Kamada : 20F 2023 Annual Report

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, 2023
      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

Kamada Ltd.

(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

[phone]

(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 Class		Trading Symbol	Name of Each Exchange on which Registered
Ordinary Shares, par value NIS 1.00 each		KMDA	The 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, 2023, the Registrant had 57,479,528 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.

• Yes ☒ No

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.

• Yes ☒ No

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	Other ☐
	Accounting Standards Board ☒

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).

☐ Yes ☒ No

	TABLE OF CONTENTS
PART I
Item 1.	Identity of Directors, Senior Management and Advisers	1
Item 2.	Offer Statistics and Expected Timetable	1
Item 3.	Key Information	1
Item 4.	Information on the Company	46
Item 4A.	Unresolved Staff Comments	77
Item 5.	Operating and Financial Review and Prospects	77
Item 6.	Directors, Senior Management and Employees	94
Item 7.	Major Shareholders and Related Party Transactions	112
Item 8.	Financial Information	115
Item 9.	The Offer and Listing	116
Item 10.	Additional Information	116
Item 11.	Quantitative and Qualitative Disclosures About Market Risk	126
Item 12.	Description of Securities Other Than Equity Securities	126
Item 13.	Defaults, Dividend Arrearages and Delinquencies	127
Item 14.	Material Modifications to the Rights of Security Holders and Use of Proceeds	127
Item 15.	Controls and Procedures	127
Item 16.	[Reserved]	127
Item 16A.	Audit Committee Financial Expert	127
Item 16B.	Code of Ethics	127
Item 16C.	Principal Accountant Fees and Services	128
Item 16D.	Exemptions from the Listing Standards for Audit Committees	128
Item 16E.	Purchase of Equity Securities by the Issuer and Affiliated Purchasers	128
Item 16F.	Change in Registrant's Certifying Accountant	128
Item 16G.	Corporate Governance	128
Item 16H.	Mine Safety Disclosure	129
Item 16I.	Disclosure Regarding Foreign Jurisdictions That Prevent Inspections	129
Item 16J.	Insider trading policies	129
Item 16K.	Cybersecurity	129
Item 17.	Financial Statements	131
Item 18.	Financial Statements	131
Item 19.	Exhibits	132

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 continued focus on driving profitable growth through expanding our growth catalysts, which include: investment in the commercialization and life cycle management of our commercial Proprietary products led by KEDRAB and CYTOGAM sales in the U.S. market; continue growing our Proprietary hyper-immune portfolio's revenues in existing and new geographic markets through registration and launch of the products in new territories; expanding sales of GLASSIA in ex-U.S. markets; generating royalties from GLASSIA sales by Takeda Pharmaceuticals Company Limited ("Takeda"); expanding our plasma collection capabilities in support of our growing demand for hyper-immune specialty plasma as well as sales of normal source plasma to the market; exploring strategic business development opportunities to identify potential acquisitions or in-licensing targeted products synergistic to our existing commercial activities that could be added to our proprietary products portfolio; continued increase of our Distribution segment revenues specifically through launching the eleven biosimilar products in Israel; and leveraging our U.S. Food and Drug Administration ("FDA")-approved hyperimmune immunoglobulins ("IgG") platform technology, manufacturing, research and development expertise to advance development and commercialization of additional product candidates, including our Inhaled Alpha-1 antitrypsin ("AAT") product candidate and identify potential commercial partners for this product;
• our current expectation to generate total revenues for the fiscal year 2024 in the range of $156 million to $160 million and adjusted EBITDA in the range of $27 million to $30 million. The projected 2024 revenue and adjusted EBITDA forecast represents double digit growth over fiscal year 2023 (for details regarding the use of non-IFRS measures, see "Item 5. Operating and Financial Review and Prospectus-Non-IFRS Financial Measures");
• our belief that sales of KEDRAB and CYTGOM will continue to increase in the coming years and will be a major growth catalyst for the foreseeable future;
• our expectation that based on current GLASSIA sales and forecasted future growth, we will receive royalties from Takeda in the range of $10 million to $20 million per year for 2024 to 2040;
• our expectation to continue the supply of CYTOGAM, HEPAGAM, VARIZIG and WINRHO SDF to Canadian Blood Services (CBS) for an additional two years out of the total three-year agreement, which commenced on April 1, 2023, for an approximate total value of $22 million, of which an aggregate of $6.4 million of such products were sold to CBS in 2023;
• our expectation to continue manufacturing HEPAGAM B, VARIZIG and WINRHO SDF at Emergent BioSolutions Inc. ("Emergent") in the foreseeable future, and, upon decision to do so, initiate in parallel a technology transfer project for transitioning 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 the 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;

