Financial Performance - KORU Medical Systems achieved record Q3 revenues of $10.4 million, a 27% increase compared to the prior year period, driven by the Core SCIg business[6, 20] - The company reported a net loss of $0.8 million but achieved a positive adjusted EBITDA of $0.09 million and generated $0.4 million in cash during Q3[6] - KORU Medical Systems is raising its 2025 revenue guidance to $40.5-$41.0 million, representing a growth of 20%-22%, and reiterating a gross margin of 61%-63%[6] Market and Growth Opportunities - The US SCIg market is forecasted to grow at 9%+ through 2029[8] - KORU Medical Systems has grown its international market share from approximately 10% to approximately 15-20% since 2024, with significant room for further penetration in the ~$60 million global SCIg market[11] Pipeline and Outlook - KORU Medical Systems has 7 collaborations/opportunities with Ig manufacturers, targeting a $450 million Total Ig TAM (Total Addressable Market)[12] - The company plans for 4 new drug additions on the KORU Freedom Infusion System by 2026, expanding internationally and pursuing drug labels independently, targeting a $1.8 billion Total TAM[13] - KORU Medical Systems is progressing with its strategic oncology infusion market entry initiative, with an anticipated market entry in 4Q25/1Q26, targeting a ~$138 million 2025 TAM[18, 19]

Financial Performance - For the three months ended September 30, 2025, net revenues increased to $10,402,163, representing a 27.2% growth compared to $8,179,977 for the same period in 2024[12] - Gross profit for the three months ended September 30, 2025, was $6,264,571, up from $5,185,991 in the prior year, indicating a gross margin improvement[12] - The net loss for the three months ended September 30, 2025, was $777,966, a decrease from the net loss of $1,580,817 in the prior year, showing improved financial performance[12] - For the nine months ended September 30, 2025, the net loss was $2,151,070, a decrease of 52.2% compared to a net loss of $4,505,490 for the same period in 2024[15] - Net loss for Q3 2025 decreased to $0.8 million, a 50.8% improvement compared to a net loss of $1.6 million in Q3 2024[85] - Net loss decreased by $2.4 million to $2.2 million, representing a 52.3% improvement compared to the prior year[92] Revenue Breakdown - Total revenue for the three months ended September 30, 2025, was $10,402,163, an increase of 27.3% compared to $8,179,977 for the same period in 2024[41] - Domestic revenue for the three months ended September 30, 2025, was $6,706,639, a decrease of 4.5% from $7,022,811 in 2024, while international revenue increased significantly to $3,695,524 from $1,157,166[41] - For the nine months ended September 30, 2025, total revenue reached $30,232,038, up 21.5% from $24,807,864 in 2024[41] - Domestic core revenues decreased by 5.0% to $6.1 million, while international core revenues surged by 229.6% to $3.7 million[79] - Domestic core revenues rose by 8.6% to $20.1 million, while international core revenues surged by 82.9% to $8.3 million[86] Expenses and Costs - Operating expenses for the three months ended September 30, 2025, totaled $7,132,250, compared to $6,889,288 in the same period of 2024, reflecting a 3.5% increase[12] - Selling, general and administrative expenses increased by $1.5 million, or 9.7%, primarily due to higher compensation and legal fees[89] - Research and development expenses decreased by $0.9 million, or 21.7%, due to lower project spending and severance-related expenses[90] - The company incurred tariff-related charges of $0.1 million during Q3 2025, expecting a gross margin impact of less than 100 basis points annually[77] Assets and Liabilities - Total current assets as of September 30, 2025, were $19,419,296, slightly up from $19,132,410 as of December 31, 2024[9] - Cash and cash equivalents decreased to $8,464,019 as of September 30, 2025, down from $9,580,947 at the end of 2024[9] - Total liabilities as of September 30, 2025, were $10,638,701, up from $10,404,836 as of December 31, 2024, reflecting an increase in financial obligations[10] - Total stockholders' equity decreased to $16,464,825 as of September 30, 2025, from $16,813,679 as of December 31, 2024, indicating a decline in shareholder value[10] - Total stockholders' equity as of September 30, 2025, was $16,464,825, a decrease from $20,353,771 at the end of 2024[17] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2025, was $632,351, a reduction from $1,259,333 in the prior year[15] - The company had a net decrease in cash and cash equivalents of $1,116,928 for the nine months ended September 30, 2025, compared to a decrease of $2,675,930 in the same period of 2024[15] - Cash on hand was approximately $8.5 million as of September 30, 2025, with inventory increasing by $1.6 million to $4.4 million[93][94] - Net cash used in investing activities