Evolv (EVLV) Q1 2025 Earnings Call May 20, 2025 04:30 PM ET Company Participants Brian Norris - Senior Vice President of Finance & Investor RelationsJohn Kedzierski - CEO, President & DirectorChris Kutsor - CFOBrett Knoblauch - Managing Director Conference Call Participants Jeremy Hamblin - Senior Research AnalystMike Latimore - Managing Director & Senior Research AnalystEric Martinuzzi - Senior Research Analyst Operator Good afternoon, and welcome to the Evolve Technology First Quarter Earnings Results Con ...

Financial Data and Key Metrics Changes - Keysight reported revenue of $1.3 billion and earnings per share of $1.7, exceeding the high end of guidance, marking the second consecutive quarter of revenue growth [6][19] - Orders grew 8% year over year and 4% sequentially to $1.3 billion, indicating a solid demand environment [6][19] - Gross margin was reported at 65%, with operating margin at 25%, an increase of 100 basis points year over year [19] Business Segment Data and Key Metrics Changes - The Communications Solutions Group (CSG) generated revenue of $913 million, up 9% on both reported and core basis, driven by strong demand in wireline and wireless sectors [21] - The Electronics Industrial Solutions Group (EISG) reported revenue of $393 million, a 5% increase, with growth in semiconductor and general electronics offsetting declines in automotive [21] - Software and services accounted for approximately 36% of total revenue, with annual recurring revenue at 28% [22] Market Data and Key Metrics Changes - Orders in the aerospace, defense, and government sector grew, driven by strength in the U.S. and Europe, with notable contracts awarded [12][61] - The demand environment in China was mixed, with overall orders flat but strengths in certain sectors [96] Company Strategy and Development Direction - The company is focused on long-term investments aligned with technology trends, particularly in AI and digital infrastructure [17][32] - Keysight is maintaining a diversified global supply chain with minimal exposure to China, actively working to mitigate tariff impacts [8][24] - The company is pursuing a balanced return of capital while investing for long-term growth, having returned over $1.7 billion to investors via repurchases over the past twelve quarters [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market leadership and operating model, noting no material adverse effects on demand from tariffs [8][25] - The company raised its full-year growth expectations, now anticipating revenue growth at the midpoint of the 5% to 7% long-term target [25] - Management highlighted a healthy pipeline of opportunities and strong customer engagements entering the second half of the fiscal year [6][25] Other Important Information - The company ended the quarter with $3.12 billion in cash and cash equivalents, generating $484 million in cash flow from operations [22] - Keysight is progressing through regulatory reviews for pending acquisitions, including Spirent and Optical Solutions Group [22][23] Q&A Session Summary Question: Update on AI traction and its significance for the business - Management views AI as a long-term secular trend with a multiyear roadmap, contributing to growth in wireline business [32][33] Question: Incremental view on top-line outlook - The company raised top-line expectations based on strong performance in the first half and a solid pipeline of opportunities [40][42] Question: Clarification on tariff impact - The estimated annual exposure to tariffs is approximately $75 million to $100 million, with efforts underway to mitigate this impact [47][48] Question: Insights on aerospace and defense orders - Orders grew in the aerospace and defense sector, with strong bookings from prime contractors in the U.S. and Europe [61][62] Question: Wireless business performance - The wireless business remains stable, with strength in network infrastructure and ongoing investments in new technologies [71] Question: Growth in Software and Services - The company is focused on growing software and services, which have shown resilience during downturns [73][74] Question: Demand for wireline testing - The wireline business is heavily R&D oriented, benefiting from increased manufacturing activity as the industry ramps up for digital infrastructure [103][104] Question: Competitive landscape for semiconductor testing - The company is well-positioned to address the complexities of semiconductor testing, with ongoing investments in optical and electrical capabilities [108][116]

Financial Data and Key Metrics Changes - Total revenue for Q3 was $2,290,000,000, representing a 15% year-over-year growth, at the high end of the guided range [36] - Product revenue grew by 16%, while total services revenue increased by 15% [36] - Next Generation Security ARR surpassed $5,000,000,000, ending the quarter at $5,090,000,000, a growth of 34% year-over-year [39] - Adjusted free cash flow generated in Q3 was $578,000,000 [44] - Total gross margin was 76%, with product gross margin at 78.4% [42] Business Line Data and Key Metrics Changes - Subscription revenue within total services grew by 18%, while support revenue rose by 10% [36] - Software firewall ARR grew approximately 20% year-over-year, driven by public cloud deployments [26] - SASE ARR grew 36% year-over-year, with 40% of SASE customers being net new to the company [28] - AI ARR reached approximately $400,000,000 in Q3, up over 2.5 times year-over-year [39] Market Data and Key Metrics Changes - The Americas region grew by 12%, EMEA by 20%, and JPEG by 23% [37] - The average duration of new contracts remained at approximately three years, with a slight decrease year-over-year [37] Company Strategy and Development Direction - The company is focused on a platformization strategy, which is resonating with customers and resulting in larger deals [6][8] - The urgency to adopt AI is becoming a strategic imperative for customers, leading to increased investments in technology transformation [10][12] - The company aims to reach a target of $15,000,000,000 in ARR by FY30 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving adjusted free cash flow margin targets over the next few years [9] - The geopolitical environment has caused some uncertainty, but the company has executed well despite challenges [84] - There is strong momentum heading into the fiscal year-end, with expectations for a robust Q4 pipeline [33] Other Important Information - The company announced its intention to acquire Protect.ai for $700,000,000 to enhance its AI security capabilities [45] - The transition to a contract manufacturing facility in Texas is expected to benefit from scale and innovation [42] Q&A Session Questions and Answers Question: How are customers thinking about the upgrade from QRadar on-premise? - Management highlighted a strong partnership with IBM to facilitate the transition from on-premise SOC to cloud-delivered SOC, indicating a significant ARR opportunity [50][51] Question: Can you unpack the details behind the product revenue growth? - Management noted that product revenue growth is driven by both hardware and software, with a notable inflection in the software firewall business due to increased AI adoption [62][66] Question: What does the AI imperative mean for Palo Alto Networks? - Management indicated that securing AI implementations is becoming a priority, leading to faster adoption of cloud firewalls and a shift from hardware to software [76][77] Question: How is the company navigating geopolitical volatility? - Management acknowledged that April was an anomalous month but expressed pride in the team's execution during a challenging quarter [84][85] Question: How does the company plan to evolve its AI product portfolio? - Management emphasized the importance of runtime security in AI and the acquisition of Protect.ai to enhance capabilities in this area [89][95]

Financial Data and Key Metrics Changes - At the end of Q1 2025, the company had over $172 million in cash and short-term investments [23] - A $200 million debt facility was executed with Hercules, providing a cash runway into the second half of 2027 [23] Business Line Data and Key Metrics Changes - The company is focused on a single development program for a rare disease called autoimmune pulmonary alveolar proteinosis (APAP) [2] - The Phase III pivotal clinical trial IMPALA two showed statistically significant improvement in DLCO compared to placebo at week 24, with sustained improvement at week 48 [7][8] - 97% of patients completed the double-blind treatment period, with no withdrawals due to drug-related adverse events [8] Market Data and Key Metrics Changes - The diagnosed prevalence of APAP in the U.S. is estimated at approximately 3,600 patients, with an additional 3,700 likely undiagnosed patients [13][14] - The potential market opportunity in the U.S. is significant, with a total of over 7,000 patients identified [15] Company Strategy and Development Direction - The company aims to establish relationships with pulmonologists and treatment centers to gain visibility into the patient population before the launch of Molbrevi [17] - A U.S. commercial team is being built prior to approval, consisting of 25 to 30 individuals responsible for patient profiling and disease awareness campaigns [22] - The pricing power for Molbrevi is projected between $300,000 and $500,000 per patient per year, aligning with other orphan drug analogues [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Molbrevi, highlighting the lack of approved medicines for APAP in the U.S. and Europe [4][11] - The company anticipates a potential PDUFA date around November if priority review is granted by the FDA [11] - There is a strong interest from U.S. pulmonologists and payers regarding Molbrevi, with 83% of pulmonologists likely to prescribe it [18][19] Other Important Information - The company launched a free blood antibody test called APAP ClearPath to facilitate quicker diagnosis of APAP [20] - The test has been piloted at an interstitial lung disease clinic, aiming to identify undiagnosed APAP patients [21] Q&A Session Summary Question: What is the current status of the regulatory submission for Molbrevi? - The company