6-K
Kamada Ltd (KMDA)
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For
the Month of May 2023
Commission
File Number 001-35948
KamadaLtd.
(Translation of registrant’s name into English)
2
Holzman Street Science Park, P.O. Box 4081 Rehovot 7670402 Israel (Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
☐ No ☒
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____
ThisForm 6-K is being incorporated by reference into the Registrant’s Form S-8 Registration Statements, File Nos. 333-192720,333-207933, 333-215983, 333-222891, 333-233267 and 333-265866.
The following exhibit is attached:
| 99.1 | Kamada Reports Strong First Quarter 2023 Financial Results; Reiterates Revenue and Profitability Guidance |
|---|---|
| 99.2 | Company's Presentation – May 2023 |
| 99.3 | Kamada Ltd's Consolidated Financial Statements as of March 31, 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:<br> May 24, 2023 | KAMADA LTD. | |
|---|---|---|
| By: | /s/<br> Nir Livneh | |
| Nir<br> Livneh<br><br> <br>Vice<br> President General Counsel and<br><br> Corporate Secretary |
2
EXHIBIT
INDEX
| EXHIBIT NO. | DESCRIPTION |
|---|---|
| 99.1 | Kamada Reports Strong First Quarter 2023 Financial Results; Reiterates Revenue and Profitability Guidance |
| 99.2 | Company's Presentation – May 2023 |
| 99.3 | Kamada Ltd's Consolidated Financial Statements as of March 31, 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
Exhibit 99.1
Kamada Reports Strong First Quarter 2023 FinancialResults; Reiterates
Revenue and Profitability Guidance
| ● | Total Revenues for First Quarter of 2023 were$30.7 Million, Up 9% Year-over-Year |
|---|---|
| ● | First Quarter 2023 EBITDA of $3.8 Million,Increase of 16% Year-over-Year |
| --- | --- |
| ● | Solid First Quarter Results and Expected ContinuedMomentum Supported by Multiple Growth Drivers Anticipated to Drive Full-Year 2023 EBITDA Growth of Over 30% Year-over-Year |
| --- | --- |
| ● | Announced $60 Million Private Placement withFIMI Opportunity Funds |
| --- | --- |
| ● | Received FDA Approval to Manufacture CYTOGAM®at the Company’s Israeli Facility; Expected t**o Positively Impact Plant Utilizationand Efficiency |
| --- | --- |
| ● | Conference Call and Live Webcast Today at8:30 AM ET |
| --- | --- |
REHOVOT, Israel, and Hoboken, NJ – May24, 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 three months ended March 31, 2023.
“We are off to an excellent start to 2023, both financially and operationally,” said Amir London, Kamada’s Chief Executive Officer. “With total revenues in the first quarter of $30.7 million, which represented year-over-year growth of 9%, and EBITDA of $3.8 million, an increase of 16% year-over-year, we achieved the top- and bottom-line growth anticipated in our business to begin the year. Importantly, we continue to effectively leverage multiple growth drivers, including KEDRAB® sales in the U.S, the profitable 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.”
“While our first quarter results are impressive, we are equally excited about our outlook for the remainder of the year,” continued Mr. London. “As such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million, which would represent profitability growth of over 30% as compared to 2022. Looking beyond 2023, based on multiple catalysts from our existing business, we continue to anticipate annual double-digit growth rate in revenues and profitability in the foreseeable years ahead.”
“Our prospects were recently further significantly enhanced by the successful completion of multiple key achievements. The $60 million financing agreement signed with FIMI will provide us with financial flexibility, allowing us to accelerate the growth of our existing business and pursue compelling business development opportunities. Moreover, regarding our existing business, the FDA approval to manufacture CYTOGAM® at our facility in Israel, and the initiation of our commercial manufacturing, will positively impact our facility’s utilization and efficiency. In addition, we are encouraged by the most recent progress achieved in our ongoing pivotal Phase 3 InnovAATe clinical trial for the inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). The study has enrolled 60 patients to date and the independent Data Safety Monitoring Board (DSMB) recently recommended study continuation without modification for the fifth time since study initiation,” concluded Mr. London.