was $0.5 million, primarily for manufacturing equipment purchases[100] - Net cash gained from financing activities was $0.04 million, mainly from employee stock option exercises[101] Stock-Based Compensation - The company reported stock-based compensation expense of $1,740,727 for the nine months ended September 30, 2025, compared to $1,924,131 in the same period of 2024[15] - Total stock-based compensation expense for time-vested stock options was $775,966 for the nine months ended September 30, 2025[50] - The company issued 183,881 shares of stock-based compensation during the nine months ended September 30, 2025[17] - The company has $3,210,584 of unrecognized compensation cost related to unvested employee restricted stock awards, RSUs, and PSUs, expected to be recognized over a weighted-average period of 26 months[57] Loans and Credit Facilities - The company entered into a loan agreement providing for a $5,000,000 revolving credit facility and a $5,000,000 term loan facility, with no outstanding borrowings as of September 30, 2025[58] Asset Management - The company has recognized total property and equipment of $8,283,277 as of September 30, 2025, an increase from $7,763,422 as of December 31, 2024[44] - The company did not record any impairment losses for the three or nine months ended September 30, 2025, indicating stable asset performance[43] Lease Obligations - Operating lease costs for the three months ended September 30, 2025, were $130,785, compared to $116,772 in 2024, reflecting an increase in lease expenses[60] - The weighted average remaining lease term for operating leases decreased from 5.1 years in 2024 to 4.3 years in 2025[62] - Total undiscounted lease payments amounted to $3.6 billion, with total lease liabilities at $3.1 billion for operating leases[62]

Revenue Performance - Total net revenues increased by $2.2 million, or 27.2%, to $10.4 million for Q3 2025 compared to $8.2 million in Q3 2024[4] - Domestic core revenues were $6.1 million, a decrease of 5.0% year-over-year, while international core revenues surged by 229.6% to $3.7 million[4] - Net revenues for the three months ended September 30, 2025, were $10,402,163, representing a 27.3% increase from $8,179,977 in the same period of 2024[21] Profitability - Gross profit rose by $1.1 million, or 20.8%, to $6.3 million, with a gross margin of 60.2%[6] - The reported net loss improved to $0.8 million, a 51% reduction from the prior year, with positive adjusted EBITDA of $0.09 million, a 121% improvement[5] - Gross profit for the nine months ended September 30, 2025, was $18,786,676, up 19.3% from $15,769,038 in 2024[21] - The net loss for the nine months ended September 30, 2025, was $2,151,070, a decrease of 52.2% from $4,505,490 in 2024[21] - GAAP Net Loss for Q3 2025 was $777,966, compared to a loss of $1,580,817 in Q3 2024[30] - Non-GAAP Adjusted EBITDA for Q3 2025 was $89,197, an improvement from a loss of $434,495 in Q3 2024[30] Expenses - Total operating expenses for Q3 2025 were $7.1 million, a 3.5% increase from the prior year, primarily due to higher compensation and legal fees[7] - Operating expenses for the three months ended September 30, 2025, totaled $7,132,250, an increase of 3.5% compared to $6,889,288 in 2024[21] - Research and development expenses for the nine months ended September 30, 2025, were $3,242,505, a decrease of 21.8% from $4,143,751 in 2024[21] Cash Position - Cash and cash equivalents stood at $8.5 million as of September 30, 2025, reflecting a cash generation of $0.4 million during the quarter[9] - Ending cash balance for the full year 2025 is projected to be greater than $8.2 million, with positive cash flow from operations[13] - Cash and cash equivalents at the end of the period were $8,464,019, down from $8,806,310 at the end of September 2024[23] - The company reported a net cash used in operating activities of $632,351 for the nine months ended September 30, 2025, compared to $1,259,333 in 2024[23] Shareholder Metrics - The basic and diluted net loss per share for the three months ended September 30, 2025, was $(0.02), compared to $(0.03) in the same period of 2024[21] - The weighted average number of common shares outstanding for the three months ended September 30, 2025, was 46,238,819, slightly up from 45,851,019 in 2024[21] - Reported Diluted Earnings Per Share for Q3 2025 was $(0.02), compared to $(0.03) in Q3 2024[30] - Non-GAAP Adjusted Diluted Earnings Per Share for Q3 2025 was $(0.00), an improvement from $(0.01) in Q3 2024[30] Future Outlook - The company raised its full-year 2025 revenue guidance to $40.5 - $41.0 million, indicating a year-over-year growth of 20% - 22%[5] - Gross margin is expected to improve in Q4 2025 despite a decrease from 63.4% in the prior year[6] - The company announced two new pharmaceutical collaborations aimed at expanding patient reach[3] Other Income and Expenses - The total other income for the three months ended September 30, 2025, was $89,563, down from $122,480 in 2024[21] - Stock-based Compensation Expense for Q3 2025 was $737,398, up from $634,608 in Q3 2024[30] - Depreciation and Amortization for Q3 2025 was $204,482, compared to $227,785 in Q3 2024[30] - Interest Income, Net for Q3 2025 was $(74,567), down from $(112,997) in Q3 2024[30] - Tax Expense (Refund) for Q3 2025 was $(150), with no tax expense recorded in Q3 2024[30]

