Foreign Filer Report • May 18, 2020
Foreign Filer Report
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For the Month of May 2020
Commission File Number 001-35948
Kamada Ltd. (Translation of registrant's name into English)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____
This Form 6-K is being incorporated by reference into the Registrant's Form S-8 Registration Statements, File Nos. 333-192720, 333-207933, 333-215983, 333-222891 and 333-233267, and the Registrant's Form F-3 Registration Statement, as amended, File No. 333-214816.
The following exhibit is attached:
99.1 Press Release: Kamada Reports First Quarter 2020 Financial Results and Highlights Recent Corporate Progress 99.2 Kamada Ltd.'s Consolidated Financial Statements as of March 31, 2020 (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 18, 2020 KAMADA LTD.
By: /s/ Orna Naveh
Orna Naveh General Counsel and Corporate Secretary
| 99.1 | Press Release: Kamada Reports First Quarter 2020 Financial Results and Highlights Recent Corporate Progress |
|---|---|
| 99.2 | Kamada Ltd.'s Consolidated Financial Statements as of March 31, 2020 (Unaudited) |
REHOVOT, Israel – May 18, 2020 — Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three months ended March 31, 2020.
"As the ongoing COVID-19 global pandemic continues to create substantial complications in daily life and business operations, we are focused on the safety and well-being of our employees, who continue to find innovative solutions to support our patients and partners," said Amir London, Kamada's Chief Executive Officer. "These efforts contributed to our strong performance in the first quarter of the year. Total revenues were \$33.3 million, an increase of 24 percent year-over-year. These results were driven by similar year-over year increase in sales of both our Proprietary and Distributed products. Based on our strong performance in the first quarter and our current outlook for the remainder of the year, we are reiterating our guidance of total revenues of between \$132 million and \$137 million for full-year 2020."
"To date, our manufacturing plant remains operational with no effect on business continuity, even amidst the emergency regulations enforced in Israel in recent months due to the COVID-19 pandemic. Moreover, based on the most recent interactions with our U.S. distribution partners regarding finished product inventory levels available for distribution in the U.S and our planned supply for the remainder of the year, we do not anticipate meaningful supply shortages in the foreseeable future in the U.S. market for GLASSIA® or KEDRAB®. In addition, based on currently available inventory levels and planned supply of our Distributed products in Israel, we do not anticipate significant supply shortages in the foreseeable future. Going forward, although certain COVID-19 pandemic-related dynamics may affect market demand and production conditions, we intend to maintain our current manufacturing and supply plans, and increased inventory levels of raw materials through our suppliers and service providers in order to appropriately manage any potential supply disruptions and secure continued manufacturing," continued Mr. London.
"As previously reported, during the first quarter, we were able to quickly focus our efforts on the development and manufacturing of a plasmaderived hyperimmune IgG product for COVID-19, which leverages our proprietary IgG platform technology, as a potential treatment for COVID-19 patients. We are pleased to report today that we have secured adequate quantities of COVID-19 convalescent plasma in Israel. This has enabled us to initiate manufacturing of the product, which is expected to be available by the end of the second quarter for compassionate use treatment in Israel, based on Israeli Ministry of Health (IMOH) regulations. Concurrently, we have ongoing discussions with the IMOH with regard to the potential initiation of related clinical trials. In addition, we were excited to recently announce our global collaboration with Kedrion Biopharma, which will allow us to more rapidly develop our plasma-derived hyperimmune IgG product for COVID-19 and broaden our international reach," concluded Mr. London.
As of March 31, 2020, the Company had cash, cash equivalents, and short-term investments of \$96.4 million, as compared to \$73.9 million at December 31, 2019. This includes the net proceeds generated from the \$25 million private placement transaction with the FIMI Opportunity Fund closed in February 2020.
Kamada management will host an investment community conference call on Monday, May 18, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), 1809 406 247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13699990. The call will also be webcast live on the Internet on the Company's website at www.kamada.com.
