EX-99.2 3 ea145094ex99-2_kamada.htm KAMADA LTD.'S CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2021 (UNAUDITED)

Exhibit 99.2

 

KAMADA LTD.

 

CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2021

(Unaudited)

 

TABLE OF CONTENTS

 

  Page
   
Consolidated Statements of Financial Position 2
   
Consolidated Statements of Profit or Loss and Other Comprehensive Income 3
   
Consolidated Statements of Changes in Equity 4-7
   
Consolidated Statements of Cash Flows 8-9
   
Notes to the Interim Consolidated Financial Statements 10-20

 

- - - - - - - - - - -

 

 

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

 

   As of
June 30,
   As of
December 31,
 
   2021   2020   2020 
   Unaudited   Audited 
   U.S Dollars in thousands 
Assets    
Current Assets            
Cash and cash equivalents  $68,416   $57,399   $70,197 
Short-term investments   36,137    47,272    39,069 
Trade receivables, net   27,743    19,823    22,108 
Other accounts  receivables   2,450    2,980    4,524 
Inventories   44,601    47,646    42,016 
Total Current Assets   179,347    175,120    177,914 
                
Non-Current Assets               
Property, plant and equipment, net   25,665    24,574    25,679 
Right-of-use-assets   3,453    3,796    3,440 
Other long term assets   3,413    1,058    1,573 
Contract assets   4,472    911    2,059 
Deferred taxes   -    632    - 
Total Non-Current Assets   37,003    30,971    32,751 
Total Assets  $216,350   $206,091   $210,665 
Liabilities               
Current Liabilities               
Current maturities of bank loans  $61   $431   $238 
Current maturities of lease liabilities   1,149    990    1,072 
Trade payables   17,948    22,760    16,110 
Other accounts payables   6,989    5,497    7,547 
Deferred revenues   -    589    - 
Total Current Liabilities   26,147    30,267    24,967 
                
Non-Current Liabilities               
Bank loans   5    63    36 
Lease liabilities   3,401    3,704    3,593 
Deferred revenues   3,025    1,025    2,025 
Employee benefit liabilities, net   1,429    1,267    1,406 
Total Non-Current Liabilities   7,860    6,059    7,060 
                
Shareholder’s Equity               
Ordinary shares   11,716    11,662    11,706 
Additional paid in capital   209,942    207,731    209,760 
Capital reserve due to translation to presentation currency   (3,490)   (3,490)   (3,490)
Capital reserve from hedges   58    411    357 
Capital reserve from share-based payments   4,746    6,204    4,558 
Capital reserve from employee benefits   (320)   (356)   (320)
Accumulated deficit   (40,309)   (52,397)   (43,933)
Total Shareholder’s Equity   182,343    169,765    178,638 
Total Liabilities and Shareholder’s Equity  $216,350   $206,091   $210,665 

 

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 

2

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

 

   Six months period ended   Three months period ended   Year ended 
   June 30,   June 30,   December 31, 
   2021   2020   2021   2020   2020 
   Unaudited   Unaudited   Audited 
   U.S Dollars In thousands 
                     
Revenues from proprietary products  $40,193   $47,942   $19,323   $22,625   $100,916 
Revenues from distribution   8,946    18,437    4,916    10,464    32,330 
                          
Total revenues   49,139    66,379    24,239    33,089    133,246 
                          
Cost of revenues from proprietary products   23,527    27,881    11,059    12,934    57,750 
Cost of revenues from distribution   7,609    15,932    4,108    9,040    27,944 
                          
Total cost of revenues   31,136    43,813    15,167    21,974    85,694 
                          
Gross profit   18,003    22,566    9,072    11,115    47,552 
                          
Research and development expenses   5,364    6,970    2,736    3,623    13,609 
Selling and marketing expenses   2,547    2,118    1,424    1,178    4,518 
General and administrative expenses   6,112    4,619    3,303    2,307    10,139 
Other expenses   570    34    563    32    49 
Operating income   3,410    8,825    1,046    3,975    19,237 
                          
