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 2023

 

Commission File Number 001-35948

 

Kamada Ltd.

(Translation of registrant’s name into English)

 

2 Holzman Street
Science Park, P.O. Box 4081
Rehovot 7670402
Israel
(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 ☐

 

This Form 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:

 

99.1   Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance
     
99.2   Company’s Presentation – November 2023
     
99.3   Kamada Ltd’s Consolidated Financial Statements as of September 30, 2023 (Unaudited)
     
101.INS   Inline XBRL Instance Document.
     
101.SCH   Inline XBRL Taxonomy Extension Schema Document.
     
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document.
     
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document.
     
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document.
     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

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, 2023 KAMADA LTD.
   
  By: /s/ Nir Livneh
   

Nir Livneh

Vice President General Counsel and
Corporate Secretary

 

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EXHIBIT INDEX

 

 

EXHIBIT NO.     DESCRIPTION
99.1   Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance
     
99.2   Company’s Presentation – November 2023
     
99.3   Kamada Ltd’s Consolidated Financial Statements as of September 30, 2023 (Unaudited)
     
101.INS   Inline XBRL Instance Document.
     
101.SCH   Inline XBRL Taxonomy Extension Schema Document.
     
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document.
     
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document.
     
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document.
     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

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Exhibit 99.1

 

Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance

 

Third Quarter 2023 Revenues were $37.9 Million Representing an 18% Increase Year-over-Year; Nine Month 2023 Revenues of $106.1 Million, Up 26% Year-over-Year

 

Third Quarter 2023 Adjusted EBITDA of $7.9 Million Representing a 31% Increase Year-over-Year; Nine Month 2023 Adjusted EBITDA of $17.7 Million, Up 67% Year-over-Year

 

Strong Third Quarter Results and Positive Outlook for Fourth Quarter Support Reiteration of Fiscal Year 2023 Revenue and Adjusted EBITDA Guidance

 

Multiple Recent Achievements with CYTOGAM®, including Availability of Product Manufactured by the Company for U.S. Commercial Sale and Presentation of New Clinical Data

 

Received Shareholder Approval and Subsequently Closed $60 Million Private Placement with FIMI Opportunity Funds

 

Conference Call and Live Webcast Today at 8:30 AM ET

 

Rehovot, Israel, and Hoboken, NJ – November 13, 2023 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), 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, today announced financial results for the three and nine months ended September 30, 2023.

 

“We are highly encouraged with our strong financial and operational momentum during the first nine months of the year,” said Amir London, Kamada’s Chief Executive Officer. “With total revenues of $106.1 million, which represent year-over-year growth of 26%, and adjusted EBITDA of $17.7 million, an increase of 67% as compared to the first nine months of 2022, we achieved the top- and bottom-line growth anticipated in our business in the first nine months of the year. We continue to effectively leverage our multiple growth drivers, including a significant increase in sales of our anti-rabies immunoglobulin product, KEDRAB® as well as the portfolio of the four FDA-approved immunoglobulins (CYTOGAM®, HEPAGAMB®, VARIZIG® and WINRHO® SDF), and our Israeli distribution business.”

 

“We expect the momentum from the first nine months of the year to extend through the fourth quarter of 2023, with annual profitability to be further meaningfully enhanced as compared to last year. As such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and adjusted EBITDA of $22 million to $26 million; the mid-point of the range would represent profitability growth of approximately 35% over 2022,” continued Mr. London.

 

“During the recent period we reported multiple achievements with CYTOGAM. Specifically, following recent FDA approval of the technology transfer process, CYTOGAM manufactured at our Israeli facility is now available for commercial sale in U.S., and new clinical data highlighting five-year real-world survival benefits of high risk CMV mismatch lung transplant patients receiving CYTOGAM were presented at IDWeek 2023. In addition, we continue to advance our pivotal phase 3 InnovAATe trial for Inhaled AAT and we recently received positive feedback from the independent Data and Safety Monitoring Board (DSMB) which recommended study continuation without modification for the sixth time since study initiation, based on encouraging safety data observed in the study to date,” added Mr. London.

 

 

 

 

“Our future prospects were also recently further buoyed by the recent closing of our $60 million private placement with FIMI Opportunity Funds. This strategic investment provides us with financial flexibility to pursue compelling business development opportunities, a process that we are currently engaged in,” concluded Mr. London.

 

Financial Highlights for the Three Months Ended September 30, 2023

 

Total revenues were $37.9 million in the third quarter of 2023, an 18% increase from the $32.2 million recorded in the third quarter of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased market share and demand for the product in the U.S. market.

 

Gross profit and gross margins were $14.8 million and 39%, respectively, in the third quarter of 2023, compared to $12.9 million and 40%, respectively, reported in the third quarter of 2022. Cost of goods sold in the Company’s Proprietary segment, for the third quarter of 2023 and 2022, included $1.3 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition.

 

Operating expenses, including R&D, Sales & Marketing (S&M), G&A and other expenses, totaled $10.4 million in the third quarter of 2023, as compared to $10.3 million in the third quarter of 2022. S&M costs, for the third quarter of 2023 and 2022, included $0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition.

 

Net income was $3.2 million, or $0.07 per share, in the third quarter of 2023, as compared to a net income of $0.5 million, or $0.01 per share, in the third quarter of 2022.

 

Adjusted EBITDA, as detailed in the tables below, was $7.9 million in the third quarter of 2023, a 31% increase as compared to $6.0 million in the third quarter of 2022.

 

Cash provided by operating activities was $0.9 million in the third quarter of 2023, as compared to cash provided by operating activities of $5.5 million in the third quarter of 2022. The change correlates to the changes in the Company’s working capital and supports overall growth.

 

Financial Highlights for the Nine Months Ended September 30, 2023

 

Total revenues for the first nine months of 2023 were $106.1 million, a 26% increase from the $83.9 million generated in the first nine months of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased market share and demand for the product in the U.S. market.

 

Gross profit and gross margins for the first nine months of 2023 were $41.1 million and 39%, respectively, compared to $31.4 million and 37%, respectively, in the first nine months of 2022. Cost of goods sold in the Company’s Proprietary segment, for the first nine months of 2023 and 2022, included $3.9 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition.

 

Operating expenses, including R&D, S&M, G&A and other expenses, totaled $33.8 million in the first nine months of 2023, as compared to $30.9 million in the prior year period. S&M costs, for the first nine months of 2023 and 2022, included $1.2 million of depreciation expenses of intangible assets generated through the IgG products acquisition. The increase in operating expenses was attributable to an increase in S&M costs associated with the acquired portfolio commercial operation, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT.

 

Net income for the first nine months of 2023 was $3.2 million, or $0.07 per share, as compared to net loss of $5.3 million, or $(0.12) per share, in the prior year period.

 

Adjusted EBITDA, as detailed in the tables below, was $17.7 million in the first nine months of 2023, a 67% increase as compared to $10.6 million in the first nine months of 2022.

 

Cash used in operating activities during the first nine months of 2023 was approximately $0.1 million, as compared to cash provided by operating activities of $21.8 million during the first nine months of 2022. The change correlates to the changes in the Company’s working capital and supports overall growth.

 

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Balance Sheet Highlights

 

As of September 30, 2023, the Company had cash, cash equivalents, and short-term investments of $52.6 million, as compared to $34.3 million as of December 31, 2022. This includes the net proceeds of $58.2 million received from the $60 million financing closed during the third quarter. In addition, during the third quarter the Company made a $17.4 million pay-down in full the outstanding balance of a bank loan. The Company is currently debt free.

 

Recent Corporate Highlights

 

Received shareholder approval for and subsequently closed $60 million private placement with FIMI Opportunity Funds.

 

Announced multiple achievements with CYTOGAM, including the availability of product manufactured by Kamada for U.S. commercial sale, presented new clinical data highlighting five-year real-world survival benefits of high risk CMV mismatch lung transplant patients receiving CYTOGAM, and the establishment of a Scientific Advisory Board focused on U.S. clinical programs for CYTOGAM.

 

The Company continues to conduct its business operations in Israel with no effect on business continuity, and its global supply of products is not expected to be interrupted as a result of the recent events in Israel.

 

Fiscal Year 2023 Guidance

 

Kamada continues to expect to generate fiscal year 2023 total revenues in the range of $138 million to $146 million. The Company also continues to anticipate generating adjusted EBITDA during 2023 in the range of $22 million to $26 million, the mid-point of the range would represent profitability growth of approximately 35% over 2022.

 

Conference Call

 

Kamada management will host an investment community conference call on Monday, November 13, at 8:30am Eastern Time to discuss these 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.), 1 809-406-247 (from Israel), or 1 201-689-8263 (International) and entering the conference identification number: 13741701. The call will also be webcast live on the Internet at:

 

https://viavid.webcasts.com/starthere.jsp?ei=1637192&tp_key=fd85a910fe.

 

Non-IFRS financial measures

 

We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure 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 this non-IFRS financial measure 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 and adjusted EBITDA are 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, plus non-cash share-based compensation expenses and certain other costs.

 

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About Kamada

 

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: CYTOGAM®, KEDRAB®, 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, 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 hyper-immune plasma used in the manufacture of KAMRHO (D). 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 lead 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) continued ability to leverage growth drivers, 2) continuing the momentum of the first three quarters of 2023 in the last quarter and ability to enhance profitability, 3) reiteration of fiscal year 2023 guidance, 4) exploration of future business development prospects in the wake of the recent private placement proceeds, and 5) positive feedback relating to inhaled ATT clinical trial. 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 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 in new locations, 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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KAMADA LTD.

