UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 30, 2023
(Exact name of Registrant as Specified in Its Charter)
| (State or Other Jurisdiction | (Commission File Number) | (IRS Employer | |||||||||
| of Incorporation) | Identification No.) | ||||||||||
| (Address of Principal Executive Offices) | (Zip Code) | ||||||||||
(650 )364-0400
Registrant's telephone number, including area code
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On October 30, 2023, Pulmonx Corporation (the “Company”) issued a press release announcing its financial results for the third fiscal quarter ended September 30, 2023. A copy of the Company’s press release dated October 30, 2023, titled “Pulmonx Reports Record Third Quarter 2023 Financial Results” is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing information (including the exhibit hereto) is being furnished under “Item 2.02 Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Pulmonx Corporation
Dated: October 30, 2023
| By: | /s/ John McKune | ||||
| John McKune | |||||
| Interim Chief Financial Officer | |||||
Exhibit 99.1
Pulmonx Reports Record Third Quarter 2023 Financial Results
Redwood City, CA – October 30, 2023 – Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx” or the "Company"), a global leader in minimally invasive treatments for lung disease, today reported financial results for the third quarter of 2023 ended September 30, 2023.
Recent Highlights
•Achieved record worldwide revenue of $17.7 million in the third quarter of 2023, a 31% increase over the same period last year and an increase of 29% on a constant currency basis
•Delivered a record $11.8 million in U.S. revenue in the third quarter of 2023, representing 41% year-over-year growth
•Realized gross margin of 74% in the third quarter of 2023
•Added 15 new U.S. treatment centers for Zephyr Valves in the third quarter 2023
•Approved for reimbursement by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the use of Zephyr Valves to treat severe COPD/emphysema patients in Japan
“Our record quarterly results were driven by strength in the U.S., reflective of traction we are seeing from our focused commercial strategy,” said Glen French, President, and Chief Executive Officer. “Awareness around the benefits of Zephyr Valve treatment continues to build as we remain intensely focused on improving the lives of more and more patients with severe COPD/emphysema.”
Third Quarter 2023 Financial Results
Total worldwide revenue in the third quarter of 2023 was $17.7 million, a 31% increase from $13.5 million in the third quarter of 2022 and a 29% increase on a constant currency basis. U.S. revenue was $11.8 million, a 41% increase from the third quarter of 2022. International revenue was $5.8 million, a 14% increase compared to the third quarter of 2022 and a 9% increase on a constant currency basis. The growth in revenue reflects continued commercial momentum and adoption of Zephyr Valve procedures.
Gross profit in the third quarter of 2023 was $13.0 million, compared to $10.2 million for the third quarter of 2022. Gross margin for the third quarter of 2023 was 74%, compared to 75% for the same period in 2022, reflecting higher inventory reserves in the quarter.
Operating expenses in the third quarter of 2023 were $28.2 million, compared to $24.1 million for the third quarter of 2022, representing an increase of 17%. The increase in operating expenses was primarily attributable to continued investments in our commercial activities, legal expenses, and higher stock-based compensation expense.
Net loss in the third quarter of 2023 was $14.9 million, or $0.39 per share, compared to a net loss of $14.2 million, or $0.38 per share, for the same period in 2022.
Adjusted EBITDA loss in the third quarter of 2023 was $9.0 million compared to $9.7 million for the same period in 2022.
Cash, cash equivalents, and marketable securities totaled $139.8 million as of September 30, 2023.
2023 Financial Outlook
Pulmonx is increasing its expectation for revenue in 2023 to now range from $67 million to $68 million, which represents approximately 25% to 27% growth over the Company's fiscal year 2022 revenue. This updated guidance compares to prior 2023 revenue guidance of $64 million to $66 million.
The Company expects gross margin for the full year 2023 to be approximately 74%.
Pulmonx also continues to expect total operating expenses for the full year 2023 to fall within the range of $112 million to $114 million, inclusive of approximately $21 million of non-cash stock-based compensation.
Webcast and Conference Call Details
Pulmonx will host a conference call today, October 30, 2023, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its third quarter financial results. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at https://investors.pulmonx.com/. The webcast will be archived on the website following the completion of the call.
Use of Non-GAAP Financial Measures
To supplement Pulmonx’s condensed consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, Pulmonx provides certain non-GAAP financial measures in this release as supplemental financial metrics. Non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results, may provide a more complete understanding of factors and trends affecting Pulmonx’s business.
