Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $44 million, representing a 17% increase year over year from $37.7 million in Q1 2024 [4][11] - Adjusted EBITDA for Q1 2025 was $11.6 million, up approximately 54% from $7.5 million in Q1 2024 [4][13] - Net income increased to $4 million or $0.07 per share, a 67% rise from $2.4 million or $0.04 per share in Q1 2024 [13] Business Line Data and Key Metrics Changes - Growth was primarily driven by increased sales of Glacia and Kamrab in ex-U.S. markets, as well as Varezig sales and Glacier royalties income [5][11] - Gross profit for Q1 2025 was $20.7 million with a gross margin of 47%, compared to $16.7 million and 44% in Q1 2024 [12] Market Data and Key Metrics Changes - The company expanded its plasma collection operation with a new center in San Antonio, Texas, which is expected to contribute annual revenues of $8 million to $10 million [9][10] - The company is active in over 35 countries, enhancing its global market presence [19] Company Strategy and Development Direction - The company is focused on a four-pillar growth strategy: organic commercial growth, business development and M&A, plasma collection operations, and advancing the Phase III inhaled Alpha-one program [6][40] - The company plans to launch two additional biosimilars later this year, with expectations of generating $15 million to $20 million in annual sales from this portfolio within the next five years [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued profitable growth throughout 2025, reiterating annual revenue guidance of $178 million to $182 million and adjusted EBITDA of $38 million to $42 million [5][6] - Management noted that the initiation of a comprehensive post-marketing research program for Cytogam aims to demonstrate its advantages in CMV disease management [7][8] Other Important Information - The company is currently at around 55% enrollment for the pivotal Phase III INNO2VATE clinical trial for inhaled alpha-one antitrypsin therapy [26] - The company maintains a strong cash position to fund new business development initiatives [13] Q&A Session Summary Question: Growth contributors for Cytogam - Management clarified that while Cytogam is a growth contributor, the significant growth this quarter came from other products, emphasizing the strength and diversity of their portfolio [16][18] Question: Impact of tariffs on global business - Management indicated that there should be no direct impact on sales from current tariff discussions, but they will continue to monitor the situation [22][24] Question: Timing of Cytogam post-marketing study completion - Management stated that the comprehensive program consists of multiple studies with varying timelines, some results expected as early as late 2025 and others extending to 2028 [30] Question: Impact of NIH spending cutbacks - Management does not anticipate any impact on the business from NIH spending cutbacks due to the unique nature of their products [31][32] Question: Tax rate changes - Management explained that the increase in tax rate is due to changes in fair tax liability, with no cash effect, and they expect to start paying taxes by the end of 2025 or early 2026 [33][34]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $44 million, representing a 17% increase year over year from $37.7 million in Q1 2024 [4][11] - Adjusted EBITDA for Q1 2025 was $11.6 million, a 54% increase compared to $7.5 million in Q1 2024 [4][13] - Net income for Q1 2025 was $4 million, or $0.07 per share, up 67% from $2.4 million, or $0.04 per share, in Q1 2024 [13] Business Line Data and Key Metrics Changes - Growth was primarily driven by increased sales of Glacia and Kamrab in ex-U.S. markets, as well as Varezig sales and Glacier royalties income [5][11] - Gross profit for Q1 2025 was $20.7 million with a gross margin of 47%, compared to $16.7 million and 44% in Q1 2024 [12] Market Data and Key Metrics Changes - The company expects to launch two additional biosimilars later in 2025, following the first biosimilar product launch in Israel, which is projected to generate approximately $2 million in revenue this year [8] - The plasma collection operation expanded with a new center in San Antonio, Texas, expected to contribute annual revenues of $8 million to $10 million [9][10] Company Strategy and Development Direction - The company is focused on a four-pillar growth strategy: organic commercial growth, business development and M&A, plasma collection operations, and advancement of the inhaled Alpha-one program [6][39] - A comprehensive post-marketing research program for Cytogam was initiated, consisting of 10 studies aimed at advancing CMV disease management [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued profitable growth throughout 2025, reiterating annual revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $38 million to $42 million [5][6] - The company is monitoring the impact of tariffs and NIH spending cuts but does not anticipate a direct impact on its business [21][31] Other Important Information - The company is currently at around 55% enrollment for the pivotal Phase III INNO2VATE clinical trial for inhaled alpha-one antitrypsin therapy [26] - The tax rate reported for the quarter was 40%, compared to 3% a year ago, with expectations of fluctuations in tax expenses through 2025 [33][34] Q&A Session Summary Question: Growth contributors and