UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended |
OR
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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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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There were
NEURONETICS, INC.
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022
Table of Contents
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
NEURONETICS, INC.
Balance Sheets
(Unaudited; In thousands, except per share data)
September 30, | December 31, | |||||
| 2022 |
| 2021 | |||
Assets |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Accounts receivable, net |
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Inventory |
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Current portion of net investments in sales-type leases |
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Current portion of prepaid commission expense |
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Current portion of note receivables | | |||||
Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Net investments in sales-type leases |
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Prepaid commission expense |
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Long-term note receivable | |
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Other assets |
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Total Assets | $ | | $ | | ||
Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued expenses |
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Deferred revenue |
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Current portion of operating lease liabilities |
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Current portion of long-term debt, net |
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Total current liabilities |
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Long-term debt, net |
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Deferred revenue |
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Operating lease liabilities |
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Total Liabilities |
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Commitments and contingencies (Note 17) |
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Stockholders’ Equity: |
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Preferred stock, $ |
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on , and December 31, 2021 |
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Common stock, $ |
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shares and on September 30, 2022, and December 31, 2021, respectively |
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Additional paid-in capital |
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Accumulated deficit |
| ( |
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Total Stockholders' Equity |
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Total Liabilities and Stockholders’ Equity | $ | | $ | | ||
The accompanying notes are an integral part of these unaudited interim financial statements.
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NEURONETICS, INC.
Statements of Operations
(Unaudited; In thousands, except per share data)
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Revenues |
| $ | |
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Cost of revenues |
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Gross Profit |
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Operating expenses: |
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Sales and marketing |
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General and administrative |
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Research and development |
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Total operating expenses |
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Loss from Operations |
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Other (income) expense: |
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Interest expense |
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Other income, net |
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Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net loss per share of common stock outstanding, basic and diluted | ( | ( | ( | ( | ||||||||
Weighted-average common shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these unaudited interim financial statements.
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NEURONETICS, INC.
Statements of Changes in Stockholders’ Equity
(Unaudited; In thousands)
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| Additional |
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Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
Balance at December 31, 2020 |
| | $ | | $ | | $ | ( | $ | | ||||
Share-based awards and options exercises |
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Issuance of common stock, net of issuance costs of $ | | | | — | | |||||||||
Share-based compensation expense |
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Net loss |
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| ( |
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Balance at March 31, 2021 |
| | $ | | $ | | $ | ( | $ | | ||||
Share-based awards and options exercises |
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Share-based compensation expense |
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Net loss |
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| ( |
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Balance at June 30, 2021 |
| | $ | | $ | | $ | ( | $ | | ||||
Share-based awards and options exercises |
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Share-based compensation expense |
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Net loss |
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Balance at September 30, 2021 |
| | $ | | $ | | $ | ( | $ | | ||||
Balance at December 31, 2021 |
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Share-based awards and options exercises |
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Share-based compensation expense |
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Net loss |
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Balance at March 31, 2022 |
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Share-based awards and options exercises |
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Share-based compensation expense |
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Net loss |
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Balance at June 30, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
Share-based awards and options exercises |
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Share-based compensation expense |
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Net loss |
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| ( |
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Balance at September 30, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
The accompanying notes are an integral part of these unaudited interim financial statements.
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NEURONETICS, INC.
Statements of Cash Flows
(Unaudited; In thousands)
Nine Months Ended September 30, | |||||||
2022 | 2021 | ||||||
Cash Flows from Operating Activities: |
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Net loss | $ | ( | $ | ( | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Share-based compensation |
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Non-cash interest expense |
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Cost of rental units purchased by customers |
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Changes in certain assets and liabilities: |
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Accounts receivable, net |
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Inventory |
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Net investments in sales-type leases |
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Prepaid commission expense |
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Prepaid expenses and other assets |
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Accounts payable |
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Accrued expenses |
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Deferred revenue |
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Net Cash Used in Operating Activities |
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Cash Flows from Investing Activities: |
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Purchases of property and equipment and capitalized software |
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Repayment (Issuance) of promissory note | | ( | |||||
Net Cash provided by (used in) Investing Activities |
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Cash Flows from Financing Activities: |
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Payments of debt issuance costs |
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Proceeds from exercises of stock options |
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Proceeds from the issuance of common stock |
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Payments of common stock offering issuance costs |
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Net Cash (used in) Provided by Financing Activities |
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Net (Decrease) Increase in Cash and Cash Equivalents |
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Cash and Cash Equivalents, Beginning of Period |
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Cash and Cash Equivalents, End of Period | $ | | $ | | |||
Supplemental disclosure of cash flow information: |
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Cash paid for interest | $ | | $ | | |||
Transfer of Inventory to PP&E | | | |||||
Supplemental disclosure of non-cash investing and financing activities: |
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Purchases of property and equipment and capitalized software in accounts payable and accrued expenses | $ | | $ | | |||
Reduction of accounts receivable in long-term note receivable | — | | |||||
The accompanying notes are an integral part of these unaudited interim financial statements.
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1. DESCRIPTION OF BUSINESS
Neuronetics, Inc., or the Company, is a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from neurohealth disorders. The Company’s first commercial product, the NeuroStar Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation, or TMS, to create a pulsed, MRI-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood. The system was cleared in 2008 by the United States Food and Drug Administration, or the FDA, to treat adult patients with major depressive disorder, or MDD, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Our NeuroStar Advanced Therapy system was also cleared in 2022 by the FDA to treat people suffering from obsessive-compulsive disorder as well as for the treatment of comorbid anxiety symptoms for adults with MDD suffering from anxiety symptoms (“anxious depression”). NeuroStar Advanced Therapy is also available in other parts of the world, including Japan, where it is listed under Japan’s national health insurance. The Company intends to continue to pursue development of its NeuroStar Advanced Therapy System for additional indications.
COVID-19
The Company is continuing to monitor the impact of the COVID-19 pandemic on all aspects of its business and geographies, including how it will continue to impact the Company’s customers, supply chain, employees and other business partners. While the Company experienced significant disruptions in March 2020 through the end of September 30, 2022 from the COVID-19 pandemic, it is unable to predict the full impact that the pandemic may have on its financial condition, results of operations and cash flows due to numerous uncertainties. These uncertainties include the scope, severity and duration of the ongoing pandemic, the actions taken to contain the pandemic or mitigate its impact and the direct and indirect economic effects of the pandemic, vaccination rates, effectiveness of treatments, and containment measures, among others. The pandemic has significantly adversely impacted global economic activity and has contributed to significant volatility and negative pressure in financial markets, and may contribute to periods of economic uncertainty in the future.
Liquidity
As of September 30, 2022, the Company had cash and cash equivalents of $
2. BASIS OF PRESENTATION
The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles, or GAAP. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASUs, promulgated by the Financial Accounting Standards Board, or FASB.
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Interim Financial Statements
The accompanying unaudited interim financial statements have been prepared from the books and records of the Company in accordance with GAAP for interim financial information and Rule 10-01 of Regulation S-X promulgated by the United States Securities and Exchange Commission, or SEC, which permit reduced disclosures for interim periods. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying balance sheets and statements of operations and stockholders’ equity and cash flows have been made. Although these interim financial statements do not include all of the information and footnotes required for complete annual financial statements, management believes the disclosures are adequate to make the information presented not misleading. Unaudited interim results of operations and cash flows for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the full year. Unaudited interim financial statements and footnotes should be read in conjunction with the audited financial statements and footnotes included in the Company’s Form 10-K filed with the SEC on March 8, 2022, wherein a more complete discussion of significant accounting policies and certain other information can be found.
Use of Estimates
The preparation of financial statements in accordance with GAAP and the rules and regulations of the SEC requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Although management believes its estimates and assumptions are reasonable when made, they are based upon information available at the time they are made. Management evaluates the estimates and assumptions on an ongoing basis and, if necessary, makes adjustments. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions, including those related to the COVID-19 pandemic, and given the subjective element of the estimates and assumptions made, actual results may differ materially from estimated results.
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company’s complete summary of significant accounting policies can be found in “Note 3. Summary of Significant Accounting Policies” in the audited financial statements included in the Company’s Form 10-K filed with the SEC on March 8, 2022.
