clpt-20230930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


þ			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

			For the quarterly period ended September 30, 2023

Or

o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

			For the transition period from_____to _____

Commission file number: 001-34822

ClearPoint Neuro, Inc.

(Exact Name of Registrant as Specified in Its Charter)


Delaware			58-2394628
(State or Other Jurisdiction			(IRS Employer
of Incorporation or Organization)			Identification Number)


120 S. Sierra Ave., Suite 100
Solana Beach, California			92075
(Address of Principal Executive Offices)			(Zip Code)

(888) 287-9109

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.01 par value per share	CLPT	Nasdaq Capital Market

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. þ Yes o No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files.) þ Yes o No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer o			Accelerated filer ☐
Non-accelerated filer þ			Smaller reporting company þ
			Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes þ No

As of November 1, 2023, there were 24,620,567 shares of common stock outstanding.

CLEARPOINT NEURO, INC.

TABLE OF CONTENTS


		Page Number
PART I – FINANCIAL INFORMATION		1

Item 1.	Financial Statements (unaudited)	1
	Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022	1
	Condensed Consolidated Statements of Operations for the three months ended September 30, 2023 and 2022	3
	Condensed Consolidated Statements of Operations for the nine months ended September 30, 2023 and 2022	3
	Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2023 and 2022	4
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022	6
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	29
Item 4.	Controls and Procedures	29

PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	30
Item 1A.	Risk Factors	30
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3.	Defaults Upon Senior Securities	30
Item 4.	Mine Safety Disclosures	30
Item 5.	Other Information	30
Item 6.	Exhibits	31

SIGNATURES		32

Trademarks, Trade Names and Service Marks

ClearPoint Neuro®, ClearPoint®, SmartFlow®, SmartFrame®, SmartGrid®, Inflexion®, SmartTwist®, SmartTip®, ClearPoint Maestro®, ClearPoint Revolution™, SmartFrame Array®, ClearPoint Orchestra™, ClearPoint Prism™, SmartFlow Flex™, ClearPointer™, When Your Path is Unclear, We Point The Way®, and MRI Interventions® are all trademarks of ClearPoint Neuro, Inc. Any other trademarks, trade names or service marks referred to in this Quarterly Report on Form 10-Q (this “Quarterly Report”) are the property of their respective owners.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report contains “forward-looking statements” as defined under the U.S. federal securities laws. The forward-looking statements relate to our expectations for performance, revenues and costs, and the adequacy of cash and cash equivalent balances and short-term investments to support operations and meet future obligations. These statements involve known and unknown risks, uncertainties and other 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.

In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these words. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain.

In evaluating forward-looking statements, you should refer to (i) the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which we filed with the United States Securities and Exchange Commission (“SEC”) on March 1, 2023 (the “2022 Form 10-K”), (ii) Item 2 of this Quarterly Report, under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations -- Factors Which May Influence Future Results of Operations" and (iii) Part II, Item 1.A of this Quarterly Report. As a result of these risk factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We do not undertake to update any of the forward-looking statements after the date of this Quarterly Report, except to the extent required by applicable securities laws.

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

CLEARPOINT NEURO, INC.

Condensed Consolidated Balance Sheets

(Dollars in thousands, except for share and per share data)


	September 30, 2023		December 31, 2022
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	24,342	$	27,615
Short-term investments, at amortized cost	—		9,874
Accounts receivable, net	2,424		2,665
Inventory, net	8,987		9,303
Prepaid expenses and other current assets	1,557		1,723
Total current assets	37,310		51,180
Property and equipment, net	1,355		806
Operating lease, right-of-use assets	3,689		1,895
Software license inventory	405		450
Licensing rights	969		1,028
Other assets	109		131
Total assets	$	43,837	$	55,490

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	789	$	272
Accrued compensation	2,288		2,824
Other accrued liabilities	953		2,065
Operating lease liabilities, current portion	384		561
Deferred product and service revenue, current portion	1,175		1,066
Total current liabilities	5,589		6,788
Operating lease liabilities, net of current portion	3,695		1,532
Deferred product and service revenue, net of current portion	524		390
2020 senior secured convertible note payable, net	9,935		9,893
Total liabilities	19,743		18,603
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at September 30, 2023 and December 31, 2022	—		—
Common stock, $0.01 par value; 90,000,000 shares authorized at September 30, 2023 and 200,000,000 shares authorized at December 31, 2022; 24,625,670 shares issued and outstanding at September 30, 2023; and 24,578,983 issued and outstanding at December 31, 2022	246		246
Additional paid-in capital	191,685		187,008
Accumulated deficit	(167,837)		(150,367)
Total stockholders’ equity	24,094		36,887
Total liabilities and stockholders’ equity	$	43,837	$	55,490

See accompanying notes to Condensed Consolidated Financial Statements.

CLEARPOINT NEURO, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

(Dollars in thousands, except for share and per share data)


	For The Three Months Ended September 30,
	2023		2022
Revenue:
Product revenue	$	2,410	$	3,130
Service and other revenue	3,352		2,016
Total revenue	5,762		5,146
Cost of revenue	2,489		1,467
Gross profit	3,273		3,679
Research and development costs	2,429		2,654
Sales and marketing expenses	2,841		2,422
General and administrative expenses	2,900		2,398
Operating loss	(4,897)		(3,795)
Other expense:
Other expense, net	(12)		(25)
Interest income, net	100		32
Net loss	$	(4,809)	$	(3,788)
Net loss per share attributable to common stockholders:
Basic and diluted	$	(0.20)	$	(0.15)
Weighted average shares used in computing net loss per share:
Basic and diluted	24,630,181		24,497,636


	For The Nine Months Ended September 30,
	2023		2022
Revenue:
Product revenue	$	7,377	$	9,750
Service and other revenue	9,768		5,627
Total revenue	17,145		15,377
Cost of revenue	7,544		5,212
Gross profit	9,601		10,165
Research and development costs	9,057		7,967
Sales and marketing expenses	9,248		6,826
General and administrative expenses	9,036		7,235
Operating loss	(17,740)		(11,863)
Other expense:
Other expense, net	(25)		(22)
Interest income (expense), net	295		(165)
Net loss	$	(17,470)	$	(12,050)
Net loss per share attributable to common stockholders:
Basic and diluted	$	(0.71)	$	(0.50)
Weighted average shares used in computing net loss per share:
Basic and diluted	24,599,191		24,058,205

See accompanying notes to Condensed Consolidated Financial Statements.

