GlobeNewswire Inc | Aug 12, 2020 04:05PM EDT

August 12, 2020

IRVINE, Calif., Aug. 12, 2020 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) today announced financial results for its second fiscal quarter and six months ended June 30, 2020.

Financial Results Three Months Ended June 30, 2020

Total revenues for the quarter were approximately $2.5 million and $2.6 million for the three months ended June 30, 2020 and 2019, respectively, a decrease of 5%.

Functional neurosurgery revenue, which consists of disposable product commercial sales related to cases utilizing the ClearPoint system, decreased 38% to $1.0 million for the three months ended June 30, 2020, from $1.7 million for the same period in 2019. This decrease was due to the effects of the COVID-19 pandemic, in which elective surgical procedures, historically representing more than 80% of the Companys ClearPoint system case volume, were temporarily suspended commencing in the second half of March 2020 and which have not yet returned to pre-pandemic levels.

Biologics and drug delivery revenues, which include sales of disposable products and services related to customer-sponsored clinical trials utilizing the ClearPoint system, increased 183% to $1.2 million for the three months ended June 30, 2020, from $413,000 for the same period in 2019. This increase in biologics and drug delivery service revenues is attributable to the establishment of additional relationships with biologic and drug delivery companies that included period-based retainers for clinical services in support of such companies respective clinical trials.

Capital equipment revenue, consisting of sales of ClearPoint reusable hardware and software, as well as service contracts related to capital equipment, decreased 51% to $240,000 for the three months ended June 30, 2020, from $485,000 for the same period in 2019. While revenues from this product line historically have varied from quarter to quarter,the Company believes that many hospitals have postponed capital equipment acquisition activities, which continued postponement the Company believes will be contingent upon the prevalence and duration of the COVID-19 pandemic.

Gross margin for the three months ended June 30, 2020 was 74%, as compared to 60% for the same period in 2019. This increase was driven primarily by the greater contribution of services to total revenue during the three months ended June 30, 2020, as compared to the same period in 2019.

Operating expenses for the three months ended June 30, 2020 were $3.3 million, a 15% increase from operating expenses of $2.9 million for the same period in 2019. This increase was comprised of: (a) research and development costs, which increased 18% resulting primarily from increases in personnel costs; and (b) general and administrative expenses, which increased 33% resulting primarily from an increase in professional fees and a decrease in the allocation of shared departmental resources to production due to reduced manufacturing activity during the 2020 second quarter. These increases were partially offset by a decrease of 2% in sales and marketing expenses, resulting primarily from a decrease in items attributable to the effects of the COVID-19 pandemic, such as incentive-based compensation and travel, which was partially offset by headcount increases in the Companys clinical and marketing teams.

Operating loss for the three months ended June 30, 2020 was $1.5 million, as compared with $1.3 million for the same period in 2019.

Cash and cash equivalent balances at June 30, 2020 were $16.0 million.

The second quarter of 2020 was significantly affected by the COVID-19 pandemic, which adversely impacted sales across all of our business lines, commented Joe Burnett, President and Chief Executive Officer of ClearPoint Neuro. More than 80% of our procedures are deemed elective, which generally resulted in the postponement or cancellation of such procedures to give our hospital customers the capacity for treating critical COVID-19 patients, which resulted in the completion of only 11 ClearPoint cases in April. As elective procedures resumed in certain cities, May case volume increased to 44 cases and June volume followed at 71 cases, representing approximately 90% of our pre-pandemic volume. Similarly, new capital placements and evaluations were effectively put on hold in the 2020 second quarter as hospitals dealt with the influx of COVID-19 patients. This said, I am immeasurably proud of our clinical support team who stood shoulder-to-shoulder with our hospital customers and ensured that cases in which the use of our ClearPoint System was integral in patient treatment were supported during the pandemic.

On a more positive note, our biologics and drug delivery business increased 183% to $1.2 million, which we believe demonstrates that our strategy in this space continues to drive new business and to provide diversification in our revenue stream. While our customer-sponsored clinical trials cases were postponed as a result of the pandemic, our pre-clinical planning and clinical services continued to progress where possible.

