Foreign Filer Report • Nov 13, 2019
Foreign Filer Report
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Washington, D.C. 20549
For the Month of November 2019
Commission File Number 001-35948
(Translation of registrant's name into English)
2 Holzman Street Science Park, P.O. Box 4081 Rehovot 7670402 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____
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 and 333-222891, 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 Financial Results for Third Quarter and First Nine Months of 2019 99.2 Kamada Ltd.'s Consolidated Financial Statements as of September 30, 2019 (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: November 13, 2019 KAMADA LTD.
By: /s/ Orna Naveh Orna Naveh General Counsel and Corporate Secretary
REHOVOT, Israel – November 13, 2019 -- Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived protein therapeutics company, today announced financial results for the three months and nine months ended September 30, 2019.
"We are pleased with our continued strong performance in the third quarter and year-to-date 2019," said Amir London, Kamada's Chief Executive Officer. "For the third quarter of 2019, total revenues were \$33.1 million, a 121% increase compared to the third quarter of 2018, which, as a reminder, was negatively impacted by our manufacturing facility labor strike. For the first nine months of 2019, total revenues were \$95.1 million, representing a 44% increase over the first nine months of 2018. Based on our continued strong performance in the third quarter, and our positive outlook for the fourth quarter of the year, we expect to achieve our full-year 2019 total revenue guidance of \$125 million to \$130 million."
"Our overall gross profit was \$12.9 million and \$37.6 million during the third quarter and nine months ended September 30, 2019, respectively," continued Mr. London. "Gross margins in our Proprietary Products segment for both the third quarter and the first nine months of 2019 were 47%, and our adjusted EBITDA for the third quarter and the first nine months of 2019 was \$7.2 million and \$21.7 million, respectively. Our cash, cash equivalents and short-term investments were \$66.8 million as of September 30, 2019, an increase of \$16.2 million compared to the end of 2018."
"As recently announced, we extended our strategic supply agreement with Takeda for GLASSIA® and we will continue to produce the product for the U.S. market through 2021. Takeda intends to complete the technology transfer of the product and pending FDA approval, will commence its own production of GLASSIA for the U.S. market," continued Mr. London. "Based on the extended agreement, we project that total revenues from sales of GLASSIA to Takeda in 2019-2021 will be in the range of \$155 million to \$180 million. While the transition of GLASSIA manufacturing to Takeda during 2021 will result in a significant reduction of Kamada's revenues, based on current GLASSIA sales in the U.S. and forecasted future growth, we expect to receive a flow of future royalty payments from Takeda in the range of \$10 million to \$20 million per year from 2022 to 2040."
"We can also report important progress in our clinical development pipeline. During the third quarter, we submitted our amended Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for our proprietary inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). We expect an update from the agency on the status of this filing in the near future. We expect to begin dosing the first patient in the Phase 3 trial in Europe before the end of 2019, and pending IND approval, we will also begin recruiting patients for this study in the U.S.," concluded Mr. London.
As of September 30, 2019, the Company had cash, cash equivalents, and short-term investments of \$66.8 million, as compared to \$50.6 million at December 31, 2018.
Kamada management will host an investment community conference call on Wednesday, November 13th 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.), 1 809 406 247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13695272.
The call will also be webcast live on the Internet on the Company's website at www.kamada.com.
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial 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. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company's flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets GLASSIA® in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other counties through local distributors. Kamada'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 and through a strategic partnership with Kedrion S.p.A. In addition to GLASSIA and KEDRAB, Kamada 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. Kamada has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency, and in addition, its intravenous AAT is in development for other indications, such as GvHD, prevention of lung transplant rejection and type-1 diabetes. Kamada also 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.
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 re-affirmation of the 2019 revenue guidance, our positive outlook for the fourth quarter of the year, our projected total revenues from sales of GLASSIA to Takeda during the years 2019-2021 will be in the range of \$155 million to \$180 million, our expectation to receive a flow of future royalty payments from Takeda in the range of \$10 million to \$20 million per year from 2022 to 2040, our expectation to receive an update from the FDA on the status of our recently filed IND amendment application with respect to our Phase 3 clinical trial for Inhaled AAT, the timing of the start of dosing of first patients in the Phase 3 clinical trial for Inhaled AAT in Europe before the end of this year and in the U.S. following IND amendment approval and expectation of higher R&D expenses due to initiation of the Phase 3 clinical trial for Inhaled AAT. 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, unexpected results of ongoing clinical studies, delays with the studies, additional competition in the markets that Kamada competes, including AAT, regulatory delays, prevailing market conditions, corporate events associated with our partners, including Takeda, 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.
