Financial Data and Key Metrics Changes - KORU Medical Systems achieved revenue of over $10 million for the second consecutive quarter, representing a 27% year-over-year growth, driven by a 30% increase in the core subcutaneous immunoglobulin (SCIG) business [4][16] - Gross profit grew by 21% year-over-year, with a gross margin of 60.2%, a decrease of 320 basis points from the prior year due to higher manufacturing costs and geographical customer mix [5][18] - The company raised its full-year revenue guidance to $40.5-$41 million, indicating a growth of approximately 20%-22% [5][21] Business Line Data and Key Metrics Changes - The SCIG business grew by 30%, supported by international expansion and strong patient growth, while the U.S. SCIG business represented the largest recurring revenue base [4][6] - International revenue grew by 230%, with the company increasing its international market share from approximately 10% to 15%-20% in the underlying $60 million OUS SCIG market [16][8] - The company has nine active collaborations with potential new drugs expected to be added to its system by the end of 2026, with a commercial potential of up to $10 million by the end of 2028 [11][12] Market Data and Key Metrics Changes - The SCIG market is projected to grow approximately 9% annually over the next five years, outpacing the IVIG segment, with significant headroom for expansion due to increasing diagnoses of secondary immunodeficiency [6][7] - The oncology infusion consumables market is projected to grow from approximately $60 million in 2025 to $138 million by 2030, indicating a significant opportunity for KORU [15] Company Strategy and Development Direction - KORU is focused on expanding its pipeline and broadening its label through new collaborations, including two new PFT collaborations announced during the quarter [5][10] - The company aims to penetrate oncology infusion centers, with a successful U.S.-based oncology study validating its value proposition in this market [5][14] - KORU's strategy includes partnering with pharmaceutical companies to accelerate adoption and growth in the subcutaneous market [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's momentum, highlighting robust growth in both U.S. and international markets, and reaffirmed guidance for gross margins and cash flow from operations [5][22] - The company anticipates continued growth driven by international opportunities and a strong SCIG market, with expectations to end the year with at least $8.2 million in cash [21][22] Other Important Information - The company reported a positive adjusted EBITDA and generated positive cash flow, reflecting disciplined operating expense management [5][19] - KORU's cash usage has decreased to $1.1 million year-to-date, representing a 60% decrease from the previous year [20] Q&A Session Summary Question: Feedback on oncology pilot study and reimbursement model - Management reported high satisfaction rates among nurses and patients, with 70% of nurses able to multitask during administration, and confirmed that existing reimbursement codes cover the administration of drugs using a pump [26][28] Question: Guidance for Q4 and 2026 outlook - Management indicated a strong acceleration in revenues expected for the second half of the year, with a split of approximately 70% U.S. business and 23-24% international business for Q4 [29][30] - For 2026, management is optimistic about growth opportunities, indicating a number starting with a two for revenue guidance [31] Question: Opportunities in the EU and market dynamics - Management highlighted significant growth potential in the EU driven by prefilled conversions, estimating a $10 million-$20 million opportunity overall [32][33] Question: Gross margin expectations - Management aims to maintain gross margins in the range of 61-63% while working towards a long-term goal of 65% [36][37] Question: Japan market entry and growth cadence - Management reported initial sales in Japan and indicated that while it remains a growth driver, the broader prefill opportunity is prioritized [39][43]

Financial Data and Key Metrics Changes - The company's Q3 2025 revenues were $25.1 million, a 4% decrease from $26.3 million in Q3 2024, primarily due to delays in significant contracts [16][17] - Gross profit was $13.6 million, or 54% of revenue, compared to $15.2 million, or 58% of revenue in the prior year [17] - Adjusted EBITDA was $3.5 million, down from $4.5 million in Q3 2024, with a revised full-year revenue guidance lowered from $111-$113 million to approximately $104 million [15][21] Business Line Data and Key Metrics Changes - The company expanded its ShotSpotter technology into two new cities and one university, but faced challenges in converting demand into bookings [4][5] - SafePoint technology gained momentum due to California's AB 2975 mandate, with multiple pilot