6-K
Kamada Ltd (KMDA)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the Month of November 2024
Commission File Number 001-35948
Kamada Ltd.
(Translation of registrant’s name into English)
2 Holzman StreetScience Park, P.O. Box 4081Rehovot 7670402Israel(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
ThisForm 6-K is being incorporated by reference into the Registrant’s Form S-8 Registration Statements, File Nos. 333-192720, 333-207933,333-215983, 333-222891, 333-233267 and 333-265866.
The following exhibit is attached:
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: November 13, 2024 | KAMADA LTD. | |
|---|---|---|
| By: | /s/<br> Nir Livneh | |
| Nir Livneh<br><br> <br>Vice President General Counsel<br> and<br><br> Corporate Secretary |
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EXHIBIT
INDEX
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Exhibit 99.1
Kamada Reports Continued Profitable Growth withStrong Third Quarter and Nine Month 2024 Financial Results; Raises Full-Year Profitability Guidance
| ● | Revenues for Third Quarter of 2024 were $41.7Million, up 10% Year-over-Year; Nine Month 2024 Total Revenues were $121.9 Million, up 15% Year-over-Year |
|---|---|
| ● | Third Quarter 2024 Adjusted EBITDA of $8.8Million, Representing an 11% Increase Year-over-Year; Nine Month 2024 Adjusted EBITDA of $25.4 Million, up 43% Year-over-Year |
| --- | --- |
| ● | Robust Third Quarter and Nine Month Resultsand Positive Outlook for Remainder of 2024 Support Increased Adjusted EBITDA Guidance to $32 Million-$35 Million, a 12% Increase of theMidpoint from the Previous Guidance, and Reiteration of Full-Year Revenue Guidance of $158 Million-$162 Million |
| --- | --- |
| ● | Company Generated $37.2 Million of Cash fromOperations During First Nine Months of 2024; as of September 30, 2024, had $72.0 Million of Available Cash |
| --- | --- |
| ● | Expanded Plasma Collection Operations withthe Opening of a New Site in Houston, TX |
| --- | --- |
| ● | Conference Call and Live Webcast Today at8:30 AM ET |
| --- | --- |
REHOVOT, Israel, and HOBOKEN, NJ – November13, 2024 -- 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 EndedSeptember 30, 2024
| · | Total revenues were $41.7 million in the third<br>quarter of 2024, a 10% increase from the prior year period. The increase in revenues was primarily attributable to increased sales of<br>KEDRAB and CYTOGAM due to increased demand for these products in the U.S. market. |
|---|---|
| · | Gross profit and gross margins were $17.2 million<br>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<br>(R&D), sales and marketing (S&M), general and administrative (G&A), and other expenses, totaled $11.9 million in the third<br>quarter of 2024, as compared to $10.4 million in the third quarter of 2023. The higher operating expenses were primarily attributable<br>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<br>to advancing the Inhaled AAT clinical trial. |
| --- | --- |
| · | Net income was $3.9 million, or $0.07 per share,<br>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,<br>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 $22.2<br>million in the third quarter of 2024, as compared to cash provided by operating activities of $0.9 million in the third quarter of 2023. |
| --- | --- |
FinancialHighlights for the Nine Months Ended September 30, 2024
| · | Total revenues for the first nine months of 2024<br>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<br>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<br>nine months of 2024 were $52.9 million and 43%, respectively, compared to $41.1 million and 39%, respectively, in the first nine months<br>of 2023. |
| --- | --- |
| · | Operating expenses, including<br>R&D, S&M, G&A, and other expenses, totaled $38.0 million in<br>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<br>attributable to an increase in S&M costs associated with the marketing activities in the U.S., as well as increased R&D costs,<br>primarily due to advancing the Inhaled AAT clinical trial. |
| --- | --- |
| · | Net profit for the first nine months of 2024<br>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<br>the prior year period. |
| --- | --- |
| · | Adjusted EBITDA, as detailed in the tables below,<br>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<br>the first nine months of 2024 was approximately $37.2 million, as compared to cash used in operating activities of $0.1 million during<br>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 Highlights
As 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.
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Fiscal Year 2024 Guidance
Kamada 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, and continues 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 Call
Kamada 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 measures
We 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.
