PEN Penumbra Inc

ALAMEDA, Calif., Feb. 22, 2024 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Financial Highlights:

• Revenue of $284.7 million for the fourth quarter of 2023, an increase of 28.7% or 27.9% in constant currency¹ compared to the fourth quarter of 2022. Revenue of $1,058.5 million for the full year 2023, an increase of 25.0% or 24.7% in constant currency¹ compared to the full year 2022.
   
• Revenue of $190.8 million from sales of our thrombectomy products in the fourth quarter of 2023, an increase of 42.4%, compared to the fourth quarter of 2022. Full year revenue of $677.3 million from sales of our thrombectomy products, an increase of 32.5% compared to the full year 2022.
    
• Income from operations of $35.0 million and Non-GAAP income from operations¹ of $37.4 million in the fourth quarter of 2023.
    
• Income from operations of $73.6 million and Non-GAAP income from operations¹ of $101.3 million for the full year 2023.
    
• Net income of $54.2 million and adjusted EBITDA¹ of $53.4 million or adjusted EBITDA margin of 18.8% in the fourth quarter of 2023. Net income of $91.0 million and adjusted EBITDA¹ of $170.6 million or adjusted EBITDA margin of 16.1% for the full year 2023.
    
• Cash and marketable investments increased $40.3 million in the fourth quarter of 2023 compared to the third quarter of 2023 driven by an increase in profitability and improvements in working capital.
    
• In 2024, Penumbra projects total revenue growth of 16% to 20%. The Company projects U.S. thrombectomy growth of 27% to 30%. Gross margin expansion is expected to be 100 to 150 basis points, and non-GAAP operating margin expansion is expected to be 100 to 200 basis points, compared to full year 2023.

In the fourth quarter of 2023, the Company made changes to its product revenue categories to provide investors with more meaningful information to understand the performance of its business and strategic direction. The Company will now report its product revenues in the following categories: thrombectomy and embolization and access. The Company is also providing its neuro and vascular product revenues for the fourth quarter and full year 2023 for the last time.

As a one-time appendix to this press release, the Company has included its previously reported revenue for each quarter and year-to-date period of 2023 and 2022 reclassified into these new product categories, including supplemental geographic information.

Fourth Quarter 2023 Financial Results
Total revenue increased to $284.7 million for the fourth quarter of 2023 compared to $221.2 million for the fourth quarter of 2022, an increase of 28.7%, or 27.9% in constant currency¹. The United States represented 71.5% of total revenue and international represented 28.5% of total revenue for the fourth quarter of 2023. Revenue from the U.S. increased 29.6% while revenue from our international regions increased 26.4%, or 23.5% in constant currency¹. We achieved record revenue from the sales of our global thrombectomy products which grew to $190.8 million for the fourth quarter of 2023, an increase of 42.4%, or 41.6% in constant currency¹ over the same period a year ago, driven primarily by the sales of our U.S. thrombectomy products which increased by 46.4% over the same period a year ago. Revenue from the sales of our global embolization and access products grew to $93.9 million for the fourth quarter of 2023, an increase of 7.6%, or 6.7% in constant currency¹ from the same period a year ago.

Gross profit for the fourth quarter of 2023 was $187.0 million, or 65.7% of total revenue compared to $138.4 million, or 62.6% of total revenue, for the fourth quarter of 2022. Gross margin is impacted by product mix, regional mix, and production initiatives to support demand and create future efficiencies. As such, with favorable product mix, improvement in productivity, and by leveraging our fixed costs on higher volume of new product sales during the year, our gross margin may be positively impacted in the future.

Total operating expenses, including a $2.4 million amortization expense of finite lived intangible assets acquired in connection with the Sixense acquisition for both periods, were $152.0 million, or 53.4% of total revenue for the fourth quarter of 2023, and $133.6 million, or 60.4% of total revenue for the fourth quarter of 2022. Excluding the charge noted above for both periods, total non-GAAP operating expenses¹ were $149.6 million, or 52.5% of total revenue for the fourth quarter of 2023, and $131.2 million, or 59.3% of total revenue for the fourth quarter of 2022.