4. RECENT ACCOUNTING PRONOUNCEMENTS
New Accounting Standards Not Yet Adopted by the Company
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). This ASU provides guidance for recognizing credit losses on financial instruments based on an estimate of current expected credit losses model. The FASB subsequently issued ASU 2019-04, to clarify and address certain items related to the amendments in Topic 326.
ASU 2019-05, Financial Instruments - Credit Losses (Topic 326): Targeted Transition Relief, was issued to provide entities that have certain instruments within the scope of ASC 326 with an option to irrevocably elect the fair value option under ASC 825-10, Financial Instruments - Overall, applied on an instrument-by-instrument basis for eligible instruments. ASU 2019-10, Topic 326, Topic 815, and Topic 842 amends the mandatory effective date for Topic 326.
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These ASUs are effective for fiscal years beginning after December 15, 2022 for entities that are eligible to be defined by the SEC as a smaller reporting company. The Company is a smaller reporting company. Although the impact upon adoption will depend on the financial instruments held by the Company at that time, the Company does not anticipate a significant impact on its financial statements based on the instruments currently held and its historical trend of bad debt expense relating to trade accounts receivable.
Other than the items noted above, there have been no new accounting pronouncements not yet effective or adopted in the current year that we believe have a significant impact, or potential significant impact, to our unaudited interim financial statements.
5. FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS
The carrying values of cash equivalents, accounts receivable, prepaids and other current assets, and accounts payable on the Company’s balance sheets approximated their fair values as of September 30, 2022 and December 31, 2021 due to their short-term nature. The carrying values of the Company’s credit facility approximated its fair value as of September 30, 2022 and December 31, 2021 due to its variable interest rate. The carrying value of the Company’s note receivable approximated its fair value as of December 31, 2021 due to its variable interest rate.
Certain of the Company’s financial instruments are measured at fair value using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
Level 1: | Inputs are quoted prices for identical instruments in active markets. |
Level 2: | Inputs are quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable. |
Level 3: | Inputs are unobservable and reflect the Company’s own assumptions, based on the best information available, including the Company’s own data. |
The following tables set forth the carrying amounts and fair values of the Company’s financial instruments as of September 30, 2022 and December 31, 2021 (in thousands):
| September 30, 2022 | ||||||||||||||
Fair Value Measurement Based on | |||||||||||||||
Quoted | Significant | ||||||||||||||
Prices In | other | Significant | |||||||||||||
Active | Observable | Unobservable | |||||||||||||
Carrying | Markets | Inputs | Inputs | ||||||||||||
| Amount |
| Fair Value |
| (Level 1) |
| (Level 2) |
| (Level 3) | ||||||
Assets | |||||||||||||||
Money market funds (cash equivalents) | $ | | $ | | $ | | $ | — | $ | — | |||||
| December 31, 2021 | ||||||||||||||
Fair Value Measurement Based on | |||||||||||||||
Quoted | Significant | ||||||||||||||
Prices In | other | Significant | |||||||||||||
Active | Observable | Unobservable | |||||||||||||
Carrying | Markets | Inputs | Inputs | ||||||||||||
Amount | Fair Value | (Level 1) | (Level 2) | (Level 3) | |||||||||||
Assets |
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Money market funds (cash equivalents) | $ | $ | $ | $ | — | $ | — | ||||||||
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6. ACCOUNTS RECEIVABLE
The following table presents the composition of accounts receivable, net as of September 30, 2022 and December 31, 2021 (in thousands):
September 30, | December 31, | |||||
| 2022 |
| 2021 | |||
Gross accounts receivable - trade | $ | | $ | | ||
Less: Allowances for doubtful accounts |
| ( |
| ( | ||
Accounts receivable, net | $ | | $ | | ||
7. PROPERTY AND EQUIPMENT AND CAPITALIZED SOFTWARE
The following table presents the composition of property and equipment, net as of September 30, 2022 and December 31, 2021 (in thousands):
September 30, | December 31, | ||||||
| 2022 |
| 2021 | ||||
Laboratory equipment | $ | | $ | | |||
Office equipment |
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Computer equipment and software |
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Manufacturing equipment |
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Leasehold improvements |
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Rental equipment |
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Property and equipment, gross |
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Less: Accumulated depreciation |
| ( |
| ( | |||
Property and equipment, net | $ | | $ | | |||
As of September 30, 2022 and December 31, 2021, the Company had capitalized software costs, net of $
Depreciation and amortization expense was $
8. NOTE RECEIVABLE
On September 29, 2021, Neuronetics, Inc. the Company entered into an exclusive,
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In the Note, Success TMS made certain representations and warranties and was required to comply with certain customary affirmative and negative covenants during the term of the Note.
On April 29, 2022, the Company entered into a Subordination Agreement (the “Subordination Agreement”) with ZW Partners, LLC, a New Jersey limited liability company (“ZW Partners”), pursuant to which the Company agreed to subordinate its rights under the Note to the rights of ZW Partners under a revolving promissory note, dated as of April 29, 2022 (the “Senior Note”), issued by Success TMS to ZW Partners in an amount up to $
On July 14, 2022, Success TMS repaid in full the Note issued on September 29, 2021 with a cash payment of $
Interest income recognized by the Company was $
9. LEASES
Lessee:
The Company has operating leases for its corporate headquarters, a training facility and office equipment, including copiers. The Company leases an approximately
Operating lease rent expense was $
The following table presents the supplemental cash flow information as a lessee related to leases (in thousands):
| Nine Months Ended | ||||||
September 30, 2022 |
| September 30, 2021 | |||||
Cash paid for amounts included in the measurement of lease liabilities: |
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Operating cash flows from operating leases | $ | | $ | | |||
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The following table sets forth by year the required future payments of operating lease liabilities (in thousands):
September 30, 2022 | |||
Remainder of 2022 | $ | | |
2023 | | ||
2024 |
| | |
2025 |
| | |
2026 |
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Thereafter |
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Total lease payments |
| | |
Less imputed interest |
| ( | |
Present value of operating lease liabilities | $ | | |
Lessor sales-type leases:
Certain customers have purchased NeuroStar Advanced Therapy Systems on a rent-to-own basis. The lease term is or
The following table sets forth the profit recognized on sales-type leases (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||
Profit recognized at commencement, net | $ | | $ | | $ | | $ | | ||||
Interest income |
| — |
| — |
| — |
| — | ||||
Total sales-type lease income | $ | | $ | | $ | | $ | | ||||
The following table sets forth a maturity analysis of the undiscounted lease receivables related to sales-type leases (in thousands):
| September 30, | ||
2022 | |||
Remainder of 2022 | $ | | |
2023 | | ||
2024 |
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2025 |
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2026 | | ||
Total sales-type lease receivables | $ | | |
As of September 30, 2022, the carrying amount of the lease receivables is $
Lessor operating leases:
NeuroStar Advanced Therapy Systems sold for which collection is not probable are accounted for as operating leases. For the three months ended September 30, 2022 and 2021, the Company recognized operating lease income of $
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The Company maintained Rental Equipment, net of $
10. PREPAID COMMISSION EXPENSE
The Company pays a commission on both NeuroStar Advanced System sales and Treatment Session sales. Since the commission paid for System sales is not commensurate with the commission paid for Treatment Sessions, the Company capitalizes commission expense associated with NeuroStar Advanced Therapy System sales commissions paid that is incremental to specifically anticipated future Treatment Session orders. In developing this estimate, the Company considered its historical Treatment Session sales and customer retention rates, as well as technology development life cycles and other industry factors. These costs are periodically reviewed for impairment.
NeuroStar Advanced Therapy System commissions are deferred and amortized on a straight-line basis over a
On the Company’s balance sheets, the current portion of capitalized contract costs is represented by the current portion of prepaid commission expense, while the long-term portion is included in prepaid commission expense. Amortization expense was $
11. ACCRUED EXPENSES
The following table presents the composition of accrued expenses as of September 30, 2022 and December 31, 2021 (in thousands):
| September 30, |
| December 31, | |||
2022 | 2021 | |||||
Compensation and related benefits | $ | | $ | | ||
Consulting and professional fees |
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Research and development expenses |
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Sales and marketing expenses | | | ||||
Warranty |
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Sales and other taxes payable |
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Other |
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Accrued expenses | $ | | $ | | ||
12. DEFERRED REVENUE
Payment terms typically require payment upon shipment or installation of the System and additional payments as access codes for Treatment Sessions are delivered, which can span several years after the System is first delivered and installed. The timing of revenue recognition compared to billings and cash collections typically results in accounts receivable. However, sometimes customer advances and deposits might be required for certain customers and are recorded as contract liabilities (deferred revenue). For multi-year agreements, the Company generally invoices customers annually at the beginning of each annual coverage period and recognizes revenue over the term of the coverage period.
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As of September 30, 2022, the Company expects to recognize approximately the following percentages of deferred revenue by year:
| Revenue |
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Year: | Recognition |
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| % | ||
| | % | |
| | % | |
| | % | |
| % | ||
Total |
| | % |
Revenue recognized for the three and nine months ended September 30, 2022 that was included in the contract liability balance at the beginning of the year was $
Customers
For the three months ended September 30, 2022 and 2021,
13. DEBT
The following table presents the composition of debt as of September 30, 2022 and December 31, 2021 (in thousands):
September 30, | December 31, | ||||||
| 2022 |
| 2021 | ||||
Outstanding principal | $ | | $ | | |||
Accrued final payment fees |
| |
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Less debt discounts |
| ( |
| ( | |||
Total debt, net |
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Less current portion |
| ( |
| — | |||
Long-term debt, net | $ | | $ | | |||
For the three months ended September 30, 2022, the Company recognized interest expense of $
For the nine months ended September 30, 2022, the Company recognized interest expense of $
Solar Credit Facility
On March 2, 2020, the Company entered into a loan and security agreement with Solar Capital Ltd., or Solar, as collateral agent, and other lenders defined in the agreement, for a credit facility, or the Solar Facility, that
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replaced the Company’s previous $
The Solar Facility originally permitted the Company to borrow up to an aggregate amount of $
Each of the Term A Loan and Term B Loan accrue interest from the date of borrowing through the date of repayment at a floating per annum rate of interest, which resets monthly and is equal to
In addition to the principal and interest payments due under the Solar Facility, the Company is required to pay a final payment fee to Solar due upon the earlier of prepayment, acceleration or the maturity date of the Term A Loan or Term B Loan portion of the Solar Facility equal to
The Company is also required to pay Solar an exit fee upon the occurrence, prior to March 2, 2030, of (a) any liquidation, dissolution or winding up of the Company, (b) transaction that results in a person obtaining control over the Company, (c) the Company achieving $
15
The Company’s obligations under the Solar Facility are secured by a first priority security interest in substantially all of its assets, including its intellectual property. The loan and security agreement requires the Company to comply with certain financial covenants, including the attainment of a minimum trailing net revenue amount beginning on December 31, 2020, as well as customary affirmative and negative covenants.
The Solar Facility contains events of default, including, without limitation, events of default upon: (i) failure to make payment pursuant to the terms of the agreement; (ii) violation of covenants; (iii) material adverse changes to the Company’s business; (iv) attachment or levy on the Company’s assets or judicial restraint on its business; (v) insolvency; (vi) material cross-defaults; (vii) significant judgments, orders or decrees for payments by the Company not covered by insurance; (viii) incorrectness of representations and warranties; (ix) incurrence of subordinated debt; (x) a termination or breach of a guaranty; (xi) revocation of governmental approvals necessary for the Company to conduct its business; and (xii) failure by the Company to maintain a valid and perfected lien on the collateral securing the borrowing. The Solar Facility includes subjective acceleration clauses which permit the lenders to accelerate the maturity date under certain circumstances, including, but not limited to, material adverse effects on a Company’s financial status or otherwise.
On December 8, 2020, the Company, Solar Capital Ltd., and our other lenders defined in the Solar Facility, executed an amendment to the Solar Facility (the “Solar Amendment”). The Solar Amendment divided the aggregate Term B Loan borrowing amount of $
The Solar Amendment also reduced the trailing twelve-month net product revenue requirement for the Amended Term B Loan portion of the facility. Subject to certain conditions, the Company has the ability to extend the interest only period on the initial Term A Loan to
On February 15, 2022, the Company, SLR Investment Corp. (formerly known as Solar Capital Ltd.) (“Solar”), and our other lenders defined in the Solar Facility, executed an amendment to the Solar Facility and the Solar Amendment (the “2022 Solar Amendment”). The 2022 Solar Amendment waived any default under the Solar Facility and Solar Amendment that resulted from the Company’s failure to comply with the minimum monthly trailing twelve months net product revenue financial covenant, beginning with the testing period for the calendar month ending December 31, 2021 and continuing to the execution date of the 2022 Solar Amendment; (ii) decreased the amount of trailing twelve months net product revenue that the Company is required to achieve, for testing periods on and from the calendar month ending January 31, 2022; (iii) modified the definition of the fourth draw period with respect to the Company’s ability to borrow the Term D Loan portion of the Solar Facility, such that after giving effect to the 2022 Solar Amendment, the Term D Loan portion of the Solar Facility is no longer available to be drawn by the Company; and (iv) modified the definition of interest only extension conditions to allow commencement of loan principal amortization under the Solar Facility to be extended to March 1, 2023. The Company was required to pay an amendment fee of $
As of September 30, 2022, the Company is in compliance with all covenants in the Solar Facility and is projected to be in compliance with the reduced minimum revenue covenant amounts going forward.
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14. COMMON STOCK
Common Stock Offering
On February 2, 2021, we closed on our public offering and sale (the “Offering”) of our common stock in which we issued and sold
Common Stock
The following table summarizes the total number of shares of the Company’s common stock issued and reserved for issuance as of September 30, 2022 and December 31, 2021 (in thousands):
| September 30, 2022 |
| December 31, 2021 | |
Shares of common stock issued |
| |
| |
Shares of common stock reserved for issuance for: |
|
|
|
|
Common stock warrants outstanding |
| |
| |
Stock options outstanding |
| |
| |
Restricted stock units outstanding |
| |
| |
Shares available for grant under stock incentive plan |
| |
| |
Shares available for sale under employee stock purchase plan |
| |
| |
Total shares of common stock issued and reserved for issuance |
| |
| |
Common Stock Warrants
The following tables summarize the Company’s outstanding common stock warrants as of September 30, 2022, and December 31, 2021:
September 30, 2022 |
|
|
|
| |
Warrants |
|
|
|
| |
Outstanding | |||||
(in thousands) | Exercise Price | Expiration Date | |||
$ | |
| |||
$ | |
| |||
$ | |
| |||
$ | |
| |||
|
|
|
| ||
December 31, 2021 |
|
|
|
| |
Warrants |
|
|
|
| |
Outstanding | |||||
(in thousands) | Exercise Price | Expiration Date | |||
$ | |
| |||
$ | |
| |||
$ | |
| |||
$ | |
| |||
|
|
|
| ||
15. LOSS PER SHARE
The Company’s basic loss per common share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period. The Company’s restricted stock awards
17
(non-vested shares) are issued and outstanding at the time of grant but are excluded from the Company’s computation of weighted-average shares outstanding in the determination of basic loss per share until vesting occurs.
A net loss cannot be diluted, so when the Company is in a net loss position, basic and diluted loss per common share are the same. If in the future the Company achieves profitability, the denominator of a diluted earnings per common share calculation will include both the weighted-average number of shares outstanding and the number of common stock equivalents, if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options, non-vested restricted stock units and non-vested performance restricted stock units using the treasury stock method, along with the effect, if any, from the potential conversion of outstanding securities, such as convertible preferred stock.
