Pulse Biosciences (NASDAQ:PLSE) provided an update on the development and commercialization of their CellFX nsPFA energy delivery system during their first quarter 2024 earnings call.
The company highlighted FDA 510(k) clearance for their non-cardiac percutaneous system, the successful treatment of patients in Italy, and the ongoing discussions with the FDA regarding their cardiac applications.
They also announced a rights offering to raise up to $60 million. Financially, the company reported an increase in total costs and expenses to $10.6 million, with cash and cash equivalents totaling $34.9 million as of March 31, 2024.
Key Takeaways
- Pulse Biosciences received FDA 510(k) clearance for their CellFX nsPFA percutaneous system for soft tissue ablation.
- The company successfully treated 30 patients in Italy and is making progress in cardiac applications.
- A rights offering of up to $60 million was announced to strengthen the company's balance sheet.
- Total costs and expenses rose to $10.6 million; cash and cash equivalents were $34.9 million as of March 31, 2024.
- High interest from physicians at major institutions for the CellFX system has been observed since FDA clearance.
- Pulse Biosciences expects the CellFX percutaneous system to be used in prominent hospitals and clinics by year-end.
- The company will present at the Heart Rhythm Society meeting, focusing on their nanosecond PFA technology.
Company Outlook
- The pilot launch in the U.S. for the percutaneous electrode has garnered significant interest from key opinion leaders.
- The company anticipates the CellFX percutaneous system to be in use in several prominent hospitals and clinics by the end of the year.
- Discussions with the FDA regarding the CellFX nsPFA Surgical Clamp are ongoing, with a first-in-human feasibility study submitted in Europe.
Bearish Highlights
- There was an increase in total costs and expenses, indicating higher spending during the quarter.
Bullish Highlights
- Pulse Biosciences expressed confidence in their patent position and the market potential of their technology.
- The successful treatment of patients in Italy and advancements in cardiac applications demonstrate the company's progress.
Misses
- The earnings call did not specify revenue figures or specific financial performance metrics aside from costs and cash reserves.
Q&A Highlights
- The company is excited to present at the upcoming Heart Rhythm Society meeting with six abstract presentations.
- They highlighted the advantages of their nanosecond PFA technology over current modalities, emphasizing the depth, durability, and speed of creating lesions.
- Pulse Biosciences' leadership expressed gratitude for the support and a commitment to delivering growth with their nanosecond PFA technology.
In summary, Pulse Biosciences is making strides with their CellFX nsPFA system, which has been well-received by the medical community following its recent FDA clearance. The company is actively engaging with the FDA on their cardiac applications and is preparing to showcase their technology at an upcoming industry event. Despite increased expenses, Pulse Biosciences is poised to expand the use of their technology in the U.S. and has a strong cash position to support their operations.
InvestingPro Insights
Pulse Biosciences (PLSE) has made notable progress with their CellFX nsPFA system, and their developments are reflected in some key financial metrics and market performance indicators. Here are some insights drawn from InvestingPro data and tips that may be of interest to investors following the company's journey:
- The market capitalization of Pulse Biosciences stands at $411.43 million, indicating a moderate size within the medical device sector, which could attract investors looking for growth potential in specialized healthcare technology.
- With a Price / Book ratio of 11.34 as of Q1 2024, the company is trading at a high multiple, suggesting that the market may have high expectations for its future growth, despite the absence of dividends as indicated by one of the InvestingPro Tips.
- The company's stock price has experienced a large uptick over the last six months, with a total return of 44.38%, showcasing significant investor optimism which may be linked to their recent FDA clearance and the successful treatment of patients in Italy.
InvestingPro Tips also reveal that while Pulse Biosciences has a high shareholder yield and liquid assets that exceed short-term obligations, it operates with a moderate level of debt and has not been profitable over the last twelve months. Analysts predict the company will be profitable this year, which could be a pivotal point for investors keeping an eye on future earnings.
Investors interested in a deeper dive into Pulse Biosciences' financial health and market performance can find more InvestingPro Tips at https://www.investing.com/pro/PLSE. There are additional tips available, which can be accessed with an InvestingPro subscription. Use the coupon code PRONEWS24 to get an extra 10% off a yearly or biyearly Pro and Pro+ subscription, offering a comprehensive view of the company's prospects and investment potential.
Full transcript - Pulse Biosciences Inc (PLSE) Q1 2024:
Operator: Greetings, and welcome to the Pulse Biosciences First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Trip Taylor. Please go ahead.
