Kamada .(KMDA)

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Kamada Announces Launch of a Comprehensive Post-Marketing Research Program for CYTOGAM®
Globenewswire· 2025-05-05 11:00
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]
Kamada Updates on Withholding Tax Procedures on Previously Announced Special Cash Dividend to Shareholders
Newsfilter· 2025-03-24 11:00
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].
Kamada .(KMDA) - 2024 Q4 - Earnings Call Transcript
2025-03-05 16:06
Kamada Ltd. (NASDAQ:KMDA) Q4 2024 Earnings Conference Call March 5, 2025 8:00 AM ET Company Participants Brian Ritchie – LifeSci Advisors Amir London – Chief Executive Officer Chaime Orlev – Chief Financial Officer Conference Call Participants Annabel Samimy – Stifel Anthony Petrone – Mizuho Group James Sidoti – Sidoti & Co. Operator Greetings, and welcome to the Kamada Fourth Quarter and Full Year 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. A brief question-and-a ...
Kamada .(KMDA) - 2024 Q4 - Earnings Call Transcript
2025-03-05 19:57
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]
Kamada .(KMDA) - 2024 Q4 - Annual Report
2025-03-05 12:16
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].
Kamada .(KMDA) - 2024 Q4 - Annual Report
2025-03-05 12:05
Exhibit 99.2 Kamada Reports Record Top and Bottom Line 2024 Financial Results and Affirms 2025 Guidance Representing Double-Digit Profitable Growth REHOVOT, Israel, and HOBOKEN, NJ – March 5, 2025 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a 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 three months and year ended December 31, 2024. "Our performa ...
Kamada .(KMDA) - 2024 Q3 - Earnings Call Transcript
2024-11-13 14:54
Financial Data and Key Metrics Changes - Total revenues for Q3 2024 were $41.7 million, a 10% increase compared to Q3 2023, while total revenues for the first 9 months of 2024 were $121.9 million, up 15% from the prior year [6][7][16] - Adjusted EBITDA for Q3 2024 was $8.8 million, an 11% increase from Q3 2023, and for the first 9 months, it was $25.4 million, up 43% from the same period in 2023 [6][21] - Net income for Q3 2024 was $3.9 million or $0.07 per diluted share, a 20% increase compared to Q3 2023, while net income for the first 9 months was $10.7 million or $0.18 per diluted share, three times the net income of the same period in 2023 [20] Business Line Data and Key Metrics Changes - The increase in revenues was primarily driven by higher sales of KEDRAB and CYTOGAM, with both products experiencing double-digit growth [17][25] - Approximately 60% of revenues during the first 9 months of 2024 were generated from the U.S. market [17] Market Data and Key Metrics Changes - The company opened a new plasma collection center in Houston, Texas, which is expected to support over 50 donor beds and have an estimated total collection capacity of over 50,000 liters annually [12][13] - The Houston center is anticipated to be one of the largest sites for specialty plasma collection in the U.S., contributing annual revenues of $8 million to $10 million at full capacity [13] Company Strategy and Development Direction - The company’s growth strategy is based on four pillars: organic growth of its existing commercial portfolio, business development and M&A transactions, expansion of plasma collection centers, and ongoing clinical trials for inhaled AAT products [9][10] - The company plans to continue expanding its biosimilar product offerings, with peak potential annual sales estimated between $30 million to $34 million [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit growth in both top and bottom lines for 2025 and beyond, supported by strong operational performance and strategic initiatives [36][38] - The company is actively engaged in discussions for potential partnerships related to its investigational late-stage product candidate [30] Other Important Information - The company generated $37.2 million in cash from operating activities during the first 9 months of 2024, ending with a cash balance of $72 million [8][22] - Operating expenses for the first 9 months of 2024 totaled $38 million, reflecting planned increases to support expanded commercial activities and ongoing clinical trials [19] Q&A Session Summary Question: Can you provide a breakdown of KEDRAB and CYTOGAM? - Management indicated that both products are growing significantly, with double-digit growth expected to continue [25] Question: What is your expectation for the max share of KEDRAB? - Management estimates KEDRAB's market share to be between 40% to 50%, with opportunities for growth in various international markets [26] Question: What is driving EBITDA expansion? - EBITDA expansion is attributed to a combination of economies of scale, operational efficiency, and a favorable sales mix [27] Question: Any update on the percent of enrollment for the InnovAATe trial? - Enrollment is approximately 50%, with ongoing discussions with the FDA regarding sample size implications [29] Question: Is there any progress on the preclinical pipeline? - Management confirmed progress in both business development and preclinical activities, including the plasma eye drops program [31]
