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Kamada Ltd.

Foreign Filer Report Nov 22, 2022

6874_rns_2022-11-22_045bcd4d-3152-41cb-befd-9dea91f7862f.pdf

Foreign Filer Report

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934

For the Month of November 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, 333-233267 and 333-265866.

The following exhibit is attached:

99.1 Kamada Reports Strong Third Quarter Financial Results Demonstrating Successful Strategic Transition and Reiterates 2022 Financial
Guidance
99.2 Kamada Ltd's Consolidated Financial Statements as of September 30, 2022 (Unaudited)
101.INS Inline XBRL Instance Document.
101.SCH Inline XBRL Taxonomy Extension Schema Document.
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 22, 2022 KAMADA LTD.

By: /s/ Yifat Philip

Yifat Philip Vice President General Counsel and Corporate Secretary

EXHIBIT NO. DESCRIPTION

99.1 Kamada Reports Strong Third Quarter Financial Results Demonstrating Successful Strategic Transition and Reiterates 2022 Financial
Guidance
99.2 Kamada Ltd's Consolidated Financial Statements as of September 30, 2022 (Unaudited)
101.INS Inline XBRL Instance Document.
101.SCH Inline XBRL Taxonomy Extension Schema Document.
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Kamada Reports Strong Third Quarter Financial Results Demonstrating Successful Strategic Transition and Reiterates 2022 Financial Guidance

  • Third Quarter 2022 Revenues of \$32.2 Million, a 40% Increase Compared to Prior Year Period; Reaping the Benefits of the Acquired IgG Portfolio
  • Strong Results Represent Completion of the Company's Strategic Transformation into a Diversified Commercial Entity with Multiple Growth Drivers
  • Adjusted EBITDA for the Third Quarter was \$6.0 Million, or 19% Margin, and for First Nine Months was \$10.6 Million or 13% Margin, Within Annual Guidance, and Representing 58% Increase Year-over-Year
  • Generated Operating Cash Flow of \$5.5 Million in the Third Quarter and \$21.8 Million in the First Nine Months of 2022, Supporting the Increase of Cash Position to \$31.3 Million as of September 30, 2022
  • Kamada's Positive Outlook for the Fourth Quarter Supports Reiteration of Fiscal Year 2022 Revenue Guidance of \$125 Million \$135 Million, Representing a 20% to 30% Increase Over 2021 and Adjusted EBITDA Margins Between 12%-15%, More Than 2.5x Over 2021

Rehovot, Israel, and Hoboken, NJ – November 22, 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 and nine months ended September 30, 2022.

"Our strong third quarter performance is consistent with our forecasted positive outlook for the second half of the year," said Amir London, Kamada's Chief Executive Officer. "Our business is beginning to reap the significant benefits of the acquired portfolio of four FDA-approved IgGs, consisting of CYTOGAM®, HEPAGAM B®, VARIZIG® and WINRHO®SDF. We have now completed our rapid transition from our past dependency on GLASSIA® sales to Takeda to a diversified, fully integrated commercial company and a global leader in the plasma-derived specialty market. In the third quarter, we generated total revenues of \$32.2 million, representing a 40% increase year-over-year, and overall gross margins increased to 40% as compared to 25% in the third quarter of 2021. Importantly, each of our expected key revenue and profitability drivers, including our new IgG portfolio, as well as KEDRAB® sales and GLASSIA royalty income, contributed significantly to our sales and profitability growth. Based on our expectation for continued revenue growth and enhanced profitability in the fourth quarter of the year, we are reiterating our full-year 2022 financial guidance, which represents a 20% to 30% increase over 2021 revenue and more than 2.5x over 2021 adjusted EBITDA."

"I am pleased to report that over recent months, as part of the establishment of our direct presence in the U.S. market, we deployed a team of U.S.-based experienced sales and medical affairs professionals who have rapidly established our operations in this key market. The U.S. sales team is making good progress in promoting our portfolio of specialty plasma-derived IgG products to physicians and other healthcare practitioners through direct engagement and opportunities at medical conventions. The Medical Affairs team is working to educate physicians, while addressing their scientific and clinical inquiries, including participating in major medical conferences in the U.S. These activities represent the first time in over a decade that these hyperimmune specialty products have been supported by field-based activity in the U.S. We are encouraged by the positive feedback received from key U.S. physicians who are seeking to publish new clinical data related to our portfolio, while conducting educational symposiums that we believe will have a positive impact on the understanding of these products, thereby contributing to continued growth in demand," continued Mr. London.

"In addition, we continue to make significant progress promoting our commercial portfolio outside the U.S. market. To this end, we recently reported an \$11.4 million agreement to supply VARIZIG to an international organization, as well as the extension of an existing tender for the supply, in Canada, of the four IgG products for a total of \$22.0 million over the next three years. These significant accomplishments are key factors in ensuring our continued growth. Looking further ahead, we continue to forecast revenue growth at a double-digit rate in the foreseeable years beyond 2022, driven by our proprietary product catalysts, our plasma collection operations, GLASSIA's royalties and the planned launch of eleven biosimilar products in Israel," concluded Mr. London.