Financial income   209    615    99    298    1,027 
Income (expense) in respect of securities measured at fair value, net *   -    102    -    -    102 
Income (expenses) in respect of currency exchange differences and derivatives instruments, net   121    65    (145)   (367)   (1,535)
Financial expenses   (116)   (135)   (63)   (58)   (266)
Income before tax on income   3,624    9,472    937    3,848    18,565 
Taxes on income   -    796    -    390    1,425 
                          
Net Income  $3,624   $8,676   $937   $3,458   $17,140 
                          
Other Comprehensive Income (loss) :                         
Amounts that will be or that have been reclassified to profit or loss when specific conditions are met                         
Gain (loss) from securities measured at fair value through other comprehensive income   -    (188)   -    -    (188)
Gain (loss) on cash flow hedges   (43)   441    30    200    876 
Net amounts transferred to the statement of profit or loss for cash flow hedges   (256)   (7)   (2)   (41)   (528)
Items that will not be reclassified to profit or loss in subsequent periods:                         
Remeasurement gain (loss) from defined benefit plan   -    -    -    -    64 
Tax effect   -    15    -    (12)   19 
Total comprehensive income  $3,325   $8,937   $965   $3,605   $17,383 
                          
Earnings per share attributable to equity holders of the Company:                         
Basic net earnings per share  $0.08   $0.20   $0.02   $0.10   $0.39 
Diluted net earnings per share  $0.08   $0.20   $0.02   $0.10   $0.38 

 

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 

3

 

 

KAMADA LTD.

 

CONSOLIDATED 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 
                                 
Balance as of January 1, 2021 (audited)  $11,706   $209,760   $(3,490)  $357   $4,558   $(320)  $(43,933)  $178,638 
Net income   -    -    -    -    -    -    3,624    3,624 
Other comprehensive income (loss)   -    -    -    (299)   -    -    -    (299)
Tax effect   -    -    -    -    -    -    -    - 
Total comprehensive income (loss)   -    -    -    (299)   -    -    3,624    3,325 
Exercise and forfeiture of share-based payment into shares   10    182    -    -    (182)   -    -    10 
Cost of share-based payment   -    -    -    -    370    -    -    370 
Balance as of June 30, 2021  $11,716   $209,942   $(3,490)  $58   $4,746   $(320)  $(40,309)  $182,343 

 

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 

4

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

 

 

   Share capital   Additional
paid in
capital
   Capital reserve from securities measured at fair value through other comprehensive income   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 
   U.S Dollars in thousands 
                                     
Balance as of January 1, 2020 (audited)  $10,425   $180,819   $145   $(3,490)  $8   $8,844   $(359)  $(61,073)  $135,319 
Net income   -    -    -    -    -    -    -    8,676    8,676 
Other comprehensive income (loss)   -    -    (188)   -    434    -    -    -    246 
Taxes effect   -    -    43    -    (31)   -    3    -    15 
Total comprehensive income (loss)   -    -    (145)   -    403    -    3    8,676    8,937 
Issuance of ordinary shares   1,217    23,684    -    -    -    -    -    -    24,901 
Exercise and forfeiture of share-based payment into shares   20    3,228    -    -    -    (3,228)   -    -    20 
Cost of share-based payment   -    -    -    -    -    588    -    -    588 
Balance as of June 30, 2020  $11,662   $207,731   $-   $(3,490)  $411   $6,204   $(356)  $(52,397)  $169,765 

 

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 

5

 

 

KAMADA LTD.

