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NeuroPace(NPCE) - 2022 Q1 - Earnings Call Transcript
2022-05-14 02:47
Financial Data and Key Metrics Changes - NeuroPace generated total revenue of $11.4 million for Q1 2022, compared to $11.2 million in Q1 2021, indicating a slight growth [23] - Initial implant revenue was $8.8 million in Q1 2022, up from $8.1 million in Q1 2021, reflecting an increase in unit sales [23] - Replacement implant revenue decreased to $2.6 million in Q1 2022 from $3.1 million in Q1 2021, with expectations for continued decline due to the transition to a longer-lasting battery model [24][30] - Gross margin for Q1 2022 was 73%, down from 76% in Q1 2021, primarily due to increased indirect labor costs and reduced production volume [25] - Total operating expenses rose to $18 million in Q1 2022 from $12.4 million in the same period of the prior year [26] - Net loss for Q1 2022 was $11.5 million, compared to $8.8 million in Q1 2021 [29] Business Line Data and Key Metrics Changes - The company experienced significant business disruption in January and early February 2022 due to the Omicron variant, but saw a recovery in procedure volumes in March [8][9] - The number of patients coming through epilepsy monitoring units (EMUs) largely returned to 2021 levels in March, although the reduced patient flow in the first half of Q1 is expected to limit RNS System implants in Q2 [10][11] Market Data and Key Metrics Changes - The company anticipates a growing backlog of patients at EMUs due to recent disruptions and the longer-term impacts of the COVID-19 pandemic [11] - The company expects to meet its 2022 revenue guidance of $45 million to $48 million, assuming no further COVID disruptions [30] Company Strategy and Development Direction - NeuroPace is focused on increasing the number of centers implanting the RNS System and enhancing utilization within those centers [12] - The company plans to educate epilepsy specialists outside of Level 4 centers to expand market opportunities [13] - The company is resuming in-person physician education events and increasing marketing efforts to generate demand [14][15] - The NAUTILUS pivotal trial is set to begin mid-year 2022 to support a PMA supplement for expanding indications to include primary generalized epilepsy [15][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery of EMU volumes and the potential for growth in patient implants as the backlog is addressed [39] - The company is making strategic investments in commercial initiatives and field team expansion to drive growth [62] - Management reiterated the importance of controlling growth factors within their influence, independent of EMU patient volumes [84] Other Important Information - The company expects replacement revenue for 2022 to be approximately $6 million, with gross margin anticipated to remain in the mid-70% range [30][31] - The company has purchased components earlier to mitigate potential supply chain risks, but is not currently experiencing supply chain disruptions [59] Q&A Session Summary Question: Can you provide more color on revenue cadence for the year? - Management is pleased with the recovery from Q1 challenges and maintains the $45 million to $48 million guidance, anticipating continued growth in initial implant revenue [36][39] Question: How much of the headwind staffing is in the EMU relative to lower patient volumes due to COVID? - Staffing challenges exacerbated by the Omicron variant impacted the ability to treat patients and schedule procedures [41][42] Question: Are you signaling that Q2 initial implants will be flat or down sequentially? - Management did not provide specific Q2 guidance but indicated that the impact of EMU processes in Q1 would affect the start of Q2 [47][48] Question: Can you remind us how long the NAUTILUS study will take to enroll? - The NAUTILUS study is expected to start enrollment around mid-year 2022, requiring about 100 patients for a one-year follow-up [49][50] Question: How are you thinking about pricing for your devices? - The company is implementing a low single-digit price increase throughout the year, with more impact expected in 2023 [87]
NeuroPace(NPCE) - 2022 Q1 - Quarterly Report
2022-05-12 21:19