Financial Highlights for the Three Months Ended March 31, 2023
| ● | Total revenues were $30.7 million in the first<br>quarter of 2023, compared to $28.1 million in the first quarter of 2022, representing a 9% increase year-over-year. |
|---|---|
| ● | Gross profit and gross margins were $11.8 million<br>and 39%, respectively, in the first quarter of 2023, compared to $11.3 million and 40%, respectively, reported in the prior year period.<br>Cost of goods sold in the Company’s Proprietary segment in the first quarter of 2023 included $1.3 million of depreciation expenses<br>associated with intangible assets generated through the IgG products acquisition. Gross profit and gross margins, excluding such intangible<br>assets depreciation, would have been $13.2 million and 43%, respectively, compared to $12.6 million and 45%, respectively, in the first<br>quarter of 2022. |
| --- | --- |
| ● | Operating expenses, including R&D, Sales<br>& Marketing (S&M), G&A and other expenses (including excess severance remuneration described below), totaled $11.6 million<br>in the first quarter of 2023, compared to $11.1 million in the first quarter of 2022. S&M costs for the most recently completed first<br>quarter included $0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition. |
| --- | --- |
| ● | During the first quarter of 2023, Kamada conducted<br>a planned workforce downsizing at its Israeli plant, optimizing staff level to its capacity needs. As a result of this downsizing, the<br>Company incurred an expense of $0.6 million for excess severance remuneration provided to employees who were laid off. The downsizing<br>is expected to result in an annualized reduction of approximately 6% in the overall Israeli labor costs. |
| --- | --- |
| ● | Finance expense, net for the first quarter of<br>2023 included a $1.8 million expense associated with the revaluation of the contingent consideration and other long-term liabilities assumed<br>as part of the IgG products acquisition. For more information with respect to such contingent consideration and other long-term liabilities,<br>please refer to Note 5 of Kamada’s 2022 financial statements included in the 2022 Annual Report on Form 20-F filed on March 15,<br>2023, with the Securities and Exchange Commission. |
| --- | --- |
| ● | Net loss was $1.8 million, or $(0.04) per share,<br>in the first quarter of 2023, in line with a net loss of $1.8 million, or $(0.04) per share, in the first quarter of 2022. Excluding depreciation<br>expenses of intangible assets and finance expenses of the contingent consideration and other assumed long-term liabilities associated<br>with the acquired IgG products, the Company would have recorded net income of $1.7 million, or $0.04 per share, in the first quarter of<br>2023, compared to $1.9 million, or $0.04 per share in the first quarter of 2022. |
| --- | --- |
| ● | EBITDA, as detailed in the tables below, was<br>$3.8 million in the first quarter of 2023, as compared to $3.3 million in the first quarter of 2022, representing a 16% increase year-over-year. |
| --- | --- |
| ● | Excluding the $0.6 million expense of the excess<br>severance remuneration paid to the employees who were laid off, EBITDA would have been $4.4 million in the first quarter of 2023, representing<br>a 33% increase year-over-year. |
| --- | --- |
| ● | Cash used by operating activities was $2.9 million<br>in the first quarter of 2023, as compared to cash provided by operating activities of $5.5 million in the first quarter of 2022. |
| --- | --- |
Balance Sheet Highlights
As of March 31, 2023, Kamada had cash, cash equivalents, and short-term investments of $27.1 million, as compared to $34.3 million on December 31, 2022. This figure does not include the expected net proceeds from the recently announced $60 million financing, which is expected to close during the second half of 2023.
Recent Corporate Highlights
| ● | Announced that it has entered into a securities<br>purchase agreement with FIMI Opportunity Funds (FIMI), the leading private equity investor in Israel, to purchase $60 million of its ordinary<br>shares in a private placement. |
|---|---|
| ● | Received FDA approval of application<br>to manufacture CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV)<br>at the Company’s facility in Beit Kama, Israel. |
| --- | --- |
| ● | Granted marketing authorization in Switzerland<br>from Swissmedic for GLASSIA® [Alpha-1 Proteinase Inhibitor (Human)], for chronic augmentation and maintenance therapy in adults with<br>clinically evident emphysema due to severe hereditary AATD. |
| --- | --- |
| ● | Announced that Chief Financial Officer (CFO)<br>Chaime Orlev will remain in role and the appointment of Nir Livneh as the Company’s Vice President, General Counsel and Corporate<br>Secretary. |
| --- | --- |
2
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 EBITDA during 2023 in the range of $22 million to $26 million, representing profitability growth of over 30% from the year ended December 31, 2022.
Conference Call
Kamada management will host an investment community conference call on Wednesday, May 24, 2023, at 8:30am Eastern Time to present the Company’s 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) using conference ID 13738719. The call will also be webcast live on the Internet at: https://viavid.webcasts.com/starthere.jsp?ei=1614685&tp_key=87fb1414ee.
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 and is expected to beneficially own approximately 38% upon the closing of the Private Placement.
3