 

Condensed Consolidated Interim Statements of Financial Position

 

   As of
September 30,
   As of
December 31,
 
   2023   2022   2022 
   Unaudited   Audited 
             
Assets            
Current Assets            
Cash and cash equivalents  $52,603   $31,252   $34,258 
Trade receivables, net   25,107    23,997    27,252 
Other accounts  receivables   1,648    6,884    8,710 
Inventories   73,795    73,029    68,785 
Total Current Assets   153,153    135,162    139,005 
                
Non-Current Assets               
Property, plant and equipment, net   27,362    25,898    26,157 
Right-of-use assets   5,494    2,793    2,568 
Intangible assets, Goodwill and other long-term assets   142,501    148,620    147,072 
Contract assets   8,546    7,164    7,577 
Total Non-Current Assets   183,903    184,475    183,374 
Total Assets  $337,056   $319,637   $322,379 
Liabilities               
Current Liabilities               
Current maturities of bank loans  $-   $4,444   $4,444 
Current maturities of lease liabilities   1,138    1,004    1,016 
Current maturities of other long term liabilities   15,989    25,095    29,708 
Trade payables   12,812    30,619    32,917 
Other accounts payables   7,318    7,948    7,585 
Deferred revenues   15    40    35 
Total Current Liabilities   37,272    69,150    75,705 
                
Non-Current Liabilities               
Bank loans   -    14,074    12,963 
Lease liabilities   4,717    2,414    2,177 
Contingent consideration   19,642    20,705    17,534 
Other long-term liabilities   36,477    39,915    37,308 
Deferred revenues   -    15    - 
Employee benefit liabilities, net   558    813    672 
Total Non-Current Liabilities   61,394    77,936    70,654 
                
Shareholder’s Equity               
Ordinary shares   15,020    11,732    11,734 
Additional paid in capital  net   265,700    210,355    210,495 
Capital reserve due to translation to presentation currency   (3,490)   (3,490)   (3,490)
Capital reserve from hedges   (98)   (257)   (88)
Capital reserve from share-based payments   6,198    5,427    5,505 
Capital reserve from employee benefits   318    212    348 
Accumulated deficit   (45,258)   (51,428)   (48,484)
Total Shareholder’s Equity   238,390    172,551    176,020 
Total Liabilities and Shareholder’s Equity  $337,056   $319,637   $322,379 

 

5

 

 

KAMADA LTD.

 

Condensed Consolidated Interim 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, 
   2023   2022   2023   2022   2022 
   Unaudited   Unaudited   Audited 
                     
Revenues from proprietary products  $86,437   $67,198   $31,436   $25,580   $102,598 
Revenues from distribution   19,650    16,702    6,498    6,637    26,741 
                          
Total revenues   106,087    83,900    37,934    32,217    129,339 
                          
Cost of revenues from proprietary products   47,863    37,856    17,447    13,151    58,229 
Cost of revenues from distribution   17,146    14,632    5,684    6,196    24,407 
                          
Total cost of revenues   65,009    52,488    23,131    19,347    82,636 
                          
Gross profit   41,078    31,412    14,803    12,870    46,703 
                          
Research and development expenses   10,694    10,181    3,180    3,118    13,172 
Selling and marketing expenses   11,573    10,435    3,711    3,843    15,284 
General and administrative expenses   10,603    9,481    3,701    3,165    12,803 
Other expenses   920    801    (157)   182    912 
Operating income (loss)   7,288    514    4,368    2,562    4,532 
                          
Financial income   92    32    67    29    91 
Income (expenses) in respect of currency exchange differences and derivatives instruments, net   726    756    553    163    298 
Financial Income (expense) in respect of contingent consideration and other long- term liabilities.   (3,358)   (5,924)   (1,288)   (2,049)   (6,266)
Financial expenses   (1,343)   (583)   (404)   (211)   (914)
Income (expense) before tax on income   3,405    (5,205)   3,296    494    (2,259)
Taxes on income   179    60    73    10    62 
                          
Net income (loss)  $3,226   $(5,265)  $3,223   $484   $(2,321)
                          
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   (334)   (830)   (90)   (46)   (776)
Net amounts transferred to the statement of profit or loss for cash flow hedges   324    519    59    231    634 
Items that will not be reclassified to profit or loss in subsequent periods:                         
Remeasurement gain (loss) from defined benefit plan   (30)   361    (106)   (59)   497 
Total comprehensive income (loss)  $3,186   $(5,215)  $3,086   $610   $(1,966)
                          
Earnings per share attributable to equity holders of the Company:                         
Basic net earnings per share  $0.07   $(0.12)  $0.07   $0.01   $(0.05)
Diluted net earnings per share  $0.06   $(0.12)  $0.06   $0.01   $(0.05)

 

6

 

 

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, 
   2023   2022   2023   2022   2022 
   Unaudited   Audited 
   U.S Dollars In thousands 
Cash Flows from Operating Activities                    
Net income (loss)  $3,226   $(5,265)  $3,223   $484   $(2,321)
                          
Adjustments to reconcile net income to net cash provided by (used in) operating activities:                         
                          
Adjustments to the profit or loss items:                         
                          
Depreciation and impairment   9,506    9,143    3,179    3,055    12,155 
Financial expenses (income), net   3,883    5,719    1,072    2,068    6,791 
Cost of share-based payment   941    935    312    366    1,153 
Taxes on income   179    60    73    10    62 
Loss (gain) from sale of property and equipment   (5)   -    -    -    - 
Change in employee benefit liabilities, net   (144)   (106)   (104)   (10)   (111)
    14,360    15,751    4,532    5,489    20,050 
Changes in asset and liability items:                         
                          
Decrease (increase) in trade receivables, net   2,078    10,744    (618)   (6,358)   7,603 
Decrease (increase) in other accounts receivables   2,716    2,917    1,177    844    (578)
Decrease (increase) in inventories   (5,011)   (5,606)   6,441    (8,509)   (1,361)
Decrease (increase) in deferred expenses   2,763    (2,596)   (279)   (2,112)   (1,340)
Increase (decrease) in trade payables   (18,617)   5,895    (13,181)   13,738    7,055 
Increase (decrease) in other accounts payables   (359)   566    49    2,083    290 
Decrease in deferred revenues   (20)   -    (23)   -    (20)
    (16,450)   11,920    (6,434)   (314)   11,649 
Cash received (paid) during the period for:                         
                          
Interest paid   (1,149)   (550)   (405)   (170)   (853)
Interest received   92    15    67    12    97 
Taxes paid   (174)   (27)   (62)   (9)   (36)
    (1,231)   (562)   (400)   (167)   (792)
                          
Net cash provided by (used in) operating activities  $(95)  $21,844   $921   $5,492   $28,586 

 

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, 
   2023   2022   2023   2022   2022 
   Unaudited   Audited 
   U.S Dollars In thousands 
Cash Flows from Investing Activities                    
Purchase of property and equipment and intangible assets  $(3,876)  $(2,807)  $(1,729)  $(1,616)  $(3,784)
Proceeds from sale of property and equipment   6    -    -    -    - 
Net cash provided by (used in) investing activities   (3,870)   (2,807)   (1,729)   (1,616)   (3,784)
                          
Cash Flows from Financing Activities                         
                          
Proceeds from exercise of share base payments   3    7    -    1    9 
Repayment of lease liabilities   (768)   (842)   (251)   (269)   (1,098)
Repayment of long-term loans   (17,407)   (1,517)   (15,185)   (1,116)   (2,628)
Repayment of other long-term liabilities   (17,500)   (4,120)   (11,500)   (877)   (5,626)
Proceeds from issuance of ordinary shares, net   58,231    -    58,231    -    - 
Net cash provided by (used in) financing activities   22,559    (6,472)   31,295    (2,261)   (9,343)
                          
Exchange differences on balances of cash and cash equivalent   (249)   100    328    (296)   212 
                          
Increase (decrease) in cash and cash equivalents   18,345    12,665    30,815    1,319    15,671 
                          
Cash and cash equivalents at the beginning of the period   34,258    18,587    21,788    29,933    18,587 
                          
Cash and cash equivalents at the end of the period  $52,603   $31,252   $52,603   $31,252   $34,258 
                          
Significant non-cash transactions                         
Right-of-use asset recognized with corresponding lease liability  $3,880   $526   $295   $230   $551 
Purchase of property and equipment and Intangible assets  $681   $134   $681   $134   $618 

 

8

 

 

KAMADA LTD.

 

NON-IFRS MEASURES

 

   Nine months period ended   Three months period ended   Year ended 
   September 30,   September 30,   December 31, 
   2023   2022   2023   2022   2022 
   In thousands 
Net income  $3,226   $(5,265)  $3,223   $484   $(2,321)
Taxes on income   179    60    73    10    62 
Financial expense (income), net   3,883    5,719    1,072    2,068    6,791 
Depreciation and amortization expense   9,506    9,143    3,179    3,055    12,155 
Non-cash share-based compensation expenses   941    935    312    366    1,153 
Adjusted EBITDA  $17,735   $10,592   $7,859   $5,983   $17,840 

 

9

 

Exhibit 99.2

 

INVESTORS MEETING NASDAQ & TASE: KMDA November 2023

 

 

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 the 2023 financial guidance, success of the inhaled AAT clinical study, its benefits and potential market size, success of the U . S . plasma collection expansion and revenue potential, and success in launching new products in the Israeli distribution business segment . These statement 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 prospected 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, the progress and results of any clinical trials, the introduction of competing products, the continued market acceptance of Kamada’s commercial products portfolio, the impact of any changes in regulation and legislation that could affect the pharmaceutical industry, the difficulty of predicting, obtaining or maintaining U . S . Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment, 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 202 2 Annual Report on Form 20 - F (filed on March 15 , 202 3 ) 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 securities laws . You should not place undue reliance on any forward - looking statement and should consider the uncertainties and risks noted above, as well as the risks and uncertainties more fully discussed under the heading “Risk Factors” of Kamada’s 202 2 Annual Report on Form 20 - F (filed on March 15 , 202 3 ) as well as in Kamada’s recent Forms 6 - K filed with the U . S . Securities and Exchange Commission . 2 Kamada / November 2023

 

 

6 FDA approved products ; global commercial network selling in over 30 countries 2023 revenues guidance of $138M - $146M; Adjusted EBITDA of $22M - $26M; rapidly growing; positive cash - flow; strong balance sheet Multiple growth drivers with limited downside ri sk and significant upside potential KAMADA HIGHLIGHTS 6 3 Kamada is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions The company is a leader in the specialty plasma - derived field focused on diseases of limited treatment alternatives The company is advancing an innovative development pipeline targeting areas of significant unmet medical need Kamada / November 2023

 

