Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $396 million, flat compared to the prior year, near the low end of the outlook range, with a 4% growth contribution from the acquisition of HSP [17][18] - Gross margin decreased to 23.6%, down 280 basis points, primarily due to changes in revenue mix and certain software depreciation now reported in cost of services [18][19] - The company reported a net loss of $200,000 for the quarter, including a noncash intangible asset impairment charge of $200,000 [20] - Adjusted net loss was $2 million, while adjusted EBITDA was $3 million [20] Business Line Data and Key Metrics Changes - PeopleReady revenue declined by 5%, driven by reduced client volumes across most verticals and geographies, but skilled businesses delivered double-digit growth [21][22] - PeopleManagement grew for the second consecutive quarter with revenue up 2%, supported by strong results from the commercial drivers business [22][23] - People Solutions revenue grew by 20%, with HSP contributing 40 percentage points of inorganic growth, offsetting a 20% organic decline [23][24] Market Data and Key Metrics Changes - Improved on-demand trends were noted in California and Florida, indicating growing momentum as the quarter ended [22] - The company is expanding its presence in the energy sector, with ongoing infrastructure investment fueling sustained demand for skilled labor [12][55] Company Strategy and Development Direction - The company is focused on accelerating digital transformation, growing market share in high-growth end markets, and optimizing sales functions to capture demand [8][9] - Strategic partnerships, such as with Omnia Partners, are aimed at unlocking new client acquisition channels and deepening enterprise client relationships [11] - The company has simplified its organizational structure and implemented targeted cost reductions, achieving approximately $90 million in permanent SG&A savings [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive momentum and signs of stabilization, expecting a return to company-wide growth in Q3 [15][26] - The outlook for Q3 includes expected revenue growth of 5% to 11% year-over-year, reflecting current market trends [26] Other Important Information - The company has strategically invested to position itself ahead of secular tailwinds while maintaining a strong balance sheet [10][12] - The digital transformation includes embedding AI-powered job matching and predictive analytics to enhance workforce solutions [14][15] Q&A Session Summary Question: Monthly trends and green shoots - Management noted double-digit growth in skilled businesses and signs of stabilization, with a return to company-wide growth expected in Q3 [32][34] Question: Unsolicited buyout offer from HireQuest - The board rejected the offer, focusing on maximizing shareholder value and positioning the company to take advantage of market drivers [36][37] Question: Sustainability of revenue growth - Management is encouraged by momentum and stabilization, with clients beginning to experience positive trends [41][42] Question: Pricing competition trends - Pay rates increased by 1.2% and bill rates by 1.8%, leading to a slight margin improvement despite ongoing pricing pressure [44][45] Question: Renewable energy business performance - The renewable pipeline remains strong, with multiple new deals signed, and the company is focused on expanding into additional energy end markets [55][57]

Financial Data and Key Metrics Changes - Vertex Pharmaceuticals reported revenue of $2,960,000,000 for Q2 2025, representing a 12% growth compared to Q2 2024 [5][41] - Non-GAAP operating income for Q2 2025 was $1,330,000,000, compared to a non-GAAP operating loss of $3,150,000,000 in Q2 2024 [43] - Net income for Q2 2025 was $1,200,000,000, a significant improvement from a net loss of $3,300,000,000 in the previous year [43] - Non-GAAP earnings per share were $4.52, compared to a loss per share of $12.83 in Q2 2024 [43] Business Line Data and Key Metrics Changes - The CF franchise continued to perform strongly, contributing to revenue growth driven by ongoing patient demand and new product launches [41][30] - CASJEVY generated $30,000,000 in revenue, while GERNAVIX contributed $12,000,000 in Q2 2025 [41] - The company is seeing rapid uptake of ElefTrek among patients new to CFTR modulators and those returning to therapy [32] Market Data and Key Metrics Changes - Revenue outside the U.S. increased by 8% year-on-year, supported by healthy CF growth and contributions from CASJEVY [41] - The launch of GERNAVIX has seen positive reactions from both physicians and patients, with approximately 150 million lives covered by payer access as of mid-July [36][37] Company Strategy and Development Direction - Vertex is focused on expanding its patient reach through multiple new product launches and advancing its R&D pipeline [5][29] - The company aims to secure DPN as its first PNP indication while continuing discussions with the FDA for broader indications [60][61] - Vertex is prioritizing investments in marketing and commercial initiatives to