[email protected] Bob Yedid LifeSci Advisors, LLC
646-597-6989 [email protected]
| As of September 30, | As of December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2018 | ||||||
| Unaudited | Audited | |||||||
| U.S Dollars in thousands | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | \$ | 27,449 | \$ | 12,871 | \$ | 18,093 | ||
| Short-term investments | 39,380 | 32,051 | 32,499 | |||||
| Trade receivables, net | 23,999 | 14,826 | 27,674 | |||||
| Other accounts receivables | 1,722 | 1,858 | 3,308 | |||||
| Inventories | 34,031 | 28,934 | 29,316 | |||||
| Total Current Assets | 126,581 | 90,540 | 110,890 | |||||
| Property, plant and equipment, net | 28,297 | 24,406 | 25,004 | |||||
| Other long term assets | 178 | 176 | 174 | |||||
| Deferred taxes | 1,445 | - | 2,048 | |||||
| Total Non-Current Assets | 29,920 | 24,581 | 27,226 | |||||
| Total Assets | \$ | 156,501 | \$ | 115,121 | \$ | 138,116 | ||
| Current Liabilities | ||||||||
| Current maturities of bank loans and leases | \$ | 1,537 | \$ | 585 | \$ | 562 | ||
| Trade payables | 13,079 | 11,512 | 17,285 | |||||
| Other accounts payables | 5,439 | 4,662 | 5,261 | |||||
| Deferred revenues | 561 | 1,854 | 461 | |||||
| Total Current Liabilities | 20,616 | 18,613 | 23,569 | |||||
| Non-Current Liabilities | ||||||||
| Bank loans and leases | 4,513 | 880 | 716 | |||||
| Deferred revenues | 347 | 677 | 668 | |||||
| Employee benefit liabilities, net | 884 | 1,035 | 787 | |||||
| Total Non-Current Liabilities | 5,744 | 2,592 | 2,171 | |||||
| Shareholder's Equity | ||||||||
| Ordinary shares | 10,420 | 10,406 | 10,409 | |||||
| Additional paid in capital | 179,589 | 178,873 | 179,147 | |||||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | |||||
| Capital reserve from hedges | 18 | (8) | (57) | |||||
| Capital reserve from securities measured at fair value through other comprehensive income | 137 | (5) | 34 | |||||
| Capital reserve from share-based payments | 9,898 | 9,246 | 9,353 | |||||
| Capital reserve from employee benefits | 4 | (337) | 4 | |||||
| Accumulated deficit | (66,435) | (100,769) | (83,024) | |||||
| Total Shareholder's Equity | 130,141 | 93,916 | 112,376 | |||||
| Total Liabilities and Shareholder's Equity | \$ | 156,501 | \$ | 115,121 | \$ | 138,116 |
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |||||
| Unaudited | Unaudited | Audited | |||||||
| U.S Dollars In thousands | |||||||||
| Revenues from proprietary products | \$ 72,521 |
\$ | 47,646 | \$ | 24,859 | 9,454 | \$ | 90,784 | |
| Revenues from distribution | 22,595 | 18,612 | 8,207 | 5,521 | 23,685 | ||||
| Total revenues | 95,116 | 66,258 | 33,066 | 14,975 | 114,469 | ||||
| Cost of revenues from proprietary products | 38,412 | 30,506 | 13,234 | 7,869 | 52,796 | ||||
| Cost of revenues from distribution | 19,056 | 15,536 | 6,968 | 4,587 | 20,201 | ||||
| Total cost of revenues | 57,468 | 46,042 | 20,202 | 12,456 | 72,997 | ||||
| Gross profit | 37,648 | 20,216 | 12,864 | 2,519 | 41,472 | ||||
| Research and development expenses | 9,730 | 7,174 | 3,477 | 2,323 | 9,747 | ||||
| Selling and marketing expenses | 3,441 | 2,724 | 1,161 | 818 | 3,630 | ||||
| General and administrative expenses | 6,851 | 6,132 | 2,230 | 1,902 | 8,525 | ||||
| Other expenses and (incomes) | 327 | 311 | 299 | - | 311 | ||||
| Operating income ( loss) | 17,299 | 3,875 | 5,697 | (2,524) | 19,259 | ||||
| Financial income | 887 | 628 | 328 | 214 | 830 | ||||
| Financial expenses | (217) | (145) | (68) | (39) | (172) | ||||
| Change in fair value of debt securities | (3) | (152) | 55 | (45) | (178) | ||||
| Income (expense) in respect of currency exchange differences and derivatives | |||||||||
| instruments, net | (503) | 334 | 25 | 3 | 602 | ||||
| Income ( loss) before taxes | 17,463 | 4,540 | 6,037 | (2,391) | 20,341 | ||||
| Taxes on income | 574 | (11) | 214 | - | (1,955) | ||||
| Net Income ( loss) | 16,889 | 4,551 | 5,823 | (2,391) | 22,296 | ||||
| Other Comprehensive Income (loss) : | |||||||||
| Items that may be reclassified to profit or loss in subsequent periods: | |||||||||
| Gain (loss) from securities measured at fair value through other | |||||||||
| comprehensive income | 132 | (1) | (66) | 28 | 51 | ||||
| Gain (loss) on cash flow hedges | 99 | (88) | 28 | 56 | (176) | ||||
| Net amounts transferred to the statement of profit or loss for cash flow | |||||||||
| hedges | (20) | 34 | (18) | 27 | 70 | ||||
| Items that will not be reclassified to profit or loss in subsequent periods: | |||||||||
| Actuarial gain (loss) from defined benefit plans | - | - | - | - | 340 | ||||
| Deferred taxes | (33) | - | 16 | - | (9) | ||||
| Total comprehensive income (loss) | \$ 17,067 |
\$ | 4,496 | \$ | 5,783 | \$ | (2,280) | \$ | 22,572 |
| Income (loss) per share attributable to equity holders of the Company: | |||||||||
| Basic income (loss) per share | \$ 0.42 |
\$ | 0.11 | \$ | 0.14 | \$ | (0.06) | \$ | 0.55 |
| Diluted income (loss) per share | \$ 0.42 |
\$ | 0.11 | \$ | 0.14 | \$ | (0.06) | \$ | 0.55 |
| Nine months period Ended September, 30 |
Three months period Ended September, 30 |
Year Ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |||||
| Unaudited | Audited | ||||||||
| U.S Dollars In thousands | |||||||||
| Cash Flows from Operating Activities | |||||||||
| Net income | \$ | 16,889 | \$ | 4,551 | \$ | 5,823 | \$ | (2,391) | \$ 22,296 |
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
|||||||||
| Adjustments to the profit or loss items: | |||||||||
| Depreciation | 3,379 | 2,814 | 1,128 | 874 | 3,703 | ||||
| Financial income, net | (164) | (665) | (340) | (133) | (1,082) | ||||
| Cost of share-based payment | 987 | 679 | 353 | 294 | 948 | ||||