Kamada Ltd. ("the Company") is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasmaderived immune globulins. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection. The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding 1) the total revenues to be in the range of \$132 million to \$137 million for fiscal 2020; 2) not anticipating meaningful supply shortages in the foreseeable future in the U.S. market for GLASSIA® or KEDRAB®; 3) not anticipating significant supply shortages in the foreseeable future for Kamada's Distributed products in Israel; 4) anticipating maintaining current manufacturing and supply plans; 5) increasing inventory levels of raw materials through suppliers and service providers in order to appropriately manage any potential supply disruptions and secure continued manufacturing; 6) anticipating availability for clinical and compassionate-use treatment in Israel of a plasmaderived hyperimmune IgG product for COVID-19, from COVID-19 convalescent plasma, by the end of the second quarter of 2020; 7) anticipating that the global collaboration with Kedrion Biopharma will allow Kamada to speed up the development of the plasma-derived hyperimmune IgG product for COVID-19 and broaden the product's international reach; and 8) anticipating that Phase 3 InnovAATe clinical trial will resume enrollment in the third quarter of 2020. Forward-looking statements are based on Kamada's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the continued evolvement of the COVID-19 pandemic, its effect and duration, availability of sufficient raw materials required to maintain manufacturing plans, the effects of the COVID-19 pandemic and related government mandates on the availability of adequate levels of work-force required to maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international delivery routes, continued demand for Kamada's products, including GLASSIA and KEDRAB, in the U.S. market and its distributed products in Israel, ability to obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, unexpected results of clinical studies and on-going compassionate-use treatments, ability to find doctors and medical facilities to collaborate on compassionate-use treatments, 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. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Chaime Orlev Chief Financial Officer [email protected]
Bob Yedid LifeSci Advisors, LLC 646-597-6989 [email protected]
| As of March 31, | As of December 31, 2019 |
||||||
|---|---|---|---|---|---|---|---|
| 2020 2019 Unaudited |
|||||||
| Audited | |||||||
| U.S Dollars in thousands | |||||||
| Assets | |||||||
| Current Assets | |||||||
| Cash and cash equivalents | \$ | 49,288 | \$ | 22,037 | \$ | 42,662 | |
| Short-term investments | 47,124 | 33,800 | 31,245 | ||||
| Trade receivables, net | 26,266 | 23,210 | 23,210 | ||||
| Other accounts receivables | 1,736 | 3,442 | 3,272 | ||||
| Inventories | 41,787 | 31,708 | 43,173 | ||||
| Total Current Assets | 166,201 | 114,197 | 143,562 | ||||
| Non-Current Assets | |||||||
| Property, plant and equipment, net | 24,379 | 24,642 | 24,550 | ||||
| Right-of-use assets | 3,800 | 4,187 | 4,022 | ||||
| Other long term assets | 1,053 | 174 | 352 | ||||
| Deferred expenses | 421 | - | - | ||||
| Deferred taxes | 939 | 1,895 | 1,311 | ||||
| Total Non-Current Assets | 30,592 | 30,898 | 30,235 | ||||
| Total Assets | \$ | 196,793 | \$ | 145,095 | \$ | 173,797 | |
| Liabilities | |||||||
| Current Liabilities | |||||||
| Current maturities of bank loans | \$ | 465 | \$ | 470 | \$ | 489 | |
| Current maturities of lease liabilities | 928 | 961 | 1,020 | ||||
| Trade payables | 18,440 | 15,255 | 24,830 | ||||
| Other accounts payables | 4,875 | 4,424 | 5,811 | ||||
| Deferred revenues | 649 | 461 | 589 | ||||
| Total Current Liabilities | 25,357 | 21,571 | 32,739 | ||||
| Non-Current Liabilities | |||||||
| Bank loans | 138 | 591 | 257 | ||||
| Lease liabilities | 3,663 | 4,036 | 3,981 | ||||
| Deferred revenues | 569 | 605 | 232 | ||||
| Employee benefit liabilities, net | 1,251 | 823 | 1,269 | ||||
| Total Non-Current Liabilities | 5,621 | 6,055 | 5,739 | ||||
| Shareholder's Equity | |||||||
| Ordinary shares | 11,647 | 10,412 | 10,425 | ||||
| Additional paid in capital net | 204,702 | 179,352 | 180,819 | ||||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | ||||
| Capital reserve from hedges | 264 | 11 | 8 | ||||
| Capital reserve from financial assets measured at fair value through other comprehensive income |
- | 118 | 145 | ||||
| Capital reserve from share-based payments | 8,903 | 9,463 | 8,844 | ||||
| Capital reserve from employee benefits | (356) | 4 | (359) | ||||
| Accumulated deficit | (55,855) | (78,401) | (61,073) | ||||