CLEARPOINT NEURO, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(Dollars in thousands)


For The Three and Nine Months Ended September 30, 2023
	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Total
	Shares	Amount
Balances, January 1, 2023	24,578,983	$	246	$	187,008	$	(150,367)	$	36,887
Issuances of common stock:
Share-based compensation	3,782	—		1,307		—		1,307
Payments for taxes related to net share settlement of equity awards	(514)	—		(5)		—		(5)
Net loss for the period	—	—		—		(5,609)		(5,609)
Balances, March 31, 2023	24,582,251	$	246	$	188,310	$	(155,976)	$	32,580
Issuances of common stock:
Share-based compensation	5,484	—		1,645		—		1,645
Payments for taxes related to net share settlement of equity awards	(11,102)	—		(77)		—		(77)
Issuance of common stock under employee stock purchase plan	51,041	—		314		—		314
Net loss for the period	—	—		—		(7,052)		(7,052)
Balances, June 30, 2023	24,627,674	$	246	$	190,192	$	(163,028)	$	27,410
Issuances of common stock:
Share-based compensation	(1,001)	—		1,584		—		1,584
Option exercises (cashless)	14,312	—		—		—		—
Payments for taxes related to net share settlement of equity awards	(15,315)	—		(91)		—		(91)
Net loss for the period	—	—		—		(4,809)		(4,809)
Balances, September 30, 2023	24,625,670	$	246	$	191,685	$	(167,837)	$	24,094


For The Three and Nine Months Ended September 30, 2022
	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Total
	Shares	Amount
Balances, January 1, 2022	23,665,991	$	237	$	182,482	$	(133,932)	$	48,787
Issuances of common stock:
Share-based compensation	29,916	—		899		—		899
Warrant and option exercises (cash and cashless)	12,211	—		3		—		3
Net loss for the period	—	—		—		(3,959)		(3,959)
Balances, March 31, 2022	23,708,118	$	237	$	183,384	$	(137,891)	$	45,730
Issuances of common stock:
Share-based compensation	379,122	4		876		—		880
Warrant exercises (cash and cashless)	367,006	4		249		—		253
Issuance of common stock under employee stock purchase plan	26,354	—		260		—		260
Net loss for the period	—	—		—		(4,303)		(4,303)
Balances, June 30, 2022	24,480,600	$	245	$	184,769	$	(142,194)	$	42,820
Issuances of common stock:
Share-based compensation	20,738	—		1,175		—		1,175
Option exercises (cash and cashless)	23,763	—		7		—		7
Payments for taxes related to net share settlement of equity awards	(24,269)	—		(336)		—		(336)
Net loss for the period	—	—		—		(3,788)		(3,788)
Balances, September 30, 2022	24,500,832	$	245	$	185,615	$	(145,982)	$	39,878

See accompanying notes to Condensed Consolidated Financial Statements.

CLEARPOINT NEURO, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(Dollars in thousands)


	For The Nine Months Ended September 30,
	2023		2022
Cash flows from operating activities:
Net loss	$	(17,470)	$	(12,050)
Adjustments to reconcile net loss to net cash flows from operating activities:
Allowance for credit losses (recoveries)	903		(92)
Depreciation and amortization	443		224
Share-based compensation	4,536		2,954
Amortization of debt issuance costs and original issue discounts	42		41
Amortization of lease right-of-use, net of accretion in lease liabilities	590		400
Accretion of discounts on short-term investments	(126)		(159)
Increase (decrease) in cash resulting from changes in:
Accounts receivable	(662)		(982)
Inventory, net	263		(3,318)
Prepaid expenses and other current assets	241		(1,150)
Other assets	22		31
Accounts payable and accrued expenses	(1,023)		1,255

Lease liabilities	(553)		(400)
Deferred revenue	243		144
Net cash flows from operating activities	(12,551)		(13,102)
Cash flows from investing activities:
Purchases of property and equipment	(696)		(214)
Acquisition of licensing rights	(167)		(678)
Purchase of short-term investments	—		(21,590)
Proceeds from maturities of short-term investments	10,000		—
Net cash flows from investing activities	9,137		(22,482)
Cash flows from financing activities:
Proceeds from stock option and warrant exercises	—		263
Payments for taxes related to net share settlement of equity awards	(173)		(336)
Proceeds from issuance of common stock under employee stock purchase plan	314		260
Net cash flows from financing activities	141		187
Net change in cash and cash equivalents	(3,273)		(35,397)
Cash and cash equivalents, beginning of period	27,615		54,109
Cash and cash equivalents, end of period	$	24,342	$	18,712

SUPPLEMENTAL CASH FLOW INFORMATION
Cash paid for:
Income taxes	$	—	$	—
Interest	$	554	$	351

NON-CASH INVESTING AND FINANCING TRANSACTIONS:


•			As discussed in Note 7, the Company entered into a lease for a manufacturing facility in Carlsbad, California, which commenced in June 2023. In connection with the new lease, the Company recorded a right-of-use asset in exchange for an operating lease liability in the amount of approximately $2.5 million.

See accompanying notes to Condensed Consolidated Financial Statements.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)


1.						Description of the Business and Financial Condition

ClearPoint Neuro, Inc. (the “Company”) is a commercial-stage medical device company focused on the development and commercialization of innovative platforms for performing minimally invasive surgical procedures in the brain. From the Company’s inception in 1998, the Company has deployed significant resources to fund its efforts to develop the foundational capabilities for enabling MRI-guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies it develops. In 2021, the Company’s efforts expanded beyond the MRI suite to encompass development and commercialization of new neurosurgical device products for the operating room setting. In 2022, the Company commercialized the ClearPoint Prism Neuro Laser Therapy System as its first therapy product offering. The Company has exclusive global commercialization rights to the ClearPoint Prism Neuro Laser Therapy System through its Swedish partner, Clinical Laserthermia Systems ("CLS").

Since 2021, a growing part of the Company’s revenue is derived from consulting services to pharmaceutical and biotech companies, academic institutions, or contract research organizations having a focus on biologics and drug delivery. The Company’s services include protocol consultation and solutions for pre-clinical study design and execution. Currently, the Company has more than 50 biologics and drug delivery customers who are evaluating or using its products and services in trials to inject gene and cell therapies directly into the brain. These relationships involve drug development programs that are at various stages of development ranging from preclinical research to late-stage regulatory trials for multiple distinct disease states. This part of the Company’s business potentially represents the largest opportunity for growth; however, the Company’s ability to grow in this market is dependent on its ability to maintain and establish new relationships with customers, such customers' continuation of research and product development plans, and such customers achieving success in completion of clinical trials and subsequent regulatory approvals of their drugs and biologics.

Macroeconomic Trends

The Company continues to monitor the impact of various macroeconomic trends, such as global economic and supply chain disruptions, geopolitical instability (including instability resulting from military conflicts), labor shortages, instability of financial institutions and inflationary conditions. Changes in domestic and global economic conditions, supply chain disruptions, labor shortages, as well as other stimulus and spending programs, have led to higher inflation, which is likely to lead to increased costs and may cause further changes in fiscal and monetary policy. Impacts from inflationary pressures, such as increasing costs for research and development of the Company's products, administrative and other costs of doing business, the potential for instability of the financial institutions where the Company maintains its deposits or other assets, and the Company's access to capital markets and other sources of funding in the future could adversely affect the Company's business, financial condition and results of operations. Additionally, these trends could adversely affect the Company's customers, which could impact their willingness to spend on the Company's products and services, or their ability to make payment, which could harm the Company's collection of accounts receivable and financial results. The rapid development and fluidity of these situations precludes any prediction as to the ultimate impact they will have on the Company's business, financial condition, results of operation and cash flows, which will depend largely on future developments.