| Taxes on income | 574 | (11) | 214 | - | (1,955) | ||||
| Loss (gain) from sale of property and equipment | (2) | 70 | - | - | 55 | ||||
| Change in employee benefit liabilities, net | 97 | (109) | 66 | (18) | (16) | ||||
| 4,871 | 2,778 | 1,421 | 1,017 | 1,653 | |||||
| Changes in asset and liability items: | |||||||||
| Decrease in trade receivables, net | 4,408 | 15,346 | 1,806 | 9,929 | 2,311 | ||||
| Decrease (increase) in other accounts receivables | 1,204 | (179) | 955 | (16) | (1,336) | ||||
| Decrease (increase) in inventories | (4,715) | (7,864) | 1,470 | (1,561) | (8,246) | ||||
| Decrease in deferred expenses | 333 | 522 | 605 | 91 | 235 | ||||
| Decrease in trade payables | (4,585) | (6,394) | (6,512) | (4,786) | (1,116) | ||||
| Increase (decrease) in other accounts payables | 379 | (1,117) | 432 | (141) | (658) | ||||
| Decrease in deferred revenues | (221) | (3,860) | (95) | (1,286) | (5,256) | ||||
| (3,197) | (3,546) | (1,339) | 2,230 | (14,066) | |||||
| Cash received (paid) during the period for: | |||||||||
| Interest paid | (182) | (42) | (58) | (12) | (54) | ||||
| Interest received | 554 | 451 | 254 | 204 | 739 | ||||
| Taxes paid | (25) | (17) | (9) | (8) | (22) | ||||
| 347 | 392 | 187 | 184 | 663 | |||||
| Net cash provided by operating activities | \$ | 18,910 | \$ | 4,175 | \$ | 6,092 | \$ | 1,040 | \$ 10,546 |
| Nine months period Ended September, 30 |
Three months period Ended September, 30 |
Year Ended December 31, |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |||||||
| Unaudited | Audited | ||||||||||
| U.S Dollars In thousands | |||||||||||
| Cash Flows from Investing Activities | |||||||||||
| Proceeds of investment in short term investments, net | (6,160) | \$ | (1,747) | \$ | (1,032) | \$ | 207 | \$ | (2,322) | ||
| Purchase of property and equipment and intangible assets | (1,488) | (2,033) | (731) | (534) | (2,884) | ||||||
| Proceeds from sale of property and equipment | 9 | 15 | - | - | 30 | ||||||
| Net cash used in investing activities | (7,639) | (3,765) | (1,763) | (327) | (5,176) | ||||||
| Cash Flows from Financing Activities | |||||||||||
| Proceeds from exercise of share base payments | 12 | 6 | 3 | 3 | 9 | ||||||
| Repayment of long-term loans and leases | (1,147) | (450) | (386) | (149) | (596) | ||||||
| Net cash used in financing activities | (1,135) | (444) | (383) | (146) | (587) | ||||||
| Exchange differences on balances of cash and cash equivalent | (780) | 224 | (332) | (52) | 629 | ||||||
| Increase in cash and cash equivalents | 9,356 | 190 | 3,614 | 515 | 5,412 | ||||||
| Cash and cash equivalents at the beginning of the period | 18,093 | 12,681 | 23,835 | 12,356 | 12,681 | ||||||
| Cash and cash equivalents at the end of the period | 27,449 | \$ | 12,871 | 27,449 | \$ | 12,871 | \$ | 18,093 | |||
| Significant non-cash transactions | |||||||||||
| Purchase of property and equipment through leases | \$ | 4,984 | \$ | - | \$ | 436 | \$ | - | \$ | - | |
| Purchase of property and equipment | \$ | 264 | \$ | 215 | \$ | 264 | \$ | 215 | \$ | 720 |
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |||||
| In thousands | |||||||||
| Net income (loss) | \$ 16,889 |
\$ | 4,551 | \$ | 5,823 | \$ | (2,391) | \$ | 22,296 |
| Taxes on income | 574 | (11) | 214 | - | (1,955) | ||||
| Financial income, net | (164) | (665) | (340) | (133) | (1,082) | ||||
| Depreciation | 3,379 | 2,814 | 1,128 | 874 | 3,703 | ||||
| Cost of share - based payments | 987 | 679 | 353 | 294 | 948 | ||||
| \$ 21,665 |
\$ | 7,368 | \$ | 7,178 | \$ | (1,356) | \$ | 23,910 |
| Nine months period ended September 30, |
Three months period ended September 30, |
Year ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |||||
| In thousands | |||||||||
| Net income (loss) | \$ 16,889 |
\$ | 4,551 | \$ | 5,823 | \$ | (2,391) | \$ | 22,296 |
| Cost of share - based payments | 987 | 679 | 353 | 294 | 948 | ||||
| Adjusted net income | \$ 17,876 |
\$ | 5,230 | \$ | 6,176 | \$ | (2,097) | \$ | 23,244 |
Exhibit 99.2
AS OF SEPTEMBER 30, 2019 (Unaudited)
| Page | |
|---|---|
| Consolidated Balance Sheets | 2 |
| Consolidated Statements of Comprehensive Income | 3 |
| Consolidated Statements of Changes in Equity | 4-7 |
| Consolidated Statements of Cash Flows | 8-9 |
| Notes to the Consolidated Financial Statements | 10-20 |
| As of September 30, | As of December 31, |
||||||
|---|---|---|---|---|---|---|---|
| 2019 2018 |
2018 | ||||||
| Unaudited | Audited | ||||||
| U.S Dollars in thousands | |||||||
| Current Assets | |||||||
| Cash and cash equivalents | \$ 27,449 |
\$ | 12,871 | \$ | 18,093 | ||
| Short-term investments | 39,380 | 32,051 | 32,499 | ||||
| Trade receivables, net | 23,999 | 14,826 | 27,674 | ||||
| Other accounts receivables | 1,722 | 1,858 | 3,308 | ||||
| Inventories | 34,031 | 28,934 | 29,316 | ||||
| Total Current Assets | 126,581 | 90,540 | 110,890 | ||||
| Property, plant and equipment, net | 28,297 | 24,406 | 25,004 | ||||
| Other long term assets | 178 | 176 | 174 | ||||
| Deferred taxes | 1,445 | - | 2,048 | ||||
| Total Non-Current Assets | 29,920 | 24,581 | 27,226 | ||||
| Total Assets | \$ 156,501 |
\$ | 115,121 | \$ | 138,116 | ||
| Current Liabilities | |||||||
| Current maturities of bank loans and leases | \$ 1,537 |
\$ | 585 | \$ | 562 | ||
| Trade payables | 13,079 | 11,512 | 17,285 | ||||
| Other accounts payables | 5,439 | 4,662 | 5,261 | ||||
| Deferred revenues | 561 | 1,854 | 461 | ||||
| Total Current Liabilities | 20,616 | 18,613 | 23,569 | ||||
| Non-Current Liabilities | |||||||
| Bank loans and leases | 4,513 | 880 | 716 | ||||
| Deferred revenues | 347 | 677 | 668 | ||||
| Employee benefit liabilities, net | 884 | 1,035 | 787 | ||||
| Total Non-Current Liabilities | 5,744 | 2,592 | 2,171 | ||||
