Foreign Filer Report • Nov 12, 2020
Foreign Filer Report
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For the Month of November 2020
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 and 333-233267, and the Registrant's Form F-3 Registration Statement, as amended, File No. 333-214816.
The following exhibits are attached:
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: November 12, 2020 KAMADA LTD.
By: /s/ Yifat Philip
Yifat Philip Vice President General Counsel and Corporate Secretary
| EXHIBIT NO. | DESCRIPTION |
|---|---|
| 99.1 | Kamada to Announce Third Quarter Ended September 30, 2020 Financial Results, Recent Achievements and Corporate |
| Development | |
| 99.2 | Kamada Ltd.'s Consolidated Financial Statements as of September 30, 2020 (Unaudited) |
REHOVOT, Israel – November 11, 2020 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three and nine months ended September 30, 2020.
"We are pleased with our solid financial and operational results during the recently completed quarter and first nine months of 2020, achieved in the midst of the COVID-19 global pandemic" said Amir London, Kamada's Chief Executive Officer. "Total revenues increased seven percent for both the three and nine months ended September 30, 2020 as compared to the same periods in 2019. Based on our solid performance in the first nine months of the year, and our positive outlook for the fourth quarter, we are reiterating our full-year 2020 total revenue guidance of \$132 million to \$137 million."
"We continue to achieve important progress in the development of our plasma derived immunoglobulin (IgG) product as a potential therapy for COVID-19 disease," continued Mr. London. "We executed an agreement with the Israeli Ministry of Health ("IMOH") to supply our product for the treatment of COVID-19 patients in Israel, under which the initial supply is expected to generate approximately \$3.4 million in revenues during the first quarter of 2021. Importantly, per recent discussions with the IMOH, the treatment utilizing our product will be provided as part of a multi-center clinical study led by the IMOH. From a supply perspective, we are ramping up our COVID-19 IgG manufacturing capacity, and we intend to increase our supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets. In addition, we completed enrollment and announced positive initial interim results from our ongoing Phase 1/2 open-label COVID-19 clinical trial in Israel. Lastly, following recent response from the U.S. Food and Drug Administration ("FDA") to our previously submitted pre-Investigational New Drug (IND) information package, we, together with our partner, Kedrion Biopharma, are currently evaluating the suitable targeted patient population for our US clinical program and will submit an IND application upon conclusion of such evaluation and successful completion of additional required activities."
"As we move into 2021 and in anticipation of the reduction in revenues due to the planned transition of GLASSIA manufacturing to Takeda, we are exploring strategic business development opportunities that will utilize and expend our core plasma-derived therapeutics development, manufacturing, and commercialization expertise. These opportunities will be funded by our strong cash position. We believe that our COVID-19 IgG program demonstrates Kamada's ability to quickly respond to emerging pandemic situations, and we plan to leverage these capabilities and our IgG platform technology as a strategic business line, with the ability to respond to other potentially similar future pandemic situations. These strategic opportunities are anticipated to be added to the expected organic commercial growth of our existing products portfolio, including KEDRAB, our distributed products in Israel, the anticipated future royalty payments from Takeda, and the contract manufacturing of an FDA approved and commercialized specialty IgG product." concluded Mr. London.

As of September 30, 2020, the Company had cash, cash equivalents, and short-term investments of \$99.7 million, as compared to \$73.9 million at December 31, 2019. This increase is mainly related to the sale of \$25 million of equity to FIMI Opportunity Fund, the leading private equity investor in Israel.
● Appointed Yifat Philip, Esq. as Vice President Legal, General Counsel and Corporate Secretary.
