This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk03: Greetings and welcome to Pulse Bioscience's third quarter 2020 earnings conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Philip Taylor, Investor Relations. Thank you. You may begin.
spk02: 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, November 9th, 2020 only, and will include forward-looking statements and opinion statements. These include statements regarding our plans and expectations relating to regulatory clearance, including the process, timelines, and expected outcomes, our commercial, operational, scientific, clinical, and financial projections, products, including the uses, benefits, and application of such products, and our commercial and regulatory strategies, the impact of the COVID-19 pandemic, 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2020. 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. Please note that this conference call will be available for audio replay on our website at PulseBiosciences.com on the News and Events section of our Investor Relations webpage. With that, I would now like to turn the call over to President and Chief Executive Officer Darren Uecker.
spk05: Thank you all for joining us this afternoon for our third quarter 2020 earnings conference call. Across the world and in our organization, we all continue to adjust to the challenges presented by COVID-19. That said, we have not adjusted the mission of Pulse Biosciences, which remains to offer bioelectric medical solutions that make meaningful differences for the betterment of patients and clinicians. Throughout these difficult times, our team has shown unwavering dedication in their efforts to bring our technology to the market. We are excited to announce the 510K application for the CellFX system has been submitted to the U.S. Food and Drug Administration. This accomplishment and additional developments have positioned Pulse Biosciences to potentially receive regulatory clearance for the CellFX system in three strategic geographies as early as the end of the first quarter of 2021. On the call today, I will discuss the substantial clinical and regulatory progress and provide details on our commercial preparations and strategies. Ed will detail the planned controlled launch and summarize recent engagements with the scientific community. Sandy will discuss the third quarter financial results. Then I will conclude, and we will open up the call for Q&A. There are two main business objectives we are focused on to position Pulse Biosciences for long-term success. The first is achieving regulatory clearance for our cell effects system in the U.S., the European Union, and Canada. The second is preparing for the commercial launch of the cell effects system. In recent months, progress towards these objectives has been significant. Before providing details on the recent progress, I will take a moment to explain what our technology does, its benefits, how it is administered to patients, and why the system we have designed is ideally suited for the dermatology markets. The CellFX system is a multi-application platform that harnesses our proprietary nanopulse stimulation, or NPS, technology. NPS technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. In the area of dermatology, this cell-specific mechanism of action is highly differentiated because it provides the ability to address cellular lesions while preventing collateral damage to the surrounding healthy skins. thus enabling treatment of lesions that was not previously practical. This provides clinicians the ability to generate improved outcomes compared to older modalities where treated skin could appear worse than the original condition. The CellFX system is a tunable, software-enabled, console-based platform that powers a handheld treatment applicator. It is designed to accommodate the clinical workflow preferred by dermatologists. Based on our extensive industry experience and a collaborative process with clinicians, we designed an integrated cloud software infrastructure we call CellFX Cloud Connect. It is the backbone of our innovative utilization-based business model that aligns the interests of patients, practices, and the company. CellFX Cloud Connect makes possible the wireless connectivity between the customer's CellFX system, our e-commerce customer portal, practice management tools to track utilization data and other metrics, and our internal customer relationship management and enterprise resource planning software system. The CellFX Marketplace is a customer portal where medical practices purchase and wirelessly download cycle units directly to the CellFX system. Cycle units are purchased and then consumed on a per lesion basis. So the more lesions the patient wants cleared, the more cycle units are required. This enables a preferred economic model as physicians have fixed costs per lesion and can charge the patient on a per lesion basis, which is aligned with the patient's preference. Our model contrasts with the currently employed disposable and single-use-based medical device models, removing the friction for the physician that can occur in those models. One last note about CellFX Cloud Connect is that it facilitates direct connectivity for Pulse to