Core Points - Kamada Ltd. has opened a new plasma collection center in Houston, Texas, which is expected to have an annual collection capacity of approximately 50,000 liters and contribute estimated annual revenues of $8 million to $10 million at full capacity [1][3] - The Houston center will collect both normal source plasma and specialty plasma, including Anti-Rabies and Anti-D, and is anticipated to be one of the largest specialty plasma collection sites in the U.S. [1][2] - The company plans to submit a prior approval supplement to the FDA and a plasma master file to the EMA for the Houston site during the first half of 2025, with expected approval decisions within 9-12 months of submission [2][5] Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, with a portfolio of FDA-approved plasma-derived products [4] - The company operates a plasma collection center in Beaumont, Texas, and is expanding its operations with the new center in Houston and a planned third center in San Antonio, Texas, expected to open in the first half of 2025 [3][4] - Kamada's commercial products include six FDA-approved plasma-derived biopharmaceutical products and the company is also advancing an innovative development pipeline targeting significant unmet medical needs [4][5]

Financial Data and Key Metrics Changes - Total revenue increased by 13% to $42.5 million for Q2 2024 compared to Q2 2023, and for the first half of 2024, total revenues were up 18% to $80.2 million compared to the prior year period [4][9] - Adjusted EBITDA for Q2 2024 was $9.1 million, a 51% increase from the prior year quarter, while for the first half of 2024, adjusted EBITDA was $16.6 million, up 68% over the prior year period [4][11] - Net income for Q2 2024 was $4.4 million or $0.08 per diluted share, compared to $1.8 million or $0.04 per share in Q2 2023 [10] Business Line Data and Key Metrics Changes - The growth in revenue was primarily driven by increased sales of KEDRAB and CYTOGAM due to higher demand in the U.S. market, with approximately 70% of revenues generated from the U.S. during the first half of 2024 [9][10] - Gross profit for Q2 2024 was $19 million, representing a 45% margin, compared to $14.4 million or 39% margin in the prior year period [9][10] Market Data and Key Metrics Changes - The company reported strong performance in the U.S. market, with KEDRAB holding a market share of approximately 40% to 50% and expectations for further growth [20] - The company anticipates that biosimilars will significantly contribute to its distribution business in Israel, with potential annual sales between $30 million to $34 million [6] Company Strategy and Development Direction - The growth strategy is built on four main pillars: organic growth of existing products, M&A transactions, opening plasma collection centers, and the ongoing Phase 3 trial of inhaled AAT targeting a $2 billion market [3][4] - The company is actively pursuing M&A opportunities to expand its commercial portfolio and support continued double-digit growth beyond 2024 [6][11] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year 2024 revenue guidance of $158 million to $162 million and adjusted EBITDA guidance of $28 million to $32 million based on strong performance in the first half of the year [5] - The company maintains a strong balance sheet with approximately $56.6 million in cash, allowing for growth acceleration and business development opportunities [6][11] Other Important Information - The company is expanding its plasma collection capacity in the U.S., with new centers expected to contribute annual revenues between $8 million to $10 million each [7] - The ongoing Phase 3 InnovAATe clinical trial for inhaled AAT therapy is progressing, with enrollment at approximately 40% to 45% [13] Q&A Session Summary Question: Inquiry about the inhaled AATD and FDA feedback - Management confirmed that they are awaiting FDA feedback on the revised statistical plan submitted and expect discussions to clarify the roadmap [12][13] Question: Enrollment status and competition - Enrollment is progressing, with challenges due to the nature of the study, but additional sites have been opened to facilitate recruitment [13] Question: AAT program commercialization partnerships - The focus is on finding partners primarily in the U.S. and Europe, with potential for one or two partners depending on the territory [16] Question: Business development opportunities - The focus is on commercial stage or near commercialization stage products, with an emphasis on supporting organic growth through M&A [17] Question: Potential for future dividends - While the company may consider dividends in the future, the current focus remains on M&A and business development [19] Question: Market share expectations for KEDRAB - KEDRAB is estimated to hold a market share of 40% to 50% in the U.S., with expectations for further growth [20]