 

CONSOLIDATED 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 
                                 
Balance as of April 1, 2021 (audited)  $11,713   $209,859   $(3,490)  $30   $4,674   $(320)  $(41,246)  $181,220 
Net income   -    -    -    -    -    -    937    937 
Other comprehensive income (loss)   -    -    -    28    -    -    -    28 
Taxes effect   -    -    -    -    -    -    -    - 
Total comprehensive income (loss)   -    -    -    28    -    -    937    965 
Exercise and forfeiture of share-based payment into shares   3    83    -    -    (83)   -    -    3 
Cost of share-based payment   -    -    -    -    155    -    -    155 
Balance as of June 30, 2021  $11,716   $209,942   $(3,490)  $58   $4,746   $(320)  $(40,309)  $182,343 

 

   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 
                                 
Balance as of April 1, 2020  $11,647   $204,702   $(3,490)   264   $8,903   $(356)  $(55,855)  $165,815 
Net income   -    -    -    -    -    -    3,458    3,458 
Other comprehensive income   -    -    -    159    -    -    -    159 
Taxes effect   -    -    -    (12)   -    -    -    (12)
Total comprehensive income (loss)   -    -    -    147    -    -    3,458    3,605 
Exercise into shares and forfeiture of share-based payment   15    3,029    -    -    (3,029)   -         15 
Cost of share-based payment   -    -    -    -    330    -    -    330 
Balance as of June 30, 2020  $11,662   $207,731   $(3,490)  $411   $6,204   $(356)  $(52,397)  $169,765 

  

6

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

 

   Share capital   Additional paid in capital   Capital reserve from securities  measured at fair value through other comprehensive  income   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 January 1, 2020 (audited)  $10,425   $180,819   $145   $(3,490)  $8   $8,844   $(359)  $(61,073)  $135,319 
Net income   -    -    -    -    -    -    -    17,140    17,140 
Other comprehensive income (loss)   -    -    (188)   -    348    -    64    -    224 
Tax effect   -    -    43    -    1    -    (25)   -    19 
Total comprehensive income (loss)   -    -    (145)   -    349    -    39    17,140    17,383 
Issuance of ordinary shares   1,217    23,678    -    -    -    -    -    -    24,895 
Exercise and forfeiture of share-based payment into shares   64    5,263    -    -    -    (5,263)   -    -    64 
Cost of share-based payment   -    -    -    -    -    977    -    -    977 
Balance as of December 31, 2020  $11,706   $209,760   $-   $(3,490)  $357   $4,558   $(320)  $(43,933)  $178,638 

 

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 

7

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

   Six months period Ended   Three months period Ended   Year Ended 
   June, 30   June, 30   December 31, 
   2021   2020   2021   2020   2020 
   Unaudited   Audited 
   U.S Dollars In thousands 
Cash Flows from Operating Activities                    
Net income  $3,624   $8,676   $937   $3,458   $17,140 
                          
Adjustments to reconcile net income to net cash provided by (used in) operating activities:                         
                          
Adjustments to the profit or loss items:                         
                          
Depreciation and impairment   2,372    2,380    1,225    1,188    4,897 
Financial expenses (income), net   (214)   (647)   109    127    672 
Cost of share-based payment   370    588    155    330    977 
Taxes on income   -    796    -    390    1,425 
Loss (gain) from sale of property and equipment   -    (6)   -    (6)   (7)
Change in employee benefit liabilities, net   23    (2)   60    16    201 
    2,551    3,109    1,549    2,045    8,165 
Changes in asset and liability items:                         
                          
Decrease (increase) in trade receivables, net   (5,646)   3,416    (7,231)   6,432    1,332 
Decrease (increase) in other accounts receivables   1,629    741    1,643    (772)   115 
Increase in inventories   (2,401)   (4,473)   (3,446)   (5,859)   1,157 
Decrease (increase) in deferred expenses   (2,362)   (911)   (1,209)   (490)   (3,085)
Increase (decrease) in trade payables   1,139    (2,719)   2,623    4,497    (9,560)
Increase (decrease) in other accounts payables   (799)   (314)   1,346    866    1,736 
Decrease in deferred revenues   1,000    793    500    396    1,204 
    (7,440)   (3,467)   (5,774)   5,070    (7,101)
Cash received (paid) during the period for:                         
                          