 

FINANCIAL GROWTH TRAJECTORY 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 4 104 129 138 - 146 2021 2022 2023 Revenues US$M 6 18 22 - 26 2021 2022 2023 Adjusted EBITDA US$M 2023 represents annual guidance 2023 represents annual guidance Kamada / November 2023 Strong First 9 - Month Results and Expected Continued Momentum Anticipated to Drive Full - Year 2023 Adjusted EBITDA Growth (mid point represents approx. 35% increase YoY)

 

 

o Product launched in the U.S in 2018 in collaboration with Kedrion o Total U.S market size > $150M o Only anti - Rabies IgG product with FDA approved label confirming safety and effectiveness in children KEDRAB Anti - Rabies Immune Globulin 12 16 18 12 16 16 31 24 25 36 10 % 20 % 23 % 27 % 32 % 0% 5% 10% 15% 20% 25% 30% 35% 0 5 10 15 20 25 30 35 40 2018 2019 2020 2021 2022 KEDRAB US Revenues (US$M) Kamada Kedrion Market Share Kamada / November 2023 5

 

 

$60M STRATEGIC INVESTMENT BY FIMI 6 Kamada / November 2023 o Proceeds from the private placement are expected to be used to accelerate the growth of the Company’s existing business and execution of strategic business development opportunities o Approximately 12.6 million ordinary shares at a price of $4.75 per share. Represents the average closing price of the Company’s shares on NASDAQ during the 20 trading days prior to the date of the agreement o Following the investment, FIMI beneficially own approximately 38% of Kamada’s outstanding ordinary shares and is a controlling shareholder of the Company, within the meaning of the Israeli Companies Law, 1999. o Secured a strategic share purchase agreement with FIMI Opportunity Funds , the leading private equity firm in Israel and an existing significant Kamada shareholder to purchase $60 million of the Company ordinary ’s shares in a private placement

 

 

FDA - APPROVED S PECIALITY PLASMA PRODUCTS; KEY FOCUS ON TRANSPLANTATION & RARE CONDITIONS KEDRAB/KAMRAB® [Rabies Immune Globulin (Human)] Post exposure prophylaxis of rabies infection CYTOGAM® [Cytomegalovirus Immune Globulin Intravenous (Human)] Prophylaxis of cytomegalovirus disease associated with transplantation VARIZIG® [Varicella Zoster Immune Globulin (Human)] Post - exposure prophylaxis of varicella in high - risk patient groups HEPGAM B® [Hepatitis B Immune Globulin (Human)] Prevention of HBV recurrence following liver transplantation WINRHO® [Rho(D) Immune Globulin (Human)] Treatment of immune thermobocytopunic purpura (ITP) & suppression of Rh isoimmunization (HDN) GLASSIA® [Alpha1 - Proteinase Inhibitor (Human)] Augmentation therapy for Alpha - 1 Antitrypsin Deficiency (AATD) Kamada / November 2023 7

 

 

CYTOGAM is the only plasma - derived IgG approved in the US and Canada for its indication o Indicated for prophylaxis of CMV disease in kidney, lung, liver, pancreas, heart and heart / lung transplants, an area of significant unmet medical need. International guidelines for the management of CMV in solid organ transplantation provide recommendations for prophylaxis in high - risk groups o Significant growth opportunities in the US, Canada and the international markets as volume of transplants continues to increase . o CYTOGAM manufactured at the Company’s facility in Israel is now available for commercial sales in the U . S . Availability in Canada is expected by the end of this year CYTOGAM CMV Immune Globulin Kamada / November 2023 8 o New clinical data highlighting five - year real - world survival benefits of high risk cmv mismatch lung transplant patients receiving CYTOGAM were presented at IDweek 2023 o Established a Scientific Advisory Board, consisting of eight U . S . based world - renowned thought leaders in the solid organ transplantation field, focuses on U . S . clinical program for CYTOGAM including new opportunities and future R&D possibilities

 

 

STRATEGIC ENTRY INTO THE U.S. PLASMA COLLECTION MARKET 9 Kamada / November 2023

 

 

STRATEGIC ENTRY INTO THE U.S. PLASMA COLLECTION MARKET Kamada Plasma was established in Q1 20 21 through the acquisition of an FDA - licensed plasma collection center in Texas, focusing on collecting hyper - immune plasma for specialty IgG’s o Strategic transaction which advances Kamad a ’s objective to evolve into a fully integrated specialty plasma company, enhancing self - supply for our hyperimmune products o Planning to open additional centers in the US, collecting hyper - immune plasma as well as normal source plasma (NSP) o Average annual revenues of a mature collection center ranges between $8M - $10M 10 Kamada / November 2023

 

 

o Non - Invasive, at - home treatment. Expected better ease of use and quality of life for AATD patients than current IV SOC o The leading new innovative AATD treatment in advanced clinical stage (Ph - 3) o Most effective mode of treatment for delivering therapeutic amounts of AAT directly into the airways o Studied in more than 200 individuals to date, with an established safety profile o Positive recent scientific advice from EMA : reconfirms overall study design and acknowledges the statistically and clinically meaningful FEV1 results demonstrated in previously study o Only 1/8th of the IV AAT dosing, more cost - effective ; Favorable market access landscape o To date enrolled over 30% of the overall required enrollment to the study o Substantial opportunity in over a $1 billion market Global, double - blind, randomized, placebo - controlled pivotal Phase 3 clinical trial to test the safety and efficacy of inhaled AAT in patients with AATD. Study design meet FDA and EMA’s requirements 11 Kamada / November 2023 INHALED AAT PHASE 3 PIVOTAL STUDY

 

 

RECENTLY APPOINTED INDEPENDENT DIRECTORS 12 Kamada / November 2023 Prof . Benjamin Dekel currently serves as the Founder and Chief Scientist of RenoVate Biopharmaceuticals Ltd . , as director at Sagol Center for Regenerative Medicine, Tel Aviv University ; as Vice - Dean, School of Medicine, Tel Aviv University ; Chief, Pediatric Nephrology and Pediatric Stem Cell Research Institute, Sheba Medical Center ; as a member of the Higher Committee on Cell and Gene Therapy, Israel Ministry of Health ; and as a member of the Scientific Advisory Board, Stemrad , Ltd . From June 2009 until June 2020 , Prof . Dekel served as Chief Scientist and a member of the board of directors of KidneyCure Inc . In 2011 , Prof . Dekel Served as a Visiting Scholar at Stanford University . From January 2003 to January 2005 , Prof . Dekel Served as a Fellow at the Weizmann Institute . Prof . Dekel holds an MD degree in Medicine from the Technion — Israel Institute of Technology and a PhD in Immunology & Transplantation Biology from the Weizmann Institute . Assaf Itshayek has over 15 years of hi - tech industry experience in senior management and finance executive positions in different industries (including online, fintech and energy) . Mr . Itshayek currently serves as a member of the board of directors of GoTo Global Ltd . , Qira Ltd . and Trinity Audio Ltd . From June 2021 until October 2022 , Mr . Itshayek served as the chief executive officer of NeraTech Media Ltd . Prior thereto, from November 2012 until June 2021 , Mr . Itshayek was at Somoto Ltd . (TASE : SMTO), initially as the chief financial officer and from December 2017 , as the chief executive officer . Prior thereto, Mr . Itshayek served as the chief financial officer of BlueSnap Inc . (from February 2021 until January 2021 ) and Digital Power Corporation Ltd . (June 2009 - May 2011 ) and served as the corporate controller of Metalink Ltd . from June 2006 until August 2008 . From December 1999 until July 2006 , Mr . Itshayek served as a TMT senior audit manager at Deloitte Brightman Almagor Zohar & Co . , a Firm in the Deloitte Global Network . Mr . Itshayek holds a B . A . degree in Business Administration and Accountancy from the College of Management and an M . B . A . degree from Tel Aviv University .

 

 

9M & Q3 SUMMARY FINANCIAL DATA 13 Kamada / November 2023 Details Q3/ 20 22 Q3/2023 9M/ 20 22 9M/2023 US $ M 25.6 31.4 67.2 86.4 PROPRIETARY 6.6 6.5 16.7 19.7 DISTRIBUTION 26% and 18% YoY increase for 9M & Q3, respectively 32.2 37.9 83.9 106.1 TOTAL REVENUES 12.9 14.8 31.4 41.1 GROSS PROFIT 40% 39% 37% 39% GROSS MARGIN (10.3) (10.4) (30.9) (33.8) OPEX 0.5 3.2 (5.3) 3.2 NET PROFIT 67% and 31% YoY increase for 9M & Q3, respectively 6.0 7.9 10.6 17.7 Adjusted EBITDA 31.3 52.6 CASH Including acquisition related intangible assets ($138M @ September 23) 319.6 337.1 TOTAL ASSETS 5 - year term loan paid down in full during Q3 - 23 18.5 0.0 BANK LOAN Acquisition related contingent consideration 85.7 72.1 CONTINGENT LIABILITIES 172.6 238.4 EQUITY

 

 

KAMADA INVESTMENT HIGHLIGHTS 14 Kamada / November 2023 A global leader; focused on areas of limited treatment alternatives Financially stable; profitable; cash - generating; continued double digit growth 6 FDA approved products with significant worldwide growth potential Leading innovative product for AAT Deficiency in late stage development; Targeting a market of over $1B Significant upside potential with limited downside

 

 

November 202 3 THANK YOU WWW.KAMADA.COM

 

 

Non - IFRS measures – Adjusted EBITDA Q3/ 20 22 Q3/2023 9M/ 20 22 9M/2023 US $ M 0.5 3.2 (5.3) 3.2 Net loss 0.0 0.1 0.1 0.2 Taxes on income 2.0 1.3 5.9 3.4 Revaluation of Acquisition related contingent consideration 0.0 (0.2) (0.2) 0.5 Other financial expense, net 1.8 1.8 5.3 5.3 Amortization of acquisition related intangible assets 1.3 1.4 3.9 4.2 Other depreciation and amortization expenses 0.4 0.3 0.9 0.9 Non - cash share - based compensation expenses 6.0 7.9 10.6 17.7 Adjusted EBITDA Kamada / November 2023 16

 

Exhibit 99.3

 

KAMADA LTD.

