EW Q2 2025: EPS raised to $2.50; TAVR sales jump double-digits
- Renewed TAVR momentum: Management highlighted strong clinical data from early TAVR studies, which is driving a renewed focus on timely management of aortic stenosis. This momentum, along with the recent asymptomatic indication approvals and forthcoming guideline updates (including CMS NCD changes), could expand the addressable market and drive long‐term growth.
- International market tailwinds: Executives noted that the exit of a key competitor in Europe and the focused efforts to regain market share in Japan, coupled with solid global sales performance outside the U.S., position the company favorably for enhanced international growth.
- Innovative, diversified product portfolio: The strong growth in emerging product lines such as TMTT—with impressive double-digit gains—and the continuous rollout of next-generation technologies like SAPIEN M3, underscore the company’s ability to drive future sales and margin expansion.
- Regulatory Uncertainties: The pace of updating the national coverage decision (NCD) and guidelines for treating asymptomatic patients remains uncertain and could delay broader market access.
- Margin Pressures: Headwinds including deferred expenses, ongoing integration risks with the GenaValve acquisition, tariffs, and negative FX impacts could compress operating margins in the second half of 2025.
- Reimbursement Risks for Asymptomatic Cases: In the absence of clear national coverage, reliance on local MACs for case‐by‐case reimbursement might lead to inconsistent patient access and slow treatment adoption.
Metric | YoY Change | Reason |
---|---|---|
Total Revenue | +10.7% YoY to $1,532.2M vs $1,385.9M | The overall revenue increase is driven by strong performance across key segments, notably a dramatic 62% surge in TMTT and an 8.9% rise in TAVR, which offset the minimal change in Surgical Structural Heart revenue. This build‐up reflects the ongoing momentum from earlier quarters, with high-growth product launches and increased market adoption supporting overall gains. |
TAVR Revenue | +8.9% YoY to $1,130.9M vs $1,038.6M | Growth in TAVR revenue stems from the continued expansion and strong adoption of the Edwards SAPIEN 3 Ultra RESILIA platform, echoing previous performance improvements and leveraging enhanced clinical outcomes and market penetration. |
TMTT Revenue | +62% YoY to $134.5M vs $83.0M | The substantial surge in TMTT revenue is attributed to accelerated adoption of the PASCAL and EVOQUE systems, with expanded market access and new regulatory approvals building upon earlier robust performance. |
Surgical Structural Heart Revenue | +1% YoY to $266.8M vs $264.3M | The Surgical Structural Heart segment saw only marginal growth, reflecting stable yet flat sales of key products. This modest increase is consistent with prior trends, indicating that premium surgical technologies are maintaining a steady performance without significant expansion. |
U.S. Revenue | +9% YoY to $889.7M vs $816.8M | U.S. revenue growth was bolstered by stronger sales of the SAPIEN 3 Ultra RESILIA valve and improved performance in TMTT offerings, continuing the upward trend observed in previous periods amid favorable domestic market conditions. |
Europe Revenue | +12.7% YoY to $378.2M vs $335.6M | The increase in Europe's revenue is driven by the successful launch of advanced technologies like the SAPIEN 3 Ultra RESILIA valve and robust results in both TAVR and TMTT segments, building on earlier achievements while benefiting from favorable foreign exchange impacts despite pricing pressures. |
Japan Revenue | +9% YoY to $95.3M vs $87.4M | Despite previous challenges from currency fluctuations and competitive pressures, Japan's revenue improved modestly due to a recovery in procedure volumes and steady adoption of Edwards' advanced therapies, reflecting an incremental turnaround from prior periods. |
Rest of World Revenue | +15.6% YoY to $169.0M vs $146.1M | The Rest of World region showed robust performance with a 15.6% increase driven by higher sales across multiple segments, including both Surgical Structural Heart and TMTT, supported by favorable constant currency growth and an expanding market base as built upon previous momentum. |
Metric | Period | Previous Guidance | Current Guidance | Change |
---|---|---|---|---|
Total Company Sales | FY 2025 | $5.7B to $6.1B | $5,900,000,000 to $6,100,000,000 | raised |
Total Company Sales Growth | FY 2025 | 8% to 10% | 9% to 10% | raised |
Adjusted EPS | FY 2025 | $2.40 to $2.50 | $2.40 to $2.50 | no change |
