Foreign Filer Report • May 14, 2019
Foreign Filer Report
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Washington, D.C. 20549
For the Month of May 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 First Quarter of 2019
99.2 Kamada Ltd.'s Consolidated Financial Statements as of March 31, 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: May 14, 2019 KAMADA LTD.
By: /s/ Chaime Orlev
Chaime Orlev Chief Financial Officer
99.1 Press Release: Kamada Reports Financial Results for First Quarter of 2019
99.2 Kamada Ltd.'s Consolidated Financial Statements as of March 31, 2019 (Unaudited)
Total Revenues for Q1 2019 were \$26.8 Million, up 54% over Q1 2018 Q1 2019 Proprietary Products Revenues up 67% Year-over-Year Gross Profit for Q1 2019 Grew 59% Year-over-Year Adjusted EBITDA was \$6.6 Million in Q1 2019, an Increase of 179% as Compared to \$2.4 Million in Q1 2018 Reiterating Full-Year 2019 Total Revenue Guidance of \$125 Million to \$130 Million
REHOVOT, Israel – May 14, 2019 -- Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived protein therapeutics company, today announced financial results for the three months ended March 31, 2019.
"We are extremely pleased with our solid start to 2019," said Amir London, Kamada's Chief Executive Officer. "Total revenues in the first quarter of 2019 were \$26.8 million, representing a 54% increase as compared to the first quarter of 2018. These results were primarily driven by increased sales of GLASSIA® and KedRAB®, our anti-rabies IgG product. From a profitability standpoint, our gross profits, as well as operating and net income, improved substantially year-over-year in the first quarter of 2019. We generated \$4.9 million in net income in the first quarter of 2019, an increase of over 292% as compared to net income of \$1.3 million in the 2018 first quarter."
"Based on our strong performance in the first quarter, and our positive outlook for the remainder of the year, we are reaffirming our full-year 2019 total revenue guidance of \$125 million to \$130 million, which, if achieved, would represent another strong year of double-digit percentage growth for Kamada over full-year 2018 total revenues," continued Mr. London. "This guidance reflects continued growth of both of our core products, GLASSIA and KedRAB, in 2019. As a reminder, our GLASSIA supply agreement with Takeda, which extends through the end of 2020, will be followed by an expected flow of future royalty payments for 20 years, until 2040."
"In addition to growing our commercial business, we are also advancing our clinical development pipeline. We announced recently the receipt of a letter from the U.S. Food and Drug Administration (FDA) stating that we have satisfactorily addressed the FDA's prior concerns and questions regarding Kamada's Inhaled AAT program. The FDA's response followed the positive scientific advice that we received in July 2018 from the Committee for Medicinal Products for Human Use of the European Medicines Agency. We intend to conduct a unified global pivotal Phase 3 clinical trial in the U.S. under an Investigational New Drug application and in Europe under a Clinical Trial Authorization in order to submit marketing applications for regulatory approval in both regions. We expect to initiate the Phase 3 study during the second half of 2019, subject to the successful completion of the FDA required Human Factor Study, which was recently initiated."
As of March 31, 2019, the Company had cash, cash equivalents, and short-term investments of \$55.8 million, as compared to \$50.6 million at December 31, 2018.
As of January 1, 2019, the Company adopted IFRS 16 (Leases), which resulted in an increase of property, plant and equipment, as well as bank loans and leases, in the amounts of \$4.1 million and \$4.7 million, respectively. Additional related information can be found in the Company's audited financial statements for the year ended December 31, 2018, included in our recently filed Annual Report on Form 20-F.
Kamada management will host an investment community conference call on Tuesday, May 14 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: 13689683. The call will also be webcast live on the Internet on the Company's website at www.kamada.com.
The call will also be archived for 90 days 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 Kamada's continued revenue growth of our marketed proprietary products, including GLASSIA and KedRAB in the U.S., re-affirmation of the 2019 revenue guidance, our expectation for 20 years of royalties from Takeda post 2020, continued prospects in our development pipeline, including: the timing of the start of the unified global pivotal Phase 3 clinical trial in the second half of 2019 for the Inhaled AAT program and successful results from such a clinical trial, the successful completion of the Human Factor Study in the second quarter of 2019, which is a necessary component to start the clinical trial for the Inhaled AAT program, and our plans to submit marketing applications for regulatory approval in both the U.S. and Europe. 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.
