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

Revenues for Third Quarter of 2024 were $41.7 Million, up 10% Year-over-Year; Nine Month 2024 Total Revenues were $121.9 Million, up 15% Year-over-YearThird Quarter 2024 Adjusted EBITDA of $8.8 Million, Representing an 11% Increase Year-over-Year; Nine Month 2024 Adjusted EBITDA of $25.4 Million, up 43% Year-over-YearRobust Third Quarter and Nine Month Results and Positive Outlook for Remainder of 2024 Support Increased Adjusted EBITDA Guidance to $32 Million-$35 Million, a 12% Increase of the Midpoint from the Previous Guidance, and Reiteration of Full-Year Revenue Guidance of $158 Million-$162 Million Company Generated $37.2 Million of Cash from Operations During First Nine Months of 2024; as of September 30, 2024, had $72.0 Million of Available CashExpanded Plasma Collection Operations with the Opening of a New Site in Houston, TXConference Call and Live Webcast Today at 8:30 AM ET REHOVOT, Israel, and HOBOKEN, N.J., Nov. 13, 2024 (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 three months and nine months ended September 30, 2024. “Our strong operational and financial momentum continued in the third quarter as we again generated solid results,” said Amir London, Kamada’s Chief Executive Officer. “While we benefit from the strength of our entire portfolio, we continue to improve the overall sales mix through increased sales of our two most profitable growth drivers KEDRAB® and CYTOGAM®. Total revenues for the first nine months of 2024 were $121.9 million, which represents year-over-year growth of 15%, and adjusted EBITDA was $25.4 million, up 43% year-over-year, representing a 21% margin of revenues. Based on our continued profitable growth and positive outlook for the remainder of 2024, we are increasing our annual adjusted EBITDA guidance to $32 million to $35 million, a 12% increase of the midpoint from our previous guidance and reiterating our full-year 2024 revenue guidance of between $158 million to $162 million.” “Importantly, we consistently demonstrate our ability to convert our reported adjusted EBITDA to operational cash flow, as we generated $37.2 million of cash from operating activities during the first nine months of the year. As of the end of the quarter, we had $72.0 million of available cash. We remain focused on identifying compelling new business development opportunities and leveraging our overall financial strength to further support our continued double-digit, longer-term growth,” added Mr. London. “We also continue to advance multiple additional existing long-term growth drivers. To this end, during the third quarter, we announced the expansion of our plasma collection operations with the opening of a new plasma collection center in Houston, TX. This new center is expected to support an estimated total collection capacity of approximately 50,000 liters annually. The center is expected to be one of the largest sites for specialty plasma collection in the U.S. and will also collect normal source plasma to be sold to third parties. Additionally, patient enrollment continues in the ongoing pivotal Phase 3 InnovAATe clinical trial for our inhaled Alpha-1 Antitrypsin therapy. The independent Data and Safety Monitoring Board (DSMB) recommended study continuation without modifications at its recently conducted semi-annual meeting. We remain engaged in active discussions with the U.S. FDA on our previously filed IND amendment consisting of a revised Statistical Analysis Plan (SAP) and study protocol, which, if approved, may allow for the acceleration of the program,” concluded Mr. London. Financial Highlights for the Three Months Ended September 30, 2024 Total revenues were $41.7million in the third quarter of 2024, a 10% increase from the prior year period. The increase in revenues was primarily attributable to increased sales of KEDRAB and CYTOGAM due to increased demand for these products in the U.S. market.Gross profit and gross margins were $17.2million and 41%, respectively, in the third quarter of 2024, compared to $14.8 million and 39%, respectively, reported in the prior year period.Operating expenses, including research and development (R&D), sales and marketing (S&M), general and administrative (G&A), and other expenses, totaled $11.9 million in the third quarter of 2024, as compared to $10.4 million in the third quarter of 2023. The higher operating expenses were primarily attributable to an increase in S&M costs associated with the marketing activities in the U.S., as well as increased R&D costs, primarily due to advancing the Inhaled AAT clinical trial.Net income was $3.9million, or $0.07 per share, in the third quarter of 2024, up 20% from a net income of $3.2 million, or $0.06 per diluted share, in the third quarter of 2023.Adjusted