remotely perform software upgrades to the CellFX system, as well as provide several service and maintenance functions in real time. Because of this ability to streamline, be responsive, and reduce disruption to the clinical workflow, CellFx Cloud Connect allows us to provide next-level support and enable practice growth for our future customers. To bring this innovative technology to market, we are initially pursuing regulatory clearances in three key geographies, the U.S., the European Union, and Canada. These markets represent our top commercial priorities. In the U.S., we are pursuing a stepwise regulatory strategy to achieve FDA clearance. This was determined to be the best fit for our technology following discussions with FDA. This approach entails an initial 510K application for a general dermatologic indication for the cell effect system, followed by subsequent applications for specific treatment indication. The application for the general dermatologic indication required preclinical data evaluating the treatment of animal skin at multiple follow-up time points. Results demonstrated strong performance in skin treatment and healing as we expected, giving us confidence in the quality of our 510K submissions. We believe the time we spent with FDA confirming the data required to support the general dermatologic indication will make FDA's review straightforward. A decision on potential clearance is on track for as early as the first quarter of 2021. Another benefit of this step-wise strategy is that it provides us the opportunity to conduct studies for cell effect system indication expansion in parallel. This summer, we completed an additional pre-submission meeting with FDA to agree on the requirements for a subsequent 510K submission for the treatment of patients with sebaceous hyperplasia, or SH. Following the guidance from this meeting, we submitted and received approval for an IDE, or Investigational Device Exemption, study, allowing us to commence a comparative pivotal study. In just over five weeks, we were able to fully enroll the study, treating 60 patients with facial SH lesions at five study sites. Cell effect system procedures and comparator group procedures will be evaluated at follow-up intervals out to 60 days post-final procedure. We were very encouraged by how quickly this study enrolled. It demonstrates the broader patient need and underlying market opportunity for SH and dermatologists' excitement about using our technology. Given where we are with the study timeline, it is likely we will accelerate the submission of this 510K for the treatment of SH to the first quarter of 2021. versus the second quarter of 2021, as we had previously communicated. Because of the versatile clinical utility of the CellFX system, to maximize its value, we will continue to seek additional indication expanding clearances with the FDA. Next in our pipeline is common non-genital wards. As we have discussed previously, findings from our previous investigational studies have shown great promise for our NPS technology's ability to clear wards. We are finalizing the IDE protocol for a comparative study to support an additional 510K application for this specific indication. Following IDE approval, we will start the study, which we anticipate will be similar in scope and duration to the SH study. To commercialize the self-effect system in the European Union, we are required to obtain CE mark approval. These efforts are focused on working with our EU notified body. As we mentioned on the last call, our notified body has accepted our technical file submission and all required supporting documents. In line with our prior expectations, we have progressed through the interactive review phase where we have actively responded to questions and requests. One important milestone in the technical file review process is the review and acceptance of the clinical evaluation report. The clinical evaluation report is a supporting document provided by Pulse in support of the CellFX system for the proposed indications for use and is reviewed by a physician subject matter expert. we are pleased to share that the clinical evaluation report for the CellFX system, which included CellFX clinical data for the treatment of sebaceous hyperplasia, debria keratosis, and warts, including our recent peer-reviewed publication, was recently accepted by the notified body. The acceptance of this report means the notified body agrees that the CellFX system is safe and performs as expected for these clinical indications for use, and we believe is a testament to the quality of the CellFX clinical data the high quality of the clinical investigators, and the peer-reviewed publication. This also means that when the CE mark is granted, we will be able to promote the use of the CellFX system for those clinical indications, sebaceous hyperplasia, seborrheic keratosis, and warts, as we commercialize in the European Union. Given the acceptance of the clinical evaluation report, we believe we are very close to having the technical file review finished and anticipate receiving the CE mark and initiating our controlled launch in the European Union as early as Q1 2021. Lastly, on the regulatory front, our Health Canada medical device license