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. Pursuant to an agreement with Takeda the Company will continue to produce Glassia for Takeda through 2021 and Takeda is planning to initiate its own production of Glassia for the U.S. market in 2021 at which point Takeda will commence payment of royalties to the Company. The Company's second leading product is KamRab®, a rabies immune globulin (Human) for postexposure 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 plasmaderived 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, and during 2020, the Company initiated the development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). 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) total revenues to be in the range of \$132 million to \$137 million for fiscal 2020; 2) ability to ramp up Kamada's COVID-19 IgG manufacturing capacity and its plan to increase its supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets; 3) ability to advance the U.S. clinical development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for COVID-19; 4) ability to explore strategic business development opportunities that utilize and expend Kamada's core plasma-derived therapeutics development, manufacturing, and commercialization expertise; and 5) Kamada's belief that its COVID-19 IgG program demonstrates its ability to quickly respond to emerging pandemic situations, and its plan to leverage these capabilities and its IgG platform technology as a strategic line of business. 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 scope, 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, ability to offset significant revenue loss associated with GLASSIA manufacturing transitioning to Takeda, continued demand for Kamada's products, including GLASSIA and KEDRAB, in the U.S. market and its Distribution segment related products in Israel, financial conditions of the Company's customer, suppliers and services providers, ability to obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies and on-going 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 September 30, | As of December 31, |
|||
|---|---|---|---|---|
| 2020 | 2019 | 2019 | ||
| Unaudited | Audited | |||
| U.S Dollars in thousands | ||||
| Assets | ||||
| Current Assets | ||||
| Cash and cash equivalents | \$ 52,487 |
\$ | 27,449 | \$ 42,662 |
| Short-term investments | 47,230 | 39,380 | 31,245 | |
| Trade receivables, net | 28,643 | 23,999 | 23,210 | |
| Other accounts receivables | 3,533 | 1,722 | 3,272 | |
| Inventories | 42,618 | 34,031 | 43,173 | |
| Total Current Assets | 174,511 | 126,581 | 143,562 | |
| Non-Current Assets | ||||
| Property, plant and equipment, net | 25,323 | 24,197 | 24,550 | |
| Right-of-use-assets | 3,694 | 4,100 | 4,022 | |
| Other long term assets | 1,081 | 178 | 352 | |
| Contract asset | 1,438 | - | - | |
| Deferred taxes | 298 | 1,445 | 1,311 | |
| Total Non-Current Assets | 31,834 | 29,920 | 30,235 | |
| Total Assets | \$ 206,345 |
\$ | 156,501 | \$ 173,797 |
| Liabilities | ||||
| Current Liabilities | ||||
| Current maturities of bank loans | \$ 322 |
\$ | 573 | \$ 489 |
| Current maturities of lease liabilities | 1,038 | 964 | 1,020 | |
| Trade payables | 15,110 | 13,079 | 24,830 | |
| Other accounts payables | 6,236 | 5,439 | 5,811 | |
| Deferred revenues | 486 | 561 | 589 | |
| Total Current Liabilities | 23,192 | 20,616 | 32,739 | |
| Non-Current Liabilities | ||||
| Bank loans | 48 | 461 | 257 | |
| Lease liabilities | 3,589 | 4,052 | 3,981 | |
| Deferred revenues | 1,525 | 347 | 232 | |
| Employee benefit liabilities, net | 1,262 | 884 | 1,269 | |
| Total Non-Current Liabilities | 6,424 | 5,744 | 5,739 | |
| Shareholder's Equity | ||||
| Ordinary shares | 11,703 | 10,420 | 10,425 | |
| Additional paid in capital | 209,650 | 179,589 | 180,819 | |
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | |
| Capital reserve from hedges | 234 | 18 | 8 | |
| Capital reserve from financial assets measured at fair value through other comprehensive | ||||
| Income | - | 137 | 145 | |
| Capital reserve from share-based payments | 4,550 | 9,898 | 8,844 | |
| Capital reserve from employee benefits | (356) | 4 | (359) | |
| Accumulated deficit | (45,562) | (66,435) | (61,073) | |
| Total Shareholder's Equity | 176,729 | 130,141 | 135,319 | |
| Total Liabilities and Shareholder's Equity | \$ 206,345 |
\$ | 156,501 | \$ 173,797 |
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||
| Unaudited | Unaudited | Audited | ||||||||
| U.S Dollars In thousands | ||||||||||
| Revenues from proprietary products | \$ | 77,633 | \$ | 72,521 | \$ | 29,691 | \$ | 24,859 | \$ | 97,696 |
| Revenues from distribution | 24,071 | 22,595 | 5,634 | 8,207 | 29,491 | |||||
| Total revenues | 101,704 | 95,116 | 35,325 | 33,066 | 127,187 | |||||
| Cost of revenues from proprietary products | 43,817 | 38,412 | 15,936 | 13,234 | 52,425 | |||||
| Cost of revenues from distribution | 20,500 | 19,056 | 4,568 | 6,968 | 25,025 | |||||
| Total cost of revenues | 64,317 | 57,468 | 20,504 | 20,202 | 77,450 | |||||
| Gross profit | 37,387 | 37,648 | 14,821 | 12,864 | 49,737 | |||||
| Research and development expenses | 10,335 | 9,730 | 3,365 | 3,477 | 13,059 | |||||
| Selling and marketing expenses | 3,297 | 3,441 | 1,179 | 1,161 | 4,370 | |||||
