EDWARDS LIFESCIENCES REPORTS THIRD QUARTER RESULTS
- Q3 sales grew 12% to $1.48 billion
- TAVR sales grew 11%
- Received CE Mark for EVOQUE
- Received approval for PASCAL Precision system
- Reiterated full year 2023 financial guidance
- Adjusted gross profit margin decreased to 76.4%
- Increased selling, general, and administrative expenses
- Increased research and development expenses
Recent Highlights and Outlook
- Q3 sales grew 12 percent to
; constant currency1 sales grew 11 percent$1.48 billion - Q3 TAVR sales grew 11 percent; constant currency sales grew 10 percent
- Q3 EPS of
; adjusted1 EPS of$0.63 $0.59 - Received CE Mark for EVOQUE, the first transfemoral tricuspid replacement system
- Received approval for PASCAL Precision system in
Japan - Received CE Mark for MITRIS RESILIA surgical mitral valve
- Completed pivotal trial enrollment for SAPIEN M3, the first transfemoral mitral replacement system
- Reiterated full year 2023 financial guidance of 10 to 13 percent constant currency sales growth
"We are pleased with our strong third quarter performance, which included multiple new therapy approvals for the treatment of patients globally and important achievements on clinical milestones, as well as another quarter of double-digit sales growth," said Bernard Zovighian, CEO. "The increasing demand for our advanced technologies, coupled with the successful execution of our innovation strategy, gives us confidence in the tremendous opportunity to address unmet patient needs and drive differentiated long-term value."
Transcatheter Aortic Valve Replacement (TAVR)
For the quarter, the company reported TAVR sales of
In the
"After more than 20 years of rigorous clinical experience and over 1 million patients treated, TAVR with SAPIEN is now a highly effective standard of care for patients suffering from aortic heart valve failure," said Larry Wood, group president of TAVR and Surgical Structural Heart. "We remain focused on improving diagnosis and treatment of the many more patients who remain untreated."
The combination of Edwards' global TAVR leadership, along with the data presented at TCT, gives the company further confidence in the future of TAVR and the company's expectation of a
Transcatheter Mitral and Tricuspid Therapies (TMTT)
Third quarter sales were
As previously announced, the company received CE Mark for the EVOQUE tricuspid valve replacement system. This groundbreaking therapy will be introduced to patients in
Surgical Structural Heart and Critical Care
Surgical Structural Heart sales for the quarter were
Critical Care sales for the quarter were
Additional Financial Results
For the quarter, the adjusted gross profit margin was 76.4 percent, compared to 81.0 percent in the same period last year. This year-over-year reduction was driven by impacts from foreign exchange. Last year, Edwards' gross profit margin was lifted by an unusually positive impact from foreign exchange.
Selling, general and administrative expenses in the third quarter were
Research and development expenses in the third quarter were
Free cash flow for the third quarter was
Cash, cash equivalents and short-term investments totaled
Outlook
Edwards' full-year sales guidance remains unchanged for both the total company and each product group. The company continues to expect full-year total company and TAVR sales growth to be in the 10 to 13 percent range on a constant currency basis.
Additionally, the company continues to expect full year 2023 adjusted earnings per share of
"We are confident in our focused and differentiated strategy given heart valve failure is largely underdiagnosed and undertreated for patients globally. We remain convinced in the tremendous opportunity to drive success in the future through our focus, innovation and leadership," said Zovighian.
About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.