CONTACTS: Chaime Orlev Chief Financial Officer [email protected]
Bob Yedid LifeSci Advisors, LLC 646-597-6989 [email protected]
| As of March 31, |
As of December 31, |
||||||
|---|---|---|---|---|---|---|---|
| 2019 2018 |
2018 | ||||||
| Unaudited | Audited | ||||||
| U.S Dollars in thousands | |||||||
| Current Assets | |||||||
| Cash and cash equivalents | \$ 22,037 |
\$ | 17,497 | \$ | 18,093 | ||
| Short-term investments | 33,800 | 30,451 | 32,499 | ||||
| Trade receivables, net | 23,210 | 17,083 | 27,674 | ||||
| Other accounts receivables | 3,442 | 2,027 | 3,308 | ||||
| Inventories | 31,708 | 28,175 | 29,316 | ||||
| 114,197 | 95,233 | 110,890 | |||||
| Property, plant and equipment, net | 28,829 | 25,125 | 25,004 | ||||
| Other long term assets | 174 | 173 | 174 | ||||
| Deferred taxes | 1,895 | - | 2,048 | ||||
| 30,898 | 25,298 | 27,226 | |||||
| \$ 145,095 |
\$ | 120,531 | \$ | 138,116 | |||
| Current Liabilities | |||||||
| Current maturities of bank loans and leases | 1,431 | 609 | 562 | ||||
| Trade payables | 15,255 | 16,951 | 17,285 | ||||
| Other accounts payables | 4,424 | 4,912 | 5,261 | ||||
| Deferred revenues | 461 | 4,977 | 461 | ||||
| 21,571 | 27,449 | 23,569 | |||||
| Non-Current Liabilities | |||||||
| Bank loans and leases | 4,627 | 1,201 | 716 | ||||
| Deferred revenues | 605 | 645 | 668 | ||||
| Employee benefit liabilities, net | 823 | 1,130 | 787 | ||||
| 6,055 | 2,976 | 2,171 | |||||
| Shareholder's Equity | |||||||
| Ordinary shares | 10,412 | 10,401 | 10,409 | ||||
| Additional paid in capital | 179,352 | 178,458 | 179,147 | ||||
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | ||||
| Capital reserve from hedges | 11 | (12) | (57) | ||||
| Capital reserve from securities measured at fair value through other comprehensive income | 118 | (33) | 34 | ||||
| Capital reserve from share-based payments | 9,463 | 9,183 | 9,353 | ||||
| Capital reserve from employee benefits | 4 | (337) | 4 | ||||
| Accumulated deficit | (78,401) | (104,064) | (83,024) | ||||
| 117,469 | 90,106 | 112,376 | |||||
| \$ 145,095 |
\$ | 120,531 | \$ | 138,116 |
| Three months period ended March 31, |
||||
|---|---|---|---|---|
| 2019 | 2018 | |||
| Unaudited | Audited | |||
| U.S Dollars in thousands | ||||
| Revenues from proprietary products | \$ 20,381 |
\$ 12,214 |
\$ 90,784 |
|
| Revenues from distribution | 6,416 | 5,227 | 23,685 | |
| Total revenues | 26,797 | 17,441 | 114,469 | |
| Cost of revenues from proprietary products | 10,490 | 6,179 | 52,796 | |
| Cost of revenues from distribution | 5,123 | 4,246 | 20,201 | |
| Total cost of revenues | 15,613 | 10,425 | 72,997 | |
| Gross profit | 11,184 | 7,016 | 41,472 | |
| Research and development expenses | 2,766 | 2,754 | 9,747 | |
| Selling and marketing expenses | 1,092 | 970 | 3,630 | |
| General and administrative expenses | 2,094 | 2,064 | 8,525 | |
| Other expense | 23 - |
311 | ||
| Operating income | 5,209 | 1,228 | 19,259 | |
| Financial income | 280 | 229 | 820 | |
| Financial expenses | (123) | (157) | (340) | |
| Income (expense) in respect of currency exchange differences and derivatives instruments, net | (313) | (44) | 602 | |
| Income before taxes | 5,053 | 1,256 | 20,341 | |
| Taxes on income | 130 | - | (1,955) | |
| Net Income | 4,923 | 1,256 | 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 | 108 | (29) | 51 | |
| Gain (loss) on cash flow hedges | 74 (37) |
(176) | ||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | (2) (21) |
70 | ||