 

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

 

AS AT SEPTEMBER 30, 2023

 

TABLE OF CONTENTS

  

  Page
   
Condensed consolidated interim statements of financial position 1
   
Condensed consolidated interim statements of profit or loss and other comprehensive income 2
   
Condensed consolidated interim statements of changes in equity 3-5
   
Condensed consolidated interim statements of cash flows 6-7
   
Notes to the condensed consolidated interim financial statements 8-15

 

- - - - - - - - - - -

 

i

 

 

KAMADA LTD.

 

Condensed Consolidated Interim Statements of Financial Position

 

   As of September 30,   As of
December 31,
 
   2023   2022   2022 
   Unaudited   Audited 
             
Assets            
Current Assets            
Cash and cash equivalents  $52,603   $31,252   $34,258 
Trade receivables, net   25,107    23,997    27,252 
Other accounts  receivables   1,648    6,884    8,710 
Inventories   73,795    73,029    68,785 
Total Current Assets   153,153    135,162    139,005 
                
Non-Current Assets               
Property, plant and equipment, net   27,362    25,898    26,157 
Right-of-use assets   5,494    2,793    2,568 
Intangible assets, Goodwill and other long-term assets   142,501    148,620    147,072 
Contract assets   8,546    7,164    7,577 
Total Non-Current Assets   183,903    184,475    183,374 
Total Assets  $337,056   $319,637   $322,379 
Liabilities               
Current Liabilities               
Current maturities of bank loans  $
-
   $4,444   $4,444 
Current maturities of lease liabilities   1,138    1,004    1,016 
Current maturities of other long term liabilities   15,989    25,095    29,708 
Trade payables   12,812    30,619    32,917 
Other accounts payables   7,318    7,948    7,585 
Deferred revenues   15    40    35 
Total Current Liabilities   37,272    69,150    75,705 
                
Non-Current Liabilities               
Bank loans   
-
    14,074    12,963 
Lease liabilities   4,717    2,414    2,177 
Contingent consideration   19,642    20,705    17,534 
Other long-term liabilities   36,477    39,915    37,308 
Deferred revenues   
-
    15    
-
 
Employee benefit liabilities, net   558    813    672 
Total Non-Current Liabilities   61,394    77,936    70,654 
                
Shareholder’s Equity               
Ordinary shares   15,020    11,732    11,734 
Additional paid in capital  net   265,700    210,355    210,495 
Capital reserve due to translation to presentation currency   (3,490)   (3,490)   (3,490)
Capital reserve from hedges   (98)   (257)   (88)
Capital reserve from share-based payments   6,198    5,427    5,505 
Capital reserve from employee benefits   318    212    348 
Accumulated deficit   (45,258)   (51,428)   (48,484)
Total Shareholder’s Equity   238,390    172,551    176,020 
Total Liabilities and Shareholder’s Equity  $337,056   $319,637   $322,379 

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

1

 

 

KAMADA LTD.

 

Condensed Consolidated Interim 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, 
   2023   2022   2023   2022   2022 
   Unaudited   Unaudited   Audited 
                     
Revenues from proprietary products  $86,437   $67,198   $31,436   $25,580   $102,598 
Revenues from distribution   19,650    16,702    6,498    6,637    26,741 
                          
Total revenues   106,087    83,900    37,934    32,217    129,339 
                          
Cost of revenues from proprietary products   47,863    37,856    17,447    13,151    58,229 
Cost of revenues from distribution   17,146    14,632    5,684    6,196    24,407 
                          
Total cost of revenues   65,009    52,488    23,131    19,347    82,636 
                          
Gross profit   41,078    31,412    14,803    12,870    46,703 
                          
Research and development expenses   10,694    10,181    3,180    3,118    13,172 
Selling and marketing expenses   11,573    10,435    3,711    3,843    15,284 
General and administrative expenses   10,603    9,481    3,701    3,165    12,803 
Other expenses   920    801    (157)   182    912 
Operating income (loss)   7,288    514    4,368    2,562    4,532 
                          
Financial income   92    32    67    29    91 
Income (expenses) in respect of currency exchange differences and derivatives instruments, net   726    756    553    163    298 
Financial Income (expense) in respect of contingent consideration and other long- term liabilities.   (3,358)   (5,924)   (1,288)   (2,049)   (6,266)
Financial expenses   (1,343)   (583)   (404)   (211)   (914)
Income (expense) before tax on income   3,405    (5,205)   3,296    494    (2,259)
Taxes on income   179    60    73    10    62 
                          
Net income (loss)  $3,226   $(5,265)  $3,223   $484   $(2,321)
                          
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   (334)   (830)   (90)   (46)   (776)
Net amounts transferred to the statement of profit or loss for cash flow hedges   324    519    59    231    634 
Items that will not be reclassified to profit or loss in subsequent periods:                         
Remeasurement gain (loss) from defined benefit plan   (30)   361    (106)   (59)   497 
Total comprehensive income (loss)  $3,186   $(5,215)  $3,086   $610   $(1,966)
                          
Earnings per share attributable to equity holders of the Company:                         
Basic net earnings per share  $0.07   $(0.12)  $0.07   $0.01   $(0.05)
Diluted net earnings per share  $0.06   $(0.12)  $0.06   $0.01   $(0.05)

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

2

 

 

KAMADA LTD.

 

Condensed Consolidated Interim Statements of Changes in Equity

 

   Share   Additional
paid in
   Capital reserve
due to
translation to
presentation
   Capital
reserve
from
   Capital
reserve
from
sharebased
   Capital
reserve
from employee
   Accumulated   Total 
   capital   capital   currency   hedges   payments   benefits   deficit   equity 
   Unaudited 
   In thousands 
Balance as of January 1, 2023 (audited)  $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   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 

 

   Share   Additional
paid in
   Capital reserve
due to
translation to
presentation
   Capital
reserve
from
   Capital reserve
from
sharebased
   Capital
reserve
from employee
   Accumulated   Total 
   capital   capital   currency   hedges   payments   benefits   deficit   equity 
   Unaudited 
   In thousands 
Balance as of January 1, 2022 (audited)  $11,725   $210,204   $(3,490)  $54   $4,643   $(149)  $(46,163)  $176,824 
Net income   -    -    -    -    -    -    (5,265)   (5,265)
Other comprehensive income (loss)   
-
    
-
    
-
    (311)   
-
    361    
-
    50 
Total comprehensive income (loss)   
-
    
-
    
-
    (311)   
-
    361    (5,265)   (5,215)
Exercise and forfeiture of share-based payment into shares   7    151    -    -    (151)   -    -    7 
Cost of share-based payment   
-
    
-
    
-
    
-
    935    
-
    
-
    935 
Balance as of September 30, 2022  $11,732   $210,355   $(3,490)  $(257)  $5,427   $212   $(51,428)  $172,551 

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

3

 

 

KAMADA LTD.

 

Condensed Consolidated Interim Statements of Changes in Equity

 

   Share   Additional
paid in
   Capital reserve
due to
translation to
presentation
   Capital
reserve
from
   Capital
reserve
from
sharebased
   Capital
reserve
from employee
   Accumulated   Total 
   capital   capital   currency   hedges   payments   benefits   deficit   equity 
   Unaudited 
   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)   
-
    
-
    
-
    32    
-
    (115)   
-
    (83)
Total comprehensive income (loss)   
-
    
-
    
-
    32    
-
    (115)   1,812    1,729 
Issuance of ordinary shares, net of issuance cost   3,283    54,948    -    -    -    -    -    58,231 
Exercise and forfeiture of share-based payment into shares   -    25    -    -    (25)   -    -    - 
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 

 

   Share
capital
   Additional
paid in
capital
   Capital reserve
due to
translation to
presentation currency
   Capital
reserve
from
hedges
   Capital
reserve
from
sharebased payments
   Capital
reserve
from
employee
benefits
   Accumulated
deficit
   Total
equity
 
   Unaudited 
   In thousands 
Balance as of July 1, 2022  $11,731   $210,319   $(3,490)  $(442)  $5,097   $271   $(51,912)  $171,574 
Net income   -    
-
    
-
    
-
    
-
    
-
    484    484 
Other comprehensive income (loss)   
-
    
-
    
-
    185    
-
    (59)   
-
    126 
Total comprehensive income (loss)   
-
    
-
    
-
    185    
-
    (59)   484    610 
Exercise and forfeiture of share-based payment into shares   1    36    
-
    
-
    (36)   
-
    
-
    1 
Cost of share-based payment   
-
    
-
    
-
    
-
    366    
-
    
-
    366 
Balance as of September 30, 2022  $11,732   $210,355   $(3,490)  $(257)  $5,427   $212   $(51,428)  $172,551 

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

4

 

 

KAMADA LTD.