| General and administrative expenses | 7,133 | 6,851 | 2,514 | 2,230 | 9,194 | |||||
| Other expenses | 34 | 327 | - | 299 | 330 | |||||
| Operating income | 16,588 | 17,299 | 7,763 | 5,697 | 22,784 | |||||
| Financial income | 865 | 887 | 250 | 328 | 1,146 | |||||
| Income (expense) in respect of securities measured at fair value, net |
102 | (3) | - | 55 | (5) | |||||
| Income (expenses) in respect of currency exchange | ||||||||||
| differences and derivatives instruments, net | (696) | (503) | (761) | 25 | (651) | |||||
| Financial expenses | (204) | (217) | (69) | (68) | (293) | |||||
| Income before tax on income | 16,655 | 17,463 | 7,183 | 6,037 | 22,981 | |||||
| Taxes on income | 1,144 | 574 | 348 | 214 | 730 | |||||
| Net Income | \$ | 15,511 | \$ | 16,889 | \$ | 6,835 | \$ | 5,823 | \$ | 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) | 132 | - | (66) | 143 | |||||
| Gain (loss) on cash flow hedges Net amounts transferred to the statement of profit or loss |
516 | 99 | 75 | 28 | 92 | |||||
| for cash flow hedges | (273) | (20) | (266) | (18) | (23) | |||||
| Items that will not be reclassified to profit or loss in subsequent periods: |
||||||||||
| Remeasurement gain (loss) from defined benefit plan | - | - | - | (388) | ||||||
| Tax effect | 29 | (33) | 14 | 16 | (11) | |||||
| Total comprehensive income | \$ | 15,595 | \$ | 17,067 | \$ | 6,658 | \$ | 5,783 | \$ | 22,064 |
| Earnings per share attributable to equity holders of the | ||||||||||
| Company: | ||||||||||
| Basic net earnings per share | \$ | 0.35 | \$ | 0.42 | \$ | 0.15 | \$ | 0.14 | \$ | 0.55 |
| Diluted net earnings per share | \$ | 0.35 | \$ | 0.42 | \$ | 0.15 | \$ | 0.14 | \$ | 0.55 |
| Nine months period Ended September 30, |
Three months period Ended September 30, |
Year Ended December 31, |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | |||||||
| Unaudited | Audited | ||||||||||
| U.S Dollars In thousands | |||||||||||
| Cash Flows from Operating Activities | |||||||||||
| Net income | \$ | 15,511 | \$ | 16,889 | \$ | 6,835 | \$ | 5,823 | \$ | 22,251 | |
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
|||||||||||
| Adjustments to the profit or loss items: | |||||||||||
| Depreciation and impairment | 3,632 | 3,379 | 1,252 | 1,128 | 4,519 | ||||||
| Financial expenses (income), net | (67) | (164) | 580 | (340) | (197) | ||||||
| Cost of share-based payment | 853 | 987 | 265 | 353 | 1,163 | ||||||
| Taxes on income | 1,144 | 574 | 348 | 214 | 730 | ||||||
| Gain from sale of property and equipment | (7) | (2) | (1) | - | (2) | ||||||
| Change in employee benefit liabilities, net | (7) | 97 | (5) | 66 | 94 | ||||||
| 5,548 | 4,871 | 2,439 | 1,421 | 6,307 | |||||||
| Changes in asset and liability items: | |||||||||||
| Decrease (increase) in trade receivables, net | (5,540) | 4,408 | (8,956) | 1,806 | 5,117 | ||||||
| Decrease (increase) in other accounts receivables | 972 | 1,204 | 231 | 955 | (214) | ||||||
| Decrease (increase) in inventories | 555 | (4,715) | 5,028 | 1,470 | (13,857) | ||||||
| Decrease (increase) in Contract asset and deferred expenses | (2,464) | 333 | (1,553) | 605 | 399 | ||||||
| Increase (decrease) in trade payables | (10,488) | (4,585) | (7,769) | (6,512) | 6,259 | ||||||
| Increase in other accounts payables | 426 | 379 | 740 | 432 | 863 | ||||||
| Increase (decrease) in deferred revenues | 1,190 | (221) | 397 | (95) | (283) | ||||||
| (15,349) | (3,197) | (11,882) | (1,339) | (1,716) | |||||||
| Cash received (paid) during the period for: | |||||||||||
| Interest paid | (158) | (182) | (51) | (58) | (243) | ||||||
| Interest received | 891 | 554 | 290 | 254 | 1,106 | ||||||
| Taxes paid | (87) | (25) | (13) | (9) | (134) | ||||||
| 646 | 347 | 226 | 187 | 729 | |||||||
| Net cash provided by (used in) operating activities | \$ | 6,356 | \$ | 18,910 | \$ | (2,382) | \$ | 6,092 | \$ | 27,571 |
| Nine months period Ended September 30, |
Three months period Ended September 30, |
Year Ended December 31, |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||
| Unaudited | Audited | |||||||||
| Cash Flows from Investing Activities | ||||||||||
| Proceeds of investment in short term investments, net | \$ | (15,646) \$ | (6,160) | \$ | - | \$ | (1,032) | \$ | 1,727 | |
| Purchase of property and equipment and intangible assets | (3,372) | (1,488) | (1,471) | (731) | (2,300) | |||||
| Proceeds from sale of property and equipment | 7 | 9 | 1 | - | 9 | |||||
| Net cash used in investing activities | (19,011) | (7,639) | (1,470) | (1,763) | (564) | |||||
| Cash Flows from Financing Activities | ||||||||||
| Proceeds from exercise of share base payments | 61 | 12 | 41 | 3 | 16 | |||||
| Repayment of lease liabilities | (815) | (794) | (275) | (265) | (1,070) | |||||
| Repayment of long-term loans | (373) | (353) | (127) | (121) | (476) | |||||