Financial Highlights for the Three Months Ended September 30, 2022

  • Total revenues were \$32.2 million in the third quarter of 2022, a 40% increase from the \$23.0 million recorded in the third quarter of 2021. Total revenues during the third quarter of 2022 included strong sales from the portfolio of four acquired FDA-approved IgG products. Total revenues included \$3.5 million of sales-based royalty income from Takeda based on GLASSIA sales in the U.S.
  • Gross profit and gross margins were \$12.9 million and 40%, respectively, in the third quarter of 2022, compared to \$5.7 million and 25%, respectively, reported in the third quarter of 2021. The increase in profitability was driven by a positive product sales mix, including sales of our four new IgG products, KEDRAB and GLASSIA royalties. Cost of goods sold in the Company's Proprietary segment in the third quarter of 2022 included \$1.3 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition. Gross profit and gross margins, excluding such intangible assets depreciation, would have been \$14.2 million and 44%, respectively.
  • Operating expenses, including R&D, Sales & Marketing (S&M), G&A and other expenses, totaled \$10.3 million in the third quarter of 2022, as compared to \$6.5 million in the third quarter of 2021. This increase was attributable to increased S&M costs associated with expanded U.S. commercial operations and increased costs associated with accelerating recruitment for the ongoing pivotal Phase 3 clinical trial of Inhaled AAT. S&M costs for the quarter included \$0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition.
  • Finance expense, net for the third 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 IgG products acquisition. 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 income was \$0.5 million, or \$0.01 per share, in the third quarter of 2022, as compared to a net loss of \$0.8 million, or \$(0.02) per share, in the third quarter of 2021. Excluding depreciation expenses of intangible assets mentioned above and finance expense associated with the revaluation of the contingent consideration and other assumed long-term liabilities, the Company would have recorded net income of \$4.3 million, or \$0.10 per share, in the third quarter of 2022.
  • Adjusted EBITDA, as detailed in the tables below, was \$6.0 million in the third quarter of 2022, as compared to \$0.6 million in the third quarter of 2021.
  • Cash provided by operating activities was \$5.5 million in the third quarter of 2022, as compared to cash used in operating activities of \$2.7 million in the third quarter of 2021.

Financial Highlights for the Nine Months Ended September 30, 2022

  • Total revenues for the first nine months of 2022 were \$83.9 million, a 16% increase from the \$72.2 million generated in the first nine months of 2021. The increase in revenues is mainly attributable to sales of the acquired four IgG products.
  • Gross profit and gross margins for the first nine months of 2022 were \$31.4 million and 37%, respectively, compared to \$23.7 million and 33%, respectively, in the prior year period. Gross profit and gross margins in the first nine months of 2022, excluding intangible assets depreciation and a \$4.3 million loss related to the labor strike concluded in July 2022, would have been \$39.7 million and 47%, respectively, representing a significant increase year-over-year.
  • Operating expenses, including R&D, S&M, G&A and other expenses, totaled \$30.9 million in the first nine months of 2022, as compared to \$21.1 million in the first nine months 2021. This increase was attributable to an increase in S&M costs associated with the recently acquired portfolio marketing and commercial operation, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT through the opening of new clinical sites and the manufacturing of clinical supply for the study. S&M costs for the first nine months included \$1.3 million of depreciation expenses of intangible assets generated through the IgG products acquisition.
  • Finance expense, net for the first nine months of 2022 included a \$5.9 million expense associated with the revaluation of the contingent consideration and other long-term liabilities, assumed as part of the IgG products acquisition.
  • Net loss for the first nine months of 2022 was \$5.3 million, or \$(0.12) per share, as compared to net income of \$2.8 million, or \$0.06 per share, in the prior year period. Excluding loss associated with the labor strike, depreciation expenses of intangible assets generated through the recent acquisition and finance expense associated with the revaluation of the contingent consideration and other assumed long-term liabilities, the Company would have recorded net income of \$10.2 million, or \$0.23 per share, in the first nine months of 2022.
  • Adjusted EBITDA, as detailed in the tables below, was \$10.6 million in the first nine months of 2022, as compared to \$6.7 million in the first nine months of 2021, representing a 58% increase year-over-year, and 13% margins, which is in line with Kamada's annual guidance. Excluding loss associated with the labor strike, Adjusted EBITDA would have been \$14.9 million, representing an 18% margin.
  • Cash provided by operating activities during the first nine months of 2022 was \$21.8 million, as compared to cash used in operating activities of \$3.9 million during the first nine months of 2021.

Balance Sheet Highlights

As of September 30, 2022, the Company had cash and cash equivalents of \$31.3 million, as compared to \$18.6 million as of December 31, 2021. Kamada's strong cash position is driven by continued positive operational cash flows, which is indicative of the significant momentum in the Company's commercial operations.

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 20% to 30% growth compared to fiscal year 2021. The Company also anticipates generating adjusted EBITDA during 2022 at a rate of 12% to 15% of total revenues, representing more than 2.5x of the adjusted EBITDA for the year ended December 31, 2021.

Recent Corporate Highlights

  • Awarded extension to existing Canadian supply tender for the portfolio of four specialty IgG products acquired in 2021. The supply extension secures ongoing sales of approximately \$7.5 million per year for 2023-2025, with an option to extend for up to an additional two years.
  • Reported acceleration of enrollment in ongoing pivotal Phase 3 clinical trial of Inhaled AAT. The independent DSMB recommended study continuation without modification for the fourth time since study initiation. Based on encouraging safety observed to date, trial inclusion criteria revised to also include patients with severe airflow limitation, thereby expanding the potential patient treatment population. Kamada intends to meet with the FDA and EMA during the first half of 2023 to discuss study progress and potential opportunities to shorten the regulatory pathway.