EBITDA, as detailed in the tables below, was $8.8 million in the third quarter of 2024, an 11% increase as compared to $7.9 million in the third quarter of 2023.Cash provided by operating activities was $22.2million in the third quarter of 2024, as compared to cash provided by operating activities of $0.9 million in the third quarter of 2023. Financial Highlights for the Nine Months Ended September 30, 2024 Total revenues for the first nine months of 2024 were $121.9 million, a 15% increase from the $106.1 million generated in the first nine months of 2023. The increase in revenues was primarily attributable to increased sales of KEDRAB and CYTOGAM due to increased demand for these products in the U.S. market.Gross profit and gross margins for the first nine months of 2024 were $52.9 million and 43%, respectively, compared to $41.1 million and 39%, respectively, in the first nine months of 2023.Operating expenses, including R&D, S&M, G&A, and other expenses, totaled $38.0 million in the first nine months of 2024, as compared to $33.8 million in the first nine months of 2023. The higher operating expenses were primarily attributable to an increase in S&M costs associated with the marketing activities in the U.S., as well as increased R&D costs, primarily due to advancing the Inhaled AAT clinical trial.Net profit for the first nine months of 2024 was $10.7 million, or $0.18 per diluted share, a 230% increase compared to net income of $3.2 million, or $0.06 per diluted share, in the prior year period.Adjusted EBITDA, as detailed in the tables below, was $25.4 million in the first nine months of 2024, a 43% increase as compared to $17.7 million in the first nine months of 2023.Cash provided by operating activities during the first nine months of 2024 was approximately $37.2 million, as compared to cash used in operating activities of $0.1 million during the first nine months of 2023. The change was correlated to the increase in profitability and changes in the Company’s working capital. Balance Sheet HighlightsAs of September 30, 2024, the Company had cash, cash equivalents, and short-term investments of $72.0 million, as compared to $55.6 million on December 31, 2023. Recent Corporate Highlights Announced the expansion of the Company’s plasma collection operations with the opening of a new plasma collection center in Houston, TX. The new 12,000 square foot center is operated by Kamada’s wholly owned subsidiary, Kamada Plasma, and is planned to support over 50 donor beds with an estimated total collection capacity of approximately 50,000 liters annually. The new center will collect normal source plasma and specialty plasma, such as Anti-Rabies and Anti-D, and is anticipated to be one of the largest sites for specialty plasma collection in the U.S. The new center also supports the Company’s strategy to become a leading global vertically integrated supplier of specialty plasma-derived products. Kamada expects to open its third plasma collection center in San Antonio, TX, during the first half of 2025, and expects each collection center to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its full capacity. Fiscal Year 2024 GuidanceKamada is increasing its adjusted EBITDA guidance from a range of $28 million to $32 million to a range of $32 million to $35 million, a 12% increase of the midpoint from the previous guidance, andcontinues to expect to generate fiscal year 2024 total revenues in the range of $158 million to $162 million, representing double digit top- and bottom-line growth year-over-year. Conference CallKamada management will host an investment community conference call on November 13, 2024, at 8:30am Eastern Time to present the Company’s results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-877-407-0792 (from within the U.S.) or 1-809-406-247 (from Israel) or 1-201-689-8263 (International) using conference ID 13749715. The call will also be webcast live on the Internet at https://viavid.webcasts.com/starthere.jsp?ei=1694075&tp_key=3a2494a103 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 2024 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 field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company’s strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company’s commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: KEDRAB®, CYTOGAM®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, the Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of Anti-Rabies and Anti-D hyper-immune plasma used in the manufacturing of the Company’s relevant products and recently opened a new plasma collection center in Houston, Texas in which it collects normal source plasma and specialty plasma. In addition to the Company’s commercial operation, it invests in research and development of new product