 

Condensed Consolidated Interim Statements of Changes in Equity

 

   Share
capital
   Additional
paid in
capital
   Capital reserve
due to
translation to
presentation currency
   Capital
reserve
from
hedges
   Capital
reserve
from
sharebased payments
   Capital
reserve
from
employee
benefits
   Accumulated
deficit
   Total
equity
 
   Audited 
   In thousands 
Balance as of January 1, 2022 (audited)  $11,725   $210,204   $(3,490)  $54   $4,643   $(149)  $(46,163)  $176,824 
Net income   
-
    
-
    
-
    
-
    
-
    
-
    (2,321)   (2,321)
Other comprehensive income (loss)   
-
    
-
    
-
    (142)   
-
    497    
-
    355 
                                         
Total comprehensive income (loss)   
-
    
-
    
-
    (142)   
-
    497    (2,321)   (1,966)
Exercise and forfeiture of share-based payment into shares   9    291    
-
    
-
    (291)        
-
    9 
Cost of share-based payment   
-
    
-
    
-
    
-
    1,153         
-
    1,153 
Balance as of December 31, 2022  $11,734   $210,495   $(3,490)  $(88)  $5,505   $348   $(48,484)  $176,020 

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

5

 

 

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, 
   2023   2022   2023   2022   2022 
   Unaudited   Audited 
   U.S Dollars In thousands 
Cash Flows from Operating Activities                    
Net income (loss)  $3,226   $(5,265)  $3,223   $484   $(2,321)
                          
Adjustments to reconcile net income to net cash provided by (used in) operating activities:                         
                          
Adjustments to the profit or loss items:                         
                          
Depreciation and impairment   9,506    9,143    3,179    3,055    12,155 
Financial expenses (income), net   3,883    5,719    1,072    2,068    6,791 
Cost of share-based payment   941    935    312    366    1,153 
Taxes on income   179    60    73    10    62 
Loss (gain) from sale of property and equipment   (5)   
-
    
-
    
-
    
-
 
Change in employee benefit liabilities, net   (144)   (106)   (104)   (10)   (111)
    14,360    15,751    4,532    5,489    20,050 
Changes in asset and liability items:                         
                          
Decrease (increase) in trade receivables, net   2,078    10,744    (618)   (6,358)   7,603 
Decrease (increase) in other accounts receivables   2,716    2,917    1,177    844    (578)
Decrease (increase) in inventories   (5,011)   (5,606)   6,441    (8,509)   (1,361)
Decrease (increase) in deferred expenses   2,763    (2,596)   (279)   (2,112)   (1,340)
Increase (decrease) in trade payables   (18,617)   5,895    (13,181)   13,738    7,055 
Increase (decrease) in other accounts payables   (359)   566    49    2,083    290 
Decrease in deferred revenues   (20)   
-
    (23)   
-
    (20)
    (16,450)   11,920    (6,434)   (314)   11,649 
Cash received (paid) during the period for:                         
                          
Interest paid   (1,149)   (550)   (405)   (170)   (853)
Interest received   92    15    67    12    97 
Taxes paid   (174)   (27)   (62)   (9)   (36)
    (1,231)   (562)   (400)   (167)   (792)
                          
Net cash provided by (used in) operating activities  $(95)  $21,844   $921   $5,492   $28,586 

 

6

 

 

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, 
   2023   2022   2023   2022   2022 
   Unaudited   Audited 
   U.S Dollars In thousands 
Cash Flows from Investing Activities                    
                     
Purchase of property and equipment and intangible assets  $(3,876)  $(2,807)  $(1,729)  $(1,616)  $(3,784)
Proceeds from sale of property and equipment   6    
-
    
-
    
-
    
-
 
Net cash provided by (used in) investing activities   (3,870)   (2,807)   (1,729)   (1,616)   (3,784)
                          
Cash Flows from Financing Activities                         
                          
Proceeds from exercise of share base payments   3    7    -    1    9 
Repayment of lease liabilities   (768)   (842)   (251)   (269)   (1,098)
Repayment of long-term loans   (17,407)   (1,517)   (15,185)   (1,116)   (2,628)
Repayment of other long-term liabilities   (17,500)   (4,120)   (11,500)   (877)   (5,626)
Proceeds from issuance of ordinary shares, net   58,231    
-
    58,231    
-
    
-
 
Net cash provided by (used in) financing activities   22,559    (6,472)   31,295    (2,261)   (9,343)
                          
Exchange differences on balances of cash and cash equivalent   (249)   100    328    (296)   212 
                          
Increase (decrease) in cash and cash equivalents   18,345    12,665    30,815    1,319    15,671 
                          
Cash and cash equivalents at the beginning of the period   34,258    18,587    21,788    29,933    18,587 
                          
Cash and cash equivalents at the end of the period  $52,603   $31,252   $52,603   $31,252   $34,258 
                          
Significant non-cash transactions                         
Right-of-use asset recognized with corresponding lease liability  $3,880   $526   $295   $230   $551 
Purchase of property and equipment and Intangible assets  $681   $134   $681   $134   $618 

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

7

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim 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 CYTOGAM®, KEDRAB®, 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, 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 added eleven biosimilar products to its Israeli distribution portfolio, which, subject to 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 hyper-immune plasma used in the manufacture of KAMRHO (D). 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.

 

8

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim Financial Statements

 

Note 2:- Significant Accounting Policies

 

  a. Basis of preparation of the interim consolidated financial statements:

 

The 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”.

 

  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.

 

The Company believes that the adoption of the Amendment will not have an effect on its financial statements.  

 

9

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim Financial Statements

 

Note 3:- Significant events in the reporting period

 

a.Grant of options to the purchase ordinary shares of the Company to employees, executive officers:

 

1.On February 27, 2023, the Company’s Board of Directors approved the grant of options to purchase up to 147,000 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:

 

  - On February 27, 2023, 60,331 options to purchase the ordinary shares of the Company, at an exercise price of NIS 16.53 (USD 4.50) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $108 thousands.

 

  -

On March 01, 2023 3,333 options to purchase ordinary shares of the Company, at an exercise price of NIS 16.63 (USD 4.57) 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 $5.7 thousands.

 

  - On March 02, 2023 40,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 16.76 (USD 4.60) 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 $71 thousands.

 

  - On April 23, 2023 40,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 17.67 (USD 4.83) 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 $65 thousands.

 

Under the US Appendix:

 

  - On February 27, 2023 3,333 options to purchase the ordinary shares of the Company, at an exercise price of USD 4.57 per share. The fair value of the options was estimated on the date of grant was estimated at $5.80 thousands.

 

2.On May 28, 2023, the Company’s Board of Directors approved the grant of 90,000 options to purchase ordinary shares of the Company, under the Israeli Share Option Plan, at an exercise price of NIS 19.46 (USD 5.25) 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 $217 thousands.

 

3.On August 15, 2023 the Company’s Board of Directors approved the grant of 20,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 20.07 (USD 5.33) 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 $36.8 thousands.

 

10

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim Financial Statements

 

Note 3:- Significant events in the reporting period (cont.)

 

4.On August 21, 2023, the Company’s Board of Directors approved the grant of options to purchase up to 54,650 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:

 

  - On August 21, 2023, 24,050 options to purchase the ordinary shares of the Company, at an exercise price of NIS 21.54 (USD 5.68) 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.

 

  - On September 26, 2023, 9,050 options to purchase ordinary shares of the Company, at an exercise price of NIS 20.60 (USD 5.39) 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 $17 thousands.

 

  - On October 4, 2023, 2,500 options to purchase ordinary shares of the Company, at an exercise price of NIS 21.51 (USD 5.39) 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 $5 thousands.

 

Under the US Appendix:

 

  - On August 21, 2023, 7,500 options to purchase ordinary shares of the Company, at an exercise price of USD 5.86 per share. The fair value of the options was estimated on the date of grant was estimated at $18 thousands.

 

  - On August 30, 2023, 9,050 options to purchase ordinary shares of the Company, at an exercise price of USD 5.91 per share. The fair value of the options was estimated on the date of grant was estimated at $22 thousands.

 

  - On September 25, 2023, 2,500 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.47 per share. The fair value of the options was estimated on the date of grant was estimated at $5.5 thousands.

 

5.

On September 7, 2023, Following the closing of the Private Placement to FIMI, the Company granted to the External Board of Directors members 32,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 21.63 (USD 5.62) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $45 thousands.

 

  b. Private Placement with FIMI Opportunity Funds

 

On September 7, 2023, the Company closed a $60 million private placement (the “Private Placement”) with FIMI Opportunity Funds (“FIMI”), the leading private equity firm in Israel and a large existing shareholder of the Company. Under the terms of the Private Placement, the Company issued an aggregate of 12,631,579 ordinary shares to FIMI at a price of $4.75 per share (which represented the average closing price of the Company’s shares on NASDAQ during the 20 trading days prior to the date of execution of the Private Placement). Following the closing of the Private Placement, FIMI beneficially owns approximately 38% of the Company’s outstanding ordinary shares and became a controlling shareholder of the Company, within the meaning of the Israeli Companies Law, 1999.

 

  c. Bank Loan

 

On September 19, 2023, the Company paid down in full the outstanding balance of a $20,000 thousand 5-year term loan borrowed during November 2021 from Bank Hapoalim, an Israeli bank.

 

11

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim 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
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
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Nine months period ended September 30, 2022            
Revenues  $67,198   $16,702   $83,900 
Gross profit  $29,342   $2,070   $31,412 
Unallocated corporate expenses             (30,898)
Finance expenses, net             (5,719)
Income before taxes on income            $(5,205)

 

   Proprietary
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 

  

   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Three months period ended September 30, 2022            
Revenues  $25,580   $6,637   $32,217 
Gross profit  $12,429   $441   $12,870 
Unallocated corporate expenses             (10,308)
Finance expenses, net             (2,068)
Income before taxes on income            $494 

 

12

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim Financial Statements

 

Note 4:- Operating Segments (cont.)

 

  b. Reporting on operating segments:

 

   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Year Ended December 31, 2022            
Revenues  $102,598   $26,741   $129,339 
Gross profit  $44,369   $2,334   $46,703 
Unallocated corporate expenses             (42,171)
Finance expenses, net             (6,791)
Income before taxes on income            $(2,259)

 

  c. Reporting on operating segments by geographic region:

 

   Nine months period ended
September 30, 2023
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America  $62,150   $
-
   $62,150 
Israel   3,119    19,650    22,769 
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 

 

13

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim Financial Statements

 

Note 4:- Operating Segments (cont.)

 

  c.

Reporting on operating segments by geographic region:

 

   Nine months period ended
September 30, 2022
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $52,866   $
-
   $52,866 
Israel   3,631    16,702    20,333 
Europe   2,192    
-
    2,192 
Latin America   5,301    
-
    5,301 
Asia   2,665    
-
    2,665 
Others   543    
-
    543 
   $67,198   $16,702   $83,900 

 

   Three months period ended
September 30, 2023
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $25,294   $
-
   $25,294 
Israel   1,017    6,498    7,515 
Europe   3,280    
-
    3,280 
Latin America   328    
-
    328 
Asia   1,479    
-
    1,479 
Others   38    
-
    38 
   $31,436   $6,498   $37,934 

 

   Three months period ended
September 30, 2022
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $20,597   $
-
   $20,597 
Israel   1,377    6,637    8,014 
Europe   750    
-
    750 
Latin America   1,775    
-
    1,775 
Asia   767    
-
    767 
Others   314    
-
    314 
   $25,580   $6,637   $32,217 

 

14

 

 

KAMADA LTD.

