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NeuroPace(NPCE) - 2023 Q3 - Earnings Call Presentation
2023-11-06 22:25
Investor Presentation November 2023 1 Disclaimer In addition to background and historical information, this presentation contains "forward-looking statements" based on NeuroPace's current expectations, estimates, forecasts and beliefs, including financial results for the third quarter ended September 30, 2023, information about NeuroPace's market opportunity, growth drivers and market penetration, commercial strategy, future pipeline, estimates of market opportunity and forecasts of market and revenue growt ...
NeuroPace(NPCE) - 2023 Q3 - Quarterly Report
2023-11-06 21:55
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ 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 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For transition period from to Commission File Number 001-40337 NEUROPACE, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or or ...
NeuroPace(NPCE) - 2023 Q2 - Earnings Call Transcript
2023-08-11 14:17
NeuroPace, Inc. (NASDAQ:NPCE) Q2 2023 Earnings Conference Call August 8, 2023 4:30 PM ET Company Participants Irina Ridley - Chief Legal Officer and Head of Investor Relations Joel Becker - Chief Executive Officer Rebecca Kuhn - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Paige Chamberlain - Wolfe Research Operator Good afternoon and welcome to NeuroPace's Second Quarter 2023 Earnings Conference Call. As a reminder, this conference is being recorded. I ...
NeuroPace(NPCE) - 2023 Q2 - Earnings Call Presentation
2023-08-11 13:23
Second quarter 2023 revenue of $16.5 million increased 62% year-over-year MOUNTAIN VIEW, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today reported financial results for the second quarter ended June 30, 2023. Recent Highlights Second Quarter 2023 Financial Results Full Year 2023 Financial Guidance Based in Mountain View, Calif., NeuroPace is a commercial-stage medical de ...
NeuroPace(NPCE) - 2023 Q2 - Quarterly Report
2023-08-08 20:56
[Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(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](index=5&type=section&id=Condensed%20Balance%20Sheets) 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](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) - 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](index=22&type=chunk) - The accumulated deficit increased from **$470.9 million** to **$490.4 million** as of June 30, 2023[22](index=22&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) 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](index=28&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) - 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](index=33&type=chunk)[34](index=34&type=chunk) - 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](index=72&type=chunk) - 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](index=35&type=chunk)[80](index=80&type=chunk)[84](index=84&type=chunk) - Total unrecognized stock-based compensation expense was **$19.0 million**, expected to be recognized over a weighted average period of **2.5 years**[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=22&type=section&id=Overview) - NeuroPace is a commercial-stage medical device company focused on the **RNS System** for treating drug-resistant focal epilepsy in adults[104](index=104&type=chunk)[105](index=105&type=chunk) - Commercial efforts target approximately **250** U.S. comprehensive epilepsy centers, representing an estimated annual market opportunity of **$1.1 billion** for initial implants[106](index=106&type=chunk)[107](index=107&type=chunk) - 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](index=111&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) 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](index=138&type=chunk) 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](index=146&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) - 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](index=151&type=chunk) - 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](index=158&type=chunk) - 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](index=161&type=chunk)[162](index=162&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=174&type=chunk) - 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](index=174&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=177&type=chunk) - No material changes occurred in internal control over financial reporting during the quarter ended June 30, 2023[179](index=179&type=chunk) [Part II. Other Information](index=36&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=78&type=chunk)[182](index=182&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) 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](index=186&type=chunk)[187](index=187&type=chunk) - 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](index=186&type=chunk)[203](index=203&type=chunk) - The company faces competition from larger, well-capitalized companies with established neuromodulation devices like **LivaNova (VNS System)** and **Medtronic (DBS System)**[120](index=120&type=chunk)[212](index=212&type=chunk) - The company has a history of net losses, expects future losses, may need additional financing, and its existing debt contains restrictive covenants[187](index=187&type=chunk)[367](index=367&type=chunk)[369](index=369&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=92&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=430&type=chunk) - There has been no material change in the planned use of the **$105.5 million** net proceeds from the April 2021 IPO[432](index=432&type=chunk) [Defaults Upon Senior Securities](index=93&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable [Mine Safety Disclosures](index=94&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable [Other Information](index=94&type=section&id=Item%205.%20Other%20Information) Not applicable [Exhibits](index=95&type=section&id=Item%206.%20Exhibits) 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](index=441&type=chunk)