Liquidity

The Company has incurred net losses since its inception, which has resulted in a cumulative deficit at September 30, 2023 of $167.8 million. In addition, the Company’s use of cash from operations amounted to $12.6 million for the nine months ended September 30, 2023, and $16.2 million for the year ended December 31, 2022. Since its inception, the Company has financed its operations principally from the sale of equity securities and the issuance of notes payable, however, there is no assurance such sale of equity securities and/or issuance of notes payable will be at terms favorable to the Company or available at all in the future. As required by generally accepted accounting principles in the U.S. ("GAAP"), the Company has evaluated its ability to continue as a going concern and has determined that based on current forecasts, existing cash and cash equivalent balances at September 30, 2023 are sufficient to support the Company's operations and meet its obligations for at least the next twelve months.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

In 2020, pursuant to the terms of a Securities Purchase Agreement (the "SPA"), the Company issued secured convertible notes to two investors which raised gross proceeds of $25 million, of which $15 million has been converted to common stock and $10 million remains outstanding (the "Outstanding First Closing Note"). See Note 6 below for additional information with respect to these notes. In February 2021, the Company completed a public offering of 2,127,660 shares of its common stock from which the net proceeds totaled approximately $46.8 million after deducting underwriting discounts and commissions, and other offering expenses paid by the Company.


2.						Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation and Use of Estimates

In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2022 audited consolidated financial statements, and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth therein. These condensed consolidated financial statements have been prepared in accordance with SEC rules for interim financial information, and, therefore, omit certain information and footnote disclosures necessary to present such statements in accordance with GAAP. The preparation of these condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures at the date of the financial statements and during the reporting period. Actual results could materially differ from these estimates. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s 2022 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by GAAP for a complete set of financial statements. The results of operations for the three and nine months ended September 30, 2023, may not be indicative of the results to be expected for the entire year or any future periods.

Inventory

Inventory is carried at the lower of cost or net realizable value. The costs of inventory are determined using the standard cost method, which approximates actual cost based on a first-in, first-out method. Items in inventory relate predominantly to the Company’s ClearPoint system and related disposables. Software license inventory related to ClearPoint systems undergoing on-site customer evaluation is included in inventory in the accompanying condensed consolidated balance sheets. All other software license inventory is classified as a non-current asset. The Company periodically reviews its inventory for excess and obsolete items and provides a reserve upon identification of potentially excess or obsolete items.

Intangible Assets

The Company is a party to a license agreement that provides rights to the Company for the development and commercialization of products. Under the terms of the license agreement, the Company made payments to the licensor upon execution of the license agreement for access to the underlying technology, and future payments will be based upon achievement of regulatory and commercialization milestones as defined in the license agreement. In 2022, the Company made a payment to the licensor for the achievement of a regulatory milestone, which acts as a prepayment for future royalties.

In conformity with Accounting Standards Codification Section 350, “Intangibles – Goodwill and Other,” the Company amortizes its investment in the upfront license rights described above over an expected useful life of up to five years, or as commercial sales occur for the royalty prepayment. In addition, the Company periodically evaluates the recoverability of its investment in the license rights and records an impairment charge in the event such evaluation indicates that the Company’s investment is not likely to be recovered.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Revenue Recognition

The Company’s revenue is comprised primarily of: (1) product revenue, resulting from the sale of functional neurosurgery, navigation, therapy, and biologics and drug delivery disposable products; (2) product revenue resulting from the sale of ClearPoint capital equipment and software; (3) consultation revenue and clinical case support revenue in connection with customer-sponsored pre-clinical and clinical trials; (4) license revenue for the granting of licenses to develop and commercialize the Company's SmartFlow Cannula devices with our customers' proprietary biologics as a combination product, and (5) revenue resulting from the service, installation, training, and shipping related to ClearPoint capital equipment and software. The Company recognizes revenue when (i) control of the Company’s products is transferred to its customers or (ii) services are provided to customers, each in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services, in a process that involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. When a contract calls for the satisfaction of multiple performance obligations for a single contract price, the Company typically allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation customarily charged by the Company. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control.

Lines of Business; Timing of Revenue Recognition

•Functional neurosurgery navigation product, biologics and drug delivery systems product, and therapy product sales: Revenue from the sale of functional neurosurgery navigation products (consisting of disposable products sold commercially and related to cases utilizing the Company's ClearPoint system), biologics and drug delivery systems products (consisting primarily of disposable products related to customer-sponsored clinical trials utilizing the ClearPoint system), and therapy products (consisting primarily of disposable laser-related products used in neurosurgical and non-neurosurgical procedures) is generally based on customer purchase orders, the predominance of which require delivery within one week of the order having been placed, and is generally recognized at the point in time of shipping to the customer, which is the point at which legal title, and risks and rewards of ownership, transfer to the customer. For certain customers, legal title and risks and rewards of ownership transfer upon delivery to the customer as stated in their respective contracts, in which case revenue is recognized upon delivery.

•Capital equipment and software sales:

◦Capital equipment and software sales preceded by evaluation periods: The predominance of capital equipment and software sales (consisting of integrated computer hardware and software that are integral components of the Company's ClearPoint system) are preceded by customer evaluation periods. During these evaluation periods, installation of, and training of customer personnel on, the systems have been completed and the systems have been in operation. Accordingly, revenue from capital equipment and software sales following such evaluation periods is recognized at the point in time that the Company is in receipt of an executed purchase agreement or purchase order.

◦Capital equipment and software sales not preceded by evaluation periods: Revenue from sales of capital equipment and software not having been preceded by an evaluation period is recognized upon delivery to the customer and installation. For capital equipment that does not require installation, revenue is recognized upon shipment, however, for those customers where legal title and risks and rewards of ownership transfer upon delivery, revenue is recognized at such time.

For both types of capital equipment and software sales described above, the determination of the point in time at which to recognize revenue represents that point at which the customer has legal title, physical possession, and the risks and rewards of ownership, and the Company has a present right to payment.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

•Functional neurosurgery navigation and therapy services: The Company recognizes revenue for such services over time as the services are delivered to the customer based on the extent of progress towards completion of the performance obligation.

•Biologics and drug delivery services and other revenue:

◦Consultation Services: The Company recognizes consultation revenue over time as the services are delivered to the customer based on the extent of progress towards completion of the performance obligation.

◦Clinical Service Access Fees: For contracts in which the Company receives a periodic fixed fee, irrespective of the number of cases attended by the Company's personnel or hours incurred during such periods, revenue is recognized ratably over the period covered by such fees. A time-elapsed output method is used for such fees because the Company transfers control evenly by providing a stand-ready service.