Conference Call

Kamada management will host an investment community conference call on Tuesday, November 22, 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: 13734312. The call will also be webcast live on the Internet at:

https://viavid.webcasts.com/starthere.jsp?ei=1582277&tp_key=8121e668e3.

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 plasmaderived 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 eleven biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched in Israel through 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.

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) fiscal year 2022 guidance, 2) revenue growth at a double-digit rate in the foreseeable years beyond 2022, driven by Kamada's proprietary product catalysts, plasma collection operations, GLASSIA's royalties and the planned launch of 11 biosimilar products in Israel, 3) continued revenue growth and enhanced profitability in the fourth quarter of the year, 4) Kamada becoming a diversified, fully integrated commercial company and a global leader in the plasma-derived specialty market, 5) optimism about the positive feedback received from key U.S. physicians to enable the expansion of sales of our IgG portfolio, 6) the encouraging safety observed to date relating to the Phase 3 clinical trial of Inhaled AAT, and 7) planned meeting with the FDA and EMA during the first half of 2023 to discuss study progress and potential opportunities to shorten the regulatory pathway. 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, 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 FDAapproved 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 [email protected]

Bob Yedid LifeSci Advisors, LLC 646-597-6989 [email protected]

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As of September 30, As of
December 31,
2022
2021
2021
Unaudited
U.S Dollars in thousands Audited
Assets
Current Assets
Cash and cash equivalents \$ 31,252 \$
99,840
\$ 18,587
Trade receivables, net 23,997 26,548 35,162
Other accounts receivables 6,884 4,392 8,872
Inventories 73,029 48,163 67,423
Total Current Assets 135,162 178,943 130,044
Non-Current Assets
Property, plant and equipment, net 25,898 25,856 26,307
Right-of-use assets 2,793 3,361 3,092
Intangible assets, Goodwill and other long-term assets 148,620 3,380 153,663
Contract assets 7,164 4,987 5,561
Total Non-Current Assets 184,475 37,584 188,623
Total Assets \$ 319,637 \$
216,527
\$ 318,667
Liabilities
Current Liabilities
Current maturities of bank loans \$ 4,444 \$
52
\$ 2,631
Current maturities of lease liabilities 1,004 1,181 1,154
Current maturities of other long term liabilities 25,095 - 17,986
Trade payables 30,619 19,010 25,104
Other accounts payables 7,948 6,346 7,142
Deferred revenues 40 - 40
Total Current Liabilities 69,150 26,589 54,057
Non-Current Liabilities
Bank loans 14,074 - 17,407
Lease liabilities 2,414 3,283 3,160
Contingent consideration 20,705 - 21,995
Other long-term liabilities 39,915 - 43,929
Deferred revenues 15 3,575 15
Employee benefit liabilities, net 813 1,467 1,280
Total Non-Current Liabilities 77,936 8,325 87,786
Shareholder's Equity
Ordinary shares 11,732 11,720 11,725
Additional paid in capital net 210,355 210,005 210,204
Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)
Capital reserve from hedges (257) 35 54
Capital reserve from share-based payments 5,427 4,817 4,643
Capital reserve from employee benefits 212 (320) (149)
Accumulated deficit (51,428) (41,154) (46,163)
Total Shareholder's Equity 172,551 181,613 176,824
Total Liabilities and Shareholder's Equity \$ 319,637 \$
216,527
\$ 318,667

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

Nine months period
ended
September 30,
Three months period
ended
September 30,
Year ended
December 31,
2022 2021 2022 2021 2021
Unaudited Unaudited Audited
U.S Dollars In thousands
Revenues from proprietary products \$ 67,198 \$ 57,316 \$ 25,580 \$ 17,123 \$ 75,521
Revenues from distribution 16,702 14,857 6,637 5,911 28,121
Total revenues 83,900 72,173 32,217 23,034 103,642
Cost of revenues from proprietary products 37,856 35,605 13,151 12,078 48,194
Cost of revenues from distribution 14,632 12,835 6,196 5,226 25,120
Total cost of revenues 52,488 48,440 19,347 17,304 73,314
Gross profit 31,412 23,733 12,870 5,730 30,328
Research and development expenses 10,181 7,909 3,118 2,545 11,357
Selling and marketing expenses 10,435 3,803 3,843 1,256 6,278
General and administrative expenses 9,481 8,803 3,165 2,691 12,636
Other expenses 801 612 182 42 753
Operating income (loss) 514 2,606 2,562 (804) (696)
Financial income 32 277 29 68 295
Income (expenses) in respect of currency exchange
differences and derivatives instruments, net
756 74 163 (48) (207)
Financial Income (expense) in respect of contingent
consideration and other long- term liabilities. (5,924) - (2,049) - (947)
Financial expenses (583) (178) (211) (61) (330)
Income before tax on income (5,205) 2,779 494 (845) (1,885)
Taxes on income 60 - 10 - 345
Net Income (loss) \$ (5,265) \$ 2,779 \$ 484 \$ (845) \$ (2,230)
Other Comprehensive Income (loss):
Amounts that will be or that have been reclassified to profit
or loss when specific conditions are met
Gain (loss) on cash flow hedges (830) 25 (46) 68 185
Net amounts transferred to the statement of profit or loss for
cash flow hedges
519 (347) 231 (91) (488)
Items that will not be reclassified to profit or loss in
subsequent periods:
Remeasurement gain (loss) from defined benefit plan 361 - (59) - 171
Total comprehensive income (loss) \$ (5,215) \$ 2,457 \$ 610 \$ (868) \$ (2,362)
Earnings per share attributable to equity holders of the
Company:
Basic net earnings per share \$ (0.12) \$ 0.06 \$ 0.01 \$ (0.02) \$ (0.05)
Diluted net earnings per share \$ (0.12) \$ 0.06 \$ 0.01 \$ (0.02) \$ (0.05)

