Kamada .(KMDA)
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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 ...
Kamada .(KMDA) - 2023 Q1 - Quarterly Report
2023-03-15 11:10
[Kamada 2022 Financial Results and 2023 Outlook](index=1&type=section&id=Kamada%202022%20Financial%20Results%20and%202023%20Outlook) [Executive Summary & Key Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Key%20Highlights) The company reported strong 2022 results with 25% revenue growth and a threefold EBITDA increase driven by its acquired IgG portfolio Fiscal Year 2022 Key Financial Metrics | Metric | FY 2022 | FY 2021 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $129.3 M | $103.6 M | +25% | | EBITDA | $17.8 M | $5.4 M | +229% (3x) | | Operating Cash Flow | $28.6 M | ($8.8 M) | N/A | | Year-End Cash Position | $34.3 M | $18.6 M | +84% | Fiscal Year 2023 Guidance | Metric | 2023 Guidance Range | Mid-point YoY Growth | | :--- | :--- | :--- | | Total Revenues | $138 M - $146 M | +9.8% | | EBITDA | $22 M - $26 M | +35% | - Key growth drivers included the **acquired portfolio of four FDA-approved IgG products**, sales of **KEDRAB** in the U.S, royalties from **GLASSIA**, and a thriving Israeli distribution business[3](index=3&type=chunk)[5](index=5&type=chunk) - The company is advancing its pivotal Phase 3 clinical trial (**InnovAATe**) for Inhaled AAT, with accelerated recruitment and plans to meet with regulatory agencies[5](index=5&type=chunk)[16](index=16&type=chunk) [Detailed Financial Performance](index=2&type=section&id=Detailed%20Financial%20Performance) The company's financials show significant year-over-year improvement in revenue and gross margin for fiscal year 2022 [Fiscal Year 2022 Financial Results](index=2&type=section&id=Fiscal%20Year%202022%20Financial%20Results) Full-year 2022 revenue grew 25% with improved gross margins, though net results were impacted by acquisition-related expenses FY 2022 vs. FY 2021 Performance | Metric | FY 2022 | FY 2021 | | :--- | :--- | :--- | | Total Revenues | $129.3 M | $103.6 M | | Gross Profit | $46.7 M | $30.3 M | | Gross Margin | 36% | 29% | | Operating Expenses | $42.2 M | $31.0 M | | Net Loss | ($2.3 M) | ($2.2 M) | | Adjusted EBITDA | $17.8 M | $5.4 M | - The increase in revenues was primarily attributable to sales of the four acquired IgG products[8](index=8&type=chunk) - Operating expenses rose due to increased Sales & Marketing costs for the acquired portfolio and higher R&D costs for the pivotal Phase 3 InnovAATe trial[8](index=8&type=chunk) - The reported net loss was significantly impacted by a **$6.3 million finance expense** associated with the revaluation of contingent consideration from the IgG products acquisition[8](index=8&type=chunk) [Fourth Quarter 2022 Financial Results](index=3&type=section&id=Fourth%20Quarter%202022%20Financial%20Results) Q4 2022 revenues increased 44% year-over-year, driving a significant gross margin improvement and a return to net income Q4 2022 vs. Q4 2021 Performance | Metric | Q4 2022 | Q4 2021 | | :--- | :--- | :--- | | Total Revenues | $45.4 M | $31.5 M | | Gross Profit | $15.3 M | $6.6 M | | Gross Margin | 34% | 21% | | Net Income (Loss) | $2.9 M | ($5.0 M) | | Adjusted EBITDA | $7.2 M | ($1.3 M) | - The increase in profitability was driven by a positive product sales mix, including sales of the four new IgG products, KEDRAB U.S sales and GLASSIA royalties[11](index=11&type=chunk) [Balance Sheet and Cash Flow](index=2&type=section&id=Balance%20Sheet%20and%20Cash%20Flow) The company nearly doubled its year-end cash position, driven by a record annual operating cash flow of $28.6 million Cash Position and Operating Cash Flow (Year-End) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Cash, Cash Equivalents, and Short-Term Investments | $34.3 M | $18.6 M | | Cash Provided by (Used in) Operating Activities | $28.6 M | ($8.8 M) | - The increase in the cash position was driven by **continued positive operational cash flows**, indicating significant momentum in commercial operations[12](index=12&type=chunk) [Business Outlook and Corporate Updates](index=4&type=section&id=Business%20Outlook%20and%20Corporate%20Updates) Kamada issued strong 2023 guidance and reported progress on key regulatory submissions and clinical trials Fiscal Year 2023 Guidance | Metric | 2023 Guidance Range | | :--- | :--- | | Total Revenues | $138 million to $146 million | | EBITDA | $22 million to $26 million | - The company has submitted applications to the U.S. FDA and Health Canada to manufacture **CYTOGAM®** at its facility in Beit Kama, Israel[16](index=16&type=chunk) - Progress in the pivotal **Phase 3 InnovAATe trial** for inhaled AAT includes accelerated recruitment and plans to meet with regulatory agencies to discuss the program[16](index=16&type=chunk) [Consolidated Financial Statements](index=7&type=section&id=Consolidated%20Financial%20Statements) This section provides the detailed audited financial statements for the year ended December 31, 2022 [Consolidated Statements of Financial Position](index=7&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) Total assets were $322.4 million as of year-end 2022, reflecting a significant increase in cash and stable equity Balance Sheet Summary (in thousands USD) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Total Current Assets | $139,005 | $130,044 | | Total Non-Current Assets | $183,374 | $188,623 | | **Total Assets** | **$322,379** | **$318,667** | | Total Current Liabilities | $75,705 | $54,057 | | Total Non-Current Liabilities | $70,654 | $87,786 | | **Total Shareholder's Equity** | **$176,020** | **$176,824** | | **Total Liabilities and Equity** | **$322,379** | **$318,667** | [Consolidated Statements of Profit or Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Profit%20or%20Loss) The company