News Release Details

MALVERN, Pa., March 08, 2022 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company with a strategic vision of transforming the lives of patients whenever and wherever they need it with the best neurohealth therapies in the world, today announced its financial and operating results for the fourth quarter and full year of 2021.

Fourth Quarter 2021 Highlights

• Exceeded guidance - Fourth quarter 2021 revenue of $15.0 million, exceeded previously issued guidance of $13.0 to $14.0 million
• Increased revenue - Fourth quarter 2021 revenue increased 9% sequentially as compared to third quarter 2021
• Achieved record-breaking quarterly treatment session revenue - Fourth quarter 2021 U.S. treatment session revenue of $11.2 million, compared to $11.0 million in fourth quarter 2020
  

Full Year 2021 Highlights

• Exceeded guidance - Full year 2021 revenue of $55.3 million, exceeded previously issued guidance of $53.3 to $54.3 million
• Full year 2021 U.S. treatment session revenue of $41.9 million
• Full year 2021 U.S. NeuroStar Advanced Therapy revenue of $9.8 million
  

Recent Operational Highlights

• Attained 510(k) clearance of innovative MT Cap technology for NeuroStar, designed to make the motor threshold determination process simpler and more efficient for clinicians and patients
• Launched software innovation with FastMT™ and SoftStart™ to enhance NeuroStar Advanced Therapy System
• Expanded HCP education and adoption with 3^rd and 4^th NeuroStar Summits in November, 2021 and March 2022, respectively, with approximately 170 prospective customers attending
• Amended existing credit facility with SLR Investment Corp, modifying the Company’s ability to extend the interest only period and resetting certain revenue covenants

Recent Marketing Highlights

• Increased key performance metrics with patients taking action to request a physician consultation through the Neurostar.com Physician Locator up, +67% increase vs. 2020
• Demonstrated category leadership with the highest Share of Voice up from 60% to 71% from 2020 to 2021
• Strengthened co-op program, Precision Pulse, launched in April 2021, showed steady increases quarter upon quarter in number of participants and dollars spent as customers took advantage of 50% co-op reimbursement at varying levels
• Initiated partnership with social media influencer and KOL, Dr. Melissa Shepard, to expand NeuroStar reach to new audience of over one million TikTok followers and over eighty thousand Instagram followers

“2021 was a transformational year for Neuronetics, during which we revamped the way we drive the commercial adoption of NeuroStar Advanced Therapy of Mental Health. Despite the ongoing macro headwinds, we made substantial progress on several of our strategic priorities that have put us in a strong position to drive acceleration growth in the future while generating significant momentum in the business as we exited the year,” said Keith J. Sullivan, President and Chief Executive Officer of Neuronetics. “With key foundation elements in place, we are turning our attention to the execution of our strategy in order to drive growth. As we look ahead to 2022, we expect to see the increased positive impacts from the strategic investments we have made over the last two years. We are incredibly excited about the position we are in to take advantage of the opportunity that lies ahead to help treat patients suffering from mental health disorders get relief.”

Fourth Quarter 2021 Financial and Operating Results for the Three Months Ended December 31, 2021

Total revenue for the three months ended December 31, 2021 was $15.0 million, a decrease of 4% compared to the three months ended December 31, 2020 revenue of $15.6 million. During the quarter, total U.S. revenue decreased by 3% and international revenue decreased by 13% over the prior year quarter. The U.S. revenue decline was driven by a decrease in U.S. NeuroStar Advanced Therapy System sales and the international revenue decline was driven by a decrease in international treatment session revenue.

U.S. NeuroStar Advanced Therapy System revenue for the three months ended December 31, 2021 was $2.8 million, a decrease of 22% compared to the three months ended December 31, 2020 revenue of $3.6 million. For the three months ended December 31, 2021 and 2020, the Company shipped 48 and 54 systems, respectively. Of the 48 systems shipped in the fourth quarter of 2021, 37 units were recognized as NeuroStar capital revenue and 11 units were recognized as operating leases contributing to operating lease revenue.

U.S. treatment session revenue for the three months ended December 31, 2021 was $11.2 million, an increase of 2% compared to the three months ended December 31, 2020 revenue of $11.0 million. The revenue growth was primarily driven by an increase in treatment session volume over the prior year quarter.

In the fourth quarter, U.S. treatment session revenue per active site was $12,183 as compared to $12,133 during the fourth quarter of 2020.

Gross margin for the fourth quarter of 2021 was 76.4%, an increase of approximately 60 basis points from the fourth quarter of 2020 gross margin of 75.8%. The increase was primarily a result of higher average sales prices of our NeuroStar Advanced Therapy System units and a higher mix of treatment session revenue in the fourth quarter of 2021.

Operating expenses during the fourth quarter of 2021 were $18.4 million, an increase of $3.9 million compared to $14.5 million in the fourth quarter of 2020. The increase was primarily driven by the implementation of new marketing initiatives, personnel costs related to our sales force, and additional stock-based compensation expense compared to the prior year quarter.

