Foreign Filer Report • Aug 16, 2023
Foreign Filer Report
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FORM 6-K
For the Month of August 2023
Commission File Number 001-35948
Kamada Ltd. (Translation of registrant's name into English)
2 Holzman Street Science Park, P.O. Box 4081 Rehovot 7670402 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
This Form 6-K is being incorporated by reference into the Registrant's Form S-8 Registration Statements, File Nos. 333-192720, 333-207933, 333-215983, 333-222891, 333-233267 and 333-265866.
| 99.1 | Kamada Reports Strong Second Quarter and First Half 2023 Financial Results; Reiterates 2023 Revenue and Profitability Guidance |
|---|---|
| 99.2 | Company's Presentation – August 2023 |
| 99.3 | Kamada Ltd's Consolidated Financial Statements as of June 30, 2023 (Unaudited) |
| 101.INS Inline XBRL Instance Document | |
| 101.SCH Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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: August 16, 2023 KAMADA LTD.
By: /s/ Nir Livneh
Nir Livneh Vice President General Counsel and Corporate Secretary
| EXHIBIT NO. | DESCRIPTION |
|---|---|
| 99.1 | Kamada Reports Strong Second Quarter and First Half 2023 Financial Results; Reiterates 2023 Revenue and Profitability Guidance |
| 99.2 | Company's Presentation – August 2023 |
| 99.3 | Kamada Ltd's Consolidated Financial Statements as of June 30, 2023 (Unaudited) |
| 101.INS | Inline XBRL Instance Document |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
| 3 |
Rehovot, Israel, and Hoboken, NJ – August 16, 2023 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced financial results for the three and six months ended June 30, 2023.
"Our strong start to 2023 continued in the second quarter, both financially and operationally," said Amir London, Kamada's Chief Executive Officer. "With total revenues for the first six months of the year of \$68.2 million, which represented year-over-year growth of 32%, and adjusted EBITDA of \$9.9 million, representing 24% growth year-overyear, we achieved the top- and bottom-line growth anticipated in our business during the first six months of the year. We continue to effectively leverage our multiple growth drivers, including a significant increase of KEDRAB® sales to Kedrion for further distribution in the U.S., as well as the portfolio of the four FDA-approved Immunoglobulins (CYTOGAM®, HEPAGAMB®, VARIZIG® and WINRHO® SDF), and our Israeli distribution business."
"Importantly, we expect the momentum in our business to continue through the second half of the year, with full-year profitability to be further meaningfully enhanced as compared to last year. As such, we are reiterating our full-year 2023 revenue guidance of \$138 million to \$146 million and adjusted EBITDA of \$22 million to \$26 million; the mid-point of the range would represent profitability growth of approximately 35% over 2022," continued Mr. London.
"We continue to advance our pivotal phase 3 InnovAATe trial for Inhaled AAT and recently received positive scientific advice from the European Medicines Agency (EMA) that reconfirmed the overall design of the on-going study and acknowledged the statistically and clinically meaningful improvement in lung function (FEV1) demonstrated in our previous Phase 2/3 European study, which served as the basis for the design and the selection of the primary endpoint of our current pivotal Phase 3 study. Discussion with the FDA regarding study progress will be completed by the end of 2023," added Mr. London.
"We are actively engaged in seeking shareholders' approval, later this month, for the \$60 million share purchase agreement previously signed with FIMI. This strategic investment will provide us with financial flexibility to pursue compelling business development opportunities, a process that we have initiated, and will be further ramped up upon receipt of shareholder approval and closing of the transaction. Additionally, the recent extension through March 2026 of our U.S distribution agreement with Kedrion for KEDRAB assures that this important product will remain a key growth catalyst for Kamada. We remain in active discussions with Kedrion to potentially further expand the scope of the collaboration," concluded Mr. London.
As of June 30, 2023, the Company had cash, cash equivalents, and short-term investments of \$21.8 million, as compared to \$34.3 million as of December 31, 2022. This figure does not include the expected net proceeds from the recently announced \$60 million financing, which is expected to close, subject to shareholders' vote, during the third quarter of 2023.
● Announced that Kedrion exercised its option to extend through March 2026 the KEDRAB distribution agreement.
Kamada continues to expect to generate fiscal year 2023 total revenues in the range of \$138 million to \$146 million. The Company also continues to anticipate generating adjusted EBITDA during 2023 in the range of \$22 million to \$26 million, the mid-point of the range would represent profitability growth of approximately 35% over 2022.
Kamada management will host an investment community conference call on Wednesday, August 16, 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: 13740401. The call will also be webcast live on the Internet at: https://viavid.webcasts.com/starthere.jsp?ei=1626943&tp_key=6e37fa90e3.