◦Clinical Service Procedure-Based Fees: The Company recognizes revenue at the point in time a case is attended by Company personnel.

◦License fees: License fees represent the use of functional intellectual property as it exists at the point in time at which the license is granted and does not require any significant development or customization. Accordingly, the Company recognizes license revenue at the point in time in which the license becomes effective and the intellectual property is made available to the customer.

•Capital equipment-related services:

◦Equipment service: Revenue from service of ClearPoint capital equipment and software previously sold to customers is based on agreements with terms ranging from one to three years and is recognized ratably on a monthly basis over the term of the service agreement. A time-elapsed output method is used for service revenue because the Company transfers control evenly by providing a stand-ready service.

The Company may also enter into contracts with customers who own ClearPoint capital equipment, which bundle maintenance and support services and access to software and hardware upgrades made commercially available over the term of the contract, for a single contract price, typically paid on an annual basis. The Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation and recognizes the revenue ratably on a monthly basis. A time-elapsed output method is used as the Company is providing a stand-ready service for each of the performance obligations.

◦Installation, training and shipping: Consistent with the Company’s recognition of revenue for capital equipment and software sales as described above, fees for installation, training and shipping in connection with sales of capital equipment and software that have been preceded by customer evaluation periods are recognized as revenue at the point in time the Company is in receipt of an executed purchase order for the equipment and software. Installation, training and shipping fees related to capital equipment and software sales not having been preceded by an evaluation period are recognized as revenue concurrent with the recognition of revenue from sales of the related capital equipment.

The Company operates in one industry segment, and the predominance of its sales are to U.S.-based customers.

Payment terms under contracts with customers generally are in a range of 30-60 days after the customers’ receipt of the Company’s invoices.

The Company’s terms and conditions do not provide for a right of return unless for: (a) product defects; or (b) other conditions subject to the Company’s approval.

See Note 3 for additional information regarding revenue recognition.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Net Loss Per Share

The Company computes net loss per share using the weighted-average number of common shares outstanding during the period. Basic and diluted net loss per share are the same because the conversion, exercise or issuance of all potential common stock equivalents, which comprise the Company’s outstanding common stock options, unvested restricted stock and restricted stock units, as described in Note 8, and the potential conversion of the Outstanding First Closing Note, as described in Note 6, would be anti-dilutive, due to the reporting of a net loss for each of the periods in the accompanying condensed consolidated statements of operations.

Concentration Risks and Other Risks and Uncertainties

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company may at times invest its excess cash in interest bearing accounts and U.S. government debt securities. It classifies all highly liquid investments with original stated maturities of three months or less from the date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months but less than twelve months as short-term investments. The Company classifies the U.S. government debt securities as held-to-maturity in accordance with ASC 320, "Investments - Debt and Equity Securities." Held-to-maturity securities are those securities that the Company has the ability and intent to hold until maturity and are recorded at amortized cost on the accompanying condensed consolidated balance sheet, adjusted for the accretion of discounts using the effective interest method.

The Company holds the remainder of its cash and cash equivalents on deposit with financial institutions in the U.S. insured by the Federal Deposit Insurance Corporation. At September 30, 2023, the Company had approximately $1.5 million in bank balances that were in excess of the insured limits.

At September 30, 2023, there were two customers whose accounts receivable balances represented 29% and 24% of accounts receivable at that date. At December 31, 2022, one customer accounted for 19% of accounts receivable at that date.

One pharmaceutical customer, a related party who is a stockholder, a noteholder, and whose chief executive officer is a representative on the Company's Board of Directors (see Note 6), for whom the Company provides hardware, software, clinical services and market development services in support of the customer's clinical trials, and from whom the Company earns a quarterly fee, accounted for 12% and 14% of total sales in the three-month periods ended September 30, 2023 and 2022, respectively, and 12% and 16% of total sales in the nine-month periods ended September 30, 2023 and 2022, respectively. There was one additional customer who comprised 10% of the total sales in the three-month period ended September 30, 2023.

Prior to granting credit to a customer, the Company generally performs credit evaluations of the customers’ financial condition. In general, the Company does not require collateral from customers in connection with an extension of credit. The accounts receivable balance is reduced by an allowance for credit losses from the potential inability of the Company's customers to make required payments. The allowance for credit losses at September 30, 2023, and December 31, 2022, was $1.0 million and $0.1 million, respectively. The Company evaluates the historic loss experience on the accounts receivable balance and also considers separately customers with receivable balances that may be negatively impacted by current economic developments and market conditions. The estimate is a result of the Company's ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses and future expectations.

The Company is subject to risks common to emerging companies in the medical device industry, including, but not limited to: new technological innovations; acceptance and competitiveness of its products; dependence on key personnel; dependence on key suppliers; dependence on third-party collaboration, license and joint development partners; changes in general economic conditions and interest rates; protection of proprietary technology; compliance with changing government regulations; uncertainty of widespread market acceptance of products; access to credit for capital purchases by customers; and product liability claims. Certain components used in manufacturing have relatively few alternative sources of supply and establishing additional or replacement suppliers for such components cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company’s supply requirements may negatively impact future operating results.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Adoption of New Accounting Standard

In June 2016, the FASB issued ASU No. 2016-13, "Financial Instruments - Credit Losses (Topic 326)," which replaces the previous incurred loss impairment methodology for most financial assets with the current expected credit loss, or CECL, methodology. The new guidance requires entities to use a forward-looking approach based on expected losses rather than incurred losses to estimate credit losses on certain types of financial instruments, including trade receivables. The Company adopted the new standard effective January 1, 2023, which did not have a material impact to the condensed consolidated financial statements.

Reclassifications

The accompanying condensed consolidated statement of operations for the three and nine months ended September 30, 2023 classifies share-based compensation in the same income statement line items as the cash compensation paid to recipient employees, rather than in general and administrative expense, as had been the practice in previous years. The accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2022 have been conformed to the 2023 presentation.