CONSOLIDATED STATEMENTS OF CASH FLOWS

Nine months period
September, 30
Ended Three months period
Ended
September, 30
Year Ended
December 31,
2022 2021 2022 2021 2021
Unaudited Audited
U.S Dollars In thousands
Cash Flows from Operating Activities
Net income (loss) \$ (5,265) \$ 2,779 \$ 484 \$ (845) \$ (2,230)
Adjustments to reconcile net income to net cash provided by
(used in) operating activities:
Adjustments to the profit or loss items:
Depreciation and impairment 9,143 3,612 3,055 1,240 5,609
Financial expenses (income), net 5,719 (173) 2,068 41 1,189
Cost of share-based payment 935 504 366 134 529
Taxes on income 60 - 10 - 345
Change in employee benefit liabilities, net (106) 61 (10) 38 45
15,751 4,004 5,489 1,453 7,717
Changes in asset and liability items:
Decrease (increase) in trade receivables, net 10,744 (4,446) (6,358) 1,200 (12,861)
Decrease (increase) in other accounts receivables 2,917 1,556 844 (73) (1,634)
Decrease (increase) in inventories (5,606) (5,963) (8,509) (3,562) (2,373)
Decrease (increase) in deferred expenses (2,596) (4,759) (2,112) (2,397) (6,883)
Increase (decrease) in trade payables 5,895 2,725 13,738 1,586 7,917
Increase (decrease) in other accounts payables 566 (1,482) 2,083 (683) (392)
Decrease in deferred revenues - 1,550 - 550 1,815
11,920 (10,819) (314) (3,379) (14,411)
Cash received (paid) during the period for:
Interest paid (550) (139) (170) (32) (228)
Interest received 15 357 12 140 375
Taxes paid (27) (32) (9) (9) (42)
(562) 186 (167) 99 105
Net cash provided by (used in) operating activities \$ 21,844 \$ (3,850) \$ 5,492 \$ (2,672) \$ (8,819)

CONSOLIDATED STATEMENTS OF CASH FLOWS

Nine months period
Ended
September, 30
Three months period
September, 30
Ended Year Ended
December 31,
2022 2021 2022 2021 2021
Unaudited Audited
U.S Dollars In thousands
Cash Flows from Investing Activities
Investment in short term investments, net \$ - \$ 39,083 \$ - \$ 36,116 \$ 39,083
Purchase of property and equipment and intangible assets (2,807) (2,986) (1,616) (1,523) (3,730)
Business combination - (1,404) - - (96,403)
Net cash provided by (used in) investing activities (2,807) 34,693 (1,616) 34,593 (61,050)
Cash Flows from Financing Activities
Proceeds from exercise of share base payments 7 14 1 4 19
Receipt of long-term loans - - - 20,000
Repayment of lease liabilities (842) (903) (269) (308) (1,221)
Repayment of long-term loans (1,517) (221) (1,116) (15) (205)
Repayment of other long-term liabilities (4,120) - (877) - -
Net cash provided by (used in) financing activities (6,472) (1,110) (2,261) (319) 18,593
Exchange differences on balances of cash and cash
equivalent 100 (90) (296) (178) (334)
Increase (decrease) in cash and cash equivalents 12,665 29,643 1,319 31,424 (51,610)
Cash and cash equivalents at the beginning of the period 18,587 70,197 29,933 68,416 70,197
Cash and cash equivalents at the end of the period \$ 31,252 \$ 99,840 \$ 31,252 \$ 99,840 \$ 18,587
Significant non-cash transactions
Right-of-use asset recognized with corresponding lease
liability
\$ 526 \$ 769 \$ 230 \$ 181 \$ 845
Purchase of property and equipment and Intangible assets \$ 134 \$ 352 \$ 134 \$ 352 \$ 1,001

NON-IFRS MEASURES – ADJUSTED EBITDA

Nine months period
ended
September 30,
Three months period
ended
September 30,
Year ended
December 31,
2022 2021 2022 2021 2021
In thousands
Net income \$ (5,265) \$ 2,779 \$ 484 \$ (845) \$ (2,230)
Taxes on income 60 - 10 - 345
Financial expense (income), net 5,719 (173) 2,068 41 1,189
Depreciation and amortization expense 9,143 3,612 3,055 1,240 5,609
Non-cash share-based compensation expenses 935 504 366 134 529
Adjusted EBITDA \$ 10,592 \$ 6,722 \$ 5,983 \$ 570 \$ 5,442

KAMADA LTD.