Gross Profit Margin | FY 2025 | 78% to 79% | 78% to 79% | no change |
Operating Margin | FY 2025 | 27% to 28% | 27% to 28% | no change |
Tax Rate | FY 2025 | 15% to 18% | 15% to 18% | no change |
Shares Outstanding Guidance | FY 2025 | no prior guidance | 585,000,000 to 590,000,000 | no prior guidance |
Foreign Exchange Impact on Sales | FY 2025 | no prior guidance | Approximately $30,000,000 upside | no prior guidance |
Tariff Impact Guidance | FY 2025 | no prior guidance | Initially expected to be $0.05, now less than half that | no prior guidance |
Sales | Third Quarter 2025 | no prior guidance | $1,460,000,000 to $1,540,000,000 | no prior guidance |
Adjusted EPS | Third Quarter 2025 | no prior guidance | $0.54 to $0.60 | no prior guidance |
Metric | Period | Guidance | Actual | Performance |
---|---|---|---|---|
Sales | Q2 2025 | Between $1.45B and $1.53B | $1,532.2M | Beat |
Topic | Previous Mentions | Current Period | Trend |
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TAVR Growth | Consistently discussed in Q1 2025 ( ), Q4 2024 ( ) and Q3 2024 ( ) as a steady driver with mid‐single digit growth and solid global performance. | Emphasized strong global TAVR sales with renewed clinical focus, increased guidance (6‑7%) and reliance on SAPIEN technology ( ). | Positive momentum: Sentiment has improved with stronger results and an upward revision in guidance, signaling confidence in future growth. |
Asymptomatic TAVR Approvals | Previously highlighted in Q1 2025 as an anticipated catalyst via EARLY TAVR data ( ) and in Q4 2024 with a mid‑2025 approval projection ( ); Q3 2024 mentioned trial results ( ). | Now, the company reported U.S. and European approvals for asymptomatic indications, positioning the platform as first‑to‑market in this space ( ). | Catalyst materializing: The transition from anticipated approvals to achieved regulatory milestones has boosted sentiment and set longer‐term growth expectations. |
Regulatory Uncertainty and Guideline Updates | In Q1 2025, regulatory processes (FDA timelines and NCD) and guideline updates were discussed with cautious optimism ( ), and Q4 2024 outlined longer‑term catalyst expectations ( ). Q3 2024 did not focus on these topics explicitly. | Discussion focused on remaining U.S. uncertainty—especially around updating the National Coverage Determination—while noting positive progress in Europe with recent CE mark approvals ( ). | Mixed outlook: While the European environment shows clarity, ongoing U.S. regulatory uncertainty continues to pose a long‑term risk despite favorable catalyst potential. |
Product Innovation and Diversified Portfolio Expansion | Covered in all prior periods—from Q3 2024 initiatives with PASCAL and EVOQUE ( ) to Q4 2024 innovations and strategic acquisitions ( ) and Q1 2025 portfolio expansion with new product approvals ( ). | Emphasized its Sharpen Focus strategy, significant growth in TMTT and surgical product segments, and new pipeline developments such as the SAPIEN M3, alongside multiple strategic acquisitions ( ). | Sustained strength: Consistent commitment to innovation with expanded portfolios and acquisitions is reinforcing a positive long‑term narrative, with continued momentum in introducing breakthrough therapies. |
International Market Dynamics and Regional Performance | Previous calls (Q1 2025 and Q4 2024) noted challenges in Japan due to weaker growth ( ) and strong European performance ( ); Q3 2024 added comments on stable global sales with some regional pressure ( ). | Emphasized robust European rollout (S3UR) and a focused effort to regain lost ground in Japan through enhanced capabilities and addressing local competitive pressures ( ). | Ongoing repositioning: While Europe remains a bright spot, efforts in Japan are intensifying to recapture market share, reflecting a cautious yet proactive stance in international markets. |
Margin Pressure, Tariffs, FX Impacts, and Cost Challenges | Consistently discussed in Q1 2025 ( ), Q4 2024 ( ) and Q3 2024 ( ); challenges from FX, tariffs and integration of acquisitions were noted as headwinds impacting margins. | Reported a decline in gross margin (e.g. 77.6%) due to additional manufacturing costs and FX impacts; noted that tariffs now impact less than originally expected, with ongoing cost management amid acquisition-related expenses ( ). | Evolving obstacles: While margin pressures remain a key concern, improvements such as a lower-than-anticipated tariff impact are emerging; overall, strategies to mitigate FX and cost issues are continuing amid operational headwinds. |
