Pulse Biosciences, Inc.
Q4 2019 Earnings Call Transcript

Published: 17 Mar 2020

[Operator:]

Greetings, welcome to Pulse Biosciences Reports for our Fourth Quarter and Full Year 2019 Final Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded.I would now like to turn the conference over to Philip Taylor, Investor Relations. Thank you. You may begin.

[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 reflects management’s views as of today, March 16th, 2020 only, and will include forward-looking statements and opinion statements. These include statements regarding our plans and expectations regarding to regulatory clearance, including the process and expected outcomes, our commercial, operational, scientific, clinical and financial production, product including the uses and applications of such product, and other future events.Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our most recent Form 10-Q and February 13th Form 8-K filed with the SEC. Our SEC filings can be found through our website at the SEC’s website.Investors are cautioned not to place undue reliance on forward-looking statements. 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 our President and Chief Executive Officer, Darrin Uecker.

[Darrin Uecker:]

Good afternoon and thank you all for joining us. Our driving focus at Pulse Biosciences remains on the clearance and commercialization of our proprietary CellFX System in aesthetic dermatology in pursuit of our mission to offer bioelectric medical solution that make a meaningful difference for the betterment of patients and clinicians.Our device to CellFX System is a multi-application platform that administers our proprietary Nano-Pulse Stimulation technology. NGS technology delivers nano-second pulses of electrical energy to non-thermally clear cells, while sparing adjacent non-cellular tissue.On today’s call, I’ll provide updates on our collaboration with the FDA and our current regulatory strategy for CellFX System. Ed will share information on our recent presence and continued engagement in the scientific community. Then I will discuss developments and plans for our clinical program. And then Sandy will provide the fourth quarter and full year 2019 financial results. Finally, I will conclude and open the call for Q&A.To begin, I would like to recap a year filled with accomplishments representative of our growth as a company and the creation of a solid foundation from which we will launch our platform technology. The cornerstone of this foundation is the strong body of clinical evidence that we have produced demonstrating the excellent safety and efficacy profile of NPS technology for aesthetic dermatology.In 2019, we enrolled 373 subjects in our clinical studies, treating over 1,800 lesions, which is up from only 108 enrolled in 2018, treating 408 lesions, bringing now our total for the end of 2019 to 552 subjects and 2,650 lesions. This is a tremendous amount of important data, and with each study completed, our conviction in the clinical utility of NPS grows.Through this clinical work we have developed a large network of leading aesthetic dermatologists who are participating in our studies and presenting data at important scientific meetings. This data has been the backbone of 12 podium presentations delivered throughout the year at the most prominent aesthetic dermatology conferences, including the American Society for Laser Medicine and Surgery, the American Academy of Dermatology and the American Society of Dermatologic Surgery.The attendance and interest of these sessions has been strong, and played an important role in increasing the awareness of NPS technology among the physicians. Along with these presentations, we have had three manuscripts published in the German Journal of Dermatologic Surgery and the American Society for Lasers in Surgery and Medicine, both of which are leading peer reviewed journals in the space. The positive outcome is demonstrated throughout this extensive clinical work has created a strong group of key opinion leader advocates for proprietary Nano-Pulse Stimulation technology.On the product side, we have been hard at work enhancing our CellFX System and the proprietary CellFX Cloud software that enables our novel and proprietary utilization based business model. From our industry experience and extensive market research, we have been able to design a delivery system and unique business model that aligns the interests of patients, practices and the company. This is accomplished by allowing practices to purchase and download cycle units to their system that are then used to treat individual lesion. The system tracks this utilization and captures relevant usage data.We understand that patients want to pay based on the number of lesions treated and dermatologists want to treat patients regardless of the amount, size or type of lesions and when costs aligned with a specific treatment. The CellFX System was designed to facilitate this type of lesion based or utilization based business model and removes friction that can exist in a more typical consumable or single use disposable based medical device business model.Additionally, the CellFX Cloud will serve as a practice management tool, helping physicians understand utilization data, practice metrics and manage customers in a web-based portal that also provides software, application and maintenance updates. The CellFX System represents the next generation energy modality device, combined with current cloud software capabilities in an easy-to-use platform that will integrate seamlessly into existing aesthetic dermatology practices.In 2019, Pulse Biosciences began preparations for commercialization outside the United States by successfully completing ISO 13485