| Proceeds from issuance of ordinary shares, net | 24,894 | - | - | - | - | |||||
| Net cash provided by (used in) financing activities | 23,767 | (1,135) | (361) | (383) | (1,530) | |||||
| Exchange differences on balances of cash and cash | ||||||||||
| equivalent | (1,287) | (780) | (699) | (332) | (908) | |||||
| Increase (decrease) in cash and cash equivalents | 9,825 | 9,356 | (4,912) | 3,614 | 24,569 | |||||
| Cash and cash equivalents at the beginning of the period | 42,662 | 18,093 | 57,399 | 23,835 | 18,093 | |||||
| Cash and cash equivalents at the end of the period | \$ | 52,487 | \$ | 27,449 | \$ | 52,487 | \$ | 27,449 | \$ | 42,662 |
| Significant non-cash transactions | ||||||||||
| Right-of-use asset recognized with corresponding lease | ||||||||||
| liability | \$ | 539 | \$ | 4,984 | \$ | 194 | \$ | 436 | \$ | 5,035 |
| Purchase of property and equipment | \$ | 973 | \$ | 264 | \$ | 973 | \$ | 264 | \$ | 992 |
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | |||||
| In thousands | |||||||||
| Net income | \$ 15,511 |
16,889\$ \$ | 6,835 | \$ | 5,823 | \$ | 22,251 | ||
| Taxes on income | 1,144 | 574 | 348 | 214 | 730 | ||||
| Financial expense (income), net | (67) | (164) | 580 | (340) | (197) | ||||
| Depreciation and amortization expense | 3,632 | 3,379 | 1,252 | 1,128 | 4,519 | ||||
| Non-cash share-based compensation expenses | 853 | 987 | 265 | 353 | 1,163 | ||||
| Adjusted EBITDA | \$ 21,073 |
\$ | 21,665 | \$ | 9,280 | \$ | 7,178 | \$ | 28,466 |
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | |||||||
| In thousands | |||||||||||
| Net income | \$ | 15,511 | \$ | 16,889 | \$ | 6,835 | \$ | 5,823 | \$ | 22,251 | |
| Share-based compensation charges | 853 | 987 | 265 | 353 | 1,163 | ||||||
| Adjusted net income | \$ | 16,364 | \$ | 17,876 | \$ | 7,100 | \$ | 6,176 | \$ | 23,414 |
| Page | |
|---|---|
| Consolidated Condensed Balance Sheets | 2 |
| Consolidated Condensed Statements of Comprehensive Income | 3 |
| Consolidated Interim Statements of Changes in Equity | 4-7 |
| Consolidated Condensed Statements of Cash Flows | 8-9 |
| Notes to the Interim Consolidated Financial Statements | 10-17 |
| As of September 30, | As of December 31, |
|||
|---|---|---|---|---|
| 2020 | 2019 | 2019 | ||
| Unaudited | Audited | |||
| Assets | U.S Dollars in thousands | |||
| Current Assets | ||||
| Cash and cash equivalents | \$ 52,487 |
\$ | 27,449 | \$ 42,662 |
| Short-term investments | 47,230 | 39,380 | 31,245 | |
| Trade receivables, net | 28,643 | 23,999 | 23,210 | |
| Other accounts receivables | 3,533 | 1,722 | 3,272 | |
| Inventories | 42,618 | 34,031 | 43,173 | |
| Total Current Assets | 174,511 | 126,581 | 143,562 | |
| Non-Current Assets | ||||
| Property, plant and equipment, net | 25,323 | 24,197 | 24,550 | |
| Right-of-use-assets | 3,694 | 4,100 | 4,022 | |
| Other long term assets | 1,081 | 178 | 352 | |
| Contract asset | 1,438 | - | - | |
| Deferred taxes | 298 | 1,445 | 1,311 | |
| Total Non-Current Assets | 31,834 | 29,920 | 30,235 | |
| Total Assets | \$ 206,345 |
\$ | 156,501 | \$ 173,797 |
| Liabilities | ||||
| Current Liabilities | ||||
| Current maturities of bank loans | \$ 322 |
\$ | 573 | \$ 489 |
| Current maturities of lease liabilities | 1,038 | 964 | 1,020 | |
| Trade payables | 15,110 | 13,079 | 24,830 | |
| Other accounts payables | 6,236 | 5,439 | 5,811 | |
| Deferred revenues | 486 | 561 | 589 | |
| Total Current Liabilities | 23,192 | 20,616 | 32,739 | |
| Non-Current Liabilities | ||||
| Bank loans | 48 | 461 | 257 | |
| Lease liabilities | 3,589 | 4,052 | 3,981 | |
| Deferred revenues | 1,525 | 347 | 232 | |
| Employee benefit liabilities, net | 1,262 | 884 | 1,269 | |
| Total Non-Current Liabilities | 6,424 | 5,744 | 5,739 | |
| Shareholder's Equity | ||||
| Ordinary shares | 11,703 | 10,420 | 10,425 | |
| Additional paid in capital | 209,650 | 179,589 | 180,819 | |
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | |
| Capital reserve from hedges | 234 | 18 | 8 | |
| Capital reserve from financial assets measured at fair value through other comprehensive | ||||
| Income | - | 137 | 145 | |
| Capital reserve from share-based payments | 4,550 | 9,898 | 8,844 | |
| Capital reserve from employee benefits | (356) | 4 | (359) | |
| Accumulated deficit | (45,562) | (66,435) | (61,073) | |
| Total Shareholder's Equity | 176,729 | 130,141 | 135,319 | |
| Total Liabilities and Shareholder's Equity | \$ 206,345 |
\$ | 156,501 | \$ 173,797 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | |||||
| Unaudited | Unaudited | Audited | |||||||
| U.S Dollars In thousands | |||||||||
| Revenues from proprietary products | \$ 77,633 |
\$ | 72,521 | \$ | 29,691 | \$ | 24,859 | \$ | 97,696 |
| Revenues from distribution | 24,071 | 22,595 | 5,634 | 8,207 | 29,491 | ||||
| Total revenues | 101,704 | 95,116 | 35,325 | 33,066 | 127,187 | ||||