application for the CellFX system has been submitted. As we were able to submit this application ahead of our expectations, it is now possible we could also receive Health Canada approval as early as the first quarter of 2021. In order to complete this application, our design controls, manufacturing, and quality systems were required to be evaluated and certified by the Medical Device Single Audit Program, also known as MDSAP. This certification, along with the previously received ISO 1345 certification, represent our ongoing commitment to the highest level of quality assurance standards for the production of our system and components. Now I would like to transition and provide a high-level overview of our commercial launch strategies. The intended result of our regulatory submissions is clearance and approval to market the CellFX system to aesthetic dermatologists in the U.S., EU, and Canada. Following potential respective clearances, we are prepared to commence controlled CellFX launches in all territories. Our controlled launch strategy is intended to place systems in thought leading key opinion leaders' practices, first anticipating that they will highlight the treatment potential of NPS technology and the CellFX system to a broader group of peers. The controlled launch physicians and their practices have been carefully selected based on their reputations among their peers for clinical excellence, as well as their known influence on acceptance of new technologies. The first wave of early adopters will look to our controlled launch participants for guidance on their own cell effects purchase decisions and advice on integrating cell effects into a successful aesthetic dermatology practice. Notably, these controlled launch dermatologists will be strategically located across the territories in the most attractive aesthetic dermatology market. They have shown great excitement and commitment to becoming early adopters of the CellFX system. As success grows with the controlled launch group, we will then expand to target a larger number of dermatologists. Our team will be focused on providing the highest level of service to these accounts while implementing efficient work streams into existing practice workflows. To support this strategy, we have hired an experienced commercial team including sales, marketing, and customer service professionals. Now I will turn the call over to Ed to provide more details on this strategy and our continued engagement with the scientific community.
spk04: Thanks, Darren. I will be discussing overall commercial readiness and market priming for the first launch of the Cellifex system in aesthetic dermatology. I'll begin by providing more details on the strategic approach to our global commercial launch. which focuses on the important role of worldwide key opinion leaders in aesthetic medicine and includes continued marketing research insights from our target aesthetic procedure market. Finally, I will highlight the continuing scientific publications of NPS clinical evidence presented to the professional dermatology community that features our unique non-thermal mechanism and how that cell-specific mechanism addresses common problems in dermatology and that are difficult to treat with older thermal technologies. First, I want to summarize our launch readiness and how our commercial teams focused strategic approach to launch with key opinion leaders or KOLs will lead to a long-term and sustainable commercial success. This top-down strategy begins with the impressive clinical evidence and mechanism of action research that has been conducted with some of the most respected scientists, and institutions in the world of aesthetic dermatology and energy-based devices. The impressive Cellifex body of evidence backed by associated centers of opinion leader advocacy will be highly leveraged in our next phase of KOL Foundation building that follows our anticipated regulatory clearance that Darren just talked about. This foundation building, which we have described to you as a controlled launch of the Cellifex system, is focused on select aesthetic device opinion leaders in North America and Europe. During the last several months, our commercial team has selected 45 centers in North America and 11 centers in the European Union to be the first positions to launch the Cellifex system and the associated cell effects commercial procedures into the respective markets and geographies. This will take place soon after commercial clearance. These controlled launch physicians and their practices were carefully selected based on a combination of their reputations among their peers for clinical excellence, as well as their known influence on acceptance of new technologies with patients, with the media, and with the next wave of physician early adopters. The first wave of early adopters will look to our controlled launch participants for guidance on their own CellFX purchase decisions and for their advice on integrating CellFX into a successful aesthetic dermatology practice. We know from our extensive clinical research and marketing research with our targeted customers that the CellFX system offers dermatologists and other skin specialists an entirely new way to address a broad range of