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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 Statements
This 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 Orlev
Chief Financial Officer
IR@kamada.com
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com
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CONDENSEDCONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of<br> September 30, | As of<br> December 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 |
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CONDENSEDCONSOLIDATED 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 |
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CONDENSEDCONSOLIDATED 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 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 |
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CONDENSEDCONSOLIDATED 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 |
8
NON-IFRSMEASURES
| 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 |
9
Exhibit 99.2
November 2024 Third Quarter & Nine Months Ended September 2024 Investors Call
FORWARD - LOOKING STATEMENT This presentation is not intended to provide investment or medical advice . It should be noted that some products under development described herein have not been found safe or effective by any regulatory agency and are not approved for any use outside of clinical trials . This presentation contains forward - looking statements, which express the current beliefs and expectations of Kamada ’ s management . Such statements include 2024 financial guidance ; growth strategy and plans for double digit growth ; progression of inhaled AAT clinical study, its benefits, potential market size and potential FDA's feedback ; growth prospects, Israeli distribution business segment and U . S . plasma segment ; success in identify and integrating M&A targets for growth . These statements involve a number of known and unknown risks and uncertainties that could cause Kamada's future results, performance or achievements to differ significantly from the projected results, performances or achievements expressed or implied by such forward - looking statements . Important factors that could cause or contribute to such differences include, but are not limited to, risks relating to Kamada's ability to successfully develop and commercialize its products and product candidates, progress and results of any clinical trials, introduction of competing products, continued market acceptance of Kamada ’ s commercial products portfolio, impact of geo - political environment in the middle east, impact of any changes in regulation and legislation that could affect the pharmaceutical industry, difficulty in predicting, obtaining or maintaining U . S . Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, restrains related to third parties ’ IP rights and changes in the health policies and structures of various countries, success of M&A strategies, environmental risks, changes in the worldwide pharmaceutical industry and other factors that are discussed under the heading “ Risk Factors ” of Kamada ’ s 2023 Annual Report on Form 20 - F (filed on March 6 , 2024 ), as well as in Kamada ’ s recent Forms 6 - K filed with the U . S . Securities and Exchange Commission . This presentation includes certain non - IFRS financial information, which is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with IFRS . The non - IFRS financial measures may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies . In accordance with the requirement of the SEC regulations a reconciliation of these non - IFRS financial measures to the comparable IFRS measures is included in an appendix to this presentation . Management uses these non - IFRS financial measures for financial and operational decision - making and as a means to evaluate period - to - period comparisons . Management believes that these non - IFRS financial measures provide meaningful supplemental information regarding Kamada ’ s performance and liquidity . Forward - looking statements speak only as of the date they are made, and Kamada undertakes no obligation to update any forward - looking statement to reflect the impact of circumstances or events that arise after the date the forward - looking statement was made, except as required by applicable law . 2
KEDRAB® CYTOGAM® HEPGAM B® VARIZIG® WINRHO® GLASSIA® KAMADA - A GLOBAL BIOPHARMACEUTICAL COMPANY 6 FDA - Approved Products 15 % CAGR (from 2021 ) $ 158 - 162 M 2024 Revenues Guidance $ 32 - 35M 1 2024 Adj. EBIDTA Guidance 4 Pillars of Growth A LEADER IN SPECIALTY PLASMA THERAPIES, WITH A PORTFOLIO OF MARKETED PRODUCTS INDICATED FOR DISEASES WITH LIMITED TREATMENT ALTERNATIVES $ 72.0 M Cash (Sep 30 , 2024 ) 3 Organic Growth M&A Transactions Inhaled AAT Pivotal Study Plasma Collection Centers 1 . Adjusted EBITDA guidance was increased from a previous $ 28 M - $ 32 M (a 12 % midpoint increase)
DELIVERING ON OUR COMMITMENTS 4
Q 3 – 24 CONTINUING THE GROWTH DOUBLE DIGIT REVENUE AND PROFITABLE INCREASE 5 For reconciliation of Adjusted EBITDA please refer to slide 16 GROSS MARGIN REVENUE 2% Q3/23 39% Q 3 / 24 41 % 10% Q3/23 $37.9 Q 3 / 24 $ 41.7 Adj. EBITDA EPS 11% Q3/23 $7.9 Q 3 / 24 $ 8.8 16% Q3/23 $0.06 Q3/24 $0.07
GROSS MARGIN REVENUE 4% 9M/23 39% 9 M/ 24 43 % 15 % 9M/23 $106.1 9 M/ 24 $ 121.9 Adj. EBITDA EPS 43% 9M/23 $17.7 9 M/ 24 $ 25.4 X3 9M/23 $0.06 9M/24 $0.18 9 M – 24 CONTINUING THE GROWTH DOUBLE DIGIT REVENUE AND PROFITABLE INCREASE 6 For reconciliation of Adjusted EBITDA please refer to slide 16