 

Notes to the Condensed Consolidated Interim Financial Statements

 

Note 4:- Operating Segments (cont.)

 

   Year ended December 31, 2022 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Geographical markets            
U.S.A and North America  $75,851   $
-
   $75,851 
Israel   5,290    26,741    32,031 
Europe   5,277    
-
    5,277 
Latin America   11,294    
-
    11,294 
Asia   4,581    
-
    4,581 
Others   305    
-
    305 
   $102,598   $26,741   $129,339 

 

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, 2023            
Derivatives instruments  $
   -
   $(98)  $
-
 
Contingent consideration   
-
    
-
    (22,326)
                
September 30, 2022               
Derivatives instruments   
 
    (180)   
 
 
Contingent consideration  $
-
   $    $(23,705)
                
December 31, 2022               
Derivatives instruments  $
-
   $(92)  $
-
 
Contingent consideration  $
-
   $
-
   $(23,534)

 

During the nine months ended on September 30, 2023 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.

 

15

 

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v3.23.3
Document And Entity Information
9 Months Ended
Sep. 30, 2023
Document Information Line Items  
Entity Registrant Name Kamada Ltd.
Document Type 6-K
Current Fiscal Year End Date --12-31
Amendment Flag false
Entity Central Index Key 0001567529
Document Period End Date Sep. 30, 2023
Document Fiscal Year Focus 2023
Document Fiscal Period Focus Q3
Entity File Number 001-35948
v3.23.3
Condensed Consolidated Interim Statements of Financial Position - USD ($)
Sep. 30, 2023
Dec. 31, 2022
Sep. 30, 2022
Current Assets      
Cash and cash equivalents $ 52,603 $ 34,258 $ 31,252
Trade receivables, net 25,107 27,252 23,997
Other accounts receivables 1,648 8,710 6,884
Inventories 73,795 68,785 73,029
Total Current Assets 153,153 139,005 135,162
Non-Current Assets      
Property, plant and equipment, net 27,362 26,157 25,898
Right-of-use assets 5,494 2,568 2,793
Intangible assets, Goodwill and other long-term assets 142,501 147,072 148,620
Contract assets 8,546 7,577 7,164
Total Non-Current Assets 183,903 183,374 184,475
Total Assets 337,056 322,379 319,637
Current Liabilities      
Current maturities of bank loans 4,444 4,444
Current maturities of lease liabilities 1,138 1,016 1,004
Current maturities of other long term liabilities 15,989 29,708 25,095
Trade payables 12,812 32,917 30,619
Other accounts payables 7,318 7,585 7,948
Deferred revenues 15 35 40
Total Current Liabilities 37,272 75,705 69,150
Non-Current Liabilities      
Bank loans 12,963 14,074
Lease liabilities 4,717 2,177 2,414
Contingent consideration 19,642 17,534 20,705
Other long-term liabilities 36,477 37,308 39,915
Deferred revenues 15
Employee benefit liabilities, net 558 672 813
Total Non-Current Liabilities 61,394 70,654 77,936
Shareholder’s Equity      
Ordinary shares 15,020 11,734 11,732
Additional paid in capital net 265,700 210,495 210,355
Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)
Capital reserve from hedges (98) (88) (257)
Capital reserve from share-based payments 6,198 5,505 5,427
Capital reserve from employee benefits 318 348 212
Accumulated deficit (45,258) (48,484) (51,428)
Total Shareholder’s Equity 238,390 176,020 172,551
Total Liabilities and Shareholder’s Equity $ 337,056 $ 322,379 $ 319,637
v3.23.3
Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Dec. 31, 2022
Income Statement [Abstract]          
Revenues from proprietary products $ 31,436 $ 25,580 $ 86,437 $ 67,198 $ 102,598
Revenues from distribution 6,498 6,637 19,650 16,702 26,741
Total revenues 37,934 32,217 106,087 83,900 129,339
Cost of revenues from proprietary products 17,447 13,151 47,863 37,856 58,229
Cost of revenues from distribution 5,684 6,196 17,146 14,632 24,407
Total cost of revenues 23,131 19,347 65,009 52,488 82,636
Gross profit 14,803 12,870 41,078 31,412 46,703
Research and development expenses 3,180 3,118 10,694 10,181 13,172
Selling and marketing expenses 3,711 3,843 11,573 10,435 15,284
General and administrative expenses 3,701 3,165 10,603 9,481 12,803
Other expenses (157) 182 920 801 912
Operating income (loss) 4,368 2,562 7,288 514 4,532
Financial income 67 29 92 32 91
Income (expenses) in respect of currency exchange differences and derivatives instruments, net 553 163 726 756 298
Financial Income (expense) in respect of contingent consideration and other long- term liabilities. (1,288) (2,049) (3,358) (5,924) (6,266)
Financial expenses (404) (211) (1,343) (583) (914)
Income (expense) before tax on income 3,296 494 3,405 (5,205) (2,259)
Taxes on income 73 10 179 60 62
Net income (loss) 3,223 484 3,226 (5,265) (2,321)
Other comprehensive income (loss) :          
Gain (loss) on cash flow hedges (90) (46) (334) (830) (776)
Net amounts transferred to the statement of profit or loss for cash flow hedges 59 231 324 519 634
Items that will not be reclassified to profit or loss in subsequent periods:          
Remeasurement gain (loss) from defined benefit plan (106) (59) (30) 361 497
Total comprehensive income (loss) $ 3,086 $ 610 $ 3,186 $ (5,215) $ (1,966)
Earnings per share attributable to equity holders of the Company:          
Basic net earnings per share (in Dollars per share) $ 0.07 $ 0.01 $ 0.07 $ (0.12) $ (0.05)
Diluted net earnings per share (in Dollars per share) $ 0.06 $ 0.01 $ 0.06 $ (0.12) $ (0.05)
v3.23.3
Condensed Consolidated Interim Statements of Changes in Equity - USD ($)
Share capital
Additional paid in capital
Capital reserve due to translation to presentation currency
Capital reserve from hedges
Capital reserve from sharebased payments
Capital reserve from employee benefits
Accumulated deficit
Total
Balance at Dec. 31, 2021 $ 11,725 $ 210,204 $ (3,490) $ 54 $ 4,643 $ (149) $ (46,163) $ 176,824
Net income             (5,265) (5,265)
Other comprehensive income (loss) (311) 361 50
Total comprehensive income (loss) (311) 361 (5,265) (5,215)
Exercise and forfeiture of share-based payment into shares 7 151     (151)     7
Cost of share-based payment 935 935
Balance at Sep. 30, 2022 11,732 210,355 (3,490) (257) 5,427 212 (51,428) 172,551
Balance at Dec. 31, 2021 11,725 210,204 (3,490) 54 4,643 (149) (46,163) 176,824
Net income (2,321) (2,321)
Other comprehensive income (loss) (142) 497 355
Total comprehensive income (loss) (142) 497 (2,321) (1,966)
Exercise and forfeiture of share-based payment into shares 9 291 (291)   9
Cost of share-based payment 1,153   1,153
Balance at Dec. 31, 2022 11,734 210,495 (3,490) (88) 5,505 348 (48,484) 176,020
Balance at Jun. 30, 2022 11,731 210,319 (3,490) (442) 5,097 271 (51,912) 171,574
Net income   484 484
Other comprehensive income (loss) 185 (59) 126
Total comprehensive income (loss) 185 (59) 484 610
Exercise and forfeiture of share-based payment into shares 1 36 (36) 1
Cost of share-based payment 366 366
Balance at Sep. 30, 2022 11,732 210,355 (3,490) (257) 5,427 212 (51,428) 172,551
Balance at Dec. 31, 2022 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 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 at Sep. 30, 2023 15,020 265,700 (3,490) (98) 6,198 318 (45,258) 238,390
Balance at Jun. 30, 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) 32 (115) (83)
Total comprehensive income (loss) 32 (115) 1,812 1,729
Issuance of ordinary shares, net of issuance cost 3,283 54,948           58,231
Exercise and forfeiture of share-based payment into shares   25     (25)      
Cost of share-based payment 321 321
Balance at Sep. 30, 2023 $ 15,020 $ 265,700 $ (3,490) $ (98) $ 6,198 $ 318 $ (45,258) $ 238,390
v3.23.3
Condensed Consolidated Interim Statements of Cash Flows - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Dec. 31, 2022
Cash Flows from Operating Activities          
Net income (loss) $ 3,223 $ 484 $ 3,226 $ (5,265) $ (2,321)
Adjustments to the profit or loss items:          
Depreciation and impairment 3,179 3,055 9,506 9,143 12,155
Financial expenses (income), net 1,072 2,068 3,883 5,719 6,791
Cost of share-based payment 312 366 941 935 1,153
Taxes on income 73 10 179 60 62
Loss (gain) from sale of property and equipment (5)
Change in employee benefit liabilities, net (104) (10) (144) (106) (111)
Adjustments to the profit or loss items 4,532 5,489 14,360 15,751 20,050
Changes in asset and liability items:          
Decrease (increase) in trade receivables, net (618) (6,358) 2,078 10,744 7,603
Decrease (increase) in other accounts receivables 1,177 844 2,716 2,917 (578)
Decrease (increase) in inventories 6,441 (8,509) (5,011) (5,606) (1,361)
Decrease (increase) in deferred expenses (279) (2,112) 2,763 (2,596) (1,340)
Increase (decrease) in trade payables (13,181) 13,738 (18,617) 5,895 7,055
Increase (decrease) in other accounts payables 49 2,083 (359) 566 290
Decrease in deferred revenues (23) (20) (20)
Total Changes in asset and liability (6,434) (314) (16,450) 11,920 11,649
Cash received (paid) during the period for:          
Interest paid (405) (170) (1,149) (550) (853)
Interest received 67 12 92 15 97
Taxes paid (62) (9) (174) (27) (36)
Cash received (paid) during the year (400) (167) (1,231) (562) (792)
Net cash provided by (used in) operating activities 921 5,492 (95) 21,844 28,586
Cash Flows from Investing Activities          
Purchase of property and equipment and intangible assets (1,729) (1,616) (3,876) (2,807) (3,784)
Proceeds from sale of property and equipment 6
Net cash provided by (used in) investing activities (1,729) (1,616) (3,870) (2,807) (3,784)
Cash Flows from Financing Activities          
Proceeds from exercise of share base payments   1 3 7 9
Repayment of lease liabilities (251) (269) (768) (842) (1,098)
Repayment of long-term loans (15,185) (1,116) (17,407) (1,517) (2,628)
Repayment of other long-term liabilities (11,500) (877) (17,500) (4,120) (5,626)
Proceeds from issuance of ordinary shares, net 58,231 58,231
Net cash provided by (used in) financing activities 31,295 (2,261) 22,559 (6,472) (9,343)
Exchange differences on balances of cash and cash equivalent 328 (296) (249) 100 212
Increase (decrease) in cash and cash equivalents 30,815 1,319 18,345 12,665 15,671
Cash and cash equivalents at the beginning of the period 21,788 29,933 34,258 18,587 18,587
Cash and cash equivalents at the end of the period 52,603 31,252 52,603 31,252 34,258
Significant non-cash transactions          
Right-of-use asset recognized with corresponding lease liability 295 230 3,880 526 551
Purchase of property and equipment and Intangible assets $ 681 $ 134 $ 681 $ 134 $ 618
v3.23.3
General
9 Months Ended
Sep. 30, 2023
General [Abstract]  
General