| Items that will not be reclassified to profit or loss in subsequent periods: | ||||
| Actuarial gain (loss) from defined benefit plans | - - |
340 | ||
| Deferred taxes | (28) | - | (9) | |
| Total comprehensive income | \$ 5,075 |
\$ 1,169 |
\$ 22,752 |
|
| Income (loss) per share attributable to equity holders of the Company: | ||||
| Basic income per share | \$ 0.12 |
\$ 0.03 |
\$ 0.55 |
|
| Diluted income per share | \$ 0.12 |
\$ 0.03 |
\$ 0.55 |
|
| Three months period Ended March 31, |
Year Ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2019 2018 Unaudited |
2018 Audited |
|||||||
| U.S Dollars in | ||||||||
| U.S Dollars in thousands | thousands | |||||||
| Net income | \$ | 4,923 | \$ | 1,256 | \$ | 22,296 | ||
| Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||
| Adjustments to the profit or loss items: | ||||||||
| Depreciation and impairment | 1,127 | 954 | 3,703 | |||||
| Financial expenses (income), net | 156 | (28) | (1,082) | |||||
| Cost of share-based payment | 315 | 201 | 948 | |||||
| Taxes on income | 130 | - | (1,955) | |||||
| Loss (gain) from sale of property and equipment | (6) | 66 | 55 | |||||
| Change in employee benefit liabilities, net | 36 | (14) | (16) | |||||
| 1,758 | 1,179 | 1,653 | ||||||
| Changes in asset and liability items: | ||||||||
| Decrease in trade receivables, net | 4,727 | 13,491 | 2,311 | |||||
| Decrease (increase) in other accounts receivables | 131 | 82 | (1,336) | |||||
| Increase in inventories | (2,392) | (7,105) | (8,246) | |||||
| Decrease (increase) in deferred expenses | (246) | 22 | 235 | |||||
| Decrease in trade payables | (2,368) | (1,941) | (1,116) | |||||
| Decrease in other accounts payables | (510) | (888) | (658) | |||||
| Decrease in deferred revenues | (63) | (772) | (5,256) | |||||
| (721) | 2,889 | (14,066) | ||||||
| Cash received (paid) during the year for: | ||||||||
| Interest paid | (63) | (16) | (54) | |||||
| Interest received | 172 | 138 | 739 | |||||
| Taxes paid | (8) | (5) | (22) | |||||
| 101 | 117 | 663 | ||||||
| Net cash provided by operating activities | \$ | 6,061 | \$ | 5,441 | \$ | 10,546 |
| Three months period Ended March 31, |
Year Ended December 31, |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2019 2018 Unaudited |
2018 Audited |
|||||||
| U.S Dollars in | ||||||||
| U.S Dollars in thousands | ||||||||
| Cash Flows from Investing Activities | ||||||||
| Investment in short term investments, net | \$ | (1,058) | \$ | (150) | \$ | (2,322) | ||
| Purchase of property and equipment and intangible assets | (304) | (259) | (2,884) | |||||
| Proceeds from sale of property and equipment | 6 | 11 | 30 | |||||
| Net cash used in investing activities | (1,356) | (398) | (5,176) | |||||
| Cash Flows from Financing Activities | ||||||||
| Proceeds from exercise of share base payments | 3 | 1 | 9 | |||||
| Repayment of long-term loans | (378) | (152) | (596) | |||||
| Net cash used in financing activities | (375) | (151) | (587) | |||||
| Exchange differences on balances of cash and cash equivalent | (386) | (76) | 629 | |||||
| Increase in cash and cash equivalents | 3,944 | 4,816 | 5,412 | |||||
| Cash and cash equivalents at the beginning of the year | 18,093 | 12,681 | 12,681 | |||||
| Cash and cash equivalents at the end of the year | \$ | 22,037 | \$ | 17,497 | \$ | 18,093 | ||
| Significant non-cash transactions | ||||||||
| Purchase of property and equipment through leases | \$ | 4,431 | - | - | ||||
| Purchase of property and equipment | \$ | 235 | \$ | 842 | \$ | 720 | ||
| Three months period Ended | Year ended | |||||||
