Kamada .(KMDA)
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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 ...
Kamada .(KMDA) - 2023 Q4 - Annual Report
2024-03-06 12:10
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 ...
Kamada .(KMDA) - 2023 Q4 - Annual Report
2024-03-06 12:01
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].
Kamada .(KMDA) - 2023 Q3 - Earnings Call Transcript
2023-11-13 16:08
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]
Kamada .(KMDA) - 2023 Q3 - Quarterly Report
2023-11-13 12:00
AS AT SEPTEMBER 30, 2023 TABLE OF CONTENTS Page | Condensed consolidated interim statements of financial position | 1 | | --- | --- | | Condensed consolidated interim statements of profit or loss and other comprehensive income | 2 | | Condensed consolidated interim statements of changes in equity | 3-5 | | Condensed consolidated interim statements of cash flows | 6-7 | | Notes to the condensed consolidated interim financial statements | 8-15 | | - - - - - - - - - - - | | i KAMADA LTD. CONDENSED CONSOLIDATED ...
Kamada .(KMDA) - 2023 Q2 - Quarterly Report
2023-08-16 11:00
Exhibit 99.3 AS OF JUNE 30, 2023 TABLE OF CONTENTS | Consolidated Statements of Financial Position | 1 | | --- | --- | | Consolidated Statements of Profit or Loss and Other Comprehensive Income | 2 | | Consolidated Statements of Changes in Equity | 3-5 | | Consolidated Statements of Cash Flows | 6-7 | | Notes to the Interim Consolidated Financial Statements | 8-14 | | - - - - - - - - - - - | | Page i KAMADA LTD. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | | | | | | | As of | | --- | --- | --- | --- | -- ...
Kamada .(KMDA) - 2023 Q1 - Earnings Call Transcript
2023-05-24 17:21
Financial Data and Key Metrics Changes - Total revenue for Q1 2023 was $30.7 million, a 9% increase from $28.1 million in Q1 2022 [6][18] - EBITDA for Q1 2023 was $3.8 million, representing a 16% increase compared to $3.3 million in Q1 2022 [6][44] - Gross profit for Q1 2023 was $11.8 million, with a margin of 39%, compared to $11.3 million and a margin of 40% in Q1 2022 [41] - Net loss for Q1 2023 was approximately $1.8 million, consistent with the prior-year period [56] Business Line Data and Key Metrics Changes - Strong sales of KEDRAB contributed significantly to revenue growth, with the product gaining market share in the US [12][18] - CYTOGAM, which generated approximately $23 million in sales in 2022, has received FDA approval for manufacturing at Kamada's facility [10] - The company anticipates continued growth from its immune globulin product portfolio and distribution business in Israel [18][30] Market Data and Key Metrics Changes - The US market for KEDRAB is estimated to be over $150 million annually, with Kamada's product being the only human rabies immune globulin clinically studied in children [12] - The market for inhaled alpha-1 antitrypsin therapy is over $1 billion in annual sales in the US and Europe, presenting a substantial opportunity for Kamada [16] Company Strategy and Development Direction - The company aims for annual double-digit revenue and profitability growth in the foreseeable future, supported by a $60 million strategic private placement with FIMI Opportunity Funds [5][8] - Kamada is focused on becoming a fully integrated specialty plasma product company, with plans to expand plasma collection capacity in the US [14][37] - The company is exploring opportunities for in-licensing and acquisitions to accelerate growth [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, reiterating full-year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million [22][30] - The company is optimistic about the impact of recent FDA approvals and ongoing clinical trials on future revenue [10][15] Other Important Information - The company incurred a $0.6 million expense for exit severance compensation due to workforce downsizing at its Israeli plant, expected to reduce overall labor costs by approximately 6% [55] - Cash used in operating activities was $2.9 million in Q1 2023, compared to cash provided by operating activities of $5.5 million in Q1 2022 [57] Q&A Session Summary Question: Were there any surprises during the quarter? - Management indicated that the quarter played out as planned, with no significant surprises [58] Question: What is the growth outlook for the year? - Management expects growth to come from KEDRAB, the new IgG portfolio, and distribution business in Israel, reiterating annual guidance [24] Question: Can you provide more details on FIMI? - FIMI is a private equity firm with a strong track record, having invested significantly in Kamada since 2019 [63]
Kamada .(KMDA) - 2022 Q4 - Earnings Call Transcript
2023-03-15 20:07
Financial Data and Key Metrics Changes - Total revenue for 2022 was approximately $129 million, representing a 25% increase from $104 million in 2021 [33][8] - EBITDA for 2022 was approximately $18 million, with a margin of 14%, a significant increase from $5.4 million and 5% margin in 2021 [53][9] - Operating cash flow reached a record $28.6 million in 2022, increasing the cash position to $34 million as of December 31, 2022, nearly double from $18.6 million at the end of 2021 [9][54] Business Line Data and Key Metrics Changes - Revenue from acquired products increased by 24% in 2022, generating gross margins over 50% [15][8] - KEDRAB, the rabies immunoglobulin, gained significant market share in the US, contributing to the overall revenue growth [19][20] - GLASSIA royalty income from Takeda was $12.2 million for 2022, with expectations of $10 million to $20 million annually through 2040 [27] Market Data and Key Metrics Changes - The US market for KEDRAB is estimated at $150 million annually, with expectations for continued growth [19] - The company is expanding its international distribution network, particularly in Latin America and the Middle East, with significant contracts secured [24][25] Company Strategy and Development Direction - The company has transitioned from dependence on GLASSIA sales to a diversified specialty plasma company with a global footprint in over 30 countries [7] - Plans to manufacture CYTOGAM at its facility in Israel are underway, with FDA approval expected by mid-2023 [18] - The company aims to leverage its strong international distribution network to grow product revenues in new territories [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth and profitability for 2023, with guidance of $138 million to $146 million in revenue and EBITDA of $22 million to $26 million [10][38] - The company anticipates annual double-digit growth in revenues and profitability in the foreseeable future [47] Other Important Information - Research and development investments increased to $13.2 million in 2022, primarily due to the ongoing Phase 3 InnovAATe trial [51] - The company expects overall expenses, including R&D and marketing, to increase by 15% to 20% in 2023 compared to 2022 [66] Q&A Session Summary Question: Will the company remain cash flow positive? - Management confirmed that the company expects to remain cash-positive and profitable, with strong cash flow generation correlated with EBITDA [40] Question: What are the biggest drivers behind the growth of the acquired products? - Growth was attributed to strong sales in the US and Canada, including significant contracts for VARIZIG and ongoing marketing efforts [57] Question: Is the company working on additional supply contracts? - Management stated that they are actively pursuing additional marketing and registration opportunities for their portfolio in new territories [59] Question: What are the expectations for gross margins in the future? - Management indicated that gross margins are expected to improve as the product mix transitions to more profitable products [60] Question: What is the opportunity with plasma collection centers? - Each mature plasma collection center is expected to contribute approximately $10 million to the top line annually, with plans for additional centers underway [80]
Kamada .(KMDA) - 2022 Q4 - Annual Report
2023-03-15 11:14
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report: Not applicable For the transition period from ____ to _____ Commission file number 001-35948 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ...