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 May 2022

 

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 ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

 

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes ☐ No ☒

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____

  

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 and 333-233267.

 

 

 

 

 

 

The following exhibit is attached:

 

99.1   Kamada Reports First Quarter 2022 Financial Results; Reiterates Revenue and Profitability Guidance with Significant Growth Expected in 2022
99.2   Kamada Ltd.'s Consolidated Financial Statements as of March 31, 2022 (Unaudited)

 

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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: May 17, 2022 KAMADA LTD.
   
  By: /s/ Yifat Philip
   

Yifat Philip

Vice President General Counsel and
Corporate Secretary

 

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EXHIBIT INDEX

 

EXHIBIT NO.   DESCRIPTION
     
99.1   Kamada Reports First Quarter 2022 Financial Results; Reiterates Revenue and Profitability Guidance with Significant Growth Expected in 2022
99.2   Kamada Ltd.'s Consolidated Financial Statements as of March 31, 2022 (Unaudited)

 

 

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Exhibit 99.1

 

Kamada Reports First Quarter 2022 Financial Results;

Reiterates Revenue and Profitability Guidance with Significant Growth Expected in 2022

 

First Quarter 2022 Revenues were $28.1 Million, Up 13% Year Over Year.

 

Kamada Reiterates Fiscal Year 2022 Revenue Guidance of $125 - $135 Million, Representing a 20% to 30% Increase over 2021 and EBITDA Margins Anticipated Between 12%-15%, More Than 2.5X over 2021 EBITDA.

 

Revenues and Profitability Margins of Recently Acquired Portfolio of Four FDA-Approved Commercial Products Within Management Expectations; Expanding Sales in Additional New Countries, Mainly in the Middle East Region.

 

GLASSIA® Royalty Income from Takeda Initiated in March 2022, Totaled $1.4 Million, Within Expected Monthly Rate.

 

Generated $5.5 Million of Operating Cash-Flows During the First Quarter; $22.0 Million of Available Cash at Quarter End.

 

Pivotal Phase 3 InnovAATe Trial for Inhaled AAT for the Treatment of Alpha-1 Antitrypsin Deficiency Progressing with the Opening of Six New Sites to Further Drive Recruitment.

 

  Continued Expansion Activities of our U.S. Plasma Collection Capabilities; An Important Component of Our Vertical Integration.

 

REHOVOT, Israel – May 17, 2022 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, today announced financial results for the three months ended March 31, 2022.

 

“Our business is off to a strong start in 2022 as we continue to execute on our corporate strategy advancing towards our core objective of becoming a global leader in the plasma-derived specialty market,” said Amir London, Kamada’s Chief Executive Officer. “We generated total revenues of $28.1 million in the first quarter, representing strong 13% growth year over year. This is the first full quarter commercializing the portfolio of the four FDA-approved commercial immunoglobulins acquired late last year. Sales and profitability levels generated by these products are in line with our plans and expectations. We continue to expand our U.S. commercial-focused infrastructure, execute on key sales and marketing initiatives to further penetrate the U.S. market with our extended product line, and expect that these four products will generate meaningful year-over-year growth. We continue to expand sales of these products in additional new countries, primarily in the Middle East.”

 

“Sales in the first quarter included $1.4 million of royalty income on GLASSIA sales by Takeda during March 2022, meeting our expected monthly rate and in line with our annual projection. In addition, we are encouraged by KEDRAB® U.S. in-market sales by Kedrion during the first quarter, which have grown in comparison to the pre-COVID pandemic sales levels, a trend that we believe will continue. In the first quarter of 2022, we generated overall gross profit and gross margins of $11.3 million and 40%, respectively, representing a strong 27% increase compared to the first quarter of 2021. This increase was mainly driven by the four new immunoglobulins portfolio, which recorded over 50% of gross profitability. Moreover, we generated $5.5 million of operating cash flows, that supported the increase of our cash position to a total of $22.0 million,” continued Mr. London.

 

Based on our strong start to the year, we are reiterating our full-year 2022 revenue guidance of between $125 million to $135 million, with expected EBITDA margins of 12% to 15%. This guidance represents a 20% to 30% increase over 2021 revenue and more than 2.5x over 2021 EBITDA. Moreover, we continue to project revenue growth at a double-digit rate in the foreseeable years ahead. Our positive long-term view is supported by the expected continued growth in the proprietary product sales, and several additional key emerging catalysts in our business. The initiation of activities to open new plasma collection centers in the U.S. will, over time, support continued revenue growth and strengthen our supply chain. The planned launch of a portfolio of 11 biosimilar products in our Israeli distribution segment from 2022 to 2028 is expected to generate more than $40 million in annual peak sales, achievable within several years of launch. Finally, our promising pipeline continues to advance, as our inhaled AAT pivotal Phase 3 trial expands to additional six EU sites by mid-year,” concluded Mr. London.