completed the submission of the BLA to the FDA and is awaiting feedback within a 60-day window [11] Question: How many patients does the company aim to reach by launch? - The company aims to have line of sight to 1,000 known APAP patients by launch, with a goal to confirm the total of 3,600 patients [15][17] Question: What are the expectations regarding payer coverage for Molbrevi? - 87% of payers indicated they intend to provide coverage with simple pre-authorization criteria, recognizing the disease burden of APAP [19]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $2,290,000,000, representing a 15% year-over-year growth, at the high end of the guided range [34] - Product revenue grew by 16%, while total services revenue increased by 15% [34] - Next Generation Security ARR surpassed $5,000,000,000, ending the quarter at $5,090,000,000, a growth of 34% year-over-year [37] - Adjusted free cash flow generated in Q3 was $578,000,000 [42] Business Line Data and Key Metrics Changes - Subscription revenue within total services grew by 18%, and support revenue rose by 10% [34] - Software firewall ARR grew approximately 20% year-over-year, driven by public cloud deployments [25] - SASE ARR grew 36% year-over-year, with 40% of SASE customers being net new to Palo Alto Networks in Q3 [26] Market Data and Key Metrics Changes - The Americas grew by 12%, EMEA by 20%, and JPEG by 23% [35] - The average duration of new contracts remained at approximately three years, with a slight decrease year-over-year [35] Company Strategy and Development Direction - The company is focused on a platformization strategy, which is resonating with customers and resulting in larger deals [5] - There is a strong emphasis on AI integration, with the urgency for customers to adopt AI becoming a strategic imperative [8] - The company aims to reach a $15,000,000,000 ARR target for FY30 [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving adjusted free cash flow margin targets over the next few years [7] - The geopolitical environment has caused some uncertainty, but the company has executed well despite challenges [82] - There is optimism about strong momentum heading into Q4, driven by continued transformation and a robust pipeline [32] Other Important Information - The company announced its intention to acquire Protect.ai for $700,000,000 to enhance its AI security capabilities [43] - The company is transitioning to a contract manufacturing facility in Texas to benefit from scale and mitigate tariffs [40] Q&A Session Summary Question: How are customers thinking about upgrading from QRadar on-premise? - Management highlighted the significant ARR uplift from transitioning customers from on-premise SOC to cloud-delivered SOC, emphasizing the potential for large deals [49][50] Question: Can you unpack the details behind product revenue growth? - Management noted that product revenue growth is driven by both hardware and software, with a notable inflection in the software firewall business due to increased AI adoption [60][66] Question: What does the AI opportunity mean for Palo Alto Networks? - Management indicated that securing AI implementations is becoming a priority for customers, leading to faster adoption of cloud firewalls and a shift from hardware to software [72][76] Question: How is the company navigating geopolitical volatility? - Management acknowledged that April was an anomalous month due to geopolitical tensions but expressed pride in the team's execution during that period [82] Question: How does the company plan to evolve its AI product portfolio? - Management discussed the importance of runtime security in AI and the acquisition of Protect.ai to enhance capabilities in this area [88][94]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $32 million, up 10% sequentially and 44% year over year, reflecting new customer acquisition and strong expansion from the installed customer base [21][43] - Annual recurring revenue (ARR) grew 34% year over year to $106 million at the end of Q1 2025 [22][44] - Adjusted EBITDA for Q1 2025 increased to $1.7 million, with an adjusted EBITDA margin of 5% [22][47] Business Line Data and Key Metrics Changes - The company welcomed over 50 new customers in Q1 2025, serving approximately 950 customers across key end markets [21] - Sales and marketing spend as a percentage of revenue is improving, indicating more effective execution by the sales team [24] - The new certified pre-owned program aims to recapture value from returning units, contributing positively to revenue and cash flow [25][26] Market Data and Key Metrics Changes - Evolve Express is deployed in 20 of the 100 largest US school districts, screening over 850,000 students and visitors daily [30] - In healthcare, the installed base has reached 500 hospital buildings, with daily visitor screenings nearly doubling year over year [31] - The company is monitoring new legislation in California mandating weapons detection systems in hospitals, indicating potential market growth [32] Company Strategy and Development Direction - The company aims to leverage its subscription