Acquisition Integration and Execution Risks | In Q1 2025, integration risks were discussed with reference to JenaValve dilution ( ) and Q3 2024 covered the integration of JC Medical and JenaValve amid regulatory review ( ); Q4 2024 made only brief reference via broader acquisitions. | Not explicitly mentioned in Q2 2025, although references to the nearing GenaValve acquisition process imply integration challenges remain ( ). | Less explicit focus: The detailed discussion on integration has diminished in Q2 2025, yet underlying execution risks persist as acquisitions progress, suggesting a cautious but less prominently featured concern. |
Robust Financial Guidance and EPS Sensitivity | Financial guidance has been strong across prior calls—Q3 2024 ( ), Q4 2024 ( ) and Q1 2025 ( )—with steady EPS targets and acknowledgment of acquisition/tariff impacts. | Raised full‑year 2025 sales guidance to 9‑10% and increased adjusted EPS expectations, though headwinds from the GenaValve acquisition and FX sensitivity remain noted ( ). | Upward revision with caution: Guidance improvements underscore robust performance; however, sensitivity to external factors (acquisitions, FX, tariffs) keeps the risk profile in check, reflecting careful optimism. |
Competitive Dynamics and Market Share Pressures | Prior periods consistently mentioned competitive challenges: Q1 2025 focused on Japan’s weaker performance ( ), Q4 2024 discussed regional pressures and stable global positioning ( ), while Q3 2024 highlighted strong global sales and premium positioning ( ). | In Q2 2025, the company reaffirmed a strong U.S. competitive stance, noted progress in capturing market share internationally (including a competitor exit), and continued efforts to regain leadership in Japan ( ). | Steady confidence: Competitive positioning is maintained, with ongoing initiatives to address regional pressures and recapture lost share, reflecting sustained strategic focus despite evolving market conditions. |
Execution and Timing Risks for Key Catalysts | Earlier periods (Q1 and Q3 2024) detailed timing uncertainties tied to regulatory reviews, clinical trial results (EARLY TAVR, NCD for EVOQUE) and new product launches ( and ); Q4 2024 noted multi‑year catalyst timelines for TAVR and TMTT ( ). | Q2 2025 mentioned catalysts (such as regulatory and product milestones) without elaborating on explicit timing risks, indicating some milestones have been achieved while others remain subject to external schedules ( ). | Slight de‑emphasis: The focus on execution risks is less detailed in Q2 2025, suggesting that while some key milestones have been reached, inherent timing uncertainties persist for upcoming regulatory and product development events. |
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EPS Guidance
Q: Why isn’t EPS raised further?
A: Management explained that despite beating expectations and revising guidance to the high end ($2.50), headwinds like the GenaValve acquisition and tariff pressures remain, yet they remain confident in sustainable growth. -
Margin Outlook
Q: What are H2 operating margins?
A: They expect H2 operating margins to settle in the mid-25% range, factoring in FX impacts, reduced tariff effects, and planned acquisition expenses. -
TAVR Performance
Q: What drove strong TAVR results?
A: A renewed clinical focus bolstered by early TAVR data and recent asymptomatic approvals helped deliver double-digit sales growth globally with steady pricing and adoption. -
Competitor Share
Q: How will you capture competitor share?
A: With a competitor exiting the market, management actively reached out to key centers and emphasized their robust long-term outcomes to maintain a premium position. -
Regulatory Changes
Q: When will CMS reopen the NCD?
A: Management believes the time is ripe and expects CMS to update coverage rules soon, streamlining operator and facility requirements to further expand TAVR access. -
EVOQUE Insights
Q: How does EVOQUE’s safety profile compare?
A: European real‐world data show EVOQUE outcomes equal to or better than trial benchmarks, reinforcing its strong safety and performance record. -
Backlog & Workflow
Q: Has the TAVR backlog improved?
A: Although patient processing still takes 3–6 months, the renewed referral focus suggests workflow improvements may be emerging, even if the backlog itself remains unchanged. -
MCD & Europe Access
Q: How do MCD changes affect access?
A: Locally, MACs evaluate cases individually, and recent CE approval in Europe now enables management to begin broader reimbursement discussions—though full market impact is still unfolding.
Research analysts covering Edwards Lifesciences.