 

 

 

 

Financial Highlights for the Three Months Ended March 31, 2022

 

Total revenues were $28.1 million in the first quarter of 2022, a 13% increase from the $24.9 million recorded in the first quarter of 2021. Total revenues during the first quarter of 2022 included first full quarter sales of the portfolio of the four FDA-approved commercial products recently acquired, and $1.4 million of sales-based royalty income from Takeda. This royalty income reflected March 2022 only, as Takeda utilized Kamada-manufactured product from its inventory prior to March 2022.

 

Gross profit and gross margins were $11.3 million and 40%, respectively, in the first quarter of 2022, compared to $8.9 million and 36%, respectively, reported in the first quarter of 2021. The increase in gross profitability was primarily driven by the four new FDA-approved commercial products, which generated gross margins of over 50%. Cost of goods sold in our Proprietary segment totaled $12.5 million in the first quarter of 2022 and included $1.3 million of depreciation expenses associated with intangible assets generated through the recent acquisition of these products. Gross profit and gross margins excluding such intangible assets depreciation would have been $12.6 million and 45%, respectively.

 

Operating expenses, including R&D, S&M, G&A and other expenses, totaled $11.1 million in the first quarter of 2022, as compared to $6.6 million in the first quarter of 2021. This increase was attributable to an increase in R&D costs, primarily due to advancing the pivotal phase 3 InnovAATe trial for Inhaled AAT related to the opening of new clinical sites and the manufacturing of clinical supply for the study, as well as increased S&M and G&A costs associated with the distribution and commercial operation for the recently acquired portfolio of four FDA-approved commercial products. S&M costs for the quarter included $0.4 million of depreciation expenses associated with intangible assets generated through the recent acquisition of the four new FDA-approved commercial products. Operating expenses excluding such intangible assets depreciation would have been $10.7 million.

 

Finance expense, net for the first quarter of 2022 included a $2.0 million expense associated with the revaluation of the contingent consideration and other long-term liabilities assumed as part of the recent acquisition of the portfolio of the four FDA-approved commercial products. For more information with respect to such contingent consideration and other long- term liabilities please refer to Note 5 of the Company’s 2021 financial statements included in the 2021 Annual Report on Form 20-F filed on March 15, 2022, with the Securities and Exchange Commission.

 

Net loss was $1.8 million, or $(0.04) per share, in the first quarter of 2022, as compared to net income of $2.7 million, or $0.06 per share, in the first quarter of 2021.

 

Adjusted EBITDA, as detailed in the tables below, was $3.3 million in the first quarter of 2022, as compared to $3.7 million in the first quarter of 2021.

 

Cash provided by operating activities was $5.5 million in the first quarter of 2022, as compared to cash provided by operating activities of $2.1 million in the first quarter of 2021.

 

Balance Sheet Highlights

 

As of March 31, 2022, the Company had cash, cash equivalents, and short-term investments of $22.0 million, as compared to $18.6 million on December 31, 2021. The increase was due to positive operational cash flows. Kamada’s working capital as of March 31, 2022, comprising of current assets (excluding cash and cash equivalents, and short-term investments) net of current liabilities, totaled $52.0 million.

 

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Fiscal Year 2022 Guidance

 

Kamada continues to expect to generate fiscal year 2022 total revenues in the range of $125 million to $135 million, which would represent a 20% to 30% growth compared to fiscal year 2021. The Company also anticipates generating EBITDA during 2022 at a rate of 12% to 15% of total revenues, representing more than 2.5x of the EBITDA for the year ended December 31, 2021. While the ongoing labor strike impacting our production facility in Israel is expected to temper our second quarter financial results, which we do not expect to be as strong as the first quarter, based on the diversification of our commercial operations which includes multiple revenue generating sources including the recently acquired portfolio of four FDA-approved commercial products, manufactured by an external contract manufacturer, the Israeli Distribution business which operates independent of the production facility, the royalty income on GLASSIA sales by Takeda, as well as current sufficient inventory levels of finished products, our positive outlook for the fiscal year remains unchanged.

 

Conference Call

 

Kamada management will host an investment community conference call on Tuesday, May 17, 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: 13729770. The call will also be webcast live on the Internet at: https://viavid.webcasts.com/starthere.jsp?ei=1547283&tp_key=3051633ddd

 

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.

