Company Awarded Extension to Existing Supply Tender Relating to its Portfolio of Four Specialty Plasma-Derived ProductsSupply Extension Secures Ongoing Sales of Approximately $5.0-$7.0 Million Per Year for the Period Between Q2-26 and Q1-28Kamada Reiterates its 2025 Full-Year Revenue Guidance of $178 Million-$182 Million and Adjusted EBITDA of $40 Million-$44 MillionKamada Projects Double-Digit Growth in Revenues and Profitability in 2026; Detailed Guidance to be Provided in January 2026 REHOVOT, Israel, an ...

Core Viewpoint - Kamada Ltd. has decided to discontinue its Phase 3 InnovAATe trial for Inhaled AAT aimed at treating Alpha-1 Antitrypsin Deficiency (AATD) due to low likelihood of demonstrating a statistically significant benefit in lung function [1][3]. Company Updates - The discontinuation of the trial follows advice from an independent Data and Safety Monitoring Board (DSMB) based on a prespecified interim futility analysis [3]. - CEO Amir London expressed disappointment over the trial's outcome but emphasized the company's strong position for future growth prospects [4]. - Kamada reiterated its full-year 2025 revenue guidance of $178 million to $182 million, aligning closely with the consensus of $180.66 million, and provided adjusted EBITDA guidance of $40 million to $44 million [5]. Future Outlook - The company projects double-digit growth in revenues and profitability for 2026, supported by its commercial portfolio, which includes six FDA-approved specialty plasma-derived products marketed in over 30 countries [6]. - Kamada is also focusing on expanding its biosimilar portfolio in Israel and increasing plasma collection capacity, while pursuing new business development opportunities to ensure long-term growth [6]. Market Reaction - Following the announcement, Kamada's stock experienced a decline of 5.51%, trading at $6.69 [7].

Kamada Corporate Update Conference Call Summary Company Overview - **Company**: Kamada - **Industry**: Biopharmaceuticals, specifically focusing on treatments for Alpha-1 deficiency Key Points and Arguments Discontinuation of Clinical Trial - Kamada announced the discontinuation of its phase 3 inhaled AAT InnovAATe clinical trial due to futility, as advised by the independent unblinded Data Safety Monitoring Board (DSMB) [2][4] - The trial was unlikely to demonstrate a statistically significant benefit in its primary endpoint of lung function, measured by FEV1 [4] - The decision to discontinue the trial is not related to safety concerns regarding the inhaled AAT treatment [5] Financial Projections and Performance - Kamada remains committed to the Alpha-1 community through the continued supply of Glassia, its leading AAT IV treatment [5] - The company is on track to meet its full-year 2025 revenue guidance of $178 million to $182 million and an annual Adjusted EBITDA of $40 million to $44 million [6] - For 2026, Kamada projects double-digit growth in revenues and profitability, supported by a robust commercial portfolio, including six FDA-approved specialty plasma-derived products marketed in over 30 countries [6] Cost Management - Annual study costs for the trial were between $5 million to $6 million per year [10] - Following the trial's discontinuation, these costs are expected to be eliminated, leading to an increase in EBITDA [10][11] Future Growth Strategy - Kamada is focused on pursuing new commercial-stage business development opportunities and expanding its plasma collection capacity [7][14] - Detailed financial guidance for 2026 will be provided in early January [7] Additional Important Information - The conference call included a caution regarding forward-looking statements that involve risks and uncertainties [3] - The company emphasized its commitment to creating long-term shareholder value and supporting clinicians and patients with its products [14]

