Foreign Filer Report • May 24, 2023
Foreign Filer Report
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For the Month of May 2023
Commission File Number 001-35948
Kamada Ltd. (Translation of registrant's name into English)
2 Holzman Street Science Park, P.O. Box 4081 Rehovot 7670402 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
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.
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____
This Form 6-K is being incorporated by reference into the Registrant's Form S-8 Registration Statements, File Nos. 333-192720, 333- 207933, 333-215983, 333-222891, 333-233267 and 333-265866.
The following exhibit is attached:
| 99.1 | Kamada Reports Strong 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) |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 24, 2023 KAMADA LTD.
By: /s/ Nir Livneh
Nir Livneh Vice President General Counsel and Corporate Secretary
| 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) |
REHOVOT, Israel, and Hoboken, NJ – May 24, 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 plasmaderived 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.
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.

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.
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.
We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company's core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain other costs.
Kamada Ltd. (the "Company") is a 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.
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.
[email protected] Brian Ritchie
LifeSci Advisors, LLC 212-915-2578 [email protected]
| 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 |
As of | |||||
|---|---|---|---|---|---|---|
| As of March 31, | December 31, | |||||
| Three months period ended March 31, |
Year ended December 31, 2022 Audited |
|||
|---|---|---|---|---|
| 2023 | ||||
| Unaudited | ||||
| 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) |
| Three months period Ended March, 31 |
Year Ended 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 |
|
| Three months period Ended March, 31 |
Year Ended 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 |
| Three months period ended March 31, |
Year ended 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 |

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 clinica l 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: °'Companys 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 re lating to Kamada's ability to successfully develop and commercial ize its products and product candidates, the progress and results of any clinical trials, the introduction of competing products, the contin ued marke t acceptance of Kamada ' s commercia l p roducts portfo l io, 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 st rate g i es , environmental risks, changes in the worldwide pharmaceutical industry and other factors that are discussed under the heading "Risk Factors" of Kamada 's 2022 Annual Report on Form 20-F (filed on March 15, 2023) as well as in Kamada's recent Forms 6-K filed with the U.S. Securities and Exchange Commission.
This presentation includes certain non-lFRS 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-lFRS financial measu res 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 reconcil iation of these non-lFRS financial measures to the comparable IFRS measures is included in an appendix to this presentation. Management uses these non-lFRS financial measures for financial and operational decisionmaking and as a means to evaluate period-to-period comparisons. Management believes that these non-lFRS 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 wel l as the risks and uncertainties more fully discussed under the headi ng "Risk Factors" of Kamada's 2022 Annual Report on Form 20-F (filed on March 15, 2023) as well as in Kama da's recent Forms 6-K filed with the U.S. Securities and Exchange Commission.
2
Kamada/ May 2023


Adjusted EB ITDA is defined as net income, plus (0 tax expense, (ii) financial income (expense), net, (iii) depreciation and amortization; and (v) non-cash share-based compensation expenses
Kamada/ May 2023

• Announcing a strategic share purchase agreement with FIMI Opportunity Funds, the leading private equity firm in Israel and an existing significant Kamada shareholder to purchase \$60 million of the Company ordinary's shares in a private placement

Kamada/ May 2023 5


[Cytomegalovirus Immune Globulin Intravenous (Human)] Prophylaxis of cytomegalovirus disease associated with transplantation

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

[Varicella Zoster Immune Globulin (Human)] Post-exposure prophylaxis of varicella in high- risk patient groups
| 11 | ||
|---|---|---|
| 6 | The Business NATER 43 |
|
| 11.0 | ||
[Rabies Immune Globulin (Human)] Post exposure prophylaxis of rabies infection
| 1 | 1000 Pro CA OFFERE |
|
|---|---|---|
[Hepatitis B Immune Globulin (Human)] Prevention of HBV recurrence fol lowing liver transplantation

[Alpha1 -Proteinase Inhibitor (Human)] Augmentation therapy for Alpha-1 Antitrypsi n Deficiency (AA TD)
6
Kamada/ May 2023