3.						Revenue Recognition

Revenue by Service Line


	Three Months Ended September 30,
(in thousands)	2023		2022
Biologics and drug delivery
Disposable products	$	455	$	798
Services and license fees	3,032		1,448
Subtotal – Biologics and drug delivery revenue	3,487		2,246
Functional neurosurgery navigation and therapy
Disposable products	1,874		2,045
Services	44		375
Subtotal – Functional neurosurgery navigation and therapy	1,918		2,420
Capital equipment and software
Systems and software products	81		287
Services	276		193
Subtotal – Capital equipment and software revenue	357		480
Total revenue	$	5,762	$	5,146

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)


	Nine Months Ended September 30,
(in thousands)	2023		2022
Biologics and drug delivery
Disposable products	$	1,395	$	2,873
Services and license fees	8,136		3,935
Subtotal – Biologics and drug delivery revenue	9,531		6,808
Functional neurosurgery navigation and therapy
Disposable products	5,550		5,706
Services	930		1,125
Subtotal – Functional neurosurgery navigation and therapy	6,480		6,831
Capital equipment and software
Systems and software products	432		1,171
Services	702		567
Subtotal – Capital equipment and software revenue	1,134		1,738
Total revenue	$	17,145	$	15,377

Contract Balances

•Contract assets – The timing of revenue recognition may differ from the time of billing to the Company's customers. In most cases, customers are billed upon shipment of such products or delivery of such services and the related contract assets, which represent an unconditional right to consideration, comprise the accounts receivable balances that are included in the accompanying condensed consolidated balance sheets. When revenue is recognized in advance of its right to bill and receive consideration, the Company records a contract asset. At September 30, 2023, the Company had $0.6 million in contract assets classified as other current assets in the accompanying condensed consolidated balance sheets. Additionally, at December 31, 2022, the Company also had $0.3 million in deferred contract costs, classified as other current assets, related to up-front costs for direct materials incurred to fulfill a customer contract. These costs were recognized as cost of revenue in the second quarter of 2023.

•Contract liabilities – Contract liabilities consist of amounts that have been invoiced and for which the Company has the right to bill, but that have not been recognized as revenue as the related goods or services have not been transferred. The Company's contract liabilities are generally comprised of the following (1) capital equipment and software-related service fees that are typically billed and collected at the inception of the service agreements, which have terms ranging from one to three years, (2) annual fees for agreements with customers that bundle the capital equipment and software-related service fees with software and hardware upgrades that are made commercially available over the term of the contract, and (3) up-front payments from customers made in connection with consulting services. The unearned portion of all such fees is classified as deferred revenue. Additionally, at December 31, 2022, the Company had a $0.5 million refund liability resulting from an up-front customer payment which was potentially refundable if the parties did not enter into the ensuing agreement. In 2023, the uncertainties underlying this amount were resolved and the amount was recognized as revenue.

During the three and nine months ended September 30, 2023, the Company recognized approximately $0.2 million and $1.0 million of revenue, respectively, which was previously included in deferred revenue in the accompanying condensed consolidated balance sheet at December 31, 2022.

Transaction price allocated to remaining performance obligations represents contracted revenue that has not yet been recognized, which includes deferred revenue that will be recognized as revenue in future periods. The majority of the remaining performance obligations relate to capital equipment and software-related service agreements and the upfront payments discussed under the heading "Contract Balances" above, which amounted to approximately $1.7 million at

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

September 30, 2023. The Company expects to recognize 69% of this revenue over the next twelve months and the remainder thereafter.


4.			Fair Value Measurement

Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.

The fair value of cash and cash equivalents of $24.3 million and $27.6 million as of September 30, 2023, and December 31, 2022, respectively, is derived using Level 1 inputs. The cash equivalents are comprised of short-term bank deposits, money market funds, and U.S. Government debt securities with original maturities of three months or less, and the carrying value is a reasonable estimate of fair value.

The Company had $9.9 million of short-term investments on December 31, 2022, consisting of twelve-month U.S. Government debt securities, which were classified as held to maturity and carried at amortized cost, adjusted for the accretion of discounts using the effective interest method. The carrying value of the debt securities approximates fair value based on Level 1 inputs. The Company held the investments to maturity, which occurred in the second quarter of 2023.


5.			Inventory

Inventory consists of the following as of September 30, 2023 and December 31, 2022:


(in thousands)	September 30, 2023		December 31, 2022
Raw materials and work in process	$	6,928	$	6,513
Software licenses	211		210
Finished goods	1,848		2,580
Inventory, net, included in current assets	8,987		9,303
Software licenses – non-current	405		450
Total	$	9,392	$	9,753


6.			Note Payable

As a result of a note financing in 2020, and further described in the following paragraphs, the Outstanding First Closing Note in an aggregate principal amount of $10 million was outstanding at September 30, 2023. At the option of the holder at any time prior to maturity on January 29, 2025, the principal amount may be convertible to the Company’s common stock at a conversion price of $6.00, subject to adjustments as set forth in the SPA and the note agreement.

On January 29, 2020 (the "Closing Date"), the Company completed a financing transaction with two investors (the "2020 Convertible Noteholders"), whereby the Company issued an aggregate principal amount of $17.5 million of secured convertible notes (the "First Closing Notes") pursuant to the SPA, which, unless earlier converted or redeemed, mature on the fifth anniversary of the issuance and bear interest at a rate equal to the sum of (i) the greater of (a) the three (3)-month Secured Overnight Financing Rate (“SOFR”) and (b) two percent (2%), plus (ii) a margin of 2% on the outstanding balance of the First Closing Notes, payable quarterly on the first business day of each calendar quarter. The First Closing Notes may be converted at a price of $6.00 per share, subject to certain adjustments set forth in the SPA and the note agreement, and may not be pre-paid without the consent of the noteholder.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

On July 31, 2023, the Company and the 2020 Convertible Noteholders entered into a third amendment to the SPA and note agreement to replace the previously used London Interbank Offered Rate ("LIBOR") and the LIBOR-based mechanics with an interest rate benchmark based on the SOFR and related SOFR-based mechanics.

In May 2021, one of the 2020 Convertible Noteholders (the “Converting Noteholder”) converted the entire $7.5 million principal amount of such Converting Noteholder’s First Closing Note, and related accrued interest, amounting to approximately $0.04 million, into 1,256,143 shares of the Company’s common stock.

The SPA gave the Company the right, but not the obligation, to request at any time on or prior to January 11, 2022, that one of the 2020 Convertible Noteholders purchase additional Second Closing Note (as defined in the SPA) and additional Third Closing Note (as defined in the SPA), and provided that such 2020 Convertible Noteholder had the right, but not the obligation, to purchase such notes.

In December 2020, upon execution of the second amendment to the SPA, the Company issued the Second Closing Note to one of the 2020 Convertible Noteholders. On November 3, 2021, the holder of the Second Closing Note converted the entire $7.5 million principal amount of such note, along with related accrued and payment in-kind interest aggregating $0.3 million, into 773,446 shares of the Company's common stock.

The aggregate carrying amount of the Outstanding First Closing Note in the accompanying September 30, 2023 and December 31, 2022 condensed consolidated balance sheets is presented net of financing costs, comprised of commissions and legal expenses, having an unamortized balance of $0.1 million at each of those respective dates.

The Outstanding First Closing Note is secured by all the assets of the Company.

The holder of the Outstanding First Closing Note is a significant customer of the Company, whose chief executive officer is a member of the Company’s Board of Directors. See Note 2, Concentration Risks and Other Risks and Uncertainties.