cash-paying aesthetic procedures that their patients will demand. As we transition to this commercial phase of the CellFX system, our controlled launch aims to accomplish two main objectives. First, it will lay the proper foundation of success for seamless practice integration, which includes comprehensive training, education support, and setting the proper expectations to create a best-in-class experience for both the physician and the patient. We believe this is one key to achieving high utilization rates for each installation as we scale up, which is a key success metric that we will directly monitor through the CellFX Cloud Connect infrastructure that Darren described earlier. Secondly, A successful controlled launch with these global KOLs creates the optimal blueprint for broader and stronger long-term adoption of the cell effect system with high utilization rates over time. It is our commercial team's experience that this next wave of early technology adopters in dermatology will base their purchase decision on the advocacy, success, and and media presence of the first wave of care wells that we have selected for our controlled launch participation. Our commercial team has deep experience in the aesthetic market with utilization-based business models, with a track record that has proven that this type of top-down approach leads to the steady adoption of new technologies and high utilization rates over time, especially as we add future applications to the cell effect system based on our ongoing clinical research investment. Darren has already discussed our anticipated regulatory clearances and timelines. As part of our launch planning process, we have been regularly conducting marketing research on aesthetic dermatology practices and how their practices are adapting to patient-related COVID-19 protections. We have tracked aesthetic procedure trends over the last three quarters with nationwide online surveys conducted with aesthetic dermatologists beginning back in May, at the beginning of the pandemic. Since that time, we have seen a consistent upward trend of procedure volumes among the majority of respondents based on the latest survey results. And the results from October show that the majority of US aesthetic procedure specialists are optimistic that procedure volumes will return to normal levels in less than six months from now compared to the survey we took just in August when the majority of physicians believed it would take six months or longer. This cautiously optimistic outlook of future aesthetic procedure demand is also supported by our ongoing monitoring of physician virtual meeting discussions and in published formal guidelines on reopening aesthetic dermatology practices safely while adjusting to changes in patient workflow PPE usage, and social distancing. The practice safety recommendations stem from a joint task force between the American Society for Dermatologic Surgery and the American Society for Lasers and Medicine and Surgery. This physician-led safety guidance demonstrates the motivation of aesthetic practices to maintain a safe and low-risk environment while responding to the pent-up demand from their aesthetic patients who have been postponing procedures as they work at home. This healthy demand is also evidenced by dermatologists seeing more emphasis from their patients for facial procedures due to the importance of looking professional while being on camera for work-at-home video meetings. As practices continue to schedule future appointments, aesthetic dermatologists are also seeing a trend towards patients making the most of each visit by scheduling multiple procedures in the same visit. As a final note on dermatology practice activity, we are encouraged by physicians reporting an upswing in the trend to resume in-person interactions with industry representatives, such as our field sales team, of course taking place within proper safety guidelines. This ongoing trend of access to physicians and their practice is an important assumption as we prepare for our sales team's role in managing the controlled launch in KOL practices with our dedicated clinical application specialty sales team that works with physicians and their staff as part of our ongoing educational best practices cell effects system launch programs. While we continue to monitor trends in the aesthetic procedure market and their adaptation to these ever-changing conditions, these recent insights and testimonies represent a distinct sign that dermatologists are in recovery mode and maintain an enthusiasm to stay on top of the latest technologies. Bridging this optimism about the future and receptiveness to emerging technologies, we continue to see a growing acceptance among the broader scientific community of the NPS system as an important new technology in peer review meetings. The Pulse team remains highly engaged in supporting our clinical investigators and key opinion leaders who continue to be invited to present our clinical research findings, results at scientific meetings, which are now being held online and being very well attended. Our NPS clinical and scientific data continues to be published in leading peer-reviewed dermatology journals. Most recently, the American Society for Dermatologic