programs underway [9] - The upcoming launch of Crime Tracer Gen 3 is expected to enhance the company's offerings significantly [8] Market Data and Key Metrics Changes - The company reported strong customer retention, with a net promoter score (NPS) of plus 70, indicating high customer satisfaction [6] - International expansion efforts showed promise, particularly with deployments in Uruguay and Brazil [4][34] Company Strategy and Development Direction - The company is focusing on realigning its sales organization and improving sales execution to convert a strong pipeline into bookings [5][15] - Strategic initiatives include enhancing AI capabilities and expanding into healthcare security markets [7][9] - The company aims to deepen penetration into existing accounts and expand into mid-sized municipalities [15] Management's Comments on Operating Environment and Future Outlook - Management acknowledged temporary setbacks in sales execution but remains optimistic about long-term growth prospects [15][23] - The company expects to see operational improvements in Q4 2025 and into 2026, with a revenue guidance of $114-$116 million for 2026 [21][23] Other Important Information - The company repurchased 160,271 shares at an average price of $12.43, totaling approximately $2 million in Q3 2025 [20] - Deferred revenue as of September 30, 2025, was $43.9 million, consistent with the previous quarter [20] Q&A Session Summary Question: Why is the margin guidance lower for 2026 compared to 2025? - Management indicated that the lower margin guidance is due to conservatism in revenue expectations and potential delays in key contracts [25] Question: What is the expected revenue for Q4 2025? - Management expects Q4 revenue to be relatively flat compared to Q3, with ongoing delays impacting bookings [28] Question: How is the sales cycle for SafePoint compared to ShotSpotter? - The sales cycle for SafePoint is shorter, around 12 months, while ShotSpotter typically takes 12-18 months due to more complex decision-making processes [35] Question: What is the status of the Chicago Gunshot Detection RFP? - Management is optimistic about the RFP process, noting that there is a line item in the mayor's budget for gunshot detection technology [56] Question: Will there be catch-up payments for the Puerto Rico contract? - Management indicated that catch-up payments are unlikely as the service has been turned off, and costs may increase for the renewal [52][53]

Financial Data and Key Metrics Changes - Net revenues decreased from $2.6 million for Q3 2024 to $0.4 million for Q3 2025, primarily due to a $1.6 million decline in product sales [9] - Cost of net revenue increased by 50% from $1 million in Q3 2024 to $1.5 million in Q3 2025, attributed to additional production overhead and a $0.5 million write-down of slow-moving 4G LTE inventory [10] - Gross margin for Q3 2025 was negative, reflecting insufficient product revenue to cover production overhead costs [10] - Research and development expenses decreased by 23% from $4.2 million in Q3 2024 to $3.3 million in Q3 2025 [11] - General and administrative expenses increased by 64% from $2.4 million in Q3 2024 to $3.9 million in Q3 2025, mainly due to higher stock-based compensation and personnel costs [12] Business Line Data and Key Metrics Changes - The company recognized its first 5G product revenue this quarter, marking a significant milestone in its commercialization path [3][9] - The initial demand for the 5G chipset has exceeded 2,500 units, indicating strong engagement from lead customers [5] Market Data and Key Metrics Changes - Gogo, the first 5G network operator, is set to activate full service before year-end 2025, representing a significant commercial deployment using GCT's 5G chipset [4] - The company is preparing for increased production and shipment volumes in late Q4 2025, aligning with customer launches [6] Company Strategy and Development Direction - The focus remains on scaling production efficiently and ensuring alignment with supply chain partners to support the transition to volume production and sustained 5G sales [8] - The company has secured $10.7 million in debt financing to accelerate production readiness and support working capital requirements [6][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving break-even adjusted EBITDA by Q3 2026, with positive cash flow expected in Q4 2026 [18] - The company anticipates substantial margin improvements as 5G product sales increase significantly starting in Q1 2026 [11] Other Important Information - The company ended the quarter with cash and cash equivalents of $8.3 million, net accounts receivable of $3.7 million, and net inventory of $1.9 million [12] Q&A Session Summary Question: What volumes are expected to ship later this year? - The company expects to ship around 2,500 units, which includes both shipped and