Rho(D) Immune Globulin Intravenous (Human)(Cangene Corp)

First Half 2025 Total Revenues were $88.8 Million, up 11% Year-over-Year; Revenues for 2025 Second Quarter were $44.8 Million, up 5% Year-over-Year First Half 2025 Adjusted EBITDA of $22.5 Million, up 35% Year-over-Year and Representing 25% Margin of Revenues; Second Quarter Adjusted EBITDA of $10.9 Million, up 20% Year-over-YearRobust First Half Results and Positive Outlook for Remainder of 2025 Support Increased Adjusted EBITDA Guidance to $40 Million-$44 Million, and Reiteration of Full-Year Revenue Guidance of $178 Million-$182 MillionAnnounced FDA Approval of its Plasma Collection Center in Houston, Texas, which is Now Cleared to Commence Commercial Sales Company Continues to Focus on Securing Commercial-Stage Business Development Opportunities to Support Continued Long-Term Profitable Growth Conference Call and Live Webcast Today at 8:30am ET REHOVOT, Israel and HOBOKEN, N.J., Aug. 13, 2025 (GLOBE NEWSWIRE) -- 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 six months ended June 30, 2025. “Results for the second quarter and first half of 2025 were strong, and we continue to generate significant profitable growth through the diversity of our commercial product portfolio and disciplined management of operational expenses,” said Amir London, Kamada’s Chief Executive Officer. “Total revenues for the first half of the year were $88.8 million, representing an 11% increase year-over-year, and adjusted EBITDA was $22.5 million, up 35% year-over-year, representing a 25% margin of revenues. Based on our strong performance in the first half of the year and positive outlook for the remainder of 2025, we are increasing our annual adjusted EBITDA guidance of between $40 million to $44 million and reiterating our full-year 2025 revenue guidance of between $178 million to $182 million." “We continue to invest in our strategic growth pillars through continuous organic growth, as demonstrated by our financial results, while focusing on securing business development and M&A opportunities to expand our portfolio of marketed products, thereby supporting continued profitable growth. In addition, we continue to ramp up plasma collection at our three Texas-based plasma collection centers and were pleased to recently receive U.S. FDA approval of our state-of-the-art plasma collection center in Houston, TX, which is now cleared to commence commercial sales. As previously stated, the center has annual collection capacity of approximately 50,000 liters of plasma and an estimated annual revenue contribution of $8 million to $10 million at its full capacity. Moreover, we continue to advance our ongoing pivotal Phase 3 InnovAATe clinical trial for our inhaled Alpha-1 Antitrypsin therapy. Enrollment is progressing, and we remain on track to conduct an interim futility analysis by the end of the year,” concluded Mr. London. Financial Highlights for the Three Months Ended June 30, 2025 Total revenues were $44.8 million in the second quarter of 2025, up 5% compared to $42.5 million in the second quarter of 2024. The increase in revenues was driven by the diversity of the Company’s portfolio, primarily attributable to increased sales of GLASSIA® in ex-U.S. markets, increased sales in our Distribution segment, VARIZIG® U.S. sales, and GLASSIA royalty income. Gross profit and gross margins were $18.9 million and 42%, respectively, in the second quarter of 2025, compared to $19.0 million and 45%, respectively, in the second quarter of 2024.The decrease in both metrics is attributable to changes in product sales mix.Operating expenses, including R&D, S&M, G&A and other expenses, totaled $11.9 million in the second quarter of 2025, as compared to $13.3 million in the second quarter of 2024. The decrease is driven by disciplined management of operational expenses.Net income was $7.4million, or $0.13per diluted share, in the second quarter of 2025, as compared to $4.4 million, or $0.08 per diluted share, in the second quarter of 2024.Adjusted EBITDA, as detailed in the tables below, was $10.9 million in the second quarter of 2025, up 20% as compared with the $9.1 million achieved in the second quarter of 2024.Cash provided by operating activities was $8.0 million in the second quarter of 2025, as compared to cash provided by operating activities of $14.0 million in the second quarter of 2024. Financial Highlights for the Six Months Ended June 30, 2025 Total revenues for the first six months of 2025 were $88.8 million, an 11% increase from the $80.2 million generated in the first six months of 2024. The increase in revenues was driven by the diversity of the Company’s portfolio, primarily attributable to increased sales of GLASSIA in ex-U.S. markets, increased sales in our Distribution segment, VARIZIG U.S. sales and GLASSIA royalty income.Gross profit and gross margins for the first six months of 2025 were $39.7 million and 45%, respectively, compared to $35.7 million and 45%, respectively, in the first