model to drive predictable long-term revenue growth, with 78% of the 2025 revenue plan already contracted [75] - The focus is on expanding the subscription base and enhancing customer engagement across various verticals, including education and healthcare [76] - The company is optimistic about the long-term potential of its AI-powered weapons detection technology, with plans to increase market penetration significantly [38] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges faced over the past year but expresses confidence in the company's ability to emerge stronger and more resilient [18][20] - The outlook for 2025 includes expected revenue growth of 20% to 25%, with a focus on achieving positive adjusted EBITDA and cash flow [40][54] - The company is committed to maintaining operational efficiency while investing in back-office improvements to support growth [54] Other Important Information - The company has resolved an FTC inquiry and completed a restatement that shifted $3.1 million in revenue to future periods [17] - The balance sheet shows $35 million in cash and equivalents, down from $52 million at the end of Q4 2024, primarily due to one-time cash disbursements [49] Q&A Session Summary Question: Success with expansions and vertical contributions - Management noted that 50% of new subscriptions came from expansions, with specific vertical contributions to be followed up later [60] Question: Impact of new California law on hospital security - Management confirmed engagement with customers in California regarding the new legislation, viewing it as a significant opportunity [63] Question: CapEx expectations for the year - Management indicated a CapEx range of $20 to $25 million to support the subscription business [68] Question: Strategy refinements and potential acquisitions - The focus remains on driving the subscription model, with 78% of the revenue outlook already contracted [75] Question: Revenue progression expectations for 2025 - Management expects to deploy at least as many units in 2025 as in 2024, with a focus on subscription growth [84] Question: Purchase versus subscription model mix - Management confirmed a preference for pure subscription models, while still offering purchase options [92] Question: New customers for Expedite product - The 12 new customers for Expedite included both existing customers and new clients, indicating strong early traction [95]

Financial Data and Key Metrics Changes - The company has indicated that it is capitalized into 2028, which supports ongoing pivotal trials [50] - The company has not disclosed specific financial metrics in this call, focusing instead on trial progress and strategic direction Business Line Data and Key Metrics Changes - The SOLO-one trial has completed randomization, with top-line data expected in the first quarter of 2026 [13] - The SOAR trial is primarily enrolling treatment-naive patients, with a small allowance for previously treated patients under specific conditions [20] Market Data and Key Metrics Changes - The company believes there is a significant market opportunity in wet AMD, with a high patient dropout rate indicating that the current market is underestimated [52] - The company is positioned to commercialize its product globally, leveraging a mature commercial team and extensive market knowledge [53] Company Strategy and Development Direction - The company aims to maximize drug exposure and potentially achieve a superior label with dosing flexibility [12] - There is a clear path forward for diabetic retinopathy and diabetic macular edema, with plans to proceed when the macro environment stabilizes [44][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA's support and the trial designs, indicating that complementary studies are favored [29] - The company is optimistic about the market prospects for its drug, emphasizing that better drugs tend to dominate the market regardless of minor differences in treatment duration [34][35] Other Important Information - The company has robust patent protection for its drug and hydrogel, with patents running until 2041 and pending methods extending to 2044 [49] - The management highlighted the importance of patient retention and the quality of enrolled patients in ongoing trials [8] Q&A Session Summary Question: Is SOAR currently enrolling both treatment naive and treatment experienced patients? - The trial is primarily for treatment-naive patients, with a small allowance for previously treated patients under specific documentation [20] Question: Based on existing clinical data, what percentage of patients do you expect in the SOLAR trial to remain rescue-free during the six months period after expecimen treatment? - The expectation is that if the drug lasts for nine months in one study, it should have a high chance of lasting for six months in another study [24] Question: How likely do you think the FDA will require a second SOAR trial? - Management does not foresee a need for a second trial, citing FDA feedback and existing agreements [29] Question: Do you believe that the first drug on the market with a six-month treatment duration for wet AMD could have a significant advantage in terms of market prospects? - Management emphasized that the better drug always wins, and they are entering the market with a significantly longer treatment duration [34][35] Question: What’s your development plan for diabetic retinopathy? - The company plans to proceed with development when the macro environment stabilizes, as there is no competition in this area [44][45] Question: Is expressly protected by any issued patents? - Yes, the drug and hydrogel are protected by patents, with comprehensive coverage of the process and materials [49]