| Shareholder's Equity | |||||||
| Ordinary shares | 10,420 | 10,406 | 10,409 | ||||
| Additional paid in capital | 179,589 | 178,873 | 179,147 | ||||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | ||||
| Capital reserve from hedges | 18 | (8) | (57) | ||||
| Capital reserve from securities measured at fair value through other comprehensive income | 137 | (5) | 34 | ||||
| Capital reserve from share-based payments | 9,898 | 9,246 | 9,353 | ||||
| Capital reserve from employee benefits | 4 | (337) | 4 | ||||
| Accumulated deficit | (66,435) | (100,769) | (83,024) | ||||
| Total Shareholder's Equity | 130,141 | 93,916 | 112,376 | ||||
| Total Liabilities and Shareholder's Equity | \$ 156,501 |
\$ | 115,121 | \$ | 138,116 |
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, |
|||
|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |
| Unaudited | Unaudited | Audited | |||
| U.S Dollars In thousands | |||||
| Revenues from proprietary products | \$ 72,521 |
\$ 47,646 |
\$ 24,859 |
9,454 | \$ 90,784 |
| Revenues from distribution | 22,595 | 18,612 | 8,207 | 5,521 | 23,685 |
| Total revenues | 95,116 | 66,258 | 33,066 | 14,975 | 114,469 |
| Cost of revenues from proprietary products | 38,412 | 30,506 | 13,234 | 7,869 | 52,796 |
| Cost of revenues from distribution | 19,056 | 15,536 | 6,968 | 4,587 | 20,201 |
| Total cost of revenues | 57,468 | 46,042 | 20,202 | 12,456 | 72,997 |
| Gross profit | 37,648 | 20,216 | 12,864 | 2,519 | 41,472 |
| Research and development expenses | 9,730 | 7,174 | 3,477 | 2,323 | 9,747 |
| Selling and marketing expenses | 3,441 | 2,724 | 1,161 | 818 | 3,630 |
| General and administrative expenses | 6,851 | 6,132 | 2,230 | 1,902 | 8,525 |
| Other expenses and (incomes) | 327 | 311 | 299 | - | 311 |
| Operating income ( loss) | 17,299 | 3,875 | 5,697 | (2,524) | 19,259 |
| Financial income | 887 | 628 | 328 | 214 | 830 |
| Financial expenses | (217) | (145) | (68) | (39) | (172) |
| Change in fair value of debt securities | (3) | (152) | 55 | (45) | (178) |
| Income (expense) in respect of currency exchange differences and derivatives | |||||
| instruments, net | (503) | 334 | 25 | 3 | 602 |
| Income ( loss) before taxes | 17,463 | 4,540 | 6,037 | (2,391) | 20,341 |
| Taxes on income | 574 | (11) | 214 | - | (1,955) |
| Net Income ( loss) | 16,889 | 4,551 | 5,823 | (2,391) | 22,296 |
| Other Comprehensive Income (loss) : | |||||
| Items that may be reclassified to profit or loss in subsequent periods: | |||||
| Gain (loss) from securities measured at fair value through other | |||||
| comprehensive income | 132 | (1) | (66) | 28 | 51 |
| Gain (loss) on cash flow hedges | 99 | (88) | 28 | 56 | (176) |
| Net amounts transferred to the statement of profit or loss for cash flow | |||||
| hedges | (20) | 34 | (18) | 27 | 70 |
| Items that will not be reclassified to profit or loss in subsequent periods: | |||||
| Actuarial gain (loss) from defined benefit plans | - | - | - | - | 340 |
| Deferred taxes | (33) | - | 16 | - | (9) |
| Total comprehensive income (loss) | \$ 17,067 |
\$ 4,496 |
\$ 5,783 |
\$ (2,280) |
\$ 22,572 |
| Income (loss) per share attributable to equity holders of the Company: | |||||
| Basic income (loss) per share | \$ 0.42 |
\$ 0.11 |
\$ 0.14 |
\$ (0.06) |
\$ 0.55 |
| Diluted income (loss) per share | \$ 0.42 |
\$ 0.11 |
\$ 0.14 |
\$ (0.06) |
\$ 0.55 |
| 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 applying |
\$ | 10,409 | \$ 179,147 |
\$ 34 |
\$ (3,490) |
\$ (57) |
\$ 9,353 |
\$ 4 |
\$ (83,024) |
\$ 112,376 |
| IFRS 16 | - | - | - | - | - | - | - | (300) | (300) | |
| Balance as at January 1, 2019 (after initially applying IFRS 16) Net income |
10,409 - |
179,147 - |
34 - |
(3,490) - |
(57) - |
9,353 - |
4 - |
(83,324) 16,889 |
112,076 16,889 |
|
| Other comprehensive income |
- | - | 132 | - | 79 | - | - | - | 211 | |
| Deferred taxes Total comprehensive income |
- - |
- - |
(29) 103 |
- - |
(4) 75 |
- - |
- - |
- 16,889 |
(33) 17,067 |
|
| Exercise into shares and forfeiture of share based payment |
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 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, 2018 |
|||||||||
| (audited) Cumulative effect of initially applying |
\$ 10,400 |
\$ 177,874 |
\$ (4) |
\$ (3,490) |
\$ 46 |
\$ 9,566 |
\$ (337) |
\$ (104,563) |
\$ 89,492 |
| IFRS 15 | - | - | - | - | - | - | - | (757) | (757) |
| Balance as at January 1, 2018 (after initially |
|||||||||
| applying IFRS 15) Net income |
10,400 - |
177,874 - |
(4) - |
(3,490) - |
46 - |
9,566 - |
(337) - |
(105,320) 4,551 |
88,735 4,551 |
| Other comprehensive loss |
- | - | (1) | - | (54) | - | - | - | (55) |
| Total comprehensive income (loss) |
- | - | (1) | - | (54) | - | - | 4,551 | 4,496 |
| Exercise into shares and forfeiture of share |
|||||||||
| based payment Cost of share |
6 | 999 | - | - | - | (999) | - | - | 6 |
| based payment Balance as of September 30, 2018 \$ |
- 10,406 |
\$ - 178,873 |
\$ - (5) |
\$ - (3,490) |
\$ - (8) |
\$ 679 9,246 |
\$ - (337) |
\$ - (100,769) |
\$ 679 93,916 |
| KAMADA LTD. | |
|---|---|
| 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, 2019 Net income |
\$ 10,418 - |
\$ 179,471 - |
\$ 187 |
- | \$ (3,490) - |
\$ 8 - |
\$ 9,663 - |
\$ 4 - |
\$ (72,258) 5,823 |
\$ 124,003 5,823 |
| Other comprehensive |
||||||||||
| income Deferred taxes |
- - |
- - |
(66) 16 |
- - |
10 - |
- - |
- - |
- - |
(56) 16 |
|
| Total | ||||||||||
| comprehensive income (loss) |
- | - | (50) | - | 10 | - | - | 5,823 | 5,783 | |
| Exercise into shares and forfeiture of share |
||||||||||
| based 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 |
|
| 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, 2018 | \$ 10,403 |
\$ 178,745 |
