Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2022 Earnings Call Transcript

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2022 Earnings Call Transcript March 30, 2023

Operator: Ladies and gentlemen, greetings, and welcome to the Pulse Biosciences' Fourth Quarter 2022 Earnings Conference Call. At this time all participants lines are in a listen-only mode. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Trip Taylor, Investor Relations. Please go ahead.

Trip Taylor: Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management's views as of today, March 30, 2023, only and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements.

We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures can be found in the press release. Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com on the News & Events section on our Investor Relations page. With that, I would now like to turn the call over to President and Chief Executive Officer, Kevin Danahy.

Kevin Danahy: Thank you, Trip. Good afternoon, everyone, and thank you all for joining us. On today's call, I will discuss our nanosecond pulsed field ablation, nsPFA, development progress and our 2023 corporate objectives. I will then turn the call over to our Chief Technology Officer, Darrin Uecker, to provide a detailed overview of our core technology and product development initiatives. Then I will review our fourth quarter financial results before concluding and opening the call for a question-and-answer session. Pulse Biosciences is going where we believe no company has gone before, accomplishing beneficial first of its time effects that have yet to be achieved in the world of pulse field ablation. Our technology has consistently demonstrated a high degree of safety, efficacy and outcomes.

In addition to the significant positive impact on patients, the knowledge gained during our previous FDA clearances has given us the present time confidence and vision to pursue the use of nsPFA on the human heart. Our FDA clearance in the treatment of over 6,000 patients with tissue-related positive results in skin proved the viability of our technology, paving the way for a differentiated cardiac applications. Our proprietary nsPFA technology has the potential to be disruptive in a unique, demonstratable and consistent manner. While it's still early days and preclinical testing is ongoing, we are encouraged by our progress to date. 2022 was a pivotal year for Pulse Biosciences. We announced a strategic shift in reprioritizing our efforts to focus on the most compelling opportunities for the application of our proprietary Nano-Pulse Stimulation technology.

Building upon our R&D work in cardiology that began several years ago, our top focus is now on developing multiple devices to deliver nanosecond pulse field ablation or nsPFA to cardiac tissue for the treatment of atrial fibrillation. We made this decision based on our existing preclinical evidence that suggests nsPFA can potentially offer a leading safety and efficacy profile compared to thermal ablation modalities in newer PFA technologies. The treatment of AF, atrial fibrillation, is a large and established high-growth market. We believe our ability to take share in this $8 billion market represents the most efficient path towards long-term value creation and a viable business model. We have adjusted our strategy and team to best pursue this opportunity.

I could not be more excited to lead the company through this pivotal time I am confident we have the technology, the team and strategy in place to maximize the impact of nsPFA and create substantial value for patients, physicians and stakeholders. Our complete existing understanding of nsPFA's impact on cells compared to thermal destruction led us to investigate cardiac tissue ablation early on. Initially, we sponsored and provided equipment to university research. Once the feasibility of the mechanism of action was proven in animal cardiac tissue, we initiated our own R&D projects. These included the development and preclinical testing of a cardiac ablation clamps for the use in cardiac surgery and a cardiac ablation catheter for the use in electrophysiology.

I will let Darrin discuss the details of the technology and product development progress shortly, but I first want to provide context around the AF market, and why we have prioritized this application for the technology going forward. The treatment of AF represents in a broad sense, one of the largest and fastest-growing markets in medical technology. Over 1.2 million catheters in surgical ablations are performed annually. And this is expected to grow by more than 10% annually due to an aging population, patient awareness, epidemiology, increased clinical evidence and technical advancements supporting treatment improvements and intervention. We expect through the parallel development of our plant and catheter devices, we can realize important technical, clinical and eventual marketing synergies.

Pulse Biosciences portfolio of devices is both a demonstration of the versatility of CellFX System and an opportunity to address emerging collaboration between surgeons and electrophysiologists treating atrial fibrillation. There is a clear emerging consensus from treating physicians that PFA is thought to be safer and faster than the present time treatment options, but we believe we can do better. Our goal is to change, how physicians treat and view AF, atrial fibrillation and in the process provide greater value to patients, physicians and cardiac centers. In the present time, we have focused the organization on two main goals to advance our nsPFA technology for the treatment of AF. One, we intend to develop and advance our cardiac clamp through the appropriate FDA regulatory path; and two, complete all catheter products and regulatory milestones required to treat our early patients.

