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): November 2, 2021
(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 November 2, 2021, Pulmonx Corporation (the “Company”) issued a press release announcing its financial results for the third fiscal quarter ended September 30, 2021. A copy of the Company’s press release dated November 2, 2021, titled “Pulmonx Reports Third Quarter 2021 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: November 2, 2021
| By: | /s/ Derrick Sung | ||||
| Derrick Sung, Ph.D. | |||||
| Chief Financial Officer | |||||
Exhibit 99.1
Pulmonx Reports Third Quarter 2021 Financial Results
Redwood City, CA – November 2, 2021 – Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx” or the "Company"), a global leader in minimally invasive treatments for severe lung disease, today reported financial results for the third quarter ended September 30, 2021.
Recent Highlights
•Achieved worldwide revenue of $13.3 million in the third quarter of 2021, a 25% increase over the same period last year
•Realized gross margin of 73% in the third quarter of 2021 as compared to 70% in the same period last year
•Added 18 new U.S. Zephyr® Valve treating centers, increasing the total to 198
•Announced positive coverage policy decisions from Anthem Blue Cross Blue Shield, Blue Cross Blue Shield of Michigan and Horizon Blue Cross Blue Shield of New Jersey, collectively representing approximately 44 million incremental covered lives
•Achieved milestone of treating over 25,000 patients worldwide with Zephyr® Valves
“Despite facing significant headwinds from COVID, we are proud to have achieved record sales in the third quarter as we benefitted from particularly strong performance in less impacted geographies,” said Glen French, President & Chief Executive Officer. “Underlying demand for our Zephyr Valve treatment continues to grow and we remain encouraged by strong patient screening volumes, the rate at which we opened new treating centers, and our success in broadly securing positive payor coverage.”
Third Quarter 2021 Financial Results
Total worldwide revenue in the third quarter of 2021 was $13.3 million, a 25% increase from $10.6 million in the third quarter of 2020 and an increase of 23% on a constant currency basis. U.S. revenue was $6.9 million, a 28% increase compared to the third quarter of 2020. International revenue was $6.4 million, a 22% increase compared to the third quarter of 2020, and a 18% increase on a constant currency basis. The increase in revenue reflects strong commercial momentum and procedure volume growth in geographic regions less impacted by COVID during the quarter, offset by lower growth in regions where COVID impacted the ability for hospitals to perform procedures.
Gross profit in the third quarter of 2021 was $9.7 million, compared to $7.5 million in the third quarter of 2020. Gross margin for the third quarter of 2021 was 73%, up from 70% for the same period in 2020. The improvement in gross margin benefited from increased production throughput and the realization of production efficiencies.
Operating expenses in the third quarter of 2021 were $19.5 million, compared to $12.8 million in the third quarter of 2020, representing an increase of 52%. The increase in operating expenses was primarily driven by an investment in personnel to expand our commercial, research and development, and general and administrative functions, stock-based compensation, and expenses associated with operating as a public company.
Net loss in the third quarter of 2021 was $10.2 million, or $0.28 per share, compared to a net loss of $3.9 million, or $1.37 per share, for the same period in 2020.
Cash, cash equivalents, and marketable securities totaled $202.6 million as of September 30, 2021.
2021 Financial Outlook
Pulmonx is maintaining its full year 2021 revenue guidance in the range of $49 to $51 million. With COVID-19 continuing to pose uncertainty, the Company expects full year 2021 revenue to fall near the low end of this range, representing at least 50% growth over the Company’s full year 2020 revenue.
Pulmonx now expects total operating expenses for the full year 2021 to fall within the range of $83 to $85 million inclusive of stock-based compensation.
Webcast and Conference Call Details
Pulmonx will host a conference call today, November 2, 2021, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its third quarter 2021 financial results. The dial-in numbers are (833) 614-1518 for domestic callers or (270) 823-1072 for international callers. The conference ID is 9545716. 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
Pulmonx has presented constant currency percentage change in revenues, a non-GAAP financial measure, in this press release. 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. Reconciliation of this non-GAAP financial measure to the most comparable GAAP measure is set forth in the tables below.
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. 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.
This non-GAAP financial measure 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 the Company’s business, 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. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on the Company and its operations, a recovery in the number of procedures performed, and the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, gross margin, profitability, guidance for 2021 full year, commercial momentum, 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 10, 2021, 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, the Company undertakes 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 the Company’s business.
About Pulmonx Corporation
Pulmonx Corporation (Nasdaq: LUNG) is a global leader in minimally invasive treatments for severe lung disease. 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, with over 100,000 valves used to treat more than 25,000 patients. For more information on the Zephyr Valves and the company, please visit www.Pulmonx.com.
Pulmonx®, Chartis®, StratX®, and Zephyr® are registered trademarks of Pulmonx Corporation.
