Q1 2025 Earnings Summary
- Zio AT Momentum: Management highlighted that Zio AT has consistently outpaced overall company growth, with widespread adoption among accounts already using the long-term continuous monitor. The sustained trials and high patient adherence suggest significant opportunity to capture additional market share.
- Primary Care Expansion: Nearly 1/3 of prescriptions now come from primary care channels, with management emphasizing the potential to tap into a 27 million patient market, indicating a massive expansion opportunity beyond traditional cardiology channels.
- Epic Integration Benefits: Early Epic Aura integration results have shown a 20% to 40% increase in average prescribing patterns among integrated accounts, which underscores operational efficiencies and enhanced market penetration that could drive future revenue growth.
- Japan Market Reimbursement Risk: The company originally anticipated around $2 million in contributions from Japan, but current reimbursement rates were lower than expected. This may hinder revenue growth in one of its strategically important international markets.
- Emerging Channel Uncertainty: While innovative channels like undiagnosed monitoring are showing promise, they currently constitute only low single-digit percentages of total volume and remain highly unpredictable. Their future contribution poses uncertainty to overall growth.
- Margin Pressure from Tariffs and Pricing Challenges: The company faces potential headwinds from global import tariffs and continued pricing pressure in the MCT segment—expected to remain flat—despite mitigation strategies, which could adversely impact profitability.
Metric | YoY Change | Reason |
---|---|---|
Total Revenue | +20% (from $131.93M to $158.68M) | Revenue growth was driven by increased volume and heightened demand for Zio services, reflecting improved market penetration and stronger primary care adoption. This increase aligns with previous period trends where operational expansion and record new account openings spurred revenue. |
Gross Profit | +24.8% (from $87.52M to $109.22M) | Gross profit increased due to higher revenue and improved cost efficiencies, which raised the gross margin from roughly 66% to 69%. The improvement builds on earlier gains where stable selling prices and enhanced operational efficiency were key factors. |
Net Loss | Improved by 33% (from –$45.67M to –$30.70M) | The reduction in net loss is primarily attributed to the revenue and gross profit increases, which helped offset rising operating expenses. Despite higher expenditure in R&D (up 26%) and SG&A (up 10%), better operational leverage led to a substantially lower net loss compared to the prior period. |
Operating Expenses | Increased from $125.65M to $141.77M | Operating expenses rose mainly due to a 26% increase in R&D spending and a 10% increase in SG&A costs, indicating further investment in innovation and market expansion. These higher costs, while adding to overall expenses, are consistent with past trends of investing in growth initiatives. |
Net Loss Per Common Share | Improved (from –$1.47 to –$0.97 per share) | The improvement in net loss per common share reflects the overall reduction in net loss alongside revenue growth and enhanced operational margins. Although operating costs increased, the dilution effect was mitigated by the stronger performance in key revenue and profit metrics compared to the previous period. |
Metric | Period | Previous Guidance | Current Guidance | Change |
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Revenue | FY 2025 | $675 million to $685 million | $690 million to $700 million | raised |
Adjusted EBITDA Margin | FY 2025 | 7% to 8% | 7.5% to 8.5% | raised |
Free Cash Flow | FY 2025 | Slightly free cash flow–negative | Slightly negative | no change |
Remediation Expenses | FY 2025 | $15 million | $15 million | no change |
Gross Margin | FY 2025 | Modest improvements | Remain flat | lowered |
Tariff Impact | FY 2025 | No prior guidance | 50 to 75 basis points negative impact | no prior guidance |
Revenue | Q2 2025 | No prior guidance | Consistent with historical averages, approx 25% of full‐year revenue | no prior guidance |
Adjusted EBITDA Margin | Q2 2025 | No prior guidance | 6% to 7% | no prior guidance |
Metric | Period | Guidance | Actual | Performance |
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Revenue | Q1 2025 | Approximately 22.5% of full-year 2025 revenue range ($675M–$685M) → $151.9M–$154.1M | $158.677M | Beat |
Topic | Previous Mentions | Current Period | Trend |
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Primary Care Expansion | Mentioned consistently in Q4 2024 with **over 50% IDNs adopting PCP prescribing via EMR integration **, in Q3 2024 with expansion into primary care accounts , and in Q2 2024 with active expansion targeting over 15 million patients and earlier care pathway initiatives. | Q1 2025 highlights that nearly 1/3 of long-term monitoring volumes now originate from primary care channels, with an emphasis on AI-driven targeting and a “land-and-expand” strategy. | Increasing focus and adoption – The messaging has evolved from building early partnerships to showcasing substantial volume contributions and strategic emphasis, with a positive sentiment toward expanding primary care access. |
Market Diversification | In Q4 2024, the company discussed international launches, innovative channel partnerships, and expanding into undiagnosed arrhythmia monitoring. Q3 2024 described a transformation into a multi-market global growth company while Q2 2024 outlined expansion plans into international markets and adjacent opportunities like sleep monitoring. | Q1 2025 emphasizes robust contributions from innovative channel partners with the strongest revenue contribution from undiagnosed arrhythmia monitoring, underscoring strategic diversification and rising market opportunity. | Consistent and growing – The focus on diversifying market opportunities is maintained and appears to be deepening, with increasing revenue contributions from nontraditional channels and thoughtful expansion into international and adjacent markets. |