Philip 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, May 7, 2024 only and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar 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 U.S. 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 in the News and 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. I'm excited to provide today's condensed update as our last call was just over five weeks ago. Mike Koffler, Vice President of Finance, will join me in the prepared remarks to review our first quarter 2021 financial results. Then Robert Duggan, Executive Chairman of the Board; Darrin Uecker, Chief Technology Officer and Director; and Mitch Levinson, Chief Strategy Officer, will join me for a question-and-answer session. During today's call, we will give you an update about our proprietary designed and engineered CellFX nsPFA energy delivery system and three novel proprietary end-effector devices. Q1 was a very active and productive quarter for Pulse Biosciences. As you know, we are making a material and significant commitment to the field of nanosecond pulsed field ablation, addressing soft tissue ablation for human beings in need. Pulse Biosciences is pleased to bring into existence a novel electrophysiology and surgical treatment modality that focuses in the nanosecond, up to billions of a second pulse duration range. This is up to two orders of magnitude faster than the millionths of a second range currently deployed in the pulsed field ablation area. This increase in pulse speed in conjunction with the capacity to increase pulse amplitude is believed by us to potentially bring out material improvements in safety and efficacy as well as overall significant improvements in treatment times and thus, treatment outcomes. Additionally, nsPFA is a very patient, physician, care provider friendly treatment option. Going forward, we are planning to do multiple clinical trials across different indications. It is important to note that inclusive of 6,000 human dermatological skin lesions treated, not a single serious adverse event has occurred. In March 2024, we received FDA 510(k) clearance for our non-cardiac CellFX nsPFA percutaneous system with soft tissue ablation indication. Soft tissue ablation is used by physicians in a wide range of procedures, including the thyroid, liver, breast and other areas of the body. Currently, we have treated 30 patients in need of soft tissue ablation for thyroid disease. Dr. Stefano Spiezia, Chief of Endocrine Surgery Division at Napoli Ospedale del Mare in Naples, Italy, our key opinion leader in the field of thyroid, in collaboration with Dr. Ralph Tufano, Medical Director, Head and Endocrine Surgery for Sarasota Memorial Health Care System, have successfully performed soft tissue ablation procedures on 30 patients with the CellFX nsPFA percutaneous system in Italy. The first patient was treated in April 2023 and the last patient in January 2024. All procedures were thyroid. Per amended protocols at our request, we have observed patients as early as one week and up to this point, as late as 180 days. Patient follow-ups are weekly for the first four weeks, then 30, 60, 90, 180 and 360 day time points following the procedure. No evidence of scarring or injury to the surrounding tissue has been observed and patients treated have been judged to be successful. Moving on to the updates of our cardiac indications, starting with our surgical clamp. In the past few weeks, we have communicated with the FDA regarding our CellFX nsPFA Surgical Clamp for cardiac procedures. The FDA has requested clinical data prior to rendering a final decision in pursuit of our request for FDA 510(k) clearance. As of today, only preclinical animal work has been performed. No patient has been treated as of yet with our CellFX nsPFA Surgical Clamp. In present time, however, we have submitted to the Ethics Committee in the Netherlands an application to start first-in-human feasibility study with the CellFX nsPFA Surgical Clamp. We anticipate their response within the next several weeks. The study is designed to treat up to 30 patients in several centers in the Netherlands. This study would provide information on first-in-human effectiveness and safety with our device. Our second device for cardiac indication is our CellFX nsPFA 360 degree Cardiac Catheter. We are pleased to announce that 24 of 30 patients have been successfully treated in Prague by Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital New York, and Dr. Petr Neuzil, Chief of Cardiology at Homolce Hospital Prague, and his team in Prague. The remaining six patients are expected to be treated within the next 45 days. The primary end points for this study are acute effectiveness at the time of the procedure and add up to 30 days for safety. Discussions with the FDA are ongoing in present time, and we will provide updates in a timely manner. Pulse Biosciences will have a strong presence at the upcoming Heart Rhythm Society, HRS meeting, May 16 to the 19 in Boston. Our CellFX nsPFA energy delivery system will be featured in a total of six poster presentation abstracts as well as a live case presentation. Before turning the call over to Mike, I will now provide additional details on our efforts to strengthen our balance sheet through the rights offering. This offer serves as a stockholder friendly avenue for Pulse Biosciences to secure the necessary capital to advance our novel end effectors towards market entrance, while offering our existing stockholders a potential non-dilutive opportunity to continue to support the company's growth. The Board of Directors has approved a rights offering of up to $60 million worth of units that will be available to all holders of record of the company's common stock as of the specified record date. This week, the company determined to initiate the rights offering in June or July, not in May, so that the early record date of May 16 will most likely be changed to a date in mid-June. The date will be selected by our Board and announced once all the necessary filings have been completed. Subscriptions may begin immediately once the company commences the rights offering, most likely in June. It is important to note that the subscription rights will expire and have no value if they are not exercised prior to the expiration date of the offering, which date will also be announced by the company once the necessary filings have been completed. Assuming that the rights offering is fully subscribed at the initial price, the company will receive gross proceeds up to $60 million, less expenses related to the rights offering. And upon exercise of all the warrants, a potential to raise up to $126 million. A fully subscribed rights offering would fund the company's growth plans into the first quarter of 2026. Please refer to our release on the rights offering for more information. Now I will pass the call over to Mike Koffler for an update on our financial results.