Our goals are clear and we understand they require time, know-how, patience and experience to execute properly. We are focused on long-term success in building the foundation for a viable business over the coming years. I will now turn it over to Darrin to discuss the technology and product road map.

Darrin Uecker: Thank you, Kevin. I think it will be helpful today to reiterate the underlying capability of our technology to better understand why it has great potential to improve the present state of cardiac tissue ablation for the treatment of AF among other applications. At Pulse Biosciences, we have developed a novel and proprietary tissue treatment platform based on nsPFA where ultrafast electrical energy pulses at nanosecond pulse durations from billions up to millionth of a second are used to stimulate cellular effects that can lead to positive therapeutic outcomes. nsPFA is broadly considered a pulse field technology, but the use of nanosecond duration pulses leads to a highly differentiated cellular mechanism of action that can be applied to a number of important clinical applications with distinct and unique benefits to patients treating MDs and post-care trained staff.

We have demonstrated that when these incredibly fast energy pulses are applied to cells, they penetrate the cell and disrupt the function of the internal organelles of the cell by creating small holes in the organelle membranes, known as poration. These organelles include the mitochondria, which is the cells power plant and the endoplasmic reticulum, which plays an important role in protein synthesis. When the function of these organelles is disrupted, the cell goes through a natural regulated cell death process. This ability to get inside the cell with nontoxic application of electrical energy, while preserving the integrity of the outer cell membrane to initiate regulated cell death is a cornerstone of our nsPFA technology. This regulated cell death process leads to a more natural healing response as the body's immune system is accustomed to dealing with cell death through this natural and regulated mechanism as opposed to sudden necrotic cell death caused by other energy-based therapies, which can lead to a significant inflammatory response that slows the return to normal tissue function.

We believe it is this ability to initiate regulated cell death through the temporary formation of pores in intracellular organelle membranes that importantly differentiates nsPFA from other energy-based therapies, such as standard PFA and radio frequency ablation. Another important and unique feature of Pulse Biosciences nsPFA is the lack of impact it has on acellular structures, such as the extracellular tissue that provides the tissue architecture in support of cellular and organ healing. While thermal energy modalities will destroy all tissue indiscriminately, nsPFA has a selective mechanism that impacts cells that leaves the acellular structure, which typically is made of collagen, intact, allowing the tissue to heal in a more natural way.

nsPFA also has been shown to spare nerve fibers or those parts of the nerve that carry electrical impulses as well as blood vessel architecture and tissue. Another significant benefit when the therapeutic intent is to clear on one itself and promote healing and a return to normal tissue function. This novel mechanism of action has been demonstrated in human clinical and preclinical studies across a large number of organs and tissue types. Evidence supporting this has been published in a number of peer-reviewed publications such as the Journal of Lasers in Surgery and Medicine, the Journal of Cosmetic and Laser Surgery and the Journal of Dermatologic Surgery. We have determined that the underlying nsPFA mechanism of action is uniquely suited to address the current challenges of cardiac tissue ablation.

Today, the treatment of AF requires the precise and safe ablation of heart tissue to block, inhibit or otherwise prevent faulty electrical signals from causing in irregular heartbeat. We believe nsPFA technology will prove to be highly differentiated from standard thermal energy modalities in use today. nsPFA should be able to deliver faster ablation through thicker tissue than thermal modalities because it is not impacted by heat sinks, such as the blood in the heart. Thermal modalities experienced charring on electrode surfaces, which prevent adequate ablations and can add undesired time and challenges to procedures. This has not happened with nsPFA because of the earlier mentioned attributes and its non-thermal nature. Because nsPFA ablation does not impact acellular tissue, such as collagen or cartilage, our technology has the potential to offer significant safety advantages over thermal modalities by allowing surgeons to ablate near and into vessels and valves without safety concerns of permanent damage.

And finally, nsPFA ablation has been shown to spare nerves of any permanent damage even when treated directly, which is another concern with thermal modalities. With nsPFA, we believe physicians can provide a more focused thorough treatment and thereby reduce their procedure times with the end goal to improve clinical outcomes and patient experience. In recent years, pulse field ablation has gained attention in electrophysiology for the treatment of AF as a result of its safety profile and potential to improve efficacy. nsPFA differs from standard PFA in that the pulse durations for nsPFA are much shorter, typically 10 times to 10,000 times shorter, which translates to appropriate energy and a more energy-efficient mechanism. In turn, less energy per nsPFA pulse allows us to design larger footprint electrodes that can treat more tissue faster with reduced concern of thermal damage that can be an issue with standard PFA.