Scheduled Note Payable Maturity

Scheduled principal payment as of September 30, 2023 with respect to the remaining note payable is summarized as follows:


Year ending December 31,	(in thousands)
2025	$	10,000
Total scheduled principal payment	10,000
Less: Unamortized financing costs	(65)
Total	$	9,935


7.			Leases

The Company subleases office space in Solana Beach, California, that serves as its corporate headquarters and houses certain management and personnel. The sublease term commenced on December 15, 2020, is set to expire on December 31, 2026, and is renewable for an additional five-year period, at the Company’s option, provided that the Company’s landlord has entered into an extension of its prime lease for the office space that encompasses the Company’s office space for at least five years.

The Company leases space in Carlsbad, California, that houses office space and a manufacturing facility under a lease that commenced on June 1, 2023 and ends on May 31, 2033. The Company has two options to extend the lease term for thirty-six or sixty months, at the fair market rental value. In the third quarter of 2023, the Company was substantially complete with the establishment of the new facility. Accordingly, the Company terminated its prior manufacturing facility lease in Irvine, California, effective October 2023. The lease termination did not have a material impact to the financial statements.

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

The aforementioned leases are classified as operating leases in conformity with GAAP. The aggregate lease costs, included in general and administrative expense, were $0.2 million and $0.1 million for each of the three months ended September 30, 2023 and 2022, respectively, and $0.5 million and $0.4 million for each of the nine months ended September 30, 2023 and 2022.


8.			Stockholders’ Equity

The Fourth Amended and Restated 2013 Incentive Compensation Plan became effective in 2022. The plan permits the issuance of options, restricted stock, restricted stock units and other awards to selected employees, directors and consultants of the Company. The equity incentive plans are more fully described in Note 9 to the consolidated financial statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2022.

Share-Based Compensation Expense

The Company records share-based compensation expense on a straight-line basis over the vesting periods of the related grants and recognizes forfeitures as they occur. The following table sets forth share-based compensation expense included in the condensed consolidated statements of operations:


	Three Months Ended September 30,
	(in thousands)
	2023		2022
Cost of revenue	26		17
Research and development	357		216
Sales and marketing	431		300
General and administrative	770		642
Share-based compensation expense	$	1,584	$	1,175


	Nine Months Ended September 30,
	(in thousands)
	2023		2022
Cost of revenue	74		33
Research and development	1,009		701
Sales and marketing	1,277		639
General and administrative	2,176		1,581
Share-based compensation expense	$	4,536	$	2,954

Share-based compensation expense by type of share-based award is summarized below:


	Three Months Ended September 30,
	(in thousands)
	2023		2022
Stock options	233		260
RSAs and RSUs	1,308		860
ESPP	43		55
	$	1,584	$	1,175

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)


	Nine Months Ended September 30,
	(in thousands)
	2023		2022
Stock options	747		830
RSAs and RSUs	3,612		1,957
ESPP	177		167
	$	4,536	$	2,954

Total unrecognized compensation expense by type of award and the weighted-average remaining requisite period over which such expense is expected to be recognized (in thousands, unless otherwise noted):


Years Ended	September 30, 2023
	Unrecognized Expense		Remaining Weighted-Average Recognition Period (in years)
Stock options	$	1,208	1.82
RSAs and RSUs	$	8,187	1.94

Stock Option Activity

Stock option activity under the Company’s current and previous plans during the nine months ended September 30, 2023 is summarized below:


	Stock Options	Weighted-average Exercise price per share		Weighted-average Remaining Contractual Life (in years)	Intrinsic Value(1) (in thousands)
Outstanding at December 31, 2022	1,398,286	$	8.69
Granted	111,107	$	8.10
Exercised	(20,000)	$	1.82
Forfeited or expired	(4,374)	$	41.52
Outstanding at September 30, 2023	1,485,019	$	8.64	5.69	$	1,867
Exercisable at September 30, 2023	1,258,707	$	8.29	5.10	$	1,867
Vested and expected to vest at September 30, 2023	1,485,019	$	8.64	5.69	$	1,867

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)


(1)			Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options.

Restricted Stock Award Activity

Restricted stock award ("RSA") activity for the nine months ended September 30, 2023 is summarized below:


	Restricted Stock Awards	Weighted - Average Grant Date Fair Value
Outstanding at December 31, 2022	684,389	$	11.10
Vested	(270,042)	$	10.06
Forfeited	(5,395)	$	12.51
Outstanding at September 30, 2023	408,952	$	11.78

Restricted Stock Unit Activity

Restricted stock unit ("RSU") activity for the nine months ended September 30, 2023 is summarized below:


	Restricted Stock Units	Weighted - Average Grant Date Fair Value
Outstanding at December 31, 2022	13,146	$	11.41
Granted	766,625	$	8.11
Vested	(13,660)	$	8.73
Outstanding at September 30, 2023	766,111	$	8.15

ESPP

On June 3, 2021, the Company’s stockholders adopted and approved the ClearPoint Neuro, Inc. Employee Stock Purchase Plan (the “ESPP”), which allows eligible employees to acquire shares of the Company’s common stock through payroll deductions at a discount to market price. A total of 400,000 shares of the Company’s common stock were made available for issuance pursuant to the terms of the ESPP. Each offering period is for six months, and the first offering period commenced on July 1, 2021. During the first offering period of 2023, 51,041 shares were purchased at an average per share price of $6.15.

Warrants

Warrants to purchase shares of the Company's common stock were issued in connection with financing transactions in 2015 and 2017. These warrants contained net exercise provisions giving the holder the option of acquiring a number of shares having a value equal to the difference between the exercise price and the current stock price, in lieu of paying the exercise price to acquire the full number of stated shares. All of the remaining outstanding warrants expired in the second quarter of 2023.

Warrant activity for the nine months ended September 30, 2023 is summarized below:

ClearPoint Neuro, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)


	Shares	Weighted - Average Exercise Price
Outstanding at December 31, 2022	36,554	$	16.23
Expired	(36,554)	$	16.23
Outstanding at September 30, 2023	—	—

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 should be read together with our unaudited Condensed Consolidated Financial Statements and the related notes thereto appearing in Part I, Item 1 of this Quarterly Report. This discussion and analysis contains forward-looking statements that are based upon current expectations and involve risks, assumptions and uncertainties. You should review the section titled “Risk Factors” appearing in our 2022 Form 10-K and in Part II, Item 1.A of this Quarterly Report for a discussion of important risk factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis. In addition, historical results and trends that might appear in this Quarterly Report should not be interpreted as being indicative of future operations.

Overview

We are a commercial-stage medical device company that develops and commercializes innovative platforms for performing minimally invasive surgical procedures in the brain. We have deployed significant resources to fund our efforts to develop the foundational capabilities for enabling MRI-guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies developed by our company. Beginning in 2021, our efforts have expanded beyond the MRI suite to encompass development and commercialization of new neurosurgical device products for the operating room. In 2022, we commercialized the ClearPoint Prism Neuro Laser Therapy System as our first therapy product offering. We have exclusive global commercialization rights to the ClearPoint Prism Neuro Laser Therapy System through our Swedish partner, Clinical Laserthermia Systems ("CLS").