[Ed Ebbers:]

Thanks, Darrin and good afternoon, everyone. NPS technology has shown that the unique capability to precisely clear common skin lesions with desirable outcomes that current thermal modalities cannot achieve. The NPS differences due to the non-thermal mechanism of the nano pulses of energy affecting cellular structures of skin lesions, while sparing the surrounding non-cellular dermis.Excitement around NPS technology in the dermatology community is growing. We continue to build a broad base of scientific evidence proving that utility of NPS technologies cellular specificity across multiple applications conditions aesthetic dermatologists see and recollects today at high volumes, but generally go untreated due to the inability of current modalities to produce desirable aesthetic outcomes.In addition to the continuing podium presentations on NPS technology at major medical meetings throughout the year, NPS technology and Pulse Biosciences have been honored by the publication of three compelling clinical study articles in peer reviewed journals in the second half of 2019. Among these journals are; lasers in surgery and medicine, which is the official journal of the American Society for Laser medicine and surgery or ASLMS.This publication is of the highest quality research and clinical scientific journal articles for which physicians and researchers that specialize in energy-based technologies, especially particularly the application to receive and read on a regular basis. The August issue of lasers in medicine and surgery featured manuscript authored by Dr. David Kaufman, and Darius Mehregan titled, a dose-response study of a novel method of selective tissue modification of cellular structures in the skin with nano pulsed electric fields.This peer reviewed article proved the ability of non-thermal NPS energy to affect only the cellular structure to skin tissue, and having no effect on the surrounding non-cellular tissue with predictable dose response effects over a world wide range of energy settings. The same data was honored by ASLMS the previous year with a Best of Basic Science and Translational Research Award, a distinction that earned this further recognition as a full journal article in this prestigious journal.Next, the Journal of Dermatologic Surgery publishes the latest most expansive and in-depth scientific content devoted to cosmetic and reconstructive skin surgery and skin cancer and is the peer reviewed publication of the prestigious American Society of Dermatologic Surgery, or ASDS. In October, Dermatologic Surgery published an article titled, safety and efficacy of nanosecond pulsed electrical field treatments of sebaceous gland hyperplasia, featuring dermatologic surgeon, Dr. Gilly Munavalli as the lead author. Dr. Munavalli is our member of our Scientific Advisory Board, and has been a consulting author or investigator in more than 100 dermatologic journal articles and 16 medical textbooks for the dermatology possibly.Also in Dermatologic Surgery another article titled safety and efficacy of Nano-Pulse Stimulation in the treatment of patients with Seborrheic Keratosis was published in December with Dr. George Hruza as lead author. Dr. Hruza is the current President of the American Academy of Dermatology, Former President of the American Society for Dermatologic Surgery, and Past President for the American Society for Lasers Medicine and Surgery. Dr. Hruza has been considered a worldwide authority in the use of energy devices.Both of these clinical articles substantiate the sound science and ability of NPS technology to clear SH and SK lesions with an excellent safety profile and high level of patient satisfaction. Each article represents the work of some of the most respected skin specialists in the world. Looking ahead, we continue to gain recognition for our scientific progress by our investigators with podium presentation at medical conferences throughout the world.Recently an international podium presentation was given by Dr. Gilly Munavalli at the International Masters Course on Ageing Skin this past January in Paris. Dr. Munavalli discussed clinical and histological findings from a study using NPS technology in treating challenging cases of nodular basal cell carcinoma. Basal cell carcinoma or BCC is the most common form of skin cancer worldwide. The nodular subtype reported in this study comprises 60% of all basal cell carcinomas.For these deep natural lesions, the current standard of care is surgical excision, which can lead to large permanent scars. This NPS feasibility study demonstrated clinical photographs and histology suggesting elimination of the treated basal cells and favorable cosmetic outcomes and a reduced potential for scar formation compared to the current standard of care for these types of skin cancers.Our technology has already been still recognized at seven medical meetings in January and February this year, and we expect to continue to receive invitations for prestigious investigators and researchers speak on NPS technology at medical meetings as they occur. This continuing validation in both peer reviewed publications and podium invitations at medical meetings helps build credibility for our technology. We feel this recognition confirms that our strategy of working with key opinion leaders to generate high quality clinical research enhances our probability for commercial success in the future.The positives and unique properties of NPS technologies are being discussed and announced throughout the aesthetic dermatology community. We have been successful in raising awareness of our differentiated technology as physicians are quite excited about the potential of a non-thermal energy device to address challenging skin conditions. We feel this is a strong indication of the future and market opportunity for NPS.In summary, and to build on what Darrin mentioned previously, through our extensive work with our network of leading investigators can KOLs in dermatology, we have now treated 3,126 lesions from 627 clinical study participants as of March 4th, representing an exceptional safety and efficacy profile across a wide range of patient ages, skin types, lesion varieties and tissue positions.We continue to demonstrate that our unique cell-specific mechanism has broad utility and dermatology, plastic surgery and other medical applications. Our growing portfolio of 99 patents is unparalleled in the energy device category and our long-term ability to build a dominant position for the use of nano pulsed energy in medical applications continues to expand. The growing scientific recognition and peer advocacy of NPS technology is a strong predictor of commercial acceptance in the future.Now, I’ll turn the call back to Darrin.

