Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $33.3 million, a 19% increase from $27.9 million in Q3 2024, primarily driven by $5.5 million in licensing revenue [13][14] - Gross margin improved to 66.1% in Q3 2025 from 58.4% in Q3 2024, attributed to a favorable sales mix and greater scale [14] - Net income for Q3 2025 was $1.3 million, compared to a net loss of $5 million in the same period last year [16] Business Line Data and Key Metrics Changes - The biologics product family, the core business, grew 4% year-over-year, which was below long-term growth expectations [8][9] - Hardware product revenue declined by 6% or $736,000 year-over-year [13] Market Data and Key Metrics Changes - The company anticipates closing the sale of non-core assets for $19.2 million, which will enhance focus on core biologics and strengthen financial position [5][6] - The anticipated revenue from the sold business was approximately $23.5 million, which was modestly unprofitable on a standalone basis [7] Company Strategy and Development Direction - The company is focusing on self-sustainability and positive cash flows, with strategic initiatives aimed at higher margin biologics and in-house manufacturing [9] - Investments are being made in the commercial team to maximize the reach of the orthobiologics portfolio [9][10] - New product launches include CollagenX, which is expected to complement existing offerings and address diverse surgical needs [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving low double-digit growth in the orthobiologics business for 2026, despite not providing specific guidance yet [23][24] - The company is optimistic about the impact of new products and the potential for growth in the surgical repair and wound care markets [11][40] Other Important Information - The company has reiterated its 2025 revenue guidance of $131 million to $135 million, reflecting an 11%-15% growth over 2024 [12] - Cash balance as of September 30, 2025, was $10.6 million, with net accounts receivable at $25.6 million and inventory at $40.7 million [17] Q&A Session Summary Question: Plans for commercial organization investments - Management indicated plans to increase the number of sales representatives from four to eight by the end of the year, with further additions expected in 2026 [22] Question: Growth expectations for orthobiologics business - Management expects low double-digit growth in orthobiologics for 2026, with ongoing efforts to optimize the product portfolio [23][24] Question: Highlights for upcoming NAS event - Management highlighted new products such as a growth factor product, advanced DBM called Trivium, and CollagenX as key offerings to showcase [25] Question: Year-over-year growth in orthobiologics - Management noted a 4% growth in orthobiologics, driven by stem cell and amnio product lines, while older demineralized bone products faced challenges [30][31] Question: Impact of amnio product pricing changes - Management expressed confidence in leveraging robust hospital contracts to capitalize on new pricing structures in the amnio market [36][38] Question: Plans for CollagenX distribution - Management sees significant potential for CollagenX in various markets, leveraging existing platforms and FDA work for future growth [40]

Financial Data and Key Metrics Changes - Revenues in Q3 2025 were $1.9 million, down from $2.4 million in Q3 2024, impacted by the expiration of the National Quantum Initiative [12] - Gross margins in Q3 2025 were 21%, compared to 51% in Q3 2024, due to revenue composition and pricing variability [12][13] - Operating loss for Q3 2025 was $20.5 million, compared to $17.3 million in the prior year [14] - GAAP net loss for Q3 2025 was higher than in Q3 2024, with a non-GAAP net loss of $10.7 million, or $0.03 per share, compared to $13.4 million, or $0.07 per share, in Q3 2024 [15] - As of September 30, 2025, the company had approximately $558.9 million in cash and equivalents, with no debt [15] Business Line Data and Key Metrics Changes - The company announced purchase orders totaling approximately $5.7 million for two 9-qubit Novera quantum computing systems, which are upgradable [6][7] - A three-year, $5.8 million contract from the Air Force Research Laboratory (AFRL) was announced to advance superconducting quantum networking [8] Market Data and Key Metrics Changes - The expiration of the National Quantum Initiative and its pending reauthorization in the U.S. Congress impacted revenue [12] - The company is engaged with various academic and government sectors to enhance quantum computing capabilities [9][10] Company Strategy and Development Direction - The company plans to deliver a 150-plus qubit system by the end of 2026 and a 1,000-plus qubit system by the end of 2027, with anticipated gate fidelity improvements [5][6] - The company is focusing on public-private partnerships to advance quantum technologies [9] - The company intends to open an Italian subsidiary to pursue business opportunities in the region [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future sales driven by recent contracts and collaborations, despite current revenue challenges [12][15] - The company is optimistic about being selected for phase B of the DARPA Quantum Benchmarking Initiative project in the coming months [10][18] Other Important Information - The company is exploring options for a new chip fab facility to enhance capabilities beyond the current 150 mm fab [63][66] - The potential investment for a new quantum fab is expected to be in the hundreds of millions of