Since 2020, we have evolved to become a company comprised of two parts. The first foundational part is a medical device company providing medical devices for neurosurgery applications. The second part is focused on partnerships in the biologics and drug delivery space.

Since 2021, a growing part of our revenue is derived from consulting services to pharmaceutical and biotech companies, academic institutions, or contract research organizations having a focus on biologics and drug delivery. Our services include protocol consultation and solutions for pre-clinical study design and execution. Currently, we have more than 50 biologics and drug delivery customers who are evaluating or using our products and services in trials to inject gene and cell therapies directly into the brain. These relationships involve drug development programs that are at various stages of development ranging from pre-clinical research to late-stage regulatory trials for multiple distinct disease states. This part of our business potentially represents the largest opportunity for growth; however, our ability to grow in this market is dependent on our ability to maintain and establish new relationships with customers, such customers' continuation of research and product development plans, and such customers achieving success in completion of clinical trials and subsequent regulatory approvals of their drugs and biologics.

Substantially all our revenue for the three and nine months ended September 30, 2023 and 2022 relates to (i) sales of our ClearPoint system products and related services and (ii) consulting services from our customers in the biologics and drug delivery space. We have financed our operations and internal growth primarily through the sale of equity securities and the issuance of convertible and other secured notes. We have incurred significant losses since our inception in 1998 as we have devoted substantial efforts to research and development. As of September 30, 2023, we had accumulated losses of $167.8 million. We may continue to incur operating losses as we expand our ClearPoint system platform and our business generally.

Factors Which May Influence Future Results of Operations

The following is a description of factors that may influence our future results of operations, and that we believe are important to an understanding of our business and results of operations.

Macroeconomic Trends

We continue to monitor the impact of various macroeconomic trends, such as global economic and supply chain disruptions, geopolitical instability (including instability resulting from military conflicts), labor shortages, instability of financial institutions and inflationary conditions. Changes in domestic and global economic conditions, supply chain disruptions, labor shortages, as well as other stimulus and spending programs, have led to higher inflation, which is likely to lead to increased costs and may cause further changes in fiscal and monetary policy. Impacts from inflationary pressures,

such as increasing costs for research and development of our products, administrative and other costs of doing business, the potential for instability of the financial institutions where we maintain our deposits or other assets, and our availability to access capital markets and other sources of funding in the future could adversely affect our business, financial condition and results of operations. Additionally, these trends could adversely affect our customers, which could impact their willingness to spend on our products and services, or their ability to make payment, which could harm the Company's collection of accounts receivable and financial results. The rapid development and fluidity of these situations precludes any prediction as to the ultimate impact they will have on our business, financial condition, results of operation and cash flows, which will depend largely on future developments.

Revenue

In 2010, we received 510(k) clearance from the FDA to market our ClearPoint system in the U.S. for general neurosurgery procedures; in February 2011 and May 2018, we also obtained CE marking for our ClearPoint system and SmartFlow cannula, respectively; and in June 2020, we obtained CE marking for version 2.0 of our ClearPoint software and our Inflexion head fixation frame. In January 2021, we received 510(k) clearance for the SmartFrame Array Neuro Navigation System. In September 2022 the ClearPoint Prism™ Neuro Laser Therapy System, which we have exclusive global right to commercialize, received 510(k) clearance through CLS. The Prism laser represents the first therapy product we have commercialized.

In 2021, we started providing consulting services to our pharmaceutical and other medical technology customers for improving outcome predictability and optimizing pre-clinical and clinical workflows. Our expertise is concentrated in benchtop testing, pre-clinical studies, clinical trial support, regulatory consultation, and over-arching translation from the pre-clinical to the clinical setting to enhance accuracy and precision of drug delivery.

Future revenue from sales of our ClearPoint platform products and services is difficult to predict and may not be sufficient to offset our continuing research and development expenses and our increasing selling, general and administrative expenses.

Generating recurring revenue from the sale of products is an important part of our business model for our ClearPoint system. Our product revenue was approximately $2.4 million and $7.4 million for the three and nine months ended September 30, 2023, respectively, and was almost entirely related to our ClearPoint system. Our service revenue was approximately $3.4 million and $9.8 million for the three and nine months ended September 30, 2023, respectively, of which 90% and 83%, respectively, is related to the biologics and drug delivery service line.

Our revenue recognition policies are more fully described in Note 2 to the Condensed Consolidated Financial Statements included above in Part I, Item 1 in this Quarterly Report.

Underlying the revenue from sales of products and services to our biologics and drug delivery customers is the number of direct customers and end users of our products and/or services (“Partners”). Our Partners consist of pharmaceutical and biotech companies, academic institutions, or customer-sponsored contract research organizations that are developing methods to deliver a wide variety of molecules, genes or proteins to targeted brain tissue or structures that would need to bypass the blood-brain barrier for the treatment of a variety of disorders. This is a novel area in which commercialization must be preceded by FDA-mandated clinical trials, which are expensive and time consuming to conduct, and for which the commercial success is uncertain, pending, in part, on the outcome of those trials. While our revenue from sales of products and services to our biologics and drug delivery customers is indicative of growth, the number of Partner relationships is also of importance as we recognize the possibility that some Partners’ research will reach commercial success, and others may not. To the extent our Partners achieve commercial success, our expectation is that we will share in such success through our Partners’ use of our products and services in their delivery of therapies. At September 30, 2023, we had more than 50 Partners, which is similar to the number of Partners as of the same date in 2022.

Cost of Revenue

Cost of revenue includes the direct costs associated with the assembly and purchase of components for functional neurosurgery navigation products, biologics and drug delivery products, non-neurosurgery therapy products, and ClearPoint capital equipment and software that we have sold, and for which we have recognized the revenue in accordance with our revenue recognition policy, as well as labor hours and materials for the cost of providing pre-clinical, consulting, and service revenue. Cost of revenue also includes the allocation of manufacturing overhead costs and depreciation of

loaned systems installed under our ClearPoint placement program, as well as provisions for obsolete, impaired, or excess inventory.

Research and Development Costs

Our research and development costs consist primarily of costs associated with the conceptualization, design, testing, and prototyping of our ClearPoint system products and enhancements. Such costs include salaries, travel, and benefits for research and development personnel; materials and laboratory supplies in research and development activities; outside consultant costs; and licensing costs related to technology not yet commercialized. We anticipate that, over time, our research and development costs may increase as we: (i) continue to develop enhancements to our ClearPoint system and SmartFlow cannula; and (ii) seek to expand the application of our technological platforms. From our inception through September 30, 2023, we have incurred approximately $90 million in research and development expenses.

Product development timelines, likelihood of success, and total costs can vary widely by product candidate. There are also risks inherent in the regulatory clearance and approval process. At this time, we are unable to estimate with any certainty the costs that we will incur in our efforts to expand the application of our technological platforms.