Conference Call and Webcast Information
Edwards Lifesciences will be hosting a conference call today at 2:00 p.m. PT to discuss its third quarter results. To participate in the conference call, dial (877) 704-2848 or (201) 389-0893. The call will also be available live and archived on the "Investor Relations" section of the Edwards web site at ir.edwards.com or www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "forecast," "potential," "predict," "early clinician feedback," "expect," "intend," "guidance," "outlook," "optimistic," "aspire," "confident" or other forms of these words or similar expressions and include, but are not limited to, statements made by Mr. Zovighian, fourth quarter and full year 2023 financial guidance, statements regarding the international adoption of TAVR, statements regarding transforming patient treatment, approvals, clinical outcomes, adoption, and the information in the Outlook section. No inferences or assumptions should be made from statements of past performance, efforts, or results which may not be indicative of future performance or results. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain, difficult to predict, and may be outside of the company's control. The company's forward-looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include risk and uncertainties associated with the COVID pandemic, clinical trial or commercial results or new product approvals and therapy adoption; unpredictability of product launches; competitive dynamics; changes to reimbursement for the company's products; the company's success in developing new products and avoiding manufacturing supply and quality issues; the impact of currency exchange rates; the timing or results of R&D and clinical trials; unanticipated actions by the
Edwards, Edwards Lifesciences, the stylized E logo, Acumen, Acumen IQ, ENCIRCLE, EVOQUE, Hypotension Prediction Index, MITRIS, MITRIS RESILIA, PASCAL, PASCAL Precision, RESILIA, SAPIEN, SAPIEN M3, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
___________________ | |
[1] | "Adjusted" amounts are non-GAAP items. "Underlying" and "constant currency" growth rates in this press release exclude foreign exchange fluctuations. Adjusted earnings per share is a non-GAAP item computed on a diluted basis and in this press release also excludes an intellectual property agreement and litigation expenses, amortization of intangible assets, fair value adjustments to contingent consideration liabilities arising from acquisitions, a significant program discontinuation, and the impact from tax law change. See "Non-GAAP Financial Information" and reconciliation tables below. |
EDWARDS LIFESCIENCES CORPORATION | |||||||
Three Months Ended | Nine Months Ended | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Net sales | $ 1,480.9 | $ 1,319.0 | $ 4,470.7 | $ 4,034.1 | |||
Cost of sales | 350.4 | 253.8 | 1,022.9 | 822.5 | |||
Gross profit | 1,130.5 | 1,065.2 | 3,447.8 | 3,211.6 | |||
Selling, general, and administrative expenses | 439.6 | 377.3 | 1,344.6 | 1,156.6 | |||
Research and development expenses | 270.3 | 233.6 | 801.8 | 713.0 | |||
Intellectual property agreement and litigation expense (income), net | 2.2 | (2.4) | 193.6 | 10.8 | |||
Change in fair value of contingent consideration liabilities | — | (12.5) | (26.2) | (36.3) | |||
Special charge | — | 66.8 | — | 66.8 | |||
Operating income | 418.4 | 402.4 | 1,134.0 | 1,300.7 | |||
Interest income, net | (15.1) | (6.9) | (32.8) | (8.4) | |||
Other (income) expense, net | (5.8) | 2.0 | (9.6) | 1.0 | |||
Income before provision for income taxes | 439.3 | 407.3 | 1,176.4 | 1,308.1 | |||
Provision for income taxes | 55.6 | 63.8 | 146.7 | 184.6 | |||
Net income | 383.7 | 343.5 | $ 1,029.7 | $ 1,123.5 | |||
Net loss attributable to noncontrolling interest | (1.2) | — | (2.8) | — | |||
Net income attributable to Edwards Lifesciences Corporation | $ 384.9 | $ 343.5 | $ 1,032.5 | $ 1,123.5 | |||
Earnings per share: | |||||||
Basic | $ 0.63 | $ 0.55 | $ 1.70 | $ 1.81 | |||
Diluted | $ 0.63 | $ 0.55 | $ 1.69 | $ 1.79 | |||
Weighted-average common shares outstanding: | |||||||
Basic | 607.0 | 619.8 | 607.2 | 621.0 | |||
Diluted | 609.5 | 624.5 | 610.2 | 626.9 | |||
Operating statistics | |||||||
As a percentage of net sales: | |||||||
Gross profit | 76.3 % | 80.8 % | 77.1 % | 79.6 % | |||
Selling, general, and administrative expenses | 29.7 % | 28.6 % | 30.1 % | 28.7 % | |||
Research and development expenses | 18.3 % | 17.7 % | 17.9 % | 17.7 % | |||
Operating income | 28.3 % | 30.5 % | 25.4 % | 32.2 % | |||
Income before provision for income taxes | 29.7 % | 30.9 % | 26.3 % | 32.4 % | |||
Net income | 25.9 % | 26.0 % | 23.0 % | 27.9 % | |||
Effective tax rate | 12.7 % | 15.7 % | 12.5 % | 14.1 % |
____________________ |
Note: Numbers may not calculate due to rounding. |
EDWARDS LIFESCIENCES CORPORATION | |||
September 30, 2023 | December 31, 2022 | ||
ASSETS | |||
Current assets | |||
Cash and cash equivalents | $ 1,410.1 | $ 769.0 | |
Short-term investments | 453.8 | 446.3 | |
Accounts receivables, net | 739.8 | 643.0 | |
Other receivables | 62.3 | 56.1 | |
Inventories | 1,032.4 | 875.5 | |
Prepaid expenses | 133.3 | 110.0 | |
Other current assets | 235.8 | 195.9 | |
Total current assets | 4,067.5 | 3,095.8 | |
Long-term investments | 704.6 | 1,239.0 | |
Property, plant, and equipment, net | 1,681.3 | 1,632.8 | |
Operating lease right-of-use assets | 90.9 | 92.3 | |
Goodwill | 1,297.4 | 1,164.3 | |
