into Q4 2024 if we secure such financing. I'll turn the call back over to Anthony.

Anthony Fernando (President and CEO)

Thanks, Shameze. Our key initiatives for 2024 center around advancing the development of our next-generation LUNA Surgical System and associated digital solutions while continuing to drive adoption of our current Senhance platform. For LUNA, we plan to freeze the system design in Q3, conduct verification and validation testing in Q4, and initiate pilot manufacturing to prepare for regulatory submissions. We continue to anticipate LUNA's 510(k) submission in the second half of 2025, clearance in the first half of 2026, and then launch following clearance.

In parallel, our digital roadmap includes integrating advanced analytical tools, innovative training and communication capabilities, and enhanced safety features into the LUNA digital ecosystem. On the ISU hardware front, we are ramping up manufacturing with partners for the future Intelligent Surgical Unit or ISU configurations, aiming to complete designs for both the integrated LUNA ISU and the standalone ISU by mid-year 2024.

For our current Senhance system, we continue to expect to initiate eight-10 new programs globally in 2024 and anticipate 15%-20% annual procedure volume growth. 2024 will be a pivotal year as we prepare to bring our LUNA platform and advanced digital capabilities to market while sustaining growth with Senhance adoption worldwide. We have a set of strategic milestones to accomplish this year, keeping us firmly on track towards our vision. With that, we would now like to open the line for questions.

Operator (participant)

Thank you. Ladies and gentlemen, we will now conduct the question-and-answer session. If you have a question, please press star one on your telephone keypad and wait for your name to be announced. You will hear a three-tone prompt acknowledging your request. If you would like to cancel your request, please press star two. Please ensure you lift the handset if you're using a speakerphone before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Your line is now open.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Thank you. Good afternoon, Anthony and Shameze. So I know you can't talk too much about your discussions with KARL STORZ. However, I just would like to understand a little bit of the timeline. So when exactly did the 10-week exclusivity period start? When would it end? And what needs to happen for them to sign a letter to actually go through the transaction and acquire you?

Anthony Fernando (President and CEO)

Hi, RK. Thanks for your question. So as you said, we continue to collaboratively work with KARL STORZ. We are currently seven weeks into the 10-week exclusivity period, and the exclusivity period began on March 28th. So as you said, we can't comment further, but the work's going on and the diligence is ongoing. And that's kind of where we are currently.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

So I mean, obviously, we are wishing for the best for the shareholders and the company. However, playing the devil's advocate, if something happens in such a way that they are not going to go through this transaction, then what's the process? Does that mean this $10 million that you got becomes a promissory note and you go on with your business in terms of generating funds and maintaining operations? Or I'm just trying to put a what-if scenario here.

Anthony Fernando (President and CEO)

That's correct, RK. It's a secured promissory note, and we would be able to continue operations as we would have otherwise.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Okay. So in terms of operations itself, normally, when some transactions like this are in progress or obviously, you had to come out and publicly talk about it, which is kind of unique, in situations like this, in the field, are you sensing anything at all in terms of people being a little bit hesitant to go through transactions that they might have started? And how is it really affecting your operations?

Anthony Fernando (President and CEO)

I mean, not sure exactly. I'll try to answer the question. I mean, typically, any transaction, one goes through diligence before entering into a definitive agreement. And in our scenario, we announced the LOI on April 3rd, primarily because of the promissory note. So otherwise, the process that's ongoing would have taken place without any public knowledge. Right now, that's the reason why we disclosed what we had to. And then as soon as we on or before the 10-week mark, that's when we'll be able to talk and give more details along with the definitive agreement.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

No, no. My question was on the commercial front. Are you seeing any hesitancy or things are happening as they would normally happen in terms of placements? And so those are the things that I'm asking about.

Anthony Fernando (President and CEO)

Okay. Sorry, RK. I misunderstood the question. Currently, it's ongoing, and we have not seen any challenges. I think KARL STORZ is a very well-known company among all of our existing and potential future customers. So we have not had any challenges there. I think it's perceived as positive news in the field, and we continue to execute on the pipeline globally.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Thank you. Thanks for taking all my questions.

Anthony Fernando (President and CEO)

Thank you, RK.

Operator (participant)

Your next question comes from the line of Ross Osborn from Cantor Fitzgerald. Your line is now open.

Speaker 5

Hi, guys. This is Matt on for Ross. Thanks for taking the questions. I just wanted to start off by asking about your Senhance initiation in Japan this past April. Now that you've placed a couple of systems in Japan, what trends are you guys seeing in terms of adoption and growth in the region?

Anthony Fernando (President and CEO)

Thanks, Matt. Thanks for your question. Japan is one of our faster-growing markets next to Europe. Primarily, this site focused on pediatrics, and there are several other sites. We've seen very good positive momentum in Japan in terms of case volume growth and also system placements. Hopefully, the pipeline also looks pretty good for the rest of the year so that we can deliver on the eight-10 systems for the full year. But Japan has been a growth driver for us in terms of placements and also case volume.

Speaker 5

Got it. That's helpful. Just switching gears a bit, I wanted to ask if you guys can provide any insight into how KARL STORZ plans to utilize your assets in terms of maybe just integrating the ISU versus continuing the development of LUNA?

Anthony Fernando (President and CEO)

Yeah, Matt. Unfortunately, I can't get into any of the details because currently, it's just purely a diligence process and those kinds of plans of integration that will come next but not at this time.

Speaker 5

Got it. Sounds good. And then I guess just one more follow-up from me. I was wondering if you guys can provide any insights into the timeline and how the potential acquisition and integration may impact your previously guided timeline for LUNA?

Anthony Fernando (President and CEO)

I mean, currently, from a timeline point of view, we are moving ahead as we've disclosed and shared with all of you on our timeline. So the LUNA program is making extremely good progress, and everything's on track. And we are not anticipating any timeline shifts because of this transaction at all.

Speaker 5

Got it. Sounds good. Thanks for the color. Thanks for taking the questions, guys.

Anthony Fernando (President and CEO)

Thank you, Matt.

Operator (participant)

There are no further questions at this time. I will now turn the call back to Mr. Anthony Fernando. Please continue.

Anthony Fernando (President and CEO)

Thank you, operator. Thank you, everyone, for joining today's call, and we look forward to updating you on our progress throughout the year.

Operator (participant)

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.