Core Insights - Cirtec Medical has appointed Shar Matin as the new Chief Executive Officer, effective September 2, 2025, bringing over 25 years of experience in the medical technology sector [1][2] - Shar Matin previously served as CEO of Cordis, where he led significant transformations and acquisitions, demonstrating a strong track record in business scaling and innovation [2][3] - The Cirtec Board expressed gratitude to outgoing CEO Brian Highley for his leadership over the past decade, highlighting his role in transforming Cirtec into an industry leader [3] Company Overview - Cirtec Medical specializes in the design, development, and manufacturing of complex Class II and III medical devices, focusing on active implant systems and interventional devices [4] - The company has extensive in-house capabilities and operates 11 global facilities, aiming to expedite time to market and reduce risk for its partners [4] - Cirtec Medical collaborates with customers across various therapies, including cardiology, neurology, and orthopedics, ensuring high quality and performance throughout the product lifecycle [4]

Summary of Coru Medical's Conference Call Company Overview - **Company Name**: Coru Medical Systems (KRMD) - **Industry**: Medical Device, specifically focused on drug delivery systems - **Core Product**: Innovative portable solutions for large volume drug delivery, allowing patients to self-administer medications at home instead of in hospitals [1][3][4] Key Points and Arguments Market Position and Growth - Coru Medical is a leader in large volume drug delivery, servicing over 45,000 patients with a recurring revenue model [5][6] - The company has received FDA approval for subcutaneous delivery in home settings since 2017, with a focus on chronic patients [5][6] - The global addressable market for subcutaneous immunoglobulin is estimated at $450 million, with a potential total addressable market of $2 billion for new drugs in development [11][13] Financial Performance - Revenue guidance for the year has been raised to $39.5 million to $40.5 million, indicating an 18% to 25% growth, with 75% of revenue being recurring [7][18] - The company reported a 21% overall growth and a 19% growth in its domestic core business, driven by conversions to pre-filled syringes [14][18] - Net losses have improved by 53% year-over-year, with a current net loss of $1.4 million [19] Product Development and Pipeline - Coru Medical has 10 collaborations with pharmaceutical companies to expand into various drug therapies, including nephrology, gastroenterology, and oncology [6][13] - The company has a pipeline of 10 new drugs, with four expected to be cleared in the next 6 to 12 months [15][52] - New product launches include a flow controller and a new pump designed for pre-filled syringes, enhancing patient convenience [16][40] International Expansion - International growth accounted for about 50% of the company's growth in the last quarter, with ambitions to increase market share from 10-15% to 50-60% in various regions [30][38] - Japan is identified as a significant emerging market, with plans to launch there by 2026 [36][38] Challenges and Risks - The company faces potential destocking issues in the U.S. market due to distributor inventory initiatives [27][28] - There is a need to navigate the complexities of reimbursement and payment structures in oncology, which is a new area for the company [47] Future Outlook - Coru Medical aims for sustainable growth of over 20%, driven by the expanding IG market, chronic patient base, new products, and international expansion [21][22] - The company is focused on maintaining cash flow positivity while investing in new product development [18][40] Additional Important Insights - The company has over 70 global patents on its Freedom system, providing a competitive edge in the market [6] - A five-year retrospective study showed a 97% adherence rate among patients using their system, indicating strong customer satisfaction [10] - The company is exploring additional drug indications, such as iron chelation antibiotics, which could provide low-risk growth opportunities [49][50] This summary encapsulates the key points discussed during the conference call, highlighting Coru Medical's market position, financial performance, product pipeline, international expansion efforts, challenges, and future outlook.

