Kamada Ltd 6-K, filed Aug 16, 2023
Kamada Ltd (KMDA)
About this 6-K
Kamada Ltd filed this 6-K on August 16, 2023.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the Month of August
Commission File Number
(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.
The following exhibits are attached:
| 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) |
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 16, 2023 | KAMADA LTD. | |
| By: | /s/ Nir Livneh | |
|
Nir Livneh Vice President General Counsel and | ||
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EXHIBIT INDEX
| 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) |
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Exhibit 99.1
Kamada Reports Strong Second Quarter and First Half 2023 Financial Results;
Reiterates 2023 Revenue and Profitability Guidance
| ● | Second Quarter 2023 Revenues were $37.4 Million, Representing a 59% Increase Year-over-Year; First Half 2023 Revenues of $68.2 Million, Up 32% Year-over-Year |
| ● | First Half 2023 Adjusted EBITDA of $9.9 Million, Up 24% Year-over-Year |
| ● | Robust Second Quarter Results and Positive Outlook for Second Half of 2023 Support Reiteration of Fiscal Year 2023 Revenue Guidance of $138 Million - $146 Million, and Adjusted EBITDA of $22 Million to $26 Million |
| ● | Extended U.S. Distribution Agreement for KEDRAB® Rabies Immunoglobulin with Kedrion Biopharma Through March 2026 |
| ● | Reports Positive Scientific Advice from European Medicines Agency (EMA) Regarding Ongoing Pivotal Inhaled AAT Study that Reconfirms the Overall Design of the Study and Acknowledges Certain Positive Results Demonstrated in Previously Completed Phase 2/3 Study |
| ● | Shareholder Vote to Approve $60 Million Private Placement with FIMI Opportunity Funds Scheduled for August 29, 2023 |
| ● | Conference Call and Live Webcast Today at 8:30 AM ET |
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-over-year, 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.
Financial Highlights for the Three Months Ended June 30, 2023
| ● | Total revenues were $37.4 million in the second quarter of 2023, a 59% increase from the $23.6 million recorded in the second quarter of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased demand for the product in the U.S. market. As a reminder, during the second quarter of 2022, a portion of sales were delayed due to the labor strike at the Company’s manufacturing facility in Israel. |
| ● | Gross profit and gross margins were $14.4 million and 39%, respectively, in the second quarter of 2023, compared to $7.2 million and 31%, respectively, reported in the second quarter of 2022. Cost of goods sold in the Company’s Proprietary segment included $1.3 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition. As a reminder, gross profit, and gross margin for the second quarter of 2022 were affected by a $3.3 million loss as a result of the labor strike at the Company’s manufacturing facility in Israel. |
| ● | Operating expenses, including R&D, Sales & Marketing (S&M), G&A and other expenses, totaled $11.8 million in the second quarter of 2023, as compared to $9.5 million in the second quarter of 2022. S&M costs included $0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition. The increase in operating expenses was attributable to an increase in S&M costs associated with the acquired portfolio commercial operation, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT. |
| ● | Net income was $1.8 million, or $0.04 per share, in the second quarter of 2023, as compared to a net loss of $3.9 million, or $(0.09) per share, in the second quarter of 2022. |
| ● | Adjusted EBITDA, as detailed in the tables below, was $6.0 million in the second quarter of 2023, as compared to $1.3 million in the second quarter of 2022. As a reminder, adjusted EBITDA for the second quarter of 2022 was affected by the labor strike related loss. Adjusted EBITDA for the second quarter of 2022, excluding such loss associated with the labor strike, would have been $4.7 million. |
| ● | Cash provided by operating activities was $1.8 million in the second quarter of 2023, as compared to cash provided by operating activities of $10.9 million in the second quarter of 2022. The change was correlated to the changes in the Company’s working capital. |
Financial Highlights for the Six Months Ended June 30, 2023
| ● | Total revenues for the first six months of 2023 were $68.2 million, a 32% increase from the $51.7 million generated in the first six months of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased demand for the product in the U.S. market. |
| ● | Gross profit and gross margins for the first six months of 2023 were $26.3 million and 39%, respectively, compared to $18.5 million and 36%, respectively, in the first half of 2022. Cost of goods sold in the Company’s Proprietary segment included $2.7 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition. As a reminder, gross profit, and gross margin for the first six months of 2022 were affected by a $3.3 million loss as a result of the labor strike at the Company’s manufacturing facility in Israel. |