Financial Data and Key Metrics Changes - In Q1 2025, the company's revenue was $2 million, reflecting a 25% decrease compared to the same period last year due to the loss of a customer [15] - The average revenue per enrolled member per month was approximately $254, down from $500 in Q4 2024 and $504 in Q1 2024 [17] - Gross margin for Q1 was 37%, a decrease from 61% in Q4 2024 and 63.6% in Q1 2024, primarily driven by the loss of a customer and a shift in member mix [20] Business Line Data and Key Metrics Changes - The total enrolled members reached 3,165 at the end of Q1, nearly doubling year over year, with over 1,150 members in the Engage program [6][16] - The company added 2,039 new members during the quarter, the highest since Q3 2021, contrasting with 1,641 in Q4 2024 and 925 in Q1 2024 [18] - The average monthly disenrollment rate was 10%, down from 19% in Q4 2024 and 22% in Q1 2024 [19] Market Data and Key Metrics Changes - The company has achieved state Medicaid provider approval in two states and is working to expand its footprint [8] - The outreach pool averaged 27,204 for the quarter, leading to a 30% enrollment rate, down from 50% in Q4 2024 [18] Company Strategy and Development Direction - The company aims to double its run rate revenue in 2025 compared to 2024, driven by successful conversions of prospective customers [6] - The Engage solution is expanding market reach by serving members who may not require the full Whole Health Plus program [7] - The company is focused on converting its strong pipeline into signed contracts while nurturing relationships with existing customers [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about converting prospective customers, particularly a large Midwestern Medicaid plan [5][10] - The overall reaction from prospects to the enhanced solution suite has been extremely positive, with health plans acknowledging the need for more intensive behavioral health support [12] - The company anticipates revenues for Q2 2025 in the range of $2.2 million to $2.6 million, representing an 8% to 22% sequential increase [22] Other Important Information - The company reported cash flow from operations for Q1 was negative $2.7 million, an improvement from negative $3.3 million in the same period last year [21] - Cash reserves stood at $4.1 million at the end of the quarter, down from $5.7 million at the end of 2024 [21] - The company has secured up to $10 million of additional financing available as needed in the short term [22] Q&A Session Summary - No specific questions or answers were documented in the provided content, indicating that the call may have concluded without a formal Q&A session.

Financial Data and Key Metrics Changes - Keysight reported revenue of $1.3 billion and earnings per share of $1.7, exceeding the high end of guidance, marking the second consecutive quarter of revenue growth [5][18] - Orders grew 8% year over year and 4% sequentially to $1.3 billion, indicating a solid demand environment [5][18] - Gross margin was reported at 65%, with operating margin increasing by 100 basis points to 25% year over year [18] Business Segment Data and Key Metrics Changes - The Communications Solutions Group (CSG) generated revenue of $913 million, up 9% on both reported and core basis, driven by strong demand in wireline and wireless sectors [21] - Aerospace, Defense and Government revenue increased by 9% to $300 million, reflecting strong order growth in the U.S. and Europe [21] - The Electronics Industrial Solutions Group (EISG) saw revenue return to growth at $393 million, a 5% increase, with semiconductor and general electronics growth offsetting declines in automotive [21] Market Data and Key Metrics Changes - Orders in the aerospace and defense sector grew, driven by investments in defense modernization in the U.S., Europe, and Asia [11][12] - The demand environment in Asia was strong, particularly in commercial communications and semiconductor sectors, although automotive demand in China remained weak [92] Company Strategy and Development Direction - Keysight is focused on long-term investments aligned with technology trends, emphasizing a diversified global supply chain with minimal exposure to China [6][24] - The company is pursuing a balanced return of capital while investing for long-term growth, having returned over $1.7 billion to investors through share repurchases [6][7] - Keysight's strategy includes expanding its software and services segment, which now accounts for approximately 36% of