support the launch of GERNAVIX and other products [48][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering strong revenue growth for 2025, reiterating guidance for total revenue in the range of $11.85 to $12,000,000,000 [44][46] - The company anticipates multiple regulatory submissions in 2026 and early 2027, with potential approvals and launches to follow [29][49] - Management highlighted the importance of ongoing discussions with the FDA to broaden indications for pain management products [60][61] Other Important Information - Vertex announced the retirement of its Chief Scientific Officer, David Alschuler, effective August 1, 2026, with Mark Bunnich set to transition into the role [8][9] - The company is advancing multiple Phase III programs that are poised for accelerated or traditional approval [28] Q&A Session Summary Question: Can you provide insights on the commercial efforts behind GERNAVIX? - Management indicated that the increase in commercial efforts was a reaction to positive feedback and payer coverage progress [54] Question: What is the strategy for pain management now that a broad PNP label is not being pursued? - Management confirmed the focus on securing the DPN indication first, with plans to broaden the label over time [60][61] Question: How is the real-world evidence generation for GERNAVIX progressing? - Management reported that formulary coverage is going well, with several large health systems adding GERNAVIX faster than expected [72] Question: What is the plan for the patient support programs as payer coverage increases? - Management stated that the patient support program will be retired as national coverage is secured [76]

Financial Data and Key Metrics Changes - In Q2 2025, net sales were $388 million, a 3% increase from $376 million in Q2 2024, achieving record quarterly sales despite adverse weather and a declining repair and remodel market [19][22] - Gross profit was $158 million with a gross margin of 40.8%, down from $168 million and 44.7% in the prior year, primarily due to one-time strategic investments and lower production levels [20][22] - Net income decreased by 13% to $76 million or $0.71 per diluted share, compared to $87 million or $0.80 per diluted share in the previous year [22][23] - Year-to-date net sales totaled $728 million, a 3% decrease from $750 million in the first half of 2024 [23] Business Line Data and Key Metrics Changes - Demand was led by strong performance in Trex composite and aluminum railing, Trex lineage decking, and the expanded mid-price select decking line [10][12] - New products launched in the last 36 months accounted for 22% of quarterly sales, significantly up from 13% in the same period last year [12][19] Market Data and Key Metrics Changes - Wood alternative products gained 170 basis points of market share from wood over the past 18 months, with Trex aggressively pursuing wood conversion as a growth strategy [10][12] - Strong demand was observed across various U.S. markets, particularly in the Western Region [10][11] Company Strategy and Development Direction - The company is focused on product development, with new products contributing significantly to sales performance and plans to continue rolling out heat mitigating technology [12][14] - Trex aims to strengthen its market position through consistent consumer messaging and commitment to channel partners, ensuring product availability at consumer purchasing points [11][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in outperforming the market despite a projected decline in the repair and remodel market for 2025 [15][24] - The company anticipates strong year-over-year comparisons in the second half of the year, driven by improved production levels and continuous improvement initiatives [24][25] Other Important Information - The Arkansas manufacturing facility is expected to become the most efficient production hub once fully operational, enhancing production capacity and reducing costs [17][24] - The company reaffirmed its full-year 2025 guidance, expecting net sales growth of 5% to 7% and adjusted EBITDA margins exceeding 31% [24] Q&A Session Summary Question: Clarification on gross margin comments for Q3 - Management clarified that the 100 basis point improvement refers to EBITDA margin, not gross margin, and that Q3 will benefit from the reversal of level loading and elimination of enhanced costs [33][34] Question: Demand picture and outperformance - Management noted strong contractor backlogs and continued outperformance against the repair and remodel market, driven by a significant number of aging wood decks in North America [41][42] Question: Broader R&R outlook changes - Management indicated that general consumer uneasiness about the economy has led to expectations of a slight decline in the repair and remodel market [55] Question: Capital allocation thoughts - Management plans to prioritize organic growth opportunities, potential acquisitions, and share buybacks as free cash flow generation increases [70][89] Question: Impact of adverse weather on sales - Management acknowledged that adverse weather conditions negatively impacted sales but did not quantify the effect [82] Question: New product introductions and demand shifts - Management confirmed that new product introductions would continue regardless of consumer demand fluctuations, as these are long-term investments [83]