Interest paid   (107)   (107)   (59)   (52)   (209)
Interest received   217    601    76    150    1,211 
Taxes paid   (23)   (74)   (9)   (13)   (101)
    87    420    8    85    901 
                          
Net cash provided by operating activities  $(1,178)  $8,738   $(3,280)  $10,658   $19,105 

 

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 

8

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   Six months period Ended   Three months period Ended   Year Ended 
   June, 30   June, 30   December 31, 
   2021   2020   2021   2020   2020 
   Unaudited   Audited 
   U.S Dollars In thousands 
Cash Flows from Investing Activities                    
                     
Proceeds of investment in short term investments, net  $2,967   $(15,646)  $11,967   $-   $(7,646)
Purchase of property and equipment and intangible assets   (1,463)   (1,901)   (1,332)   (1,005)   (5,488)
Proceeds from sale of property and equipment   -    6    -    6    7 
Acquisition of  subsidiary (LLC), net (1)   (1,404)   -    -         - 
Net cash used in investing activities   100    (17,541)   10,635    (999)   (13,127)
                          
Cash Flows from Financing Activities                         
                          
Proceeds from exercise of share base payments   10    20    3    15    64 
Repayment of lease liabilities   (595)   (540)   (306)   (262)   (1,103)
Repayment of long-term loans   (206)   (247)   (85)   (124)   (492)
Proceeds from issuance of ordinary shares, net   -    24,895    -    -    24,895 
                          
Net cash provided by (used in) financing activities   (791)   24,128    (388)   (371)   23,364 
                          
Exchange differences on balances of cash and cash equivalent   88    (588)   13    (1,177)   (1,807)
                          
Increase in cash and cash equivalents   (1,781)   14,737    6,980    8,111    27,535 
                          
Cash and cash equivalents at the beginning of the period   70,197    42,662    61,436    49,288    42,662 
                          
Cash and cash equivalents at the end of the period  $68,416   $57,399   $68,416   $57,399   $70,197 
                          
Significant non-cash transactions                         
Right-of-use asset recognized with corresponding lease liability  $588   $345   $286   $287   $539 
Purchase of property and equipment  $748   $722   $748   $722   $722 

 

Appendix A (1)  Six months period Ended
June, 30
2021
 
Acquisition of a subsidiary that was first consolidated    
     
Current Assets (exclusive of cash and cash equivalents)   (184)
Non Current Assets   (1,460)
Current Liabilities   240 
    (1,404)

 

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 

9

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1: General

 

Kamada Ltd. (the “Company”) is a global specialty plasma-derived biopharmaceutical company with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company’s strategy is focused on driving profitable growth from its current commercial products, its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company. The Company’s two leading commercial products are GLASSIA® and KEDRRAB®. GLASSIA was the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited (“Takeda”) and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce GLASSIA for Takeda through 2021 and Takeda will initiate its own production of GLASSIA for the U.S. market in 2021, at which point Takeda will commence payment of royalties to the Company until 2040. KEDRAB is an FDA approved anti-rabies immune globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion S.p.A. The Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two leading development programs; an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial and a plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added nine biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched in Israel between the years 2022 and 2025.

 

Pursuant to the agreement with Takeda (as detailed on Note 17 of the Company’s annual financial statements as of December 31, 2020) the Company continues to produce Glassia for Takeda through 2021. Takeda will complete the technology transfer of Glassia and will initiate its own production of Glassia for the U.S. market in 2021. Accordingly, following the transition of manufacturing to Takeda, the Company will terminate the manufacturing and sale of Glassia to Takeda resulting in a significant reduction in revenues. Pursuant to the agreement, upon initiation of sales of Glassia manufactured by Takeda, Takeda will pay royalties to the Company at a rate of 12% on net sales through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually, for each of the years from 2022 to 2040. See note 3c below regarding a recent amendment to the agreement with Takeda.