revenue, with a focus on simulation and virtual prototyping [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in market leadership and the strength of the operating model despite macroeconomic uncertainties [6][25] - The company raised its full-year revenue growth expectations to the midpoint of its 5% to 7% long-term target, anticipating a strong Q3 based on a solid backlog [25] - Management noted that while tariffs pose risks, they have not seen material adverse effects on demand and are actively working to mitigate tariff impacts [24][25] Other Important Information - Keysight's cash flow from operations was strong at $484 million, with free cash flow of $457 million [22] - The company has a backlog of $2.4 billion entering Q3, indicating a solid scheduled shipment position [25] - Keysight is progressing through regulatory reviews for pending acquisitions, including Spirent and Optical Solutions Group [22] Q&A Session Summary Question: Update on AI traction and its significance for the business - Management views AI as a long-term trend with a multiyear roadmap, contributing to growth in wireline business, which grew double digits in the first half [30][33] Question: Incremental improvement in top-line outlook - The increase in top-line expectations is based on strong performance in the first half and a solid pipeline of opportunities [39] Question: Clarification on tariff impact - The estimated annual tariff exposure is $75 million to $100 million, with efforts underway to mitigate this impact [44][45] Question: Insights on aerospace and defense orders - Orders grew in the U.S. and Europe, with notable contracts awarded, indicating a strong spending environment [56] Question: Understanding the wireless business performance - The wireless business remains stable, with strength in network infrastructure and ongoing investments in new technologies [66] Question: Growth in Software and Services segment - The company is focused on growing software and services, which have shown resilience during downturns, with double-digit growth in simulation business [70] Question: Demand in wireline and semiconductor testing - The wireline business remains heavily R&D oriented, benefiting from increased manufacturing activity as the industry ramps up for digital infrastructure [96]

Financial Data and Key Metrics Changes - The company reported revenues of $53 million for the fiscal year 2024, indicating a strong cash-generating position for a biotech firm [6][29] - Cash at the end of the last quarter was $34.7 million, with projections to approach cash flow positive by the end of 2024 [29][30] Business Line Data and Key Metrics Changes - The first product, El Eliza, has generated approximately $12 million in Brazil, while global sales through Pfizer are only $50 million out of a $1 billion market, indicating commercialization challenges [9][34] - The second product, El Fabrio, is expected to capture 15% to 20% of a $3.1 billion market, potentially generating $130 million to $150 million in sales for Protalix [13][19] Market Data and Key Metrics Changes - The Fabry market was valued at $2.2 billion last year, with expectations for growth to $3.1 billion by 2030 [12][13] - The gout treatment market is projected to be $5.6 billion with a 6.4% CAGR, highlighting significant potential for the PRX-115 product [25] Company Strategy and Development Direction - The company aims to enhance its platform and explore rare renal diseases, while also focusing on the development of PRX-115 for gout treatment [28][30] - A strategic partnership with Chiesi is crucial, with a tiered royalty agreement that could yield significant revenue based on sales performance [14][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in commercialization for El Eliza but remains optimistic about future partnerships to improve market penetration [10][34] - The company believes that by 2030, total sales could reach between $120 million to $230 million, contingent on successful product launches and market acceptance [35] Other Important Information - The company has no debt and has cleaned its balance sheet, positioning itself for a fresh start [30] - Management noted that the share price drop following the first quarter results was disproportionate and attributed it to market reactions rather than operational failures [31][34] Q&A Session Summary Question: Is it reasonable to liken the competitive advantage of PRX-115 to that of El Fabrio? - Management believes PRX-115 could represent an even stronger competitive advantage due to its potential dosing regimen, which could significantly reduce treatment frequency compared to existing therapies [37] Question: What are the implications of sales fluctuations? - Sales are highly dependent on shipment logistics, and even minor delays can impact revenue recognition, but the company remains optimistic about profitability [38] Question: What are the expected costs for the upcoming trials? - The projected costs for the trials are manageable, estimated at around $24 million over two and a half years, which is significantly lower than previous trials [39]