Financial Data and Key Metrics Changes - Q3 2025 revenue was $240 million, a slight year-over-year decrease of 0.2% and 2% on a currency-neutral basis [4][9] - Adjusted EBITDA for the quarter was $78.7 million, down 2.4% reported and 4.4% on a currency-neutral basis, with a margin of 32.8% [4][16] - Free cash flow improved to $7.9 million compared to negative $1.8 million in Q3 2024 [17] - Total debt outstanding was $1.38 billion, with net leverage at 4.3 times, slightly up from 4.2 times in Q3 2024 [18] Business Line Data and Key Metrics Changes - Creative revenue was $144.9 million, up 8.4% year-on-year, driven by Premium Access revenue [11][12] - Editorial revenue was $89.3 million, down 3.7% year-on-year, primarily due to declines in news and sports [13] - Agency revenue declined 22% year-on-year, reflecting ongoing macro uncertainty [12][13] Market Data and Key Metrics Changes - Revenue growth in the Americas was 0.8% on a currency-neutral basis, while EMEA was down 4% and APAC down 10.8% [15] - Annual subscription revenue increased to 58.4% of total revenue, up from 52.4% in Q3 2024, with growth driven by Premium Access [10] Company Strategy and Development Direction - The company is focusing on AI initiatives, including partnerships for content licensing with technology platforms [5][25] - The merger with Shutterstock is a key strategic focus, with ongoing regulatory reviews impacting the timeline [6][19] - The company aims to enhance operational efficiency through AI deployment within its business functions [26] Management's Comments on Operating Environment and Future Outlook - Management noted headwinds from tough year-on-year comparisons due to a strong editorial calendar in Q3 2024 [9][21] - The company updated its full-year revenue guidance to $942 million-$951 million, reflecting a year-on-year growth of 0.3%-1.2% [21][22] - Management expressed optimism about the potential for AI-related revenue streams in the future [25] Other Important Information - The company is facing legal challenges, including a favorable ruling in a trademark infringement case against Stability AI [7][8] - SG&A expenses increased to $101 million, primarily due to SOX compliance efforts and ongoing litigation costs [15][16] Q&A Session Summary Question: Can you elaborate on Getty's key AI initiatives and their potential revenue impacts for 2026? - Management highlighted multiple licensing deals, including a confidential agreement with Perplexity, which could develop into a material revenue stream [24][25] Question: How are the corporate and media customer segments performing? - Media segment saw a 3% decline, particularly in broadcast and production, while corporate segment remains healthy with close to 100% retention [27][28] Question: What is the retention rate for Premium Access subscriptions? - Premium Access has the highest retention rates among subscriptions, remaining consistent over time [29][30] Question: What drove the sequential recovery in creative revenue? - The recovery was attributed to a normalization of revenue allocation between creative and editorial, along with a significant deal that provided upfront revenue recognition [32][34]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $29.4 million, representing a 3% growth compared to Q3 2024 [13][21] - Non-GAAP gross margin reached nearly 40% in Q3 2025, with a 350 basis point increase year-over-year [19][21] - Non-GAAP operating loss was $10.4 million, over 35% lower than the operating loss of $16.1 million in the prior year [20][21] Business Line Data and Key Metrics Changes - Tablo console sales increased by 8% in Q3 2025, with a significant growth in the average size of sales opportunities, which increased by more than 20% [12][17] - Product revenue was $20.6 million, slightly ahead of $20.3 million in the prior year, with consumable sales at $12.2 million [17][21] - Recurring revenue from Tablo consumables and service was $21.1 million, slightly ahead of Q3 2024 [17] Market Data and Key Metrics Changes - The demand for insourcing dialysis with Outset's technology continues to grow, supported by clinical, operational, and financial benefits [11][12] - The company is approaching 1,000 acute sites using Tablo, with a run rate of a million treatments per year [23] Company Strategy and Development Direction - The company is focusing on enterprise-wide insourcing and managing large opportunities that span multiple hospitals within health systems [11][23] - The strategy includes optimizing inventory levels and gradually increasing production to mitigate gross margin impacts [19][20] - The company aims to reach a gross margin milestone of 50% in the future [12][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that while progress has been made, there is still work to be done in transforming the sales process and improving execution [10][12] - The resignation of the Head of Sales may cause internal disruption, but the team remains committed to customer service [13][21] - Management remains optimistic about future growth, citing strong