| Total Shareholder's Equity | 165,815 | 117,469 | 135,319 | ||||
| Total Liabilities And Shareholder's Equity | \$ | 196,793 | \$ | 145,095 | \$ | 173,797 |
| Three months period ended March 31, |
Year ended December 31, |
||||||
|---|---|---|---|---|---|---|---|
| 2020 2019 |
2019 | ||||||
| Unaudited | Audited | ||||||
| U.S Dollars in thousands | |||||||
| Revenues from proprietary products | \$ | 25,317 | \$ | 20,381 | \$ | 97,696 | |
| Revenues from distribution | 7,973 | 6,416 | 29,491 | ||||
| Total revenues | 33,290 | 26,797 | 127,187 | ||||
| Cost of revenues from proprietary products | 14,947 | 10,490 | 52,425 | ||||
| Cost of revenues from distribution | 6,892 | 5,123 | 25,025 | ||||
| Total cost of revenues | 21,839 | 15,613 | 77,450 | ||||
| Gross profit | 11,451 | 11,184 | 49,737 | ||||
| Research and development expenses | 3,347 | 2,766 | 13,059 | ||||
| Selling and marketing expenses | 940 | 1,092 | 4,370 | ||||
| General and administrative expenses | 2,312 | 2,094 | 9,194 | ||||
| Other expense | 2 | 23 | 330 | ||||
| Operating income | 4,850 | 5,209 | 22,784 | ||||
| Financial income | 317 | 280 | 1,146 | ||||
| Income (expense) in respect of securities measured at fair value, net | 102 | (52) | (5) | ||||
| Income (expense) in respect of currency exchange differences and derivatives instruments, net | 432 | (313) | (651) | ||||
| Financial expense | (77) | (71) | (293) | ||||
| Income before tax on income | 5,624 | 5,053 | 22,981 | ||||
| Taxes on income | 406 | 130 | 730 | ||||
| Net Income | \$ | 5,218 | \$ | 4,923 | \$ | 22,251 | |
| 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 | (188) | 108 | 143 | ||||
| Gain on cash flow hedges | 241 | 74 | 92 | ||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | 34 | (2) | (23) | ||||
| Items that will not be reclassified to profit or loss in subsequent periods: | |||||||
| Remeasurement gain (loss) from defined benefit plan | - | - | (388) | ||||
| Tax effect | 27 | (28) | (11) | ||||
| Total comprehensive income | \$ | 5,332 | \$ | 5,075 | \$ | 22,064 | |
| Earnings per share attributable to equity holders of the Company: | |||||||
| Basic income per share | \$ | 0.12 | \$ | 0.12 | \$ | 0.55 | |
| Diluted income per share | \$ | 0.12 | \$ | 0.12 | \$ | 0.55 | |
| Three months period Ended March 31, |
Year Ended December 31, |
||||||
|---|---|---|---|---|---|---|---|
| 2020 2019 Unaudited |
2019 Audited |
||||||
| U.S Dollars in thousands | |||||||
| Net income | \$ | 5,218 | \$ | 4,923 | \$ | 22,251 | |
| Adjustments to reconcile net income to net cash provided by operating activities: | |||||||
| Adjustments to the profit or loss items: | |||||||
| Depreciation and impairment | 1,192 | 1,127 | 4,519 | ||||
| Financial expenses (income), net | (774) | 156 | (197) | ||||
| Cost of share-based payment | 258 | 315 | 1,163 | ||||
| Taxes on income | 406 | 130 | 730 | ||||
| Loss (gain) from sale of property and equipment | - | (6) | (2) | ||||
| Change in employee benefit liabilities, net | (18) | 36 | 94 | ||||
| 1,064 | 1,758 | 6,307 | |||||
| Changes in asset and liability items: | |||||||
| Decrease (increase) in trade receivables, net | (3,016) | 4,727 | 5,117 | ||||
| Decrease (increase) in other accounts receivables | 1,513 | 131 | (214) | ||||
| Decrease (increase) in inventories | 1,386 | (2,392) | (13,857) | ||||
| Decrease (increase) in deferred expenses | (421) | (246) | 399 | ||||
| Increase (decrease) in trade payables | (7,216) | (2,368) | 6,259 | ||||
| Increase (decrease) in other accounts payables | (1,180) | (510) | 863 | ||||
| Increase (decrease) in deferred revenues | 397 | (63) | (283) | ||||
| (8,537) | (721) | (1,716) | |||||
| Cash received (paid) during the year for: | |||||||
| Interest paid | (55) | (63) | (243) | ||||
| Interest received | 451 | 172 | 1,106 | ||||
| Taxes paid | (61) | (8) | (134) | ||||
| 335 | 101 | 729 | |||||
| Net cash provided by (used in) operating activities | \$ | (1,920) \$ | 6,061 | \$ | 27,571 |
| Three months period Ended March 31, |
|||||
|---|---|---|---|---|---|
| 2020 2019 |
2019 | ||||
| Unaudited | |||||
| U.S Dollars in thousands | |||||
| Cash Flows from Investing Activities | |||||
| Investment in short term investments, net | \$ (15,646) \$ |
(1,058) | \$ 1,727 |
||
| Purchase of property and equipment and intangible assets | (896) | (304) | (2,300) | ||
| Proceeds from sale of property and equipment | - | 6 | 9 | ||
| Net cash used in investing activities | (16,542) | (1,356) | (564) | ||
| Cash Flows from Financing Activities | |||||
| Proceeds from exercise of share base payments | 5 | 3 | 16 | ||
| Repayment of lease liabilities | (278) | (263) | (1,070) | ||
| Repayment of long-term loans | (123) | (115) | (476) | ||
| Proceeds from issuance of ordinary shares, net | 24,894 | - | - | ||