backlogged orders for Q4 [15] Question: How will customer shipments evolve in Q1? - The company is adding more wafers to significantly increase supply in Q1, supporting ongoing demand from Airspan and other customers [17] Question: What is the confidence level for reaching break-even adjusted EBITDA? - The company has been tracking adjusted EBITDA trends and anticipates reaching break-even by Q3 2026, with positive cash flow in Q4 2026 [18] Question: How is pricing holding up for the 5G products? - The company is seeing prices both above and below the expected average selling price, which remains a good benchmark [19] Question: What are the key focus areas for preparing the supply chain for higher volume production? - Key areas include ensuring wafer production starts early, having proper testing in place, and preparing assembly houses for increased demand [21]

Financial Data and Key Metrics Changes - The third quarter of 2025 marked the strongest performance in the past two years, with gross revenue reaching $2 million, of which 12% was derived from subscription-based sales, indicating a significant improvement in core fundamentals [3][4] - The shift towards recurring and integrated systems revenue is driving margin expansion and positioning the company for profitability [9] Business Line Data and Key Metrics Changes - The adoption of BolaWrap is increasing, with a reported 92% field success rate and zero reported deaths or serious injuries, showcasing its effectiveness compared to traditional tools like Tasers and pepper spray [5][6] - The company has expanded its product family to include Wrap Vision and Wrap Reality, enhancing its offerings beyond just hardware sales to a multi-year subscription model [8][9] Market Data and Key Metrics Changes - The U.S. law enforcement market consists of approximately 18,000 agencies and about 1 million officers, presenting a substantial opportunity for growth [10] - The counter-UAS market, which the company is targeting with its Merlin and Panda programs, is projected to exceed $15 billion globally by 2030 [10][11] Company Strategy and Development Direction - The company is transitioning from a device manufacturer to a provider of non-lethal response subscription solutions, focusing on training, policy alignment, and integrated systems [3][6] - The establishment of Wrap Federal aims to expand into defense and homeland security markets, aligning with federal procurement standards [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing adoption of non-lethal tools, driven by tighter policies and increasing demand for safer law enforcement practices [4][21] - The company is optimistic about its future capital needs and plans to approach capital markets for potential public secondary offerings [15] Other Important Information - The company opened a new manufacturing and training facility in Norton, Virginia, to support its Made in America production strategy and enhance R&D capabilities [12][13] - The focus on integrated training and policy discussions is seen as crucial for the successful deployment of non-lethal tools [34] Q&A Session Summary Question: Future capital needs and public secondary offerings - Management indicated that they see the potential to tap into capital markets and will continue to evaluate financial options [15] Question: Difference between non-lethal and less-lethal - The company clarified that its device is classified as non-lethal, distinguishing it from other less-lethal products in the market [16][17] Question: Confidence in adoption and movement away from other tools - Management cited documented deployment data showing significant adoption of BolaWrap, with usage outpacing traditional tools like Tasers [21][22] Question: Updates on the potential Chile deal - The company is actively engaging with Chile and anticipates real business opportunities in the near future [32][33] Question: Plans to obtain sales and sales force description - The company has ramped up its sales and marketing team significantly, indicating a strong push to capitalize on current market opportunities [45][46]

Financial Data and Key Metrics Changes - Revenues grew by 28% or $1.3 million to a record $6 million in Q3 2025 compared to $4.7 million in Q3 2024 [5][26] - Gross margin was 91%, with adjusted gross margin improving to 92.8% from 91.5% year-over-year [5][27] - Net income improved to $290,000 from a loss of $810,000 in the prior year, with earnings per share increasing to $0.01 [5][28] - Adjusted EBITDA reached a record $631,000, up from a negative $160,000 in Q3 2024 [5][29] Business Line Data and Key Metrics Changes - Banking and lending grew approximately 80%, representing about 50% of quarterly revenue [14] - Retail declined approximately 5%, accounting for about 30% of quarterly revenue [14] - Title insurance grew approximately 120%, representing just