8-K
ClearPoint Neuro, Inc. (CLPT)
UNITED STATESSECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of theSecurities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 10, 2021
CLEARPOINT NEURO, INC.
(Exact name of registrant as specified in its charter)
| DELAWARE | 001-34822 | 58-2394628 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (I.R.S. Employer<br><br> <br>Identification Number) |
120 S. Sierra Ave., Suite 100Solana Beach, California 92075
(Address of principal executive offices, zip code)
(949) 900-6833
(Registrant’s telephone number, including areacode)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ¨
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. ¨
| Item 2.02. | Results of Operations and Financial Condition. |
|---|
On August 10, 2021, ClearPoint Neuro, Inc. (the “Company”) issued a press release announcing its financial performance for the second fiscal quarter ended June 30, 2021. A copy of the press release is furnished herewith as Exhibit 99.1.
The information in Item 2.02 of this Form 8-K, as well as Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 7.01. | Regulation FD Disclosure. |
|---|
On August 10, 2021, the Company posted an updated investor presentation to its website at http://ir.stockpr.com/clearpointneuro/investor-presentations. A copy of the investor presentation is being furnished herewith as Exhibit 99.2. The Company may use the investor presentation from time to time in conversations with analysts, investors and others.
The information in Item 7.01 of this Form 8-K, as well as Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
The following exhibit is furnished herewith:
| Exhibit 99.1 | Press Release dated August 10, 2021 |
|---|---|
| Exhibit 99.2 | Investor Presentation dated August 2021 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 10, 2021 | CLEARPOINT NO, INC. |
|---|---|
| By: | |
All values are in Euros.
Exhibit 99.1
ClearPoint Neuro Reports Second Quarter 2021 Results
Record Case Volume Supported Clinically During the Quarter
SOLANA BEACH, CA, August 10, 2021 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its second quarter ended June 30, 2021.
Second Quarter Highlights
- Reported revenue of $3.4 million, a 38% year-over-year increase;
- Clinical team supported a record 249 cases, a 98% year-over- year increase;
- Increased biologics and drug delivery revenue to $1.4 million, a 19% year-over-year increase;
- Added biologics and drug delivery relationships bringing current count of active partners to approximately 35 from approximately 30 in Q1 2021; and
- Announced FDA clearance of the SmartFrame Array and performed first human cases.
Business Outlook
- The Company continues to estimate total case volume supported to be in the range of 900 – 1000 for 2021; and
- The Company continues to estimate revenue to be between $16.0 and $17.5 million for 2021.
“The ClearPoint Neuro team enjoyed multiple significant successes in the 2021 second quarter, headlined by our record case volume result, which demonstrated a return to pre-pandemic levels a quarter ahead of schedule,” commented Joe Burnett, the Company’s President and Chief Executive Officer. “Also encouraging has been the resumption of clinical and pre-clinical activities by our biologics and drug delivery partners who have resumed lab-based activities and enrollment in human clinical trials, which we believe puts the regulatory pathway for their therapies back on track. We are currently working with more than 30 partners in the drug delivery space and expect to add additional partners in the second half of 2021. Further, our development and production teams remain on track for all the programs we announced in February, which keeps our planned timelines and key milestones on schedule. While we are monitoring the impact of the new Delta wave of COVID-19 cases, which has again started to put pressure on elective procedures at several customer sites as hospital ICU beds fill up, we believe our biologics and drug delivery business will make up for any potential impact in the second half and we continue to estimate that the range of cases supported by our clinical team will be in a range of 900 – 1000, and that our revenues will be in a range of $16.0 - $17.5 million for 2021.”
Financial Results – Quarter Ended June 30, 2021
Total revenue was $3.4 million for the three months ended June 30, 2021, and $2.5 million for the three months ended June 30, 2020, which represents an increase of $0.9 million, or 38%.
Functional neurosurgery navigation revenue, which consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 74% to $1.9 million for the three months ended June 30, 2021, from $1.1 million for the same period in 2020. This increase reflects the resumption in the three months ended June 30, 2021, of elective surgical procedures, which were postponed or cancelled during the three months ended June 30, 2020, due to the effects of the COVID-19 pandemic.
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored clinical trials utilizing our products, increased 19% to $1.4 million for the three months ended June 30, 2021, from $1.2 million for the same period in 2020. This increase was due to an increase, during the quarter ended June 30, 2021, relative to the same period in 2020, in biologic and drug delivery service revenue of $0.2 million, and an increase in biologic and drug delivery product revenue of $0.04 million.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, were $0.2 million for each of the three months ended June 30, 2021. Revenue from this product line historically has varied from quarter to quarter, and overall, the Company believes that hospitals’ capital equipment acquisition activities remain at a low level, relative to the acquisition activity prior to the onset in 2020 of the COVID-19 pandemic.