dollars, significantly less than a CMOS fab [66] Q&A Session Summary Question: Can you discuss the DARPA phase B and the feedback received? - Management noted that while not selected for phase B, constructive feedback was received, focusing on error correction and long-range coupling [17][18] Question: What is the comfort level for achieving 99% fidelity by 2027? - Management is confident in achieving 99.7% fidelity at 150-plus qubits by 2026 and 99.8% at 1,000 qubits by 2027 [21][22] Question: Will the 1,000-qubit system use chiplet-based architecture? - The plan is to use 36-qubit chiplets for the 1,000-qubit system, with confidence in achieving the fidelity targets [27][28] Question: How will revenue recognition work for the Novera system sales? - Revenue for the two Novera systems will be recognized upon shipment, expected in Q1 and Q2 of 2026 [31] Question: What is the expected impact of the National Quantum Initiative funding? - The recent reinstatement of funding to $625 million over five years is seen as a positive step, though discussions for higher funding amounts are ongoing [88][89] Question: What is the company's strategy regarding potential M&A? - The company is open to exploring M&A opportunities to accelerate its roadmap but believes it can execute its plans organically [50][51]

Financial Data and Key Metrics Changes - The company reported record results in Q3, with adjusted EBITDA of $20.8 million, up approximately 15% year-over-year and 6% sequentially [6][14] - Total rental revenue grew 11.1% year-over-year and 4.9% sequentially to $41.5 million, reflecting a 27,000 horsepower increase during the quarter [14] - Net income was $5.8 million or $0.46 per diluted share, an increase of $800,000 year-over-year and $600,000 sequentially [15] Business Line Data and Key Metrics Changes - Rented horsepower ended the quarter at approximately 526,000, an 11% increase year-over-year and 5% sequentially [15] - Fleet utilization reached a record 84.1%, up 204 basis points year-over-year and 45 basis points sequentially [15] - The company added a significant number of large horsepower units under long-term contracts, with roughly half being electric units [5][8] Market Data and Key Metrics Changes - The company is seeing strong demand in oil production, particularly in production efficiency, reliability, and emissions performance [9] - Rising electricity demand and LNG infrastructure buildout are creating durable growth opportunities for compression services [9] - The company is optimistic about continued demand for compression, driven by AI and data center expansion [9] Company Strategy and Development Direction - The company plans to add approximately 90,000 horsepower over 2025 and early 2026, with a significant number of new large horsepower units already under contract [8] - The company aims to maintain a balance between shareholder returns and growth, as evidenced by the inaugural dividend and its increase [7][16] - The focus remains on technology leadership and service excellence to improve competitive positioning [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver improved performance despite global macroeconomic uncertainty [9] - The company raised its full-year 2025 adjusted EBITDA guidance to $78 million-$81 million, reflecting a 2% increase at the midpoint from previous guidance [17] - Preliminary expectations for 2026 growth CapEx are set at $50 million-$70 million, indicating another year of organic growth [17] Other Important Information - The company has improved its income tax receivable and is awaiting payment processing [11] - Capital expenditures totaled $41.9 million, with $39.1 million allocated to growth CapEx [15] - The leverage ratio was 2.5x, remaining the lowest among public compression peers [16] Q&A Session Summary Question: Can you talk about the outlook for 2026 and customer conversations? - Management noted that there is no hesitancy from customers regarding 2026 contracts, with a broad range of interest observed [22][23] Question: What are the opportunities for margin improvement? - Management indicated that margins are expected to remain in the low 60s in the near term, with potential for improvement through a shift to large horsepower [25] Question: Is the majority of demand still for gas lift in the Permian? - Management confirmed that while gas lift remains the majority, there is growing demand for data center natural gas loads [29][30] Question: How is the relationship with Devon Energy developing? - Management highlighted a long-term relationship with Devon, emphasizing technology and service quality as key drivers for expansion [46][47] Question: How does the company balance dividend increases with growth opportunities? - Management stated that while they aim for a growing dividend, it will not impact the ability to grow the business significantly [44][45] Question: What is the outlook for capital expenditures in 2026? - Management indicated that 2026 is expected to be in line with 2024, with significant growth opportunities anticipated [54][55]

KalVista Pharmaceuticals (NasdaqGM:KALV) Q3 2025 Earnings Call November 11, 2025 08:30 AM ET Company ParticipantsBen Palleiko - CEONicole Sweeny - Chief Commercial OfficerBrian Piekos - CFOPaul Audia - CMORyan Baker - Head of Investor RelationsConference Call ParticipantsNone - AnalystNone - AnalystJoe Schwartz - AnalystStacy Ku - AnalystDebanjana Chatterjee - AnalystMaury Raycroft - AnalystNone - AnalystOperatorThank you for standing by. Welcome to KalVista Pharmaceuticals' 2025 third-quarter financial upd ...