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| ● | Operating expenses, including R&D, S&M, G&A and other expenses, totaled $23.4 million in the first six months of 2023, as compared to $20.6 million in the first half of 2022. S&M costs included $0.8 million of depreciation expenses of intangible assets generated through the IgG products acquisition. The increase in operating expenses was attributable to an increase in S&M costs associated with the acquired portfolio commercial operation, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT. |
| ● | Net profit for the first six months of 2023 was $3,000, or less than one cent per share, as compared to net loss of $5.7 million, or $(0.13) per share, in the prior year period. |
| ● | Adjusted EBITDA, as detailed in the tables below, was $9.9 million in the first six months of 2023, as compared to $4.6 million in the first six months of 2022. As a reminder, adjusted EBITDA for the first six months of 2022 were affected by a $3.3 million loss as result of the labor strike at the Company’s manufacturing facility in Israel. The adjusted EBITDA for the first six months of 2023 represented a 24% increase compared to the adjusted EBITDA excluding labor strike related loss for the first six months of 2022. |
| ● | Cash used in operating activities during the first six months of 2023 was approximately $1.0 million, as compared to cash provided by operating activities of $16.4 million during the first six months of 2022. The change was correlated to the changes in the Company’s working capital. |
Balance Sheet Highlights
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.
Recent Corporate Highlights
| ● | Announced that Kedrion exercised its option to extend through March 2026 the KEDRAB distribution agreement. |
Fiscal Year 2023 Guidance
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.
Conference Call
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.
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Non-IFRS financial measures
We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company’s core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain other costs.
About Kamada
Kamada Ltd. (the “Company”) is a 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.
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Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: (1) 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.
CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com
Brian Ritchie
LifeSci Advisors, LLC
(212) 915-2578
britchie@LifeSciAdvisors.com
5
KAMADA LTD.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of June 30, | As of December 31, | |||||||||||
| 2023 | 2022 | 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 | ||||||
6
KAMADA LTD.
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 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
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | 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 | |||||||||
8
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | 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 | ||||||||||
9
KAMADA LTD.
NON-IFRS MEASURES – ADJUSTED EBITDA
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | 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 | ||||||||||
10
Exhibit 99.2
INVESTORS MEETING NASDAQ & TASE: KMDA August 2023
FORWARD LOOKING STATEMENT This presentation is not intended to provide investment or medical advice . It 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 statements, which express the current beliefs and expectations of Kamada’s management . Such statements include the 2023 financial guidance, success of the inhaled AAT clinical study, its benefits and potential market size, success of the U . S . plasma collection expansion and revenue potential, and success in launching new products in the Israeli distribution business segment . These statement involve a number of known and unknown risks and uncertainties that could cause Kamada's future results, performance or achievements to differ significantly from the prospected results, performances or achievements expressed or implied by such forward - looking statements . Important factors that could cause or contribute to such differences include, but are not limited to, risks relating to Kamada's ability to successfully develop and commercialize its products and product candidates, the progress and results of any clinical trials, the introduction of competing products, the continued market acceptance of Kamada’s commercial products portfolio, the impact of any changes in regulation and legislation that could affect the pharmaceutical industry, the difficulty of predicting, obtaining or maintaining U . S . Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment, restrains related to third parties’ IP rights and changes in the health policies and structures of various countries, success of M&A strategies, environmental risks, changes in the worldwide pharmaceutical industry and other factors that are discussed under the heading “Risk Factors” of Kamada’s 202 2 Annual Report on Form 20 - F (filed on March 15 , 202 3 ) as well as in Kamada’s recent Forms 6 - K filed with the U . S . Securities and Exchange Commission . This presentation includes certain non - IFRS financial information, which is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with IFRS . The non - IFRS financial measures may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies . In accordance with the requirement of the SEC regulations a reconciliation of these non - IFRS financial measures to the comparable IFRS measures is included in an appendix to this presentation . Management uses these non - IFRS financial measures for financial and operational decision - making and as a means to evaluate period - to - period comparisons . Management believes that these non - IFRS financial measures provide meaningful supplemental information regarding Kamada’s performance and liquidity . Forward - looking statements speak only as of the date they are made, and Kamada undertakes no obligation to update any forward - looking statement to reflect the impact of circumstances or events that arise after the date the forward - looking statement was made, except as required by applicable securities laws . You should not place undue reliance on any forward - looking statement and should consider the uncertainties and risks noted above, as well as the risks and uncertainties more fully discussed under the heading “Risk Factors” of Kamada’s 202 2 Annual Report on Form 20 - F (filed on March 15 , 202 3 ) as well as in Kamada’s recent Forms 6 - K filed with the U . S . Securities and Exchange Commission . 2 Kamada / August 2023
6 FDA approved products ; global commercial network selling in over 30 countries 2023 revenues guidance of $138M - $146M; Adjusted EBITDA of $22M - $26M; rapidly growing; positive cash - flow; strong balance sheet Multiple growth drivers with limited downside ri sk and significant upside potential KAMADA HIGHLIGHTS 6 3 Kamada is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions The company is a leader in the specialty plasma - derived field focused on diseases of limited treatment alternatives The company is advancing an innovative development pipeline targeting areas of significant unmet medical need Kamada / August 2023
FINANCIAL GROWTH TRAJECTORY Adjusted EBITDA is defined as net income, plus (i) tax expense, (ii) financial income (expense), net, (iii) depreciation and amortization ; and (v) non - cash share - based compensation expenses 4 104 129 138 - 146 2021 2022 2023 Revenues US$M 6 18 22 - 26 2021 2022 2023 Adjusted EBITDA US$M 2023 represents annual guidance 2023 represents annual guidance Kamada / August 2023 Strong First Half Results and Expected Continued Momentum Anticipated to Drive Full - Year 2023 Adjusted EBITDA Growth (mid point represents approx. 35% increase YoY)
$60M STRATEGIC INVESTMENT BY FIMI 5 Kamada / August 2023 • Proceeds from the private placement are expected to be used to accelerate the growth of the Company’s existing business and execution of strategic business development opportunities • Approximately 12.6 million ordinary shares at a price of $4.75 per share. Represents the average closing price of the Company’s shares on NASDAQ during the 20 trading days prior to the date of the agreement • Upon the closing of the transaction, FIMI is expected to beneficially own approximately 38% of Kamada’s outstanding ordinary shares and will become a controlling shareholder of the Company, within the meaning of the Israeli Companies Law, 1999. • 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
FDA - APPROVED S PECIALITY PLASMA PRODUCTS; KEY FOCUS ON TRANSPLANTATION & RARE CONDITIONS KEDRAB/KAMRAB® [Rabies Immune Globulin (Human)] Post exposure prophylaxis of rabies infection CYTOGAM® [Cytomegalovirus Immune Globulin Intravenous (Human)] Prophylaxis of cytomegalovirus disease associated with transplantation VARIZIG® [Varicella Zoster Immune Globulin (Human)] Post - exposure prophylaxis of varicella in high - risk patient groups HEPGAM B® [Hepatitis B Immune Globulin (Human)] Prevention of HBV recurrence following liver transplantation WINRHO® [Rho(D) Immune Globulin (Human)] Treatment of immune thermobocytopunic purpura (ITP) & suppression of Rh isoimmunization (HDN) GLASSIA® [Alpha1 - Proteinase Inhibitor (Human)] Augmentation therapy for Alpha - 1 Antitrypsin Deficiency (AATD) Kamada / August 2023 6
STRATEGIC ENTRY INTO THE U.S. PLASMA COLLECTION MARKET Kamada Plasma was established in Q1 20 21 through the acquisition of an FDA - licensed plasma collection center in Texas, focusing on collecting hyper - immune plasma for specialty IgG’s o Strategic transaction which advances Kamad a ’s objective to evolve into a fully integrated specialty plasma company, enhancing self - supply for our hyperimmune products o Planning to open additional centers in the US, collecting hyper - immune plasma as well as normal source plasma (NSP) o Average annual revenues of a mature collection center ranges between $8M - $10M 7 Kamada / August 2023