Cytogam investment - Management clarified that Cytogam did not significantly contribute to growth this quarter, with the increase coming from other products [15][18] Question: Updates on CMV guidelines - Management indicated that new clinical data from ongoing studies could lead to updates in CMV management guidelines [19][20] Question: Impact of tariffs on global business - Management stated that there should be no direct impact on sales from tariffs, but they will continue to monitor the situation [21][24] Question: Timing of Cytogam post-marketing study completion - The comprehensive program is expected to span around four years, with some results available as early as late 2025 [30] Question: Impact of NIH spending cuts - Management does not anticipate any impact from NIH spending cuts on the business [31] Question: Tax rate changes - The tax rate change was due to shifts between deferred tax assets and liabilities, with expectations of a clearer effective tax rate by the end of 2025 [33][34] Question: Annual guidance implications from strong Q1 - Management will monitor progress in Q2 and may update guidance if strong performance continues [37]

分组1 - Kamada reported quarterly earnings of $0.07 per share, matching the Zacks Consensus Estimate, and showing an increase from $0.04 per share a year ago [1] - The company posted revenues of $44.02 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 5.28%, compared to $37.74 million in the same quarter last year [2] - Kamada shares have increased approximately 13.1% since the beginning of the year, outperforming the S&P 500's gain of 0.1% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is $0.07 on revenues of $44.55 million, and for the current fiscal year, it is $0.27 on revenues of $179.87 million [7] - The Medical - Biomedical and Genetics industry, to which Kamada belongs, is currently ranked in the top 30% of over 250 Zacks industries, indicating a favorable outlook [8]

Core Insights - Kamada Ltd. reported total revenues of $44.0 million for Q1 2025, marking a 17% increase year-over-year, driven by strong sales of GLASSIA® and KAMRAB® in international markets [2][6] - Adjusted EBITDA for the same period was $11.6 million, reflecting a 54% year-over-year increase, indicating effective management of operational expenses alongside revenue growth [2][6] - The company reiterated its full-year 2025 revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $38 million to $42 million, projecting continued profitable growth [2][9] Financial Performance - Revenues for Q1 2025 were $44.0 million, up from $37.7 million in Q1 2024, primarily due to increased sales in international markets [6] - Gross profit was $20.7 million with a gross margin of 47%, compared to $16.8 million and 44% in Q1 2024, attributed to a favorable product sales mix [6] - Operating expenses totaled $13.0 million, a slight increase from $12.7 million in Q1 2024, demonstrating the company's ability to manage costs effectively [6] Strategic Initiatives - The company is focusing on four strategic growth pillars: organic commercial growth, business development and M&A, plasma collection operations, and advancing the Phase 3 Inhaled AAT program [2][12] - Kamada opened a new plasma collection center in San Antonio, Texas, expected to generate annual revenues of $8 million to $10 million at full capacity [3][12] - A comprehensive post-marketing research program for CYTOGAM® has been initiated to support its use in managing cytomegalovirus (CMV) disease in organ transplantation [2][12] Balance Sheet Highlights - As of March 31, 2025, the company had cash and cash equivalents of $76.3 million, a slight decrease from $78.4 million at the end of 2024 [7] - Total assets increased to $375.1 million from $343.2 million at the end of 2024, reflecting growth in both current and non-current assets [17] - Current liabilities rose to $57.0 million from $37.2 million at the end of 2024, indicating increased operational activity [18] Market Outlook - The company anticipates a year-over-year revenue increase of approximately 12% and a 17% increase in adjusted EBITDA based on the midpoint of its 2025 guidance [9] - A three-year contract for the supply of KAMRAB and VARIZIG in Latin America is expected to generate approximately $25 million in total revenue, with a portion included in the 2025 revenue guidance [12]

Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, specializing in specialty plasma-derived therapies [3] - The company has a portfolio of six FDA-approved specialty plasma-derived products, including KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG®, and HEPAGAM B® [3] - FIMI Opportunity Funds is the controlling shareholder, owning approximately 38% of the outstanding ordinary shares [3] Financial Results Announcement - Kamada will release its financial results for the first quarter ending March 31, 2025, prior to the opening of U.S. financial markets on May 14, 2025 [1] - An investment community conference call will be held on the same day at 8:30am ET to discuss the results and answer questions [2] Growth Strategy - The company aims for organic growth through commercialization and life cycle management of its proprietary products [3] - Kamada is pursuing new business development opportunities, including in-licensing, collaboration, and M&A to enhance its product portfolio [3] - The company is expanding plasma collection operations to support revenue growth and meet increasing demand for hyper-immune plasma [3] - Kamada is advancing the development of additional product candidates, with a focus on unmet medical needs, including the InnovAATe clinical trial for Inhaled AAT [3]

