EW · Edwards Lifesciences

205 filings

8-K

EW 8-K Current Reports

Edwards Lifesciences - 205 current reports

Filing record · 2016–202610-K1110-Q328-K88

Showing 1-50 of 205 filings

8-K

Leadership Changes

Edwards Lifesciences 8-K Report, Executive Changes (Aug 28, 2026)

Edwards Lifesciences Corporation (EW) has announced the upcoming retirement of Donald E. Bobo, Jr., Corporate Vice President of Strategy and Corporate Development. Mr. Bobo intends to retire by mid-year 2027, with a transition of his duties expected to occur during 2027. The company has initiated a search process to identify his successor. Following his retirement, Mr. Bobo is expected to continue contributing to the company as a consultant until the end of 2027, ensuring a smooth handover and continued strategic support.

Aug 28, 2026 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jul 23, 2026)

Edwards Lifesciences (EW) reported second-quarter 2026 results that beat expectations on the top line and raised its sales guidance. Q2 net sales rose 13.6% to $1.74 billion (12.5% constant currency), with TAVR up 11.3% to $1.26 billion and TMTT up 47.3% to $195.9 million (about $198.6 million including Implantable Heart Failure Management revenue, per the sales reconciliation table). Surgical grew 6.5% to $284 million. Management attributes TAVR strength to heightened focus on aortic stenosis, the exit of a competitor in Q2 2025, and SAPIEN durability data, and notes stable average selling prices. EVOQUE and PASCAL are cited as key TMTT growth drivers, with SAPIEN M3 in a measured launch. Profitability was mixed. GAAP diluted EPS fell to $0.42 from $0.57 because of a $188.2 million non-cash valuation allowance on R&D tax credits, triggered by California budget legislation enacted June 29, 2026, and a 53.6% quarterly effective tax rate. Adjusted EPS was $0.78 versus $0.67 a year earlier, helped by stronger topline and planned phasing of R&D and SG&A investments. Gross margin was 77.5% (77.6% adjusted), and management now expects gross margin at the low end of its 78% to 79% full-year range because of FX hedging costs. The company also guided the 2026 effective tax rate to the high end of its previous 16% to 19% range. Edwards raised full-year 2026 total company constant currency sales growth guidance to 10% to 11% (from 9% to 11%), TAVR growth to 8% to 9%, and TMTT sales to $760 to $780 million. It reaffirmed adjusted EPS guidance of $2.95 to $3.05, and expects Q3 2026 sales of $1.63 to $1.71 billion and adjusted EPS of $0.71 to $0.77. Near-term catalysts include a CMS final decision memo on the TAVR National Coverage Determination expected in September, TCT presentations (PROGRESS and CLASP IITR) and expected Q4 approvals of next-generation PASCAL and the PASCAL tricuspid indication.

Jul 23, 2026 8-K

Leadership ChangesShareholder MattersExhibits & Filings

Edwards Lifesciences 8-K Report, Executive Changes (May 8, 2026)

Edwards Lifesciences Corporation (EW) held its Annual Meeting of Stockholders on May 7, 2026, where key proposals related to executive compensation and corporate governance were voted upon. The most significant outcome for investors is the approval of the Amended and Restated Long-Term Stock Incentive Compensation Program. This program amendment includes an increase of 7,000,000 shares available for issuance, bringing the total to 341,500,000 shares. This expansion of the equity pool is crucial for future employee and executive compensation, potentially influencing long-term shareholder value through incentive alignment. Additionally, all director nominees were elected, and stockholders approved the advisory proposal on executive compensation and the ratification of PricewaterhouseCoopers LLP as the independent registered public accounting firm. The overwhelming approval of these proposals suggests continued confidence from shareholders in the company's leadership, compensation strategies, and financial oversight.

May 8, 2026 8-K

Leadership ChangesRegulation FD

Edwards Lifesciences 8-K Report, Executive Changes (May 4, 2026)

Edwards Lifesciences (EW) filed an 8-K on May 4, 2026 announcing that Theodora ("Doretta") Mistras will become Corporate Vice President and Chief Financial Officer, effective May 29, 2026, succeeding Scott Ullem, who had announced his planned transition in October 2025 and will remain on as a strategic advisor. Mistras comes from Viatris, where she has been CFO since March 2024, and previously spent time as a managing director in healthcare investment banking at Citigroup and Goldman Sachs. The appointment is a planned, orderly leadership transition rather than a response to a performance issue, and the filing discloses no changes to guidance or financial results. The compensation package is substantial and signals the company's intent to secure a seasoned finance leader. It includes a base salary of $925,000, a target annual bonus of at least 100% of base salary, a $2,013,000 sign-on bonus subject to a 24-month clawback for voluntary resignation or termination for misconduct, and an initial RSU grant with a $8,000,000 grant-date value vesting 43.75%, 50%, and 6.25% over three years. She is also slated for a fiscal 2026 annual equity award with a $4,500,000 grant-date value. Full vesting of the initial RSUs is triggered by termination without Cause, resignation for Good Reason, or death or disability, which are standard protections for executive retention. For investors, the key takeaways are continuity in financial leadership through a planned handover, a new CFO with a deep capital markets and healthcare investment banking background, and a compensation structure that aligns her incentives with multi-year stock performance. The filing does not disclose any financial metrics, guidance, or reasons beyond the stated transition, so the market impact is likely to be limited absent further commentary from management.

May 4, 2026 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Apr 23, 2026)

Edwards Lifesciences (NYSE: EW) reported first-quarter 2026 results that beat its internal expectations, with net sales of $1.65 billion, up 16.7% reported and 12.7% on a constant-currency basis. TAVR sales of $1.20 billion grew 11.0% constant currency, driven by SAPIEN growth in the U.S. and faster growth outside the U.S., with stable global average selling prices. TMTT sales were $173 million (adjusted, excluding $2.0 million of heart failure revenue), and Surgical sales were $276 million, up 5.9% constant currency. Management cited the EARLY TAVR data and European guideline updates as drivers of a shift toward earlier intervention in severe aortic stenosis, and noted that CMS is reconsidering the TAVR National Coverage Determination. GAAP diluted EPS was $0.66, while adjusted EPS was $0.78. The GAAP figure was pressured by a $123.6 million pre-tax ($99.0 million after-tax) impairment on a VIE investment and $37.1 million of litigation expenses, partly offset by a $65.2 million remeasurement gain. Gross margin was 78.0% GAAP (78.2% adjusted), down from 78.7% due to a weaker dollar and new-therapy manufacturing costs. SG&A fell to 31.7% of sales and R&D to 16.0%, and GAAP operating margin rose to 29.0% (31.4% adjusted). The company ended the quarter with about $2.4 billion in cash against roughly $600 million of total debt, and it completed a $500 million accelerated share repurchase with about $1.5 billion remaining under its authorization. Management raised full-year 2026 guidance: constant-currency sales growth to 9%-11% (from 8%-10%), TAVR growth to 7%-9% (from 6%-8%), and adjusted EPS to $2.95-$3.05 (the low end was raised from $2.90 and the midpoint moved to $3.00). Implied total sales are $6.5-$6.9 billion and TAVR sales $4.7-$5.0 billion, with TMTT guidance held at $740-$780 million and Surgical guidance held at mid-single-digit growth. Q2 2026 guidance calls for sales of $1.66-$1.74 billion and adjusted EPS of $0.70-$0.76.

Apr 23, 2026 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Feb 10, 2026)

Edwards Lifesciences (EW) reported fourth-quarter 2025 results that beat the top line and were in line with its prior margin guidance. Q4 sales rose 13.3% to $1.57 billion (11.6% constant currency), led by TAVR at $1.16 billion (up 12.0%, 10.6% constant currency) and TMTT at $156 million (up more than 40%). Surgical sales were $254 million, up 4%. GAAP diluted EPS was just $0.11, but that figure was depressed by a $208.6 million intellectual property and litigation charge and a $99.8 million impairment on its JenaValve investment. Adjusted EPS was $0.58, which management said also reflected a higher-than-expected tax rate. Q4 GAAP operating margin was 9.6% versus 23.7% adjusted, with SG&A rising to 38.4% of sales from 35.5% as strategic patient-access spending was partly pulled forward from earlier quarters. Management raised its confidence in 2026 guidance, now calling for constant currency sales growth of 8% to 10% and adjusted EPS of $2.90 to $3.05. TMTT is expected to grow 35% to 45% to $740 million to $780 million, and full-year operating margin is expected at the high end of the 28% to 29% range. First-quarter 2026 guidance calls for sales of $1.55 to $1.63 billion and adjusted EPS of $0.70 to $0.76. Management pointed to several catalysts: long-term PARTNER 3 and PARTNER 2 data, the EARLY TAVR trial, new European guidelines, FDA approval of SAPIEN M3, and a possible updated TAVR national coverage determination (NCD) that CMS has opened for reconsideration. The company ended 2025 with about $3.0 billion in cash and roughly $600 million in total debt. The filing is a routine Item 2.02 earnings disclosure furnished under Exhibit 99.1 and is not deemed filed under the Exchange Act. For investors, the key questions are whether the growth in TAVR and TMTT holds through 2026, whether SG&A investment converts into higher patient access, and how large and recurring the IP litigation charges and tax rate changes are.