Financial Data and Key Metrics Changes - Total revenues grew 16% in Q2 2025 and 15% year-over-year compared to the same periods in 2024, driven by strong global demand and new patient starts [13][19] - Non-GAAP diluted earnings per share increased to $1.44, reflecting a growth rate more than three times that of revenue growth [18] - Operating cash flow reached $185 million in Q2, a 55% increase compared to the same period in 2024 [18] Business Line Data and Key Metrics Changes - VOXZOGO revenue increased 20% year-over-year to $221 million, supported by global expansion and new patient starts [13][20] - Enzyme Therapies revenue rose 15% year-over-year to $555 million, with Palynziq and Vimizim contributing significantly to growth [15][26] - Rocadian revenue was $9 million in Q2, primarily from the U.S. and Italy [15] Market Data and Key Metrics Changes - The company expects second half VOXZOGO revenue to be higher than the first half, with full-year revenue guidance adjusted to between $900 million and $935 million [14][15] - The company anticipates continued strong growth in the second half of 2025, leading to an increase in full-year guidance for total revenues [11][19] Company Strategy and Development Direction - The company plans to advance BMN 333, a long-acting therapy for achondroplasia, to a registrational Phase 2/3 study in the first half of next year [9][28] - The acquisition of Inozyme broadens the enzyme therapies portfolio, with a focus on BMN 401 for ENPP1 deficiency [10][31] - The company aims to augment its portfolio with strategic business development transactions to diversify growth strategies [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong growth and value creation for stakeholders through the remainder of 2025 and beyond [11][19] - The management highlighted the essential nature of their medicines and strong patient support programs as key factors in maintaining availability for patients [26] Other Important Information - The company expects to account for the Inozyme acquisition as an asset purchase, impacting financial results in 2025 [19] - The company is on track to submit applications for age extension for Palynziq to include adolescents in the U.S. and EU in the second half of this year [30] Q&A Session Summary Question: Clarification on BMN 333 and safety profile - Management confirmed that the agent referred to is Trans Con CNP and stated that no unexpected safety issues have been observed in the healthy volunteer study [36][38] Question: Thoughts on competitive landscape for achondroplasia - Management noted that while early data showed added growth with growth hormone, long-term benefits remain uncertain, and further data is needed to assess the impact of combinations [42][45] Question: Contributions to VOXZOGO guidance - Management explained that the adjustment in guidance is primarily due to shifting large orders and a better understanding of revenue trends as the year progresses [50][52] Question: Update on ITC proceedings - Management expects the initial determination from the ITC on June 8, 2026, with a completion date targeted for October 8, 2026 [56][58] Question: Details on BMN 333 trial design - Management refrained from providing specific details on powering but expressed confidence in the biological hypothesis being tested [58][60] Question: Update on citizen petition with the FDA - Management stated that the FDA is reviewing the citizen petition and no updates are expected until the PDUFA date of November 30 [88][90]

Financial Data and Key Metrics Changes - In Q2 2025, the company generated revenues of $732 million, a 9.7% increase compared to the prior period, driven by a 13.5% increase in rental revenue [20][8] - Diluted earnings per share were reported at $3.33, benefiting from new aircraft deliveries and significant insurance proceeds [8] - The net benefit from Russia insurance settlements was $344 million in Q2, with an additional $60 million expected in Q3, leading to a total recovery of 104% of the initial write-off [9][27] Business Line Data and Key Metrics Changes - The company purchased 12 new aircraft, adding approximately $890 million in flight equipment, and sold four aircraft for $126 million in proceeds [9][22] - The weighted average fleet age increased slightly to 4.8 years, while fleet utilization remained at 100% [9] - The sales pipeline is currently valued at $1.4 billion, with a projected total of $1.5 billion in aircraft sales for 2025 [10][23] Market Data and Key Metrics Changes - Commercial aircraft demand remains robust, with strong lease rates and high extension activity noted [12][19] - The company anticipates around $600 million in aircraft deliveries for Q3 2025, with a total expected delivery range of $3 billion to $3.5 billion for the year [10][11] - Global passenger traffic is