Income from operations was $35.0 million for the fourth quarter of 2023 compared to income from operations of $4.8 million for the fourth quarter of 2022. Excluding the amortization expense of finite lived intangible assets acquired in connection with the Sixense acquisition of $2.4 million for both periods, non-GAAP income from operations¹ was $37.4 million for the fourth quarter of 2023 compared to $7.2 million for the fourth quarter of 2022.

Full Year 2023 Financial Results
Total revenue increased to $1,058.5 million for the year ended December 31, 2023 compared to $847.1 million for the year ended December 31, 2022, an increase of 25.0%, or 24.7% in constant currency¹. The United States represented 71.5% of total revenue and international represented 28.5% of total revenue for the year ended December 31, 2023. Revenue from the U.S. increased 28.0% while revenue from our international regions increased 18.0%, or 17.3% in constant currency¹. Revenue from the sales of our global thrombectomy products grew to $677.3 million for the year ended December 31, 2023, an increase of 32.5%, or 32.3% in constant currency¹ over the same period a year ago, driven primarily by sales of our U.S. vascular thrombectomy products which increased 45.2% over the same period a year ago. Revenue from the sales of our global embolization and access products grew to $381.2 million for the year ended December 31, 2023, an increase of 13.4%, or 13.2% in constant currency¹ compared to the year ended December 31, 2022.

Gross profit for the year ended December 31, 2023 was $682.6 million, or 64.5% of total revenue, compared to $535.2 million, or 63.2% of total revenue, for the year ended December 31, 2022. Gross margin is impacted by product mix, regional mix, and production initiatives to support demand and create future efficiencies. As such, with favorable product mix, improvement in productivity, and by leveraging our fixed costs on higher volume of new product sales during the year, our gross margin may be positively impacted in the future.

Total operating expenses for the year ended December 31, 2023 were $609.1 million, or 57.5% of total revenue, which included a one-time $18.2 million expense associated with the acquisition of in-process research and development ("IPR&D") and a $9.5 million amortization expense of finite lived intangible assets acquired in connection with the Sixense acquisition. This compares to total operating expenses of $529.1 million, or 62.5% of total revenue, for the year ended December 31, 2022, which included a $8.3 million amortization expense of finite lived intangible assets acquired in connection with the Sixense acquisition. Excluding the charges noted above, total non-GAAP operating expenses¹ were $581.4 million, or 54.9% of total revenue during the year ended December 31, 2023, and $520.8 million, or 61.5% of total revenue during the year ended December 31, 2022. R&D expenses were $84.4 million for the year ended December 31, 2023, compared to $79.4 million for the year ended December 31, 2022. SG&A expenses were $506.5 million for the year ended December 31, 2023, compared to $449.7 million for the year ended December 31, 2022.

Income from operations was $73.6 million for the year ended December 31, 2023 compared to income from operations of $6.1 million for the year ended December 31, 2022. Excluding the one-time expense associated with the acquired IPR&D of $18.2 million and the amortization expense of finite lived intangible assets acquired in connection with the Sixense acquisition of $9.5 million, non-GAAP income from operations¹ was $101.3 million for the year ended December 31, 2023. This compares to non-GAAP income from operations¹ of $14.4 million for the year ended December 31, 2022, excluding the amortization expense of finite lived intangible assets acquired in connection with the Sixense acquisition of $8.3 million.

Full Year 2024 Financial Outlook
The Company projects total revenue for 2024 to be in the range of $1,230.0 million to $1,270.0 million, representing year over year growth of 16% to 20% compared to 2023 revenue of $1,058.5 million. The Company also projects the U.S. thrombectomy franchise will grow 27% to 30% year-over-year, primarily driven by its Computer-Assisted Vacuum Thrombectomy ("CAVT") products. The Company also expects gross margin expansion in the range of 100 to 150 basis points and total non-GAAP operating margin expansion in the range of 100 to 200 basis points in 2024 compared to full year 2023.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss financial results for the fourth quarter and year ended December 31, 2023 after market close on Thursday, February 22, 2024 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone by dialing (888) 596-4144 for domestic and international callers (conference id: 4604622), or the webcast can be accessed on the "Events and Presentations" section under the "Investors" tab of the Company's website at: www.penumbrainc.com. The webcast will be available on the Company's website for at least two weeks following the completion of the call.