Surgery, or ASDS, hosted their annual conference earlier this month as a virtual meeting. We were pleased that NPS technology was highlighted in three different sessions and two e-posters. Of particular note, NPS technology was featured in a session course entitled, What's Next? The Procedures That Will Change the Way We Treat Our Patients. which was moderated by Dr. Matthew Abram, the current president of the ASDS. Dr. Abram was joined by Dr. Victor Ross, the past president of the American Society for Laser Surgery and Medicine, and a current Pulse Scientific Advisory Board member, and by Pulse Clinical Investigator, Dr. Roy Geronimus. In this session, both Dr. Ross and Dr. Geronimus highlighted our cell-specific non-thermal NPS technology as one innovation that will define the field of dermatology in the near future, acknowledging the unmet need in addressing a wide variety of cellular-based skin problems and highlighting successful clinical study results in sebaceous hyperplasia, cutaneous non-dental warts, and seborrheic keratosis, as well as our early findings with nodular basal subcarcinoma, or BCC. as we had reported on our last call in August. With the international cache of the ASDS Annual Meeting, dissemination of MPS clinical research provides global visibility and will help boost our international outreach efforts, as we can confidently expect that any positive clinical research will be viewed in good favor by the international market. In the area of peer-reviewed research on NPS technology published in prominent dermatology journals, we were pleased to learn that our study evaluating the safety of NPS energy levels on facial skin was published in the Journal of Cosmetic and Laser Therapy by lead author Dr. James Newman and titled A Dose Response Study of Nanosecond Electrical Pulses on Facial Skin. The results of this study demonstrate that NPS technology applied to facial skin is safe and effective for removing lesions residing in the epidermis of facial skin, such as sebaceous hyperplasia. The study also further demonstrated the cell-specific effect of NPS technology in clearing the cellular-based structures in a targeted area while sparing damage to the non-cellular dermis. Looking forward, we plan on increased international presence and will continue to work with our esteemed clinical investigators on abstract and publication submissions at key international conferences and in their journals. As the energy and enthusiasm for NPS technology continues to mount among aesthetic dermatologists, our optimism grows about the positive reception for the future commercial adoption of the Cell Effect System by the specialized audiences of physicians who purchase and utilize medical devices for dermatology applications. Now, I'll turn the call over to Sandy for the financial results.
spk01: Thank you, Ed. For the third quarter of 2020, operating expenses were $12.9 million compared to $12 million for the prior year period. Increases in research and development costs and to a lesser extent, increases in general administrative costs drove the increase in operating costs. Operating expenses for the three months ended September 30, 2020 included $2.6 million of non-cash stock-based compensation versus $2.7 million in the prior year period. General and administrative expenses consist of salaries and related employee expenses for executives, sales and marketing, finance, legal, human resources, information technology, and administrative personnel, as well as professional fees, patent fees and costs, insurance costs, and other general corporate expenses. General and administrative expenses increased by approximately $165,000 to $5.8 million for the three-month period ended September 30, 2020, from $5.6 million during the same period in 2019, primarily related to increases in personnel, business insurance, and facility expansion costs, offset by a reduction in recruitment-related costs from a year ago, as well as a reduction in travel expenses primarily related to COVID-19. Research and development expenses consist of salaries and related expenses for manufacturing and research and development personnel, as well as clinical trials and consulting costs related to the design, development, and enhancement of our potential future products. Research and development expenses increased by approximately $800,000 to $7 million for the three-month period ended September 30, 2020. from $6.2 million during the same period in 2019, primarily due to increases in personnel and an increase in consulting and outside services related to our GLP preclinical studies in support of our 510 submission offset by a reduction in clinical trial expenses from a year ago. Net loss for the first quarter ended September 30, 2020 with $12.9 million compared to $11.7 million for the third quarter ended September 30th, 2019. Cash and cash equivalents and investments totaled $29.6 million as of September 30th, 2020 compared to 37.8 million as of June 30th, 2020. Cash utilized in the three months ended September 30th, 2020 was $8.2 million. This compares with $7.9 million of cash utilized in the three months ended June 30, 2020, excluding net proceeds received in the rights offering. Now I'll turn the call back to Darren.