Feb 10, 2026 8-K

Regulation FDExhibits & Filings

Edwards Lifesciences 8-K Report, Regulation FD Disclosure (Jan 12, 2026)

Edwards Lifesciences (EW) disclosed in an 8-K filed January 12, 2026 that the U.S. District Court for the District of Columbia granted the Federal Trade Commission's motion for a preliminary injunction blocking Edwards' proposed acquisition of JenaValve Technology, Inc. As a result, Edwards will not complete the deal. The company publicly disagreed with the decision, arguing the acquisition would have served a large, growing, and underserved patient population with aortic regurgitation (AR), a condition it describes as under-detected, under-referred, and highly lethal if untreated. The strategic implication is that Edwards loses a direct route into the AR valve market, and it will need to rely on its internal programs, principally the SOJOURN transcatheter AR valve and the pivotal JOURNEY trial, to address that segment. The filing does not quantify any termination fee, deal costs, or write-offs, so investors should look to upcoming disclosures for the financial impact of the abandoned transaction. On the financial side, Edwards raised its full-year 2026 adjusted diluted EPS guidance to $2.90–$3.05 from $2.80–$2.95, a range that is roughly $0.10 higher at both ends. The company said further updates would come at its fourth-quarter earnings call in February. Adjusted EPS excludes litigation expenses, intangible amortization, impairment losses, and separation costs, and the company does not reconcile this non-GAAP guidance to GAAP.

Jan 12, 2026 8-K

Leadership ChangesRegulation FDExhibits & Filings

Edwards Lifesciences 8-K Report, Executive Changes (Oct 30, 2025)

Edwards Lifesciences (NYSE: EW) disclosed on October 30, 2025 that Chief Financial Officer Scott Ullem has decided to step down from his role by mid-year 2026. The announcement was made via an Item 5.02 disclosure of a compensatory/officer change and an Item 7.01 Regulation FD press release (Exhibit 99.1). The company is initiating a search for a successor CFO, and the stated goal is continuity and a smooth transfer of responsibilities. The filing is a planned, non-distressed transition. Ullem will remain with the company in an advisory role after a new CFO is appointed, which suggests a deliberate handover rather than an abrupt departure. The filing does not disclose any financial results, guidance changes, or operational problems, and it contains no information on the terms of Ullem's transition, severance, or the timing of the successor search beyond the mid-2026 window. For investors, the key items to monitor are the identity and background of the incoming CFO, whether the search concludes before Ullem leaves, and whether the transition affects reporting cadence or capital allocation priorities. Because the filing is a leadership change without accompanying financial news, it is generally viewed as a governance event rather than a fundamental catalyst, though finance-leadership turnover can warrant closer attention during a period of execution on structural heart growth initiatives.

Oct 30, 2025 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Oct 30, 2025)

Edwards Lifesciences (EW) reported third-quarter 2025 results on October 30, 2025, with net sales of $1.553 billion, up 14.7% year over year (12.6% adjusted, which excludes FX and newly acquired products). Growth was broad-based across product groups. TAVR sales reached $1.15 billion, up 12.4% (10.6% constant currency), and management said demand was better than expected as clinicians prioritized treating aortic stenosis patients, aided by new ESC/EACTS guidelines that recommend intervention regardless of symptoms. TMTT (mitral and tricuspid) sales were $145.2 million, up 59.3%, driven by PASCAL and EVOQUE, while Surgical grew 7.5% to $258 million. Profitability was mixed. GAAP EPS was $0.50, but adjusted EPS was $0.67, which excludes items such as an $90.4 million litigation expense, a $40.0 million intangible asset impairment, and a $12.5 million contingent consideration gain. Adjusted gross margin fell to 77.9% from 80.7%, mainly due to foreign exchange, and SG&A rose to 33.1% of sales from 31.1% as the company invested in transcatheter therapies. Management said adjusted operating margin of 27.5% was above expectations, partly because some spending was deferred to Q4. The company ended the quarter with roughly $3 billion in cash, about $600 million in total debt, and a share repurchase authorization of about $2.1 billion. Management raised full-year 2025 guidance: total sales growth is now at the high end of 9-10%, TAVR underlying growth is 7-8% (up from 6-7%), and adjusted EPS is $2.56-$2.62 (up from a prior high end of $2.45-$2.55). Q4 guidance calls for sales of $1.51-$1.59 billion and adjusted EPS of $0.58-$0.64. Guidance assumes current tariffs remain in place, and any changes could materially affect results.

Oct 30, 2025 8-K

Other EventsExhibits & Filings

Edwards Lifesciences 8-K Report, Corporate Update (Aug 19, 2025)

Edwards Lifesciences (NYSE: EW) disclosed in an 8-K filed August 19, 2025, that it entered an accelerated share repurchase (ASR) agreement to buy back $500 million of its common stock. Under the ASR, Edwards receives an initial delivery of approximately 5 million shares now, with the remaining shares delivered at the ASR's maturity. The final total share count will depend on the volume-weighted average share price over the agreement's term, so the ultimate number of shares retired is not yet fixed. The company is funding the repurchase entirely with existing cash, and management states that it has repurchased more than $800 million of shares in 2025 to date. After this transaction, roughly $600 million remains under the share repurchase authorization approved by the Board of Directors. The filing is an Item 8.01 (Other Events) disclosure, so it reports a capital allocation action rather than a change in operating results, guidance, or financial condition. For investors, the key takeaways are that Edwards is actively returning capital to shareholders while still holding remaining authorization capacity, and that the cash outlay is a meaningful but not transformative use of its balance sheet. The filing does not disclose the initial share price, the expected final share count, the ASR's maturity date, or any impact on EPS or leverage, so those details would need to come from subsequent filings or the company's earnings materials.

Aug 19, 2025 8-K

Regulation FDExhibits & Filings

Edwards Lifesciences 8-K Report, Regulation FD Disclosure (Aug 6, 2025)

On August 6, 2025, Edwards Lifesciences (NYSE: EW) disclosed that the U.S. Federal Trade Commission (FTC) has moved to block its proposed acquisition of JenaValve Technology, Inc., a company focused on treatments for aortic regurgitation (AR). Edwards publicly disagrees with the FTC's decision, argues the deal would accelerate availability and innovation of AR therapies, and says it intends to keep pursuing regulatory approval, estimating a final determination by the end of Q1 2026. The filing is a Regulation FD disclosure furnishing the press release (Exhibit 99.1), so the information is not deemed "filed" under Section 18 of the Exchange Act. The most actionable item for investors is the revised 2025 guidance. Edwards states there is no impact to revenue guidance, and it raised the high end of its full-year 2025 adjusted diluted EPS guidance to $2.45-$2.55 from $2.40-$2.50. Management expects minimal impact on Q3 adjusted EPS guidance. The guidance change is likely tied to the deal's removal from near-term expense assumptions, but the filing does not explicitly quantify the drivers, so investors should treat that link as an inference. The key open question is whether the transaction ultimately closes. The FTC's action introduces regulatory risk, and the outcome remains uncertain until the final determination expected by Q1 2026. The filing's forward-looking statements caution that results could differ materially, and the company does not provide a GAAP reconciliation for its non-GAAP EPS guidance.

Aug 6, 2025 8-K

Leadership Changes

Edwards Lifesciences 8-K Report, Executive Changes (Jul 25, 2025)

Edwards Lifesciences Corporation (EW) has filed an 8-K report detailing a significant executive departure. Larry L. Wood, Corporate Vice President and Group President for Transcatheter Aortic Valve Replacement (TAVR) and Surgical Structural Heart, has resigned to pursue an opportunity outside the cardiovascular industry. Mr. Wood's resignation is effective September 1, 2025. This change in leadership, particularly within the TAVR segment, is a key development for investors to monitor. While the departure is for a non-competitive reason, the transition of responsibilities will be crucial. Daniel J. Lippis, currently overseeing key Asian markets, will assume leadership for the TAVR business unit. Investors should assess the company's communication regarding the strategic implications of this transition and Mr. Lippis's ability to drive the TAVR segment forward.

Jul 25, 2025 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jul 24, 2025)

Edwards Lifesciences reported strong second-quarter 2025 results, with GAAP net sales of $1.53 billion, up 11.9% year over year (10.6% on an adjusted, constant-currency basis). Growth was broad-based: TAVR sales rose 8.9% to $1.13 billion (7.8% constant currency), the TMTT franchise more than doubled its contribution with sales of $134.5 million (up 61.9%, driven by PASCAL and EVOQUE), and Surgical grew 7.7% to $267 million. Management said TAVR growth exceeded expectations, citing SAPIEN adoption, its asymptomatic-patient approval in the U.S., and a modest share gain in Europe after a competitor exited. Profitability was mixed. Gross margin fell to 77.5% from 79.9%, reflecting new-therapy manufacturing costs and foreign exchange. SG&A rose to 32.8% of sales and R&D fell to 18.0% of sales. GAAP operating margin was 26.8%, flat year over year, and 28.2% on an adjusted basis, helped by better-than-expected sales and deferred spending that management expects to hit the second half. GAAP net income from continuing operations fell about 8% to $335.9 million because of a $47.1 million ($37.6 million after tax) impairment on a cost-method investment and a higher effective tax rate of 16.1% versus 5.2%. Adjusted diluted EPS was $0.67, and GAAP diluted EPS from continuing operations was $0.57. Edwards raised its full-year guidance: total sales growth to 9% to 10% ($5.9 billion to $6.1 billion), TAVR growth to 6% to 7% ($4.3 billion to $4.5 billion), and adjusted EPS to the high end of the original $2.40 to $2.50 range. TMTT and Surgical sales guidance was unchanged. For Q3 2025, the company guided to sales of $1.46 billion to $1.54 billion and adjusted EPS of $0.54 to $0.60. Management also flagged higher second-half SG&A, partly tied to JenaValve, and said guidance assumes current tariffs remain in place.

