SI-BONE (SIBN) Q1 2025 Earnings Call May 05, 2025 04:30 PM ET Company Participants Saqib Iqbal - Senior Director of FP&A and Investor RelationsLaura Francis - Chief Executive OfficerAnshul Maheshwari - Chief Financial OfficerPhillip Dantoin - Assistant Vice PresidentYoung Li - Senior VP - Equity ResearchCaitlin Cronin - Director Conference Call Participants Craig Bijou - Equity Research AnalystDavid Turkaly - Research AnalystDavid Saxon - Senior AnalystRavi Misra - Associate Analyst - Medtech Equity Researc ...

Financial Data and Key Metrics Changes - The company reported revenue of $872 million for Q3 2025, an increase of 19% year-over-year and 5% sequentially [11] - Non-GAAP earnings per share (EPS) was $2.52, exceeding guidance [11][16] - Gross margin was reported at 12%, impacted by contra revenue from a warrant agreement [15][24] Business Line Data and Key Metrics Changes - Optical communications revenue was $657 million, up 11% year-over-year and 2% sequentially [12] - Datacom revenue was $251 million, down 18% year-over-year and 16% sequentially, primarily due to product transitions at a large customer [12][16] - Telecom revenue reached $406 million, up 42% year-over-year and 17% sequentially, driven by strong demand in data center interconnect applications [12][16] - Non-optical communications revenue was $215 million, up 53% year-over-year and 15% sequentially, with automotive revenue increasing by 76% [14][15] Market Data and Key Metrics Changes - The telecom market showed strong growth trends, expected to continue into Q4 2025 [6][17] - The automotive segment experienced outsized growth but may moderate in the near term [7][18] Company Strategy and Development Direction - The company announced a new commercial relationship with Amazon Web Services, expected to boost revenue starting in FY 2026 [7][8] - Expansion plans are on track with Building 10 construction underway to meet long-term capacity needs [9][78] - The company remains optimistic about future growth driven by new product ramps and strong demand in telecom and non-optical communications [17][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute well and maintain a consistent track record of revenue growth [10][17] - The company anticipates continued year-over-year growth in Q4 2025, with revenue guidance between $860 million and $900 million [18] - Management noted that while there may be short-term margin headwinds due to new product ramps, long-term growth drivers remain intact [56][58] Other Important Information - The company repurchased over $100 million worth of shares this fiscal year, reflecting confidence in its financial position [9][16] - Effective GAAP tax rate was reported at 5.8%, with expectations for a mid-single-digit rate for the fiscal year [16] Q&A Session Summary Question: Datacom revenue decline specifics - Management clarified that the decline in Datacom revenue was primarily due to strong growth in the DCI segment, which offset some of the expected decline in 800 gig products [21][22] Question: Gross margin concerns - Management indicated that the $4 million impact from the warrant agreement affected gross margin by about 40 basis points, but this is not expected to recur [23][24] Question: Datacom revenue transition - Management noted that the decline in 800 gig products is more likely due to share allocation rather than inventory issues, with a significant ramp for 1.6 terabit products expected in the second half of the year [30][36] Question: Amazon engagement and margin opportunities - Management expects the relationship with Amazon to expand over time, with multiple product types being ramped, although significant revenue is anticipated in FY 2026 [37][39] Question: Telecom growth sustainability - Management expressed confidence in the sustainability of telecom growth, citing several strong growth factors including new system wins and improving market dynamics [42][44] Question: Tariff impacts - Management reported no material impacts from global tariffs to date, as customers typically handle tariffs under FOB shipping terms [17][75] Question: Building 10 construction timeline - Management confirmed that Building 10 is on track for an 18-month completion timeline, with potential for early production [78][79] Question: Amazon revenue potential - Management indicated that while specific revenue details cannot be disclosed, they are optimistic about the potential for significant revenue growth from Amazon [86][90]