customer demand and a growing pipeline of larger deals [41][42] Other Important Information - The company revised its 2025 revenue guidance to a range of $115 million to $120 million, down from $122 million to $126 million [21][22] - Cash balances at the end of the quarter were $182 million, with a projected cash use of less than $50 million in 2025 [20][21] Q&A Session Summary Question: What factors contributed to the guidance trim? - Management indicated that a large console opportunity shifted from Q3 to Q4, and the departure of the Head of Sales was also a consideration in the revised guidance [26][27] Question: Can you elaborate on console revenues and order timing? - Console revenues showed positive growth, but management expressed frustration with execution and the ability to predict deal timing [29][30] Question: What qualities are being sought in a new sales leader? - The company is looking for someone with a background in capital equipment and enterprise sales, who can strategically lead and coach the sales team [32][34] Question: What is the growth outlook for 2026? - Management has not provided specific guidance for 2026 but remains optimistic about growth potential, emphasizing that demand continues to grow [40][42] Question: Are there any order cancellations or drops in the pipeline? - Management confirmed that no deals have fallen out of the pipeline, and the sales team is actively working to close pending opportunities [63][64]

Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $17.2 million, a decrease of $24.5 million compared to Q3 2024, while revenues for the nine months ended September 30, 2025, were $74.8 million, down $54.7 million year-over-year [14] - Total operating expenses for Q3 2025 were $33.7 million, down from $52.4 million in Q3 2024, and for the nine months ended September 30, 2025, total operating expenses were $119.8 million compared to $191.8 million in the prior year [14][15] - The net loss for Q3 2025 was approximately $13.5 million or $0.49 per diluted share, compared to a net loss of $6.9 million or $0.26 per diluted share in Q3 2024 [16] Business Line Data and Key Metrics Changes - The ARCT-032 program for cystic fibrosis is progressing with a planned 12-week study to begin in the first half of 2026, following positive interim data from the ongoing phase 2 clinical trial [5][9] - The ARCT-810 program for ornithine transcarbamylase deficiency is preparing for regulatory meetings in 2026 to discuss pivotal trial strategies for both pediatric and adult populations [9][10] Market Data and Key Metrics Changes - The Costave COVID-19 vaccine program has faced delays in the BLA filing due to regulatory changes by the FDA, impacting commercial visibility in the U.S. [13] - The Japanese partner, Meiji Seika Pharma, has launched a two-dose vial of Costave updated for the JN.1 variant in Japan, marking the first distribution of this presentation [10] Company Strategy and Development Direction - The company is focused on advancing its mRNA therapeutics and vaccines pipeline, with a commitment to addressing the unmet medical needs in cystic fibrosis and OTC deficiency [9][18] - Cost reductions are being implemented to extend the runway for the cystic fibrosis and OTC programs, while expecting continued support from CSL for commercialization in Asia and Europe [13][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for ARCT-032 to address significant unmet medical needs in cystic fibrosis [7][8] - The company remains in a strong financial position with a cash runway extended into 2028, allowing for the achievement of near-term milestones [17] Other Important Information - The company plans to add additional sites for the upcoming 12-week study to accelerate enrollment, particularly targeting countries with higher prevalence of class one CF patients [78] - The FDA's stance on CT imaging as a potential endpoint for approval is still under discussion, with management indicating that it may serve as a supportive endpoint rather than a primary one [54] Q&A Session Summary Question: Have you been able to do some PK/PD modeling for the third-dose cohort? - Management confirmed that the third cohort is being evaluated similarly to the first two cohorts, with additional data collection planned for the 12-week study [21] Question: What are the optionalities for the OTC pivotal programs? - Management indicated that separate discussions with regulatory agencies will be held for adult and pediatric populations, focusing on different biomarkers for each group [24] Question: Do you expect improvements in mucus over time in the CF study? - Management noted that mucus plugs form in smaller airways and that improvements are expected over time, with the 12-week study designed to assess this [28] Question: What metrics will drive the go/no-go decision for the 15-mg dose? - Management stated that safety and tolerability will be key metrics, along with observing a dose response in mucus plug reduction [37] Question: When should we expect to see data from the 15-mg cohort? - Data from