Financial Performance - Total revenues for the six months ended June 30, 2024, increased to $80.2 million, up 17.5% from $68.2 million in the same period of 2023[7] - Revenues from proprietary products reached $72.9 million, a 32.5% increase compared to $55.0 million in the prior year[7] - Gross profit for the six months ended June 30, 2024, was $35.7 million, representing a gross margin of 44.5%[7] - Operating income for the six months ended June 30, 2024, was $9.7 million, compared to $2.9 million in the same period of 2023[7] - Net income for the six months ended June 30, 2024, was $6.8 million, significantly higher than $3,000 in the prior year[7] - The company reported a basic net earnings per share of $0.12 for the six months ended June 30, 2024, compared to $0.00 in the prior year[7] - The net income for the six months ending June 30, 2024, was $6,791,000, compared to a net income of $3,000 for the same period in 2023[9] - The company reported a total comprehensive income of $4,403,000 for the quarter ending June 30, 2024, compared to $1,729,000 for the same quarter in 2023[9] - Net income for the six months ended June 30, 2024, was $6.791 million, compared to $4.426 million for the same period in 2023, representing a 53.4% increase[15] - The Company reported an income before taxes of $4,489 thousand for the three months ended June 30, 2024, compared to $1,905 thousand for the same period in 2023, representing a significant increase of approximately 135.5%[33][34] Cash and Assets - Cash and cash equivalents as of June 30, 2024, were $56.5 million, up from $21.8 million as of December 31, 2023[4] - Total current assets increased to $166.4 million from $129.7 million at the end of 2023[4] - Cash provided by operating activities for the six months ended June 30, 2024, was $14.983 million, a significant recovery from a cash outflow of $1.016 million in the same period last year[15] - Total cash and cash equivalents at the end of the period were $56.547 million, compared to $21.788 million at the end of the previous year[18] Liabilities and Equity - Total liabilities decreased to $99.9 million as of June 30, 2024, from $137.6 million at the end of 2023[4] - As of June 30, 2024, total equity for Kamada Ltd. was $251,152,000, reflecting an increase from $244,021,000 as of January 1, 2024[8] - The accumulated deficit decreased to $(33,409,000) as of June 30, 2024, from $(40,200,000) as of January 1, 2024[8] - The company reported a contingent consideration liability of $19,928 thousand as of June 30, 2024, indicating potential future obligations[40] Expenses - Research and development expenses for the six months ended June 30, 2024, were $9.1 million, compared to $7.5 million in the same period of 2023[7] - The company reported a depreciation and impairment expense of $6.466 million for the six months ended June 30, 2024, slightly up from $6.327 million in the prior year[15] - The Company reported unallocated corporate expenses of $26,023 thousand for the six months ended June 30, 2024, compared to $23,355 thousand for the same period in 2023[32] Product and Market Development - The company has a portfolio of six FDA-approved plasma-derived biopharmaceutical products and is advancing an innovative development pipeline targeting significant unmet medical needs[20] - Kamada Ltd. acquired CYTOGAM, WINRHO SDF, VARIZIG, and HEPGAM B from Saol Therapeutics in November 2021, enhancing its commercial capabilities in the U.S. market[21] - The company is progressing the InnovAATe clinical trial for its leading investigational product, an inhaled AAT for the treatment of AAT deficiency[20] - The company distributes its products in over 30 countries, leveraging its expertise in the Israeli market for additional pharmaceutical products[20] - The Company has two operating segments: Proprietary Products and Distribution, focusing on the development and distribution of plasma-derived protein therapeutics[32] Strategic Partnerships and Shareholder Information - The Company has a strategic partnership with Takeda Pharmaceuticals, receiving royalties of 12% on net sales of GLASSIA until August 2025, with a minimum annual payment of $5 million until 2040[22] - FIMI Opportunity Funds owns approximately 38% of the Company's outstanding ordinary shares, making it a controlling shareholder[23] Share-Based Payments - The cost of share-based payments for the six months ending June 30, 2024, was $482,000[8] - The Company granted options to purchase 27,468 ordinary shares, with a fair value of $48 thousand for Israeli options and $18 thousand for U.S. options[29] - The fair value of options granted on July 21, 2024, was estimated at $25 thousand under the Israeli Share Option Plan and $15 thousand under the US Appendix[41] - The company exercised and forfeited share-based payments into shares amounting to $2,000 for the six months ending June 30, 2024[9] Geographic Revenue Breakdown - The Company generated revenues of $68,153 thousand for the six months ended June 30, 2023, compared to $80,208 thousand for the same period in 2024, reflecting a growth of approximately 17.6%[31][32] - Total revenue for the three months ended June 30, 2023, was $30,940 thousand, with the U.S. market contributing $17,690 thousand[39] - For the year ended December 31, 2023, total revenue reached $115,458 thousand, with the U.S. market again leading at $73,741 thousand[39] - The company generated $8,615 thousand in revenue from Latin America for the three months ended June 30, 2023[39] - Revenue from Israel for the same period was $1,107 thousand, contributing to a total of $7,610 thousand from the region[39] - The Asia market generated $930 thousand in revenue for the three months ended June 30, 2023[39] - The total revenue from Canada for the three months ended June 30, 2023, was $2,336 thousand[39] - The company’s total revenue for the year ended December 31, 2023, was $142,519 thousand, with significant contributions from multiple geographical markets[39] Accounting Standards - The Company is examining the effects of new accounting standards, including IFRS 18, which will be effective from January 1, 2027, with no plans for early adoption[28]