expanding at approximately 5% year-to-date, according to IATA data [16] Company Strategy and Development Direction - The company is focused on maintaining a strong balance sheet while considering opportunities to return capital to shareholders [14][29] - The cancellation of the A350 freighter order frees up over $1 billion in future capital commitments, allowing for more disciplined aircraft purchases [13][29] - The company aims to continue maximizing available capital through aircraft sales while maintaining a disciplined approach to new aircraft orders [10][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding airline profitability due to declining fuel prices and a weaker U.S. dollar benefiting international carriers [15][18] - There is a positive outlook for the airline industry despite geopolitical uncertainties, with management noting strong conversations with customers [14][17] - The company expects portfolio yields to trend higher due to strong lease rates and the roll-off of lower-yielding leases [19][20] Other Important Information - The company will now report maintenance revenue as a separate line item for clarity, with maintenance revenue up $16 million in the quarter [20][21] - Interest expense rose by approximately $19 million year-over-year, driven by an increase in the composite cost of funds [24][25] - The company maintains a strong liquidity position with $7.9 billion in cash and $31 billion in unencumbered assets [29] Q&A Session Summary Question: Update on lease expirations and yield improvement - Management confirmed that the guidance for a 150 to 200 basis point improvement in yield remains valid, tracking as expected [35][36] Question: Capital allocation strategy - Management indicated that buybacks are attractive, but maintaining a strong balance sheet is a priority [39] Question: Demand from airline customers and tariff impacts - Management noted no significant change in passenger aircraft demand, but some caution in the cargo markets due to tariffs [80] Question: Production stability from OEMs - Management reported reasonable production stability from Boeing and Airbus, with no significant changes in delivery projections [72][73] Question: Expectations for end of lease revenue - Management expects similar levels of end of lease revenue in 2026 as in 2025, depending on market conditions [55] Question: Aircraft sales expectations for 2026 - Management targets $1.5 billion in aircraft sales for 2025 and anticipates maintaining that level in subsequent years [51][52]

Financial Data and Key Metrics Changes - Air Lease generated revenues of $732 million, a 9.7% increase over the prior period, driven by a 13.5% increase in rental revenue [21][7] - Diluted earnings per share were $3.33, benefiting from new aircraft deliveries and significant insurance proceeds [7][21] - The company recognized a net benefit from insurance settlements of $344 million during the second quarter, boosting book value per share to $65.53 [27][21] Business Line Data and Key Metrics Changes - The fleet's net book value and book value per common share reached all-time record levels [7] - The weighted average fleet age rose slightly to 4.8 years, while the weighted average lease term remained unchanged at 7.2 years [9] - Fleet utilization remained at 100% [9] Market Data and Key Metrics Changes - The aircraft sales pipeline increased to $1.4 billion, reflecting strong demand in the secondary market [10][24] - The company expects around $1.5 billion in total aircraft sales for 2025, with $300 million projected for the third quarter [11][10] - Lease rates remain strong, with extensions yielding higher rates than previous contracts [12][58] Company Strategy and Development Direction - The company canceled its order for seven A350 freighter aircraft, freeing up over $1 billion in future capital commitments [13] - Air Lease is focused on maintaining a strong balance sheet while considering opportunities to return capital to shareholders [14][29] - The order book is fully placed through 2026, with a disciplined approach to aircraft investment [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the airline industry's recovery, noting a 27% rise in adjusted operating profit for Lufthansa Group and a 44% increase for Air France KLM [15][16] - The company anticipates continued strong demand for commercial aircraft, with global passenger traffic expanding at around 5% year-to-date [16] - Management highlighted the positive impact of declining fuel prices and U.S. dollar weakness on airline profitability [15][14] Other Important Information - The company expects to recognize an additional $60 million net benefit from insurance settlements in the third quarter [8] - Interest expense rose by approximately $19 million year-over-year, driven by a 29 basis point increase in the composite cost of funds [25] - The company maintains a strong liquidity position with $7.9 billion in cash and $31 billion in unencumbered assets [29] Q&A Session Summary Question: Update on lease expirations and maturities - Management confirmed that guidance for a 150 to 200 basis