The following potentially dilutive securities outstanding as of September 30, 2022 and 2021 have been excluded from the denominator of the diluted loss per share of common stock outstanding calculation (in thousands):
September 30, | |||||
| 2022 |
| 2021 | ||
Stock options | | | |||
Non-vested performance restricted stock units |
| |
| | |
Non-vested restricted stock units |
| |
| | |
Common stock warrants |
| |
| | |
16. SHARE-BASED COMPENSATION
The amount of share-based compensation expense recognized by the Company by location in its statements of operations for the three and nine months ended September 30, 2022 and 2021 is as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2022 |
| 2021 |
| 2022 |
| 2021 | |||||||
Cost of revenues | $ | | $ | | $ | | | ||||||
Sales and marketing |
| |
| |
| | | ||||||
General and administrative |
| |
| |
| | | ||||||
Research and development |
| |
| |
| | | ||||||
Total | $ | | $ | | $ | | $ | | |||||
2018 Equity Incentive Plan
In June 2018, the Company adopted the 2018 Equity Incentive Plan, or 2018 Plan, which authorized the issuance of up to
18
simulation valuation model. As of September 30, 2022, there were
2020 Inducement Incentive Plan
In December 2020, the Company adopted the 2020 Inducement Incentive Plan, which authorized the issuance of up to
Stock Options
The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022:
|
|
|
|
|
|
| Aggregate | |||
Number of | Weighted- | Weighted- | average | |||||||
Shares under | average | Remaining | Intrinsic | |||||||
Option | Exercise Price | Contractual | Value | |||||||
(in thousands) | per Option | Life (in years) | (in thousands) | |||||||
Outstanding at December 31, 2021 |
| | $ | |
|
| ||||
Granted |
| — | $ | — |
|
|
|
| ||
Exercised |
| ( | $ | |
|
|
| |||
Forfeited |
| ( | $ | |
|
|
|
| ||
Outstanding at September 30, 2022 |
| | $ | |
|
| $ | | ||
Exercisable at September 30, 2022 |
| | $ | |
|
| $ | | ||
Vested and expected to vest at September 30, 2022 |
| | $ | |
|
| $ | | ||
The Company recognized share-based compensation expense related to stock options of $
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Restricted Stock Units and Performance Restricted Stock Units
The following table summarizes the Company’s restricted stock unit and performance restricted stock unit activity for September 30, 2022:
| Non-vested |
| Weighted- |
| Non-vested |
| Weighted- | |||
Restricted | average | Performance Restricted | average | |||||||
Stock Units | Grant-date | Stock Units | Grant-date | |||||||
(in thousands) | Fair Value | (in thousands) | Fair Value | |||||||
Non-vested at December 31, 2021 | | $ | |
| | $ | | |||
Granted |
| | $ | |
| — | $ | — | ||
Vested |
| ( | $ | |
| — | $ | — | ||
Forfeited |
| ( | $ | |
| — | $ | — | ||
Non-vested at September 30, 2022 |
| | $ | |
| | $ | |
The Company recognized $
The Company did not grant performance restricted stock units during the period ended September 30, 2022. For the period ended December 31, 2021, the grant-date fair value of the performance restricted stock units was estimated at the time of grant using the following inputs and assumptions in the Monte Carlo simulation valuation model:
December 31, 2021 |
| ||
Closing price of common stock | $ | | |
Risk-free interest rate | | % | |
Expected volatility | | % |
17. COMMITMENTS AND CONTINGENCIES
Legal Matters
The Company is subject from time to time to various claims and legal actions arising during the ordinary course of its business. Management believes that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on the Company’s results of operations, financial condition, or cash flows.
18. GEOGRAPHICAL SEGMENT INFORMATION
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company currently operates in
20
The following geographic data includes revenue generated from the Company’s third-party distributors. The Company’s revenue was generated in the following geographic regions and by product line for the periods indicated (in thousands):
Revenues by Geography |
| ||||||||||
Three Months Ended September 30, |
| ||||||||||
2022 | 2021 |
| |||||||||
% of | % of |
| |||||||||
Amount | Revenues | Amount | Revenues |
| |||||||
(in thousands, except percentages) | |||||||||||
United States |
| $ | |
| | % | $ | |
| | % |
International |
| |
| | % |
| |
| | % | |
Total revenues | $ | |
| | % | $ | |
| | % | |
U.S. Revenues by Product Category |
| ||||||||||
Three Months Ended September 30, |
| ||||||||||
2022 | 2021 |
| |||||||||
% of | % of |
| |||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| |||
| (in thousands, except percentages) | ||||||||||
NeuroStar Advanced Therapy System | $ | | | % | $ | | | % | |||
Treatment sessions |
| |
| | % |
| |
| | % | |
Other |
| |
| | % |
| |
| | % | |
Total U.S. revenues | $ | |
| | % | $ | |
| | % | |
International Revenues by Product Category |
| ||||||||||
Three Months Ended September 30, |
| ||||||||||
2022 | 2021 |
| |||||||||
% of | % of |
| |||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| |||
| (in thousands, except percentages) | ||||||||||
NeuroStar Advanced Therapy System | $ | |
| | % | $ | |
| | % | |
Treatment sessions |
| |
| | % |
| |
| | % | |
Other |
| |
| | % |
| |
| | % | |
Total International revenues | $ | |
| | % | $ | |
| | % | |
Revenues by Geography |
| |||||||||||
Nine Months Ended September 30, |
| |||||||||||
2022 | 2021 |
| ||||||||||
% of | % of |
| ||||||||||
Amount | Revenues | Amount | Revenues |
| ||||||||
(in thousands, except percentages) | ||||||||||||
United States |
| $ | |
| | % | $ | |
| | % | |
International |
| |
| | % |
| |
| | % | ||
Total revenues | $ | |
| | % | $ | |
| | % | ||
21
U.S. Revenues by Product Category |
| |||||||||||
Nine Months Ended September 30, |
| |||||||||||
2022 | 2021 |
| ||||||||||
% of | % of |
| ||||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| ||||
| (in thousands, except percentages) | |||||||||||
NeuroStar Advanced Therapy System | $ | | | % | $ | | | % | ||||
Treatment sessions |
| |
| | % |
| |
| | % | ||
Other |
| |
| | % |
| |
| | % | ||
Total U.S. revenues | $ | |
| | % | $ | |
| | % | ||
International Revenues by Product Category |
| |||||||||||
Nine Months Ended September 30, |
| |||||||||||
2022 | 2021 |
| ||||||||||
% of | % of |
| ||||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| ||||
| (in thousands, except percentages) | |||||||||||
NeuroStar Advanced Therapy System | $ | |
| | % | $ | |
| | % | ||
Treatment sessions |
| |
| | % |
| |
| | % | ||
Other |
| |
| | % |
| |
| | % | ||
Total International revenues | $ | |
| | % | $ | |
| | % | ||
19. SEVERANCE
The Company entered into transition agreements outlining the separation with certain former employees during the period ended September 30, 2022 and 2021. In connection with these agreements, the Company recorded $
20. RISKS AND UNCERTAINTIES
Information About Significant Customers
Significant customers are those which represent more than 10% of the Company’s total revenue or are considered significant based on combination of quantitative and qualitative factors during the periods.
Nine Months Ended September 30, |
| ||||||||||
2022 | 2021 |
| |||||||||
% of | % of |
| |||||||||
Amount | Revenues | Amount | Revenues |
| |||||||
(in thousands, except percentages) | |||||||||||
Customer 1 |
| $ | |
| | % | $ | |
| | % |
Total | $ | |
| | % | $ | |
| | % | |
22
Accounts receivable outstanding related to these customers as of September 30, 2022 was as follows (in thousands):
September 30, | |||
2022 | |||
Customer 1 |
| $ | |
Total accounts receivable | $ | |
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations, as well as other sections in this Quarterly Report on Form 10-Q, should be read in conjunction with our unaudited interim financial statements and related notes thereto included elsewhere herein. In addition to historical financial information, some of the information contained in the following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts, including statements regarding our future results of operations and financial position, business strategy, current and prospective products, product approvals, research and development costs, current and prospective collaborations, timing and likelihood of success, plans and objectives of management for future operations and future results of current and anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties, assumptions and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, without limitation, risks and uncertainties related to: the ongoing impact of the novel coronavirus, or COVID-19, pandemic on general political and economic uncertainty, including as a result of efforts by governmental authorities to mitigate the COVID-19 pandemic and the related impact on resource allocations, manufacturing and supply chains and patient access to commercial products; our ability to execute our business continuity as well as our operational and budget plans in light of the COVID-19 pandemic; our ability to achieve or sustain profitable operations due to our history of losses; our reliance on the sale and usage of our NeuroStar Advanced Therapy System to generate revenues; the scale and efficacy of our salesforce; availability of coverage and reimbursement from third-party payors for treatments using our products; physician and patient demand for treatments using our products; developments in respect of competing technologies and therapies for the indications that our products treat; product defects; our ability to obtain and maintain intellectual property protection for our technology; developments in clinical trials or regulatory review of NeuroStar Advanced Therapy System for additional indications; developments in regulation in the United States and other applicable jurisdictions; and the impacts on our operational and budget plans due to inflation. For a discussion of these and other related risks, please refer to our recent SEC filings which are available on the SEC’s website at www.sec.gov. These forward-looking statements are based on our expectations and assumptions as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we undertake no duty or obligation to update any forward-looking statements contained in this Quarterly Report on Form 10-Q as a result of new information, future events or changes in our expectations.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K filed with the SEC, on March 8, 2022. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
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Overview
We are a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from neurohealth disorders. Our first commercial product, the NeuroStar® Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation, or TMS, to create a pulsed, MRI-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood. The system is cleared by the United States Food and Drug Administration, or FDA, to treat adult patients with major depressive disorder, or MDD, that have failed to achieve satisfactory improvement from prior antidepressant medication in the current MDD episode. Our NeuroStar Advanced Therapy system was also cleared in 2022 by the FDA to treat people suffering from obsessive-compulsive disorder as well as for the treatment of anxious depression. NeuroStar Advanced Therapy is also available in other parts of the world, including Japan, where it is listed under Japan’s national health insurance. NeuroStar Advanced Therapy is safe, clinically effective, reproducible and precise and we believe is supported by the largest clinical data set of any competing TMS system. We believe we are the market leader in TMS therapy based on over 141,070 global patients treated with over 5.1 million of our Treatment Sessions through September 30, 2022. We generated revenues of $16.5 million and $13.8 million for the three months ended September 30, 2022 and 2021, respectively, and $47.0 million and $40.3 million for the nine months ended September 30, 2022 and 2021, respectively.