Core Points - Kamada has announced the discontinuation of its Phase III inhaled AAT InnovAATe clinical trial [3] - The company provided an update on its financial projections during the corporate update call [3] Company Update - The decision to discontinue the clinical trial was communicated in a press release issued earlier [3] - The corporate update call included participation from Kamada's CEO Amir London and CFO Chaime Orlev [2] Financial Projections - The financial projections discussed in the call are a key focus for the company moving forward [3]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cemtrex, Inc. (CETX) has increased by 284% to $11.79 - Treasure Global Inc. (TGL) has risen by 135% to $59.83 - Top Wealth Group Holding Limited (TWG) is up 95% at $11.73 - Fulcrum Therapeutics, Inc. (FULC) has gained 49% to $13.29 - MetaVia Inc. (MTVA) is up 33% at $10.90 - Kymera Therapeutics, Inc. (KYMR) has increased by 31% to $87.58 - Confluent, Inc. (CFLT) is up 27% at $29.40 - Immix Biopharma, Inc. (IMMX) has risen by 23% to $6.85 - Nurix Therapeutics, Inc. (NRIX) is up 18% at $21.46 - SU Group Holdings Limited (SUGP) has increased by 15% to $6.44 [3] Premarket Losers - SMX (Security Matters) Public Limited Company (SMX) has decreased by 27% to $242.01 - Meihua International Medical Technologies Co., Ltd. (MHUA) is down 27% at $10.20 - Polyrizon Ltd. (PLRZ) has declined by 16% to $10.90 - Fly-E Group, Inc. (FLYE) is down 16% at $6.90 - Sensei Biotherapeutics, Inc. (SNSE) has decreased by 14% to $8.29 - Kentucky First Federal Bancorp (KFFB) is down 10% at $4.00 - Arteris, Inc. (AIP) has declined by 7% to $16.27 - Fusion Fuel Green PLC (HTOO) is down 6% at $3.89 - Kamada Ltd. (KMDA) has decreased by 5% to $6.69 - iOThree Limited (IOTR) is down 5% at $3.11 [4]

Core Insights - Kamada Ltd. announced the discontinuation of the Phase 3 InnovAATe trial for Inhaled AAT due to an interim futility analysis indicating low likelihood of achieving statistically significant benefits in lung function [1][5] - The company remains committed to supporting the Alpha-1 Antitrypsin Deficiency (AATD) community through its existing product GLASSIA and is focused on future growth prospects despite the trial's outcome [2][5] Financial Guidance - Kamada reiterated its full-year 2025 revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $40 million to $44 million [2][5] - The company projects double-digit growth in revenues and profitability for 2026, with detailed guidance to be provided in January 2026 [2][5] Business Strategy - Kamada's growth strategy includes organic growth from its commercial activities, business development opportunities, and expansion of plasma collection operations [4][6] - The company currently operates three plasma collection centers in the U.S. and aims to enhance its marketed products portfolio through potential collaborations and acquisitions [4][6] Company Overview - Kamada is a global biopharmaceutical company specializing in products for rare and serious conditions, particularly in the specialty plasma-derived therapies field [4][6] - The company is controlled by FIMI Opportunity Funds, which owns approximately 38% of its outstanding shares [6]