 

These financial statements have been prepared in a condensed format as of June 30, 2021 and for the three months then ended (“interim consolidated financial statements”).

 

These financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2020 and for the year then ended and the accompanying notes (“annual consolidated financial statements”).

 

10

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED 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:

 

The accounting policy applied in the preparation of the interim consolidated financial statements is consistent with that applied in the preparation of the annual consolidated financial statements, except for the following:

 

i.Amendments to IFRS 9, IFRS 7, IFRS 16, IFRS 4 and IAS 39 regarding the IBOR reform:

 

In August 2020, the IASB issued amendments to IFRS 9, “Financial Instruments”, IFRS 7, “Financial Instruments: Disclosures”, IAS 39, “Financial Instruments: Recognition and Measurement”, IFRS 4, “Insurance Contracts”, and IFRS 16, “Leases” (the “Amendments”).

 

The Amendments provide practical expedients when accounting for the effects of the replacement of benchmark InterBank Offered Rates (IBORs) by alternative Risk Free Interest Rates (RFRs).

 

Pursuant to one of the practical expedients, an entity will treat contractual changes or changes to cash flows that are directly required by the reform as changes to a floating interest rate. That is, an entity recognizes the changes in interest rates as an adjustment of the effective interest rate without adjusting the carrying amount of the financial instrument. The use of this practical expedient is subject to the condition that the transition from IBOR to RFR takes place on an economically equivalent basis.

 

In addition, the Amendments permit changes required by the IBOR reform to be made to hedge designations and hedge documentation without the hedging relationship being discontinued, provided certain conditions are met. The Amendments also provide temporary relief from having to meet the “separately identifiable” requirement according to which a risk component must also be separately identifiable to be eligible for hedge accounting.

 

The Amendments include new disclosure requirements in connection with the expected effect of the reform on an entity’s financial statements, such as how the entity is managing the process to transition to the interest rate reform, the risks to which it is exposed due to the reform and quantitative information about IBOR-referenced financial instruments that are expected to change.

 

The Amendments are effective for annual periods beginning on or after January 1, 2021. The Amendments are to be applied retrospectively. However, restatement of comparative periods is not required. Early application is permitted.

 

The adoption of the Amendment does not have an effect on the Company’s financial statements.

 

11

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 2:Significant Accounting Policies (continued)

 

b.Implementation of new accounting standards (continued):

 

ii.Amendment to IAS 1, Presentation of Financial Statements: Classification of Liabilities as Current or Non-Current

 

In January 2020, the IASB issued an amendment to IAS 1, “Presentation of Financial Statements” (the “IAS 1 Amendment “) regarding the criteria for determining the classification of liabilities as current or non-current. The IAS 1 Amendment replaces certain requirements for classifying liabilities as current or non-current. Thus for example, according to the IAS 1 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, this instead of the requirement that there be an “unconditional” right. According to the IAS1 Amendment, a right is in existence at the reporting date only if the entity complies with conditions for deferring settlement at that date. Furthermore, the IAS 1 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 IAS 1Amendment is effective for reporting periods beginning on or after January 1, 2023 with earlier application being permitted. The IAS1 Amendment is applicable retrospectively, including an amendment to comparative data.

 

The Company has not yet commenced examining the effects of applying the IAS 1 Amendment on the financial statements.

 

iii.Amendment to IAS 37, Provisions, Contingent Liabilities and Contingent Assets

 

In May 2020, the IASB issued an amendment to IAS 37, regarding which costs a company should include when assessing whether a contract is onerous (the “IAS 37 Amendment”). According to the IAS 37 Amendment, when assessing whether a contract is onerous, the costs of fulfilling a contract that should be taken into consideration are costs that relate directly to the contract, which include as follows:

 

-Incremental costs; and
-An allocation of other costs that relate directly to fulfilling a contract (such as depreciation expenses for fixed assets used in fulfilling that contract and other contracts).