Financial Data and Key Metrics Changes - Revenues in Q3 2025 were $1.9 million, down from $2.4 million in Q3 2024, impacted by the expiration of the National Quantum Initiative [12] - Gross margins in Q3 2025 were 21%, compared to 51% in Q3 2024, due to revenue composition and pricing variability [12][13] - Operating loss for Q3 2025 was $20.5 million, compared to $17.3 million in the prior year [14] - GAAP net loss for Q3 2025 was higher than in Q3 2024, primarily due to non-cash changes in fair value of derivative liabilities [15] - As of September 30, 2025, the company had approximately $558.9 million in cash and equivalents, with no debt [15] Business Line Data and Key Metrics Changes - The company announced purchase orders totaling approximately $5.7 million for two 9-qubit Novera quantum computing systems, which are upgradable [6][7] - A three-year, $5.8 million contract from the Air Force Research Laboratory (AFRL) was announced to advance superconducting quantum networking [8] Market Data and Key Metrics Changes - The expiration of the National Quantum Initiative and its pending reauthorization in the U.S. Congress impacted revenue [12] - The company is engaged with various academic and government institutions to advance quantum computing capabilities [9][10] Company Strategy and Development Direction - The company plans to deliver a 100+ qubit chiplet-based quantum system by the end of 2025, with a roadmap to deploy a 150+ qubit system by the end of 2026 and a 1,000+ qubit system by the end of 2027 [5][6] - The company is focusing on public-private partnerships to advance quantum technologies [9] - The company intends to open an Italian subsidiary to pursue business opportunities in the region [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future sales driven by recent contracts and collaborations, despite current revenue challenges [12][15] - The company is focused on achieving quantum advantage within the next three to five years, targeting 1,000 qubits with 99.9% fidelity [18][22] - Management is optimistic about potential funding increases for quantum initiatives from the U.S. government [88][89] Other Important Information - The company is exploring options for a new chip fab facility to enhance capabilities beyond the current 150 mm fab [63][66] - The potential investment for a new quantum fab could be in the hundreds of millions of dollars, significantly less than a traditional CMOS fab [66] Q&A Session Summary Question: Can you talk about DARPA phase B and the feedback received? - Management noted that while not selected for phase B, constructive feedback was received, focusing on error correction and long-range coupling [17][18] Question: What is the comfort level for achieving 99% fidelity by 2027? - Management expressed confidence in achieving 99.7% fidelity at 150+ qubits by 2026 and 99.8% at 1,000 qubits by 2027 [22][23] Question: Will the 1,000-qubit system be chiplet-based? - The plan is to use 36-qubit chiplets for the 1,000-qubit system, with no significant challenges anticipated for long-range coupling [28][30] Question: How will revenue recognition work for the Novera sales? - Revenue for the two Novera systems will be recognized upon shipment, expected in Q1 and Q2 of 2026 [32] Question: What is the expected gross margin profile moving forward? - Management indicated that margins may improve with upcoming sales, particularly from Novera systems [71] Question: What types of applications will the 1,000-qubit system run? - The system is expected to handle complex applications like drug discovery and financial forecasting, which current CPUs and GPUs struggle with [76][77] Question: How does the recent funding from the Energy Department affect the business? - The reinstatement of the National Quantum Initiative funding is seen as a positive step, although discussions for higher funding amounts are ongoing [88][89]

Financial Data and Key Metrics Changes - Total consolidated revenues for Q3 2025 were $45.1 million, reflecting a 1% year-over-year increase compared to pro forma Q3 2024 [24] - Third-quarter net loss attributable to common stockholders was $33.2 million, a year-over-year decline of approximately $700,000 or 2%, with a net loss per share of $2.61, improving by $3.28 per share or 56% compared to Q3 2024 [31] - Non-GAAP adjusted net loss attributable to common stockholders for Q3 was $7.2 million, representing an improvement of around $18 million or 71% versus the comparable period in 2024 [32] Business Line Data and Key Metrics Changes - Hospitality revenues declined 4% year-over-year in Q3, primarily due to lower revenues at the Tin Building and softness in certain legacy standalone restaurants [25] - Same-store hospitality revenue rose 11%, driven by the success of the Long Club and the strong launch of Dutano [25] - Entertainment segment revenues decreased 5% year-over-year, primarily due to hosting seven fewer concerts at the Rooftop at Pier 17 compared to the prior year [26] Market Data and Key Metrics Changes - International visitation to New York City remains below pre-pandemic levels, currently at about 90% of 2019 volume, while domestic travel remains resilient [6][7] - Total New York City visitation is projected to reach almost 65 million visitors in 2025, surpassing 2024 levels and approaching pre-pandemic visitation levels [7] Company Strategy and Development Direction - The company aims to refine