Item 8.01 Other Events.
Preliminary Second Quarter 2020 Financial Results
Preliminary revenue for the second quarter of 2020 is expected to be approximately $0.1 million, compared to $0.5 million in the second quarter of 2019. The Company’s revenue was generated almost exclusively through sales of the PoNS device pursuant to supply agreements with neuroplasticity clinics in Canada.
Gross profit for the second quarter of 2020 is expected to be approximately $0.1 million, compared to gross profit of $0.3 million in the second quarter of 2019. Operating expenses for the second quarter of 2020 are expected to be approximately $3.7 million, compared to $6.1 million in the second quarter of 2019. The year-over-year decrease in operating expenses was primarily driven by an expected decrease of approximately $1.5 million, or 39%, in selling, general and administrative expenses. The decrease in selling, general and administrative expenses was primarily due to a reduction in commercial operations expenses coupled with a reduction in wages and salaries.
Six Months Ended June 30, 2020 Financial Results
Preliminary revenue for the six months ended June 30, 2020 is expected to be approximately $0.3 million, compared to $1.2 million in the prior year period. The Company’s revenue was generated almost exclusively through sales of the PoNS device pursuant to supply agreements with neuroplasticity clinics in Canada.
Gross profit for the six months ended June 30, 2020 is expected to be approximately $0.2 million, compared to gross profit of $0.7 million in the prior year period. Operating expenses for the six months ended June 30, 2020 are expected to be approximately $7.8 million, compared to $13.4 million in the prior year period.
The Company has not completed the preparation of its financial statements for the quarter ended June 30, 2020 and additional details with respect to the quarter ended June 30, 2020 results of operations are not yet available. The Company plans to release quarter ended June 30, 2020 actual results after the completion of its quarterly review.
Cash Position
As of June 30, 2020, the Company had cash of $5.3 million, compared to $5.5 million at December 31, 2019. The Company had no debt outstanding at June 30, 2020.
Regulatory Update
On August 4, 2020, the Company submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNSTM) device for the treatment of gait deficit due to symptoms of Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program.
Forward-Looking Statements
The second quarter 2020 financial results contained in this Current Report on Form 8-K are subject to finalization in connection with the preparation of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. This Current Report on Form 8-K may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act and
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Section 21E of the Exchange Act. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements about Registrant’s preliminary second quarter 2020 financial information, future clinical and regulatory development plans for the PoNS device, the success of the Registrant’s planned study and the potential receipt of regulatory clearance of the PoNS device in the United States. These forward-looking statements are based on information currently available to the Registrant and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including the uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including the Registrant’s capital requirements to achieve its business objectives and other risks detailed from time to time in the filings made by the Registrant with securities regulators, and including the risks and uncertainties about the Registrant’s business described in the “Risk Factors” sections of the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed on May 11, 2020 and its other filings with the United States Securities and Exchange Commission. The Registrant is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.