Net loss for the fourth quarter of 2021 was $(7.6) million, or $(0.29) per share, as compared to the fourth quarter 2020 net loss of $(3.7) million, or $(0.19) per share. Net loss per share was based on 26,371,382 and 19,014,994 weighted-average common shares outstanding for the fourth quarters of 2021 and 2020, respectively.

EBITDA for the fourth quarter of 2021 was $(6.3) million as compared to the fourth quarter of 2020 EBITDA of $(2.4) million. See the accompanying financial table that reconciles EBITDA, which is a non-GAAP financial measure, to net loss.

Full Year Financial and Operating Results

Total revenues increased by $6.1 million, or 12%, from $49.2 million for the year ended December 31, 2020 to $55.3 million for the year ended December 31, 2021. For the period ended December 31, 2021, U.S. revenue increased by 12% and international revenue increased by 8% over the comparative prior year period. The U.S. revenue growth was primarily due to an increase in U.S. treatment session revenue and the international revenue growth was primarily driven by an increase in international NeuroStar Advanced Therapy Systems sales.

U.S. NeuroStar Advanced Therapy System revenue decreased by $1.3 million, or 12%, in the year ended December 31, 2021 compared to the year ended December 31, 2020. For the period ended December 31, 2021 and 2020, the Company shipped 147 and 166 systems, respectively. Of the 147 systems shipped in 2021, 129 units were recognized as NeuroStar capital revenue and 18 units were recognized as operating leases contributing to operating lease revenue.

U.S. treatment session revenues increased by 20% from $34.9 million for the year end December 31, 2020 to $41.9 million for the year ended December 31, 2021. The revenue growth was primarily driven by an increase in treatment session volume over the prior year period.

Gross margin for the full year 2021 was 78.9%, an increase of approximately 240 basis points from the full year 2020 gross margin of 76.5%. The increase in gross margin was the result of a higher mix of treatment session revenue for the full year 2021.

Operating expenses during the full year 2021 were $71.2 million, an increase of $11.2 million, or 19%, compared to $60.0 million in the full year 2020. The increase was primarily driven by implementation of new marketing initiatives, IT consulting costs for new system implementations and additional stock-based compensation expense compared to the prior year.

Net loss for the full year 2021 was $(31.2) million, or $(1.22) per share, as compared to full year 2020 net loss of $(27.5) million, or $(1.46) per share. Net loss per share was based on 25,479,425 and 18,834,534 weighted-average common shares outstanding for the years ended 2021 and 2020, respectively. There were 26,394,844 shares outstanding as of December 31, 2021.

EBITDA for the full year 2021 was $(26.1) million as compared to $(22.0) million for the full year 2020. The decrease in EBITDA is primarily due to the increase in net loss in the current period compared to the comparative prior period. See the accompanying financial table that reconciles EBITDA, which is a non-GAAP financial measure, to net loss.

Cash and cash equivalents were $94.1 million and $49.0 million as of December 31, 2021 and 2020, respectively.

MT Cap FDA 510(k) Clearance and U.S. Commercial Launch

In December of 2021, the Company received 510(k) clearance on their MT Cap technology for NeuroStar® Advanced Therapy for Mental Health. The MT Cap provides a target starting location and step-by-step map to guide the process of identifying a patient’s motor threshold (MT) and reduce multiple steps during the initial assessment for NeuroStar. The MT Cap leverages NeuroStar’s unique floating coil locking system, making mapping and determining motor thresholds seamless. Determining and locating a patient’s motor threshold is a critical component of the treatment process and can take up to 30 minutes for each patient. Now, when the MT Cap is combined with the recently launched FastMT™, these technology innovations provide an average 40% time savings during the MT activity. In March of 2022, the Company announced the nationwide commercial launch of the MT Cap in the U.S.

FastMT™ and SoftStart™ Software Enhancements to NeuroStar Therapy System

In October of 2021, the Company launched upgraded NeuroStar Advanced therapy systems with FastMT™ and SoftStart™, two significant software enhancements features related to a patient’s motor threshold assessment. FastMT™ and SoftStart™ enable faster motor threshold determination by reducing the number of steps in the process, allow health care professionals to automatically ramp pulse sequences to the prescribed treatment level for a patient, the ability to request and manage digital benefits investigation for new leads and the ability to schedule recurring patient outcome surveys through our TrakStar patient data management system.

November 2021 and March 2022 NeuroStar Summits

In November of 2021 in Nashville, TN, and March 2022 in San Diego, CA, the Company held its third and fourth NeuroStar Summit events, respectively, designed to provide prospective customers with a comprehensive understanding of the clinical and practice benefits of partnering with NeuroStar. The Summits were interactive events with approximately 170 prospective customers able to experience the NeuroStar Advanced Therapy System, interact with peers and hear from experts. Post survey results were extremely positive, and the Company plans to hold more Summits in the future.