We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decisionmaking, 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 commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company's strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company's commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D). In addition to the Company's commercial operation, it invests in research and development of new product candidates. The Company's leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company's lead shareholder, beneficially owning approximately 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) Expectation that the momentum in our business to continue through the second half of the year, with profitability to be further meaningfully enhanced as compared to last year; (2) 2023 revenue guidance in the range of \$138 Million to \$146 Million; (3) 2023 adjusted EBITDA to be in the range of \$22 million to \$26 million, with the mid-point of the range representing profitability growth of approximately 35% over 2022; (4) Discussion with the FDA regarding study progress to be completed by the end of 2023; (5) Potential expansion of the scope of the collaboration between Kamada and Kedrion; (6) effectively leveraging multiple growth drivers, including significant increase of KEDRAB sales to Kedrion, the portfolio of four FDA approved IgGs acquired in late 2021, the sales of our other Proprietary products in the international markets, and our Israeli distribution business; (7) shareholder approval and expected closing of the recently announced \$60 million financing in the third quarter of 2023; (8) The financing providing the Company with financial flexibility, allowing the Company to accelerate the growth of its existing business and pursue compelling business development opportunities; and (9) Optimism about AATD Phase 3 clinical trial progress, including preliminary outcome from EMA discussions. 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 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 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]
Brian Ritchie LifeSci Advisors, LLC (212) 915-2578 [email protected]
| As of June 30, 2023 |
2022 | As of December 31, 2022 |
|||
|---|---|---|---|---|---|
| Unaudited | Audited | ||||
| U.S Dollars in thousands | |||||
| Assets | |||||
| Current Assets | |||||
| Cash and cash equivalents | \$ 21,788 |
\$ | 29,933 | \$ | 34,258 |
| Trade receivables, net | 24,581 | 17,738 | 27,252 | ||
| Other accounts receivables | 3,077 | 6,410 | 8,710 | ||
| Inventories | 80,237 | 64,520 | 68,785 | ||
| Total Current Assets | 129,683 | 118,601 | 139,005 | ||
| Non-Current Assets | |||||
| Property, plant and equipment, net | 26,936 | 25,914 | 26,157 | ||
| Right-of-use assets | 5,517 | 2,810 | 2,568 | ||
| Intangible assets, Goodwill and other long-term assets | 143,986 | 150,449 | 147,072 | ||
| Contract assets | 8,267 | 6,361 | 7,577 | ||
| Total Non-Current Assets | 184,706 | 185,534 | 183,374 | ||
| Total Assets | \$ 314,389 |
\$ | 304,135 | \$ | 322,379 |
| Liabilities | |||||
| Current Liabilities | |||||
| Current maturities of bank loans | \$ 4,444 |
\$ | 4,449 | \$ | 4,444 |
| Current maturities of lease liabilities | 1,063 | 1,010 | 1,016 | ||
| Current maturities of other long term liabilities | 25,077 | 20,117 | 29,708 | ||
| Trade payables | 27,969 | 17,954 | 32,917 | ||
| Other accounts payables | 7,235 | 6,110 | 7,585 | ||
| Deferred revenues | 38 | 40 | 35 | ||
| Total Current Liabilities | 65,826 | 49,680 | 75,705 | ||
| Non-Current Liabilities | |||||
| Bank loans | 10,741 | 15,185 | 12,963 | ||
| Lease liabilities | 4,972 | 2,492 | 2,177 | ||
| Contingent consideration | 19,028 | 23,121 | 17,534 | ||
| Other long-term liabilities | 36,514 | 41,304 | 37,308 | ||
| Deferred revenues | 0 | 15 | | ||
| Employee benefit liabilities, net | 556 | 764 | 672 | ||
| Total Non-Current Liabilities | 71,811 | 82,881 | 70,654 | ||
| Shareholder's Equity | |||||
| Ordinary shares | 11,737 | 11,731 | 11,734 | ||
| Additional paid in capital net | 210,727 | 210,319 | 210,495 | ||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | ||
| Capital reserve from hedges | (67) | (442) | (88) | ||
| Capital reserve from share-based payments | 5,902 | 5,097 | 5,505 | ||
| Capital reserve from employee benefits | 424 | 271 | 348 | ||
| Accumulated deficit | (48,481) | (51,912) | (48,484) | ||
| Total Shareholder's Equity | 176,752 | 171,574 | 176,020 | ||
| Total Liabilities and Shareholder's Equity | \$ 314,389 |
\$ | 304,135 | \$ | 322,379 |
| Six months period ended June 30, |
Three months period ended June 30, |
Year ended December 31, |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |||||||
| Unaudited | Unaudited | Audited | |||||||||
| U.S Dollars in thousands | |||||||||||
| Revenues from proprietary products | \$ | 55,001 | \$ | 41,618 | \$ | 30,940 | \$ | 18,607 | \$ | 102,598 | |
| Revenues from distribution | 13,152 | 10,065 | 6,503 | 4,983 | 26,741 | ||||||
| Total revenues | 68,153 | 51,683 | 37,443 | 23,590 | 129,339 | ||||||
| Cost of revenues from proprietary products | 30,416 | 24,705 | 17,192 | 12,256 | 58,229 | ||||||
| Cost of revenues from distribution | 11,462 | 8,436 | 5,815 | 4,094 | 24,407 | ||||||
| Total cost of revenues | 41,878 | 33,141 | 23,007 | 16,350 | 82,636 | ||||||
| Gross profit | 26,275 | 18,542 | 14,436 | 7,240 | 46,703 | ||||||
| Research and development expenses | 7,514 | 7,063 | 4,283 | 2,643 | 13,172 | ||||||
| Selling and marketing expenses | 7,862 | 6,592 | 3,940 | 3,271 | 15,284 | ||||||
| General and administrative expenses | 6,902 | 6,316 | 3,484 | 3,311 | 12,803 | ||||||
| Other expenses | 1,077 | 619 | 98 | 309 | 912 | ||||||
| Operating income (loss) | 2,920 | (2,048) | 2,631 | (2,294) | 4,532 | ||||||
| Financial income | 25 | 3 | - | 1 | 91 | ||||||
| Income (expenses) in respect of currency exchange differences and derivatives instruments, net |
173 | 593 | 22 | 424 | 298 | ||||||
| Financial Income (expense) in respect of contingent consideration and other long- term liabilities. |
(2,070) | (3,875) | (309) | (1,865) | (6,266) | ||||||