| Cost of revenues from proprietary products | 43,817 | 38,412 | 15,936 | 13,234 | 52,425 | ||||
| Cost of revenues from distribution | 20,500 | 19,056 | 4,568 | 6,968 | 25,025 | ||||
| Total cost of revenues | 64,317 | 57,468 | 20,504 | 20,202 | 77,450 | ||||
| Gross profit | 37,387 | 37,648 | 14,821 | 12,864 | 49,737 | ||||
| Research and development expenses | 10,335 | 9,730 | 3,365 | 3,477 | 13,059 | ||||
| Selling and marketing expenses | 3,297 | 3,441 | 1,179 | 1,161 | 4,370 | ||||
| General and administrative expenses | 7,133 | 6,851 | 2,514 | 2,230 | 9,194 | ||||
| Other expenses | 34 | 327 | - | 299 | 330 | ||||
| Operating income | 16,588 | 17,299 | 7,763 | 5,697 | 22,784 | ||||
| Financial income | 865 | 887 | 250 | 328 | 1,146 | ||||
| Income (expense) in respect of securities measured at fair value, net |
102 | (3) | - | 55 | (5) | ||||
| Income (expenses) in respect of currency exchange | |||||||||
| differences and derivatives instruments, net Financial expenses |
(696) (204) |
(503) (217) |
(761) (69) |
25 (68) |
(651) (293) |
||||
| Income before tax on income Taxes on income |
16,655 | 17,463 | 7,183 | 6,037 | 22,981 | ||||
| 1,144 | 574 | 348 | 214 | 730 | |||||
| Net Income | \$ 15,511 |
\$ | 16,889 | \$ | 6,835 | \$ | 5,823 | \$ | 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) | 132 | - | (66) | 143 | ||||
| Gain (loss) on cash flow hedges | 516 | 99 | 75 | 28 | 92 | ||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges |
(273) | (20) | (266) | (18) | (23) | ||||
| Items that will not be reclassified to profit or loss in | |||||||||
| subsequent periods: | |||||||||
| Remeasurement gain (loss) from defined benefit plan | - | - | - | (388) | |||||
| Tax effect | 29 | (33) | 14 | 16 | (11) | ||||
| Total comprehensive income | \$ 15,595 |
\$ | 17,067 | \$ | 6,658 | \$ | 5,783 | \$ | 22,064 |
| Earnings per share attributable to equity holders of the Company: |
|||||||||
| Basic net earnings per share | \$ 0.35 |
\$ | 0.42 | \$ | 0.15 | \$ | 0.14 | \$ | 0.55 |
| Diluted net earnings per share | |||||||||
| \$ 0.35 |
\$ | 0.42 | \$ | 0.15 | \$ | 0.14 | \$ | 0.55 |
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, 2020 (audited) \$10,425 \$ | 180,819 \$ | 145 \$ | (3,490) \$ | 8 \$ 8,844 \$ |
(359) \$ | (61,073) \$135,319 | ||||||
| Net income | - | - | - | - | - | - | - | 15,511 | 15,511 | |||
| Other comprehensive income (loss) | - | - | (188) | - | 243 | - | - | - | 55 | |||
| Taxes effect | - | - | 43 | - | (17) | - | 3 | - | 29 | |||
| Total comprehensive income (loss) | - | - | (145) | - | 226 | - | 3 | 15,511 | 15,595 | |||
| Issuance of ordinary shares | 1,217 | 23,684 | - | - | - | - | - | - | 24,901 | |||
| Exercise and forfeiture of share-based payment into shares |
61 | 5,147 | - | - | - | (5,147) | - | - | 61 | |||
| Cost of share-based payment | - | - | - | - | - | 853 | - | - | 853 | |||
| Balance as of September 30, 2020 | \$11,703 \$ | 209,650 \$ | (3,490) \$ - \$ |
234 \$ | 4,550 \$ | (356) \$ | (45,562) \$176,729 |
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) | \$10,409 \$ | 179,147 \$ | 34 \$ | (3,490) \$ | (57) \$ | 9,353 \$ | 4 \$ | (83,024) \$112,376 | |
| Cumulative effect of initially applying IFRS 16 | - | - | - | - | - | - | - | (300) | (300) |
| Balance as at January 1, 2019 (after initially | |||||||||
| applying IFRS 16) | 10,409 | 179,147 | 34 | (3,490) | (57) | 9,353 | 4 | (83,324) 112,076 | |
| Net income | - | - | - | - | - | - | - | 16,889 | 16,889 |
| Other comprehensive income | - | - | 132 | - | 79 | - | - | - | 211 |
| Taxes effect | - | - | (29) | - | (4) | - | - | - | (33) |
| Total comprehensive income (loss) | - | - | 103 | - | 75 | - | - | 16,889 | 17,067 |
| Exercise and forfeiture of share-based payment into shares |
11 | 442 | - | - | - | (442) | - | - | 11 |
| Cost of share-based payment | - | - | - | - | - | 987 | - | - | 987 |
| Balance as of September 30, 2019 | \$10,420 \$ | 179,589 \$ | 137 \$ | (3,490) \$ | 18 \$ | 9,898 \$ | 4 \$ | (66,435) \$130,141 |
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 |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
|||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unaudited | |||||||||||||
| U.S Dollars In thousands | |||||||||||||
| Balance as of July 1, 2020 Net income |
\$11,662 \$ - |
207,731 \$ - |
- \$ - |
(3,490) \$ - |
411 - |
\$ 6,204 \$ - |
(356) \$ - |
6,835 | (52,397) \$169,765 6,835 |
||||
| Other comprehensive income | - | - | - | - | (191) | - | - | - | (191) | ||||
| Taxes effect | - | - | - | - | 14 | - | - | - | 14 | ||||
| Total comprehensive income (loss) Exercise into shares and forfeiture of share-based |
- | - | - | - | (177) | - | - | 6,835 | 6,658 | ||||
| payment | 41 | 1,919 | - | - | - | (1,919) | - | 41 | |||||
| Cost of share-based payment | - | - | - | - | - | 265 | - | - | 265 | ||||