Sales and Marketing, and General and Administrative Expenses

Our sales and marketing, and general and administrative expenses consist primarily of salaries, incentive-based compensation, travel and benefits, including share-based compensation; marketing costs; professional fees, including fees for outside attorneys and accountants; occupancy costs; insurance; and other general and administrative expenses, which include, but are not limited to, corporate licenses, director fees, hiring costs, taxes, postage, office supplies, information technology and meeting costs. Our sales and marketing expenses are expected to continue to increase due to costs associated with the continued commercialization of our products and services and the increased headcount necessary to support growth in operations.

Critical Accounting Policies and Estimates

There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 30, 2023, as compared to the critical accounting policies and estimates described in our 2022 Form 10-K.

Results of Operations

Three Months Ended September 30, 2023, Compared to the Three Months Ended September 30, 2022


	Three Months Ended September 30,
(Dollars in thousands)	2023		2022		Percentage Change
Product revenue	$	2,410	$	3,130	(23)	%
Service and other revenue	3,352		2,016		66	%
Total revenue	5,762		5,146		12	%
Cost of revenue	2,489		1,467		70	%
Gross profit	3,273		3,679		(11)	%
Research and development costs	2,429		2,654		(8)	%
Sales and marketing expenses	2,841		2,422		17	%
General and administrative expenses	2,900		2,398		21	%
Other expense:
Other expense, net	(12)		(25)		NM%
Interest income, net	100		32		213	%
Net loss	$	(4,809)	$	(3,788)	27	%

NM – The percentage change is not meaningful.

Revenue. Total revenue was $5.8 million for the three months ended September 30, 2023, and $5.1 million for the three months ended September 30, 2022, which represents an increase of $0.6 million, or 12%.


	Three Months Ended September 30,
(Dollars in thousands)	2023		2022		Percentage Change
Biologics and drug delivery
Disposable products	$	455	$	798	(43)	%
Services and license fees	3,032		1,448		109	%
Subtotal – Biologics and drug delivery revenue	3,487		2,246		55	%
Functional neurosurgery navigation and therapy
Disposable products	1,874		2,045		(8)	%
Services	44		375		(88)	%
Subtotal – Functional neurosurgery navigation and therapy	1,918		2,420		(21)	%
Capital equipment and software
Systems and software products	81		287		(72)	%
Services	276		193		43	%
Subtotal – Capital equipment and software revenue	357		480		(26)	%
Total revenue	$	5,762	$	5,146	12	%

Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored pre-clinical and clinical trials, increased 55% to $3.5 million for the three months ended September 30, 2023, from $2.2 million for the same period in 2022. This increase is attributable to a $1.6 million increase in service revenue related to new pre-clinical trials and consulting agreements entered into with our Partners during the three months ended September 30, 2023, compared to the same period in 2022, partially offset by a $0.3 million decrease in product revenue.

Functional neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, decreased 21% to $1.9 million for the three months ended September 30, 2023, from $2.4 million for the same period in 2022. The decrease is driven by lower service revenue of $0.3 million as a result of pausing a co-development program with one of our Brain Computer Interface partners and lower product revenue of $0.2 million due to lower utilization in hospitals during the three months ended September 30, 2023, compared to the same period in 2022.

Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 26% to $0.4 million for the three months ended September 30, 2023, from $0.5 million for the same period in 2022 due primarily to a decrease in the placements of ClearPoint capital and software.

Cost of Revenue and Gross Profit. Cost of revenue was $2.5 million, resulting in gross profit of $3.3 million and gross margin of 57%, for the three months ended September 30, 2023, and was $1.5 million, resulting in gross profit of $3.7 million and representing a gross margin of 71%, for the three months ended September 30, 2022. The decrease in gross margin was primarily due to an increase in biologics and drug delivery pre-clinical services, which, to date, have had a lower margin than prior year, as we launch new services and increase our presence in this space. Increased costs related to the transition to the new manufacturing facility also contributed to the decrease in gross margin compared to prior year.

Research and Development Costs. Research and development costs were $2.4 million for the three months ended September 30, 2023, compared to $2.7 million for the same period in 2022, a decrease of $0.2 million, or 8%. The decrease was due primarily to reprioritization of certain research and development initiatives, partially offset by higher personnel and share-based compensation costs.

Sales and Marketing Expenses. Sales and marketing expenses were $2.8 million for the three months ended September 30, 2023, compared to $2.4 million for the same period in 2022, an increase of $0.4 million, or 17%. This increase was due primarily to additional personnel costs, including share-based compensation, resulting from increases in headcount.

General and Administrative Expenses. General and administrative expenses were $2.9 million for the three months ended September 30, 2023, compared to $2.4 million for the same period in 2022, an increase of $0.5 million, or 21%. This

increase was due primarily to an increase in the allowance for credit losses of $0.5 million, partially offset by lower professional fees of $0.1 million.

Interest Income (Expense). Net interest income for the three months ended September 30, 2023 was $0.1 million, compared to $0.03 million for the same period in 2022. The increase in interest income was due to higher interest rates and the Company's investment in U.S. Government debt securities, offset partially by the higher amount of interest paid on the 2020 Secured Convertible Note during the three months ended September 30, 2023, relative to the same period in 2022. See Note 6 to the Condensed Consolidated Financial Statements included above in Part 1, Item 1 in this Quarterly Report for additional information with respect to the 2020 secured notes.

Nine Months Ended September 30, 2023, Compared to the Nine Months Ended September 30, 2022


	Nine Months Ended September 30,
(Dollars in thousands)	2023		2022		Percentage Change
Product revenue	$	7,377	$	9,750	(24)	%
Service and other revenue	9,768		5,627		74	%
Total revenue	17,145		15,377		11	%
Cost of revenue	7,544		5,212		45	%
Gross profit	9,601		10,165		(6)	%
Research and development costs	9,057		7,967		14	%
Sales and marketing expenses	9,248		6,826		35	%
General and administrative expenses	9,036		7,235		25	%
Other expense:
Other expense, net	(25)		(22)		NM%
Interest income (expense), net	295		(165)		279	%
Net loss	$	(17,470)	$	(12,050)	45	%

NM – The percentage change is not meaningful.

Revenue. Total revenue was $17.1 million for the nine months ended September 30, 2023, and $15.4 million for the nine months ended September 30, 2022, which represents an increase of $1.8 million, or 11%.


	Nine Months Ended September 30,
(Dollars in thousands)	2023		2022		Percentage Change
Biologics and drug delivery
Disposable products	$	1,395	$	2,873	(51)	%
Services and license fees	8,136		3,935		107	%
Subtotal – Biologics and drug delivery revenue	9,531		6,808		40	%
Functional neurosurgery navigation and therapy
Disposable products	5,550		5,706		(3)	%
Services	930		1,125

SEC Form 10-Q filed by ClearPoint Neuro Inc.