Kamada Conference Call Summary Company Overview - Kamada is a global publicly traded biopharmaceutical company specializing in plasma-derived immunoglobulins with six FDA-approved products marketed in over 35 countries [5][6][17] - The company has experienced solid double-digit growth in both revenue and profitability, with Q3 results showing over 30% growth compared to the previous year [5][10] Key Growth Strategies 1. Organic Growth - Kamada's growth is driven by its existing product portfolio and marketing activities, with a focus on increasing awareness of its products in acute life-saving situations [6][10] - The company is optimistic about expanding its market presence, as it operates in niches with limited competition [5][6] 2. Mergers and Acquisitions (M&A) - Kamada is actively seeking M&A opportunities to enhance its product portfolio, focusing on commercial assets that can leverage its existing infrastructure [6][11] - A transaction is expected to be finalized in the coming months, which could significantly contribute to growth starting in 2026 [6][11] 3. Plasma Collection Centers - The company has opened its own plasma collection centers, enhancing its independence in sourcing plasma and allowing for additional revenue streams [7][50] - Each center is projected to contribute between $8 million and $10 million in revenue upon full ramp-up, with an overall expectation of $15 million to $20 million in additional revenue from plasma collection [7][50] Product Development and Clinical Trials Alpha-1 Antitrypsin Deficiency (AATD) - Kamada is in a pivotal phase three study for an inhaled AAT product, which is expected to provide a more efficient treatment option for patients with alpha-1 deficiency [8][21] - The market for AATD treatments is valued at $1.4 billion, growing at 7%-8% annually, with Kamada aiming for a $2 billion market opportunity upon successful trial results [22][23] Challenges in Recruitment - Recruitment for the clinical study has been challenging due to the availability of existing IV treatments, necessitating a focus on countries where such treatments are not reimbursed [25][26] - The company has adjusted its study parameters to maintain statistical power while addressing recruitment difficulties [26][27] Product Portfolio and Market Position Diverse Product Range - Kamada's portfolio includes various products, with different products leading growth in different quarters, showcasing the company's diverse market presence [38][39] - KEDRAB, an anti-herpes immunoglobulin, has a minimum purchase agreement of $180 million over four years, indicating strong market demand [39][40] CYTOGAM and VARIZIG - CYTOGAM, used in organ transplantation, addresses a significant unmet medical need, with ongoing clinical studies to generate new data [41][43] - VARIZIG, for chickenpox outbreaks in immunocompromised populations, has seen increased usage due to enhanced awareness efforts [44][45] Distribution Business and Biosimilars - Kamada has expanded its distribution business in Israel and the MENA region, representing various companies and launching new biosimilar products [53][54] - The distribution business is expected to generate an additional $15 million to $20 million in revenue, improving overall gross margins [54][55] Financial Position and Future Outlook - Kamada ended the quarter with $72 million in cash and is positioned for future M&A transactions, with a credit line of $40 million available [56][58] - The company is optimistic about its growth trajectory, with expectations for positive contributions from M&A activities starting in 2026 [56][60] Conclusion - Kamada is strategically positioned for growth through organic expansion, M&A, and enhanced plasma collection capabilities, with a strong focus on addressing unmet medical needs in its product offerings [47][49][60]

Financial Data and Key Metrics Changes - Total revenues for the first nine months of 2025 were $135.8 million, representing an 11% year-over-year increase [4][10] - Adjusted EBITDA was $34.2 million, up 35% year-over-year, with a 25% margin on revenues [4] - Net income for the first nine months of 2025 was $16.6 million, or $0.29 per diluted share, up 56% compared to the first nine months of 2024 [12] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by increased sales of Glassia in ex-U.S. markets, particularly in Latin America and the CIS region [5] - The anti-CMV immunoglobulin Cytogam is undergoing a comprehensive post-marketing research program to demonstrate its advantages [6][31] - The company launched its first biosimilar product in Israel, expected to generate approximately $2.5 million in revenues in 2025, with plans for two additional biosimilars [7] Market Data and Key Metrics Changes - The company has a significant market share in the U.S. for its anti-rabies immunoglobulin Kamrab, with a firm commitment for minimum orders through 2027 [4] - Sales of Cytogam have been below expectations due to inventory management and fewer transplants performed in some hospitals [33] Company Strategy and Development Direction - The company is guided by a four-pillar growth strategy, including organic commercial growth, business development, M&A transactions, plasma collection operations, and advancing its inhaled AAT program [4][39] - Active due diligence is being conducted over several potential commercial targets, with expectations to secure transactions in early 2026 [8][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing to generate profitable growth through the remainder of 2025, reiterating annual revenue guidance of $178 million-$182 million [4] - The company is addressing challenges in the Cytogam market and expects resumed growth in the coming months [33] Other Important Information - The Houston plasma collection facility has received FDA approval, with expectations for the San Antonio site to follow in early 2026 [9] - Each plasma collection center is expected to generate annual revenues of $8 million-$10 million at full capacity [9] Q&A Session Summary Question: Details on the Cytogam study and its differences from previous clinical data - The SHILD study will test Cytogam's use in late CMV after antiviral treatment, differing from its current prophylactic use [15][16] Question: Enrollment status for the ATD treatment - Enrollment is at 60-65%, with completion expected by early 2027 and top-line results anticipated in H1 2029 [18][20] Question: Performance of the distribution business - The distribution business has seen actual usage growth, with expectations for continued growth due to a richer product portfolio [24] Question: Plasma collection relative to proprietary product needs - Currently, the majority of plasma collected is normal source plasma, with plans to increase specialty plasma collection over time [25][26] Question: Interim data release for the ATD treatment clinical trial - Results from the interim analysis will be shared through a press release before the end of the year [27][28] Question: Performance of Cytogam and growth drivers - Cytogam sales have been below plan due to inventory management and fewer transplants, but growth is expected to resume [31][33] Question: Future of Glassia royalties - Royalties from Glassia are expected to be above $10 million in 2026, with single-digit growth anticipated thereafter [34][35] Question: Current business development activities - The company is conducting thorough due diligence for potential transactions, with expectations for successful integration of new assets [36][37]