The pervasiveness of the pandemic continues to result in uncertainty as to the timing of the resumption to pre-pandemic levels of elective procedures, capital placements and customer-sponsored clinical trials. Accordingly, we are not yet providing a forecast for the balance of 2020. While we do not expect elective procedures to decline to the level seen in April, we anticipate, and have observed, that hospitals in cities struggling with COVID-19 cases will suspend elective procedures to ensure ventilator access and bed capacity. Furthermore, it should be noted that patients flow through a diagnostic and treatment process before they are referred to surgery. Accordingly, it follows that diagnostic work-ups delayed in March and April will cause the resulting surgeries to be similarly delayed.

While we view the current situation as a temporary setback, our team continues to work tirelessly to execute on our four-pillar growth strategy, staying true to our course.

Teleconference Information

Investors and analysts are invited to listen to a live broadcast review of the Company's 2020 second quarter and six months financial results today at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) that may be accessed by visiting the Company's website at www.clearpointneuro.com and selecting Investors / News / IR Calendar.

Investors and analysts who would like to participate in the conference call may do so via telephone at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.

For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until August 26, 2020 by calling (877) 660-6853, or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's website at www.clearpointneuro.com, on the Investor Relations page.

About ClearPoint Neuro

ClearPoint Neuros mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Companys current product portfolio include deep-brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in 60 active clinical sites in the United States. The Companys SmartFlow cannula is being used in partnership or evaluation with more than 20 individual biologics and drug delivery companies in various stages from preclinical research to late stage regulatory trials. To date, more than 3,500 cases have been performed and supported by the Companys field-based clinical specialist team which offers support and services for our partners. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements

Statements herein concerning the Companys plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of COVID-19 and the measures adopted to contain its spread; future revenues from sales of the Companys ClearPoint Neuro Navigation System products; the Companys ability to market, commercialize and achieve broader market acceptance for the Companys ClearPoint Neuro Navigation System products; and estimates regarding the sufficiency of the Companys cash resources. More detailed information on these and additional factors that could affect the Companys actual results are described in the Risk Factors section of the Companys Annual Report on Form 10-K for the year ended December 31, 2019, and the Companys Quarterly Report on Form 10-Q for the three months ended March 31, 2020, both of which have been filed with the Securities and Exchange Commission, and the Companys Quarterly Report on Form 10-Q for the three months ended June 30, 2020, which the Company intends to file with the Securities and Exchange Commission on or before August 14, 2020.

Contact: Harold A. Hurwitz, Chief Financial Officer(949) 900-6833hhurwitz@clearpointneuro.com

Jacqueline Keller, Vice President, Marketing(949) 900-6833jkeller@clearpointneuro.com

CLEARPOINT NEURO, INC.Condensed Consolidated Balance Sheets

June 30, December 31, 2020 2019 (Unaudited)ASSETS Current assets: Cash and cash equivalents $ 16,032,082 $ 5,695,722 Accounts receivable, net 1,163,663 1,089,917 Inventory, net 3,598,980 3,240,218 Prepaid expenses and other current assets 537,940 357,227 Total current assets 21,332,665 10,383,084 Property and equipment, net 342,584 447,162 Operating lease rights of use 321,155 374,218 Software license inventory 506,800 504,400 Licensing rights 517,207 135,000 Other assets 12,438 82,573 Total assets $ 23,032,849 $ 11,926,437 LIABILITIES AND STOCKHOLDERS? EQUITY Current liabilities: Accounts payable $ 1,491,377 $ 965,783 Accrued compensation 969,877 1,408,292 Other accrued liabilities 334,627 328,460 Operating lease liabilities, current 110,914 113,520 portionDeferred product and service revenue 620,126 1,016,892 Paycheck Protection Program loan payable, 296,677 - current portionTotal current liabilities 3,823,598 3,832,947 Accrued interest - 959,659 Operating lease liabilities, net of 227,714 276,669 current portionDeferred product and service revenue, net 228,286 197,862 of current portion2020 senior secured convertible notes 16,814,099 - payable, net2010 junior secured notes payable, net - 2,072,583 Paycheck Protection Program loan payable, 599,323 - net of current portionTotal liabilities 21,693,020 7,339,720 Commitments and contingencies Stockholders? equity: Preferred stock, $0.01 par value;25,000,000 shares authorized; none issued - - and outstanding at June 30, 2020 andDecember 31, 2019Common stock, $0.01 par value;200,000,000 shares authorized; 15,512,687shares issued and outstanding at June 30, 155,127 152,353 2020; and 15,235,308 issued andoutstanding at December 31, 2019Additional paid-in capital 117,640,195 117,173,984 Accumulated deficit (116,455,493 ) (112,739,620 )Total stockholders? equity 1,339,829 4,586,717 Total liabilities and stockholders? $ 23,032,849 $ 11,926,437 equity