| Financial expenses | (939) | (372) | (439) | (178) | (914) | ||||||
| Income (expense) before tax on income | 109 | (5,699) | 1,905 | (3,912) | (2,259) | ||||||
| Taxes on income | 106 | 50 | 93 | 9 | 62 | ||||||
| Net Income (loss) | \$ | 3 | \$ | (5,749) \$ | 1,812 | \$ | (3,921) \$ | (2,321) | |||
| Other Comprehensive Income (loss) : | |||||||||||
| Amounts that will be or that have been reclassified to profit or loss when specific conditions are met: |
|||||||||||
| Gain (loss) on cash flow hedges | (244) | (784) | (88) | (676) | (776) | ||||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges |
265 | 288 | 120 | 222 | 634 | ||||||
| Items that will not be reclassified to profit or loss in subsequent periods: |
|||||||||||
| Remeasurement gain (loss) from defined benefit plan | 76 | 420 | (115) | 420 | 497 | ||||||
| Tax effect | - | - | - | - | - | ||||||
| Total comprehensive income (loss) | \$ | 100 | \$ | (5,825) \$ | 1,729 | \$ | (3,955) \$ | (1,966) | |||
| Earnings per share attributable to equity holders of the Company: | |||||||||||
| Basic net earnings per share | \$ | 0.00 | \$ | (0.13) | \$ | 0.04 | \$ | (0.09) | \$ | (0.05) | |
| Diluted net earnings per share | \$ | 0.00 | \$ | (0.13) | \$ | 0.04 | \$ | (0.09) | \$ | (0.05) | |
| 7 |
| Six months period Ended June, 30 |
Three months period Ended June, 30 |
Year Ended December 31, |
|||
|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |
| Unaudited | Audited | ||||
| U.S Dollars In thousands | |||||
| Cash Flows from Operating Activities | |||||
| Net income (loss) | \$ 3 |
\$ (5,749) \$ |
1,812 | \$ (3,921) \$ |
(2,321) |
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
|||||
| Adjustments to the profit or loss items: | |||||
| Depreciation and impairment | 6,327 | 6,088 | 3,204 | 3,061 | 12,155 |
| Financial expenses (income), net | 2,811 | 3,651 | 726 | 1,618 | 6,791 |
| Cost of share-based payment | 629 | 569 | 214 | 376 | 1,153 |
| Taxes on income | 106 | 50 | 93 | 9 | 62 |
| Loss (gain) from sale of property and equipment | (5) | - | - | - | - |
| Change in employee benefit liabilities, net | (40) | (96) | (32) | (84) | (111) |
| 9,828 | 10,262 | 4,205 | 4,980 | 20,050 | |
| Changes in asset and liability items: | |||||
| Decrease (increase) in trade receivables, net | 2,696 | 17,102 | (3,610) | 3,610 | 7,603 |
| Decrease (increase) in other accounts receivables | 1,539 | 2,073 | 177 | 1,484 | (578) |
| Decrease (increase) in inventories | (11,452) | 2,903 | (482) | 241 | (1,361) |
| Decrease (increase) in deferred expenses | 3,042 | (484) | (512) | (374) | (1,340) |
| Increase (decrease) in trade payables | (5,436) | (7,843) | 1,276 | 5,806 | 7,055 |
| Increase (decrease) in other accounts payables | (408) | (1,517) | (170) | (745) | 290 |
| Decrease in deferred revenues | 3 | - | (381) | - | (20) |
| (10,016) | 12,234 | (3,702) | 10,022 | 11,649 | |
| Cash received (paid) during the period for: | |||||
| Interest paid | (744) | (380) | (403) | (186) | (853) |
| Interest received | 25 | 3 | 0 | 1 | 97 |
| Taxes paid | (112) | (18) | (94) | (9) | (36) |
| (831) | (395) | (497) | (194) | (792) | |
| Net cash provided by (used in) operating activities | (1,016) \$ \$ |
16,352 | \$ 1,818 |
\$ 10,887 |
\$ 28,586 |
| Six months period Ended June, 30 |
Three months period Ended June, 30 |
Year Ended December 31, |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | ||||||
| Unaudited | Audited | |||||||||
| U.S Dollars In thousands | ||||||||||
| Cash Flows from Investing Activities | ||||||||||
| Purchase of property and equipment and intangible assets | \$ | (2,147) \$ | (1,191) \$ | (1,048) \$ | (678) \$ | (3,784) | ||||
| Proceeds from sale of property and equipment | 6 | - | - | - | - | |||||
| Business combination | - | - | - | - | - | |||||
| Net cash provided by (used in) investing activities | (2,141) | (1,191) | (1,048) | (678) | (3,784) | |||||
| Cash Flows from Financing Activities | ||||||||||
| Proceeds from exercise of share base payments | 3 | 6 | 2 | 3 | 9 | |||||
| Receipt of long-term loans | - | - | - | - | - | |||||
| Repayment of lease liabilities | (517) | (573) | (246) | (278) | (1,098) | |||||
| Repayment of long-term loans | (2,222) | (401) | (1,111) | (385) | (2,628) | |||||
| Repayment of other long-term liabilities | (6,000) | (3,243) | (4,500) | (1,743) | (5,626) | |||||
| Net cash provided by (used in) financing activities | (8,736) | (4,211) | (5,855) | (2,403) | (9,343) | |||||
| Exchange differences on balances of cash and cash equivalent | (577) | 396 | (248) | 160 | 212 | |||||
| Increase (decrease) in cash and cash equivalents | (12,470) | 11,346 | (5,333) | 7,966 | 15,671 | |||||
| Cash and cash equivalents at the beginning of the period | 34,258 | 18,587 | 27,121 | 21,967 | 18,587 | |||||
| Cash and cash equivalents at the end of the period | \$ | 21,788 | \$ | 29,933 | \$ | 21,788 | \$ | 29,933 | \$ | 34,258 |
| Significant non-cash transactions | ||||||||||
| Right-of-use asset recognized with corresponding lease liability | \$ | 3,585 | \$ | 296 | \$ | 5 | \$ | 121 | \$ | 551 |
| Purchase of property and equipment and Intangible assets | \$ | 840 | \$ | 775 | \$ | 840 | \$ | 775 | \$ | 618 |
| Six months period ended June 30, |
Three months period ended June 30, |
Year ended December 31, |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |||||||
| In thousands | |||||||||||
| Net income | \$ | 3 | \$ | (5,749) \$ | 1,812 | \$ | (3,921) \$ | (2,321) | |||
| Taxes on income | 106 | 50 | 93 | 9 | 62 | ||||||
| Financial expense (income), net | 2,811 | 3,651 | 726 | 1,618 | 6,791 | ||||||
| Depreciation and amortization expense | 6,327 | 6,088 | 3,204 | 3,202 | 12,155 | ||||||
| Non-cash share-based compensation expenses | 629 | 569 | 214 | 414 | 1,153 | ||||||
| Adjusted EBITDA | \$ | 9,876 | \$ | 4,639 | \$ | 6,049 | \$ | 1,322 | \$ | 17,840 |
INVESTORS MEETING NASDAQ & TASE: KMDA August 2023

This presentation is not intended to provide in should be noted that some products under development described herein have not been found safe or effective by any regulatory agency and are not approved for any use outside of clinical trials.