 

About Kamada

 

Kamada Ltd. (the “Company”) is a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, 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 our current commercial activities as well as our manufacturing and development expertise in the plasma-derived biopharmaceutical market. The Company’s commercial products portfolio includes its developed and FDA approved products GLASSIA® and KEDRAB® as well as its recently acquired FDA approved plasma-derived hyperimmune products CYTOGAM®, HEPAGAM B®, VARIZIG® and WINRHO®SDF. The Company has additional four plasma-derived products which are registered in markets outside the U.S. 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, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has a diverse portfolio of development pipeline products including 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. 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 11 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 2028. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.

 

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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) 2022 revenue guidance in the range of $125 million to $135 million, a 20% to 30% growth compared to 2021, 2) 2022 EBITDA, as a rate of total revenues, of 12% to 15%, 3) expected continued growth at a double-digit rate in the foreseeable years ahead, 4) expectation of rapid return to revenue and profitability growth in 2022, 5) plans for the opening of new plasma collection centers in the U.S., 6) expectation of peak potential annual biosimilar sales to over $40 million for the eleven(11) Biosimilar product candidates to be distributed in the Israel market, 7) expansion of inhaled AAT pivotal Phase 3 trial with up to six additional clinical sites to be opened by mid-2022, 8) the four FDA-approved commercial immunoglobulins to generate meaningful year-over-year growth and expanding sales of these products in additional new countries, mainly in the Middle East, 9) KEDRAB U.S. in-market sales by Kedrion during the first quarter, grown in comparison to the pre-COVID pandemic sales levels, and our believe this trend will continue, 10) optimism about strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise, and 11) the belief that those opportunities are may be significant steps toward accomplishing our strategic goal of becoming a fully integrated specialty plasma company. 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 continued evolvement of the COVID-19 pandemic, its scope, effect and duration, availability of sufficient raw materials required to maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international delivery routes, impact of the workforce downsizing plan, 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 recent 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

 

Bob Yedid

LifeSci Advisors, LLC

646-597-6989

Bob@LifeSciAdvisors.com

 

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CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

 

   As of March 31,   As of
December 31,
 
   2022   2021   2021 
   Unaudited   Audited 
   U.S Dollars in thousands 
Assets    
Current Assets            
Cash and cash equivalents  $21,967   $61,436   $18,587 
Short-term investments   -    48,038    - 
Trade receivables, net   21,568    20,367    35,162 
Other accounts  receivables   7,867    4,091    8,872 
Inventories   64,761    41,155    67,423 
Total Current Assets   116,163    175,087    130,044 
                
Non-Current Assets               
Property, plant and equipment, net   26,098    25,492    26,307 
Right-of-use assets   2,990    3,479    3,092 
Intangible assets, Goodwill and other long-term assets   151,858    3,175    153,663 
Contract assets   5,987    3,295    5,561 
Total Non-Current Assets   186,933    35,441    188,623 
Total Assets  $303,096   $210,528   $318,667 
Liabilities               
Current Liabilities               
Current maturities of bank loans  $3,725   $127   $2,631 
Current maturities of lease liabilities   1,017    1,092    1,154 
Current maturities of other long term liabilities   19,095    -    17,986 
Trade payables   11,682    15,076    25,104 
Other accounts payables   6,670    5,682    7,142 
Deferred revenues   40    -    40 
Total Current Liabilities   42,229    21,977    54,057 
                
Non-Current Liabilities               
Bank loans   16,296    20    17,407 
Lease liabilities   3,056    3,417    3,160 
Contingent consideration   22,551         21,995 
Other long-term liabilities   42,531         43,929 
Deferred revenues   15    2,525    15 
Employee benefit liabilities, net   1,268    1,369    1,280 
Total Non-Current Liabilities   85,717    7,331    87,786 
                
Shareholder’s Equity               
Ordinary shares   11,728    11,713    11,725 
Additional paid in capital  net   210,269    209,859    210,204 
Capital reserve due to translation to presentation currency   (3,490)   (3,490)   (3,490)
Capital reserve from hedges   12    30    54 
Capital reserve from share-based payments   4,771    4,674    4,643 
Capital reserve from employee benefits   (149)   (320)   (149)
Accumulated deficit   (47,991)   (41,246)   (46,163)
Total Shareholder’s Equity   175,150    181,220    176,824 
Total Liabilities and Shareholder’s Equity  $303,096   $210,528   $318,667 

 

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CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

 

   Three months period ended   Year ended 
   March 31,   December 31, 
   2022   2021   2021 
   Unaudited   Audited 
   U.S Dollars in thousands 
             