\$ | (33) | \$ (3,490) |
\$ (91) |
\$ 9,080 |
\$ (337) |
\$ (98,378) |
\$ 95,899 |
| Net income Other |
- | - | - | - | - | - | - | (2,391) | (2,391) | |
| comprehensive income |
- | - | 28 | - | 83 | - | - | - | 111 | |
| Total | ||||||||||
| comprehensive income (loss) |
- | - | 28 | - | 83 | - | - | (2,391) | (2,280) | |
| Exercise into shares and |
forfeiture of sharebased payment 3 128 - - - (128) - - 3 Cost of sharebased payment - - - - - 294 - - 294 Balance as of September 30, 2018 \$ 10,406 \$ 178,873 \$ (5) \$ (3,490) \$ (8) \$ 9,246 \$ (337) \$ (100,769) \$ 93,916
| 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, 2018 Cumulative effect of initially applying |
\$ | 10,400 | \$ 177,874 |
\$ (4) |
\$ (3,490) |
\$ 46 |
\$ 9,566 |
\$ (337) |
\$ (104,563) |
\$ 89,492 |
||||||||||||||
| IFRS 15 | - | - | - | - | - | - | - | (757) | (757) | |||||||||||||||
| Balance as at January 1, 2018 (after initially |
||||||||||||||||||||||||
| applying IFRS 15) | 10,400 | 177,874 | (4) | (3,490) | 46 | 9,566 | (337) | (105,320) | 88,735 | |||||||||||||||
| net income Other comprehensive income (loss) |
- - |
- - |
- 38 |
- - |
- (103) |
- - |
- 341 |
22,296 - |
22,296 276 |
|||||||||||||||
| Total comprehensive income (loss) |
- | - | 38 | - | (103) | - | 341 | 22,296 | 22,572 | |||||||||||||||
| Exercise into shares and forfeiture of share |
||||||||||||||||||||||||
| based payment | 9 | 1,161 | - | - | - | (1,161) | - | - | 9 | |||||||||||||||
| Cost of share based payment |
- | - | - | - | - | 948 | - | - | 948 | |||||||||||||||
| Deferred taxes | - | 112 | - | - | - | - | - | - | 112 | |||||||||||||||
| Balance as of December 31, 2018 \$ |
10,409 | \$ 179,147 |
\$ 34 |
\$ (3,490) |
\$ (57) |
\$ 9,353 |
\$ 4 |
\$ (83,024) |
\$ 112,376 |
| Nine months period Ended September, 30 |
Three months period Ended September, 30 |
Year Ended December 31, |
||||
|---|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | ||
| Unaudited | Audited | |||||
| U.S Dollars In thousands | ||||||
| Cash Flows from Operating Activities | ||||||
| Net income | \$ 16,889 |
\$ 4,551 |
\$ | 5,823 | \$ (2,391) |
\$ 22,296 |
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
||||||
| Adjustments to the profit or loss items: | ||||||
| Depreciation | 3,379 | 2,814 | 1,128 | 874 | 3,703 | |
| Financial income, net | (164) | (665) | (340) | (133) | (1,082) | |
| Cost of share-based payment | 987 | 679 | 353 | 294 | 948 | |
| Taxes on income | 574 | (11) | 214 | - | (1,955) | |
| Loss (gain) from sale of property and equipment | (2) | 70 | - | - | 55 | |
| Change in employee benefit liabilities, net | 97 | (109) | 66 | (18) | (16) | |
| 4,871 | 2,778 | 1,421 | 1,017 | 1,653 | ||
| Changes in asset and liability items: | ||||||
| Decrease in trade receivables, net | 4,408 | 15,346 | 1,806 | 9,929 | 2,311 | |
| Decrease (increase) in other accounts receivables | 1,204 | (179) | 955 | (16) | (1,336) | |
| Decrease (increase) in inventories | (4,715) | (7,864) | 1,470 | (1,561) | (8,246) | |
| Decrease in deferred expenses | 333 | 522 | 605 | 91 | 235 | |
| Decrease in trade payables | (4,585) | (6,394) | (6,512) | (4,786) | (1,116) | |
| Increase (decrease) in other accounts payables | 379 | (1,117) | 432 | (141) | (658) | |
| Decrease in deferred revenues | (221) | (3,860) | (95) | (1,286) | (5,256) | |
| (3,197) | (3,546) | (1,339) | 2,230 | (14,066) | ||
| Cash received (paid) during the period for: | ||||||
| Interest paid | (182) | (42) | (58) | (12) | (54) | |
| Interest received | 554 | 451 | 254 | 204 | 739 | |
| Taxes paid | (25) | (17) | (9) | (8) | (22) | |
| 347 | 392 | 187 | 184 | 663 | ||
| Net cash provided by operating activities | \$ 18,910 |
\$ 4,175 |
\$ | 6,092 | \$ 1,040 |
\$ 10,546 |
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, |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |||||
| Unaudited | Audited | ||||||||
| U.S Dollars In thousands | |||||||||
| Cash Flows from Investing Activities | |||||||||
| Proceeds of investment in short term investments, net | (6,160) | \$ | (1,747) | \$ | (1,032) | \$ | 207 | \$ | (2,322) |
| Purchase of property and equipment and intangible assets | (1,488) | (2,033) | (731) | (534) | (2,884) | ||||
| Proceeds from sale of property and equipment | 9 | 15 | - | - | 30 | ||||
| Net cash used in investing activities | (7,639) | (3,765) | (1,763) | (327) | (5,176) | ||||
| Cash Flows from Financing Activities | |||||||||
| Proceeds from exercise of share base payments | 12 | 6 | 3 | 3 | 9 | ||||
| Repayment of long-term loans and leases | (1,147) | (450) | (386) | (149) | (596) | ||||
| Net cash used in financing activities | (1,135) | (444) | (383) | (146) | (587) | ||||
| Exchange differences on balances of cash and cash equivalent | (780) | 224 | (332) | (52) | 629 | ||||
| Increase in cash and cash equivalents | 9,356 | 190 | 3,614 | 515 | 5,412 | ||||
| Cash and cash equivalents at the beginning of the period | 18,093 | 12,681 | 23,835 | 12,356 | 12,681 | ||||
| Cash and cash equivalents at the end of the period | 27,449 | \$ | 12,871 | 27,449 | \$ | 12,871 | \$ | 18,093 | |
| Significant non-cash transactions | |||||||||
| Purchase of property and equipment through leases | \$ 4,984 |
\$ | - | \$ | 436 | \$ | - | \$ | - |
| Purchase of property and equipment | \$ 264 |
\$ | 215 | \$ | 264 | \$ | 215 | \$ | 720 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
These Financial Statements have been prepared in a condensed format as of September 30, 2019 and for the three and nine 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, 2018 and for the year then ended and the accompanying notes ("annual 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:
