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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]
Kamada .(KMDA) - 2024 Q2 - Quarterly Report
2024-08-14 11:00
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]
Kamada to Announce Second Quarter and First Half Ended June 30, 2024 Financial Results and Host Conference Call on August 14, 2024
GlobeNewswire News Room· 2024-08-07 11:00
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]
Kamada .(KMDA) - 2024 Q1 - Earnings Call Transcript
2024-05-08 15:55
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]
Kamada to Announce First Quarter 2024 Financial Results and Host Conference Call on May 8, 2024
Newsfilter· 2024-05-01 11:00
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 .(KMDA) - 2023 Q4 - Earnings Call Transcript
2024-03-06 19:22
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 ...