Core Viewpoint - Kamada Ltd. is set to release its financial results for the second quarter and first half of 2024 on August 14, 2024, prior to the opening of U.S. financial markets [1] Company Overview - Kamada Ltd. is a global biopharmaceutical company focused on rare and serious conditions, with a portfolio of marketed products and a strong presence in the specialty plasma-derived field [3] - The company has six FDA-approved plasma-derived biopharmaceutical products, including KEDRAB®, CYTOGAM®, WINRHO SDF®, VARIZIG®, HEPAGAM B®, and GLASSIA®, along with KAMRAB® and KAMRHO (D)® [3] - Kamada distributes its products in over 30 countries, leveraging its expertise in the Israeli market to distribute more than 25 pharmaceutical products from international manufacturers [3] - The company has added eleven biosimilar products to its distribution portfolio in Israel, expected to launch by 2028, pending regulatory approvals [3] - Kamada owns an FDA-licensed plasma collection center in Beaumont, Texas, specializing in hyper-immune plasma collection [3] Financial Communication - Management will host a conference call on August 14, 2024, at 8:30 AM Eastern Time to discuss the financial results and answer questions from shareholders and interested parties [2]

Financial Data and Key Metrics Changes - The company reported total revenues of $37.7 million for Q1 2024, representing a year-over-year growth of 23% compared to $30.7 million in Q1 2023 [5][11] - Adjusted EBITDA for Q1 2024 was $7.5 million, a 96% increase from the previous year, resulting in a 20% margin of revenues [5][27] - Net income for Q1 2024 was $2.3 million or $0.04 per diluted share, compared to a net loss of $1.8 million or a loss of $0.04 per share in Q1 2023 [27] Business Line Data and Key Metrics Changes - The growth in revenues was primarily driven by increased sales of KEDRAB and CYTOGAM due to heightened demand in the US market [11][21] - Operating expenses totaled $12.7 million, an increase of approximately 9% over the prior year, aligned with expectations to support expanded commercial activities and the Phase 3 InnovAATe trial [12] Market Data and Key Metrics Changes - Nearly 70% of revenues in Q1 2024 were generated from the US market [26] - The company successfully launched BEVACIZUMAB KAMADA, a biosimilar to Avastin, in Israel, which is expected to contribute to revenue growth [22] Company Strategy and Development Direction - The company is focusing on expanding its biosimilar portfolio, with expectations of significant contributions to revenue from these products in the coming years [8][15] - The company is actively pursuing business development opportunities to add commercial products to its portfolio, which is anticipated to support growth beyond 2024 [7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued momentum throughout 2024, raising full-year revenue guidance to between $158 million and $162 million and adjusted EBITDA guidance to between $28 million and $32 million [19][27] - The company is encouraged by the positive feedback from the FDA regarding its inhaled Alpha-1 Antitrypsin therapy program, which may lead to accelerated development [9][23] Other Important Information - The company ended Q1 2024 with approximately $48 million in cash, providing financial strength for growth and development opportunities [7] - The company is expanding its plasma collection capacity, with new centers being established in Texas [10] Q&A Session Summary Question: What is the main driver of the revenue increase? - The main driver for the revenue increase has been primarily CYTOGAM, with a successful relaunch and increased physician awareness contributing to growth [29] Question: Can you provide details on the biosimilar program? - The current biosimilar portfolio is expected to generate between $32 million to $36 million in revenues, with each product contributing $2 million to $4 million over time [15] Question: What are the dynamics of biosimilars in Israel? - The dynamics in Israel are similar to those in the US, with market share dependent on the timing of product approvals and the company's first-mover advantage [43] Question: What areas is the company pursuing for business development? - The company is evaluating multiple opportunities in plasma-derived and transplantation products, looking for commercial-stage products to fuel growth [44] Question: Can you elaborate on the revised statistical analysis plan for the inhaled AAT program? - The revised plan, based on positive FDA feedback, aims to reduce sample size requirements and has been submitted for review, with expected feedback in the second half of the year [47]

REHOVOT, Israel and HOBOKEN, N.J., May 01, 2024 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA, TASE: KMDA.TA))), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that it will release financial results for the first quarter ended March 31, 2024, prior to the open of the U.S. financial markets on Wednesday, May 8, 2024. Kamada management will host an investment ...