half of 2024. The increase in gross profit is in line with the increase in total revenues.Operating expenses, including R&D, S&M, G&A and other expenses, totaled $24.8 million in the first six months of 2025, as compared to $26.0 million in the first half of 2024. The decrease is driven by disciplined management of operational expenses.Net income for the first six months of 2025 was $11.3 million, or $0.19 per diluted share, up 67% as compared to net income of $6.8 million or $0.12 per diluted share, in the first six months of 2024.Adjusted EBITDA, as detailed in the tables below, was $22.5 million in the first six months of 2025, a 35% increase as compared to $16.6 million in the first six months of 2024.Cash provided by operating activities during the first six months of 2025 was approximately $7.5 million, as compared to $15.0 million during the first six months of 2024. The decrease is associated with an increase in working capital. Balance Sheet HighlightsAs of June 30, 2025, the Company had cash and cash equivalents of $66.0 million, as compared to $78.4 million as of December 31, 2024. The decrease in cash balance is associated with the payment of a special cash dividend in the total amount of $11.5 million. Recent Corporate Highlights Announced that the U.S. Food and Drug Administration (FDA) has approved the supplement to the Company’s existing Biologics License Application (BLA) for its collection center in Houston, TX. The center is now cleared to commence commercial sales of normal source plasma. The 12,000 square foot Houston facility supports 50 donor beds, with a planned capacity of approximately 50,000 liters per year and is anticipated to be one of the largest sites for specialty plasma collection in the U.S. Kamada awarded the Israeli Outstanding Exporter Award for 2024. The award was granted by the Israeli Ministry of Economy and Industry for the Company’s growing export revenues. The award was presented to Mr. London by the President of the State of Israel, Mr. Isaac Herzog. Fiscal 2025 GuidanceKamada is increasing its adjusted EBITDA guidance from a range of $38 million to $42 million to a range of $40 million to $44 million and continues to expect to generate fiscal year 2025 total revenues in the range of $178 million to $182 million, representing double digit top- and bottom-line growth year-over-year. Conference Call DetailsKamada's management will host an investment community conference call on Wednesday, August 13 at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the call by dialing 1-877-413-7208 (from within the U.S.), 1-201-689-8555 (International), or 1-809-406-247 Investors (from Israel) using conference I.D. 13754604. The call will be webcast live on the internet at: https://viavid.webcasts.com/starthere.jsp?ei=1726126&tp_key=61b4d50ef5 Non-IFRS financial measuresWe present EBITDA and adjusted EBITDA because we use these non-IFRS financial measures to assess our operational performance, for financial and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes these non-IFRS financial measures are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company’s core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA is defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, whereas adjusted EBITDA is the EBITDA plus non-cash share-based compensation expenses and certain other costs. For the projected 2025 adjusted EBITDA information presented herein, the Company is unable to provide a reconciliation of this forward measure to the most comparable IFRS financial measure because the information for these measures is dependent on future events, many of which are outside of the Company’s control. Additionally, estimating such forward-looking measures and providing a meaningful reconciliation consistent with the Company’s accounting policies for future periods is meaningfully difficult and requires a level of precision that is unavailable for these future periods and cannot be accomplished without unreasonable effort. Forward-looking non-IFRS measures are estimated in a manner consistent with the relevant definitions and assumptions noted in the Company’s adjusted EBITDA for historical periods. About Kamada Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. The Company’s strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth from its commercial activities, including continued investment in the commercialization and life cycle management of its proprietary products, which include six FDA-approved specialty plasma-derived products: KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG® and HEPAGAM B®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom products, and the products in the distribution segment portfolio, mainly through the launch of several biosimilar products in Israel. Second: the Company aims to secure significant new business development, in-licensing, collaboration and/or merger and acquisition opportunities, which are anticipated to enhance the Company’s marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term growth. Third: the Company is expanding its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers, and to support its increasing demand for hyper-immune plasma. The Company currently owns three operating plasma collection centers in the United States, in Beaumont Texas, Houston Texas, and San Antonio, Texas. Lastly, the Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need, with the lead product candidate Inhaled AAT, for which the Company is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares. Cautionary Note Regarding Forward-Looking StatementsThis release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: 1) increasing its adjusted EBITDA guidance to a range of $40 million to $44 million and reiteration of 2025 full-year guidance of $178 million to $182 million, 2) double digit growth in fiscal year 2025, 3) continued investment in the Company's four strategic growth pillars, consisting of organic commercial growth, business development and M&A transactions, plasma collection operations, and advancement of the pivotal Phase 3 Inhaled AAT program, 4) continued progress of the InnovAATe clinical trial and conducting an interim futility analysis by the end of 2025, 5) continued focus on securing commercial-stage business development and M&A opportunities to expand the portfolio of marketed products to support continued long-term profitable growth, 6) plasma collection center in Houston, TX, supporting 50 donor beds, with planned capacity of approximately 50,000 liters per year and is anticipated to be one of the largest sites for specialty plasma collection in the U.S., and 7) expected annual revenues contribution from sales of normal source plasma collected in the Houston collection centers at $8 million to $10 million at full capacity. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to the evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, effect of tariffs on overall international trade and specifically on Kamada’s ability to continue maintaining expected sales and profit levels in light of such tariffs, the effect on establishment and timing of business initiatives, Kamada’s ability to leverage new business opportunities and integrate it with its existing product portfolio, unexpected results of clinical and development programs, regulatory delays, and other risks detailed in Kamada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC’s website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. CONTACTS:Chaime OrlevChief Financial OfficerIR@kamada.com Brian RitchieLifeSci Advisors, LLC212-915-2578britchie@LifeSciAdvisors.com ---tables to follow--- CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION As of As of June 30, December 31, 2025 2024 2024 Unaudited Assets Current Assets Cash and cash equivalents$65,985 $56,547 $78,435 Trade receivables, net 30,501 26,228 21,547 Other accounts receivables 4,704 4,940 5,546 Inventories 82,079 78,713 78,819 Total Current Assets 183,269 166,428 184,347 Non-Current Assets Property, plant and equipment, net 37,894 31,971 36,245 Right-of-use assets 9,250 7,552 9,617 Intangible assets, Goodwill and other long-term assets 99,640 106,517 103,226 Goodwill 30,313 30,313 30,313 Contract assets 7,807 8,257 8,019 Deferred taxes - - 488 Total Non-Current Assets 184,904 184,610 187,908 Total Assets$368,173 $351,038 $372,255 Liabilities Current Liabilities Current maturities of lease liabilities 1,866 1,494 1,631 Current maturities of other long term liabilities 9,850 12,610 10,181 Trade payables 25,077 19,532 27,735 Other accounts payables 8,804 7,233 9,671 Deferred revenues 177 27 171 Total Current Liabilities 45,774 40,896 49,389 Non-Current Liabilities Lease liabilities 9,549 7,065 9,431 Contingent consideration 18,884 17,085 20,646 Other long-term liabilities 32,782 34,238 32,816 Deferred taxes 659 - - Employee benefit liabilities, net 571 602 509 Total Non-Current Liabilities 62,445 58,990 63,402 Shareholder’s Equity Ordinary shares 15,077 15,023 15,028 Additional paid in capital net 268,243 266,313 266,933 Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)Capital reserve from hedges 456 (12) 51 Capital reserve from share-based payments 5,226 6,444 6,316 Capital reserve from employee benefits 374 283 364 Accumulated deficit (25,932) (33,409) (25,738)Total Shareholder’s Equity 259,954 251,152 259,464 Total Liabilities and Shareholder’s Equity$368,173 $351,038 $372,255 CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME Six months period ended Three months period ended Year ended June 30, June 30, December 31, 2025 2024 2025 2024 2024 Unaudited Unaudited Revenues from proprietary products$78,453 $72,904 $38,436 $39,146 $141,447 Revenues from distribution 10,319 7,304 6,318 3,326 19,506 Total revenues 88,772 80,208 44,754 42,472 160,953 Cost of revenues from proprietary products 40,580 38,338 20,842 20,718 73,708 Cost of revenues from distribution 8,514 6,168 4,983 2,803 17,278 Total cost of revenues 49,094 