This presentation contains forward-looking statement beliefs and expectations of Kamada's management. Such statements include the 2023 financial guidance, sucess of the inical study, its bentis and potential market size, suces of the U.S. planes poential could cause Kamada's future results, performantly from the prospected results, performances or achievements expressed or implied by such foneral-looking statements in tould cause or ontribute to such diferences include by risk relain to kanadas abilit to continued market acceptance of Kamada's portfolio, the impact of any changes in regulation that could affect the pharmaceutical industry, the difficuly of predicing, obtaining U.S. Food and Drug Aminister (ency, and other regulaty annority appovals,
the regulatory environment, restrains related in th environmental isks, changes in the worldwide industry and other factors that are discussed under the heading "Risk Factor" of Kamada's 2022 Anual Report on Form 20-F (filed on March 15, 2023) as well as in Kamada's recent Forms 6-K filed with the U.S. Securities and Exchange Commission.
This presentation includes cetain non-FRS financial intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with IPS. The non-FRS financial measures may not be comparable to, similary titled measures used by other companies with the requirement of the SEC regulation of these non-FRS financial measures to the comparable IFRS measures is included in an appentation. Management uses these non-FRS financial measures for financial and operational decisionmaking and as a means to evaluate period comparisons. Management believes that these non-FRS financial supplemental information regarding Kamada's performance and liquidity.
Forward-looking statements speak only as of the are made, and Kamada undertakes no obligation to update any forward-hoking statement to reflect the impact of circumstances or events that arse after the date the reserved was nade, except as required by applices laws. You should not place undue reliance on any forward-looking statement and risks noted above, as well as the risks and uncertainties more fully discussed under the heading "fisk Factors" of Kanada's 2022 Anual Report on Form 20-F (filed on March 15, 2023) as well as in Kamada's recent Forms 6-K filed with the U.S. Securities and Exchange Commission.
Kamada / August 2023
Kamada is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions
The company is a leader in the specialty plasma-derived field focused on diseases of limited treatment alternatives
The company is advancing an innovative development pipeline targeting areas of significant unmet medical need




2023 represents annual guidance
Adjusted EBITDA is defined as net income, plus (i) tax expense, (ii) financial income (expense), net, (iii) depreciation
and amortization; and (v) non-cash share-based comp
ਪ Kamada / August 2023
· Announcing a strategic share purchase agreement with FIMI Opportunity Funds, the leading private equity firm in Israel and an existing significant Kamada shareholder to purchase \$60 million of the Company ordinary's shares in a private placement

Kamada / August 2023


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[Hepatitis B Immune Globulin (Human)] Prevention of HBV recurrence following liver transplantation

[Varicella Zoster Immune Globulin (Human)] Post-exposure prophylaxis of varicella in high- risk patient groups

[Alpha1-Proteinase Inhibitor (Human)] Augmentation therapy for Alpha-1 Antitrypsin Deficiency (AATD)

[Rho(D) Immune Globulin (Human)] Treatment of immune thermobocytopunic purpura (ITP) & suppression of Rh isoimmunization (HDN)
Kamada / August 2023

Kamada Plasma was established in Q1 2021 through the acquisition of an FDA-licensed plasma collection center in Texas, focusing on collecting hyperimmune plasma for specialty IgG's

Kamada / August 2023


Global, double-blind, randomized, placebo-controlled pivotal Phase 3 clinical trial to test the safety and efficacy of inhaled AAT in patients with AATD. Study design meet FDA and EMA's requirements
Kamada / August 2023
| US \$ M | H1/2023 H1/2022 Q2/2023 | Q2/2022 | Details | ||
|---|---|---|---|---|---|
| PROPRIETARY | 55.0 | 41.6 | 30.9 | 18.6 | |
| DISTRIBUTION | 13.2 | 10.1 | 6.5 | 5.0 | |
| TOTAL REVENUES | 68.2 | 51.7 | 37.4 | 23.6 | 32% and 59% YoY increase for H1 & Q2, respectively |
| GROSS PROFIT | 26.3 | 18.5 | 14.4 | 7.2 | |
| GROSS MARGIN | 39% | 36% | 39% | 31% | |
| OPEX | (23.4) | (20.6) | (11.8) | (9.5) | |
| NET PROFIT | 0.0 | (5.7) | 1.8 | (3.9) | |
| Adjusted EBITDA | 9.9 | 4.6 | 6.0 | 1.3 | 24% YoY increase for H1 (2022 excl \$3.3M labor strike related loss) |
| CASH | 21.8 | 29.9 | |||
| TOTAL ASSETS | 314.4 | 304.1 | Including acquisition related intangible assets (\$140M @ June 23) | ||
| BANK LOAN | 15.2 | 19.6 | 5-year term loan | ||
| CONTINGENT LIABILITIES | 80.6 | 84.5 | Acquisition related contingent consideration | ||
| EQUITY | 176.8 | 171.6 |
9
Kamada / August 2023


