Foreign Filer Report • May 17, 2022
Foreign Filer Report
Open in ViewerOpens in native device viewer
FORM 6-K
For the Month of May 2022
Commission File Number 001-35948
Kamada Ltd. (Translation of registrant's name into English)
(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) |
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
| 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) |
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 FDAapproved 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.
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.

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.
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
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.
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 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.
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 plasmaderived 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.
Chaime Orlev Chief Financial Officer [email protected]
Bob Yedid LifeSci Advisors, LLC 646-597-6989 [email protected]
| 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) 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) Accumulated deficit (47,991) (41,246) Total Shareholder's Equity 175,150 181,220 176,824 Total Liabilities and Shareholder's Equity \$ 303,096 \$ 210,528 \$ 318,667 |
As of March 31, | As of December 31, |
|||||
|---|---|---|---|---|---|---|---|
| (3,490) (149) (46,163) |
|||||||
| Three months period ended March 31, |
Year ended 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 Tax effect |
- - |
- - |
171 - |
||||
| 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) | |
| 2022 2021 2021 Unaudited Audited U.S Dollars in thousands Net income \$ (1,828) \$ 2,687 \$ 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 Financial expense (income), net 2,033 (323) Cost of share-based payment 193 215 Taxes on income 41 - (Gain) loss from sale of property and equipment - - Change in employee benefit liabilities, net (12) (37) 5,282 1,002 Changes in asset and liability items: Decrease(increase) in trade receivables, net 13,492 1,585 Decrease (increase) in other accounts receivables 589 (14) Decrease (increase) in inventories 2,662 1,045 Decrease (increase) in deferred expenses (110) (1,153) Increase (decrease) in trade payables (13,649) (1,484) Increase (decrease) in other accounts payables (772) (2,145) Increase (decrease) in deferred revenues - 500 (1,666) 2,212 Cash received (paid) during the year for: |
Three months period Ended March 31, |
|||
|---|---|---|---|---|
| U.S Dollars in thousands |
||||
| (2,230) | ||||
| 5,609 | ||||
| 1,189 | ||||
| 529 | ||||
| 345 | ||||
| - | ||||
| 45 | ||||
| 7,717 | ||||
| (12,861 | ||||
| (1,634) | ||||
| (2,373 | ||||
| (6,883 | ||||
| 7,917) | ||||
| (392) | ||||
| (1,815 | ||||
| (14,411) | ||||
| 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) |
| Three months period Ended March 31, |
||||||
|---|---|---|---|---|---|---|
| 2022 | 2021 | 2021 | ||||
| Unaudited | ||||||
| U.S Dollars in thousands | Audited 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 |
| Three months period Ended March 31, |
Year ended 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 |
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 |
| - - - - - - - - - - - |
| As of March 31, | As of December 31, |
|||||
|---|---|---|---|---|---|---|
| 2022 | 2021 | |||||
| Audited | ||||||
| Unaudited | 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.
| Three months period ended March 31, |
Year ended 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.
| 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 Unaudited |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|
|---|---|---|---|---|---|---|---|---|---|
| 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.
| 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.
| Three months period Ended March 31, 2022 2021 |
Year Ended December 31, 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.
| Three months period Ended March 31, |
||||
|---|---|---|---|---|
| 2022 | 2021 | 2021 | ||
| Unaudited | Audited | |||
| Cash Flows from Investing Activities | U.S Dollars in thousands | U.S Dollars in thousands |
||
| 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.
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.
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".
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 noncurrent 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.
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:
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.
a. General:
The company has two operating segments, as follows:
| 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 |

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) |
| 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 |
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 U.S Dollars in thousands |
Total | |||||
| 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 |
a. Classification of financial instruments by fair value hierarchy
| 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.
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.
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.