Zio AT Performance | In Q4 2024, Zio AT was noted for strong performance and market share gains. Q3 2024 reported record registrations and solid volume growth , and Q2 2024 discussed FDA remediation-related challenges alongside steady performance. | Q1 2025 reports the strongest quarter in company history for Zio AT, with record revenue volumes, accelerated YoY growth, and advanced AI features contributing to superior performance and market share gains. | Robust and accelerating – Zio AT’s performance remains consistently strong with clear signs of momentum and enhanced competitive positioning over time. |
Margin Dynamics | Q4 2024 mentioned that Zio AT had slightly lower gross margins compared to Zio monitor but still contributed positively. Q3 2024 saw gross margins around 68.8% with stable operations , and Q2 2024 highlighted improved margins driven by automation and operational efficiencies. | Q1 2025 shows gross margins at 68.8% with an improved adjusted EBITDA margin (an increase of 750 basis points), and full‐year guidance is supportive of continued margin improvement despite tariff impacts. | Steady improvement – The margins continue to improve as operational efficiencies and volume leverage offset pricing challenges, reflecting a positive outlook on profitability. |
Epic Integration and Workflow Enhancements | Q4 2024 emphasized positive feedback, streamlined EMR integration, and competitive conversion. Q3 2024 detailed the Epic Aura integration that significantly reduced integration time and improved workflows , while Q2 2024 previewed rollout plans in partnership with Epic. | Q1 2025 reports that early Epic Aura integration has driven a 20-40% increase in prescribing patterns and has a strong pipeline with many new Aura accounts, reinforcing its role in enhancing operational efficiency. | Enhanced impact and adoption – Integration with Epic remains a key strategic enabler, with rising customer adoption and measurable improvements in workflow and prescribing, demonstrating an upward trajectory in its positive impact. |
Tariff Impact and Pricing Pressure on Gross Margins | Q4 2024 discussed potential negative impacts of 50-75 basis points on gross margins from tariffs along with a low single-digit pricing headwind due to Medicare declines. Q3 and Q2 did not specifically address this topic. | Q1 2025 reiterates the tariff impact within a 50-75 bps range and acknowledges a low single-digit pricing headwind, while detailing active mitigation strategies such as supply chain adjustments and inventory management. | Stable, with increased clarity – The discussion remains consistent with earlier mentions, but Q1 2025 provides further strategic clarity on mitigation efforts, indicating a measured and stable approach to pricing pressures. |
Emerging Channels and Innovative Partnerships (Undiagnosed Monitoring) | Q4 2024 outlined innovative partnerships in national value-based care programs with strong early results. Q3 2024 had limited mention, while Q2 2024 detailed proactive monitoring strategies, high diagnostic yields, and solid product-market fit in the undiagnosed arrhythmia space. | Q1 2025 emphasizes that innovative channel partners now deliver the strongest revenue contribution from undiagnosed arrhythmia monitoring, with a new partnership signaled and continued efforts in primary care integration driving early-stage value. | Increasing emphasis and early success – Although still in early stages, the emerging channel strategy is showing greater revenue impact and increased optimism, suggesting a growing role in the company’s future growth. |
International Expansion and Reimbursement Challenges (e.g., Japan) | Q4 2024 discussed European launches and initial steps in Japan with pending reimbursement decisions. Q3 2024 detailed Japanese PMDA regulatory approval and European market strategies. Q2 2024 focused on preparation for broad European launches and a forthcoming PMDA decision in Japan with a letter of intent in place. | In Q1 2025, the focus shifts toward the commercial launch in Japan featuring a 14‑day, PMDA-cleared AI solution, though reimbursement was set at the Holter level with plans to pursue enhanced rates through further clinical evidence. | Maturing from evaluation to commercialization – The emphasis has shifted from preparatory activities to active launch plans, particularly in Japan, indicating a maturation of international efforts despite reimbursement challenges. |
Zio MCT Product Launch Delays and Cost Servicing Risks | Q3 2024 included a discussion of a voluntary delay in regulatory submissions for Zio MCT to ensure comprehensive documentation, along with detailed servicing cost risks and additional testing requirements. Q4 2024 confirmed plans to submit despite ongoing remediation. Q2 2024 expected submission in late 2024 with launch in 2025. | Q1 2025 does not mention any new delays; instead, the company reaffirms the plan to submit the Zio MCT application in Q3 2025 and expresses confidence in managing cost servicing risks, reflecting a stabilization in messaging compared to earlier discussions. | Stabilized timeline with mitigated risks – Earlier voluntary delays are now reaffirmed as part of a deliberate process; cost servicing concerns remain acknowledged but appear to be under control, signaling a settled strategy moving forward. |