Other intangible assets, net | 429.8 | 285.2 | |
Deferred income taxes | 651.9 | 484.0 | |
Other assets | 447.4 | 299.1 | |
Total assets | $ 9,370.8 | $ 8,292.5 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities | |||
Accounts payable and accrued liabilities | $ 1,214.6 | $ 996.9 | |
Operating lease liabilities | 24.3 | 25.5 | |
Total current liabilities | 1,238.9 | 1,022.4 | |
Long-term debt | 596.8 | 596.3 | |
Contingent consideration liabilities | — | 26.2 | |
Taxes payable | 81.2 | 143.4 | |
Operating lease liabilities | 70.0 | 69.5 | |
Uncertain tax positions | 312.1 | 267.5 | |
Litigation agreement accrual | 104.4 | 143.0 | |
Other liabilities | 240.3 | 217.5 | |
Total liabilities | 2,643.7 | 2,485.8 | |
Stockholders' equity | |||
Common stock | 649.9 | 646.3 | |
Additional paid-in capital | 2,211.3 | 1,969.3 | |
Retained earnings | 8,622.5 | 7,590.0 | |
Accumulated other comprehensive loss | (250.1) | (254.9) | |
Treasury stock, at cost | (4,576.1) | (4,144.0) | |
Total Edwards Lifesciences Corporation stockholders' equity | 6,657.5 | 5,806.7 | |
Noncontrolling interest | 69.6 | — | |
Total equity | 6,727.1 | 5,806.7 | |
Total liabilities and equity | $ 9,370.8 | $ 8,292.5 |
EDWARDS LIFESCIENCES CORPORATION
Non-GAAP Financial Information
To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses non-GAAP historical financial measures. Management makes adjustments to the GAAP measures for items (both charges and gains) that (a) do not reflect the core operational activities of the Company, (b) are commonly adjusted within the Company's industry to enhance comparability of the Company's financial results with those of its peer group, or (c) are inconsistent in amount or frequency between periods (albeit such items are monitored and controlled with equal diligence relative to core operations). The Company uses the term "underlying" when referring to non-GAAP sales and sales growth information, which excludes currency exchange rate fluctuations. The Company uses the term "adjusted" to also exclude intellectual property litigation expenses, intellectual property agreements, amortization of intangible assets, fair value adjustments to contingent consideration liabilities arising from acquisitions, a significant program discontinuation, and the impact from tax law changes.
Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results, and evaluating current performance. These non-GAAP financial measures are used in addition to, and in conjunction with, results presented in accordance with GAAP and reflect an additional way of viewing aspects of the Company's operations by investors that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting the Company's business and facilitate comparability to historical periods.
Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. A reconciliation of non-GAAP historical financial measures to the most comparable GAAP measure is provided in the tables below.
Fluctuations in currency exchange rates impact the comparative results and sales growth rates of the Company's underlying business. Management believes that excluding the impact of currency exchange rate fluctuations from its sales growth provides investors a more useful comparison to historical financial results. The impact of the fluctuations has been detailed in the "Reconciliation of Sales by Product Group and Region."
Guidance for sales and sales growth rates is provided on an "underlying basis," and projections for diluted earnings per share, net income and growth, gross profit margin, taxes, and free cash flow are also provided on a non-GAAP basis, as adjusted, for the items identified above due to the inherent difficulty in forecasting such items without unreasonable efforts. The Company is not able to provide a reconciliation of the non-GAAP guidance to comparable GAAP measures due to the unknown effect, timing, and potential significance of special charges or gains, and management's inability to forecast charges associated with future transactions and initiatives.
Management considers free cash flow to be a liquidity measure which provides useful information to management and investors about the amount of cash generated by business operations, after deducting payments for capital expenditures, which can then be used for strategic opportunities or other business purposes including, among others, investing in the Company's business, making strategic acquisitions, strengthening the balance sheet, and repurchasing stock.
The items described below are adjustments to the GAAP financial results in the reconciliations that follow:
Intellectual Property Litigation Expenses - The Company incurred intellectual property litigation expenses of
Change in Fair Value of Contingent Consideration Liabilities - The Company recorded expense of
Amortization of Intangible Assets - The Company recorded amortization expense related to developed technology and patents in the amount of
Intellectual Property Agreement - The Company recorded a
Program Discontinuation - The Company recorded a
Provision for Income Taxes - During the third quarter of 2023, the Company recorded a
The income tax impacts of the expenses and gains discussed above are based upon the items' forecasted effect upon the Company's full year effective tax rate. Adjustments to forecasted items unrelated to the expenses and gains above, as well as impacts related to interim reporting, will have an effect on the income tax impact of these items in subsequent periods.