Part I. Financial Information [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) NeuroPace, Inc.'s unaudited Q1 2022 financial statements show a **$11.5 million** net loss, driven by increased operating expenses [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$129.0 million** by March 31, 2022, while total liabilities increased to **$66.2 million** Condensed Balance Sheet Data (in thousands) | | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Total Current Assets** | $122,420 | $132,816 | | **Total Assets** | $128,982 | $133,562 | | **Total Current Liabilities** | $12,057 | $9,301 | | **Total Liabilities** | $66,159 | $60,059 | | **Total Stockholders' Equity** | $62,823 | $73,503 | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2022 revenue slightly increased to **$11.4 million**, but net loss widened to **$11.5 million** due to increased operating expenses Statement of Operations Highlights (in thousands) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | **Revenue** | $11,374 | $11,217 | | **Gross Profit** | $8,259 | $8,493 | | **Total Operating Expenses** | $18,021 | $12,367 | | **Loss from Operations** | $(9,762) | $(3,874) | | **Net Loss** | $(11,461) | $(8,810) | | **Net Loss Per Share** | $(0.47) | $(32.73) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Operating activities used **$11.4 million** cash in Q1 2022, leading to a **$11.7 million** net cash decrease for the quarter Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(11,393) | $(5,936) | | **Net cash used in investing activities** | $(306) | $(5,035) | | **Net cash provided by (used in) financing activities** | $1 | $(1,578) | | **Net decrease in cash and cash equivalents** | $(11,698) | $(12,549) | [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail accounting policies, IPO, liquidity, debt, and stock-based compensation, including ASC 842 adoption - The company has an accumulated deficit of **$435.2 million** as of March 31, 2022, but management believes existing cash, cash equivalents, and short-term investments of **$103.2 million** are sufficient to fund operations for at least the next 12 months[28](index=28&type=chunk)[29](index=29&type=chunk) - The company has a **$50.0 million** term loan with CRG Partners at **12.5%** interest per year, with the interest-only period extended to September 30, 2025, and the 2022 minimum annual net revenue covenant reduced to **$43.0 million** in March 2022[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk) - Total unrecognized stock-based compensation expense related to unvested stock options and restricted stock units was **$27.3 million** as of March 31, 2022, to be recognized over a weighted average remaining period of **3.4 years**[105](index=105&type=chunk) - Upon adoption of lease accounting standard ASC 842 on January 1, 2022, the company recognized right-of-use assets of **$6.1 million** and lease liabilities of **$7.5 million**[56](index=56&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2022 financial results, noting **1%** revenue growth to **$11.4 million**, increased operating expenses, and sufficient liquidity [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q1 2022 results show **1%** revenue growth to **$11.4 million**, gross margin decline, and **46%** operating expense increase, leading to a **$9.8 million** loss Q1 2022 vs Q1 2021 Results of Operations (in thousands) | | 2022 | 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $11,374 | $11,217 | $157 | 1% | | **Gross Profit** | $8,259 | $8,493 | $(234) | (3)% | | **Research and development** | $5,577 | $4,100 | $1,477 | 36% | | **Selling, general and administrative** | $12,444 | $8,267 | $4,177 | 51% | | **Loss from operations** | $(9,762) | $(3,874) | $(5,888) | 152% | | **Net loss** | $(11,461) | $(8,810) | $(2,651) | 30% | - Gross margin decreased to **72.6%** in Q1 2022 from **75.7%** in Q1 2021, primarily due to higher fixed costs per unit resulting from reduced production volume caused by COVID-19 volatility[148](index=148&type=chunk) - SG&A expenses increased by **$4.2 million (51%)** due to additional personnel, increased stock-based compensation, public company operating costs, and higher marketing and travel expenses[150](index=150&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2022, the company held **$103.2 million** in cash and investments, confirming sufficient capital for 12 months - As of March 31, 2022, the company had cash, cash equivalents and short-term marketable debt securities of **$103.2 million**[160](index=160&type=chunk) - The company believes its existing cash and investments will enable it to fund operating expenses for at least 12 months from the report's issuance date[160](index=160&type=chunk) Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(11,393) | $(5,936) | | **Net cash used in investing activities** | $(306) | $(5,035) | | **Net cash provided by (used in) financing activities** | $1 | $(1,578) | [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate sensitivity on **$103.2 million** in cash and investments, not materially affected by a **10%** interest rate change - The company's main market risk is interest rate sensitivity on its **$103.2 million** portfolio of cash, cash equivalents, and short-term marketable debt securities[174](index=174&type=chunk) - Management states that due to the short-term and