We designed the NeuroStar Advanced Therapy System as a non-invasive therapeutic alternative to treat patients who suffer from MDD and to address many of the key limitations of other treatment options. We generate revenues from initial capital sales of our systems, recurring Treatment Sessions and service and repair and extended warranty contracts. We derive the majority of our revenues from recurring Treatment Sessions. For the three months ended September 30, 2022, revenues from sales of our Treatment Sessions and NeuroStar Advanced Therapy Systems represented 73% and 24% of our U.S. revenues, respectively, and 71% and 26% for the nine months ended September 30, 2022 and 2021, respectively.
We currently sell our NeuroStar Advanced Therapy System and recurring Treatment Sessions in the United States with the collaborative support of our 198 employees as of September 30, 2022. Our sales force targets an estimated 50,000 psychiatrists across 26,000 psychiatric practices in the United States, based on data from Symphony Health and our own internal estimates that treat approximately 42% of the total MDD patients in the United States who meet our labeled indication and are insured. Some of our customers have and may purchase more than one NeuroStar Advanced Therapy System. Based on our commercial data, we believe our customers can recoup their initial capital investment in our system by providing a standard course of treatment to approximately 12 patients. We believe our customers can generate approximately $8,500 of average revenue per patient for a standard course of treatment, which may provide meaningful incremental income to their practices. We have a diverse customer base, including psychiatrists in group psychiatric practices, pain management physicians and other medical professionals in the United States. For the three and nine months ended September 30, 2022, one customer accounted for more than 10% of our revenues.
We market our products in a few select markets outside the United States through independent distributors. International revenues represented 2% and 4% of our total revenues for the three months ended September 30, 2022 and 2021, respectively, and 2% and 3% for the nine months ended September 30, 2022 and 2021, respectively. In October 2017, we entered into an exclusive distribution agreement with Teijin Pharma Limited, or Teijin, for the distribution of our NeuroStar Advanced Therapy Systems and Treatment Sessions to customers who will treat patients with MDD in Japan. We received regulatory approval for our system in Japan in September 2017 and we received the initial reimbursement of JPY 12,000 per Treatment Session, which went into effect on June 1, 2019. We expect our international revenues to increase over time as a percentage of our total revenues as we grow system placements and utilization in Japan.
Our research and development efforts are focused on the following: hardware and software product developments and enhancements of our NeuroStar Advanced Therapy System and clinical developments relating to additional indications. We outsource the manufacture of components of our NeuroStar Advanced
25
Therapy Systems that are produced to our specifications, and individual components are either shipped directly from our third-party contract manufacturers to our customers or consolidated into pallets at our Malvern, Pennsylvania facility prior to shipment. Final installation of these systems occurs at the customer site.
Our total revenues increased by $2.7 million, or 20%, from $13.8 million for the three months ended September 30, 2021 to $16.5 million for the three months ended September 30, 2022 and increased by $6.7 million, or 17%, from $40.3 million for the nine months ended September 30, 2021 to $47.0 million for the nine months ended September 30, 2022. For the three and nine months ended September 30, 2022, our U.S. revenues were $16.2 million and $45.9 million compared to $13.3 million and $38.9 million for three and nine months ended September 30, 2021, which represents an increase of 22% and 18% period over period. The increase was primarily attributable to an increase in Treatment Session sales period over period. We incurred net losses of $7.6 million and $28.9 million for the three and nine months ended September 30, 2022 compared to net losses of $8.2 million and $23.6 million for three and nine months ended September 30, 2021. We expect to continue to incur losses for the next several years as we invest in our commercial organization to support our planned sales growth and while continuing to invest in our pipeline indications. As of September 30, 2022, we had an accumulated deficit of $337.6 million.
COVID-19
Throughout 2020, 2021 and the nine months ended September 30, 2022, the Company experienced a material impact to revenue, particularly with regards to U.S. Treatment Session revenues as a result of the COVID-19 pandemic. The Company expects that capital equipment sales and Treatment Session revenues will continue to be impacted by the pandemic as customers defer capital purchase decisions and delay new patient treatment starts. System utilization has also declined compared to pre-COVID-19 projections.
We have monitored the impact of the COVID-19 pandemic on all aspects of our business and geographies, including how it has and will continue to impact the Company’s customers, supply chain, employees and other business partners. While we experienced significant disruptions in the current period and the nine months ended September 30, 2022 from the COVID-19 pandemic, we are unable to predict the ultimate impact that the COVID-19 pandemic may have on our financial condition, results of operations and cash flows due to numerous uncertainties. These uncertainties include the scope, severity and duration of the ongoing pandemic, the actions taken to contain the pandemic or mitigate its impact and the direct and indirect economic effects of the pandemic, vaccination rates and containment measures, among others. The outbreak of COVID-19 in many countries, including the United States, has significantly adversely impacted global economic activity.
The situation surrounding the COVID-19 pandemic remains fluid, and we are actively managing our response in collaboration with business partners and assessing potential impacts to our financial position and operating results, as well as potential adverse developments in our business. For further information regarding the impact of COVID-19 on the Company, see Item 1A titled “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021.
Components of Our Results of Operations
Revenues
To date, we have generated revenues primarily from the capital portion of our business and related sales and rentals of the NeuroStar Advanced Therapy System and the recurring revenues from our sale of Treatment Sessions in the United States.
NeuroStar Advanced Therapy System Revenues. NeuroStar Advanced Therapy System revenues consist primarily of sales or rentals of a capital component, including upgrades to the equipment attributable to the initial sale of the system. NeuroStar Advanced Therapy Systems can be purchased outright or on a rent-to-own basis by certain customers.
26
Treatment Session Revenues. Treatment Session revenues primarily include sales of NeuroStar Treatment Sessions and SenStar treatment links. The NeuroStar Treatment Sessions are access codes that are delivered electronically in the United States. The SenStar treatment links are disposable units containing single-use access codes that are sold and used outside the United States. Access codes are purchased separately by our customers, primarily on an as-needed basis, and are required by the NeuroStar Advanced Therapy System in order to deliver Treatment Sessions.
Other Revenues. Other revenues are derived primarily from service and repair, extended warranty contracts and D-tect sales with our existing customers.
We refer you to the section titled “Critical Accounting Policies and Use of Estimates—Revenue Recognition” appearing in our Form 10-K filed with the SEC on March 8, 2022. We also refer you to “Note 3. Summary of Significant Accounting Policies.”