the 15-mg cohort is expected in the first quarter of next year, with plans to transition quickly to the 12-week study thereafter [44] Question: What is the age range for the pediatric population in the OTC program? - Management indicated that the age cutoff for pediatric patients will be determined in discussions with regulatory agencies [80]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $10.1 million, a 10% increase year-over-year, driven by a higher number of revenue units despite a lower average selling price (ASP) [16][4] - The company delivered 186 MyoPro revenue units, up 16%, with 57% of those units from authorizations and orders received in Q3 [16] - ASP decreased by 5% year-over-year to approximately $54,300, but normalized for accounting changes, ASP increased by 3% [16][17] - Gross margin for Q3 2025 was 63.8%, down from 75.4% in the prior year, impacted by higher payroll, lease expenses, and material costs [20][21] - Operating loss for Q3 2025 was $3.5 million, compared to a loss of $1 million in the prior year [23] Business Line Data and Key Metrics Changes - International revenue reached a record $1.8 million, up 63%, primarily from Germany, representing 18% of total revenue [18] - Revenue from the O&P channel was a record $900,000, up 154% year-over-year, representing 9% of total revenue [18] - The pipeline stood at 1,669 patients, a 32% increase year-over-year, with 826 patients added in Q3 [19] Market Data and Key Metrics Changes - Medicare Part B patients represented 54% of revenue in Q3, while Medicare Advantage revenue was 18%, down 18% year-over-year due to high pre-authorization denials [17] - The company signed an additional contract with a payer, increasing covered lives to 35 million among private payers [12] Company Strategy and Development Direction - The company aims to diversify revenue streams, focusing less on advertising-driven revenues and more on the MyoPro Connect platform and O&P channel penetration [26] - Key initiatives include improving patient identification, expanding the MyoPro Connect program, and reducing operating costs [5][14] - The company is enhancing manufacturing processes to improve gross margin and operating leverage as revenues grow [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the O&P channel and the MyoPro Connect program, expecting to see more patient pipeline adds through these channels [40] - The company reiterated its full-year 2025 revenue guidance of $40-$42 million, representing over 23% growth from the previous year [14][26] Other Important Information - The company entered into a loan agreement providing a term loan facility of $17.5 million to support growth and operational needs [25] - Cash balance as of September 30, 2025, was $20.1 million after the loan funding [25] Q&A Session Summary Question: Scale of U.S. O&P business - The company shipped approximately $900,000 worth of units, roughly 30 units, in the O&P channel during Q3 [31] Question: Customer acquisition cost improvements - The new head of marketing is reviewing the effectiveness of various advertising channels to generate more leads at a lower cost [32] Question: Backlog drop drivers - About 40% of the backlog drop was attributed to Germany, with some cleanup in the backlog during Q3 [34] Question: Future operating expenses - Operating expenses are expected to grow, but the company aims to manage them to generate operating leverage [36] Question: Pipeline adds and market saturation - Management believes there is still significant market opportunity and expects growth through innovative patient outreach [40] Question: Q4 growth expectations - Growth in Q4 is anticipated from fill units and authorizations/orders received within the quarter [42] Question: Debt decision rationale - The company believes it can manage the debt and expects to be closer to breakeven within 18 months [46] Question: O&P clinics training progress - Several hundred clinicians have undergone training, with goals to expand the number actively placing orders [54] Question: International business performance - Germany's success is attributed to a network of O&P partners and favorable reimbursement conditions [62]

Financial Data and Key Metrics Changes - Revenue for the fiscal second quarter increased by 128% year-over-year, reaching $1.8 million, up from $0.8 million in the same period last year [4][15] - The company reported a gross loss of $0.3 million for the fiscal second quarter, an improvement from a loss of $1.1 million for the same period last year [16] - Net loss attributed to common stockholders was $7.9 million, or a loss of $1.25 per share, compared to a net loss of $13.4 million, or a loss of $5.67 per share, for the same quarter last year [18] Business Line Data and Key Metrics Changes - The company introduced a capital purchase sales model in the U.S. and had its first hospital purchase of LungFit PH [6] - The sales pipeline remains robust, with substantial opportunities across the U.S. as awareness of LungFit PH builds [4] Market Data and Key Metrics Changes - The