Constant currency calculations show reported current period revenues as if the foreign exchange rates remain the same as those in effect in the comparable prior year period. Pulmonx uses results on a constant currency basis as one measure to evaluate its performance. Pulmonx calculates constant currency by calculating current-year results using foreign currency exchange rates from the applicable comparable period in the prior year. Pulmonx generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. Pulmonx believes the presentation of results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Pulmonx generally uses constant currency to facilitate management's financial and operational decision-making, including evaluation of Pulmonx’s historical operating results.
The Company defines Adjusted EBITDA as earnings before interest income or expense, taxes, depreciation and amortization and stock-based compensation and may also exclude certain non-recurring, irregular or one-time items not reflective of our ongoing core business operations. Management believes in order to properly understand short-term and long-term financial trends, investors may wish to consider the impact of these excluded items in addition to GAAP measures. Further, management uses adjusted EBITDA for strategic and annual operating planning. We believe these non-GAAP financial measures are useful as a supplement in evaluating our ongoing operational performance and enhancing an overall understanding of our past financial performance.
Reconciliation of these non-GAAP financial measures to the most comparable GAAP measures is set forth in the tables below.
The non-GAAP financial measures used by Pulmonx should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. Because non-GAAP financial measures exclude the effect of items that increase or decrease the company's reported results of operations, management strongly encourages investors to review, when they become available, the Company's consolidated financial statements and publicly filed reports in their entirety. The Company's definition of non-GAAP measures may differ from similarly titled measures used by others.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect our strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. These forward-looking statements include, but are not limited to, statements regarding our commercial strategy to grow the adoption of our Zephyr Valve treatment and expand our global treatable market, our expectations regarding account activity and productivity, our possible or assumed future results of operations, including long-term outlook, descriptions of our revenues, total operating expenses, gross margin, profitability, guidance for full year 2023, commercial momentum, physician engagement and awareness of the benefits of the Zephyr Valve, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Pulmonx’s public filings with the Securities and Exchange Commission (“SEC”), including the Quarterly Report on Form
10-Q filed with the SEC on August 4, 2023, available at www.sec.gov. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical fact are forward-looking statements. Except to the extent required by law, we undertake no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business.
About Pulmonx Corporation
Pulmonx Corporation (Nasdaq: LUNG) is a global leader in minimally invasive treatments for chronic obstructive pulmonary disease (COPD). Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who despite medical management are still profoundly symptomatic. Pulmonx received FDA pre-market approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, is included in global treatment guidelines and is widely considered a standard of care treatment option for improving breathing, activity and quality of life in patients with severe emphysema. For more information on the Zephyr Valves and the company, please visit www.Pulmonx.com.
Investor Contact
Brian Johnston
Gilmartin Group
investors@pulmonx.com
Pulmonx Corporation
Consolidated Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||
| Revenue | $ | 17,668 | $ | 13,502 | $ | 49,397 | $ | 38,237 | ||||||||||||||||||
| Cost of goods sold | 4,639 | 3,350 | 13,045 | 9,556 | ||||||||||||||||||||||
| Gross profit | 13,029 | 10,152 | 36,352 | 28,681 | ||||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||||
| Research and development | 4,220 | 4,366 | 14,184 | 11,494 | ||||||||||||||||||||||
| Selling, general and administrative | 23,985 | 19,717 | 70,184 | 61,197 | ||||||||||||||||||||||