[Darrin Uecker:]

Thanks, Ed. I’d like to quickly touch on the clinical programs we have underway to expand the application pipeline. Furthest along as our non-genital warts pivotal study, we are pleased to report we have completed enrollment and are tracking according to plan. Warts represent a very difficult lesion for dermatologist to treat. The rate of success in a single treatment is low and the condition usually requires multiple treatments and a sub-optimal outcome. We are excited to offer physicians a better option to treat the many patients they see with warts. Additional feasibility work is being done in back acne and basal cell carcinoma. We look forward to providing updates on these studies when available.Taking a step back, we would like to acknowledge the difficult and trying circumstances presented by the COVID-19 outbreak. The safety and health of our employees is our top priority. In observation of the recommendations from government and health authorities, we have taken the appropriate precautions to ensure the safety of everyone at Pulse Biosciences.At this point, none of these actions have had an impact on our operation. We are particularly encouraged that our interactions with FDA have moved forward without an issue and we look forward to our upcoming Q-Sub teleconference. This is an extremely fluid situation and we will continue to monitor closely.Now, I’m excited to introduce our new CFO, Sandy Gardiner. It has been great to have her on Board since she began in late November. To remind you, she brings prior CFO experience from other public aesthetic medical device companies, and we’ve appreciated her immediate positive impact. For the first time, I will turn the call over to Sandy Gardiner for an update on our financials.

[Sandy Gardiner:]

Thank you, Darrin. It is great to join the strong team at Pulse Biosciences. I am very excited about the company’s opportunity to introduce a proprietary technology in the aesthetic dermatology market and expand into additional applications in the future.Turning now to the fourth quarter financial. Cash, cash equivalents and investments totaled $25.4 million as of December 31st, 2019, compared to $34.5 million as of September 30th, 2019. Cash used in the fourth quarter totaled $9.1 million. Operating expenses for the three months ended December 31st, 2019 were $13.9 million, compared to $9.1 million for the prior year period. The increase in operating expenses was driven by expansion of operational infrastructure, including marketing and sales functions as well as expansion of the research and development teams and clinical trial costs.Net loss for the quarter ended December 31, 2019 was $13.8 million, compared to $9 million for the quarter ended December 31, 2018. For the full year, 2019 cash usage totaled $34.2 million. Operating expenses for the full year ended December 31, 2019 were $48 million, compared to $38 million in 2018. The increase in operating expenses was driven by expansion of operational infrastructure, including marketing and sales functions, as well as the expansion of the research and development team and clinical trial costs.Net loss for the full year 2019 was $47 million, compared to $37.5 million in 2018. In February, we announced that Board of Directors had approved rights offering to raise an additional $30 million.Now I will turn the call back over to Darrin for closing remarks.