• Non - Invasive, at - home treatment. Expected better ease of use and quality of life for AATD patients than current IV SOC • The leading new innovative AATD treatment in advanced clinical stage (Ph - 3 ) • Most effective mode of treatment for delivering therapeutic amounts of AAT directly into the airways • Studied in more than 200 individuals to date, with an established safety profile • Positive recent scientific advice from EMA : reconfirms overall InnovAATe study design and acknowledges the statistically and clinically meaningful FEV 1 results demonstrated in previously study • Only 1 / 8 th of the IV AAT dosing, more cost - effective ; Favorable market access landscape • Enrolled 62 patients to date (July 2023 ) • Substantial opportunity in over a $ 1 billion market 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 8 Kamada / August 2023 INHALED AAT PHASE 3 PIVOTAL STUDY
H1 & Q2 SUMMARY FINANCIAL DATA 9 Kamada / August 2023 Details Q2/ 20 22 Q2/2023 H1/ 20 22 H1/2023 US $ M 18.6 30.9 41.6 55.0 PROPRIETARY 5.0 6.5 10.1 13.2 DISTRIBUTION 32% and 59% YoY increase for H1 & Q2, respectively 23.6 37.4 51.7 68.2 TOTAL REVENUES 7.2 14.4 18.5 26.3 GROSS PROFIT 31% 39% 36% 39% GROSS MARGIN (9.5) (11.8) (20.6) (23.4) OPEX (3.9) 1.8 (5.7) 0.0 NET PROFIT 24% YoY increase for H1 (2022 excl $3.3M labor strike related loss) 1.3 6.0 4.6 9.9 Adjusted EBITDA 29.9 21.8 CASH Including acquisition related intangible assets ($140M @ June 23) 304.1 314.4 TOTAL ASSETS 5 - year term loan 19.6 15.2 BANK LOAN Acquisition related contingent consideration 84.5 80.6 CONTINGENT LIABILITIES 171.6 176.8 EQUITY
KAMADA INVESTMENT HIGHLIGHTS 10 Kamada / August 2023 A global leader; focused on areas of limited treatment alternatives Financially stable; profitable; cash - generating; continued double digit growth 6 FDA approved products with significant worldwide growth potential Leading innovative product for AAT Deficiency in late stage development; Targeting a market of over $1B Significant upside potential with limited downside
August 202 3 THANK YOU WWW.KAMADA.COM
Non - IFRS measures – Adjusted EBITDA Q2/ 20 22 Q2/2023 H1/ 20 22 H1/2023 US $ M (3.9) 1.8 (5.7) 0.0 Net loss 0.0 0.1 0.1 0.1 Taxes on income 1.9 0.3 3.9 2.1 Revaluation of Acquisition related contingent consideration (0.2) 0.4 (0.2) 0.7 Other financial expense, net 1.8 1.8 3.5 3.5 Amortization of acquisition related intangible assets 1.4 1.4 2.6 2.8 Other depreciation and amortization expenses 0.4 0.2 0.6 0.6 Non - cash share - based compensation expenses 1.3 6.0 4.6 9.9 Adjusted EBITDA Kamada / July 2023 12
Exhibit 99.3
KAMADA LTD.
CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2023
TABLE OF CONTENTS
- - - - - - - - - - -
i
KAMADA LTD.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of June 30, | As of December 31, | |||||||||||
| 2023 | 2022 | 2022 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Assets | ||||||||||||
| Current Assets | ||||||||||||
| Cash and cash equivalents | $ | $ | $ | |||||||||
| Trade receivables, net | ||||||||||||
| Other accounts receivables | ||||||||||||
| Inventories | ||||||||||||
| Total Current Assets | ||||||||||||
| Non-Current Assets | ||||||||||||
| Property, plant and equipment, net | ||||||||||||
| Right-of-use assets | ||||||||||||
| Intangible assets, Goodwill and other long-term assets | ||||||||||||
| Contract assets | ||||||||||||
| Total Non-Current Assets | ||||||||||||
| Total Assets | $ | $ | $ | |||||||||
| Liabilities | ||||||||||||
| Current Liabilities | ||||||||||||
| Current maturities of bank loans | $ | $ | $ | |||||||||
| Current maturities of lease liabilities | ||||||||||||
| Current maturities of other long term liabilities | ||||||||||||
| Trade payables | ||||||||||||
| Other accounts payables | ||||||||||||
| Deferred revenues | ||||||||||||
| Total Current Liabilities | ||||||||||||
| Non-Current Liabilities | ||||||||||||
| Bank loans | ||||||||||||
| Lease liabilities | ||||||||||||
| Contingent consideration | ||||||||||||
| Other long-term liabilities | ||||||||||||
| Deferred revenues | ||||||||||||
| Employee benefit liabilities, net | ||||||||||||
| Total Non-Current Liabilities | ||||||||||||
| Shareholder’s Equity | ||||||||||||
| Ordinary shares | ||||||||||||
| Additional paid in capital net | ||||||||||||
| Capital reserve due to translation to presentation currency | ( | ) | ( | ) | ( | ) | ||||||
| Capital reserve from hedges | ( | ) | ( | ) | ( | ) | ||||||
| Capital reserve from share-based payments | ||||||||||||
| Capital reserve from employee benefits | ||||||||||||
| Accumulated deficit | ( | ) | ( | ) | ( | ) | ||||||
| Total Shareholder’s Equity | ||||||||||||
| Total Liabilities and Shareholder’s Equity | $ | $ | $ | |||||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
1
KAMADA LTD.