| Net cash provided by (used in) financing activities | 24,498 | (375) | (1,530) | ||
| Exchange differences on balances of cash and cash equivalent | 590 | (386) | (908) | ||
| Increase in cash and cash equivalents | 6,626 | 3,944 | 24,569 | ||
| Cash and cash equivalents at the beginning of the year | 42,662 | 18,093 | 18,093 | ||
| Cash and cash equivalents at the end of the year | \$ 49,288 \$ |
22,037 | \$ 42,662 |
||
| Significant non-cash transactions | |||||
| Purchase of property and equipment through capital lease | \$ 58 \$ |
4,431 | \$ 5,035 |
||
| Purchase of property and equipment | \$ 579 \$ |
235 | \$ 992 |
| Three months period Ended March 31, |
Year ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2019 | ||||||
| U.S. Dollars in thousands | ||||||||
| Net income (loss) | \$ | 5,218 | \$ | 4,923 | \$ | 22,251 | ||
| Taxes on income | 406 | 130 | 730 | |||||
| Financial income, net | (774) | 156 | (197) | |||||
| Depreciation and amortization expense | 1,192 | 1,127 | 4,519 | |||||
| Cost of share - based payments | 258 | 315 | 1,163 | |||||
| Adjusted EBITDA | \$ | 6,300 | \$ | 6,651 | \$ | 28,466 |
| Three months period Ended March 31, |
Year ended December 31, |
||||
|---|---|---|---|---|---|
| 2020 2019 |
2019 U.S. Dollars in thousands |
||||
| Net income (loss) | \$ 5,218 |
\$ | 4,923 | \$ | 22,251 |
| Cost of share - based payments | 258 | 315 | 1,163 | ||
| Adjusted net income | \$ 5,476 |
\$ | 5,238 | \$ | 23,414 |
| Page | |
|---|---|
| Consolidated Balance Sheets | 2 |
| Consolidated Statements of Comprehensive Income | 3 |
| Consolidated Statements of Changes in Equity | 4-6 |
| Consolidated Statements of Cash Flows | 7-8 |
| Notes to the Consolidated Financial Statements | 9-15 |
| - - - - - - - - - - - | |
| As of March 31, |
As of December 31, |
||||||
|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2019 | |||||
| Unaudited | Audited | ||||||
| Assets | U.S Dollars in thousands | ||||||
| Current Assets | |||||||
| Cash and cash equivalents | \$ | 49,288 | \$ | 22,037 | \$ 42,662 |
||
| Short-term investments | 47,124 | 33,800 | 31,245 | ||||
| Trade receivables, net | 26,266 | 23,210 | 23,210 | ||||
| Other accounts receivables | 1,736 | 3,442 | 3,272 | ||||
| Inventories | 41,787 | 31,708 | 43,173 | ||||
| Total Current Assets | 166,201 | 114,197 | 143,562 | ||||
| Non-Current Assets | |||||||
| Property, plant and equipment, net | 24,379 | 24,642 | 24,550 | ||||
| Right-of-use assets | 3,800 | 4,187 | 4,022 | ||||
| Other long term assets | 1,053 | 174 | 352 | ||||
| Deferred expenses | 421 | - | - | ||||
| Deferred taxes | 939 | 1,895 | 1,311 | ||||
| Total Non-Current Assets | |||||||
| 30,592 | 30,898 | 30,235 | |||||
| Total Assets | \$ | 196,793 | \$ | 145,095 | \$ 173,797 |
||
| Liabilities | |||||||
| Current Liabilities | |||||||
| Current maturities of bank loans | \$ | 465 | \$ | 470 | \$ 489 |
||
| Current maturities of lease liabilities | 928 | 961 | 1,020 | ||||
| Trade payables | 18,440 | 15,255 | 24,830 | ||||
| Other accounts payables | 4,875 | 4,424 | 5,811 | ||||
| Deferred revenues | 649 | 461 | 589 | ||||
| Total Current Liabilities | 25,357 | 21,571 | 32,739 | ||||
| Non-Current Liabilities | |||||||
| Bank loans | 138 | 591 | 257 | ||||
| Lease liabilities | 3,663 | 4,036 | 3,981 | ||||
| Deferred revenues | 569 | 605 | 232 | ||||
| Employee benefit liabilities, net | 1,251 | 823 | 1,269 | ||||
| Total Non-Current Liabilities | 5,621 | 6,055 | 5,739 | ||||
| Shareholder's Equity | |||||||
| Ordinary shares | 11,647 | 10,412 | 10,425 | ||||
| Additional paid in capital net | 204,702 | 179,352 | 180,819 | ||||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | ||||
| Capital reserve from hedges | 264 | 11 | 8 | ||||
| Capital reserve from financial assets measured at fair value through other comprehensive income |
- | 118 | 145 | ||||
| Capital reserve from share-based payments | 8,903 | 9,463 | 8,844 | ||||
| Capital reserve from employee benefits | (356) | 4 | (359) | ||||
| Accumulated deficit | (55,855) | (78,401) | (61,073) | ||||
| Total Shareholder's Equity | 165,815 | 117,469 | 135,319 | ||||
| Total Liabilities And Shareholder's Equity | \$ | 196,793 | \$ | 145,095 | \$ 173,797 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Three months period ended March 31, |
Year ended December 31, |
|||||
|---|---|---|---|---|---|---|
| 2020 | 2019 | 2019 | ||||
| Unaudited | Audited | |||||
| U.S Dollars in thousands | ||||||
| Revenues from proprietary products | \$ 25,317 |
\$ | 20,381 | \$ | 97,696 | |
| Revenues from distribution | 7,973 | 6,416 | 29,491 | |||
| Total revenues | 33,290 | 26,797 | 127,187 | |||
| Cost of revenues from proprietary products | 14,947 | 10,490 | 52,425 | |||