| Balance as of September 30, 2020 | \$11,703 \$ Share capital |
209,650 \$ Additional paid in capital |
- \$ Capital reserve from securities measured at fair value through other comprehensive income |
(3,490) \$ Capital reserve due to translation to presentation currency U.S Dollars In thousands |
Unaudited | 234 Capital reserve from hedges |
\$ 4,550 \$ Capital reserve from sharebased payments |
(356) \$ Capital reserve from employee benefits |
Accumulated deficit |
(45,562) \$176,729 Total equity |
|||
| Balance as of July 1, 2019 | \$10,418 \$ | 179,471 \$ | 187 \$ | (3,490) \$ | 8 \$ 9,663 \$ |
4 \$ | (72,258) \$124,003 | ||||||
| Net income | - | - | - | - | - | - | - | 5,853 | 5,823 | ||||
| Other comprehensive income | - | - | (66) | - | 10 | - | - | - | (56) | ||||
| Taxes effect | - | - | 16 | - | - | - | - | - | 16 | ||||
| Total comprehensive income (loss) Exercise into shares and forfeiture of share-based |
- | - | (50) | - | 10 | - | - | 5,853 | 5,783 | ||||
| payment | 2 | 118 | - | - | - | (118) | - | - | 2 | ||||
| Cost of share-based payment | - | - | - | - | - | 353 | - | - | 353 | ||||
| Balance as of September 30, 2019 | \$10,420 \$ | 179,589 \$ | 137 \$ | (3,490) \$ | 18 \$ | 9,898 \$ | 4 \$ | (66,435) \$130,141 |
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 | \$10,409 \$ | 179,147 \$ | 34 \$ | (3,490) \$ | (57) | \$ 9,353 \$ |
4 \$ | (83,024) \$112,376 | |
| Cumulative effect of initially applying IFRS 16 | - | - | - | - | - | - | - | (300) | (300) |
| Balance as at January 1, 2019 (after initially applying IFRS 16) |
10,409 | 179,147 | 34 | (3,490) | (57) | 9,353 | 4 | (83,324) 112,076 | |
| Net income | - | - | - | - | - | - | - | 22,251 | 22,251 |
| Other comprehensive income (loss) | - | - | 143 | - | 69 | - | (388) | - | (176) |
| Taxes effect | - | - | (32) | - | (4) | - | 25 | - | (11) |
| Total comprehensive income (loss) | - | - | 111 | - | 65 | - | (363) | 22,251 | 22,064 |
| Exercise into shares and forfeiture of share based payment |
16 | 1,672 | - | - | - | (1,672) | - | - | 16 |
| Cost of share-based payment | - | - | - | - | - | 1,163 | - | - | 1,163 |
| Balance as of December 31, 2019 | \$10,425 \$ | 180,819 \$ | 145 \$ | (3,490) \$ | 8 | \$ 8,844 \$ |
(359) \$ | (61,073) \$135,319 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Nine months period Ended September 30, |
Three months period Ended September 30, |
Year Ended December 31, |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2020 2019 |
2020 2019 |
2019 | ||||||||
| Unaudited | Audited | |||||||||
| U.S Dollars In thousands | ||||||||||
| Cash Flows from Operating Activities | ||||||||||
| Net income | \$ | 15,511 | \$ | 16,889 | \$ | 6,835 | \$ | 5,823 | \$ | 22,251 |
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
||||||||||
| Adjustments to the profit or loss items: | ||||||||||
| Depreciation and impairment | 3,632 | 3,379 | 1,252 | 1,128 | 4,519 | |||||
| Financial expenses (income), net | (67) | (164) | 580 | (340) | (197) | |||||
| Cost of share-based payment | 853 | 987 | 265 | 353 | 1,163 | |||||
| Taxes on income | 1,144 | 574 | 348 | 214 | 730 | |||||
| Gain from sale of property and equipment | (7) | (2) | (1) | - | (2) | |||||
| Change in employee benefit liabilities, net | (7) | 97 | (5) | 66 | 94 | |||||
| 5,548 | 4,871 | 2,439 | 1,421 | 6,307 | ||||||
| Changes in asset and liability items: | ||||||||||
| Decrease (increase) in trade receivables, net | (5,540) | 4,408 | (8,956) | 1,806 | 5,117 | |||||
| Decrease (increase) in other accounts receivables | 972 | 1,204 | 231 | 955 | (214) | |||||
| Decrease (increase) in inventories | 555 | (4,715) | 5,028 | 1,470 | (13,857) | |||||
| Decrease (increase) in Contract asset and deferred expenses | (2,464) | 333 | (1,553) | 605 | 399 | |||||
| Increase (decrease) in trade payables | (10,488) | (4,585) | (7,769) | (6,512) | 6,259 | |||||
| Increase in other accounts payables | 426 | 379 | 740 | 432 | 863 | |||||
| Increase (decrease) in deferred revenues | 1,190 | (221) | 397 | (95) | (283) | |||||
| (15,349) | (3,197) | (11,882) | (1,339) | (1,716) | ||||||
| Cash received (paid) during the period for: | ||||||||||
| Interest paid | (158) | (182) | (51) | (58) | (243) | |||||
| Interest received | 891 | 554 | 290 | 254 | 1,106 | |||||
| Taxes paid | (87) | (25) | (13) | (9) | (134) | |||||
| 646 | 347 | 226 | 187 | 729 | ||||||
| Net cash provided by (used in) operating activities | \$ | 6,356 | \$ | 18,910 | \$ | (2,382) | \$ | 6,092 | \$ | 27,571 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Nine months period Ended September 30, |
Three months period Ended September 30, |
Year Ended December 31, |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||
| Unaudited | Audited | |||||||||
| U.S Dollars In thousands | ||||||||||
| Cash Flows from Investing Activities | ||||||||||