As detailed below regarding the initial adoption of IFRS 16, "Leases" ("the Standard"), the Company chose to apply the provisions of the Standard using the modified retrospective approach (without restatement of comparative data).
The accounting policy for leases applied before December 31, 2018, is as follows:
The criteria for classifying leases as finance or operating leases depend on the substance of the agreements and are made at the inception of the lease in accordance with the following principles as set out in IAS 17.
Leases in which substantially all the risks and rewards of ownership of the leased asset are not transferred to the Company are classified as operating leases. Lease payments are recognized as an expense in profit or loss on a straight-line basis over the lease term.
The accounting policy for leases applied effective from January 1, 2019, is as follows:
The Company accounts for a contract as a lease when the contract terms convey the right to control the use of an identified asset for a period of time in exchange for consideration.
The Company as a lessee:
For leases in which the Company is the lessee, the Company recognizes on the commencement date of the lease a right-of-use asset and a lease liability, excluding leases whose term is up to 12 months and leases for which the underlying asset is of low value. For these excluded leases, the Company has elected to recognize the lease payments as an expense in profit or loss on a straight-line basis over the lease term. In measuring the lease liability, the Company has elected to apply the practical expedient in the Standard and does not separate the lease components from the non-lease components (such as management and maintenance services, etc.) included in a single contract.
On the commencement date, the lease liability includes all unpaid lease payments discounted at the interest rate implicit in the lease, if that rate can be readily determined, or otherwise using the Company's incremental borrowing rate. After the commencement date, the Company measures the lease liability using the effective interest rate method.
On the commencement date, the right-of-use asset is recognized in an amount equal to the lease liability plus lease payments already made on or before the commencement date and initial direct costs incurred less any lease incentives received. The right-of-use asset is measured applying the cost model and depreciated over the shorter of its useful life or the lease term. The Company tests for impairment of the right-of-use asset whenever there are indications of impairment pursuant to the provisions of IAS 36.
A non-cancellable lease term includes both the periods covered by an option to extend the lease when it is reasonably certain that the extension option will be exercised and the periods covered by a lease termination option when it is reasonably certain that the termination option will not be exercised.
In the event of any change in the expected exercise of the lease extension option or in the expected non-exercise of the lease termination option, the Company remeasures the lease liability based on the revised lease term using a revised discount rate as of the date of the change in expectations. The total change is recognized in the carrying amount of the right-of-use asset until it is reduced to zero, and any further reductions are recognized in profit or loss.
In a transaction in which the Company is a lessee of an underlying asset (head lease) and the asset is subleased to a third party, the Company assesses whether the risks and rewards incidental to ownership of the right-of-use asset have been transferred to the sub-lessee, among others, by evaluating the sublease term with reference to the useful life of the right-of-use asset arising from the head lease.
When substantially all the risks and rewards incidental to ownership of the right-of-use asset have been transferred to the sub-lessee, the Company accounts for the sublease as a finance lease, otherwise it is accounted for as an operating lease.
The new Standard is effective for annual periods beginning on or after January 1, 2019.
Initial adoption of new financial reporting and accounting standards and amendments to existing financial reporting and accounting standards:
In January 2016, the IASB issued IFRS 16, "Leases" ("the Standard"), which supersedes IAS 17, "Leases" ("the old Standard"), IFRIC 4, "Determining Whether an Arrangement Contains a Lease", and SIC-15, "Operating Leases - Incentives". According to the Standard, a lease is a contract, or part of a contract, that conveys the right to use an asset for a period of time in exchange for consideration.
The effects of the adoption of the Standard are as follows:
According to the Standard, lessees are required to recognize all leases in the statement of financial position (excluding certain exceptions, see below). Lessees will recognize a liability for lease payments with a corresponding right-of-use asset, similar to the accounting treatment for finance leases under the old standard, IAS 17, "Leases". Lessees will also recognize interest expense and depreciation expense separately.
The Standard includes two exceptions which allow lessees to account for leases based on the existing accounting treatment for operating leases - leases for which the underlying asset is of low value and short-term leases (up to one year).
Certain right-of-use assets were measured as if the Standard has been applied from the commencement date of the lease but for the purpose of calculation, the lessee's incremental borrowing rate on the date of initial adoption was used, while the carrying amount of other right-of-use assets are identical to the carrying amount of the lease liability.