company added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, and El Salvador, expanding its international coverage to 35 countries [10][11] - The company anticipates reaching its goal of 60 countries under partnership by calendar 2026 [11] Company Strategy and Development Direction - The company is preparing for the launch of its second-generation LungFit system, expected in late calendar 2026, pending FDA approval [8] - A national group purchasing agreement for therapeutic gases with Premier has been awarded, providing access to nearly 3,000 hospitals [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of growth post-launch of the second-generation LungFit PH, anticipating a steeper growth curve [23] - The company is navigating complexities in hospital sales cycles, with expectations for sequential growth to resume in upcoming quarters [4] Other Important Information - The company raised $12 million in debt and plans to file a registration statement for an additional $20 million through an equity line of credit [5] - The company reported a 37% reduction in total operating expenses year-over-year, down to just above $7.4 million from $11.7 million [16] Q&A Session Summary Question: Expected growth drivers leading into the potential approval of the second-generation LungFit PH - Management believes the trajectory post-launch will be significantly steeper, with international expansion and the introduction of a capital purchase model as key growth drivers [23][24] Question: Comments on timing for commercialization of the second-gen LungFit PH - Management indicated that FDA timing is not the limiting factor, but supply chain issues are affecting the timeline [26] Question: Comparison between the new model and prior ones - The second-generation machine will be about 60% the size of the original, with improved user interface and longer maintenance intervals [28][29] Question: Insights on international deals and pricing models - The international model involves selling to distributors who then use various models, including capital equipment purchases and disposables [33] Question: Update on the updated guidance of $8 million-$10 million - Management noted that the transition in leadership may cause some disruption, but the revenue target is achievable based on current performance [35][36]

Financial Data and Key Metrics Changes - Worldwide revenue reached $48.7 million in Q3 2025, representing approximately 21% growth year-over-year [4][17] - U.S. revenue grew over 21% to $46.4 million, driven by increased adoption of solutions [4][17] - Positive adjusted EBITDA of $2.3 million for the quarter, translating to an adjusted EBITDA margin of approximately 5% [5][19] - Gross profit was $38.8 million, an increase of $6.9 million or 21.8%, with a gross margin of 79.8% [17][18] - Net loss narrowed to $4.6 million, or $0.11 per diluted share, compared to a net loss of $6.6 million, or $0.16 per diluted share [18][19] Business Line Data and Key Metrics Changes - The flagship solutions continue to perform well in a large, under-penetrated market, with double-digit volume growth across all modalities [5][6] - The interventional case volume doubled compared to Q3 2024, indicating strong adoption of clinically validated solutions [7] - The number of procedures using more than two Granite implants per case grew approximately 40% in the quarter [9] Market Data and Key Metrics Changes - International revenue in Q3 was $2.3 million, representing 10.2% growth, with expectations for acceleration in 2026 due to the launch of iFuse TORQUE [17][18] - The company added 330 physicians in the quarter, marking a 27% year-over-year increase in active physicians [12][48] Company Strategy and Development Direction - The company aims to expand its addressable market by adding new applications of technology and expertise, focusing on compromised bone [22][23] - Plans to launch several innovative solutions over the next five years to address poor bone quality [12][54] - The company is focused on operational excellence, with a disciplined pricing strategy and ongoing supply chain optimization initiatives [18][19] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth, expanding margins, and achieving positive free cash flow in 2026 [22][34] - The company anticipates continued physician engagement and adoption trends, with a significant opportunity to increase procedure density [12][15] - Management highlighted the importance of favorable reimbursement changes and the potential for new product launches to drive growth [37][61] Other Important Information - The company achieved its second consecutive quarter of net cash flow breakeven, ending the quarter with $145.7 million in cash and marketable securities [20][21] - The company is actively pursuing regulatory clearance to commercialize additional products across several international markets [17][56] Q&A Session Summary Question: Discussion on physician density and operating leverage - Management emphasized the importance of physician density and the opportunity to grow by