Revenues from proprietary products  $23,011   $20,870   $75,521 
Revenues from distribution   5,082    4,030    28,121 
                
Total revenues   28,093    24,900    103,642 
                
Cost of revenues from proprietary products   12,449    12,468    48,194 
Cost of revenues from distribution   4,342    3,501    25,120 
                
Total cost of revenues   16,791    15,969    73,314 
                
Gross profit   11,302    8,931    30,328 
                
Research and development expenses   4,420    2,628    11,357 
Selling and marketing expenses   3,321    1,123    6,278 
General and administrative expenses   3,005    2,809    12,636 
Other expense   310    7    753 
Operating income   246    2,364    (696)
                
Financial income   2    110    295 
Income in respect of securities measured at fair value, net   -    -    - 
Income (expense) in respect of currency exchange differences and derivatives instruments, net   169    266    (207)
Financial Income (expense) in respect of contingent consideration and other long- term liabilities.   (2,010)        (947)
Financial expense   (194)   (53)   (330)
Income before tax on income   (1,787)   2,687    (1,885)
Taxes on income   41    -    345 
                
Net Income  $(1,828)  $2,687   $(2,230)
                
Other Comprehensive Income (loss) :               
Amounts that will be or that have been reclassified to profit or loss when specific conditions are me               
Gain (loss) from securities measured at fair value through other comprehensive income   -    -    - 
Gain on cash flow hedges   (108)   (73)   185 
Net amounts transferred to the statement of profit or loss for cash flow hedges   66    (254)   (488)
Items that will not be reclassified to profit or loss in subsequent periods:               
Remeasurement gain (loss) from defined benefit plan   -    -    171 
Tax effect   -    -    - 
Total comprehensive income  $(1,870)  $2,360   $(2,362)
                
Earnings per share attributable to equity holders of the Company:               
Basic income per share  $(0.04)  $0.06   $(0.05)
Diluted income per share  $(0.04)  $0.06   $(0.05)

 

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CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   Three months period Ended   Year Ended 
   March 31,   December 31, 
   2022   2021   2021 
   Unaudited   Audited 
   U.S Dollars in thousands   U.S Dollars
in thousands
 
Net income  $(1,828)  $2,687   $(2,230)
                
Adjustments to reconcile net income to net cash provided by operating activities:               
                
Adjustments to the profit or loss items:               
                
Depreciation and amortization   3,027    1,147    5,609 
Financial expense (income), net   2,033    (323)   1,189 
Cost of share-based payment   193    215    529 
Taxes on income   41    -    345 
(Gain) loss from sale of property and equipment   -    -    - 
Change in employee benefit liabilities, net   (12)   (37)   45 
    5,282    1,002    7,717 
Changes in asset and liability items:               
Decrease(increase) in trade receivables, net   13,492    1,585    (12,861 
Decrease (increase) in other accounts receivables   589    (14)   (1,634)
Decrease (increase) in inventories   2,662    1,045    (2,373 
Decrease (increase) in deferred expenses   (110)   (1,153)   (6,883 
Increase (decrease) in trade payables   (13,649)   (1,484)   7,917)
Increase (decrease) in other accounts payables   (772)   (2,145)   (392)
Increase (decrease) in deferred revenues   -    500    (1,815 
                
    2,212    (1,666)   (14,411)
Cash received (paid) during the year for:               
                
Interest paid   (194)   (48)   (228)
Interest received   2    141    375 
Taxes paid   (9)   (14)   (42)
    (201)   79    105 
                
Net cash provided by (used in) operating activities  $5,465   $2,102   $(8,819)

 

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CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   Three months period Ended   Year Ended 
   March 31,   December 31, 
   2022   2021   2021 
   Unaudited   Audited 
   U.S Dollars in thousands   U.S Dollars
in thousands
 
Cash Flows from Investing Activities            
             
Investment in short term investments, net  $-   $(9,000)  $39,083 
Purchase of property and equipment and intangible assets   (513)   (131)   (3,730)
Proceeds from sale of property and equipment   -    -    7 
Business combination   -    (1,404    (96,403)
Net cash used in investing activities   (513)   (10,535)   (61,050)
                
Cash Flows from Financing Activities               
                
Proceeds from exercise of share base payments   3    7    19 
Receipt of long-term loans   -    -    20,000 
Repayment of lease liabilities   (295)   (289)   (1,221)
Repayment of long-term loans   (16)   (121)   (205)
Repayment of other long-term liabilities   (1,500)   -    - 
Net cash provided by (used in) financing activities   (1,808)   (403)   18,593 
                