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

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

Kamada / May 2023
® KAMADA
May 2023
| US \$ M | Ql/2022 Ql/2023 | Details | |
|---|---|---|---|
| PROPRIETARY | 23 .0 | 24.1 | |
| DISTRIBUTION | 5.1 | 6.6 | |
| TOTAL REVENUES | 28.1 | 30.7 | 9% YoY increase. |
| GROSS PROFIT | 11.3 | 11.8 | |
| GROSS MARGIN | 40% | 39% | |
| OPEX | (11.1) | (11 .6) | |
| NET PROFIT | (1.8) | (1.8) | Amortization (\$1.8M) & finance costs on LT liabilities (\$1.8) |
| EBITDA | 3.3 | 3.8 | 16% YoY increase (Exe. excess severance EBITDA- \$4.4M (33% YoY) |
| CASH | 22 | 27 | |
| ASSETS | 304 | 31 7 | Including acquisition related intangible assets (\$ 141 .SM) |
| BANK LOAN | (20) | (16) | 5-year term loan |
| CONTINGENT LIABILITIES | (84) | (85) | Acquisition related contingent liabilities |
| EQUITY | (175) | (175) | 9 |
Kamada/ May 2023
Page
| Consolidated Statements of Financial Position | 1 |
|---|---|
| Consolidated Statements of Profit or Loss and Other Comprehensive Income | 2 |
| Consolidated Statements of Changes in Equity | 3-4 |
| Consolidated Statements of Cash Flows | 5-6 |
| Notes to the Interim Consolidated Financial Statements | 7-13 |
i
| As of March 31, | As of 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.
| Three months period ended March 31, |
Year ended 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 Cost of revenues from distribution |
13,224 5,647 |
12,449 4,342 |
58,229 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.
| Share capital |
Additional paid in capital |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|
|---|---|---|---|---|---|---|---|---|
| Unaudited | ||||||||
| In thousands | ||||||||
| Balance as of 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.
| Share capital |
Additional paid in capital |
Capital reserve through other presentation currency |
Capital reserve due to translation to from hedges Unaudited |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|
|---|---|---|---|---|---|---|---|---|
| In thousands | ||||||||
| Balance as of January 1, 2022 (audited) Net income Other comprehensive |
\$ 11,725 - |
\$ 210,204 - |
\$ (3,490) \$ - |
54 - |
\$ 4,643 - |
\$ (149) \$ - |
(1,828) | (46,163) \$ 176,824 (1,828) |
| 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 capital |
Additional paid in capital |
Capital reserve through other presentation currency |
Capital reserve due to translation to from hedges Unaudited |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|
| In thousands | ||||||||
| Balance as of January 1, 2022 (audited) Net income |
\$ 11,725 - |
\$ 210,204 - |
\$ (3,490) \$ - |
54 - |
\$ 4,643 - |
\$ (149) \$ - |
(2,321) | (46,163) \$ 176,824 (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.
| Three months period Ended March, 31 |
Year Ended 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 |
| Three months period Ended March, 31 |
||||
|---|---|---|---|---|
| 2023 | 2022 | December 31, 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.
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 plasmaderived 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.
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".
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.
i. Grant of Option to employees and executive officers
On February 27, 2023, the Company's Board of Directors approved the grant of options to purchase up to 147,000 options to purchase ordinary shares of the Company under the 2011 Plan and the US Appendix. The Company granted, out of the above mentioned, to employees and executive officers the following:
Under the Israeli Share Option Plan:
Under the US Appendix:
a. General:
The company has two operating segments, as follows:
| Proprietary | ||||||||
|---|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||||
| U.S Dollars in thousands | ||||||||
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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) |
b. Reporting on operating segments:
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Audited | |||||||
| Year Ended December 31, 2022 | |||||||
| Revenues | \$ | 102,598 | \$ 26,741 |
\$ | 129,339 | ||
| Gross profit | \$ | 44,369 | \$ 2,334 |
\$ | 46,703 | ||
| Unallocated corporate expenses | (42,171) | ||||||
| Finance expenses, net | (6,791) | ||||||
| Income before taxes on income | \$ | (2,259) |
| Three months period ended March 31, 2023 |
|||||
|---|---|---|---|---|---|
| Proprietary 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 |
c. Reporting on operating segments by geographic region:
| Three months period ended March 31, 2022 |
||||||
|---|---|---|---|---|---|---|
| Proprietary Products |
Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Geographical markets | ||||||
| U.S.A and North America. | \$ 16,951 |
\$ | - | \$ | 16,951 | |
| Israel | 1,627 | 5,082 | 6,709 | |||
| Europe | 1,052 | - | 1,052 | |||
| Latin America | 2,030 | - | 2,030 | |||
| Asia | 984 | - | 984 | |||
| Others | 367 | - | 367 | |||
| \$ 23,011 |
\$ | 5,082 | \$ | 28,093 | ||
| Year ended December 31, 2022 | |||||
|---|---|---|---|---|---|
| Proprietary Products |
Distribution U.S Dollars in thousands |
Total | |||
| Audited | |||||
| Geographical markets | |||||
| U.S.A and North America | \$ 75,851 |
\$ | - | \$ | 75,851 |
| Israel | 5,290 | 26,741 | 32,031 | ||
| Europe | 5,277 | - | 5,277 | ||
| Latin America | 11,293 | - | 11,293 | ||
| Asia | 4,581 | - | 4,581 | ||
| Others | 305 | - | 305 | ||
| \$ 102,597 |
\$ | 26,741 | \$ | 129,338 |
| Level 1 | Level 2 | Level 3 | |||
|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||
| March 31, 2023 | |||||
| Derivatives instruments | \$ - |
\$ (91) |
\$ - |
||
| Contingent consideration | - | - | (24,115) | ||
| March 31, 2022 | |||||
| Derivatives instruments | (51) | ||||
| Contingent consideration | \$ - |
\$ | \$ (22,251) |
||
| December 31, 2022 | |||||
| - | |||||
| Contingent consideration | \$ - |
\$ - |
\$ (23,534) |
||
| Derivatives instruments | \$ - |
\$ (92) |
\$ |
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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