Skip to main content

KAMADA LTD

For the period ended Dec 31, 2024. Filed Mar 5, 2025.

View on SEC.gov

About this filing

The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.

FY2024 · Filed Mar 5, 2025

KMDA$7.23+5.2%Stored close · as of Nov 6, 2026
See the whole filing, with its images and exhibits

Cover page

Show cover page

**UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

☐** REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934**

OR

☒** ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**

For the fiscal year ended December 31,2024

OR

☐** TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**

OR

☐** SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**

Date of event requiring this shell company report: Not applicable

For the transition period from ____ to _____

Commission file number 001-35948

(Exact name of registrant as specified in its charter)

N/A

(Translation of Registrant’s name into English)

State of Israel

(Jurisdiction of incorporation or organization)

2 Holzman St.

**Science Park

P.O Box 4081

Rehovot 7670402

**Israel

**(Address of principal executive offices)

**Amir London, Chief Executive Officer

2 Holzman St., Science Park

**Rehovot 7670402, Israel

+972 8 9406472

**(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of Each ClassTrading SymbolName of Each Exchange on which Registered
Ordinary Shares, par value NIS 1.00 eachKMDAThe Nasdaq Stock Market LLC

Securities registered or to be registered pursuant to Section 12(g) of the Act.None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.None

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

As of December 31, 2024, the Registrant had 57,505,031 Ordinary Shares outstanding.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer”, “accelerated filer”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer☐Accelerated filer☒Non-accelerated filer☐Emerging growth company☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards†provided pursuant to Section 13(a) of the Exchange Act.☐

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP ☐International Financial Reporting Standards as issued by the International Accounting Standards Board ☒Other ☐

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17☐ Item 18☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

TABLE OF CONTENTS

PART I
Item 1.Identity of Directors, Senior Management and Advisers1
Item 2.Offer Statistics and Expected Timetable1
Item 3.Key Information1
Item 4.Information on the Company42
Item 4A.Unresolved Staff Comments73
Item 5.Operating and Financial Review and Prospects73
Item 6.Directors, Senior Management and Employees88
Item 7.Major Shareholders and Related Party Transactions106
Item 8.Financial Information108
Item 9.The Offer and Listing109
Item 10.Additional Information109
Item 11.Quantitative and Qualitative Disclosures About Market Risk118
Item 12.Description of Securities Other Than Equity Securities119
PART II
Item 13.Defaults, Dividend Arrearages and Delinquencies120
Item 14.Material Modifications to the Rights of Security Holders and Use of Proceeds120
Item 15.Controls and Procedures120
Item 16.[Reserved]121
Item 16A.Audit Committee Financial Expert121
Item 16B.Code of Ethics121
Item 16C.Principal Accountant Fees and Services121
Item 16D.Exemptions from the Listing Standards for Audit Committees121
Item 16E.Purchase of Equity Securities by the Issuer and Affiliated Purchasers121
Item 16F.Change in Registrant’s Certifying Accountant121
Item 16G.Corporate Governance122
Item 16H.Mine Safety Disclosure122
Item 16I.Disclosure Regarding Foreign Jurisdictions That Prevent Inspections122
Item 16J.Insider trading policies122
Item 16K.Cybersecurity123
PART III
Item 17.Financial Statements125
Item 18.Financial Statements125
Item 19.Exhibits126

i

In this Annual Report on Form 20-F (this “Annual Report”), unless the context indicates otherwise, references to “NIS” are to the legal currency of Israel, “U.S. dollars,” “$” or “dollars” are to United States dollars, and the terms “we”, “us”, the “Company”, “our company”, “our”, and “Kamada” refer to Kamada Ltd., along with its consolidated subsidiaries.