The main effect of the initial adoption of the Standard relates to existing leases in which the Company is the lessee. According to the Standard, as explained in paragraph above, excluding certain exceptions, the Company recognizes a lease liability and a corresponding right-of-use asset for each lease in which it is the lessee. This accounting treatment is different than the accounting treatment applied under the old Standard according to which the lease payments in respect of leases for which substantially all the risks and rewards incidental to ownership of the leased asset were not transferred to the lessee were recognized as an expense in profit or loss on a straight-line basis over the lease term.
The Company elected to use the exemptions proposed by the standard with respect to lease contracts for which the underlying asset is of low value. The Company has leases of certain office equipment (i.e. printing and photocopying machines) that are considered of low value.
The Company also applied the available practical expedients wherein it the initial adoption of the Standard: (i) The Company elected not to reassess based on the principles in the Standard whether contracts are or contain a lease, and instead continued to classify contracts as leases that were previously identified as leases under IAS 17. (ii) used a single discount rate to a portfolio of leases with reasonably similar characteristics, (iii) relied on its assesments on whether leases are onerous immediately before the date of initial application, (iv) used hindsight in determining the lease term where the contract contains options to extend or terminate the lease and (v) Applied the shortterm leases exemptions to leases with lease term that ends within 12 months at the date of initial application.
Impact on the statement of financial position (increase/(decrease)) as of January 1, 2019, September 30, 2019 and on the results for the nine and three ended at September 30, 2019 is presented below:
| According to the previous |
According to the current |
||||
|---|---|---|---|---|---|
| accounting policy | Difference | accounting policy | |||
| U.S Dollars in thousands | |||||
| As of January 1, 2019 | |||||
| Non-current assets: | |||||
| Property, plant and equipment (right-of-use assets) | \$ | 25,004 | \$ | 4,162 | \$ 29,166 |
| Liabilities | |||||
| Current maturities of bank loans and leases | 562 | 810 | 1,372 | ||
| Bank loans and leases | 716 | 3,907 | 4,623 | ||
| Other accounts paybles | 5,261 | (255) | 5,006 | ||
| Shareholder's Equity | |||||
| Accumulated deficit | \$ | 112,376 | \$ | (300) | \$ 112,076 |
| As of September 30, 2019 | |||||
| Assets | |||||
| Property, plant and equipment (right-of-use assets) | \$ | 24,197 | \$ | 4,100 | \$ 28,297 |
| Liabilities | |||||
| Current maturities of bank loans and leases | 573 | 964 | 1,537 | ||
| Bank loans and leases | \$ | 461 | \$ | 4,052 | \$ 4,513 |
The lease liabilities as at January 1, 2019 can be reconciled to the operating lease commitments as of December 31, 2018 as follows:
| U.S Dollars | |
|---|---|
| In thousands | |
| Future minimum payments for non-cancellable leases as per IAS 17 according to the financial statements as of December 31, 2018 | \$ 5,434 |
| Weighted average incremental borrowing rate as at January 1, 2019* | 3.06%-4.6% |
| Discounted operating lease commitment at January 1, 2019 | 4,685 |
| Add: | |
| Leases of other equipment | 32 |
| Leases that were previously identified as leases under IAS 17 | 138 |
| Lease liabilities as at January 1, 2019 | \$ 4,855 |
*The weighted average incremental borrowing rate was evaluated based on credit risk, terms of the leases and other economic variables. The weighted average incremental borrowing rate was used to discount future lease payments in the calculation of the lease liability on the date of initial adoption of the Standard.
Amount recognized in the ststement of financial position and profit or loss
Set out below, are the carrying amounts of the Company's right-of-use assets and lease liabilities and the movements during the period:
| Right-of-use-assets | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Rented Offices | Vehicles and | Lease | |||||||
| other equipment | Total | liabilities | |||||||
| U.S Dollars in thousands | |||||||||
| As of January 1, 2019 | \$ | 3,466 | \$ | 696 | \$ | 4,162 | \$ | 4,855 | |
| Additions | - | 694 | 694 | 819 | |||||
| Write-off | - | (56) | (56) | (59) | |||||
| Depreciation expense | (325) | (375) | (700) | - | |||||
| Interest expense | - | - | - | 365 | |||||
| Payments | - | - | - | (794) | |||||
| As of September 30, 2019 | \$ | 3,141 | \$ | 959 | \$ | 4,100 | \$ | 5,186 |
| Right-of-use-assets | ||||||||
|---|---|---|---|---|---|---|---|---|
| Rented Offices | Vehicles and | Lease | ||||||
| other equipment | Total | liabilities | ||||||
| U.S Dollars in thousands | ||||||||
| As of July 1, 2019 | \$ | 3,249 | \$ | 697 | \$ | 3,946 | \$ | 4,946 |
| Additions | - | 436 | 436 | 432 | ||||
| Write-off | - | (44) | (44) | (43) | ||||
| Depreciation expense | (108) | (130) | (238) | - | ||||
| Interest expense | - | - | - | 116 | ||||
| Payments | - | - | - | (266) | ||||
| As of September 30, 2019 | \$ | 3,141 | \$ | 959 | \$ | 4,100 | \$ | 5,186 |

| Operating lease expense Depreciation of right of use assets |
Expense decrease (increase) For the nine months ended on September 30, 2019 U.S Dollars in thousands \$ 853 (700) |
Expense decrease (increase) For the three months ended on September 30, 2019 U.S Dollars in thousands \$ 294 (238) |
|
|---|---|---|---|
| Operating income | 153 | 56 | |
| Finance expense | (152) | (50) | |
| Net Income (loss) | \$ 1 |
\$ 6 |
|
| For the nine months ended on September 30, 2019 | According to the previous accounting policy |
Difference U.S Dollars in thousands |
According to the current accounting policy |
| Cash flows from operating activities | \$ 18,222 |
\$ 689 |
\$ 18,910 |
| Cash flows from financing activities | \$ (446) |
\$ (689) |
\$ (1,135) |
| According to the previous accounting policy |
Difference U.S Dollars in thousands |
According to the current accounting policy |
|
| For the three months ended on September 30, 2019 | |||
| Cash flows from operating activities | \$ 5,859 |
\$ 233 |
\$ 6,092 |
| Cash flows from financing activities | (150) \$ |
(233) \$ |
(383) \$ |
In June 2017, the IASB issued IFRIC 23, "Uncertainty over Income Tax Treatments" ("the Interpretation"). The Interpretation clarifies the accounting for recognition and measurement of assets or liabilities in accordance with the provisions of IAS 12, "Income Taxes", in situations of uncertainty involving income taxes. The Interpretation provides guidance on considering whether some tax treatments should be considered collectively, examination by the tax authorities, measurement of the effects of uncertainty involving income taxes on the financial statements and accounting for changes in facts and circumstances in respect of the uncertainty.