CONSOLIDATED FINANCIAL STATEMENTS

AS OF SEPTEMBER 30, 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 4-6
Consolidated Statements of Cash Flows 7-8
Notes to the Interim Consolidated Financial Statements 9-16

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As of September 30, As of
December 31,
2022 2021 2021
Unaudited Audited
U.S Dollars in thousands
Assets
Current Assets
Cash and cash equivalents \$ 31,252 \$ 99,840 \$
18,587
Trade receivables, net 23,997 26,548 35,162
Other accounts receivables 6,884 4,392 8,872
Inventories 73,029 48,163 67,423
Total Current Assets 135,162 178,943 130,044
Non-Current Assets
Property, plant and equipment, net 25,898 25,856 26,307
Right-of-use assets 2,793 3,361 3,092
Intangible assets, Goodwill and other long-term assets 148,620 3,380 153,663
Contract assets 7,164 4,987 5,561
Total Non-Current Assets 184,475 37,584 188,623
Total Assets \$ 319,637 \$ 216,527 \$
318,667
Liabilities
Current Liabilities
Current maturities of bank loans \$ 4,444 \$ 52 \$
2,631
Current maturities of lease liabilities 1,004 1,181 1,154
Current maturities of other long term liabilities 25,095 - 17,986
Trade payables 30,619 19,010 25,104
Other accounts payables 7,948 6,346 7,142
Deferred revenues 40 - 40
Total Current Liabilities 69,150 26,589 54,057
Non-Current Liabilities
Bank loans 14,074 - 17,407
Lease liabilities 2,414 3,283 3,160
Contingent consideration 20,705 - 21,995
Other long-term liabilities 39,915 - 43,929
Deferred revenues 15 3,575 15
Employee benefit liabilities, net 813 1,467 1,280
Total Non-Current Liabilities 77,936 8,325 87,786
Shareholder's Equity
Ordinary shares 11,732 11,720 11,725
Additional paid in capital net 210,355 210,005 210,204
Capital reserve due to translation to presentation currency (3,490) (3,490) (3,490)
Capital reserve from hedges (257) 35 54
Capital reserve from share-based payments 5,427 4,817 4,643
Capital reserve from employee benefits 212 (320) (149)
Accumulated deficit (51,428) (41,154) (46,163)
Total Shareholder's Equity 172,551 181,613 176,824
Total Liabilities and Shareholder's Equity \$ 319,637 \$ 216,527 \$
318,667

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

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

Nine months period ended
September 30,
Three months period ended
September 30,
Year ended
December 31,
2022 2021 2022 2021 2021
Unaudited Unaudited Audited
U.S Dollars In thousands
Revenues from proprietary products
Revenues from distribution
\$ 67,198
16,702
\$ 57,316
14,857
\$ 25,580
6,637
\$ 17,123
5,911
\$ 75,521
28,121
Total revenues 83,900 72,173 32,217 23,034 103,642
Cost of revenues from proprietary products
Cost of revenues from distribution
37,856
14,632
35,605
12,835
13,151
6,196
12,078
5,226
48,194
25,120
Total cost of revenues 52,488 48,440 19,347 17,304 73,314
Gross profit 31,412 23,733 12,870 5,730 30,328
Research and development expenses
Selling and marketing expenses
General and administrative expenses
Other expenses
10,181
10,435
9,481
801
7,909
3,803
8,803
612
3,118
3,843
3,165
182
2,545
1,256
2,691
42
11,357
6,278
12,636
753
Operating income (loss) 514 2,606 2,562 (804) (696)
Financial income
Income (expenses) in respect of currency exchange
differences and derivatives instruments, net
32
756
277
74
29
163
68
(48)
295
(207)
Financial Income (expense) in respect of contingent
consideration and other long- term liabilities.
(5,924) - (2,049) - (947)
Financial expenses (583) (178) (211) (61) (330)
Income before tax on income (5,205) 2,779 494 (845) (1,885)
Taxes on income 60 - 10 - 345
Net Income (loss) \$ (5,265) \$ 2,779 \$ 484 \$ (845) \$ (2,230)
Other Comprehensive Income (loss):
Amounts that will be or that have been reclassified to profit
or loss when specific conditions are met
Gain (loss) on cash flow hedges (830) 25 (46) 68 185
Net amounts transferred to the statement of profit or loss for
cash flow hedges
Items that will not be reclassified to profit or loss in
subsequent periods:
519 (347) 231 (91) (488)
Remeasurement gain (loss) from defined benefit plan 361 - (59) - 171
Total comprehensive income (loss) \$ (5,215) \$ 2,457 \$ 610 \$ (868) \$ (2,362)
Earnings per share attributable to equity holders of the
Company:
Basic net earnings per share \$ (0.12) \$ 0.06 \$ 0.01 \$ (0.02) \$ (0.05)
Diluted net earnings per share \$ (0.12) \$ 0.06 \$ 0.01 \$ (0.02) \$ (0.05)