|---|---|---|---|---|---|---|---|---|
| March 31, | December 31, | |||||||
| 2019 | 2018 | 2018 | ||||||
| In thousands | In thousands | |||||||
| Net income (loss) | \$ | 4,923 | \$ | 1,256 | \$ | 22,296 | ||
| Taxes on income | 130 | - | (1,955) | |||||
| Financial expense (income), net | 156 | (72) | (1,082) | |||||
| Depreciation and amortization expense | 1,127 | 954 | 3,703 | |||||
| Share-based compensation charges | 315 | 201 | 948 | |||||
| Expense (Income) in respect of translation differences and derivatives instruments, net | 313 | 44 | (602) | |||||
| \$ | 6,964 | \$ | 2,383 | \$ | 23,308 |
| Three months period Ended March 31, |
Year ended December 31, |
||||||
|---|---|---|---|---|---|---|---|
| 2019 | 2018 | 2018 | |||||
| In thousands | In thousands | ||||||
| Net income | \$ | 4,923 | \$ | 1,256 | \$ | 22,296 | |
| Share-based compensation charges | 315 | 201 | 948 | ||||
| Adjusted net income | \$ | 5,238 | \$ | 1,457 | \$ | 23,244 |
Exhibit 99.2
| Page | |
|---|---|
| Consolidated Balance Sheets | 2 |
| Consolidated Statements of Comprehensive Income | 3 |
| Consolidated Statements of Changes in Equity | 4-6 |
| Consolidated Statements of Cash Flows | 7-8 |
| Notes to the Consolidated Financial Statements | 9-15 |
| As of March 31, |
As of December 31, |
|||
|---|---|---|---|---|
| 2019 | 2018 | 2018 | ||
| Unaudited | Audited | |||
| U.S Dollars in thousands | ||||
| Current Assets | ||||
| Cash and cash equivalents | \$ 22,037 |
\$ | 17,497 | \$ 18,093 |
| Short-term investments | 33,800 | 30,451 | 32,499 | |
| Trade receivables, net | 23,210 | 17,083 | 27,674 | |
| Other accounts receivables | 3,442 | 2,027 | 3,308 | |
| Inventories | 31,708 | 28,175 | 29,316 | |
| 114,197 | 95,233 | 110,890 | ||
| Property, plant and equipment, net | 28,829 | 25,125 | 25,004 | |
| Other long term assets | 174 | 173 | 174 | |
| Deferred taxes | 1,895 | - | 2,048 | |
| 30,898 | 25,298 | 27,226 | ||
| \$ 145,095 |
\$ | 120,531 | \$ 138,116 |
|
| Current Liabilities | ||||
| Current maturities of bank loans and leases | \$ 1,431 |
\$ | 609 | \$ 562 |
| Trade payables | 15,255 | 16,951 | 17,285 | |
| Other accounts payables | 4,424 | 4,912 | 5,261 | |
| Deferred revenues | 461 21,571 |
4,977 27,449 |
461 23,569 |
|
| Non-Current Liabilities | ||||
| Bank loans and leases Deferred revenues |
4,627 | 1,201 | 716 | |
| Employee benefit liabilities, net | 605 | 645 | 668 | |
| 823 6,055 |
1,130 2,976 |
787 2,171 |
||
| Shareholder's Equity | ||||
| Ordinary shares | 10,412 | 10,401 | 10,409 | |
| Additional paid in capital | 179,352 | 178,458 | 179,147 | |
| Capital reserve due to translation to presentation currency | (3,490) | (3,490) | (3,490) | |
| Capital reserve from hedges | 11 | (12) | (57) | |
| Capital reserve from securities measured at fair value through other comprehensive income | 118 | (33) | 34 | |
| Capital reserve from share-based payments | 9,463 | 9,183 | 9,353 | |
| Capital reserve from employee benefits Accumulated deficit |
4 | (337) | 4 | |
| (78,401) 117,469 |
(104,064) 90,106 |
(83,024) 112,376 |
||
| \$ 145,095 |
\$ | 120,531 | \$ 138,116 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Three months period ended March 31, |
|||||||
|---|---|---|---|---|---|---|---|
| 2019 | 2018 | December 31, 2018 |
|||||
| Unaudited | Audited | ||||||
| U.S Dollars in thousands | |||||||
| Revenues from proprietary products | \$ | 20,381 | \$ | 12,214 | \$ | 90,784 | |
| Revenues from distribution | 6,416 | 5,227 | 23,685 | ||||