ii

• our intention to expand our Proprietary plasma-derived 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 eleven biosimilar products through 2028 and that sales generated by the launch of the biosimilar products portfolio will become a major growth catalyst, and our estimate that the potential aggregate peak revenues, achievable within several years of launch, generated by the distribution of all eleven biosimilar products, will be in the range of approximately $30 million to $34 million annually;
• our ability to procure adequate quantities of plasma and fraction IV from our suppliers, which are acceptable for use in our manufacturing processes;
• our intention to leverage our experience with plasma collection to establish additional plasma collection centers in the United States with the intention of collecting normal source plasma to be sold for manufacturing by third parties, as well as hyper-immune specialty plasma required for manufacturing of our proprietary products; our expectation to commence operations at our new plasma collection center in Uvalde, Texas during 2024, following the completion of its construction and obtaining the required regulatory approvals, and to lease a subsequent facility and initiate construction activities to establish our third plasma collection center during early 2024; and our expectation that the expansion of our plasma collection capabilities will allow us to better support our plasma needs as well as generate additional revenues through sales of collected normal source plasma;
• our intention to seek new long-term supply agreements for hyper-immune plasma with additional plasma-collection companies;
• our intention to enhance our current manufacturing capabilities;
• our intention to implement staff reductions when needed in order to adjust to lower plant utilization;
• 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 2024 through 2027, with aggregate revenues to us of approximately $180 million for such four-year period;
• our anticipation that KEDRAB's in market sales in the U.S. will continue to grow through the eight-year term of our new agreement with Kedrion;
• our belief that anti-rabies products based on equine serum are inferior to products made from human plasma;
• our belief that the exit of Sanofi S.A. from the U.S anti-Rabies IgG market, as well as some additional international markets, creates an opportunity for us to expand KEDRAB's U.S. market share;
• our belief that in light of the recent business combination of Kedrion and Bio Products Laboratories Ltd. ("BPL"), as well as the recent binding memorandum of understanding we entered into with Kedrion, we do not anticipate that BPL will continue to advance the development efforts for its anti-Rabies IgG product in the U.S. market;
• 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;
• our belief that the administration of CYTOGAM together with the available antivirals may provide additional protection in preventing 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 intention to seek registration of CYTOGAM in various other territories as well as explore label expansion of CYTOGAM to be used in other indication;

iii

• our belief that given the expected continued increase in liver transplants in ex-U.S. countries, and with our planned direct marketing efforts, HEPAGAM usage may grow;
• our expectation that sales of VARIZIG, WINRHO SDF and HEPGAM B will grow in 2024 in comparison to 2023;
• our expectation, based on Takeda's publication, that Takeda will commence sales of GLASSIA in Canada during 2024, following which we will be entitled to royalty income on such sales;
• our belief that our relationships with our strategic partners, including with Kedrion, Takeda and PARI, will continue without disruption;
• 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 belief that we will be able to continue to meet our customers' demand for our proprietary products;
• 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 AAT by infusion in the U.S. market 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;
• the legislation or regulation in countries where we sell our products that affect product pricing, reimbursement, market access or distribution channels may affect our sales and profitability;
• 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 enter into discussions with the IMOH regarding the potential extension of the supply agreement for the snake bite antiserums prior to its expiration;
• 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 AATD will continue to grow;
• our expectation that the AATD's diagnosis will continue to increase going forward as awareness of AATD increases;
• our expectation that the number of patients treated for AATD will continue to increase going forward as awareness of AATD increases, and our expectation based on recent reimbursement approvals for treatment of AATD in a number of European countries that additional European countries will approve such reimbursement during the coming years;
• 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 Alpha-1 Deficiency (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;
• FDA's expressed willingness to potentially accept a P<0.1 alpha level in evaluating InnovAATe for meeting the efficacy primary endpoint for registration, which may allow for the acceleration of the program, and our plan to present a revised statistical analysis plan (SAP) and study protocol for the InnovAATe study and to seek the FDA's feedback by mid-2024;
• 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;

iv

• our belief that Inhaled AAT for AATD will enable us to treat significantly more patients from the same amount of fraction IV and production capacity and therefore 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 ADA on AAT levels in plasma with Inhaled AAT and IV AAT treatments and our plan to initiate such study 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 intention to vigorously defend ourselves against the lawsuit filed against us by a third-party distributor 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 approximately $15.0 million on account of contingent consideration, inventory related liability and the assumed liabilities under the asset purchase agreement entered into with Saol in November 2021, during the next 12 months;
• 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.

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, 2023, 2022 and 2021 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 3.627, the exchange rate published by the Bank of Israel as of December 31, 2023.

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

PART I

Item 1. Identity of Directors, Senior Management and Advisers

Not applicable.