Significant upside potential with limited downside

Kamada / August 2023
August 2023

| US \$ M | H1/2023 H1/2022 Q2/2023 | Q2/2022 | ||
|---|---|---|---|---|
| Net loss | 0.0 | (5.7) | 1.8 | (3.9) |
| Taxes on income | 0.1 | 0.1 | 0.1 | 0.0 |
| Revaluation of Acquisition related contingent consideration | 2.1 | 3.9 | 0.3 | 1.9 |
| Other financial expense, net | 0.7 | (0.2) | 0.4 | (0.2) |
| Amortization of acquisition related intangible assets | 3.5 | 3.5 | 1.8 | 1.8 |
| Other depreciation and amortization expenses | 2.8 | 2.6 | 1.4 | 1.4 |
| Non-cash share-based compensation expenses | 0.6 | 0.6 | 0.2 | 0.4 |
| Adjusted EBITDA | 9.9 | 4.6 | 6.0 | 1.3 |
12 Kamada / July 2023
| Page | |
|---|---|
| Consolidated Statements of Financial Position | 1 |
| Consolidated Statements of Profit or Loss and Other Comprehensive Income | 2 |
| Consolidated Statements of Changes in Equity | 3-5 |
| Consolidated Statements of Cash Flows | 6-7 |
| Notes to the Interim Consolidated Financial Statements | 8-14 |
| - - - - - - - - - - |
i
| As of June 30, | As of December 31, |
|||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | 2022 Audited |
||||
| Unaudited | ||||||
| U.S Dollars in thousands | ||||||
| Assets | ||||||
| Current Assets | ||||||
| Cash and cash equivalents | \$ 21,788 |
\$ | 29,933 | \$ | 34,258 | |
| Trade receivables, net | 24,581 | 17,738 | 27,252 | |||
| Other accounts receivables | 3,077 | 6,410 | 8,710 | |||
| Inventories | 80,237 | 64,520 | 68,785 | |||
| Total Current Assets | 129,683 | 118,601 | 139,005 | |||
| Non-Current Assets | ||||||
| Property, plant and equipment, net | 26,936 | 25,914 | 26,157 | |||
| Right-of-use assets | 5,517 | 2,810 | 2,568 | |||
| Intangible assets, Goodwill and other long-term assets | 143,986 | 150,449 | 147,072 | |||
| Contract assets | 8,267 | 6,361 | 7,577 | |||
| Total Non-Current Assets | 184,706 | 185,534 | 183,374 | |||
| Total Assets | \$ 314,389 |
\$ | 304,135 | \$ | 322,379 | |
| Liabilities | ||||||
| Current Liabilities | ||||||
| Current maturities of bank loans | \$ 4,444 |
\$ | 4,449 | \$ | 4,444 | |
| Current maturities of lease liabilities | 1,063 | 1,010 | 1,016 | |||
| Current maturities of other long term liabilities | 25,077 | 20,117 | 29,708 | |||
| Trade payables | 27,969 | 17,954 | 32,917 | |||
| Other accounts payables | 7,235 | 6,110 | 7,585 | |||
| Deferred revenues | 38 | 40 | 35 | |||
| Total Current Liabilities | 65,826 | 49,680 | 75,705 | |||
| Non-Current Liabilities | ||||||
| Bank loans | 10,741 | 15,185 | 12,963 | |||
| Lease liabilities | 4,972 | 2,492 | 2,177 | |||
| Contingent consideration | 19,028 | 23,121 | 17,534 | |||
| Other long-term liabilities | 36,514 | 41,304 | 37,308 | |||
| Deferred revenues | 0 | 15 | | |||
| Employee benefit liabilities, net | 556 | 764 | 672 | |||
| Total Non-Current Liabilities | 71,811 | 82,881 | 70,654 | |||
| Shareholder's Equity | ||||||
| Ordinary shares | 11,737 | 11,731 | 11,734 | |||
| Additional paid in capital net | 210,727 | 210,319 | 210,495 | |||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | |||
| Capital reserve from hedges | (67) | (442) | (88) | |||
| Capital reserve from share-based payments | 5,902 | 5,097 | 5,505 | |||
| Capital reserve from employee benefits | 424 | 271 | 348 | |||
| Accumulated deficit | (48,481) | (51,912) | (48,484) | |||
| Total Shareholder's Equity | 176,752 | 171,574 | 176,020 | |||
| Total Liabilities and Shareholder's Equity | \$ 314,389 |
\$ | 304,135 | \$ | 322,379 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Six months period ended June 30, |
Three months period ended June 30, |
Year ended December 31, |
||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | ||
| Unaudited | Unaudited | Audited | ||||
| U.S Dollars in thousands | ||||||
| Revenues from proprietary products | \$ 55,001 |
\$ | 41,618 | \$ 30,940 |
\$ 18,607 |
\$ 102,598 |
| Revenues from distribution | 13,152 | 10,065 | 6,503 | 4,983 | 26,741 | |
| Total revenues | 68,153 | 51,683 | 37,443 | 23,590 | 129,339 | |
| Cost of revenues from proprietary products | 30,416 | 24,705 | 17,192 | 12,256 | 58,229 | |
| Cost of revenues from distribution | 11,462 | 8,436 | 5,815 | 4,094 | 24,407 | |
| Total cost of revenues | 41,878 | 33,141 | 23,007 | 16,350 | 82,636 | |
| Gross profit | 26,275 | 18,542 | 14,436 | 7,240 | 46,703 | |
| Research and development expenses | 7,514 | 7,063 | 4,283 | 2,643 | 13,172 | |
| Selling and marketing expenses | 7,862 | 6,592 | 3,940 | 3,271 | 15,284 | |
| General and administrative expenses | 6,902 | 6,316 | 3,484 | 3,311 | 12,803 | |
| Other expenses | 1,077 | 619 | 98 | 309 | 912 | |
| Operating income (loss) | 2,920 | (2,048) | 2,631 | (2,294) | 4,532 | |
| Financial income | 25 | 3 | - | 1 | 91 | |
| Income (expenses) in respect of currency exchange differences | ||||||
| and derivatives instruments, net | 173 | 593 | 22 | 424 | 298 | |
| Financial Income (expense) in respect of contingent | ||||||