6 18 24 32 - 35 1 2021 2022 2023 2024 104 129 143 158 – 162 2021 2022 2023 2024 ADJUSTED EBITDA US$M 77% CAGR 2024 represents annual guidance 2024 represents annual guidance ANNUAL DOUBLE - DIGIT GROWTH TRAJECTORY REVENUES US$M 15% CAGR 9 M $ 122 M ( 76 %) 7 9 M $ 25 M ( 76 %) 1. Adjusted EBITDA guidance was increased from a previous $28M - $32M (a 12% midpoint increase) Generated $37.2M of operating cash flow during the first nine months of 2024
KAMADA ’ S ROADMAP FOR ANNUAL DOUBLE - DIGIT GROWTH 8 Organic Growth Portfolio of 6 FDA - approved products; Over 30 territories M&A Transactions Support growth through M&A transactions Plasma Collection Centers Each new collection center contributes annual revenues of $ 8 M - $ 10 M Inhaled AAT Phase III pivotal clinical study, targeting a market of over $ 2 B
9 6 FDA - APPROVED SPECIALTY PLASMA PRODUCTS KEDRAB® [Rabies Immune Globulin (Human)] Post exposure prophylaxis of rabies infection CYTOGAM® [Cytomegalovirus Immune Globulin (Human)] Prophylaxis of CMV disease associated with transplants HEPGAM B® [Hepatitis B Immune Globulin (Human)] Prevention of HBV recurrence following liver transplants VARIZIG® [Varicella Zoster Immune Globulin (Human)] Post - exposure prophylaxis of varicella in high - risk patients WINRHO® [Rho(D) Immune Globulin (Human)] Treatment of ITP & suppression of Rh isoimmunization (HDN) KEY FOCUS ON TRANSPLANTS & RARE CONDITIONS For Important Safety Information, visit www.Kamada.com GLASSIA® [Alpha 1 - Proteinase Inhibitor (Human)] Augmentation therapy for Alpha - 1 Antitrypsin Deficiency (AATD)
DISTRIBUTION SEGMENT GROWTH More than 25 products exclusively licensed from leading international pharmaceutical companies, marketed in the Israeli market EXCLUSIVE DISTRIBUTOR IN ISRAEL FOR LEADING BIOPHARMACEUTICAL COMPANIES Key areas : plasma - derived, respiratory, rare diseases, infectious diseases, biosimilar portfolio of 11 product candidates, mainly from Alvotech First biosimilar was launched in Q 1 / 2024 and second product expected to be launched by end of 2024 The other Biosimilar products are expected to be launched through 2028 , upon receipt of regulatory approval Biosimilar portfolio represents the main growth driver with estimated peak annual sales of $30 - 34M 10
11 M&A TRANSACTIONS SEEKING THE NEXT BREAKTHROUGH Exploring strategic business development opportunities to identify potential acquisition or in - licensing Focusing on products synergistic to our existing commercial and/or production activities Strong financial position and proven successful M&A capabilities
12 KAMADA PLASMA EXPANDING VERTICAL INTEGRATION & REVENUE GROWTH Collecting hyper - immune plasma for our specialty IgG products and normal source plasma (NSP) to support revenue growth Recently opened a new plasma collection center in Houston, Texas ; planning to open another center in San Antonio, Texas (H 1 - 25 ) Average annual revenues of a mature collection center ranges from $ 8 M to $ 10 M
INHALED AAT PHASE 3 PIVOTAL STUDY Non - Invasive, at - home treatment. Expected better ease of use and quality of life for AATD patients than current IV SOC Most effective mode of treatment for delivering therapeutic amounts of AAT directly into the airways Studied in more than 200 individuals to date, with an established safety profile Only 1 / 8 th of the IV AAT dosing, more cost - effective; favorable market access landscape STUDY D ESIGN EXPECTED ADVANTAGES Ɗ čŃč randomization; 9 active sites; ~ 45 % of patients enrolled to date; Open Label Extension (OLE) initiated Mid 2024 Inhaled AAT ĔČ mg Ɗ once Ɗ daily o r Ɗ placebo, Ɗ during Ɗ two Ɗ years of Ɗ treatment Primary Ɗ Endpoint: Lung Ɗ function - FEV č Secondary Ɗ Endpoints Ń Lung Ɗ density - CT Ɗ densitometry Ɗ and Ɗ other Ɗ disease Ɗ severity Ɗ parameters 13 POTENTIAL TRANSFORMATIVE TREATMENT IN AATD - RELATED LUNG DISEASE
$ 2 Billion A substantial market opportunity ( 2028 ) In discussion with the FDA on an IND amendment with revised statistical analysis plan and study protocol FDA recently reconfirmed overall study design, endorsed positive safety data to date, and expressed willingness to potentially accept a P< 0.1 alpha level in evaluating the trial ’ s efficacy primary endpoint INHALED AAT PHASE 3 PIVOTAL STUDY InnovAATe – a global, double - blind, randomized, placebo - controlled pivotal Phase 3 clinical trial testing the safety and efficacy of inhaled AAT in patients with AATD. Study design meets FDA and EMA ’ s requirements Source: CantorFizgerald, JAN 11 2024 14
15 DETAILS FY 2023 Q3/23 Q3/24 9M/23 9M/24 US $ M Driven by two key growth drivers, KEDRAB® & CYTOGAM® 115.5 31.4 37.1 86.4 110.0 PROPRIETARY 27.1 6.5 4.6 19.7 11.9 DISTRIBUTION 15% YoY increase; 9M revenues - 76% of mid - point annual guidance 142.5 37.9 41.7 106.1 121.9 TOTAL REVENUES 55.5 14.8 17.2 41.1 52.9 GROSS PROFIT 4 basis point increase YoY 39 % 39 % 41 % 39 % 43 % GROSS MARGIN ( 45.4 ) ( 10.4 ) ( 11.9 ) ( 33.8 ) ( 38.0 ) OPEX 8.3 3.2 3.9 3.2 10.7 NET PROFIT 43% YoY increase; 21% of revenues & 76% of mid - point annual guidance 24.1 7.9 8.8 17.7 25.4 Adjusted EBITDA Generated $37.2M of operating cash flow during 9M/24 55.6 52.6 72.0 CASH Including acquisition related intangible assets ($131M @ September 24) 354.9 337.1 351.2 TOTAL ASSETS 5 - year term loan paid down in full during Q3 - 23 0.0 0.0 0.0 BANK LOAN Increase associated with new plasma collection centers in the U.S. 8.8 5.9 11.2 LEASE LIABILITIES Acquisition related contingent consideration 68.2 72.1 61.2 CONTINGENT LIABILITIES 244.0 238.4 255.3 EQUITY Contingent and lease liabilities net of available cash ( 21.4 ) ( 25.4 ) ( 0.4 ) NET DEBT Adjusted EBITDA is defined as net income, plus ( i ) tax expense, (ii) financial income (expense), net, (iii) depreciation and amortization ; and (v) non - cash share - based compensation expenses STRONG 9 M 2024 FINANCIAL RESULTS
