On May 11, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the first quarter of 2022 (Press release, Pulse Biosciences, MAY 11, 2022, View Source [SID1234614219]).
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Company Updates
Increased the overall CellFX System commercial session utilization four week moving average1 during Q1 with decreasing trend in early Q2 due to transition in commercial strategy.
Appointed new commercial leadership and began initiation of the CellFX System utilization program in May with nine commercial clinics to establish commercial integration best practices. Established program goal for each clinic of 40 commercial sessions per month. Average monthly utilization of the nine participating clinics during Q1 was 14 sessions per month.
Generated first quarter 2022 revenue of $444 thousand.
Completed one commercial sale of a CellFX System in the first quarter of 2022.
Transitioned 10 Controlled Launch Program participants to commercial use in the first quarter totaling 39 commercial conversions at the end of the first quarter. There are 20 clinics remaining in the Controlled Launch program after a total of 11 clinics have opted out as of the end of Q1.
Met with FDA regarding the Additional Information (AI) letter response to the sebaceous hyperplasia 510(k). Provided additional analysis of the clinical data following the meeting, at FDA’s request, and anticipate further communication prior to any formal response to the AI letter.
1 Utilization is measured as commercial sessions defined as individual patient treatments, regardless of the number of lesions treated, performed using CellFX Systems that have been purchased or converted to commercial use from the controlled launch program.
"In the first quarter of 2022 we took steps to refocus our CellFX dermatology efforts by bringing in new commercial leadership. We have prioritized increasing CellFX System utilization at a subset of our commercial clinics, with the goal of developing commercial integration best practices that will drive utilization across all clinics. While these best practices are being established there will be a reduced focus on capital sales," said Darrin Uecker, President and CEO of Pulse Biosciences. "We also continue to prioritize indication expansion for the CellFX System and are actively working with FDA on this process."
First Quarter 2022 Results
Revenue for the three months ended March 31, 2022 was $444 thousand. System revenue for the three months ended March 31, 2022 was $367 thousand. Cycle units revenue for the three months ended March 31, 2022 was $77 thousand resulting from the purchase of cycle units to be used with commercial systems. Total revenues of $331 thousand were recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems during the quarter.
Total GAAP cost and expenses representing cost of revenues, research and development, sales and marketing and general and administrative expenses for the three months ended March 31, 2022 were $17.7 million, compared to $18.5 million for the prior year period. Non-GAAP cost and expenses for the three months ended March 31, 2022 were $14.7 million, compared to $11.3 million for the same period in the prior year. The year-over-year increase in non-GAAP cost and expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities. The first quarter of 2022 also included a discrete restructuring charge of $733 thousand, of which $706 thousand remains in accrued expenses as of March 31, 2022.
GAAP net loss for the three months ended March 31, 2022 was ($17.3) million compared to ($18.6) million for the three months ended March 31, 2021. Non-GAAP net loss for the three months ended March 31, 2022 was ($14.2) million compared to ($11.4) million for the three months ended March 31, 2021.
Cash, cash equivalents and investments totaled $12.7 million as of March 31, 2022 compared to $59.9 million as of March 31, 2021 and $28.6 million as of December 31, 2021. Cash used in the first quarter of 2022 totaled $15.9 million compared to $10.7 million used in the same period in the prior year and $13.4 million used in the fourth quarter of 2021.
Reconciliations of GAAP to non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."
Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today, May 11, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source