| consideration and other long- term liabilities. | (2,070) | (3,875) | (309) | (1,865) | (6,266) | |
| Financial expenses | (939) | (372) | (439) | (178) | (914) | |
| Income (expense) before tax on income | 109 | (5,699) | 1,905 | (3,912) | (2,259) | |
| Taxes on income | 106 | 50 | 93 | 9 | 62 | |
| Net Income (loss) | \$ | 3 \$ |
(5,749) \$ | 1,812 | \$ (3,921) \$ |
(2,321) |
| Other Comprehensive Income (loss) : | ||||||
| Amounts that will be or that have been reclassified to profit or | ||||||
| loss when specific conditions are met: | ||||||
| Gain (loss) on cash flow hedges | (244) | (784) | (88) | (676) | (776) | |
| Net amounts transferred to the statement of profit or loss for cash | ||||||
| flow hedges | 265 | 288 | 120 | 222 | 634 | |
| Items that will not be reclassified to profit or loss in subsequent | ||||||
| periods: | ||||||
| Remeasurement gain (loss) from defined benefit plan | 76 | 420 | (115) | 420 | 497 | |
| Tax effect | - | - | - | - | | |
| Total comprehensive income (loss) | \$ | 100 \$ |
(5,825) \$ | 1,729 | \$ (3,955) \$ |
(1,966) |
| Earnings per share attributable to equity holders of the Company: | ||||||
| Basic net earnings per share | \$ | 0.00 \$ |
(0.13) \$ | 0.04 | \$ (0.09) \$ |
(0.05) |
| Diluted net earnings per share | \$ | 0.00 \$ |
(0.13) \$ | 0.04 | \$ (0.09) \$ |
(0.05) |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Share capital |
Additional paid in capital |
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 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | ||||||||||||||||
| Balance as of January 1, 2023 (audited) |
\$ | 11,734 | \$ | 210,495 | \$ | (3,490) \$ | (88) \$ | 5,505 | \$ | 348 | \$ | (48,484) \$ | 176,020 | |||
| Net income Other comprehensive income (loss) |
- - |
- - |
- - |
- 21 |
- - |
- 76 |
3 - |
3 97 |
||||||||
| Tax effect | - | - | - | - | - | - | - | - | ||||||||
| Total comprehensive income (loss) Exercise and forfeiture of share |
- | - | - | 21 | - | 76 | 3 | 100 | ||||||||
| based payment into shares | 3 | 232 | - | - | (232) | - | - | 3 | ||||||||
| Cost of share-based payment Balance as of June 30, 2023 |
\$ | - 11,737 |
\$ | - 210,727 |
\$ | - (3,490) \$ |
- (67) \$ |
629 5,902 |
\$ | - 424 |
\$ | - (48,481) \$ |
629 176,752 |
|||
| 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 |
|||||||||
| U.S Dollars in thousands | ||||||||||||||||
| Balance as of January 1, 2022 (audited) |
\$ | 11,725 | \$ | 210,204 | \$ | (3,490) \$ | 54 | \$ | 4,643 | \$ | (149) \$ | (46,163) \$ | 176,824 | |||
| Net income | - | - | - | - | - | - | (5,749) | (5,749) | ||||||||
| Other comprehensive income (loss) |
- | - | - | (496) | - | 420 | - | (76) | ||||||||
| Tax effect | - | - | - | - | - | - | - | - | ||||||||
| Total comprehensive income (loss) Exercise and forfeiture of share |
- | - | - | (496) | - | 420 | (5,749) | (5,825) | ||||||||
| based payment into shares | 6 | 115 | - | - | (115) | - | - | 6 | ||||||||
| Cost of share-based payment | - | - | - | - | 504 | - | - | 504 |
Cost of share-based payment Balance as of June 30, 2022 \$
11,731
\$ 210,319 \$
The accompanying Notes are an integral part of the Consolidated Financial Statements.
(442)
\$ 5,097 \$
271 \$
(51,912) \$
171,574
(3,490) \$
| Share capital |
Additional paid in capital |
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 |
||
|---|---|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||||
| Balance as of April 1, 2023 | |||||||||
| (Audited) | \$ | 11,736 | \$ 210,665 |
\$ (3,490) \$ |
(99) \$ | 5750 | \$ 539 |
\$ (50,293) \$ |
174,808 |
| Net income | - | - | - | - | - | - | 1,812 | 1,812 | |
| Other comprehensive income (loss) |
- | - | - | 32 | - | (115) | - | (83) | |
| Tax effect | - | - | - | - | - | - | - | | |
| Total comprehensive income (loss) | - | - | - | 32 | - | (115) | 1,812 | 1,729 | |
| Exercise and forfeiture of share | |||||||||
| based payment into shares | 1 | 62 | - | - | (62) | - | - | 1 | |
| Cost of share-based payment | - | - | - | - | 214 | - | - | 214 | |
| Balance as of June 30, 2023 | \$ | 11,737 | \$ 210,727 |
\$ (3,490) \$ |
(67) \$ | 5,902 | \$ 424 |
\$ (48,481) \$ |
176,752 |
| Share capital |
Additional paid in capital |
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 |
||
| U.S Dollars in thousands | |||||||||
| Balance as of April 1, 2022 (Audited) |
\$ | 11,728 | \$ 210,269 |
\$ (3,490) \$ |
12 | \$ 4,771 |
\$ (149) \$ |
(47,991) \$ | 175,150 |
| Net income | - | - | - | - | - | - | (3,921) | (3,921) | |
| Other comprehensive income (loss) |
- | - | - | (454) | - | 420 | - | (34) | |
| Taxes effect | - | - | - | - | - | - | - | | |
| Total comprehensive income (loss) | - | - | - | (454) | - | 420 | (3,921) | (3,955) | |
| Exercise and forfeiture of share based payment into shares |
3 | 50 | - | - | (50) | - | - | 3 |
Cost of share-based payment - - - - 376 - - 376
Balance as of June 30, 2022 \$ 11,731 \$ 210,319 \$ (3,490) \$ (442) \$ 5,097 \$ 271 \$ (51,912) \$ 171,574 The accompanying Notes are an integral part of the Consolidated Financial Statements.