over 2% of quarterly revenue [14] - SaaS revenue increased by 26% to $5.9 million, making up about 98% of total revenue [26] Market Data and Key Metrics Changes - Significant growth was noted with a leading lease-to-own company, which grew over 700% [6] - A major bank and credit card issuer grew over 60% year-over-year and purchased additional transaction capacity [6] - The company entered into two-year agreements with a top title insurance company, expected to generate six-digit annual recurring revenue [7] Company Strategy and Development Direction - The company aims to diversify its revenue sources, reducing reliance on retail, which has been a headwind [33] - Focus on upselling existing clients and pursuing verticals such as title insurance and automotive [25] - Continued investment in product innovations, including a new Optical Character Recognition product and enhanced customer interfaces [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about growth despite economic headwinds, attributing success to diversification [76] - The company anticipates maintaining strong cash positions and positive adjusted EBITDA for the year [29][31] - Management highlighted the importance of real-time ID verification as a critical step in fraud prevention [21] Other Important Information - Intellicheck was named a Leader in the IDC MarketScape Worldwide Identity Verification and Financial Services 2025 Vendor Assessment [8] - The company is making progress with a global social media client, although the ramp-up has taken longer than expected [9][10] Q&A Session Summary Question: Are retail headwinds pretty much gone? - Management noted that retail has seen softening but diversification has helped mitigate impacts [33][34] Question: How much of the $6 million in revenue qualifies as new business? - Management estimated that new business might account for about 7-10% of total revenue [38] Question: Is there anything one-time or seasonal affecting SaaS revenue? - Management confirmed that there were no one-time impacts, and the regional bank's contribution was a full quarter's impact [44][47] Question: What are the dynamics driving incremental EBITDA margins? - Management indicated that stable operating costs and revenue growth are contributing to improved margins [55][60] Question: How is the company prioritizing cash balance? - Management emphasized reinvesting in R&D and marketing while remaining prudent with spending [71]

Financial Data and Key Metrics Changes - For Q3 2025, research and development expenses decreased to $17.5 million from $19.0 million in Q3 2024, primarily due to reduced spending on the Revitalize One study and lower stock-based compensation [17] - Selling, general, and administrative expenses increased to $5.2 million from $4.8 million in the same period last year, reflecting one-time costs associated with the issuance of warrants [17] - The company reported a net loss of $45.6 million, compared to a net loss of $23.2 million in Q3 2024, largely driven by a $23.5 million non-cash accounting change in the fair value of warrants [17] - As of September 30, 2025, cash and cash equivalents stood at approximately $77.7 million, bolstered by $83 million from recent underwritten offerings, extending the cash runway into early 2027 [18] Business Line Data and Key Metrics Changes - Revita, the company's endoscopic procedural therapy, demonstrated significant clinical results, with treated patients losing an additional 2.5% of total body weight while sham group patients regained about 10% after discontinuing tirzepatide [6][8] - Enrollment in the Remain One pivotal cohort was completed in Q2 2025, with over 60% of patients randomized as of October 31, 2025, ahead of schedule [7] Market Data and Key Metrics Changes - The company anticipates nearly 1 million annual procedures at peak adoption for Revita, translating to a substantial revenue opportunity [13] - Revita's unit economics are expected to create strong incentives for adoption at clinical sites, with gross margins comparable to or better than other advanced endoscopic interventions [13] Company Strategy and Development Direction - The company is focused on advancing clinical programs and regulatory milestones, with a clear path for multiple catalysts expected within the next 12 months, including pivotal data and potential PMA submission [19] - Revita is positioned as a transformative therapy for obesity, particularly in post-GLP-1 weight maintenance, complementing existing chronic drug therapies [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical and regulatory milestones, emphasizing the strong data supporting Revita and the growing market need for effective obesity treatments [4][19] - The company is optimistic about the potential for Revita to significantly reduce weight regain rates, which is a critical challenge for patients discontinuing