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2022 | ||||||||||||||||
| Unaudited | Unaudited | Audited | ||||||||||||||||||
U.S Dollars in thousands |
||||||||||||||||||||
| Revenues from proprietary products | $ | $ | $ | $ | $ | |||||||||||||||
| Revenues from distribution | ||||||||||||||||||||
| Total revenues | ||||||||||||||||||||
| Cost of revenues from proprietary products | ||||||||||||||||||||
| Cost of revenues from distribution | ||||||||||||||||||||
| Total cost of revenues | ||||||||||||||||||||
| Gross profit | ||||||||||||||||||||
| Research and development expenses | ||||||||||||||||||||
| Selling and marketing expenses | ||||||||||||||||||||
| General and administrative expenses | ||||||||||||||||||||
| Other expenses | ||||||||||||||||||||
| Operating income (loss) | ( |
) | ( |
) | ||||||||||||||||
| Financial income | - | |||||||||||||||||||
| Income (expenses) in respect of currency exchange differences and derivatives instruments, net | ||||||||||||||||||||
| Financial Income (expense) in respect of contingent consideration and other long- term liabilities. | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
| Financial expenses | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
| Income (expense) before tax on income | ( |
) | ( |
) | ( |
) | ||||||||||||||
| Taxes on income | ||||||||||||||||||||
| Net Income (loss) | $ | $ | ( |
) | $ | $ | ( |
) | $ | ( |
) | |||||||||
| 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 | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | ||||||||||||||||||||
| Items that will not be reclassified to profit or loss in subsequent periods: | ||||||||||||||||||||
| Remeasurement gain (loss) from defined benefit plan | ( |
) | ||||||||||||||||||
| Tax effect | - | - | ||||||||||||||||||
| Total comprehensive income (loss) | $ | $ | ( |
) | $ | $ | ( |
) | $ | ( |
) | |||||||||
| Earnings per share attributable to equity holders of the Company: | ||||||||||||||||||||
| Basic net earnings per share | $ | $ | ( |
) | $ | $ | ( |
) | $ | ( |
) | |||||||||
| Diluted net earnings per share | $ | $ | ( |
) | $ | $ | ( |
) | $ | ( |
) | |||||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
2
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
| Share | Additional paid in | Capital reserve due to translation to presentation | Capital reserve from | Capital reserve from sharebased | Capital reserve from employee | Accumulated | Total | |||||||||||||||||||||||||
| capital | capital | currency | hedges | payments | benefits | deficit | equity | |||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||
| U.S Dollars in thousands | ||||||||||||||||||||||||||||||||
| Balance as of January 1, 2023 (audited) | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | $ | ( | ) | $ | ||||||||||||||||||
| Net income | ||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | - | |||||||||||||||||||||||||||||||
| Tax effect | ||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | ||||||||||||||||||||||||||||||||
| Exercise and forfeiture of share-based payment into shares | ( | ) | ||||||||||||||||||||||||||||||
| Cost of share-based payment | ||||||||||||||||||||||||||||||||
| Balance as of June 30, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | $ | ( | ) | $ | ||||||||||||||||||
| Share | Additional paid in | Capital reserve due to translation to presentation | Capital reserve from | Capital reserve from sharebased | Capital reserve from employee | Accumulated | Total | |||||||||||||||||||||||||
| capital | capital | currency | hedges | payments | benefits | deficit | equity | |||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||
| U.S Dollars in thousands | ||||||||||||||||||||||||||||||||
| Balance as of January 1, 2022 (audited) | $ | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||
| Net income | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Tax effect | ||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Exercise and forfeiture of share-based payment into shares | ( | ) | ||||||||||||||||||||||||||||||
| Cost of share-based payment | ||||||||||||||||||||||||||||||||
| Balance as of June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | $ | ( | ) | $ | ||||||||||||||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
3
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
| Share | Additional paid in | Capital reserve due to translation to presentation | Capital reserve from | Capital reserve from sharebased | Capital reserve from employee | Accumulated | Total | |||||||||||||||||||||||||
| capital | capital | currency | hedges | payments | benefits | deficit | equity | |||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||
| U.S Dollars in thousands | ||||||||||||||||||||||||||||||||
| Balance as of April 1, 2023 (Audited) | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | $ | ( | ) | $ | ||||||||||||||||||