Financial Data and Key Metrics Changes - Vertex Pharmaceuticals reported total revenue of $2,770 million for Q1 2025, representing a 3% growth compared to Q1 2024 [7][41] - U.S. revenue grew by 9% year-over-year, driven by ongoing patient demand and the early launch of AlifTrex [41] - Ex-U.S. revenue declined by 5% year-over-year, impacted by illegal copy products in Russia [42][43] - Non-GAAP earnings per share were $4.06, down from $4.76 in Q1 2024, primarily due to increased operating expenses [45] Business Line Data and Key Metrics Changes - The launch of AlifTrex, Vertex's fifth CF medicine, is showing positive early dynamics and feedback from physicians and patients [7][8] - Gernavix, the first oral non-opioid for moderate to severe acute pain, has been launched and is seeing early uptake [33][34] - CASJEVI generated $14 million in revenue during Q1 2025, indicating initial traction in the market [43] Market Data and Key Metrics Changes - The company is expanding its reach with the global launch of Kashyvi, a gene-edited therapy for sickle cell disease and beta thalassemia, with over 65 authorized treatment centers activated [28][30] - In the U.S., formal commercial coverage for Kashyvi is either in place or provided through single case agreements, with significant progress in Medicaid coverage [29][30] Company Strategy and Development Direction - Vertex is focused on commercialization and expanding its product portfolio, with a strong emphasis on advancing its R&D pipeline [7][8] - The company aims to bring most CF patients to normal levels of CFTR function through its next-generation CFTR regimen [12] - Vertex is also advancing multiple pivotal development programs in diabetic peripheral neuropathy, type one diabetes, and kidney diseases [8][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, raising the low end of 2025 total revenue guidance to a range of $11.85 billion to $12 billion [45][46] - The company anticipates continued growth from its CF medicines and expects to ramp up revenue from Gernavix in the second half of 2025 [46][47] Other Important Information - Vertex ended Q1 2025 with $11.4 billion in cash and investments, having repurchased approximately $425 million worth of shares [45] - The company is committed to investing in R&D, with a guidance range for combined non-GAAP R&D and SG&A expenses set at $4.9 billion to $5 billion for the full year 2025 [48] Q&A Session Summary Question: Feedback on Elephthrex launch and chronic pain indications for Gernavix - Management noted that sweat chloride is not routinely used in clinical practice, but the combination of Elephthrex's benefits, including non-inferiority to Trikafta and additional mutation coverage, is compelling [56][58] Question: Impact of tariffs and Russia issue on CF business - The impact from the Russia issue is estimated at $100 million for Q1 and $200 million for the full year, which is included in current guidance [61][62] - Tariffs currently have an immaterial impact due to a well-balanced global supply chain and minimal exposure to China [62][63] Question: Early adopters of Elephthrex and payer coverage for Gernavix - Uptake of Elephthrex is seen across all patient groups, with the fastest uptake among those newly eligible for CFTR modulators [68] - Gernavix is being used in various settings, including surgery and non-surgery, with broad uptake and positive feedback from physicians [75]

Vertex Pharmaceuticals (VRTX) Q1 2025 Earnings Call May 05, 2025 04:30 PM ET Speaker0 Good day, and welcome to the Vertex Pharmaceuticals First Quarter twenty twenty five Earnings Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Ms. Susie Lisa. Please go ahead, ma'am. Speaker1 Good evening, all. My name is Susie Lisa, and as the Senior Vice ...