point improvement in yield remains valid, tracking as expected [34] Question: Capital allocation strategy - Management indicated that buybacks are attractive, but maintaining a strong balance sheet is a priority [39] Question: Demand from airline customers - Management noted that there is no change in positive momentum for passenger aircraft demand, with some caution in the cargo markets due to tariffs [82][81] Question: Production stability from OEMs - Management confirmed that Boeing has met delivery projections, while Airbus has not experienced further slippage since earlier notifications [73] Question: Expectations for end of lease revenue - Management expects similar levels of end of lease revenue in 2026 as in 2025, depending on lease extensions [56] Question: Aircraft sales expectations - Management targets $1.5 billion in aircraft sales for 2025 and anticipates maintaining this level in subsequent years [51][50]

Financial Data and Key Metrics Changes - The company reported revenue of $86.2 million for Q2 2025, a decrease of $800,000 or 1% compared to Q2 2024, primarily due to a $12.5 million decrease in revenue from dermatological tests, offset by an $11.7 million increase from non-dermatological tests [17][18] - Adjusted revenue for Q2 2025 was $86.2 million, also a decrease of 1% compared to the previous year [18] - The gross margin for Q2 2025 was 77.3%, down from 80.7% in Q2 2024, while adjusted gross margin was 79.5% compared to 83.2% in the same period last year [19] - Net income for Q2 2025 was $4.5 million, compared to $8.9 million in Q2 2024, with diluted earnings per share at $0.15 versus $0.31 in the prior year [22] Business Line Data and Key Metrics Changes - For DecisionDx Melanoma, the company delivered 9,981 test reports in Q2 2025, a sequential increase of approximately 16% compared to Q1 2025 and a year-over-year increase of about 4% compared to Q2 2024 [7][8] - DecisionDx SCC test reports totaled 4,762 in Q2 2025, with revenue from this test estimated at just above $15 million [10][17] - Tissue Cypher test reports reached 9,170 in Q2 2025, representing a 92% year-over-year growth compared to Q2 2024 [12] Market Data and Key Metrics Changes - The company expects continued solid growth in the second half of 2025, reiterating expectations for high single-digit volume growth for DecisionDx Melanoma for the full year [8] - The collaboration with the National Cancer Institute's SEER program is ongoing, enhancing the clinical management of melanoma patients [9] Company Strategy and Development Direction - The company is focused on investing in near-term growth initiatives, including expanding clinical evidence and optimizing the commercial team [6] - The M&A strategy aims to complement the existing portfolio to drive mid- to long-term value creation, with a focus on tests that have established reimbursement and high clinical value [24] - The company is pursuing a multi-omics approach for improved test value in Barrett's esophagus and other GI diseases [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value of their tests and the ability to create value for shareholders in the near and long term [26] - The company is optimistic about the potential for their atopic dermatitis test and expects to launch it by the end of 2025 [14][44] - Management acknowledged challenges in the reimbursement environment but remains committed to providing innovative tests that significantly impact patient care [47] Other Important Information - The company ended Q2 2025 with $275.9 million in cash, cash equivalents, and marketable securities, positioning it well for future investments [6][23] - The company has submitted reconsideration requests for DecisionDx SCC to Novitas and MolDx, with expectations of a response from MolDx by Labor Day [58][59] Q&A Session Summary Question: Plans for FDA approval after breakthrough designation for DecisionDx Melanoma - Management is moving forward with efforts to seek FDA submission but did not disclose specific timing [30] Question: Payment status for DecisionDx SCC volume - The company receives episodic payments on commercial claims, but these are not significant percentages [31][33] Question: Insights on GI sales rep productivity - The sales team is expected to reach full productivity in the third and fourth quarters of 2025 [36] Question: Reimbursement outlook for atopic dermatitis test - The company is pursuing multiple reimbursement avenues and expects limited revenue impact in 2026 [44] Question: Continuation of DecisionDx SCC offering - The company plans to keep the test available in the marketplace while moderating volume due to educational sales efforts [46] Question: Drivers for revenue guidance increase - The company raised its revenue guidance due to strong business drivers and historical seasonal trends [48] Question: Growth expectations for Tissue Cypher - The company anticipates continued growth in Tissue Cypher volumes without significant seasonality expected [56] Question: Progress with private payers for DecisionDx Melanoma - The company continues to generate data to support payer