Exchange differences on balances of cash and cash equivalent   236    75    (334)
                
Increase (decrease) in cash and cash equivalents   3,380    (8,761)   (51,610)
                
Cash and cash equivalents at the beginning of the year   18,587    70,197    70,197 
                
Cash and cash equivalents at the end of the year  $21,967   $61,436   $18,587 
                
Significant non-cash transactions               
Purchase of property and equipment through capital lease  $174   $302   $845 
Purchase of property and equipment  $254   $670   $1,001 

 

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NON-IFRS MEASURES - EBITDA

 

   Three months period Ended   Year ended 
   March 31,   December 31, 
   2022   2021   2021 
   U.S. Dollars in thousands 
Net (loss) income  $(1,828)  $2,687   $(2,230)
Taxes on income   41    -    345 
Financial expense (income), net   2,033    (323)   1,189 
Depreciation and amortization expense   2,886    1,147    5,609 
Non-cash share-based compensation expenses   155    215    529 
EBITDA  $3,286   $3,726   $5,442 

 

 

9

 


Exhibit 99.2

 

KAMADA LTD.

 

CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF MARCH 31, 2022

 

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 4-5
   
Consolidated Statements of Cash Flows 6-7
   
Notes to the Interim Consolidated Financial Statements 8-14

  

- - - - - - - - - - -

 

1

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

 

   As of March 31,   As of December 31, 
   2022   2021   2021 
   Unaudited   Audited 
   U.S Dollars in thousands 
Assets    
Current Assets            
Cash and cash equivalents  $21,967   $61,436   $18,587 
Short-term investments   -    48,038    - 
Trade receivables, net   21,568    20,367    35,162 
Other accounts  receivables   7,867    4,091    8,872 
Inventories   64,761    41,155    67,423 
Total Current Assets   116,163    175,087    130,044 
                
Non-Current Assets               
Property, plant and equipment, net   26,098    25,492    26,307 
Right-of-use assets   2,990    3,479    3,092 
Intangible assets, Goodwill and other long-term assets   151,858    3,175    153,663 
Contract assets   5,987    3,295    5,561 
Total Non-Current Assets   186,933    35,441    188,623 
Total Assets  $303,096   $210,528   $318,667 
Liabilities               
Current Liabilities               
Current maturities of bank loans  $3,725   $127   $2,631 
Current maturities of lease liabilities   1,017    1,092    1,154 
Current maturities of other long term liabilities   19,095    -    17,986 
Trade payables   11,682    15,076    25,104 
Other accounts payables   6,670    5,682    7,142 
Deferred revenues   40    -    40 
Total Current Liabilities   42,229    21,977    54,057 
                
Non-Current Liabilities               
Bank loans   16,296    20    17,407 
Lease liabilities   3,056    3,417    3,160 
Contingent consideration   22,551         21,995 
Other long-term liabilities   42,531         43,929 
Deferred revenues   15    2,525    15 
Employee benefit liabilities, net   1,268    1,369    1,280 
Total Non-Current Liabilities   85,717    7,331    87,786 
                
Shareholder's Equity               
Ordinary shares   11,728    11,713    11,725 
Additional paid in capital  net   210,269    209,859    210,204 
Capital reserve due to translation to presentation currency   (3,490)   (3,490)   (3,490)
Capital reserve from hedges   12    30    54 
Capital reserve from share-based payments   4,771    4,674    4,643 
Capital reserve from employee benefits   (149)   (320)   (149)
Accumulated deficit   (47,991)     (41,246)   (46,163)
Total Shareholder's Equity   175,150    181,220    176,824 
Total Liabilities and Shareholder's Equity  $303,096   $210,528   $318,667 

 

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

 

   Three months period ended   Year ended 
   March 31,   December 31, 
   2022   2021   2021 
   Unaudited   Audited 
   U.S Dollars in thousands 
             
Revenues from proprietary products  $23,011   $20,870   $75,521 
Revenues from distribution   5,082    4,030    28,121 
                
Total revenues   28,093    24,900    103,642 
                
Cost of revenues from proprietary products   12,449    12,468    48,194 
Cost of revenues from distribution   4,342    3,501    25,120 
                
Total cost of revenues   16,791    15,969    73,314 
                
Gross profit   11,302    8,931    30,328 
                
Research and development expenses   4,420    2,628    11,357 
Selling and marketing expenses   3,321    1,123    6,278 
General and administrative expenses   3,005    2,809    12,636 
Other expense   310    7    753 
Operating income   246    2,364    (696)
                