Gross margin for the three months ended June 30, 2021, was 67%, as compared with gross margin of 68% for the same period in 2020. This decrease in gross margin was due primarily to a decreased contribution, during the three months ended June 30, 2021, as compared to the same period in 2020, from service revenue, which carries a higher gross margin relative to product lines, substantially offset by an increased contribution from functional neurosurgery navigation disposable product sales, which carry a higher gross margin relative to other product lines.
Research and development costs were $2.1 million for the three months ended June 30, 2021, compared to $0.8 million for the same period in 2020, an increase of $1.3 million, or 161%. The increase was due primarily to increases in personnel costs due to growth in headcount, and software development and product development costs. Sales and marketing expenses were $1.6 million for the three months ended June 30, 2021, compared to $1.1 million for the same period in 2020, an increase of $0.5 million, or 42%. This increase was due primarily to increases in marketing personnel costs resulting from increases in headcount, and a commensurate increase in marketing activities including our expansion into Europe. General and administrative expenses were $2.0 million for the three months ended June 30, 2021, compared to $1.2 million for the same period in 2020, an increase of $0.8 million, or 63%. This increase was due primarily to increases in state franchise taxes, share-based compensation, occupancy costs, insurance and professional fees related primarily to public company reporting.
At June 30, 2021, the Company had cash and cash equivalents totaling $61.5 million as compared to $20.1 million at December 31, 2020, with the increase resulting primarily from the completion of a public offering of its common stock in February 2021.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's 2021 second quarter on Tuesday, August 10, 2021 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada and then entering conference I.D. number 13721705.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until September 10, 2021, 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 Neuro’s 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 Company’s 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 over 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately 35 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 4,500 cases have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements herein concerning the Company’s 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 the COVID-19 pandemic and the measures adopted to contain its spread; future revenue from sales of the Company’s ClearPoint Neuro Navigation System products; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System products; and risks inherent in the research and development of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2021, both of which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2021, which the Company intends to file with the Securities and Exchange Commission on or before August 16, 2021.
Contact:
Danilo D’Alessandro, Chief Financial Officer
(949) 900-6833
Caroline Corner, Investor Relations
CLEARPOINT NEURO, INC.
Consolidated Statements of Operations
(Unaudited)
(Dollars in thousands, except for per share data)
| For The Three Months Ended<br> <br>June 30, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | |||||
| Revenue: | ||||||
| Product revenue | $ | 2,363 | $ | 1,636 | ||
| Service and other revenue | 1,050 | 842 | ||||
| Total revenue | 3,413 | 2,478 | ||||
| Cost of revenue | 1,123 | 802 | ||||
| Gross profit | 2,290 | 1,676 | ||||
| Research and development costs | 2,123 | 812 | ||||
| Sales and marketing expenses | 1,592 | 1,125 | ||||
| General and administrative expenses | 1,982 | 1,214 | ||||
| Operating loss | (3,407 | ) | (1,475 | ) | ||
| Other expense: | ||||||
| Other (expense) income, net | (96 | ) | 11 | |||
| Interest expense, net | (240 | ) | (197 | ) | ||
| Net loss | $ | (3,743 | ) | $ | (1,661 | ) |
| Net loss per share attributable to common stockholders: | ||||||
| Basic and diluted | $ | (0.17 | ) | $ | (0.11 | ) |
| Weighted average shares used in computing net loss per share: | ||||||
| Basic and diluted | 21,523,393 | 15,504,169 | ||||
| For The Six Months Ended<br> <br>June 30, | ||||||
| --- | --- | --- | --- | --- | --- | --- |
| 2021 | 2020 | |||||
| Revenues: | ||||||
| Product revenues | $ | 5,525 | $ | 3,814 | ||
| Service and other revenues | 1,918 | 1,779 | ||||
| Total revenues | 7,443 | 5,593 | ||||
| Cost of revenues | 2,539 | 1,733 | ||||
| Gross profit | 4,904 | 3,860 | ||||
| Research and development costs | 3,687 | 1,631 | ||||
| Sales and marketing expenses | 3,167 | 2,423 | ||||
| General and administrative expenses | 3,638 | 2,490 | ||||
| Operating loss | (5,588 | ) | (2,684 | ) | ||