| Cost of revenues from distribution | 6,892 | 5,123 | 25,025 | |||
| Total cost of revenues | 21,839 | 15,613 | 77,450 | |||
| Gross profit | 11,451 | 11,184 | 49,737 | |||
| Research and development expenses | 3,347 | 2,766 | 13,059 | |||
| Selling and marketing expenses | 940 | 1,092 | 4,370 | |||
| General and administrative expenses | 2,312 | 2,094 | 9,194 | |||
| Other expense | 2 | 23 | 330 | |||
| Operating income | 4,850 | 5,209 | 22,784 | |||
| Financial income | 317 | 280 | 1,146 | |||
| Income (expense) in respect of securities measured at fair value, net * Income (expense) in respect of currency exchange differences and derivatives instruments, |
102 | (52) | (5) | |||
| net | 432 | (313) | (651) | |||
| Financial expense | (77) | (71) | (293) | |||
| Income before tax on income | 5,624 | 5,053 | 22,981 | |||
| Taxes on income | 406 | 130 | 730 | |||
| Net Income | \$ 5,218 |
\$ | 4,923 | \$ | 22,251 | |
| 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 | (188) | 108 | 143 | |||
| Gain on cash flow hedges | 241 | 74 | 92 | |||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | 34 | (2) | (23) | |||
| Items that will not be reclassified to profit or loss in subsequent periods: | ||||||
| Remeasurement gain (loss) from defined benefit plan | - | - | (388) | |||
| Tax effect | 27 | (28) | (11) | |||
| Total comprehensive income | \$ 5,332 |
\$ | 5,075 | \$ | 22,064 | |
| Earnings per share attributable to equity holders of the Company: | ||||||
| Basic income per share | \$ 0.12 |
\$ | 0.12 | \$ | 0.55 | |
| Diluted income per share | \$ 0.12 |
\$ | 0.12 | \$ | 0.55 | |
* Refer to note 5c for additional information.
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Share capital |
Additional paid in capital |
Capital reserve from securities measured at fair value through other comprehensive income |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges Unaudited |
Capital reserve from share based payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|||
|---|---|---|---|---|---|---|---|---|---|---|---|
| In thousands | |||||||||||
| Balance as of January 1, 2020 (audited) |
\$ 10,425 | \$ 180,819 |
\$ 145 |
\$ | (3,490) \$ | 8 | \$ 8,844 |
\$ (359) \$ |
(61,073) \$135,319 | ||
| Net income | - | - | - | - | - | - | - 5,218 |
5,218 | |||
| Other comprehensive income (loss) |
- | - | (188) | - | 275 | - | - | - 87 |
|||
| Tax effect | - | - | 43 | - | (19) | - | 3 | - 27 |
|||
| Total comprehensive income (loss) |
- | - | (145) | - | 256 | - | 3 5,218 |
5,332 | |||
| Issuance of ordinary shares Exercise and forfeiture of share-based payment into shares |
1,217 5 |
23,684 199 |
- - |
- - |
- - |
- (199) |
- - |
- 24,901 - 5 |
|||
| Cost of share-based payment |
- | - | - | - | - | 258 | - | - 258 |
|||
| Balance as of March 31, 2020 |
\$ 11,647 | \$ 204,702 |
\$ | - \$ |
(3,490) \$ | 264 | \$ 8,903 |
(356) \$ \$ |
(55,855) \$165,815 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Share capital |
Additional paid in capital |
Capital reserve from securities measured at fair value through other comprehensive income |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges Unaudited |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|
|---|---|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||||
| Balance as of January 1, 2019 (audited) Cumulative effect of initially application of IFRS 16 |
\$ 10,409 \$ - |
179,147 \$ - |
34 \$ - |
(3,490) \$ - |
(57) \$ - |
9,353 \$ - |
- | 4 \$ (300) |
(83,024) \$112,376 (300) |
| Balance as at January 1, 2019 (after initially application of IFRS 16) Net income |
10,409 - |
179,147 - |
34 - |
(3,490) - |
(57) - |
9,353 - |
4 - |
(83,324) 4,923 |
112,076 4,923 |
| Other comprehensive income Tax effect |
- - |
- - |
108 (24) |
- - |
72 (4) |
- - |
- - |
- - |
180 (28) |
| Total comprehensive income (loss) |
- | - | 84 | - | 68 | - | - | 4,923 | 5,075 |
| Exercise and forfeiture of share-based payment into shares |
3 | 205 | - | - | - | (205) | - | - | 3 |
| Cost of share-based payment |
- | - | - | - | - | 315 | - | - | 315 |
| Balance as of March 31, 2019 |
\$ 10,412 \$ | 179,352 \$ | 118 \$ | (3,490) \$ | 11 \$ | 9,463 \$ | 4 \$ | (78,401) \$117,469 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Share capital |
Additional paid in capital |
Capital reserve from securities measured at fair value through other comprehensive income |
Capital reserve due to translation to presentation currency |
Capital reserve from hedges Audited |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|
|---|---|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||||
| Balance as of January 1, 2019 (audited) Cumulative effect of initially application |
\$ 10,409 \$ | 179,147 \$ | 34 \$ | (3,490) \$ | (57) \$ | 9,353 \$ | 4 \$ | (83,024) \$112,376 | |