Jul 24, 2025 8-K

Leadership ChangesShareholder MattersExhibits & Filings

Edwards Lifesciences 8-K Report, Executive Changes (May 8, 2025)

Edwards Lifesciences Corporation (EW) has filed an 8-K report detailing the outcomes of its 2025 Annual Meeting of Stockholders. The primary financial information relevant to investors concerns the approval of amendments to the company's Employee Stock Purchase Plans (ESPPs). Stockholders overwhelmingly approved the amendment and restatement of both the U.S. ESPP and the International ESPP, significantly increasing the number of shares available for issuance under these plans. This move indicates a continued commitment to employee stock ownership and may signal management's anticipation of future stock price appreciation, as more shares will be available for purchase by employees at potentially favorable prices.

May 8, 2025 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Apr 23, 2025)

Edwards Lifesciences (EW) reported first-quarter 2025 results that beat expectations on the top line and profitability. Net sales rose 6.2% reported (7.9% adjusted for FX and acquisitions) to $1.41 billion. TAVR sales grew 3.8% reported and 5.4% at constant currency, with the company citing stable pricing and strong SAPIEN 3 Ultra RESILIA performance. TMTT (mitral and tricuspid) was the standout, growing 58% to $115 million, driven by PASCAL and EVOQUE, and management raised its 2025 TMTT sales guidance to $530-550 million. Surgical sales grew 1% to $251 million. Profitability was solid, with GAAP operating margin of 27.9% (29.1% adjusted) and GAAP diluted EPS of $0.62 (adjusted $0.64). Gross margin improved to 78.7%, and R&D fell to 18.0% of sales from 19.3% a year earlier, reflecting prioritized spending. SG&A was 33.0% of sales, somewhat better than planned due to deferred spending that management flagged may shift later in the year. Cash of about $3.1 billion against roughly $600 million of total debt gives a strong balance sheet. The 2025 outlook is mixed. Total sales guidance rose to $5.7-6.1 billion, largely on favorable FX, but management expects margin pressure from a weaker dollar, announced tariffs, and the expected JenaValve acquisition close. The company reaffirmed its 27-28% operating margin and $2.40-2.50 adjusted EPS guidance, and it projects Q2 sales of $1.45-1.53 billion. Investors should note that the guidance explicitly assumes current tariffs remain in place and that the filing discloses a pending Critical Care divestiture, with separation costs and a discontinued-operations loss in the quarter.

Apr 23, 2025 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Feb 11, 2025)

Edwards Lifesciences reported fourth-quarter 2024 sales of $1.39 billion, up 9.4% on a GAAP basis and 8.8% on a constant-currency basis, which the company described as better than expected with growth across all product groups. TAVR sales rose 6% to $1.04 billion, and Transcatheter Mitral and Tricuspid Therapies (TMTT) more than doubled in growth terms, rising 88% to $105 million. Full-year 2024 sales reached $5.44 billion, up 8.6%, with TMTT up 78% to $352 million. Surgical Structural Heart sales were $244 million, up 6%. Profitability was mixed on a GAAP basis but in line with management's plan. Q4 GAAP diluted EPS from continuing operations was $0.58, versus $0.55 a year earlier, and adjusted EPS was $0.59. The GAAP operating margin was 22.6%, compared with 25.6% adjusted. Gross margin was 78.9% GAAP and 79.0% adjusted, down from 80.2% a year earlier. Higher SG&A (35.5% of sales, up from 32.9%) reflects TMTT field teams, Critical Care sale transition costs, and acquisitions. R&D rose 12% to $271 million. Management reiterated 2025 guidance of 8%-10% constant-currency sales growth, adjusted EPS of $2.40-$2.50, and adjusted operating margin of 27%-28%. It guided Q1 2025 sales to $1.35-$1.43 billion and adjusted EPS to $0.58-$0.64. The balance sheet remains strong, with about $3.0 billion in cash and equivalents against roughly $600 million of total debt. Management continues to expect FDA approval of the asymptomatic severe aortic stenosis TAVR indication by mid-2025, which is the key near-term catalyst. Full-year 2024 results also include large discontinued-operations income of $2.77 billion, tied to the Critical Care divestiture, so investors should focus on continuing-operations figures when assessing the core business.

Feb 11, 2025 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Oct 24, 2024)

Edwards Lifesciences (EW) reported third quarter 2024 results on October 24, 2024, with sales from continuing operations rising 8.9% GAAP (9.6% on a constant-currency basis) to $1,354.4 million. Growth was led by Transcatheter Mitral and Tricuspid Therapies (TMTT), which grew 73% to $91.1 million on the PASCAL and EVOQUE launches, while TAVR grew 6.5% to $1,023.3 million and Surgical Structural Heart grew 4.3% to $240.0 million (5.1% constant currency). Diluted EPS was $5.13 on a GAAP basis, but this was inflated by $2.7 billion of income from discontinued operations tied to the sale of the Critical Care business. Continuing-operations diluted EPS was $0.61 GAAP and $0.67 adjusted, which the company described as slightly ahead of its own Q3 guidance. Profitability held up well on an adjusted basis. The adjusted gross margin was 80.7%, up from 79.9% a year earlier, and GAAP operating margin was 25.9%, down from 29.4%, reflecting higher SG&A (31.1% of sales, driven by field-force expansion for the transcatheter launches), R&D up 4% to $253.4 million, and $32.9 million in restructuring charges tied to a global workforce realignment. Management reiterated full-year 2024 sales growth guidance of 8% to 10% on a constant-currency basis, along with its product-group guidance, and guided Q4 sales to $1.33 to $1.39 billion and Q4 adjusted EPS to $0.53 to $0.57. Balance sheet and capital return remained strong. Cash and equivalents were about $3.5 billion and total debt about $600 million at September 30, 2024. Edwards repurchased $1.0 billion of stock in the quarter and has roughly $1.4 billion left under its current authorization. The company also flagged clinical catalysts at the TCT conference, including EARLY TAVR, CLASP IID two-year outcomes, and TRISCEND II one-year data, which investors will watch for effects on the long-term TAVR and TMTT growth outlook.

Oct 24, 2024 8-K

Regulation FDExhibits & Filings

Edwards Lifesciences 8-K Report, Regulation FD Disclosure (Sep 3, 2024)

On September 3, 2024, Edwards Lifesciences (EW) filed an 8-K announcing that it completed the previously disclosed sale of its Critical Care product group to Becton, Dickinson and Company (BD) for $4.2 billion in an all-cash transaction. Management said the net proceeds will fund strategic initiatives, including previously announced acquisitions and share repurchases. The divestiture leaves Edwards focused as a structural heart company. Alongside the closing, the Board authorized an additional $1.5 billion in share repurchases. Edwards also entered into a $500 million accelerated share repurchase (ASR) agreement and, earlier in August, had already repurchased $500 million of stock through a 10b5-1 plan and open-market purchases. After the latest $1 billion repurchase, the company reports $1.4 billion of remaining authorization for future buybacks. CEO Bernard Zovighian framed the sale as sharpening the company's focus on TAVR, transcatheter mitral and tricuspid therapy (TMTT), surgical leadership, and implantable therapies for aortic regurgitation and non-valvular structural heart disease. The filing itself is brief; the press release notes the company will present its strategy and outlook at the Wells Fargo Healthcare Conference on September 5, 2024. The filing contains no financial results, so investors should look to the accompanying materials and subsequent filings for the financial impact of the divestiture.

Sep 3, 2024 8-K

Earnings & ResultsRegulation FDOther Events

Edwards Lifesciences 8-K Report, Financial Results (Jul 24, 2024)

Edwards Lifesciences reported second-quarter 2024 results for continuing operations with net sales of $1,385.9 million, up 7% reported and 8% on a constant-currency basis. GAAP diluted EPS was $0.61 and adjusted EPS was $0.70, which included a $0.04 benefit from a lower-than-expected adjusted tax rate of 8.4%. The standout was Transcatheter Mitral and Tricuspid Therapies (TMTT), with sales of $83.0 million, up 75%, driven by PASCAL and early EVOQUE adoption. TAVR, the core franchise, grew only 5% (6% constant currency) to about $1.04 billion, and management cut full-year TAVR growth guidance to 5-7% from 8-10%. Adjusted gross margin was 77.1%, down from 77.7%, while adjusted SG&A and R&D rose as a percentage of sales to fund TMTT and TAVR field expansion and clinical trials. The company also announced two structural heart acquisitions: JenaValve, a developer of a transcatheter aortic regurgitation valve with FDA approval anticipated in late 2025, and Endotronix, a heart failure sensor company that recently received FDA approval for Cordella. The combined upfront cash price is about $1.2 billion, plus up to $445 million in milestone payments, and both deals remain subject to closing conditions including antitrust and foreign investment approvals. Management expects minimal revenue from these deals in 2025. Separately, the previously announced $4.2 billion sale of the Critical Care business is on track to close in late Q3 2024. Liquidity remains solid, with $2.0 billion in cash and short-term investments against roughly $600 million of total debt. For investors, the key tension is between a strong TMTT growth engine and a weaker-than-expected TAVR franchise. The TAVR guidance cut is the most important operating signal, since TAVR is the largest revenue driver. The acquisitions add long-term optionality in aortic regurgitation and heart failure but carry integration and execution risk, and the Critical Care divestiture will reshape the reported revenue base in the second half of the year. The company guided Q3 2024 sales of $1.56-1.64 billion, including Critical Care for the full quarter, and EPS of $0.67-0.71.