[Darrin Uecker:]

Thank you, Sandy. To conclude, we have made significant strides as a company over the past year. We have conducted many clinical studies generating an enormous amount of positive clinical data on the safety and efficacy profile of NPS technology and our CellFX System.Elevated our standing in the scientific community through 12 podium presentations on our technology by top KOLs in the field, had three peer reviewed articles published and finalized development of the CellFX System with a proprietary cloud infrastructure to support a unique utilization-based business model.All these things are important to the ultimate, commercial success of the CellFX System. We believe that once FDA clearance is achieved, the value will be realized by the company, our customers and patients. Our confidence in the long-term success of Pulse Biosciences has only increased through 2019 and we are excited about the opportunity ahead.Joining me now for Q&A is Ed Ebbers, Executive Vice President and General Manager, Dermatology and Sandy Gardiner, Executive Vice President and Chief Financial Officer. Operator, let’s open the call for question.

[Operator:]

Thank you. [Operator Instructions] Our first question is from Sean Kang with H.C. Wainwright. Please proceed.

[Sean Kang:]

Hi, thanks for taking my question. This is Sean Kang for RK at – Yeah, hi H.C. Wainwright. My first question is about operating expenses and cash only. So I thought that it was above like you know, 20% quarter-over-quarter increase in G&A and some increase in R&D as well. Should we expect moderate increase in 2020 and beyond?

[Sandy Gardiner:]

So we should – sorry, this is Sandy, nice to meet you over the phone. So we – our operating expenses we expect to remain largely consistent in 2020 versus 2019, because we have been fully staffed as you know, it was sort of the second half of last year that we hired our commercial organization so we would expect those increases to actually come in the second half of 2019. But now we are at a stable base. And we’ve been, you know, at that same operating expense level and cash utilization has been in the $8 million to $9 million per quarter and we do expect that to stay consistent, at least until the back half of the year.

[Sean Kang:]

I see. Thank you. That’s very helpful. And one last question is, I think I heard that you plan to start on hyperplasia study in Q3, is that correct?

[Darrin Uecker:]

Yeah, so – hey, Sean, this is Darrin. You know, this is our best estimate at this particular time as I mentioned this is something that, you know, we intend to meet with FDA on in advance of starting that study, of course, and working through the details of what that study will look like. And just as a reminder to those that have been following us, you know, coming out of the last 510(k) and preparing for the next, I think that sebaceous hyperplasia study will be one where we do a comparative trial. And so it will be important for us to work with FDA on that, which is what we expect to do.

[Sean Kang:]

Okay, sounds good. Very helpful, that’s all.

[Darrin Uecker:]

Okay, great. I’d also like to mention quickly that our Chairman, Bob Duggan is also on the line and available to answer your question.

[Operator:]

Our next question is from [Brian Privett] [ph], Private Investor. Please proceed.

[Unidentified Participant:]

Hi guys. I had a question in regards to the rights offering. Can you add a little color or timeline on when that might happen was part A of my question? And part B of my question is, you mentioned the 501 – the 510(k) general could be available in four months, what does that mean for commercialization?

[Darrin Uecker:]

Go ahead.

[Sandy Gardiner:]

Sure. So I’ll address the rights offering and then hand it over to Darrin. So there are certain components that we have to complete before we file the registration statement with the SEC. We – our goal is to complete all those elements by the end of this month or early April, and submit that to the SEC, and that then that would initiate the registration statement for the rights offering.

[Darrin Uecker:]

So, hey, this is Darrin, and I’ll comment on the FDA just to kind of lay that out again. So, based on conversations, again, informal conversations that we’ve had with FDA, we think that this going after a general dermatologic indication as a first step really makes the most sense. So we have subsequently submitted a request for a Q what’s called the Q-Submission or Q-Sub meeting. Fortunately, FDA has been very responsive and gotten back to us. I mean it looks like that meeting is going to happen now in May, that will be a teleconference with FDA.So coming out of that meeting, which we hope will kind of solidify the requirements for a general dermatological indication. Then we’ll finalize you know data that needs to be generated for that and prepare a 510(k) to be submitted. And our expectation is that that 510(k) would be submitted in approximately four months after the meeting, if we’re able to solidify those requirements at that meeting.Now, until we have that formal meeting, we won’t know exactly what those requirements will be or what we’ll need to do for that 510(k). You know, but our assumption today is that, that we have a pretty good understanding of what would be expected, and that that meeting will result in the solidification of that. And so, if you take that, and then four months after that you assume a 510(k) submission, you know, then it’s towards the end of the year, and our goal would certainly be to try to get in before the end of the year a 510(k) clearance with a general dermatologic indication for the CellFX System.