its focus and priorities to stabilize and optimize operating models, emphasizing financial discipline and thoughtful capital deployment [4] - Plans include further reinvestment into existing assets to fill vacancies and improve space utilization, while also seeking opportunities to create long-term value through partnerships in real estate-driven hospitality and entertainment [5] - The company is committed to enhancing the Seaport as a cultural and experiential destination, leveraging events to drive foot traffic and awareness [45][46] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the mixed picture of the New York City market, with a focus on curating high-quality experiences to drive visitation and customer spending [10] - The company remains optimistic about the performance of new concepts and events, which are expected to enhance the overall guest experience and drive incremental spending [16][18] - Management plans to outline a go-forward strategy for the Tin Building in the next earnings call, indicating a focus on improving operational efficiency [53] Other Important Information - The sale of 250 Water Street is expected to positively impact historical cash burn by more than $7 million, eliminating interest expenses and related carrying costs [10] - The company has completed technology initiatives to centralize point-of-sale and procurement systems across hospitality businesses, enhancing purchasing power and financial visibility [14] Q&A Session Summary Question: What are the biggest levers to drive profitability? - Management highlighted the importance of getting tenants open and operational, focusing on operational models, and creating efficiencies in G&A to achieve break-even and profitability [37] Question: Can you discuss the demand for prospective spaces? - Management noted strong demand for restaurant space and is focusing on finding the right partners and experiences for the community [38][39] Question: What is the expected timing for tenant openings? - Management anticipates increased velocity in tenant openings in the back half of the year, with specific timelines for various tenants [40][41] Question: How will special events drive exposure and awareness? - Management emphasized that events like the Macy's Wine and Food Festival are crucial for marketing and pulling visitors to the Seaport, enhancing its position as a cultural destination [43][44] Question: Will the restructuring with Jean-Georges lead to break-even in 2026? - Management stated that they are not in a position to provide forward guidance on the Tin Building's performance in 2026 but are focused on outlining plans in the next earnings call [52][53] Question: What are the expectations for capital expenditures in Q4? - Management indicated that capital expenditures for Q4 will likely be light, with a ramp-up expected in the first half of 2026 [59]

Financial Data and Key Metrics Changes - The company reported record results in Q3, with adjusted EBITDA of $20.8 million, up approximately 15% year-over-year and 6% sequentially [6][14] - Total rental revenue grew 11.1% year-over-year and 4.9% sequentially to $41.5 million, driven by a 27,000 horsepower increase [14] - Net income was $5.8 million or $0.46 per diluted share, an increase of $800,000 year-over-year and $600,000 sequentially [14] - The leverage ratio was 2.5 times, up from 2.31 times in the previous quarter, remaining the lowest among public compression peers [16] Business Line Data and Key Metrics Changes - Rented horsepower ended the quarter at approximately 526,000, an 11% increase year-over-year and 5% sequentially [15] - Fleet utilization reached a record 84.1%, up 204 basis points year-over-year and 45 basis points sequentially [15] - Rental adjusted gross margin was $25.5 million, up $2.6 million year-over-year and $1.5 million sequentially, with a margin percentage of 61.5% [14] Market Data and Key Metrics Changes - The company is taking market share in large horsepower compression, with all new sets under long-term contracts [5] - Devon Energy now represents more than 10% of year-to-date revenue, indicating strong customer relationships [5] Company Strategy and Development Direction - The company plans to add approximately 90,000 horsepower over 2025 and early 2026, with significant new electric and gas units already under contract [8] - The company aims to optimize fleet assets and improve rental revenue per horsepower, which finished the quarter at $27.08 per horsepower per month, a 1.7% sequential increase [10] - The company is focused on balancing capital returns with growth opportunities, having initiated a quarterly dividend of $0.10 per share [7][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver improved performance despite global macroeconomic uncertainty, citing strong demand for compression tied to existing production [9] - The company anticipates continued growth in 2026, with preliminary expectations for growth CapEx of $50 million to $70 million [17] - Management highlighted the importance of technology and service excellence in maintaining competitive advantages [7][9] Other Important Information - The company is not focused on real estate investments but aims to convert non-productive assets into productive horsepower [11] - The company is seeing strong demand for compression driven by rising electricity demand and LNG infrastructure buildout [9] Q&A Session Summary Question: Can