Cost of Revenues and Gross Margin
Cost of revenues primarily consists of the costs of components and products purchased from our third-party contract manufacturers of our NeuroStar Advanced Therapy Systems as well as the cost of treatment packs for individual Treatment Sessions. We use third-party contract manufacturing partners to produce the components for and assemble the completed NeuroStar Advanced Therapy Systems. Cost of revenues also includes costs related to personnel, warranty, shipping, and our operations and field service departments. We expect our total cost of revenues to increase to the extent our revenues grow.
Our gross profit is calculated by subtracting our cost of revenues from our revenues. We calculate our gross margin as our gross profit divided by our revenues. Our gross margin has been and will continue to be affected by a variety of factors, primarily product sales mix, pricing and third-party contract manufacturing costs. Our gross margins on revenues from sales of NeuroStar Advanced Therapy Systems are lower than our gross margins on revenues from sales of Treatment Sessions and, as a result, the sales mix between NeuroStar Advanced Therapy Systems and Treatment Sessions can affect the gross margin in any reporting period.
Sales and Marketing Expenses
Sales and marketing expenses consist of market research and commercial activities related to the sale of our NeuroStar Advanced Therapy Systems and Treatment Sessions and salaries and related benefits, sales commissions and share-based compensation for employees focused on these efforts. Other significant sales and marketing costs include conferences and trade shows, promotional and marketing activities, including direct and online marketing, practice support programs and radio media campaigns, travel and training expenses.
We anticipate that our sales and marketing expenses will increase for the remainder of 2022 compared to same-period 2021 expenses as we continue to execute on our growth initiatives and expand our business in the United States.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel expenses, including salaries and related benefits, share-based compensation and travel expenses, for employees in executive, finance, information technology, legal and human resource functions. General and administrative expenses also include the cost of insurance, outside legal fees, accounting and other consulting services, audit fees from our independent registered public accounting firm, board of directors’ fees and other administrative costs, such as corporate facility costs, including rent, utilities, depreciation and maintenance not otherwise included in cost of revenues.
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We anticipate that our general and administrative expenses will remain flat compared to our 2021 expenses.
Research and Development Expenses
Research and development expenses consist primarily of personnel expenses, including salaries and related benefits and share-based compensation for employees in clinical development, product development, regulatory and quality assurance functions, as well as expenses associated with outsourced professional scientific development services and costs of investigative sites and consultants that conduct our preclinical and clinical development programs. We typically use our employee, consultant and infrastructure resources across our research and development programs.
We plan to incur additional research and development expenses in the near future as we expect to continue our development of TMS Therapy for the treatment of additional patient populations and new indications related to neurohealth disorders, as well as for various hardware and software development projects. As a result, we expect our research and development expenses to increase for the remainder of 2022 compared to same-period 2021 expenses.
Interest Expense
Interest expense consists of cash interest payable under our credit facility and non-cash interest attributable to the accrual of final payment fees and the amortization of deferred financing costs related to our indebtedness.
Other Income, Net
Other income, net consists primarily of interest income earned on our money market account balances and note receivables.
Results of Operations
Comparison of the three months ended September 30, 2022 and 2021
Three Months Ended |
| |||||||||||
September 30, | Increase / (Decrease) | |||||||||||
| 2022 |
| 2021 |
| Dollars |
| Percentage |
| ||||
(in thousands, except percentages) |
| |||||||||||
Revenues | $ | 16,498 | $ | 13,799 | $ | 2,699 |
| 20 | % | |||
Cost of revenues |
| 3,570 |
| 3,144 |
| 426 |
| 14 | % | |||
Gross Profit |
| 12,928 |
| 10,655 |
| 2,273 |
| 21 | % | |||
Gross Margin |
| 78.4 | % |
| 77.2 | % |
|
|
| |||
| ||||||||||||
Operating expenses: |
|
|
|
|
|
|
| |||||
Sales and marketing |
| 11,643 |
| 9,827 |
| 1,816 |
| 18 | % | |||
General and administrative |
| 6,391 |
| 6,435 |
| (44) |
| (1) | % | |||
Research and development |
| 2,348 |
| 1,575 |
| 773 |
| 49 | % | |||
Total operating expenses |
| 20,382 |
| 17,837 |
| 2,545 | 14 | % | ||||
Loss from Operations |
| (7,454) | (7,182) |
| (272) |
| (4) | % | ||||
Other (income) expense: |
|
|
|
|
|
| ||||||
Interest expense |
| 1,061 |
| 993 |
| 68 |
| 7 | % | |||
Other income, net |
| (906) |
| (24) |
| (882) |
| 3,675 | % | |||
Net Loss | $ | (7,609) | $ | (8,151) | $ | 542 |
| 7 | % | |||
28
Revenues by Geography |
| ||||||||||
Three Months Ended September 30, |
| ||||||||||
2022 | 2021 |
| |||||||||
% of | % of |
| |||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| |||
(in thousands, except percentages) |
| ||||||||||
United States | $ | 16,244 | 98 | % | $ | 13,280 | 96 | % | |||
International |
| 254 |
| 2 | % |
| 519 |
| 4 | % | |
Total revenues | $ | 16,498 |
| 100 | % | $ | 13,799 |
| 100 | % | |
U.S. Revenues by Product Category |
| ||||||||||
Three Months Ended September 30, |
| ||||||||||
2022 | 2021 |
| |||||||||
% of | % of |
| |||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| |||
(in thousands, except percentages) |
| ||||||||||
NeuroStar Advanced Therapy System | $ | 3,934 | 24 | % | $ | 2,612 | 20 | % | |||
Treatment sessions |
| 11,864 |
| 73 | % |
| 10,259 |
| 77 | % | |
Other |
| 446 |
| 3 | % |
| 409 |
| 3 | % | |
Total U.S. revenues | $ | 16,244 |
| 100 | % | $ | 13,280 |
| 100 | % | |
Revenues
Total revenue for the three months ended September 30, 2022 was $16.5 million, an increase of 20% compared to the three months ended September 30, 2021 revenue of $13.8 million. During the quarter, total U.S. revenue increased by 22% and international revenue decreased by 51% over the prior year quarter. The U.S. revenue growth was primarily driven by an increase in Treatment sessions sales and the decline in international revenue was primarily driven by a decrease in international NeuroStar Advanced Therapy Systems sales.
U.S. NeuroStar Advanced Therapy System revenue for the three months ended September 30, 2022 was $3.9 million, an increase of 50% compared to the three months ended September 30, 2021 revenue of $2.6 million. For the three months ended September 30, 2022 and 2021, the Company sold 49 and 33 systems, respectively, that were recognized as NeuroStar capital revenue during each period. Additionally, for the three months ended September 30, 2022 and 2021, the Company executed 1 and 7 operating lease agreements, respectively, that contributed to operating lease revenue.
U.S. Treatment Session revenue for the three months ended September 30, 2022 was $11.9 million, an increase of 16% compared to the three months ended September 30, 2021 revenue of $10.3 million. The revenue growth was primarily driven by an increase in the number of accounts utilizing our PHQ 10 tool. As a result, our treatment session volume in our local per click accounts, those utilizing our PHQ 10 tool increased 36.9% compared to third quarter of 2021.
Cost of Revenues and Gross Margin
Cost of revenues increased by $0.5 million, or 14%, from $3.1 million for the three months ended September 30, 2021 to $3.6 million for the three months ended September 30, 2022. Gross margin increased from 77.2% for the three months ended September 30, 2021 to 78.4% for the three months ended September 30, 2022. The increase was primarily a result of a change in product mix compared to the prior year quarter.
Sales and Marketing Expenses
Sales and marketing expenses increased by $1.8 million, or 18%, from $9.8 million for the three months ended September 30, 2021 to $11.6 million for the three months ended September 30, 2022. The increase was expected and primarily due to new marketing initiative related costs, including trade shows, digital paid
29
media costs and market research, and sales personnel expenses related to salary, benefits, commissions and share-based compensation incurred in the current period versus the prior year quarter.
General and Administrative Expenses
General and administrative expenses remained materially consistent from $6.4 million for the three months ended September 30, 2021 to $6.3 million for the three months ended September 30, 2022.
Research and Development Expenses
Research and development expenses increased by $0.7 million, or 49%, from $1.6 million for the three months ended September 30, 2021 to $2.3 million for the three months ended September 30, 2022. The increase was primarily due to a reduction in product development costs related to the capitalization of certain of the Company’s software project costs, which was partially offset by an increase in clinical development costs versus the prior year quarter.