Jul 24, 2024 8-K

Regulation FDOther EventsExhibits & Filings

Edwards Lifesciences 8-K Report, Regulation FD Disclosure (Jul 15, 2024)

On July 15, 2024, Edwards Lifesciences (NYSE: EW) disclosed that it has exercised its option to acquire Innovalve Bio Medical Ltd., an early-stage transcatheter mitral valve replacement (TMVR) company in which Edwards made an initial investment in 2017. Edwards expects to pay approximately $300 million in cash at closing, which is expected by the end of 2024. The filing does not disclose Innovalve's revenue, earnings, or clinical data, so the financial impact on Edwards cannot be assessed from this document alone. Strategically, the deal extends Edwards' mitral franchise into TMVR replacement, complementing its existing mitral repair and replacement programs. Management says Innovalve's technology, combined with Edwards' mitral expertise, could broaden the population treatable with a TMVR platform. Innovalve will join the transcatheter mitral and tricuspid therapies (TMTT) product group led by Corporate Vice President Daveen Chopra. The press release also reiterates that Edwards' SAPIEN M3 remains on track to become the first approved transfemoral TMVR system in Europe by the end of 2025. The main risks are closing risk (timing, or the possibility the deal does not close), transaction costs, management distraction, and integration. Because Innovalve is described as early-stage, the commercial and clinical payoff is likely years away, so the near-term impact on Edwards' results is probably limited to the cash outlay and associated costs. Investors should watch for closing confirmation, any disclosed Innovalve clinical milestones, and how the purchase is accounted for in future filings.

Jul 15, 2024 8-K

Leadership Changes

Edwards Lifesciences 8-K Report, Executive Changes (Jul 10, 2024)

Edwards Lifesciences Corporation (EW) has announced a significant addition to its Board of Directors with the appointment of David T. Feinberg, M.D., effective immediately. Dr. Feinberg brings a wealth of experience spanning nearly three decades in health system management and health information technology services. His extensive background includes leadership roles at prominent organizations such as Oracle Health (Chairman), Cerner Corporation (CEO), Google Health (Vice President), and Geisinger Health (President and CEO), as well as significant experience within UCLA Health. This appointment is particularly noteworthy given Dr. Feinberg's deep expertise in healthcare operations, technology, and quality improvement, which are highly relevant to Edwards Lifesciences' mission in advanced medical technologies. His role as a member of the Board's Audit Committee will further enhance the board's oversight capabilities. Investors may view this as a positive development, signaling a continued focus on strategic growth and operational excellence within the company.

Jul 10, 2024 8-K

Leadership Changes

Edwards Lifesciences 8-K Report, Executive Changes (Jun 17, 2024)

Edwards Lifesciences Corp (EW) announced a key leadership change within its finance department. Robert W.A. Sellers, the current Senior Vice President and Principal Accounting Officer, will retire effective July 1, 2024. This retirement marks the end of Mr. Sellers' tenure, and the company has promptly named his successor. Andrew M. Dahl, who joined Edwards in February 2024 as Senior Vice President and Corporate Controller, will step into the role of Principal Accounting Officer upon Mr. Sellers' retirement. Mr. Dahl brings a wealth of experience from his previous roles at Medtronic PLC, Polaris Industries, and Deloitte & Touche LLP, including extensive background in financial reporting and controls. The company has confirmed that Mr. Dahl's appointment is standard and he has no material business relationships or family ties that would require disclosure under SEC regulations.

Jun 17, 2024 8-K

Regulation FDOther EventsExhibits & Filings

Edwards Lifesciences 8-K Report, Regulation FD Disclosure (Jun 3, 2024)

On June 3, 2024, Edwards Lifesciences (EW) disclosed that it has entered into a Stock and Asset Purchase Agreement to sell its Critical Care product group to Becton, Dickinson and Company (BD) for $4.2 billion in cash. The transaction replaces the previously announced spin-off of Critical Care, which Edwards is no longer pursuing. The sale is structured as an all-cash deal, and Edwards expects the after-tax proceeds to fund strategic growth investments. Management framed the divestiture as a way to sharpen focus on structural heart disease, the company's core strategy. Proceeds are intended to strengthen balance sheet flexibility for investments in aortic, mitral, tricuspid and pulmonic technologies, as well as interventional heart failure. The company stated that the transaction is expected to have an immaterial impact on 2024 adjusted EPS if it closes as anticipated. The deal is expected to close by the end of 2024, subject to customary conditions, including required antitrust and foreign investment approvals. Investors should monitor regulatory progress, as failure to close or delays could affect the company's business and share price. Other key terms, such as break fees and the precise after-tax proceeds, were not disclosed in this filing.

Jun 3, 2024 8-K

Shareholder Matters

Edwards Lifesciences 8-K Report, Shareholder Vote Results (May 8, 2024)

Edwards Lifesciences Corporation (EW) has filed an 8-K report detailing the results of its Annual Meeting of Stockholders held on May 7, 2024. The filing confirms the election of all director nominees, with substantial support from shareholders. Additionally, shareholders provided advisory approval for the company's executive compensation, ratified the appointment of PricewaterhouseCoopers LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024, and approved the Amended and Restated Long-Term Stock Incentive Compensation Program. These outcomes indicate strong shareholder confidence in the company's leadership, financial oversight, and long-term incentive structures. For investors, the overwhelming support for director nominees and the approval of key proposals signal stability and alignment between management and the shareholder base. The ratification of the auditor and the incentive program are routine but important votes that maintain operational continuity and provide a framework for future executive performance and retention. The minimal 'against' votes on these matters, particularly executive compensation and the incentive program, suggest that current shareholder concerns, if any, are not widespread or are being addressed through other company communications.

May 8, 2024 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Apr 25, 2024)

Edwards Lifesciences (NYSE: EW) reported first-quarter 2024 results that beat the top-line expectations embedded in its prior guidance, with net sales up 10% on a reported and constant-currency basis to $1.60 billion (GAAP net sales $1,598.2M vs. $1,459.6M a year ago). Growth was led by Transcatheter Mitral and Tricuspid Therapies (TMTT), which rose 75% to $73 million on PASCAL adoption, while TAVR sales grew 6% to $1.01 billion (8% constant currency adjusted for billing days), driven by the U.S. and Japan. Critical Care grew 13% to $251 million and Surgical Structural Heart grew 7% to $266 million. Management raised its full-year 2024 sales growth outlook to the high end of the prior 8-10% range, lifted Surgical Structural Heart and Critical Care sales expectations and raised TMTT sales guidance to $320-340 million, while maintaining TAVR guidance of 8-10% constant-currency growth and adjusted EPS guidance of $2.70-2.80. Profitability was mixed. GAAP diluted EPS was $0.58 (up from $0.56), and adjusted EPS was $0.66 versus $0.62 a year earlier. Adjusted gross margin declined to 76.0% from 77.5%, reflecting a less favorable foreign exchange impact than in the prior year, while SG&A rose to 30.6% of sales and R&D to 17.8% of sales, driven by transcatheter field personnel and valve innovation spending. GAAP operating income was roughly flat at $387.5 million, held back by $41.3 million of separation costs tied to the planned spin-off of Critical Care. Cash flow and the balance sheet warrant attention. Operating cash flow was negative $53.5 million, largely because of a $305.1 million tax deposit made to mitigate interest on contested tax liabilities; adjusted free cash flow, which excludes that deposit and separation payments, was $206 million. Cash and short-term investments totaled $1.7 billion against roughly $600 million of total debt. Guidance for second-quarter sales of $1.62-1.70 billion and adjusted EPS of $0.67-0.71 was also issued.

Apr 25, 2024 8-K

Leadership Changes

Edwards Lifesciences 8-K Report, Executive Changes (Mar 26, 2024)

Edwards Lifesciences Corporation (EW) announced significant changes to its Board of Directors, effective in conjunction with the upcoming 2024 Annual Meeting of Stockholders on May 7, 2024. Most notably, Michael A. Mussallem, the current Non-Executive Chairman, has decided to retire from his position and will not seek re-election to the Board. This marks the end of a long tenure for Mr. Mussallem, who has been instrumental in the company's leadership.