 

The IAS 37 Amendment is effective retrospectively for annual periods beginning on or after January 1, 2022, in respect of contracts where the entity has not yet fulfilled all its obligations. Early application is permitted. Upon application of the Amendment, the entity will not restate comparative data, but will adjust the opening balance of retained earnings at the date of initial application, by the amount of the cumulative effect of the Amendment.

 

The Company has not yet commenced examining the effects of the IAS 37 Amendment on the financial statements.

 

iv.Amendment to IAS 16, Property, Plant and Equipment

 

In May 2020, the IASB issued an amendment to IAS 16, “Property, Plant and Equipment” (the “IAS 16 Amendment”) The Amendment annuls the requirement by which in the calculation of costs directly attributable to fixed assets, the net proceeds from selling certain items that were produced while the Company tested the functioning of the asset should be deducted (such as samples that were produced when testing the equipment). Instead, such proceeds shall be recognized in profit or loss according to the relevant standards and the cost of the sold items will be measured according to the measurement requirements of IAS 2, Inventories.

 

The IAS 16 Amendment is effective for annual periods beginning on or after January 1, 2022. Early application is permitted. The IAS 16 Amendment shall be applied on a retrospective basis, including an amendment of comparative data, only with respect to fixed asset items that have been brought to the location and condition required for them to operate in the manner intended by management subsequent to the earliest reporting period presented at the date of initial application of the IAS 16 Amendment. The cumulative effect of the Amendment will adjust the opening balance of retained earnings for the earliest reporting period presented.

 

The Company has not yet commenced examining the effects of the Amendment on the financial statements.

 

12

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 

Note 3:Significant events in the reportimg period

 

a. Effects of the COVID-19 Pandemic Outbreak:

 

Following the global COVID-19 outbreak, there has been a decrease in economic activity worldwide, including Israel. The spread of the COVID-19 pandemic led, inter alia, to a disruption in the global supply chain, a decrease in global transportation, restrictions on travel and work that were announced by the State of Israel and other countries worldwide as well as a decrease in the value of financial assets and commodities across all markets in Israel and the world.

 

The Company’s business activity and commercial operation were affected by these factors, and the Company has taken several actions to ensure its manufacturing plant remains operational with limited disruption to its business continuity. The Company continues to maintain higher inventory levels of raw materials through its suppliers and service providers to appropriately manage any potential supply disruptions and secure continued manufacturing. In addition, the Company is actively engaging its freight carriers to ensure inbound and outbound international delivery routes remain operational and identify alternative routes, if needed.

 

The Company is complying with the State of Israel mandates and recommendations with respect to its work-force management and has taken several precautionary health and safety measures to safeguard its employees and continues to monitor and assess orders issued by the State of Israel and other applicable governments to ensure compliance with evolving COVID-19 guidelines.

 

While COVID-19 related disruption continues to have various effect on the Company’s business activities, commercial operation, revenues and operational expenses, as a results of the actions taken by the Company to date, its overall results of operations were not materially affected however, a number of factors, including but not limited to, continued effect of the factors mentioned above as well as, continued demand for the Company’s products, including GLASSIA and KEDRAB, in the U.S. market and its distributed products in Israel, financial conditions of the Company’s customer, suppliers and services providers, the Company’s ability to manage operating expenses, additional competition in the markets that the Company competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise, may have an effect on the Company’s future financial position and results of operations.

 

The financial impact of these factors cannot be reasonably estimated at this time due to substantial uncertainty but may materially affect our business, financial condition and results of operations. The Company assess the impact of the COVID-19 pandemic in a number of possible scenarios and concluded that there are no uncertainties that may cast significant doubt on its ability to continue as a going concern or affect significantly on the Company liquidity.