increasing the use of technology across different procedure types [24][25] - Operating leverage is expected to range between 1.25-1.75 times, with a focus on delivering strong top-line growth [27][28] Question: Guidance update and momentum in Q4 - Management raised the full-year revenue guidance to $198 million-$200 million, reflecting continued outperformance and strong momentum heading into Q4 [30][32] Question: Trends in cash burn expectations - Management expects to use some cash in Q4 for building surgical capacity but remains confident in achieving free cash flow in 2026 [34] Question: Insights on TNT and NTAP adoption - Management expressed excitement about the NTAP, which represents a significant reimbursement improvement, and noted strong interest from national distributors for TNT [57][59] Question: Long-term profitability and operating leverage - Management highlighted the unique business model that allows for high ASP and operating leverage, with expectations for margin expansion as new products contribute to revenue [61][62]

Financial Data and Key Metrics Changes - Total net sales for Q3 2025 were $13.2 million, down 5% sequentially but up 21% year-over-year from $10.9 million [17] - Adjusted EBITDA for the quarter was positive at $669,000, up from an adjusted EBITDA loss of $204,000 in the prior year period [21] - Gross margin for Q3 was 49.8%, up from 48.1% in the prior year period and up 160 basis points sequentially [20] Business Line Data and Key Metrics Changes - Food Service Technology (FST) net sales rose to $4.8 million, up 13% year-over-year, driven by hardware sales and growing recurring revenue [6][17] - Recurring FST revenue climbed to $3.3 million, generating a modest uptick in ARPU to $792 per unit from $700 in the prior year quarter [6][17] - Casino and gaming sales were $7.1 million, up 58% year-over-year but down 7% sequentially, reflecting market rebound and challenges in domestic demand [12][18] Market Data and Key Metrics Changes - The company experienced challenges in the domestic casino market, with indications of slowing demand from partners [12][18] - International markets showed strong performance, contrasting with domestic challenges [13] Company Strategy and Development Direction - The company is focused on a "land and expand" strategy, emphasizing repeatable execution and leveraging competitive advantages [5] - An acquisition of a perpetual license for the BOHA source code was completed for $2.55 million, providing operational freedom and long-term value creation [5][24] - Future projects include the potential development of an app store for BOHA terminals to enhance software revenue [11] Management's Comments on Operating Environment and Future Outlook - Management expects fourth quarter sales to be impacted by domestic market dynamics but remains optimistic about recovery in 2026 [12][31] - The company maintains full-year revenue guidance of $50 million-$53 million, reflecting continued FST expansion and casino stability [13] Other Important Information - The company has $20 million in cash on the balance sheet, providing ample working capital and flexibility [14][22] - Operating expenses for Q3 increased by 8% year-over-year to $6.5 million, with G&A expenses rising due to higher incentive and share-based compensation [21] Q&A Session Summary Question: Update on casino and gaming initiatives and competitive landscape - Management has adjusted the sales compensation plan to incentivize new customer acquisition and competitive wins, focusing on maintaining market share against a major competitor [27][29] Question: Magnitude of fourth quarter impact on casino and gaming - Management noted that demand has weakened and expects the fourth quarter to be weaker than the third quarter, but anticipates recovery in 2026 [30][31] Question: Regulatory developments in non-charitable gaming markets - Management highlighted opportunities for state governments to generate revenue through gaming, suggesting potential for expansion as states follow suit [32][34] Question: New logo acquisition in FST and pipeline development - Management acknowledged that while new logo acquisition was below expectations, the pipeline remains strong, and the focus is on improving metrics throughout the sales process [35][36]

Financial Data and Key Metrics Changes - Quanterix reported total revenue of $40.2 million for Q3 2025, representing a 12% year-over-year increase [11] - The company ended the quarter with $138 million in cash, cash equivalents, marketable securities, and restricted cash [14][16] - Adjusted EBITDA was a loss of $11.9 million, compared to a loss of $5.5 million in the same quarter of the previous year [14] Business Line Data and Key Metrics Changes - Simoa contributed $23 million in revenue, reflecting a 36% organic revenue decline, while Spatial reported $17.2 million, down 9% year over year [11] - Consumable revenue totaled $18.8 million, with $12.3 million from Simoa and $6.5 million from Spatial [12] - Accelerator Lab revenue was $8 million, with $5 million