Core Viewpoint - Kamada Ltd. has launched a new post-marketing research program to generate data supporting the benefits of CYTOGAM® in managing cytomegalovirus (CMV) in solid organ transplantation [1][3] Research Program Overview - The research program aims to advance CMV disease management through strategies focused on late-onset CMV prevention, alternative dosing strategies, and potential new applications of CYTOGAM [2] - It includes health economic studies to analyze the cost burden of CMV in solid organ transplantation and a clinical practice study on current CMV management in lung transplantation [2][6] Clinical Data and Collaborations - Kamada has engaged Key Opinion Leaders (KOLs) to study clinical experiences with CYTOGAM, presenting findings at various medical conferences [4] - Notable studies include a five-year retrospective cohort study on lung-transplant patients and an analysis of stored samples from a previous randomized controlled study, demonstrating CYTOGAM's potential benefits [4] Financial Performance - For the year ended December 31, 2024, Kamada reported revenues of $22.5 million from CYTOGAM sales, reflecting a 31% increase from the previous fiscal year [3] Product Information - CYTOGAM is the only FDA-approved immunoglobulin product for the prophylaxis of CMV disease associated with solid organ transplantation [5]

Core Viewpoint - Kamada Ltd. has received a tax ruling from the Israel Tax Authority regarding a special cash dividend of $0.20 per share, totaling approximately $11.5 million, which is set to be paid on April 7, 2025, to shareholders of record as of March 17, 2025 [1][2]. Tax Ruling and Dividend Distribution - The ruling allows Nasdaq Shareholders from countries with a tax treaty with Israel to potentially benefit from a reduced withholding tax rate on the dividend [2][7]. - Nasdaq Shareholders who are Israeli corporate shareholders may qualify for an exemption from Israeli withholding tax under the ruling [2][12]. - The company will withhold 25% of the dividend amount on the payment date and remit it to the Tax Agent, with the remaining 75% distributed to shareholders [8][13]. Documentation and Compliance - Nasdaq Shareholders must submit required forms to the Tax Agent to benefit from the reduced withholding tax rate, with a deadline of May 5, 2025 [5][17]. - Specific documentation is required for shareholders declaring residency in a Treaty State, including bank account details and proof of residency [9][10]. - Non-Israeli corporate shareholders must provide additional documentation, such as a register of shareholders or partners as of the record date [11]. Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, with a portfolio of FDA-approved specialty plasma-derived products [19]. - The company's growth strategy includes organic growth, business development, expansion of plasma collection operations, and advancing product candidates in clinical trials [19].

Financial Data and Key Metrics Changes - Total revenue for 2024 was $161 million, a 13% increase from $143 million in 2023, meeting the top end of guidance [8][22] - Adjusted EBITDA reached a record $34.1 million, representing a 42% year-over-year growth from $24.1 million in 2023 [8][27] - Net income for 2024 was $14.5 million, or $0.25 per diluted share, up 75% from $8.3 million, or $0.15 per diluted share, in 2023 [26] Business Line Data and Key Metrics Changes - KEDRAB sales contributed $50 million in total sales during 2024, with a minimum commitment of $135 million from Kedrion for the remaining three years [23][49] - CYTOGAM sales were $23 million, a 31% increase compared to 2023 [24] - Gross profit for 2024 was $70 million with a gross margin of 43%, up from $55.5 million and 39% in 2023 [24] Market Data and Key Metrics Changes - The company expanded its presence in the MENA region and won a three-year contract for KAMRAB and VARIZIG in Latin America, expected to generate approximately $25 million in revenue [14][15] - The company launched its first biosimilar product in Israel in 2024 and plans to launch two additional biosimilars in 2025 [15][16] Company Strategy and Development Direction - The growth strategy focuses on organic growth, business development and M&A, expansion of plasma collection operations, and advancing the inhaled AAT product [12] - The company aims to continue delivering double-digit profitable growth in 2025, forecasting annual revenues of $178 million to $182 million [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's business prospects, citing strong financial results and a favorable outlook for 2025 [10] - The company is well-positioned with ample liquidity to execute on growth strategies and M&A activities [9][54] Other Important Information - A special cash dividend of $0.20 per share was declared, reflecting confidence in the company's financial health and commitment to shareholder value [9][54] - The company opened a second plasma collection center in Houston and plans to open a third center in San Antonio, expected to contribute $8 million to $10 million in annual revenues each [18][64] Q&A Session Summary Question: Inquiry about