Pulmonx(LUNG)

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Pulmonx(LUNG) - 2023 Q1 - Quarterly Report
2023-05-08 21:12
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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: 001-39562 PULMONX CORPORATION (Exact name of registrant as specified in its charter) Delaware 77-0424412 (State or other jur ...
Pulmonx(LUNG) - 2023 Q1 - Earnings Call Transcript
2023-05-03 03:55
Pulmonx Corporation (NASDAQ:LUNG) Q1 2023 Earnings Conference Call May 2, 2023 4:30 PM ET Company Participants Laine Morgan - Investor Relations Glen French - President and Chief Executive Officer Derrick Sung - Chief Financial Officer Conference Call Participants Travis Steed - BofA Securities Rick Wise - Stifel Jason Bednar - Piper Sandler Operator Thank you for standing by. Welcome to the Pulmonx First Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, today’s conference is bei ...
Pulmonx(LUNG) - 2022 Q4 - Annual Report
2023-03-01 21:08
Financial Performance - For the years ended December 31, 2022 and 2021, the company incurred net losses of $58.9 million and $48.7 million, respectively, with an accumulated deficit of $350.3 million as of December 31, 2022[160]. - The company’s ability to achieve profitability is contingent upon generating significant additional revenue, which remains uncertain given its current financial losses[160]. - The company expects to continue incurring net losses for the next several years, requiring substantial additional capital to finance planned operations, with an accumulated deficit of $350.3 million as of December 31, 2022[237][238]. - Quarterly and annual operating results may fluctuate significantly, making future performance difficult to predict[209]. - Failure to meet revenue expectations could negatively affect the company's financial condition and results of operations[213]. Market and Product Dependence - The company relies solely on the Zephyr Valve for revenue, which is currently approved only for treating severe emphysema, limiting its market potential[165]. - Sales of Zephyr Valves and delivery catheters accounted for most of the company's revenue for the years ended December 31, 2022 and 2021, and are expected to continue to do so[166]. - The annual total addressable market for the current and future products may be smaller than estimated, potentially impairing sales growth[214]. - A significant portion of the company's sales are outside the United States, exposing it to foreign currency risks, which have negatively impacted revenue from international markets[278]. Regulatory and Compliance Risks - The company must maintain necessary regulatory approvals for its products, such as the Zephyr Valve, to avoid negative impacts on business and financial condition[283]. - The company is subject to extensive government regulation, and any failure to comply could result in enforcement actions that adversely affect business operations[287]. - The company is subject to various anti-bribery and anti-corruption laws, and non-compliance could result in civil or criminal penalties impacting its financial condition[275]. - The company is subject to ongoing regulatory scrutiny, including compliance with the federal Anti-Kickback Statute and False Claims Act, which could impact its business operations and financial condition[306]. - The company must ensure that its marketing and promotional activities comply with FDA regulations to avoid enforcement actions[318]. Competition and Market Challenges - The emergence of competing technologies and the need to enhance the Zephyr Valve or develop new products are critical for maintaining market share[166]. - The competitive landscape includes products like the Spiration Valve System and the InterVapor System, which may offer alternative treatment options for severe emphysema[231]. - The company faces competition from larger, established companies that may acquire or in-license competitive products, potentially impacting market penetration[234]. - The healthcare industry is experiencing significant consolidation, which may lead to demands for price concessions affecting the company's product pricing[269]. Operational and Supply Chain Risks - The company relies on a direct sales force to sell the Zephyr Valve, and any loss of trained personnel could negatively impact business operations[194]. - The company depends on single-source suppliers for components, making it vulnerable to supply shortages and price fluctuations[202]. - Manufacturing risks may adversely affect the company's ability to produce products in sufficient quantities, impacting gross margins and overall financial condition[205]. - The company relies heavily on transport services for timely delivery of its products, and any performance issues or price increases by shipping carriers could adversely affect its business[244]. Clinical and Product Development - The company anticipates significant investments in clinical trials to provide evidence of the safety and efficacy of its solution, as well as in