GLP-1 therapies [9][22] Other Important Information - The company has established a ready-to-activate commercial model with experienced physicians at major clinical centers across the U.S. [12] - Revita's durable activity is expected to provide economic advantages by potentially reducing the need for ongoing drug therapy and associated health risks [11] Q&A Session Summary Question: What are the expectations for the six-month updates for Reveal One and Remain One Midpoint? - Management expects the six-month Reveal dataset to show consistency in results, with a goal of less than 5% weight regain, which would be a compelling outcome [21][23] Question: Can you clarify the German registry data regarding weight loss maintenance? - The average weight loss at one year was 8%, and at two years was 8.9%, indicating no waning of effect [26][27] Question: What are the manufacturing needs for Revita? - The company is confident in its current manufacturing capabilities to support clinical studies and is preparing for scale [41]

Financial Data and Key Metrics Changes - Total operating expenses for Q3 2025 were $11.5 million, a 35% decrease from $17.8 million in Q3 2024 [11] - GAAP net loss for Q3 2025 was $11.1 million, or $1.86 per share, compared to a GAAP net loss of $17.1 million, or $2.90 per share in Q3 2024 [11] - Non-GAAP adjusted net loss for Q3 2025 was $11.3 million, or adjusted net loss of $1.91 per share, compared to $17 million, or $2.87 per share in Q3 2024 [12] - Cash burn rate for Q3 2025 was approximately $10.5 million, with an expectation of full year 2025 cash burn to be around $50 million [12] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $8 million, down from $10.8 million in Q3 2024 [11] - General and administrative expenses for Q3 2025 were $3.2 million, compared to $5.7 million in Q3 2024 [11] - Sales and marketing expenses for Q3 2025 were $350,000, down from $1.2 million in Q3 2024 [11] Company Strategy and Development Direction - The main priority is achieving design freeze of the production equivalent system by year-end 2026, which is essential for clinical entry and commercialization [6][9] - The company is focusing on reducing cash burn through targeted outsourcing and structural changes while preserving core technology [7][9] - A consulting firm has been engaged to perform a gap analysis and assist with outsourcing strategies, expected to be completed by the end of November [8][10] Management's Comments on Operating Environment and Future Outlook - Management remains committed to transforming surgical care and emphasizes transparency in communication regarding progress and challenges [14] - The company is actively exploring opportunities to bolster its balance sheet and reduce cash burn for 2026 [12][13] - There is confidence in driving a material reduction in cash burn going forward while maintaining momentum toward design freeze [12][13] Other Important Information - The company strengthened its balance sheet with approximately $5.9 million in gross proceeds from a registered direct offering [9] - The company plans to share updates about the development of its platform through social media and its investor relations website [10] Q&A Session Summary Question: Confirmation of timeline for system built to standard for regulatory testing and clinical use - Management confirmed that the timeline for design freeze is still targeted for mid-2026, and they are working to mitigate any disruptions from outsourcing initiatives [17][18] Question: Additional details on the PREDV system and outsourcing initiative - Management clarified that the outsourcing initiative is not a restart but aims to improve manufacturability and reduce costs while maintaining the timeline [20][21] Question: Development builds and surgeon testing - Management stated that they have been conducting regular testing with surgeons, including cadaver labs, and have seen improvements in system stability and efficiency [28][30] Question: Consulting engagement duration and cost - The consulting engagement with PA Consulting is expected to be short and completed by the end of the month, with a fixed fee that was deemed reasonable [35][36] Question: Status with hospital and health system partners - Management reported strong ongoing relationships with hospital partners, with active communication and surgeon engagement [38][39]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 decreased by 12.8% to $4.0 million compared to $4.6 million in Q3 2024 [10] - SaaS revenue grew by 14.6% to $1.6 million, driven by early payables automation successes [10] - Professional services revenue decreased by 28% to $1.9 million, contributing to a net loss of $370,000, an improvement from a net loss of $393,000 in the same period last year [10][12] - Adjusted EBITDA for the quarter was $105,000, down from $480,000 in Q3 2024, primarily