[Unidentified Participant:]

Okay, thank you.

[Darrin Uecker:]

Yeah, thank you.

[Operator:]

[Operator Instructions] Our next question is from Michael Fox with Park City Capital. Please proceed.

[Michael Fox:]

Hi, thanks for taking my call everybody. Can you just –

[Darrin Uecker:]

Hey, Mike.

[Michael Fox:]

How’re you doing, Darrin? Could you talk about –

[Darrin Uecker:]

Yeah, I’m doing all right.

[Michael Fox:]

Great. Could you talk about kind of the – just a little bit more color and kind of like give us a flavor of the tone of the conversations with the FDA? And then also – and, you know, and how it transpired with the general dermatology path? And then given that we’ve been working with the FDA for quite some time, do we get any – like does it benefit us that we’ve been working with them for a while? Are we just really starting at square one on this application?

[Darrin Uecker:]

Yeah, thanks. Those are really good questions. So I think, you know, my feeling is that all the interactions we’ve had with FDA up until now benefit us going forward. So I think where we’re at is, you know, kind of coming out of this last 510(k) is that, you know, FDA is you know, we’ve gotten, you know, I think very good signs from FDA, that they believe that, you know, this is a 510(k) device.So I think that is extremely positive. I think that we under – you know, they believe that because of all the data and everything we’ve done in the past 510(k). So I think that, for one is very positive, it shows that they have a, you know, a pretty good understanding of the technology itself and what we’re trying to do with it, you know, where we ended with the last submission as we described on our previous call.And I think in our press release was that, the clinical data that we provided just didn’t give them enough to be able to come to a substantial equivalence conclusion in terms of the benefit risk and largely, you know, where they ended up was that they wanted to see comparative data.And so really, I think all the data we provided has been very informative. It’s helped, you know, FDA understand this technology, which again, is a new technology for them. So, you know, I think it takes time for reviewers to really begin to understand the technology and how it can be used in skin. And now we have, I think, some pretty good clarity on kind of what their expectations will be with regard to specific clinical indications.The idea of a general dermatologic indication came about through conversation with FDA and I think really their desire that, that we introduced this technology through the FDA in kind of a stepwise approach, because it allows them to provide clearances and perform reviews of the technology in a kind of a more digestible form.So when we do the general derm indication, you know, our expectation is, that will be a relatively small amount of data, in addition to data that we provided previously, and then with each new specific indication, it will really be largely based on that clinical data. And so I think, you know, kind of through this, all this work we’ve been doing with FDA.I think what we’ve realized is that, for a new technology like this, it makes, you know, it’s a lot easier for them to kind of do this in a stepwise approach, and for us to provide data in that kind of stepwise approach. And that’s kind of really where we’re at. So I think the last 510(k) we provided a lot of information, two clinical studies worth and a lot of preclinical data. And so now from that we’re kind of going in a more stepwise fashion.And I think, you know, the other thing we’re doing coming out of that is to have these Q-Submission meetings. So I think those are, you know, our ability to sit with FDA to agree on kind of the requirements of the data prior to anything being submitted to FDA. And so I think all those things put us in a very good position going forward.And, you know, I’ve been involved in a number of new technologies, new medical device technologies in my career, I mean most notably in the medical robotics field where, you know, we introduced the first FDA clearance robot to the market. And, you know, it takes time, I think, is the lesson as you’re going with – as you’re introducing these new technologies to reviewers that have never seen it before to work through that process. And I think that’s what we’ve experienced, for sure over the last, you know, 12 months or so.And I think it definitely benefits as going forward. We’re much further along than we were prior. And I think we have a much better understanding of the requirements that FDA is wanting, and I think they have a much better understanding of the technology, you know, today. So hopefully that helps.