Growth Momentum and New Account Acquisition | Q4 2024 reported record new account openings, with new store growth contributing approximately 56% to volume gains. Q3 2024 highlighted record new account numbers and noted longer sales cycles for larger, EHR-integrated accounts. Q2 2024 described strong revenue growth with new store contributions of about 40% and significant policy wins. | Q1 2025 reports 20.3% YoY revenue growth with new store growth accounting for roughly 65% of the volume increase, driven by robust performance in both existing and new channel initiatives, despite extended sales cycles. | Accelerating and robust – The growth momentum continues to trend upward, with an increasing share of new accounts and high volume growth amid extended sales cycles, reflecting strong market demand and effective customer acquisition strategies. |
Regulatory and Legal Risks (FDA Scrutiny, DOJ Investigations) | Q4 2024 emphasized proactive remediation of FDA warning letters and 483 observations and noted incremental legal costs ($11M in 2024, rising to $15M in 2025). Q3 2024 detailed significant investments in quality systems and an expanded regulatory team, and Q2 2024 provided comprehensive updates on FDA remediation actions and DOJ inquiries. | Q1 2025 continues to emphasize robust remediation efforts, with a commitment to overhauling the quality management system and allocating necessary resources; legal costs remain predictable ($15M for 2025), and the messaging underlines that these regulatory challenges are being effectively managed without hindering growth. | Consistent proactive management – Regulatory and legal risks remain a priority, yet the sentiment has shifted to a more controlled and managed approach, with robust resource deployment and a focus on exceeding regulatory expectations rather than reacting to new crises. |
Coverage Policy Changes and Payer-driven Access | Only discussed in Q2 2024, where favorable policy changes opened coverage for an additional 2.9 million lives and impacted over 25 million commercial members, supported by data demonstrating Zio's clinical benefits. | Not mentioned in Q1 2025 or other periods provided. | Low-frequency topic – Coverage and payer-driven access were highlighted in Q2 2024; the absence of further discussion suggests that it remains a background factor rather than a dynamic strategic focus in current messaging. |
Strategic Partnerships for Multi-sensing Capabilities | Q3 2024 featured a detailed partnership with BioIntelliSense to incorporate multi-sensor capabilities into ACM products. Q4 2024 mentioned in-licensing technology to enable multi-parameter sensing for future hardware iterations. Q2 2024 did not address this topic. | In Q1 2025, the company highlighted a strategic focus on building a multiparameter sensing platform, citing the BioIntelliSense transaction and expressing openness to M&A opportunities if strategically attractive, underscoring a long-term innovation horizon. | Emerging strategic priority – The emphasis on multi-sensing capabilities is growing, with increasing focus on integrating advanced sensors to expand product functionalities and explore new indications over the next several years. |
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Primary Care Growth
Q: How high can PCP share get?
A: Management sees a huge potential in primary care, tapping into an untapped market of 27 million patients, which could dramatically expand their prescription base. -
Revenue Guidance
Q: What drove the raised guidance?
A: Strong Q1 performance—especially 20%+ growth driven by Zio AT—has lifted full‑year revenue guidance to $690–700M, underscoring sustainable momentum. -
Zio AT & MCT
Q: How does AT momentum affect MCT launch?
A: Consistent Zio AT success, with devices worn nearly 14 days, bolsters confidence in a Q3 Zio MCT filing, reflecting the product’s inherent superiority. -
Japan Reimbursement
Q: How is Japan reimbursement evolving?
A: Although initial reimbursement in Japan fell short of the original $2M expectation, management is committed to proving product superiority to secure improved rates in the future. -
Channel Mix Breakdown
Q: What drives the revenue channel mix?
A: The growth mix is mainly led by Zio AT, with primary care now representing over 33% of prescriptions and innovative channels moving from virtually zero to low single-digit percentages—a sign of broadening reach. -
Zio MCT Filing Timeline
Q: Is MCT submission on track?
A: They remain confident about filing Zio MCT in Q3 2025, with no red flags from the FDA—even as details on facility reinspections aren’t provided. -
Competitor Influence
Q: Is AT growth due to competitors exiting?
A: Management attributes AT’s strong performance to the product’s superior features and organic customer growth—not merely to competitors leaving the market. -
Epic Integration Impact
Q: What effect has Epic integration had?
A: Early integrated accounts experienced an average daily prescribing increase of around 20%, with some even reaching 40%, a positive sign that is still being fully evaluated. -
Innovative Channel Volume
Q: How is the innovative channel performing?
A: Though it currently makes up only a low single-digit percentage of total volume, its fast growth indicates a promising new revenue avenue for the company. -
Overall MCT Market Health
Q: How is the MCT market performing?
A: The MCT market remains largely flat due to CMS pricing pressures, yet modest market share gains here could yield an incremental revenue boost. -
Multiparameter Sensing
Q: What steps are taken on multiparameter sensors?
A: They are advancing multiparameter sensing through internal innovation and selective acquisitions, aiming to complement their product suite steadily. -
Tariff Mitigation
Q: Can tariffs be passed to customers?
A: While supply chain adjustments are underway, pricing changes will be evaluated carefully to offset tariff impacts without sacrificing market share. -
FDA Leadership Consistency
Q: Are FDA contacts consistent?
A: Yes, the same senior FDA officials remain engaged, ensuring stable and ongoing regulatory discussions.
Research analysts covering iRhythm Technologies.