 

13

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 3:Significant events in the reportimg period (continued)

 

b. Acquisition of an FDA-Licensed Plasma Collection Center:

 

On March 31, 2021 the Company acquired the plasma collection center and certain related rights and assets from the privately-held B&PR of Beaumont, TX, USA. The plasma collection facility primarily specializes in the collection of hyper-immune plasma used for the Anti-D immunoglobulin, which is manufactured by the Company and distributed in international markets. The acquisition was consummated through Kamada Plasma LLC, a newly formed wholly owned subsidiary of the Company, which will operate the Company’s plasma collection activity in the U.S.

 

In consideration for the assets acquired, the Company committed to a pay a total amount of $1,654 thousands, of which $ 1,404 thousands was paid at the closing of the acquisition, and the balance in the amount of $250 thousands will be paid on March 31, 2022.

 

The Company incurred acquisition-related costs of $140 thousand related mainly to legal and other consulting fees. These costs were recorded in general and administrative expenses in the statement of profit and loss during 2020 and the first quarter of 2021.

 

Identifiable assets acquired and liabilities assumed:

 

   U.S Dollars in thousands 
     
Inventories  $184 
Intangible assets (1)   1,378 
Property, plant and equipment, net   82 
Total acquired assets   1,644 
Assumed liabilities   (240)
Net identifiable assets  $1,404 

 

(1)The fair value of intangible assets (FDA-License for plasma collection and goodwill) has been determined provisionally pending completion of an independent valuation. If new information is obtained within one year from the acquisition date about facts and circumstances that existed at the acquisition date, the Company will retrospectively adjust the relevant amounts that were recognized at the time of the acquisition.

 

c. Amendment to GLASSIA® License Agreement with Takeda:

 

On March 31, 2021, the Company entered into an amendment to the Technology License Agreement with Takeda with respect to GLASSIA. Pursuant to the amendment, upon completion of the transition of GLASSIA manufacturing to Takeda, expected by the end of 2021, the Company will transfer to Takeda the GLASSIA U.S. Biologics License Application (BLA). In consideration for the BLA transfer, the Company will receive a $2,000 thousand payment from Takeda. In addition, the terms of the final sales-based milestone of $5,000 thousand due to Kamada under the license agreement were amended. As a result of such amendment the Company recognized the $5,000 thousand milestone as a revenue during the first quarter of 2021.

 

d. Worforce Downsizing:

 

As a result of the transition of GLASSIA manufacturing to Takeda, Kamada initiated during the second quarter of 2021 a workforce downsizing program which is expected to continue through the beginning of the third quarter of 2021. During the second quarter of 2021 the Company accounted for $550 thousand of costs associated with termination benefits which were recorded as a one-time expense in the other operating expenses.

 

14

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 4:Operating Segments

 

a. General:

 

The company has two operating segments, as follows:

 

Proprietary Products - Development, manufacturing, sales and distribution of plasma-derived protein therapeutics.
     
Distribution - Distribute imported drug products in Israel, which are manufactured by third parties.

 

b. Reporting on operating segments:

 

   Six months period ended June 30, 2021 
   Proprietary         
   Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
             
Revenues    $40,193   $8,946   $49,139 
Gross profit    $16,666   $1,337   $18,003 
Unallocated corporate expenses               (14,593)
Finance income, net               214 
Income before taxes on income            $3,624 

 

15

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 4:Operating Segments (continued)

 

b.Reporting on operating segments: (continued)

 

   Six months period ended June 30, 2020 
   Proprietary         
   Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
             
Revenues    $47,942   $18,437   $66,379 
Gross profit    $20,061   $2,505   $22,566 
Unallocated corporate expenses               (13,741)
Finance income, net               647 
Income before taxes on income              $9,472 

 

   Three months period ended June 30, 2021 
   Proprietary         
   Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
             
Revenues    $19,323   $4,916   $24,239 
Gross profit    $8,264   $808   $9,072 
Unallocated corporate expenses               (8,026)
Finance expenses, net               (109)
Income before taxes on income              $937 

 

16

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 4:Operating Segments (continued)

 

b.Reporting on operating segments (continued):

 

   Three months period ended June 30, 2020 
   Proprietary         
   Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
             