NeuroPace(NPCE) - 2023 Q1 - Earnings Call Transcript
2023-05-07 11:42
Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2023 was $14.5 million, representing a growth of 27% compared to $11.4 million in the first quarter of 2022 and a sequential increase of 13% from $12.8 million in the fourth quarter of 2022 [3][6] - Gross margin for the first quarter of 2023 was 72%, down from 73% in the first quarter of 2022 and up from 69% in the fourth quarter of 2022 [56] - Net loss for the first quarter of 2023 was $10.4 million, compared to a net loss of $11.5 million in the first quarter of 2022 [75] Business Line Data and Key Metrics Changes - Replacement implant revenue generated $1.2 million in the first quarter, which is a decrease from previous quarters as expected [47] - The DIXI Medical distribution partnership contributed positively to revenue, with expectations for continued growth as the business matures [10][54] - Initial implant revenue growth was driven by increased utilization of the RNS System within Comprehensive Epilepsy Centers (CECs) [22][62] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in the generalized epilepsy market, which represents about 40% of drug-resistant epilepsy patients [30][73] - The company reported stable patient volumes in Epilepsy Monitoring Units (EMUs) over the past year, indicating a gradual recovery from pre-pandemic levels [53] Company Strategy and Development Direction - The company aims to increase utilization of the RNS System by expanding patient selection, managing the patient pipeline, and driving adoption with new prescribers and implanting centers [22][23] - The strategy includes leveraging the DIXI Medical product line to enhance patient identification and conversion to RNS System implants [54][62] - The company is focused on closing the treatment gap for drug-resistant epilepsy patients by educating physicians on the benefits of the RNS System [72] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory for initial implants and the DIXI Medical products, while also acknowledging the challenges in replacement implant revenue [62][75] - The company expects total revenue for 2023 to range between $52 million and $54 million, an increase from the previous guidance of $50 million to $52 million [53][57] - Management highlighted the importance of the NAUTILUS study for primary generalized epilepsy and the NIH study for Lennox-Gastaut syndrome as key clinical priorities [46][73] Other Important Information - Cash and short-term investments as of March 31, 2023, were $67.6 million, with long-term borrowings totaling $53.9 million [7] - Operating expenses for the first quarter of 2023 were $18.7 million, slightly higher than $18 million in the same period of the prior year, but as a percentage of revenue, they were lower for both R&D and SG&A [25] Q&A Session Summary Question: Can you provide specifics on revenue from the three lines? - Management indicated that while replacement revenue was $1.2 million, they did not disclose specific figures for DIXI Medical and new patient revenue due to competitive reasons [33][39] Question: How is the DIXI Medical product impacting patient conversion? - Management noted that the DIXI Medical product is providing visibility into the diagnostic process, which is helping to convert patients to RNS System implants [82] Question: What is the outlook for the NAUTILUS study? - Enrollment for the NAUTILUS study is on track to be completed in the first quarter of 2024, with results expected to support a PMA supplement for generalized epilepsy [46][80]
NeuroPace(NPCE) - 2023 Q1 - Quarterly Report
2023-05-04 21:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For transition period from to Commission File Number 001-40337 NEUROPACE, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 22-3550230 (I.R.S. Employer Iden ...
NeuroPace(NPCE) - 2022 Q4 - Earnings Call Transcript
2023-03-03 03:21
NeuroPace, Inc. (NASDAQ:NPCE) Q4 2022 Results Conference Call March 2, 2023 4:30 PM ET Company Participants Trip Taylor - Gilmartin Group Michael Favet - President, CEO & Director Rebecca Kuhn - CFO, VP, Finance & Administration and Assistant Secretary Conference Call Participants Michael Polark - Wolfe Research Frank Takkinen - Lake Street Capital Markets Robbie Marcus - JPMorgan Vik Chopra - Wells Fargo Drew Ranieri - Morgan Stanley Operator Good afternoon, and welcome to NeuroPace's Fourth Quarter Earnin ...
NeuroPace(NPCE) - 2022 Q4 - Annual Report
2023-03-02 22:14
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ 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 001-40337 NEUROPACE, INC. (Exact name of registrant as specified in its charter) Delaware 22-3550230 (State or Other Jurisd ...
Neuropace (NPCE) Investor Presentation - Slideshow
2022-12-02 10:33
I - NEUROPACE, N O V E M B E R 2 0 2 2 Personalized, data-driven treatment for epilepsy 1 Disclaimer | 2 In addition to background and historical information, this presentation contains "forward-looking statements" based on NeuroPace's current expectations, estimates, forecasts and beliefs, including financial results for the third quarter ended September 30, 2021, information about NeuroPace's market opportunity, growth drivers and market penetration, commercial strategy, future pipeline, indication and TA ...