| Net income | ||||||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Tax effect | ||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | ( | ) | ||||||||||||||||||||||||||||||
| Exercise and forfeiture of share-based payment into shares | ( | ) | ||||||||||||||||||||||||||||||
| Cost of share-based payment | ||||||||||||||||||||||||||||||||
| Balance as of June 30, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | $ | ( | ) | $ | ||||||||||||||||||
| Share capital | Additional paid in capital | Capital reserve due to translation to presentation currency | Capital reserve from hedges | Capital reserve from sharebased payments | Capital reserve from employee benefits | Accumulated deficit | Total equity | |||||||||||||||||||||||||
| Unaudited | ||||||||||||||||||||||||||||||||
| U.S Dollars in thousands | ||||||||||||||||||||||||||||||||
| Balance as of April 1, 2022 (Audited) | $ | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||
| Net income | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Taxes effect | ||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Exercise and forfeiture of share-based payment into shares | ( | ) | ||||||||||||||||||||||||||||||
| Cost of share-based payment | ||||||||||||||||||||||||||||||||
| Balance as of June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | $ | ( | ) | $ | ||||||||||||||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
4
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
| Share capital | Additional paid in capital | Capital reserve due to translation to presentation currency | Capital reserve from hedges | Capital reserve from sharebased payments | Capital reserve from employee benefits | Accumulated deficit | Total equity | |||||||||||||||||||||||||
| Audited | ||||||||||||||||||||||||||||||||
| U.S Dollars in thousands | ||||||||||||||||||||||||||||||||
| Balance as of January 1, 2022 (audited) | $ | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||
| Net income | ( | ( | ) | |||||||||||||||||||||||||||||
| Other comprehensive income (loss) | ( | ) | ||||||||||||||||||||||||||||||
| Taxes effect | ||||||||||||||||||||||||||||||||
| Total comprehensive income (loss) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Exercise and forfeiture of share-based payment into shares | ( | ) | ||||||||||||||||||||||||||||||
| Cost of share-based payment | ||||||||||||||||||||||||||||||||
| Balance as of December 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | $ | $ | ( | ) | $ | ||||||||||||||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
5
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | December 31, | ||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2022 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| U.S Dollars in thousands | ||||||||||||||||||||
| Cash Flows from Operating Activities | ||||||||||||||||||||
| Net income (loss) | $ | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | |||||||||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||||||||||||||||||||
| Adjustments to the profit or loss items: | ||||||||||||||||||||
| Depreciation and impairment | ||||||||||||||||||||
| Financial expenses (income), net | ||||||||||||||||||||
| Cost of share-based payment | ||||||||||||||||||||
| Taxes on income | ||||||||||||||||||||
| Loss (gain) from sale of property and equipment | ( | ) | ||||||||||||||||||
| Change in employee benefit liabilities, net | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| Changes in asset and liability items: | ||||||||||||||||||||
| Decrease (increase) in trade receivables, net | ( | ) | ||||||||||||||||||
| Decrease (increase) in other accounts receivables | ( | ) | ||||||||||||||||||
| Decrease (increase) in inventories | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Decrease (increase) in deferred expenses | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Increase (decrease) in trade payables | ( | ) | ( | ) | ||||||||||||||||
| Increase (decrease) in other accounts payables | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Decrease in deferred revenues | ( | ) | ( | ) | ||||||||||||||||
| ( | ) | ( | ) | |||||||||||||||||
| Cash received (paid) during the period for: | ||||||||||||||||||||
| Interest paid | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| Interest received | ||||||||||||||||||||
| Taxes paid | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||
| Net cash provided by (used in) operating activities | $ | ( | ) | $ | $ | $ | $ | |||||||||||||
6
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | 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 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||
| Proceeds from sale of property and equipment | ||||||||||||||||||||
| Business combination | ||||||||||||||||||||
| Net cash provided by (used in) investing activities | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| Cash Flows from Financing Activities | ||||||||||||||||||||
| Proceeds from exercise of share base payments | ||||||||||||||||||||