Financial Data and Key Metrics Changes - The company reported quarterly revenue of $145.5 million, with $134 million attributed to Orlodayo, marking a significant increase from the previous year [6][28] - Annual revenue guidance for Orlodayo has been raised to between $580 million and $600 million, reflecting a growth of 33% to 37% over last year [6][29] - Operating profit for Q1 2025 was $21.2 million, with net income reported as slightly positive [29] - Cash at the end of the quarter stood at $317 million, and the company reduced its outstanding debt by $75 million, bringing it down to $249 million [28][30] Business Line Data and Key Metrics Changes - The U.S. commercial team successfully transitioned patients from free drug to paid status, achieving a 10 percentage point increase in the paid patient rate, now at 84% [10][12] - The paid rate among Medicare patients improved significantly, with 89% now receiving paid therapy [93] - The gross to net ratio improved, with expectations to maintain it around 15% for the full year [14][51] Market Data and Key Metrics Changes - The company noted a strong demand for Orlodayo, with new prescriptions slightly exceeding the best quarter from the previous year [8][10] - The percentage of U.S. patients who strongly prefer oral prophylaxis increased to 70%, up from 51% in 2023 [10] - The company anticipates reaching $1 billion in global revenue by 2029, with a more profitable path than previously expected [13][64] Company Strategy and Development Direction - The company is focusing on expanding its pipeline, with significant milestones achieved, including the submission of a pediatric NDA for Orlodayo [16] - The company aims to capture more revenue from Orlodayo as the patient base continues to grow, with a long-term goal of 85% paid therapy [12][13] - The company is committed to disciplined capital allocation to create sustainable long-term revenue growth while reducing debt [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of the paid rate improvement, viewing 84% as a new floor for future performance [118] - The company is optimistic about the impact of the Inflation Reduction Act on patient affordability and access to Orlodayo [11][57] - Management highlighted the importance of real-world evidence in convincing payers of the drug's efficacy, which has improved payer conversations [94] Other Important Information - The company is preparing for the launch of a pediatric formulation of Orlodayo, with expectations for rapid deployment following approval [106] - The company is also advancing its clinical pipeline, with a focus on rare diseases and the potential for transformative treatments [16][18] Q&A Session Summary Question: What is the potential impact of the pediatric launch on Orlodayo? - Management expects the pediatric launch to be a significant tailwind, with around 500 pediatric patients in the U.S. potentially appropriate for prophylactic therapy [35][36] Question: Can you elaborate on the improvements in getting patients onto paid drug? - The team made investments in the reauthorization process and improved their execution, leading to a higher paid rate [46][47] Question: What benchmarks are being set for the DME program? - The company is looking for a clear reduction in retinal edema as a benchmark for moving forward with the DME program [41][97] Question: How sustainable is the paid rate improvement? - Management believes the paid rate improvement is sustainable, with 84% being a new baseline for future performance [118] Question: What is the expected timeline for the pediatric formulation launch? - The company aims to minimize the lag time between approval and market availability, similar to previous launches [106][107]

Financial Data and Key Metrics Changes - Total product revenues for Q1 2025 were $121.5 million, representing a year-over-year growth of 62% compared to $75 million in Q1 2024 [16][17] - Net loss for Q1 2025 was $59.4 million or $1.22 per share, an improvement from a net loss of $68.4 million or $1.44 per share in Q1 2024 [20] - Cash and cash equivalents at the end of Q1 2025 were $300.9 million, down from $315.4 million at year-end [20] Business Line Data and Key Metrics Changes - Avelity net product sales were $96.2 million for Q1 2025, representing 80% year-over-year growth from $53.4 million in Q1 2024 [17] - Sunosi net product revenues were $25.2 million for Q1 2025, a 17% year-over-year increase from $21.6 million in Q1 2024 [17][18] - Avelity led the market in TRx growth in Q1 with approximately 167,000 prescriptions, reflecting 76% year-over-year growth [21] Market Data and Key Metrics Changes - Avelity coverage remained stable in Q1 with 78% of all lives covered across channels and 63% in the commercial segment [22] - Sunosi total prescriptions were over 46,000, representing a 12% growth versus Q1 2024 [23] - Payer coverage for Sunosi was stable with 83% of lives covered across channels [25] Company Strategy and Development Direction - The company aims to advance three novel NDA stage product candidates: AXS-fourteen for fibromyalgia, AXS-five for Alzheimer's disease agitation, and AXS-twelve for narcolepsy [6][10] - The company is focused on executing multiple Phase III clinical programs to broaden the potential of current products and candidates [6] - The company anticipates a strong launch for Cymbravo, with positive feedback from healthcare providers regarding its clinical profile [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate trade policy developments, stating that any potential impact would be immaterial [13] - The company expects 2025 to be a catalyst-rich year with potentially five marketed products across six indications by 2026 [15] - Management remains optimistic about achieving cash flow positivity based on the current operating plan [20][96] Other Important Information - The company has submitted an NDA for AXS-fourteen and anticipates a decision in Q2 2025 [7] - AXS-five has been granted breakthrough therapy designation by the FDA, with an sNDA submission planned for Q3 2025 [9] - The company is closely monitoring the competitive landscape, particularly regarding new entrants in the narcolepsy treatment space [35] Q&A Session Summary Question: Recent interactions with the FDA regarding developmental agents - Management indicated that dialogue with the FDA remains status quo and no changes have been noted regarding review teams or agency responsiveness [30] Question: DTC advertising plans for Avelity - A national campaign is expected to launch later this year, with a focus on engaging patients [34] Question: Coverage expectations for Avelity - Management aims to increase the number of covered lives and reduce utilization management barriers [68] Question: Expected cadence of coverage for Cymbravo - Management is focused on securing access quickly, acknowledging the competitive market [48] Question: Sales potential for AXS-fourteen in fibromyalgia - Management is enthusiastic about the market opportunity, with approximately 17 million people diagnosed in the U.S. [63] Question: Profitability outlook for 2025 - Management remains confident in achieving cash flow positivity but has not provided specific guidance on timing for profitability [96]

