UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):
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| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
ITEM 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
On January 11, 2022, Pulse Biosciences, Inc. announced certain preliminary financial and operational results for the fiscal quarter and full year ended December 31, 2021. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by this reference. The financial information in the press release is unaudited and subject to adjustment in the final audited financial statements to be filed with the Company’s Annual Report on Form 10-K. The Company expects to report its complete 2021 financial results on its fourth-quarter and full-year earnings call, which it will hold later in the first quarter of 2022.
This information, as well as Exhibit 99.1, is intended to be furnished under Item 2.02 of Form 8-K, “Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
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| Press Release issued by Pulse Biosciences, Inc. dated January 11, 2022. | |||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| By: | /s/ Sandra A. Gardiner |
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| Sandra A. Gardiner Chief Financial Officer, Executive Vice President of Finance and Administration, and Treasurer (Principal Financial and Accounting Officer) |
Date: January 11, 2022
Pulse Biosciences Announces Preliminary Fourth Quarter and Full Year 2021 Financial and Operational Results
HAYWARD, Calif. [Business Wire] – January 11, 2022. Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced preliminary unaudited fourth quarter 2021 financial and operational results.
Recent Highlights:
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Preliminary unaudited full year 2021 revenue is expected to be in the range of $1.3 million to $1.4 million, including preliminary unaudited fourth quarter 2021 revenue of approximately $750 thousand |
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Completed the first two commercial sales of CellFX Systems in the fourth quarter of 2021 |
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Transitioned 17 Controlled Launch Program participants to commercial use of their acquired CellFX System, bringing the total number of commercial conversions to 29 at the end of the fourth quarter of 2021 |
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Completed onboarding CellFX Controlled Launch Program participants, increasing the total number of program participants to 70. Six clinics have opted out of the program to date. |
“We are proud of our accomplishments in 2021,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We achieved regulatory approval for the CellFX System in the U.S., Europe and Canada, onboarded Controlled Launch Program participants, expanded commercialization across each geography and continued to advance our clinical and regulatory initiatives. These achievements position Pulse Biosciences to drive meaningful growth in 2022 and beyond as we leverage the full potential of NPS technology in dermatology and other medical specialties.”
The Company’s fourth quarter 2021 financial results are preliminary and are subject to the completion of the Company’s 2021 audit. Complete fourth quarter and full year 2021 financial results will be announced in March.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX® System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of applications for which an optimal solution remains unfulfilled. The initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. Visit pulsebiosciences.com to learn more.
To stay informed about the CellFX System, please visit CellFX.com and sign-up for updates.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding the commercialization of the CellFX System to drive Company growth, such as statements relating to the effectiveness of the Company’s NPS technology and the CellFX System to improve patient outcomes, statements concerning the value of the Company’s utilization-based revenue model, statements relating to the Company’s pipeline of product candidates, market opportunities and commercial launch plans, including statements about the Company’s ability to pursue applications for NPS technology outside of dermatology, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
Contacts
Investors:
Pulse Biosciences
Sandra Gardiner, EVP and CFO
510.241.1077
IR@pulsebiosciences.com
or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
Media:
Tosk Communications
Nadine D. Tosk
504.453.8344
nadinepr@gmail.com or
press@pulsebiosciences.com