Appropriate controlled energy and shorter duration pulses will stimulate less muscle contraction than nerve stimulation during treatment. And as such, reduces the need for stronger sedation and paralytics that are often used with standard PFA. For these reasons, we believe nsPFA will provide meaningful benefits in both efficacy and safety over standard PFA. On the product development side, we are working with top KOLs and to develop AF treatment solutions to be used in the catheter lab and in the operating room. The differentiated benefits of our nsPFA technology will be incorporated in the design of both a surgical clamp for the treatment of AF in the operating room by cardiac surgeons and a catheter that is navigated into the heart through the vascular system for the treatment of AF by electrophysiologists in EP lab.

While these devices serve different physician specialties, they are both providing a highly differentiated solution for the treatment of AF and both make use of the core nsPFA technology, so the development of these devices is highly leveraged. Both devices are currently being tested in preclinical models. Over the last several years, we have been researching and developing nsPFA cardiac ablation surgical tools, and we now have achieved what we believe is an on-target initial commercial design for a cardiac ablation clamp. The cardiac ablation clamp is designed to be used and what is commonly referred to as the Cox-Maze procedure, a procedure performed by cardiac surgeons specifically for the treatment of AF. During this procedure, cardiac surgeons create lines of ablation in the heart in order to block aberrant electrical signals and cure the patient of AF.

Today, this has done with thermal modalities, and we believe nsPFA can offer a faster, more precise, safer and easier to perform ablation procedure. In 2023, we plan to perform the necessary device testing, including continued preclinical testing to prepare for regulatory clearance and human clinical use. In parallel with the continued device testing, we expect to meet with the U.S. Food and Drug Administration, or FDA, to discuss the regulatory requirements for a potential FDA clearance in order to market our cardiac clamp in the United States. This will be done as part of the FDA's standard Q submission process, also known as a pre-submission meeting. We expect that our first meeting on this topic with the FDA will take place in the second quarter of 2023.

After meeting with FDA, we expect to have better clarity on time lines to regulatory clearance and first-in-human clinical use. Turning to our second product in development, the cardiac catheter ablation device. Just like the clamp, our catheter delivers an electric field as opposed to thermal energy to destroy heart muscle cells and should provide many of the same safety and efficacy benefits. The catheter design is unique and enables a circumferential or circular ablation in the single treatment. This feature should expedite treatment times compared to thermal modalities, especially when performing the common, but challenging treatment approach of ablating around the pulmonary veins. The catheter has also been in development for several years, and we have accrued substantial learning while working with leaders in the electrophysiology field to optimize its design and evaluate performance in preclinical studies.

We believe our current design is suitable to pursue a first-in-human clinical study following currently planned additional preclinical safety studies. In the U.S., we expect the catheter will require an FDA premarket approval or PMA submission to achieve approval to market and sell the device. The process to complete these trials will take several years. We strive to have a solid understanding of the devices performance as we go forward, and we look forward to providing updates along the way. We have accomplished a great deal with both of our nsPFA devices and the preclinical data we continue to produce is very encouraging. Notably, last month, the company highlighted a poster presentation at the prestigious 2023 AF Symposium in Boston. The poster was titled Novel Nanosecond Pulse Field Ablation Compatible with 3D Mapping & Navigation System.

The poster highlighted the integration of our nsPFA system with a compatible 3D mapping and navigation system. The preclinical study demonstrated the ability to navigate the catheter for accurate ablation integrate pre and post ablation voltage maps with the same catheter. To further increase awareness for our technology among the cardiology community, we have submitted multiple abstracts highlighting nsPFA for presentation at the upcoming Heart Rhythm Society Meeting in May. We look forward to sharing more updates on our progress in the future as we accomplish the next important milestones. Now, I'll turn the call back to Kevin for an update on our financial results.