| Total revenues | 26,797 | 17,441 | 114,469 | ||||
| Cost of revenues from proprietary products | 10,490 | 6,179 | 52,796 | ||||
| Cost of revenues from distribution | 5,123 | 4,246 | 20,201 | ||||
| Total cost of revenues | 15,613 | 10,425 | 72,997 | ||||
| Gross profit | 11,184 | 7,016 | 41,472 | ||||
| Research and development expenses | 2,766 | 2,754 | 9,747 | ||||
| Selling and marketing expenses | 1,092 | 970 | 3,630 | ||||
| General and administrative expenses | 2,094 | 2,064 | 8,525 | ||||
| Other expense | 23 | - | 311 | ||||
| Operating income | 5,209 | 1,228 | 19,259 | ||||
| Financial income | 280 | 229 | 820 | ||||
| Financial expenses | (123) | (157) | (340) | ||||
| Income (expense) in respect of currency exchange differences and derivatives instruments, net | (313) | (44) | 602 | ||||
| Income before taxes | 5,053 | 1,256 | 20,341 | ||||
| Taxes on income | 130 | - | (1,955) | ||||
| Net Income | 4,923 | 1,256 | 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 | 108 | (29) | 51 | ||||
| Gain (loss) on cash flow hedges | 74 | (37) | (176) | ||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | (2) | (21) | 70 | ||||
| Items that will not be reclassified to profit or loss in subsequent periods: | |||||||
| Actuarial gain (loss) from defined benefit plans | - | - | 340 | ||||
| Deferred taxes | (28) | - | (9) | ||||
| Total comprehensive income | \$ | 5,075 | \$ | 1,169 | \$ | 22,752 | |
| Income (loss) per share attributable to equity holders of the Company: | |||||||
| Basic income per share | \$ | 0.12 | \$ | 0.03 | \$ | 0.55 | |
| Diluted income per share | \$ | 0.12 | \$ | 0.03 | \$ | 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, 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, 2018 (after initially |
|||||||||||||||||||||||||||||||
| applying IFRS 15) | 10,409 | 179,147 | 34 | (3,490) | (57) | 9,353 | 4 | (83,324) | 112,076 | ||||||||||||||||||||||
| net income | - | - | - | - | - | - | - | 4,923 | 4,923 | ||||||||||||||||||||||
| Other comprehensive income, net |
- | - | 84 | - | 68 | - | - | - | 152 | ||||||||||||||||||||||
| Total comprehensive |
|||||||||||||||||||||||||||||||
| income (loss) | - | - | 84 | - | 68 | - | - | 4,923 | 5,075 | ||||||||||||||||||||||
| Exercise and forfeiture of share based payment |
|||||||||||||||||||||||||||||||
| into shares | 3 | 205 | - | - | - | (205) | - | - | 3 | ||||||||||||||||||||||
| Cost of share based payment |
- | - | - | - | - | 315 | - | - | 315 | ||||||||||||||||||||||
| Balance as of March 31, 2019 |
\$ | 10,412 | \$ | 179,352 | \$ | 118 | \$ | (3,490) | \$ | 11 | \$ | 9,463 | \$ | 4 | \$ | (78,401) | \$ 117,469 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Additional Share paid in capital 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 U.S Dollars in thousands |
Capital reserve from sharebased payments |
Capital reserve from employee benefits |
Accumulated deficit |
Total equity |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance as of | |||||||||||||||||
| January 1, 2018 | |||||||||||||||||
| (audited) | \$ 10,400 |
\$ | 177,874 | \$ | (4) | \$ | (3,490) | \$ | 46 | \$ 9,566 |
\$ | (337) | \$ (104,563) |
\$ | 89,492 | ||
| Cumulative effect | |||||||||||||||||
| of initially applying | |||||||||||||||||
| 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 | - | - | - | - | - | - | - | 1,256 | 1,256 | ||||||||
| Other | |||||||||||||||||
| comprehensive loss |
- | - | (29) | - | (58) | - | - | - | (87) | ||||||||
| Total comprehensive |
|||||||||||||||||