EDWARDS LIFESCIENCES CORPORATION | ||||||||||||
Three Months Ended September 30, 2023 | ||||||||||||
Net Sales | Gross | Operating | Net Income | Diluted | Effective | |||||||
GAAP | $ 1,480.9 | 76.3 % | $ 418.4 | $ 384.9 | $ 0.63 | 12.7 % | ||||||
Non-GAAP adjustments: (A) (B) | ||||||||||||
Intellectual property litigation expenses | — | — | 2.2 | 1.3 | — | 0.1 | ||||||
Amortization of intangible assets | — | 0.1 | 1.2 | 1.0 | — | — | ||||||
Foreign tax credit suspension | — | — | — | (23.2) | (0.04) | 5.3 | ||||||
Prior period ongoing tax impacts | — | — | — | (3.4) | — | 0.7 | ||||||
Adjusted | $ 1,480.9 | 76.4 % | $ 421.8 | $ 360.6 | $ 0.59 | 18.8 % | ||||||
Three Months Ended September 30, 2022 | ||||||||||||
Net Sales | Gross | Operating | Net Income | Diluted | Effective | |||||||
GAAP | $ 1,319.0 | 80.8 % | $ 402.4 | $ 343.5 | $ 0.55 | 15.7 % | ||||||
Non-GAAP adjustments: (A) (B) | ||||||||||||
Intellectual property litigation expenses | — | — | (2.4) | (2.2) | — | — | ||||||
Change in fair value of contingent consideration liabilities | — | — | (12.5) | (12.1) | (0.02) | 0.4 | ||||||
Amortization of intangible assets | — | 0.1 | 1.5 | 1.3 | — | — | ||||||
Program discontinuation | — | 0.1 | 68.4 | 53.3 | 0.08 | 0.9 | ||||||
Adjusted | $ 1,319.0 | 81.0 % | $ 457.4 | $ 383.8 | $ 0.61 | 17.0 % | ||||||
Nine Months Ended September 30, 2023 | ||||||||||||
Net Sales | Gross | Operating | Net Income | Diluted | Effective | |||||||
GAAP | $ 4,470.7 | 77.1 % | $ 1,134.0 | $ 1,032.5 | $ 1.69 | 12.5 % | ||||||
Non-GAAP adjustments: (A) (B) | ||||||||||||
Intellectual property agreement | — | — | 176.0 | 138.7 | 0.23 | 1.1 | ||||||
Intellectual property litigation expenses | — | — | 17.6 | 13.6 | 0.02 | 0.1 | ||||||
Change in fair value of contingent consideration liabilities | — | — | (26.2) | (24.1) | (0.04) | 0.1 | ||||||
Amortization of intangible assets | — | 0.1 | 4.0 | 3.3 | 0.01 | — | ||||||
Foreign tax credit suspension | — | — | — | (23.2) | (0.04) | 1.8 | ||||||
Adjusted | $ 4,470.7 | 77.2 % | $ 1,305.4 | $ 1,140.8 | $ 1.87 | 15.6 % | ||||||
Nine Months Ended September 30, 2022 | ||||||||||||
Net Sales | Gross | Operating | Net Income | Diluted | Effective | |||||||
GAAP | $ 4,034.1 | 79.6 % | $ 1,300.7 | $ 1,123.5 | $ 1.79 | 14.1 % | ||||||
Non-GAAP adjustments: (A) (B) | ||||||||||||
Intellectual property litigation expenses | — | — | 10.8 | 8.4 | 0.02 | 0.1 | ||||||
Change in fair value of contingent consideration liabilities | — | — | (36.3) | (34.0) | (0.05) | 0.2 | ||||||
Amortization of intangible assets | — | 0.1 | 4.4 | 3.8 | — | — | ||||||
Program discontinuation | — | 0.1 | 68.4 | 53.3 | 0.08 | 0.4 | ||||||
Adjusted | $ 4,034.1 | 79.8 % | $ 1,348.0 | $ 1,155.0 | $ 1.84 | 14.8 % |
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(A) | See description of non-GAAP adjustments under "Non-GAAP Financial Information." |
(B) | The tax effect on non-GAAP adjustments is calculated based upon the impact of the relevant tax jurisdictions' statutory tax rates on the Company's estimated annual effective tax rate, or discrete rate in the quarter, as applicable. The impact on the effective tax rate is reflected on each individual non-GAAP adjustment line item. |