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) 2023 revenue guidance in the range of $138 Million to $146 Million; (2) 2023 EBITDA of $22 million to $26 million representing profitability growth of over 30% from the year ended December 31, 2022; (3) commercial manufacturing of CYTOGAM® in Israel shortly, which will positively impact the facility’s utilization and efficiency; (4) expected annual double-digit growth rate in revenues and profitability in the foreseeable years ahead; (5) effectively leveraging multiple growth drivers, including KEDRAB® sales in the U.S, 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; (6) receiving net proceeds from the recently announced $60 million financing; (7) closing of the recently announced $60 million financing during the second half 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; (9) the downsizing is expected to result in an annualized reduction of approximately 6% in overall Israeli labor costs; and (10) optimism about AATD Phase 3 clinical trial progress. 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, success in receiving the necessary shareholder and regulatory approvals for the Private Placement, timing of Kamada’s release of its financial results for the second quarter of 2023, overall stock market conditions and specifically Kamada’s stock price, availability of sufficient raw materials required to maintain manufacturing plans, continued utilization of Kamada’s Israeli manufacturing site, continuation of inbound and outbound international delivery routes, continued demand for the IgG product portfolio, FDA and international health authorities’ approval process, financial conditions of the Company’s customers, 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, 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:
Amir London
Chief Executive Officer
IR@kamada.com
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com
4
CONSOLIDATEDSTATEMENTS OF FINANCIAL POSITION
| As of | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| As of March 31, | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Unaudited | Audited | ||||||||
| Assets | |||||||||
| Current Assets | |||||||||
| Cash and cash equivalents | $ | 27,121 | 21,967 | $ | 34,258 | ||||
| Trade receivables, net | 20,925 | 21,568 | 27,252 | ||||||
| Other accounts receivables | 3,603 | 7,867 | 8,710 | ||||||
| Inventories | 79,754 | 64,761 | 68,785 | ||||||
| Total Current Assets | 131,403 | 116,163 | 139,005 | ||||||
| Non-Current Assets | |||||||||
| Property, plant and equipment, net | 26,496 | 26,098 | 26,157 | ||||||
| Right-of-use assets | 5,836 | 2,990 | 2,568 | ||||||
| Intangible assets, Goodwill and other long-term assets | 145,305 | 151,858 | 147,072 | ||||||
| Contract assets | 7,755 | 5,987 | 7,577 | ||||||
| Total Non-Current Assets | 185,392 | 186,933 | 183,374 | ||||||
| Total Assets | 316,795 | 303,096 | $ | 322,379 | |||||
| Liabilities | |||||||||
| Current Liabilities | |||||||||
| Current maturities of bank loans | $ | 4,444 | 3,725 | $ | 4,444 | ||||
| Current maturities of lease liabilities | 1,438 | 1,017 | 1,016 | ||||||
| Current maturities of other long term liabilities | 29,414 | 19,095 | 29,708 | ||||||
| Trade payables | 26,210 | 11,682 | 32,917 | ||||||
| Other accounts payables | 7,350 | 6,670 | 7,585 | ||||||
| Deferred revenues | 419 | 40 | 35 | ||||||
| Total Current Liabilities | 69,275 | 42,229 | 75,705 | ||||||
| Non-Current Liabilities | |||||||||
| Bank loans | 11,852 | 16,296 | 12,963 | ||||||
| Lease liabilities | 4,992 | 3,056 | 2,177 | ||||||
| Contingent consideration | 18,115 | 22,551 | 17,534 | ||||||
| Other long-term liabilities | 37,280 | 42,531 | 37,308 | ||||||
| Deferred revenues | - | 15 | - | ||||||
| Employee benefit liabilities, net | 473 | 1,268 | 672 | ||||||
| Total Non-Current Liabilities | 72,712 | 85,717 | 70,654 | ||||||
| Shareholder’s Equity | |||||||||
| Ordinary shares | 11,736 | 11,728 | 11,734 | ||||||
| Additional paid in capital net | 210,665 | 210,269 | 210,495 | ||||||
| Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | (3,490 | ) | |||
| Capital reserve from hedges | (99 | ) | 12 | (88 | ) | ||||
| Capital reserve from share-based payments | 5,750 | 4,771 | 5,505 | ||||||
| Capital reserve from employee benefits | 539 | (149 | ) | 348 | |||||
| Accumulated deficit | (50,293 | ) | (47,991 | ) | (48484 | ) | |||
| Total Shareholder’s Equity | 174,808 | 175,150 | 176,020 | ||||||
| Total Liabilities and Shareholder’s Equity | $ | 316,795 | 303,096 | $ | 322,379 |
5
CONSOLIDATEDSTATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
| Three months period ended | Year ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| March 31, | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Unaudited | Audited | ||||||||
| Revenues from proprietary products | 24,061 | 23,011 | $ | 102,598 | |||||
| Revenues from distribution | 6,649 | 5,082 | 26,741 | ||||||
| Total revenues | 30,710 | 28,093 | 129,339 | ||||||
| Cost of revenues from proprietary products | 13,224 | 12,449 | 58,229 | ||||||
| Cost of revenues from distribution | 5,647 | 4,342 | 24,407 | ||||||
| Total cost of revenues | 18,871 | 16,791 | 82,636 | ||||||
| Gross profit | 11,839 | 11,302 | 46,703 | ||||||
| Research and development expenses | 3,231 | 4,420 | 13,172 | ||||||
| Selling and marketing expenses | 3,922 | 3,321 | 15,284 | ||||||
| General and administrative expenses | 3,418 | 3,005 | 12,803 | ||||||
| Other expenses | 979 | 310 | 912 | ||||||
| Operating income (loss) | 289 | 246 | 4,532 | ||||||
| Financial income | 25 | 2 | 91 | ||||||
| Income (expense) in respect of securities measured at fair value, net | - | - | - | ||||||
| Income (expenses) in respect of currency exchange differences and derivatives instruments, net | 151 | 169 | 298 | ||||||
| Revaluation of long-term liabilities | (1,761 | ) | (2,010 | ) | (6,266 | ) | |||
| Financial expenses | (500 | ) | (194 | ) | (914 | ) | |||
| Income before tax on income | (1,796 | ) | (1,787 | ) | (2,259 | ) | |||
| Taxes on income | 13 | 41 | 62 | ||||||
| Net Income (loss) | $ | (1,809 | ) | (1,828 | ) | $ | (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) from securities measured at fair value through other comprehensive income | |||||||||
| Gain (loss) on cash flow hedges | (156 | ) | (108 | ) | (776 | ) | |||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | 145 | 66 | 634 | ||||||
| Items that will not be reclassified to profit or loss in subsequent periods: | |||||||||
| Remeasurement gain (loss) from defined benefit plan | 191 | - | 497 | ||||||
| Tax effect | - | - | - | ||||||
| Total comprehensive income (loss) | $ | (1,629 | ) | (1,870 | ) | $ | (1,966 | ) | |
| Earnings per share attributable to equity holders of the Company: | |||||||||
| Basic net earnings per share | (0.04 | ) | (0.04 | ) | $ | (0.05 | ) | ||
| Diluted net earnings per share | (0.04 | ) | (0.04 | ) | $ | (0.05 | ) |
6
CONSOLIDATEDSTATEMENTS OF CASH FLOWS
| Three months period Ended | Year Ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| March, 31 | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Audited | |||||||||
| Cash Flows from Operating Activities | |||||||||
| Net income (loss) | $ | (1,809 | ) | (1,828 | ) | $ | (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 | 3,123 | 3,027 | 12,155 | ||||||
| Financial expenses (income), net | 2,085 | 2,033 | 6,791 | ||||||
| Cost of share-based payment | 415 | 193 | 1,153 | ||||||
| Taxes on income | 13 | 41 | 62 | ||||||
| Loss (gain) from sale of property and equipment | (22 | ) | - | - | |||||
| Change in employee benefit liabilities, net | (8 | ) | (12 | ) | (111 | ) | |||
| 5,606 | 5,282 | 20,050 | |||||||
| Changes in asset and liability items: | |||||||||
| Decrease (increase) in trade receivables, net | 6,306 | 13,492 | 7,603 | ||||||
| Decrease (increase) in other accounts receivables | 1,362 | 589 | (578 | ) | |||||
| Decrease (increase) in inventories | (10,970 | ) | 2,662 | (1,361 | ) | ||||
| Decrease (increase) in deferred expenses | 3,554 | (110 | ) | (1,340 | ) | ||||
| Increase (decrease) in trade payables | (6,712 | ) | (13,649 | ) | 7,055 | ||||
| Increase (decrease) in other accounts payables | (238 | ) | (772 | ) | 290 | ||||
| Decrease in deferred revenues | 384 | - | (20 | ) | |||||
| (6,314 | ) | 2,212 | 11,649 | ||||||
| Cash received (paid) during the period for: | |||||||||
| Interest paid | (341 | ) | (194 | ) | (853 | ) | |||
| Interest received | 25 | 2 | 97 | ||||||
| Taxes paid | (18 | ) | (9 | ) | (36 | ) | |||
| (334 | ) | (201 | ) | (792 | ) | ||||
| Net cash provided by (used in) operating activities | $ | (2,851 | ) | 5,465 | $ | 28,586 |
7
CONSOLIDATEDSTATEMENTS OF CASH FLOWS
| Three months period Ended | Year Ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| March, 31 | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Audited | |||||||||
| Cash Flows from Investing Activities | |||||||||
| Purchase of property and equipment and intangible assets | (1,117 | ) | (513 | ) | (3,784 | ) | |||
| Proceeds from sale of property and equipment | 24 | - | - | ||||||
| Business combination | - | - | - | ||||||
| Net cash provided by (used in) investing activities | (1,093 | ) | (513 | ) | (3,784 | ) | |||
| Cash Flows from Financing Activities | |||||||||
| Proceeds from exercise of share base payments | 1 | 3 | 9 | ||||||
| Receipt of long-term loans | - | - | - | ||||||
| Repayment of lease liabilities | (271 | ) | (295 | ) | (1,098 | ) | |||
| Repayment of long-term loans | (1,111 | ) | (16 | ) | (2,628 | ) | |||
| Repayment of other long-term liabilities | (1,500 | ) | (1,500 | ) | (5,626 | ) | |||
| Net cash provided by (used in) financing activities | (2,881 | ) | (1,808 | ) | (9,343 | ) | |||
| Exchange differences on balances of cash and cash equivalent | (312 | ) | 236 | 212 | |||||
| Increase (decrease) in cash and cash equivalents | (7,137 | ) | 3,380 | 15,671 | |||||
| Cash and cash equivalents at the beginning of the period | 34,258 | 18,587 | 18,587 | ||||||
| Cash and cash equivalents at the end of the period | $ | 27,121 | 21,967 | $ | 34,258 | ||||
| Significant non-cash transactions | |||||||||
| Right-of-use asset recognized with corresponding lease liability | $ | 3,580 | 174 | $ | 551 | ||||
| Purchase of property and equipment and Intangible assets | $ | 292 | 254 | $ | 618 |
8
NON-IFRS MEASURES
| Three months period ended | Year ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| March 31, | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| In thousands | |||||||||
| Net income | $ | (1,809 | ) | $ | (1,828 | ) | $ | (2,321 | ) |
| Taxes on income | 13 | 41 | 62 | ||||||
| Financial expense (income), net | 2,085 | 2,033 | 6,791 | ||||||
| Depreciation and amortization expense | 3,123 | 2,886 | 12,155 | ||||||
| Non-cash share-based compensation expenses | 415 | 155 | 1,153 | ||||||
| Adjusted EBITDA | $ | 3,827 | $ | 3,286 | $ | 17,840 |
9
Exhibit 99.2
INVESTORS MEETING NASDAQ & TASE: KMDA May 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, the information on the slide titled : “Company’s Growth Catalysts Driving Financial Results,” projected future royalties from Takeda for Glassia, 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 / May 2023
6 FDA approved products ; global commercial network selling in over 30 countries 2023 revenues guidance of $138M - $146M; EBITDA of $22M - $26M; rapidly growing; positive cash - flow; strong balance sheet Multiple growth drivers with limited downside ri sk and significant upside potential KAMADA HIGHLIGHTS 6 3 Kamada is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions The company is a leader in the specialty plasma - derived field focused on diseases of limited treatment alternatives The company is advancing an innovative development pipeline targeting areas of significant unmet medical need Kamada / May 2023