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 CYTOGAM®, KEDRAB®, 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, 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 added eleven biosimilar products to its Israeli distribution portfolio, which, subject to 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 hyper-immune plasma used in the manufacture of KAMRHO (D). 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.

v3.23.3
Significant Accounting Policies
9 Months Ended
Sep. 30, 2023
Significant Accounting Policies [Abstract]  
Significant Accounting Policies

Note 2:- Significant Accounting Policies

 

  a. Basis of preparation of the interim consolidated financial statements:

 

The 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”.

 

  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.

 

The Company believes that the adoption of the Amendment will not have an effect on its financial statements.  

v3.23.3
Significant Events in the Reporting Period
9 Months Ended
Sep. 30, 2023
Significant Events in the Reporting Period [Abstract]  
Significant Events in the Reporting Period

Note 3:- Significant events in the reporting period

 

a.Grant of options to the purchase ordinary shares of the Company to employees, executive officers:

 

1.On February 27, 2023, the Company’s Board of Directors approved the grant of options to purchase up to 147,000 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:

 

  - On February 27, 2023, 60,331 options to purchase the ordinary shares of the Company, at an exercise price of NIS 16.53 (USD 4.50) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $108 thousands.

 

  -

On March 01, 2023 3,333 options to purchase ordinary shares of the Company, at an exercise price of NIS 16.63 (USD 4.57) 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 $5.7 thousands.

 

  - On March 02, 2023 40,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 16.76 (USD 4.60) 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 $71 thousands.

 

  - On April 23, 2023 40,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 17.67 (USD 4.83) 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 $65 thousands.

 

Under the US Appendix:

 

  - On February 27, 2023 3,333 options to purchase the ordinary shares of the Company, at an exercise price of USD 4.57 per share. The fair value of the options was estimated on the date of grant was estimated at $5.80 thousands.

 

2.On May 28, 2023, the Company’s Board of Directors approved the grant of 90,000 options to purchase ordinary shares of the Company, under the Israeli Share Option Plan, at an exercise price of NIS 19.46 (USD 5.25) 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 $217 thousands.

 

3.On August 15, 2023 the Company’s Board of Directors approved the grant of 20,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 20.07 (USD 5.33) 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 $36.8 thousands.

 

4.On August 21, 2023, the Company’s Board of Directors approved the grant of options to purchase up to 54,650 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:

 

  - On August 21, 2023, 24,050 options to purchase the ordinary shares of the Company, at an exercise price of NIS 21.54 (USD 5.68) 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.

 

  - On September 26, 2023, 9,050 options to purchase ordinary shares of the Company, at an exercise price of NIS 20.60 (USD 5.39) 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 $17 thousands.

 

  - On October 4, 2023, 2,500 options to purchase ordinary shares of the Company, at an exercise price of NIS 21.51 (USD 5.39) 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 $5 thousands.

 

Under the US Appendix:

 

  - On August 21, 2023, 7,500 options to purchase ordinary shares of the Company, at an exercise price of USD 5.86 per share. The fair value of the options was estimated on the date of grant was estimated at $18 thousands.

 

  - On August 30, 2023, 9,050 options to purchase ordinary shares of the Company, at an exercise price of USD 5.91 per share. The fair value of the options was estimated on the date of grant was estimated at $22 thousands.

 

  - On September 25, 2023, 2,500 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.47 per share. The fair value of the options was estimated on the date of grant was estimated at $5.5 thousands.

 

5.

On September 7, 2023, Following the closing of the Private Placement to FIMI, the Company granted to the External Board of Directors members 32,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 21.63 (USD 5.62) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $45 thousands.

 

  b. Private Placement with FIMI Opportunity Funds

 

On September 7, 2023, the Company closed a $60 million private placement (the “Private Placement”) with FIMI Opportunity Funds (“FIMI”), the leading private equity firm in Israel and a large existing shareholder of the Company. Under the terms of the Private Placement, the Company issued an aggregate of 12,631,579 ordinary shares to FIMI at a price of $4.75 per share (which represented the average closing price of the Company’s shares on NASDAQ during the 20 trading days prior to the date of execution of the Private Placement). Following the closing of the Private Placement, FIMI beneficially owns approximately 38% of the Company’s outstanding ordinary shares and became a controlling shareholder of the Company, within the meaning of the Israeli Companies Law, 1999.

 

  c. Bank Loan

 

On September 19, 2023, the Company paid down in full the outstanding balance of a $20,000 thousand 5-year term loan borrowed during November 2021 from Bank Hapoalim, an Israeli bank.

v3.23.3
Operating Segments
9 Months Ended
Sep. 30, 2023
Operating Segments [Abstract]  
Operating Segments

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
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
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Nine months period ended September 30, 2022            
Revenues  $67,198   $16,702   $83,900 
Gross profit  $29,342   $2,070   $31,412 
Unallocated corporate expenses             (30,898)
Finance expenses, net             (5,719)
Income before taxes on income            $(5,205)

 

   Proprietary
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 

  

   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Three months period ended September 30, 2022            
Revenues  $25,580   $6,637   $32,217 
Gross profit  $12,429   $441   $12,870 
Unallocated corporate expenses             (10,308)
Finance expenses, net             (2,068)
Income before taxes on income            $494 

 

  b. Reporting on operating segments:

 

   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Year Ended December 31, 2022            
Revenues  $102,598   $26,741   $129,339 
Gross profit  $44,369   $2,334   $46,703 
Unallocated corporate expenses             (42,171)
Finance expenses, net             (6,791)
Income before taxes on income            $(2,259)

 

  c. Reporting on operating segments by geographic region:

 

   Nine months period ended
September 30, 2023
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America  $62,150   $
-
   $62,150 
Israel   3,119    19,650    22,769 
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 

 

  c.

Reporting on operating segments by geographic region:

 

   Nine months period ended
September 30, 2022
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $52,866   $
-
   $52,866 
Israel   3,631    16,702    20,333 
Europe   2,192    
-
    2,192 
Latin America   5,301    
-
    5,301 
Asia   2,665    
-
    2,665 
Others   543    
-
    543 
   $67,198   $16,702   $83,900 

 

   Three months period ended
September 30, 2023
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $25,294   $
-
   $25,294 
Israel   1,017    6,498    7,515 
Europe   3,280    
-
    3,280 
Latin America   328    
-
    328 
Asia   1,479    
-
    1,479 
Others   38    
-
    38 
   $31,436   $6,498   $37,934 

 

   Three months period ended
September 30, 2022
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $20,597   $
-
   $20,597 
Israel   1,377    6,637    8,014 
Europe   750    
-
    750 
Latin America   1,775    
-
    1,775 
Asia   767    
-
    767 
Others   314    
-
    314 
   $25,580   $6,637   $32,217 

 

   Year ended December 31, 2022 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Geographical markets            
U.S.A and North America  $75,851   $
-
   $75,851 
Israel   5,290    26,741    32,031 
Europe   5,277    
-
    5,277 
Latin America   11,294    
-
    11,294 
Asia   4,581    
-
    4,581 
Others   305    
-
    305 
   $102,598   $26,741   $129,339 
v3.23.3
Financial Instruments
9 Months Ended
Sep. 30, 2023
Financial Instruments [Abstract]  
Financial Instruments

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, 2023            
Derivatives instruments  $
   -
   $(98)  $
-
 
Contingent consideration   
-
    
-
    (22,326)
                
September 30, 2022               
Derivatives instruments   
 
    (180)   
 
 
Contingent consideration  $
-
   $    $(23,705)
                
December 31, 2022               
Derivatives instruments  $
-
   $(92)  $
-
 
Contingent consideration  $
-
   $
-
   $(23,534)

 

During the nine months ended on September 30, 2023 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.

v3.23.3
Accounting Policies, by Policy (Policies)
9 Months Ended
Sep. 30, 2023
Accounting Policies [Abstract]  
Basis of preparation of the interim consolidated financial statements
  a. Basis of preparation of the interim consolidated financial statements:

The 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”.

Implementation of new accounting standards
  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.