Kamada .(KMDA) - 2024 Q3 - Quarterly Report
2024-11-13 12:24
Financial Performance - Total revenues for the nine months ended September 30, 2024, reached $121.948 million, a 14.0% increase from $106.087 million in the same period of 2023[9] - Gross profit for the nine months ended September 30, 2024, was $52.936 million, compared to $41.078 million for the same period in 2023, reflecting a 28.9% increase[9] - Net income for the nine months ended September 30, 2024, was $10.654 million, significantly up from $3.226 million in the same period of 2023, marking a 230.5% increase[9] - For the nine months ended September 30, 2024, the Company reported total revenues of $121.948 million, a 15% increase from $106.087 million in the same period of 2023[70][72] - U.S. revenue for the nine months ended September 30, 2024, was $84,779 thousand, up from $55,220 thousand in 2023, indicating a significant increase of about 53%[77] - The company reported a total income of $8,429 thousand for the nine months ended September 30, 2024, compared to a loss of $45,426 thousand in the previous period[77] Expenses and Liabilities - Research and development expenses for the nine months ended September 30, 2024, totaled $12.512 million, up from $10.694 million in the same period of 2023, indicating a 16.9% increase[9] - The Company incurred unallocated corporate expenses of $37.963 million for the nine months ended September 30, 2024, compared to $33.790 million in the prior year[70][72] - Total expenses for the nine months ended September 30, 2024, were $45,426 thousand, compared to $1,635 thousand in the previous period, indicating a significant increase in operational costs[77] - Total liabilities as of September 30, 2024, were $95.940 million, compared to $98.666 million as of September 30, 2023, showing a decrease of 2.8%[6] Assets and Equity - Total current assets as of September 30, 2024, were $164.409 million, compared to $153.153 million as of September 30, 2023, representing a 7.3% increase[6] - Total assets as of September 30, 2024, amounted to $351.209 million, up from $337.056 million as of September 30, 2023, reflecting a 4.0% increase[6] - The balance as of September 30, 2024, was $15,024, with total equity of $255,269[24] - The balance as of September 30, 2023, was $15,020, with total equity amounting to $238,390[20] Cash Flow - Cash provided by operating activities for the nine months ended September 30, 2024, was $37,196,000, a substantial recovery from a cash outflow of $95,000 in the same period last year[36] - The company’s cash and cash equivalents increased to $72.001 million as of September 30, 2024, from $52.603 million as of September 30, 2023, a rise of 36.8%[6] - Cash and cash equivalents at the end of the period increased to $72,001,000 from $52,603,000 at the end of the same period in 2023[40] Product Development and Market Presence - The company plans to continue investing in research and development to enhance its proprietary products and expand its market presence[9] - 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[43] - Kamada Ltd. acquired CYTOGAM, WINRHO SDF, VARIZIG, and HEPGAM B from Saol Therapeutics in November 2021 to enhance its commercial capabilities in the U.S. market[44] - The company markets GLASSIA in the U.S. through a partnership with Takeda, which includes a royalty agreement of 12% on net sales until August 2025[45] - Kamada Ltd. is progressing the InnovAATe clinical trial for its leading investigational product, an inhaled AAT for the treatment of AAT deficiency[43] Shareholder Information - The company issued ordinary shares net of issuance costs totaling $58,231 during the period[20] - The cost of share-based payments for the period was $950[20] - The Company granted a total of 27,468 options to purchase ordinary shares under the 2011 Plan and the US Appendix, with a fair value of approximately $66 thousand[61][62][63] - The exercise price for options granted under the Israeli Share Option Plan was NIS 23.91 (USD 6.67) and NIS 22.01 (USD 6.06) for different tranches[62][64] Accounting and Compliance - 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[54][58] - The Company’s income before taxes on income for the nine months ended September 30, 2024, was $3.405 million, compared to $3.296 million for the same period in 2023[70][72] Segment Performance - The Company operates two segments: Proprietary Products, which generated $110.032 million in revenues, and Distribution, which generated $11.916 million for the nine months ended September 30, 2024[71][72]
Kamada Announces Expansion of Plasma Collection Operations in Texas with the Opening of New Site in Houston
GlobeNewswire News Room· 2024-09-23 11:00
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]
Kamada .(KMDA) - 2024 Q2 - Earnings Call Transcript
2024-08-14 17:45
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]