The Interpretation has been initially applied in these financial statements.
The initial adoption of the Interpretation did not have a material effect on the Company's financial statements.
a. General:
The company has two operating segments, as follows:
Proprietary Products - Medicine development, manufacture and sale of plasma-derived therapeutics products.
Distribution - Distribution of drugs in Israel manufacture by third parties, majority of which are produced from plasma or its
| Proprietary | ||||||
|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Nine months period ended September 30, 2019 | ||||||
| Revenues | \$ 72,521 |
\$ | 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 |
derivatives products.
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Nine months period ended September 30, 2018 | |||||||
| Revenues | \$ | 47,646 | \$ | 18,612 | \$ | 66,258 | |
| Gross profit | \$ | 17,140 | \$ | 3,076 | \$ | 20,216 | |
| Unallocated corporate expenses | (16,341) | ||||||
| Finance income, net | 665 | ||||||
| Income before taxes on income | \$ | 4,540 |
| 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 | ||||||||||
| Three months period ended September 30, 2018 | ||||||||||
| Revenues | \$ | 9,453 | \$ | 5,522 | \$ | 14,975 | ||||
| Gross profit | \$ | 1,584 | \$ | 935 | \$ | 2,519 | ||||
| Unallocated corporate expenses | (5,043) | |||||||||
| Finance income, net | 133 | |||||||||
| Income(Loss) before taxes on income | \$ | (2,391) | ||||||||
| Proprietary |
| Products | Distribution | Total | ||||
|---|---|---|---|---|---|---|
| U.S Dollars in thousands | ||||||
| Unaudited | ||||||
| Year Ended December 31, 2018 | ||||||
| Revenues | \$ 90,784 |
\$ | 23,685 | \$ | 114,469 | |
| Gross profit | \$ 37,988 |
\$ | 3,484 | \$ | 41,472 | |
| Unallocated corporate expenses | (22,213) | |||||
| Finance income, net | 1,082 | |||||
| Income before taxes on income | \$ | 20,341 |
c. Reporting on operating segments by geographic region: (cont.)
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Nine months period ended September 30, 2019 | Unaudited | ||||||
| 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 & others | 1,531 | - | 1,531 | ||||
| \$ | 72,521 | \$ 22,595 |
\$ | 95,116 | |||
| Proprietary | |||||||
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Nine months period ended September 30, 2018 | Unaudited | ||||||
| Geographical markets | |||||||
| U.S.A. | \$ | 37,128 | \$ - |
\$ | 37,128 | ||
| Israel | 3,150 | 18,612 | 21,762 | ||||
| Europe | 2,684 | - | 2,684 | ||||
| Latin America | 2,814 | - | 2,814 | ||||
| Asia & others | 1,870 | - | 1,870 | ||||
| \$ | 47,646 | \$ 18,612 |
\$ | 66,258 | |||
| Proprietary Products Distribution Total |
|||||||
| U.S Dollars in thousands | |||||||
| Three months period ended September 30, 2019 | Unaudited | ||||||
| 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 & others | 498 | - | 498 | ||||
| \$ | 24,859 | \$ 8,207 |
\$ | 33,066 | |||
| Proprietary | |||||||
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Three months period ended September 30, 2018 | Unaudited | ||||||
| Geographical markets | |||||||
| U.S.A. | \$ | 6,586 | \$ - |
\$ | 6,586 | ||
| Israel | 953 | 5,522 | 6,475 | ||||
| Europe | 400 | - | 400 | ||||
| Latin America | |||||||
| 1,093 | - | 1,093 | |||||
| Asia & others | 421 | - | 421 |
c. Reporting on operating segments by geographic region: (cont.)
| Proprietary | |||||
|---|---|---|---|---|---|
| Products | Distribution | Total | |||
| U.S Dollars in thousands | |||||
| Year ended December 31, 2018 | Audited | ||||
| Geographical markets | |||||
| U.S.A. | \$ 75,331 |
\$ | - | \$ | 75,331 |
| Israel | 4,408 | 23,685 | 28,093 | ||
| Europe | 3,594 | - | 3,594 | ||
| Latin America | 3,994 | - | 3,994 | ||
| Asia & others | 3,457 | - | 3,457 | ||
| \$ 90,784 |
\$ | 23,685 | \$ | 114,469 |
Financial assets (liabilities) measured at fair value
| Level 1 | Level 2 | ||||
|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||
| 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 | ||
| September 30, 2018 | |||||
| Fair value through other comprehensive income : | |||||
| Debt securities (corporate and government) | \$ | 1,667 | \$ | 8,137 | |
| Derivatives instruments | - | 72 | |||
| \$ | 1,667 | \$ | 8,209 | ||
| December 31, 2018 | |||||
| Fair value through other comprehensive income: | |||||
| Debt securities (corporate and government) | \$ | 1,588 | \$ | 8,736 | |
| Derivatives instruments | - | (64) | |||
| \$ | 1,588 | \$ | 8,672 |
b. During the nine months ended on September 30, 2019 there were no transfers due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument.
The grant of the equity instruments to Mr. London and the Board of Directors members are subject to the approval of the General Meeting of Shareholders of the Company that is expected to take place by the end of 2019.
c. During the thired qurter of 2019 Kamada entered into extension of GLASSIA® Supply and Distribution Agreement with Takeda through 2021.
Based on licensing and technology transfer agreement between the companies, upon initiation of sales of GLASSIA manufactured by Takeda which is expected to take place during 2021, Takeda will pay royalties to Kamada at a rate of 12% on net sales through August 2025, and a rate of 6% thereafter until 2040, with a minimum of \$5 million annually, for each of the years from 2022 to 2040.
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