The Company believes that the adoption of the Amendment will not have an effect on its financial statements.  

v3.23.3
Operating Segments (Tables)
9 Months Ended
Sep. 30, 2023
Operating Segments [Abstract]  
Schedule of Reporting on Operating Segments Reporting on operating segments:
   Proprietary
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
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Nine months period ended September 30, 2022            
Revenues  $67,198   $16,702   $83,900 
Gross profit  $29,342   $2,070   $31,412 
Unallocated corporate expenses             (30,898)
Finance expenses, net             (5,719)
Income before taxes on income            $(5,205)
   Proprietary
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 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Three months period ended September 30, 2022            
Revenues  $25,580   $6,637   $32,217 
Gross profit  $12,429   $441   $12,870 
Unallocated corporate expenses             (10,308)
Finance expenses, net             (2,068)
Income before taxes on income            $494 

 

   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Year Ended December 31, 2022            
Revenues  $102,598   $26,741   $129,339 
Gross profit  $44,369   $2,334   $46,703 
Unallocated corporate expenses             (42,171)
Finance expenses, net             (6,791)
Income before taxes on income            $(2,259)
Schedule of Reporting on Operating Segments Geographic Region Reporting on operating segments by geographic region:
   Nine months period ended
September 30, 2023
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America  $62,150   $
-
   $62,150 
Israel   3,119    19,650    22,769 
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 

 

   Nine months period ended
September 30, 2022
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $52,866   $
-
   $52,866 
Israel   3,631    16,702    20,333 
Europe   2,192    
-
    2,192 
Latin America   5,301    
-
    5,301 
Asia   2,665    
-
    2,665 
Others   543    
-
    543 
   $67,198   $16,702   $83,900 
   Three months period ended
September 30, 2023
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $25,294   $
-
   $25,294 
Israel   1,017    6,498    7,515 
Europe   3,280    
-
    3,280 
Latin America   328    
-
    328 
Asia   1,479    
-
    1,479 
Others   38    
-
    38 
   $31,436   $6,498   $37,934 
   Three months period ended
September 30, 2022
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $20,597   $
-
   $20,597 
Israel   1,377    6,637    8,014 
Europe   750    
-
    750 
Latin America   1,775    
-
    1,775 
Asia   767    
-
    767 
Others   314    
-
    314 
   $25,580   $6,637   $32,217 

 

   Year ended December 31, 2022 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Geographical markets            
U.S.A and North America  $75,851   $
-
   $75,851 
Israel   5,290    26,741    32,031 
Europe   5,277    
-
    5,277 
Latin America   11,294    
-
    11,294 
Asia   4,581    
-
    4,581 
Others   305    
-
    305 
   $102,598   $26,741   $129,339 
v3.23.3
Financial Instruments (Tables)
9 Months Ended
Sep. 30, 2023
Financial Instruments [Abstract]  
Schedule of Financial Assets (Liabilities) Measured at Fair Value Financial assets (liabilities) measured at fair value
   Level 1   Level 2   Level 3 
   U.S Dollars in thousands 
September 30, 2023            
Derivatives instruments  $
   -
   $(98)  $
-
 
Contingent consideration   
-
    
-
    (22,326)
                
September 30, 2022               
Derivatives instruments   
 
    (180)   
 
 
Contingent consideration  $
-
   $    $(23,705)
                
December 31, 2022               
Derivatives instruments  $
-
   $(92)  $
-
 
Contingent consideration  $
-
   $
-
   $(23,534)
v3.23.3
Significant Events in the Reporting Period (Details)
Oct. 04, 2023
USD ($)
$ / shares
shares
Oct. 04, 2023
USD ($)
₪ / shares
shares
Sep. 26, 2023
USD ($)
$ / shares
shares
Sep. 26, 2023
USD ($)
₪ / shares
shares
Sep. 25, 2023
USD ($)
$ / shares
shares
Sep. 19, 2023
USD ($)
Sep. 07, 2023
USD ($)
$ / shares
shares
Sep. 07, 2023
USD ($)
$ / shares
₪ / shares
shares
Aug. 30, 2023
USD ($)
$ / shares
shares
Aug. 21, 2023
USD ($)
$ / shares
shares
Aug. 21, 2023
USD ($)
₪ / shares
shares
Aug. 15, 2023
USD ($)
$ / shares
shares
Aug. 15, 2023
USD ($)
₪ / shares
shares
May 28, 2023
USD ($)
$ / shares
shares
May 28, 2023
USD ($)
₪ / shares
shares
Apr. 23, 2023
USD ($)
$ / shares
shares
Apr. 23, 2023
USD ($)
₪ / shares
shares
Mar. 01, 2023
USD ($)
$ / shares
shares
Mar. 01, 2023
USD ($)
₪ / shares
shares
Feb. 27, 2023
USD ($)
$ / shares
shares
Feb. 27, 2023
USD ($)
₪ / shares
shares
Mar. 02, 2022
USD ($)
$ / shares
₪ / shares
shares
Significant Events in the Reporting Period (Details) [Line Items]                                            
Option granted | shares                   7,500 7,500                 3,333 3,333  
Exercise price | $ / shares                   $ 5.86                   $ 4.57    
Fair value of options (in Dollars)                   $ 18,000 $ 18,000                 $ 5,800 $ 5,800  
Private placement with fimi opportunity funds (in Dollars)             $ 60,000,000 $ 60,000,000                            
Issued ordinary shares | shares             12,631,579 12,631,579                            
Price per share (in Dollars per share) | $ / shares             $ 4.75 $ 4.75                            
Outstanding shares percentage             38.00% 38.00%                            
Loan borrowed period           5 years                                
Outstanding balance value (in Dollars)           $ 20,000,000                                
Board of Directors [Member]                                            
Significant Events in the Reporting Period (Details) [Line Items]                                            
Option granted | shares                   54,650 54,650 20,000 20,000 90,000 90,000         147,000 147,000  
Exercise price | (per share)                       $ 5.33 ₪ 20.07 $ 5.25 ₪ 19.46              
Fair value of options (in Dollars)                       $ 36,800 ₪ 36,800 $ 217,000 ₪ 217,000              
Option [Member]                                            
Significant Events in the Reporting Period (Details) [Line Items]                                            
Option granted | shares 2,500 2,500 9,050 9,050 2,500   32,000 32,000 9,050 24,050 24,050         40,000 40,000 3,333 3,333 60,331 60,331 40,000
Exercise price | (per share) $ 5.39 ₪ 21.51 $ 5.39 ₪ 20.6 $ 5.47   $ 5.62 $ 21.63 $ 5.91 $ 5.68 $ 21.54         $ 4.83 ₪ 17.67 $ 4.57 ₪ 16.63 $ 4.5 $ 16.53 ₪ 16.76
Fair value of options (in Dollars) $ 5,000 ₪ 5,000 $ 17,000 ₪ 17,000 $ 5,500   $ 45,000 $ 45,000 $ 22,000 $ 48,000 $ 48,000         $ 65,000 ₪ 65,000 $ 5,700 ₪ 5,700 $ 108,000 $ 108,000 ₪ 71,000
Exercise prices for share option (in Dollars per share) | $ / shares                                           ₪ 4.6
v3.23.3
Operating Segments (Details) - Schedule of Reporting on Operating Segments - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Dec. 31, 2022
Operating Segments (Details) - Schedule of Reporting on Operating Segments [Line Items]          
Revenues $ 37,934 $ 32,217 $ 106,087 $ 83,900 $ 129,339
Gross profit 14,803 12,870 41,078 31,412 46,703
Unallocated corporate expenses (10,435) (10,308) (33,790) (30,898) (42,171)
Finance expenses, net (1,072) (2,068) (3,883) (5,719) (6,791)
Income before taxes on income 3,296 494 3,405 (5,205) (2,259)
Proprietary Products [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments [Line Items]          
Revenues 31,436 25,580 86,437 67,198 102,598
Gross profit 13,989 12,429 38,574 29,342 44,369
Distribution [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments [Line Items]          
Revenues 6,498 6,637 19,650 16,702 26,741
Gross profit $ 814 $ 441 $ 2,504 $ 2,070 $ 2,334
v3.23.3
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2023
Sep. 30, 2022
Sep. 30, 2023
Sep. 30, 2022
Dec. 31, 2022
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Total $ 37,934 $ 32,217 $ 106,087 $ 83,900 $ 129,339
U.S.A and North America [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Total 25,294 20,597 62,150 52,866 75,851
Israel [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Total 7,515 8,014 22,769 20,333 32,031
Europe [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Total 3,280 750 6,724 2,192 5,277
Latin America [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Total 328 1,775 10,365 5,301 11,294
Asia [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Total 1,479 767 3,958 2,665 4,581
Others [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Total 38 314 121 543 305
Proprietary Products [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Proprietary Products 31,436 25,580 86,437 67,198 102,598
Proprietary Products [Member] | U.S.A and North America [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Proprietary Products 25,294 20,597 62,150 52,866 75,851
Proprietary Products [Member] | Israel [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Proprietary Products 1,017 1,377 3,119 3,631 5,290
Proprietary Products [Member] | Europe [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Proprietary Products 3,280 750 6,724 2,192 5,277
Proprietary Products [Member] | Latin America [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Proprietary Products 328 1,775 10,365 5,301 11,294
Proprietary Products [Member] | Asia [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Proprietary Products 1,479 767 3,958 2,665 4,581
Proprietary Products [Member] | Others [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Proprietary Products 38 314 121 543 305
Distribution [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Distribution 6,498 6,637 19,650 16,702 26,741
Distribution [Member] | U.S.A and North America [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Distribution
Distribution [Member] | Israel [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Distribution 6,498 6,637 19,650 16,702 26,741
Distribution [Member] | Europe [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Distribution
Distribution [Member] | Latin America [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Distribution
Distribution [Member] | Asia [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Distribution
Distribution [Member] | Others [Member]          
Operating Segments (Details) - Schedule of Reporting on Operating Segments Geographic Region [Line Items]          
Distribution
v3.23.3
Financial Instruments (Details) - Schedule of Financial Assets (Liabilities) Measured at Fair Value - USD ($)
Sep. 30, 2023
Dec. 31, 2022
Sep. 30, 2022
Level 1 [Member]      
Financial Instruments (Details) - Schedule of Financial Assets (Liabilities) Measured at Fair Value [Line Items]      
Derivatives instruments
Contingent consideration
Level 2 [Member]      
Financial Instruments (Details) - Schedule of Financial Assets (Liabilities) Measured at Fair Value [Line Items]      
Derivatives instruments (98) (92) (180)
Contingent consideration  
Level 3 [Member]      
Financial Instruments (Details) - Schedule of Financial Assets (Liabilities) Measured at Fair Value [Line Items]      
Derivatives instruments
Contingent consideration $ (22,326) $ (23,534) $ (23,705)

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