FINANCIAL GROWTH TRAJECTORY Adjusted EBITDA is defined as net income, plus (i) tax expense, (ii) financial income (expense), net, (iii) depreciation and amortization ; and (v) non - cash share - based compensation expenses 4 104 129 138 - 146 2021 2022 2023 Revenues US$M 6 18 22 - 26 2021 2022 2023 EBITDA US$M 2023 represents annual guidance 2023 represents annual guidance Kamada / May 2023 Solid First Quarter Results and Expected Continued Momentum Anticipated to Drive Full - Year 2023 EBITDA Growth of Over 30% Year - over - Year
$60M STRATEGIC INVESTMENT BY FIMI 5 Kamada / May 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 6 Kamada / May 2023 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 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) VARIZIG® [Varicella Zoster Immune Globulin (Human)] Post - exposure prophylaxis of varicella in high - risk patient groups
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 / May 2023
• Non - Invasive, at - home treatment. Expected better ease of use and quality of life for AATD patients than current IV SOC • 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 • Demonstrated positive effect on lung function (FEV 1 ) decline in a previous placebo - controlled study • Only 1 / 8 th of the IV AAT dosing, more cost - effective ; Favorable market access landscape • The leading new innovative AATD treatment in advanced clinical stage (Ph - 3 ) • Enrolled 60 patients to date (May 2023 ) • Substantial opportunity in over a $ 1 billion market 8 Kamada / March 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 INHALED AAT PHASE 3 PIVOTAL STUDY
Q1 SUMMARY OF FINANCIAL DATA Details Q1/2023 Q1/ 20 22 US $ M 24.1 23.0 PROPRIETARY 6.6 5.1 DISTRIBUTION 9% YoY increase. 30.7 28.1 TOTAL REVENUES 11.8 11.3 GROSS PROFIT 39% 40 % GROSS MARGIN (11.6) ( 11.1 ) OPEX Amortization ($1.8M) & finance costs on LT liabilities ($1.8) (1.8) (1.8) NET PROFIT 16% YoY increase (Exc. excess severance EBITDA - $4.4M (33% YoY) 3.8 3.3 EBITDA 27 22 CASH Including acquisition related intangible assets ($141.5M) 317 304 ASSETS 5 - year term loan (16) (20) BANK LOAN Acquisition related contingent liabilities (85) (84) CONTINGENT LIABILITIES (175) (175) EQUITY 9 Kamada / May 2023 16% increase in EBITDA compared to Q1/2022
KAMADA INVESTMENT HIGHLIGHTS 10 Kamada / May 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
May 202 3 THANK YOU WWW.KAMADA.COM
Exhibit 99.3
KAMADA LTD.
CONSOLIDATED FINANCIAL STATEMENTS
AS OF MARCH 31, 2023
TABLE OF CONTENTS
| Page | |
|---|---|
| Consolidated Statements of Financial Position | 1 |
| Consolidated Statements of Profit or Loss and Other<br> Comprehensive Income | 2 |
| Consolidated Statements of Changes in Equity | 3-4 |
| Consolidated Statements of Cash Flows | 5-6 |
| Notes to the Interim Consolidated Financial Statements | 7-13 |
i
KAMADA LTD.
CONSOLIDATEDSTATEMENTS OF FINANCIAL POSITION
| As of | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| As of March 31, | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Unaudited | Audited | ||||||||
| Assets | |||||||||
| Current Assets | |||||||||
| Cash and cash equivalents | $ | 27,121 | 21,967 | $ | 34,258 | ||||
| Trade receivables, net | 20,925 | 21,568 | 27,252 | ||||||
| Other accounts receivables | 3,603 | 7,867 | 8,710 | ||||||
| Inventories | 79,754 | 64,761 | 68,785 | ||||||
| Total Current Assets | 131,403 | 116,163 | 139,005 | ||||||
| Non-Current Assets | |||||||||
| Property, plant and equipment, net | 26,496 | 26,098 | 26,157 | ||||||
| Right-of-use assets | 5,836 | 2,990 | 2,568 | ||||||
| Intangible assets, Goodwill and other long-term assets | 145,305 | 151,858 | 147,072 | ||||||
| Contract assets | 7,755 | 5,987 | 7,577 | ||||||
| Total Non-Current Assets | 185,392 | 186,933 | 183,374 | ||||||
| Total Assets | 316,795 | 303,096 | $ | 322,379 | |||||
| Liabilities | |||||||||
| Current Liabilities | |||||||||
| Current maturities of bank loans | $ | 4,444 | 3,725 | $ | 4,444 | ||||
| Current maturities of lease liabilities | 1,438 | 1,017 | 1,016 | ||||||
| Current maturities of other long term liabilities | 29,414 | 19,095 | 29,708 | ||||||
| Trade payables | 26,210 | 11,682 | 32,917 | ||||||
| Other accounts payables | 7,350 | 6,670 | 7,585 | ||||||
| Deferred revenues | 419 | 40 | 35 | ||||||
| Total Current Liabilities | 69,275 | 42,229 | 75,705 | ||||||
| Non-Current Liabilities | |||||||||
| Bank loans | 11,852 | 16,296 | 12,963 | ||||||
| Lease liabilities | 4,992 | 3,056 | 2,177 | ||||||
| Contingent consideration | 18,115 | 22,551 | 17,534 | ||||||
| Other long-term liabilities | 37,280 | 42,531 | 37,308 | ||||||
| Deferred revenues | - | 15 | - | ||||||
| Employee benefit liabilities, net | 473 | 1,268 | 672 | ||||||
| Total Non-Current Liabilities | 72,712 | 85,717 | 70,654 | ||||||
| Shareholder’s Equity | |||||||||
| Ordinary shares | 11,736 | 11,728 | 11,734 | ||||||
| Additional paid in capital net | 210,665 | 210,269 | 210,495 | ||||||
| Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | (3,490 | ) | |||
| Capital reserve from hedges | (99 | ) | 12 | (88 | ) | ||||
| Capital reserve from share-based payments | 5,750 | 4,771 | 5,505 | ||||||
| Capital reserve from employee benefits | 539 | (149 | ) | 348 | |||||
| Accumulated deficit | (50,293 | ) | (47,991 | ) | (48484 | ) | |||
| Total Shareholder’s Equity | 174,808 | 175,150 | 176,020 | ||||||
| Total Liabilities and Shareholder’s Equity | $ | 316,795 | 303,096 | $ | 322,379 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
1
KAMADA LTD.
CONSOLIDATEDSTATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
| Three months period ended | Year ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| March 31, | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Unaudited | Audited | ||||||||
| Revenues from proprietary products | 24,061 | 23,011 | $ | 102,598 | |||||
| Revenues from distribution | 6,649 | 5,082 | 26,741 | ||||||
| Total revenues | 30,710 | 28,093 | 129,339 | ||||||
| Cost of revenues from proprietary products | 13,224 | 12,449 | 58,229 | ||||||
| Cost of revenues from distribution | 5,647 | 4,342 | 24,407 | ||||||
| Total cost of revenues | 18,871 | 16,791 | 82,636 | ||||||
| Gross profit | 11,839 | 11,302 | 46,703 | ||||||
| Research and development expenses | 3,231 | 4,420 | 13,172 | ||||||
| Selling and marketing expenses | 3,922 | 3,321 | 15,284 | ||||||
| General and administrative expenses | 3,418 | 3,005 | 12,803 | ||||||
| Other expenses | 979 | 310 | 912 | ||||||
| Operating income (loss) | 289 | 246 | 4,532 | ||||||
| Financial income | 25 | 2 | 91 | ||||||
| Income (expense) in respect of securities measured at fair value, net | - | - | - | ||||||
| Income (expenses) in respect of currency exchange differences and derivatives instruments, net | 151 | 169 | 298 | ||||||
| Revaluation of long-term liabilities | (1,761 | ) | (2,010 | ) | (6,266 | ) | |||
| Financial expenses | (500 | ) | (194 | ) | (914 | ) | |||
| Income before tax on income | (1,796 | ) | (1,787 | ) | (2,259 | ) | |||
| Taxes on income | 13 | 41 | 62 | ||||||
| Net Income (loss) | $ | (1,809 | ) | (1,828 | ) | $ | (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) from securities measured at fair value through other comprehensive income | |||||||||
| Gain (loss) on cash flow hedges | (156 | ) | (108 | ) | (776 | ) | |||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | 145 | 66 | 634 | ||||||
| Items that will not be reclassified to profit or loss in subsequent periods: | |||||||||
| Remeasurement gain (loss) from defined benefit plan | 191 | - | 497 | ||||||
| Tax effect | - | - | - | ||||||
| Total comprehensive income (loss) | $ | (1,629 | ) | (1,870 | ) | $ | (1,966 | ) | |
| Earnings per share attributable to equity holders of the Company: | |||||||||
| Basic net earnings per share | (0.04 | ) | (0.04 | ) | $ | (0.05 | ) | ||
| Diluted net earnings per share | (0.04 | ) | (0.04 | ) | $ | (0.05 | ) |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
2
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CHANGESIN EQUITY
| Additional | Capital<br><br> reserve<br> due to<br><br> translation to | Capital reserve | Capital reserve from | Capital reserve from | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Share | paid in | presentation | from | sharebased | employee | Accumulated | Total | ||||||||||||||
| capital | capital | currency | hedges | payments | benefits | deficit | equity | ||||||||||||||
| Unaudited | |||||||||||||||||||||
| 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 | - | - | - | - | - | - | (1,809 | ) | (1,809 | ) | |||||||||||
| Other comprehensive income (loss) | - | - | - | (11 | ) | - | 191 | - | 180 | ||||||||||||
| Total comprehensive income (loss) | - | - | - | (11 | ) | - | 191 | (1,809 | ) | (1,629 | ) | ||||||||||
| Exercise and forfeiture of share-based payment into shares | 2 | 170 | (170 | ) | 2 | ||||||||||||||||
| Cost of share-based payment | 415 | 415 | |||||||||||||||||||
| Balance as of March 31, 2023 | $ | 11,736 | $ | 210,665 | $ | (3,490 | ) | $ | (99 | ) | $ | 5,750 | $ | 539 | $ | (50,293 | ) | $ | 174,808 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
3
KAMADA LTD.