Mar 26, 2024 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Feb 6, 2024)

Edwards Lifesciences (EW) reported fourth-quarter 2023 results on February 6, 2024, with net sales up 14% reported (13% constant currency) to $1.53 billion, and TAVR sales of $979 million growing 13%. Full-year 2023 sales reached $6.0 billion, up 12%, while GAAP diluted EPS was $2.30 and adjusted EPS was $2.51. Q4 GAAP diluted EPS of $0.61 compares with $0.65 a year earlier, reflecting higher SG&A and R&D spending, a $9.9 million IP litigation expense, and a $17.2 million charge tied to the planned spin-off of Critical Care. Adjusted Q4 EPS of $0.64 was flat year over year, and the adjusted gross margin fell to 76.8% from 81.0%, which management attributed mainly to foreign exchange. The quarter's main investor takeaways are the early U.S. FDA approval of the EVOQUE tricuspid replacement system, which prompted management to move TMTT 2024 sales toward the high end of the $280 to $320 million range, and reaffirmed 2024 guidance of 8 to 10% constant-currency sales growth to $6.3 to $6.6 billion with adjusted EPS of $2.70 to $2.80. Q1 2024 guidance calls for sales of $1.53 to $1.61 billion and adjusted EPS of $0.62 to $0.66. Management also highlighted the planned spin-off of Critical Care, which is a key structural event for the company's future. Balance sheet and capital return remained strong. Cash and short-term investments totaled $1.6 billion at year-end, and total debt was about $600 million. Edwards repurchased $867 million of stock in 2023, including a $400 million accelerated share repurchase in Q4, and roughly $1 billion remains under its authorization. Full-year adjusted free cash flow was $943 million, though Q4 free cash flow was only $48 million. Investors should also note the $139 million and $37 million charges in 2023 tied to the Medtronic IP agreement, which weighed on GAAP results.

Feb 6, 2024 8-K

Regulation FDOther EventsExhibits & Filings

Edwards Lifesciences 8-K Report, Regulation FD Disclosure (Dec 7, 2023)

Edwards Lifesciences (EW) used its December 7, 2023 annual investor conference to outline a sharpened strategic focus on structural heart disease and to announce two capital allocation and portfolio actions. The company announced its intention to complete a tax-free spin-off of its Critical Care product group at the end of 2024, with Katie Szyman, the Corporate Vice President of Critical Care since 2015, slated to become CEO of the new standalone company. A mid-2024 Form 10 filing is planned, with more details to follow during 2024. Separately, the Board approved $1 billion of additional share repurchase authorization, which management described as consistent with past practice of replenishing the program when prior authorizations near completion. On the operating side, management reaffirmed 2023 guidance (sales of $5.9-$6.1 billion, adjusted EPS of $2.47-$2.53) and provided initial 2024 guidance calling for sales of $6.3-$6.6 billion, representing 8%-10% constant-currency growth, and adjusted EPS of $2.70-$2.80, or 9%-11% growth. TAVR is expected to drive the bulk of growth, with 2024 sales of $4.0-$4.3 billion, while TMTT is projected at $280-$320 million. Free cash flow is guided to $1.1-$1.4 billion. Key pipeline catalysts include early completion of enrollment in the PROGRESS moderate aortic stenosis trial in early 2024, EARLY TAVR data at TCT 2024, and expected U.S. approval of EVOQUE in mid-2024. For investors, the spin-off is the most consequential item, as it simplifies Edwards into a pure-play structural heart company while creating a separate monitoring business. Because the filing provides no financial details on Critical Care's standalone economics, dis-synergy costs, or capital structure, the value implications remain to be determined when the Form 10 is filed. Investors should also note that the 2024 guidance is forward-looking and subject to clinical trial, approval, reimbursement, and currency risks described in the company's SEC filings.

Dec 7, 2023 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Oct 25, 2023)

Edwards Lifesciences reported third-quarter 2023 net sales of $1.48 billion, up 12% year over year (11% in constant currency), with growth led by TAVR ($961 million, up 11%) and a sharp rise in the early-stage transcatheter mitral and tricuspid (TMTT) franchise ($52 million, up 76%). GAAP diluted EPS was $0.63, versus $0.55 a year earlier, while adjusted EPS was $0.59, down from $0.61 in the prior-year quarter. Growth was not fully reflected in profitability: adjusted gross margin fell to 76.4% from 81.0%, mainly because of foreign exchange, and SG&A and R&D rose to 29.7% and 18.3% of sales as the company invested in field personnel and clinical trials. Cash generation and the balance sheet remained solid. Free cash flow was $356 million, cash and short-term investments totaled about $1.9 billion, and total debt was about $600 million. The company repurchased roughly $174 million of stock in the quarter under a 10b5-1 plan. Management reiterated full-year 2023 constant-currency sales growth of 10% to 13% and adjusted EPS of $2.50 to $2.60, and guided fourth-quarter sales to $1.45 to $1.53 billion and diluted EPS to $0.60 to $0.66. The key investor takeaways are continued double-digit top-line momentum, new product approvals (EVOQUE CE Mark, PASCAL Precision in Japan, MITRIS RESILIA CE Mark) and completed ENCIRCLE pivotal enrollment for SAPIEN M3, balanced against near-term margin pressure from currency and higher operating spending. Nine-month results were also affected by a $176 million pre-tax intellectual property agreement charge tied to a Medtronic covenant not to sue, which is excluded from adjusted results.

Oct 25, 2023 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jul 26, 2023)

Edwards Lifesciences reported second-quarter 2023 net sales of $1.53 billion, up 11% year over year (12% on a constant-currency basis), with all four product groups growing at double-digit constant-currency rates. TAVR sales of $992 million grew 9% (10% constant currency), aided by improved hospital staffing and the ramp of SAPIEN 3 Ultra RESILIA, which is expected to become the majority of U.S. TAVR sales before year-end. Growth was softer than expected in Japan, where sales declined 4% reported. Profitability was weighed down by a $139 million charge in the quarter related to a 15-year intellectual property agreement (a $300 million payment, about half expensed and half amortized over 15 years). GAAP diluted EPS was $0.50 versus $0.65 a year earlier, while adjusted EPS was $0.66 versus $0.63. Adjusted gross margin fell to 77.7% from 80.5%, mainly due to less favorable foreign exchange, and SG&A and R&D spending rose as the company invested in its transcatheter field force and TAVR clinical programs. Management raised full-year 2023 sales guidance to $5.9-6.1 billion (from a prior high end of $5.6-6.0 billion) and narrowed underlying growth guidance to 10-13%, citing improving hospital staffing and a strong first half. Adjusted EPS guidance was lifted to $2.50-2.60 from $2.48-2.60. Third-quarter guidance calls for sales of $1.44-1.52 billion and adjusted EPS of $0.55-0.61. Liquidity remained solid, with $1.5 billion in cash and short-term investments against roughly $600 million of debt.

Jul 26, 2023 8-K

Leadership ChangesShareholder MattersCorporate Changes+1

Edwards Lifesciences 8-K Report, Executive Changes (May 15, 2023)

This 8-K filing from Edwards Lifesciences (EW) details several key events that occurred around their 2023 Annual Meeting of Stockholders on May 10th, 2023. Most notably, the company announced an increase in CEO Bernard J. Zovighian's annual base salary to $1,050,000 and an incentive pay target of $1,470,000. This compensation adjustment reflects his prior appointment as Chief Executive Officer. Furthermore, the filing reports on the outcomes of various shareholder proposals. All director nominees were elected, and shareholders approved the company's executive compensation on an advisory basis, favoring annual "say-on-pay" votes. A significant amendment to the company's Certificate of Incorporation to provide exculpation for officers, as permitted by Delaware law, was also approved by stockholders. However, a shareholder proposal requesting an independent board chairman policy was not approved. The appointment of PricewaterhouseCoopers LLP as the independent registered public accounting firm for fiscal year 2023 was also ratified.

May 15, 2023 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Apr 26, 2023)

Edwards Lifesciences (NYSE: EW) reported first-quarter 2023 results that beat its internal expectations, with net sales up 9% reported (13% constant currency) to $1.46 billion. Growth was led by Surgical Structural Heart (up 12%, or 17% constant currency) and TAVR (up 8%, or 11% constant currency, with U.S. TAVR procedures growing in the low double digits and ex-U.S. procedures up roughly 10%). GAAP EPS was $0.56 and adjusted EPS was $0.62, versus $0.60 adjusted in the prior-year quarter. Adjusted gross margin slipped to 77.5% from 77.8% due to foreign exchange, while SG&A and R&D rose sharply as the company invests in transcatheter field personnel and valve innovation. GAAP operating income fell 11.5% to $388.4 million, largely due to a $37.0 million charge tied to a 15-year covenant-not-to-sue with Medtronic and $43.5 million of total IP and litigation expenses. Management raised full-year 2023 sales growth guidance to 10-12% (from 9-12%), with total sales expected at the high end of the $5.6-6.0 billion range, and lifted adjusted EPS guidance to $2.48-2.60 (the low end was raised from $2.45). The company generated $253 million of free cash flow, ended the quarter with about $1.3 billion in cash and short-term investments against roughly $600 million of debt, and repurchased about $250 million of stock. It has about $650 million left on its buyback authorization. The filing also notes that CEO Michael Mussallem is retiring next month, with Bernard Zovighian succeeding him, and that the TRISCEND II pivotal trial for the EVOQUE tricuspid valve has completed enrollment. For investors, the quarter shows solid underlying demand and disciplined guidance, but the margin pressure from higher operating spending, the one-time Medtronic charge, and the leadership transition are the items to monitor. Note that the company's sales growth figures are presented on both reported and constant-currency bases, and the adjusted figures are non-GAAP measures.