you talk about the outlook for 2026 and customer conversations? - Management noted that there is no hesitancy from customers regarding 2026 contracts, with a broad range of interest observed [22][23] Question: What are the opportunities for margin improvement? - Management indicated that margins are expected to remain in the low 60s in the near term, with potential for improvement through a mix shift to large horsepower [25] Question: Is the majority of demand still for gas lift in the Permian? - Management confirmed that while gas lift remains the majority, there is growing demand for data center natural gas loads, creating incremental opportunities [29][30] Question: How did the relationship with Devon Energy develop? - Management explained that the long-term relationship with Devon was strengthened by demonstrating the capabilities of their technology and service [46][47] Question: What is the outlook for capital expenditures in 2026? - Management indicated that 2026 is expected to be in line with 2024, with significant growth anticipated [54][55]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $85.5 million, down 16.7% from $102.7 million in Q3 2024 [17] - Non-GAAP gross margin was 35%, slightly up from the prior year period [18] - Non-GAAP net income for Q3 2025 was $1.7 million or $0.02 per diluted share, compared to $14.1 million or $0.16 per diluted share in Q3 2024 [22] - Free cash flow generated in Q3 2025 was $3.3 million, reflecting strong cash generation [23] Business Line Data and Key Metrics Changes - North America was the strongest region, contributing $36 million in revenue, while India contributed $24.4 million [17] - Research and development expenses were $6.8 million, down from $8.6 million in Q3 2024 [18] - Sales and marketing expenses increased to $12 million from $10.4 million in Q3 2024, reflecting increased business in North America [19] Market Data and Key Metrics Changes - Visibility improved in North America and India, with renewed order flow from a major carrier in India [14][15] - The company is optimistic about growth in 2026, driven by opportunities in both CSPs and private networks segments [15] Company Strategy and Development Direction - The company is focusing on high-capacity, low-latency connectivity solutions driven by AI and data-intensive applications [8] - Ceragon's E-band and point-to-multipoint offerings are positioned to address network capacity and resiliency challenges [9][10] - The company is pursuing additional potential acquisitions to enhance its capabilities [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for Q4 and 2026, citing improved visibility and a strong funnel of opportunities [28][29] - The company is encouraged by the growth in private networks and the demand for higher capacity driven by AI [32][33] - Management noted that the impact of the U.S. government shutdown has not been significant so far [51] Other Important Information - The company has been awarded contracts for private 5G and Wi-Fi technologies, showcasing its capabilities in managed services [12] - The balance sheet remains solid, with cash position increasing to $43 million [22] Q&A Session Summary Question: Outlook for the fourth quarter and 2026 growth - Management is optimistic about Q4, driven by visibility from India and North America, and sees potential for growth in 2026 across all regions [28][29] Question: Drivers of tier one ramp-up in North America - The increase is driven by demand for higher capacity due to 5G and fixed wireless access [37] Question: Update on E2E and commercial activity - E2E is meeting plans, with significant opportunities expected to materialize [39] Question: Supply chain concerns regarding component availability - There are slight increases in component costs, but no significant impact on overall costs is anticipated [40][41] Question: Defense and security business opportunities - The company sees numerous opportunities in defense and security, particularly with its 60 GHz product [56][58]

Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $13.5 million for Q3 2025, a 29% increase compared to $10.5 million in the same period last year [5][15] - Gross profit for the quarter was $10.2 million, up from $7.7 million in the prior year, maintaining a gross margin of 75% [16] - Operating profit increased to approximately $1.3 million from $0.3 million year-over-year [16] - Adjusted EBITDA rose to $2 million from $1.1 million in the prior year [16] - The company ended the quarter with $70.7 million in cash and cash equivalents, an increase of $1.1 million from the end of 2024 [17] - Remaining performance obligations grew to $65 million, a 37% year-over-year increase [17] Business Line Data and Key Metrics Changes - The company shipped 90 Deep TMS systems during the quarter, representing a 43% increase compared to the same period last year, bringing the total install base to over 1,600 systems globally [5][15] - Approximately 70% of recent customer engagements were structured as multi-year lease agreements, indicating a strong transition to this sales model [8] Market Data and Key Metrics Changes - The company is focusing on expanding its market presence, particularly in Asia-Pacific and Europe, with strong demand anticipated from countries like Japan, China, South Korea, and India [36][38] - The company has received FDA clearance for an accelerated treatment protocol for major depressive