| Other income (expense): | ||||||
| Other (expense) income, net | (122 | ) | 6 | |||
| Interest expense, net | (571 | ) | (1,038 | ) | ||
| Net loss | $ | (6,281 | ) | $ | (3,716 | ) |
| Net loss per share attributable to common stockholders: | ||||||
| Basic and diluted | $ | (0.31 | ) | $ | (0.24 | ) |
| Weighted average shares used in computing net loss per share: | ||||||
| Basic and diluted | 20,195,488 | 15,471,222 |
CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(Dollars in thousands, except for per share data)
| December 31,<br> 2020 | |||||
|---|---|---|---|---|---|
| ASSETS | |||||
| Current assets: | |||||
| Cash and cash equivalents | 61,524 | $ | 20,099 | ||
| Accounts receivable, net | 2,407 | 1,881 | |||
| Inventory, net | 3,575 | 3,238 | |||
| Prepaid expenses and other current assets | 1,003 | 244 | |||
| Total current assets | 68,509 | 25,462 | |||
| Property and equipment, net | 349 | 319 | |||
| Operating lease rights of use | 2,489 | 2,736 | |||
| Software license inventory | 519 | 589 | |||
| Licensing rights | 309 | 353 | |||
| Other assets | 151 | 59 | |||
| Total assets | 72,326 | $ | 29,518 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable | 1,252 | $ | 300 | ||
| Accrued compensation | 1,411 | 1,595 | |||
| Other accrued liabilities | 892 | 349 | |||
| Operating lease liabilities, current portion | 462 | 394 | |||
| Deferred product and service revenue | 368 | 562 | |||
| Total current liabilities | 4,385 | 3,200 | |||
| Operating lease liabilities, net of current portion | 2,203 | 2,446 | |||
| Deferred product and service revenue, net of current portion | 268 | 215 | |||
| 2020 senior secured convertible notes payable, net | 17,504 | 21,280 | |||
| Total liabilities | 24,360 | 27,141 | |||
| Commitments and contingencies | |||||
| Stockholders’ equity: | |||||
| Preferred stock, 0.01 par value; 25,000,000 shares authorized; none issued and outstanding at June 30, 2021 and December 31, 2020 | — | — | |||
| Common stock, 0.01 par value; 200,000,000 shares authorized; 22,322,344 shares issued and outstanding at June 30, 2021; and 17,047,584 issued and outstanding at December 31, 2020 | 223 | 170 | |||
| Additional paid-in capital | 173,546 | 121,729 | |||
| Accumulated deficit | (125,803 | ) | (119,522 | ) | |
| Total stockholders’ equity | 47,966 | 2,377 | |||
| Total liabilities and stockholders’ equity | 72,326 | $ | 29,518 |
All values are in US Dollars.
CLEARPOINT NEURO, INC.
Consolidated Statements of Cash Flows
(Dollars in thousands)
| For<br> The Six Months Ended <br> June 30, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | |||||
| Cash<br> flows from operating activities: | ||||||
| Net<br> loss | $ | (6,281 | ) | $ | (3,716 | ) |
| Adjustments<br> to reconcile net loss to net cash flows from operating activities: | ||||||
| Allowance<br> for doubtful accounts | 92 | 2 | ||||
| Depreciation<br> and amortization | 62 | 116 | ||||
| Share-based<br> compensation | 567 | 469 | ||||
| Payment-in-kind<br> interest | 189 | — | ||||
| Amortization<br> of debt issuance costs and original issue discounts | 54 | 821 | ||||
| Amortization<br> of lease rights of use, net of accretion in lease liabilities | 267 | 50 | ||||
| Increase<br> (decrease) in cash resulting from changes in: | ||||||
| Accounts<br> receivable | (617 | ) | (76 | ) | ||
| Inventory,<br> net | (304 | ) | (313 | ) | ||
| Prepaid<br> expenses and other current assets | (760 | ) | (181 | ) | ||
| Other<br> assets | (93 | ) | 70 | |||
| Accounts<br> payable and accrued expenses | 1,312 | 93 | ||||
| Accrued<br> interest | — | (960 | ) | |||
| Lease<br> liabilities | (195 | ) | (48 | ) | ||
| Deferred<br> revenue | (142 | ) | (366 | ) | ||
| Net<br> cash flows from operating activities | (5,849 | ) | (4,039 | ) | ||
| Cash<br> flows from investing activities: | ||||||
| Purchases<br> of property and equipment | (5 | ) | — | |||
| Acquisition<br> of licensing rights | — | (441 | ) | |||
| Net<br> cash flows from investing activities | (5 | ) | (441 | ) | ||
| Cash<br> flows from financing activities: | ||||||
| Proceeds<br> from issuance of 2020 senior secured convertible notes, net of financing costs and discount | — | 16,758 | ||||
| Proceeds<br> from issuance of Paycheck Protection Program loan | — | 896 | ||||
| Proceeds<br> from public offering of common stock, net of offering costs | 46,785 | — | ||||
| Proceeds<br> from stock option and warrant exercises | 494 | — | ||||
| Repayment<br> of notes payable | — | (2,838 | ) | |||
| Net<br> cash flows from financing activities | 47,279 | 14,816 | ||||
| Net<br> change in cash and cash equivalents | 41,425 | 10,336 | ||||
| Cash<br> and cash equivalents, beginning of period | 20,099 | 5,696 | ||||
| Cash<br> and cash equivalents, end of period | $ | 61,524 | $ | 16,032 | ||
| SUPPLEMENTAL<br> CASH FLOW INFORMATION | ||||||
| Cash<br> paid for: | ||||||
| Income<br> taxes | $ | — | $ | — | ||
| Interest | $ | 353 | $ | 1,043 |
Exhibit 99.2