Financial Data and Key Metrics Changes - The company achieved record revenues of $10,200,000 in Q2 2025, representing a 21% growth year-over-year [21] - For the first half of 2025, revenue grew 19% to $19,800,000 compared to $16,600,000 in the same period of 2024 [25] - Gross margin for Q2 was 63.5%, a decline of 150 basis points year-over-year, primarily due to tariff impacts and prior year inventory adjustments [22] - Cash balance at the end of Q2 was $8,100,000, with cash usage of $600,000 during the quarter [24] Business Line Data and Key Metrics Changes - Domestic core revenues were $7,100,000, a 15% increase over the prior year, driven by new patient starts and market share gains [21] - International core business revenues reached $2,200,000, representing a 34% growth over the prior year, fueled by expansion into new geographies [21] - Pharma services and clinical trials revenues were $900,000, reflecting a 42% growth over the prior year, driven by clinical trial orders from a non-IG partner [21] Market Data and Key Metrics Changes - The company serves approximately 45,000 patients primarily on IG therapy for chronic conditions, providing a stable base of recurring revenue [7] - The total addressable market for new drugs is estimated at approximately $1,800,000,000, based on patient populations and dosing schedules [16] - The company expects continued strong growth in international markets, particularly from prefilled syringe conversions [27] Company Strategy and Development Direction - The company is focused on three growth pillars: expanding the domestic core business, international expansion, and enabling the delivery of additional drug therapies [8] - The strategy includes pursuing new drugs for the Freedom Infusion platform, with five new drugs expected to be commercialized by 2026 [14] - The company aims to sustain over 20% growth through investments in core international and new product initiatives [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to maintain momentum through the remainder of 2025, supported by strong results and an expanding pipeline [29] - The company anticipates positive cash flow from operations for the full year 2025, with a focus on disciplined capital allocation [24][27] - Management highlighted the ongoing shift from hospital IV treatments to subcutaneous therapies as a favorable macro trend [30] Other Important Information - The FDA recently approved an expanded indication for Empivalli, creating further opportunities for the company [10] - The company has initiated a US-based oncology pilot program with over 50 patients enrolled, which will inform strategic decisions around oncology opportunities [10] Q&A Session Summary Question: Guidance expectations for domestic vs. international markets - Management indicated that international markets are driving significant growth, with expectations for continued acceleration in the second half of the year, while domestic growth may see a temporary dip due to a distributor's inventory reduction program [36][37] Question: Success factors for prefilled syringe conversions - The company noted that the conversion from vials to prefilled syringes is driven by patient preference and efficiency, with expectations for continued growth in this area [38] Question: Market share expectations in converted markets - Management stated that their market share in a specific converted market has increased to the low 20% range, with further opportunities for growth in additional markets [44] Question: Growth rates in the domestic SCIG market - The company reported high single-digit to low double-digit growth rates in the domestic SCIG market, driven by new patient starts [48] Question: Updates on product delays and next-gen pump submission - Management explained that delays in consumables were due to improvements in comfort and convenience, and they remain confident in the timeline for the next-gen pump submission by late 2025 or early 2026 [50][52] Question: Expectations for international growth and Japan launch - Management confirmed that the Japan launch is expected to contribute to revenue in 2025, with a larger impact anticipated in 2026 [83]

Q2 2025 Earnings Call August 6, 2025 1 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements. Forward-looking statements discuss the Company's current expectations and projections relating to its financial position, results of operations, plans, objectives, future performance, and business. Forwa ...