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

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
Unaudited
Capital
reserve
from
employee
benefits
Accumulated
deficit
Total
equity
In thousands
Balance as of January 1, 2022 (audited)
Net income
\$
11,725
-
\$
210,204
-
\$
(3,490) \$
-
54
-
\$
4,643
-
\$
(149) \$
-
(5,265) (46,163) \$ 176,824
(5,265)
Other comprehensive income (loss) - - - (311) - 361 - 50
Tax effect - - - - - - - -
Total comprehensive income (loss)
Exercise and forfeiture of share-based
- - - (311) - 361 (5,265) (5,215)
payment into shares
Cost of share-based payment
7 151 - - (151) - - 7
Balance as of September 30, 2022 -
\$
11,732
-
\$
210,355
-
\$
(3,490) \$
-
(257) \$
935
5,427
-
\$
212
-
\$
935
(51,428) \$ 172,551
Share
capital
Additional
paid in
capital
Capital
reserve
due to
Capital
translation to
reserve
presentation
from
currency
hedges
Unaudited
Capital
reserve
from
sharebased
payments
Capital
reserve
from
employee
benefits
Accumulated
deficit
Total
equity
In thousands
Balance as of January 1, 2021 (audited)
Net income
\$
11,706
-
\$
209,760
-
\$
(3,490) \$
-
357
-
\$
4,558
-
\$
(320) \$
-
2,779 (43,933) \$ 178,638
2,779
Other comprehensive income (loss)
Tax effect
-
-
-
-
-
-
(322)
-
-
-
-
-
-
-
(322)
-
Total comprehensive income (loss)
Exercise and forfeiture of share-based
- - - (322) - - 2,779 2,457
payment into shares 14 245 - - (245) - - 14
Cost of share-based payment - - - - 504 - - 504

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

Balance as of September 30, 2021 \$ 11,720 \$ 210,005 \$ (3,490) \$ 35 \$ 4,817 \$ (320) \$ (41,154) \$ 181,613

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
Unaudited
In thousands
Balance as of July 1, 2022 \$
11,731
\$
210,319
\$
(3,490) \$
(442) \$ 5,097 \$
271
\$ (51,912) \$ 171,574
Net income - - - - - - 484 484
Other comprehensive income (loss)
Tax effect
- - - 185 - (59) - 126
- - - - - - - -
Total comprehensive income (loss)
Exercise and forfeiture of share-based
- - - 185 - (59) 484 610
payment into shares 1 36 - - (36) - - 1
Cost of share-based payment - - - - 366 - - 366
Balance as of September 30, 2022 \$
11,732
\$
210,355
(3,490) \$
\$
(257) \$ 5,427 \$
212
\$ (51,428) \$ 172,551
Share
capital
Additional
paid in
capital
Capital
reserve
due to
translation to
presentation
currency
Capital
reserve
from
hedges
Capital
reserve
from
sharebased
payments
Unaudited
Capital
reserve
from
employee
benefits
Accumulated
deficit
Total
equity
In thousands
Balance as of July 1, 2021 \$
11,716
\$
209,942
(3,490) \$
\$
58 \$
4,746
(320) \$
\$
(40,309) \$ 182,343
Net income - - - - - - (845) (845)
Other comprehensive income (loss) - - - (23) - - - (23)
Taxes effect - - - - - - - -
Total comprehensive income (loss) - - - (23) - - (845) (868)
Exercise and forfeiture of share-based
payment into shares 4 63 - - (63) - - 4
Cost of share-based payment - - - - 134 - - 134
Balance as of September 30, 2021 \$
11,720
\$
210,005
(3,490) \$
\$
35 \$
4,817
(320) \$
\$
(41,154) \$ 181,613

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

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
Audited
Capital
reserve
from
employee
benefits
Accumulated
deficit
Total
equity
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)
Taxes 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) \$
\$
(46,163) \$ 176,824

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

CONSOLIDATED STATEMENTS OF CASH FLOWS

Nine months period Ended
September, 30
2022
Three months period Ended
September, 30
Year Ended
December 31,
2021 2022 2021 2021
Unaudited Audited
U.S Dollars In thousands
Cash Flows from Operating Activities
Net income (loss) \$ (5,265) \$ 2,779 \$ 484 \$ (845) \$ (2,230)
Adjustments to reconcile net income to net cash provided by
(used in) operating activities:
Adjustments to the profit or loss items:
Depreciation and impairment 9,143 3,612 3,055 1,240 5,609
Financial expenses (income), net 5,719 (173) 2,068 41 1,189
Cost of share-based payment 935 504 366 134 529
Taxes on income 60 - 10 - 345
Change in employee benefit liabilities, net (106) 61 (10) 38 45
15,751 4,004 5,489 1,453 7,717
Changes in asset and liability items:
Decrease (increase) in trade receivables, net 10,744 (4,446) (6,358) 1,200 (12,861)
Decrease (increase) in other accounts receivables 2,917 1,556 844 (73) (1,634)
Decrease (increase) in inventories (5,606) (5,963) (8,509) (3,562) (2,373)
Decrease (increase) in deferred expenses (2,596) (4,759) (2,112) (2,397) (6,883)
Increase (decrease) in trade payables 5,895 2,725 13,738 1,586 7,917
Increase (decrease) in other accounts payables 566 (1,482) 2,083 (683) (392)
Decrease in deferred revenues - 1,550 - 550 1,815
11,920 (10,819) (314) (3,379) (14,411)
Cash received (paid) during the period for:
Interest paid (550) (139) (170) (32) (228)
Interest received 15 357 12 140 375
Taxes paid (27) (32) (9) (9) (42)
(562) 186 (167) 99 105
Net cash provided by (used in) operating activities \$ 21,844 \$ (3,850) \$ 5,492 \$ (2,672) \$ (8,819)