16 NON - IFRS MEASURES – ADJUSTED EBITDA FY 2023 Q 3 / 23 Q 3 / 24 9 M/ 23 9 M/ 24 US $ M 8.3 3.2 3.9 3.2 10.7 NET PROFIT 0.1 0.1 0.1 0.2 0.2 TAXES ON INCOME 1.0 1.3 1.8 3.4 5.3 REVALUATION OF ACQUISITION RELATED CONTINGENT CONSIDERATION 0.7 ( 0.2 ) ( 0.4 ) 0.5 ( 1.2 ) OTHER FINANCIAL EXPENSE, NET 7.1 1.8 1.8 5.3 5.3 AMORTIZATION OF ACQUISITION RELATED INTANGIBLE ASSETS 5.7 1.4 1.5 4.2 4.4 OTHER DEPRECIATION AND AMORTIZATION EXPENSES 1.3 0.3 0.2 0.9 0.7 NON - CASH SHARE - BASED COMPENSATION EXPENSES 24.1 7.9 8.8 17.7 25.4 ADJUSTED EBITDA Adjusted EBITDA is defined as net income, plus ( i ) tax expense, (ii) financial income (expense), net, (iii) depreciation and amortization ; and (v) non - cash share - based compensation expenses
KEDRAB® CYTOGAM® HEPGAM B® VARIZIG® WINRHO® GLASSIA® KAMADA - SIGNIFICANT UPSIDE POTENTIAL 6 FDA - Approved Products 15 % CAGR (from 2021 ) $ 158 - 162 M 2024 Revenues Guidance $ 32 - 35M 1 2024 Adj. EBIDTA Guidance 4 Pillars of Growth DELIVERING ON OUR COMMITMENTS $ 72.0 M Cash (Sep 30, 2024) 17 Organic Growth M&A Transactions Inhaled AAT Pivotal Study Plasma Collection Centers 1 . Adjusted EBITDA guidance was increased from a previous $ 28 M - $ 32 M (a 12 % midpoint increase)
THANK YOU www.kamada.com
Exhibit 99.3
KAMADA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIALSTATEMENTS (Unaudited)
AS OF September 30, 2024
TABLE OF CONTENTS
| Page | |
|---|---|
| Condensed Consolidated Statements of Financial Position | 1 |
| Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income | 2 |
| Condensed Consolidated interim Statements of Changes in Equity | 3-7 |
| Condensed Consolidated interim Statements of Cash Flows | 8-9 |
| Notes to the Condensed Consolidated Financial Statements | 10-16 |
i
KAMADA LTD.
CONDENSEDCONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of<br> September 30, | As of<br> December 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 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
1
KAMADA LTD.
CONDENSEDCONSOLIDATED 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 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
2
KAMADA LTD.
CONDENSEDCONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
| Share | Additional <br> paid in | Capital reserve <br> due to<br> translation to<br> presentation | Capital <br> reserve <br> from | Capital reserve <br> from <br> sharebased | Capital <br> reserve <br> from employee | Accumulated | Total | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| capital | capital | currency | hedges | payments | benefits | deficit | equity | ||||||||||||||
| Unaudited | |||||||||||||||||||||
| U.S Dollars In thousands | |||||||||||||||||||||
| Balance as of January 1, 2024 | $ | 15,021 | $ | 265,848 | $ | (3,490 | ) | $ | 140 | $ | 6,427 | $ | 275 | $ | (40,200 | ) | $ | 244,021 | |||
| Net income | - | - | - | - | - | - | 10,654 | 10,654 | |||||||||||||
| Other comprehensive income (loss) | - | - | - | (124 | ) | - | 8 | - | (116 | ) | |||||||||||
| Total comprehensive income (loss) | - | - | - | (124 | ) | - | 8 | 10,654 | 10,538 | ||||||||||||
| Exercise and forfeiture of share-based payment into shares | 3 | 740 | - | - | (740 | ) | - | 3 | |||||||||||||
| Cost of share-based payment | 707 | 707 | |||||||||||||||||||
| Balance as of September 30, 2024 | $ | 15,024 | 266,588 | (3,490 | ) | 16 | 6,394 | 283 | (29,546 | ) | 255,269 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
3
KAMADA LTD.
CONDENSED CONSOLIDATED INTERIMSTATEMENTS OF CHANGES IN EQUITY
| Share | Additional <br> paid in | Capital reserve <br> due to<br> translation to<br> presentation | Capital <br> reserve <br> from | Capital reserve <br> from <br> sharebased | Capital <br> reserve <br> from employee | Accumulated | Total | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| capital | capital | currency | hedges | payments | benefits | deficit | equity | |||||||||||||||
| Unaudited | ||||||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||||
| Balance as of January 1, 2023 | $ | 11,734 | $ | 210,495 | $ | (3,490 | ) | $ | (88 | ) | $ | 5,505 | $ | 348 | $ | (48,484 | ) | $ | 176,020 | |||
| Net income | - | - | - | - | - | - | 3,226 | 3,226 | ||||||||||||||
| Other comprehensive income (loss) | - | - | - | (10 | ) | - | (30 | ) | - | (40 | ) | |||||||||||
| Total comprehensive income (loss) | - | - | - | (10 | ) | - | (30 | ) | 3,226 | 3,186 | ||||||||||||
| Issuance of ordinary shares, net of issuance cost net | 3,283 | 54,948 | - | - | - | - | - | 58,231 | ||||||||||||||
| Exercise and forfeiture of share-based payment into shares | 3 | 257 | - | - | (257 | ) | - | - | 3 | |||||||||||||
| Cost of share-based payment | - | - | - | - | 950 | - | - | 950 | ||||||||||||||
| Balance as of September 30, 2023 | $ | 15,020 | $ | 265,700 | $ | (3,490 | ) | $ | (98 | ) | $ | 6,198 | $ | 318 | $ | (45,258 | ) | $ | 238,390 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
4
KAMADA LTD.
