Heartbeam Inc (BEAT) 2023 Q1 法說會逐字稿

Greetings, and welcome to the HeartBeam first-quarter 2023 financial results conference call. (Operator Instructions) As a reminder, this conference is being recorded.

Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You were cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.

Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors.

A press release detailing these results crossed the wires this afternoon at 4:01 PM Eastern Time and is available in the Investor Relations section of our company's website, heartbeam.com. Your host today, Branislav Vajdic, Chief Executive Officer, and Founder; Rob Eno, President; and Rick Brounstein, Chief Financial Officer will present results of operations for the first quarter ended March 31, 2023. (Operator Instructions) At this time, I will turn the call over to HeartBeam Chief Executive Officer, Branislav Vajdic.

Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to today's first-quarter 2023 financial results conference call. On today's call, we will be speaking with you about some very important updates concerning our recent fundraising efforts and adjustments to our strategic focus. Recently, we completed a $25 million secondary offering and a $1.5 million registered direct offering. This $26.5 million will enable us to execute on upcoming product development, clinical and regulatory milestones, and extends our cash runway into late 2024.

With the addition of this funding, we took the opportunity to adjust our strategic focus to enable timely delivery of our ambulatory vector electrocardiogram or VECG products, our key future value drivers. Going forward, our immediate focus is on obtaining an FDA 510(k) clearance for the HeartBeam AIMIGo credit card-sized VECG device, followed by a second FDA clearance on the system's ability to synthesize a 12-lead electrocardiogram or ECG. Rob will focus on that topic and discuss in more detail our strategic focus and product timelines in a moment.

Recently, we announced the acquisition of substantially all assets from LIVMOR, a digital health solution company. LIVMOR Halo+ AFib Detection System is world's first FDA-cleared prescription wearable for continuous cardiac data monitoring. This acquisition extends our reach in remote monitoring and detection with full ownership of an FDA clearance product.

On May 3, of this year, we closed a secondary offering of $25 million followed by a registered direct offering of $1.5 million for a total of $26.5 million. Mostly, Public Ventures, the offering was oversubscribed from the initial $15 million. Even at the $25 million level, we did not meet the demand. I believe this speaks to the quality of our company and the Public Ventures community's understanding of our future.

So who is Public Ventures? They are wholly owned subsidiary of MDB Capital Holdings. MDB and Public Ventures have proven to be a tremendous strategic partnership to HeartBeam. Public Ventures is a member-driven investor community with a mission of backing visionary public companies that have the potential to become market leaders in their technology category.

We are pleased that after extensive due diligence, MDB and Public Ventures strongly supported HeartBeam and themselves actually invested in our financing. We believe that we are the leader in the mobile VECG space, and we are encouraged that Public Ventures built the investment thesis around this position.

I would like now to turn the call over to our President, Rob Eno, to further discuss our strategic focus and provide product update. Rob?

Thank you, Branislav, and thanks to everyone joining us today. Expanding on Branislav's mention of our strategic focus, we're now primarily focused on obtaining an initial 510(k) clearance from FDA for the HeartBeam AIMIGo VECG device, followed by a second clearance on the system's ability to synthesize a 12-lead ECG. Together, these two HeartBeam AIMIGo FDA clearances, the hardware and the system's ability to synthesize a 12-lead ECG will enable physicians to remotely monitor patients and immediately interpret any concerning cardiac events. We see this as an important value-creation path.

In addition, we'll be undertaking clinical trials in 2023 and beyond to demonstrate the performance of the HeartBeam AIMIGo platform, which we believe is the most advanced ambulatory cardiac detection platform available. These initial studies will focus on the 12-lead synthesis and on the performance of the system as a whole.

We believe these studies will be key to driving clinical and patient adoption. We also plan to add world-leading key opinion leaders to our medical advisory board. These KOLs who will help guide our clinical and regulatory development will be announced in the near future. Our co -- our initial commercial launch activities will be for the second version of HeartBeam AIMIGo after we obtain the FDA clearance for the 12-lead equivalent. We are not currently emphasizing commercial activities for either the HeartBeam the AIMI software product or the HeartBeam AIMIGo V1 system.

This year, we will be undertaking an aggressive pre-commercial effort. We'll be defining the initial market segments for the HeartBeam AIMIGo system and identifying potential business partners, both for HeartBeam AIMIGo and other technologies in our portfolio. And finally, we'll continue aggressive development of our intellectual property through our partnership with PatentVest, a unified technology development and patent law firm focused on creating IP leadership for development-stage technology companies. The partnership is focused on the goal of creating clear leadership in the area of ambulatory VECG cardiac detection.

Now turning to our product timelines and updates, we expect to file for FDA 510(k) clearance for Version 1 of the HeartBeam the AIMIGo VECG device in the coming days. This submission is focused on the HeartBeam AIMIGo hardware as a three-lead collection device. Our current estimate is for clearance by the fourth quarter of 2023.