Financial income   2    110    295 
Income in respect of securities measured at fair value, net   -    -    - 
Income (expense) in respect of currency exchange differences and derivatives instruments, net   169    266    (207)
Financial Income (expense) in respect of contingent consideration and other long- term liabilities.   (2,010)        (947)
Financial expense   (194)   (53)   (330)
Income before tax on income   (1,787)   2,687    (1,885)
Taxes on income   41    -    345 
                
Net Income  $(1,828)  $2,687   $(2,230)
                
Other Comprehensive Income (loss) :               
Amounts that will be or that have been reclassified to profit or loss when specific conditions are me               
Gain (loss) from securities measured at fair value through other comprehensive income   -    -    - 
Gain on cash flow hedges   (108)   (73)   185 
Net amounts transferred to the statement of profit or loss for cash flow hedges   66    (254)   (488)
Items that will not be reclassified to profit or loss in subsequent periods:               
Remeasurement gain (loss) from defined benefit plan   -    -    171 
Tax effect   -    -    - 
Total comprehensive income  $(1,870)  $2,360   $(2,362)
                
Earnings per share attributable to equity holders of the Company:               
Basic income per share  $(0.04)  $0.06   $(0.05)
Diluted income per share  $(0.04)  $0.06   $(0.05)

  

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 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, 2022 (audited)  $11,725   $210,204   $                 -   $(3,490)  $54   $4,643   $(149)  $(46,163)  $176,824 
Net income   -    -    -    -    -    -    -    (1,828)   (1,828)
Other comprehensive income (loss)   -    -    -    -    (42)   -    -    -    (42)
Tax effect   -    -    -    -    -    -    -    -    - 
Total comprehensive income (loss)   -    -    -    -    (42)   -    -    (1,828)   (1,870)
Exercise and forfeiture of share-based payment into shares   3    65    -    -    -    (65)   -    -    3 
Cost of share-based payment   -    -    -    -    -    193    -    -    193 
Balance as of March 31, 2022  $11,728   $210,269   $-   $(3,490)  $12   $4,771   $(149)  $(47,991)  $175,150 

 

   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   -    -    -    -    -    -    2,687    2,687 
Other comprehensive income (loss)   -    -    -    (327)   -    -    -    (327)
Tax effect   -    -    -    -    -    -    -    - 
Total comprehensive income (loss)   -    -    -    (327)   -    -    2,687    2,360 
Exercise and forfeiture of share-based payment into shares   7    99    -    -    (99)   -    -    7 
Cost of share-based payment   -    -    -    -    215    -    -    215 
Balance as of March 31, 2021  $11,713   $209,859   $(3,490)  $30   $4,674   $(320)  $(41,246)  $181,220 

 

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 
   In thousands 
                                     
Balance as of January 1, 2021 (audited)  $11,706   $209,760   $             -   $(3,490)  $357   $4,558   $(320)  $(43,933)  $178,638 
Net income   -    -    -    -    -    -    -    (2,230)   (2,230)
Other comprehensive income (loss)   -    -    -    -    (303)   -    171    -    (132)
Tax effect   -    -    -    -    -    -    -    -    - 
Total comprehensive income (loss)   -    -    -    -    (303)   -    171    (2,230)   (2,362)
Exercise and forfeiture of share-based payment into shares   19    444    -    -    -    (444)   -    -    19 
Cost of share-based payment   -    -    -    -    -    529    -    -    529 
Balance as of December 31, 2021  $11,725   $210,204   $-   $(3,490)  $54   $4,643   $(149)  $(43,933)  $176,824 

 

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

 

5

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   Three months period Ended   Year Ended 
   March 31,   December 31, 
   2022   2021   2021 
   Unaudited   Audited 
   U.S Dollars in thousands   U.S Dollars
in thousands
 
Net income  $(1,828)  $2,687   $(2,230)
                
Adjustments to reconcile net income to net cash provided by operating activities:               
                
Adjustments to the profit or loss items:               
                
Depreciation and amortization   3,027    1,147    5,609 
Financial expense (income), net   2,033    (323)   1,189 
Cost of share-based payment   193    215    529 
Taxes on income   41    -    345 
(Gain) loss from sale of property and equipment   -    -    - 
Change in employee benefit liabilities, net   (12)   (37)   45 
    5,282    1,002    7,717 
Changes in asset and liability items:               
Decrease(increase) in trade receivables, net   13,492    1,585    (12,861 
Decrease (increase) in other accounts receivables   589    (14)   (1,634)
Decrease (increase) in inventories   2,662    1,045    (2,373 
Decrease (increase) in deferred expenses   (110)   (1,153)   (6,883 
Increase (decrease) in trade payables   (13,649)   (1,484)   7,917)
Increase (decrease) in other accounts payables   (772)   (2,145)   (392)
Increase (decrease) in deferred revenues   -    500    (1,815 
                
    2,212    (1,666)   (14,411)
Cash received (paid) during the year for:               
                
Interest paid   (194)   (48)   (228)
Interest received   2    141    375 
Taxes paid   (9)   (14)   (42)
    (201)   79    105 
                
Net cash provided by (used in) operating activities  $5,465   $2,102   $(8,819)

 

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

 

6

 

 

KAMADA LTD.