Credit Facility Amendment

In February of 2022, the Company announced it has amended its term loan agreement with its current lenders, investment affiliates managed by SLR Investment Corp. (SLR), which was originally entered into on March 2, 2020 and subsequently amended on April 20, 2020 and December 2, 2020. This amendment includes modifications to the ability of the Company to extend the interest-only period, the reduction of certain revenue covenants, and the elimination of the final term loan tranche available to the Company.

Business Outlook

For the full year 2022, the Company expects to report total worldwide revenue between $58.0 million and $62.0 million.

For the full year 2022, the Company expects total operating expenses to be between $86.0 million and $90.0 million.

For the first quarter of 2022, the Company expects to report total worldwide revenue of between $13.0 million and $14.0 million.

Webcast and Conference Call Information

Neuronetics’ management team will host a conference call on March 8, 2022 beginning at 8:30 a.m. Eastern Time. Investors interested in listening to the conference call on your telephone, please dial (877) 472-8990 for United States callers or +1 (629) 228-0778 for international callers and reference confirmation code 7313349, approximately ten minutes prior to start time. To access the live audio webcast or subsequent archived recording, visit the Investor Relations section of Neuronetics’ website at ir.neuronetics.com. The replay will be available on the Company’s website for approximately 60 days.

About Neuronetics

Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience and the largest TMS company in the industry, Neuronetics is redefining patient and physician expectations by designing and developing products that improve the quality of life for people suffering from neurohealth conditions. An FDA-cleared, non-drug, noninvasive treatment for people with depression, Neuronetics’ NeuroStar® Advanced Therapy system is today’s leading transcranial magnetic stimulation (TMS) treatment for major depressive disorder in adults with over four million treatments delivered. NeuroStar is widely researched and backed by the largest clinical data set of any TMS system for depression, including the world’s largest depression Outcomes Registry. Neuronetics is committed to transforming lives by offering an exceptional treatment option that produces extraordinary results. For safety information and indications for use, visit NeuroStar.com.

“Safe harbor” statement under the Private Securities Litigation Reform Act of 1995:

Statements in the press release regarding Neuronetics, Inc. (the “Company”) that are not historical facts constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by terms such as “outlook,” “potential,” “believe,” “expect,” “plan,” “anticipate,” “predict,” “may,” “will,” “could,” “would” and “should” as well as the negative of these terms and similar expressions. These statements include those relating to: the Company’s business outlook and current expectations for upcoming quarter and fiscal year 2022, including with respect to revenue, operating expense, growth, and any statements of assumptions underlying any of the foregoing items. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to: the impact of COVID-19 on the Company’s operational and budget plans as well as general political and economic conditions, including as a result of efforts by governmental authorities to mitigate COVID-19, such as travel bans, shelter in place orders and third-party business closures and the related impact on resource allocations, manufacturing and supply chains and patient access to commercial products; the Company’s ability to execute its business continuity; the Company’s ability to achieve or sustain profitable operations due to its history of losses; the Company’s reliance on the sale and usage of its NeuroStar Advanced Therapy for Mental Health System to generate revenues; the scale and efficacy of the Company’s salesforce as well as the Company’s ability to retain talent; availability of coverage and reimbursement from third-party payors for treatments using the Company’s products; physician and patient demand for treatments using the Company’s products; developments in respect of competing technologies and therapies for the indications that the Company’s products treat; product defects; the Company’s ability to obtain and maintain intellectual property protection for its technology; developments in clinical trials or regulatory review of NeuroStar Advanced Therapy for Mental Health System for additional indications; and developments in regulation in the United States and other applicable jurisdictions. For a discussion of these and other related risks, please refer to the Company’s recent SEC filings which are available on the SEC’s website at www.sec.gov. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, or changes in the Company’s expectations.

Investor Contact:

Mike Vallie or Mark Klausner
Westwicke Partners
443-213-0499
ir@neuronetics.com

Media Contact:

EvolveMKD
646-517-4220
NeuroStar@evolvemkd.com

Non-GAAP Financial Measures (Unaudited)

EBITDA is not a measure of financial performance under generally accepted accounting principles in the United States, or GAAP, and should not be construed as a substitute for, or superior to, GAAP net loss. However, management uses both the GAAP and non-GAAP financial measures internally to evaluate and manage the Company’s operations and to better understand its business. Further, management believes the addition of the non-GAAP financial measure provides meaningful supplementary information to, and facilitates analysis by, investors in evaluating the Company’s financial performance, results of operations and trends. The Company’s calculation of EBITDA may not be comparable to similarly designated measures reported by other companies, because companies and investors may differ as to what type of events warrant adjustment.

The following table reconciles reported net loss to EBITDA:

Source: Neuronetics