Apr 26, 2023 8-K

Corporate ChangesExhibits & Filings

Edwards Lifesciences 8-K Report, Bylaw Amendment (Feb 21, 2023)

Edwards Lifesciences Corporation (EW) has filed an 8-K report detailing amendments to its Bylaws, primarily related to director nominations and corporate governance. These changes, effective February 16, 2023, aim to align the company's procedures with new universal proxy rules (Rule 14a-19) and enhance the disclosure requirements for shareholder nominations. The amendments seek to provide greater clarity and robustness to the director nomination process, ensuring compliance and facilitating shareholder engagement within a structured framework. For investors, these updates signify a proactive approach by Edwards Lifesciences to modernize its governance practices. The incorporation of universal proxy rules and enhanced informational requirements for director nominees are designed to ensure a more efficient and transparent shareholder meeting process. While these changes do not directly impact the company's financial performance or strategic operations, they are crucial for maintaining good corporate governance, which can indirectly influence investor confidence and long-term shareholder value.

Feb 21, 2023 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jan 31, 2023)

Edwards Lifesciences reported fourth-quarter 2022 results that were modest on a reported basis but stronger underlying. Q4 net sales rose 1% to $1.35 billion (7% at constant currency), with TAVR flat at $868 million (up 5% underlying). GAAP diluted EPS was $0.65, and adjusted EPS rose 25% to $0.64. Full-year 2022 sales were $5.38 billion (up 3% reported, 8% underlying), GAAP diluted EPS was $2.44, and adjusted EPS grew 12% to $2.48. Management attributed the reported-basis shortfall to a challenging healthcare environment, including staffing constraints and COVID-related disruption, and said conditions are gradually improving. Adjusted gross margin expanded to 81.0% from 76.8%, helped by the FX hedging program and the weaker euro and yen against the dollar. The company reaffirmed its 2023 outlook: underlying sales growth of 9% to 12%, implying $5.6 to $6.0 billion in sales, and adjusted EPS of $2.45 to $2.60. For Q1 2023 it guided to sales of $1.37 to $1.45 billion and adjusted EPS of $0.58 to $0.64. Capital return remained significant, with $1.7 billion of stock repurchased in 2022 (including a $750 million accelerated share repurchase in Q4) and roughly $900 million left under the current authorization. Full-year free cash flow was about $1.0 billion, and the balance sheet holds about $1.2 billion of cash and short-term investments against roughly $600 million of total debt. The filing also points to pipeline and portfolio developments. Edwards began a U.S. rollout of SAPIEN 3 Ultra RESILIA, which uses anti-calcification tissue technology aimed at improving valve durability. Transcatheter mitral and tricuspid (TMTT) sales were $32 million in Q4 and $116 million for the year, growing nearly 50% at constant currency, with the U.S. PASCAL launch beginning. Edwards also exited the HARPOON surgical mitral repair program in Q3 2022, which resulted in a $68.4 million charge that was partly reversed by a $6.1 million gain in Q4. Investors should weigh the strong underlying growth and capital returns against the heavy reliance on TAVR and the company's dependence on a recovery in hospital procedure volumes.

Jan 31, 2023 8-K

Leadership ChangesRegulation FDExhibits & Filings

Edwards Lifesciences 8-K Report, Executive Changes (Dec 8, 2022)

Edwards Lifesciences (EW) disclosed on December 8, 2022 a planned CEO succession. Chairman and CEO Michael A. Mussallem, who recently turned 70, informed the Board on December 6, 2022 that he will retire as CEO at the May 11, 2023 Annual Meeting of Stockholders. He will stand for election at that meeting as non-executive Chairman. Bernard J. Zovighian, currently corporate vice president and general manager of the Transcatheter Mitral and Tricuspid Therapies (TMTT) business, will succeed him as CEO. He becomes President of the company effective January 1, 2023, and CEO on May 11, 2023. The Board had also approved an increase in his base salary and annual cash incentive objective to $800,000 each, effective January 1, 2023. The filing also describes related organizational changes effective January 1, 2023. Larry Wood, currently corporate vice president and general manager of the TAVR business, will become corporate vice president and group president of TAVR and Surgical Structural Heart, with responsibility for both businesses. Daveen Chopra, who has led Surgical Structural Heart since 2018, will take over TMTT. Wood's base salary and annual incentive objective will rise to $750,000 each, effective January 1, 2023. For investors, this is a planned, orderly transition rather than an unexpected departure. Mussallem's move to non-executive Chairman preserves institutional continuity, and Zovighian has an internal track record, including leading TMTT and having held senior roles across the company since 2015. The filing does not disclose any change to financial guidance, pipeline, or operating results, so the near-term investment implications depend mainly on execution during the transition and on how the new structure performs in the TAVR and TMTT franchises.

Dec 8, 2022 8-K

Other EventsExhibits & Filings

Edwards Lifesciences 8-K Report, Corporate Update (Nov 1, 2022)

Edwards Lifesciences Corporation (EW) announced on November 1, 2022, its entry into an Accelerated Share Repurchase Agreement (ASR). This move signifies management's confidence in the company's stock and its commitment to returning capital to shareholders. While the specific details of the ASR agreement, such as the total dollar amount or the number of shares to be repurchased, are not fully detailed in this 8-K filing itself, the press release incorporated by reference likely provides these crucial figures. Investors should review the associated press release for a comprehensive understanding of the share repurchase program's scope and potential impact on the company's financials and stock valuation.

Nov 1, 2022 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Oct 27, 2022)

Edwards Lifesciences (EW) reported third-quarter 2022 results that were mixed: GAAP net sales rose just 0.7% to $1.319 billion, but constant-currency sales grew 6.7% (underlying basis), with the gap driven by a strong U.S. dollar. GAAP diluted EPS was $0.55, while adjusted EPS rose 13% to $0.61 after excluding a $0.07 per share charge tied to the discontinuation of the HARPOON surgical mitral repair program. TAVR, the company's core franchise at $862 million in sales, grew only 1% reported (6% constant currency), held back by persistent U.S. hospital staffing shortages and COVID-related headwinds in Japan. Adjusted gross margin expanded to 81.0% from 76.3%, aided by FX hedging gains. Management lowered its 2022 outlook. Total company sales are now expected at the low end of the previous $5.35–$5.55 billion range, and TAVR sales at the low end of $3.5–$3.7 billion. Adjusted EPS guidance was revised to $2.40–$2.50, versus the prior $2.50–$2.65 range, which the company had previously guided to the bottom of. Management attributes the pressure to hospital staffing constraints and a strong dollar, which it expects to persist into the near term. Management also flagged that EVOQUE CE Mark approval is now anticipated in late 2023 due to EU Medical Devices Regulation delays. From a balance sheet perspective, Edwards remains well capitalized, with $1.7 billion in cash and short-term investments, $250 million of third-quarter free cash flow, and total stockholders' equity of $6.2 billion. Product approvals during the quarter, including FDA approval for the SAPIEN 3 Ultra RESILIA valve and PASCAL Precision for degenerative mitral regurgitation, support the long-term innovation narrative. The company continues to cite a $10 billion global TAVR opportunity and a $5 billion TMTT opportunity by 2028.

Oct 27, 2022 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jul 28, 2022)

Edwards Lifesciences (NYSE: EW) reported second-quarter 2022 results on July 28, 2022, with net sales of $1.37 billion, flat year-over-year against an elevated prior-year comparison, though underlying sales (excluding foreign exchange) grew 5%. GAAP diluted EPS was $0.65 and adjusted EPS was $0.63. TAVR, the company's core franchise, generated $907 million (up 1% reported, 5% underlying), with U.S. TAVR sales held back by ongoing hospital staffing constraints while ex-U.S. underlying TAVR growth was in the mid-teens. Adjusted gross margin improved to 80.5% from 75.9%, aided by the FX hedging program, and R&D rose 11% to $251 million as the company funds eight pivotal trials. The key negative for investors is the guidance cut. Management lowered its second-half underlying sales growth outlook to approximately 10%, citing FX headwinds and slower-than-expected recovery in COVID-related hospital staffing. Full-year 2022 sales guidance is now $5.35 to $5.55 billion, and adjusted EPS is expected at the bottom of the original $2.50 to $2.65 range. Third-quarter guidance calls for sales of $1.30 to $1.37 billion and adjusted EPS of $0.58 to $0.66, and management still expects strong double-digit adjusted EPS growth in the second half. Balance sheet and capital return remained solid. Edwards generated $289 million of free cash flow in the quarter, ended with $1.5 billion in cash and short-term investments, repurchased $355 million of stock under a 10b5-1 plan, and has $1.9 billion remaining under its buyback authorization after the Board increased it in July. Management reiterated its long-term view that the global TAVR opportunity will reach $10 billion by 2028 and the TMTT opportunity $5 billion, with pivotal trial readouts expected later in 2022.

Jul 28, 2022 8-K

Material AgreementsFinancial EventsExhibits & Filings

Edwards Lifesciences 8-K Report, Material Agreement (Jul 21, 2022)

Edwards Lifesciences Corporation (EW) announced on July 20, 2022, its entry into a new five-year credit agreement, effective July 15, 2022. This agreement establishes a $750 million multi-currency unsecured revolving credit facility, replacing the company's previous 2018 credit agreement. The new facility offers improved pricing and terms compared to its predecessor. The company has the option to increase the facility size by an additional $250 million, subject to lender approval. Borrowings under the new revolving facility will be subject to variable interest rates tied to the Secured Overnight Financing Rate (SOFR) or a base rate, plus an applicable margin based on leverage or debt ratings. The facility matures on July 15, 2027, and is intended for general corporate purposes, with no amounts borrowed as of the filing date. The agreement includes customary covenants and financial restrictions, such as a maximum leverage ratio.