CONSOLIDATED STATEMENTS OF CHANGESIN EQUITY
| Share<br><br> capital | Additional<br><br> paid in<br><br> capital | Capital reserve<br><br> through<br><br> other<br><br> presentation<br><br> currency | Capital<br><br> reserve<br><br> due to<br><br> translation to<br><br> from<br><br> hedges | Capital<br><br> reserve<br><br> from<br><br> sharebased<br><br> payments | Capital<br><br> reserve<br><br> from<br><br> employee<br><br> benefits | Accumulated<br><br> deficit | Total equity | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unaudited | **** | |||||||||||||||||||||
| **** | In thousands | |||||||||||||||||||||
| Balance as of January 1, 2022 (audited) | $ | 11,725 | $ | 210,204 | $ | (3,490 | ) | $ | 54 | $ | 4,643 | $ | (149 | ) | $ | (46,163 | ) | $ | 176,824 | |||
| Net income | - | - | - | - | - | - | (1,828 | ) | (1,828 | ) | ||||||||||||
| Other comprehensive income (loss) | - | - | - | (42 | ) | - | - | - | (42 | ) | ||||||||||||
| Total comprehensive income (loss) | - | - | - | (42 | ) | - | - | (1,828 | ) | (1,870 | ) | |||||||||||
| Exercise and forfeiture of share-based payment into shares | 3 | 65 | - | (65 | ) | - | 3 | |||||||||||||||
| Cost of share-based payment | - | 193 | - | 193 | ||||||||||||||||||
| Balance as of March 31, 2022 | $ | 11,728 | $ | 210,269 | $ | (3,490 | ) | $ | 12 | $ | 4,771 | $ | (149 | ) | $ | (47,991 | ) | $ | 175,150 | |||
| Share<br><br> capital | Additional<br><br> paid in<br><br> capital | Capital reserve<br><br> through<br><br> other<br><br> presentation<br><br> currency | Capital<br><br> reserve<br><br> due to<br><br> translation to<br><br> from<br><br> hedges | Capital<br><br> reserve<br><br> from<br><br> sharebased<br><br> payments | Capital<br><br> reserve<br><br> from<br><br> employee<br><br> benefits | Accumulated<br><br> deficit | Total<br><br> equity | |||||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Unaudited | **** | |||||||||||||||||||||
| **** | In thousands | |||||||||||||||||||||
| Balance as of January 1, 2022 (audited) | $ | 11,725 | $ | 210,204 | $ | (3,490 | ) | $ | 54 | $ | 4,643 | $ | (149 | ) | $ | (46,163 | ) | $ | 176,824 | |||
| Net income | - | - | - | - | - | - | (2,321 | ) | (2,321 | ) | ||||||||||||
| Other comprehensive income (loss) | - | - | - | (142 | ) | - | 497 | - | 355 | |||||||||||||
| 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.
4
KAMADA LTD.
CONSOLIDATEDSTATEMENTS OF CASH FLOWS
| Three months period Ended | Year Ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| March, 31 | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Audited | |||||||||
| Cash Flows from Operating Activities | |||||||||
| Net income (loss) | $ | (1,809 | ) | (1,828 | ) | $ | (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 | 3,123 | 3,027 | 12,155 | ||||||
| Financial expenses (income), net | 2,085 | 2,033 | 6,791 | ||||||
| Cost of share-based payment | 415 | 193 | 1,153 | ||||||
| Taxes on income | 13 | 41 | 62 | ||||||
| Loss (gain) from sale of property and equipment | (22 | ) | - | - | |||||
| Change in employee benefit liabilities, net | (8 | ) | (12 | ) | (111 | ) | |||
| 5,606 | 5,282 | 20,050 | |||||||
| Changes in asset and liability items: | |||||||||
| Decrease (increase) in trade receivables, net | 6,306 | 13,492 | 7,603 | ||||||
| Decrease (increase) in other accounts receivables | 1,362 | 589 | (578 | ) | |||||
| Decrease (increase) in inventories | (10,970 | ) | 2,662 | (1,361 | ) | ||||
| Decrease (increase) in deferred expenses | 3,554 | (110 | ) | (1,340 | ) | ||||
| Increase (decrease) in trade payables | (6,712 | ) | (13,649 | ) | 7,055 | ||||
| Increase (decrease) in other accounts payables | (238 | ) | (772 | ) | 290 | ||||
| Decrease in deferred revenues | 384 | - | (20 | ) | |||||
| (6,314 | ) | 2,212 | 11,649 | ||||||
| Cash received (paid) during the period for: | |||||||||
| Interest paid | (341 | ) | (194 | ) | (853 | ) | |||
| Interest received | 25 | 2 | 97 | ||||||
| Taxes paid | (18 | ) | (9 | ) | (36 | ) | |||
| (334 | ) | (201 | ) | (792 | ) | ||||
| Net cash provided by (used in) operating activities | $ | (2,851 | ) | 5,465 | $ | 28,586 |
5
KAMADA LTD.
CONSOLIDATEDSTATEMENTS OF CASH FLOWS
| Three months period Ended | Year Ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| March, 31 | December 31, | ||||||||
| 2023 | 2022 | 2022 | |||||||
| Audited | |||||||||
| Cash Flows from Investing Activities | |||||||||
| Purchase of property and equipment and intangible assets | (1,117 | ) | (513 | ) | (3,784 | ) | |||
| Proceeds from sale of property and equipment | 24 | - | - | ||||||
| Business combination | - | - | - | ||||||
| Net cash provided by (used in) investing activities | (1,093 | ) | (513 | ) | (3,784 | ) | |||
| Cash Flows from Financing Activities | |||||||||
| Proceeds from exercise of share base payments | 1 | 3 | 9 | ||||||
| Receipt of long-term loans | - | - | - | ||||||
| Repayment of lease liabilities | (271 | ) | (295 | ) | (1,098 | ) | |||
| Repayment of long-term loans | (1,111 | ) | (16 | ) | (2,628 | ) | |||
| Repayment of other long-term liabilities | (1,500 | ) | (1,500 | ) | (5,626 | ) | |||
| Net cash provided by (used in) financing activities | (2,881 | ) | (1,808 | ) | (9,343 | ) | |||
| Exchange differences on balances of cash and cash equivalent | (312 | ) | 236 | 212 | |||||
| Increase (decrease) in cash and cash equivalents | (7,137 | ) | 3,380 | 15,671 | |||||
| Cash and cash equivalents at the beginning of the period | 34,258 | 18,587 | 18,587 | ||||||
| Cash and cash equivalents at the end of the period | $ | 27,121 | 21,967 | $ | 34,258 | ||||
| Significant non-cash transactions | |||||||||
| Right-of-use asset recognized with corresponding lease liability | $ | 3,580 | 174 | $ | 551 | ||||
| Purchase of property and equipment and Intangible assets | $ | 292 | 254 | $ | 618 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
6
KAMADA LTD.