low-risk nature of its investments, an immediate **10%** change in interest rates would not materially affect their fair value[174](index=174&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2022, and a material weakness in internal control was fully remediated - Management concluded that disclosure controls and procedures were effective as of March 31, 2022[177](index=177&type=chunk) - A previously disclosed material weakness related to segregation of duties over the review and approval of account reconciliations and manual journal entries was remediated as of March 31, 2022[178](index=178&type=chunk)[179](index=179&type=chunk) Part II. Other Information [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) Legal proceedings include a CFIUS inquiry and an October 2021 stockholder lawsuit, which the company is defending - The company received an inquiry from the Committee on Foreign Investment in the United States (CFIUS) in April 2021 and is cooperating fully[79](index=79&type=chunk)[81](index=81&type=chunk) - A stockholder lawsuit was filed against the company and its board of directors in October 2021, alleging claims related to reverse stock splits, which the company believes have no merit[82](index=82&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Key risks include COVID-19 impact, single product and supplier reliance, competition, and a history of net losses - The COVID-19 pandemic has negatively impacted and is expected to continue to impact sales and operations due to delayed or canceled elective procedures, hospital staffing shortages, and reduced patient diagnostic evaluations[189](index=189&type=chunk)[192](index=192&type=chunk) - The business depends on a single product, the RNS System, and its success hinges on market acceptance, clinician adoption, and expanding patient referrals to Level 4 Comprehensive Epilepsy Centers (CECs)[200](index=200&type=chunk) - The company relies on single-source suppliers for key components like printed circuit assemblies and batteries, making it vulnerable to supply disruptions and price fluctuations[214](index=214&type=chunk)[215](index=215&type=chunk) - The company has a history of net losses, with an accumulated deficit of **$435.2 million** as of March 31, 2022, and expects to incur losses for the foreseeable future[368](index=368&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=94&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred this quarter; **$105.5 million** IPO proceeds are being used as planned - There were no unregistered sales of equity securities in the quarter ended March 31, 2022[435](index=435&type=chunk) - The company received net proceeds of **$105.5 million** from its April 2021 IPO and confirms there has been no material change in the planned use of these funds[437](index=437&type=chunk) [Defaults Upon Senior Securities](index=95&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - The company states this item is "Not applicable"[439](index=439&type=chunk) [Mine Safety Disclosures](index=96&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - The company states this item is "Not applicable"[441](index=441&type=chunk) [Other Information](index=96&type=section&id=Item%205.%20Other%20Information) The company reports that this item is not applicable - The company states this item is "Not applicable"[442](index=442&type=chunk) [Exhibits](index=97&type=section&id=Item%206.%20Exhibits) This section lists 10-Q exhibits, including the Term Loan Agreement amendment, officer certifications, and XBRL data - Key exhibits filed include the First Amendment to the Term Loan Agreement, CEO and CFO certifications pursuant to Sarbanes-Oxley Sections 302 and 906, and XBRL data files[444](index=444&type=chunk)
NeuroPace(NPCE) - 2021 Q4 - Earnings Call Transcript
2022-03-10 23:54
Financial Data and Key Metrics Changes - Total revenue for Q4 2021 was $11 million, a 2% increase from $10.8 million in Q4 2020 [32] - Initial implant revenue in Q4 2021 was $8.5 million, representing a 10% growth over Q4 2020 [11][32] - Full year 2021 revenue was $45.2 million, a 10% increase compared to 2020 [12] - Gross margin for Q4 2021 was 73%, down from 76% in Q4 2020 [35] - Net loss for Q4 2021 was $10.7 million, compared to $4.6 million in Q4 2020 [38] Business Line Data and Key Metrics Changes - Initial system implants accounted for 75% of total revenue in 2021, growing 20% over 2020 [12] - Revenue from replacement implants in Q4 2021 was $2.5 million, a 19% decrease compared to Q4 2020 [34] - The number of active implanting accounts increased to 150 in 2021, up from 132 in 2020 [33] Market Data and Key Metrics Changes - The company experienced a decline in procedure volumes in January 2022 due to COVID-19 variants, but saw improvement in February and March [14][15] - The