due to reduced professional services revenue [12] Business Line Data and Key Metrics Changes - SaaS revenue, including hosting, increased to $1.6 million, while software maintenance services decreased by 11.9% to $0.3 million [10] - Professional services revenue constituted 48% of total revenue, down from 57% the previous year [11] - Storage and retrieval services showed strong margins at 71%, up from 50.6% last year, due to price increases [11] Market Data and Key Metrics Changes - The company is experiencing a recovery in professional services revenue following the renewal of a large state contract [4] - The K-12 education market is showing positive momentum, with 31 new SaaS deals closed recently [8] - Homebuilders, despite a tough year, are expected to contribute to SaaS revenue growth [6] Company Strategy and Development Direction - The company aims to build a longer backlog while expanding other revenue streams, particularly in storage and retrieval services [5] - AI is being integrated into development and sales efforts, enhancing product offerings and customer engagement [6] - The strategy includes reinvesting cash flow into sales and marketing to drive growth and attract new investors [43] Management's Comments on Operating Environment and Future Outlook - Management expects 2025 revenues to be lower than 2024 due to professional services weakness but anticipates SaaS revenue growth [14] - The company is optimistic about fourth quarter SaaS revenues exceeding those of Q4 2024 and fiscal year 2026 SaaS revenues surpassing 2025 [15] - Management highlighted a strong competitive position and diverse solutions with ample cross-selling opportunities [42] Other Important Information - The company has maintained a strong gross margin of 64.2%, up from 59.8% last year, driven by a favorable revenue mix [11] - Cash on hand as of September 30, 2025, was $3.2 million, with no debt on the balance sheet [12][13] Q&A Session Summary Question: What kind of ARR are we looking at for the K-12 deals? - The K-12 deals will drive over $100,000 in annual ARR, with potential for significant growth as the company gains access to more customers through partnerships [21][22] Question: Are homebuilders willing to expand beyond payables into other modules? - There is interest from customers in expanding into document management systems, indicating potential for cross-selling [25][26] Question: Will there be any churn in SaaS revenue? - The company has historically experienced low churn rates, around 5%, and expects net growth despite some churn [36][40]

Financial Data and Key Metrics Changes - In Q3 2025, Ascendis Pharma achieved total revenue of €214,000,000, up from €103,000,000 in Q2 2025, with a strong contribution from Europad and Skytropha [25][26] - Operating profit for Q3 2025 was €11,000,000, indicating a positive operating income development [25][26] - Cash and cash equivalents increased to €539,000,000 from €494,000,000 at the end of Q2 2025 [28] Business Line Data and Key Metrics Changes - Europad generated revenue of €143,000,000 in Q3 2025, showing strong growth in patient prescriptions and prescribers [9][25] - Skytropha contributed €50,700,000 in revenue, with a 3% growth in demand despite a foreign currency headwind [25][26] - Collaboration revenue included €20,000,000 driven by a milestone related to Europad [26] Market Data and Key Metrics Changes - In the U.S., over 4,250 patients have been prescribed Europad by more than 2,000 unique healthcare providers, indicating strong demand [10][12] - The overall insurance approval rate for Europad is around 70%, with most approvals occurring within eight weeks [12][28] - Europad is now commercially available in over 30 countries, with full reimbursement in Germany, Austria, and Spain [15] Company Strategy and Development Direction - The company aims to achieve €5,000,000,000 or more in annual product revenue by 2030, focusing on expanding its commercial organization and product offerings [23] - Ascendis Pharma is advancing its TransCon technology platform to ensure a continuous flow of new programs and products [23] - The company is also pursuing partnerships to enhance its market presence, particularly in Japan and China [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability of prescription rates and patient retention, indicating a strong foundation for future growth [33] - The company anticipates continued revenue growth driven by new patient enrollments and stable pricing in Q4 2025 [28] - Management noted that the competitive landscape does not pose significant threats to Europad's market position due to its unique properties [72] Other Important Information - TransCon CNP is under priority review by the FDA, with a PDUFA date of November 30, 2025, and is expected to become a leading treatment for children with achondroplasia [19][20] - The