from Simoa and $3 million from Spatial, showing a sequential increase of $1 million [12] Market Data and Key Metrics Changes - U.S. academic revenue declined approximately 30%, tracking the decline in academic grants, while pharma revenue declined 23% year over year [12] - Demand across the broader industry remains uneven, but signs of stabilization are noted, particularly in academic, government, and pharma markets [6] Company Strategy and Development Direction - The company is focused on integrating operations following the acquisition of Akoya, having realized $67 million of the targeted $85 million in synergies [5][8] - Significant investments are being made in Alzheimer's diagnostics and new assays across Simoa Spatial franchises, with approximately $27 million invested in R&D year to date [6][9] - The integration of Simoa and Spatial is expected to unlock new growth avenues, particularly in oncology and multimodal biomarker strategies [7][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven in 2026 and expects to finish the year with around $120 million in cash and no debt [6][9] - The company anticipates continued improvement in the operating environment, with a focus on capturing synergies and enhancing profitability [10][16] - Management remains cautious about the impact of the government shutdown on Q4 guidance, but believes risks have bottomed out [40] Other Important Information - The company is preparing for the launch of an early access program for Simoa ONE, which is expected to be a catalyst for future instrument growth in Alzheimer's diagnostics [9][67] - Diagnostics-related revenue was $2.4 million in the quarter, with expectations for stronger traction in 2026 based on established pricing recommendations [9][50] Q&A Session Summary Question: What is the outlook for Simoa consumables given the decline? - Management noted that while order volume was consistent, the order size was smaller due to a challenging academic grant environment, but expects smaller projects to scale in 2026 [20][22] Question: What are the plans for Q4 regarding integration and synergies? - Management confirmed that a single manufacturing team has been implemented and lab services are being combined, with expectations to capture remaining synergies in early 2026 [24][25] Question: How is the Akoya business expected to perform in Q4? - Management modeled a slight step down in Akoya's revenue for Q4 due to market uncertainty but noted strong execution in Q3 [28][29] Question: What is the competitive landscape and how is the company addressing it? - Management acknowledged competition in high sensitivity platforms but emphasized their unique position in the four to five marker space, which is expected to benefit from discovery progress [41][43] Question: What is the expected ramp-up for LucentAD in 2026? - Management indicated that established pricing will support stronger traction and growth in diagnostics revenue, with ongoing partnerships in Asia contributing positively [50][70]

Financial Data and Key Metrics Changes - Operating expenses decreased from $27.3 million in Q3 2024 to $21.2 million in Q3 2025, a 22% reduction [19] - Net loss for the quarter increased to $45.5 million, or $0.87 per share, primarily due to a $22.5 million non-cash loss on fair value adjustments related to warrant liabilities [20] - Loss from operations decreased 22% to $21.2 million in Q3 2025 from $27.3 million in Q3 2024, with a per-share loss dropping 58% to $0.41 from $0.97 [21][22] Business Line Data and Key Metrics Changes - The primary focus remains on the development of INO 3107, with significant progress in regulatory submissions and preparations for a potential launch [5][19] - The company is advancing next-generation DNA medicine candidates, including DMAP and DPROT technologies, which have shown promising results in clinical and preclinical studies [6][24] Market Data and Key Metrics Changes - The company anticipates a potential PDUFA date for INO 3107 around mid-2026, following the expected acceptance of the BLA submission by the FDA by year-end 2025 [5][8] - Market research indicates that INO 3107 has a differentiated product profile that appeals to both physicians and patients, with a significant reduction in surgeries reported [15][16] Company Strategy and Development Direction - The company aims to position INO 3107 as a preferred treatment for RRP patients, emphasizing its advantages over competitors, particularly regarding the treatment regimen and reduced need for surgeries [6][10] - The company is also exploring partnerships and development opportunities to advance its pipeline beyond INO 3107, including INO 3112 and INO 5401 [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO 3107 to meet significant unmet needs in the RRP community, highlighting the importance of reducing the number of surgeries required [10][12] - The company is preparing for a swift launch of INO 3107 if approved, with ongoing market research and operational preparations [18][19] Other Important Information - The company has