Financial Performance - The company reported net revenues of $10.2 million for Q2 2025, a 20.9% increase from $8.4 million in Q2 2024, driven by a 15.3% growth in domestic core and a 33.9% growth in international core revenues[75]. - Gross profit for Q2 2025 was $6.5 million, an 18.2% increase compared to $5.5 million in Q2 2024, with a gross margin of 63.5%, down from 65.0% in the prior year due to a one-time inventory valuation adjustment[76]. - For the six months ended June 30, 2025, total net revenues increased by 19.3% to $19.8 million, with domestic core revenues rising by 15.8% to $14.0 million and international core revenues increasing by 34.8% to $4.6 million[86]. - Gross profit for the first half of 2025 was $12.5 million, an 18.3% increase from $10.6 million in the same period of 2024, with a gross margin of 63.1%[87]. - The net loss for Q2 2025 decreased to $206,867, a 79.1% improvement from a net loss of $988,715 in Q2 2024, attributed to increased gross profit[84]. - Net loss decreased by $1.6 million, or 53.1%, to $1.4 million for the six months ended June 30, 2025, driven by an increase in gross profit of $1.9 million, or 18.3%[90]. Operating Expenses - Operating expenses for Q2 2025 were $6.8 million, a slight increase of 1.7% from $6.7 million in Q2 2024, primarily due to higher selling, general, and administrative expenses[77]. - Selling, general and administrative expenses increased by $0.7 million, or 6.2%, to $11.3 million for the six months ended June 30, 2025, compared to the prior year[88]. - Total operating expenses increased by $0.3 million, or 2.5%, to $14.1 million for the six months ended June 30, 2025[88]. - Research and development expenses increased by 5.3% to $1.2 million in Q2 2025, driven by higher temporary headcount spend related to new product development[83]. - Research and development expenses decreased by $0.3 million, or 11.5%, to $2.3 million for the six months ended June 30, 2025, primarily due to lower project spending[89]. Cash Flow and Financial Position - Cash on hand was $8.1 million as of June 30, 2025, with expectations that it will be sufficient to meet requirements for at least the next twelve months[91]. - Net cash used in operating activities was $0.7 million for the six months ended June 30, 2025, compared to $0.3 million in the prior year[95]. - Net cash used in investing activities was $0.5 million for the six months ended June 30, 2025, primarily for capital expenditures related to manufacturing equipment[97]. - Net cash used in financing activities was $0.4 million for the six months ended June 30, 2025, due to payments on a note payable for insurance premium financing[98]. - Future capital requirements may vary and could necessitate drawing on credit facilities or seeking additional financing[93]. Inventory and Tariff Impact - Inventory position increased by $1.1 million to $3.9 million at June 30, 2025, compared to December 31, 2024[92]. - The company incurred tariff-related charges of $0.1 million in Q2 2025, expecting a gross margin impact of less than 100 basis points on an annualized basis[77]. Market Focus - The company is focused on expanding its market presence and enhancing its product offerings in the subcutaneous drug delivery market[73]. - The company’s revenues from pharma services and clinical trials increased by 42.1% to $0.9 million in Q2 2025, primarily due to higher revenues from product sales for clinical trials[79].

Revenue Growth - Total net revenues increased by $1.8 million, or 20.9%, to $10.2 million for Q2 2025 compared to $8.4 million in Q2 2024[5] - Domestic core revenues were $7.1 million, a 15.3% increase year-over-year, driven by higher consumable volumes and market share gains[6] - International core revenues rose to $2.2 million, a 33.9% increase from the prior year, attributed to higher consumable and pump volumes[7] - Pharma Services and Clinical Trials net revenues reached $0.9 million, a 42.1% increase over the prior year period[6] - Net revenues for the three months ended June 30, 2025, were $10,194,800, representing a 20.9% increase from $8,430,089 in the same period of 2024[25] Profitability - Gross profit increased by $1.0 million, or 18.2%, to $6.5 million, with a gross margin of 63.5%[8] - Gross profit for the six months ended June 30, 2025, was $12,522,104, up from $10,583,048 in 2024, indicating a 18.3% growth[25] - The net loss for the six months ended June 30, 2025, was $1,373,105, a decrease from $2,924,673 in 2024, reflecting a 53% improvement[27] - The company reported a basic and diluted net loss per share of $0.03 for the six months ended June 30, 2025, compared to a loss of $0.06 in 2024, showing a 50% improvement[25] Expenses - Total operating expenses for Q2 2025 were $6.8 million, a slight increase of 1.7% from the prior year[9] - Operating expenses for the three months ended June 30, 2025, totaled $6,788,424, slightly higher