disorder, which is expected to enhance patient appeal and drive demand [10] Company Strategy and Development Direction - The company’s strategy includes elevating market awareness of Deep TMS, advancing its R&D roadmap, and broadening patient access through global extension and health system integration [9] - The company is pursuing minority equity investments in mental health providers to enhance market awareness and expand access to Deep TMS [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s growth trajectory, citing strong market demand and a solid book-to-bill ratio of 1.3x for the quarter [8] - The company raised its revenue guidance for the full year 2025 to a range of $51 million-$52 million, reflecting a year-over-year growth rate of 24%-27% [18] Other Important Information - The company announced a virtual investor and analyst day on December 1 to discuss operational, clinical, regulatory, and financial progress in more detail [14] Q&A Session Summary Question: Can you discuss the accelerated protocol and its current treatments? - Management highlighted that the accelerated protocol shortens the acute phase from four weeks to six days, increasing treatment frequency, which is driving demand for growth [20] Question: What can be expected regarding minority equity investments? - Management indicated a robust pipeline for minority investments, aiming to sign at least one more agreement by year-end, with promising opportunities for 2026 [21] Question: Any updates on Neurolief's activities in Japan and the EU? - Management anticipates FDA clearance for Neurolief by year-end, which will enable marketing and distribution through various channels [22] Question: What are the expectations for system placements from minority partners? - Management noted that minority investments are expected to lead to the opening of 10-15 new clinics annually, with early investments showing over 50% utilization growth [28][29] Question: Will there be changes in metrics reporting going forward? - Management plans to provide more granularity on metrics such as system shipments and performance of minority investments during the analyst day [35] Question: What is the outlook for international growth? - Management expects strong growth from Asia-Pacific and Europe, with increasing demand in countries like Japan, China, and Germany [36][38]

Financial Data and Key Metrics Changes - Sales of EKTERLY reached $13.7 million for the launch period through September 30, including $1.4 million recorded in July [22] - Total operating expenses for the period were $59.7 million, consisting of approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net came in toward the low end of the expected range this quarter, driven largely by lower copay utilization typical for this time of year [23] Business Line Data and Key Metrics Changes - EKTERLY's adoption in the U.S. has been steady and linear, with strong demand for treating HAE attacks [4] - The company has received 937 start forms, representing more than 10% of the HAE community, indicating strong early engagement [15] - The average number of cartons per shipment is on the high end of the expected range, aligning with utilization among high-burden patients [22] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia, Germany, and ongoing discussions for launches in the U.K. and Japan [5][20] - In Germany, the launch recorded first-day commercial sales, validating prescriber enthusiasm [19] - Awareness levels among healthcare providers are exceptionally high, with 100% of tier one HCPs and 95% of all target HCPs reporting awareness of EKTERLY [16] Company Strategy and Development Direction - The company aims to establish EKTERLY as the foundational therapy for HAE treatment, focusing on aggressive execution and global expansion [24] - Plans to complete more agreements for expanding access in geographies where the company will not launch on its own [5] - The company is committed to demonstrating the real-world benefits of EKTERLY through ongoing data generation and patient education [6] Management's Comments on Operating Environment and Future Outlook - Management is encouraged by EKTERLY's early momentum and rapid growth, reinforcing the belief in its long-term success [24] - The company expects refill patterns to normalize as adoption expands beyond the highest burden patients [17] - Management acknowledges potential disruptions to demand during the holiday season but remains optimistic about the fundamentals of demand [51] Other Important Information - The company has recently hired key personnel to strengthen its capabilities, including a Chief Operating Officer and a Chief People Officer [7] - The recent convertible note offering has fully financed the company through profitability, allowing a focus on executing the EKTERLY launch [7] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Approximately half of the patients who have switched to EKTERLY self-report an attack rate of two or more attacks per month, indicating a high burden [28] Question: Refill rates and access dynamics - Refill frequencies for high-burden patients are currently about once a month, significantly higher than the typical three to four months for other therapies [38] Question: Insurance negotiations and payer policies - The company anticipates wrapping up discussions with larger payers and PBMs to establish favorable policies for EKTERLY early in 2026 [71]