| 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 |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||||||||||
| Balance as of January 1, 2022 (audited) |
\$ 11,725 |
\$ | 210,204 | \$ | (3,490) | \$ | 54 | \$ | 4,643 | \$ | (149) | \$ | (46,163) | \$ | 176,824 |
| Net income | - | - | - | - | - | - | (2,321) | (2,321) | |||||||
| Other comprehensive income (loss) |
- | - | - | (142) | - | 497 | - | 355 | |||||||
| Taxes effect | - | - | - | - | - | - | - | - | |||||||
| Total comprehensive income (loss) | - | - | - | (142) | - | 497 | (2,321) | (1,966) | |||||||
| Exercise and forfeiture of share based payment into shares |
9 | 291 | - | - | (291) | - | 9 | ||||||||
| Cost of share-based payment | - | - | - | - | 1,153 | - | 1,153 | ||||||||
| Balance as of December 31, 2022 | \$ 11,734 |
\$ | 210,495 | \$ | (3,490) \$ | (88) | \$ | 5,505 | \$ | 348 | \$ | (48,484) \$ | 176,020 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Six months period Ended June, 30 |
Three months period Ended June, 30 |
Year Ended December 31, |
|||
|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | |
| Unaudited | Audited | ||||
| U.S Dollars in thousands | |||||
| Cash Flows from Operating Activities | |||||
| Net income (loss) | \$ 3 |
\$ (5,749) \$ |
1,812 | \$ (3,921) \$ |
(2,321) |
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
|||||
| Adjustments to the profit or loss items: | |||||
| Depreciation and impairment | 6,327 | 6,088 | 3,204 | 3,061 | 12,155 |
| Financial expenses (income), net | 2,811 | 3,651 | 726 | 1,618 | 6,791 |
| Cost of share-based payment | 629 | 569 | 214 | 376 | 1,153 |
| Taxes on income | 106 | 50 | 93 | 9 | 62 |
| Loss (gain) from sale of property and equipment | (5) | - | - | - | - |
| Change in employee benefit liabilities, net | (40) | (96) | (32) | (84) | (111) |
| 9,828 | 10,262 | 4,205 | 4,980 | 20,050 | |
| Changes in asset and liability items: | |||||
| Decrease (increase) in trade receivables, net | 2,696 | 17,102 | (3,610) | 3,610 | 7,603 |
| Decrease (increase) in other accounts receivables | 1,539 | 2,073 | 177 | 1,484 | (578) |
| Decrease (increase) in inventories | (11,452) | 2,903 | (482) | 241 | (1,361) |
| Decrease (increase) in deferred expenses | 3,042 | (484) | (512) | (374) | (1,340) |
| Increase (decrease) in trade payables | (5,436) | (7,843) | 1,276 | 5,806 | 7,055 |
| Increase (decrease) in other accounts payables | (408) | (1,517) | (170) | (745) | 290 |
| Decrease in deferred revenues | 3 | - | (381) | - | (20) |
| (10,016) | 12,234 | (3,702) | 10,022 | 11,649 | |
| Cash received (paid) during the period for: | |||||
| Interest paid | (744) | (380) | (403) | (186) | (853) |
| Interest received | 25 | 3 0 |
1 | 97 | |
| Taxes paid | (112) | (18) | (94) | (9) | (36) |
| (831) | (395) | (497) | (194) | (792) | |
| (1,016) \$ 16,352 |
\$ 1,818 |
\$ 10,887 |
\$ 28,586 |
| Six months period Ended | June, 30 | Three months period Ended | June, 30 | Year Ended December 31, |
||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | 2022 | ||||
| Unaudited | Audited | |||||||
| U.S Dollars In thousands | ||||||||
| Cash Flows from Investing Activities | ||||||||
| Purchase of property and equipment and intangible assets | \$ (2,147) \$ |
(1,191) \$ | (1,048) \$ | (678) \$ | (3,784) | |||
| Proceeds from sale of property and equipment | 6 | - | - | - | - | |||
| Business combination | - | - | - | - | - | |||
| Net cash provided by (used in) investing activities | (2,141) | (1,191) | (1,048) | (678) | (3,784) | |||
| Cash Flows from Financing Activities | ||||||||
| Proceeds from exercise of share base payments | 3 | 6 | 2 | 3 | 9 | |||
| Receipt of long-term loans | - | - | - | - | - | |||
| Repayment of lease liabilities | (517) | (573) | (246) | (278) | (1,098) | |||
| Repayment of long-term loans | (2,222) | (401) | (1,111) | (385) | (2,628) | |||
| Repayment of other long-term liabilities | (6,000) | (3,243) | (4,500) | (1,743) | (5,626) | |||
| Net cash provided by (used in) financing activities | (8,736) | (4,211) | (5,855) | (2,403) | (9,343) | |||
| Exchange differences on balances of cash and cash equivalent | (577) | 396 | (248) | 160 | 212 | |||
| Increase (decrease) in cash and cash equivalents | (12,470) | 11,346 | (5,333) | 7,966 | 15,671 | |||
| Cash and cash equivalents at the beginning of the period | 34,258 | 18,587 | 27,121 | 21,967 | 18,587 | |||
| Cash and cash equivalents at the end of the period | \$ 21,788 |
\$ | 29,933 | \$ | 21,788 | \$ | 29,933 | \$ 34,258 |
| Significant non-cash transactions | ||||||||
| Right-of-use asset recognized with corresponding lease liability | \$ 3,585 |
\$ | 296 | \$ | 5 | \$ | 121 | \$ 551 |
| Purchase of property and equipment and Intangible assets | \$ 840 |
\$ | 775 | \$ | 840 | \$ | 775 | \$ 618 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
Kamada Ltd. (the "Company") is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company's strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company's commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB®, KAMRHO (D) ® and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, Middle East and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years added eleven biosimilar products to its Israeli distribution portfolio, which, subject to European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D). In addition to the Company's commercial operation, it invests in research and development of new product candidates. The Company's leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial.
In November 2021, the Company acquired CYTOGAM, WINRHO SDF, VARIZIG and HEPGAM B from Saol Therapeutics Ltd. ("Saol"). The acquisition of this portfolio furthered the Company's core objective to become a fully integrated specialty plasma company with strong commercial capabilities in the U.S. market, as well as to expand to new markets, mainly in the Middle East/North Africa region, and to broaden the Company's portfolio offering in existing markets. The Company's wholly owned U.S. subsidiary, Kamada Inc., is responsible for the commercialization of the four products in the U.S. market, including direct sales to wholesalers and local distributers. Refer to Note 5 in our annual Financial report for further details on this acquisition.
a. Basis of preparation of the interim consolidated financial statements:
The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, "Interim Financial Reporting".
b. Implementation of new accounting standards:
The Amendment, together with the subsequent amendment to IAS 1 (see hereunder) replaces certain requirements for classifying liabilities as current or noncurrent. According to the Amendment, a liability will be classified as non-current when the entity has the right to defer settlement for at least 12 months after the reporting period, and it "has substance" and is in existence at the end of the reporting period. According to the subsequent amendment, as published in October 2022, covenants with which the entity must comply after the reporting date do not affect classification of the liability as current or non-current. Additionally, the subsequent amendment adds disclosure requirements for liabilities subject to covenants within 12 months after the reporting date, such as disclosure regarding the nature of the covenants, the date they need to be complied with and facts and circumstances that indicate the entity may have difficulty complying with the covenants. Furthermore, the Amendment clarifies that the conversion option of a liability will affect its classification as current or noncurrent, other than when the conversion option is recognized as equity.
The Amendment and subsequent amendment are effective for reporting periods beginning on or after January 1, 2024 with earlier application being permitted. The Amendment and subsequent amendment are applicable retrospectively, including an amendment to comparative data.
The Company believes that the adoption of the Amendment will not have an effect on its financial statements.
Grant of options to the purchase ordinary shares of the Company to employees, executive officers.