Following this first clearance, we're planning a second FDA submission for Version 2, which includes generation of a synthesized 12-lead ECG from the same device. Once we have both clearances in hand, we'll focus on a limited market release in the pursuit of initial commercialization.

I'll now turn the call over to Rick Brounstein, Chief Financial Officer, to discuss operational updates and financials.

Thank you, Rob. Turning to our financials, I will now give a brief review of our financial results. A full breakdown is available in our regulatory filings,10 Q was just issued, and in the press release that crossed the wire after market close today.

General and administrative expenses for the first quarter of 2023 were $2.5 million compared to $1.4 million for the first quarter of 2022. This reflects the growth in our team and other costs in support of being a public company.

Research and development expenses for the first quarter of 2023 were $1.7 million compared to $0.7 million for the first quarter of 2022. Our focus on R&D consisted largely of product development and regulatory costs for both our products and specifically for HeartBeam AIMIGo hardware, where we have utilized our professional services agreement with Triple Ring Technologies. Triple Ring represented about 30% of our investment in R&D this quarter.

Additionally, on the regulatory side, there are the costs of supporting our upcoming FDA submissions of our products. We also invest in research costs in support of future product pipeline coming from our patented VECG platform technology, and this is the basis for our patent portfolio, which now includes 10 issued patents.

Net loss for the first quarter of 2023 was $4.1 million compared to $2.1 million for the first quarter of 2022. We ended the first quarter of 2023 with just under $1 million in cash and cash equivalents compared to $3.6 million as of December 31, '22, having invested the proceeds from the November IPO in 2021 to accelerate our product development path.

This cash balance does not include the net proceeds of approximately $20.46 million from the common stock financing that we recently completed. Of importance in the recent financing is the fact that the 17.7 million shares offered did not include any warrants in our balance sheet as a result, because of very simple and straightforward capital structure with approximately 20 million shares now outstanding.

Regarding our capital raise, we intend to use these proceeds to achieve several important upcoming milestones. As a result of our new strategic goals in our commercialization plan, we've reduced our budgeted cash expenses to approximately $15 million for the next 12 months to focus on clinical and product development and FDA clearances. We will not undertake commercial efforts in this period.

The balance of proceeds is expected to fund operations into late 2024, provide us a cash runway as we develop our VECG products and as we prepare for commercialization. We expect no material commercial revenue for 2023 but believe we've raised sufficient funds to get us to this important inflection point, the FDA clearance of the second version of HeartBeam AIMIGo. To reemphasize this important point, with the capital just raise, we believe we have sufficient capital through late 2024.

I'll now turn the call back over to Branislav for his closing thoughts.

Thank you, Rick. We are incredibly optimistic for the future of HeartBeam. After this capital raise, we are highly focused on executing on our product development, clinical and regulatory milestones, and our cash runway is now extended into late 2024. We also are adjusting our strategic focus to enable timely delivery of our HeartBeam breakthrough ambulatory VECG products, the company's key future value drivers.

The key element of this focus is the HeartBeam AIMIGo credit-card-sized VECG device. Beyond that, looking at the product pipeline, we think that the application of our artificial intelligence methods will be of great value to us. We will have a unique data set from patients who have actually reported their ECG on a periodic basis, monthly, weekly, or even more frequently; that will be to develop the data for our patient population will be of tremendous [value]. Applying artificial intelligence to this data set, this is extremely data rich -- richer than the standard 12-lead ECG. We'll yield, we strongly believe, additional insight into cardiovascular disease and further help cardiovascular patients.

On the right-hand side of this slide, we show the 12-lead patch. As we reported last quarter, we have received a patent on that technology, which is disruptive and has the potential to make a significant impact on the patch industry projected to be at $4.8 billion by 2030. We are currently evaluating how and when to best take advantage of this patch.

Looking ahead, we remain confident in our product milestones. Our next milestones on the commercialization path include 510(k) submission for the HeartBeam AIMIGo VECG Version 1 product followed by the FDA clearance.

I'd like to share one final thought. We are all very excited about our partnership with Public Ventures and our refined strategic focus. We believe we are closer to our goal of making our VECG technology a new standard of care, which in turn will help millions of cardiovascular patients around the world. I look forward to providing our shareholders with further updates in the near term. I thank you all for your attention and would like, at this point, to answer any questions that you have. Operator?

(Operator Instructions) Okay, seeing that there are no audio questions, I would like to mention that we will now take questions from webcast viewers.

First question from webcast viewers asked, you describe an adjustment to your strategic focus, what exactly has changed from your previous trends to now with the new strategy focus and what are you not doing?

Rob, would you like to comment?

Sir, I'll take this one. So as we mentioned, the primary focus now is the HeartBeam AIMIGo device, and in particular, obtaining the two FDA clearances that we need: the first for the device and the second for the 12-lead synthesis. The biggest change in this strategy is deemphasizing the commercialization of the HeartBeam AIMI software product as well as Version 1 of HeartBeam AIMIGo, which is the three-lead device before we add the 12-lead synthesis,

In other words, the first product that we'll be commercializing is HeartBeam AIMIGo V2 system. However, this year, we will be preparing for commercial efforts by defining the initial market segments HeartBeam AIMIGo and identifying potential business partners, both for AIMIGo and other technologies in the portfolio.