Interest Expense
Interest expense remained constant at $1.0 million for the three months ended September 30, 2022.
Other Income, Net
Other income, net increased by $0.9 million from $0.02 million for the three months ended September 30, 2021 to $0.9 million for the three months ended September 30, 2022, primarily as a result of increased interest income earned on the Company’s note receivables.
30
Comparison of the nine months ended September 30, 2022 and 2021
Nine Months Ended |
| ||||||||||||
September 30, | Increase / (Decrease) | ||||||||||||
| 2022 |
| 2021 |
| Dollars |
| Percentage |
| |||||
(in thousands, except percentages) |
| ||||||||||||
Revenues | $ | 47,008 | $ | 40,290 | $ | 6,718 |
| 17 | % | ||||
Cost of revenues |
| 11,093 |
| 8,115 |
| 2,978 |
| 37 | % | ||||
Gross Profit |
| 35,915 |
| 32,175 |
| 3,740 |
| 12 | % | ||||
Gross Margin |
| 76.4 | % |
| 79.9 | % |
|
|
| ||||
| |||||||||||||
Operating expenses: |
|
|
|
|
|
|
| ||||||
Sales and marketing |
| 37,977 |
| 27,431 |
| 10,546 |
| 38 | % | ||||
General and administrative |
| 19,125 |
| 19,220 |
| (95) |
| (0) | % | ||||
Research and development |
| 6,197 |
| 6,179 |
| 18 |
| 0 | % | ||||
Total operating expenses |
| 63,299 |
| 52,830 |
| 10,469 |
| 20 | % | ||||
Loss from Operations |
| (27,384) |
| (20,655) |
| (6,729) |
| (33) | % | ||||
Other (income) expense: |
|
|
|
|
|
|
| ||||||
Interest expense |
| 3,039 |
| 2,955 |
| 84 |
| 3 | % | ||||
Other income, net |
| (1,554) |
| (53) |
| (1,501) |
| (2,832) | % | ||||
Net Loss | $ | (28,869) | $ | (23,557) | $ | (5,312) |
| (23) | % | ||||
Revenues by Geography |
| |||||||||||
Nine Months Ended September 30, |
| |||||||||||
2022 | 2021 |
| ||||||||||
% of | % of |
| ||||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| ||||
(in thousands, except percentages) |
| |||||||||||
United States | $ | 45,893 | 98 | % | $ | 38,891 | 97 | % | ||||
International |
| 1,115 |
| 2 | % |
| 1,399 |
| 3 | % | ||
Total revenues | $ | 47,008 |
| 100 | % | $ | 40,290 |
| 100 | % | ||
U.S. Revenues by Product Category |
| |||||||||||
Nine Months Ended September 30, |
| |||||||||||
2022 | 2021 |
| ||||||||||
% of | % of |
| ||||||||||
| Amount |
| Revenues |
| Amount |
| Revenues |
| ||||
(in thousands, except percentages) |
| |||||||||||
NeuroStar Advanced Therapy System | $ | 11,959 | 26 | % | $ | 6,945 | 18 | % | ||||
Treatment sessions |
| 32,627 |
| 71 | % |
| 30,688 |
| 79 | % | ||
Other |
| 1,307 |
| 3 | % |
| 1,258 |
| 3 | % | ||
Total U.S. revenues | $ | 45,893 |
| 100 | % | $ | 38,891 |
| 100 | % | ||
31
Revenues
Total revenue for the nine months ended September 30, 2022 was $47.0 million, an increase of 17% compared to the nine months ended September 30, 2021 revenue of $40.3 million. During the nine months ended September 30, 2022, total U.S. revenue increased by 18% and international revenue decreased by 20% over the nine months ended September 30, 2021. The U.S. revenue growth was primarily driven by an increase in Treatment Session sales and the decline in international revenue was primarily driven by a decrease in international NeuroStar Advanced Therapy Systems sales.
U.S. NeuroStar Advanced Therapy System revenue for the nine months ended September 30, 2022 was $12.0 million, an increase of 72% compared to the nine months ended September 30, 2021 revenue of $6.9 million. For the nine months ended September 30, 2022 and 2021, the Company sold 153 and 92 systems, respectively, that were recognized as NeuroStar capital revenue during each period. Additionally, for the nine months ended September 30, 2022 and 2021, the Company executed 2 and 7 operating lease agreements, respectively, that contributed to operating lease revenue.
U.S. treatment session revenue for the nine months ended September 30, 2022 was $32.6 million, an increase of 6% compared to the nine months ended September 30, 2021 revenue of $30.7 million. The revenue growth was primarily driven by an increase in the number of accounts utilizing our PHQ 10 tool. As a result, our treatment session volume in our local per click accounts, those utilizing our PHQ 10 tool increased 36.3% compared to prior year period.
Cost of Revenues and Gross Margin
Cost of revenues increased by $3.0 million, or 37%, from $8.1 million for the nine months ended September 30, 2021 to $11.1 million for the nine months ended September 30, 2022. The increase was due to revenue growth versus the prior year period. Gross margin decreased from 79.9% for the nine months ended September 30, 2021 to 76.4% for the nine months ended September 30, 2022. The decrease was primarily a result of a change in the product mix of revenues versus the prior year period.
Sales and Marketing Expenses
Sales and marketing expenses increased by $10.6 million, or 38%, from $27.4 million for the nine months ended September 30, 2021 to $38.0 million for the nine months ended September 30, 2022. The increase was expected and primarily due to new marketing initiative related costs, including trade shows, digital paid media costs and market research, and sales personnel expenses related to salary, benefits, commissions and share-based compensation incurred versus the prior year period.
General and Administrative Expenses
General and administrative expenses remained materially consistent from $19.2 million for the nine months ended September 30, 2021 to $19.1 million for the nine months ended September 30, 2022.
Research and Development Expenses
Research and development expenses remained materially consistent at $6.2 million for the nine months ended September 30, 2022 and 2021.
Interest Expense
Interest expense remained constant at $3.0 million for the nine months ended September 30, 2021 and 2022.
32
Other Income, Net
Other income, net increased by $1.5 million from $0.05 million for the nine months ended September 30, 2021 to $1.6 million for the nine months ended September 30, 2022, primarily as a result of increased interest income earned on the Company’s note receivables.
Liquidity and Capital Resources
Overview
On February 2, 2021, we closed on our secondary public offering and sale (the “Offering”) of our common stock in which we issued and sold 5,566,000 shares of our common stock, which included shares pursuant to an option granted to underwriters to purchase additional shares, at a public offering price of $15.50 per share. We received net proceeds of $80.6 million after deducting underwriting discounts, commissions and offering expenses. Our common stock is listed on the Nasdaq Global Market under the trading symbol “STIM”.
As of September 30, 2022, we had cash and cash equivalents of $73.7 million and an accumulated deficit of $337.6 million, compared to cash and cash equivalents of $94.1 million and an accumulated deficit of $308.7 million as of December 31, 2021. We incurred negative cash flows from operating activities of $27.6 million and $23.5 million for the nine months ended September 30, 2022 and 2021, respectively. We have incurred operating losses since our inception, and we anticipate that our operating losses will continue in the near term as we seek to expand our sales and marketing initiatives to support our growth in existing and new markets, invest funds in additional research and development activities and utilize cash for other corporate purposes. The Company’s primary sources of capital to date have been proceeds from its IPO, the Offering, private placements of its convertible preferred securities, borrowings under its credit facility and revenues from sales of its products. As of September 30, 2022, the Company had $35.0 million of borrowings outstanding under its credit facility, which has a final maturity in February 2025. Management believes that the Company’s cash and cash equivalents as of September 30, 2022 and anticipated revenues from sales of its products are sufficient to fund the Company’s operations for at least 12 months from the issuance of these financial statements.
If our cash and cash equivalents and anticipated revenues from sales or our products are insufficient to satisfy our liquidity requirements, we may seek to sell additional common or preferred equity or debt securities or enter into a new credit facility or another form of third-party funding or seek other debt financing. If we raise additional funds by issuing equity or equity-linked securities, our stockholders would experience dilution and any new equity securities could have rights, preferences and privileges superior to those of holders of our common stock. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. We cannot be assured that additional equity, equity-linked or debt financing will be available on terms favorable to us or our stockholders, or at all. It is also possible that we may allocate significant amounts of capital towards products or technologies for which market demand is lower than expected and, as a result, abandon such efforts. If we are unable to maintain our current financing or obtain adequate additional financing when we require it, or if we obtain financing on terms which are not favorable to us, or if we expend capital on products or technologies that are unsuccessful, our ability to continue to support our business growth and to respond to business challenges could be significantly limited, or we may be required to delay the development, commercialization and marketing of our products.