research and development for future generations of its products[239]. - The clinical trial process is lengthy and expensive, with uncertain outcomes that may delay commercialization of future products[320]. - The company may need to conduct additional clinical studies to support new indications or approvals, which could incur further costs and delays[325]. - The FDA and other regulatory authorities may require additional pre-clinical studies or clinical trials, impacting the timeline for product approvals[322]. Cybersecurity and Data Privacy - The company does not carry cyber insurance, exposing it to potential losses from data breaches or other cyber incidents[226]. - The company is investing in protections and monitoring practices related to data and IT to reduce risks associated with evolving cyber threats[258]. - The company may face significant liability related to the privacy of health information obtained from healthcare providers, which could result in criminal penalties under HIPAA[351]. - Non-compliance with data privacy laws could lead to substantial fines, penalties, and adverse publicity, negatively affecting business operations[350]. Human Resources and Training - The company faces challenges in growing the number of trained physicians due to low patient demand and training capacity limitations[178]. - The company has experienced difficulty in hiring and retaining qualified personnel, which may impact its research and development programs and clinical operations[246]. Legal and Litigation Risks - The company faces risks related to product liability claims, which could result in substantial liabilities and reputational harm[223]. - The company received a civil investigative demand from the U.S. Department of Justice regarding its relationships with healthcare providers related to the sales and marketing of Zephyr Valves[305]. - The company is subject to fraud and abuse laws, and violations could lead to substantial penalties, negatively affecting financial condition and operations[299]. Environmental and Compliance Costs - Environmental compliance costs are expected to increase, with potential liabilities for hazardous substance management and remediation[356]. - Compliance with new privacy laws, such as the CCPA and CPRA, may require additional investments and changes in business processes[344].
Pulmonx(LUNG) - 2022 Q4 - Earnings Call Transcript
2023-02-23 02:48
Pulmonx Corporation. (NASDAQ:LUNG) Q4 2022 Earnings Conference Call February 22, 2023 4:30 PM ET Company Participants Laine Morgan - Investor Relations, Gilmartin Group Glen French - President and Chief Executive Officer Derrick Sung - Chief Financial Officer Conference Call Participants Rick Wise - Stifel Jason Bednar - Piper Sandler Operator Good day and thank you for standing by. Welcome to Pulmonx Q4 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speak ...
Pulmonx Corp (LUNG) Investor Presentation - Slideshow
2022-11-16 17:53
NASDAQ: LUNG November 2022 © 2022 Pulmonx Corporation1 Forward Looking Statement This presentation and certain statements made during this presentation contain forward-looking statements that involve risks and uncertainties. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business ...
Pulmonx(LUNG) - 2022 Q3 - Quarterly Report
2022-11-08 21:26
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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: 001-39562 PULMONX CORPORATION (Exact name of registrant as specified in its charter) Delaware 77-0424412 (State or other ...
Pulmonx(LUNG) - 2022 Q3 - Earnings Call Transcript
2022-11-06 17:03
Pulmonx Corporation (NASDAQ:LUNG) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Laine Morgan - Investor Relations Glen French - President and Chief Executive Officer Derrick Sung - Chief Financial Officer Conference Call Participants Rick Wise - Stifel Jason Bednar - Piper Sandler Operator Good afternoon and welcome to Pulmonx Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answe ...
Pulmonx(LUNG) - 2022 Q2 - Quarterly Report
2022-08-08 20:28
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | ...
Pulmonx(LUNG) - 2022 Q2 - Earnings Call Transcript
2022-08-03 01:40
Pulmonx Corporation (NASDAQ:LUNG) Q2 2022 Earnings Conference Call August 2, 2022 4:30 PM ET Company Participants Laine Morgan - Gilmartin Group Glen French - President and Chief Executive Officer Derrick Sung - Chief Financial Officer Conference Call Participants Cecilia Furlong - Morgan Stanley Travis Steed - BofA Securities David Ko - Canaccord Genuity Larry Biegelsen - Wells Fargo Joseph Downing - PSC Joanne Wuensch - Citi Operator Good afternoon, and welcome to Pulmonx Second Quarter 2022 Earnings Conf ...
Pulmonx (LUNG) Investor Presentation - Slideshow
2022-06-04 14:54
NASDAQ: LUNG May 2022 © 2022 Pulmonx Corporation1 Forward Looking Statement This presentation and certain statements made during this presentation contain forward-looking statements that involve risks and uncertainties. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strat ...