company is conducting a clinical trial for higher doses of TransCon PTH, which is expected to enhance treatment options for patients [100] Q&A Session Summary Question: Expectations for new patient enrollments on YorbaPath in the U.S. - Management indicated stable prescription rates and positive trends in new patient enrollments, with a strong foundation for continued growth [32][33] Question: Impact of seasonality on Q4 performance - Management does not expect significant seasonality impacts in Q4, citing a stable prescription environment [40] Question: Conversion rate for YorbaPath and future expectations - Management expects the conversion rate to improve over time, with a current approval rate of 70% [44][48] Question: Progress in different segments of the hypoparathyroidism market - Management noted strong traction among highly symptomatic patients, while emphasizing the need for patient education in less aware segments [61][63] Question: Commercial strategy for TransCon CNP - Management anticipates a significant portion of revenue will come from switching patients from existing therapies, particularly in markets with high treatment penetration [96][97]

Financial Data and Key Metrics Changes - Total revenue for the third quarter of 2025 was $6.8 million, down from $8.2 million in the same quarter of 2024, with core revenue at $6.4 million compared to $8.1 million in the prior year [18][19] - Gross margin improved to 77% in Q3 2025 from 76% in Q3 2024, while non-GAAP adjusted gross margin decreased to 81% from 85% [21][22] - Total operating expenses were $19.4 million, a decrease from $20.3 million in Q3 2024, including $3.1 million in restructuring charges [22][23] Business Line Data and Key Metrics Changes - Instrument revenue was $1.4 million in Q3 2025, down from $1.8 million in Q3 2024, while license revenue fell to $1.8 million from $2.5 million [19] - Processing assembly (PA) revenue decreased to $2.6 million from $3.4 million in the same period [19] - Program-related revenue from SPLs was $0.4 million in Q3 2025 [19] Market Data and Key Metrics Changes - 53% of core revenue in Q3 2025 was derived from SPL customers, consistent with the prior year [19] - The company reported a total of 165 patients globally who have completed cell collection, with 39 patients receiving infusions of CASGEVY [20] Company Strategy and Development Direction - The company is focused on transforming into an end-to-end platform for cell and gene therapy, with plans for organic and inorganic growth [16][17] - A restructuring initiative was implemented, resulting in a 34% reduction in workforce, aimed at maximizing cash for investments and aligning operating expenses with the current environment [10][12] - The company anticipates annualized savings of $17 million to $19 million from the restructuring, with a focus on maintaining innovation through its Field Application Scientist team [12][13] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a challenging operating environment but expressed optimism about stabilization in biotech funding and customer confidence [28][31] - The company expects to see a ramp-up in SecureDX services and a new product launch in early 2026, which could contribute to future growth [36][37] - Management remains confident in the long-term potential of cell and gene therapy and the role of the company in this space [16][17] Other Important Information - The company reiterated its guidance for 2025, expecting core revenue to be flat to a 10% decline compared to 2024 [24] - The company ended Q3 2025 with $158 million in cash equivalents and investments, with no debt [23] Q&A Session Summary Question: What is the current operating environment for the company and its customers? - Management noted that while the environment has been challenging, there are signs of stabilization in biotech funding and customer confidence [28][31] Question: How does the recent FDA leadership change affect customer confidence? - Management indicated that there have been no reported delays in customer programs due to FDA changes, and the focus on curative therapies aligns with the company's offerings [32][43] Question: What are the expectations for SecureDX and the new product launch? - Management expressed optimism about the ramp-up of SecureDX services and the potential impact of the new product launch in early 2026 [36][37] Question: Can you provide insights on M&A activities? - The company is actively looking for M&A opportunities that align with its end-to-end platform strategy, focusing on best-in-class assets that do not impact financial health [51][52] Question: What is the outlook for CASGEVY and its contribution to revenue? - Management is encouraged by the recent acceleration in patient cell collections and expects corresponding royalty contributions to grow as more SPL partners advance their programs [56][57]