| Receipt of long-term loans | ||||||||||||||||||||
| Repayment of lease liabilities | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| Repayment of long-term loans | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| Repayment of other long-term liabilities | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| Net cash provided by (used in) financing activities | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| Exchange differences on balances of cash and cash equivalent | ( | ) | ( | ) | ||||||||||||||||
| Increase (decrease) in cash and cash equivalents | ( | ) | ( | ) | ||||||||||||||||
| Cash and cash equivalents at the beginning of the period | ||||||||||||||||||||
| Cash and cash equivalents at the end of the period | $ | $ | $ | $ | $ | |||||||||||||||
| Significant non-cash transactions | ||||||||||||||||||||
| Right-of-use asset recognized with corresponding lease liability | $ | $ | $ | $ | $ | |||||||||||||||
| Purchase of property and equipment and Intangible assets | $ | $ | $ | $ | $ | |||||||||||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
7
KAMADA LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1:- General
General description of the Company and its activity
Kamada Ltd. (the “Company”) is a 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.
8
KAMADA LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 2:- Significant Accounting Policies
| a. | Basis of preparation of the interim consolidated financial statements: |
The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, “Interim Financial Reporting”.
| b. | Implementation of new accounting standards: |
Amendment to IAS 1, Presentation of Financial Statements: Classification of Liabilities as Current or Non-Current and subsequent amendment: Non-Current Liabilities with Covenants
The Amendment, together with the subsequent amendment to IAS 1 (see hereunder) replaces certain requirements for classifying liabilities as current or non-current. 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 non-current, 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.
9
KAMADA LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 3:- Significant events in the reporting period
| Grant of options to the purchase ordinary shares of the Company to employees, executive officers. |
On February 27, 2023, the Company’s Board of Directors
approved the grant of options to purchase up to
The Company granted, out of the above mentioned, to employees and executive officers the following:
Under the Israeli Share Option Plan:
| - | On February 27, 2023, |
| - | On March 01, 2023 |
| - | On March 02, 2023 |
| - | On April 23, 2023 |
Under the US Appendix:
| - | On February 27, 2023 |
On May 28, 2023, the Company’s Board
of Directors approved the grant of
10
KAMADA LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 4:- Operating Segments
| a. | General: |
The company has two operating segments, as follows:
| Proprietary Products | - | Development, manufacturing, sales and distribution of proprietary plasma-derived protein therapeutics. |
| Distribution | - | Distribute imported drug products in Israel, which are manufactured by third parties. |
| b. | Reporting on operating segments: |
| Proprietary Products | Distribution | Total | ||||||||||
| U.S Dollars in thousands | ||||||||||||
| Unaudited | ||||||||||||
| Six months period ended June 30, 2023 | ||||||||||||
| Revenues | $ | $ | $ | |||||||||
| Gross profit | $ | $ | $ | |||||||||
| Unallocated corporate expenses | ( | ) | ||||||||||
| Finance expenses, net | ( | ) | ||||||||||
| Income before taxes on income | $ | |||||||||||
| Proprietary Products | Distribution | Total | ||||||||||
| U.S Dollars in thousands | ||||||||||||
| Unaudited | ||||||||||||
| Six months period ended June 30, 2022 | ||||||||||||
| Revenues | $ | $ | $ | |||||||||
| Gross profit | $ | $ | $ | |||||||||
| Unallocated corporate expenses | ( | ) | ||||||||||
| Finance expenses, net | ( | ) | ||||||||||
| Income before taxes on income | $ | ( | ) | |||||||||
| Proprietary Products | Distribution | Total | ||||||||||
| U.S Dollars in thousands | ||||||||||||
| Unaudited | ||||||||||||
| Three months period ended June 30, 2023 | ||||||||||||
| Revenues | $ | $ | $ | |||||||||
| Gross profit | $ | $ | $ | |||||||||
| Unallocated corporate expenses | ( | ) | ||||||||||
| Finance expenses, net | ( | ) | ||||||||||
| Income before taxes on income | $ | |||||||||||
| Proprietary Products |
Distribution | Total | ||||||||||
| U.S Dollars in thousands | ||||||||||||
| Unaudited | ||||||||||||
| Three months period ended June 30, 2022 | ||||||||||||
| Revenues | $ | $ | $ | |||||||||
| Gross profit | $ | $ | $ | |||||||||
| Unallocated corporate expenses | ( |
) | ||||||||||
| Finance expenses, net | ( |
) | ||||||||||
| Income before taxes on income | $ | ( |
) | |||||||||
11
KAMADA LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 4:- Operating Segments (cont.)