| ofIFRS 16 Balance as at January 1, 2019 (after initially application of IFRS 16) |
- 10,409 |
- 179,147 |
- 34 |
- (3,490) |
- (57) |
0 9,353 |
0 4 |
(300) (83,324) |
(300) 112,076 |
| Net income Other comprehensive income Tax effect |
- - - |
- - - |
- 143 (32) |
- - - |
- 69 (4) |
- - - |
- (388) 25 |
22,251 - - |
22,251 (176) (11) |
| Total comprehensive income Exercise and forfeiture of |
- | - | 111 | - | 65 | - | (363) | 22,251 | 22,064 |
| share-based payment into shares Cost of share-based |
16 | 1,672 | - | - | - | (1,672) | - | - | 16 |
| payment Balance as of December 31, 2019 |
- \$ 10,425 \$ |
- 180,819 \$ |
- 145 \$ |
- (3,490) \$ |
- 8 \$ |
1,163 8,844 \$ |
- (359) \$ |
- | 1,163 (61,073) \$135,319 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Three months period Ended March 31, 2020 |
Year Ended December 31, |
||||||
|---|---|---|---|---|---|---|---|
| 2019 | 2019 | ||||||
| Unaudited | Audited U.S Dollars in thousands |
||||||
| U.S Dollars in thousands |
|||||||
| Net income | \$ | 5,218 | \$ | 4,923 | \$ | 22,251 | |
| Adjustments to reconcile net income to net cash provided by operating activities: | |||||||
| Adjustments to the profit or loss items: | |||||||
| Depreciation and impairment | 1,192 | 1,127 | 4,519 | ||||
| Financial expenses (income), net | (774) | 156 | (197) | ||||
| Cost of share-based payment | 258 | 315 | 1,163 | ||||
| Taxes on income | 406 | 130 | 730 | ||||
| Loss (gain) from sale of property and equipment | - | (6) | (2) | ||||
| Change in employee benefit liabilities, net | (18) | 36 | 94 | ||||
| 1,064 | 1,758 | 6,307 | |||||
| Changes in asset and liability items: | |||||||
| Decrease (increase) in trade receivables, net | (3,016) | 4,727 | 5,117 | ||||
| Decrease (increase) in other accounts receivables | 1,513 | 131 | (214) | ||||
| Decrease (increase) in inventories | 1,386 | (2,392) | (13,857) | ||||
| Decrease (increase) in deferred expenses | (421) | (246) | 399 | ||||
| Increase (decrease) in trade payables | (7,216) | (2,368) | 6,259 | ||||
| Increase (decrease) in other accounts payables | (1,180) | (510) | 863 | ||||
| Increase (decrease) in deferred revenues | 397 | (63) | (283) | ||||
| (8,537) | (721) | (1,716) | |||||
| Cash received (paid) during the year for: | |||||||
| Interest paid | (55) | (63) | (243) | ||||
| Interest received | 451 | 172 | 1,106 | ||||
| Taxes paid | (61) | (8) | (134) | ||||
| 335 | 101 | 729 | |||||
| Net cash provided by (used in) operating activities | \$ | (1,920) | \$ | 6,061 | \$ | 27,571 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Three months period Ended March 31, 2020 2019 Unaudited |
Year Ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2019 Audited |
||||||||
| U.S Dollars in thousands |
||||||||
| Cash Flows from Investing Activities | thousands | |||||||
| Investment in short term investments, net | \$ | (15,646) | \$ | (1,058) | \$ | 1,727 | ||
| Purchase of property and equipment and intangible assets | (896) | (304) | (2,300) | |||||
| Proceeds from sale of property and equipment | - | 6 | 9 | |||||
| Net cash used in investing activities | (16,542) | (1,356) | (564) | |||||
| Cash Flows from Financing Activities | ||||||||
| Proceeds from exercise of share base payments | 5 | 3 | 16 | |||||
| Repayment of lease liabilities | (278) | (263) | (1,070) | |||||
| Repayment of long-term loans | (123) | (115) | (476) | |||||
| Proceeds from issuance of ordinary shares, net | 24,894 | - | - | |||||
| Net cash provided by (used in) financing activities | 24,498 | (375) | (1,530) | |||||
| Exchange differences on balances of cash and cash equivalent | 590 | (386) | (908) | |||||
| Increase in cash and cash equivalents | 6,626 | 3,944 | 24,569 | |||||
| Cash and cash equivalents at the beginning of the year | 42,662 | 18,093 | 18,093 | |||||
| Cash and cash equivalents at the end of the year | \$ | 49,288 | \$ | 22,037 | \$ | 42,662 | ||
| Significant non-cash transactions | ||||||||
| Purchase of property and equipment through capital lease | \$ | 58 | \$ | 4,431 | \$ | 5,035 | ||
| Purchase of property and equipment | \$ | 579 | \$ | 235 | \$ | 992 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
Kamada Ltd. ("the Company") is a plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company's flagship product is Glassia® ("Glassia"), the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets Glassia in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited ("Takeda") and in other countries through local distributors. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KedRab® ("KedRab") through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KedRab, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection. The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties.