| income (loss) | - | - | (29) | - | (58) | - | - | 1,256 | 1,169 | ||||||||
| Exercise and | |||||||||||||||||
| forfeiture of share | |||||||||||||||||
| based payment | |||||||||||||||||
| into shares | 1 | 584 | - | - | - | (584) | - | - | 1 | ||||||||
| Cost of share | |||||||||||||||||
| based payment | - | - | - | - | - | 201 | - | - | 201 | ||||||||
| Balance as of | |||||||||||||||||
| March 31, 2018 | \$ 10,401 |
\$ | 178,458 | \$ | (33) | \$ | (3,490) | \$ | (12) | \$ 9,183 |
\$ | (337) | \$ (104,064) |
\$ | 90,106 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Additional Share paid in capital 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 |
|||||||||||||||||
| (audited) Cumulative effect of initially applying |
\$ | 10,400 | \$ | 177,874 | \$ | (4) | \$ | (3,490) | \$ | 46 | \$ | 9,566 | \$ | (337) | \$ | (104,563) | \$ 89,492 |
| IFRS 15 Balance as at January 1, 2018 (after initially |
- | - | - | - | - | - | - | (757) | (757) | ||||||||
| applying IFRS 15) net income |
10,400 - |
177,874 - |
(4) - |
(3,490) - |
46 - |
9,566 - |
(337) - |
(105,320) 22,296 |
88,735 22,296 |
||||||||
| Other comprehensive |
|||||||||||||||||
| income Total comprehensive |
- | - | 38 | - | (103) | - | 341 | - | 276 | ||||||||
| income (loss) Exercise and forfeiture of share based payment |
- | - | 38 | - | (103) | - | 341 | 22,296 | 22,572 | ||||||||
| into shares | 9 | 1,161 | - | - | - | (1,161) | - | - | 9 | ||||||||
| Cost of share based payment |
- | - | - | - | - | 948 | - | - | 948 | ||||||||
| Deferred taxes Balance as of December 31, 2018 |
- | 112 | - | - | - | - | - | - | 112 | ||||||||
| (audited) | \$ | 10,409 | \$ | 179,147 | \$ | 34 | \$ | (3,490) | \$ | (57) | \$ | 9,353 | \$ | 4 | \$ | (83,024) | \$ 112,376 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Three months period Ended March 31, 2019 2018 |
Year Ended December 31, 2018 |
||||||
|---|---|---|---|---|---|---|---|
| Audited | |||||||
| Unaudited U.S Dollars in thousands |
|||||||
| Net income | \$ | 4,923 | \$ | 1,256 | \$ | thousands 22,296 |
|
| Adjustments to reconcile net income to net cash provided by operating activities: | |||||||
| Adjustments to the profit or loss items: | |||||||
| Depreciation and impairment | 1,127 | 954 | 3,703 | ||||
| Financial expenses (income), net | 156 | (28) | (1,082) | ||||
| Cost of share-based payment | 315 | 201 | 948 | ||||
| Taxes on income | 130 | - | (1,955) | ||||
| Loss (gain) from sale of property and equipment | (6) | 66 | 55 | ||||
| Change in employee benefit liabilities, net | 36 | (14) | (16) | ||||
| 1,758 | 1,179 | 1,653 | |||||
| Changes in asset and liability items: | |||||||
| Decrease in trade receivables, net | 4,727 | 13,491 | 2,311 | ||||
| Decrease (increase) in other accounts receivables | 131 | 82 | (1,336) | ||||
| Increase in inventories | (2,392) | (7,105) | (8,246) | ||||
| Decrease (increase) in deferred expenses | (246) | 22 | 235 | ||||
| Decrease in trade payables | (2,368) | (1,941) | (1,116) | ||||
| Decrease in other accounts payables | (510) | (888) | (658) | ||||
| Decrease in deferred revenues | (63) | (772) | (5,256) | ||||
| (721) | 2,889 | (14,066) | |||||
| Cash received (paid) during the year for: | |||||||
| Interest paid | (63) | (16) | (54) | ||||
| Interest received | 172 | 138 | 739 | ||||
| Taxes paid | (8) | (5) | (22) | ||||
| 101 | 117 | 663 | |||||
| Net cash provided by operating activities | \$ | 6,061 | \$ | 5,441 | \$ | 10,546 |
The accompanying Notes are an integral part of the Consolidated Financial Statements.