CONDENSED CONSOLIDATED INTERIMSTATEMENTS OF CHANGES IN EQUITY
| Share | Additional <br> paid in | Capital reserve <br> due to<br> translation to<br> presentation | Capital <br> reserve <br> from | Capital reserve <br> from <br> sharebased | Capital <br> reserve <br> from employee | Accumulated | Total | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| capital | capital | currency | hedges | payments | benefits | deficit | equity | |||||||||||||
| Unaudited | ||||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||
| Balance as of July 1, 2024 | $ | 15,023 | $ | 266,313 | $ | (3,490 | ) | $ | (12 | ) | $ | 6,444 | $ | 283 | $ | (33,409 | ) | $ | 251,152 | |
| Net income | - | - | - | - | - | - | 3,863 | 3,863 | ||||||||||||
| Other comprehensive income (loss) | - | - | - | 28 | - | - | - | 28 | ||||||||||||
| Total comprehensive income (loss) | - | - | - | 28 | - | - | 3,863 | 3,891 | ||||||||||||
| Exercise and forfeiture of share-based payment into shares | 1 | 275 | - | - | (275 | ) | 1 | |||||||||||||
| Cost of share-based payment | - | - | 225 | - | - | 225 | ||||||||||||||
| Balance as of September 30, 2024 | $ | 15,024 | $ | 266,588 | $ | (3,490 | ) | $ | 16 | $ | 6,394 | $ | 283 | $ | (29,546 | ) | $ | 255,269 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
5
KAMADA LTD.
CONDENSED CONSOLIDATED INTERIMSTATEMENTS OF CHANGES IN EQUITY
| Share | Additional <br> paid in | Capital reserve <br> due to<br> translation to<br> presentation | Capital <br> reserve <br> from | Capital reserve <br> from <br> sharebased | Capital <br> reserve <br> from employee | Accumulated | Total | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| capital | capital | currency | hedges | payments | benefits | deficit | equity | |||||||||||||||
| Unaudited | ||||||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||||
| Balance as of July 1, 2023 | $ | 11,737 | $ | 210,727 | $ | (3,490 | ) | $ | (67 | ) | $ | 5,902 | $ | 424 | $ | (48,481 | ) | $ | 176,752 | |||
| Net income | - | - | - | - | - | - | 3,223 | 3,223 | ||||||||||||||
| Other comprehensive income (loss) | - | - | - | (31 | ) | - | (106 | ) | - | (137 | ) | |||||||||||
| Total comprehensive income (loss) | - | - | - | (31 | ) | - | (106 | ) | 3,223 | 3,086 | ||||||||||||
| Issuance of ordinary shares, net of issuance cost net | 3,283 | 54,948 | - | - | - | - | - | 58,231 | ||||||||||||||
| Exercise and forfeiture of share-based payment into shares | 0.31 | 25 | - | - | (25 | ) | - | - | 0.31 | |||||||||||||
| Cost of share-based payment | - | - | - | - | 321 | - | - | 321 | ||||||||||||||
| Balance as of September 30, 2023 | $ | 15,020 | $ | 265,700 | $ | (3,490 | ) | $ | (98 | ) | $ | 6,198 | $ | 318 | $ | (45,258 | ) | $ | 238,390 |
6
KAMADA LTD.
CONDENSED CONSOLIDATED INTERIMSTATEMENTS OF CHANGES IN EQUITY
| Share<br> capital | Additional<br> paid in<br> capital | Capitalreserve due to translation to presentation currency | Capital<br> reserve<br> from<br> hedges | Capital<br> reserve<br> from<br> sharebased payments | Capital<br> reserve<br> from<br> employee<br> benefits | Accumulated<br> deficit | Total<br> equity | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S Dollars In thousands | |||||||||||||||||||||
| Balance as of January 1, 2023 | $ | 11,734 | $ | 210,495 | $ | (3,490 | ) | $ | (88 | ) | $ | 5,505 | $ | 348 | $ | (48,484 | ) | $ | 176,020 | ||
| Net income | - | - | - | - | - | - | 8,284 | 8,284 | |||||||||||||
| Other comprehensive income (loss) | - | - | - | 228 | - | (73 | ) | - | 155 | ||||||||||||
| Total comprehensive income (loss) | - | - | 228 | - | (73 | ) | 8,284 | 8,439 | |||||||||||||
| Exercise and forfeiture of share-based payment into shares | 4 | 405 | - | - | (405 | ) | - | - | 4 | ||||||||||||
| Issuance of ordinary shares, net of issuance cost net | 3,283 | 54,948 | - | - | - | - | - | 58,231 | |||||||||||||
| Cost of share-based payment | - | - | - | - | 1,327 | - | - | 1,327 | |||||||||||||
| Balance as of December 31, 2023 | $ | 15,021 | $ | 265,848 | $ | (3,490 | ) | $ | 140 | $ | 6,427 | $ | 275 | $ | (40,200 | ) | $ | 244,021 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
7
KAMADA LTD.
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 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<br> 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 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
8
KAMADA LTD.