NOTES TOCONSOLIDATED 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, the 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 and 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 (“IL MOH”) approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas that it acquired in March 2021, 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. The Company has additional product candidates in early development stage.
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.
The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited (“Takeda”). Historically, the Company generated revenues on sales of GLASSIA, manufactured by the Company, to Takeda for further distribution in the United States. In accordance with the agreement with Takeda, the Company ceased the production and sale of GLASSIA to Takeda during 2021, and during the first quarter of 2022, Takeda began to pay the Company royalties on sales of GLASSIA manufactured by Takeda, at a rate of 12% on net sales through August 2025 and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually for each of the years from 2022 to 2040. Refer to Note 19 in our annual Financial report for further details on the engagement with Takeda.
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KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 2:- Significant Accounting Policies
| a. | Basis<br>of preparation of the interim consolidated financial statements: |
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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. | Disclosure of New Standards in the Period Prior to Their Adoption: |
|---|---|
| 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.
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KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 3:- Significant events in the reporting period
| i. | Grant of Option to employees and executive officers |
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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:
| - | On February 27, 2023, 60,333 options to purchase the ordinary shares of the Company, at an exercise price of NIS 16.53 (USD 4.50) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $108 thousands. |
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| - | On March 01, 2023 3,333 options to purchase ordinary shares of the Company, at an exercise price of NIS 16.63 (USD 4.57) per share. The fair value of the options was estimated on the date of grant at $5.7 thousands. |
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| - | On March 02, 2023 40,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 16.76 (USD 4.60) per share. The fair value of the options was estimated on the date of grant at $71 thousands. |
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| - | On April 23, 2023 40,000 options to purchase ordinary shares of the Company, at an exercise price of NIS 17.67 (USD 4.83) per share. The fair value of the options was estimated on the date of grant at $65 thousands. |
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Under the US Appendix:
| - | On February 27, 2023 3,333 options to purchase the ordinary shares of the Company, at an exercise price of USD 4.57 per share. The fair value of the options was estimated on the date of grant was estimated at $5.80 thousands. |
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KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 4:- Operating Segments
| a. | General: |
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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<br> Products | Distribution | Total | |||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Three months period ended March 31, 2023 | |||||||
| Revenues | $ | 24,061 | $ | 6,649 | $ | 30,710 | |
| Gross profit | $ | 10,837 | $ | 1,002 | $ | 11,839 | |
| Unallocated corporate expenses | (11,550 | ) | |||||
| Finance expenses, net | (2,085 | ) | |||||
| Income before taxes on income | $ | (1,796 | ) | ||||
| Proprietary<br> Products | Distribution | Total | |||||
| --- | --- | --- | --- | --- | --- | --- | --- |
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Three months period ended March 31, 2022 | |||||||
| Revenues | $ | 23,011 | $ | 5,082 | $ | 28,093 | |
| Gross profit | $ | 10,562 | $ | 740 | $ | 11,302 | |
| Unallocated corporate expenses | (11,056 | ) | |||||
| Finance expenses, net | (2,033 | ) | |||||
| Income before taxes on income | $ | (1,787 | ) |
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KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 4:- Operating Segments (cont.)
| b. | Reporting on operating segments: | ||||||
|---|---|---|---|---|---|---|---|
| Proprietary<br> 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: |
|---|
| Three months period ended <br> March 31, 2023 | ||||||
|---|---|---|---|---|---|---|
| Proprietary<br> Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America | $ | 16,830 | $ | - | $ | 16,830 |
| Israel | 994 | 6,649 | 7,643 | |||
| Europe | 3,334 | - | 3,334 | |||
| Latin America | 1,316 | - | 1,316 | |||
| Asia | 1,550 | - | 1,550 | |||
| Others | 38 | - | 38 | |||
| $ | 24,061 | $ | 6,649 | $ | 30,710 |
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KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 4:-Operating Segments (cont.)
| c. | Reporting on operating segments by geographic region: | |||||
|---|---|---|---|---|---|---|
| Three months period ended <br> March 31, 2022 | ||||||
| --- | --- | --- | --- | --- | --- | --- |
| Proprietary<br> Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America. | $ | 16,951 | $ | - | $ | 16,951 |
| Israel | 1,627 | 5,082 | 6,709 | |||
| Europe | 1,052 | - | 1,052 | |||
| Latin America | 2,030 | - | 2,030 | |||
| Asia | 984 | - | 984 | |||
| Others | 367 | - | 367 | |||
| $ | 23,011 | $ | 5,082 | $ | 28,093 |
| Year ended December 31, 2022 | ||||||
|---|---|---|---|---|---|---|
| Proprietary<br> 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 |
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KAMADA LTD.
NOTES TOCONSOLIDATED FINANCIAL STATEMENTS
Note 5:- Financial Instruments
| a. | Classification of financial instruments by fair value hierarchy |
|---|
Financial assets (liabilities) measured at fair value
| Level 1 | Level 2 | Level 3 | |||||
|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||
| March 31, 2023 | |||||||
| Derivatives instruments | $ | - | ) | $ | - | ||
| Contingent consideration | - | (24,115 | ) | ||||
| March 31, 2022 | |||||||
| Derivatives instruments | |||||||
| Contingent consideration | $ | - | $ | (22,251 | ) | ||
| December 31, 2022 | |||||||
| Derivatives instruments | $ | - | ) | $ | - | ||
| Contingent consideration | $ | - | $ | (23,534 | ) |
All values are in US Dollars.
During the three months ended on March 31, 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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