This Annual Report contains forward-looking statements that relate to future events or our future financial performance, which express the current beliefs and expectations of our management in light of the information currently available to it. Such statements involve a number of known and unknown risks, uncertainties and other factors that could cause our actual future results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements include all statements that are not historical facts and can be identified by words such as, but without limitation, “believe”, “expect”, “anticipate”, “estimate”, “intend”, “plan”, “target”, “likely”, “may”, “will”, “would”, or “could”, or other words, expressions or phrases of similar substance or the negative thereof. We have based these forward-looking statements largely on our management’s current expectations and future events and financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs. Forward-looking statements include, but are not limited to, statements about:

●our strategy is focused on driving profitable growth through four growth pillars: (i) continued investment in the commercialization and life cycle management of our commercial proprietary products (which comprise six FDA-approved specialty plasma-derived products: KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG® and HEPAGAM B®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom products) (the “Proprietary Products”), led by KEDRAB and CYTOGAM sales in the U.S. market, as well as the products in our Distribution segment portfolio, mainly through the launch of several biosimilar products in Israel; (ii) our goal to secure significant new business development, in-licensing, collaboration, and/or merger and acquisition opportunities in 2025, and our belief that such opportunities will enhance our marketed products portfolio and leverage our financial strength and existing commercial infrastructure to drive long-term growth; (iii) expanding our plasma collection operations to support revenue growth through sales of normal source plasma and in support of our growing demand for hyper-immune specialty; and (iv) advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need, with our lead product candidate Inhaled AAT, for which we are continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial;
●our current expectation to generate total revenues for the fiscal year 2025 in the range of $178 million to $182 million and adjusted EBITDA in the range of $38 million to $42 million. The midpoint of the projected 2025 revenue and adjusted EBITDA forecast represents a year-over-year increase of 12% in revenues and 17% in adjusted EBITDA (for details regarding the use of non-IFRS measures, see “Item 5. Operating and Financial Review and Prospectus—Non-IFRS Financial Measures”);
●our plan to pay a special cash dividend on April 7, 2025, based on our announcement on March 5, 2025, of a special cash dividend of $0.20 per share (approximately $11.5 million in the aggregate), with a record date (ex-dividend date) of March 17, 2025;
●our belief that a significant portion of our revenues has been, and will continue to be, derived from sales of our Proprietary Products and that KEDRAB and CYTOGAM will continue to be our two leading products in our existing Proprietary Products portfolio for the foreseeable future;
●our expectation that based on current GLASSIA sales by Takeda and forecasted future growth, we will receive royalties from Takeda in the range of $10 million to $20 million per year for 2025 to 2040;
●our expectation to continue manufacturing HEPAGAM B, VARIZIG and WINRHO SDF at Emergent BioSolutions Inc. (“Emergent”) in the foreseeable future, and our plan to transition the manufacturing of these products to our manufacturing facility in Beit Kama, Israel, subject to executing a new amended manufacturing services agreement with Emergent covering operational aspects and technology transfer related services and scope, and our anticipation that if initiated, such a technology transfer may be completed within four to five years following initiation thereof;
●our intention to expand our Proprietary Products business, including that of CYTOGAM, HEPGAM B, VARIZIG and WINRHO SDF, by leveraging our existing strong international distribution network to grow our commercial revenue in the existing markets in which we sell our products, as well as to expand to geographic markets in which these products are not currently sold;
●our expectation that, subject to European Medicines Agency (“EMA”) and subsequently the Israeli Ministry of Health (“IMOH”) approvals, we will launch in Israel two biosimilar products in 2025 and the remaining biosimilar products are expected to be launched in Israel over the coming years, at a rate of 1-3 products per year, while continuing to explore opportunities to in-license additional biosimilar products and expand the portfolio and that sales generated by the launch of the biosimilar products portfolio will serve as a major growth catalyst, and our estimate that revenues from sales of our existing biosimilar products portfolio in Israel will increase to between approximately $15 million to $20 million within the next five years and will continue to grow thereafter, subject to the continued launch of the entire portfolio as scheduled;
●our ability to procure adequate quantities of plasma and fraction IV from our suppliers, which are acceptable for use in our manufacturing processes;