spk05: Thank you, Sandy. To conclude, we have maintained a focus on our core objectives throughout these challenging times and taken huge strides towards bringing nanopulse stimulation technology delivered by the CellFX system to clinicians and patients. Regulatory submissions to achieve FDA clearance, CE mark approval, and a Health Canada medical device license could potentially all occur as early as the first quarter of 2021. We completed enrollment of 60 patients in our first FDA IDEA-approved pivotal study comparing the cell effect system to electrodesiccation in just over five weeks and ahead of schedule. Our continued engagement with the scientific community and a strategic commercial launch plan positioned Pulse Biosciences for success. We are very excited about this pivotal time in the company's history and the momentum we are building towards commercial launch of the CellFX system. We look forward to providing you updates in the future. Joining me now for Q&A are Ed Ebbers, Executive Vice President and General Manager, Dermatology, and Sandy Gardner, Executive Vice President and Chief Financial Officer. Operator, please open the call for questions.
spk03: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. Our first question comes from Sean Kang with HC Wainwright. Please proceed with your questions.
spk06: Hi, thank you for taking my question. So I have a question about the regulatory pathway strategy in ex-U.S. region, basically Canada and EU. So would you take a similar approach or like step-by-step regulatory strategy in those regions as well?
spk05: Yeah, hey, Sean, it's Darren. Thanks for the question. So if I understood your question right, Um, your question is about the regulatory strategy in Canada and the EU?
spk06: Yeah, so basically you're going for general indication first and then add specific indication later, similar to what we're doing in Europe.
spk05: I understand. Yeah, I understand your question. Thank you. So as I mentioned in the prepared remarks, with regard to the CE mark in the EU, Part of our technical file, we included the clinical evaluation report. The clinical evaluation report included clinical data in support of sebaceous hyperplasia, seborrheic keratosis, and warts. And so it's actually well beyond a sort of general indication. It's more of a sort of a general indication plus indications including those three factors. lesions that I just mentioned, sebaceous hyperplasia, seborrheic keratosis, and warts. So, you know, like I said, you know, we're very hopeful that we're getting down to kind of the final Q&A on our CE mark with our notified body. And when that comes in, we have confidence that at that time, you know, we will be able to ship and commercialize in the EU the and promote the cell effect system for those specific indications. So unlike the U.S., I think we're in a position to be able to market to those indications immediately as we receive the CE mark. As it relates to Health Canada and the medical device license in Canada, our submission also included those three indications. So it's a bit early in that process to be able to comment at all on what might be what might come out of that approval through Health Canada, but certainly our submission included those three indications.
spk06: I see. Just a quick follow-up question to that is, would you seek commercial partners in Canada and EU, or would you just directly market your product over there?
spk04: Yes, this is Pat answering that question. I would describe our model as a hybrid direct and distributive model, and it varies by market and country. In the instance of Canada, we will be hiring our own direct sales force to cover Canada and expand as the installed base justifies that expansion with direct employees. In the instance of the EU, we are in the process of recruiting and hiring an EU-based sales and operations team to directly launch in the largest and most influential markets, and specifically to provide the level of support for the controlled launch for EU opinion leaders that matches our highest standards. And then we will be looking at, for other smaller markets, closely managing distributors in those countries where it makes sense, again, with our own people directly involved with distributors to make sure the standards of training and education meet that of our direct sales team. So that's our distribution plan going forward. That's very helpful. Thank you.
spk03: As a reminder, if you'd like to ask a question, please press star 1 on your telephone keypad. One moment, please, while we poll for questions. There are no further questions at this time. At this point, I'd like to turn the call back over to Darren Uecker for closing comments.
spk05: All right. Thank you, Operator. And thank you, everybody, for joining us on the call today. And a last thank you for the Pulse Biosciences team and all of our partners who have really helped us make tremendous progress over the last several quarters during these challenging times. Thank you very much. We look forward to updating you very soon.
spk03: This concludes today's conference. You may disconnect your lines at this time. We thank you for your
Disclaimer