Our current and future funding requirements will depend on many factors, including:
| ● | the impact of COVID-19 and related governmental responses; |
| ● | our ability to achieve revenue growth and improve operating margins, particularly in light of a high interest rate and high inflation environment; |
| ● | compliance with the terms and conditions, including covenants, set forth in our credit facility; |
33
| ● | the cost of expanding our operations and offerings, including our sales and marketing efforts; |
| ● | our ability to improve or maintain coverage and reimbursement arrangements with domestic third-party and government payors; |
| ● | our rate of progress in establishing coverage and reimbursement arrangements from international commercial third-party and government payors, particularly in Japan; |
| ● | our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of our products and maintaining or improving our sales to our current customers; |
| ● | the cost of research and development activities, including research and development relating to additional indications of neurohealth disorders; |
| ● | the effect of competing technological and market developments; |
| ● | costs related to international expansion; and |
| ● | the potential cost of and delays in product development as a result of any regulatory oversight applicable to our products. |
As of September 30, 2022, there were no significant changes to our material cash requirements as set forth in our Form 10-K, filed with the SEC on March 8, 2022.
Cash Flows
The following table sets forth a summary of our cash flows for the nine months ended September 30, 2022 and 2021:
Nine Months Ended September 30, | |||||||
| 2022 |
| 2021 | ||||
(in thousands) | |||||||
Net Cash Used in Operating Activities | $ | (27,639) | $ | (23,459) | |||
Net Cash Provided by (Used in) Investing Activities |
| 7,234 |
| (9,038) | |||
Net Cash (Used in) Provided by Financing Activities |
| (38) |
| 82,974 | |||
Net (Decrease) Increase in Cash and Cash Equivalents | $ | (20,443) | $ | 50,477 | |||
Net Cash Used in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2022 was $27.6 million, consisting primarily of a net loss of $28.9 million and an increase in net operating assets of $7.1 million, partially offset by non-cash charges of $8.3 million. The increase in net operating assets was primarily due to increases in accounts receivable and inventory and decreases in accounts payable as a result of timing. Non-cash charges consisted of depreciation and amortization, non-cash interest expense, share-based compensation, and the cost of rental units purchased by customers.
Net cash used in operating activities for the nine months ended September 30, 2021 was $23.5 million, consisting primarily of a net loss of $23.6 million and an increase in net operating assets of $7.5 million, partially offset by non-cash charges of $7.6 million. The increase in net operating assets was primarily due to increases in accounts receivable and inventory and decreases in accounts payable and accrued expenses as a result of timing and the 2021 payment of the 2020 bonus compensation accrued as of December 31, 2020. Non-cash charges consisted of depreciation and amortization, non-cash interest expense, share-based compensation, and the cost of rental units purchased by customers.
34
Net Cash Provided by and Used in Investing Activities
Net cash provided by investing activities for the nine months ended September 30, 2022 was $7.2 million which was attributable to the repayment of our promissory note, partially offset by purchases of property and equipment and capitalized software costs.
Net used in investing activities for the nine months ended September 30, 2021 was $9.0 million which was due to the issuance of our promissory note and purchases of property and equipment and capitalized software costs.
Net Cash Used in and Provided by Financing Activities
Net cash used in financing activities for the nine months ended September 30, 2022 was $0.04 million and consisted of the amendment fee paid in relation to the 2022 Solar Amendment, which was offset by cash proceeds related to stock option exercises.
Net cash provided by financing activities for the nine months ended September 30, 2021 was $82.9 million and primarily consisted of additional proceeds from our Offering and cash proceeds related to stock option exercises.
Indebtedness
Refer to “Note 13. Debt” in our unaudited financial statements and related notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q for information regarding our current Solar credit facility.
Common Stock Offering
Refer to “Note 14. Common Stock” in our unaudited financial statements and related notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q for information regarding the Offering.
JOBS Act Accounting Election
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or JOBS Act, and are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, or Securities Act, for complying with new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to avail ourselves of this exemption from complying with new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. Section 107 of the JOBS Act provides that we can elect to opt out of the extended transition period at any time, which election is irrevocable.
Recent Accounting Pronouncements
We refer you to “Note 3. Summary of Significant Accounting Policies” and “Note 4. Recent Accounting Pronouncements” in “Notes to Interim Financial Statements” located in “Part I – FINANCIAL INFORMATION, Item 1. Financial Statements.”
35
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We refer you to the information described in the “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” section of the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2022. There have been no material changes to our market risk described therein.
We continue to monitor inflationary factors, such as increases in our cost of revenues and operating expenses that may adversely affect our operating results. Although we have begun to experience price increases in certain parts of our business, inflation for the nine months ended September 30, 2022 has not had a significant impact on our financial condition, results of operations or cash flows to date, a high rate of inflation in the future may have an adverse effect on our ability to maintain and increase our gross margin or decrease our operating expenses as a percentage of our revenues if our selling prices of our products do not increase as much or more than our costs increase.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Principal Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Principal Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2022.
Changes in Internal Control over Financial Reporting
During the quarter ended September 30, 2022, there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) which materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
36
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are subject from time to time to various claims and legal actions arising during the ordinary course of our business. We believe that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on our results of operations, financial condition, or cash flows.
Item 1A. Risk Factors.
You should carefully consider the information described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2022. There have been no material changes to the risk factors described therein.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Not applicable.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
Item 6. Exhibits.
The following is a list of exhibits filed as part of this Quarterly Report on Form 10-Q. Where so indicated, exhibits that were previously filed are incorporated by reference. For exhibits incorporated by reference, the location of the exhibit in the previous filing is indicated.
Exhibit |
| Description |
31.1* | ||
31.2* | ||
32.1** | ||
32.2** | ||
101 | The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, were formatted in Inline XBRL (Extensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Stockholders’ Equity, and (iv) Consolidated Statements of Cash Flows. The instance document does not appear in the Interactive Data File because its XBRL tags are imbedded within the Inline XBRL document. | |
104 | Cover Page Interactive Data File (Formatted as Inline XBRL and included in Exhibit 101). |
* | Filed herewith. |
37
** | This certification is being furnished solely to accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C Section 1350 and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
38
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, thereunto duly authorized.
| NEURONETICS, INC. | ||
(Registrant) | |||
Date: November 8, 2022 | By: | /s/ Keith J. Sullivan | |
Name: | Keith J. Sullivan | ||
Title: | President and Chief Executive Officer | ||
(Principal Executive Officer) | |||
Date: November 8, 2022 | By: | /s/ Stephen Furlong | |
Name: | Stephen Furlong | ||
Title: | SVP, Chief Financial Officer and Treasurer | ||
(Principal Financial and Accounting Officer) | |||
39
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
I, Keith J. Sullivan, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Neuronetics, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures, and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report, any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 8, 2022 | By: | /s/ Keith J. Sullivan |
| Name: | Keith J. Sullivan |
| Title: | President and Chief Executive Officer |
| | (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
I, Stephen Furlong, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Neuronetics, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures, and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report, any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 8, 2022 | By: | /s/ Stephen Furlong |
| Name: | Stephen Furlong |
| Title: | SVP, Chief Financial Officer and Treasurer |
| | (Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report on Form 10-Q of Neuronetics, Inc. (the “Company”) for the fiscal quarter ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
| (1) | the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
Date: November 8, 2022 | By: | /s/ Keith J. Sullivan |
| Name: | Keith J. Sullivan |
| Title: | President and Chief Executive Officer |
| | (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report on Form 10-Q of Neuronetics, Inc. (the “Company”) for the fiscal quarter ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
| (1) | the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) | the information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
Date: November 8, 2022 | By: | /s/ Stephen Furlong |
| Name: | Stephen Furlong |
| Title: | SVP, Chief Financial Officer and Treasurer |
| | (Principal Financial and Accounting Officer) |