About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries. The Penumbra logo is a trademark of Penumbra, Inc. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.

Non-GAAP Financial Measures
In addition to financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company uses the following non-GAAP financial measures in this press release: a) constant currency, b) non-GAAP operating expenses, non-GAAP income from operations, non-GAAP net income and non-GAAP diluted earnings per share ("EPS") and c) adjusted EBITDA.

Constant Currency. The Company's constant currency revenue disclosures estimate the impact of changes in foreign currency rates on the translation of the Company's current period revenue as compared to the applicable comparable period in the prior year. This impact is derived by taking the current local currency revenue and translating it into U.S. dollars based upon the foreign currency exchange rates used to translate the local currency revenue for the applicable comparable period in the prior year, rather than the actual exchange rates in effect during the current period. It does not include any other effect of changes in foreign currency rates on the Company's results or business.

Non-GAAP operating expenses, non-GAAP income from operations, non-GAAP net income and non-GAAP diluted EPS. The adjustments to the GAAP financial measures reflect the exclusion of:

• the one-time expense associated with the acquisition of IPR&D in the third quarter of 2023;
• the effect of the amortization of finite lived intangible assets acquired in connection with the Sixense acquisition over their estimated useful lives;
• the excess tax benefits or tax deficiencies associated with share-based compensation arrangements; and
• the release of the valuation allowance associated with Federal R&D tax credits and partial release of the valuation allowance associated with California deferred tax assets.

Adjusted EBITDA. The Company's adjusted EBITDA reflects the exclusion from GAAP net income (loss) of:

• non-cash operating charges such as stock-based compensation and depreciation and amortization; and
• non-operating items such as the one-time expense associated with the acquisition of IPR&D, interest income, interest expense, and provision for (benefit from) income taxes.

Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in the tables below.

Our management believes the non-GAAP financial measures disclosed in this press release are useful to investors in assessing the operating performance of our business and provide meaningful comparisons to prior periods and thus a more complete understanding of our business than could be obtained absent this disclosure. Specifically, we consider the change in constant currency revenue as a useful metric as it provides an alternative framework for assessing how our underlying business performed excluding the effect of foreign currency rate fluctuations. We consider non-GAAP operating expenses, non-GAAP income from operations, non-GAAP net income and non-GAAP diluted EPS useful metrics as they provide an alternative framework for assessing how our underlying business performed excluding the one-time expense associated with the acquisition of IPR&D in the third quarter of 2023, the amortization expense of finite lived intangible assets acquired in connection with the Sixense acquisition, the excess tax benefits or tax deficiencies associated with share-based compensation arrangements, and the release of the valuation allowance release associated with Federal R&D tax credits and partial release of the valuation allowance associated with California deferred tax assets. Further, we consider adjusted EBITDA a useful metric as it provides an alternative framework for assessing how our underlying business performed excluding non-cash operating charges such as stock-based compensation and depreciation and amortization and non-operating items such as the one-time expense associated with the acquisition of IPR&D, interest income, interest expense, and provision for (benefit from) income taxes.

The non-GAAP financial measures included in this press release may be different from, and therefore may not be comparable to, similarly titled measures used by other companies. These non-GAAP measures should not be considered in isolation or as alternatives to GAAP measures. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business.

Forward-Looking Statements
Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission ("SEC"), including our Annual Report on Form 10-K for the year ended December 31, 2023, which we expect to file with the SEC on or before February 29, 2024. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.

Investor Relations
Penumbra, Inc.
510-995-2461
investors@penumbrainc.com

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SOURCE Penumbra, Inc.