Earnings Labs

Pulse Biosciences, Inc. (PLSE)

Q3 2022 Earnings Call· Thu, Nov 10, 2022

$20.81

-4.67%

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Transcript

Operator

Operator

Greetings and welcome to Pulse Biosciences Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Philip Taylor. Thank you. You may begin.

Philip Taylor

Analyst

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 10, 2022, 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 and Events section of 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

Analyst

Thank you, Trip. Good afternoon, everyone, and thank you for joining us. On today's call, I will discuss our refreshed vision for the company, including our strategic shift in focus to advance our core NPS technology controlled by the CellFX system in specific sectors of healthcare. I will also highlight the recent changes we made to the organization to support this new strategic direction. And I will turn the call over to our new Chief Technical Officer, Darrin Uecker to discuss our product initiatives; and Sandy will cover the financial results and we will open the call to questions. To start, I’m very excited to lead the company through this next exciting chapter. In present time, the vast majority of our focus is centered on evaluating opportunities in cardiac healthcare where we are confident we can create significant value with our Nano-Pulse field technology. Pulse Biosciences is positioned to make this decisive strategic shift. The preclinical work that we have already completed provides mounting evidence, NPS driven by a novel proprietary CellFX system can be safe and effective in cardiac tissue ablation. We made the decision to move forward with the use of NPS, controlled by CellFX and cardiac tissue ablation for the treatment of atrial fibrillation as our lead application. Atrial fibrillation or AF is a type of heart arrhythmia are irregular heartbeat caused by faulty electrical signals in the heart. AF is a highly prevalent condition and is growing significantly with an aging population. It is estimated that 35 million people worldwide are affected by AF. The treatment of AF is performed in hospitals in both the in and outpatient procedure. Treatment requires the precise and safe ablation of heart tissue to block or otherwise prevent these faulty electrical signals from causing the irregular heartbeat. We believe NPS controlled by CellFX is suited to perform an integral role for this application. Darrin will provide more detail on the novel and proprietary mechanism of NPS and why we believe the application of NPS controlled by CellFX in AF can result in a highly differentiated solution of significant value to patients, physician, cardiac centers and Pulse Biosciences stakeholders. As an update on dermatology, we have taken steps to significantly reduce our footprint by reducing the related sales, marketing and support staff. Now I'd like to turn it over to Darrin.

Darrin Uecker

Analyst

Thank you, Kevin. As Chief Technology Officer, I look forward to leading the product development and technology advancement of NPS technology and our CellFX system. And I'm excited to be working closely with our Chief Strategy Officer, Mitch Levinson, to move our NPS technologies into new application areas. At Pulse Biosciences, we have developed a novel and proprietary tissue treatment platform based on Nano-Pulse Stimulation or NPS where ultra fast electrical energy pulses with nanosecond pulse durations from billions up to a millionth of a second are used to stimulate cellular effects that can lead to positive therapeutic outcomes. NPS 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. And nanosecond pulse is an incredibly fast pulse. To give a sense of the scale, a nanosecond is to a second what a second is to 31.7 years. It’s an incredibly short amount of time. 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 cell’s power plant and the endoplasmic reticulum, which plays an important role in protein synthesis. When the function of these organelles is disrupted, cell goes through a natural regulated cell death process. This ability to get inside the cell with a non-toxic application of electrical energy, while preserving the integrity of the outer cell membrane to initiate regulated cell death is a cornerstone of NPS. The regulated cell death process leads to a more natural healing response as the body’s immune system is…

Sandy Gardiner

Analyst

Thank you, Darrin. Given our shift in focus to advance NPS technology outside dermatology, there was no revenue recognized in the third quarter of 2022. Moving down the income statement, I’ll focus my comments on our non-GAAP results. I encourage you to review today’s earnings release for a detailed reconciliation of non-GAAP measures for the most comparable GAAP measures. For the third quarter of 2022, non-GAAP costs and expenses representing cost of revenues, research and development, sales and marketing, and general administrative expenses were $16.8 million compared to $13 million for the prior year period and $12.2 million for the prior quarter. Non-GAAP cost of revenues was approximately $8.3 million for the three month period ended September 30, 2022. This includes a $7.2 million inventory reserve for excess and obsolete inventory as it relates to the dermatology business. Non-GAAP research and development expenses decreased by approximately $1.9 million from a year ago to $4.1 million for the three month period ended September 30, 2022 primarily as a result of headcount and expense reductions as part of our restructuring plan. In addition to decreases in compensation and other employee related expenses, reductions were also achieved in paid services, sponsored research and clinical site fees and costs. Non-GAAP sales and marketing expenses decreased by approximately $1.4 million from a year ago to $2 million for the three month period ended September 30, 2022 primarily due to our decision to end commercial activities in dermatology. Non-GAAP general and administrative expenses decreased by approximately $592,000, $2.4 million for the three month period ended September 30, 2022 primarily as a result of headcount and expense reductions as part of our restructuring plan. Non-GAAP net loss for the third quarter of 2022 was $16.8 million compared to a net loss of $12.4 million for the third quarter of 2021 and $11.9 million for the second quarter of 2022. On September 20, 2022 we entered into an 18-month term loan agreement with Robert Duggan, our Executive Chairman for principal sum of $65 million. The loan agreement bears interest at a rate per annum equal to 5% payable quarterly commencing on January 1, 2023. Cash and cash equivalents totaled $69.2 million as of September 30, 2022 compared to $28.6 million as of December 31, 2021 and $14.8 million as of June 30, 2022. Cash used in the third quarter of 2022 totaled $10.6 million compared to $13.8 million used in the same period in the prior year and $12.8 million used in the second quarter of 2022. Now I will turn the call back to Kevin for final remarks.

Kevin Danahy

Analyst

Thank you, Sandy. This strategic shift in focus to pursue the treatment of AF with NPS controlled by CellFX is an important and natural progression for our company. We have the core team with the right experience and dedication to deliver on this exciting opportunity. We look forward to keeping you updated on our progress. And with that, joining me for Q&A are Darrin Uecker, Chief Technical Officer and Sandy Gardiner, Executive Vice President and Chief Financial Officer. Operator, please open the calls for questions.

Operator

Operator

[Operator Instructions] There are no questions at this time. This concludes today's conference. You may disconnect your lines at this time and we thank you for your participation.

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Analyst