candidates. The Company’s leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it 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) positive outlook for the remainder of 2024, supporting an increased annual adjusted EBITDA guidance to $32 Million-$35 Million and reiteration of Full-Year revenue guidance of $158 Million-$162 Million; 2) identifying compelling new business development opportunities leveraging the Company's overall financial strength and supporting continued double-digit growth longer-term; 3) continued patient enrollment in the ongoing pivotal Phase 3 InnovAATe clinical trial; 4) continued engagement in active discussions with the U.S. FDA on the previously filed IND amendment, which, if approved, may allow for the acceleration of the program; 5) the new site in Houston, TX supporting over 50 donor beds with an estimated total collection capacity of approximately 50,000 liters annually and be one of the largest sites for specialty plasma collection in the U.S. and will also collect normal source plasma to be sold to third parties; 6) the new site in Houston, TX support the Company’s strategy to become a leading global vertically-integrated supplier of specialty plasma-derived products; and 7) the Company's expectation to open its third plasma collection center in San Antonio, TX, during the first half of 2025, and that such center will contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its 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. 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, continuation of inbound and outbound international delivery routes, continued demand for Kamada’s products, financial conditions of the Company’s customer, suppliers and services providers, Kamada’s ability to integrate the new product portfolio into its current product portfolio, Kamada’s ability to grow the revenues of its new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived hyperimmune commercial products, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies, Kamada’s ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise, 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 CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION As ofSeptember 30, As ofDecember 31, 2024 2023 2023 Unaudited U.S Dollars In thousands Assets Current Assets Cash and cash equivalents $72,001 $52,603 $55,641 Trade receivables, net 16,295 25,107 19,877 Other accounts receivables 4,555 1,648 5,965 Inventories 71,558 73,795 88,479 Total Current Assets 164,409 153,153 169,962 Non-Current Assets Property, plant and equipment, net 33,746 27,362 28,224 Right-of-use assets 9,854 5,494 7,761 Intangible assets, Goodwill and other long-term assets 135,041 142,501 140,465 Contract assets 8,159 8,546 8,495 Total Non-Current Assets 186,800 183,903 184,945 Total Assets $351,209 $337,056 $354,907 Liabilities Current Liabilities Current maturities of lease liabilities 1,586 1,138 1,384 Current maturities of other long term liabilities 9,480 15,989 14,996 Trade payables 14,786 12,812 24,804 Other accounts payables 8,104 7,318 8,261 Deferred revenues 41 15 148 Total Current Liabilities 33,997 37,272 49,593 Non-Current Liabilities Lease liabilities 9,574 4,717 7,438 Contingent consideration 17,630 19,642 18,855 Other long-term liabilities 34,121 36,477 34,379 Employee benefit liabilities, net 618 558 621 Total Non-Current Liabilities 61,943 61,394 61,293 Shareholder’s Equity Ordinary shares 15,024 15,020 15,021 Additional paid in capital 266,588 265,700 265,848 Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)Capital reserve from hedges 16 (98) 140 Capital reserve from share-based payments 6,394 6,198 6,427 Capital reserve from employee benefits 283 318 275 Accumulated deficit (29,546) (45,258) (40,200)Total Shareholder’s Equity 255,269 238,390 244,021 Total Liabilities and Shareholder’s Equity $351,209 $337,056 $354,907 CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME Nine months period ended Three months period ended Year ended September 30, September 30, December 31, 2024 2023 2024 2023 2023 Unaudited Unaudited U.S Dollars In thousands except for share and per share data Revenues from proprietary products $110,032 $86,437 $37,128 $31,436 $115,458 Revenues from distribution 11,916 19,650 4,612 6,498 27,061 Total revenues 121,948 106,087 41,740 37,934 142,519 Cost of revenues from proprietary products 59,207 47,863 20,869 17,447 63,342 Cost of revenues from distribution 9,805 17,146 3,637 5,684 23,687 Total cost of revenues 69,012 65,009 24,506 23,131 87,029 Gross profit 52,936 41,078 17,234 14,803 55,490 Research and development expenses 12,512 10,694 3,414 3,180 13,933 Selling and marketing expenses 13,862 11,573 4,501 3,711 16,193 General and administrative expenses 11,578 10,603 4,014 3,701 14,381 Other expenses (income) 11 920 11 (157) 919 Operating income 14,973 7,288 5,294 4,368 10,064 Financial income 1,434 92 646 67 588 Income (expenses) in respect of currency exchange differences and derivatives instruments, net 255 726 (60) 553 55 Financial Income (expense) in respect of contingent consideration and other long- term liabilities. (5,316) (3,358) (1,766) (1,288) (980)Financial expenses (471) (1,343) (167) (404) (1,298)Income before tax on income 10,875 3,405 3,947 3,296 8,429 Taxes on income 221 179 84 73 145 Net income $10,654 $3,226 $3,863 $3,223 $8,284 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 (63) (334) 32 (90) (186)Net amounts transferred to the statement of profit or loss for cash flow hedges (61) 324 (4) 59 414 Items that will not be reclassified to profit or loss in subsequent periods: Remeasurement gain (loss) from defined benefit plan 8 (30) - (106) (73)Total comprehensive income (loss) $10,538 $3,186 $3,891 $3,086 $8,439 Earnings per share attributable to equity holders of the Company: Basic net earnings per share $0.19 $0.07 $0.07 $0.07 $0.17 Diluted net earnings per share $0.18 $0.06 $0.07 $0.06 $0.15 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS Nine months period Ended Three months period Ended Year Ended September, 30 September, 30 December 31, 2024 2023 2024 2023 2023 Unaudited Audited U.S Dollars In thousands Cash Flows from Operating Activities Net income $10,654 $3,226 $3,863 $3,223 $8,284 Adjustments to reconcile net income to net cash provided by (used in) operating activities: Adjustments to the profit or loss items: Depreciation 9,708 9,506 3,242 3,179 12,714 Financial expenses, net 4,098 3,883 1,347 1,072 1,635 Cost of share-based payment 700 941 224 312 1,314 Taxes on income 221 179 84 73 145 Loss (gain) from sale of property and equipment 11 (5) 12 - (5)Change in employee benefit liabilities, net 6 (144) 17 (104) (125) 14,744 14,360 4,926 4,532 15,678 Changes in asset and liability items: Decrease (increase) in trade receivables, net 3,249 2,078 10,004 (618) 7,835 Decrease (increase) in other accounts receivables 1,452 2,716 510 1,177 (1,150)Decrease (increase) in inventories 16,920 (5,011) 7,155 6,441 (19,694)Decrease (increase) in deferred expenses 336 2,763 97 (279) 2,814 Decrease in trade payables (10,747) (18,617) (5,655) (13,181) (8,885)Increase (decrease) in other accounts payables (157) (359) 881 49 765 Increase (decrease) in deferred revenues (107) (20) 14 (23) 113 10,946 (16,450) 13,006 (6,434) (18,202)Cash received (paid) during the period for: Interest paid (424) (1,149) (158) (405) (1,228)Interest received 1,434 92 646 67 - Taxes paid (158) (174) (70) (62) (217) 852 (1,231) 418 (400) (1,445) Net cash provided by (used in) operating activities $37,196 $(95) $22,213 $921 $4,315 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS Nine months period Ended Three months period Ended Year Ended September, 30 September, 30 December 31, 2024 2023 2024 2023 2023 Unaudited U.S Dollars In thousands Cash Flows from Investing Activities Purchase of property and equipment and intangible assets $(7,816) $(3,876) $(2,124) $(1,729) $(5,850)Proceeds from sale of property and equipment 1 6 - - 7 Net cash provided by (used in) investing activities (7,815) (3,870) (2,124) (1,729) (5,843) Cash Flows from Financing Activities Proceeds from exercise of share base payments 3 3 1 - 4 Repayment of lease liabilities (890) (768) (319) (251) (850)Repayment of long-term loans - (17,407) - (15,185) (17,407)Repayment of other long-term liabilities (12,316) (17,500) (4,468) (11,500) (17,300)Proceeds from issuance of ordinary shares, net - 58,231 - 58,231 58,231 Net cash provided by (used in) financing activities (13,203) 22,559 (4,786) 31,295 22,678 Exchange differences on balances of cash and cash equivalent 182 (249) 151 328 233 Increase (decrease) in cash and cash equivalents 16,360 18,345 15,454 30,815 21,383 Cash and cash equivalents at the beginning of the period 55,641 34,258 56,547 21,788 34,258 Cash and cash equivalents at the end of the period $72,001 $52,603 $72,001 $52,603 $55,641 Significant non-cash transactions Right-of-use asset recognized with corresponding lease liability $3,163 $3,880 $2,642 $295 $6,546 Purchase of property and equipment and Intangible assets $1,040 $681 $1,040 $681 $646 NON-IFRS MEASURES Nine months period ended Three months period ended Year ended September 30, September 30, December 31, 2024 2023 2024 2023 2023 U.S Dollars In thousands Net income $10,654 $3,226 $3,863 $3,223 $8,284 Taxes on income 221 179 84 73 145 Financial expense (income), net 4,098 3,883 1,347 1,072 1,635 Depreciation and amortization expense 9,708 9,506 3,242 3,179 12,714 Non-cash share-based compensation expenses 700 941 224 312 1,314 Adjusted EBITDA $25,381 $17,735 $8,760 $7,859 $24,092