| Total operating expenses | 28,205 | 24,083 | 84,368 | 72,691 | ||||||||||||||||||||||
| Loss from operations | (15,176) | (13,931) | (48,016) | (44,010) | ||||||||||||||||||||||
| Interest income | 1,490 | 477 | 4,027 | 781 | ||||||||||||||||||||||
| Interest expense | (893) | (286) | (2,327) | (707) | ||||||||||||||||||||||
| Other income (expense), net | (262) | (432) | (316) | (597) | ||||||||||||||||||||||
| Net loss before tax | (14,841) | (14,172) | (46,632) | (44,533) | ||||||||||||||||||||||
| Income tax expense | 59 | — | 323 | 107 | ||||||||||||||||||||||
| Net loss | $ | (14,900) | $ | (14,172) | $ | (46,955) | $ | (44,640) | ||||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.39) | $ | (0.38) | $ | (1.24) | $ | (1.21) | ||||||||||||||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 38,119,824 | 37,190,352 | 37,838,822 | 37,001,136 | ||||||||||||||||||||||
Pulmonx Corporation
Condensed Consolidated Balance Sheets
(in thousands)
(Unaudited)
| September 30, | December 31, | ||||||||||
| 2023 | 2022 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 94,945 | $ | 101,736 | |||||||
| Restricted cash | 236 | 231 | |||||||||
| Short-term marketable securities | 21,537 | 39,402 | |||||||||
| Accounts receivable, net | 10,091 | 8,677 | |||||||||
| Inventory | 16,131 | 14,564 | |||||||||
| Prepaid expenses and other current assets | 4,424 | 4,343 | |||||||||
| Total current assets | 147,364 | 168,953 | |||||||||
| Long-term marketable securities | 23,271 | 5,924 | |||||||||
| Long-term inventory | 3,445 | 5,283 | |||||||||
| Property and equipment, net | 4,065 | 4,694 | |||||||||
| Goodwill | 2,333 | 2,333 | |||||||||
| Intangible assets, net | 62 | 154 | |||||||||
| Right of use assets | 4,061 | 5,806 | |||||||||
| Other long-term assets | 415 | 529 | |||||||||
| Total assets | $ | 185,016 | $ | 193,676 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 3,189 | $ | 1,758 | |||||||
| Accrued liabilities | 13,684 | 13,276 | |||||||||
| Income taxes payable | — | 19 | |||||||||
| Deferred revenue | 85 | 120 | |||||||||
| Short-term debt | 91 | 90 | |||||||||
| Current lease liabilities | 3,436 | 3,229 | |||||||||
| Total current liabilities | 20,485 | 18,492 | |||||||||
| Deferred tax liability | 97 | 94 | |||||||||
| Long-term lease liabilities | 1,537 | 3,849 | |||||||||
| Long-term debt | 37,154 | 17,234 | |||||||||
| Total liabilities | 59,273 | 39,669 | |||||||||
| Stockholders' equity: | |||||||||||
| Common stock | 38 | 38 | |||||||||
| Additional paid-in capital | 521,034 | 502,712 | |||||||||
| Accumulated other comprehensive income | 1,944 | 1,575 | |||||||||
| Accumulated deficit | (397,273) | (350,318) | |||||||||
| Total stockholders' equity | 125,743 | 154,007 | |||||||||
| Total liabilities and stockholders' equity | $ | 185,016 | $ | 193,676 | |||||||
Pulmonx Corporation
Reconciliation of Reported Revenue % Change to Constant Currency Revenue % Change
(in thousands)
(Unaudited)
| Three Months Ended September 30, | |||||||||||||||||||||||||||||
| 2023 | 2022 | % Change | FX Impact % | Constant Currency % Change | |||||||||||||||||||||||||
| United States | $ | 11,838 | $ | 8,402 | 40.9 | % | — | % | 40.9 | % | |||||||||||||||||||
| International | 5,830 | 5,100 | 14.3 | % | 5.3 | % | 9.0 | % | |||||||||||||||||||||
| Total | $ | 17,668 | $ | 13,502 | 30.9 | % | 2.1 | % | 28.8 | % | |||||||||||||||||||
| Nine Months Ended September 30, | |||||||||||||||||||||||||||||
| 2023 | 2022 | % Change | FX Impact % | Constant Currency % Change | |||||||||||||||||||||||||
| United States | $ | 32,197 | $ | 23,031 | 39.8 | % | — | % | 39.8 | % | |||||||||||||||||||
| International | 17,200 | 15,206 | 13.1 | % | (0.2) | % | 13.3 | % | |||||||||||||||||||||
| Total | $ | 49,397 | $ | 38,237 | 29.2 | % | (0.1) | % | 29.3 | % | |||||||||||||||||||
Pulmonx Corporation
Reconciliation of Net Loss to Non-GAAP Adjusted EBITDA
(in thousands)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
| GAAP Net loss | $ | (14,900) | $ | (14,172) | $ | (46,955) | $ | (44,640) | |||||||||||||||
| Depreciation and amortization | 415 | 383 | 1,261 | 1,127 | |||||||||||||||||||
| Stock-based compensation | 6,003 | 4,302 | 16,503 | 12,198 | |||||||||||||||||||
| Interest (income)/expense, net | (597) | (191) | (1,700) | (74) | |||||||||||||||||||
| Provision for income taxes | 59 | — | 323 | 107 | |||||||||||||||||||
| Adjusted EBITDA | $ | (9,020) | $ | (9,678) | $ | (30,568) | $ | (31,282) | |||||||||||||||