Jul 21, 2022 8-K

Shareholder Matters

Edwards Lifesciences 8-K Report, Shareholder Vote Results (May 4, 2022)

Edwards Lifesciences Corporation (EW) filed an 8-K on May 4, 2022, detailing the results of its 2022 Annual Meeting of Stockholders held on May 3, 2022. The meeting's primary focus was on shareholder votes regarding director elections, executive compensation, auditor ratification, and a shareholder proposal. All incumbent directors were overwhelmingly re-elected, indicating strong shareholder confidence in the current board's leadership and strategy. Similarly, the advisory vote on executive compensation received majority approval, suggesting alignment between shareholder and management views on compensation practices. The ratification of PricewaterhouseCoopers LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2022, also passed with substantial support. This signifies continued trust in the company's financial reporting and audit processes. However, a shareholder proposal to lower the ownership threshold required to call a special meeting was notably not approved, highlighting a divergence in opinion on corporate governance mechanisms related to shareholder activism.

May 4, 2022 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Apr 26, 2022)

Edwards Lifesciences (EW) reported first-quarter 2022 results on April 26, 2022, with net sales of $1.34 billion, up 10.2% reported and 12.7% underlying (excluding FX). Growth was broad-based: TAVR sales of $881 million rose 11% (14% underlying), with U.S. TAVR up about 10% and international underlying TAVR up roughly 20%. Surgical Structural Heart ($221 million, +4%) and Critical Care ($212 million, +8%) also grew, while TMTT remained small at $27 million but more than tripled on a reported basis from a low base. GAAP diluted EPS was $0.59 and adjusted EPS was $0.60. Adjusted gross margin expanded to 77.8% from 76.0%, largely from favorable FX, while SG&A rose to 27.6% of sales and R&D to 17.0%. Cash flow and capital return were solid. Free cash flow was $221 million (operating cash flow of $294 million less $73 million of capex), and the company repurchased roughly $400 million of stock in the quarter, including a $250 million accelerated share repurchase. Cash, cash equivalents and short-term investments totaled $1.5 billion at quarter-end, with long-term debt essentially flat at about $596 million. Management reaffirmed full-year 2022 guidance of underlying sales growth in the low double digits to $5.5–$6.0 billion (including a roughly $170 million FX headwind) and adjusted EPS of $2.50–$2.65. Second-quarter guidance calls for sales of $1.36–$1.44 billion and adjusted EPS of $0.61–$0.69. For investors, the key takeaways are steady TAVR execution despite Omicron-related hospital disruption in January, continued pipeline progress (EARLY TAVR and PROGRESS trials, SAPIEN X4 ALLIANCE trial starting in Q2, PASCAL Precision U.S. approval expected late 2022, EVOQUE Europe approval expected late 2022), and a guidance reaffirmation that implies continued but unchanged expectations. The filing is an earnings release furnished under Item 2.02 and is not deemed filed, so it carries no new disclosure beyond the press release itself.

Apr 26, 2022 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jan 26, 2022)

Edwards Lifesciences (EW) reported Q4 and full-year 2021 results on January 26, 2022, via an 8-K furnishing its earnings press release. Full-year 2021 sales reached $5.23 billion, up 19% reported (18% underlying), and Q4 sales rose 12% to $1.33 billion (13% underlying). GAAP diluted EPS was $2.38 for the year, while adjusted EPS of $2.22 grew 19%. Q4 GAAP diluted EPS was $0.53 versus adjusted EPS of $0.51. Growth was broad-based, though TAVR sales were tempered in late December by Omicron-related hospital capacity constraints in the U.S. Outside the U.S., underlying TAVR sales grew roughly 20% in Q4, and TMTT sales more than doubled for the full year to $86 million. Profitability and cash generation were strong. Full-year GAAP operating margin reached 32.3%, aided by a $124 million gain from the change in fair value of contingent consideration, and adjusted free cash flow totaled $1.4 billion versus $734 million in 2020. Cash, equivalents and short-term investments stood at roughly $1.5 billion at year-end, against total debt of about $600 million. Adjusted gross margin improved to 76.8% in Q4, while R&D rose 19% to $233 million as TMTT trial activity increased and SG&A climbed to 31.9% of sales as commercial activity resumed. Management reaffirmed full-year 2022 guidance: sales of $5.5 to $6.0 billion (low double-digit growth) and adjusted EPS of $2.50 to $2.65. Q1 2022 guidance calls for sales of $1.27 to $1.35 billion and adjusted EPS of $0.54 to $0.62. Management also cited milestones including completed enrollment in the CLASP IID and EARLY TAVR pivotal trials, FDA approval of SAPIEN 3 with Alterra for pulmonic valve replacement, and expected U.S. approval later in 2022 of PASCAL for degenerative mitral regurgitation. The company estimates the global TAVR opportunity will double to $10 billion by 2028 and the TMTT opportunity will reach $5 billion.

Jan 26, 2022 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Oct 27, 2021)

Edwards Lifesciences reported third-quarter 2021 net sales of $1.31 billion, up 15% reported and 14% on an underlying basis (excluding FX). Growth was broad: TAVR sales rose 15% to $858 million, Critical Care rose 18% to $213 million, and Surgical Structural Heart rose 7% to $217 million. Management attributed the slowdown in U.S. TAVR (up 12%, versus about 20% growth outside the U.S.) to Delta-variant-related deferrals of procedures in the last two months of the quarter, and said it expects many of those patients to be treated later. Diluted GAAP EPS was $0.54, compared with $0.52 a year earlier. Adjusted EPS, which excludes IP litigation, contingent consideration fair-value changes, and intangible amortization, was also $0.54, up from $0.51. Adjusted gross margin improved to 76.3% from 75.5%, while SG&A (up about 19%) and R&D (up 22%) grew faster than sales, and GAAP operating margin fell to 29.8% from 31.4%. Management held full-year 2021 guidance: sales of $5.2–5.4 billion, with total company growth still expected in the high-teens, and adjusted EPS at the high end of the $2.07–2.27 range. Fourth-quarter guidance calls for sales of $1.30–1.38 billion, including TAVR sales of $850–910 million, and adjusted EPS of $0.53–0.59. The balance sheet remains strong, with about $3.1 billion in cash and investments against $596 million of total debt. Year-to-date free cash flow was $1.1 billion, although Q3 free cash flow of $471 million was lower than Q2 and lower than the quarterly run rate implied by year-to-date results. Management also reiterated long-term opportunity targets: a TAVR market above $7 billion by 2024 and a TMTT opportunity of about $3 billion by 2025. The company remains on track for U.S. approval of PASCAL for degenerative mitral regurgitation in late 2022. Note that this 8-K furnishes the press release under Item 2.02, so the release is not deemed "filed" under the Exchange Act.

Oct 27, 2021 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jul 29, 2021)

Edwards Lifesciences (EW) reported strong second quarter 2021 results, with net sales of $1.376 billion, up 49% reported and 44% on an underlying basis versus the prior year, as the business recovered from COVID-related disruption in 2020. Growth was broad-based across all four product groups, led by transcatheter aortic valve replacement (TAVR), where sales reached $902 million, up 52% reported and 48% underlying. GAAP diluted EPS was $0.78, while adjusted diluted EPS was $0.64; the gap reflects a $102.6 million non-cash benefit from a reduction in the fair value of contingent consideration liabilities, which management excluded from adjusted results. Adjusted gross margin improved to 75.9% from 74.4%, though SG&A and R&D spending rose sharply as commercial activity and clinical trial investment resumed. Management raised full-year 2021 guidance: sales are now expected at $5.2 to $5.4 billion (previously $4.9 to $5.3 billion), and adjusted EPS is expected at the high end of the prior $2.07 to $2.27 range. Underlying TAVR growth guidance was lifted to around 20% from 15% to 20%. For the third quarter, the company projects sales of $1.29 to $1.37 billion and adjusted EPS of $0.50 to $0.56. Free cash flow for the quarter was $457 million, and the company ended the period with $2.6 billion in cash and investments against $595 million of total debt, while repurchasing $112 million of stock. The filing also highlights longer-term opportunity: management reiterated that the global TAVR market should exceed $7 billion by 2024, and that the transcatheter mitral and tricuspid (TMTT) opportunity could roughly triple to about $3 billion by 2025, though TMTT sales remained small at $22 million in the quarter. Investors should note that the company's results still depend on the pace of COVID-related recovery, vaccine adoption, and the timing of pivotal trial readouts and reimbursement decisions.

Jul 29, 2021 8-K

Corporate ChangesExhibits & Filings

Edwards Lifesciences 8-K Report, Bylaw Amendment (Jul 15, 2021)

Edwards Lifesciences Corporation (EW) filed an 8-K on July 15, 2021, to announce amendments to its corporate Bylaws. These changes primarily focus on modernizing meeting procedures and clarifying governance provisions. Key updates include enabling virtual stockholder meetings and electronic delivery of notices and proxies, aligning with recent Delaware law amendments. This offers greater flexibility and accessibility for shareholder participation and communication. Further enhancements address director nominations, allowing only stockholders of record to nominate candidates and clarifying the maximum number of nominees. The Bylaws also refine procedures for meeting adjournments and the signing of stock certificates. Notably, a new exclusive forum provision designates U.S. federal district courts for Securities Act of 1933 litigation, aiming to streamline legal proceedings. These amendments are designed to improve operational efficiency and corporate governance for the company.