ii

●our intention to expand our plasma collection operations; our expectation that our plasma collection center in Houston, Texas will become one of the largest hyper-immune plasma collection sites in the United States and will also collect normal source plasma for sale to third parties, and to commence operations at our third plasma collection center in San Antonio, Texas by the end of the first quarter of 2025, following the completion of its construction and obtaining the required regulatory approvals; and our expectation that the expansion of our plasma collection capabilities will allow us to better support our hyper-immune plasma needs, potentially lower our raw material costs, as well as generate additional revenues through sales of collected normal source plasma to other plasma-derived manufacturers;
●our expectation that each of the Houston and San-Antonio plasma collection centers, once fully operational, will contribute annual revenues of $8 million to $10 million in sales of normal source plasma;
●our intention to apply for EMA approval of both the Houston and San Antonio plasma collection centers to enable future sales of normal source plasma to potential European customers;
●our intention to seek new long-term supply agreements for hyper-immune plasma with additional plasma-collection companies;
●our expectations regarding the potential market opportunities for our products and product candidates;
●our expectation that Kedrion Biopharma Inc. (“Kedrion”) will purchase from us annual minimum quantities of KEDRAB during fiscal years 2025 through 2027 pursuant to the fifth amendment to the supply and distribution agreement between the parties, through which, Kedrion committed to purchase minimum quantities of KEDRAB with an aggregate revenues to us of approximately $180.0 million during the first four year period of the amendment (i.e., 2024 through 2027), of which approximately $135.0 million are expected during the remaining three years of such four-year period (i.e., 2025 through 2027);
●our belief that anti-rabies products based on equine serum are inferior to products made from human plasma;
●our belief that the administration of CYTOGAM together with the available antivirals may provide additional protection in preventing cytomegalovirus (“CMV”) disease for certain high-risk transplant populations, such as lung and heart transplant; and that there is an under-utilization of CYTOGAM as CMV prophylaxis in high-risk patients who undergo a solid organ transplant due to the lack of collection and presentation of new clinical and medical data and awareness regarding the benefits of combination of CYTOGAM and antiviral therapy, and that by addressing these deficits, increased utilization of CYTOGAM can be achieved;
●our belief that our ongoing clinical and medical affairs activities, which include collaborations with leading U.S.-based solid organ transplantation experts, to generate and present new real-world data on the benefits of CYTOGAM, as well as planned prospective investigator-initiated studies evaluating the benefits and potential innovative uses of CYTOGAM, continue to raise awareness for CYTOGAM and support sustained sales growth;
●our belief that our ongoing registration and marketing activities in additional countries, will support the continued usage of HEPAGAM B in ex-U.S. markets;
●our belief that we will be able to register our Proprietary Products, including CYTOGAM, HEPGAM B, VARIZIG and WINRHO SDF, in additional countries where they are not currently registered, and our belief that this would lead to additional sales worldwide;
●our expectations regarding the potential actions or inactions of existing and potential competitors of our products, including our belief that there will be no new supplier of plasma derived AAT products in the U.S. or European markets in the near future;
●our expectation that key U.S. physicians will publish new clinical data related to some of our products, and our belief that the educational symposiums that they conduct will have a positive impact on the understanding of our portfolio and thereby contributing to continued growth in demand;
●our projection that changes in the product sales mix and geographic sales mix may have an effect on our sales and profitability;
●our expectation to finalize the discussions with the IMOH regarding the potential extension of the supply agreement for the snake bite antiserums until the end of 2025, in the coming weeks;
●our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates;
●our belief that the market opportunity for AAT products for the treatment of Alpha-1 Antitrypsin Deficiency (“AATD”) will continue to grow;
●our expectation that the AATD’s diagnosis will continue to increase going forward as awareness of AATD increases;