RECONCILIATION OF SALES BY PRODUCT GROUP AND REGION | ||||||||||||||
2022 Adjusted | ||||||||||||||
Sales by Product Group (QTD) | 3Q 2023 | 3Q 2022 | Change | GAAP Growth Rate* | FX Impact | 3Q 2022 | Underlying Growth Rate * | |||||||
Transcatheter Aortic Valve Replacement | $ 960.9 | $ 862.3 | $ 98.6 | 11.4 % | $ 11.4 | $ 873.7 | 9.9 % | |||||||
Transcatheter Mitral and Tricuspid Therapies | 52.4 | 29.7 | 22.7 | 76.0 % | 1.9 | 31.6 | 65.3 % | |||||||
Surgical Structural Heart | 246.6 | 219.7 | 26.9 | 12.2 % | 2.4 | 222.1 | 11.0 % | |||||||
Critical Care | 221.0 | 207.3 | 13.7 | 6.6 % | 0.5 | 207.8 | 6.3 % | |||||||
Total | $ 1,480.9 | $ 1,319.0 | $ 161.9 | 12.3 % | $ 16.2 | $ 1,335.2 | 10.9 % | |||||||
2022 Adjusted | ||||||||||||||
Sales by Product Group (YTD) | YTD | YTD | Change | GAAP Growth Rate* | FX Impact | YTD 3Q | Underlying Growth Rate * | |||||||
Transcatheter Aortic Valve Replacement | $ 2,900.4 | $ 2,650.5 | $ 249.9 | 9.4 % | $ (17.1) | $ 2,633.4 | 10.2 % | |||||||
Transcatheter Mitral and Tricuspid Therapies | 141.6 | 84.6 | 57.0 | 67.3 % | 1.1 | 85.7 | 65.2 % | |||||||
Surgical Structural Heart | 751.1 | 669.0 | 82.1 | 12.3 % | (8.1) | 660.9 | 13.7 % | |||||||
Critical Care | 677.6 | 630.0 | 47.6 | 7.6 % | (10.8) | 619.2 | 9.5 % | |||||||
Total | $ 4,470.7 | $ 4,034.1 | $ 436.6 | 10.8 % | $ (34.9) | $ 3,999.2 | 11.8 % | |||||||
2022 Adjusted | ||||||||||||||
Sales by Region (QTD) | 3Q 2023 | 3Q 2022 | Change | GAAP Growth | FX Impact | 3Q 2022 | Underlying Growth Rate * | |||||||
$ 869.9 | $ 786.8 | $ 83.1 | 10.6 % | $ — | $ 786.8 | 10.6 % | ||||||||
322.3 | 270.1 | 52.2 | 19.3 % | 22.7 | 292.8 | 10.0 % | ||||||||
108.4 | 104.1 | 4.3 | 4.1 % | (4.2) | 99.9 | 8.0 % | ||||||||
Rest of World | 180.3 | 158.0 | 22.3 | 14.2 % | (2.3) | 155.7 | 15.8 % | |||||||
Outside of | 611.0 | 532.2 | 78.8 | 14.8 % | 16.2 | 548.4 | 11.3 % | |||||||
Total | $ 1,480.9 | $ 1,319.0 | $ 161.9 | 12.3 % | $ 16.2 | $ 1,335.2 | 10.9 % | |||||||
2022 Adjusted | ||||||||||||||
Sales by Region (YTD) | YTD | YTD | Change | GAAP Growth | FX Impact | YTD 3Q | Underlying Growth Rate * | |||||||
$ 2,614.3 | $ 2,337.1 | $ 277.2 | 11.9 % | $ — | $ 2,337.1 | 11.9 % | ||||||||
989.6 | 884.0 | 105.6 | 11.9 % | 8.6 | 892.6 | 10.9 % | ||||||||
340.4 | 362.5 | (22.1) | (6.1) % | (27.4) | 335.1 | 1.6 % | ||||||||
Rest of World | 526.4 | 450.5 | 75.9 | 16.9 % | (16.1) | 434.4 | 21.2 % | |||||||
Outside of | 1,856.4 | 1,697.0 | 159.4 | 9.4 % | (34.9) | 1,662.1 | 11.8 % | |||||||
Total | $ 4,470.7 | $ 4,034.1 | $ 436.6 | 10.8 % | $ (34.9) | $ 3,999.2 | 11.8 % |
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* Numbers may not calculate due to rounding. |
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SOURCE Edwards Lifesciences Corporation
FAQ
What were the Q3 sales growth and TAVR sales growth for Edwards Lifesciences?
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