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Kevin Danahy: Thank you, Darrin. We did not recognize revenue in the fourth quarter of 2022. Moving down the income statement, I will focus my comments on non-GAAP results. I encourage you to review today's earnings release for the detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the fourth quarter 2022, we reduced non-GAAP total costs and expenses by $9.1 million to $7.7 million compared to $16.8 million in the third quarter of 2022 and by $4.7 million year-over-year compared to $12.3 million in the prior year period. The decrease in operating expenses were driven by the discontinuation of the commercial dermatology activity in the prior headcount reduction in restructuring. Non-GAAP net loss for the quarter ending December 31, 2022, was $8.1 million compared to $11.5 million for the quarter ending December 31, 2021.

Cash, cash equivalents, and investments totaling $61.1 million as of December 31, 2022, compared to $28.6 million as of December 31, 2021, and $69.2 million as of September 30, 2022. Cash used in the fourth quarter of 2022 totaled $8 million and was reduced compared to both $13.4 million used in the same period in the prior year and $10.6 million used in the third quarter of 2022. As a result of tightening corporate strategic focus, in 2023, we expect quarterly cash burn to be approximately $8 million, consistent with the fourth quarter results. We have amended the terms of our loan agreement with Robert Duggan, extending the maturity date until September 30, 2024. We have the capital needed to finance our first-in-human clinical trials and remain confident we will achieve the optimal capital structure to advance our strategy and growth trajectories.

Now, I will provide some closing remarks. The addressable market for AF intervention is multibillions of dollars and growing. With a management team that has deep experience and the strategy in place, execution is the present time focus. We understand that global regulatory approvals and evaluations are needed. Management is experienced in the field of robotics and energy ablation and maintain a proven track record of development, achieving regulatory approvals and launching disruptive new medical devices. Additionally, the financial leadership team has excellent depth of experience and is working diligently to optimize the company's capital structure and fund our future. As an innovative bioelectric medicine company committed to health innovation and increasing quality life, we are confident we can have a meaningful impact on patients.

Our recent accomplished milestones discussed today are propelling us towards development completion, clinical work and ultimately delivering patients in need the benefit of Pulse Biosciences nsPFA. We look forward to providing progress updates on the next call. Today, we would like to invite investor questions. And with that, operator, please open the call for questions.

Operator: Thank you. Hey Kevin, who would be participating along with you in this session?

Kevin Danahy: Yes. Thank you so much, operator. Joining me today is Executive Chairman of the Board, Robert Duggan; and Chief Technology Officer, Darrin Uecker, and I am Kevin Danahy, the President and CEO. So we did have a couple of questions that came in online. I'll read off with this. The first question that came in was, why pivot to cardiac? So, I'll jump in on this one, and then I'll ask Darrin or Bob, if they would like to give a little bit more color. Our complete nsPFA impact understanding on how we compare to thermal destruction led us really to investigate cardiac ablation early on. Initially, we sponsored, like we said in the script today, university research, and then once we have the feasibility of the mechanism of action, and what it was proven on cardiac tissue and animals, we started our own R&D projects.

After that, we took this information, and we started doing our own preclinical testing, which led to the development of the cardiac ablation clamp for cardiac surgery and cardiac ablation catheter for the use in electrophysiology. So this wasn't really a pivot. It's something that we've been working on for a long period of time. Darrin, do you have anything you would add to that?

Darrin Uecker: No. I think that's perfect. I mean I think it was really €“ we were led to these applications by physicians and really the outcomes that we saw in preclinical data.

Robert Duggan: Kevin. I'll make a comment. Darrin and I go back over 20 years in robotics. And at the early moment, in the life of opportunity €“ evaluating opportunity for robotics in human health care, cardiac seemed to be the area of most opportunity. And then over time, proved to be incredibly difficult to pull that off. But we did learn quite a bit about heart and the importance of the heart. And essentially, the heart is energy-based. It's critical and essential to the heart's function. So with the nano-pulse field, we have an ability to use energy to complement the heart function or to correct misfunction in the heart. So it's a one-off opportunity that we feel is outstanding in terms of size. It's not been penetrated by anyone else at the field and the power of energy and the speed of that energy that we can bring to the table.

So that's why we're in it. And I complement your comments and Darrin's comments earlier here about the size of that market, the significance of it and the challenge to get it cleared and to prove it to be effective, which is what we're going after in the next 12 months. And as you said earlier, we'll keep our stakeholders apprised as to our progress in development. But I can assure you, we're approaching this with a tremendous amount of confidence and excitement as potentially the outcomes will be €“ could be iconic and make €“ turn this into a very disruptive and powerful technology for all involved.