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    Three months period Ended     Year Ended  
    March 31,     December 31,  
    2022     2021     2021  
    Unaudited     Audited  
    U.S Dollars in thousands     U.S Dollars
in thousands
 
Cash Flows from Investing Activities                  
                   
Investment in short term investments, net   $ -     $ (9,000 )   $ 39,083  
Purchase of property and equipment and intangible assets     (513 )     (131 )     (3,730 )
Proceeds from sale of property and equipment     -       -       7  
Business combination     -       (1,404       (96,403 )
Net cash used in investing activities     (513 )     (10,535 )     (61,050 )
                         
Cash Flows from Financing Activities                        
                         
Proceeds from exercise of share base payments     3       7       19  
Receipt of long-term loans     -       -       20,000  
Repayment of lease liabilities     (295 )     (289 )     (1,221 )
Repayment of long-term loans     (16 )     (121 )     (205 )
Repayment of other long-term liabilities     (1,500 )     -       -  
Net cash provided by (used in) financing activities     (1,808 )     (403 )     18,593  
                         
Exchange differences on balances of cash and cash equivalent     236       75       (334 )
                         
Increase (decrease) in cash and cash equivalents     3,380       (8,761 )     (51,610 )
                         
Cash and cash equivalents at the beginning of the year     18,587       70,197       70,197  
                         
Cash and cash equivalents at the end of the year   $ 21,967     $ 61,436     $ 18,587  
                         
Significant non-cash transactions                        
Purchase of property and equipment through capital lease   $ 174     $ 302     $ 845  
Purchase of property and equipment   $ 254     $ 670     $ 1,001  

 

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

 

7

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1:- General

 

General description of the Company and its activity

 

Kamada Ltd. (the “Company”) is a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, 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 our current commercial activities as well as our manufacturing and development expertise in the plasma-derived biopharmaceutical market. The Company’s commercial products portfolio includes its developed and FDA approved products GLASSIA® and KEDRRAB® as well as its recently acquired FDA approved plasma-derived hyperimmune products CYTOGAM®, HEPAGAM B®, VARIZIG® and WINRHO®SDF. The Company has additional four plasma-derived products which are registered in markets outside the U.S. 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, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has a diverse portfolio of development pipeline products including 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. 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 eleven 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 2028.

 

In November 2021, the Company acquired a portfolio of four FDA approved plasma-derived hyperimmune commercial products from Saol Therapeutics (“Saol”). The acquisition of this portfolio furthers 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., will be 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 of the Company’s annual financial statements as of December 31, 2021.

 

The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited (“Takeda”). Pursuant to an agreement with Takeda, the Company terminated the production and sale of GLASSIA to Takeda during 2021 resulting in a significant reduction in revenues. Takeda initiated its own production of GLASSIA for the U.S. market. Commencing 2022, Takeda pays royalties to the Company at a rate of 12% on GLASSIA’s net sales through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually. Refer to Note 19 of the Company’s annual financial statements as of December 31, 2021.

 

8

 

 

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:

 

  i. 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 Amendment”) regarding the criteria for determining the classification of liabilities as current or non-current. The Amendment replaces certain requirements for classifying liabilities as current or non-current. Thus for example, 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, this instead of the requirement that there be an “unconditional” right. According to the 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 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 is effective for reporting periods beginning on or after January 1, 2023 with earlier application being permitted. The Amendment is 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.  

  

  ii. Amendment to IAS 12, Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction

 

The Amendment narrows the scope of the exemption from recognizing deferred taxes as a result of temporary differences created at the initial recognition of assets and/or liabilities, so that it does not apply to transactions that give rise to equal and offsetting temporary differences.  

 

As a result, companies will need to recognize a deferred tax asset or a deferred tax liability for these temporary differences at the initial recognition of transactions that give rise to equal and offsetting temporary differences, such as lease transactions and provisions for decommissioning and restoration.