| Three months period Ended March 31, 2019 2018 Unaudited |
Year Ended December 31, 2018 |
||||||
|---|---|---|---|---|---|---|---|
| Audited | |||||||
| U.S Dollars in thousands | |||||||
| Cash Flows from Investing Activities | |||||||
| Investment in short term investments, net | \$ | (1,058) | \$ | (150) | \$ (2,322) |
||
| Purchase of property and equipment and intangible assets | (304) | (259) | (2,884) | ||||
| Proceeds from sale of property and equipment | 6 | 11 | 30 | ||||
| Net cash used in investing activities | (1,356) | (398) | (5,176) | ||||
| Cash Flows from Financing Activities | |||||||
| Proceeds from exercise of share base payments | 3 | 1 | 9 | ||||
| Repayment of long-term loans | (378) | (152) | (596) | ||||
| Net cash used in financing activities | (375) | (151) | (587) | ||||
| Exchange differences on balances of cash and cash equivalent | (386) | (76) | 629 | ||||
| Increase in cash and cash equivalents | 3,944 | 4,816 | 5,412 | ||||
| Cash and cash equivalents at the beginning of the year | 18,093 | 12,681 | 12,681 | ||||
| Cash and cash equivalents at the end of the year | \$ | 22,037 | \$ | 17,497 | \$ 18,093 |
||
| Significant non-cash transactions | |||||||
| Purchase of property and equipment through capital lease | \$ | 4,431 | - | - | |||
| Purchase of property and equipment | \$ | 235 | \$ | 842 | \$ 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 March 31, 2019 and for the three months then ended ("interim consolidated financial statements").
These financial statements should be read in conjunction with the Company's annual financial statements as of December 31, 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:
IFRS 16, replaced IAS 17 (Leases), and affected the accounting treatment for lessees with respect to leased assets. Pursuant to IFRS 16, all leases (except short term leases and small asset leases) were recognized in the balance sheet. Initially, the lease liability and the right-of-use asset are measured at the present value of future lease payments (defined as economically unavoidable payments). The right-of-use asset is subsequently depreciated in a similar way to other assets such as tangible assets, i.e. typically in a straight-line over the lease term. Lessees are required to separately recognize the interest expense on the lease liability and the depreciation expense on the right-of-use asset. Lessees are also required to re-measure the lease liability upon the occurrence of certain events (e.g., a change in the lease term, a change in future lease payments resulting from a change in an index or rate used to determine those payments). The lessee generally recognizes the amount of the re-measurement of the lease liability as an adjustment to the right-of-use asset.
The new Standard is effective for annual periods beginning on or after January 1, 2019.
The Company adopted IFRS 16 using the cumulative effect method without changing comparative information. The cumulative impact adjusted the opening balance of the equity at the date of initial application (i.e. January 1, 2019). In some leases, the right-of-use-assets were recognized based on the amount equal to the lease liabilities, adjusted for any prepaid and accrued lease payments previously recognized. The Company elected to apply the standard to contracts that were previously identified as leases applying IAS 17. The Company therefore did not apply the standard to contracts that were not previously identified as containing a lease applying IAS 17.
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: (i) used a single discount rate to a portfolio of leases with reasonably similar characteristics, (ii) relied on its assesments on whether leases are onerous immediately before the date of initial application, (iii) used hindsight in determining the lease term where the contract contains options to extend or terminate the lease and (iv) Applied the short-term 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 at January 1, 2019, March 31,2019 and on the results for the reporting period ended at March 31, 2019 is presented below:
| accounting policy Difference accounting policy U.S Dollars in thousands As of January 01, 2019 Assets Property, plant and equipment (right-of-use assets) \$ 25,004 \$ 4,162 \$ Liabilities Current maturities of bank loans and leases 562 810 Bank loans and leases 716 3,907 Other accounts paybles 5,261 (255) Shareholder's Equity Accumulated deficit \$ 112,376 \$ (300) \$ As of March 31, 2019 Assets Property, plant and equipment (right-of-use assets) \$ 24,771 \$ 4,058 \$ Liabilities |
According to the previous |
According to the current |
|||||
|---|---|---|---|---|---|---|---|
| 29,166 | |||||||
| 1,372 | |||||||
| 4,623 | |||||||
| 5,006 | |||||||
| 112,076 | |||||||
