NeuroPace(NPCE) - 2023 Q2 - Quarterly Report

Part I. Financial Information Financial Statements (Unaudited) The unaudited financial statements for H1 2023 show increased revenue and reduced net loss, with total assets decreasing due to lower short-term investments Condensed Balance Sheets Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,855 | $6,605 | | Short-term investments | $55,716 | $70,804 | | Total assets | $102,232 | $114,106 | | Long-term debt | $54,854 | $52,913 | | Total liabilities | $81,006 | $79,329 | | Total stockholders' equity | $21,226 | $34,777 | | Accumulated deficit | ($490,352) | ($470,853) | Condensed Statements of Operations and Comprehensive Loss Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $16,510 | $10,200 | $30,982 | $21,574 | | Gross profit | $11,972 | $7,466 | $22,344 | $15,725 | | Loss from operations | ($7,854) | ($10,974) | ($16,173) | ($20,736) | | Net loss | ($9,124) | ($12,690) | ($19,499) | ($24,151) | | Net loss per share | ($0.36) | ($0.52) | ($0.77) | ($0.99) | Condensed Statements of Stockholders' Equity - Total stockholders' equity decreased from $34.8 million to $21.2 million due to a $19.5 million net loss for the six-month period[22] - The accumulated deficit increased from $470.9 million to $490.4 million as of June 30, 2023[22] Condensed Statements of Cash Flows Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($14,058) | ($22,051) | | Net cash provided by investing activities | $15,368 | $7,930 | | Net cash (used in) provided by financing activities | ($60) | $636 | | Net increase (decrease) in cash | $1,250 | ($13,485) | - The decrease in cash used in operating activities was primarily due to a lower net loss compared to the prior year period[28][162][163] Notes to Unaudited Condensed Financial Statements - The company has an accumulated deficit of $490.4 million but believes its $63.6 million in cash and investments are sufficient for the next 12 months[33][34] - An exclusive distribution agreement with DIXI Medical requires minimum product purchases of $2.4 million in the first year, with 10% annual increases for two subsequent years[72] - The Term Loan with CRG Partners was amended, increasing the interest rate to 13.5% and reducing the 2023 minimum annual net revenue covenant to $45.0 million, with the company in compliance[35][80][84] - Total unrecognized stock-based compensation expense was $19.0 million, expected to be recognized over a weighted average period of 2.5 years[97] Management's Discussion and Analysis of Financial Condition and Results of Operations Management attributes Q2 2023 revenue growth to increased initial implant sales and the DIXI agreement, leading to reduced net loss despite slightly lower gross margins Overview - NeuroPace is a commercial-stage medical device company focused on the RNS System for treating drug-resistant focal epilepsy in adults[104][105] - Commercial efforts target approximately 250 U.S. comprehensive epilepsy centers, representing an estimated annual market opportunity of $1.1 billion for initial implants[106][107] - As of June 30, 2023, the company had an accumulated deficit of $490.4 million and $63.6 million in cash, cash equivalents, and short-term investments[111] Results of Operations Comparison of Three Months Ended June 30, 2023 and 2022 (in thousands) | Metric | Q2 2023 | Q2 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $16,510 | $10,200 | $6,310 | 62% | | Gross Profit | $11,972 | $7,466 | $4,506 | 60% | | Loss from Operations | ($7,854) | ($10,974) | $3,120 | (28)% | | Net Loss | ($9,124) | ($12,690) | $3,566 | (28)% | - Q2 2023 revenue growth was driven by initial implant sales, increased pricing, and DIXI Medical distribution, while replacement revenue decreased from 21% to 5%[138] Comparison of Six Months Ended June 30, 2023 and 2022 (in thousands) | Metric | H1 2023 | H1 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $30,982 | $21,574 | $9,408 | 44% | | Gross Profit | $22,344 | $15,725 | $6,619 | 42% | | Loss from Operations | ($16,173) | ($20,736) | $4,563 | (22)% | | Net Loss | ($19,499) | ($24,151) | $4,652 | (19)% | - Gross margin for H1 2023 decreased to 72.1% from 72.9% in H1 2022, primarily due to lower margins on DIXI Medical products[146] Liquidity and Capital Resources - As of June 30, 2023, the company held $63.6 million in cash and investments, with $54.9 million outstanding under its Term Loan[151] - The company believes existing cash and investments will be sufficient to fund operating expenses for at least 12 months from the report's issuance date[158] - Net cash used in operating activities improved to $14.1 million for H1 2023, compared to $22.1 million for the same period in 2022[161][162] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate sensitivity on its short-term, low-risk cash and investments, with no material impact from a 10% rate change expected - The company's financial instruments are exposed to potential loss from adverse changes in interest rates[174] - As of June 30, 2023, cash, cash equivalents, and short-term investments totaled $63.6 million, primarily in interest-bearing money market and fixed income mutual funds[174] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting - The principal executive and financial officers concluded that disclosure controls and procedures were effective as of June 30, 2023[177] - No material changes occurred in internal control over financial reporting during the quarter ended June 30, 2023[179] Part II. Other Information Legal Proceedings The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - The company is not involved in any pending legal proceedings expected to materially affect its business, operations, financial condition, or cash flows[78][182] Risk Factors Key risks include reliance on the RNS System, market acceptance, competition, supply chain vulnerabilities, regulatory oversight, historical losses, and debt covenants - The business relies primarily on the RNS System, approved only for adults with drug-resistant focal epilepsy in the U.S., depending on market adoption within this specific population[186][187] - The company depends on a limited number of single-source suppliers for key RNS System components, creating vulnerability to supply shortages and price fluctuations[186][203] - The company faces competition from larger, well-capitalized companies with established neuromodulation devices like LivaNova (VNS System) and Medtronic (DBS System)[120][212] - The company has a history of net losses, expects future losses, may need additional financing, and its existing debt contains restrictive covenants[187][367][369] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered equity sales occurred, and there was no material change in the planned use of $105.5 million net IPO proceeds from April 2021 - There were no unregistered sales of equity securities in the period[430] - There has been no material change in the planned use of the $105.5 million net proceeds from the April 2021 IPO[432] Defaults Upon Senior Securities Not applicable Mine Safety Disclosures Not applicable Other Information Not applicable Exhibits This section lists exhibits filed with the Form 10-Q, including corporate governance documents, material contracts, and CEO/CFO certifications - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Sections 302 and 906, and Inline XBRL documents[441]