| b. | Reporting on operating segments: |
| Proprietary Products | Distribution | Total | ||||||||||
| U.S Dollars in thousands | ||||||||||||
| Audited | ||||||||||||
| Year Ended December 31, 2022 | ||||||||||||
| Revenues | $ | $ | $ | |||||||||
| Gross profit | $ | $ | $ | |||||||||
| Unallocated corporate expenses | ( | ) | ||||||||||
| Finance expenses, net | ( | ) | ||||||||||
| Income before taxes on income | $ | ( | ) | |||||||||
| 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 | $ | $ | $ | |||||||||
| Israel | ||||||||||||
| Europe | ||||||||||||
| Latin America | ||||||||||||
| Asia | ||||||||||||
| Others | ||||||||||||
| $ | $ | $ | ||||||||||
12
KAMADA LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 4:- Operating Segments (cont.)
| 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. | $ | $ | $ | |||||||||
| Israel | ||||||||||||
| Europe | ||||||||||||
| Latin America | ||||||||||||
| Asia | ||||||||||||
| Others | ||||||||||||
| $ | $ | $ | ||||||||||
| 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. | $ | $ | $ | |||||||||
| Israel | ||||||||||||
| Europe | ||||||||||||
| Latin America | ||||||||||||
| Asia | ||||||||||||
| Others | ||||||||||||
| $ | $ | $ | ||||||||||
| 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. | $ | $ | $ | |||||||||
| Israel | ||||||||||||
| Europe | ||||||||||||
| Latin America | ||||||||||||
| Asia | ||||||||||||
| Others | ||||||||||||
| $ | $ | $ | ||||||||||
| Year ended December 31, 2022 | ||||||||||||
| Proprietary Products | Distribution | Total | ||||||||||
| U.S Dollars in thousands | ||||||||||||
| Audited | ||||||||||||
| Geographical markets | ||||||||||||
| U.S.A and North America | $ | $ | $ | |||||||||
| Israel | ||||||||||||
| Europe | ||||||||||||
| Latin America | ||||||||||||
| Asia | ||||||||||||
| Others | ||||||||||||
| $ | $ | $ | ||||||||||
13
KAMADA LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 5:- Financial Instruments
| a. | Classification of financial instruments by fair value hierarchy |
Financial assets (liabilities) measured at fair value
| Level 1 | Level 2 | Level 3 | ||||||||||
| U.S Dollars in thousands | ||||||||||||
| June 30, 2023 | ||||||||||||
| Derivatives instruments | $ | $ | ( | ) | $ | |||||||
| Contingent consideration | ( | ) | ||||||||||
| June 30, 2022 | ||||||||||||
| Derivatives instruments | ( | ) | ||||||||||
| Contingent consideration | $ | $ | $ | ( | ) | |||||||
| December 31, 2022 | ||||||||||||
| Derivatives instruments | $ | $ | ( | ) | $ | |||||||
| Contingent consideration | $ | $ | $ | ( | ) | |||||||
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.
14