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

CONSOLIDATED STATEMENTS OF CASH FLOWS

Nine months period Ended
September, 30
Three months period Ended
September, 30
Year Ended
December 31,
2022 2021 2022 2021 2021
Unaudited Audited
U.S Dollars In thousands
Cash Flows from Investing Activities
Investment in short term investments, net \$ - \$ 39,083 \$ - \$ 36,116 \$ 39,083
Purchase of property and equipment and intangible assets (2,807) (2,986) (1,616) (1,523) (3,730)
Business combination - (1,404) - - (96,403)
Net cash provided by (used in) investing activities (2,807) 34,693 (1,616) 34,593 (61,050)
Cash Flows from Financing Activities
Proceeds from exercise of share base payments 7 14 1 4 19
Receipt of long-term loans - - - 20,000
Repayment of lease liabilities (842) (903) (269) (308) (1,221)
Repayment of long-term loans (1,517) (221) (1,116) (15) (205)
Repayment of other long-term liabilities (4,120) - (877) - -
Net cash provided by (used in) financing activities (6,472) (1,110) (2,261) (319) 18,593
Exchange differences on balances of cash and cash
equivalent
100 (90) (296) (178) (334)
Increase (decrease) in cash and cash equivalents 12,665 29,643 1,319 31,424 (51,610)
Cash and cash equivalents at the beginning of the period 18,587 70,197 29,933 68,416 70,197
Cash and cash equivalents at the end of the period \$ 31,252 \$ 99,840 \$ 31,252 \$ 99,840 \$ 18,587
Significant non-cash transactions
Right-of-use asset recognized with corresponding lease
liability
\$ 526 \$ 769 \$ 230 \$ 181 \$ 845
Purchase of property and equipment and Intangible assets \$ 134 \$ 352 \$ 134 \$ 352 \$ 1,001

The accompanying Notes are an integral part of the 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.

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" ("IAS 1 Amendment") regarding the criteria for determining the classification of liabilities as current or non-current. 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 IAS 1 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 noncurrent, other than when the conversion option is recognized as equity.

The IAS 1 Amendment is effective for reporting periods beginning on or after January 1, 2023 with earlier application being permitted. IAS 1 Amendment is applicable retrospectively, including an amendment to comparative data.

The Company believes that the adoption of IAS 1 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 ("IAS 12 Amendment")

IAS 12 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.

IAS 12 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 IAS 12 Amendment on the financial statements.

Note 3:- Significant events in the reporting period

i 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 1,327,500, 400,000 and 270,000 ordinary shares of the Company to employees and executive officers, CEO and Board of Directors members, respectively.

As of September 30, 2022, the Company granted, out the above mentioned, to employees and executive officers total of:

  • Under the Israeli Share Option Plan:

On February 28, 2022, 1,105,100 options to purchase the ordinary shares of the Company, at an exercise price of NIS 19.36 (USD 5.97) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$2,222 thousands.

On March 01, 2022, 10,000 options to purchase the ordinary shares of the Company, at an exercise price of NIS 19.54 (USD 6.04) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$21 thousands.

On March 13, 2022, 15,000 options to purchase the ordinary shares of the Company, at an exercise price of NIS 18.92 (USD 5.80) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$29 thousands.

On May 01, 2022, 18,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.64 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$40 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 December 2022

  • Under the US Share Option Plan:

On February 28, 2022, 23,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 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 \$49 thousands.

On March 01, 2022, 18,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 6.06 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$41 thousands.

On March 15, 2022, 60,000 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.88 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$135 thousands.

On July 16, 2022, 60,000 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.04 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$119 thousands.

On September 01, 2022, 18,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.16 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$36 thousands.

  • On August 23, 2022, the Company's Board of Directors approved the grant of 79,300 options to purchase the ordinary shares of the Company:

Under the Israeli Share Option Plan:

51,200 options to purchase the ordinary shares of the Company, at an exercise price of NIS 17.18-17.41 (USD 5.27-5.31) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$89 thousands.

Under the US Share Option Plan:

28,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.36 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$59 thousands.

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

  • ii Labor strike at the Company's manufacturing plant at Beit Kama, Israel
    • On April 26, 2022, during the course of 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.

On July 15, 2022, the Company, the Employees's Committee, and the Histadrut, signed a new collective agreement detailing the understandings reached between the parties. The agreement will be effective through the end of 2029, while certain economic terms may be renegotiated by the parties following the lapse of the first four years of the term of the agreement. As a result of execution of the agreement the labor strike ended, and the unionized employees returned to work at the Beit Kama production facility.

As a result of the labor strike, the Company recorded, during the second quarter and the Third quarter of 2022, a loss of \$3,342 and \$917 thousand respectively recorded in the cost of revenues from proprietary products and was comprised of \$3,082 and \$917 thousands of overhead cost charges due to lower than standard production level in the second quarter and the third quarter respectively and \$260 thousands in the second quarter due to loss of in-process materials.

iii Increase in the yield of high-quality corporate bonds

As of September 30, 2022, there was an increase, compared to December 31, 2021, in the yield of high-quality corporate bonds which effect the discount rate of defined benefit obligations.