engagement, despite resistance from the payer community [102]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 totaled $77.7 million, representing a 16.4% year-over-year increase [23] - Gross margin was 79.5%, a 70 basis point increase compared to the same quarter last year [23] - Adjusted EBITDA was $3 million, or 3.9% of revenue, doubling from the previous year [24] Business Line Data and Key Metrics Changes - New buyer acquisition increased by 74% year-over-year, marking the highest number of new customers in the company's history [6][23] - Active buyers rose to 1.5 million, up 16.5% year-over-year, while orders increased by 20.8% to 1.5 million [23] Market Data and Key Metrics Changes - The closure of the de minimis loophole is expected to increase prices for ultrafast fashion goods, potentially benefiting the company [8] - The company noted a dynamic advertising market, with fluctuations in spending from competitors impacting customer acquisition [9] Company Strategy and Development Direction - The company aims to maintain gross margin and bottom line efficiency while reinvesting in acquiring new buyers and sellers [7] - Ongoing innovation in AI-driven product experiences is a key focus, with improvements in customer engagement and conversion rates [10][11] - The company is expanding its seller experience to make it the default platform for selling secondhand clothing online [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive momentum and growth potential, despite caution regarding the current consumer environment [25][27] - The company is optimistic about the long-term success of its resale as a service (RAS) strategy, with renewed conversations with over 60 apparel brands [17][59] Other Important Information - The company generated $800,000 in cash during Q2, ending the quarter with $56.2 million in cash and securities [25] - The company plans to maintain profitability expectations while focusing on growth and cash generation [27] Q&A Session Summary Question: What drove the Q2 revenue outperformance and new buyer growth? - Management highlighted a combination of improved product experience, strong operations, and high-quality supply as key drivers [34][35] Question: Why is the Q4 guidance conservative? - Management noted seasonal downshifts in resale and increased marketing rates as factors influencing the conservative guidance [41] Question: What are the dynamics behind gross margin performance? - The growth in premium supply drove average selling prices, while new customer acquisition typically requires higher incentives [47] Question: What are the demographics of new buyers? - New buyers resemble previous customers, with a significant addressable market for female secondhand shoppers in the US [54] Question: What are the challenges in the AI journey? - The complexity of managing a large catalog and ensuring effective product recommendations were noted as challenges [87] Question: What is the long-term outlook for new buyer growth rates? - Management expects continued growth in the addressable market, with significant potential for acquiring new customers [89]

Financial Data and Key Metrics Changes - In Q2 2025, Syndax Pharmaceuticals reported net product sales of nearly $100 million for Revuforge and Nyktymbo, significantly exceeding expectations [5] - Revuforge net revenue increased by 43% quarter over quarter to $28.6 million, despite one-third of patients pausing treatment for stem cell transplants [5][39] - Nyktymbo generated $36.2 million in net revenue in its first full quarter, up from $13.6 million in the first two months of launch [13][39] Business Line Data and Key Metrics Changes - Revuforge has treated over 500 patients, with approximately 90% of usage in KMT2A patients, and has penetrated 25% of the annual 2,000 patient incidents [8][18] - Nyktymbo is already profitable for Syndax, contributing $9.4 million in collaboration revenue in Q2 2025 [14][40] - The average treatment duration for Revuforge is expected to increase to 6-12 months as treatment patterns mature [21][66] Market Data and Key Metrics Changes - The market opportunity for Revuforge is projected to exceed $5 billion across relapsed refractory and frontline settings [24] - The addressable market for Revuforge in the U.S. is expected to increase to $2 billion with the anticipated approval of the supplemental new drug application (sNDA) for relapsed-refractory mutant NPM1 AML [12] - Nyktymbo targets a $2 billion total addressable market in chronic GVHD, with a current indication for 6,500 patients requiring three or more lines of therapy [26] Company Strategy and Development Direction - Syndax aims to expand Revuforge into earlier lines of therapy and additional patient populations, enhancing its market position [6][12] - The company is focused on maintaining a stable operating expense base while fully funding strategic priorities [39][42] - Syndax is advancing its leadership in menin inhibition and exploring additional indications for Nyktymbo, including idiopathic pulmonary fibrosis [37][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching profitability with current resources, citing strong performance from both product launches [43][45] - The company anticipates continued growth driven by strong physician enthusiasm and robust adoption of Revuforge and Nyktymbo [45][48] - Management highlighted the importance of clinical data and physician feedback in driving future growth and market penetration [29][31] Other Important Information - Syndax has a strong financial position with $518 million in cash and equivalents as of June 30, 2025 [43] - The company has strengthened its leadership team with the addition of Dr. Nick Botwood as Head of R&D and Chief Medical Officer [15] Q&A Session Summary Question: Path to profitability and assumptions for REVIVORGE and Nyktymbo - Management indicated that profitability is expected with existing resources, and both product launches are outperforming expectations [51][52] Question: Patients proceeding to transplant and maintenance therapy - Management noted that patients typically proceed to transplant after 2-3 cycles of treatment, and they expect a high percentage of patients to return for maintenance therapy [55][60] Question: Treatment duration observations in real-world practice - Management confirmed that the average treatment duration is expected to be 4-6 months in the first year, potentially increasing to 6-12 months as treatment patterns mature [62][66] Question: KMT-2A patient penetration and revenue growth - Management stated that they expect to reach 50% penetration of the identified KMT-2A population by the end of the year, with significant growth potential remaining [76][80] Question: FDA approval confidence and remaining open items - Management expressed confidence in the FDA approval process, indicating good progress and consistent dialogue with the agency [92][96]

Financial Data and Key Metrics Changes - Worldwide revenue for Q2 2025 was $48.6 million, representing a growth of 21.7% year-over-year [30] - U.S. revenue was $46.4 million, reflecting a growth of 22.8% [31] - Adjusted EBITDA was positive at $1 million, compared to an adjusted EBITDA loss of $2.7 million in the prior year [34] - Net loss narrowed to $6.2 million or $0.14 per diluted share, compared to a net loss of $8.9 million or $0.22 per diluted share in the prior year [34] - Cash and marketable securities increased to $145.5 million, marking the first quarter of cash flow breakeven [35] Business Line Data and Key Metrics Changes - U.S. procedure volume increased by 25%, with double-digit growth across all modalities [10][32] - The physician base grew by 25%, reaching a record of 1,440 U.S. physicians performing procedures [22] - Average territory productivity reached $2.1 million, representing a 23% increase year-over-year [25] Market Data and Key Metrics Changes - International revenue was $2.2 million, impacted by delayed regulatory clearance for iFuse Torque in Europe [32] - The company expects iFuse Torque to boost revenue growth in Europe starting in 2026 [32] Company Strategy and Development Direction - The company aims to expand its platform of solutions targeting challenging procedures, improving surgical outcomes with lower failure rates [6][8] - Focus on innovation, physician engagement, commercial execution, and operational excellence as key priorities [12] - Plans to launch new products targeting outpatient settings and expand into new addressable markets [21][86] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand across the portfolio and the effectiveness of their strategy [44] - The company anticipates continued growth driven by strong physician engagement and product adoption [80] - Guidance for full-year revenue was updated to $195 million to $198 million, implying year-over-year growth of approximately 17% to 18% [36] Other Important Information - The company achieved cash flow breakeven ahead of schedule, indicating potential for consistent positive free cash flow [35] - Leadership changes were announced, with Tony Recoupero retiring and Nicholas Kerr promoted to Chief Commercial Officer [27][28] Q&A Session Summary Question: Guidance on top line growth and assumptions for the second half - Management highlighted strong first-half performance and confidence in continued demand, with a sequential decline expected in Q3 due to seasonality [40][46] Question: Gross margin guidance and pricing pressure - Management discussed maintaining gross margin guidance at 78.5% to 79%, embedding assumptions for ASP pressure while acknowledging potential for better-than-expected outcomes [51][56] Question: Growth of interventional doctors using products - Management noted strong growth from interventional doctors and the potential for further engagement with new product launches [60][62] Question: International market contribution and torque rollout in Europe - Management expressed optimism about the torque product's impact in Europe, with expectations for growth in 2026 [95] Question: Capital deployment priorities - Management indicated a focus on continued investment in R&D and commercial initiatives while maintaining a strong cash position [98]