On February 27, 2023, the Company's Board of Directors approved the grant of options to purchase up to 147,000 options to purchase ordinary shares of the Company under the 2011 Plan and the US Appendix.
The Company granted, out of the above mentioned, to employees and executive officers the following:
Under the Israeli Share Option Plan:
Under the US Appendix:
On May 28, 2023, the Company's Board of Directors approved the grant of 90,000 options to purchase ordinary shares of the Company, under the Israeli Share Option Plan, at an exercise price of NIS 19.46 (USD 5.25) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated on the date of grant at \$217 thousands.
a. General:
The company has two operating segments, as follows:
| Proprietary Products |
Distribution U.S Dollars in thousands |
Total | |
|---|---|---|---|
| Six months period ended June 30, 2023 | Unaudited | ||
| Revenues | \$ 55,001 \$ |
13,152 | \$ 68,153 |
| Gross profit | \$ 24,585 \$ |
1,690 | \$ 26,275 |
| Unallocated corporate expenses | (23,355) | ||
| Finance expenses, net | (2,811) | ||
| Income before taxes on income | \$ 109 |
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Six months period ended June 30, 2022 | |||||||
| Revenues | \$ 41,618 |
\$ 10,065 |
\$ 51,683 |
||||
| Gross profit | \$ 16,913 |
\$ 1,629 |
\$ 18,542 |
||||
| Unallocated corporate expenses | (20,590) | ||||||
| Finance expenses, net | (3,651) | ||||||
| Income before taxes on income | (5,699) \$ |
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Three months period ended June 30, 2023 | ||||||
| Revenues | \$ | 34,940 | \$ | 6,503 | \$ | 37,443 |
| Gross profit | \$ | 13,748 | \$ | 688 | \$ | 14,436 |
| Unallocated corporate expenses | (11,805) | |||||
| Finance expenses, net | (726) | |||||
| Income before taxes on income | \$ | 1,905 |
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Three months period ended June 30, 2022 | ||||||
| Revenues | \$ | 18,607 | \$ | 4,983 | \$ | 23,590 |
| Gross profit | \$ | 6,351 | \$ | 899 | \$ | 7,240 |
| Unallocated corporate expenses | (9,534) | |||||
| Finance expenses, net | (1,618) | |||||
| Income before taxes on income | \$ | (3,912) |

b. Reporting on operating segments:
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Audited | ||||||
| Year Ended December 31, 2022 | ||||||
| Revenues | \$ 102,598 |
\$ | 26,741 | \$ | 129,339 | |
| Gross profit | \$ 44,369 |
\$ | 2,334 | \$ | 46,703 | |
| Unallocated corporate expenses | (42,171) | |||||
| Finance expenses, net | (6,791) | |||||
| Income before taxes on income | \$ | (2,259) |
c. Reporting on operating segments by geographic region:
| Six months period ended June 30, 2023 |
||||||
|---|---|---|---|---|---|---|
| Proprietary Products Distribution |
Total | |||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America | \$ 36,856 |
\$ - |
\$ | 36,856 | ||
| Israel | 2,101 | 13,152 | 15,252 | |||
| Europe | 3,550 | - | 3,550 | |||
| Latin America | 9,931 | - | 9,931 | |||
| Asia | 2,480 | - | 2,480 | |||
| Others | 83 | - | 83 | |||
| \$ 55,001 |
\$ 13,152 |
\$ | 68,153 |
c. Reporting on operating segments by geographic region:
| Six months period ended June 30, 2022 |
||||||
|---|---|---|---|---|---|---|
| Proprietary Products Distribution |
Total | |||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America. | \$ 28,562 \$ - \$ |
28,562 | ||||
| Israel | 2,254 10,065 |
12,319 | ||||
| Europe | 5,149 - |
5,149 | ||||
| Latin America | 3,526 - |
3,526 | ||||
| Asia | 1,760 - |
1,760 | ||||
| Others | 367 - |
367 | ||||
| \$ 41,618 \$ 10,065 \$ |
51,683 | |||||
| Three months period ended | ||||||
| June 30, 2023 | ||||||
| Proprietary | ||||||
| Products Distribution Total |
||||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America. | \$ 20,026 \$ - \$ |
20,026 | ||||
| Israel | 1,107 6,503 |
7,610 | ||||
| Europe | 216 - |
216 | ||||
| Latin America | 8,615 - |
8,615 | ||||
| Asia | 930 - |
930 | ||||
| Others | 46 - |
46 | ||||
| \$ 30,940 \$ 6,503 \$ |
37,443 | |||||
| Three months period ended June 30, 2022 |
||||||
| Proprietary | ||||||
| Products Distribution Total |
||||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America. | \$ 11,611 \$ - \$ |
11,611 | ||||
| Israel | 627 4,983 |
5,610 | ||||
| Europe | 4,097 - |
4,097 | ||||
| Latin America | 1,496 - |
1,496 | ||||
| Asia | 776 - |
776 | ||||
| Others | - - |
| ||||
| \$ 18,607 \$ 4,983 \$ |
23,590 | |||||
| Year ended December 31, 2022 | ||||||
| Proprietary | ||||||
| Products Distribution Total |
||||||
| U.S Dollars in thousands | ||||||
| Audited | ||||||
| Geographical markets U.S.A and North America |
\$ 75,851 \$ - \$ |
75,851 | ||||
| Israel | 5,290 26,741 |
32,031 | ||||
| Europe | 5,277 - |
5,277 | ||||
| Latin America | 11,293 - |
11,293 | ||||
| Asia | ||||||
| 4,581 - |
4,581 | |||||
| Others | 305 - |
305 | ||||
| \$ 102,597 \$ 26,741 \$ |
129,338 |
| Level 1 | Level 2 | Level 3 | |||
|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||
| June 30, 2023 | |||||
| Derivatives instruments | \$ | \$ | (72) \$ | - | |
| Contingent consideration | - | - | (21,712) | ||
| June 30, 2022 | |||||
| Derivatives instruments | (437) | ||||
| Contingent consideration | \$ - |
\$ | (23,121) \$ |
||
| December 31, 2022 | |||||
| Derivatives instruments | \$ - |
\$ | (92) | \$ - |
|
| Contingent consideration | \$ - |
\$ | - | (23,534) \$ |
During the six months ended on June 30, 2023 there were no transfers due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument.
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