CLEARPOINT NEURO, INC.Condensed Consolidated Statements of Operations (Unaudited)

For The Three Months Ended June 30, 2020 2019 Revenues: Product revenues $ 1,593,070 $ 2,194,194 Service and other revenues 884,712 412,204 Total revenues 2,477,782 2,606,398 Cost of revenues 640,805 1,030,316 Research and development costs 822,301 697,803 Sales and marketing expenses 1,124,378 1,143,056 General and administrative expenses 1,365,084 1,028,291 Operating loss (1,474,786 ) (1,293,068 )Other income (expense): Other income, net 10,851 1,693 Interest expense, net (197,113 ) (259,020 )Net loss $ (1,661,048 ) $ (1,550,395 )Net loss per share attributable to common stockholders:Basic and diluted $ (0.11 ) $ (0.13 )Weighted average shares outstanding: Basic and diluted 15,504,169 12,302,667

For The Six Months Ended June 30, 2020 2019 Revenues: Product revenues $ 3,696,455 $ 4,358,148 Service and other revenues 1,896,921 720,767 Total revenues 5,593,376 5,078,915 Cost of revenues 1,558,141 1,916,798 Research and development costs 1,651,829 1,282,343 Sales and marketing expenses 2,422,972 2,183,769 General and administrative expenses 2,643,592 1,961,322 Operating loss (2,683,158 ) (2,265,317 )Other income (expense): Other income, net 6,131 7,322 Interest expense, net (1,038,846 ) (513,125 )Net loss $ (3,715,873 ) $ (2,771,120 )Net loss per share attributable to common stockholders:Basic and diluted $ (0.24 ) $ (0.24 )Weighted average shares outstanding: Basic and diluted 15,471,222 11,676,872

CLEARPOINT NEURO, INC.Condensed Consolidated Statements of Cash Flows (Unaudited)

For The Six Months Ended June 30, 2020 2019 Cash flows from operating activities: Net loss $ (3,715,873 ) $ (2,771,120 )Adjustments to reconcile net loss tonet cash flows from operating activities:Depreciation and amortization 116,026 69,600 Share-based compensation 468,985 356,580 Amortization of debt issuance costs and 821,301 363,465 original issue discountsAmortization of lease rights of use, 49,782 51,255 net of accretion in lease liabilitiesIncrease (decrease) in cash resulting from changes in:Accounts receivable (73,746 ) (137,931 )Inventory, net (313,476 ) (201,503 )Prepaid expenses and other current (180,712 ) (216,953 )assetsOther assets 70,134 11,899 Accounts payable and accrued expenses 93,347 716,222 Accrued interest (959,661 ) - Lease liabilities (48,280 ) (50,285 )Deferred revenue (366,341 ) 389,201 Net cash flows from operating (4,038,514 ) (1,419,570 )activities Cash flows from investing activities: Acquisition of licensing rights (441,341 ) (150,000 )Net cash flows from investing (441,341 ) (150,000 )activities Cash flows from financing activities: Proceeds from issuance of 2020 seniorsecured convertible notes, net of 16,757,871 - financing costs and discountProceeds from issuance of Paycheck 896,000 - Protection Program loanProceeds from private placement of - 7,522,010 common stockProceeds from stock option warrant - 383,075 exercisesRepayment of notes payable (2,837,656 ) (1,975,000 )Net cash flows from financing 14,816,215 5,930,085 activitiesNet change in cash and cash equivalents 10,336,360 4,360,515 Cash and cash equivalents, beginning of 5,695,722 3,101,133 periodCash and cash equivalents, end of $ 16,032,082 $ 7,461,648 period SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for: Income taxes $ - $ - Interest $ 1,043,371 $ 164,157