Kevin Danahy: Awesome. Thank you, Bob. Another question that came in was just to ask how should we view success for Pulse Biosciences in 2023? And I think as we mentioned in the call today that we really have two main goals in 2023 to advance nsPFA in the treatment of AF. Number one, we intend to develop and advance our cardiac clamp through the appropriate FDA regulatory path. And number two, we hope to complete all the catheter product and regulatory milestones required to treat our early patients. So, I think that's how we're measuring ourselves, and how I would say that we should be measured. Anything Bob or Darrin to add to that? Okay. And then last question...

Robert Duggan: I'll jump in. Yes. So basically, heart procedures come about in three ways open procedure, which can be incredibly invasive. I've had the honor of being present in up to 50 of those. And it's €“ I would rather watch and be a part of it. But it is challenging, but it is also through precision approach and the use of the technology available, things such as a coronary artery bypass graft proved to be patent for almost 20 years. It's an incredible procedure created by doctors at the Cleveland Clinic years ago. And Darrin and I happen to become very friendly with a number of them as they evaluate an opportunity for robotics there. So then you have less invasive surgery and then you have catheter-based. So the catheter base are you would recognize stents in the placement of stents early on as something that was effective, but very, very less challenging and dramatic to the patients.

So really the business of repairing graphs and arteries with graphs came over on to the stent side. So we believe we've got the best of all worlds here. We can help in open procedures. Most of the open procedures that take place involve either the presence of or the risk of creating ablation and a fibrillation in the heart. So while the heart is open, you can apply a clamp to this and generate the ablation in areas that are needed and necessary with the clamp that we have under study. Some of the top doctors from robotics 20 years ago are now the top doctors in performing these procedures. So Kevin knows them. They know Kevin, they know myself, Darrin is very close with most of these teams. So it's with great excitement that they're welcoming us back into their lives.

So, we're thrilled with the opportunity and it's pretty exciting. And you'll hear more from us as we achieve success in that, in first-in-humans. On the other side of the catheter, that's a very challenging opportunity. But we had in defectors creators at our company, and they were right on the market, and that was where we had a very strong patent base prior to merging with Intuitive Surgical, which has created tremendous success on its own right in the area of robotics. And have some activity, decent activity in the area of heart valves and heart valve repair. So these are areas we're familiar with. We're very excited about it. Electrophysiologists that we're working with view this as a disruptive, distinctly different and nicely improved technology.

We're excited about it, and we look to get the first in-human because that's really the validation, and since these procedures will be open, I mean, we'll know what's happened right after the procedure. This is not like a Phase 3 drug trial where you might have to dose 2,000 patients and in your statistics to bear after the completion of those patients have been thoroughly evaluated. This is €“ when the person gets off the table or on the table, you know how well you're doing with that patient. So, we're pursuing that activity as we speak. And I would think during €“ over the next year, we will be able to come back to you with results. Two things here. If we hit obstacles that we think increase the risk or diminish the return. As soon as we validate that, we will be back out to our stakeholders.

As we achieve success, we'll make sure that on a timely basis, as is appropriate, we'll relate to the stakeholders as well. So that's where we stand on these issues. If you catch the excitement of my voice, it's real. The team that is working on this, if I'm excited, they're like excited square, so this is going to be the real fun year for our company. Back to you, Kevin.

Kevin Danahy: Yes. Thank you, Bob. Last question that came in, and I'll give this one over to Darrin, is what was the significance of the AF Symposium poster?

Darrin Uecker: Yes. That's a good question. So the AF Symposium is really one of the top meetings €“ scientific meetings in the treatment of AF that's held annually. And I think typically, there are between 3,000 and maybe 5,000 attendees, which are the top electrophysiologists around the world and health care providers and people from industry. And the acceptance of our poster, I think, was a real validation of the technology and what the organizers of the meeting, believe is the potential of the technology. So, we were honored and very pleased to be a part of that important meeting. We had a lot of great conversation with a number of electrophysiologists who are excited to see it. We got to mention from the podium about the potential of nsPFA from one of the key physicians.

So it was really a great meeting for us. It's great to be able to demonstrate what we've been doing preclinically and to show that to the scientific community and to have it accepted by the scientific community as something that they want to hear about and get excited about going forward.

Kevin Danahy: Thank you, Darrin. All right, operator, we can open up the questions.

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