| 28,829 | |||||||
| Current maturities of bank loans and leases | 599 | 832 | 1,431 | ||||
| Bank loans and leases 689 3,938 4,627 |
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 | ||
| Operating lease commitments as at 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: | ||
| Payments relating to leases of other equipment | 32 | |
| Commitments relating to leases previously classified as finance leases | 138 | |
| Lease liabilities as at January 1, 2019 | \$ | 4,855 |
Amount recognized in the ststement of financial position and profit or loss
Set out below, are the carrying amounts of the Group's right-of-use assets and lease liabilities and the movements during the period:
| Right-of-use-assets | ||||||||
|---|---|---|---|---|---|---|---|---|
| Rented Offices |
Vehicles and other equipment |
Total | Lease liabilities |
|||||
| U.S Dollars in thousands | ||||||||
| As at January 1, 2019 | \$ | 3,466 | \$ | 696 | \$ | 4,162 | \$ 4,855 |
|
| Additions | - | 141 | 141 | 270 | ||||
| Write-off | - | (16) | (16) | (17) | ||||
| Depreciation expense | (108) | (121) | (229) | - | ||||
| Interest expense | - | - | - | 153 | ||||
| Payments | - | - | - | (263) | ||||
| As at March 31, 2019 | \$ | 3,358 | \$ | 700 | \$ | 4,058 | \$ 4,998 |
|
| Expense decrease (increase) U.S Dollars in thousands |
||||||||
| For the three months ended on March 31, 2019 | ||||||||
| Operating lease expense Depreciation of right of use assets |
\$ | 276 (229) |
||||||
| Operating income | 47 |
Finance expense (51) Net Income (loss) \$ (4)
| According to the previous accounting policy |
According to the current Difference accounting policy |
||
|---|---|---|---|
| U.S Dollars in thousands | |||
| For the three months ended on March 31, 2019 | |||
| Cash flows | |||
| Cash flows from operating activities | \$ 5,836 |
225 6,061 |
|
| Cash flows from financing activities | \$ (150) |
(225) (375) |
|
| Operating Segments Note 3:- |
|||
| a. General: |
|||
| The company has two operating segments, as follows: | |||
| Proprietary Products | - | Medicine development, manufacture and sale of plasma-derived therapeutics products. | |
| Distribution | - derivatives products. |
Distribution of drugs in Israel manufacture by third parties, majority of which are produced from plasma or its | |
| b. Reporting on operating segments: |
|||
| Proprietary | |||
| Products | Distribution Total |
||
| U.S Dollars in thousands | |||
| Unaudited | |||
| Three months period ended March 31, 2019 | |||
| Revenues | \$ 20,381 |
\$ 6,416 \$ 26,797 |
|
| Gross profit | \$ 9,891 |
\$ 1,293 \$ 11,184 |
|
| Unallocated corporate expenses | (5,975) | ||
| Finance expenses, net | (156) | ||
| Income before taxes on income | \$ 5,053 |
| Proprietary | |||||||
|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Three months period ended March 31, 2018 | |||||||
| Revenues | \$ | 12,214 | \$ | 5,227 | \$ | 17,441 | |
| Gross profit | \$ | 6,035 | \$ | 981 | \$ | 7,016 | |
| Unallocated corporate expenses | (5,788) | ||||||
| Finance expenses, net | 28 | ||||||
| Income before taxes on income | \$ | 1,256 | |||||
| Proprietary | ||||||||
|---|---|---|---|---|---|---|---|---|
| Products | Distribution | Total | ||||||
| U.S Dollars in thousands | ||||||||
| Audited | ||||||||
| 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 expenses, net | 1,082 | |||||||
| Income before taxes on income | \$ | 20,341 | ||||||
| Three months period ended March 31, 2019 | |||||||
|---|---|---|---|---|---|---|---|
| Proprietary Products |
Distribution | Total | |||||
| U.S Dollars in thousands | |||||||
| Unaudited | |||||||
| Geographical markets | |||||||
| U.S.A. | \$ 18,062 |
\$ | - | \$ | 18,062 | ||
| Israel | 547 | 6,416 | 6,963 | ||||
| Europe | 873 | - | 873 | ||||
| Latin America | 239 | - | 239 | ||||
| Asia & others | 660 | - | 660 | ||||
| \$ 20,381 |
\$ | 6,416 | \$ | 26,797 |
Proprietary
| Proprietary Products |
Distribution | Total | |||||
|---|---|---|---|---|---|---|---|
| U.S Dollars in thousands | |||||||
| 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 | ||||
| March 31, 2019 | ||||
| Fair value through other comprehensive income : | ||||
| Debt securities (corporate and government) | \$ 1,661 |
\$ | 8,849 | |
| Derivatives instruments | - | 19 | ||
| \$ 1,661 |
\$ | 8,868 | ||
| March 31, 2018 | ||||
| Fair value through other comprehensive income : | ||||
| Debt securities (corporate and government) | \$ 1,578 |
\$ | 8,711 | |
| Derivatives instruments | - | * | ||
| \$ 1,578 |
\$ | 8,711 | ||
| 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 |
* Represent an amount of less 1 thousand.
b. During the three months ended on March 31, 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.
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