Item 2. Offer Statistics and Expected Timetable

Not applicable.

Item 3. Key Information

1. [Reserved]
2. Capitalization and Indebtedness Not applicable.
3. Reasons for the Offer and Use of Proceeds Not applicable.
4. Risk Factors

Our business, liquidity, financial condition, and results of operations could be adversely affected, and even materially so, if any of the risks described below occur. As a result, the trading price of our securities could decline, and investors could lose all or part of their investment. This Annual Report including the consolidated financial statements contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially and adversely from those anticipated, as a result of certain factors, including the risks facing the Company as described below and elsewhere in the Annual Report. You should carefully consider the risks and uncertainties included herewith. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business. Material risks that may affect our business, operating results and financial condition include, but are not necessarily limited to, those relating to:

• Our business is currently highly concentrated on our two leading products, KEDRAB and CYTOGAM, as well as on royalty income generated from GLASSIA sales by Takeda. Any adverse market event with respect to such products and income would have a material adverse effect on our business and financial condition.
• A significant portion of our net revenue has been and will continue to be driven from sales of our proprietary products, and in our largest geographic region, the United States. Any adverse market event with respect to some of our proprietary products or the United States would have a material adverse effect on our business.
• Our ability to maintain and expand sales of our commercial products portfolio in the U.S. and ex-U.S. markets is critical to our profitability and financial stability.
• We have excess manufacturing plant capacity in our manufacturing facility, which may result in reduction in operating profits, if not effectively managed.
• We have invested and intend to continue to invest in expanding our U.S. plasma collection operations in order to reduce our dependency on third-party suppliers in terms of plasma supply needs as well as to generate sales from commercialization of collected normal source plasma, and our ability to successfully expand this operation is important to support our future growth and profitability.
• We have several product development candidates, including our Inhaled AAT for AATD, as well as several other early-stage development projects. There can be no assurance that the development activities associated with these products will materialize and result in the FDA, EMA or any other relevant agencies granting us marketing authorization for any of these products.
• In our Proprietary Products segment, we rely on Kedrion for the sales of our KEDRAB product in the United States, and any disruption to our relationships with Kedrion would have an adverse effect on our future results of operations and profitability.
• Sales of CYTOGAM, HEPGAM B, VARIZIG and WINRHO SDF in the U.S. market are critical in order to support future growth, future results of operations and profitability and any adverse market event with respect to such products would have an adverse effect on our future results of operations and profitability.
• We rely in large part on third parties for the sale, distribution and delivery of our products, and any disruption to our relationships with these third-party distributors would have an adverse effect on our future results of operations and profitability.

1

• Continued availability of several of our products in the Proprietary segment, is dependent on our ability to maintain existing engagements with contract manufacturing organizations to manufacture these products and any disruption to our relationship with such manufacturers would have an adverse effect on the availability of products, our future results of operations and profitability.
• Our Proprietary Product segment operates in a highly competitive market.
• We would become supply-constrained and our financial performance would suffer if we were unable to obtain adequate quantities of source plasma or plasma derivatives or specialty ancillary products that meet the regulatory requirement of the FDA, EMA, Health Canada or the regulatory authorities in Israel, or if our suppliers were to fail to modify their operations to meet regulatory requirements or if prices of the source plasma or plasma derivatives were to raise significantly.
• Our Distribution segment is dependent on a few suppliers, and any disruption to our relationship with these suppliers, or their inability to supply us with the products we sell, in a timely manner, in adequate quantities and/or at a reasonable cost, would have a material adverse effect on our business, financial condition and results of operations.
• Laws and regulations governing the conduct of international operations may negatively impact our development, manufacture, and sale of products outside of the United States and require us to develop and implement costly compliance programs.
• If our manufacturing facility in Beit Kama, Israel was to suffer a serious accident, contamination, force majeure event (including, but not limited to, a war, terrorist attack, earthquake, major fire or explosion etc.) materially affecting our ability to operate and produce saleable plasma-derived protein therapeutics, all of our manufacturing capacity could be shut down for an extended period.
• Our business and operations would suffer in the event of computer system failures, cyber-attacks on our systems or deficiency in our cyber security measures.
• Our success depends in part on our ability to obtain and maintain protection in the United States and other countries for the intellectual property relating to or incorporated into our technology and products, including the patents protecting our manufacturing process.
• We have incurred significant losses since our inception and while we were profitable in the year ended December 31, 2023 and the two years ended December 31, 2020, we incurred operating losses in the 2022 and 2021 fiscal years and may not be able to sustain profitability.
• Our business requires substantial capital, including potential investments in large capital projects, to operate and grow and to achieve our strategy of realizing increased operating leverage, for which we may incur debt or issue additional equity.
• Our share price may be volatile.
• Our business could be adversely affected by political, economic and military instability in Israel and its region.