Core Insights - iRhythm Technologies Inc reported Q1 2025 revenue of $158.7 million, a 20.3% increase year over year, surpassing the consensus estimate of $153.38 million [1] - The adjusted EPS loss was 95 cents, an improvement from a loss of $1.23 a year ago, also beating the consensus estimate of 98 cents [1] - Gross profit reached $109.2 million, up 24.8% from $87.5 million in the same period of 2024, with a gross margin of 68.8%, an increase from 66.3% [2] Revenue and Growth - The revenue increase was primarily driven by heightened demand for Zio services [1] - iRhythm's fiscal 2025 sales guidance is projected at $690 million to $700 million, an increase from the previous guidance of $675 million to $685 million and above the consensus of $681.56 million [3] Market Expansion - The company has recently launched its Zio long-term continuous ECG monitoring system in Japan, expanding its market presence to a total of six markets outside the U.S. [3] Analyst Ratings and Price Action - Analysts have shown positive sentiment, with Wells Fargo upgrading iRhythm from Equal-Weight to Overweight and raising the price target from $104 to $130 [5] - Baird and Needham also maintained their Outperform and Buy ratings, respectively, with increased price targets [5] - Following the positive earnings report, IRTC stock rose by 19.1% to $129.37 [4]

Financial Data and Key Metrics Changes - The company reported FFO per share of $0.64, which was a penny above the high end of guidance [6][10] - Same store revenue growth decreased by 0.4% year over year, an improvement from a decline of 1.6% in the previous quarter [8][10] - Average occupancy for the same store portfolio was down 50 basis points to 89.5%, narrowing from a decline of 120 basis points in the fourth quarter [9][10] - Same store operating expenses grew by only 0.6% year over year, better than expectations [10][12] Business Line Data and Key Metrics Changes - The company closed on the acquisition of the remaining 80% interest in a joint venture, acquiring a portfolio of 28 early-stage lease-up stores [11] - The third-party management platform added 33 stores, ending the quarter with 869 third-party stores under management [12] Market Data and Key Metrics Changes - Strong markets such as New York City boroughs, Chicago, and Washington D.C. continue to show strength, while supply-impacted markets like Northern New Jersey, Phoenix, and Atlanta are stabilizing [7][12] - In Texas markets, Dallas is facing challenges due to supply and pricing decisions, while Austin shows signs of recovery [34][35] Company Strategy and Development Direction - The company remains focused on optimizing its platform while maintaining high customer service standards [6][10] - The management expressed confidence in the long-term health of the self-storage industry due to the quality and geographic diversity of its portfolio [7][12] - The company is cautious about the economic environment, maintaining a conservative outlook for gradual improvement in operational metrics in 2025 [13] Management's Comments on Operating Environment and Future Outlook - Management noted uncertainty in the economy affecting consumer decisions, which could impact storage demand [13] - The company does not foresee improvement in the housing market and expects a gradual recovery without sharp reacceleration [13] - Management highlighted the resilience of the self-storage business, noting that demand drivers include everyday life events and business needs [18][19] Other Important Information - The balance sheet remains strong with a net debt to EBITDA ratio of 4.8 times [12] - The company is monitoring the impact of macroeconomic factors on its operations and is prepared to adjust strategies accordingly [13][54] Q&A Session Summary Question: What are the drivers of demand in the current environment? - Management indicated that demand is driven by everyday life events and business needs, despite a slow housing market [18] Question: What was occupancy in April? - Occupancy ended at 89.9% in April, showing a slight improvement [21] Question: How does the company view the leasing season? - Management expects a muted leasing season compared to pre-pandemic levels, with no significant growth anticipated [30] Question: What is the outlook for Texas markets? - Management noted that while Austin is recovering, Dallas faces challenges due to supply and competitive pricing [34][35] Question: How is the company managing expenses? - The company has been proactive in managing staffing and operational expenses, leading to better-than-expected results [50] Question: What is the strategy for acquisitions? - The company is open to acquisitions but faces challenges due to market volatility and seller expectations [53][54] Question: How does the company view potential recession impacts? - Management believes the self-storage business is resilient during economic downturns, with demand potentially increasing due to life changes [88][90]