reported total revenues of $129.3 million and a net loss of $2.3 million for the full year 2022 Income Statement Summary - Full Year (in thousands USD) | Account | FY 2022 | FY 2021 | | :--- | :--- | :--- | | Total Revenues | $129,339 | $103,642 | | Gross Profit | $46,703 | $30,328 | | Operating Income (Loss) | $4,532 | ($696) | | **Net Income (Loss)** | **($2,321)** | **($2,230)** | | Basic Net Earnings Per Share | ($0.05) | ($0.05) | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The company generated $28.6 million in cash from operating activities, a strong reversal from the prior year's cash use Cash Flow Summary - Full Year (in thousands USD) | Activity | FY 2022 | FY 2021 | | :--- | :--- | :--- | | Net Cash from Operating Activities | $28,586 | ($8,819) | | Net Cash from Investing Activities | ($3,784) | ($61,050) | | Net Cash from Financing Activities | ($9,343) | $18,593 | | **Increase (Decrease) in Cash** | **$15,671** | **($51,610)** | | **Cash at End of Period** | **$34,258** | **$18,587** | [Non-IFRS Measures Reconciliation](index=11&type=section&id=Non-IFRS%20Measures%20Reconciliation) A reconciliation from IFRS net loss to non-IFRS Adjusted EBITDA resulted in $17.8 million for fiscal year 2022 Reconciliation to Adjusted EBITDA - Full Year (in thousands USD) | Line Item | FY 2022 | FY 2021 | | :--- | :--- | :--- | | Net Income (Loss) | ($2,321) | ($2,230) | | Taxes on income | $62 | $345 | | Financial expense (income), net | $6,791 | $1,189 | | Depreciation and amortization | $12,155 | $5,609 | | Non-cash share-based compensation | $1,153 | $529 | | **Adjusted EBITDA** | **$17,840** | **$5,442** |
Kamada .(KMDA) - 2022 Q3 - Earnings Call Transcript
2022-11-22 15:35
Financial Data and Key Metrics Changes - Total revenues for Q3 2022 were $32.2 million, a 40% increase year-over-year, with gross margins rising to 40% from 25% in Q3 2021 [10][34] - Adjusted EBITDA for Q3 2022 was $6 million, representing a 19% margin, while for the first nine months of 2022, adjusted EBITDA was $10.6 million, a 58% increase compared to the previous year [10][41] - The company generated positive cash flow from operating activities for the third consecutive quarter, resulting in a cash position of $31.3 million as of September 30, 2022 [11][43] Business Line Data and Key Metrics Changes - The growth in revenues was primarily driven by strong sales of the recently acquired IgG products, including CYTOGAM, HEPAGAM, VARIZIG, and WINRHOSDF [8][34] - KEDRAB sales also grew significantly during Q3 2022, contributing to the overall revenue increase [21][36] - Royalty income from GLASSIA sales to Takeda amounted to $3.5 million in Q3 2022, representing pure profit for the company [22][36] Market Data and Key Metrics Changes - The U.S. market is seeing a positive trend in KEDRAB sales, which is expected to continue as the product gains market share in a $150 million market [21] - Internationally, a significant $11.4 million agreement to supply VARIZIG was signed, with anticipated revenues expected in Q4 2022 [17][18] - The company is also expanding its presence in the U.S. market with a dedicated sales team promoting its portfolio of specialty plasma-derived immunoglobulins [14][16] Company Strategy and Development Direction - The company is focused on achieving double-digit growth rates in the foreseeable future, driven by its proprietary product categories [31][58] - Kamada is actively pursuing additional commercial contracts in strategic territories and has established a direct presence in the U.S. market [19][24] - The company plans to expand its plasma collection capabilities in the U.S. to enhance its competitive position [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving continued revenue growth and enhanced profitability in Q4 2022, reiterating full-year revenue guidance of $125 million to $135 million [12][58] - The management highlighted the successful strategic transition of the company and the positive feedback from U.S. physicians regarding the product portfolio [8][16] - Future catalysts include the ongoing Phase 3 InnovAATe clinical trial and the anticipated FDA approval for CYTOGAM production [26][20] Other Important Information - Research and development investments increased to $10.2 million in the first nine months of 2022, primarily due to the InnovAATe trial expansion [39] - Selling and marketing expenses rose due to the establishment of U.S. commercial operations and pre-commercial activities for new product launches [39] Q&A Session Summary Question: How will the company achieve its full-year revenue guidance? - Management indicated that the fourth quarter will benefit from the VARIZIG supply agreement, significant pending orders in the Israel Distribution segment, and continued growth of the new IgG portfolio products [46][47] Question: Should increased operating expenses be expected in 2023? - Management confirmed that 2023 will see a full year of U.S. sales and marketing activities, with expected operational expenses increasing by approximately 10% to 12% compared to 2022 [48][49] Question: Will sales growth from acquired products come from international contracts or U.S. market activities? - Management stated that both aspects are contributing to growth, with ongoing sales activities in the U.S. and international contracts already yielding results [50][52] Question: What is the coverage strategy for transplant centers? - The company is focusing on larger transplant centers and those that have not used its products recently, aiming to cover 150 to 200 centers with a dedicated team [53][54] Question: Is there an ongoing effort to expand the product portfolio? - Management confirmed that the company is building the right infrastructure to look for synergistic products, with efforts continuing through 2023 [55]