Kamada Ltd. (NASDAQ:KMDA) Q4 2023 Results Earnings Conference Call March 6, 2024 8:30 AM ET Company Participants Brian Ritchie - Investor Relations, LifeSci Advisors Amir London - Chief Executive Officer Chaime Orlev - Chief Financial Officer Conference Call Participants Annabel Samimy - Stifel Financial Operator Greetings. Welcome to Kamada Ltd.'s Fourth Quarter and Full Year 2023 Earnings Conference Call. This time, all participants are in a listen-only mode. A question-and-answer session will follow the ...

Exhibit 99.1 Kamada Reports Strong Fiscal Year and Fourth Quarter 2023 Financial Results, and Provides Full-Year 2024 Guidance Representing Double-Digit Growth in Revenue and Profitability Rehovot, Israel, and Hoboken, NJ – March 6, 2024 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced financial results for the th ...

Financial Projections - The company expects total revenues for fiscal year 2024 to be in the range of $156 million to $160 million, representing double-digit growth over fiscal year 2023[22]. - Adjusted EBITDA for fiscal year 2024 is projected to be between $27 million and $30 million[22]. - The company anticipates receiving royalties from Takeda in the range of $10 million to $20 million per year for GLASSIA sales from 2024 to 2040[22]. - The company expects to generate approximately $180 million in aggregate revenues from KEDRAB sales to Kedrion from fiscal years 2024 through 2027[23]. Product Development and Launch Plans - The company plans to launch eleven biosimilar products in Israel by 2028, with potential peak revenues estimated between $30 million and $34 million annually[23]. - The company plans to initiate a technology transfer project for manufacturing HEPAGAM B, VARIZIG, and WINRHO SDF to its facility in Beit Kama, Israel, subject to a new agreement with Emergent[22]. - The company is engaged in the early-stage development of several product candidates, including a recombinant AAT product candidate, but there is no assurance of obtaining marketing authorization from regulatory agencies[53]. - The company plans to conduct an open label extension study for the InnovAATe trial in mid-2024, with the FDA endorsing the study's design and safety assessment[52]. Revenue Composition and Market Performance - Revenue from proprietary products, including KEDRAB, CYTOGAM, and GLASSIA, comprised approximately 81% of total revenues for the year ended December 31, 2023[42]. - Sales of KEDRAB, CYTOGAM, and GLASSIA accounted for approximately 23%, 12%, and 11% of total revenues, respectively, totaling 46% for the year ended December 31, 2023[39]. - Approximately 52% of total revenues were generated in the United States for the year ended December 31, 2023[43]. - Sales to Kedrion accounted for approximately 23%, 13%, and 12% of total revenues for the years ended December 31, 2023, 2022, and 2021, respectively, with a binding agreement extending distribution until December 31, 2031, expected to generate approximately $180 million in revenue from 2024 to 2027[55]. Operational Expansion and Challenges - The company aims to expand its plasma collection capabilities, including a new center in Uvalde, Texas, expected to commence operations in 2024[23]. - The company has invested in expanding U.S. plasma collection operations, including a new center in Uvalde, Texas, expected to commence operations in 2024[48]. - The expansion of plasma collection operations aims to reduce dependency on third-party suppliers and generate revenue through commercialization, but operational and regulatory challenges may hinder success[50]. - The company faces potential legal claims amounting to $6.7 million from a terminated distribution agreement in Russia and Ukraine, with ongoing litigation proceedings[69]. Competition and Market Risks - The company competes with major players like CSL Behring, Takeda, and Grifols in the Proprietary Products segment, which may impact market share and pricing strategies[70]. - Grifols' AAT product holds at least 50% market share in the U.S. and over 70% globally, posing significant competition for the company's AAT products[80]. - The company anticipates challenges in winning tender bids due to competitive pricing pressures from larger competitors with greater financial resources[65]. - The company faces significant competition in the Distribution segment from larger companies, which may lead to reduced profitability or operating losses if market share is not maintained[132]. Regulatory Compliance and Risks - Regulatory compliance with cGMP is critical; failure to adhere could result in product rejection, destruction, and increased costs[88]. - The company is subject to extensive ongoing regulatory obligations that could result in significant additional expenses and negatively impact commercialization of current and future products[192]. - Regulatory compliance failures may result in severe consequences, including fines, sanctions, and potential withdrawal of products from the market[194]. - The FDA and other regulatory authorities may impose additional requirements for production process changes, affecting operational flexibility[114]. Supply Chain and Manufacturing Risks - The company relies on third-party distributors for sales and distribution, and any disruption could adversely affect future results[38]. - The company relies on a limited number of suppliers for key products, which poses risks if these suppliers face capacity constraints or disruptions[121]. - The company is dependent on maintaining relationships with third-party manufacturers like Prothya for CYTOGAM production, with risks of supply shortages if compliance is not met[64]. - The company may face challenges in passing increased costs of source plasma to customers due to price controls in principal markets, potentially reducing profit margins[102]. Labor and Environmental Considerations - The company experienced a gross profit impact of $4.3 million due to a labor strike at the Beit Kama facility in 2022[210]. - The collective bargaining agreement with the Histadrut is effective through the end of 2029, with potential renegotiation of certain economic terms after four years[210]. - The company is subject to extensive environmental, health, and safety regulations, which may incur substantial capital costs and operating expenses for compliance[209]. - Future audits by environmental authorities may require the company to perform corrective actions to comply with guidelines[209].

Financial Data and Key Metrics Changes - Total revenues for Q3 2023 were approximately $37.9 million, representing an 18% year-over-year increase, while total revenues for the first nine months of 2023 were $106.1 million, reflecting a 26% increase [8][17] - Adjusted EBITDA for Q3 2023 was $7.9 million, up 31% from $6 million in Q3 2022, and for the first nine months of 2023, adjusted EBITDA was $17.7 million, a 67% increase compared to $10.6 million in the same period of 2022 [44][17] - Net income for Q3 2023 was approximately $3.2 million or $0.06 per share, compared to a net income of $500,000 or $0.01 per share in the prior year period [44] Business Line Data and Key Metrics Changes - KEDRAB sales to Kedrion significantly contributed to revenue growth, driven by increased demand in the U.S. market [8][10] - The company has established a U.S. team to promote its specialty immunoglobulin portfolio, including CYTOGAM and VARIZIG, marking the first field-based activity for these products in over a decade [5][10] Market Data and Key Metrics Changes - The U.S. market has shown a significant increase in demand for the company's products, particularly KEDRAB, which has gained market share due to FDA label expansion and effective commercial activities by Kedrion [18][56] - The availability of Kamada-manufactured CYTOGAM in the U.S. is expected to enhance future growth potential [19] Company Strategy and Development Direction - The company anticipates annual double-digit revenue and profitability growth beyond 2023, with a focus on expanding its plasma collection capabilities and enhancing its product portfolio [4][20] - A $60 million private placement was completed to provide financial flexibility for growth and business development opportunities [11][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year 2023 guidance of $138 million to $146 million in revenue and $22 million to $26 million in adjusted EBITDA, indicating a projected profitability growth of approximately 35% compared to 2022 [25][44] - The company is optimistic about the ongoing demand for its products and the potential for continued growth in the U.S. market [18][62] Other Important Information - The company is now debt-free following the closure of its outstanding bank loan [26][45] - A Scientific Advisory Board has been established to support the U.S. clinical program for CYTOGAM and explore future research opportunities [12] Q&A Session Summary Question: What are the key drivers behind KEDRAB's growth? - Management indicated that multiple dynamics, including label expansion and increased sales focus, are driving KEDRAB's significant market share growth [36][37] Question: Any updates on pipeline efforts? - Management highlighted progress in the inhaled AAT program and positive discussions with regulators, including the EMA and FDA [38][39] Question: Can you elaborate on the diversity of the business? - Management noted investments in medical and commercial activities around CYTOGAM and VARIZIG, contributing to overall growth [50][51] Question: What are the business development plans following the private placement? - The company is looking to leverage additional funds for business development initiatives, particularly in the transplantation field [52][64] Question: Any updates on clinical studies or early-stage programs? - Management mentioned ongoing enrollment in the AAT clinical trial and three early-stage programs in preclinical development [58]