completed the rolling submission of its BLA for INO 3107, marking a significant milestone in its development efforts [5][8] - The company has a cash balance of $50.8 million as of the end of Q3 2025, with an estimated cash runway into the second quarter of 2026 [22] Q&A Session Summary Question: Has Pepcimios officially launched, and how significant is their head start? - Pepcimios became available to order as of October 21, and the company expects single-digit penetration into the prevalent population before their own expected approval in mid-2026 [26][27] Question: Will INO 3107 have a similar label to Pepcimios, and is a pivotal study required for ex-U.S. approval? - The company believes their data would justify a broad label similar to Pepcimios, and any confirmatory study will be valuable for European filings [31][33][38] Question: What is the Salesforce preparedness post-3107 approval? - The company is advancing launch preparations and plans to have a field force ready to engage in scientific exchange and payer discussions ahead of approval [42] Question: Are there any cross-reactivity issues for patients switching from Pepcimios to INO 3107? - There is no anticipated cross-reactivity issue, but patients will need to complete the entire treatment regimen of INO 3107 [45] Question: Can you comment on the levels of expression achieved for the dMAb technology? - The company reported sustained expression of monoclonal antibodies over 72 weeks, with concentrations in the blood exceeding 1 microgram per ml, indicating promising results [49][50]

Financial Data and Key Metrics Changes - Revenue grew 20% to $377.4 million, with adjusted EBITDA rising 19% to $27.3 million, yielding adjusted EPS of $0.25 [5][14][15] - Total resident count increased by 13% to 203,766, driven by both organic growth and acquisitions [5][14] - Adjusted EBITDA margins held steady at 7.2%, reflecting the dilutive impact from recent acquisitions and greenfield startups [5][15] Business Line Data and Key Metrics Changes - The pharmacy segment experienced strong performance, with significant contributions from new acquisitions in Washington and Oregon [14][15] - Gross profit increased to $74.7 million, with a margin of 19.8% [15] - The company noted that its four- to five-year locations are performing at or above the consolidated adjusted EBITDA margin, while newer locations are progressing steadily [15] Market Data and Key Metrics Changes - Guardian holds a national market share of 13% in serving assisted living facilities, with 37 pharmacies having over 20% market share and 12 pharmacies exceeding 40% [8][9] - The company serves nearly 204,000 residents, primarily in-house, and expects to benefit from demographic trends as the aging population grows [9][10] Company Strategy and Development Direction - The company aims to drive organic growth through new customer facility wins, higher resident adoption, and greenfield expansions, while also pursuing targeted acquisitions [10][11] - Guardian is focused on enhancing profitability by integrating new pharmacies and leveraging technology and operational efficiencies [10][11] - The company is navigating policy changes proactively and advocating for legislative solutions to address industry challenges [6][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in offsetting anticipated EBITDA headwinds despite expected flat revenue growth in 2026 [6][10] - The company highlighted the importance of local leadership and scale in executing its growth strategy [7][10] - Management noted that the acquisition pipeline remains active, with a disciplined approach to selecting operators and markets [18] Other Important Information - The company filed an S-3 shelf registration for up to 6 million shares to provide financial flexibility [12] - Cash position improved to $36 million, with strong cash generation and no debt outstanding [17] Q&A Session Summary Question: Comparison of vaccine program contribution this year to last year - Management noted steady performance in the vaccine program, with a stronger start in September compared to last year [22][23] Question: Resident count and acquisition impact - Management confirmed that recent acquisitions are included in the Q3 resident count, with expectations for steady growth in Q4 [24][25] Question: Status of negotiations with PBMs regarding IRA issues - Management indicated that discussions are ongoing and they are growing more confident in offsetting headwinds [26][27] Question: Margin impact from acquisitions - Management highlighted that recent acquisitions are dilutive to margins but are expected to improve over time as they mature [33][41] Question: Changes in Medicare Part D plans and resident switching - Management stated it is early in the process to assess the impact of changes in Part D plans, with ongoing efforts to optimize plans for residents [46][48] Question: Changes in drug consumption patterns - Management observed a steady growth in acuity among residents, leading to increased utilization of certain brand medications [50]