44,506 25,825 23,521 90,986 Gross profit 39,678 35,702 18,929 18,951 69,967 Research and development expenses 7,465 9,098 3,219 4,803 15,185 Selling and marketing expenses 9,068 9,361 4,558 4,730 18,428 General and administrative expenses 8,265 7,564 4,067 3,778 15,702 Other expenses 14 - 14 - 601 Operating income 14,866 9,679 7,071 5,640 20,051 Financial income 987 788 453 508 2,118 Income (expenses) in respect of currency exchange differences and derivatives instruments, net (723) 315 (974) 191 (94)Financial expense in respect of contingent consideration and other long- term liabilities. (2,380) (3,550) (605) (1,705) (8,081)Financial expenses (384) (304) (192) (145) (660)Income before tax on income 12,366 6,928 5,753 4,489 13,334 Taxes on income (1,026) (137) 1,623 (63) 1,128 Net Income$11,340 $6,791 $7,376 $4,426 $14,462 Other Comprehensive Income (loss) : Amounts that will be or that have been reclassified to profit or loss when specific conditions are met Gain (loss) on cash flow hedges 563 (95) 677 (24) (30)Net amounts transferred to the statement of profit or loss for cash flow hedges (158) (57) (104) - (59)Items that will not be reclassified to profit or loss in subsequent periods: Remeasurement gain (loss) from defined benefit plan 10 8 2 1 89 Total comprehensive income (loss)$11,755 $6,647 $7,951 $4,403 $14,462 Earnings per share attributable to equity holders of the Company: Basic net earnings per share 0.20 $0.12 $0.13 $0.08 $0.25 Diluted net earnings per share 0.19 $0.12 $0.13 $0.08 $0.25 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS Six months period Ended Three months period Ended Year Ended June, 30 June, 30 December 31, 2025 2024 2025 2024 2024 Unaudited U.S Dollars In thousands Cash Flows from Operating Activities Net income$11,340 $6,791 $7,376 $4,426 $14,462 Adjustments to reconcile net income to net cash provided by (used in) operating activities: Adjustments to the profit or loss items: Depreciation and impairment 7,357 6,466 3,746 3,229 13,808 Financial expenses net 2,500 2,751 1,318 1,151 6,717 Cost of share-based payment 270 476 95 235 874 Taxes on income 1,026 137 (1,623) 63 (1,128)Loss (gain) from sale of property and equipment (8) (1) - (1) 11 Change in employee benefit liabilities, net 74 (11) 58 (7) 52 11,219 9,818 3,594 4,670 20,334 Changes in asset and liability items: Increase in trade receivables, net (8,670) (6,755) (2,113) (7,365) (1,977)Decrease in other accounts receivables 1,078 942 1,749 1,458 593 Decrease (increase) in inventories (3,260) 9,765 (3,721) 5,634 9,659 Decrease in contract asset 212 239 118 127 476 Increase (decrease) in trade payables (4,131) (5,092) (383) 3,693 1,226 Increase (decrease) in other accounts payables (883) (1,038) 1,161 1,013 1,413 Increase (decrease) in deferred revenues 6 (121) (28) 1 23 (15,648) (2,060) (3,217) 4,561 11,413 Cash received (paid) during the period for: Interest paid (384) (266) (208) (137) (594)Interest received 987 788 453 508 2,118 Taxes (paid) received (6) (88) 23 (65) (139) 597 434 268 306 1,385 Net cash provided by operating activities$7,508 $14,983 $8,021 $13,963 $47,594 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS (continued) Six months period Ended Three months period Ended Year Ended June, 30 June, 30 December 31, 2025 2024 2025 2024 2024 Unaudited Audited U.S Dollars In thousands Cash Flows from Investing Activities Purchase of property and equipment and intangible assets (3,482) (5,692) (2,014) (3,010) (10,740)Proceeds from sale of property and equipment 8 1 - 1 1 Net cash used in investing activities (3,474) (5,691) (2,014) (3,009) (10,739) Cash Flows from Financing Activities Proceeds from exercise of share base payments 49 2 3 1 7 Repayment of lease liabilities (418) (571) (404) (327) (1,251)Repayment of other long-term liabilities (4,509) (7,848) (4,184) (2,352) (12,667)Dividends Paid (11,534) - (11,534) - - Net cash used in financing activities (16,412) (8,417) (16,119) (2,678) (13,911) Exchange differences on balances of cash and cash equivalent (72) 31 (153) 77 (150) Increase (decrease) in cash and cash equivalents (12,450) 906 (10,265) 8,353 22,794 Cash and cash equivalents at the beginning of the period 78,435 55,641 76,250 48,194 55,641 Cash and cash equivalents at the end of the period$65,985 $56,547 $65,985 $56,547 $78,435 Significant non-cash transactions Right-of-use asset recognized with corresponding lease liability$509 $521 $157 $215 $3,304 Purchase of property and equipment and Intangible assets$1,030 $272 $1,030 $272 $1,955 NON-IFRS MEASURES Six months period ended Three months period ended Year ended June 30, June 30, December 31, 2025 2024 2025 2024 2024 In thousands Net income$11,340 $6,791 $7,376 $4,426 $14,462 Taxes on income 1,026 137 (1,623) 63 (1,128)Financial expense (income), net 2,500 2,751 1,318 1,151 6,717 Depreciation and amortization expense 7,357 6,466 3,746 3,229 13,218 Non-cash share-based compensation expenses 270 476 95 235 867 Adjusted EBITDA$22,493 $16,621 $10,912 $9,104 $34,136