Company Performance - Kamada reported quarterly earnings of $0.09 per share, missing the Zacks Consensus Estimate of $0.10 per share, but showing an increase from $0.07 per share a year ago, resulting in an earnings surprise of -10.00% [1] - The company posted revenues of $47.01 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 1.64% and increasing from $41.74 million year-over-year [2] - Over the last four quarters, Kamada has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Outlook - Kamada shares have increased approximately 9.4% since the beginning of the year, compared to the S&P 500's gain of 14.4% [3] - The company's earnings outlook, including current consensus earnings expectations for upcoming quarters, will be crucial for investors [4] - The current consensus EPS estimate for the coming quarter is $0.11 on revenues of $45.85 million, and for the current fiscal year, it is $0.39 on revenues of $180.87 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Kamada belongs, is currently in the top 36% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Kamada's stock performance [5][6]

Core Insights - Kamada Ltd. reported strong financial results for the third quarter and the first nine months of 2025, with total revenues of $135.8 million, an 11% year-over-year increase, and adjusted EBITDA of $34.2 million, up 35% year-over-year [2][6][11]. Financial Performance - Third quarter revenues reached $47.0 million, a 13% increase from $41.7 million in the same quarter of 2024 [6][7]. - Gross profit for the third quarter was $19.8 million, with a gross margin of 42%, compared to $17.2 million and 41% in the prior year [7]. - For the first nine months of 2025, gross profit was $59.4 million, with a gross margin of 44%, up from $52.9 million and 43% in the same period of 2024 [11][12]. - Net income for the first nine months was $16.6 million, or $0.29 per diluted share, a 56% increase from $10.7 million, or $0.18 per diluted share, in the same period of 2024 [11][12]. Operational Highlights - The company generated $17.9 million in cash from operating activities during the first nine months of 2025, contributing to a cash position of $72.0 million as of September 30, 2025 [2][9]. - Kamada continues to invest in plasma collection operations, recently receiving FDA approval for its Houston facility, which is expected to be one of the largest collection centers for specialty plasma in the U.S. [4][12]. - The company is advancing its pivotal Phase 3 InnovAATe clinical trial for inhaled Alpha-1 Antitrypsin therapy, with an interim futility analysis expected by the end of 2025 [4][11]. Strategic Initiatives - Kamada is focused on expanding its product portfolio and securing long-term sales agreements for normal source plasma [4][12]. - The company has launched a comprehensive post-marketing research program for CYTOGAM® to support its benefits in managing cytomegalovirus (CMV) in solid organ transplantation [3][12]. - The company reiterated its full-year 2025 revenue guidance of $178 million to $182 million and adjusted EBITDA guidance of $40 million to $44 million, indicating a positive outlook for the remainder of the year [2][11].