Pursuant to the agreement with Takeda (as detailed on Note 17 of the Company's annual financial statements as of December 31, 2019) the Company will continue to produce Glassia for Takeda through 2021. Takeda is planning to complete the technology transfer of Glassia, and pending FDA approval, will initiate its own production of Glassia for the U.S. market in 2021. Accordingly, following the transition of manufacturing to Takeda, the Company will terminate the manufacturing and sale of Glassia to Takeda resulting in a significant reduction in revenues. Pursuant to the agreement, upon initiation of sales of Glassia manufactured by Takeda, Takeda will pay royalties to the Company 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.
These Financial Statements have been prepared in a condensed format as of March 31, 2020 and for the three months then ended ("interim consolidated financial statements").
These financial statements should be read in conjunction with the Company's annual financial statements as of December 31, 2019 and for the year then ended and the accompanying notes ("annual consolidated financial statements").
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".
The accounting policy applied in the preparation of the interim consolidated financial statements is consistent with that applied in the preparation of the annual consolidated financial statements, except for the following:
Amendments to IFRS 9, IFRS 7 and IAS 39
In September 2019, the IASB published an amendment to IFRS 9, "Financial Instruments", IFRS 7, "Financial Instruments: Disclosures" and IAS 39," Financial Instruments: Recognition and Measurement" ("the Amendment").
In view of global regulatory changes, numerous countries have considered introducing a reform in the benchmark Interbank Offered Rates ("IBORs") (LIBOR, the London Interbank Offered Rate, being one of the most common examples) and switching to a risk-free interest rate alternative ("RFR") which extensively rely on data of specific transactions. The IBOR reform leads to uncertainty regarding the dates and amounts to be attributed to future cash flows relating to both hedging instruments and hedged items that rely on existing IBORs.
According to the existing accounting guidance of IFRS 9 and IAS 39, entities that have entered into the above hedges are facing uncertainty as a result of the IBOR reform which is likely to affect their ability to continue meeting the effective hedging requirements underlying existing transactions as well as the hedging requirements of future transactions. In order to resolve this uncertainty, the IASB issued the Amendment to offer transitional reliefs for entities that apply IBOR-based hedge accounting. The Amendment represents phase one in the reform that will include additional amendments in the future.
The Amendment also permits certain reliefs in applying the hedge accounting effectiveness tests during the period of transition from IBORs to RFRs. These reliefs assume that the benchmark interest underlying the hedge will not change as a result of the expected interest reform. The reliefs will be effective indefinitely, until the occurrence of one of the events specified in the Amendment. The Amendment also requires entities to provide specific disclosures of the application of any reliefs.
The Amendment was applied retrospectively for annual periods beginning on or after January 1, 2020.
The Company estimates that the adoption of the Amendment will have no effect on its financial statements since it does not currently enter into substantial IBOR-based hedges.
a. Effects of the COVID-19 Outbreak:
Following the global COVID-19 outbreak, there has been a decrease in economic activity worldwide, including Israel. The spread of the COVID-19 pandemic led, inter alia, to a disruption in the global supply chain, a decrease in global transportation, restrictions on travel and work that were announced by the State of Israel and other countries worldwide as well as a decrease in the value of financial assets and commodities across all markets in Israel and the world.
To date the Company's manufacturing plant remains operational with no effect on business continuity.
The Company intends to maintain its current manufacturing and supply plans and increased its inventory levels of raw materials through our suppliers and service providers in order to appropriately manage any potential supply disruptions and secure continued manufacturing. In addition, the Company is actively engaging its freight carriers to ensure inbound and outbound international delivery routes remain operational and identify alternative routes, if needed.
The Company is complying with the State of Israel mandates and recommendations with respect to its work-force management and currently maintains the work-force levels required to support its ongoing commercial operations. The Company has taken a number of precautionary health and safety measures to safeguard its employees and continues to monitor and assess orders issued by the State of Israel and other applicable governments to ensure compliance with evolving COVID-19 guidelines.
While the impact of the COVID-19 pandemic on the Company's financial results for the first quarter of 2020 was not material, and the Company expects meeting its annual sales guidance, a number of COVID-19 pandemic-related dynamics may still affect market demand for the Company's products, availability of raw materials and potential effects on the Company's employees all of which may have an effect on the Company's future financial position and results of operations.
In addition, on such date, the Company's shareholders approved the grant of options to purchase 212,000 Ordinary Shares of the Company at an exercise price of NIS 23.67 per share to members of the Company's Board of Directors. The fair value of the options calculated on the date of grant was estimated at \$356 thousands using the binomial option valuation model.
a. General:
The company has two operating segments, as follows:
Proprietary Products - Medicine development, manufacture and sale of plasma-derived therapeutics products.