the futility analysis for the inhaled AAT program - Management confirmed that the futility analysis will be blinded and conducted by an external group, focusing on conditional efficacy data [34][35] Question: Additional growth drivers for KEDRAB and CYTOGAM - Management indicated that KEDRAB's growth is driven by international expansion, while CYTOGAM will see advancements in clinical work and presentations at medical conferences [46][52] Question: Reason for declaring a special dividend - The decision was based on strong financial results and a solid cash position, allowing the company to pay dividends while pursuing business development activities [54][55] Question: Details on the third plasma collection center - The San Antonio center is expected to reach peak revenue in 24 to 30 months, collecting both specialty and normal source plasma [63][64] Question: Impact of in-house plasma collection on gross margins - Management noted that using in-house collected plasma will improve cost efficiencies, but it will take time to replace purchased plasma with collected plasma [82][83]

Financial Data and Key Metrics Changes - Total revenue for 2024 was $161 million, a 13% increase from $143 million in 2023, meeting the annual guidance [22][8] - Adjusted EBITDA reached a record $34.1 million, representing a 42% year-over-year growth from $24.1 million in 2023 [27][8] - Net income for 2024 was $14.5 million, or $0.25 per diluted share, up 75% from $8.3 million, or $0.15 per diluted share in 2023 [26][22] - Cash generated from operations was $47.6 million, with a year-end cash balance of $78.4 million [9][8] Business Line Data and Key Metrics Changes - KEDRAB sales contributed $50 million in total sales during 2024, with a minimum commitment from Kedrion of $135 million for the remaining three years of the agreement [23][22] - CYTOGAM sales were $23 million, up 31% compared to 2023 [24][22] - Gross profit for 2024 was $70 million, with gross margins improving to 43% from 39% in 2023 [24][22] Market Data and Key Metrics Changes - The company expanded its presence in the MENA region and secured a three-year contract for KAMRAB and VARIZIG in Latin America, expected to generate approximately $25 million in revenue [14][15] - The company launched its first biosimilar product in Israel in 2024, with plans for two additional launches in 2025 [15][12] Company Strategy and Development Direction - The growth strategy focuses on organic growth, business development and M&A, expansion of plasma collection operations, and advancing the inhaled AAT product trial [12][10] - The company aims to continue delivering double-digit profitable growth in 2025, with forecasted revenues of $178 million to $182 million [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's business prospects, citing strong financial results and a favorable outlook for 2025 [10][9] - The company is well-positioned to execute on its growth strategy with ample liquidity and a solid cash position [9][10] Other Important Information - A special cash dividend of $0.20 per share was declared, reflecting the company's strong financial performance and commitment to shareholder value [9][10] - The company opened a second plasma collection center in Houston and is set to open a third center in San Antonio, expected to contribute $8 million to $10 million in annual revenues each [18][17] Q&A Session Summary Question: Inquiry about the futility analysis for the inhaled AAT program - Management confirmed that the futility analysis will be blinded and conducted by an external group, focusing on conditional efficacy data [33][34] Question: Additional growth drivers for KEDRAB and CYTOGAM - Management indicated that KEDRAB's growth is driven by international expansion, while CYTOGAM will see advancements in clinical work and presentations at medical conferences [46][52] Question: Reason for declaring a special dividend - The decision was based on strong financial results and a solid cash position, allowing the company to pay dividends while pursuing business development activities [53][54] Question: Details on the third plasma collection center - The San Antonio center is expected to reach peak revenue in 24 to 30 months, collecting both specialty and normal source plasma [62][63] Question: Impact of internal plasma collection on gross margins - Management noted that using internally collected plasma will improve cost efficiencies, but it will take time to replace purchased plasma with collected plasma [82][83]

Financial Projections - The company expects total revenues for fiscal year 2025 to be in the range of $178 million to $182 million, representing a year-over-year increase of 12%[22]. - Adjusted EBITDA for fiscal year 2025 is projected to be between $38 million and $42 million, indicating a 17% increase year-over-year[22]. - A special cash dividend of $0.20 per share, totaling approximately $11.5 million, is planned for April 7, 2025[22]. - The company anticipates receiving royalties from Takeda in the range of $10 million to $20 million per year from 2025 to 2040 based on GLASSIA sales[22]. - The company has a commitment from Kedrion Biopharma Inc. to purchase minimum quantities of KEDRAB, generating approximately $180 million in revenue from 2024 to 2027[24]. Revenue Sources - Revenue from Proprietary Products comprised approximately 88%, 81%, and 79% of total revenues for the years