| Proceeds of investment in short term investments, net | \$ | (15,646) | \$ | (6,160) | \$ | - | \$ | (1,032) | \$ | 1,727 |
| Purchase of property and equipment and intangible assets | (3,372) | (1,488) | (1,471) | (731) | (2,300) | |||||
| Proceeds from sale of property and equipment | 7 | 9 | 1 | - | 9 | |||||
| Net cash used in investing activities | (19,011) | (7,639) | (1,470) | (1,763) | (564) | |||||
| Cash Flows from Financing Activities | ||||||||||
| Proceeds from exercise of share base payments | 61 | 12 | 41 | 3 | 16 | |||||
| Repayment of lease liabilities | (815) | (794) | (275) | (265) | (1,070) | |||||
| Repayment of long-term loans | (373) | (353) | (127) | (121) | (476) | |||||
| Proceeds from issuance of ordinary shares, net | 24,894 | - | - | - | - | |||||
| Net cash provided by (used in) financing activities | 23,767 | (1,135) | (361) | (383) | (1,530) | |||||
| Exchange differences on balances of cash and cash equivalent |
(1,287) | (780) | (699) | (332) | (908) | |||||
| Increase (decrease) in cash and cash equivalents | 9,825 | 9,356 | (4,912) | 3,614 | 24,569 | |||||
| Cash and cash equivalents at the beginning of the period | 42,662 | 18,093 | 57,399 | 23,835 | 18,093 | |||||
| Cash and cash equivalents at the end of the period | \$ | 52,487 | \$ | 27,449 | \$ | 52,487 | \$ | 27,449 | \$ | 42,662 |
| Significant non-cash transactions | ||||||||||
| Right-of-use asset recognized with corresponding lease liability |
\$ | 539 | \$ | 4,984 | \$ | 194 | \$ | 436 | \$ | 5,035 |
| Purchase of property and equipment | \$ | 973 | \$ | 264 | \$ | 973 | \$ | 264 | \$ | 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, and during 2020, the Company initiated the development of a plasma derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasmaderived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties.
Pursuant to an 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 September 30, 2020 and for the nine and 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".
b. Implementation of new accounting standards
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. Early adoption is permitted.
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.
The Company's business activity and commercial operation were affected by these factors, and the Company has taken several actions to ensure its manufacturing plant remains operational with limited disruption to its business continuity. The Company increased its inventory levels of raw materials through its 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 expedited shipments of certain of its products to its customer to minimize any potential shortages.
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.
The COVID-19 outbreak affected some of the Company's research and development programs resulting in certain delays while a new development program for a plasma derived immunoglobulin IgG therapy for COVID-19 was initiated. In addition, the Company taken action to reduce certain costs and activities throughout its business operations.
While COVID-19 related disruption had various effect on the Company's business activities, commercial operation, revenues and operational expenses, as a results of the actions taken by the Company to date, its overall results of operations for the nine months of 2020 and financial position as of September 30, 2020 were not materially affected. The Company expects that its continued actions will allow meeting its annual revenue guidance, however, a number of factors, including but not limited to, continued effect of the factors mentioned above as well as, continued demand for the Company's products, including GLASSIA and KEDRAB, in the U.S. market and its distributed products in Israel, financial conditions of the Company's customer, suppliers and services providers, the Company's ability to manage operating expenses, additional competition in the markets that the Company competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise, 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 the Company's Board of Directors members. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$356 thousands.
d. On August 11, 2020 the Company's Board of directors approved the grant of options to purchase 10,000 Ordinary Shares of the Company at an exercise price of NIS 29.68 per share to the Company's Board of Directors member. The initiatl fair value estimation of the options at the date of grant was estimated at \$ 32 thousands. This grant is subject to the approval of the Company's shareholders.
In addition, on such date, the Company's Board of directors approved the grant of options to purchase 80,000 Ordinary Shares of the Company at an exercise price of NIS 29.41-29.68 per share to certain Company's empolyees. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at \$256 thousands.