 

The Amendment is effective for annual periods beginning on or after January 1, 2023, by amending the opening balance of the retained earnings or adjusting a different component of equity in the period the Amendment was first adopted. Earlier application is permitted.

 

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

 

9

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 3:- Significant events in the reporting period

 

Grant of options to the purchase ordinary shares of the Company to employees, executive officers, CEO and Board of Directors members

  

On February 28, 2022, the Company’s Board of Directors approved the grant of options to purchase up to 1,345,600, 400,000 and 270,000 ordinary shares of the Company to employees and executive officers, CEO and Board of Directors members, respectively.

 

As of March 31, 2022, out of the above mentioned, the Company granted to employees and executive officers a total of:

 

  - 1,130,100 options to purchase the ordinary shares of the Company, under the Israeli Share Option Plan, at exercise prices that ranged between NIS 19.36-18.92 (USD 5.80-6.05) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $2,272 thousands.

 

  - 101,200 options to purchase the ordinary shares of the Company, under the US Share Option Plan, at exercise prices that ranged between USD 5.88-6.10 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $226 thousands.

 

The grant of options to the CEO and the Board of Directors members are subject to the approval of the General Meeting of Shareholders that is expected to take place during 2022.

 

10

 

 

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 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 
Three months period ended March 31, 2022            
Revenues  $23,011   $5,082   $28,093 
Gross profit  $10,562   $740   $11,302 
Unallocated corporate expenses             (11,056)
Finance expenses, net             (2,033)
Income before taxes on income            $(1,787)

 

   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Three months period ended March 31, 2021            
Revenues  $20,870   $4,030   $24,900 
Gross profit  $8,402   $529   $8,931 
Unallocated corporate expenses             (6,567)
Finance expenses, net             323 
Income before taxes on income            $2,687 

 

11

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED 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, 2021            
Revenues  $75,521   $28,121   $103,642 
Gross profit  $27,327   $3,001   $30,328 
Unallocated corporate expenses             (31,024)
Finance expenses, net             (1,189)
Income before taxes on income            $(1,885)

 

  c. Reporting on operating segments by geographic region:

 

    Three months period ended
March 31, 2022
 
    Proprietary
Products
    Distribution     Total  
    U.S Dollars in thousands  
    Unaudited  
Geographical markets                  
U.S.A and North America   $ 16,951     $ -     $ 16,951  
Israel     1,627       5,082       6,709  
Europe     1,052       -       1,052  
Latin America     2,030       -       2,030  
Asia     984       -       984  
Others     367       -       367  
    $ 23,011     $ 5,082     $ 28,093  

 

12

 

 

KAMADA LTD.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

Note 4:-Operating Segments (cont.)

 

c.Reporting on operating segments by geographic region:

 

   Three months period ended
March 31, 2021
 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Unaudited 
Geographical markets            
U.S.A and North America.  $13,883   $-   $13,883 
Israel   1,986    4,030    6,016 
Europe   2,427    -    2,427 
Latin America   2,175    -    2,175 
Asia   380    -    380 
Others   19    -    19 
   $20,870   $4,030   $24,900 

 

   Year ended December 31, 2021 
   Proprietary
Products
   Distribution   Total 
   U.S Dollars in thousands 
   Audited 
Geographical markets            
U.S.A and North America  $49,763   $-   $49,763 
Israel   7,653    28,121    35,774 
Europe   5,677    -    5,677 
Latin America   9,127    -    9,127 
Asia   3,167    -    3,167 
Others   134    -    134 
   $75,521   $28,121   $103,642 

 

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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   Level 3 
  

U.S Dollars in thousands

 
March 31, 2022            
Derivatives instruments  $-   $(58)   - 
Contingent consideration   -    -   $(22,551)
                
March 31, 2021               
Derivatives instruments  $-   $66   $- 
                
December 31, 2021               
Derivatives instruments  $-   $73   $- 
Contingent consideration  $-   $-   $(21,995)

 

During the three months ended on March 31, 2022 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.

 

Note 6:- Subsequent events

 

In November 2018, the Company signed a collective bargaining agreement with the Histadrut and the Employees’ Committee, which expired on December 31, 2021. On April 26, 2022, during the Company’s negotiations with the Histadrut - General Federation of Labor in Israel (the “Histadrut”) and the Employees’ Committee of Kamada’s Beit Kama production facility in Israel (the “Employee’s Committee”), on the extension of a collective bargaining agreement, the Employee’s Committee elected to declare a labor strike in the Beit Kama plant. As the strike was initiated by the Employee's Committee, the Company cannot currently predict how long it will last.

 

 

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