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Pulse Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results
HAYWARD, Calif. [Business Wire] – February 22, 2021 – Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing its Nano-Pulse Stimulation™ (NPS™) technology, today announced financial results for the fourth quarter and full year ended December 31, 2020.
Recent Highlights
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Received U.S. Food and Drug Administration (FDA) clearance for the CellFX® System for dermatologic procedures requiring ablation and resurfacing of the skin |
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Received CE mark approval for the CellFX System |
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Initiated the CellFX System Controlled Launch program in the U.S. and Europe, including system implementations and completion of the first procedures performed by participating Key Opinion Leader (KOL) aesthetic dermatologists |
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Continued preparation to make an FDA 510(k) submission for a sebaceous hyperplasia (SH) specific indication for the CellFX System as early as the end of the first quarter of 2021 |
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Enrolled and treated the first patients in an IDE pivotal comparison study to evaluate the treatment of cutaneous non-genital warts using the CellFX System |
“Our diligent efforts throughout 2020 resulted in regulatory clearances for the CellFX System in the U.S. and Europe. We believe these achievements highlight the safety and efficacy of our CellFX System for use in aesthetic dermatology. Along with our clinical investigators, we have built a strong foundation from which we intend to expand CellFX System indications for use, first in aesthetic dermatology and subsequently for other applications over time, as we execute on our stepwise regulatory strategy,” said Darrin Uecker, President and CEO of Pulse Biosciences. “The detailed and thoughtful preparation by our team has enabled the immediate implementation of our Controlled Launch program of the CellFX System integrated with CellFX CloudConnect services. In both the U.S. and in Europe, we now have KOLs performing CellFX procedures. This measured approach is our top focus in 2021 and will lay the groundwork for long term adoption of the CellFX System with CellFX CloudConnect and growth for Pulse Biosciences.”
Fourth Quarter 2020 Results
Cash, cash equivalents and investments totaled $20.5 million as of December 31, 2020, compared to $29.6 million as of September 30, 2020. Cash used in the fourth quarter of 2020 totaled $9.1 million. Excluding net proceeds received in our June 2020 rights offering, cash use for the full year ended December 31, 2020 totaled $34.6 million, compared to $34.2 million for the full year 2019.
Operating expenses for the three months ended December 31, 2020 were $13.8 million, compared to $13.9 million for the prior year period. Fourth quarter 2020 operating expenses included stock-based compensation expense of $2.4 million, compared to $3.5 million in the fourth quarter of 2019.
Operating expenses for the twelve months ended December 31, 2020 were $50.0 million, compared to $48.0 million for the prior year period. Stock-based compensation expense for the twelve months ended December 31, 2020 was $10.1 million, compared to $11.3 million in the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure and increased headcount to support preparations for commercialization.
Net loss for the three months ended December 31, 2020 was ($13.8) million in line with the same ($13.8) million for the three months ended December 31, 2019. Net loss for the twelve months ended December 31, 2020 was ($49.9) million, compared to ($47.0) million for the twelve months ended December 31, 2019.
Impact of COVID-19
The COVID-19 pandemic had minimal impact on our operations in the fourth quarter of 2020. Product development, execution of clinical trials, regulatory timelines and controlled commercial launch have
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Pulse Biosciences, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
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Other than as discussed above and elsewhere in this Annual Report on Form 10-K, we are not currently aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition in the near term, although it is possible that new trends or events may develop in the future that could have a material effect on our financial condition.
Even if we are able to generate revenues, there can be no assurances that we will be able to achieve profitability or positive operating cash flows.
We expect general and administrative expenses to increase in the future as we hire personnel and incur additional costs to support our commercialization efforts, research and development activities and our operation as a public company, including higher legal, accounting, insurance, compliance, compensation and other costs.
Also, it is possible that delivery from some of our suppliers of certain materials used in the production of our product candidates could be delayed due to COVID-19 which could affect our ability to obtain sufficient materials for our product candidates.
Assets to be disposed of are separately presented in the consolidated balance sheet, reported at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated.
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Financial Statements, Disclosures and Schedules
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Pulse Biosciences, Inc. provided additional information to their SEC Filing as exhibits
Ticker: PLSE
CIK: 1625101
Form Type: 10-K Annual Report
Accession Number: 0001625101-21-000014
Submitted to the SEC: Fri Mar 12 2021 5:24:09 PM EST
Accepted by the SEC: Fri Mar 12 2021
Period: Thursday, December 31, 2020
Industry: Surgical And Medical Instruments And Apparatus