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 |
The accompanying Notes are an integral part of the unaudited Consolidated Financial Statements.
9
KAMADA LTD.
NOTES TOTHE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1:- General
General description of the Company and its activity
Kamada Ltd. (the “Company”) is 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 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®, VARIZIG®, WINRHO SDF®, 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 and in addition have eleven biosimilar products in its Israeli distribution portfolio, which, subject to European Medicines Agency (EMA) and Israeli Ministry of Health (“IL MOH”) 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.
In November 2021, the Company acquired CYTOGAM, WINRHO SDF, VARIZIG and HEPGAM B from Saol Therapeutics Ltd. (“Saol”). The acquisition of this portfolio furthered the Company’s core objective to become a fully integrated specialty plasma company with strong commercial capabilities in the U.S. market, as well as to expand to new markets, mainly in the Middle East/North Africa region, and to broaden the Company’s portfolio offering in existing markets. The Company’s wholly owned U.S. subsidiary, Kamada Inc., is responsible for the commercialization of the four products in the U.S. market, including direct sales to wholesalers and local distributers. Refer to Note 5 in our annual Financial report for further details on this acquisition.
The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited (“Takeda”). Historically, the Company generated revenues on sales of GLASSIA, manufactured by the Company, to Takeda for further distribution in the United States. In accordance with the agreement with Takeda, the Company ceased the production and sale of GLASSIA to Takeda during 2021, and during the first quarter of 2022, Takeda began to pay the Company royalties on sales of GLASSIA manufactured by Takeda, at a rate of 12% on net sales through August 2025 and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually for each of the years from 2022 to 2040. Refer to Note 18 in our annual Financial report for further details on the engagement with Takeda.
The Company’s ordinary shares are listed for trading on the Tel Aviv Stock Exchange and the NASDAQ Global Select Market.
FIMI Opportunity Funds (“FIMI”), the leading private equity firm in Israel beneficially owns approximately 38% of the Company’s outstanding ordinary shares and is a controlling shareholder of the Company; within the meaning of the Israeli Companies Law, 1999. Refer to Note 20 for further details and Item 7 within the Company annual reports on Form 20-F.
10
KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 2:- Significant Accounting Policies
| a. | Basis of preparation of the interim consolidated financial statements: |
|---|
The unaudited interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, “Interim Financial Reporting”.
These financial statements have been prepared in a condensed format as of September 30, 2024, and for the three and nine months then ended. The accounting policies applied in the preparation of the interim consolidated financial statements are consistent with those followed in the preparation of the annual consolidated financial statements, unless disclosed otherwise. Therefore, these unaudited interim financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2023, and for the year then ended and accompanying notes (“annual consolidated financial statements”).
In management’s opinion, the unaudited interim consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect all adjustments, which include only normal recurring adjustments necessary for the fair presentation. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the full year ending December 31, 2024 or any other future interim or annual period
| b. | Implementation of new accounting standards: |
|---|---|
| Amendment to IAS 1, Presentation of Financial Statements: Classification of Liabilities as Current or Non-Current and subsequent amendment: Non-Current Liabilities with Covenants | |
| --- |
The Amendment, together with the subsequent amendment to IAS 1 (see hereunder) replaces certain requirements for classifying liabilities as current or non-current. According to the Amendment, a liability will be classified as non-current when the entity has the right to defer settlement for at least 12 months after the reporting period, and it “has substance” and is in existence at the end of the reporting period. According to the subsequent amendment, as published in October 2022, covenants with which the entity must comply after the reporting date do not affect classification of the liability as current or non-current. Additionally, the subsequent amendment adds disclosure requirements for liabilities subject to covenants within 12 months after the reporting date, such as disclosure regarding the nature of the covenants, the date they need to be complied with and facts and circumstances that indicate the entity may have difficulty complying with the covenants. Furthermore, the Amendment clarifies that the conversion option of a liability will affect its classification as current or non-current, other than when the conversion option is recognized as equity.
The Amendment and subsequent amendment are effective for reporting periods beginning on or after January 1, 2024 with earlier application being permitted. The Amendment and subsequent amendment are applicable retrospectively, including an amendment to comparative data.
As of June 30, 2024, the Company does not have impact on its financial statement.
| IFRS 18, Presentation and Disclosure in Financial Statements |
|---|
This standard replaces IAS 1, Presentation of Financial Statements. The purpose of the standard is to provide improved structure and content to the financial statements, particularly the income statement.
The standard includes new disclosure and presentation requirements that were taken from IAS 1, Presentation of Financial Statements, with small changes.
As part of the new disclosure requirements, companies will be required to present two subtotals in the income statement: operating profit and profit before financing and taxes. Furthermore, for most companies, the results in the income statements will be classified into three categories: operating profit, profit from investments and profit from financing.
Furthermore, the standard adds specific guidance for aggregation and disaggregation of items in the financial statements and in the notes. The standard will encourage companies to avoid classifying items as ‘other’ (for example, other expenses), and using this classification will lead to additional disclosure requirements.
The standard is effective from annual reporting periods beginning on or after January 1, 2027 with earlier application being permitted.
The Company is examining the effects of the standard on its financial statements with no plans for early adoption.
11
KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 3:- Significant events in the reporting period
On February 29, 2024, the Company’s Board of Directors approved the grant of options to purchase up to 27,468 options to purchase ordinary shares of the Company under the 2011 Plan and the US Appendix.