The effect of the changes in the aforementioned discount rate resulted in a reduction in the employee benefit liability, net as of September 30, 2022, in relation to December 31, 2021, in the amount of \$361 thousand which were recognized against other comprehensive income in the Nine-month period that ended on September 30, 2022.

iv During May 2022, the Company terminated a distribution agreement with a third-party engaged to distribute the Company's proprietary products in Russia and Ukraine (the "Distributor"), and a power of attorney granted, in connection with such distribution agreement, to an affiliate of the Distributor (the "Affiliate). On July 18, 2022, the Affiliate notified the Company of the filing of a request for a conciliation hearing with the Court in Geneva relying on the terminated power of attorney and seeking damages for the alleged inability to sell the remaining product inventory previously acquired from the Company and compensation for the lost customer base. The purpose of a conciliation hearing is to explore the possibility of an out-of-court settlement and not to address the merits of the claims. The outcome of such hearing is not binding. Nonetheless, the conciliation request has not yet been formally served upon the Company, which is a procedural request to proceed with the hearing. At this stage, it is not possible to assess the prospects and scope of any claims against the Company and any potential liabilities as such conciliation request is an initial procedure and the claims are not fully substantiated. The Company intends to vigorously defend itself against any claims if and when they arise from these matters.

Note 4:- Operating Segments

a. General:

The company has two operating segments, as follows:

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

Note 4:- Operating Segments (cont.)

b. Reporting on operating segments:

Proprietary
Products Distribution Total
U.S Dollars in thousands
Unaudited
Nine months period ended September 30, 2022
Revenues \$ 67,198
\$
16,702 \$ 83,900
Gross profit \$ 29,342
\$
2,070 \$ 31,412
Unallocated corporate expenses (30,898)
Finance expenses, net (5,719)
Income before taxes on income \$ (5,205)
Proprietary
Products Distribution Total
U.S Dollars in thousands
Unaudited
Nine months period ended September 30, 2021
Revenues \$
57,316
\$ 14,857 \$ 72,173
Gross profit \$
21,711
\$ 2,022 \$ 23,733
Unallocated corporate expenses (21,127)
Finance expenses, net 173
Income before taxes on income \$ 2,779
Proprietary
Products Distribution Total
U.S Dollars in thousands
Unaudited
Three months period ended September 30, 2022
Revenues \$
25,580
\$ 6,637 \$ 32,217
Gross profit \$
12,429
\$ 441 \$ 12,870
Unallocated corporate expenses (10,308)
Finance expenses, net (2,068)
Income before taxes on income \$ 494
Proprietary
Products Distribution Total
U.S Dollars in thousands
Unaudited
Three months period ended September 30, 2021
Revenues \$ 17,123 \$ 5,911 \$ 23,034
Gross profit \$ 5,045 \$ 685 \$ 5,730
Unallocated corporate expenses (6,534)
Finance expenses, net (41)
Income before taxes on income \$ (845)

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:

Nine months period ended
September 30, 2022
Proprietary
Products
Distribution Total
U.S Dollars in thousands
Unaudited
Geographical markets
U.S.A and North America \$
52,866
\$
-
\$ 52,866
Israel 3,631 16,702 20,333
Europe 2,192 - 2,192
Latin America 5,301 - 5,301
Asia 2,665 - 2,665
Others 543 - 543
\$
67,198
\$
16,702
\$ 83,900
Nine months period ended
September 30, 2021
Proprietary
Products
Distribution
Total
U.S Dollars in thousands
Unaudited
Geographical markets
U.S.A and North America \$ 39,265 - \$ 39,265
Israel 6,437 14,857 21,294
Europe 4,491 - 4,491
Latin America 5,255 - 5,255
Asia 1,753 - 1,753
Others 115 - 115
\$ 57,316 \$
14,857
\$ 72,173

Note 4:- Operating Segments (cont.)

c. Reporting on operating segments by geographic region:

Three months period ended
September 30, 2022
Proprietary
Products
Distribution
Total
U.S Dollars in thousands
Unaudited
Geographical markets
U.S.A and North America. \$ 20,597 \$ - \$ 20,597
Israel 1,377 6,637 8,014
Europe 750 - 750
Latin America 1,775 - 1,775
Asia 767 - 767
Others 314 - 314
\$ 25,580 \$ 6,637 \$ 32,217
Three months period ended
September 30, 2021
Proprietary
Products
Distribution
Total
U.S Dollars in thousands
Unaudited
Geographical markets
U.S.A and North America. \$
12,710
- \$ 12,710
Israel 849 5,911 6,760
Europe 1,097 1,097
Latin America 1,652 1,652
Asia 734 734
Others 81 82
\$
17,123
\$
5,911
\$ 23,034
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

Note 5:- Financial Instruments

a. Classification of financial instruments by fair value hierarchy

Financial assets (liabilities) measured at fair value

Level 1 Level 2 Level 3
U.S Dollars in thousands
September 30, 2022
Derivatives instruments \$ - \$ (180) -
Contingent consideration - - \$
(23,705)
September 30, 2021
Derivatives instruments \$ - \$ (40) \$
-
December 31, 2021
Derivatives instruments \$ - \$ 73 \$
-
Contingent consideration \$ - \$ - \$
(21,995)

During the Nine months ended on September 30, 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.

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