a. General:
The company has two operating segments, as follows:
| Proprietary Products | - | Research and 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:
| Proprietary | ||||||||
|---|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||||
| U.S Dollars in thousands | ||||||||
| Unaudited | ||||||||
| Nine months period ended September 30, 2020 | ||||||||
| Revenues | \$ 77,633 |
\$ 24,071 |
\$ 101,704 |
|||||
| Gross profit | \$ 33,816 |
\$ 3,571 |
\$ 37,387 |
|||||
| Unallocated corporate expenses | (20,799) | |||||||
| Finance income, net | 67 | |||||||
| Income before taxes on income | \$ 16,655 |
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Nine months period ended September 30, 2019 | |||||||
| Revenues | \$ | 75,521 | \$ | 22,595 | \$ | 95,116 | |
| Gross profit | \$ | 34,109 | \$ | 3,539 | \$ | 37,648 | |
| Unallocated corporate expenses | (20,349) | ||||||
| Finance income, net | 164 | ||||||
| Income before taxes on income | \$ | 17,463 |
| Proprietary Products |
Distribution | Total | |||
|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||
| Unaudited | |||||
| Three months period ended September 30, 2020 | |||||
| Revenues | \$ 29,691 |
\$ | 5,634 \$ |
35,325 | |
| Gross profit | \$ 13,755 |
\$ | 1,066 \$ |
14,821 | |
| Unallocated corporate expenses | (7,058) | ||||
| Finance expenses, net | (580) | ||||
| Income before taxes on income | \$ | 7,183 |
b. Reporting on operating segments (cont.):
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Three months period ended September 30, 2019 | ||||||
| Revenues | \$ 24,859 |
\$ 8,207 |
\$ 33,066 |
|||
| Gross profit | \$ 11,624 |
\$ 1,240 |
\$ 12,864 |
|||
| Unallocated corporate expenses | (7,167) | |||||
| Finance income, net | 340 | |||||
| Income before taxes on income | \$ 6,037 |
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Year Ended December 31, 2019 | ||||||
| Revenues | \$ | 97,696 | \$ | 29,491 | \$ | 127,187 |
| Gross profit | \$ | 45,271 | \$ | 4,466 | \$ | 49,737 |
| Unallocated corporate expenses | (26,953) | |||||
| Finance income, net | 197 | |||||
| Income before taxes on income | \$ | 22,981 |
c. Reporting on operating segment by geographic region
| Proprietary Products |
Distribution | Total | |||
|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||
| Unaudited | |||||
| Nine months period ended September 30, 2020 | |||||
| Geographical markets | |||||
| U.S.A. | \$ 66,339 |
\$ | - | \$ | 66,339 |
| Israel | 3,132 | 24,071 | 27,203 | ||
| Europe | 3,690 | - | 3,690 | ||
| Latin America | 3,976 | - | 3,976 | ||
| Asia | 444 | - | 444 | ||
| Others | 52 | - | 52 | ||
| \$ 77,633 |
\$ | 24,071 | \$ | 101,704 | |
c. Reporting on operating segments by geographic region: (cont.)
| Proprietary Products |
Distribution | Total | |||||
|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Nine months period ended September 30, 2019 | |||||||
| Geographical markets | |||||||
| U.S.A. | \$ | 63,081 | \$ | - | \$ | 63,081 | |
| Israel | 1,969 | 22,595 | 24,564 | ||||
| Europe | 3,120 | - | 3,120 | ||||
| Latin America | 2,820 | - | 2,820 | ||||
| Asia | 1,485 | - | 1,485 | ||||
| Others | 46 | - | 46 | ||||
| \$ | 75,521 | \$ | 22,595 | \$ | 95,116 | ||
| Proprietary | |||||||
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Three months period ended September 30, 2020 | |||||||
| Geographical markets | |||||||
| U.S.A. | \$ | 25,879 | \$ | - | \$ | 25,879 | |
| Israel | 1,126 | 5,634 | 6,760 | ||||
| Europe | 403 | - | 403 | ||||
| Latin America | 2,104 | - | 2,104 | ||||
| Asia | 158 | - | 158 | ||||
| Others | 21 | - | 21 | ||||
| \$ | 29,691 | \$ | 5,634 | \$ | 35,325 | ||
| Proprietary Products Distribution U.S Dollars in thousands Unaudited |
Total | ||||||
| Three months period ended September 30, 2019 | |||||||
| Geographical markets | |||||||
| U.S.A. | \$ | 20,676 | \$ | - | \$ | 20,676 | |
| Israel | 696 | 8,207 | 8,903 | ||||
| Europe | 1,746 | - | 1,746 | ||||
| Latin America | 1,243 | - | 1,243 | ||||
| Asia | 475 | - | 475 | ||||
| Others | 23 | 23 | |||||
| \$ | 24,859 | \$ | 8,207 | \$ | 33,066 | ||
| Proprietary | |||||||
| Products Distribution |
Total | ||||||
| U.S Dollars in thousands | |||||||
| Audited | |||||||
| Year ended December 31, 2019 | |||||||
| Geographical markets | |||||||
| U.S.A. | \$ | 84,572 | \$ | - | \$ | 84,572 | |
| Israel | 2,486 | 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 | ||
| Level 1 | Level 2 | |
|---|---|---|
| U.S Dollars in thousands | ||
| September 30, 2020 | ||
| Fair value through other comprehensive income : | ||
| Derivatives instruments | - | 329 |
| \$ - |
\$ 329 |
|
| September 30, 2019 | ||
| Fair value through other comprehensive income : | ||
| Debt securities (corporate and government) | \$ 2,760 |
\$ 8,931 |
| Derivatives instruments | - | (140) |
| \$ 2,760 |
\$ 8,791 |
|
| December 31, 2019 | ||
| Fair value through other comprehensive income: | ||
| Debt securities (corporate and government) | \$ 4,289 |
\$ 8,543 |
| Derivatives instruments | - | 15 |
| \$ 4,289 |
\$ 8,558 |
|
b. During the nine months ended on September 30, 2020 there were no transfers of any financial instrument from Level 1 to Level 2, and there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument.
c. During the nine months ended September 30, 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 Compnay recognized a loss of \$102 thousands in the Consolidated Statements of Comprehensive Income.
The Company will manufacture the product, to be supplied to the MoH, from convalescent plasma collected and supplied by the Israeli National Blood Services, a division of Magen David Adom (MADA), and additional Israeli medical institutions. The initial order, planned to be supplied during the beginning of 2021, is sufficient to treat approximately 500 hospitalized patients. This initial supply is expected to generate approximately \$3.4 million in revenue for Kamada once delivered.
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