The Company granted, out of the above mentioned, to employees and executive officers the following:
Under the Israeli Share Option Plan:
| - | 20,800 options to purchase the ordinary shares of the Company, at an exercise price of NIS 23.91 (USD 6.67) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $48 thousands. |
|---|
Under the US Appendix:
| - | 6,668 options to purchase the ordinary shares of the Company, at an exercise price of USD 6.62 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated on the date of grant at $18 thousands. |
|---|
On July 21, 2024, the Company’s Board of Directors approved the grant of options to purchase up to 15,081 options to purchase ordinary shares of the Company, under the 2011 Plan and the US Appendix.
Under the Israeli Share Option Plan:
| - | 9,049 options to purchase the ordinary shares of the Company, at an exercise price of NIS 22.01 (USD 6.06) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $36 thousands. |
|---|
Under the US Appendix:
| - | 6,032 options to purchase the ordinary shares of the Company, at an exercise price of USD 6.07 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated on the date of grant at $21 thousands. |
|---|
The Company uses the binomial model when estimating the grant date fair value of equity-settled share options. The measurement was made at the grant date of equity-settled share options since the options were granted to employees and Board of Directors members.
The following table lists the inputs to the binomial model used for the fair value measurement of equity-settled share options for the above plan.
Under the Israeli Share Option Plan:
| Dividend yield (%) | ||
|---|---|---|
| Expected volatility of the share prices (%) | 33%-129 | % |
| Risk-free interest rate (%) | 3.74%-4.87 | % |
| Contractual term of up to (years) | 6.5 | |
| Exercise multiple | 1 | |
| Weighted average share prices (NIS) | 20.82-22.77 | |
| Expected average forfeiture rate (%) | 5.5%-8.50 | % |
Under the US Appendix:
| Dividend yield (%) | ||
|---|---|---|
| Expected volatility of the share prices (%) | 42%-97 | % |
| Risk-free interest rate (%) | 3.04%-6.11 | % |
| Contractual term of up to (years) | 6.5 | |
| Exercise multiple | 1 | |
| Weighted average share prices () | 5.88-6.3 | |
| Expected average forfeiture rate (%) | 5.5%-8.50 | % |
All values are in US Dollars.
12
KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 4:- Operating Segments
| a. | General: |
|---|
The company has two operating segments, as follows:
| Proprietary Products | - | Development, manufacturing, sales and distribution of proprietary plasma-derived protein therapeutics. |
|---|---|---|
| Distribution | - | Distribute imported drug products in Israel, which are manufactured by third parties. |
| b. | Reporting on operating segments: | ||||||
|---|---|---|---|---|---|---|---|
| Proprietary<br> Products | Distribution | Total | |||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Nine months period ended September 30, 2024 | |||||||
| Revenues | $ | 110,032 | $ | 11,916 | $ | 121,948 | |
| Gross profit | $ | 50,825 | $ | 2,111 | $ | 52,936 | |
| Unallocated corporate expenses | (37,963 | ) | |||||
| Finance expenses, net | (4,098 | ) | |||||
| Income before taxes on income | $ | 10,875 | |||||
| Proprietary<br> Products | Distribution | Total | |||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Nine months period ended September 30, 2023 | |||||||
| Revenues | $ | 86,437 | $ | 19,650 | $ | 106,087 | |
| Gross profit | $ | 38,574 | $ | 2,504 | $ | 41,078 | |
| Unallocated corporate expenses | (33,790 | ) | |||||
| Finance expenses, net | (3,883 | ) | |||||
| Income before taxes on income | $ | 3,405 | |||||
| Proprietary<br> Products | Distribution | Total | |||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Three months period ended September 30, 2024 | |||||||
| Revenues | $ | 37,128 | $ | 4,612 | $ | 41,740 | |
| Gross profit | $ | 16,259 | $ | 975 | $ | 17,234 | |
| Unallocated corporate expenses | (11,940 | ) | |||||
| Finance expenses, net | (1,347 | ) | |||||
| Income before taxes on income | $ | 3,947 | |||||
| Proprietary<br> Products | Distribution | Total | |||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Three months period ended September 30, 2023 | |||||||
| Revenues | $ | 31,436 | $ | 6,498 | $ | 37,934 | |
| Gross profit | $ | 13,989 | $ | 814 | $ | 14,803 | |
| Unallocated corporate expenses | (10,435 | ) | |||||
| Finance expenses, net | (1,072 | ) | |||||
| Income before taxes on income | $ | 3,296 |
13
KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 4:- Operating Segments (cont.)