ended December 31, 2024, 2023, and 2022, respectively[44]. - Sales of KEDRAB, CYTOGAM, and royalty income from GLASSIA accounted for approximately 31%, 14%, and 10% of total revenues for the year ended December 31, 2024, totaling 55%[42]. - A significant portion of net revenue, approximately 62%, 52%, and 50% for the years ended December 31, 2024, 2023, and 2022, respectively, was generated in the United States[45]. - Sales to Kedrion accounted for approximately 31%, 23%, and 13% of total revenues for the years ended December 31, 2024, 2023, and 2022, respectively, with projected minimum aggregate revenues of approximately $180 million over the four-year period from 2024 to 2027[54]. Product Development and Clinical Trials - The InnovAATe clinical trial for Inhaled AAT is ongoing, with recruitment expected to be completed by the end of 2026 and treatment for the last patient by the end of 2028[26]. - The company is engaged in the InnovAATe clinical trial for its lead investigational product, Inhaled AAT for AATD, with a planned reduction in study sample size from 220 to approximately 180 patients[51]. - The Phase 2/3 clinical trial for Inhaled AAT for AATD did not meet its primary or secondary endpoints, leading to the withdrawal of the Marketing Authorization Application in Europe[133]. - The company plans to conduct an interim futility analysis for the InnovAATe clinical study by the end of 2025, which could impact business prospects[147]. Plasma Collection Operations - The Houston and San Antonio plasma collection centers are expected to contribute annual revenues of $8 million to $10 million each from normal source plasma sales once fully operational[24]. - The company plans to expand its plasma collection operations, with a third center in San Antonio expected to commence operations by the end of Q1 2025[24]. - The company owns an FDA-licensed plasma collection center in Beaumont, Texas, and has opened a new plasma collection center in Houston, Texas, expected to be one of the largest in the U.S.[48]. - The company has expanded its plasma collection operations with a new center in Houston, Texas, expected to be one of the largest hyper-immune plasma collection sites in the U.S.[98]. - The company is in advanced stages of constructing a third plasma collection site in San Antonio, Texas, anticipated to open by the end of Q1 2025[98]. Market and Competitive Landscape - Future growth is dependent on the ability to maintain and expand sales of commercial products in the U.S. and international markets[41]. - The Proprietary Products segment faces competition from large biopharmaceutical companies, including CSL Behring and Takeda, which have significant advantages in market resources and experience[67]. - The company’s products do not benefit from patent protection, leading to potential revenue reductions due to competition from similar products[73]. - The company may face significant risks in product development due to potential obstacles such as supply shortages, clinical trial failures, and regulatory approval delays[154]. Regulatory and Compliance Challenges - Regulatory compliance is critical, as noncompliance could lead to significant inventory impairment provisions and write-offs, adversely affecting financial results[100]. - The company is subject to evolving regulatory requirements, which could increase compliance costs and impact profit margins[108]. - The company must comply with comprehensive privacy and security standards, with non-compliance potentially leading to litigation and significant costs[176]. - Noncompliance with healthcare fraud laws could lead to severe penalties, including exclusion from federal healthcare programs[197]. Risks and Uncertainties - The company may face operational, technical, and regulatory challenges in establishing and maintaining plasma collection operations, which could affect its investment returns[50]. - The company faces risks related to donor availability, which can be impacted by factors such as reimbursement rates and competition, potentially leading to decreased plasma supply[91]. - The company may not be able to successfully build a commercial organization or program, which is critical for transitioning from research to market[150]. - The company may seek partnerships or joint ventures to augment its product pipeline, facing risks if third parties fail to meet obligations[156]. Pricing and Reimbursement - The company’s pricing and reimbursement depend on government regulations, with potential impacts from healthcare system reforms[205]. - The company may be adversely affected by government or private third-party payors limiting reimbursement amounts for its products[203]. - The company must conduct clinical trials for reimbursement approval in some countries, which can be time-consuming and expensive[204]. Intellectual Property and Patent Issues - The patent landscape in biotechnology and pharmaceuticals is highly complicated and uncertain, involving complex legal, factual, and scientific questions[218]. - Changes in patent laws or their interpretation may diminish the value and strength of the company's intellectual property[218]. - The company may fail to apply for or be unable to obtain necessary patents to protect its technology or products[218]. - Many patents relate to processes used to produce products rather than the products themselves, which may not be patentable[218].