Core Viewpoint - Novo Nordisk's stock has experienced a decline of -2.2% over the past month, underperforming the Zacks S&P 500 composite's -0.5% change and the Zacks Large Cap Pharmaceuticals industry's -2% loss, raising questions about its near-term performance [1] Earnings Estimate Revisions - The consensus earnings estimate for the current quarter is $0.91 per share, reflecting a year-over-year increase of +9.6%, with a recent change of +2.2% over the last 30 days [4] - For the current fiscal year, the consensus earnings estimate is $3.85, indicating a +17.4% change from the previous year, with a +1.3% change in the last 30 days [4] - The next fiscal year's consensus earnings estimate is $4.71, showing a +22.4% change from the prior year, with a +2.1% change over the past month [5] - Novo Nordisk holds a Zacks Rank 3 (Hold), influenced by recent changes in consensus estimates and other earnings-related factors [6] Revenue Growth Forecast - The consensus sales estimate for the current quarter is $11.33 billion, indicating a year-over-year increase of +19.1% [10] - The sales estimates for the current and next fiscal years are $50.66 billion and $58.15 billion, reflecting changes of +20.3% and +14.8%, respectively [10] Last Reported Results and Surprise History - In the last reported quarter, Novo Nordisk achieved revenues of $12.26 billion, a year-over-year increase of +28.9%, and an EPS of $0.91 compared to $0.71 a year ago [11] - The reported revenues exceeded the Zacks Consensus Estimate of $11.34 billion by +8.11%, and the EPS surprise was +9.64% [11] - Over the last four quarters, Novo Nordisk surpassed consensus EPS estimates twice and revenue estimates twice [12] Valuation - Novo Nordisk is graded B in the Zacks Value Style Score, indicating it is trading at a discount to its peers [16]

Core Viewpoint - Costco has been trending positively in the stock market, outperforming the S&P 500 and the discount retail industry, raising questions about its future stock performance [1] Earnings Estimate Revisions - The current quarter's earnings estimate for Costco is $4.25 per share, reflecting a year-over-year increase of +12.4% with a recent change of +0.5% in the consensus estimate [4] - For the current fiscal year, the consensus earnings estimate is $17.96, indicating a change of +11.5% from the previous year, with a slight change of +0.1% over the last 30 days [4] - The next fiscal year's consensus earnings estimate stands at $19.73, showing a change of +9.9% from the prior year, with no change in the estimate over the past month [5] Revenue Growth Forecast - Costco's consensus sales estimate for the current quarter is $63 billion, representing a year-over-year change of +7.7% [10] - The sales estimates for the current and next fiscal years are $274.3 billion and $292.89 billion, indicating changes of +7.8% and +6.8%, respectively [10] Last Reported Results and Surprise History - In the last reported quarter, Costco achieved revenues of $63.72 billion, a year-over-year increase of +9%, with an EPS of $4.02 compared to $3.71 a year ago [11] - The reported revenues exceeded the Zacks Consensus Estimate of $63.22 billion by +0.79%, while the EPS fell short by -1.71% [11] - Over the last four quarters, Costco surpassed consensus EPS estimates three times and revenue estimates two times [12] Valuation - Costco is graded D in the Zacks Value Style Score, indicating it is trading at a premium compared to its peers [16] - Valuation multiples such as price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF) are essential for assessing whether Costco's stock is overvalued or undervalued [14][15] Bottom Line - The information presented may assist in evaluating the market interest surrounding Costco, with a Zacks Rank of 3 suggesting it may perform in line with the broader market in the near term [17]