Distribution - Distribution in Israel of drugs manufactured by third parties, majority of which are produced from plasma or its derivatives products.
b. Reporting on operating segments:
| Three months period ended March 31, 2020 |
||||||
|---|---|---|---|---|---|---|
| Proprietary | ||||||
| Products Distribution |
Total | |||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Revenues | \$ 25,317 |
\$ | 7,973 | \$ | 33,290 | |
| Gross profit | \$ 10,370 |
\$ | 1,081 | \$ | 11,451 | |
| Unallocated operational expenses | (6,601) | |||||
| Finance income (expense), net | 774 | |||||
| Income before taxes on income | \$ | 5,624 | ||||
b. Reporting on operating segments (continued):
| Three months period ended March 31, 2019 |
|||||||
|---|---|---|---|---|---|---|---|
| Proprietary Products |
Distribution | Total | |||||
| U.S Dollars in thousands Unaudited |
|||||||
| Revenues | \$ 20,381 |
\$ | 6,416 | \$ | 26,797 | ||
| Gross profit | \$ 9,891 |
\$ | 1,293 | \$ | 11,184 | ||
| Unallocated operational expenses | (5,975) | ||||||
| Finance income (expense), net | (156) | ||||||
| Income before taxes on income | \$ | 5,053 |
| Year ended December 31, 2019 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Proprietary Products |
Distribution | Total | |||||||
| U.S Dollars in thousands | |||||||||
| Audited | |||||||||
| Revenues | \$ | 97,696 | \$ | 29,491 | \$ 127,187 |
||||
| Gross profit | \$ | 45,271 | \$ | 4,466 | \$ | 49,737 | |||
| Unallocated operational expenses Finance income (expense), net |
(26,953) | 197 | |||||||
| Income before taxes on income | \$ | 22,981 |
c. Reporting on operating segments by geographic region:
| Three months period ended March 31, 2020 | |||||||
|---|---|---|---|---|---|---|---|
| Proprietary Products |
Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Geographical markets | |||||||
| U.S.A. | \$ 22,721 |
\$ | - | \$ | 22,721 | ||
| Israel | 589 | 7,973 | 8,562 | ||||
| Europe | 553 | - | 553 | ||||
| Latin America | 858 | - | 858 | ||||
| Asia | 113 | 113 | |||||
| Others | 483 | - | 483 | ||||
| \$ 25,317 |
\$ | 7,973 | \$ | 33,290 |
| Proprietary | ||||||||
|---|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||||
| U.S Dollars in thousands | ||||||||
| Unaudited | ||||||||
| Geographical markets | ||||||||
| U.S.A. | \$ 18,062 |
\$ | - | \$ | 18,062 | |||
| Israel | 547 | 6,416 | 6,963 | |||||
| Europe | 873 | - | 873 | |||||
| Latin America | 239 | - | 239 | |||||
| Asia | 660 | - | 660 | |||||
| Others | - | - | - | |||||
| \$ 20,381 |
\$ | 6,416 | \$ | 26,797 |
| Year ended December 31, 2019 | ||||||
|---|---|---|---|---|---|---|
| Proprietary | ||||||
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Audited | ||||||
| Geographical markets | ||||||
| U.S.A. | \$ 84,572 |
\$ | - | \$ | 84,572 | |
| Israel | 2,468 | 29,491 | 31,959 | |||
| Europe | 4,701 | - | 4,701 | |||
| Latin America | 3,792 | - | 3,792 | |||
| Asia | 2,067 | - | 2,067 | |||
| Others | 96 | - | 96 | |||
| \$ 97,696 |
\$ | 29,491 | \$ | 127,187 |
a. Classification of financial instruments by fair value hierarchy
Financial assets (liabilities) measured at fair value
| March 31, 2020 | Level 1 | Level 2 U.S Dollars in thousands |
|||
|---|---|---|---|---|---|
| Derivatives instruments | - | (245) | |||
| \$ | - | \$ | (245) | ||
| March 31, 2019 | |||||
| Debt securities (corporate and government) measured at fair value through other comprehensive income | \$ | 1,661 | \$ | 8,849 | |
| Derivatives instruments | - | 19 | |||
| \$ | 1,661 | \$ | 8,868 | ||
| December 31, 2019 | |||||
| Debt securities (corporate and government) measured at fair value through other comprehensive income | \$ | 4,289 | \$ | 8,543 | |
| Derivatives instruments | - | 15 | |||
| \$ | 4,289 | \$ | 8,558 | ||
b. During the three months ended March 31, 2020 there were no transfers from Level 1 to Level 2, and to or from Level 3 due to the fair value measurement of any financial instrument.
c. During the three months ended March 31, 2020, the Company divested all of its investments in debt securities (corporate and government) and realized the fair value of such debt securities through other comprehensive income. As a result, the Company recognized \$102 thousands in Consolidated Statements of Comprehensive Income.
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