iii

●our expectation that the number of patients treated for AATD will continue to increase going forward as awareness of AATD increases, and our expectation that additional European countries will approve such reimbursement during the coming years, based on recent reimbursement approvals for treatment of AATD in a number of European countries;
●our plan to continue to develop our pipeline, primarily focusing on the pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of AATD and to explore new strategic business development opportunities;
●our ability to attract partners for development programs for Inhaled AAT for AATD in the United States and the European Union, and to maintain such partnerships, if we decide to pursue such direction, as well as the impact on our business resulting from such partnerships, or from a failure to form such partnerships or fully realize the benefits of such partnerships;
●our intention to submit a revised statistical analysis plan (“SAP”) and study protocol for the InnovAATe study as an Investigational New Drug Application (“IND”) amendment during the second half of 2025 and our expectation to receive additional feedback from the FDA within a few months of submission, as well as our intention to approach the EMA Committee of Medicinal Products for Human Use (“CHMP”) again after obtaining agreement from the FDA on the IND amendment;
●our plan to reduce the InnovAATe study sample size from 220 patients to approximately 180 patients, and to conduct an interim futility analysis by the end of 2025;
●our forecast to complete recruitment for the InnovAATe study (Last Patient In) by the end of 2026 and complete the two years of treatment for the last enrolled patient (Last Patient Out) by the end of 2028;
●our belief that Inhaled AAT for AATD will increase patient convenience and reduce the need for patients to use intravenous infusions of AAT products, thereby decreasing the need for clinic visits or nurse home visits and reducing medical costs;
●our belief that Inhaled AAT for AATD, if approved, will enable us to treat significantly more patients from the same amount of plasma and production capacity and may be more cost effective for patients and payors and may increase our profitability;
●our belief that the inhaled formulation of AAT would be more effective in reducing inflammation of the lung tissue and inhibiting the uncontrolled neutrophil elastase that causes the breakdown of the lung tissue and emphysema;
●our intention to conduct a sub-study in North America in which approximately 30 patients will be evaluated for the effect of anti-drug antibodies (“ADA”) on AAT levels in plasma with Inhaled AAT and IV AAT treatments and our plan to initiate such study during 2026;
●our plan to test our anti-tuberculosis IgG product in-vivo during 2025;
●our ability to obtain and/or maintain regulatory approvals for our products and new product candidates, the rate and degree of market acceptance, and the clinical utility of our products;
●our ability to maintain compliance with government regulations and licenses;
●our plan to advance our other early-stage development programs until completion of proof-of-concept, at which point we plan to evaluate continued internal development, partnering or out-licensing;
●our intention to defend ourselves against the lawsuit filed against us by a third-party distributor with the tribunal of first instance in Geneva, as a result of the termination of the distribution agreement for distribution of our Proprietary Products in Russia and Ukraine;
●our belief that our current cash and cash equivalents and expected future cash to be generated by our operational activities will be sufficient to satisfy our liquidity requirements for at least the next 12 months;
●our expectation that our capital expenditures will increase in the coming years mainly due to the planned expansion of our plasma collection operations as well as potentially to facilitate the transition of manufacturing of HEPGAM B, VARIZIG and WINRHO SDF to our manufacturing facility in Beit Kama, Israel;
●our expectations to pay, during the next 12 months, approximately $10.4 million on account of contingent consideration and assumed liabilities, under the asset purchase agreement entered into with Saol in November 2021;
●our ability to obtain and maintain protection for the intellectual property, trade secrets and know-how relating to or incorporated into our technology and products;
●our expectations regarding our ability to utilize Israeli tax incentives against future income; and
●our expectations regarding taxation, including that we will not be classified as a passive foreign investment company for the taxable year ending December 31, 2024, and beyond.

iv

All forward-looking statements involve risks, assumptions and uncertainties. You should not rely upon forward-looking statements as predictors of future events. The occurrence of the events described, and the achievement of the expected results, depend on many events and factors, some or all of which may not be predictable or within our control. Actual results may differ materially from expected results. See the sections “Item 3. Key Information — D. Risk Factors” and “Item 5. Operating and Financial Review and Prospectus,” as well as elsewhere in this Annual Report, for a more complete discussion of these risks, assumptions and uncertainties and for other risks, assumptions and uncertainties. These risks, assumptions and uncertainties are not necessarily all of the important factors that could cause actual results to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results.

All of the forward-looking statements we have included in this Annual Report are based on information available to us as of the date of this Annual Report and speak only as of the date hereof. We undertake no obligation, and specifically decline any obligation, to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this Annual Report might not occur.

The audited consolidated financial statements for the years ended December 31, 2024, 2023 and 2022 included in this Annual Report have been prepared in accordance with the international financial reporting standards (“IFRS”) as issued by the international accounting standards board (“IASB”).

Unless otherwise noted, NIS amounts presented in this Annual Report are translated at the rate of $1.00 = NIS 3.647,the exchange rate published by the Bank of Israel as of December 31, 2024.

We have proprietary rights to trademarks used in this Annual Report that are important to our business, many of which are registered under applicable intellectual property laws. Solely for convenience, trademarks and trade names referred to in this Annual Report may appear without the “®” or “™” symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trademarks, trade names or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Each trademark, trade name or service mark of any other company appearing in this Annual Report is the property of its respective holder.

v

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.