Our next question asked, what is PatentVest? How will you work with them? And what does this say about your IP position?

Let me answer that question. As we described in the call, PatentVest, actually a subsidiary of MDB, is a unified technology development, as well as a patent law firm, focused on creating IP leadership for companies like ours. The partnership with PatentVest is focused on the goal of creating clear leadership in the area of ambulatory VECG target detection. And we believe that we have a very strong and growing actually IP position and that we are the leaders in this emerging field of ambulatory VECG.

In our interactions with due diligence with MDB and Public Ventures, we know that they are fully subscribed to that view and share our view as well. PatentVest is one of the attractive elements of Public Ventures, and we believe we'll add significant value to our IP portfolio. And at this point, we are confident that their strategic contributions to our IP strategy will actually strengthen our IP position significantly.

Our next question asked, is the decision to deemphasize the AIMI product related to any difficulties with the FDA?

Rob Please go ahead.

Great. Thank you. And it looks like we had a couple of other similar questions on this, so hopefully, this addresses it. So no, no difficulties in the FDA process. In fact, it's -- the regulatory process for HeartBeam AIMI is well underway and we've had very positive discussions with FDA. We are still pursuing the HeartBeam AIMI clearance for a couple of reasons.

First, the AIMI algorithm is a key part of our future, AIMIGo product roadmap. It uses the VECG technology to provide additional information on top of the 12-lead for patients with potential heart attacks, and that's going to be an important differentiator for us.

In addition, while our current focus is clearly on the development and regulatory clearances for HeartBeam AIMIGo, we do continue to think that the AIMI product can make a big impact in the hospital in the emergency room environment. So we're going to be exploring various options around this commercialization, both in terms of timing and approach.

Our next question asked, what are you doing with the other products you discussed in the presentation such as the watch and AI?

Let me just say that the priority is very much with the AIMIGo system and the upcoming FDA clearances. At the same time, we continue to have advanced development efforts on these other products. In particular, we are developing our artificial intelligence, AI strategy and continue to believe this is a very compelling area, a source of differentiation in the future. This is all driven by the [amount] of rich data our system produces. The same goes for the watch. We believe that in the future this will make for a very compelling product offering.

Our next question asks, can you outline the next upcoming milestones that we should look forward to track your new direction?

Yes. In full alignment with our refined focus here, we remain focused on the major event of FDA submission and actual clearance for our AIMIGo product. So we'll submit the initial FDA 510(k) application for the first version of this product in the coming days.

The other upcoming milestones include a 510(k) clearance of the first version of the device and submission of the second version of the device. And this will clear the synthesized 12 lead-ECG. We will continue, of course, to update you on our plans, but I would like to conclude by saying that we plan to announce a new key member for the management team as well as the medical advisory board.

Our next question asked, if you are approached by a company interested in licensing your technology, would you consider it?

Rob, go ahead.

I can take that and feel free to add on. As we've talked about business development is a really important part of our focus. We realize that we have -- we're a small company with a lot of great technologies and IP in our portfolio. So we will be certainly open to talking with all potential partners about involvement throughout the portfolio. It's too early to say specifically about licensing for any particular technology, but wanted to emphasize that business development discussions with a range of partners is a really key part of our strategy going forward.

And our last webcast question asked, how dependent do you expect the second product will be on the commercial success of the first product?

Rob?

Yeah. And I just have to say I'm not 100% sure on the definitions in this product of the first and second product, so I apologize if I don't answer this question correctly as intended when it was asked. The first product that we've discussed in the past is the AIMI software product. We are planning to go through, as we say, with the FDA clearance for that, which is underway. And we do not have current plans to commercialize that. As I mentioned, we will be focusing on placing that algorithm into our AIMIGo platform going forward as well as looking at all options of commercializing that either directly or through partners, et cetera.

And then, the other product that we've talked about is the AIMIGo V1, which we are close to submitting that FDA application, as we've said. And that one again will not be commercialized on its own. That is the hardware, a three-lead device, and we're going to use that as the basis of our second clearance, where we do the 12-lead synthesis on top of that. That's AIMIGo V2, which we will be commercializing.

So AIMIGo V2 is the first product we're commercializing. AIMI and AIMIGo V1 are still key parts of the strategy as building blocks.

(Operator Instructions) Seeing no audio questions, I would now like to turn the call back over to Dr. Vajdic for his closing remarks.

Thank you, operator. I would like to thank each of you for joining our earnings conference call today and look forward to continuing to update you on our ongoing progress and growth. If we were unable to answer any of your questions, please reach out to our IR firm, MZ Group, who will be more than happy to assist. Thank you and have a good day.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.