than $6,671,784 in 2024, marking a 1.8% increase[25] - Research and development expenses for the six months ended June 30, 2025, were $2,309,398, down from $2,609,907 in 2024, a decrease of 11.5%[25] Cash Position - Ending cash balance was $8.1 million, reflecting a quarterly cash usage of $0.6 million[12] - Cash and cash equivalents at the end of the period were $8,054,716, down from $10,458,001 at the end of June 2024, representing a decrease of 22.9%[27] Guidance and Future Outlook - The company raised its full-year 2025 revenue guidance to $39.5 - $40.5 million, representing growth of 18% - 20%[17] - Adjusted EBITDA for Q2 2025 was $0.3 million, compared to an adjusted EBITDA loss of $0.4 million in Q2 2024[11] - Non-GAAP adjusted EBITDA for the six months ended June 30, 2025, was $14,943, compared to a loss of $1,312,913 in 2024, indicating a significant turnaround[34] Share Information - The weighted average number of common shares outstanding for the three months ended June 30, 2025, was 46,193,709, compared to 45,811,373 in 2024, an increase of 0.8%[34] Product Development - The company submitted a 510(k) filing to add a new drug to the Freedom Infusion System, indicating ongoing product development efforts[4] Other Income - Total other income for the six months ended June 30, 2025, was $201,911, slightly down from $228,727 in 2024, reflecting a decrease of 11.7%[25]

Financial Data and Key Metrics Changes - Revenue for the first quarter reached $9,600,000, representing an 18% increase year-over-year [7] - Gross margin improved to 62.8%, a 50 basis point increase compared to the same period last year [8][26] - The company raised its 2025 revenue guidance to a range of $38,500,000 to $39,500,000, indicating a 15% to 17% year-over-year growth [9][29] Business Line Data and Key Metrics Changes - Domestic core revenues were $6,900,000, reflecting a 16% increase year-over-year, driven by new patient starts and market share gains [23] - International core business revenues reached $2,400,000, representing a 36% growth over the prior year [24] - Pharma services and clinical trials revenues declined by 39% to $300,000 due to lower clinical trial orders [25] Market Data and Key Metrics Changes - The overall SCIG market grew approximately 10% in Q1, while the company's domestic core business grew 16% [12] - Internationally, the company achieved 36% growth, driven by patient growth and new distributor relationships [12] - The total international SCIG total addressable market (TAM) is estimated at $60,000,000, with the company currently holding approximately a 10% share [16] Company Strategy and Development Direction - The company aims to expand its platform to support subcutaneous delivery of additional large volume drugs, capitalizing on the shift from IV to subcutaneous formulations [11] - The strategic vision includes strengthening the core business while pursuing new drug opportunities, with a focus on operational efficiencies and market expansion [10][11] - The company plans to submit two additional commercialized drugs for FDA clearance by the end of 2025, increasing its pipeline to five planned submissions [8][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for its core business, citing a resilient market growth even amid macroeconomic uncertainties [15] - The company is optimistic about its international expansion plans, targeting a market share increase to 30% to 40% over the next several years [16] - Management reiterated expectations for positive cash flow from operations in 2025, with a focus on improving operating leverage [30] Other Important Information - The company has nine active collaborations with pharmaceutical partners and plans to expand its addressable market through these partnerships [11][17] - The company is actively monitoring the changing policy environment regarding tariffs and has low exposures to tariffs due to the majority of raw materials being of US origin [27] Q&A Session Summary Question: Thoughts on adding new drugs without current partnerships - Management is excited about pursuing drugs independently, leveraging strong relationships with specialty pharmacies, and sees significant upside potential [41][43] Question: Revenue cadence throughout the year - Management expects international growth to be around 30%, with some impact from distributor stocking orders in Q2 [45][47] Question: Prefilled syringe opportunity and tender updates - Prefilled syringe penetration in the US is over 65%, with plans for further penetration outside the US [52][54] Question: Tariff impact on guidance - Tariff impacts are included in the gross margin guidance, with an estimated impact of under 100 basis points [57][84] Question: Market opportunity for new drugs - The iron chelation drug has an estimated patient base of 30,000, while the antibiotic drug has over 300,000 patients, with significant market potential [90][91]