Revenues    $22,625   $10,464   $33,089 
Gross profit    $9,691   $1,424   $11,115 
Unallocated corporate expenses               (7,140)
Finance expenses, net               (127)
Income before taxes on income              $3,848 

 

   Year Ended December 31, 2020 
   Proprietary         
   Products   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
             
Revenues    $100,916   $32,330   $133,246 
Gross profit    $43,166   $4,386   $47,552 
Unallocated corporate expenses               (28,315)
Finance expenses, net               (672)
Income before taxes on income              $18,565 

 

17

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 4:Operating Segments (continues)

 

c.Reporting on operating segments by geographic region:

 

   Six months period ended June 30, 2021 
   Proprietary Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America    $26,556    -   $26,576 
Israel     5,588    8,946    14,534 
Europe     3,394    -    3,394 
Latin America     3,603    -    3,603 
Asia     1,019    -    1,019 
Others     33    -    33 
   $40,193   $8,946   $49,139 

 

   Six months period ended June 30, 2020 
   Proprietary Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America  $40,460   $-   $40,460 
Israel   2,005    18,437    20,442 
Europe   3,287    -    3,287 
Latin America   1,873    -    1,873 
Asia   296    -    296 
Others   21    -    21 
   $47,942   $18,437   $66,379 

 

   Three months period ended June 30, 2021 
   Proprietary Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.    $12,672        $12,672 
Israel     3,602    4,916    8,518 
Europe     967         967 
Latin America     1,428         1,428 
Asia     640         640 
Others     14         14 
   $19,323   $4,916   $24,239 

 

18

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

 

Note 4:Operating Segments (continued)

 

c.Reporting on operating segments by geographic region (continued):

 

   Three months period ended June 30, 2020 
   Proprietary Products   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America    $17,256   $-   $17,256 
Israel     1,417    10,464    11,881 
Europe     2,733    -    2,733 
Latin America     1,015    -    1,015 
Asia      183    -    183 
Others     21    -    21 
   $22,625   $10,464   $33,089 

 

   Year ended December 31, 2020 
   Proprietary Products   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Geographical markets            
U.S.A and North America    $84,949   $-   $84,949 
Israel     3,814    32,330    36,144 
Europe     4,461    -    4,461 
Latin America     6,867    -    6,867 
Asia     766    -    766 
Others     59    -    59 
   $100,916   $32,330   $133,246 

 

19

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 5:Financial Instruments

 

a.Classification of financial instruments by fair value hierarchy:

 

Financial assets (liabilities) measured at fair value

 

   Level 1   Level 2 
   U.S Dollars in thousands 
June 30, 2021        
Derivatives instruments  $-   $23 
           
June 30, 2020          
Derivatives instruments  $-   $560 
           
December 31, 2020          
Derivatives instruments  $-   $448 

 

During the three months ended on June 30, 2021 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.

 

- - -

 

20

 

 

Adjusted EBITDA                    
   Six months period ended   Three months period ended   Year ended 
   June 30,   June 30,   December 31, 
   2021   2020   2021   2020   2020 
   In thousands 
Net income  $3,624   $8,676   $937   $3,458   $17,140 
Taxes on income   -      796    -      390    1,425 
Financial expense (income), net   (214)   (647)   109    127    692 
Depreciation and amortization expense   2,372    2,380    1,225    1,188    4,897 
Non-cash share-based compensation expenses   370    588    155    330    977 
Adjusted EBITDA  $6,152   $11,793   $2,426   $5,493   $25,131 

 

Adjusted net income                    
   Six months period ended   Three months period ended   Year ended 
   June 30,   June 30,   December 31, 
   2021   2020   2021   2020   2020 
   In thousands 
Net income  $3,624   $8,676   $937   $3,458   $17,140 
Share-based compensation charges   370    588    155    330    977 
Adjusted net income  $3,994   $9,264   $1,092   $3,788   $18,117 

 

 

21