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Pulmonx(LUNG) - 2024 Q3 - Quarterly Report

Revenue and Financial Performance - Revenue for the three months ended September 30, 2024, was $20.4 million, a 15.3% increase from $17.7 million for the same period in 2023, with a gross margin of 73.7%[130] - For the nine months ended September 30, 2024, revenue was $60.0 million, up 21.4% from $49.4 million in the same period in 2023, with a gross margin of 74.0%[130] - Revenue increased by $2.7 million, or 15.4%, to $20.4 million for the three months ended September 30, 2024, compared to $17.7 million for the same period in 2023[158] - For the nine months ended September 30, 2024, revenue increased by $10.6 million, or 21.5%, to $60.0 million compared to $49.4 million for the same period in 2023[167] - Revenue from sales outside the United States represented 32.4% of total revenue for the nine months ended September 30, 2024, compared to 34.8% for the same period in 2023[205] Net Loss and Financial Position - The company reported a net loss of $14.1 million for Q3 2024, compared to a net loss of $14.9 million in Q3 2023, and a net loss of $43.2 million for the nine months ended September 30, 2024, compared to $47.0 million for the same period in 2023[130] - The company anticipates continued net losses for the next several years and expects to require substantial additional funding, which may include future equity and debt financings[131] - The company recorded a net loss of $43.2 million for the nine months ended September 30, 2024, compared to a net loss of $47.0 million for the same period in 2023[186][187] Cash and Liquidity - As of September 30, 2024, the company had an accumulated deficit of $454.4 million and cash, cash equivalents, and marketable securities totaling $107.8 million[130] - The company had cash, cash equivalents, and marketable securities totaling $107.8 million as of September 30, 2024, which is expected to fund operating expenses for at least the next 12 months[195] - The company reported a net cash used in operating activities of $24.8 million for the nine months ended September 30, 2024, compared to $29.2 million for the same period in 2023, reflecting a decrease of approximately 15%[186][187] - Cash provided by investing activities was $3.4 million for the nine months ended September 30, 2024, compared to $0.7 million for the same period in 2023, indicating a significant increase in cash flow from investments[188][189] Expenses - Research and development expenses decreased by $0.5 million, or 11.3%, to $3.7 million for the three months ended September 30, 2024[161] - Selling, general and administrative expenses increased by $1.4 million, or 5.9%, to $25.4 million for the three months ended September 30, 2024[162] - Research and development expenses for the nine months ended September 30, 2024, decreased by $0.6 million, or 4.3%, to $13.6 million[169] - Selling, general and administrative expenses increased by $4.9 million, or 7.0%, to $75.1 million for the nine months ended September 30, 2024[170] Debt and Financing - Outstanding debt under the CIBC Agreement was $36.9 million with an annual effective interest rate of 9.5% as of September 30, 2024[204] - Interest expense on the CIBC Loan was $0.9 million for both the three months ended September 30, 2024, and September 30, 2023, while it totaled $2.7 million and $2.3 million for the nine months ended September 30, 2024, and September 30, 2023, respectively[182] - The company extended the interest-only period of the CIBC Loan from 24 months to 36 months in May 2024, with principal repayment now scheduled to begin in November 2025[179] - The company drew $20.0 million from the Amended Tranche B of the CIBC Loan in February 2023, which has the same interest rate and repayment terms as Tranche A[178] Research and Development - The company has invested heavily in research and development, focusing on continuous improvements to its solutions and clinical studies to support regulatory submissions[131] - The AeriSeal System is currently in a global clinical trial called CONVERT II to support a PMA application, aiming to treat severe emphysema patients not eligible for Zephyr Valve treatment[125] Market and Operational Insights - Approximately 96% of revenue for the nine months ended September 30, 2024, was generated in markets where the company sells directly[126] - The company is expanding its commercial operations in the U.S. and internationally, with a focus on increasing awareness and adoption of its solutions among pulmonologists[126] - The Zephyr Valve treatment has received positive coverage policies from major commercial payors, including Aetna and Humana, and Medicare covers the solution when medically necessary[137] Currency and Inflation Impact - A 10% change in foreign currency exchange rates would have impacted revenues by approximately $1.9 million and operating expenses by $1.4 million for the nine months ended September 30, 2024, resulting in a net impact of $0.5 million on net loss[205] - Inflation has increased costs related to transportation, wages, and other expenses, although it has not materially impacted the financial position to date[206] - A 10% change in foreign currency exchange rates would have impacted revenues by approximately $1.7 million and operating expenses by $1.4 million for the nine months ended September 30, 2023, resulting in a net impact of $0.3 million on net loss[205]