Michael Koffler: Thank you, Kevin. Today, I will highlight our GAAP and non-GAAP financial results. I encourage you to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the first quarter of 2024, total GAAP costs and expenses increased by $1 million to $10.6 million compared to $9.6 million in the prior year period. The increase in GAAP cost and expenses was primarily driven by an increase in non-cash stock-based compensation expense, which was $1.8 million in the first quarter of 2024 compared to $0.9 million in the prior year period. Total non-GAAP cost and expenses in the first quarter of 2024 increased by $0.3 million to $8.6 million compared to $8.3 million in the prior year period. The increase in total non-GAAP costs and expenses was primarily driven by an increase in research and development expenses to support the advancement of our CellFX nsPFA devices. GAAP net loss in the first quarter of 2024 was $10.1 million compared to $9.8 million in the prior year period. Non-GAAP net loss in the first quarter of 2024 was $8.1 million compared to $8.6 million in the prior year period. Cash and cash equivalents totaled $34.9 million as of March 31, 2024, compared to $44.4 million as of December 31, 2023. Cash used in the first quarter of 2024 totaled $9.5 million compared to $7.2 million used in the same period in the prior year and $6.9 million used in the fourth quarter of 2023. The sequential quarterly increase was driven mainly by $2 million in 2023 annual cash bonus payouts. I will now turn the call back over to Kevin.
Kevin Danahy: Thank you, Mike. It is an exciting year for Pulse Biosciences as we continue to advance our novel platform technology into the hands of more physicians for the benefit of more patients. In future earnings calls, we will provide real-time updates on events and interactions as they unfold. Joining me for the question-and-answer session today are Executive Chairman of the Board, Robert Duggan; Chief Technology Officer and Director, Darrin Uecker; and Chief Strategy Officer, Mitch Levinson. Operator, please open the call for questions.
A - Philip Taylor: Thank you, Kevin. Now we're going to address a few questions we've received over e-mail. Then we'll open up the line for questions from the audience. The first one is, how is the pilot launch going in the U.S. with the percutaneous electrode now that it's approved? What's the interest level and when can we anticipate a full commercial launch?
Mitchell Levinson: Yeah. Hey, Trip. This is Mitch. I can take that one. Since our 510(k) clearance we got a few weeks ago, we've reached out to the KOLs that we were targeting for our pilot program, and the interest has been just really high. We've got a lot of physicians at major institutions that want to evaluate our system for soft tissue ablation. As some of you may know, in institutions like this and hospitals, there's an approval process. It usually takes several weeks, sometimes longer, to approve bringing in new technologies. We've got multiple KOLs currently working through that approval process. We expect our CellFX percutaneous system is going to be used in a number of prominent hospitals and clinics by the end of this year. Right now, we are just really focused on building the appropriate training around the system, providing strong clinical support, and just ensuring that we are doing everything we can to help our physician customers get the best possible clinical outcomes that they can with our technology.
Philip Taylor: Great. Operator, can you please open the line for questions now?
Operator: Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Your first question comes from Anthony Petrone with Mizuho Group. Please go ahead.
Anthony Petrone: Thank you, and congratulations on the progress here. Maybe a little bit just on the FDA dialogue. It sounds like that's moving in the right direction. They've sort of given a little bit of guidance here, I think, on just kind of the clinical pathway going forward. And so maybe anything you could add there on how broad based a pivotal program could look like? How many sites? How many patients? And I guess, your early views on timing of when this could be launched? And I have one follow-up. Thanks.