[Michael Fox:]

Yeah, that’s great and then one follow-up. The number of KOLs that you guys currently have that are supportive of the device. How does that play into the FDA’s decision or path and – or does it at all?

[Darrin Uecker:]

You know, I don’t – there’s no kind of formal. There’s nothing formalized that FDA would lean on with regard to, you know, the KLOs that are involved in our clinical studies, they certainly are aware and they’ve seen our publication. So they’re certainly aware of the folks that have been involved and I think they do, you know, have a lot of respect for them. That being said, you know, FDA has, you know, their own internal medical officers and they rely largely on those medical officers for these types of things.

[Michael Fox:]

Okay, great. Thanks a lot.

[Darrin Uecker:]

Thanks a lot, Mike. So since we’re here, I think I would like to ask, Bob, if you wouldn’t mind making a few comments, since we got you on the line, we’re fortunate enough to have you on the line today and no questions have come up specifically. Maybe you could make a few comments.

[Bob Duggan:]

Yeah. Thank you, Darrin. It’s my pleasure. I think you, Sandy, Ed and the team have been very forthright in describing where we’re at our current condition. In my opinion, the FDA challenge has obfuscated just how well the company is doing across the other important divisions and departments that between you know, marketing, sales, service, manufacturing, QA, advantage development of the product, we’ve got a spectacular team. They’ve performed really well. The KOLs that have joined and the number of podium presentations and the work they’ve done is highly unusual for product as yet to be clear, it shows the enthusiasm and their reach, I think to the FDA we’ve had no events that had to be reported.No events, conditions for patients that have not resolved over time. In that regard, it’s all been good. We – you know, well over 2,000 lesions treated. So we certainly harbor no concerns, considerations, doubts or reservations that our product is effective, it’s needed, it’s wanted, the KOLs are saying the same thing. And I think we’ve appropriately are going after the correct indication now, which is why Darrin was able to collapse the time by a good six months between now and getting clearance.With regard to Brian’s question on the rights offering. I’m hopeful that occurs within the next 90 days. We will give you a more of an update when we do our filing, which should take place in that early part of April. That would be subject to SEC review. But given that our 10-Ks in and all of our filings have gone without question or further scrutiny from the SEC. If we do not receive any concern back from them, it will be less than the 90-day period.We’re going to set the price where all current shareholders have a right to participate, we’ll do our best to encourage them to do so my former company Pharmacyclics is doing a very dry period of 2008-2009, we had 85% participation without actually the price of the stock appreciated during the curfew time, we offered no warrants or extra value other than just our common stock.I’m very excited about participating. I’m very excited about the company’s future. Clearly, no one appreciates an equity that goes down in price other than Warren Buffett who said that is when his favorite company he likes to see them to appreciate in price, not many of us stand up and say the same thing. But we’ve got a great company with a very bright future, top notch people, they’re being patient here, they’re sticking right to the project that they have in hand and I predict a very, very bright future for everybody involved including our current shareholders.So those of you that have been longed the stock for quite a while, your patience is appreciated. It does take a while I just noticed that things some of the great companies in America have hit some challenges and the stocks who have lost a lot of their value including my former Pharmacyclics, Amazon, Apple with Steve Jobs things happen that we don’t want or anticipate, such good people work their way through it. Just like the country is working its way through coronavirus. We will work our way through our issues. There are maybe fraction of the coronavirus but yeah, I’m quite positive and if there’s any questions, I can be reached or you can ask then we’ll be now be happy to respond.Okay, Darrin, back over to you. Thanks to all of you –

[Darrin Uecker:]

All righty –

[Bob Duggan:]

For just praying for the team. Yeah, really appreciate it.

[Darrin Uecker:]

Thanks a lot, Bob. Appreciate you jumping on the call with us. And with that, I think we will. All right with that I think we will close operator. Thank you everybody for joining the call. We very much appreciate your support, and we will keep you apprised of our progress.

[Operator:]

Thank you. This does conclude today’s conference. You may disconnect your lines at this time. And thank you for your participation.