| b. | Reporting on operating segments: | ||||||
|---|---|---|---|---|---|---|---|
| Proprietary<br> Products | Distribution | Total | |||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| U.S Dollars in thousands | |||||||
| Year Ended December 31, 2023 | |||||||
| Revenues | $ | 115,458 | $ | 27,061 | $ | 142,519 | |
| Gross profit | $ | 52,116 | $ | 3,374 | $ | 55,490 | |
| Unallocated corporate expenses | (45,426 | ) | |||||
| Finance expenses, net | (1,635 | ) | |||||
| Income before taxes on income | $ | 8,429 |
| c. | Reporting on operating segments by geographic region: |
|---|
| Nine months period ended <br> September 30, 2024 | ||||||
|---|---|---|---|---|---|---|
| Proprietary<br> Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A | $ | 84,779 | $ | - | $ | 84,779 |
| Israel | 4,701 | 11,916 | 16,617 | |||
| Canada | 7,873 | - | 7,873 | |||
| Europe | 3,220 | - | 3,220 | |||
| Latin America | 7,588 | - | 7,588 | |||
| Asia | 1,837 | - | 1,837 | |||
| Others | 34 | - | 34 | |||
| $ | 110,032 | $ | 11,916 | $ | 121,948 | |
| c. | Reporting on operating segments by geographic region: | |||||
| --- | --- | |||||
| Nine months period ended <br> September 30, 2023 | ||||||
| --- | --- | --- | --- | --- | --- | --- |
| Proprietary<br> Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A | $ | 55,220 | $ | - | $ | 55,220 |
| Israel | 3,119 | 19,650 | 22,769 | |||
| Canada | 6,930 | 6,930 | ||||
| Europe | 6,724 | - | 6,724 | |||
| Latin America | 10,365 | - | 10,365 | |||
| Asia | 3,958 | - | 3,958 | |||
| Others | 121 | - | 121 | |||
| $ | 86,437 | $ | 19,650 | $ | 106,087 |
14
KAMADA
LTD.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note4:- Operating Segments (cont.)
| Three<br> months period ended <br> September 30, 2024 | ||||||
|---|---|---|---|---|---|---|
| Proprietary<br><br> Products | Distribution | Total | ||||
| U.S<br> Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A | $ | 29,610 | $ | - | $ | 29,610 |
| Israel | 1,144 | 4,612 | 5,756 | |||
| Canada | 2,108 | 2,108 | ||||
| Europe | 1,542 | - | 1,542 | |||
| Latin America | 2,353 | - | 2,690 | |||
| Asia | 337 | - | 337 | |||
| Others | 34 | - | 34 | |||
| $ | 37,128 | $ | 4,612 | $ | 41,740 | |
| Three<br> months period ended <br> September 30, 2023 | ||||||
| --- | --- | --- | --- | --- | --- | --- |
| Proprietary<br><br> Products | Distribution | Total | ||||
| U.S<br> Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A | $ | 23,932 | $ | - | $ | 23,932 |
| Israel | 1,017 | 6,498 | 7,515 | |||
| Canada | 1,362 | - | 1,362 | |||
| Europe | 3,280 | - | 3,280 | |||
| Latin America | 328 | - | 328 | |||
| Asia | 1,479 | - | 1,479 | |||
| Others | 38 | - | 38 | |||
| $ | 31,436 | $ | 6,498 | $ | 37,934 | |
| Year<br> ended December 31, 2023 | ||||||
| --- | --- | --- | --- | --- | --- | --- |
| Proprietary<br><br> Products | Distribution | Total | ||||
| U.S<br> Dollars in thousands | ||||||
| Geographical markets | ||||||
| U.S.A | $ | 73,741 | $ | - | $ | 73,741 |
| Israel | 4,235 | 27,061 | 31,296 | |||
| Canada | 11,162 | 11,162 | ||||
| Europe | 7,088 | - | 7,088 | |||
| Latin America | 12,928 | - | 12,928 | |||
| Asia | 6,147 | - | 6,147 | |||
| Others | 157 | - | 157 | |||
| $ | 115,458 | $ | 27,061 | $ | 142,519 |
15
KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 5:- Financial Instruments
| a. | Classification of financial instruments by fair value hierarchy |
|---|
Financial assets (liabilities) measured at fair value
| Level 1 | Level 2 | Level 3 | |||||
|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||
| September 30, 2024 | |||||||
| Derivatives instruments | $ | - | $ | - | |||
| Contingent consideration | - | (20,472 | ) | ||||
| September 30, 2023 | |||||||
| Derivatives instruments | ) | ||||||
| Contingent consideration | $ | - | $ | (22,326 | ) | ||
| December 31, 2023 | |||||||
| Derivatives instruments | $ | - | $ | - | |||
| Contingent consideration | $ | - | $ | (21,855 | ) |
All values are in US Dollars.
During the Nine months ended on September 30, 2024 there were no transfers due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument.
Changes in Contingent consideration liability:
| January 1,<br> 2024 | Payments | Revaluation | September 30,<br> 2024 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| U.S. Dollars in thousands | |||||||||
| Contingent consideration | 21,855 | (3,000 | ) | 1,617 | 20,472 | ||||
| Total | $ | 21,855 | $ | (3,000 | ) | $ | 1,617 | $ | 20,472 |
| January 1,<br> 2023 | Payments | Revaluation | September 30,<br> 2023 | ||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| U.S. Dollars in thousands | |||||||||
| Contingent consideration | 23,534 | (3,000 | ) | 1,792 | 22,326 | ||||
| Total | $ | 23,534 | $ | (3,000 | ) | $ | 1,792 | $ | 22,326 |
| January 1,<br> 2023 | Payments | Revaluation | December 31,<br> 2023 | ||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| U.S. Dollars in thousands | |||||||||
| Contingent consideration | 23,534 | (3,000 | ) | 1,321 | 21,855 | ||||
| Total | $ | 23,534 | $ | (3,000 | ) | $ | 1,321 | $ | 21,855 |
The contingent consideration fair value as of December 31, 2023, was based on an Option Pricing Method (OPM), “Monte Carlo Simulation” model. In measuring the contingent consideration liability, the Company used an appropriate risk-adjusted discount rate of 11.4% and volatility of 15.17%. totaled $21,855 thousand. Refer to Note 16 in our annual Financial report for further details.
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