company anticipates that EMU volumes will eventually return to pre-pandemic levels, creating significant opportunities for growth [16] Company Strategy and Development Direction - The company plans to increase the number of implanting centers and enhance utilization of the RNS System [17] - Targeting epilepsy specialists outside of Level 4 centers to expand patient access to the RNS System [18] - The company received FDA approval for the NAUTILUS pivotal trial to expand indications to include primary generalized epilepsy [21] Management's Comments on Operating Environment and Future Outlook - Management remains cautious about near-term uncertainty due to COVID-19's impact on hospital and patient behavior [39] - For 2022, the company expects revenue to range between $45 million to $48 million, with initial implant revenue projected at $39 million to $42 million [40] - Management noted that the longer battery life of the neurostimulator will reduce replacement revenue in the coming years [27] Other Important Information - The company completed a successful IPO in April 2021, raising net proceeds of $105.5 million [30] - As of the end of 2021, there were 282 patients actively treated with first-generation devices, with a significant number expected to reach the end of their battery life in 2022 [28] Q&A Session Summary Question: How does the company view the trends for Q1 and the impact of COVID? - Management indicated that Q1 guidance of $10 million to $11 million is based on observed trends and assumes improvement in COVID conditions [45][46] Question: What are the barriers to adoption aside from COVID? - Management highlighted the need for increased education among physicians and expanding the number of prescribing doctors within comprehensive epilepsy centers [64][66] Question: When does the company expect EMU patient volumes to return to pre-COVID levels? - Management assumes that EMU volumes will not significantly impact revenue in 2022, with a return to pre-pandemic levels expected later in the year [60] Question: How does the company plan to utilize the expanded sales force? - The focus will be on increasing utilization within existing centers and bringing on new centers, particularly targeting epilepsy specialists outside Level 4 centers [52][54] Question: What is the expected impact of clinical trial revenue for 2022? - Management expects minimal revenue from clinical trials in 2022 due to conservative assumptions around reimbursement and timing of patient enrollment [80]
NeuroPace(NPCE) - 2021 Q4 - Annual Report
2022-03-10 22:19
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, 2021 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) - 2021 Q4 - Earnings Call Presentation
2022-03-10 21:32
I - NEUROPACE, M A R C H 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 fourth quarter and full year ended December 31, 2021, information about NeuroPace's market opportunity, growth drivers and market penetration, commercial strategy, future pipeline, indicatio ...
NeuroPace(NPCE) - 2021 Q3 - Earnings Call Presentation
2021-11-11 00:30
I - NEUROPACE, N O V E M B E R 2 0 2 1 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 information about NeuroPace's market opportunity, commercial strategy, growth, FDA approvals, future pipeline, product performance, indication and TAM Expansion Opportunities, expectations for hiring, clinical ...
NeuroPace(NPCE) - 2021 Q3 - Earnings Call Transcript
2021-11-10 23:25
NeuroPace, Inc. (NASDAQ:NPCE) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Matt Bacso - Investor Relations Mike Favet - Chief Executive Officer Rebecca Kuhn - Chief Financial Officer Conference Call Participants Robbie Marcus - JPMorgan Drew Ranieri - Morgan Stanley Danielle Antalffy - SVB Leerink Michael Polark - Baird Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are de ...
NeuroPace(NPCE) - 2021 Q3 - Quarterly Report
2021-11-10 22:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 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) Washington, D.C. 20549 FORM 10-Q (Mark One) (State or other jurisdiction of incorporation or or ...
NeuroPace(NPCE) - 2021 Q2 - Earnings Call Transcript
2021-08-14 07:00
NeuroPace, Inc. (NASDAQ:NPCE) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Matt Bacso - Investor Relations Mike Favet - Chief Executive Officer Rebecca Kuhn - Chief Financial Officer Conference Call Participants Drew Ranieri - Morgan Stanley Danielle Antalffy - SVB Leerink Operator Good morning and welcome to NeuroPace???s Second Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I would now like to tu ...
NeuroPace(NPCE) - 2021 Q2 - Quarterly Report
2021-08-12 21:10
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 June 30, 2021 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 organiz ...