Investor Contact
Brian Johnston
Gilmartin Group
investors@pulmonx.com
Pulmonx Corporation
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September30, | |||||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||||||
| Revenue | $ | 13,261 | $ | 10,612 | $ | 34,708 | $ | 22,903 | ||||||||||||||||||
| Cost of goods sold | 3,522 | 3,150 | 9,329 | 8,779 | ||||||||||||||||||||||
| Gross profit | 9,739 | 7,462 | 25,379 | 14,124 | ||||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||||
| Research and development | 2,815 | 1,997 | 9,355 | 4,988 | ||||||||||||||||||||||
| Selling, general and administrative | 16,686 | 10,813 | 50,962 | 32,114 | ||||||||||||||||||||||
| Total operating expenses | 19,501 | 12,810 | 60,317 | 37,102 | ||||||||||||||||||||||
| Loss from operations | (9,762) | (5,348) | (34,938) | (22,978) | ||||||||||||||||||||||
| Interest income | 99 | 9 | 306 | 98 | ||||||||||||||||||||||
| Interest expense | (207) | (1,103) | (630) | (2,914) | ||||||||||||||||||||||
| Other income (expense), net | (267) | 2,631 | (202) | 3,052 | ||||||||||||||||||||||
| Net loss before tax | (10,137) | (3,811) | (35,464) | (22,742) | ||||||||||||||||||||||
| Income tax expense | 44 | 49 | 191 | 192 | ||||||||||||||||||||||
| Net loss | $ | (10,181) | $ | (3,860) | $ | (35,655) | $ | (22,934) | ||||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.28) | $ | (1.37) | $ | (0.99) | $ | (10.33) | ||||||||||||||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 36,449,399 | 2,814,798 | 35,958,217 | 2,220,734 | ||||||||||||||||||||||
Pulmonx Corporation
Condensed Consolidated Balance Sheets
(in thousands)
(Unaudited)
| September 30, 2021 | December 31, 2020 | ||||||||||
| Assets | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 188,075 | $ | 231,561 | |||||||
| Restricted cash | 231 | 231 | |||||||||
| Short-term marketable securities | 11,774 | — | |||||||||
| Accounts receivable, net | 6,919 | 4,228 | |||||||||
| Inventory | 14,985 | 10,741 | |||||||||
| Prepaid expenses and other current assets | 5,660 | 3,228 | |||||||||
| Total current assets | 227,644 | 249,989 | |||||||||
| Long-term marketable securities | 2,798 | — | |||||||||
| Property and equipment, net | 4,703 | 1,474 | |||||||||
| Goodwill | 2,333 | 2,333 | |||||||||
| Intangible assets, net | 308 | 400 | |||||||||
| Right of use assets | 8,474 | 8,976 | |||||||||
| Other long-term assets | 558 | 536 | |||||||||
| Total assets | $ | 246,818 | $ | 263,708 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 4,434 | $ | 1,472 | |||||||
| Accrued liabilities | 12,374 | 8,651 | |||||||||
| Income taxes payable | — | 94 | |||||||||
| Deferred revenue | 157 | 71 | |||||||||
| Current lease liabilities | 1,946 | 2,238 | |||||||||
| Term loan, current | 3,306 | — | |||||||||
| Total current liabilities | 22,217 | 12,526 | |||||||||
| Deferred tax liability | 70 | 62 | |||||||||
| Long-term lease liabilities | 7,440 | 7,618 | |||||||||
| Credit agreement | 537 | 564 | |||||||||
| Term loan | 13,547 | 16,804 | |||||||||
| Other long-term liabilities | 179 | — | |||||||||
| Total liabilities | 43,990 | 37,574 | |||||||||
| Stockholders' equity | |||||||||||
| Common stock | 37 | 36 | |||||||||
| Additional paid-in capital | 479,636 | 467,147 | |||||||||
| Accumulated other comprehensive income | 1,544 | 1,685 | |||||||||
| Accumulated deficit | (278,389) | (242,734) | |||||||||
| Total stockholders' equity | 202,828 | 226,134 | |||||||||
| Total liabilities and stockholders' equity | $ | 246,818 | $ | 263,708 | |||||||
Pulmonx Corporation
Reconciliation of Reported Revenue % Change to Constant Currency Revenue % Change
(in thousands)
(Unaudited)
| Three months ended September 30, | |||||||||||||||||||||||||||||
| 2021 | 2020 | % Change | FX Impact % | Constant Currency % Change | |||||||||||||||||||||||||
| United States | $ | 6,861 | $ | 5,345 | 28.4 | % | — | % | 28.4 | % | |||||||||||||||||||
| International | 6,400 | 5,267 | 21.5 | % | 3.5 | % | 18.0 | % | |||||||||||||||||||||
| Total | $ | 13,261 | $ | 10,612 | 25.0 | % | 1.8 | % | 23.2 | % | |||||||||||||||||||
| Nine months ended September 30, | |||||||||||||||||||||||||||||
| 2021 | 2020 | % Change | FX Impact % | Constant Currency % Change | |||||||||||||||||||||||||
| United States | $ | 17,716 | $ | 11,315 | 56.6 | % | — | % | 56.6 | % | |||||||||||||||||||
| International | $ | 16,992 | $ | 11,588 | 46.6 | % | 9.7 | % | 36.9 | % | |||||||||||||||||||
| Total | $ | 34,708 | $ | 22,903 | 51.5 | % | 4.9 | % | 46.6 | % | |||||||||||||||||||