Risks Related to Our Business

Our business is currently highly concentrated on our two leading products, KEDRAB and CYTOGAM, as well as on royalty income generated from GLASSIA sales by Takeda. Any adverse market event with respect to such products and income would have a material adverse effect on our business and financial condition.

Our business currently relies on the sales of KEDRAB, our Human Rabies Immune Globulin (HRIG), and CYTOGAM, our Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), as well as royalty income on sales of GLASSIA, our intravenous AAT product, by Takeda. Revenue from sales of these products and royalties comprised approximately 23%, 12% and 11%, respectively (46% in total), of our total revenues for the year ended December 31, 2023.

In the event that KEDRAB or CYTOGAM were to lose significant sales or were to be substantially or completely displaced in the market, we would lose a significant and material source of our total revenues. Similarly, if these products were to become the subject of litigation and/or an adverse governmental action or ruling causing us to cease the manufacturing, export or sales of these products, our business and financial condition would be adversely affected.

2

We are entitled to royalty payments from Takeda on GLASSIA sales in the United States (as well as in Canada, Australia and New Zealand, to the extent GLASSIA will be approved and sales will be generated in these other markets) 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. For the year ended December 31, 2023 and the period between March and December 2022, we accounted for $16.1 million and $12.2 million, respectively, of sales-based royalty income from Takeda, and based on forecasted future growth, we project receiving royalties from Takeda in the range of $10 million to $20 million per year during 2024 to 2040. However, any reduction in sales of GLASSIA by Takeda or should Takeda reduce its manufacturing and marketing of GLASSIA for any reason (including but not limited to inability to adequately or sufficiently manufacture GLASSIA, regulatory limitations, difficulties in marketing, reduction in market size, or changes in corporate focus), our future expected royalty income from Takeda's sales of GLASSIA would be adversely impacted, which would have an adverse effect on our revenues and profitability.

A significant portion of our net revenue has been and will continue to be driven from sales of our proprietary products, and in our largest geographic region, the United States. Any adverse market event with respect to some of our proprietary products or the United States would have a material adverse effect on our business.

A significant portion of our revenues has been, and will continue to be, derived from sales of our proprietary products, including those of KEDRAB, CYTOGAM, HEPGAM B, VARIZIG, WINRHO SDF and GLASSIA, as well as royalty income from GLASSIA sales by Takeda. Revenue from our Proprietary products comprised approximately 81%, 79% and 73% of our total revenues for the years ended December 31, 2023, 2022 and 2021, respectively. If some of our proprietary products were to lose significant sales or were to be substantially or completely displaced in the market, we would lose a significant and material source of our total revenues. Similarly, if these products were to become the subject of litigation and/or an adverse governmental action or ruling causing us to cease the manufacturing, export or sales of these products, our business and financial condition would be adversely affected.

A significant portion of our sales and income are generated in the United States and comprised approximately 52%, 50% and 48% of our total revenues for the years ended December 31, 2023, 2022 and 2021, respectively. If our sales or income generated in the United States were significantly impacted by material changes to government or private payor reimbursement, other regulatory developments, competition or other factors, then our business and financial condition would be adversely affected.

Our ability to maintain and expand sales of our commercial products portfolio in the U.S. and ex-U.S. markets is critical to our profitability and financial stability.

Our Proprietary commercial products portfolio, comprising of KEDRAB, CYTOGAM, WINRHO SDF, VARIZIG, HEPGAM B and GLASSIA, as well as KAMRAB, KAMRHO (D) and two types of equine-basedanti-snake venom (ASV) products, are currently distributed in the U.S. market, where we market and distribute some of these products directly based on our sales and marketing personnel, and in approximately 30 additional ex-U.S. international markets, including the Middle East and North Africa ("MENA") region, where we had little to no prior sales and operational experience prior to the consummation of the acquisition of CYTOGAM, WINRHO SDF, VARIZIG, HEPGAM B from Saol in November 2021. While we intend to leverage our existing strong international distribution network to grow our commercial revenue in the existing markets in which we sell our products, we also plan to expand to geographic markets in which these products are not currently sold, and we may not be successful in developing additional markets for these products.

Our ability to successfully maintain and expand our recently established U.S. based commercial and distribution infrastructure, and maintain and expand ex-U.S. commercialization, is critical for our future growth, profitability and financial stability. Given our limited prior experience in some of the required activities and responsibilities, including operation of direct sales in the U.S. market, knowledge and experience in the MENA region, as well as other operational, technical, regulatory, financial and compliance challenges, we may not be able to continue to expand our existing commercial operation, which may materially adversely affect the operating results of our business as well as our financial condition.

3