Kevin Danahy: Darrin, do you want to take that?
Darrin Uecker: Yeah. Sure. Thanks, Anthony. This is on the clamp, right? I apologize.
Anthony Charles: Yeah. That would be right, on the cardiac clamp. Yes.
Darrin Uecker: Yeah. So I think as we discussed on our last call, we received an additional information letter from the FDA. That led to a couple of meetings with FDA, one that we had very recently, and very collaborative, great discussion with FDA as we're moving this forward. As of today, as we mentioned, we remain in the 510(k) process. After receiving the AI letter, that goes on hold with regard to the review cycle, as you probably know. And I think we had good dialogue with FDA about the need or request for human clinical data. And so we're really in the process of discussing that with FDA and coming to some agreement on what that clinical program would look like and likewise, the regulatory path going forward. Right now, we really don't have much to report on that in terms of timing. One of the things on the clinical side that we have discussed is a first-in-human feasibility study for our clamp, which will happen in Europe in the Netherlands and that we've submitted to the Ethics Committee there. We expect to hear back from the Ethics Committee within the next several weeks and then commence that study soon thereafter. And so we've got a lot going on, on that side. FDA is aware of that study, and we'll just be working with FDA over the next period of time to finalize what's going to be required for the clamp in the United States.
Anthony Charles: That's helpful. And then a follow-up would be just on HRS. Looking ahead here, you have a live case with CellFX that's being presented post the presentations as well. The market here in the United States is now officially underway with PulseSelect and FARAPULSE out there. So what are you expecting out of HRS? And I guess, from the perspective of Pulse Biosciences, are you surprised at the rate of adoption by the early PFA catheters? And maybe just the expectations on physician feedback for CellFX out of HRS? Thanks, again.
Kevin Danahy: Go ahead, Darrin.
Darrin Uecker: Yeah. Thanks, Kevin. I would – I guess, I would say we’re really looking forward to HRS. We have 6 abstract presentations, as you mentioned, and those are both actually on the catheter and our clamp. So that is something that is very encouraging to get both of our products into HRS for this important meeting. And then as you mentioned, we have a live case in the PFA Summit at the beginning of the meeting. And as it relates to PFA, in general, I think we are not surprised by the progress of PFA and the progress that we’re seeing in the United States by those other devices. I think it seems the data is pretty clear that PFA offers some pretty significant advantages over current modalities. What we’re excited about and looking forward to at HRS is talking about nanosecond PFA and our view that it’s sort of a next generation as it relates to PFA and what the differentiation is in terms of the lesions that we create, the integrity and durability of those lesions, the depth of those lesions, the speed with which GPs are able to create those lesions. So all those things, we think, are going to be really important to both physicians and patients. And we’re looking forward to HRS to be able to talk about that and present our – both our preclinical and clinical data that supports those different benefits. So we think it’s going to be a really exciting meeting for PFA, in general, but also, of course, for nanosecond PFA and Pulse Biosciences.
Anthony Charles: That’s very helpful. Thank you.
Operator: Next question, Robert Lovgren with Medical Hope Production. Please go ahead.
Robert Lovgren: This question is for Bob. A little preliminary. The -- this ablation and catheters and so on is a real surgical coming. Basically, you, Bob's feel though that you have all the patents and the head of all the other people plus, of course, the machine itself? Or you think you're the tip of the spear?
Robert Duggan: Well, a head of Bob and a tip would be somewhat similar, right? But you really put your patent base together, evaluate it thoroughly, which we're constantly doing. At this point, we're very pleased with what we have and what we are generating. The asset test is when you bring it to market. It's not against the law to develop anything you want. You can copy, you can alter, and you can go de novo. But when you bring it to market, that's where the patents really swing in, so we will find out. But I am -- yes, I'm Bob Duggan. I'm confident that we're in a good position there, and I like the speed at which we continue to evolve our patent base. I hope that answers your question, Bob.
Robert Lovgren: Thank you.
Robert Duggan: You’re welcome.
Operator: I would like to turn the floor over to Kevin Danahy for closing remarks.
Kevin Danahy: Thank you, operator. In closing, I just want to thank you all for continuing to support and giving us the confidence that we have in our company. We are dedicated to delivering value and growth with nsPFA, and we look forward to the opportunities that lie ahead. Thank you for joining us today, and we remain committed to driving success for this company. Thank you.
Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.