Jul 15, 2021 8-K

Leadership ChangesShareholder MattersRegulation FD+1

Edwards Lifesciences 8-K Report, Executive Changes (May 5, 2021)

Edwards Lifesciences' May 5, 2021 Form 8-K reports the results of its May 4, 2021 Annual Meeting and a board action to expand its share repurchase program. Stockholders re-elected all eight director nominees, approved the advisory say-on-pay proposal, approved amendments to the U.S. and International Employee Stock Purchase Plans, and ratified PricewaterhouseCoopers LLP as auditor for fiscal 2021. Two stockholder proposals, one on action by written consent and one on including non-management employees as director candidates, were rejected. Management's recommendations prevailed on every item. The most important financial item is the Board's May 4, 2021 approval of an additional $1 billion repurchase authorization with no expiration date. The company disclosed that $262 million remained under the program as of May 1, 2021, which implies roughly $1.26 billion of total capacity after the new authorization. Repurchases may be made in the open market, under a Rule 10b5-1 plan, or in privately negotiated transactions, and their timing will depend on market conditions and corporate needs. The authorization signals management's continued emphasis on capital return. Governance changes are modest. Dr. William J. Link retired from the Board immediately before the Annual Meeting after 12 years of service, and Nicholas J. Valeriani, a director since 2014, succeeded him as Chair of the Compensation and Governance Committee. The ESPP amendments add 3.3 million shares to the U.S. plan and 1.2 million shares to the International plan. Investors should note that the filing's text describes both increases as applying to the U.S. ESPP, which appears to be a drafting error, and that the press release is dated May 5, 2020, which also appears to be a typo.

May 5, 2021 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Apr 20, 2021)

Edwards Lifesciences (EW) reported first-quarter 2021 results that beat expectations, with net sales of $1.22 billion, up 8% reported and 5% on an underlying (FX-neutral) basis, and diluted EPS of $0.54 versus $0.49 a year earlier. Growth was led by TAVR, which generated $792 million (up 7% reported, 4% underlying), while Surgical Structural Heart ($213 million, up 10%) and Critical Care ($196 million, up 7%) also contributed. Management said structural heart procedures increased through the winter months and described sales as better than expected, though it acknowledged that COVID-19 will weigh on structural heart patients in the near term. Profitability was steady: GAAP operating margin was 31.5% and adjusted gross margin was 76.0%, down from 76.7%, reflecting FX headwinds and COVID-related costs. SG&A rose to 27.2% of sales and R&D to 17.0%, as investment in transcatheter programs continued. The company raised its full-year 2021 adjusted EPS guidance to $2.07–$2.27 from $2.00–$2.20, while reiterating full-year sales guidance of $4.9–$5.3 billion and underlying TAVR growth of 15–20%. Second-quarter guidance calls for sales of $1.25–$1.33 billion and adjusted EPS of $0.54–$0.60. Balance sheet strength continued, with $2.1 billion in cash and investments against $595 million of total debt, and free cash flow of $195 million. Edwards repurchased $303 million of stock (3.6 million shares) through an accelerated share repurchase and a 10b5-1 plan, and that ASR has now been completed. For investors, the key points are the operating beat, the EPS guidance raise, and the early-stage regulatory and pipeline milestones: Japan approval for low-surgical-risk TAVR, a U.S. pivotal trial in moderate aortic stenosis, and a planned first U.S. commercial approval for the PASCAL mitral system late in 2022. The TMTT business is still small at $16 million in quarterly sales, so near-term results remain driven by TAVR.

Apr 20, 2021 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jan 27, 2021)

Edwards Lifesciences reported fourth quarter 2020 results on January 27, 2021, with Q4 sales up 1% to $1.19 billion (underlying sales flat) and GAAP diluted EPS of $0.49, or $0.50 on an adjusted basis (up 2%). Growth was muted by COVID-19: U.S. sales fell 3.7% in the quarter, while international sales rose 9.2% (5.3% underlying). TAVR, the company's core franchise, grew 2% reported but was flat underlying, with U.S. sales down mid-single digits and OUS sales up high-single digits on an underlying basis. Surgical Structural Heart (down 1%) and Critical Care (down 1%) were also soft, with HemoSphere capital orders in the U.S. weakening as hospitals limited capital spending. Full-year 2020 results were distorted by a $367.9 million litigation settlement charge related to transcatheter mitral and tricuspid patent litigation, which drove GAAP diluted EPS down to $1.30 from $1.64. Excluding non-GAAP items, adjusted EPS was flat at $1.86 and sales rose 1% to $4.39 billion. Balance sheet strength remained solid, with $2.2 billion in cash and investments against $595 million of total debt, and Q4 free cash flow of $287 million. Note that the $233 million litigation settlement accrual now sits on the balance sheet. Looking forward, management reiterated full-year 2021 sales guidance of $4.9 to $5.3 billion and adjusted EPS of $2.00 to $2.20, and expects underlying sales growth in the mid-teens (15-20% in the TAVR outlook commentary). The company guided Q1 2021 sales of $1.1 to $1.2 billion and adjusted EPS of $0.43 to $0.50, with early-2021 COVID headwinds expected to give way to more normalized growth in the second half. Investors will focus on the pace of U.S. TAVR recovery and the early progress of the TMTT (transcatheter mitral and tricuspid therapies) franchise, which generated only $13 million in Q4 sales but is targeted to reach a $3 billion global opportunity by 2025.

Jan 27, 2021 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Oct 22, 2020)

Edwards Lifesciences (EW) reported third quarter 2020 results on October 21, 2020, disclosed in an 8-K furnished under Item 2.02. Net sales were $1.14 billion, up 4% on both a reported and underlying basis, and TAVR remained the primary growth engine with global sales of $745 million, up 6%. GAAP diluted EPS was $0.52, while adjusted EPS grew 9% to $0.51. Adjusted gross margin was 75.5%, down slightly from 75.9% a year earlier, pressured by foreign currency and COVID-related costs. Management raised the low end of full-year 2020 adjusted EPS guidance to $1.85–$1.95 from $1.75–$1.95. The quarter's most important signals for investors are the TAVR recovery and the outlook. Management said hospitals have largely resumed treating aortic stenosis patients alongside COVID patients, and it guided to similar underlying sales growth in Q4 2020 and a return to double-digit TAVR growth in 2021. The TMTT (transcatheter mitral and tricuspid) franchise remains early-stage, with only $12 million of quarterly sales, but management reiterated a $3 billion global market opportunity by 2025 and said enrollment in its five pivotal trials is back to pre-COVID rates, though initial results could slip by a couple of quarters. Surgical Structural Heart was flat at $203 million, and Critical Care was flat at $181 million, helped by a one-time European TruWave order. Balance sheet and cash generation remained solid. Free cash flow was $113 million for the quarter, and the company held $1.9 billion in cash and investments against $595 million of total debt. Investors should note that the reported results benefited from a $9.0 million fair-value gain on contingent consideration, and that 2020 year-to-date GAAP results were heavily affected by a $367.9 million patent litigation settlement recorded in Q2 2020. Adjusted figures exclude these items and other non-GAAP adjustments, so GAAP and adjusted comparisons should be read carefully.

Oct 22, 2020 8-K

Earnings & ResultsExhibits & Filings

Edwards Lifesciences 8-K Report, Financial Results (Jul 23, 2020)

Edwards Lifesciences reported second-quarter 2020 results that were heavily affected by the COVID-19 pandemic. Net sales fell 15% year over year to $925 million (down 14% on an underlying, FX-adjusted basis), with TAVR sales down 12% to $594 million and Surgical Structural Heart and Critical Care both declining more sharply than TAVR. GAAP results turned to a net loss of $121.9 million, or $(0.20) per diluted share, driven primarily by a $367.9 million charge to settle patent litigation related to transcatheter mitral and tricuspid repair products. Excluding that charge and other non-GAAP items, adjusted EPS fell 26% to $0.34. Adjusted gross margin contracted to 74.4% from 76.4%, reflecting COVID-related costs and FX headwinds, while SG&A and R&D fell in dollar terms as elective procedures and clinical trial activity slowed. Management said TAVR procedure volumes improved steadily through May and June, with roughly 90% of active sites performing TAVR cases, and that the company expects third-quarter sales of $1.0 to $1.2 billion, roughly in line with 2019 levels. Full-year 2020 sales guidance of $4.0 to $4.5 billion was reiterated, while adjusted EPS guidance was raised to $1.75 to $1.95 on a post-split basis from $1.58 to $1.75. The guidance rests on a progressive recovery in the second half and remains highly dependent on how the pandemic evolves. Edwards ended the quarter with $1.7 billion in cash and investments against $595 million of total debt, and generated $123 million of free cash flow. From a longer-term perspective, the company received FDA approval to start the TRISCEND II pivotal trial for the EVOQUE tricuspid replacement system, which has breakthrough device designation, and it reiterated its target of U.S. approval for PASCAL in degenerative mitral regurgitation in 2022. The filing also reflects a three-for-one stock split effective May 29, 2020, so per-share figures are not directly comparable to prior periods reported on a pre-split basis.

Jul 23, 2020

Page 1 of 5